CN103316115A - Traditional Chinese medicinal composition and preparation method thereof - Google Patents

Traditional Chinese medicinal composition and preparation method thereof Download PDF

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CN103316115A
CN103316115A CN2013102909442A CN201310290944A CN103316115A CN 103316115 A CN103316115 A CN 103316115A CN 2013102909442 A CN2013102909442 A CN 2013102909442A CN 201310290944 A CN201310290944 A CN 201310290944A CN 103316115 A CN103316115 A CN 103316115A
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fructus mume
galla chinensis
extract
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chinese medicine
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石强
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Abstract

The invention relates to a traditional Chinese medicinal composition and a preparation method thereof. The traditional Chinese medicinal composition is composed of a dark plum and Chinese gall water decoction and concentration extract, a dark plum ethanol extract and a Chinese gall acetone extract according to a ratio of 1-5:3-7:4-8. The composition has an extremely good curative effect on the cancer chemotherapy related diarrhoea and has a synergistic effect on the cancer chemotherapy.

Description

A kind of Chinese medicine composition and preparation method thereof
Technical field
The present invention relates to a kind of Chinese medicine composition, relate more specifically to a kind of Chinese medicine composition that is comprised of Fructus Mume Galla Chinensis water boiling concentration extract, Fructus Mume ethanol extraction and Galla Chinensis acetone extract, the preparation method of this Chinese medicine composition and this Chinese medicine composition 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 no matter 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, and 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.
Fructus Mume is that the dry almost ripe fruit by rose department plant plum processes, and can astringe the lung astringing intestine to stop diarrhea.Be used for chronic diarrhea; Dysentery; The diseases such as vomiting.Galla Chinensis comes from supplementary Amplifications of the Compendium of Materia Medica, and is cold in nature, and sour in the mouth, puckery is returned large intestine channel; Liver Channel; Kidney channel can be astringed the lung astringing intestine to stop diarrhea.Cure mainly the chronic dysentery chronic diarrhea.In recent years, Fructus Mume and Galla Chinensis 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 play simultaneously the effect that suppresses tumor the cancer chemotherapy induced diarrhea, has finished the present invention thus.
Summary of the invention
A kind of Chinese medicine composition provided by the invention is made of in the ratio of 1-5:3-7:4-8 by weight Fructus Mume Galla Chinensis water boiling concentration extract, Fructus Mume ethanol extraction and Galla Chinensis acetone extract.
Above-mentioned Chinese medicine composition, wherein the usage ratio of Fructus Mume Galla Chinensis water boiling concentration extract, Fructus Mume ethanol extraction and Galla Chinensis acetone extract is 5:7:8.
Wherein, Fructus Mume Galla Chinensis water boiling concentration extract, Fructus Mume ethanol extraction 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 Fructus Mume Galla Chinensis water boiling concentration extract is in the above-mentioned Chinese medicine composition:
Be that 1-5:1 gets Fructus Mume, Galla Chinensis according to proportion compatibility, distilled water immersion, 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 Fructus Mume ethanol extraction is in the above-mentioned Chinese medicine composition:
The Fructus Mume of drying is pulverized, sieved, 75% alcohol reflux filters, and medicinal residues add 75% alcohol reflux, filter, 2 filtrates are merged, centrifugal 15 minutes of 3000rpm, separation of supernatant, water bath method is concentrated, drying under reduced pressure becomes dry extract again, pulverizes, and sieves, and get final product.
Galla Chinensis acetone extract preparation method is in the above-mentioned Chinese medicine composition:
Galla Chinensis is pulverized, and adds acetone, the water-bath lixiviate, and crude extract filters, and slowly drips 1% CaCl behind the activated carbon decolorizing 2Until no longer produce precipitation, the centrifugal 15min of 10000r/min gets precipitation, drips 0.01mol/L HCl until precipitation is dissolved fully, the bag filter of packing into, and dialysis 48h, the rotary evaporation postlyophilization, and get final product.
The present invention also provides the preferred preparation method of this Chinese medicine composition, comprising:
(1) preparation of Fructus Mume Galla Chinensis water boiling concentration extract
Be that 1-5:1 gets Fructus Mume, Galla Chinensis according to proportion compatibility, distilled water immersion, 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 Fructus Mume ethanol extraction
The Fructus Mume of drying is pulverized, sieved, 75% alcohol reflux filters, and medicinal residues add 75% alcohol reflux, filter, 2 filtrates are merged, centrifugal 15 minutes of 3000rpm, separation of supernatant, water bath method is concentrated, drying under reduced pressure becomes dry extract again, pulverizes, and sieves, and get final product.
(3) Galla Chinensis acetone extract preparation
Galla Chinensis is pulverized, and adds acetone, the water-bath lixiviate, and crude extract filters, and slowly drips 1% CaCl behind the activated carbon decolorizing 2Until no longer produce precipitation, the centrifugal 15min of 10000r/min gets precipitation, drips 0.01mol/L HCl until precipitation is dissolved fully, the bag filter of packing into, and dialysis 48h, the rotary evaporation postlyophilization, and get final product.
