CN1237984C - Prepn. method of freezing-drying powder injection for anticancer made of Chinese herb medicines - Google Patents
Prepn. method of freezing-drying powder injection for anticancer made of Chinese herb medicines Download PDFInfo
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Abstract
The present invention discloses a preparation method of a freeze-drying traditional Chinese medicine powdered injection for resisting cancer, which is characterized in that the freeze-drying powdered injection is prepared from effective fractions extracted from traditional Chinese medicine comprising ginseng and milkvetch root, and ammothamnine, wherein the ginseng and the milkvetch root are extracted by alcohol first and then by water, and are purified by means of ultrafiltration so as to obtain the effective fractions, namely total saponins of ginseng, total saponins of milkvetch root, ginseng polysaccharide and milkvetch root polysaccharide. After the effective fractions are mixed with the ammothamnine, and a mixture of the effective fractions and the ammothamnine is prepared into the freeze-drying traditional Chinese medicine powdered injection for resisting cancer according to requirements for preparing a freeze-drying powdered injection. Pharmacological experimental results show that the freeze-drying traditional Chinese medicine powdered injection for resisting cancer in the present invention has high pharmacological activity.
Description
Affiliated technical field
The invention belongs to field of traditional Chinese medicine pharmacy, be specifically related to a kind of preparation method of Chinese medicine medicine for preventing lyophilized injectable powder.
Background technology
Cancer is a class serious threat human life and healthy disease.According to up-to-date statistics, the annual newfound cancer patient of China is about about 1,000,000, seizes about 6,000,000 people's life every year in global cancer, and 1,000 ten thousand people are placed dead edge, along with going from bad to worse of environment for human survival, the incidence rate of cancer is ascendant trend year by year.World Health Organization's prediction 21 century cancer will become human " first killer ".Modern medicine mainly is that the operative treatment cooperation is put, chemotherapy to treatment for cancer at present.Though though operation can be removed primary lesion, but can not fundamentally stop the regeneration and the breeding of cancerous cell, and this root of cancer return and transfer in the future just, though put, chemotherapy can kill cancerous cell, but simultaneously a large amount of normal tissue cells is suffered damage, bring out gastrointestinal reaction, bone marrow depression and Liver and kidney, impairment of cardiac function, make patient's health weak more, be difficult to accept further treatment.And the traditional Chinese medical herbal treatment cancer more has long history, repeatedly practises, gropes with great concentration through ancient Chinese medicine doctor, has formed the theoretical system of self uniqueness.And in the clinical development in thousands of years, formed own uniqueness some the treatment rules, as strengthening vital QI to eliminate pathogenic factors, heat-clearing and toxic substances removing, rules such as blood circulation promoting and blood stasis dispelling, particularly pass through numerous traditional Chinese medical science in recent years, combination of Chinese and Western medicine worker's continuous effort, courageously practice, confirmed that also the Chinese medicine cancer has anti-cancer and inhibiting tumor, the human body immunity improving function, reduce the chemicotherapy toxicity, regulate the body equilibrium between yin and yang, played medicine to disease subtracts or As the medicine took effect, the symptoms lessened effect to being in harmony of cancer treating, improve the outstanding role of band cancer survival rate and life quality, the particularly rehabilitation of Chinese medicine after to cancer operation, and the efficacy enhancing and toxicity reducing aspect of chemicotherapy brought into play important effect, be subjected to patient's welcome deeply.Some patient adopts that miraculous rehabilitation is no wonder behind the Chinese medicine.
People start from the end of the fifties to the Chinese medicine STUDY ON POLYSACHAROSE, discovery to the fungus polysaccharide antitumaous effect, through in recent years polysaccharide constantly being furtherd investigate, its effect there has been new understanding again, it participates in the adjusting of the various biosiss of cell, as the transmission and the impression of information between immunocyte, closely related with the mediation of the polysaccharide body of cell surface.
