CN1864718A - A polysaccharide composition for tumor aid treatment, its preparation and application - Google Patents
A polysaccharide composition for tumor aid treatment, its preparation and application Download PDFInfo
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Abstract
The invention provides a medicinal composition comprising codonopsis pilosula polysaccharides, polysaccharoses and matrimony vine polysaccharides which are extracted from the significant portions of codonopsis pilosula, astragalus root and fruit of Chinese wolfberry. The invention also provides the preparing process and use of the composition, which can enhance body immunological functions for cancer patients.
Description
(1) technical field:
The present invention relates to a kind of herbal polysaccharide compositions and preparation and application of tumor aid treatment, be specifically related to a kind of compositions of effective site Radix Codonopsis polysaccharide, astragalus polysaccharides and the lycium barbarum polysaccharide of from Chinese crude drug Radix Codonopsis, the Radix Astragali and Fructus Lycii, extracting and suitable preparation thereof, and the application of said composition in preparation chemotherapy of tumors or radiotherapy or postoperative adjuvant therapy medicaments or health food.
(2) background technology:
According to 1997 years of World Health Organization (WHO), because of cancer mortality has 6,300,000 people approximately, account for 12% of total death toll in the whole world 5,800,000,000 populations in 1996, be the second largest cause of the death that is only second to cardiovascular disease.The annual tumor patient of newly making a definite diagnosis in the whole world is all more than 1,030 ten thousand people since 1996, to the end of the year 1999 whole world tumor patient sum exceeded 4,000 ten thousand people.World Health Organization's calendar year 2001 report, world's cancer morbidity and mortality rate have risen 22% than the nineteen ninety, also will rise about 50% in 20 years from now on.Therefore, the medicine of treatment and prophylaxis of tumours disease becomes the research and development focus of whole pharmaceuticals industry.Along with the rising of tumor incidence and continuing to bring out of new drug, great variety will take place in anticarcinogen market, and research, development and production new antitumor drug particularly natural anti-cancer drugs becomes the new focus that increases on the medical market.In China, the research of the antitumor drug of Chinese herbal medicine and active component thereof has been one of state key basic research development and planning project.Be the chemical synthetic drug except that a few antitumor drug such as mitoxantrone, alkyl urea and cisplatin in the antitumor drug of listing China nineties in 20th century, a series of antitumor drug (containing the human immunity regulator) of go on the market (or still in development stage) are the composition that extracts from natural herbal.The anticancer main mechanism of Chinese herbal medicine extract is: (1) presses down tumor killing cell; (2) adjust anticancer potential such as immunity of organism,, prolong the vital stage to improve patient's quality of life; (3) sensitization of raising chemicotherapy effect; (4) Attenuation of reduction toxic and side effects of chemoradiotherapy.Wherein, polysaccharide is extracted into the antitumor drug that is divided into main medicinal ingredient, and not only untoward reaction is less in therapeutic process, and has the function of strengthening the body resistance, is the newtype drug that mediator's body immunity function is beneficial to eliminate interior tumor cell (tissue).The test of polysaccharide combination chemotherapy tumor shows, polysaccharide can not only produce the obvious synergistic effect, significantly improve cellular immunization, the humoral immune function of body, and can resist the toxicity of chemotherapy effectively, and this mainly can promote hematopoietic cell to break up, grow relevant with polysaccharide.Polysaccharide is used for the advantage that antitumor has the following aspects on the whole: (1) improves the life quality of tumor patient; (2) survival period of prolongation tumor patient; (3) improve immunological function of cancer patients, strengthen resistance against diseases; (4) vigor of promotion regenerative cell.For many years, we have carried out systematic research to Chinese crude drug Radix Codonopsis, the Radix Astragali and three kinds of medical materials of Fructus Lycii, find to compare with polysaccharide composition effect in the single medical material, the compositions of three kinds of medical material polysaccharide compositions has more significant pharmacological action: can significantly promote lymhocyte transformation rate, can significantly strengthen the non-specific immunity and the humoral immune function of mice with tumor, strengthen cytophagous phagocytic function, by strengthening mice with tumor immunity kill tumor cell; Can significantly reduce the lipid peroxidation of mice with tumor immunocyte, obviously suppress the growth rate of gross tumor volume and weight, reduce cancer cell metastasis and diffusion, prolong the time-to-live of mice with tumor, improve its life quality.We utilize the extraction process of modern Chinese medicine that above-mentioned three flavor medical materials are made with extra care, effective site polysaccharide with the effective ingredient enrichment that obtains becomes to be grouped into total polysaccharides as main active component, can be made into suitable pharmaceutical formulation and be used for the auxiliary treatment of tumor disease, also can be widely used in field of health care food.
(3) summary of the invention:
The present invention is directed to the deficiencies in the prior art, provide the compositions of a kind of Radix Codonopsis polysaccharide that from Chinese crude drug Radix Codonopsis, the Radix Astragali and Fructus Lycii, extracts, astragalus polysaccharides and lycium barbarum polysaccharide, with its auxiliary treatment after as tumor disease radiotherapy or chemotherapy or operative treatment and the health food that prolongs patient's life, raise immunity, improves the pharmaceutical preparation of cancer patient quality of life or be prepared into various suitable (or suitable dosage forms).
