CN101347446A - Medicament composition containing astragalus polysaccharide and ginseng bud saponin and uses thereof - Google Patents

Medicament composition containing astragalus polysaccharide and ginseng bud saponin and uses thereof Download PDF

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CN101347446A
CN101347446A CNA2007100440868A CN200710044086A CN101347446A CN 101347446 A CN101347446 A CN 101347446A CN A2007100440868 A CNA2007100440868 A CN A2007100440868A CN 200710044086 A CN200710044086 A CN 200710044086A CN 101347446 A CN101347446 A CN 101347446A
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preparation
astragalus polysaccharides
composition
compositions
ginseng bud
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CN101347446B (en
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杨义芳
林梦感
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Shanghai Institute of Pharmaceutical Industry
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Shanghai Institute of Pharmaceutical Industry
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Abstract

The invention provides a medicine composition including astragalus polysaccharides and ginseng rhizome saponin and the usage thereof. The medicine composition is characterized in that the weight proportion of astragalus polysaccharides and ginseng rhizome saponin is 0.01 to 200:1. The invention also provides the application of the medicine composition in preparing antineoplastic drugs, strengthening the curing effect of radiotherapy and chemotherapy, decreasing the toxicity and side effect of radiotherapy and chemotherapy and improving the immunity.

Description

A kind of medical composition and its use that contains astragalus polysaccharides and ginseng bud saponin
Technical field
The present invention relates to a kind of medical composition and its use, be specifically related to a kind of composition and use thereof that contains astragalus polysaccharides and ginseng bud saponin.
Background technology
The Radix Astragali (Radix Astragalus) is the dry root of leguminous plant Radix Astragali or Radix Astagali, and sweet in the mouth, warm in nature is returned lung, spleen channel, is important QI invigorating Chinese medicine.Astragalus polysaccharides is one of its main effective ingredient, modern pharmacological research proves, astragalus polysaccharides have improve immune function of human body, antitumor, Antiradiation injury, blood sugar regulation, the anti-ageing effect of waiting for a long time (Zhang Xiaomei. the immunoregulation effect of astragalus polysaccharides and antitumor action progress, University Of Dalian's journal, 2003,24 (6): 101~104; Bao Wenqi, Lv Mei, Wang Zhixiang. the pharmacological research progress of astragalus polysaccharides. Henan agricultural sciences, 2005, (4): 78~80).
Rhizoma Ginseng (Rhizoma Ginseng) is Araliaceae Radix Ginseng (Panax ginsengC.A.Mey.) rhizome, is the under ground portion of Radix Ginseng stem, is positioned at the upper end of root, is the dish nodular, and sweet in the mouth, little hardship are warm in nature, return stomach, spleen, lung meridian.Ginseng bud saponin is one of its main effective ingredient.Pharmacological research shows, ginseng bud saponin has resisting fatigue, anoxia enduring, diuresis, calmness and anticonvulsant action, the effect that also may have strengthening the body resistance, control to defying age and cardiovascular disease has positive meaning (Zhang Yonghe, Li Jingdao. the Rhizoma Ginseng research overview, Yanbian University's medical journal, 1990,13 (3): 222~223).Chinese patent " CN1053107C " record Rhizoma Ginseng has the effect identical with the Radix Ginseng main root, so need not go reed.And, from Rhizoma Ginseng, extract saponin and compare with from Radix Ginseng, extracting saponin, can reduce cost greatly, turn waste into wealth.
In the Chinese prescription, the similar compatibility of drugs of performance effect uses, and can heighten the effect of a treatment, and this selects an important content in the medicine prescription when being the Chinese traditional treatment disease: " mutual reinforcement between ".Determining of Chinese medicine compound, be on the basis of analyzing pathogenesis, determine therapy, under the guidance of therapy, form the prescription that meets state of an illness needs, prescription is made up of medicine, but it is not the rabble that arbitrarily uses Chinese medicine, but is foundation with the therapy, select appropriate drug, appropriate drug dosage, under the guidance of theory of Chinese medical science, combine.
Primordial QI reinforcing sheet, primordial QI reinforcing granule, primordial QI reinforcing capsule all are made up of astragalus polysaccharides and Rhizoma Ginseng.But existing these three kinds of preparations are and directly are used as medicine after Radix Ginseng reed head is pulverized, and are refining through extracting, and the astragalus polysaccharides that is used as medicine is crude product, so bioavailability is low.
Summary of the invention
Low and have a problem of side effect for the bioavailability that solves the pharmaceutical composition that contains astragalus polysaccharides and Rhizoma Ginseng of the prior art, the present invention is by a large amount of experimentatioies, invent a kind of compositions that contains astragalus polysaccharides and ginseng bud saponin, and proposed its application in curative effect that strengthens radiation and chemotherapy and reduction toxic and side effects; This pharmaceutical composition also can enhancing body's immunological function.
An object of the present invention is to provide a kind of pharmaceutical composition that contains astragalus polysaccharides and ginseng bud saponin, it is characterized in that, the weight ratio of astragalus polysaccharides and ginseng bud saponin is 0.01~200: 1, preferred 0.08~170: 1, more preferably 0.9~130: 1, more preferably 9~90: 1, more preferably 10~40: 1, most preferably 16~24: 1.
The present composition can further comprise the acceptable excipient of pharmacy according to the preparation needs, makes pharmaceutical preparation, and wherein to contain the percentage by weight of this pharmaceutical preparation be 40~85% for astragalus polysaccharides and ginseng bud saponin.Preferred dosage form is injection, tablet, pellet, granule, capsule or solution, most preferably pellet.
