CN103263493A - Traditional Chinese medicine composition and preparation method thereof - Google Patents
Traditional Chinese medicine composition and preparation method thereof Download PDFInfo
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- CN103263493A CN103263493A CN2013101736997A CN201310173699A CN103263493A CN 103263493 A CN103263493 A CN 103263493A CN 2013101736997 A CN2013101736997 A CN 2013101736997A CN 201310173699 A CN201310173699 A CN 201310173699A CN 103263493 A CN103263493 A CN 103263493A
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Abstract
The invention relates to a natural pharmaceutical composition and a preparation method thereof, and application of the natural pharmaceutical composition in preparation of attenuated synergistic medicines in cancer chemotherapy. The natural pharmaceutical composition is composed of coptis/nutgall water-decocted concentrated extract, berberine and nutgall acetone extract in a ratio of (6-9):(3-8):(1-3). The composition has excellent curative effects on diarrhoea related to cancer chemotherapy, and meanwhile, has a synergistic action on cancer chemotherapy.
Description
Technical field
The present invention relates to a kind of natural drug composition, relate more specifically to a kind of natural drug composition of being made up of Rhizoma Coptidis Galla Chinensis water boiling concentration extract, berberine and Galla Chinensis acetone extract, the preparation method of this natural drug composition and this natural drug composition are for the preparation of reducing cancer chemotherapy dependency diarrhoea 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.The chemotherapy prescription with or unite with toxicity such as all can cause that the patient suffers from diarrhoea, diarrhoea makes the chemotherapy dependency suffer from diarrhoea again behind the chemotherapy of tumors.Emerging and applying along with chemotherapeutics such as 5-fluorouracil, taxanes, hydroxy camptothecin, irinotecan, xeloda etc. in recent years, the incidence rate of chemotherapy dependency diarrhoea improves year by year, and 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 dependency diarrhoea has been become the important component part of tumor patient wholistic therapy.
Chemotherapy dependency diarrhoea 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 at present still unmatchful anticancer disease chemotherapy have the Chinese patent medicine of 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 cancer chemotherapy dependency diarrhoea and playing the chemotherapeutic sensitivity effect that is easy to promote becomes clinical problem demanding prompt solution.
Rhizoma Coptidis is the dry rhizome of ranunculaceae plant Rhizoma Coptidis, Coptis deltoidea C.Y.Cheng et Hsiao or Coptis Teeta Wall, is used for diseases such as the intestines and stomach is damp and hot, dysentery.Galla Chinensis can be astringed the lung, and astringing intestine to stop diarrhea cures mainly the chronic dysentery chronic diarrhea.In recent years, Rhizoma Coptidis and Galla Chinensis antitumaous effect are confirmed, the inventor is through research and the experiment of each a large amount of formula proportion, obtained optimal drug ratio compositions of the present invention at last, and proved that it has fabulous curative effect and can finish the present invention thus simultaneously to chemotherapeutic sensitivity cancer chemotherapy dependency diarrhoea.
Summary of the invention
A kind of natural drug composition provided by the invention, by Rhizoma Coptidis Galla Chinensis water boiling concentration extract, berberine and Galla Chinensis acetone extract by weight in 6-9: the ratio of 3-8: 1-3 is formed.
Above-mentioned natural drug composition, wherein the usage ratio of Rhizoma Coptidis Galla Chinensis water boiling concentration extract, berberine and Galla Chinensis acetone extract is 9: 8: 3.
Wherein, Rhizoma Coptidis Galla Chinensis water boiling concentration extract, berberine 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, Rhizoma Coptidis Galla Chinensis water boiling concentration preparation method of extract is in the above-mentioned natural drug composition:
Be 1-5 according to proportion compatibility: 1 gets Rhizoma Coptidis, Galla Chinensis, adds 10 times of amount distilled water, soaks 1h, heating decocts 1h, silk filters, and preserves filtrate, and medicinal residues add 6 times of distilled water again, soak, decoct, filter with method, twice filtrate is mixed, and heating is concentrated into small size, ultrafiltration membrance filter, adopt 70 ℃ of drying under reduced pressure 36h of vacuum drying oven to get yellow powder, namely.
