CN100371015C - A kind of antiviral Chinese herbal medicine product - Google Patents

Abstract

The present invention relates to a kind of antiviral Chinese herbal medicine product, more specifically, the present invention relates to the medicine product and/or (drug) prescription that uses traditional Chinese medicine or Chinese medicine extract as raw material, and this product and prescription are used for antiviral, especially Anti-retroviral infection or hepatitis B and C virus infection, especially anti-HIV infection, especially anti-HIV/AIDS treatment. The present invention also relates to a method for treating virus infection of warm-blooded animals by using the pharmaceutical product or product formulation, especially the clinical effect of human infection virus is particularly good. The invention also relates to the preparation method of the product and the prescription.

Description

A kind of antiviral Chinese herbal medicine product

technical field

The present invention relates to an antiviral herbal medicinal product, and more particularly to certain pharmaceutical (combination) products and/or (pharmaceutical) formulations based on plant material or plant-derived material as components, their antiviral The use of viruses, especially retroviral infections, especially against HIV infection, especially AIDS, the invention also relates to the use of plant-based or plant-derived materials for the manufacture of such products or preparations for Treatment of viruses, especially retrovirus infections, especially AIDS, the present invention also relates to a method of treatment comprising administering to a warm-blooded animal in need thereof (especially to humans) an effective amount of pharmaceutical products or preparations.

Background technique

Plants, plant parts or plant extracts known in traditional Chinese herbal medicine are reported in certain literatures for stimulating the immune system or for treating viral diseases. However, to date no successful Chinese herbal medicine-based drug has been marketed which would treat (at least to a considerable degree alleviate) HIV infection, in particular, AIDS or other viral infections.

According to the latest information provided by the United Nations, it is estimated that approximately 48 million people worldwide are currently infected with HIV. AIDS is usually fatal if left untreated, except in rare cases where spontaneous remission or even spontaneous recovery has been reported.

Another virus that poses serious problems to human health is the hepatitis B virus (HBV). In addition to causing acute hepatitis, HBV can cause chronic infection leading to often fatal cirrhosis and liver cancer. By 2000, 2 billion people had been reported to have been infected with HBV (Fact Sheet WHO/204, World Health Organization (October 2000)).

Various treatments based on eg protease inhibitors (PI) and reverse transcriptase inhibitors (RT) are known. Often, two or more of these drugs are used in combination, for example in HAART (Highly Active Antiretroviral Therapy). A typical treatment regimen involves two nucleoside RT inhibitors and a PI or a non-nucleoside RT inhibitor. They have serious adverse side effects such as myelosuppression such as neuropathy, myopathy, dyslipidemia (resulting in eg loss of facial fat and increase of adipose tissue in certain areas such as chest, waist, neck and shoulders). A further side effect is to act on the liver, causing steatohepatitis and liver failure. Various other harmful side effects are also known.

To make matters worse, treated patients require treatment for life, resulting in long-term toxic effects.

In addition, there is a high risk that, due to mutations and recombinations, the AIDS-inducing active substance (retrovirus HIV-1 or HIV-2) becomes resistant to the drugs used. Also, lifelong treatment is usually required.

Treatment to date has involved treatment after the virus has entered the cells of the immune system infected by AIDS and thus has been limited to cases where the virus is already inside the cells.

For now, the focus is on experimental compounds that block HIV entry into cells, rather than only fighting HIV when they have entered cells. The first drug of this type, known as a fusion inhibitor, was developed last year by the Swiss company Roche and the US biotech group Trimeris. However, the corresponding drug (Fuzeon) is expensive and must be injected twice a day, so its sales have so far been disappointing. In early 2004, other pharmaceutical companies, such as Schering-Plough and Pfizer, reported a different class of entry inhibitors that block the entry and exit of cells called CCR5 and could be given orally as a pill. SmithklineBeecham is also working on such CCR5 products.

The literature reports the inhibition of further cell infection by humic acids (eg HS-1500) by inhibiting cell fusion of infected cells (see EP 0 537 430) - however, in vivo treatment has not proven sufficiently successful.

Some market analysts predict that although most companies, under pressure from activists, decide to cut drug prices in poor countries, such as African countries where the epidemic is very prevalent, the HIV/AIDS market will still grow exponentially, and by 2012 it will to $12 billion.

Considering the development of drug resistance, the different possibilities for intervening in viral infections, and the planned and affordable price of drugs, further studies with, for example, known or new (preferably new) mechanisms of action and/or combinations thereof There is a long-felt need for drugs and treatments that would allow for the treatment (at least alleviation) of AIDS and other retroviral infections in humans, such as those caused by HTLV-1.

Chinese herbal medicine has been around for a long time, and it has gained a reputation for offering a wide range of products for the treatment of many diseases and disorders. Chinese herbal medicine in particular is not just a symptomatic treatment, but a treatment approach aimed at harmonizing, balancing, and holistic. In addition, Chinese herbal medicine Treating a disease exhibits no or only few undesired adverse effects.

The problem to be solved by the present invention is to provide a new pharmaceutical product or formulation capable of treating retroviral infections (such as AIDS) and exhibiting favorable properties, such as allowing long-term and short-term treatment, which adopts toxic A less bulky composition, and/or compared to currently used chemical entities based on known mainly single agents or combinations for the treatment of retroviral infections such as AIDS, provides a further approach. Another problem to be solved by the present invention is to provide new drugs and treatments with (for example) known or new (preferably new) and/or combinations thereof mechanisms of action for the treatment of retroviral infections such as AIDS . It can be seen that the product of the present invention can also be used to treat other viral infections, especially hepatitis B and C virus infections, and has certain therapeutic and preventive effects on influenza virus infections.

Contents of the invention

Surprisingly, experiments have shown that the application of a cocktail of plant extracts and powdered plant materials from at least largely known herbal medicines can at least alleviate the symptoms of AIDS and/or reduce the patient's viral load to a considerably low extent, thereby effectively improving or approaching cure in infected patients, and providing a novel treatment (including prevention) option. Experiments also showed that these cocktails were able to abolish or even prevent cell fusion, which normally occurs in HIV-infected cells and results in large and abnormally shaped (virulent) cells with many multinucleates. Therefore, at least part of the effect of the new antiviral infection products and preparations may be due to this mechanism of action, but it cannot be limited to this possible mechanism of action (the mechanism of action may be complex and multiple).

Detailed description of the invention

(A) In one embodiment, the present invention relates to a product comprising one formulation or two or more formulations for simultaneous, sequential and/or separate application (=administration to warm-blooded animals, especially humans) , wherein each formulation contains at least one of the following components, and one formulation contains (or, if two or more formulations are present, when they are combined, two or More formulations together) at least 3, preferably 6, more preferably 10, most preferably all of the following components of:

Extract of Radix Isatidis,

extract of licorice,

Trichosanthes extract,

pinellia extract,

Ginger Extract,

Astragalus extract,

Salvia extract,

Honey-roasted licorice extract,

trichosanthes,

Panax ginseng or American ginseng powder,

Angelica powder, and

Cordyceps powder,

The formulation is absent or present with one or more pharmaceutically acceptable carriers and/or coating materials.

(B) Preferably, this embodiment relates to corresponding products wherein one formulation contains (or, if two or more formulations are present, when they are combined, two or more of said products The preparation contains) all the components mentioned in the preceding paragraph.

(C) More preferably, the product according to the first two paragraphs is a product containing two or more (preferably two) formulations for sequential or simultaneous (preferably simultaneous) administration.

(D) Still more preferably, the present invention relates to a product according to any of the preceding three paragraphs, wherein said formulation is a capsule or a tablet, preferably a tablet.