Pharmaceutical preparation of the present invention is preferably the pellet that is become to be grouped into by following percentage by weight:
Astragalus polysaccharides 45.68%
Ginseng bud saponin 4.32%
Microcrystalline Cellulose 39%
Polyvinylpyrrolidone 5%
OPADRY?II(85G64874) 6%;
Or:
Astragalus polysaccharides 53.66%
Ginseng bud saponin 6.34%
Microcrystalline Cellulose 30%
Polyvinylpyrrolidone 4%
OPADRY?II(85G64874) 6%;
Or:
Astragalus polysaccharides 69.45%
Ginseng bud saponin 0.55%
Microcrystalline Cellulose 21%
Polyvinylpyrrolidone 3%
OPADRY?II(85G64874) 6%;
Or:
Astragalus polysaccharides 76.82%
Ginseng bud saponin 3.18%
Microcrystalline Cellulose 12%
Polyvinylpyrrolidone 2%
OPADRY?II(85G64874) 6%;
Or:
Astragalus polysaccharides 75.37%
Ginseng bud saponin 4.63%
Microcrystalline Cellulose 12%
Polyvinylpyrrolidone 2%
OPADRY?II(85G64874) 6%;
Or:
Astragalus polysaccharides 69.59%
Ginseng bud saponin 0.41%
Microcrystalline Cellulose 21%
Polyvinylpyrrolidone 3%
OPADRY?II(85G64874) 6%;
Or:
Astragalus polysaccharides 4.68%
Ginseng bud saponin 55.32%
Microcrystalline Cellulose 30%
Polyvinylpyrrolidone 4%
OPADRY?II(85G64874) 6%;
Or:
Astragalus polysaccharides 36.68%
Ginseng bud saponin 43.32%
Microcrystalline Cellulose 12%
Polyvinylpyrrolidone 2%
OPADRY?II(85G64874) 6%;
Or:
Astragalus polysaccharides 78.15%
Ginseng bud saponin 1.85%
Microcrystalline Cellulose 12%
Polyvinylpyrrolidone 2%
OPADRY?II(85G64874) 6%;
Or:
Astragalus polysaccharides 59.30%
Ginseng bud saponin 0.70%
Microcrystalline Cellulose 30%
Polyvinylpyrrolidone 4%
OPADRY?II(85G64874) 6%。
Another object of the present invention provides aforementioned pharmaceutical compositions or the application of said medicine preparation in the medicine of preparation antitumor drug, the curative effect that strengthens radiation and chemotherapy, the toxic and side effects that reduces radiation and chemotherapy and preparation raising immunologic function.
The inventor passes through great deal of experimental, invented the present composition with scientific matching, said composition is owing to contain refining astragalus polysaccharides and the ginseng bud saponin that extracts, make it in above-mentioned application, have incomparable advantage compared to existing technology, characteristics with the little and determined curative effect of dose, and it is controlled to reach product quality safety.
Among the present invention, astragalus polysaccharides by patent application [Yang Yifang is permitted Potiria pectinifera (Mukller et Tro Sehel), Huang Chunyue. a kind of method of refining astragalus polysaccharide. Chinese invention patent: 200610024178.5] described method separation and Extraction; Ginseng bud saponin press document [permitted Potiria pectinifera (Mukller et Tro Sehel). the research of primordial QI reinforcing polysaccharide glucoside extract and pro-liposome thereof. Shanghai Institute of Pharmaceutical Industry, 2006] described method separation and Extraction.Extract the astragalus polysaccharides and the ginseng bud saponin that obtain according to the method described above and further make preparation, carry out following experimental example according to different proportion.
The specific embodiment
Embodiment 1
The preparation of astragalus polysaccharides:
Get 1 kilogram of Milkvetch Root, pulverize, and microwave extraction (70 ℃, 4 times, 30 minutes/time) must the water extract.Filter, filtrate adds 4 times of water gaging dilutions (adding water continuously according to transit dose) after 0.2 μ m micro-filtration membrane in the process of crossing film.Collect filtered solution, crossing molecular cut off is that 1,000 daltonian ultrafilter membrane concentrates.Collect trapped fluid, precipitate with ethanol, dry purity is 86.29% astragalus polysaccharides 81.50 grams.
Embodiment 2
The preparation of ginseng bud saponin:
Get 1 kilogram of Rhizoma Ginseng medical material, pulverize, 75% alcohol reflux (4 times, 2 hours/time), extracting solution concentrate the back spray drying powder that gets dry extract.Add water 2L, ultrasonic dissolution is pressed sample on 1g extract/10g D101 resin, adsorb a night after, add water 30L flushing after, reuse 50% ethanol 40L eluting is collected pure washing liquid, concentrates, lyophilization must be made with extra care saponin 58.5g, purity is 85.37%.
Embodiment 3
The preparation of compositions A:
Get microcrystalline Cellulose 390g and put in the multifunctional fluidized bed granulating and coating machine, spray into 10% polyvinylpyrrolidone aqueous solution 250ml, make the micropill core particle with this by side.Get the astragalus polysaccharides 456.8g for preparing by embodiment 1 method and prepare ginseng bud saponin 43.2g by embodiment 2 methods and add water and make into solid content about 30%, become rubber cement through the refiner homogenizing, cross 60 mesh sieves, continuation is by side spray grain, round as a ball, and then add 10% an amount of polyvinylpyrrolidone aqueous solution in serosity, be mixed, continue the side spray, repeatedly screening divides and gets 50~80 orders therebetween, 40~70 orders, 30~40 order pillers are as the ball core of subsequent operation, coarse granule and fine powder after each screening, add water, 10% polyvinylpyrrolidone aqueous solution with an amount of becomes rubber cement through the refiner homogenizing, crosses 60 mesh sieves, the same method, side sprays into.Collect 30~60 mesh sieve micropills at last, spray 18%OPADRY II (85G64874) (Shanghai Colorcon Coating Technology Co., Ltd's production) aqueous solution at the bottom of the fluid bed, coating, coating increase weight about 6%.Packing, promptly.