The preparation method of berberine is in the above-mentioned natural drug composition:
Rhizoma Coptidis is pulverized, and adds ethanol, heating in water bath backflow 0.5h, sucking filtration, filtering residue repeats aforesaid operations 2 times, merging filtrate, decompression recycling ethanol, add 1% acetic acid heating for dissolving, drip concentrated hydrochloric acid in the filtrate to muddy, cooling, sucking filtration, solid respectively washs once with frozen water and acetone, adds hot water and boils to just dissolving, regulating pH with lime cream is 8.5-9.8, and cooling filters out impurities, be chilled to room temperature, sucking filtration, oven dry is namely.
Galla Chinensis acetone extract preparation method is in the above-mentioned natural drug 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
2Till no longer producing precipitation, the centrifugal 15min of 10000r/min gets precipitation, drips 0.01mol/L HCl until precipitation dissolving fully, the bag filter of packing into, and dialysis 48h, the rotary evaporation postlyophilization, namely.
The present invention also provides the preferred manufacturing procedure of this natural drug composition, comprising:
(1) preparation of Rhizoma Coptidis Galla Chinensis water boiling concentration extract
Be 1-5 according to proportion compatibility: 1 gets Rhizoma Coptidis, Galla Chinensis, adds 10 times of amount distilled water, soaks 1h, heating decocts 1h, silk filters, and preserves filtrate, and medicinal residues add 6 times of distilled water again, soak, decoct, filter with method, twice filtrate is mixed, and heating is concentrated into small size, ultrafiltration membrance filter, adopt 70 ℃ of drying under reduced pressure 36h of vacuum drying oven to get yellow powder, namely.
(2) preparation of berberine
Rhizoma Coptidis is pulverized, and adds ethanol, heating in water bath backflow 0.5h, sucking filtration, filtering residue repeats aforesaid operations 2 times, merging filtrate, decompression recycling ethanol, add 1% acetic acid heating for dissolving, drip concentrated hydrochloric acid in the filtrate to muddy, cooling, sucking filtration, solid respectively washs once with frozen water and acetone, adds hot water and boils to just dissolving, regulating pH with lime cream is 8.5-9.8, and cooling filters out impurities, be chilled to room temperature, sucking filtration, oven dry is namely.
(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
2Till no longer producing precipitation, the centrifugal 15min of 10000r/min gets precipitation, drips 0.01mol/L HCl until precipitation dissolving fully, the bag filter of packing into, and dialysis 48h, the rotary evaporation postlyophilization, namely.
(4) choose Rhizoma Coptidis Galla Chinensis water boiling concentration extract, berberine and Galla Chinensis acetone extract in proportion, evenly mix, namely.
The preparation method of above-mentioned natural drug composition, also comprise: the product that step (4) makes is further made the capsule that contains natural drug composition 100mg or 200mg specification by the pharmacy means of routine, maybe will make the tablet that contains natural drug composition 100mg or 200mg specification by wet granulation technology.
The beneficial effect of natural drug composition of the present invention aspect anti-chemotherapy dependency diarrhoea and inhibition tumor is as follows:
1, natural drug composition of the present invention causes the diarrhea of mouse Study of model to show at irinotecan: the diarrhoea reaction for the irinotecan induced mice has tangible antagonism.
2, proved that this natural drug composition can strengthen chemotherapeutics to the inhibitory action of tumor, adopted mouse tumor model, observed this natural drug composition and cyclophosphamide combined to the inhibitory action of mouse interior tumor.Studies show that: this natural drug composition can obviously increase cyclophosphamide for the inhibitory action of tumor.
3, the inventor makes up Rhizoma Coptidis Galla Chinensis water boiling concentration extract, berberine and Galla Chinensis acetone extract originally, and by the consumption proportion between definite these components of a large amount of experiments, makes said composition performance synergism, obtains unexpected effect.Through experimentation repeatedly, ratio between each component of natural drug composition of the present invention is at 6-9: 3-8: produce synergism during 1-3, potentiation is obvious, extraordinary effect is played in side effect, especially the usage ratio of each component be 9: 8: 3 o'clock especially obvious, this is that the inventor pays a large amount of creative works and obtains, and those of ordinary skills only can't obtain this proportioning and optimum amount ratio by disclosed content.
