CN103356940A - Natural drug extract and its preparation method - Google Patents
Natural drug extract and its preparation method Download PDFInfo
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- CN103356940A CN103356940A CN2013103044929A CN201310304492A CN103356940A CN 103356940 A CN103356940 A CN 103356940A CN 2013103044929 A CN2013103044929 A CN 2013103044929A CN 201310304492 A CN201310304492 A CN 201310304492A CN 103356940 A CN103356940 A CN 103356940A
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Abstract
The invention relates to a natural drug extract and its preparation method. The natural drug extract is composed of an astragalus Alpinia katsumadai decocted concentrated extract, astragalus polysaccharides and an Alpinia katsumadai ethyl acetate extract in a ratio of 2-8:3-9:2-3. The composition provided in the invention has excellent efficacy on cancer chemotherapy related diarrhea and simultaneously has a synergistic effect on cancer chemotherapy.
Description
Technical field
The present invention relates to a kind of natural drug extract, relate more specifically to a kind of natural drug extract that is comprised of Radix Astragali Semen Alpiniae Katsumadai water boiling concentration extract, astragalus polysaccharides and Semen Alpiniae Katsumadai ethyl acetate extract, the preparation method of this natural drug extract and this natural drug extract are for the preparation of reducing the cancer chemotherapy induced diarrhea and treatment of cancer being played purposes in the medicine of potentiation.
Background technology
Malignant tumor is current harm humans existence, one of healthy principal disease, and its treatment means comprises operation, chemotherapy, radiotherapy, Chinese medicine, and the effect of chemotherapeutic treatment tumor is particularly outstanding.Chemotherapeutic is alone or unite with the toxicity such as all can cause that the patient suffers from diarrhoea, and diarrhoea is again Chemotherapy-induced Diarrhea behind the chemotherapy of tumors.In recent years emerging and applying along with chemotherapeutics such as 5-fluorouracil, taxanes, hydroxy camptothecin, irinotecan, xeloda etc., the incidence rate of Chemotherapy-induced Diarrhea improves year by year, if do not carry out active treatment, easily cause patient's dehydration, malnutrition, serum electrolyte disorder, acid base imbalance etc., it is unfavorable greatly not only the rehabilitation of body to be brought, also bring certain difficulty to CC, therefore effective treatment of Chemotherapy-induced Diarrhea has been become the important component part of tumor patient wholistic therapy.
Chemotherapy-induced Diarrhea is with regard to its clinical manifestation, surely belongs to the Chinese medicine category of " having loose bowels ", and Chinese medicine attracts people's attention for the research of having loose bowels, but there is no at present the Chinese patent medicine that the antagonism cancer chemotherapy has alleviating diarrhoea and potentiation.Therefore, research and develop a kind of high-efficiency low-toxicity, cheap, the natural Chinese medicine that can be used for alleviating the cancer chemotherapy induced diarrhea and playing the chemotherapeutic sensitivity effect that is easy to promote becomes clinical problem demanding prompt solution.
The Radix Astragali is the root of leguminous herbaceous plant's Radix Astagali, Radix Astragali, and the Radix Astragali has invigorating QI to consolidate the body surface resistance, diuresis poison holding, evacuation of pus effect.Be used for the chronic diarrhea proctoptosis.Semen Alpiniae Katsumadai is the seed of zingiberaceous plant Semen Alpiniae Katsumadai Alpinia katsumadai Hayata.The Compendium of Material Medica of Ming Dynasty's Li Shizhen (1518-1593 A.D.) is replenished its effect for can " summer-heat that cures the wound is told lower leakage dysentery, dysphagia and regurgitation, feeling of fullness acid regurgitation " etc., the coldness and pain in the epigastrium of the cloudy taste that stagnate of main cold-damp; Feeling of fullness expands, vomiting; The disease such as have loose bowels.In recent years, the Radix Astragali and Semen Alpiniae Katsumadai antitumaous effect are confirmed, the inventor is through research and the experiment of each a large amount of formula proportion, obtained at last optimal drug ratio compositions of the present invention, it is the compositions of novelty, and proved that it has fabulous curative effect and can simultaneously to chemotherapeutic sensitivity, finish thus the present invention the cancer chemotherapy induced diarrhea.
