CN101904974A - Chinese medicinal composition for treating malignant tumor diseases and preparation method thereof - Google Patents
Chinese medicinal composition for treating malignant tumor diseases and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a Chinese medicinal composition and a preparation method and application thereof. The Chinese medicinal composition is prepared from 20 to 40 percent of astragalus extract, 20 to 40 percent of asparagus root extract, 5 to 25 percent of finger citron extract and 15 to 35 percent of American ginseng in percentage by weight. Pharmacological experiments and clinical experiments show that the Chinese medicinal composition provided by the invention has the functions of strengthening body resistance and eliminating evil, nourishing yin and tonifying qi, clearing heat and releasing toxin, eliminating tuberculosis and dissipating stagnation, and mainly treats the symptoms of qi and yin deficiency, qi stagnation, blood stasis, phlegm coagulation, toxin aggregation and the like caused by malignant tumors; when the Chinese medicinal composition is used with radiation therapy and chemical therapy, the Chinese medicinal composition has the effects of increasing efficacy, reducing toxicity and inhibiting growth and transfer of the tumors, can reverse the medicament resistance of tumor cells and promote apoptosis of the tumor cells, and has not obvious toxic or side effect; and meanwhile, the preparation method for the Chinese medicinal composition has the advantages of quality stability and controllability, extraction of high active ingredient content and strong operability, and is suitable for industrialized mass production.
Description
Technical field
The present invention relates to a kind of medicine, be specifically related to a kind of Chinese medicine composition and preparation method thereof and the application of this Chinese medicine composition in the treatment malignancy disease.
Background technology
Tumor has become the No.1 killer that 21 century threatens human survival, has 6,700,000 people to die from various tumor diseases every year on average.China is one of world cancer country occurred frequently, and annual newly-increased 2,200,000 cancer patients account for global sum and reach 20%, existing cancer patient 4,500,000 people, and present a rapidly rising trend every year.The medicine for the treatment of tumor clinically at present mainly contains chemical drugs, but because chemotherapeutics toxicity is big, in the kill tumor cell also non-selectivity kill human body self immunocytes such as leukocyte, lymphocyte, cause patient usually because because of the low accompanying infection of autoimmune ability, the patient uses erious adverse reaction, and the course of treatment is long, and the expense height has bigger limitation in clinical use.Chinese medicine is that the natural class medicine of representative has characteristics such as toxic and side effects is little, action target spot is various, better tolerance with Chinese medicine having special advantages aspect the treatment tumor, is more and more coming into one's own aspect the treatment tumor.Because the research and development risk height of new drug has high input, the cycle is long, rarely has the appearance of antineoplastic Chinese traditional medicine in recent years, and Western medicine accounts for 75% of tumor medication market at present, and Chinese patent medicine only accounts for 25%.Therefore, it is good to research and develop a kind of antitumous effect, and the low antineoplastic Chinese traditional medicine of untoward reaction is significant.
Summary of the invention
Goal of the invention: the objective of the invention is to solve the deficiencies in the prior art, provide a kind of proportioning scientific and reasonable, determined curative effect, clinical safe in utilization, the Chinese medicine composition that untoward reaction is low, another object of the present invention provide the preparation method and the application in preparation treatment malignancy disease medicine thereof of this Chinese medicine composition.
Technical scheme: in order to realize above purpose, Chinese medicine composition provided by the present invention is made by the following raw materials by weight percent medicine: Radix Astragali extract 20%～40%, Radix Asparagi extract 20%～40%, Fructus Citri Sarcodactylis extract 5%～25%, Radix Panacis Quinquefolii extract 15%～35%.
As preferred version, Chinese medicine composition provided by the invention is made by the following raw materials by weight percent medicine: Radix Astragali extract 25%～35%, Radix Asparagi extract 25%～35%, Fructus Citri Sarcodactylis extract 10～20%, Radix Panacis Quinquefolii extract 20～30%.
As further preferred version, Chinese medicine composition provided by the invention is made by the following raw materials by weight percent medicine: Radix Astragali extract 30%, Radix Asparagi extract 30%, Fructus Citri Sarcodactylis extract 15%, Radix Panacis Quinquefolii extract 25%.
Chinese medicine composition provided by the invention can become oral liquid, granule, capsule or tablets and other formulations medicine with each extracts of bulk drugs with pharmaceutically acceptable preparing carriers.