4, this natural drug composition Rhizoma Coptidis Galla Chinensis water boiling concentration extract, berberine and each component of Galla Chinensis acetone extract all can obtain by conventional means, wherein component such as berberine also can be buied by commerce, 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 natural drug 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 Rhizoma Coptidis Galla Chinensis water boiling concentration extract
Be 1-5 according to proportion compatibility: 1 gets Rhizoma Coptidis, Galla Chinensis, adds 10 times of amount distilled water, soaks 1h, heating decocts 1h, silk filters, and preserves filtrate, and medicinal residues add 6 times of distilled water again, soak, decoct, filter with method, twice filtrate is mixed, and heating is concentrated into small size, ultrafiltration membrance filter, adopt 70 ℃ of drying under reduced pressure 36h of vacuum drying oven to get yellow powder, namely.
(2) preparation of berberine
Rhizoma Coptidis is pulverized, and adds ethanol, heating in water bath backflow 0.5h, sucking filtration, filtering residue repeats aforesaid operations 2 times, merging filtrate, decompression recycling ethanol, add 1% acetic acid heating for dissolving, drip concentrated hydrochloric acid in the filtrate to muddy, cooling, sucking filtration, solid respectively washs once with frozen water and acetone, adds hot water and boils to just dissolving, regulating pH with lime cream is 8.5-9.8, and cooling filters out impurities, be chilled to room temperature, sucking filtration, oven dry is namely.
(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
2Till no longer producing precipitation, the centrifugal 15min of 10000r/min gets precipitation, drips 0.01mol/L HCl until precipitation dissolving fully, the bag filter of packing into, and dialysis 48h, the rotary evaporation postlyophilization, namely.
Second step: the preparation of preparation
(1) preparation of natural drug composition capsule preparations of the present invention
Take by weighing Rhizoma Coptidis Galla Chinensis water boiling concentration extract 45mg, berberine 40mg and the Galla Chinensis acetone extract 15mg of above-mentioned steps preparation respectively, take by weighing starch 395mg, magnesium stearate 5mg simultaneously, evenly mix, fill and make capsule.
(2) preparation of natural drug composition tablet of the present invention
Take by weighing Rhizoma Coptidis Galla Chinensis water boiling concentration extract 45mg, berberine 40mg and the Galla Chinensis acetone extract 15mg of above-mentioned steps preparation respectively, take by weighing starch 295mg, lactose 100mg simultaneously, evenly mix 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 Rhizoma Coptidis Galla Chinensis water boiling concentration extract, berberine and Galla Chinensis acetone extract is 9: 8: 3.The inventor to above-mentioned each composition usage ratio at 6-9: 3-8: the compositions that the multiple proportioning combination in the time of between the 1-3 obtains has been carried out and last identical experiment, find that all the natural drug composition in this amount ranges can obtain good synergism, can play good effect and treatment for cancer is had potentiation cancer chemotherapy dependency diarrhoea.Below be the pharmacodynamics data that preferred embodiment obtains:
Test example 1: the pharmacodynamic study of natural drug composition treatment chemotherapy dependency diarrhoea effect
1, test material
(1) Rhizoma Coptidis, Galla Chinensis is purchased in 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 Rhizoma Coptidis Galla Chinensis water boiling concentration extract 10g.kg
-1(being equivalent to contain the crude drug amount), the C group is berberine 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 natural drug 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 chemotherapy dependency diarrhoea model at every day 1 time.B, C, D, E group were irritated stomach 8 days with corresponding extract continuously, and mice is placed metabolic cage, spread white filter paper at the bottom of the cage with observation stool situation, and observed mice crissum situation and Mus tail fecal pollution situation, stimulated the anus defecation in conjunction with cotton swab, and 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: the wet and not molding of moderate diarrhoea, stool.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, the degree of Rhizoma Coptidis Galla Chinensis water boiling concentration extract group chemotherapy dependency diarrhoea is lower than model group, and natural drug composition group of the present invention diarrhoea incidence rate obviously alleviates.The results are shown in Table 1.