(E) Still more preferably, the present invention relates to a product according to any one of the preceding four paragraphs, wherein said extract components are obtained by specific gravity (in all cases mentioned, relative Specific gravity in water) is 1.15～1.35, preferably 1.2～1.3 concentrated solution preparation, especially wherein said extract components can be obtained by water extraction (when used in this description, particularly preferably refers to obtained by water extraction).

(F) Most preferably, the present invention relates to a product according to any of the preceding five paragraphs, wherein said components are present in the following relative parts by weight:

Radix isatidis extract 10-60, preferably 20-50, more preferably 30-40, most preferably 36;

Licorice extract 20-80, preferably 30-70, more preferably 45-55, most preferably 51;

Trichosanthes extract 5-45, preferably 15-35, more preferably 20-30, most preferably 24;

Pinellia extract 0.5-10, preferably 1-6, more preferably 1.5-5, most preferably 3;

The extract of dried ginger is preferably 1-6, more preferably 1.5-5, most preferably 3;

Astragalus extract 10-80, preferably 20-70, more preferably 35-55, most preferably 45;

Salvia miltiorrhiza extract 3-35, preferably 5-30, more preferably 10-25, most preferably 18;

The extract of licorice with honey is 2-40, preferably 5-30, more preferably 10-20, most preferably 15;

Trichosanthes 5-45, preferably 15-35, more preferably 20-30, most preferably 24;

Ginseng or American ginseng powder 3-50, preferably 5-35, more preferably 10-30, most preferably 20;

Angelica powder 20-80, preferably 30-70, more preferably 40-60, most preferably 48; and

Cordyceps sinensis powder 0.05-5, preferably 0.1-1, more preferably 0.25-0.75, most preferably 0.5.

(G) In another embodiment, the present invention relates to a pharmaceutical formulation, especially in the form of a tablet or capsule, comprising at least 3, preferably 4, most preferably all of the following components:

Extract of Radix Isatidis,

extract of licorice,

Trichosanthes extract,

pinellia extract,

extract of dried ginger, and

trichosanthes.

One or more pharmaceutically acceptable carriers and/or coating materials may be absent or present in the pharmaceutical formulation. Said pharmaceutical formulations are effective alone in the treatment of retroviral infections such as HIV infections such as AIDS.

(H) is preferably a tablet or capsule according to the preceding paragraph, wherein said extract component is prepared from a concentrated solution having a specific gravity of 1.15 to 1.35, preferably 1.2 to 1.3, before final drying, more preferably wherein The extract components are obtainable by water extraction (in particular obtained by water extraction).

(I) more preferably according to the tablet or capsule of any paragraph in the preceding two paragraphs, wherein said component exists with following relative weight part:

Radix isatidis extract 10-60, preferably 20-50, more preferably 30-40, most preferably 36;

Licorice extract 20-80, preferably 30-70, more preferably 45-55, most preferably 51;

Trichosanthes extract 5-45, preferably 15-35, more preferably 20-30, most preferably 24;

Pinellia extract 0.5-10, preferably 1-6, more preferably 1.5-5, most preferably 3;

The extract of dried ginger is preferably 1-6, more preferably 1.5-5, most preferably 3;

Trichosanthes 5-45, preferably 15-35, more preferably 20-30, most preferably 24.

(J) In another embodiment, the present invention relates to a pharmaceutical formulation, especially in the form of a tablet or capsule, comprising at least 3, preferably 4, most preferably all of the following components:

Astragalus extract,

Salvia extract,

Honey-roasted licorice extract,

Panax ginseng or American ginseng powder,

Angelica powder, and

Cordyceps powder.

One or more pharmaceutically acceptable carriers and/or coating materials may be absent or present in the pharmaceutical formulation. Said pharmaceutical formulation is effective alone in the treatment of retroviral infections, such as HIV infections, such as AIDS, and is a preferred embodiment of the invention, thereby forming a preferred embodiment of the invention.

(K) Preferably, the invention here relates to a tablet or capsule according to the preceding paragraph, wherein said extract fraction is prepared from a concentrated solution with a specific gravity of 1.15 to 1.35, preferably 1.2 to 1.3, before final drying, More preferably wherein said extract components are obtainable by water extraction.

(L) Most preferably the present invention relates to a tablet or capsule according to any one of the preceding two paragraphs, wherein said components are present in the following relative parts by weight:

Astragalus extract 10-80, preferably 20-70, more preferably 35-55, most preferably 45;

Salvia miltiorrhiza extract 3-35, preferably 5-30, more preferably 10-25, most preferably 18;

The extract of licorice with honey is 2-40, preferably 5-30, more preferably 10-20, most preferably 15;

Ginseng or American ginseng powder 3-50, preferably 5-35, more preferably 10-30, most preferably 20;

Angelica powder 20-80, preferably 30-70, more preferably 40-60, most preferably 48; and

Cordyceps sinensis powder 0.05-5, preferably 0.1-1, more preferably 0.25-0.75, most preferably 0.5.

(M) In another embodiment, the present invention relates to a product as given above comprising a pharmaceutical preparation in combination with another pharmaceutical preparation, in particular according to paragraphs (G), (H) above The pharmaceutical preparation (most preferably tablet or capsule) given in any paragraph in (I) and the pharmaceutical preparation (preferably tablet) according to any paragraph in the above paragraphs (J), (K) and (L) or capsules) for the simultaneous or sequential treatment of retroviral infections in warm-blooded animals, especially humans. Compared with the formulations provided separately in paragraphs (G)-(I) or paragraphs (J)-(L) respectively, this combination shows a superior effect in virus therapy, so this type of product is particularly preferred.

(N) In another embodiment, the present invention relates to the use of the following components in the preparation of the various products described above, the respective components selected for each of these formulations (such as tablets or capsules) To prepare products according to any one of the above paragraphs (A) to (F) or paragraph (M), to prepare pharmaceutical preparations (especially tablets or capsules) according to any one of the above paragraphs (G) to (I) ), and/or a pharmaceutical preparation (especially a tablet or capsule) according to any of the above paragraphs (J) to (L):

Extract of Radix Isatidis,

extract of licorice,

Trichosanthes extract,

pinellia extract,

Ginger Extract,

Astragalus extract,

Salvia extract,

Honey-roasted licorice extract,

trichosanthes,

Panax ginseng or American ginseng powder,

Angelica powder, and

Cordyceps powder.

(O) Another embodiment of the invention relates to a product according to any of paragraphs (A)-(F) or (M) and/or according to any of paragraphs (G)-(I) and/or Use of the pharmaceutical preparation (in particular tablet or capsule) of any of paragraphs (J) to (M) in the treatment of HIV infection, especially in the treatment of AIDS.

(P) Another aspect of the invention relates to a pharmaceutical product prepared according to any of paragraphs (A)-(F) or paragraph (M) and/or according to any of paragraphs (G)-(I) and/or the method of any one of paragraphs (J) to (L) for a pharmaceutical preparation (especially a tablet or capsule), said method comprising:

(a) one or more batches of one or more components described in the preceding paragraph in the form of an extract are mixed with one or more components in the form of a powder; and

(b) Adding a pharmaceutically acceptable carrier to each batch.

The present invention also relates to a method of treatment (including prophylaxis) of a warm-blooded animal (especially human) patient suffering from a retroviral infection, especially HIV infection, most especially AIDS, comprising administering to a patient in need thereof A therapeutically effective amount of the product or formulation according to the invention, in particular as defined above, is administered for the disease.

Most preferably, the invention relates to the methods, treatment regimens, uses, products and formulations given in the examples.