Radix Ginseng is one of genuine medicinal materials of abounding with of Changbaishan area, is used as medicine with its root, has good actions such as " strongly invigorating primordial QI promote the production of body fluid admittedly take off, the Fructus Alpiniae Oxyphyllae of calming the nerves ", is famous valuable ingredient of Chinese medicine.Studies confirm that through Chinese scholars, contain effective ingredient such as ginsenoside, ginseng polysaccharide, ginseng essential oil in the Radix Ginseng, ginseng polysaccharide's pharmacological experiment study confirms: the ginseng polysaccharide has stimulation to immunologic function, can promote the raising of human body non-specific immunity, the ginseng polysaccharide is mainly by galactose, compositions such as galacturonic acid, arabinose and rhamnose, toxicological experiment confirms that it has no side effect; The Radix Astragali is a kind of conventional Chinese medicine, sweet in the mouth, warm in nature, tonifying Qi and lifting yang is arranged, strengthening superficial resistance to stop perspiration, effect such as expelling pus and toxin by strengthening QI and granulation promoting, China's pharmacopeia regulation, medicinal Astragalis has two kinds: the dry root of leguminous plant Radix Astagali and Radix Astragali, Recent study finds to remove in the Radix Astragali astragaloside, micromolecular compounds such as flavone have stronger biological activity, macromolecular compound such as astragalus polysaccharides (APS) have many-sided activity too, astragalus polysaccharides can improve immune function of human body, strengthening the cell physiological metabolism, improve macrophage activity, is ideal immunostimulant, it can promote the T cell, the B cell, the function of immunocytes such as NK cell, panimmunity defective diseases such as acquired immune deficiency syndrome (AIDS) all there is good preventive and therapeutic effect, suppresses EAS in addition, effects such as two-ways regulation blood glucose, delaying cell aging helps life lengthening.When astragalus polysaccharides and ginseng polysaccharide's compatibility, can significantly improve active anticancer, reduce chemotherapy side effect, use the obviously counting of leukocyte increasing of this medicine after cancer patient's chemotherapy.
Standard No. is the method for making that [method for making] write down the injection of the Radix Astragali, Radix Ginseng, kurarinone prescription in the drug standard of WS-11222 (ZD-1222)-2002, this preparation method has only been utilized Radix Ginseng, Radix Astragali glycoside component, the a large amount of ginseng polysaccharide with antitumor action, astragalus polysaccharides are rejected, and are unfortunate really.
Summary of the invention
Based on above situation, the present invention has not only adopted modern ultrafiltration technology purification ginseng polysaccharide, astragalus polysaccharides, thereby provides material base for obtaining the stronger preparation of pharmacologically active.
The objective of the invention is to use modern means of science and technology that the good Radix Ginseng total saponins of active anticancer, Radix Astragali total saponins, ginseng polysaccharide, astragalus polysaccharides in Radix Ginseng, the Radix Astragali are extracted purification, adopt freeze-drying to make a kind of Chinese medicine lyophilized injectable powder that is used for the treatment of tumor, make the anticancer pharmacological action of this ejection preparation stronger.
The present invention is achieved by the following technical solutions.