Embodiment 4
The preparation of compositions B:
Get microcrystalline Cellulose 300g and put in the multifunctional fluidized bed granulating and coating machine, spray into 10% polyvinylpyrrolidone aqueous solution 200ml, make the micropill core particle with this by side.Get the astragalus polysaccharides 536.6g for preparing by embodiment 1 method and prepare ginseng bud saponin 63.4g by embodiment 2 methods and add water and make into solid content about 30%, become rubber cement through the refiner homogenizing, cross 60 mesh sieves, continuation is by side spray grain, round as a ball, and then add 10% an amount of polyvinylpyrrolidone aqueous solution in serosity, be mixed, continue the side spray, repeatedly screening divides and gets 50~80 orders therebetween, 40~70 orders, 30~40 order pillers are as the ball core of subsequent operation, coarse granule and fine powder after each screening, add water, 10% polyvinylpyrrolidone aqueous solution with an amount of becomes rubber cement through the refiner homogenizing, crosses 60 mesh sieves, the same method, side sprays into.Collect 30~60 mesh sieve micropills at last, spray 18%OPADRY II (85G64874) (Shanghai Colorcon Coating Technology Co., Ltd's production) aqueous solution at the bottom of the fluid bed, coating, coating increase weight about 6%.Packing, promptly.
Embodiment 5
The preparation of compositions C:
Get microcrystalline Cellulose 210g and put in the multifunctional fluidized bed granulating and coating machine, spray into 10% polyvinylpyrrolidone aqueous solution 150ml, make the micropill core particle with this by side.Get the astragalus polysaccharides 694.5g for preparing by embodiment 1 method and prepare ginseng bud saponin 5.5g by embodiment 2 methods and add water and make into solid content about 30%, become rubber cement through the refiner homogenizing, cross 60 mesh sieves, continuation is by side spray grain, round as a ball, and then add 10% an amount of polyvinylpyrrolidone aqueous solution in serosity, be mixed, continue the side spray, repeatedly screening divides and gets 50~80 orders therebetween, 40~70 orders, 30~40 order pillers are as the ball core of subsequent operation, coarse granule and fine powder after each screening, add water, 10% polyvinylpyrrolidone aqueous solution with an amount of becomes rubber cement through the refiner homogenizing, crosses 60 mesh sieves, the same method, side sprays into.Collect 30~60 mesh sieve micropills at last, spray 18%OPADRY II (85G64874) (Shanghai Colorcon Coating Technology Co., Ltd's production) aqueous solution at the bottom of the fluid bed, coating, coating increase weight about 6%.Packing, promptly.
Embodiment 6
The preparation of compositions D:
Get microcrystalline Cellulose 120g and put in the multifunctional fluidized bed granulating and coating machine, spray into 10% polyvinylpyrrolidone aqueous solution 100ml, make the micropill core particle with this by side.Get the astragalus polysaccharides 768.2g for preparing by embodiment 1 method and prepare ginseng bud saponin 31.8g by embodiment 2 methods and add water and make into solid content about 30%, become rubber cement through the refiner homogenizing, cross 60 mesh sieves, continuation is by side spray grain, round as a ball, and then add 10% an amount of polyvinylpyrrolidone aqueous solution in serosity, be mixed, continue the side spray, repeatedly screening divides and gets 50~80 orders therebetween, 40~70 orders, 30~40 order pillers are as the ball core of subsequent operation, coarse granule and fine powder after each screening, add water, 10% polyvinylpyrrolidone aqueous solution with an amount of becomes rubber cement through the refiner homogenizing, crosses 60 mesh sieves, the same method, side sprays into.Collect 30~60 mesh sieve micropills at last, spray 18%OPADRY II (85G64874) (Shanghai Colorcon Coating Technology Co., Ltd's production) aqueous solution at the bottom of the fluid bed, coating, coating increase weight about 6%.Packing, promptly.
Embodiment 7
The preparation of compositions E:
Get microcrystalline Cellulose 120g and put in the multifunctional fluidized bed granulating and coating machine, spray into 10% polyvinylpyrrolidone aqueous solution 100ml, make the micropill core particle with this by side.Get the astragalus polysaccharides 753.7g for preparing by embodiment 1 method and prepare ginseng bud saponin 46.3g by embodiment 2 methods and add water and make into solid content about 30%, become rubber cement through the refiner homogenizing, cross 60 mesh sieves, continuation is by side spray grain, round as a ball, and then add 10% an amount of polyvinylpyrrolidone aqueous solution in serosity, be mixed, continue the side spray, repeatedly screening divides and gets 50~80 orders therebetween, 40~70 orders, 30~40 order pillers are as the ball core of subsequent operation, coarse granule and fine powder after each screening, add water, 10% polyvinylpyrrolidone aqueous solution with an amount of becomes rubber cement through the refiner homogenizing, crosses 60 mesh sieves, the same method, side sprays into.Collect 30~60 mesh sieve micropills at last, spray 18%OPADRY II (85G64874) (Shanghai Colorcon Coating Technology Co., Ltd's production) aqueous solution at the bottom of the fluid bed, coating, coating increase weight about 6%.Packing, promptly.
Embodiment 8
The preparation of composition F:
Get microcrystalline Cellulose 210g and put in the multifunctional fluidized bed granulating and coating machine, spray into 10% polyvinylpyrrolidone aqueous solution 150ml, make the micropill core particle with this by side.Get the astragalus polysaccharides 695.9g for preparing by embodiment 1 method and prepare ginseng bud saponin 4.1g by embodiment 2 methods and add water and make into solid content about 30%, become rubber cement through the refiner homogenizing, cross 60 mesh sieves, continuation is by side spray grain, round as a ball, and then add 10% an amount of polyvinylpyrrolidone aqueous solution in serosity, be mixed, continue the side spray, repeatedly screening divides and gets 50~80 orders therebetween, 40~70 orders, 30~40 order pillers are as the ball core of subsequent operation, coarse granule and fine powder after each screening, add water, 10% polyvinylpyrrolidone aqueous solution with an amount of becomes rubber cement through the refiner homogenizing, crosses 60 mesh sieves, the same method, side sprays into.Collect 30~60 mesh sieve micropills at last, spray 18%OPADRY II (85G64874) (Shanghai Colorcon Coating Technology Co., Ltd's production) aqueous solution at the bottom of the fluid bed, coating, coating increase weight about 6%.Packing, promptly.
