JPH0476972B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION [Industrial Application Field] The present invention relates to a therapeutic agent for gastrointestinal diseases and a method for producing the same, and particularly to a therapeutic agent for gastrointestinal diseases in the form of an extract and a method for producing the same.

[Background of the Invention] In general, gastrointestinal symptoms commonly experienced on a daily basis, such as diarrhea, constipation, nausea, vomiting, heartburn, stomach pain, and abdominal pain, are caused by abnormalities in the digestive juice secretion function and gastrointestinal motility function. In addition to the above-mentioned functions, diseases such as gastric and duodenal ulcers, ulcerative colitis, and erosive gastritis, which are important among gastrointestinal diseases, are caused by the immune function of the gastrointestinal tract and these diseases. It occurs in connection with dysregulation of the blood circulation function necessary to maintain these three functions, and because these gastrointestinal functions are closely controlled by the central nervous system, the above symptoms and Diseases are caused by various stresses and strong psychological influences.

Therefore, when treating the above-mentioned diseases caused by psychological factors such as stress,
While taking into account the elimination of psychogenic causes such as stress and appropriate dietary therapy, antacids, digestive enzymes, bittering agents, antispasmodics, or gastric digestive aids containing these, which enhance gastric juice secretion and gastric motility. A parasympathomimetic agent and a sympatholytic depressant that stimulate appetite and increase appetite, an ulcer treatment drug that neutralizes and suppresses gastric secretion and gastric motility through antacids and parasympathetic nerve blockers, and Anchusan. Internal medicine therapy using Chinese herbal medicines such as

However, when the drugs used in the above drug therapy are chemically prepared, they can be highly effective in treating gastrointestinal diseases or symptoms if they are simple and mild; If the symptoms are severe or in combination, satisfactory drug effects may not be obtained, or even if the disease is temporarily cured, the disease may recur, and it tends to be accompanied by various side effects.
Furthermore, when the drug is prepared only from medicinal plants, such as Annachusan, there is a problem in that although there is no risk of side effects occurring, a sufficient therapeutic effect cannot be obtained.

[Findings based on research] Therefore, in view of the above situation, the present inventor conducted various studies and found that (1) Kakidou (herbal medicine name: Renzengusa): 3 to 30 parts by weight, and licorice. (Same, Licorice): Various preparations such as solutions, powders, granules, pills, tablets, and capsules containing crude drug extracts extracted from crude drugs at a blending ratio of 2.5 to 25 parts by weight should be promptly released. Not only does it symptomatically cure symptoms such as stomach pain, abdominal bloating, diarrhea, constipation, nausea, vomiting, heartburn, and loss of appetite, but it also has remarkable anti-ulcer, anti-stress, and anti-inflammatory effects in various gastrointestinal diseases. With continuous use, it promotes the proliferation of granulation in the gastrointestinal ulcer area and calms inflammation on the inner wall of the gastrointestinal tract, thereby preventing gastrointestinal diseases, especially stress-induced gastritis, enteritis, and gastric and duodenal ulcers. (2) A drug for treating gastrointestinal diseases with such medicinal effects is particularly effective if it contains 300 to 900 parts by weight of herbal medicines in the above-mentioned proportions. The active ingredients of the herbal medicine are leached into the boiling water by heating and boiling with water, and the leached liquid is evaporated and concentrated until the amount of the water becomes approximately half or less to one-sixth. It has been found that the present invention can be produced by preparing a concentrated liquid containing a herbal medicine extract, that is, a concentrated liquid containing a crude drug extract.

[Objective and Structure of the Invention] This invention was invented based on the above knowledge, and exhibits excellent medicinal efficacy against gastrointestinal diseases, particularly gastritis and enteritis caused by stress, and gastric and duodenal ulcers. The purpose of this drug is to provide a drug for treating gastrointestinal diseases that has no side effects even when taken for a long period of time, and a method for producing the same. and (2) heating and boiling the herbal medicine in the above-mentioned mixing ratio with 300 to 900 parts by weight of water to leach the active ingredients of the herbal medicine into the boiling water, and then pouring the leached liquid into the boiling water. This method relates to the method for producing a therapeutic drug for gastrointestinal diseases, which comprises evaporating and concentrating the product to approximately half or less to one-sixth of its volume, and then formulating the thus obtained concentrate.

[Specific Description of the Invention] 1. Compounding ratio of crude drugs The crude drugs used in this invention refer to those that are normally supplied to the market in a dry state, and therefore, these prescribed in this invention are The blending ratio of the herbal medicine is based on the weight of the herbal medicine in a dry state.