When the extract of each raw material of Chinese medicine composition provided by the invention is made oral liquid,, filter, add syrup, regulate pH value, make oral liquid the extract adding distil water dissolving of each raw material.
When the extract of each raw material of Chinese medicine composition provided by the invention is made tablet,, add magnesium stearate lubricant when needing the extract of each raw material and lactose or corn starch, mix homogeneously, granulate, tabletting is made tablet then.
When the extract of each raw material of Chinese medicine composition provided by the invention is made capsule the extract of each raw material and carrier lactose or corn starch mix homogeneously, granulate, the encapsulated then capsule of making.
When the extract of each raw material of Chinese medicine composition provided by the invention is made granule, the extract of each raw material and diluent lactose or corn starch mix homogeneously, granulate, drying is made granule.
The preparation method of Chinese medicinal composition preparation provided by the invention specifically may further comprise the steps:
(1) get radix astragali coarse powder, add 15～20 times of water gaging supersound extraction of medical material 60～80 minutes, the water extract is through ultrafiltration membrance filter, ultrafiltrate is held back 50000～6000 molecular weight parts, concentrates, and adds 95% ethanol to determining alcohol and reaches 80%, precipitate polysaccharide, vacuum drying, astragalus polysaccharides; 15～20 times of 80% ethanol ultrasonic extraction of astragalus root dregs reuse after the supersound extraction of fetching water then 60～80 minutes, extracting solution reclaims ethanol, and the water extract merging with below 6000 molecular weight after the ultrafilter membrane ultrafiltration concentrates last D
21The type macroporous adsorbent resin, with concentration 0%～80% alcoholic solution gradient elution, eluent concentrating under reduced pressure, vacuum drying gets Radix Astragali total saponins, and is standby;
(2) get the Radix Asparagi medical material and add 5～8 times of amount concentration 80～85% ethanol heating extraction three times, each 1.5～2 hours, merge extractive liquid, filtered, regulate pH value to 7, reclaim ethanol, continue to be concentrated into 70 ℃ of relative densities 1.25～1.30 again to there not being the alcohol flavor, add 8～10 times of water gagings then, stir evenly, leave standstill, filter, filtrate is concentrated into 70 ℃ of relative densities 1.15～1.20, adds ethanol then and makes concentration of alcohol reach 70%, leave standstill, filter filtrate recycling ethanol, concentrate, vacuum drying gets Radix Asparagi extract, and is standby;
(3) get the Fructus Citri Sarcodactylis medical material with 80～90% soak with ethanol after percolation extract, then percolation is remained the medicinal residues water and decocts 3 times, filter, merge 3 times filtrate, be concentrated into the extractum shape, add ethanol and make concentration of alcohol reach 80%, placement is spent the night, sucking filtration, must precipitate, will precipitate respectively with 95% ethanol, acetone and ether washing, drying, promptly get Fructus Citri Sarcodactylis extract, standby;
(4) get Radix Panacis Quinquefolii powder and be broken into coarse powder, add 10～12 times of amount 70% alcohol reflux 3 times, each 1.5～2 hours time, extracting solution is evaporated to 2g crude drug/L, D on the concentrate
101Macroporous adsorptive resins with 85% ethanol elution resin, eluent drying under reduced pressure, gets American ginseng total saponins, and is standby;
(5) American ginseng total saponins that obtains of the Radix Asparagi extract that obtains of the astragalus polysaccharides crude product that obtains of combining step (1) and Radix Astragali total saponins, step (2), Fructus Citri Sarcodactylis extract that step (3) obtains and step (4) becomes the medicine of oral liquid, granule, capsule or Tabules with pharmaceutically acceptable preparing carriers.
The preparation method of above-described Chinese medicinal composition preparation, as preferably, step (1) is got radix astragali coarse powder, adds 20 times of water gaging supersound extraction of medical material 80 minutes, aqueous extract.
As preferably, step (2) is got the Radix Asparagi medical material and is added 8 times of amount concentration 80% ethanol heating extraction three times, each 1.5 hours.
As preferably, step (3) is got the Fructus Citri Sarcodactylis medical material with 90% soak with ethanol 30～60 minutes, and it is closely colourless that percolation is extracted into percolate, then percolation remained the medicinal residues water and decoct 3 times.