(4) choose in proportion Fructus Mume Galla Chinensis water boiling concentration extract, Fructus Mume ethanol extraction and Galla Chinensis acetone extract, evenly mix, and get final product.
The preparation method of above-mentioned Chinese medicine composition also comprises: the product that step (4) makes is further made capsule or the tablet that contains Chinese medicine composition 100mg or 200mg specification by the pharmacy means of routine.
The beneficial effect of Chinese medicine composition of the present invention aspect anti-Chemotherapy-induced Diarrhea and inhibition tumor is as follows:
1, Chinese medicine composition 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 Chinese medicine composition can strengthen chemotherapeutics to the inhibitory action of tumor, adopted mouse tumor model, observed this Chinese medicine composition and cyclophosphamide combined to the inhibitory action of mouse interior tumor.Studies show that: this Chinese medicine composition can obviously increase cyclophosphamide for the inhibitory action of tumor.
3, the inventor makes up Fructus Mume Galla Chinensis water boiling concentration extract, Fructus Mume ethanol extraction and Galla Chinensis acetone 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 Chinese medicine composition of the present invention has produced unexpected synergism when 1-5:3-7:4-8, potentiation is obvious, extraordinary effect is played in side effect, especially especially obvious when the usage ratio of each component is 5:7:8, this is that the inventor pays a large amount of creative works and obtains, and those of ordinary skills only can't simply obtain this ratio range and optimum amount ratio by disclosed content.
4, this Chinese medicine composition Fructus Mume Galla Chinensis water boiling concentration extract, Fructus Mume ethanol extraction and each component of Galla Chinensis acetone extract all can obtain by conventional means, and such compositions itself has the convenience of acquisition, 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 Chinese medicine composition 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 Fructus Mume Galla Chinensis water boiling concentration extract
Be that 1-5:1 gets Fructus Mume, Galla Chinensis according to proportion compatibility, distilled water immersion, 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 Fructus Mume ethanol extraction
The Fructus Mume of drying is pulverized, sieved, 75% alcohol reflux filters, and medicinal residues add 75% alcohol reflux, filter, 2 filtrates are merged, centrifugal 15 minutes of 3000rpm, separation of supernatant, water bath method is concentrated, drying under reduced pressure becomes dry extract again, pulverizes, and sieves, and get final product.
(3) Galla Chinensis acetone extract preparation
Galla Chinensis is pulverized, and adds acetone, the water-bath lixiviate, and crude extract filters, and slowly drips 1% CaCl behind the activated carbon decolorizing 2Until no longer produce precipitation, the centrifugal 15min of 10000r/min gets precipitation, drips 0.01mol/L HCl until precipitation is dissolved fully, the bag filter of packing into, and dialysis 48h, the rotary evaporation postlyophilization, and get final product.
Second step: the preparation of preparation
(1) preparation of Chinese medicinal composition capsules preparation of the present invention
Take by weighing respectively Fructus Mume Galla Chinensis water boiling concentration extract 25mg, Fructus Mume ethanol extraction 35mg and the Galla Chinensis acetone extract 40mg of above-mentioned steps preparation, take by weighing simultaneously starch 395mg, magnesium stearate 5mg, evenly mix, fill and make capsule.
(2) preparation of Chinese medicine composition tablet of the present invention
Take by weighing respectively Fructus Mume Galla Chinensis water boiling concentration extract 25mg, Fructus Mume ethanol extraction 35mg and the Galla Chinensis acetone extract 40mg 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 Fructus Mume Galla Chinensis water boiling concentration extract, Fructus Mume ethanol extraction and Galla Chinensis acetone extract is 5:7:8.Inventor's compositions that the multiple proportioning combination between 1-5:3-7:4-8 the time obtains to above-mentioned each composition usage ratio carried out with on identical experiment, find that all the Chinese medicine composition 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 traditional Chinese medicine composition for treating Chemotherapy-induced Diarrhea effect
1, test material
(1) Fructus Mume, Galla Chinensis 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 Fructus Mume Galla Chinensis water boiling concentration extract 10g.kg -1(being equivalent to contain the crude drug amount), the C group is Fructus Mume ethanol extraction 10g.kg -1(being equivalent to contain the crude drug amount), D group Galla Chinensis acetone extract 10g.kg -1(being equivalent to contain the crude drug amount), the E group is Chinese medicine composition 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, Chinese medicine composition 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
Figure 2013102909442100002DEST_PATH_IMAGE001
Annotate: a is equivalent to contain the crude drug amount
Test example 2: the pharmacodynamic study of Chinese medicine composition 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 Chinese medicine composition 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
Chinese medicine composition 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 Chinese medicine composition of the present invention is to S 180The tumor inhibition effect of mice
Group Suppression ratio (%)
Cyclophosphamide 32.5
Compositions is low+cyclophosphamide 44.1
Height+cyclophosphamide 56.7

