CN103223042A - Traditional chinese medicine composition - Google Patents
Traditional chinese medicine composition Download PDFInfo
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- CN103223042A CN103223042A CN2013101187237A CN201310118723A CN103223042A CN 103223042 A CN103223042 A CN 103223042A CN 2013101187237 A CN2013101187237 A CN 2013101187237A CN 201310118723 A CN201310118723 A CN 201310118723A CN 103223042 A CN103223042 A CN 103223042A
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- pericarpium citri
- citri reticulatae
- nobiletin
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Abstract
The invention relates to a natural pharmaceutical composition, a preparation method thereof and the usage in preparing an attenuated synergistic medicament in cancer chemotherapy, wherein the natural pharmaceutical composition consists of decoction condensed extract product of Andrographis and dried orange peel, andrographolide and nobiletin in a proportion of (6-8):(5-7):(1-5). The composition has good curative effect to cancer chemotherapy related diarrhoea and increases effect to 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 Herba Andrographis Pericarpium Citri Reticulatae water boiling concentration extract, andrographolide and Nobiletin, the preparation method of this natural drug composition and this natural drug composition are being used for preparing the purposes that reduces cancer chemotherapy dependency diarrhoea and treatment of cancer is played 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.Chemotherapy no matter singly 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, chemotherapy dependency diarrheal incidence rate 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, therefore also bring certain difficulty, to the important component part of chemotherapy dependency diarrheal effective treatment having become tumor patient wholistic therapy to CC.
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, but still unmatchful anticancer disease chemotherapy has the Chinese patent medicine of alleviating diarrhoea and potentiation at present.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.
Herba Andrographis is herb or the leaf of acanthaceous plant Herba Andrographis (Andrographis paniculata (Burm.f.) Nees), and the nature and flavor bitter cold cures mainly damp-heat dysentery.Pericarpium Citri Reticulatae, the mature peel for rutaceae orange (Citrus reticulata Blanco) and variety thereof is used for fullness in the epigastrium and chest, lack of appetite and vomiting.In recent years, Herba Andrographis and Pericarpium Citri Reticulatae antitumaous effect are confirmed, especially andrographolide and Nobiletin.The inventor is through the research and the experiment of each a large amount of formula proportion, obtained optimal drug ratio compositions of the present invention at last, it is the compositions of novelty, and proved that it has fabulous curative effect and can play potentiation to treatment of cancer cancer chemotherapy dependency diarrhoea, has finished the present invention thus.
Summary of the invention
A kind of natural drug composition provided by the invention, by Herba Andrographis Pericarpium Citri Reticulatae water boiling concentration extract, andrographolide and Nobiletin by weight in 6-8: the ratio of 5-7: 1-5 is formed.
Above-mentioned natural drug composition, wherein the usage ratio of Herba Andrographis Pericarpium Citri Reticulatae water boiling concentration extract, andrographolide and Nobiletin is 8: 7: 5.
Wherein, Herba Andrographis Pericarpium Citri Reticulatae water boiling concentration extract, andrographolide 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, Herba Andrographis Pericarpium Citri Reticulatae water boiling concentration preparation method of extract is in the above-mentioned natural drug composition:
According to proportion compatibility is to get Herba Andrographis, Pericarpium Citri Reticulatae at 1: 1, adds 10 times of amount distilled water, soaks 1h, heating decocts 1h on the electric furnace that adds asbestos gauge, 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, promptly.
The preparation method of andrographolide is in the above-mentioned natural drug composition:
It is an amount of to take by weighing Common Andrographis Herd, the enzymolysis pre-treatment, the ethanol hot dipping is filtered, reclaim alcoholic acid, get extractum, wash, remove chlorophyll with petroleum ether, water layer is spent the night with chloroform extraction, be divided into water layer, chloroform layer and intermediate layer,, get Ling Jingti and be andrographolide intermediate layer precipitate ethyl alcohol recrystallization.
The Nobiletin preparation method is in the above-mentioned natural drug composition:
Get the Pericarpium Citri Reticulatae medical material, coarse pulverization is sieved, measure the petroleum ether reflux, extract, 5 times for 20 times, each 6h merges petroleum ether extract, after reclaiming petroleum ether,, place with the mixed solvent heating for dissolving of 2 kinds of solvent compositions of 0.25 times of amount, to be crystallized separating out fully, after the filtration, dry under 80 ℃ the Pericarpium Citri Reticulatae total flavones, use ethyl acetate extraction, concentrate, the utilization polyamide column chromatography is with the mixed solvent eluting of 2 kinds of solvent compositions, in conjunction with thin layer chromatography, collect and contain the Nobiletin eluent, volatilize solvent, recrystallizing methanol gets yellow solid, fusing point 137-138 ℃, be Nobiletin.
The present invention also provides the preferred manufacturing procedure of this natural drug composition, comprising:
(1) preparation of Herba Andrographis Pericarpium Citri Reticulatae water boiling concentration extract
According to proportion compatibility is to get Herba Andrographis, Pericarpium Citri Reticulatae at 1: 1, adds 10 times of amount distilled water, soaks 1h, heating decocts 1h on the electric furnace that adds asbestos gauge, 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, be Herba Andrographis Pericarpium Citri Reticulatae water boiling concentration extract.