As preferably, step (4) is got Radix Panacis Quinquefolii powder and is broken into coarse powder, adds 12 times of amount 70% alcohol reflux 3 times, and each 2 hours time, extracting solution is evaporated to 2g crude drug/L, D on the concentrate
101Macroporous adsorptive resins, with 85% ethanol elution resin, the volume of collecting eluant is 6 times of column volumes, gets the eluent drying under reduced pressure, gets American ginseng total saponins.
Beneficial effect: antitumor Chinese provided by the invention is compared with prior art and is had the following advantages:
1, the present invention is according to Chinese medical theory, adopt the theory of determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs to carry out the Chinese prescription screening, the Chinese medicine composition proportioning that provides is scientific and reasonable, experimental result shows, Chinese medicine composition provided by the invention has the good restraining growth of tumour cell and can promote the effect of apoptosis of tumor cells, and multiple malignant cell is all had strong killing action, have wide range of applications; And experimental result shows that Chinese medicine composition provided by the invention has the body resistance strengthening and constitution consolidating and immunologic function facilitation, and the generation of cAMP content and promotion tumor necrosis factor (INF) in the adjustable body, bring into play many target spots, the effect of many organ treatment tumors can reduce the tumor patient misery, prolongs life cycle, improve the effect of patient's life quality, and studies show that through long-term experiment Chinese medicine composition provided by the invention is safe, toxic and side effects is low.
2, the extract of Chinese medicine composition provided by the invention can make things convenient for and pharmaceutical carriers is prepared into multiple dosage form, taking convenience clinically; The preparation method of while Chinese medicine composition provided by the invention, workable, especially according to each herbal medicine effective ingredient chemical property design extraction and purification process, the extract active constituent content height that obtains, impurity is few, and have absorb fast, can bring into play drug effect rapidly, advantage such as dosage is few clinically, and process stabilizing is fit to industrialized great production.
The specific embodiment:
Further illustrate the present invention below in conjunction with specific embodiment, should understand these embodiment only is used to the present invention is described and is not used in and limit the scope of the invention, after having read the present invention, those skilled in the art all fall within the application's claims institute restricted portion to the modification of the various equivalent form of values of the present invention.
Embodiment 1
1, the crude drug of Chinese medicine composition is formed: 30 kilograms of Radix Astragali extracts, 30 kilograms of Radix Asparagi extracts, 15 kilograms of Fructus Citri Sarcodactylis extracts, 25 kilograms of Radix Panacis Quinquefolii extracts.
2, the preparation method of Chinese medicinal composition preparation:
(1) get radix astragali coarse powder, add 20 times of water gaging supersound extraction 80 minutes, the water extract is through ultrafiltration membrance filter, and ultrafiltrate is held back 50000～6000 molecular weight parts, concentrates, and adds 95% ethanol to determining alcohol and reaches 80%, precipitate polysaccharide, vacuum drying, the astragalus polysaccharides crude product; 20 times of 80% ethanol ultrasonic extraction of astragalus root dregs reuse after the water intaking supersound extraction 80 minutes, extracting solution reclaims ethanol, and the water extract merging with below 6000 molecular weight after the ultrafiltration concentrates last D
21The type macroporous adsorbent resin, with concentration 0%～80% alcoholic solution gradient elution, eluent concentrating under reduced pressure, vacuum drying gets Radix Astragali total saponins, and is standby;
(2) get the Radix Asparagi medical material and add 8 times of amount concentration 80% ethanol heating extraction three times, each 1.5 hours, merge extractive liquid, filtered, regulate pH value to 7, reclaim ethanol, continue to be concentrated into 70 ℃ of relative densities 1.25～1.30 again to there not being the alcohol flavor, add 10 times of water gagings then, stir evenly, leave standstill, filter, filtrate is concentrated into 70 ℃ of relative densities 1.15～1.20, adds ethanol then and makes concentration of alcohol reach 70%, leave standstill, filter filtrate recycling ethanol, concentrate, vacuum drying gets Radix Asparagi extract, and is standby;
