CN103655836A - Natural pharmaceutical composition, and preparation method and application thereof - Google Patents
Natural pharmaceutical composition, and preparation method and application thereof Download PDFInfo
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- CN103655836A CN103655836A CN201310664309.6A CN201310664309A CN103655836A CN 103655836 A CN103655836 A CN 103655836A CN 201310664309 A CN201310664309 A CN 201310664309A CN 103655836 A CN103655836 A CN 103655836A
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Abstract
The invention relates to a natural pharmaceutical composition, and a preparation method and application thereof. The natural pharmaceutical composition is composed of 2-7 parts of coptis/dried orange peel water decoction concentrated extract, 5-7 parts of berberine and 5-6 parts of nobiletin. The composition has curative effect on cancer chemotherapy related diarrhoea.
Description
Technical field
The present invention relates to a kind of natural drug composition, relate more specifically to a kind of natural drug composition being comprised of Rhizoma Coptidis Pericarpium Citri Reticulatae water boiling concentration extract, berberine and Nobiletin, the preparation method of this natural drug composition and this natural drug composition reduce the purposes in cancer chemotherapy induced diarrhea medicine in preparation.
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 cell toxicant antitumor drug, alone or combine with the toxicity such as all can cause that patient suffers from diarrhoea, and after chemotherapy of tumors, diarrhoea is again Chemotherapy-induced Diarrhea.In recent years along with chemotherapeutics emerging and applying 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 to CC, bring certain difficulty, 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, for the research of having loose bowels, attracts people's attention, but there is no at present the Chinese patent medicine that antagonism cancer chemotherapy has alleviating diarrhoea effect.Therefore, research and develop a kind of high-efficiency low-toxicity, cheap, the natural Chinese medicine that can be used for of being easy to promote alleviates cancer chemotherapy induced diarrhea becomes clinical problem demanding prompt solution.
Rhizoma Coptidis is the dry rhizome of ranunculaceae plant Rhizoma Coptidis Coptis chinensis Franch., Coptis deltoidea C.Y.Cheng et Hsiao Coptis deltoidea C. Y. Cheng et Hsiao or Coptis Teeta Wall Coptis teeta Wall., and hardship is cold.GUIXIN, spleen, stomach, liver, gallbladder, large intestine channel, the disease such as, dysentery damp and hot for the intestines and stomach.Pericarpium Citri Reticulatae, mature peel for rutaceae orange (Citrus reticulata Blanco) and variety thereof, have another name called Pericarpium Citri tangerinae, for fullness in the epigastrium and chest, lack of appetite and vomiting, cough ant phlegm, the inventor, through research and the experiment of each a large amount of formula proportion, has finally obtained optimal drug ratio compositions of the present invention, is the compositions of novelty, and proved that it is effective in cure to cancer chemotherapy induced diarrhea, completed thus the present invention.
Summary of the invention
A kind of natural drug composition provided by the invention, consists of in the ratio of 2-7:5-7:5-6 by weight Rhizoma Coptidis Pericarpium Citri Reticulatae water boiling concentration extract, berberine and Nobiletin.
Above-mentioned natural drug composition, wherein the usage ratio of Rhizoma Coptidis Pericarpium Citri Reticulatae water boiling concentration extract, berberine and Nobiletin is 7:7:6.
Wherein, Rhizoma Coptidis Pericarpium Citri Reticulatae water boiling concentration extract, berberine can be by well known to a person skilled in the art the conventional method acquisition of purifying, and the natural drug of the present invention that adopts these compositions that conventional method obtains or the one-tenth that adopts business to buy to be grouped into all can obtain identical curative effect.
Preferably, in above-mentioned natural drug composition, the preparation method of Rhizoma Coptidis Pericarpium Citri Reticulatae water boiling concentration extract is:
According to proportion compatibility, be that 1-5:1 gets Rhizoma Coptidis, Pericarpium Citri Reticulatae, distilled water immersion, heating decocts, and filters, and medicinal residues are adding distil water again, with method, soaks, decocts, filters, and twice filtrate is mixed, and heating is concentrated, ultrafiltration membrance filter, drying under reduced pressure, obtains.
In above-mentioned natural drug composition, the preparation method of berberine is:
Rhizoma Coptidis is pulverized, and adds ethanol, reflux, sucking filtration, filtering residue repeats aforesaid operations, merging filtrate, and decompression recycling ethanol, adds 1% acetic acid heating for dissolving, sucking filtration, drips concentrated hydrochloric acid to muddy in filtrate, cooling, sucking filtration, frozen water washed twice, once, heating water to solid just dissolves and boils washing with acetone, lime cream regulates pH to be 8.5～9.8, cooling, filters out impurities, be chilled to room temperature, sucking filtration, dries and get final product.