Embodiment 9
The preparation of compositions G:
Get microcrystalline Cellulose 300g and put in the multifunctional fluidized bed granulating and coating machine, spray into 10% polyvinylpyrrolidone aqueous solution 200ml, make the micropill core particle with this by side.Get the astragalus polysaccharides 46.8g for preparing by embodiment 1 method and prepare ginseng bud saponin 553.2g by embodiment 2 methods and add water and make into solid content about 30%, become rubber cement through the refiner homogenizing, cross 60 mesh sieves, continuation is by side spray grain, round as a ball, and then add 10% an amount of polyvinylpyrrolidone aqueous solution in serosity, be mixed, continue the side spray, repeatedly screening divides and gets 50~80 orders therebetween, 40~70 orders, 30~40 order pillers are as the ball core of subsequent operation, coarse granule and fine powder after each screening, add water, 10% polyvinylpyrrolidone aqueous solution with an amount of becomes rubber cement through the refiner homogenizing, crosses 60 mesh sieves, the same method, side sprays into.Collect 30~60 mesh sieve micropills at last, spray 18%OPADRY II (85G64874) (Shanghai Colorcon Coating Technology Co., Ltd's production) aqueous solution at the bottom of the fluid bed, coating, coating increase weight about 6%.Packing, promptly.
Embodiment 10
The preparation of compositions H:
Get microcrystalline Cellulose 120g and put in the multifunctional fluidized bed granulating and coating machine, spray into 10% polyvinylpyrrolidone aqueous solution 100ml, make the micropill core particle with this by side.Get the astragalus polysaccharides 366.8g for preparing by embodiment 1 method and prepare ginseng bud saponin 433.2g by embodiment 2 methods and add water and make into solid content about 30%, become rubber cement through the refiner homogenizing, cross 60 mesh sieves, continuation is by side spray grain, round as a ball, and then add 10% an amount of polyvinylpyrrolidone aqueous solution in serosity, be mixed, continue the side spray, repeatedly screening divides and gets 50~80 orders therebetween, 40~70 orders, 30~40 order pillers are as the ball core of subsequent operation, coarse granule and fine powder after each screening, add water, 10% polyvinylpyrrolidone aqueous solution with an amount of becomes rubber cement through the refiner homogenizing, crosses 60 mesh sieves, the same method, side sprays into.Collect 30~60 mesh sieve micropills at last, spray 18%OPADRY II (85G64874) (Shanghai Colorcon Coating Technology Co., Ltd's production) aqueous solution at the bottom of the fluid bed, coating, coating increase weight about 6%.Packing, promptly.
Embodiment 11
The preparation of composition I:
Get microcrystalline Cellulose 120g and put in the multifunctional fluidized bed granulating and coating machine, spray into 10% polyvinylpyrrolidone aqueous solution 100ml, make the micropill core particle with this by side.Get the astragalus polysaccharides 781.5g for preparing by embodiment 1 method and prepare ginseng bud saponin 18.5g by embodiment 2 methods and add water and make into solid content about 30%, become rubber cement through the refiner homogenizing, cross 60 mesh sieves, continuation is by side spray grain, round as a ball, and then add 10% an amount of polyvinylpyrrolidone aqueous solution in serosity, be mixed, continue the side spray, repeatedly screening divides and gets 50~80 orders therebetween, 40~70 orders, 30~40 order pillers are as the ball core of subsequent operation, coarse granule and fine powder after each screening, add water, 10% polyvinylpyrrolidone aqueous solution with an amount of becomes rubber cement through the refiner homogenizing, crosses 60 mesh sieves, the same method, side sprays into.Collect 30~60 mesh sieve micropills at last, spray 18%OPADRY II (85G64874) (Shanghai Colorcon Coating Technology Co., Ltd's production) aqueous solution at the bottom of the fluid bed, coating, coating increase weight about 6%.Packing, promptly.
Embodiment 12
The preparation of compositions J:
Get microcrystalline Cellulose 300g and put in the multifunctional fluidized bed granulating and coating machine, spray into 10% polyvinylpyrrolidone aqueous solution 200ml, make the micropill core particle with this by side.Get the astragalus polysaccharides 593.0g for preparing by embodiment 1 method and prepare ginseng bud saponin 7.0g by embodiment 2 methods and add water and make into solid content about 30%, become rubber cement through the refiner homogenizing, cross 60 mesh sieves, continuation is by side spray grain, round as a ball, and then add 10% an amount of polyvinylpyrrolidone aqueous solution in serosity, be mixed, continue the side spray, repeatedly screening divides and gets 50~80 orders therebetween, 40~70 orders, 30~40 order pillers are as the ball core of subsequent operation, coarse granule and fine powder after each screening, add water, 10% polyvinylpyrrolidone aqueous solution with an amount of becomes rubber cement through the refiner homogenizing, crosses 60 mesh sieves, the same method, side sprays into.Collect 30~60 mesh sieve micropills at last, spray 18%OPADRY II (85G64874) (Shanghai Colorcon Coating Technology Co., Ltd's production) aqueous solution at the bottom of the fluid bed, coating, coating increase weight about 6%.Packing, promptly.
Test example 1
The present composition is to the efficacy enhancing and toxicity reducing effect of cyclophosphamide chemotherapy
1) material
Kunming kind white mice, body weight 18-22g, male and female half and half.
Cyclophosphamide (CTX), the permanent auspicious medical company limited production in Jiangsu, lot number: 06030221.