One. process recipes
Get the Radix Ginseng decoction pieces, put into the Chinese medicine multi-function extractor, use 70%-90% ethanol extraction 2-4 hour, extract 2-4 time, extracting solution is concentrated into the clear paste that relative density is 1.10-1.20, and the residue after the extraction is used in addition; Get Radix Astragali decoction pieces, put into the Chinese medicine multi-function extractor, water decocts 2-4 time, each 2-4 hour, after the decoction, extracting solution was concentrated into the clear paste that relative density is 1.10-1.20, merge with the Radix Ginseng clear paste, add ethanol and make determining alcohol reach 70%90%, leave standstill, filter, filtrate recycling ethanol is to the greatest extent, and is standby, precipitation is put into the Chinese medicine multi-function extractor with after the Radix Ginseng residue mixes, water decoction 3-5 time, each 3-5 hour, extracting solution merged the filtering and concentrating drying and crushing; The powder of getting after the pulverizing is complete with 40 ℃-60 ℃ hot water dissolving, use the 0.1-0.3um filter element filtering, filtrate adds hot water, and to keep temperature be 40 ℃-60 ℃, carries out ultrafiltration with the hollow fiber column of molecular cut off 3000-10000, and ultrafiltration is during to original volume 1/2-1/3, add hot water to original volume, keeping temperature is 40 ℃-60 ℃, and permeate discards during ultrafiltration, circulation fluid ultrafiltration 3-5 time, be concentrated into pol for the last time and be 1%-4%, standby.Get above-mentioned standby raw material, mix with kurarinone, after the lyophilization, the requirement of lyophilized injectable powder is prepared into a kind of Chinese medicine lyophilized injectable powder that is used for the treatment of tumor routinely.
Two. check and analysis
The commercially available Conair of lyophilized injectable powder of the present invention (Qianluchun Science and Technology Co., Ltd., Beijing's laboratory provides) injection (medicine wholesaling firm in the Temple of the White Dagoba, Beijing buys, and pharmacy joint-stock company in Changbai Mountain produces)
1. the check and analysis of glycoside
(1) check and analysis of Radix Ginseng total saponins
According to the method check and analysis of check and analysis Radix Ginseng total saponins among the WS3-B-3809-98,, see Table 1 through calculating Radix Ginseng total saponins (in the ginsenoside Re's) content:
(2) check and analysis of Radix Astragali total saponins
[assay] according to 249 pages of Radixs Astragali of Pharmacopoeia of the People's Republic of China version in 2000 carries out check and analysis, through calculating the content of Radix Astragali total saponins (in astragaloside), sees Table 1:
Each constituent content of two kinds of preparations of table 1 relatively
| Group | Radix Ginseng total saponins (in the ginsenoside Re) | Radix Astragali total saponins (in astragaloside) |
| Lyophilized injectable powder mg/g of the present invention | 72.3 | 89.4 |
| Commercially available Conair injection mg/g | 55.4 | 75.3 |
2. the check and analysis of polysaccharide
The utilization high performance liquid chromatography is carried out check and analysis.
Various monosaccharide standard substance are biochemical reagents, and other is an analytical reagent.
Instrument: Beckman-332 type high performance liquid chromatograph, Tianjin, island RID-6A differential refraction detector, chromatographic column MICROSORB-MVTM86-700-C5NH25 μ m.
Method: sample thief adds ethanol precipitation, carry out with the high speed centrifugation instrument centrifugal, centrifugal sediment with dissolved in distilled water after, sample introduction 20u1.
Calculate through check and analysis, obtain the comparison of two kinds of preparation polyoses contents, see Table 2:
Two kinds of preparation polyoses contents of table 2
| Group | Vegetable polysaccharides content mg/g |
| Lyophilized injectable powder of the present invention | 398.7 |
| Commercially available Conair injection | Do not detect |
By above experimental data, it is high more a lot of than the content of the effective site of commercially available Conair injection that we can learn that extraction and purification process of the present invention prepares effective site in the preparation, and therefore, extraction and purification process of the present invention has certain practical significance.