In above-mentioned natural drug composition, Nobiletin preparation method is:
Pericarpium Citri Reticulatae is pulverized, sieves, and petroleum ether reflux, extract, 2 times, merge extractive liquid,, reclaims petroleum ether, with the mixed solvent heating for dissolving of 2 kinds of solvent compositions of 0.25 times of amount, place, to be crystallized separating out completely, after filtration, at 80 ℃, dry, be extracted with ethyl acetate, concentrated, polyamide column chromatography, with the mixed solvent eluting of 2 kinds of solvent compositions, in conjunction with thin layer chromatography, collect containing Nobiletin eluent and volatilize solvent, recrystallizing methanol, obtains.
The present invention also provides the preferred preparation method of this natural drug composition, comprising:
(1) preparation of Rhizoma Coptidis Pericarpium Citri Reticulatae water boiling concentration extract
According to proportion compatibility, be that 1-5:1 gets Rhizoma Coptidis, Pericarpium Citri Reticulatae, distilled water immersion, heating decocts, and filters, and medicinal residues are adding distil water again, with method, soaks, decocts, filters, and twice filtrate is mixed, and heating is concentrated, ultrafiltration membrance filter, drying under reduced pressure, obtains.
(2) preparation of berberine
Rhizoma Coptidis is pulverized, and adds ethanol, reflux, sucking filtration, filtering residue repeats aforesaid operations, merging filtrate, and decompression recycling ethanol, adds 1% acetic acid heating for dissolving, sucking filtration, drips concentrated hydrochloric acid to muddy in filtrate, cooling, sucking filtration, frozen water washed twice, once, heating water to solid just dissolves and boils washing with acetone, lime cream regulates pH to be 8.5～9.8, cooling, filters out impurities, be chilled to room temperature, sucking filtration, dries and get final product.
(3) Nobiletin preparation
Pericarpium Citri Reticulatae is pulverized, sieves, and petroleum ether reflux, extract, 2 times, merge extractive liquid,, reclaims petroleum ether, with the mixed solvent heating for dissolving of 2 kinds of solvent compositions of 0.25 times of amount, place, to be crystallized separating out completely, after filtration, at 80 ℃, dry, be extracted with ethyl acetate, concentrated, polyamide column chromatography, with the mixed solvent eluting of 2 kinds of solvent compositions, in conjunction with thin layer chromatography, collect containing Nobiletin eluent and volatilize solvent, recrystallizing methanol, obtains.
(4) choose in proportion Rhizoma Coptidis Pericarpium Citri Reticulatae water boiling concentration extract, berberine and Nobiletin, evenly mix, obtain.
The preparation method of above-mentioned natural drug composition, also comprise: the product that step (4) is made further makes by conventional pharmacy means the capsule that contains natural drug composition 100mg or 200mg specification, maybe by the tablet of making by wet granulation technology containing natural drug composition 100mg or 200mg specification.
Natural drug composition of the present invention is as follows at the beneficial effect of anti-Chemotherapy-induced Diarrhea:
1, natural drug composition of the present invention, causes the research of diarrhea of mouse model to show at irinotecan: the diarrhoea reaction for irinotecan induced mice has obvious antagonism.
2, the inventor combines Rhizoma Coptidis Pericarpium Citri Reticulatae water boiling concentration extract, berberine and Nobiletin originally, and determines the consumption proportion between these components by great many of experiments, makes said composition bring into play good synergism, obtains unexpected effect.Pass through our experimentation repeatedly, ratio between each component of natural drug composition of the present invention has produced unexpected synergism when 2-7:5-7:5-6, potentiation is obvious, especially especially obvious when the usage ratio of each component is 7:7:6, this is that the inventor pays a large amount of creative works and obtains, and those of ordinary skills only cannot simply obtain this ratio range and optimum amount ratio by disclosed content.
3, this natural drug composition Rhizoma Coptidis Pericarpium Citri Reticulatae water boiling concentration extract, berberine and each component of Nobiletin all can obtain by conventional means, and berberine also can be buied by business, and such compositions itself has the convenience of acquisition, lower-cost effect.This is also the product that has splendid curative effect and higher industrial practicality concurrently that inventor obtains by a large amount of creative work sides.
The specific embodiment
Below by embodiment and test example, further set forth the preparation of natural drug composition of the present invention, with and at the beneficial effect of anti-Chemotherapy-induced Diarrhea.
Embodiment
The first step: the preparation of various extracts
(1) preparation of Rhizoma Coptidis Pericarpium Citri Reticulatae water boiling concentration extract
According to proportion compatibility, be that 1-5:1 gets Rhizoma Coptidis, Pericarpium Citri Reticulatae, distilled water immersion, heating decocts, and filters, and medicinal residues are adding distil water again, with method, soaks, decocts, filters, and twice filtrate is mixed, and heating is concentrated, ultrafiltration membrance filter, drying under reduced pressure, obtains.