The primordial QI reinforcing capsule, Pharmaceutical Factory, Chengdu Huashen Group Corp., Ltd., lot number: 050903.
Pharmaceutical composition A~J presses the preparation of experimental example 3~12 methods.
2) method
Modeling: get H 22Tumor ascites mice is put to death from disconnected cervical vertebra, under the gnotobasis, extracts ascites in superclean bench, places ice bath, and the counting oncocyte is adjusted concentration to 2 * 10 6/ mL, it is subcutaneous to be inoculated in mice forelimb axillary fossa with 0.2mL/ inoculum concentration only, sets up the tumor-bearing mice animal model.
The grouping administration: the mice random packet, 10 every group, male and female half and half begin administration next day in inoculation tumor strain, and each group was by the continuous per os gastric infusion of following dosage 12 days.Cyclophosphamide group: 10ml/kg normal saline; Cyclophosphamide+primordial QI reinforcing Capsules group: primordial QI reinforcing capsule 650mg/kg body weight; Cyclophosphamide+compositions A group: compositions A 178mg/kg body weight; Cyclophosphamide+compositions B group: compositions B304mg/kg body weight; Cyclophosphamide+compositions C group: compositions C 352mg/kg body weight; Cyclophosphamide+compositions D group: compositions D 424mg/kg body weight; Cyclophosphamide+compositions E group: compositions E 541mg/kg body weight; Cyclophosphamide+composition F group: composition F 468mg/kg body weight; Cyclophosphamide+compositions G group: compositions G 348mg/kg body weight; Cyclophosphamide+compositions H group: compositions H 444mg/kg body weight; Cyclophosphamide+composition I group: composition I 417mg/kg body weight; Cyclophosphamide+compositions J group: compositions J 275mg/kg body weight.Simultaneously, the 1st, 3, each organized the dosage intraperitoneal injection of cyclophosphamide with the 30mg/kg body weight in 5 days.
Observe general situation every day, behind last administration 0.5h, the tail vein is got blood examination and is surveyed blood leukocytes number (WBC), RBC number (RBC), puts to death animal, weighs, and cuts open and gets tumor body, spleen, thymus, calculates tumour inhibiting rate and organ index.
Figure A20071004408600161
3) result
The result is as shown in table 1 below.As seen, the compositions of astragalus polysaccharides of the present invention and ginseng bud saponin can improve tumour inhibiting rate, rising spleen index and thymus index and peripheral white blood cell and RBC number, show that the present composition can strengthen the curative effect of cyclophosphamide, reduce the toxic and side effects that cyclophosphamide causes, and be better than existing preparation primordial QI reinforcing capsule.
Table 1 present composition is to the efficacy enhancing and toxicity reducing effect of cyclophosphamide chemotherapy (X ± s)
Figure A20071004408600162
Annotate: compare * P<0.05, * * P<0.01 with the cyclophosphamide group; Compare △ P<0.05, △ △ P<0.01 with cyclophosphamide+primordial QI reinforcing Capsules group.
Test example 2 present compositions are to the efficacy enhancing and toxicity reducing effect of cisplatin chemotherapy
1) material
The C57BL/6J black rat, body weight 18-22g, male and female half and half.
Cisplatin (DDP), Qilu Pharmaceutical Co., Ltd. produces, lot number: 0507027.
The primordial QI reinforcing capsule, Pharmaceutical Factory, Chengdu Huashen Group Corp., Ltd., lot number: 050903.
Pharmaceutical composition A~J presses the preparation of experimental example 3~12 methods.
2) method
Modeling: get the Lewis tumor-bearing mice, put to death from disconnected cervical vertebra, under the gnotobasis, cut open in superclean bench and to get the tumor body, shred grinding homogenate, cross 100 order cells sieve, place ice bath, the counting oncocyte is adjusted concentration to 2 * 10 6/ mL, it is subcutaneous to be inoculated in mice forelimb axillary fossa with 0.2mL/ inoculum concentration only, sets up the tumor-bearing mice animal model.
The grouping administration: the mice random packet, 10 every group, male and female half and half begin administration next day in inoculation tumor strain, and each group was by the continuous per os gastric infusion of following dosage 12 days.Cisplatin group: 10ml/kg normal saline; Cisplatin+primordial QI reinforcing Capsules group: primordial QI reinforcing capsule 650mg/kg body weight; Cisplatin+compositions A group: compositions A 178mg/kg body weight; Cisplatin+compositions B group: compositions B 304mg/kg body weight; Cisplatin+compositions C group: compositions C 352mg/kg body weight; Cisplatin+compositions D group: compositions D 424mg/kg body weight; Cisplatin+compositions E group: compositions E 541mg/kg body weight; Cisplatin+composition F group: composition F 468mg/kg body weight; Cisplatin+compositions G group: compositions G 348mg/kg body weight; Cisplatin+compositions H group: compositions H 444mg/kg body weight; Cisplatin+composition I group: composition I 417mg/kg body weight; Cisplatin+compositions J group: compositions J 275mg/kg body weight.Simultaneously, the 1st, 3, each organized the dosage lumbar injection cisplatin with the 5mg/kg body weight in 5 days.
Observe general situation every day, behind last administration 0.5h, the tail vein is got blood examination and is surveyed blood leukocytes number (WBC), RBC number (RBC), puts to death animal, weighs, and cuts open and gets tumor body, spleen, thymus, calculates tumour inhibiting rate and organ index.
3) result
The result is as shown in table 2 below.As seen, the compositions of astragalus polysaccharides of the present invention and ginseng bud saponin can improve tumour inhibiting rate, rising spleen index and thymus index and peripheral white blood cell and RBC number, show that the present composition can strengthen the curative effect of cisplatin, reduce the toxic and side effects that cisplatin causes, and be better than existing preparation primordial QI reinforcing capsule.