Summary of the invention
A kind of natural drug extract provided by the invention is made of in the ratio of 2-8:3-9:2-3 by weight Radix Astragali Semen Alpiniae Katsumadai water boiling concentration extract, astragalus polysaccharides and Semen Alpiniae Katsumadai ethyl acetate extract.
Above-mentioned natural drug extract, wherein the usage ratio of Radix Astragali Semen Alpiniae Katsumadai water boiling concentration extract, astragalus polysaccharides and Semen Alpiniae Katsumadai ethyl acetate extract is 8:9:3.
Wherein, Radix Astragali Semen Alpiniae Katsumadai water boiling concentration extract, astragalus polysaccharides can be by well known to a person skilled in the art the conventional method acquisition of purifying, and adopt these compositions that conventional method obtains or the natural drug of the present invention that adopts the commercial one-tenth of buying to be grouped into all can obtain identical curative effect.
Preferably, the preparation method of Radix Astragali Semen Alpiniae Katsumadai water boiling concentration extract is in the above-mentioned natural drug extract:
Be 1-6 according to proportion compatibility: 1 gets the Radix Astragali, Semen Alpiniae Katsumadai, distilled water immersion, and heating decocts, and filters, and medicinal residues are adding distil water again, soaks, decocts, filters with method, and twice filtrate is mixed, and heating is concentrated, ultrafiltration membrance filter, drying under reduced pressure, and get final product.
The preparation method of astragalus polysaccharides is in the above-mentioned natural drug extract:
The Radix Astragali is pulverized, and with drying behind the 95% ethanol extraction saponin, adds distilled water, dropwise add saturated limewater, adjust pH leaves standstill 10min with the moistening material, microwave radiation 1min, radiation 1min again behind the 1min of interval filters to get extracting solution, repeat aforesaid operations 2-3 time, merge extractive liquid,, concentrated, regulate pH=7 with 10% hydrochloric acid, add 95% ethanol, wash out polysaccharide, filter, washing with alcohol is drying to obtain astragalus polysaccharides.
Semen Alpiniae Katsumadai ethyl acetate extract preparation method is in the above-mentioned natural drug extract:
The Semen Alpiniae Katsumadai of drying is pulverized, crossed the 20-40 mesh sieve, with 70% industrial alcohol heating and refluxing extraction 3 times, each 2 h, decompression and solvent recovery gets dry extract, extractum is put to room temperature after being diluted to suspension with hot water, with ethyl acetate extraction, reclaims solvent, drying is pulverized, and sieves, and get final product.
The present invention also provides the preferred preparation method of this natural drug extract, comprising:
(1) preparation of Radix Astragali Semen Alpiniae Katsumadai water boiling concentration extract
Be 1-6 according to proportion compatibility: 1 gets the Radix Astragali, Semen Alpiniae Katsumadai, distilled water immersion, and heating decocts, and filters, and medicinal residues are adding distil water again, soaks, decocts, filters with method, and twice filtrate is mixed, and heating is concentrated, ultrafiltration membrance filter, drying under reduced pressure, and get final product.
(2) preparation of astragalus polysaccharides
The Radix Astragali is pulverized, and with drying behind the 95% ethanol extraction saponin, adds distilled water, dropwise add saturated limewater, adjust pH leaves standstill 10min with the moistening material, microwave radiation 1min, radiation 1min again behind the 1min of interval filters to get extracting solution, repeat aforesaid operations 2-3 time, merge extractive liquid,, concentrated, regulate pH=7 with 10% hydrochloric acid, add 95% ethanol, wash out polysaccharide, filter, washing with alcohol is drying to obtain astragalus polysaccharides.