General terms or symbols used herein before or after in the context of the present disclosure, unless otherwise stated, have the following meanings: for simultaneous, sequential or separate application (application=administration) containing two or more preparations A product relates to a kit of parts, for example comprising one or more formulations in one kit (or kits characterized for being used in combination). Preferably, the agents are selected such that they are active alone or in particular in combination against the disease to be treated (eg retroviral infection, eg HIV infection, especially AIDS). More preferably, the product comprises up to three (most preferably two) formulations comprising in total at least 3, preferably 6, more preferably 10, most preferably all of the above mentioned components.

"Simultaneously" means that the ingredients are administered at approximately the same time (preferably within a time difference of less than one minute, especially exactly at the same time), for example after a meal.

"Sequentially" means staggered over time, it means that the agents can be administered individually at intervals such that they preferably still exhibit a (preferably synergistic) interaction in the individual to be treated (e.g. a human), That is, the combination therapy is effective. Whether this is the case can be determined inter alia by following the level of RANTES in the blood, a cytokine with antiretroviral activity, which has been shown to increase in the case of treatment with a preparation or product according to the invention. A level indicating the presence of the relevant active ingredient of said component in the blood of the treated individual (eg, human) at least over a certain time interval.

"Separately" means that the components of the formulation are administered such that no overlapping of measurable blood levels of the active ingredients from the components occurs, ie they do not act in an overlapping manner (simultaneously).

Of course, clinical applications are not static.

Embodiments of the invention are also possible (and include) any combination of two or more applied simultaneously, sequentially or separately. "Any combination" means that the individual formulations that are each part of the product may be administered simultaneously at one time point, followed by administration of only one formulation at a later time point, followed by the other formulation or both formulations at a still further time point. Combinations of one or more formulations, and the like.

Alternatively, the components (at least 10, more preferably all) may be present in a fixed combination (as a mixture) in a single formulation.

By the term formulation (=unit formulation), they denote pharmaceutical formulations.

Possible pharmaceutical preparations are, for example, those for parenteral or enteral (preferably enteral) administration.

The previously and hereinafter mentioned components and combinations are particularly useful in pharmaceutically acceptable oral formulations or, in a broader aspect of the invention, in topical formulations such as in the vagina or elsewhere where there is a risk of infection such as during sexual intercourse It is particularly useful in creams or lotions for drug administration, etc.).

The pharmaceutical preparation includes one or more of the above and below-mentioned components, preferably 4 to 8 of them per unit preparation, or when they all exist in one preparation, preferably in combination with the drug Combined with an acceptable carrier.

Any one or more suitable conventional formulation materials may be used. Suitable carriers for preferably oral administration include, but are not limited to, gelatin, acacia, lactose, starch, magnesium stearate, talc, vegetable oils, polyalkylene glycols, petrolatum, and the like.

In addition, additives such as flavoring agents, preservatives, complexing agents, pigments, dyes, stabilizers, surfactants, emulsifiers, wetting agents, solubilizers, buffers, etc. can be added in accordance with accepted pharmaceutical preparation production practices .

The pharmaceutical preparations may be formulated in any conventional form, including, inter alia: (a) solid forms for oral administration, such as tablets, capsules (e.g. hard or soft gelatin capsules), pills, sachets, powders, granules, etc. (b) formulations for topical administration, such as solutions, suspensions, ointments, creams, hydrogels, lipogels, micropowders, and the like. The pharmaceutical preparations can be sterilized and/or can contain auxiliaries such as preservatives, stabilizers, wetting agents, emulsifiers, salts for varying the osmotic pressure and/or buffers.

For topical application to the skin or mucous membranes, one or more of the aforementioned components are preferably prepared as ointments, tinctures, creams, gels, solutions, lotions; and as dry powders for inhalation; suspensions Agents, shampoos, soaps, perfumes, etc. Virtually any conventional composition may be utilized in the present invention.

Wherever used, the term treatment or therapy also includes prophylactic treatment.

Examples of preferred oral formulation dosage forms include tablets (including pills), sachets, or capsules of hard or soft gelatin, methylcellulose, or another suitable material that dissolves readily in the digestive tract. Each tablet, pill, sachet or capsule may preferably contain from about 10 to about 2000 mg, more preferably from about 20 to about 1500 mg, of one or more of the above-mentioned ingredients. Oral dosages contemplated in accordance with the present invention will vary with the individual patient's needs (eg, patient's condition, size, age, possible intervention with other therapeutic measures, etc.) as determined by the prescribing physician.

Generally, however, in the treatment of adults, a daily dose of 4 to 40 grams is applied, whether dispersed in more than one (preferably two) formulations or combined in one formulation, which daily dose relates to the present invention as a whole. The weight of all components of the product or preparation is more preferably 20-35 grams per day, preferably administered at 2-6, more preferably 2-4 (eg 3) different time points, especially after the patient has eaten. Such dosages may be administered according to any dosage regimen determined by the physician according to the needs of the patient. In the case of children, lower doses are usually recommended, for example half the dose used in adults. If the white, red and yellow tablets given in the examples are given, they can be administered three times a day (for example, after meals), preferably 2 to 5 (especially 3) yellow tablets, 2 to 5 (especially 3) ) red slices and 2 to 5 (especially 3) white slices. The course of treatment is preferably, for example, at least 3 to 12 months, more preferably longer than 6 months.

The therapeutic dosage generally depends on the route of administration, the age, weight and disease state of the individual.

Preferably, the formulations according to the invention are capsules or tablets, most preferably tablets. The tablets may be coated with coatings customary in pharmaceutical formulation practice, for example sugar-containing coatings colored for identification of different formulations.

Preferred relative amounts of one or more (active) components of the formulation are such that the formulation comprises 20 to 100%, more preferably 50 to 98%, such as 70 to 95%, of said components, The remainder is, for example, pharmaceutically acceptable component or components selected from, for example, pharmaceutically acceptable carrier materials and coatings.

Especially in the case of AIDS with opportunistic infections (such as pneumonia), the product or preparation of the present invention can be used concomitantly with known drugs (such as antibiotics or antivirals), if necessary, concomitant antibiotic therapy and/or Or concomitant antiviral therapy in the case of viral opportunistic infections, and concomitant use in the case of concomitant tuberculosis, malaria, etc.

The active ingredients used in the products and formulations for carrying out the invention are given above. The various components actually mentioned all have a long tradition of use in Chinese herbal medicine.

Preferably at least 10 of these components are applied or present in the product of the invention. For example, when the raw material can exist in two forms of extract and powder, only one of them can be used, preferably both forms are used together.

Radix isatidis, the dried root from the plant Isatis indigo, can be used in the present invention in the form of an extract.

Glycyrrhiza licorice, which is the dried root and rhizome of Glycyrrhiza glabra, Glycyrrhiza inflate or Glycyrrhiza glabra, can be used in the present invention in the form of extract.

Gualou, which is the dried mature fruit of the plant Trichosanthes or Trichosanthes bilateralus, can be used in the present invention in the form of extract.

Trichosanthes trichosanthes, which is the dried root of the plant Trichosanthes or trichosanthes, can be used in the present invention in the form of powder.

Pinellia, the dried root or tuber of Pinellia araceae plant, can be used in the present invention in the form of extract.

Dried ginger, which is the dried rhizome of Zingiberaceae plant Zingiber officinale, can be used in the present invention in the form of extract.

Astragalus, which is the dried root of the leguminous plant Astragalus, can be used in the present invention in the form of an extract.

Salvia miltiorrhiza is the dry root and rhizome of Salvia miltiorrhiza, which can be used in the present invention in the form of extract.