(2) preparation of berberine
Rhizoma Coptidis is pulverized, and adds ethanol, reflux, sucking filtration, filtering residue repeats aforesaid operations, merging filtrate, and decompression recycling ethanol, adds 1% acetic acid heating for dissolving, sucking filtration, drips concentrated hydrochloric acid to muddy in filtrate, cooling, sucking filtration, frozen water washed twice, once, heating water to solid just dissolves and boils washing with acetone, lime cream regulates pH to be 8.5～9.8, cooling, filters out impurities, be chilled to room temperature, sucking filtration, dries and get final product.
(3) Nobiletin preparation
Pericarpium Citri Reticulatae is pulverized, sieves, and petroleum ether reflux, extract, 2 times, merge extractive liquid,, reclaims petroleum ether, with the mixed solvent heating for dissolving of 2 kinds of solvent compositions of 0.25 times of amount, place, to be crystallized separating out completely, after filtration, at 80 ℃, dry, be extracted with ethyl acetate, concentrated, polyamide column chromatography, with the mixed solvent eluting of 2 kinds of solvent compositions, in conjunction with thin layer chromatography, collect containing Nobiletin eluent and volatilize solvent, recrystallizing methanol, obtains.
Second step: the preparation of preparation
(1) preparation of natural drug composition capsule preparations of the present invention
Take respectively Rhizoma Coptidis Pericarpium Citri Reticulatae water boiling concentration extract 35mg, berberine 35mg and Nobiletin 30mg prepared by above-mentioned steps, take starch 395mg, magnesium stearate 5mg simultaneously, evenly mix filled capsules.
(2) preparation of natural drug composition tablet of the present invention
Take respectively Rhizoma Coptidis Pericarpium Citri Reticulatae water boiling concentration extract 35mg, berberine 35mg and Nobiletin 30mg prepared by above-mentioned steps, take starch 295mg, lactose 100mg simultaneously, evenly mix, with wet granulation, dry, after granulate, mix tabletting with 5mg magnesium stearate.
Drug effect and pharmacology's data:
In following test example, compositions is: the usage ratio of Rhizoma Coptidis Pericarpium Citri Reticulatae water boiling concentration extract, berberine and Nobiletin is 7:7:6.Inventor's compositions that the multiple proportioning combination between 2-7:5-7:5-6 time obtains to above-mentioned each composition usage ratio carried out with on identical experiment, all find that the natural drug composition in this amount ranges can obtain good synergism, can play good effect to cancer chemotherapy induced diarrhea.Below the pharmacodynamics data preferred embodiment obtaining:
Test example: the pharmacodynamic study of natural drug composition treatment Chemotherapy-induced Diarrhea effect
1, test material
(1) Rhizoma Coptidis, Pericarpium Citri Reticulatae, is purchased from medical material market.
(2) mice, male, ad lib drinking-water before experiment.
2, test method:
Mice is divided into 5 groups at random, and 5 every group, A group is model group, and B group is Rhizoma Coptidis Pericarpium Citri Reticulatae water boiling concentration extract 10g.kg
-1(being equivalent to containing crude drug amount), C group is berberine 10g.kg
-1(being equivalent to containing crude drug amount), D group Nobiletin 10g.kg
-1(being equivalent to containing crude drug amount), E group is natural drug composition 10g.kg of the present invention
-1(being equivalent to containing crude drug amount), irinotecan intraperitoneal injection (75mg/kg), every day 1 time, continuous 4 days, copies Chemotherapy-induced Diarrhea model.B, C, D, E group by corresponding extract gavage 8 days, is placed in metabolic cage by mice continuously, spreads white filter paper to observe stool situation, and observe mice crissum situation and Mus tail fecal pollution situation at the bottom of cage, and in conjunction with cotton swab stimulation anus defecation, every day, observed and recorded was 2 times.The scoring of diarrhoea degree standard is as follows: 0 minute: defecate normal or do not have; 1 minute: laxativeness, stool is visible slight wet soft; 2 minutes: moderate diarrhoea, stool wets and not molding.And there is slight crissum painted; 3 minutes, severe diarrhoea, watery stool is also painted with severe crissum.
3, experimental result
With model group comparison, natural drug 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
Note: a is equivalent to containing crude drug amount.