(3) Semen Alpiniae Katsumadai ethyl acetate extract preparation
The Semen Alpiniae Katsumadai of drying is pulverized, crossed the 20-40 mesh sieve, with 70% industrial alcohol heating and refluxing extraction 3 times, each 2 h, decompression and solvent recovery gets dry extract, extractum is put to room temperature after being diluted to suspension with hot water, with ethyl acetate extraction, reclaims solvent, drying is pulverized, and sieves, and get final product.
(4) choose in proportion Radix Astragali Semen Alpiniae Katsumadai water boiling concentration extract, astragalus polysaccharides and Semen Alpiniae Katsumadai ethyl acetate extract, evenly mix, and get final product.
The preparation method of above-mentioned natural drug extract, also comprise: the product that step (4) makes is further made the capsule that contains natural drug extract 100mg or 200mg specification by the pharmacy means of routine, maybe will make the tablet that contains natural drug extract 100mg or 200mg specification by wet granulation technology.
The beneficial effect of natural drug extract of the present invention aspect anti-Chemotherapy-induced Diarrhea and inhibition tumor is as follows:
1, natural drug extract of the present invention causes studies show that of diarrhea of mouse model at irinotecan: the diarrhoea reaction for the irinotecan induced mice has obvious antagonism.
2, proved that this natural drug extract can strengthen chemotherapeutics to the inhibitory action of tumor, adopted mouse tumor model, observed this natural drug extract and cyclophosphamide combined to the inhibitory action of mouse interior tumor.Studies show that: this natural drug extract can obviously increase cyclophosphamide for the inhibitory action of tumor.
3, the inventor makes up Radix Astragali Semen Alpiniae Katsumadai water boiling concentration extract, astragalus polysaccharides and Semen Alpiniae Katsumadai ethyl acetate extract originally, and determine consumption proportion between these components by great many of experiments, make said composition bring into play good synergism, obtain unexpected effect.Pass through our repeatedly experimentation, ratio between each component of natural drug extract of the present invention has produced unexpected synergism when 2-8:3-9:2-3, potentiation is obvious, extraordinary effect is played in side effect, especially especially obvious when the usage ratio of each component is 8:9:3, this is that the inventor pays a large amount of creative works by keeping punching and obtains on the paper basis of delivering before, and those of ordinary skills only can't simply obtain this ratio range and optimum amount ratio by disclosed content.
4, this natural drug extract Radix Astragali Semen Alpiniae Katsumadai water boiling concentration extract, astragalus polysaccharides and each component of Semen Alpiniae Katsumadai ethyl acetate extract all can obtain by conventional means, some of them component for example astragalus polysaccharides and Semen Alpiniae Katsumadai ethyl acetate extract also can be buied by commerce, and such compositions itself has and obtains convenient, lower-cost effect.This also is the product that has splendid curative effect and higher industrial practicality concurrently that the inventor obtains by a large amount of creative work sides.
The specific embodiment
Further set forth the preparation of natural drug extract of the present invention below by embodiment and test example, with and the beneficial effect in diarrhea and antitumor, used.
Embodiment
The first step: the preparation of various extracts
(1) preparation of Radix Astragali Semen Alpiniae Katsumadai water boiling concentration extract
Be 1-6 according to proportion compatibility: 1 gets the Radix Astragali, Semen Alpiniae Katsumadai, distilled water immersion, and heating decocts, and filters, and medicinal residues are adding distil water again, soaks, decocts, filters with method, and twice filtrate is mixed, and heating is concentrated, ultrafiltration membrance filter, drying under reduced pressure, and get final product.