Honey-roasted licorice, licorice processed with honey, can be used in the present invention in the form of extract.

Ginseng or American ginseng, which is the dried root of Araliaceae plant Panax ginseng or American ginseng, can be used in the present invention in the form of powder.

Angelica sinensis, the dried root of the umbelliferous plant Angelica sinensis, can be used in the present invention in the form of powder.

Cordyceps sinensis is a composite of the subunit of the Ergotaceae fungus Cordyceps sinensis that parasitizes on the larvae of the Batidae insects and the body of the larvae, and can be used in the present invention in the form of powder.

When "relative parts by weight" is mentioned in the context, it means the relative weight of said components mentioned above or below which form part of the product or preparation according to the invention.

When an "extract" is used in the present disclosure, conventional solvents such as alcohols (e.g. ethanol) or ethers (e.g. diethyl ether), by extraction with a liquid or superfluid gas (e.g. carbon dioxide), or preferably by extraction with an aqueous solution ( The extract is obtained eg by extraction with a buffer or salt), more preferably with water. Each component is extracted, either alone as an extract or in combination with one or more of the other plants or plant parts extracted. Preferably, the extraction is carried out by heating the solvent, especially water, for example by boiling, preferably by heating with steam. The extract is then usually at least partially concentrated, preferably by evaporation (e.g. application of vacuum), by drying in the presence of a desiccant (e.g. dry silica gel, calcium chloride, "phosphorus pentoxide" or molecular sieves or a combination of two or more of these) under evaporation, or by drying with a drying gas (eg nitrogen), and/or freeze-drying. Preferably, the concentration is carried out such that the corresponding extract or mixture of extracts obtained is a concentrated solution with a specific gravity of 1.15 to 1.35, such as 1.2 to 1.3 (relative specific gravity is preferably given in g/ml).

When the component is a powder, either commercially obtained or obtained by grinding plants or plant parts (such as roots, etc.), for components in powder form, these plants or plant parts are used as Raw materials, alone or together with one or more different plants or plant parts used as other components used in the manufacture of products or formulations according to the invention.

Preferably the method according to the invention is carried out such that the above-mentioned components are extracted as a preformed mixture (for example from the extraction of one or more raw materials in the same batch as described above) and/or as a single The components, with the powder composition either as individual components or as a mixture of one or more of said components, and in admixture with a pharmaceutically acceptable carrier material. A further step is the formulation of unit preparations, such as the formation of capsules or especially tablets (pills), which may include the step of coating with a coating, in order to be able to distinguish part or whole of the preparations of the products of the invention. The coating is colored. If the product of the invention has more than one unit formulation, the manufacture may further include the preparation of packaging for one or more components and/or accompanying information (e.g. in the form of package literature) recommending or describing The formulations are preferably used simultaneously, sequentially or (not a preferred mode of the invention) separately.

Preferably, the process is as described in Example 1, 2 or 3, but using relative parts by weight ranges as described above in paragraphs (F), (I) or (L) respectively, and also The resulting tablets were allowed to have different colors.

Detailed ways:

The following examples illustrate the invention without limiting its scope.

Embodiment 1 : " white tablet " that is used for AIDS treatment

The tablet is prepared from the following ingredients in the following amounts (for the formulation of the pill base):

(1) Banlangen 36 grams

(2) Licorice 51g

(3) Trichosanthes 24 grams

(4) Gualou 24 grams

(5) pinellia 3 grams

(6) Dried ginger 3 grams

Choose high-quality Chinese medicine according to the formula given above about the pill base.

The above-mentioned ingredients (1), (2), (4), (5) and (6) (the latter two also combat nausea caused by eg ingredient (4)) were transferred into an empty extraction container. After mixing with water (by weight, traditional Chinese medicine: water=1:10) for 0.5 hours, they were boiled for 2 hours using steam. The resulting mixture was passed through a filter (pore size 3 x 3 mm), the liquid was separated from the boiled raw material and then set aside (first batch of extract). Then add a certain amount of water (by weight, traditional Chinese medicine: water=1:8). Using steam, the material was further boiled for 2 hours. The filtration step was repeated to obtain a liquid extract (second batch of extract) from the extraction vessel.

The boiled liquid first and second extracts thus obtained are then collected in a settling vessel after removing the dust formed on the first boiled liquid. The liquid mixture of the two batches of extracts was left overnight in the settling vessel.

Thereafter, the water on top of the liquid extract is carefully removed. The remaining liquid is placed in a concentrating vessel to concentrate the extract in liquid form to obtain a concentrated solution with a specific gravity of 1.2-1.3.

After that, the Chinese medicinal ingredient (3) is ground into powder, which is then added to the extract in the form of a concentrated solution with a specific gravity of 1.2-1.3.

To said material for tablet formation in a dry container, a portion (5% by weight) of white fine wheat starch for tablet formation (for tablet formation and to allow dissolution and rupture of the tablet in the stomach molding powder).

The dried plant-derived mixture from the dry container is then ground to blend the extract powder and added to the tablet forming powder. After thorough mixing, the resulting agglomerate (vegetable derived mixture) was pelletized and tablets were formed by compressing the agglomerate in a standard tablet press to produce tablets each containing 1000 mg of the plant derived mixture.

Finally, the tablets were coated with sugar together with white pigment and talc powder (sugar: talc powder = 1:19) with a weight ratio of vegetable derived mixture to coating of 75:25 or less.

Packaging the final product (white tablets). Dry and store at room temperature, stable within five years.

Tablets with a content of 1000mg/tablet, 3-5 tablets each time, three times a day, take after meals. No obvious side effects. For children, reduce the dose, usually 2-3 tablets each time, three times a day. The preparation can be used alone to treat HIV/AIDS, and can also be used in combination with the tablet of Example 2 and/or 3, according to the patient's condition or determined by the doctor. The course of treatment is 3-12 months, preferably longer than 6 months, and three courses of treatment can be repeated according to the condition or the patient's requirements.

Embodiment 2 : " red tablet " that is used for AIDS treatment

The tablet is prepared (tablet or pill prescription) from the following ingredients in the following amounts:

(A) American ginseng dry powder 20 grams

(B) Angelica Powder 48g

(C) Cordyceps powder 0.5g

(D) Astragalus 45g

(E) Danshen 18g

(F) Roasted licorice with honey 15g

According to the prescription requirements mentioned above, high-quality and authentic Chinese herbal medicines are carefully selected as the ingredients of the above "red tablet". The specific production method is as follows: firstly put the selected Chinese medicinal ingredients (D), (E) and (F) into the vacuum extraction tank according to the formula ratio. The weight ratio of water and raw medicinal materials is 10:1, put them into a tank, soak for about half an hour, heat and boil with high-pressure steam for two hours, filter out the boiled medicinal liquid, and then add water to the medicinal residue in the tank ( This time, the ratio of water and medicinal materials is 8:1), boiled with steam for two hours, and filtered out the boiled medicinal liquid for the second time. Then, remove the sediment (dust on the original drug, etc.) from the extracts that have been boiled and filtered twice, put the extracted medicinal solution in a precipitation tank, and settle for 12 hours (precipitation should be stored overnight). Twelve hours later, remove the top clear water in the sedimentation tank, and the rest is the extract of the medicinal material. Put the extract of the medicinal material into the concentration tank, and concentrate the extract to a specific gravity of 1.2-1.3 In this way, the wet ointment for extracting traditional Chinese medicine is ready.