Two. pharmacology embodiment
Embodiment one
To mice S
180The tumor growth inhibitory action
Laboratory animal: healthy mice, body weight 16-20g, male and female are respectively done.(Beijing University of Chinese Medicine provides)
Tumor strain: mice S
180(Beijing University of Chinese Medicine provides)
Experiment medicine: normal saline (Qianluchun Science and Technology Co., Ltd., Beijing's laboratory provides)
Commercially available Conair injection (medicine wholesaling firm in the Temple of the White Dagoba, Beijing buys, and pharmacy joint-stock company in Changbai Mountain produces)
Lyophilized injectable powder of the present invention (Qianluchun Science and Technology Co., Ltd., Beijing's laboratory provides)
Experimental technique: get and inoculate the mice S that goes down to posterity
180, in homogenizer, add normal saline, make mice S
180The tumor homogenate, again with normal saline 1: 3 dilution, getting 0.2ml then, to inject oxter, a mice left side subcutaneous, weighed in 24 hours, mice gastric infusion every day once, administration volume identical (0.5ml/ is only), totally 7 days.Next day is put to death mice in drug withdrawal, and the subcutaneous tumors piece is peeled off in the also carefulness of weighing, and takes by weighing tumor in the EM50 electronic balance and weighs, and calculate tumour inhibiting rate, sees Table 3:
Two kinds of preparations of table 3 are to mice S
180The tumor growth inhibitory action
| Group | Tumor body weight mg | Tumour inhibiting rate |
| Normal saline | 1.4965 | 100％ |
| Commercially available Conair injection | 0.9924 | 33.7％* |
| Lyophilized injectable powder of the present invention | 0.8893 | 40.6％** |
* P＜0.01, (0.01, * * P and * P relatively (0.05 for * * P
Embodiment two
Comparison to the rats'liver tumor suppression
Laboratory animal: 30 of rats, 150g～180g, male and female are regardless of, and are divided into 3 groups, 10 every group, are respectively applied for blank group, two kinds of preparation experimental grouies.
Experiment medicine: the commercially available Conair of normal saline (Qianluchun Science and Technology Co., Ltd., Beijing's laboratory provides) injection (medicine wholesaling firm in the Temple of the White Dagoba, Beijing buys, and pharmacy joint-stock company in Changbai Mountain produces)
Lyophilized injectable powder of the present invention (Qianluchun Science and Technology Co., Ltd., Beijing's laboratory provides)
Experimental technique: get rat and do inoculation in the liver of W256, inoculate after 7 days, press the dosage intraperitoneal injection of anesthesia of 35mg/kg with pentobarbital sodium, fixing, cutting open the belly exposes liver, and tumor surface maximum diameter (a) and path (b) are pressed (a*b on the measurement liver
2)/2=V (gross tumor volume).Separate stomach, arteria duodenalis, common hepatic artery and proper hepatic artery, ligation stomach, arteria duodenalis far-end, with silver brain clip blocking-up common hepatic artery, in sending into proper hepatic artery again at the gastroduodenal artery upper cut and after inserting external diameter 0.3mm conduit under the operating loupe, inject respectively by the experiment grouping then and be subjected to the reagent thing, postoperative tube drawing ligation gastroduodenal artery, decontrol the common hepatic artery silver brain clip, sew up the incision again, place animal housing to wait to revive rat, continue breeding observing, performed the operation back 8 days, detect gross tumor volume by last method, see Table 1:
Two kinds of preparations of table 4 are to the inhibition of tumor
| Medicine name | Administration pre-neoplastic volume mm 3 | Gross tumor volume mm after the administration 3 | Change in volume percent |
| Blank group | 3.85 | 5.13 | +33.2％ |
| Commercially available Conair injection | 3.76 | 3.01 | -19.9％* |
| Lyophilized injectable powder of the present invention | 3.79 | 2.85 | -24.8％** |
Annotate: * * P＜0.01, * P＜0.01, * * and * be P＜0.05 relatively
As stated above, experimentizing, observing the survival of rats natural law, seeing Table 5
Table 5 survival of rats natural law relatively
| Medicine name | Survival natural law (average) |
| Blank group | 17.2 my god |
| Commercially available Conair injection | 21.8 it * |
| Lyophilized injectable powder of the present invention | 28.3 it * * |
Annotate: * * P＜0.01, * P＜0.01, * * and * be P＜0.05 relatively
Embodiment three
Physics, chemistry and biological factor all can be brought out cancer, but the 80%-90% of people's cancer pathogenic factor thinks what the Environmental Chemistry material caused.