Table 2 present composition is to the efficacy enhancing and toxicity reducing effect of cisplatin chemotherapy (X ± s)
Figure A20071004408600181
Annotate: compare * P<0.05, * * P<0.01 with cisplatin; Compare △ P<0.05, △ △ P<0.01 with cisplatin+primordial QI reinforcing Capsules group.
Test example 3 present compositions are to the efficacy enhancing and toxicity reducing effect of 5-fluorouracil chemotherapy
1) material
Kunming kind white mice, body weight 18-22g, male and female half and half.
5-fluorouracil (5-Fu), Shanghai Xudong Hipu Medicine Co., Ltd, lot number: 061007.
The primordial QI reinforcing capsule, Pharmaceutical Factory, Chengdu Huashen Group Corp., Ltd., lot number: 050903.
Pharmaceutical composition A~J presses the preparation of experimental example 3~12 methods.
2) method
Modeling: get H 22Tumor ascites mice is put to death from disconnected cervical vertebra, under the gnotobasis, extracts ascites in superclean bench, places ice bath, and the counting oncocyte is adjusted concentration to 2 * 10 6/ mL, it is subcutaneous to be inoculated in mice forelimb axillary fossa with 0.2mL/ inoculum concentration only, sets up the tumor-bearing mice animal model.
The grouping administration: the mice random packet, 10 every group, male and female half and half begin administration next day in inoculation tumor strain, and each group was by the continuous per os gastric infusion of following dosage 12 days.5-fluorouracil group: 10ml/kg normal saline; 5-fluorouracil+primordial QI reinforcing Capsules group: primordial QI reinforcing capsule 650mg/kg body weight; 5-fluorouracil+compositions A group: compositions A 178mg/kg body weight; 5-fluorouracil+compositions B group: compositions B 304mg/kg body weight; 5-fluorouracil+compositions C group: compositions C 352mg/kg body weight; 5-fluorouracil+compositions D group: compositions D 424mg/kg body weight; 5-fluorouracil+compositions E group: compositions E 541mg/kg body weight; 5-fluorouracil+composition F group: composition F 468mg/kg body weight; 5-fluorouracil+compositions G group: compositions G 348mg/kg body weight; 5-fluorouracil+compositions H group: compositions H 444mg/kg body weight; 5-fluorouracil+composition I group: composition I 417mg/kg body weight; 5-fluorouracil+compositions J group: compositions J 275mg/kg body weight.Simultaneously, the 1st, 3, each organized the dosage lumbar injection 5-fluorouracil with the 20mg/kg body weight in 5 days.
Observe general situation every day, behind last administration 0.5h, the tail vein is got blood examination and is surveyed blood leukocytes number (WBC), RBC number (RBC), puts to death animal, weighs, and cuts open and gets tumor body, spleen, thymus, calculates tumour inhibiting rate and organ index.
3) result
The result is as shown in table 3 below.As seen, the compositions of astragalus polysaccharides of the present invention and ginseng bud saponin can improve tumour inhibiting rate, rising spleen index and thymus index and peripheral white blood cell and RBC number, show that the present composition can strengthen the curative effect of 5-fluorouracil, reduce the toxic and side effects that 5-fluorouracil causes, and be better than existing preparation primordial QI reinforcing capsule.
Table 3 present composition is to the efficacy enhancing and toxicity reducing effect of 5-fluorouracil chemotherapy (X ± s)
Figure A20071004408600191
Annotate: compare * P<0.05, * * P<0.01 with the 5-fluorouracil group; Compare △ P<0.05, △ △ P<0.01 with 5-fluorouracil+primordial QI reinforcing Capsules group.
Test example 4 present compositions are right 60The efficacy enhancing and toxicity reducing effect of Co radiotherapy
1) material
Kunming kind white mice, body weight 18-22g, male and female half and half.
The primordial QI reinforcing capsule, Pharmaceutical Factory, Chengdu Huashen Group Corp., Ltd., lot number: 050903.
Pharmaceutical composition A~J presses the preparation of experimental example 3~12 methods.
2) method
Modeling: get H 22Tumor ascites mice is put to death from disconnected cervical vertebra, under the gnotobasis, extracts ascites in superclean bench, places ice bath, and the counting oncocyte is adjusted concentration to 2 * 10 6/ mL, it is subcutaneous to be inoculated in mice forelimb axillary fossa with 0.2mL/ inoculum concentration only, sets up the tumor-bearing mice animal model.
The grouping administration: the mice random packet, 10 every group, male and female half and half begin administration next day in inoculation tumor strain, and each group was by the continuous per os gastric infusion of following dosage 12 days. 60Co radiation group: 10ml/kg normal saline; 60Co radiation+primordial QI reinforcing Capsules group: primordial QI reinforcing capsule 650mg/kg body weight; 60Co radiation+compositions A group: compositions A 178mg/kg body weight; 60Co radiation+compositions B group: compositions B304mg/kg body weight; 60Co radiation+compositions C group: compositions C 352mg/kg body weight; 60Co radiation+compositions D group: compositions D 424mg/kg body weight; 60Co radiation compositions E group: compositions E 541mg/kg body weight; 60Co radiation+composition F group: composition F 468mg/kg body weight; 60Co radiation+compositions G group: compositions G 348mg/kg body weight; 60Co radiation+compositions H group: compositions H 444mg/kg body weight; 60Co radiation+composition I group: composition I 417mg/kg body weight; 60Co radiation+compositions J group: compositions J 275mg/kg body weight.Simultaneously, the 5th, 10 day each group with the dose irradiation of a 5Gy (exposure dose rate is 0.55Gy/min) 60The Co ray.
Observe general situation every day, behind last administration 0.5h, the tail vein is got blood examination and is surveyed blood leukocytes number (WBC), RBC number (RBC), puts to death animal, weighs, and cuts open and gets tumor body, spleen, thymus, calculates tumour inhibiting rate and organ index.