(3) get the Fructus Citri Sarcodactylis medical material with 90% soak with ethanol after percolation be extracted into closely colourlessly, then percolation is remained the medicinal residues water and decocts 3 times, filter, merge 3 times filtrate, be concentrated into the extractum shape, add ethanol and make concentration of alcohol reach 80%, placement is spent the night, sucking filtration, must precipitate, will precipitate respectively with 95% ethanol, acetone and ether washing, drying, promptly get Fructus Citri Sarcodactylis extract, standby;
(4) get Radix Panacis Quinquefolii powder and be broken into coarse powder, add 12 times of amount 70% alcohol reflux 3 times, each 2 hours time, extracting solution is evaporated to 2g crude drug/L, D on the concentrate
101Macroporous adsorptive resins, with 85% ethanol elution resin, the volume of collecting eluant is 6 times of column volumes, gets the eluent drying under reduced pressure, gets American ginseng total saponins, and is standby;
(5) American ginseng total saponins that obtains of the Radix Asparagi extract that obtains of the astragalus polysaccharides crude product that obtains of combining step (1) and Radix Astragali total saponins, step (2), Fructus Citri Sarcodactylis extract that step (3) obtains and step (4), add lactose then, the corn starch mix homogeneously, add magnesium stearate lubricant, mix homogeneously, granulate, tabletting is made tablet then.(lot number: 001)
Embodiment 2
1, the crude drug of Chinese medicine composition is formed: 40 kilograms of Radix Astragali extracts, 40 kilograms of Radix Asparagi extracts, 25 kilograms of Fructus Citri Sarcodactylis extracts, 35 kilograms of Radix Panacis Quinquefolii extracts.
2, the preparation method of Chinese medicinal composition preparation:
(1) get radix astragali coarse powder, add 15 times of water gaging supersound extraction 60 minutes, the water extract is through ultrafiltration membrance filter, and ultrafiltrate is held back 50000～6000 molecular weight parts, concentrates, and adds 95% ethanol to determining alcohol and reaches 80%, precipitate polysaccharide, vacuum drying, the astragalus polysaccharides crude product; 18 times of 80% ethanol ultrasonic extraction of astragalus root dregs reuse after the water intaking supersound extraction 60 minutes, extracting solution reclaims ethanol, and the water extract merging with below 6000 molecular weight after the ultrafiltration concentrates last D
21The type macroporous adsorbent resin, with concentration 0%～80% alcoholic solution gradient elution, eluent concentrating under reduced pressure, vacuum drying gets Radix Astragali total saponins, and is standby;
(2) get the Radix Asparagi medical material and add 6 times of amount concentration 80% ethanol heating extraction three times, each 2 hours, merge extractive liquid, filtered, regulate pH value to 7, reclaim ethanol, continue to be concentrated into 70 ℃ of relative densities 1.25～1.30 again to there not being the alcohol flavor, add 10 times of water gagings then, stir evenly, leave standstill, filter, filtrate is concentrated into 70 ℃ of relative densities 1.15～1.20, adds ethanol then and makes concentration of alcohol reach 70%, leave standstill, filter filtrate recycling ethanol, concentrate, vacuum drying gets Radix Asparagi extract, and is standby;
(3) get the Fructus Citri Sarcodactylis medical material with 90% soak with ethanol after percolation be extracted into closely colourlessly, then percolation is remained the medicinal residues water and decocts 3 times, filter, merge 3 times filtrate, be concentrated into the extractum shape, add ethanol and make concentration of alcohol reach 80%, placement is spent the night, sucking filtration, must precipitate, will precipitate respectively with 95% ethanol, acetone and ether washing, drying, promptly get Fructus Citri Sarcodactylis extract, standby;
(4) get Radix Panacis Quinquefolii powder and be broken into coarse powder, add 10 times of amount 70% alcohol reflux 3 times, each 1.5 hours time, extracting solution is evaporated to 2g crude drug/L, D on the concentrate
101Macroporous adsorptive resins, with 85% ethanol elution resin, the volume of collecting eluant is 8 times of column volumes, gets the eluent drying under reduced pressure, gets American ginseng total saponins, and is standby;
(5) American ginseng total saponins that obtains of the Radix Asparagi extract that obtains of the astragalus polysaccharides crude product that obtains of combining step (1) and Radix Astragali total saponins, step (2), Fructus Citri Sarcodactylis extract that step (3) obtains and step (4), add diluent lactose or corn starch mix homogeneously then, granulate, drying is made granule.(lot number: 002)
Embodiment 3
1, the crude drug of Chinese medicine composition is formed: 20 kilograms of Radix Astragali extracts, 20 kilograms of Radix Asparagi extracts, 10 kilograms of Fructus Citri Sarcodactylis extracts, 15 kilograms of Radix Panacis Quinquefolii extracts.