(2) preparation of astragalus polysaccharides
The Radix Astragali is pulverized, and with drying behind the 95% ethanol extraction saponin, adds distilled water, dropwise add saturated limewater, adjust pH leaves standstill 10min with the moistening material, microwave radiation 1min, radiation 1min again behind the 1min of interval filters to get extracting solution, repeat aforesaid operations 2-3 time, merge extractive liquid,, concentrated, regulate pH=7 with 10% hydrochloric acid, add 95% ethanol, wash out polysaccharide, filter, washing with alcohol is drying to obtain astragalus polysaccharides.
(3) Semen Alpiniae Katsumadai ethyl acetate extract preparation
The Semen Alpiniae Katsumadai of drying is pulverized, crossed the 20-40 mesh sieve, with 70% industrial alcohol heating and refluxing extraction 3 times, each 2 h, decompression and solvent recovery gets dry extract, extractum is put to room temperature after being diluted to suspension with hot water, with ethyl acetate extraction, reclaims solvent, drying is pulverized, and sieves, and get final product.
Second step: the preparation of preparation
(1) preparation of natural drug extract capsule preparation of the present invention
Take by weighing respectively Radix Astragali Semen Alpiniae Katsumadai water boiling concentration extract 30mg, astragalus polysaccharides 40mg and the Semen Alpiniae Katsumadai ethyl acetate extract 30mg of above-mentioned steps preparation, take by weighing simultaneously starch 395mg, magnesium stearate 5mg, evenly mix, be filled to capsule.
(2) preparation of natural drug extract tablet of the present invention
Take by weighing respectively Radix Astragali Semen Alpiniae Katsumadai water boiling concentration extract 30mg, astragalus polysaccharides 40mg and the Semen Alpiniae Katsumadai ethyl acetate extract 30mg of above-mentioned steps preparation, take by weighing simultaneously starch 295mg, lactose 100mg, evenly mix, with wet granulation, drying, mix with the 5mg magnesium stearate behind the granulate, be pressed into tablet.
Drug effect and pharmacology's data:
Compositions is in following test example: the usage ratio of Radix Astragali Semen Alpiniae Katsumadai water boiling concentration extract, astragalus polysaccharides and Semen Alpiniae Katsumadai ethyl acetate extract is 8:9:3.Inventor's compositions that the multiple proportioning combination between 2-8:3-9:2-3 the time obtains to above-mentioned each composition usage ratio carried out with on identical experiment, find that all the natural drug extract in this amount ranges can obtain good synergism, can play good effect and the treatment of cancer is had potentiation the cancer chemotherapy induced diarrhea.Below be the pharmacodynamics data that preferred embodiment obtains:
Test example 1: the pharmacodynamic study of natural drug extract for treating Chemotherapy-induced Diarrhea effect
1, test material
(1) Radix Astragali, Semen Alpiniae Katsumadai is purchased from medical material market.
(2) mice, male, ad lib drinking-water before the experiment.
2, test method:
Mice is divided into 5 groups at random, and 5 every group, the A group is model group, and the B group is Radix Astragali Semen Alpiniae Katsumadai water boiling concentration extract 10g.kg
-1(being equivalent to contain the crude drug amount), the C group is astragalus polysaccharides 10g.kg
-1(being equivalent to contain the crude drug amount), D group Semen Alpiniae Katsumadai ethyl acetate extract 10g.kg
-1(being equivalent to contain the crude drug amount), the E group is natural drug extract 10g.kg of the present invention
-1(being equivalent to contain the crude drug amount), irinotecan intraperitoneal injection (75mg/kg), continuous 4 days, copies the Chemotherapy-induced Diarrhea model at every day 1 time.B, C, D, E group with corresponding extract gavage 8 days, places metabolic cage with mice continuously, spreads white filter paper at the bottom of the cage observing the stool situation, and observes mice crissum situation and Mus tail fecal pollution situation, and in conjunction with cotton swab stimulation anus defecation, every day, observed and recorded was 2 times.Diarrhoea degree standard scoring is as follows: 0 minute: stool is normal or do not have; 1 minute: laxativeness, stool is visible slight wet soft; 2 minutes: moderate diarrhoea, stool wet and not molding.And there is slight crissum painted; 3 minutes, severe diarrhoea, watery stool is also painted with the severe crissum.