(2) preparation of andrographolide
It is an amount of to take by weighing Common Andrographis Herd, the enzymolysis pre-treatment, the ethanol hot dipping is filtered, reclaim alcoholic acid, get extractum, wash, remove chlorophyll with petroleum ether, water layer is spent the night with chloroform extraction, be divided into water layer, chloroform layer and intermediate layer,, get Ling Jingti and be andrographolide intermediate layer precipitate ethyl alcohol recrystallization.
(3) Nobiletin preparation
Get the Pericarpium Citri Reticulatae medical material, coarse pulverization is sieved, measure the petroleum ether reflux, extract, 5 times for 20 times, each 6h merges petroleum ether extract, after reclaiming petroleum ether,, place with the mixed solvent heating for dissolving of 2 kinds of solvent compositions of 0.25 times of amount, to be crystallized separating out fully, after the filtration, dry under 80 ℃ the Pericarpium Citri Reticulatae total flavones, use ethyl acetate extraction, concentrate, the utilization polyamide column chromatography is with the mixed solvent eluting of 2 kinds of solvent compositions, in conjunction with thin layer chromatography, collect and contain the Nobiletin eluent, volatilize solvent, recrystallizing methanol gets yellow solid, fusing point 137-138 ℃, be Nobiletin.
(4) choose Herba Andrographis Pericarpium Citri Reticulatae water boiling concentration extract, andrographolide and Nobiletin in proportion, uniform mixing, promptly.
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 the inhibitory action of chemotherapeutics to tumor, adopted mouse tumor model, observed this natural drug composition and cyclophosphamide combined inhibitory action mouse interior tumor.Studies show that: this natural drug composition can obviously increase the inhibitory action of cyclophosphamide for tumor.
3, the inventor is originally with Herba Andrographis Pericarpium Citri Reticulatae water boiling concentration extract, andrographolide and Nobiletin make up, and by the consumption proportion between definite these components of a large amount of experiments, make said composition bring into play good synergism, pass through our experimentation repeatedly, ratio between each component of natural drug composition of the present invention is at 6-8: 5-7: potentiation is obvious during 1-5, extraordinary effect is played in side effect, especially the usage ratio of each component be 8: 7: 5 o'clock especially obvious, 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 composition Herba Andrographis Pericarpium Citri Reticulatae water boiling concentration extract, andrographolide and each component of Nobiletin 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 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 Herba Andrographis Pericarpium Citri Reticulatae water boiling concentration extract
According to proportion compatibility is to get Herba Andrographis, Pericarpium Citri Reticulatae at 1: 1, adds 10 times of amount distilled water, soaks 1h, heating decocts 1h on the electric furnace that adds asbestos gauge, 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, be Herba Andrographis Pericarpium Citri Reticulatae water boiling concentration extract.
(2) preparation of andrographolide
It is an amount of to take by weighing Common Andrographis Herd, the enzymolysis pre-treatment, the ethanol hot dipping is filtered, reclaim alcoholic acid, get extractum, wash, remove chlorophyll with petroleum ether, water layer is spent the night with chloroform extraction, be divided into water layer, chloroform layer and intermediate layer,, get Ling Jingti and be andrographolide intermediate layer precipitate ethyl alcohol recrystallization.
(3) Nobiletin preparation
Get the Pericarpium Citri Reticulatae medical material, coarse pulverization is sieved, measure the petroleum ether reflux, extract, 5 times for 20 times, each 6h merges petroleum ether extract, after reclaiming petroleum ether,, place with the mixed solvent heating for dissolving of 2 kinds of solvent compositions of 0.25 times of amount, to be crystallized separating out fully, after the filtration, dry under 80 ℃ the Pericarpium Citri Reticulatae total flavones, use ethyl acetate extraction, concentrate, the utilization polyamide column chromatography is with the mixed solvent eluting of 2 kinds of solvent compositions, in conjunction with thin layer chromatography, collect and contain the Nobiletin eluent, volatilize solvent, recrystallizing methanol gets yellow solid, fusing point 137-138 ℃, be Nobiletin.
Second step: the preparation of preparation
(1) preparation of natural drug composition capsule preparations of the present invention
Take by weighing Herba Andrographis Pericarpium Citri Reticulatae water boiling concentration extract 40mg, andrographolide 35mg and the Nobiletin 25mg of above-mentioned steps preparation respectively, take by weighing starch 395mg, magnesium stearate 5mg simultaneously, uniform mixing is filled to capsule.