2, the preparation method of Chinese medicinal composition preparation:
(1) get radix astragali coarse powder, add 18 times of water gaging supersound extraction 80 minutes, the water extract is through ultrafiltration membrance filter, and ultrafiltrate is held back 50000～6000 molecular weight parts, concentrates, and adds 95% ethanol to determining alcohol and reaches 80%, precipitate polysaccharide, vacuum drying, the astragalus polysaccharides crude product; 18 times of 80% ethanol ultrasonic extraction of astragalus root dregs reuse after the water intaking supersound extraction 80 minutes, extracting solution reclaims ethanol, and the water extract merging with below 6000 molecular weight after the ultrafiltration concentrates last D
21The type macroporous adsorbent resin, with concentration 0%～80% alcoholic solution gradient elution, eluent concentrating under reduced pressure, vacuum drying gets Radix Astragali total saponins, and is standby;
(2) get the Radix Asparagi medical material and add 6 times of amount concentration 85% ethanol heating extraction three times, each 2 hours, merge extractive liquid, filtered, regulate pH value to 7, reclaim ethanol, continue to be concentrated into 70 ℃ of relative densities 1.25～1.30 again to there not being the alcohol flavor, add 10 times of water gagings then, stir evenly, leave standstill, filter, filtrate is concentrated into 70 ℃ of relative densities 1.15～1.20, adds ethanol then and makes concentration of alcohol reach 70%, leave standstill, filter filtrate recycling ethanol, concentrate, vacuum drying gets Radix Asparagi extract, and is standby;
(3) get the Fructus Citri Sarcodactylis medical material with 90% soak with ethanol after percolation be extracted into closely colourlessly, then percolation is remained the medicinal residues water and decocts 3 times, filter, merge 3 times filtrate, be concentrated into the extractum shape, add ethanol and make concentration of alcohol reach 80%, placement is spent the night, sucking filtration, must precipitate, will precipitate respectively with 95% ethanol, acetone and ether washing, drying, promptly get Fructus Citri Sarcodactylis extract, standby;
(4) get Radix Panacis Quinquefolii powder and be broken into coarse powder, add 10 times of amount 70% alcohol reflux 3 times, each 1.5 hours time, extracting solution is evaporated to 2g crude drug/L, D on the concentrate
101Macroporous adsorptive resins, with 85% ethanol elution resin, the volume of collecting eluant is 8 times of column volumes, gets the eluent drying under reduced pressure, gets American ginseng total saponins, and is standby;
(5) American ginseng total saponins that obtains of the Radix Asparagi extract that obtains of the astragalus polysaccharides crude product that obtains of combining step (1) and Radix Astragali total saponins, step (2), Fructus Citri Sarcodactylis extract that step (3) obtains and step (4), then and lactose, corn starch mix all with, granulate, the encapsulated then capsule of making.(lot number: 003)
Embodiment 4
1, the crude drug of Chinese medicine composition is formed: 35 kilograms of Radix Astragali extracts, 35 kilograms of Radix Asparagi extracts, 20 kilograms of Fructus Citri Sarcodactylis extracts, 30 kilograms of Radix Panacis Quinquefolii extracts.
2, the preparation method of Chinese medicinal composition preparation is with embodiment 2.
Embodiment 5
1, the crude drug of Chinese medicine composition is formed: 25 kilograms of Radix Astragali extracts, 25 kilograms of Radix Asparagi extracts, 10 kilograms of Fructus Citri Sarcodactylis extracts, 20 kilograms of Radix Panacis Quinquefolii extracts.
2, the preparation method of Chinese medicinal composition preparation is with embodiment 3.