Afterwards, the Chinese herbal medicine components (A), (B) and (C) are ground into powder, and evenly added to the extracted wet ointment with a specific gravity of 1.2-1.3. An appropriate amount of maltodextrin (approximately 5% by weight) is additionally added, which is used to shape the tablet and/and to disintegrate in the stomach. And these extracted wet pastes and maltodextrin are put into a drying tank together for drying.

Then the dried concentrated and dried mixture is first made into granules for use in tableting. After the above various preparations are completed, the granular drug mixture is made into tablets containing 1000 mg of raw medicinal material with a standard tablet press. After the tablet is made, it can be coated with sugar coating according to requirements or needs. If the coating is red sugar coating, it becomes a red tablet. Also can not add sugar coating, directly carry out final packing, use. Generally, the ratio of sugar-coated and vegetarian tablets is 25:75, or less than 25 is better.

Packaging the final product (red tablets). Dry and store at room temperature, it can be stored for three to five years; the content is 1000mg/tablet, 3-5 tablets each time, three times a day, after meals, the course of treatment is 3-12 months, preferably more than 6 months, according to the condition or patient requirements Three courses of treatment can be repeated. No obvious side effects. For children, reduce the dose, usually 2-3 tablets each time, three times a day. The red tablets can be used alone to treat HIV/AIDS, and can also be used in combination with the white tablets or/and yellow tablets of the preparations of Examples 1 and 3, depending on the patient's condition or by the doctor.

Example 3. The Compound Prescription "Pink Tablets" for the Treatment of HIV/AIDS

This prescription is the compound side of the white tablet side of embodiment 1 and the red tablet side of embodiment 2, and the composition of this sheet and specific content and processing method thereof are as follows:

First the selected Chinese medicinal material components (1), (2), (4), (5), (6) and the Chinese medicinal material components (D) and (E) described in the embodiment 2 described in the selected embodiment 1 , (F) drop into the vacuum extraction tank by the formula ratio described in embodiment 1 and 2. The weight ratio of water and raw medicinal materials is 10:1, put them into a tank, soak for about half an hour, heat and boil with high-pressure steam for two hours, filter out the boiled medicinal liquid, and then add water to the medicinal residue in the tank ( This time, the ratio of water and medicinal materials is 8:1), boiled with steam for two hours, and filtered out the boiled medicinal liquid for the second time. Then, remove the sediment (dust on the original drug, etc.) from the extracted solution that was boiled and filtered twice, and put the extracted medicinal solution in a precipitation tank for about 12 hours of precipitation (precipitation should be stored overnight). After 12 hours, remove the top clear water in the settling tank, and the remainder is the extract of medicinal materials. Put this medicinal extract into the concentration tank, and concentrate the extract to a specific gravity of 1.2-1.3. Get the desired extract from herbal wet ointment.

Afterwards, the Chinese herbal medicine component (3) described in Example 1 and the Chinese herbal medicine component (A), (B), (C) described in Example 2 are ground into powder, and evenly added to a specific gravity of 1.2-1.3 extracts in wet ointments. In addition, a suitable amount of maltodextrin (approximately 5% by weight) is added, which is used to shape the tablet and/and break up in the stomach. These extract wet pastes and maltodextrin are put into a drying tank together for drying.

Then the dried concentrated and dried mixture is made into granules for tableting. After the above various preparations are completed, the granular drug mixture is made into tablets containing 1000 mg of raw medicinal material with a standard tablet press. After the tablet is made, sugar-coated tablets can be added according to requirements or needs. If the tablet is yellow sugar-coated, it will become a yellow tablet. Also can not add sugar coating, directly carry out final packing, use. Generally, the ratio of sugar-coated and vegetarian tablets is 25:75 or better than 25 sugar-coated.

Package the final product (yellow tablets). Dry and store at room temperature, it can be stored for three to five years; the content is 1000mg/tablet. The difference is that because this prescription is a compound prescription, its curative effect is stronger than that of white and red tablets alone, so it can be used alone clinically. When used alone, take 6-10 tablets each time, three times a day, after meals. The course of treatment is 3-12 months, preferably more than 6 months. Three courses of treatment can be repeated according to the condition or patient's requirements. No obvious side effects. For children, reduce the dose, usually 2-3 tablets each time, three times a day. The yellow tablet can be used alone to treat HIV/AIDS, and can also be used in combination with the white tablet or/and red tablet of the preparations of Examples 1 and 2, depending on the patient's condition or by the doctor.

Example 4. Treatment of HIV/AIDS patients during white and red tablets

The combination of white tablets and red tablets is mostly used in clinical medicine, but patients sometimes only take white tablets or red tablets for various reasons. Using the pure traditional Chinese medicine preparation series products of this invention, the clinical curative effect is encouraging in the combined anti-HIV/AIDS treatment, whether it is the improvement of the patient's clinical symptoms, the increase in body weight, the recovery of energy and physical strength, or the patient's medication. The comparison of the blood test results before and after and/or other inspection indexes have all proved the new, special and superior characteristics of the inventive product. Beneficial effects were also shown in patients who took white or red tablets alone. There are many successful cases. In view of professional ethics or respect for patients' privacy, the cases listed below are only given here with the consent of the patients.

The viral load (V.L), copies/ml, mentioned in this article is a specific quantitative determination of HIV virus replication in vivo. Its mechanism is based on polymerase chain reaction to determine the genome (RNA) of HIV. The measuring equipment used was produced by Roche Company of Switzerland, and the assay result was gene strand RNA copy/ml. The determination of the number of CD4 cells is to use standard detection equipment to measure the number of immune cells. The level of viral load can show the degree of HIV infection of the patient, the higher the degree of infection, the more serious the infection; the viral load of healthy people is zero; the level of CD4 cell number can show the level of immune function of the patient, the lower the number, the lower the immune level , On the contrary, it is high, and the normal CD4 cell count is 400-1500 cells/μl.

Case 1 ^# and 2 ^#

Case 1 ^# and 2 ^# are a couple from Zambia. 1 ^#patient is male, born in 1966; 2 ^#patient is female, born in 1973. The couple had their first visit on April 16, 2003, and they had been diagnosed with HIV infection outside before coming to the clinic. The two came to take the newly invented anti-HIV/AIDS pure Chinese medicine preparation through the introduction of another doctor. The treatment of the couple was a combination of white tablets and red tablets, five white tablets / time, five red tablets / time, three times a day, after meals. So far, the patient continues to be treated with the drug, and the viral load and the number of CD4 cells were measured before, during and after the treatment (August 2, 2004). The following table is the test results of three times before, during and after treatment:

Patient and test time Viral load (RNA copies/ml) CD4 cell count (T helper cells) (cell number/μl blood) 1^#May 2, 2003 198,000 95 1^#November 3, 2003 112,000 150 1^#August 2, 2004 26,000 163 2^#May 2, 2003 17,000 94 2^#November 3, 2003 4,950 180 2^# August 2, 2004 10,800 267

Note: The normal value of CD4 cell number: 400-600 to 1500 cells/μl blood.

Judging from the test results of the above patients, the combined use of white tablets and red tablets in the treatment of HIV/AIDS is very effective. Specifically, it can significantly reduce the HIV RNA viral load, and can also significantly increase (enhance) the number of immune cells CD4 cells.

Case 3 ^#

Case 3 ^# is a male patient from Windhock, the capital of Namibia, aged 48. He was first diagnosed on December 6, 2001, and took medication until March 6, 2002. He terminated the treatment and took the medication for three months. The second visit was on May 8, 2003, and the treatment was discontinued on November 8, 2003 after six months of medication. His third consultation was on April 24, 2004, and he has been taking medication so far (August 2004). This patient is also used in combination of four white tablets/time and four red tablets/time, three times a day, after meals.