(2) preparation of natural drug composition tablet of the present invention
Take by weighing Herba Andrographis Pericarpium Citri Reticulatae water boiling concentration extract 40mg, andrographolide 35mg and the Nobiletin 25mg of above-mentioned steps preparation respectively, take by weighing starch 295mg, lactose 100mg simultaneously, uniform mixing is 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 Herba Andrographis Pericarpium Citri Reticulatae water boiling concentration extract, andrographolide and Nobiletin is 8: 7: 5.The inventor to above-mentioned each composition usage ratio at 6-8: 5-7: the compositions that the multiple proportioning combination in the time of between the 1-5 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) Herba Andrographis, Pericarpium Citri Reticulatae
(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 Herba Andrographis Pericarpium Citri Reticulatae water boiling concentration extract 10g.kg
-1(being equivalent to contain the crude drug amount), the C group is andrographolide 10g.kg
-1(being equivalent to contain the crude drug amount), D group Nobiletin 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, duplicates 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, Herba Andrographis Pericarpium Citri Reticulatae water boiling concentration extract group chemotherapy dependency diarrheal degree 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 Herba Andrographis Pericarpium Citri Reticulatae water boiling concentration extract, andrographolide and Nobiletin by weight in 6-8: the ratio of 5-7: 1-5 is formed
Wherein Herba Andrographis Pericarpium Citri Reticulatae water boiling concentration preparation method of extract is:
According to proportion compatibility is to get Herba Andrographis, Pericarpium Citri Reticulatae at 1: 1, adds 10 times of amount distilled water, soaks 1h, heating decocts 1h on the electric furnace that adds asbestos gauge, 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, be Herba Andrographis Pericarpium Citri Reticulatae water boiling concentration extract;
Wherein the preparation method of andrographolide is:
It is an amount of to take by weighing Common Andrographis Herd, the enzymolysis pre-treatment, the ethanol hot dipping is filtered, reclaim alcoholic acid, get extractum, wash, remove chlorophyll with petroleum ether, water layer is spent the night with chloroform extraction, be divided into water layer, chloroform layer and intermediate layer,, get Ling Jingti and be andrographolide intermediate layer precipitate ethyl alcohol recrystallization;
Wherein the preparation method of Nobiletin is:
Get the Pericarpium Citri Reticulatae medical material, coarse pulverization is sieved, measure the petroleum ether reflux, extract, 5 times for 20 times, each 6h merges petroleum ether extract, after reclaiming petroleum ether,, place with the mixed solvent heating for dissolving of 2 kinds of solvent compositions of 0.25 times of amount, to be crystallized separating out fully, after the filtration, dry under 80 ℃ the Pericarpium Citri Reticulatae total flavones, use ethyl acetate extraction, concentrate, the utilization polyamide column chromatography is with the mixed solvent eluting of 2 kinds of solvent compositions, in conjunction with thin layer chromatography, collect and contain the Nobiletin eluent, volatilize solvent, recrystallizing methanol gets yellow solid, fusing point 137-138 ℃, be Nobiletin.
2. natural drug composition as claimed in claim 1, wherein the usage ratio of Herba Andrographis Pericarpium Citri Reticulatae water boiling concentration extract, andrographolide and Nobiletin is 8: 7: 5.
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 Herba Andrographis Pericarpium Citri Reticulatae water boiling concentration extract
According to proportion compatibility is to get Herba Andrographis, Pericarpium Citri Reticulatae at 1: 1, adds 10 times of amount distilled water, soaks 1h, heating decocts 1h on the electric furnace that adds asbestos gauge, 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, be Herba Andrographis Pericarpium Citri Reticulatae water boiling concentration extract;
(2) preparation of andrographolide
It is an amount of to take by weighing Common Andrographis Herd, the enzymolysis pre-treatment, the ethanol hot dipping is filtered, reclaim alcoholic acid, get extractum, wash, remove chlorophyll with petroleum ether, water layer is spent the night with chloroform extraction, be divided into water layer, chloroform layer and intermediate layer,, get Ling Jingti and be andrographolide intermediate layer precipitate ethyl alcohol recrystallization;
(3) preparation of Nobiletin
Get the Pericarpium Citri Reticulatae medical material, coarse pulverization is sieved, measure the petroleum ether reflux, extract, 5 times for 20 times, each 6h merges petroleum ether extract, after reclaiming petroleum ether,, place with the mixed solvent heating for dissolving of 2 kinds of solvent compositions of 0.25 times of amount, to be crystallized separating out fully, after the filtration, dry under 80 ℃ the Pericarpium Citri Reticulatae total flavones, use ethyl acetate extraction, concentrate, the utilization polyamide column chromatography is with the mixed solvent eluting of 2 kinds of solvent compositions, in conjunction with thin layer chromatography, collect and contain the Nobiletin eluent, volatilize solvent, recrystallizing methanol gets yellow solid, fusing point 137-138 ℃, be Nobiletin;
(4) choose Herba Andrographis Pericarpium Citri Reticulatae water boiling concentration extract, andrographolide and Nobiletin uniform mixing in proportion, promptly.
4. the preparation method of natural drug composition as claimed in claim 3, 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.
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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| CN103655836A (en) * | 2013-12-11 | 2014-03-26 | 张宗升 | Natural pharmaceutical composition, and preparation method and application thereof |
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Application publication date: 20130731 |