The experiment of embodiment 6 antitumor pharmacology
Chinese medicine composition is to the experimentation of people's tumor inhibition effect in the nude mouse
(1) to MGC in the nude mouse
-803The cell inhibiting effect
Experimental technique: with the MGC of adherent growth in the Tissue Culture Flask
-803Cell is prepared into cell suspension, adjusts cell concentration, and mirror is counting down, in every Mus right fore oxter inoculation 5 * 10
6Individual MGC
-803Cell is inoculated 24 altogether, and it is divided into treatment group (Chinese medicine composition provided by the invention, lot number 001, gastric infusion 2g/kg) at random, and (prestige wheat Yiganning capsule is 2g/kg) with blank group (waiting the capacity normal saline), 8 every group for matched group.Inoculate after 48 hours, medication continuous 21 days, after the drug withdrawal, is put to death animal and is observed MGC
-803Cell growing state and claim tumor heavy in nude mouse.Concrete experimental result sees Table 1.
MGC in the table 1 pair nude mouse
-803The cell inhibiting effect
(2) to esophageal carcinoma Eca-109 cell inhibiting effect in the nude mouse
Experimental technique: preparation esophageal carcinoma Eca-109 cell suspension, adjust cell concentration, 5 * 106/0.2ml of every Mus right front oxter inoculation Eca-109 cell inoculates 30 altogether, is divided into treatment group (Chinese medicine composition provided by the invention at random, lot number 002. gastric infusion, 2g/kg), matched group (prestige wheat Yiganning capsule, gastric infusion, 2g/kg) with blank group (waiting the capacity normal saline), every group 10, after 24 hours, the beginning medication, once a day, continuous 24 days, after the drug withdrawal, put to death animal, observe the tumor growth situation and cut open and get tumor tissue and weigh, concrete experimental result sees Table 2.
Eca-109 cell inhibiting effect in the table 2 pair nude mouse
(3) to the inhibitory action of people's casing slime adenocarcinoma in the nude mouse
Get tumor source nude mice, take out tumor tissue, be cut into the fritter of 0.3-0.4mm, the back that tumor tissue is seeded in nude mice is subcutaneous, inoculate 21 altogether, in back 24 days of inoculation, remove 6 tumor growths too little animal relatively, be divided into treatment group (Chinese medicine composition provided by the invention at random, lot number 003, gastric infusion, 2g/kg), matched group (Tianxian Capsule, gastric infusion, 2g/kg) with blank group (waiting the capacity normal saline), 5 every group, continuous use 21 days, 24h puts to death animal after the last administration, cut open and get tumor tissue and weigh, calculate suppression ratio (%), concrete experimental result sees Table 3.
The inhibitory action of people's casing slime adenocarcinoma in the table 3 pair nude mouse
Shown by above experimental result: Chinese medicine composition provided by the invention is to the low differentiation of people's stomach mucinous adenocarcinoma MGC-
803, human esophagus cancer Eca-
109Transplant in cell strain and the people's casing slime adenocarcinoma nude mouse and have the obvious suppression effect, and contrast medicine prestige wheat Yiganning capsule group and contrast medicine Tianxian Capsule group effect more excellent (P＜0.01), the effect that has very strong anti-human malignant lesion in the Chinese medicine composition object provided by the invention is described, can be used for the treatment of malignancy disease.
Embodiment 7 Chinese medicine compositions are to the experiment of immunoregulation effect
(1) to the influence of rat cAMP in plasma content
Experimental technique: get 30 of Wistar rats, body weight 150～180g, male and female dual-purpose, be divided into the normal control group at random, lotus tumor matched group and treatment group, inoculation S180 sarcoma, after 24 hours, the treatment group gavages Chinese medicine composition of the present invention (lot number 001), and 2ml/ is (2g/kg) only, continuous 14 days, the normal control group such as gavages at the capacity normal saline, cAMP content is measured in the rat heart blood sampling after 15 days, the results are shown in Table 4.
The influence of table 4 pair rat plasma cAMP content (x ± SD)
*P＜0.05 (comparing) with lotus tumor matched group
Experimental result by table 4 shows: Chinese medicine composition provided by the invention can make the cAMP content that significantly improves tumor-bearing mice (
*P＜0.05), shows that further Chinese medicine composition provided by the invention has the effect of obvious raising tumor patient immunologic function, is of value to the rehabilitation of tumor disease.