The patient wrote a letter in July 2004 to report his physical improvement and his feelings after taking the medicine. He wrote that before the treatment, his skin all over his body, such as his legs, eyes (including eyeballs), inside and outside ears, and reproductive organs, were all ulcerated and sores, and the pain was severe. Or most of the time, rashes, itching, and boils all over the body appear one after another. Before medication treatment, the general state of an illness is heavier, it is difficult to heal, and sometimes the pain is unbearable, and the torment of this disease is suffered. After treatment, the above-mentioned symptoms basically all disappeared, and even if small boils occasionally occurred, they would heal quickly by themselves. Also, before the medication, the night sweats were particularly severe, and when I woke up, I found that the pillows and sheets were soaked in sweat. Now the night sweats are no longer happening. After treatment, my appetite increased greatly. Although I have been treated intermittently for more than two years, my weight has risen from 70kg before treatment to about 90kg now (such as busy work, long-distance business trip, rest, and diet can not be normal. There will be occasional short-term weight loss of 1-2kg). Now my physical fitness has improved significantly, and I no longer feel powerless, lack of energy, and body pains as before the medication. In the end, he happily described that his skin is shiny and healthy; his withered hair is much stronger than before, and he no longer sees the skin sores all over his body one after another, and his hair has no luster; especially the place where the beard grows is small. An embarrassing condition in which sores never go away.

The patient's condition report fully demonstrated that the combination of white tablets and red tablets has a particularly positive and reliable clinical effect. Although the treatment was discontinued for the second time, the curative effect of the drug was not diminished, and the patient's response was particularly good. This further confirms that the drug or therapy does not produce drug resistance.

Case 4 ^#

Case 4 ^# , male, born in 1973, from the Netherlands in Europe. He was first diagnosed in May 2002. So far (August 2004), although it has been more than two years, he still insists on taking medicine. He was referred by an old doctor from Holland for medical treatment. Before coming here, his physical condition was very bad, basically full-term AIDS. As far as his physical condition is concerned, he lost more than 10 kilograms in weight, his physical fitness declined significantly, and his appetite was extremely poor. He also coughed and sweated a lot (especially night sweats). He could no longer go to work normally and had to take a sick leave. As a result of blood tests, the viral load is greater than 50,000 copies/ml, and the number of CD4 cells is less than 350 cells/μl.

To this patient's treatment, also be the white sheet 4 sheets/time of adopting, the combination therapy of red sheet 4 sheets/time. After 23 months of treatment, his weight has increased by nearly 10 kg (he is now over 70 kg), and all the clinical symptoms before coming to the clinic have disappeared. Not only has he been able to go to work normally, but he also insists on going to the gym to exercise twice a week. He already feels the importance of a healthy life and is enjoying his healthy life. The last blood test was done in January 2004, and the results were very encouraging. The viral load has dropped to less than 70 copies/ml and the number of CD4 cells has risen to more than 900 cells/μl.

In this way, judging from the improvement of the patient's recovery and quality of life in this case, the combined CD4 has greatly increased, far exceeding the initial 350 cells/μl; and the viral load has dropped to an extremely low level. All have fully confirmed that the newly invented pure Chinese medicine preparation can not only reduce the virus, but also improve the immune cells of the human body. It does provide new therapeutic drugs and treatment methods (including preventive treatment) for antiviral treatment in the medical field, especially anti-HIV/AIDS treatment.

Case 5 : Infected in Africa, living in the United States

The patient is female, 33 years old, a company employee. The patient was first diagnosed in 2000; he was an early HIV carrier at that time. Although the physique was acceptable, the viral load at that time was higher than 50,000 cobs/ML, and the number of immune cells was about 500. The red tablet described in Example 1 was used, 8 tablets each time, 3 times a day, and he moved to the U.S. less than half a year after the medication, and was interrupted for 14 months because of studying in the U.S. In May of 2002, he asked to continue taking the medicine. The patient recovered satisfactorily during the follow-up consultation in 2002, but due to the long interruption time, the HIV viral load rose to more than 58,000 cobs/ml. After another year of treatment, the patient underwent blood tests four times in a hospital in the United States. Although the immune cells decreased slightly to over 400, the HIV viral load gradually decreased, and the level of decline was satisfactory. In August 2003, the last test results confirmed that the viral load was only over 2,000 copies/ml. Still in contact by phone, mail order medication, and on medication and recovery.

Case 6 : Remittance to buy medicine is expected to recover

Patient male, 35 years old, businessman. Patients get in touch by telephone and fax, get enough information and confidence, and remit money to buy medicines. This patient is also an early HIV patient, and his spouse is HIV negative. Although he is not particularly uncomfortable, he wants to get completely cured through treatment. Before taking the medicine, he did not conduct any tests on the number of immune cells and HIV viral load, and he was only newly diagnosed as an HIV-positive infection. Adopt the white tablet described in embodiment 2; Each 8, every day 3 times, take after meal. The first test was done 6 months later, and the results were very satisfactory to the patient. The CD ₄ cells were 358 cells/μl, and the HIV viral load was 1200 copies/ml. After taking the medicine for half a year, there were no side effects, and he felt very good, so he was more confident. He insisted on taking the medicine again, and after five months, he had a second blood test, and the results were even more encouraging. Although the _CD4 cells dropped slightly to more than 340, the HIV viral load was only 310 copies/ml. The patient telephones happily and tells the inventor to insist on medication until the HIV virus completely disappears on his body.

Example 5.

Chinese medicine product of the present invention is carried out in vitro anti-HIV activity test with CEM-SS cell, and the results are as follows:

The red sheet of embodiment 1:

IC ₅₀ (50% effective concentration) = 0.0656 mg/ml,

CC ₅₀ (50% cytotoxic concentration) = 0.402 mg/ml,

SI (safety index, also called therapeutic index TI, CC ₅₀ /IC ₅₀ )=6.13

The white sheet of embodiment 2:

_IC50 = 0.111 mg/ml,

_CC50 = 1.030 mg/ml,

SI(CC ₅₀ /IC ₅₀ )=9.27

The pornographic film of embodiment 3:

_IC50 = 0.033mg/ml,

_CC50 = 0.457 mg/ml,

SI(CC ₅₀ /IC ₅₀ )=13.79

Example 6. Using in vitro scientific experiments to identify and confirm the drug action mechanism of the invented drug red tablets, white tablets and red and white mixed preparations to block HIV from entering T lymphocyte fusion.

The principle of experimental identification

If HIV wants to enter the normal T lymphocytes of the human body, it must rely on the fusion reaction between the outer membrane of the virus and the host T lymphocyte membrane. The occurrence of the fusion reaction between the virus and the cell is the result of the interaction of four proteins on the surface of the two envelopes. The two proteins on the surface of the virus cell membrane of HIV are gp120 and gp41; while the two proteins on the surface of the host cell (T lymphocyte) membrane are the main receptor CD4 protein and the co-receptor CXCR4 or/and CCR5 of the cell fusion reaction protein.

The fusion reaction between HIV and CD4 cells can be clearly seen with the naked eye under a high-power electron microscope. If HIV virus cells containing gp120 and gp41 are cultured together with T lymphocytes carrying CD4 receptors or/and CXCR4 and CCR5 co-receptors in a suitable medium, the fusion reaction between the two will be appears automatically. The continuous formation of virus cells with gp120 and gp41 can be seen under the microscope. Due to the occurrence of fusion reaction, typical abnormal morphology and multinucleated fused cells can be seen under a high-power microscope. After the cells are stained, the specific number of fused cells can be found.