Claims (5)

1. one kind is reduced the cancer chemotherapy induced diarrhea and the treatment cancer is played the Chinese medicine composition of potentiation, it is characterized in that said composition is made of in the ratio of 1-5:3-7:4-8 by weight Fructus Mume Galla Chinensis water boiling concentration extract, Fructus Mume ethanol extraction and Galla Chinensis acetone extract
Wherein the preparation method of Fructus Mume Galla Chinensis water boiling concentration extract is:
Be that 1-5:1 gets Fructus Mume, Galla Chinensis according to proportion compatibility, distilled water immersion, 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 Fructus Mume ethanol extraction is:
The Fructus Mume of drying is pulverized, sieved, 75% alcohol reflux filters, and medicinal residues add 75% alcohol reflux, filter, 2 filtrates are merged, centrifugal 15 minutes of 3000rpm, separation of supernatant, water bath method is concentrated, drying under reduced pressure becomes dry extract again, pulverizes, and sieves, and get final product;
Wherein the preparation method of Galla Chinensis acetone extract is:
Galla Chinensis is pulverized, and adds acetone, the water-bath lixiviate, and crude extract filters, and slowly drips 1% CaCl behind the activated carbon decolorizing 2Until no longer produce precipitation, the centrifugal 15min of 10000r/min gets precipitation, drips 0.01mol/L HCl until precipitation is dissolved fully, the bag filter of packing into, and dialysis 48h, the rotary evaporation postlyophilization, and get final product.
2. Chinese medicine composition as claimed in claim 1 is characterized in that wherein the usage ratio of Fructus Mume Galla Chinensis water boiling concentration extract, Fructus Mume ethanol extraction and Galla Chinensis acetone extract is 5:7:8.
3. such as the preparation method of the Chinese medicine composition of claim 1 or 2, it is characterized in that the method comprises:
(1) preparation of Fructus Mume Galla Chinensis water boiling concentration extract
Be that 1-5:1 gets Fructus Mume, Galla Chinensis according to proportion compatibility, distilled water immersion, 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 Fructus Mume ethanol extraction
The Fructus Mume of drying is pulverized, sieved, 75% alcohol reflux filters, and medicinal residues add 75% alcohol reflux, filter, 2 filtrates are merged, centrifugal 15 minutes of 3000rpm, separation of supernatant, water bath method is concentrated, drying under reduced pressure becomes dry extract again, pulverizes, and sieves, and get final product;
(3) preparation of Galla Chinensis acetone extract
Galla Chinensis is pulverized, and adds acetone, the water-bath lixiviate, and crude extract filters, and slowly drips 1% CaCl behind the activated carbon decolorizing 2Until no longer produce precipitation, the centrifugal 15min of 10000r/min gets precipitation, drips 0.01mol/L HCl until precipitation is dissolved fully, the bag filter of packing into, and dialysis 48h, the rotary evaporation postlyophilization, and get final product;
(4) choose in proportion Fructus Mume Galla Chinensis water boiling concentration extract, the Fructus Mume ethanol extraction evenly mixes with the Galla Chinensis acetone extract, and get final product.
4. the preparation method of Chinese medicine composition as claimed in claim 3, characterized by further comprising: the product that step (4) makes is further made the capsule that contains Chinese medicine composition 100mg or 200mg specification by the pharmacy means of routine, maybe will make the tablet that contains Chinese medicine composition 100mg or 200mg specification by wet granulation technology.
5. such as the purposes of each described Chinese medicine composition 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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CN103655976A (en) * 2013-12-14 2014-03-26 张宗升 Natural composition and preparation method thereof

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CN103655976A (en) * 2013-12-14 2014-03-26 张宗升 Natural composition and preparation method thereof

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Application publication date: 20130925