In this invention, if the blending ratio of persimmon: licorice falls outside the range of 3 to 30 parts by weight: 2.5 to 25 parts by weight, the desired effect will not be achieved in the treatment of gastrointestinal diseases. The blending ratio was determined as above.

This blending ratio expressed in parts by weight is further 9 to 9.
Preferably 16:7.5-13, especially approximately 12:
Most preferably it is 10.

2 Types of Preparation The therapeutic drug for gastrointestinal diseases of the present invention may of course be in the form of the concentrate itself containing the herbal medicine extract, but it may also be harmful to the efficacy of the herbal medicine extract extracted from the herbal medicine in the above-mentioned mixing ratio. If it contains this as an active ingredient, it can be used as a solution, powder, granule, pill, tablet, etc.
or capsules, for which additives used in conventional formulations, such as water, excipients such as lactose, glucose, starch, Arabic A binder such as rubber, gelatin, or alcohol, or a disintegrant such as starch, agar powder, or CMC may be appropriately blended, but those containing starch and lactose as excipients are particularly preferred.

3. Leaching of the crude drug extract and concentration of the leaching liquid The crude drug extract used in this invention contains 300 to 900 parts by weight of the crude drug at the above-mentioned mixing ratio, preferably
The resulting leachate is heated and boiled with 500 to 700 parts by weight, and most preferably 600 parts by weight, of water, and the resulting leachate is reduced to approximately half to one-sixth, preferably approximately half to one-fourth, of the amount of water. 1,
Most preferably, it is important to prepare it in the form of a concentrated liquid obtained by evaporating and concentrating it to about one-third, and either the blending ratio of water or the degree of concentration of the leachate is within the above range. If it deviates from the above, the crude drug extract may not be extracted sufficiently or the active ingredients may be destroyed, making it impossible to obtain a gastrointestinal disease treatment with the desired medicinal effect. The degree of enrichment was determined as above.

Therefore, in producing the drug for treating gastrointestinal diseases of the present invention, 12 parts by weight of persimmons and 10 parts by weight of licorice are heated and boiled with 600 parts by weight of water, and the active ingredients of the herbal medicines are added to the boiling water. While leaching, the amount of water is approximately 1/3 of the amount of water.
It is most preferable to evaporate and concentrate until .

The water used as a leaching agent is preferably highly purified water such as distilled water or deionized water, and "evaporating and concentrating until the amount of water is approximately half or less to one-sixth" refers to the leaching solution. During the evaporation and concentration of water, the amount of water can be reduced to less than half by measuring by eye or by other simple methods, such as a scale marked on the inner wall of the boiling pot or a level gauge attached to the outside of the boiling pot. It means to evaporate and concentrate to a state where it can be recognized that the amount has been reduced to one to six times.

As mentioned above, the concentrate containing the herbal medicine extract can be used as the gastrointestinal disease therapeutic agent of the present invention by subsequently applying various formulation methods. A liquid medicine consisting of a concentrated liquid or the concentrated liquid is placed in a vacuum pot, and the concentrated liquid is further concentrated to a paste-like state under reduced pressure at a temperature of about 60 to 70°C, while a predetermined amount of excipients are added. It is particularly preferred to use the mixture in the form of granules prepared by adding the agent and stirring to form a clay-like mixture, which is then formed into granules using a granulator and then dried.

[Examples and effects based on the examples] Next, the present invention will be explained by way of examples.

First, we prepared persimmon and licorice as herbal medicines, and distilled water as an infusion agent.

Next, 12 kg of persimmon, 10 kg of licorice, and 600 g of distilled water were charged into a boiling pot and heated to boil, thereby leaching the extract of the herbal medicine into the distilled water. It was evaporated and concentrated until it was reduced to approximately one third.

Next, the crude drug residues are removed by cooling and filtering the concentrated leachate, and the filtrate is put into a vacuum cooker, and the mixture is heated under reduced pressure with appropriate stirring at a temperature of 60 to 70°C. During further concentration, 4.5 kg of corn starch and 200 g of lactose were added as excipients to form a clay-like mixture, and the clay-like mixture was formed into granules using a granulator.

Next, the granules containing some moisture were dried in a dryer to obtain 3 kg of dried herbal medicine extract and 4.5 kg of excipients.
After preparing 7.5 kg of granules, it is evenly distributed into 3000 aluminum foil sachets using a weighing and packaging machine, sealed, and each bag contains 1 g of dried crude drug extract and excipients. Agent: 3,000 sachets were manufactured in which each sachet contained 2.5 g of the granular therapeutic agent of the present invention each containing 1.5 g.