3) result
The result is as shown in table 4 below.As seen, the compositions of astragalus polysaccharides of the present invention and ginseng bud saponin can improve tumour inhibiting rate, and rising spleen index and thymus index and peripheral white blood cell and RBC number show that the present composition can strengthen 60The curative effect of Co radiotherapy reduces 60The toxic and side effects that the Co radiation causes, and be better than existing preparation primordial QI reinforcing capsule.
Table 4 present composition is right 60The efficacy enhancing and toxicity reducing effect of Co radiotherapy (X ± s)
Figure A20071004408600211
Annotate: with 60Co radiation group compares, * P<0.05, * * P<0.01; With 60Co radiation+primordial QI reinforcing Capsules group compares, △ P<0.05, △ △ P<0.01.
Test example 5 present compositions are to the influence of hydrocortisone immunosuppressed mice
1) material
Kunming kind white mice, body weight 18-22g, male and female half and half.
Hydrocortisone (HY), Tianjin gold credit aminoacid company limited, lot number: 0601272.
The primordial QI reinforcing capsule, Pharmaceutical Factory, Chengdu Huashen Group Corp., Ltd., lot number: 050903.
Pharmaceutical composition A~J presses the preparation of experimental example 3~12 methods.
2) method
Modeling: hydrocortisone 30mg/kg body weight mice, lumbar injection, the next day once, totally 5 times, set up the immunosuppressant animal model.
The grouping administration: the mice random packet, 10 every group, male and female half and half begin administration next day in inoculation tumor strain, and each group was by the continuous per os gastric infusion of following dosage 12 days.Hydrocortisone: 10ml/kg normal saline; Hydrocortisone+primordial QI reinforcing Capsules group: primordial QI reinforcing capsule 650mg/kg body weight; Hydrocortisone+compositions A group: compositions A 178mg/kg body weight; Hydrocortisone+compositions B group: compositions B 304mg/kg body weight; Hydrocortisone+compositions C group: compositions C 352mg/kg body weight; Hydrocortisone+compositions D group: compositions D 424mg/kg body weight; Hydrocortisone+compositions E group: compositions E 541mg/kg body weight; Hydrocortisone+composition F group: composition F 468mg/kg body weight; Hydrocortisone+compositions G group: compositions G 348mg/kg body weight; Hydrocortisone+compositions H group: compositions H 444mg/kg body weight; Hydrocortisone+composition I group: composition I 417mg/kg body weight; Hydrocortisone+compositions J group: compositions J 275mg/kg body weight.
Observe general situation every day, behind last administration 0.5h, the tail vein is got blood examination and is surveyed blood leukocytes number (WBC), RBC number (RBC), puts to death animal, weighs, and cuts open and gets spleen, thymus, calculates organ index.
3) result
The result is as shown in table 5 below.As seen, the compositions of astragalus polysaccharides of the present invention and ginseng bud saponin can raise spleen index and thymus index and peripheral white blood cell and RBC number, show that the present composition can alleviate the immunosuppressive action that hydrocortisone causes, and be better than existing preparation primordial QI reinforcing capsule.
Table 5 present composition is to the influence of hydrocortisone immunosuppressed mice (X ± s)
Figure A20071004408600221
Annotate: compare * P<0.05, * * P<0.01 with the hydrocortisone group; Compare △ P<0.05, △ △ P<0.01 with hydrocortisone+primordial QI reinforcing Capsules group.
The antitumor action of test example 6 present compositions
1) material
Kunming mouse (H 22), F1 mice (C 26), C57BL/6 mice (Lewis lung cancer), body weight 18-22g, male.
The primordial QI reinforcing capsule, Pharmaceutical Factory, Chengdu Huashen Group Corp., Ltd., lot number: 050903.
Pharmaceutical composition A~J presses the preparation of experimental example 3~12 methods.
2) method
Modeling: get well-grown rat liver cancer H 22Ascites, intestinal cancer C 26With Lewis lung cancer tumor piece, under the gnotobasis, adjust concentration to 2 * 10 with normal saline 7/ mL, it is subcutaneous to be inoculated in mice forelimb axillary fossa with 0.2mL/ inoculum concentration only, sets up the tumor-bearing mice animal model.
The grouping administration: the mice random packet, 10 every group, male and female half and half begin administration next day in inoculation tumor strain.Blank group: 10ml/kg normal saline; Primordial QI reinforcing Capsules group: primordial QI reinforcing capsule 650mg/kg body weight; Present composition A group: compositions A 178mg/kg body weight; Present composition B group: compositions B 304mg/kg body weight; Present composition C group: compositions C 352mg/kg body weight; Present composition D group: compositions D 424mg/kg body weight; Present composition E group: compositions E 541mg/kg body weight; Present composition F group: composition F 468mg/kg body weight; Present composition G group: compositions G 348mg/kg body weight; Present composition H group: compositions H444mg/kg body weight; Present composition I group: composition I 417mg/kg body weight; Present composition J group: compositions J 275mg/kg body weight.
Per os gastric infusion 12 days (be administered once every day) is observed general situation every day continuously, behind last administration 0.5h, puts to death animal, weighs, and cuts open and gets the tumor body, calculates tumour inhibiting rate.
3) result
The result is as shown in table 6 below.As seen, the compositions of astragalus polysaccharides of the present invention and ginseng bud saponin has anti-rat liver cancer H 22, intestinal cancer C 26With the effect of Lewis lung cancer, there is not notable difference with existing preparation primordial QI reinforcing capsule.
The antitumor action of table 6 present composition (X ± s)
Figure A20071004408600241

Claims (24)

1. a medical composition and its use that contains astragalus polysaccharides and ginseng bud saponin is characterized in that, the weight ratio of astragalus polysaccharides and ginseng bud saponin is 0.01~200: 1.
2. pharmaceutical composition as claimed in claim 1 is characterized in that, the weight ratio of astragalus polysaccharides and ginseng bud saponin is 0.08~170: 1.