Two kinds of preparations bring out the inhibition of rat liver cancer to diethylnitrosamine (DENA)
Laboratory animal: 30 of rats, about 120g, male and female are regardless of, and are divided into 3 groups, 10 every group, are respectively applied for blank group, two kinds of preparation experimental grouies.
Experiment medicine: the commercially available Conair of normal saline (Qianluchun Science and Technology Co., Ltd., Beijing's laboratory provides) injection (medicine wholesaling firm in the Temple of the White Dagoba, Beijing buys, and pharmacy joint-stock company in Changbai Mountain produces)
Lyophilized injectable powder of the present invention (Qianluchun Science and Technology Co., Ltd., Beijing's laboratory provides)
Experimental technique: feed rat with the drinking-water that contains diethylnitrosamine (DENA), 36 all primary hepatocarcinoma that get, the embodiment administration is pressed in administration respectively, presses embodiment two methods, calculates and sees Table 6
Two kinds of preparations of table 6 are to the inhibition of tumor
| Medicine name | Administration pre-neoplastic volume mm 3 | Gross tumor volume mm after the administration 3 | Change in volume percent |
| Blank group | 9.75 | 14.53 | +49.0％ |
| Commercially available Conair injection | 9.87 | 7.34 | -25.6％* |
| Lyophilized injectable powder of the present invention | 9.96 | 6.98 | -29.9％** |
Annotate: * * P＜0.01, * P＜0.01, * * and * be P＜0.05 relatively
Table 7 survival of rats natural law relatively
| Medicine name | Survival natural law (average) |
| Blank group | 11.5 my god |
| Commercially available Conair injection | 16.6 it * |
| Lyophilized injectable powder of the present invention | 20.8 it * * |
Annotate: * * P＜0.01, * P＜0.01, * * and * be P＜0.05 relatively
Conclusion: show that by above pharmacological evaluation lyophilized injectable powder of the present invention is better than the pharmacological action of commercially available Conair injection, helps treatment for cancer.
Three. preparation embodiment
Embodiment one
Get Radix Ginseng decoction pieces 80 gram, put into the Chinese medicine multi-function extractor, with 70% ethanol extraction 2 hours, extract 2 times, it is 1.10 clear paste that extracting solution is concentrated into relative density, standby after the residue drying after the extraction; Get Radix Astragali decoction pieces 200 grams, put into the Chinese medicine multi-function extractor, water decocts 2 times, each 2 hours, after the decoction, it is 1.10 clear paste that extracting solution is concentrated into relative density, merges with the Radix Ginseng clear paste, adding ethanol makes alcoholic degree reach 70%, leave standstill, filter, filtrate recycling ethanol is to most, standby, the precipitation drying for standby; Get above-mentioned in dried precipitation with after residue mixes, put into the Chinese medicine multi-function extractor, water decocts 3 times, each 3 hours, extracting solution merged concentrate drying and pulverizes; The powder of getting after the pulverizing is complete with 40 ℃ hot water dissolving, use 0.1 filter element filtering, filtrate adds hot water, and to keep temperature be 40 ℃, carries out ultrafiltration with the hollow fiber column that intercepts molecular weight 3000, and ultrafiltration is during to original volume 1/2, add hot water to original volume, keeping temperature is 40 ℃, and permeate discards during ultrafiltration, circulation fluid ultrafiltration 3 times, be concentrated into pol for the last time and be 1%, standby.Get above-mentioned standby raw material, mix, after the lyophilization, be prepared into a kind of Chinese medicine lyophilized injectable powder that is used for the treatment of tumor by the requirement of lyophilized injectable powder with kurarinone 5 gram.