3, experimental result
Compare with model group, natural drug extract group Incidence of Diarrhea of the present invention obviously alleviates.The results are shown in Table 1.
Table 1 present composition is on mice Chemotherapy-induced Diarrhea incidence rate and scoring impact
Annotate: a is equivalent to contain the crude drug amount
Test example 2: the pharmacodynamic study of natural drug extract antitumor action of the present invention
1, experiment material
(1) Kunming mouse, body weight 20 ± 2g, ad lib drinking-water before the experiment, 24h natural light irradiation.
(2) cyclophosphamide, the permanent auspicious medical Pharmacy stock Co., Ltd in Jiangsu product.
2, test method:
To mice S
180The inhibition test of sarcoma growth
Employing was gone down to posterity 5-7 days, and well-grown milky ascites is diluted to tumor cell suspension with an amount of physiological saline solution, and cell number is 10
7/ mL, 5 every group, the right axillary fossa subcutaneous vaccination of every Mus 0.2mL(contains oncocyte 2 * 10
6Individual).The inoculation next day random packet, experimental group natural drug extract of the present invention is divided into (200,100mg/mL) two dosage groups, every Mus gavage 0.5 ml gives cyclophosphamide 10gkg simultaneously
-1D
-1Negative control group gives 0.5 mL distilled water; The positive drug group gives cyclophosphamide 10gkg
-1D
-1, successive administration 10 days.The conventional raising, drinking-water, food is not limit.Drug withdrawal next day, mice all takes off cervical vertebra puts to death, and strips subcutaneous solid tumor tumor piece, weighs, and calculates tumor control rate (%) by following formula:
Tumor control rate=(the average tumor of the matched group average tumor of heavy (C)-experimental group heavy (T))/average tumor of matched group heavy (C)
3, result of the test
Natural drug extract of the present invention is low, high dose group all can strengthen the cyclophosphamide agent with to S
180The effect of inhibition degree, especially the strongest with the high dose group effect.(such as table 2)
Table 2 natural drug extract of the present invention is to S
180The tumor inhibition effect of mice
| Group | Suppression ratio (%) |
| Cyclophosphamide | 32.5 |
| Compositions is low+cyclophosphamide | 37.1 |
| Height+cyclophosphamide | 45.6 |
Claims (5)
1. one kind is reduced the cancer chemotherapy induced diarrhea and the treatment cancer is played the natural drug extract of potentiation, it is characterized in that said composition is made of in the ratio of 2-8:3-9:2-3 by weight Radix Astragali Semen Alpiniae Katsumadai water boiling concentration extract, astragalus polysaccharides and Semen Alpiniae Katsumadai ethyl acetate extract
Wherein the preparation method of Radix Astragali Semen Alpiniae Katsumadai water boiling concentration extract is:
Be 1-6 according to proportion compatibility: 1 gets the Radix Astragali, Semen Alpiniae Katsumadai, distilled water immersion, and heating decocts, and filters, and medicinal residues are adding distil water again, soaks, decocts, filters with method, and twice filtrate is mixed, and heating is concentrated, ultrafiltration membrance filter, drying under reduced pressure, and get final product;
Wherein the preparation method of astragalus polysaccharides is:
The Radix Astragali is pulverized, and with drying behind the 95% ethanol extraction saponin, adds distilled water, dropwise add saturated limewater, adjust pH leaves standstill 10min with the moistening material, microwave radiation 1min, radiation 1min again behind the 1min of interval filters to get extracting solution, repeat aforesaid operations 2-3 time, merge extractive liquid,, concentrated, regulate pH=7 with 10% hydrochloric acid, add 95% ethanol, wash out polysaccharide, filter, washing with alcohol is drying to obtain;
Wherein the preparation method of Semen Alpiniae Katsumadai ethyl acetate extract is:
The Semen Alpiniae Katsumadai of drying is pulverized, crossed the 20-40 mesh sieve, with 70% industrial alcohol heating and refluxing extraction 3 times, each 2 h, decompression and solvent recovery gets dry extract, extractum is put to room temperature after being diluted to suspension with hot water, with ethyl acetate extraction, reclaims solvent, drying is pulverized, and sieves, and get final product.