Table 1 present composition is to mice chemotherapy dependency diarrhoea incidence rate and scoring influence
Annotate: a is equivalent to contain the crude drug amount
Test example 2: the pharmacodynamic study of natural drug 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).Inoculation random packet next day, experimental group natural drug composition of the present invention is divided into (200,100mg/mL) two dosage groups, every Mus is irritated stomach 0.5ml, gives cyclophosphamide 10gkg simultaneously
-1D
-1Negative control group gives 0.5mL 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 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.(as table 2)
Table 2 natural drug composition of the present invention is to S
180The tumor inhibition effect of mice
Claims (5)
1. natural drug composition that reduces cancer chemotherapy dependency diarrhoea and the treatment cancer is played potentiation, it is characterized in that said composition by Rhizoma Coptidis Galla Chinensis water boiling concentration extract, berberine and Galla Chinensis acetone extract by weight in 6-9: the ratio of 3-8: 1-3 is formed
Wherein Rhizoma Coptidis Galla Chinensis water boiling concentration preparation method of extract is:
Be 1-5 according to proportion compatibility: 1 gets Rhizoma Coptidis, Galla Chinensis, adds 10 times of amount distilled water, soaks 1h, heating decocts 1h, silk filters, and preserves filtrate, and medicinal residues add 6 times of distilled water again, soak, decoct, filter with method, twice filtrate is mixed, and heating is concentrated into small size, ultrafiltration membrance filter, adopt 70 ℃ of drying under reduced pressure 36h of vacuum drying oven to get yellow powder, namely;
Wherein the preparation method of berberine is:
Rhizoma Coptidis is pulverized, and adds ethanol, heating in water bath backflow 0.5h, sucking filtration, filtering residue repeats aforesaid operations 2 times, merging filtrate, decompression recycling ethanol, add 1% acetic acid heating for dissolving, drip concentrated hydrochloric acid in the filtrate to muddy, cooling, sucking filtration, solid respectively washs once with frozen water and acetone, adds hot water and boils to just dissolving, regulating pH with lime cream is 8.5-9.8, and cooling filters out impurities, be chilled to room temperature, sucking filtration, oven dry is namely;
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
2Till no longer producing precipitation, the centrifugal 15min of 10000r/min gets precipitation, drips 0.01mol/L HCl until precipitation dissolving fully, the bag filter of packing into, and dialysis 48h, the rotary evaporation postlyophilization, namely.
2. natural drug composition as claimed in claim 1 is characterized in that wherein the usage ratio of Rhizoma Coptidis Galla Chinensis water boiling concentration extract, berberine and Galla Chinensis acetone extract is 9: 8: 3.
3. as the preparation method of the natural drug composition of claim 1 or 2, it is characterized in that this method comprises:
(1) preparation of Rhizoma Coptidis Galla Chinensis water boiling concentration extract
Be 1-5 according to proportion compatibility: 1 gets Rhizoma Coptidis, Galla Chinensis, adds 10 times of amount distilled water, soaks 1h, heating decocts 1h, silk filters, and preserves filtrate, and medicinal residues add 6 times of distilled water again, soak, decoct, filter with method, twice filtrate is mixed, and heating is concentrated into small size, ultrafiltration membrance filter, adopt 70 ℃ of drying under reduced pressure 36h of vacuum drying oven to get yellow powder, namely;
(2) preparation of berberine
Rhizoma Coptidis is pulverized, and adds ethanol, heating in water bath backflow 0.5h, sucking filtration, filtering residue repeats aforesaid operations 2 times, merging filtrate, decompression recycling ethanol, add 1% acetic acid heating for dissolving, drip concentrated hydrochloric acid in the filtrate to muddy, cooling, sucking filtration, solid respectively washs once with frozen water and acetone, adds hot water and boils to just dissolving, regulating pH with lime cream is 8.5-9.8, and cooling filters out impurities, be chilled to room temperature, sucking filtration, oven dry is namely;
(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
2Till no longer producing precipitation, the centrifugal 15min of 10000r/min gets precipitation, drips 0.01mol/L HCl until precipitation dissolving fully, the bag filter of packing into, and dialysis 48h, the rotary evaporation postlyophilization, namely;
(4) choose Rhizoma Coptidis Galla Chinensis water boiling concentration extract in proportion, berberine evenly mixes with the Galla Chinensis acetone extract, namely.
4. the preparation method of natural drug composition as claimed in claim 3, it is characterized in that also comprising: the product that step (4) makes is further made the capsule that contains natural drug composition 100mg or 200mg specification by the pharmacy means of routine, maybe will make the tablet that contains natural drug composition 100mg or 200mg specification by wet granulation technology.
5. as the purposes of each described natural drug composition of claim 1-2 in preparing the medicine that reduces the reaction of cancer chemotherapy dependency diarrhoea and the treatment cancer is played potentiation.
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Cited By (1)
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Application publication date: 20130828 |