Embodiment two
Get Radix Ginseng decoction pieces 120 gram, put into the Chinese medicine multi-function extractor, with 90% ethanol extraction 4 hours, extract 4 times, it is 1.20 clear paste that extracting solution is concentrated into relative density, standby after the residue drying after the extraction; Get Radix Astragali decoction pieces, put into the Chinese medicine multi-function extractor, water decocts 4 times, and each 4 hours, after the decoction, it is 1.20 clear paste that extracting solution is concentrated into relative density, merges with the Radix Ginseng clear paste, adds ethanol and makes alcoholic degree reach 90%, leaves standstill, filter, filtrate recycling ethanol is to the greatest extent, and is standby, the precipitation drying for standby; Get above-mentioned in dried precipitation with after residue mixes, put into the Chinese medicine multi-function extractor, water decocts 5 times, each 5 hours, extracting solution merged concentrate drying and pulverizes; The powder of getting after the pulverizing is complete with 60 ℃ hot water dissolving, use the 0.3um filter element filtering, filtrate adds hot water, and to keep temperature be 60 ℃, carries out ultrafiltration with the hollow fiber column that intercepts molecular weight 10000, and ultrafiltration is during to original volume 1/3, add hot water to original volume, keeping temperature is 60 ℃, and permeate discards during ultrafiltration, circulation fluid ultrafiltration 5 times, be concentrated into pol for the last time and be 4%, standby.Get above-mentioned standby raw material, mix, after the lyophilization, be prepared into a kind of Chinese medicine lyophilized injectable powder that is used for the treatment of tumor by the requirement of lyophilized injectable powder with kurarinone 20 gram.
Embodiment three
Get Radix Ginseng decoction pieces 100 gram, put into the Chinese medicine multi-function extractor, with 80% ethanol extraction extraction in 3 hours 3 times, it is 1.15 clear paste that extracting solution is concentrated into relative density, standby after the residue drying after the extraction; Get Radix Astragali decoction pieces 300 grams, put into the Chinese medicine multi-function extractor, water decocts 3 times, each 3 hours, after the decoction, it is 1.15 clear paste that extracting solution is concentrated into relative density, merges with the Radix Ginseng clear paste, adding ethanol makes alcoholic degree reach 80%, leave standstill, filter, filtrate recycling ethanol is to most, standby, the precipitation drying for standby; Get above-mentioned in dried precipitation with after residue mixes, put into Chinese medicine multi-function extractor water and decoct 4 times, each 4 hours, extracting solution merged concentrate drying and pulverizes; The powder of getting after the pulverizing is complete with 50 ℃ hot water dissolving, use the 0.2um filter element filtering, filtrate adds hot water, and to keep temperature be 50 ℃, carries out ultrafiltration with the hollow fiber column of molecular cut off 8000, and ultrafiltration is during to original volume 1/2, add hot water to original volume, keeping temperature is 50 ℃, and permeate discards during ultrafiltration, circulation fluid ultrafiltration 4 times, be concentrated into pol for the last time and be 3%, standby.Get above-mentioned standby raw material, mix, after the lyophilization, be prepared into a kind of Chinese medicine lyophilized injectable powder that is used for the treatment of tumor by the requirement of lyophilized injectable powder with kurarinone 10 gram.
Embodiment four
Get Radix Ginseng decoction pieces 1000 gram, put into the Chinese medicine multi-function extractor, with 75% ethanol extraction 3 hours, extract 3 times, it is 1.10 clear paste that extracting solution is concentrated into relative density, standby after the residue drying after the extraction; Get Radix Astragali decoction pieces 3000 grams, put into the Chinese medicine multi-function extractor, water decocts 3 times, each 3 hours, after the decoction, it is 1.10 clear paste that extracting solution is concentrated into relative density, merges with the Radix Ginseng clear paste, adding ethanol makes alcoholic degree reach 85%, leave standstill, filter, filtrate recycling ethanol is to most, standby, the precipitation drying for standby; Get above-mentioned in dried precipitation with after residue mixes, put into the Chinese medicine multi-function extractor, water decocts 3 times, each 3 hours, extracting solution merged concentrate drying and pulverizes; The powder of getting after the pulverizing is complete with 45 ℃ hot water dissolving, use the 0.1um filter element filtering, filtrate adds hot water, and to keep temperature be 45 ℃, carries out ultrafiltration with the hollow fiber column of molecular cut off 5000, and ultrafiltration is during to original volume 1/2, add hot water to original volume, keeping temperature is 45 ℃, and permeate discards during ultrafiltration, circulation fluid ultrafiltration 5 times, be concentrated into pol for the last time and be 2%, standby.Get above-mentioned standby raw material, mix, after the lyophilization, be prepared into a kind of Chinese medicine lyophilized injectable powder that is used for the treatment of tumor by the requirement of lyophilized injectable powder with kurarinone 100 gram.