(2) to the influence of tumor necrosis factor (INF)
Experimental technique: get 20 of Wistar rat, be divided into matched group and treatment group at random, equal lumbar injection 10mg bacillus calmette-guerin vaccines, the treatment group gavages Chinese medicine composition 2ml/ of the present invention, and only (lot number 002,2g/kg), continuous 14 days, matched group such as gavaged at the capacity normal saline.The 15th day intraperitoneal injection 80 μ gLPS, blood sampling after 90 minutes.
Get test serum, be diluted to variable concentrations; Target cell L929 is adjusted into 2 * 106/ml cell with 10% calf serum, RPM1-1640 culture fluid, adds in the 96 porocyte culture plates; 100 μ l/ holes add the test serum 100 μ l/ holes of different extension rates again; Cultivated 18 hours.The result judges: the maximum dilution multiple with 50% target cell death is that INF tires.Concrete outcome sees Table 5.
The table 5 pair facilitation that rat INF induces
*P＜0.001 (comparing) with the normal control group
Shown by table 5 experimental result: Chinese medicine composition provided by the invention can obviously promote inducing of INF, and (P＜0.001) illustrates that Chinese medicine composition provided by the invention can reach the antineoplastic purpose by inducing tumor necrosis factor INF.
Show by above experimental result, Chinese medicine composition provided by the invention has the body resistance strengthening and constitution consolidating, immunological function of cancer patients is had the raising effect, and the generation of interior cAMP content of adjustable body and promotion tumor necrosis factor (INF), patient self anti-tumor function can be strengthened.
And Chinese medicine composition clinical test results provided by the invention shows: to lung cancer chemotherapy patient 40 examples of syndrome of deficiency of both qi and yin; wherein one group of 20 example only used chemotherapeutic; another is organized and also takes Chinese medicine composition provided by the present invention after 20 examples are taken chemotherapeutic; through clinical observation in 2 months; the latter promptly takes tumor patient obvious effective rate that chemotherapeutic takes Chinese medicine composition again up to 95%; has notable difference (P＜0.005) with single comparing with the chemotherapeutic group; and clinical symptoms has obvious improvement; patients with lung cancer quality of life is improved; and the toxicity that chemotherapy causes obviously alleviates; show the effect that Chinese medicine composition provided by the present invention has protection and improves immunologic function, and experimental result shows that peripheral hemogram is also had obvious protective effect.
The present invention is according to Chinese medical theory, adopt the theory of determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs to carry out the proportioning prescription, show by above experimental result, Chinese medicine composition provided by the invention has strengthening vital QI to eliminate pathogenic factors, Replenishing QI and nourishing YIN, heat-clearing and toxic substances removing, the function of the nuclear eliminating stagnation that disappears, cure mainly the syndrome of deficiency of both qi and yin and the stagnation of QI due to the malignant tumor, blood stasis, expectorant coagulates, poison is poly-etc. doublely sees disease, has efficacy enhancing and toxicity reducing with the chemicotherapy logotype, suppress growth of tumor and transferance, and the drug resistance of energy reversing tumor cell, impel the apoptosis of tumor cell, and do not have obvious toxic-side effects, illustrate that Chinese medicine composition provided by the invention can be used to prepare the antineoplastic new medicine.
The above only is a preferred implementation of the present invention; should be pointed out that for those skilled in the art, under the prerequisite that does not break away from the principle of the invention; can also make some improvements and modifications, these improvements and modifications also should be considered as protection scope of the present invention.
Claims (6)
1. a Chinese medicine composition is characterized in that, it is made by the following raw materials by weight percent medicine: Radix Astragali extract 20%～40%, Radix Asparagi extract 20～40%, Fructus Citri Sarcodactylis extract 5%～25%, Radix Panacis Quinquefolii extract 15%～35%.
2. Chinese medicine composition according to claim 1, it is characterized in that it is made by the following raw materials by weight percent medicine: Radix Astragali extract 25%～35%, Radix Asparagi extract 25%～35%, Fructus Citri Sarcodactylis extract 10～20%, Radix Panacis Quinquefolii extract 20～30%.
3. Chinese medicine composition according to claim 2 is characterized in that, it is made by the following raw materials by weight percent medicine: Radix Astragali extract 30%, Radix Asparagi extract 30%, Fructus Citri Sarcodactylis extract 15%, Radix Panacis Quinquefolii extract 25%.