Next, in order to evaluate the efficacy of the therapeutic agent of the present invention thus produced, the following clinical test was conducted.

(1) While working at a dental clinic as a dental medical clerk, he developed gastritis due to mental stress.
I took over-the-counter gastrointestinal medicine for five months, but I felt no improvement, so I went to see a specialist and was diagnosed with neurogenic gastritis as a result of an X-ray examination.As per the doctor's instructions, I started taking conventional medicine and eating. therapy,
A patient (female, 26 years old) who was continuing exercise therapy and stable mental lifestyle therapy, was given two doses of the therapeutic drug of the present invention on the first day instead of the conventional therapeutic drug mentioned above.
(1 packet after breakfast, 0.5 packets each after lunch and dinner), and 1.5 packets per day on days 2 to 5 (3 times of 0.5 packets after each meal). Symptoms such as stomach pain, heartburn, dizziness, and nausea disappeared.

After that, continue 1 as above from 6th to 20th day.
After taking 1.5 sachets per day, I stopped taking the therapeutic agent of the present invention according to the doctor's instructions, and continued to live a regular life, have a proper diet, exercise therapy, and maintain a stable mental lifestyle, and then started taking this drug. After 30 days, the patient was able to maintain a healthy condition similar to that of a normal person even without the above treatment, and spontaneous recovery was achieved.

(2) After eating or on an empty stomach, you may feel discomfort or pain in your stomach, such as heaviness, tightness, or heaviness, as well as symptoms such as burping, heartburn, dizziness, fatigue, and bad breath, which may cause X-ray examination. A patient (male, 42 years old) who has been diagnosed with chronic gastritis as a result of endoscopy and who is continuing to work and take conventional drug therapy as prescribed by his doctor, and who has been diagnosed with chronic gastritis for about 7 months since the onset of his illness. The therapeutic agent of the present invention instead of the therapeutic agent of
Same as above, i.e. 2 sachets on the 1st day, 2-5
When I took 1.5 packets per day on the first day,
The symptoms mentioned above disappeared and then continued for 6 to 25 days.
After taking 1.5 packets per day in the same way until day 1,
After discontinuing taking the therapeutic agent of the present invention under the doctor's instructions and continuing diet therapy, exercise therapy, and a regular lifestyle, 40 days after starting to take this drug.
After a few days, the patient was able to maintain the same health status as a normal person without the above treatment, and the disease healed naturally.

(3) Constant pain and discomfort in the stomach due to accumulated stress from work and repeated irregular lifestyles.
I developed heartburn, general fatigue, irritability, and dizziness.About 5 months after the onset of the disease, an X-ray examination revealed that I had neurogenic gastritis.I started taking conventional treatment medications as directed by my doctor, and the company For a patient (male, 50 years old) who continues to work, the therapeutic agent of the present invention was administered in place of the above-mentioned conventional therapeutic agent at the same dosage as above, i.e., 2 sachets on the 1st day and on the 2nd to 5th days. When I took 1.5 packets per day, the above symptoms disappeared, and I continued to take 1.5 packets per day from 6th to 20th day.
As per the doctor's instructions, I stopped taking the drug of this invention and started stable mental lifestyle therapy while paying attention to proper diet, exercise, and a regular lifestyle, and 30 days after I started taking this drug. was able to maintain a state of health comparable to that of a normal person even without the above treatment, and the disease was completely cured.

(4) In addition to causing lower abdominal pain immediately after eating, gas accumulates in the abdomen and makes the stomach bloat, and the intestines make rumbling sounds, while symptoms such as palpitations, headache, dizziness, and insomnia appear, and X-ray examination shows that the condition is chronic. The patient (male, 47 years old), who was diagnosed with enteritis and was currently working at a company while continuing to take conventional medications, diet, and stable mental lifestyle therapy under the instructions of a doctor, was given the above treatment. The therapeutic agent of the present invention was administered once on days 1 to 5 instead of the conventional therapeutic agent.
2 sachets per day (1 sachet after breakfast, 0.5 sachets each after lunch and dinner), and 1.5 sachets on days 6 to 10.
When I took each sachet (0.5 sachets after each meal), I experienced lower abdominal pain, rumbling in the intestines, palpitations, headache, dizziness,
The symptoms of insomnia were improved, the nervous irritation disappeared, and the discomfort that had lasted for about three months disappeared.