3. pharmaceutical composition as claimed in claim 2 is characterized in that, the weight ratio of astragalus polysaccharides and ginseng bud polysaccharide is 0.9~130: 1.
4. pharmaceutical composition as claimed in claim 3 is characterized in that, the weight ratio of astragalus polysaccharides and ginseng bud polysaccharide is 9~90: 1.
5. pharmaceutical composition as claimed in claim 4 is characterized in that, the weight ratio of astragalus polysaccharides and ginseng bud polysaccharide is 10~40: 1.
6. pharmaceutical composition as claimed in claim 5 is characterized in that, the weight ratio of astragalus polysaccharides and ginseng bud polysaccharide is 16~24: 1.
7. pharmaceutical preparation is characterized in that, described preparation comprises arbitrary described pharmaceutical composition and the acceptable excipient of pharmacy in the claim 1 to 6.
8. pharmaceutical preparation as claimed in claim 7 is characterized in that, the percentage by weight that described pharmaceutical composition accounts for described pharmaceutical preparation is 40%-85%.
9. pharmaceutical preparation as claimed in claim 7 is characterized in that, described preparation is injection, tablet, pellet, granule, capsule or solution.
10. pharmaceutical preparation as claimed in claim 9 is characterized in that, described preparation is a pellet.
11. pharmaceutical preparation as claimed in claim 10 is characterized in that, the percentage by weight composition of described preparation is as follows:
Astragalus polysaccharides 45.68%
Ginseng bud saponin 4.32%
Microcrystalline Cellulose 39%
Polyvinylpyrrolidone 5%
OPADRY?II 6%。
12. pharmaceutical preparation as claimed in claim 10 is characterized in that, the percentage by weight composition of described preparation is as follows:
Astragalus polysaccharides 53.66%
Ginseng bud saponin 6.34%
Microcrystalline Cellulose 30%
Polyvinylpyrrolidone 4%
OPADRY?II 6%。
13. pharmaceutical preparation as claimed in claim 10 is characterized in that, the percentage by weight composition of described preparation is as follows:
Astragalus polysaccharides 69.45%
Ginseng bud saponin 0.55%
Microcrystalline Cellulose 21%
Polyvinylpyrrolidone 3%
OPADRY?II 6%。
14. pharmaceutical preparation as claimed in claim 10 is characterized in that, the percentage by weight composition of described preparation is as follows:
Astragalus polysaccharides 76.82%
Ginseng bud saponin 3.18%
Microcrystalline Cellulose 12%
Polyvinylpyrrolidone 2%
OPADRY?II 6%。
15. pharmaceutical preparation as claimed in claim 10 is characterized in that, the percentage by weight composition of described preparation is as follows:
Astragalus polysaccharides 75.37%
Ginseng bud saponin 4.63%
Microcrystalline Cellulose 12%
Polyvinylpyrrolidone 2%
OPADRY?II 6%。
16. pharmaceutical preparation as claimed in claim 10 is characterized in that, the percentage by weight composition of described preparation is as follows:
Astragalus polysaccharides 69.59%
Ginseng bud saponin 0.41%
Microcrystalline Cellulose 21%
Polyvinylpyrrolidone 3%
OPADRY?II 6%。
17. pharmaceutical preparation as claimed in claim 10 is characterized in that, the percentage by weight composition of described preparation is as follows:
Astragalus polysaccharides 4.68%
Ginseng bud saponin 55.32%
Microcrystalline Cellulose 30%
Polyvinylpyrrolidone 4%
OPADRY?II 6%。
18. pharmaceutical preparation as claimed in claim 10 is characterized in that, the percentage by weight composition of described preparation is as follows:
Astragalus polysaccharides 36.68%
Ginseng bud saponin 43.32%
Microcrystalline Cellulose 12%
Polyvinylpyrrolidone 2%
OPADRY?II 6%。
19. pharmaceutical preparation as claimed in claim 10 is characterized in that, the percentage by weight composition of described preparation is as follows:
Astragalus polysaccharides 78.15%
Ginseng bud saponin 1.85%
Microcrystalline Cellulose 12%
Polyvinylpyrrolidone 2%
OPADRY?II 6%。
20. pharmaceutical preparation as claimed in claim 10 is characterized in that, the percentage by weight composition of described preparation is as follows:
Astragalus polysaccharides 59.30%
Ginseng bud saponin 0.70%
Microcrystalline Cellulose 30%
Polyvinylpyrrolidone 4%
OPADRY?II 6%。
21. arbitrary described pharmaceutical composition of claim 1 to 6 or the arbitrary described pharmaceutical preparation of claim 7 to 20 application in the medicine of preparation enhancing chemotherapy and radiation curative effect.
22. arbitrary described pharmaceutical composition of claim 1 to 6 or the arbitrary described pharmaceutical preparation of claim 7 to 20 application in the medicine of preparation reduction chemotherapy and radiation toxic and side effects.
23. arbitrary described pharmaceutical composition of claim 1 to 6 or the arbitrary described pharmaceutical preparation of claim 7 to 20 application in the medicine of preparation raising immunologic function.
24. arbitrary described pharmaceutical composition of claim 1 to 6 or the arbitrary described pharmaceutical preparation of claim 7 to 20 application in the preparation antitumor drug.
CN2007100440868A 2007-07-20 2007-07-20 Medicament composition containing astragalus polysaccharide and ginseng bud saponin and uses thereof Expired - Fee Related CN101347446B (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106361838A (en) * 2016-11-17 2017-02-01 甘肃中医药大学 Anticancer composition containing paeoniae rubra radix (PRR) and astragalus root, and preparation method and application thereof

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106361838A (en) * 2016-11-17 2017-02-01 甘肃中医药大学 Anticancer composition containing paeoniae rubra radix (PRR) and astragalus root, and preparation method and application thereof

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