4. according to each described Chinese medicine composition of claim 1 to 3, it is characterized in that, each extracts of bulk drugs is become the medicine of oral liquid, granule, capsule or Tabules with pharmaceutically acceptable preparing carriers.
5. the preparation method of each described Chinese medicine composition of claim 1 to 3 is characterized in that may further comprise the steps:
(1) get radix astragali coarse powder, add 15～20 times of water gaging supersound extraction 60～80 minutes, the water extract is through ultrafiltration membrance filter, ultrafiltrate is held back 50000～6000 molecular weight parts, concentrates, and adds 95% ethanol to determining alcohol and reaches 80%, precipitate polysaccharide, vacuum drying, astragalus polysaccharides; 15～20 times of 80% ethanol ultrasonic extraction of astragalus root dregs reuse after the water intaking supersound extraction 60～80 minutes, extracting solution reclaims ethanol, and the water extract merging with below 6000 molecular weight after the ultrafiltration concentrates last D
21The type macroporous adsorbent resin, with concentration 0%～80% alcoholic solution gradient elution, eluent concentrating under reduced pressure, vacuum drying gets Radix Astragali total saponins, and is standby;
(2) get the Radix Asparagi medical material and add 5～8 times of amount concentration 80～85% ethanol heating extraction three times, each 1.5～2 hours, merge extractive liquid, filtered, regulate pH value to 7, reclaim ethanol, continue to be concentrated into 70 ℃ of relative densities 1.25～1.30 again to there not being the alcohol flavor, add 8～10 times of water gagings then, stir evenly, leave standstill, filter, filtrate is concentrated into 70 ℃ of relative densities 1.15～1.20, adds ethanol then and makes concentration of alcohol reach 70%, leave standstill, filter filtrate recycling ethanol, concentrate, vacuum drying gets Radix Asparagi extract, and is standby;
(3) get the Fructus Citri Sarcodactylis medical material with 90% soak with ethanol after percolation extract, then percolation is remained the medicinal residues water and decocts 3 times, filter, merge 3 times filtrate, be concentrated into the extractum shape, add ethanol and make concentration of alcohol reach 80%, placement is spent the night, sucking filtration, must precipitate, will precipitate respectively with 95% ethanol, acetone and ether washing, drying, promptly get Fructus Citri Sarcodactylis extract, standby;
(4) get Radix Panacis Quinquefolii powder and be broken into coarse powder, add 10～12 times of amount 70% alcohol reflux 3 times, each 1.5～2 hours time, extracting solution is evaporated to 2g crude drug/L, D on the concentrate
101Macroporous adsorptive resins with 85% ethanol elution resin, gets the eluent drying under reduced pressure, gets American ginseng total saponins, and is standby;
(5) American ginseng total saponins that obtains of the Radix Asparagi extract that obtains of the astragalus polysaccharides that obtains of combining step (1) and Radix Astragali total saponins, step (2), Fructus Citri Sarcodactylis extract that step (3) obtains and step (4) becomes the medicine of oral liquid, granule, capsule or Tabules with pharmaceutically acceptable preparing carriers.
6. the application of each described Chinese medicine composition of claim 1 to 3 in the preparation antitumor drug.
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| CN102784284A (en) * | 2012-08-24 | 2012-11-21 | 常熟雷允上制药有限公司 | Preparation method of sugar-free oral liquid with anti-cancer effect |
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| CN1399999A (en) * | 2001-07-26 | 2003-03-05 | 李新民 | Medicine for curing malignant turnor and its preparation method |
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| 《中医药学刊》 20020430 孙忠慧 《几种中药材及制剂抗卵巢癌研究探要》 199-200 1-6 第20卷, 第2期 2 * |
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| CN102784284A (en) * | 2012-08-24 | 2012-11-21 | 常熟雷允上制药有限公司 | Preparation method of sugar-free oral liquid with anti-cancer effect |
| CN102784284B (en) * | 2012-08-24 | 2015-03-11 | 常熟雷允上制药有限公司 | Preparation method of sugar-free oral liquid with anti-cancer effect |
| CN103768534A (en) * | 2014-02-17 | 2014-05-07 | 南京中医药大学 | Traditional Chinese medicinal composition with anti-tumor activity |
| CN103768534B (en) * | 2014-02-17 | 2017-06-23 | 南京中医药大学 | A kind of Chinese medicine composition with antitumor activity |
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