Embodiment five
Get Radix Ginseng decoction pieces 200 gram, put into the Chinese medicine multi-function extractor, with 85% ethanol extraction 2 hours, extract 3 times, it is 1.20 clear paste that extracting solution is concentrated into relative density, standby after the residue drying after the extraction; Get Radix Astragali decoction pieces 600 grams, put into the Chinese medicine multi-function extractor, water decocts 4 times, each 2 hours, after the decoction, it is 1.20 clear paste that extracting solution is concentrated into relative density, merges with the Radix Ginseng clear paste, adding ethanol makes alcoholic degree reach 85%, leave standstill, filter, filtrate recycling ethanol is to most, standby, the precipitation drying for standby; Get above-mentioned in dried precipitation with after residue mixes, put into the Chinese medicine multi-function extractor, water decocts 5 times, each 3 hours, extracting solution merges concentrate drying to be pulverized; The powder of getting after the pulverizing is complete with 55 ℃ hot water dissolving, use the 0.2um filter element filtering, filtrate adds hot water, and to keep temperature be 55 ℃, is that 5000 hollow fiber columns carry out ultrafiltration with molecular cut off, and ultrafiltration is during to original volume 1/3, add hot water to original volume, keeping temperature is 55 ℃, and permeate discards during ultrafiltration, circulation fluid ultrafiltration 4 times, be concentrated into pol for the last time and be 3%, standby.Get above-mentioned standby raw material, mix with kurarinone 20 grams, freezing
After the drying, be prepared into a kind of Chinese medicine lyophilized injectable powder that is used for the treatment of tumor by the requirement of lyophilized injectable powder.
Embodiment six
Get Radix Ginseng decoction pieces 2000 gram, put into the Chinese medicine multi-function extractor, with 75% ethanol extraction 4 hours, extract 2 times, it is 1.20 clear paste that extracting solution is concentrated into relative density, standby after the residue drying after the extraction; Get Radix Astragali decoction pieces 6000 grams, put into the Chinese medicine multi-function extractor, water decocts 4 times, each 2 hours, after the decoction, it is 1.10 clear paste that extracting solution is concentrated into relative density, merges with the Radix Ginseng clear paste, adding ethanol makes alcoholic degree reach 80%, leave standstill, filter, filtrate recycling ethanol is to most, standby, the precipitation drying for standby; Get above-mentioned in dried precipitation with after residue mixes, put into the Chinese medicine multi-function extractor, water decocts 4 times, each 4 hours, extracting solution merged concentrate drying and pulverizes; The powder of getting after the pulverizing is complete with 50 ℃ hot water dissolving, use the 0.1um filter element filtering, filtrate adds hot water and keeps temperature to be 50 ℃ carrying out ultrafiltration with molecular cut off 8000 hollow fiber columns, ultrafiltration adds hot water to original volume during to original volume 1/3, and keeping temperature is 50 ℃, permeate discards during ultrafiltration, circulation fluid ultrafiltration 4 times is concentrated into pol for the last time and is 2%, and is standby.Get above-mentioned standby raw material, mix, after the lyophilization, be prepared into a kind of Chinese medicine lyophilized injectable powder that is used for the treatment of tumor by the requirement of lyophilized injectable powder with kurarinone 200 gram.