2. natural drug extract as claimed in claim 1 is characterized in that wherein the usage ratio of Radix Astragali Semen Alpiniae Katsumadai water boiling concentration extract, astragalus polysaccharides and Semen Alpiniae Katsumadai ethyl acetate extract is 8:9:3.
3. such as the preparation method of the natural drug extract of claim 1 or 2, it is characterized in that the method comprises:
(1) preparation of Radix Astragali Semen Alpiniae Katsumadai water boiling concentration extract
Be 1-6 according to proportion compatibility: 1 gets the Radix Astragali, Semen Alpiniae Katsumadai, distilled water immersion, and heating decocts, and filters, and medicinal residues are adding distil water again, soaks, decocts, filters with method, and twice filtrate is mixed, and heating is concentrated, ultrafiltration membrance filter, drying under reduced pressure, and get final product;
(2) preparation of astragalus polysaccharides
The Radix Astragali is pulverized, and with drying behind the 95% ethanol extraction saponin, adds distilled water, dropwise add saturated limewater, adjust pH leaves standstill 10min with the moistening material, microwave radiation 1min, radiation 1min again behind the 1min of interval filters to get extracting solution, repeat aforesaid operations 2-3 time, merge extractive liquid,, concentrated, regulate pH=7 with 10% hydrochloric acid, add 95% ethanol, wash out polysaccharide, filter, washing with alcohol is drying to obtain;
(3) preparation of Semen Alpiniae Katsumadai ethyl acetate extract
The Semen Alpiniae Katsumadai of drying is pulverized, crossed the 20-40 mesh sieve, with 70% industrial alcohol heating and refluxing extraction 3 times, each 2 h, decompression and solvent recovery gets dry extract, extractum is put to room temperature after being diluted to suspension with hot water, with ethyl acetate extraction, reclaims solvent, drying is pulverized, and sieves, and get final product;
(4) choose in proportion Radix Astragali Semen Alpiniae Katsumadai water boiling concentration extract, astragalus polysaccharides evenly mixes with the Semen Alpiniae Katsumadai ethyl acetate extract, and get final product.
4. the preparation method of natural drug extract as claimed in claim 3 characterized by further comprising: the product that step (4) makes is further made capsule or the tablet that contains natural drug extract 100mg or 200mg specification by the pharmacy means of routine.
5. such as the purposes of each described natural drug extract of claim 1-2 in preparing the medicine that reduces the reaction of cancer chemotherapy induced diarrhea and the treatment cancer is played potentiation.
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| CN103656426A (en) * | 2013-12-11 | 2014-03-26 | 张宗升 | Natural pharmaceutical composition and preparation method thereof |
| EP3254686A1 (en) * | 2016-06-06 | 2017-12-13 | Charsire Biotechnology Corp. | Soybean seed extract, method for producing the same and uses thereof |
| JP2018087182A (en) * | 2016-11-10 | 2018-06-07 | フィトヘルス・コーポレイションＰｈｙｔｏｈｅａｌｔｈ Ｃｏｒｐｏｒａｔｉｏｎ | Method for enhancing effect of immunotherapy for cancer |
| US10543243B2 (en) | 2016-06-06 | 2020-01-28 | Charsire Biotechnology Corp. | Soybeam seed extract, method for producing the same and uses thereof |
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| EP3254686A1 (en) * | 2016-06-06 | 2017-12-13 | Charsire Biotechnology Corp. | Soybean seed extract, method for producing the same and uses thereof |
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Application publication date: 20131023 |