Claims (5)
1. reduce a natural drug composition for cancer chemotherapy induced diarrhea, it is characterized in that said composition consists of in the ratio of 2-7:5-7:5-6 by weight Rhizoma Coptidis Pericarpium Citri Reticulatae water boiling concentration extract, berberine and Nobiletin,
Wherein the preparation method of Rhizoma Coptidis Pericarpium Citri Reticulatae water boiling concentration extract is:
According to proportion compatibility, be that 1-5:1 gets Rhizoma Coptidis, Pericarpium Citri Reticulatae, distilled water immersion, heating decocts, and filters, and medicinal residues are adding distil water again, with method, soaks, decocts, filters, and twice filtrate is mixed, and heating is concentrated, ultrafiltration membrance filter, drying under reduced pressure, obtains;
Wherein the preparation method of berberine is:
Rhizoma Coptidis is pulverized, and adds ethanol, reflux, sucking filtration, filtering residue repeats aforesaid operations, merging filtrate, and decompression recycling ethanol, adds 1% acetic acid heating for dissolving, sucking filtration, drips concentrated hydrochloric acid to muddy in filtrate, cooling, sucking filtration, frozen water washed twice, once, heating water to solid just dissolves and boils washing with acetone, lime cream regulates pH to be 8.5～9.8, cooling, filters out impurities, be chilled to room temperature, sucking filtration, dries and get final product;
Wherein the preparation method of Nobiletin is:
Pericarpium Citri Reticulatae is pulverized, sieves, and petroleum ether reflux, extract, 2 times, merge extractive liquid,, reclaims petroleum ether, with the mixed solvent heating for dissolving of 2 kinds of solvent compositions of 0.25 times of amount, place, to be crystallized separating out completely, after filtration, at 80 ℃, dry, be extracted with ethyl acetate, concentrated, polyamide column chromatography, with the mixed solvent eluting of 2 kinds of solvent compositions, in conjunction with thin layer chromatography, collect containing Nobiletin eluent and volatilize solvent, recrystallizing methanol, obtains.
2. natural drug composition as claimed in claim 1, wherein the usage ratio of Rhizoma Coptidis Pericarpium Citri Reticulatae water boiling concentration extract, berberine and Nobiletin is 7:7:6.
3. the preparation method of natural drug composition as claimed in claim 1 or 2, is characterized in that the method comprises:
(1) preparation of Rhizoma Coptidis Pericarpium Citri Reticulatae water boiling concentration extract
According to proportion compatibility, be that 1-5:1 gets Rhizoma Coptidis, Pericarpium Citri Reticulatae, distilled water immersion, heating decocts, and filters, and medicinal residues are adding distil water again, with method, soaks, decocts, filters, and twice filtrate is mixed, and heating is concentrated, ultrafiltration membrance filter, drying under reduced pressure, obtains;
(2) preparation of berberine
Rhizoma Coptidis is pulverized, and adds ethanol, reflux, sucking filtration, filtering residue repeats aforesaid operations, merging filtrate, and decompression recycling ethanol, adds 1% acetic acid heating for dissolving, sucking filtration, drips concentrated hydrochloric acid to muddy in filtrate, cooling, sucking filtration, frozen water washed twice, once, heating water to solid just dissolves and boils washing with acetone, lime cream regulates pH to be 8.5～9.8, cooling, filters out impurities, be chilled to room temperature, sucking filtration, dries and get final product;
(3) preparation of Nobiletin
Pericarpium Citri Reticulatae is pulverized, sieves, and petroleum ether reflux, extract, 2 times, merge extractive liquid,, reclaims petroleum ether, with the mixed solvent heating for dissolving of 2 kinds of solvent compositions of 0.25 times of amount, place, to be crystallized separating out completely, after filtration, at 80 ℃, dry, be extracted with ethyl acetate, concentrated, polyamide column chromatography, with the mixed solvent eluting of 2 kinds of solvent compositions, in conjunction with thin layer chromatography, collect containing Nobiletin eluent and volatilize solvent, recrystallizing methanol, obtains;
(4) choose in proportion Rhizoma Coptidis Pericarpium Citri Reticulatae water boiling concentration extract, berberine evenly mixes with Nobiletin, obtain.
4. the preparation method of natural drug composition as claimed in claim 3, also comprise: the product that step (4) is made further makes by conventional pharmacy means the capsule that contains natural drug composition 100mg or 200mg specification, maybe by the tablet of making by wet granulation technology containing natural drug composition 100mg or 200mg specification.
5. the natural drug composition as described in claim 1-2 any one reduces the purposes in cancer chemotherapy induced diarrhea medicine in preparation.
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103223042A (en) * | 2013-03-27 | 2013-07-31 | 张宗升 | Traditional chinese medicine composition |
| CN103316112A (en) * | 2013-07-04 | 2013-09-25 | 石强 | Natural pharmaceutical composition |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103223042A (en) * | 2013-03-27 | 2013-07-31 | 张宗升 | Traditional chinese medicine composition |
| CN103316112A (en) * | 2013-07-04 | 2013-09-25 | 石强 | Natural pharmaceutical composition |
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Application publication date: 20140326 |