Embodiment seven
Get Radix Ginseng decoction pieces 600 gram, put into the Chinese medicine multi-function extractor, with 90% ethanol extraction 4 hours, extract 3 times, it is 1.15 clear paste that extracting solution is concentrated into relative density, standby after the residue drying after the extraction; Get Radix Astragali decoction pieces 1800 grams, put into the Chinese medicine multi-function extractor, water decocts 3 times, each 2 hours, after the decoction, it is 1.10 clear paste that extracting solution is concentrated into relative density, merges with the Radix Ginseng clear paste, adding ethanol makes alcoholic degree reach 70%, leave standstill, filter, filtrate recycling ethanol is to most, standby, the precipitation drying for standby; Get above-mentioned in dried precipitation with after residue mixes, put into the Chinese medicine multi-function extractor, water decocts 5 times, each 3 hours, extracting solution merged concentrate drying and pulverizes; The powder of getting after the pulverizing is complete with 50 ℃ hot water dissolving, use the 0.2um filter element filtering, filtrate adds hot water, and to keep temperature be 50 ℃, carries out ultrafiltration with molecular cut off 5000 hollow fiber columns, and ultrafiltration is during to original volume 1/3, add hot water to original volume, keeping temperature is 50 ℃, and permeate discards during ultrafiltration, circulation fluid ultrafiltration 5 times, be concentrated into pol for the last time and be 2%, standby.Get above-mentioned standby raw material, mix, after the lyophilization, be prepared into a kind of Chinese medicine lyophilized injectable powder that is used for the treatment of tumor by the requirement of lyophilized injectable powder with kurarinone 60 gram.
Claims (3)
1. the preparation method of a Chinese medicine medicine for preventing lyophilized injectable powder is characterized by:
(1) takes by weighing the following weight proportion raw material: 80～120 parts of Radix Ginsengs, 200～400 parts of the Radixs Astragali, 5～20 parts of kurarinones;
(2) get the Radix Ginseng decoction pieces, put into the Chinese medicine multi-function extractor, use 70%-90% ethanol extraction 2-4 hour, extract 2-4 time, extracting solution is concentrated into the clear paste that relative density is 1.10-1.20, and is standby after the residue drying after the extraction;
(3) get Radix Astragali decoction pieces, put into the Chinese medicine multi-function extractor, water decocts 2-4 time, each 2-4 hour, after the decoction, extracting solution is concentrated into the clear paste that relative density is 1.10-1.20, merges with the Radix Ginseng clear paste, adding ethanol makes alcoholic degree reach 70%-90%, leave standstill, filter, filtrate recycling ethanol is to most, standby, precipitation is dry;
(4) get residue after dried precipitation and Radix Ginseng extract and mix after, put into the Chinese medicine multi-function extractor, water decocts 3-5 time, each 3-5 hour, the pulverizing of extracting solution merging concentrate drying, standby;
(5) powder of getting after the pulverizing is complete with 40 ℃-60 ℃ hot water dissolving, with 0.1-0.3 μ m filter element filtering, filtrate adds hot water, and to keep temperature be 40 ℃-60 ℃, carries out ultrafiltration with hollow fiber column, and ultrafiltration is during to original volume 1/2-1/3, add hot water to original volume, keeping temperature is 40 ℃-60 ℃, and permeate discards during ultrafiltration, circulation fluid ultrafiltration 3-5 time, be concentrated into pol for the last time and be 1%-4%, standby;
(6) get above-mentioned standby raw material, after kurarinone mixes, lyophilization, the requirement of lyophilized injectable powder is prepared into a kind of Chinese medicine medicine for preventing lyophilized injectable powder routinely.
2. according to the preparation method of claim 1, the molecular cut off of described hollow fiber column is 3000-10000.
3. Chinese medicine medicine for preventing lyophilized injectable powder of making according to the preparation method of claim 1 or 2.
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| CN101816690B (en) * | 2006-09-28 | 2012-02-01 | 成都中医药大学 | Gensenoside double-layer osmotic pump tablet and preparation method thereof |
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