Materials required for experimental identification:

HeLa-SX22-1 carries CD4 or/and CCR5, CXCR4 cells (see 2003, Koch, E.C et al., "Antiviral Therapy" No. 8, 285-487; Walker et al., "Antiviral Therapy" No. 8, 463-470; and 1998 Klim Kaif et al., Arch. Virol 143, 2109-2131). These cells contain a beta-Galacfosidase downstream gene in the HIV-LTR region regulated by HIV TAT. It is the existence of this gene that when the host cells are infected, the reagent Gal is added to stain the infected cells blue (sometimes this experiment is also called blue cell experiment).

CL-4/gp120 and gp41 cells, these cells are exactly the well-known HIV cells with HIV envelope protein, and this cell is exactly the model system cell without HIV virus (see the article written by Krausslich et al. in 1993, in pp. 192, 605-617).

Experimental identification of cell culture:

As a control group, HeLa cells can grow in simple standard DMEM medium. While HeLa-SX22-1 cells were grown in standard DMEM medium containing 1 μg of puromycin and 1 mg of gentamycin/ml. CL-4 cells can also grow in standard simple DMEM.

Experimental identification procedure:

These two kinds of cells (HeLa or HeLa-SX22-1 cells and CL-4 cells) were prepared separately, and the number of the two was counted in advance, and suspended in 3ml of medium (DMEM), and then the A suspension of one million cells was placed in this DMEM medium respectively.

Wash HeLa/HeLa-SX22-1 cells into DMEM without puromycin and Genta, then the DMEM solution containing this HeLa or HeLa-SX22-1 cells is diluted to 100,000 cells/ml DMEM liquid. CL4 cells were diluted three-fold. And 12ml of CL-4 cells and 6ml of HeLa or HeLs-SX22-1 cells were mixed together at a ratio of 2:1.

Put this 2:1 mixed 150 μl DMEM solution containing two kinds of cells into each small vessel (about 15,000 cells each) of a microtiter test plate containing forty-eight liquid vessels. In addition, each Add 450 μl standard DMEM medium to a small container.

The concentration of HumicAcid containing HS-1500 (seeing the article by Schneider.J et al., 1996 "Virology" magazine No. 218, 389-295) is 2.2mg/mlPBS ready, and then prepare standard DMEM diluted ten times, and then On this basis, each 2-fold dilution was made into DMEM of 220, 110, 55, 27.5, and 13.75 μg/ml. On the basis of 200 μg and then diluted to 600 μg, the final required concentrations were 27.5, 13.7, 6.9, 3.4 and 1.7 μg/ml. Then prepare the effective extracts of white tablets, red tablets, and white and red mixed preparations as discussed above. The method is as follows: use a small porcelain pestle equipped with a high-speed motor to mix the white tablets, red tablets, and white tablets. Mix the tablets with the red tablets, pulverize at room temperature for 3 to 4 minutes, then add an appropriate amount of PBS, and continue to drive the small motor to pulverize for one minute. Then, use the centrifuge of 3500X9 to carry out sedimentation filtration to the medicine semi-fluid thin mixture liquid that is pulverized into above. The model of the filter is 0.22μm, and the filtered liquid is stored in a four-degree environment until it is used (probably no more than one day and one night). With low-pressure freeze-drying, and the weight of the test tube used was measured in advance, the drug extract concentration required for the experiment was made into a stock solution of 81 mg/ml (red tablet, white tablet and red tablet-white tablet mixed extract). This mother solution was diluted 3 times with DMEM solution respectively, and its concentration was 27mg/ml. In addition to the prepared 27mg/ml concentration of these stock solutions, solutions of 13.6, 6.8, 3.4 and 1.7mg/ml should be obtained by diluting twice.

200 μl of these pre-prepared solutions were then duplicated into 600 μl and put into each small culture container. The final culture concentrations of various tablets (red tablet, white tablet and red tablet-white tablet mixed extract) were 6.75, 3.4, 1.7, 0.8 and 0.42 mg/ml. The cells were cultured for 20 hours, and then fixed and stained with Hemacolour (a common stain for cells--Merch, DarmStadt, FRG). Afterwards, the cells were washed once with PBS solution, and stored in an environment at 4°C until counting, and those abnormally large fusion cells containing more than four nuclei were counted.

Due to the toxicity of the extract at the highest concentrations of the drug, there were no large, abnormally confluent cells with more than four nuclei. Results were obtained only at these four concentrations. The concentrations are: A.3.4; B.1.7; C.0.84; D.0.42mg/ml (see the table below for specific results).

result

Listed in the table below are the counts of confluent cells at each of the different inhibitor concentrations:

inhibitor concentration The number of fusion cells after using different concentrations of red slice extract The number of fusion cells after using different concentrations of white flake extract The number of fusion cells after mixing extracts with different concentrations of red flakes and white flakes Without any inhibitors (average of seven small containers) A 14.5 7.5 11 B 35 33 42 C 68 42.5 51 D 62 72.5 74 93.3

Using HS-1500 as a control, the influence of different concentrations of HS on the number of fusion cells is as follows: HS-1500 is 13.7 μg/ml, fusion is 0; 6.9 μg/ml is 9; 3.4 μg/ml is 49 , and 1.7μg/ml is 94 fusion cells.

The half effective concentration _EC50 of the tested white, red and white-red mixture (HeLa cells were used in the experiment) is as follows:

effective substance Half effective concentration EC₅₀ White flakes extract 0.86mg/ml Red Flake Extract 1.58mg/ml White and red tablet mixed extract 1.50mg/ml HS-1500 6.9μg/ml

Although HS1500 is more potent, it is more toxic. Compared with this, the difference of the test drug extract is only 2 points, which is not very meaningful.

In this mechanistic assay, the _EC50 was higher compared to the antiviral (HIV) activity assay done (data not shown here). For example, the extract of white flakes is 2 times higher, and the extract of red flakes is 10 times higher. And this difference is also true in the reference substance HS-1500. The reason for this phenomenon may be that the interaction between cells requires more receptor ligands (ligands) on the cell membrane than the interaction between cells and viruses.

discuss

Because the invented new drug Chinese medicine preparation can prevent the cell fusion caused by HIV, the fusion between HIV and cells is prevented (suppressed). Therefore, it can be concluded that at least fusion inhibition (prevention) is one of the potential mechanisms for this series of products or prescriptions to inhibit HIV. It has been prevented (inhibited) before HIV enters cells, which has greater advantages compared with other currently used ARVs that only act on a certain replication link after HIV enters cells.