After that, continue in the same way from day 11 to day 15.
After taking 1.5 packets each, we stopped taking the therapeutic agent of the present invention according to the doctor's instructions, and continued diet therapy, appropriate exercise, and mental lifestyle therapy. Even without the above treatment, the patient was able to maintain a state of health similar to that of a normal person, and the disease was cured naturally.

(5) As a result of repeatedly leading an irregular lifestyle under the stress of work, I suddenly started coughing up blood, and as a result of X-ray and endoscopy tests, I was diagnosed with an early gastric ulcer, and a doctor For a patient (male, 52 years old) who continues to receive drug therapy as a conventional medical treatment under the direction of
The therapeutic agent of the present invention is used in place of the conventional therapeutic agent, from 1 to
On the 3rd day, take 3 sachets per day (1 each after each meal)
When I continued to take 1.5 sachets per day (0.5 sachets each after each meal) from 4th to 20th day, the symptoms such as water rash pain, heartburn, hyperacidity, and vomiting disappeared, and after that, as per the doctor's instructions. After discontinuing taking the therapeutic drug of the present invention, I focused on resting my mind and body, avoiding stress, and protecting my stomach through cannibal therapy.
After a few days, the ulcer site was completely healed and returned to its original state of health.

(6) The patient had severe pain in the abdomen when fasting, at night, and early in the morning, and was also experiencing severe heartburn and abdominal discomfort, which led to an X-ray examination and endoscopy, which revealed that he had an early duodenal ulcer. A patient (male, 45 years old) who was diagnosed with the disease and continues to take conventional drug therapy as a medical treatment under the direction of a doctor, was given the therapeutic drug of the present invention in place of the conventional therapeutic drug in the same manner as above. ~3 sachets per day on the 5th day, and 3 sachets per day on the 6th to 30th days
After taking 1.5 sachets at a time, the pain, heartburn, and abdominal discomfort disappeared.Thereafter, as per the doctor's instructions, the patient stopped taking the therapeutic agent of the present invention and continued to maintain a regular diet, avoid stress, and maintain mental stability. However, 95 days after starting to take this drug, the patient returned to his original state of health without any special treatment, and the ulcer site was completely healed.

(7) Because of the pain in my water lining after every meal and the severe pain that radiated from my back to my left shoulder, I underwent an X-ray examination and an endoscopy, and was diagnosed with a mid-stage gastric ulcer. For a patient (female, 66 years old) who is continuing drug therapy as a medical treatment, the therapeutic agent of the present invention was administered in the same manner as above in place of the conventional therapeutic agent.
When I took 3 sachets per day on the 5th day and 1.5 sachets per day on the 6th to 40th days, I experienced pain,
After my nausea, heartburn, etc. disappeared, I stopped using the therapeutic agent of this invention based on the doctor's instructions, and tried to rest my mind and body mainly through diet therapy and avoid stress.
After a few days, the patient returned to his previous state of health without the above treatment, and the ulcer site was completely healed.

[Overall Effects of the Invention] As is clear from the above explanation, according to the present invention, symptoms such as pain, diarrhea, constipation, nausea, heartburn, loss of appetite, and abdominal bloating caused by gastrointestinal diseases are rapidly alleviated. In addition to being effective in treating gastrointestinal diseases, especially stress-induced gastritis and enteritis, as well as gastric and duodenal ulcers, it is possible to lead to the fundamental treatment of these diseases. To provide a therapeutic drug for gastrointestinal diseases which can be used for a long period of time and which does not cause any side effects even when taken for a long period of time, and a method for producing the same.

Claims (1)

[Scope of Claims] 1. An effective crude drug extract extracted from crude drugs in a blending ratio of 3 to 30 parts by weight of Kakidou (herbal medicine name, Renzenso) and 2.5 to 25 parts by weight of Licorice (licorice root). A drug for treating gastrointestinal diseases that contains it as an ingredient. 2. A crude drug containing 3 to 30 parts by weight of Kakidou (herbal medicine name, Renzenso) and 2.5 to 25 parts by weight of Licorice (licorice) is heated and boiled with 300 to 900 parts by weight of water, and then The active ingredients of the crude drug are leached into boiling water, and the leached liquid is evaporated and concentrated until the amount of the water becomes approximately half or less to one-sixth, and then the concentrated liquid thus obtained is formulated. A method for producing a drug for treating gastrointestinal diseases, which contains as an active ingredient a crude drug extract extracted from the crude drug.