Claims (20)

1. A pharmaceutical product for the treatment of HIV infection, wherein the pharmaceutical product is prepared from the following components as all active ingredient raw materials: Radix Radix, Radix Glycyrrhizae, Trichosanthes, Pinellia, Dried Ginger, Radix Astragali, Salvia Miltiorrhiza, Honey-roasted licorice, trichosanthes, ginseng or American ginseng, angelica and cordyceps; of which isatis root, licorice, Trichosanthes, pinellia, dried ginger, astragalus, salvia and honey-roasted licorice in the form of their water extracts, trichosanthes, ginseng or American ginseng, angelica and Cordyceps in its powder form; The absence or presence of one or more pharmaceutically acceptable carriers and/or coating materials in the formulation; Wherein said component exists in following relative weight parts: Banlangen extract 10-60; Licorice extract 20-80; Trichosanthes extract 5-45; Pinellia extract 0.5-10; Ginger extract 1-6; Astragalus extract 10-80; Salvia miltiorrhiza extract 3-35%; Extract of honey-roasted licorice 2-40; Trichosanthes 5~45; Ginseng or American ginseng powder 3-50; Angelica powder 20-80; and Cordyceps powder 0.05～5. 2. The pharmaceutical product according to claim 1, wherein said extract fraction is prepared from a concentrated solution having a specific gravity of 1.15 to 1.35 before final drying. 3. The pharmaceutical product according to claim 2, wherein said extract fraction is prepared from a concentrated solution having a specific gravity of 1.2 to 1.3 before final drying. 4. The pharmaceutical product according to any one of claims 1-3, wherein said components are present in the following relative parts by weight: The extract of Radix isatidis 20-50; Licorice extract 30-70; Trichosanthes extract 15-35; Pinellia extract 1-6; Ginger extract 1.5-5; Astragalus extract 20-70; Salvia miltiorrhiza extract 5-30; Extract of honey-roasted licorice 5-30; Trichosanthes 15~35; Ginseng or American ginseng powder 5~35; Angelica Powder 30-70; and Cordyceps powder 0.1～1. 5. The pharmaceutical product according to claim 4, wherein said components are present in the following relative parts by weight: Banlangen extract 30-40; Licorice extract 45-55; The extract of Trichosanthes 20～30; Pinellia extract 1.5-5; Ginger extract 1.5-5; Astragalus extract 35-55; Salvia miltiorrhiza extract 10-25; Extract of honey-roasted licorice 10-20; Trichosanthes 20-30; Ginseng or American ginseng powder 10-30; Angelica Powder 40-60; and Cordyceps powder 0.25～0.75. 6. The pharmaceutical product according to claim 5, wherein said components are present in the following relative parts by weight: Extract of Radix isatidis 36; Extract of licorice 51; Trichosanthes extract 24; Pinellia extract 3; Ginger extract 3; Astragalus extract 45; Extract of Salvia miltiorrhiza 18; Extract of honey-roasted licorice 15; Trichosanthum 24; Ginseng or American ginseng powder 20; Angelica Powder 48; and Cordyceps powder 0.5. 7. The pharmaceutical product according to any one of claims 1 to 3, wherein said formulation is a capsule, pill, granule or tablet. 8. The pharmaceutical product according to claim 7, wherein said formulation is a tablet. 9. A pharmaceutical product for the treatment of HIV infection, wherein the pharmaceutical product is prepared from the following components as the raw materials of all active ingredients: Radix Radix Radix, Licorice Root, Trichosanthes Pinelliae, Pinellia Rhizome, Dried Ginger and Trichosanthes Radix Radix Radix Radix Radix , Licorice, Trichosanthes, Pinellia and Dried Ginger in the form of their water extracts, and Trichosanthes in their powder form; The absence or presence of one or more pharmaceutically acceptable carriers and/or coating materials in the formulation; Wherein said component exists in following relative weight parts: Banlangen extract 10-60; Licorice extract 20-80; Trichosanthes extract 5-45; Pinellia extract 0.5-10; Ginger extract 1-6; Trichosanthes 5-45. 10. The pharmaceutical product according to claim 9, wherein said extract fraction is prepared from a concentrated solution having a specific gravity of 1.15 to 1.35 before final drying. 11. The pharmaceutical product according to claim 10, wherein said extract fraction is prepared from a concentrated solution having a specific gravity of 1.2 to 1.3 before final drying. 12. The pharmaceutical product according to any one of claims 9-11, wherein said components are present in the following relative parts by weight: The extract of Radix isatidis 20-50; Licorice extract 30-70; Trichosanthes extract 15-35; Pinellia extract 1-6; Ginger extract 1.5-5; Trichosanthes 15-35. 13. The pharmaceutical product according to claim 12, wherein said components are present in the following relative parts by weight: Banlangen extract 30-40; Licorice extract 45-55; The extract of Trichosanthes 20～30; Pinellia extract 1.5-5; Ginger extract 1.5-5; Trichosanthes 20-30. 14. The pharmaceutical product according to claim 13, wherein said components are present in the following relative parts by weight: Extract of Radix isatidis 36; Extract of licorice 51; Trichosanthes extract 24; Pinellia extract 3; Ginger extract 3; trichosanthes24. 15. The pharmaceutical product according to any one of claims 9-11, wherein said formulation is a capsule, pill, granule or tablet. 16. The pharmaceutical product according to claim 15, wherein said formulation is a tablet. 17. A process for the preparation of a pharmaceutical product according to any one of claims 1-8, said process comprising: The methods include: (a) Weighing the required amount of isatidis, licorice, trichosanthes, pinellia, dried ginger, astragalus, salvia miltiorrhiza and honey-roasted licorice, and extracting with water in one or more batches to obtain a water extract; (b) weighing the required amount of Trichosanthin, Panax Ginseng or American Ginseng, Chinese Angelica and Cordyceps sinensis in the form of powder, or grinding the raw material in the form of root block into powder; (c) mixing the aqueous extract with the components in powder form; and (d) adding a pharmaceutically acceptable carrier to the mixture; (e) processed into a suitable dosage form; and (f) Optionally, when the product consists of multiple preparations, each preparation is packaged in one packaging box, or in different packaging boxes marked with instructions for use together. 18. A method of preparing a pharmaceutical product according to any one of claims 9-16, said method comprising: The methods include: (a) Weigh the required amount of Radix Radix Radix, Radix Glycyrrhizae, Trichosanthes Pinelliae, Pinellia Pinellia and Dried Ginger, and extract with water in one or more batches to obtain the water extract; (b) take the trichosanthes powder of powder form of required amount; (c) mixing the aqueous extract with the components in powder form; and (d) adding a pharmaceutically acceptable carrier to the mixture; (e) processed into a suitable dosage form; and (f) Optionally, when the product consists of multiple preparations, each preparation is packaged in one packaging box, or in different packaging boxes marked with instructions for use together. 19. The use of the following components combined as all active ingredients in the preparation of medicines for treating or preventing HIV infection, said components are: Radix Radix, Licorice, Trichosanthes, Pinellia, Dried Ginger, Astragalus, Salvia, Honey Licorice, Trichosanthes, Ginseng or American Ginseng, Angelica and Cordyceps; of which Radix Isatidis, Licorice, Trichosanthes, Pinellia, Dried Ginger, Astragalus, Salvia Miltiorrhiza and Honey Roasted Licorice in the form of their aqueous extracts, Trichosanthes, Ginseng or American Ginseng, Angelica and Cordyceps in its powder form; Wherein said component exists in following relative weight parts: Banlangen extract 10-60; Licorice extract 20-80; Trichosanthes extract 5-45; Pinellia extract 0.5-10; Ginger extract 1-6; Astragalus extract 10-80; Salvia miltiorrhiza extract 3-35%; Extract of honey-roasted licorice 2-40; Trichosanthes 5~45; Ginseng or American ginseng powder 3-50; Angelica powder 20-80; and Cordyceps powder 0.05～5; The medicament is absent or present with one or more pharmaceutically acceptable carriers and/or coating materials. 20. The use of the following components in combination as all active ingredients for the preparation of medicines for the treatment or prevention of HIV infection, said components are: Radix Radix, Licorice, Trichosanthes Pinelliae, Dried Ginger and Trichosanthes Fenii; wherein Radix Radix, Radix Glycyrrhizae , Gualou, Pinellia and Dried Ginger in the form of their water extracts, and Trichosanthes in their powder form; Wherein said component exists in following relative weight parts: Banlangen extract 10-60; Licorice extract 20-80; Trichosanthes extract 5-45; Pinellia extract 0.5-10; Ginger extract 1-6; Trichosanthes 5~45; The medicament is absent or present with one or more pharmaceutically acceptable carriers and/or coating materials.