At first, active component with the function that suppresses tumor, adjusting immunity provided by the invention is the compositions total polysaccharides that derives from the effective site polysaccharose substance that extracts in Chinese crude drug Radix Codonopsis, the Radix Astragali and the Fructus Lycii, and wherein the actual content sum of total polysaccharides is not less than 50% of total extract.
Next, the polysaccharide composition that the active component with the function that suppresses tumor, adjusting immunity provided by the invention is Radix Codonopsis, the Radix Astragali and three kinds of medical materials of Fructus Lycii combines.These three kinds of polysaccharide compositions no matter be plant extract or derive from chemosynthesis, may be used among the effective active composition of the present composition; In addition, total polysaccharides also comprises the compositions that the pure product of above-mentioned polysaccharide adding of the same type pure product that extraction separation comes out from above-mentioned three flavor crude drugs or chemosynthesis are formed according to the proportion of hereinafter describing, and the actual content of wherein total polysaccharide is not less than 50% of total extract.
The medicine of tumor aid treatment of the present invention is promptly gone up the acceptable pharmaceutical excipient by above-mentioned total polysaccharides and physiology and is formed.Dosage form of the present invention is mainly oral formulations, comprises tablet such as ordinary tablet, slow releasing tablet, controlled release tablet, oral cavity disintegration tablet etc., and hard capsule, soft capsule, pill, granule, oral liquid etc.The effective site used in view of the present invention is compound of polysaccharide, thus can also be made into suitable parenteral dosage form, as liquid preparations such as lyophilized injectable powder, injectable powder, injection, infusion solutions.In addition, said composition has very strong adjusting body's immunity, improves the function of body constitution, can also be widely used in various after being ill the rehabilitation medicine and the preparation of various health foods, comprise directly being the suitable preparations such as capsule, tablet, oral liquid of main component preparation with the said composition, also can be used as food additive, be applied to food (as bread, noodles etc.), health tea, health beverage etc.
Following detailed will help further to understand the present invention.
Unless otherwise indicated, the part term of this description is defined as follows:
Radix Codonopsis: or its crude drug, being meant campanulaceae plant Radix Codonopsis (Codonopsis pilosula), its root is medicinal, and sweet in the mouth is flat.Record in " book on Chinese herbal medicine justice " " Radix Codonopsis power energy spleen reinforcing nourishing the stomach, the lung moistening and production of body fluid promoting, gas in the strong fortune, this is very mutually not far away with Radix Ginseng.Its outstanding valuable person, spleen invigorating fortune and not dry is then grown stomach-Yin and wet, and lung moistening and do not violate is cold and coolly nourished blood and is not grown greasyly partially, inspires clear sun, gas in the vibration, and do not have dry fraud just." successive dynasties traditional Chinese medical science scholar thinks that Radix Codonopsis has invigorating the spleen and replenishing QI, effects such as promoting the production of body fluid to quench thirst, strengthening the spleen and tonifying the lung.Use the root of Radix Codonopsis in the present invention, its pulverizing or section can be used to extract effective site.
The Radix Astragali: or its crude drug is meant the root of leguminous plant Radix Astagali (Astragalus membranaceus BungeVar.mongholicus[Bunge] P.K.Hsiao) or Radix Astragali (Astragalus membranaceus[Fisch.] Bunge.) or the tcm and herbal slice of making.The Radix Astragali, the original name Radix Astragali, the beginning is stated from Shennong's Herbal, classifies as top grade.Its sweet in the mouth, warm in nature, have tonifying Qi and lifting yang, benefit is defended consolidating superficial resistance, the effect of expelling pus and promoting granulation, inducing diuresis to remove edema.Be subjected to the attention of ancient Chinese medicine doctor, clinical practice is very extensive.The extraction that the root coarse powder or the section of the Radix Astragali can be beneficial to effective site in the present invention.
Fructus Lycii: or its crude drug, be the fruit of plant of Solanaceae (Lycium barbarum L.[L.halimifolium Mill.]), sweet in the mouth is flat, is the traditional tonic Chinese medicine of China, and the beginning is stated from Shennong's Herbal, is listed in top grade.Ming Dynasty's Li Shizhen (1518-1593 A.D.) is put down in writing Fructus Lycii in Compendium of Material Medica have " hard muscles and bones ... mend the vital essence various symptoms and signs of deficiency, make eye bright and calm the nerves, make us long-lived " etc. effect.Be usually used in traditional medicine that asthenia damage of essence, soreness of the waist and knees, vertigo and tinnitus, interior-heat are quenched one's thirst, blood deficiency and yellow complexion etc.What use in the present invention is the fruit (fresh fruit or dry fruit all can) of Fructus Lycii.
Radix Codonopsis polysaccharide: be meant by the described method of this description and from the Radix Codonopsis crude drug, extract the polysaccharose substance that obtains, and wherein polyoses content is not less than 50% (w/w) of total extract; Astragalus polysaccharides: be meant by the described method of this description and from Radix Astragali crude drug, extract the total polysaccharides that the polysaccharose substance that obtains is formed, and wherein polyoses content is not less than 50% (w/w) of total extract; Lycium barbarum polysaccharide: be meant by the described method of this description and from the Fructus Lycii crude drug, extract the polysaccharose substance that obtains, and wherein lycium barbarum polysaccharide content is not less than 50% (w/w) of total extract.
Total polysaccharides: be meant and from Chinese crude drug Radix Codonopsis, the Radix Astragali and Fructus Lycii, extract the compositions that Radix Codonopsis polysaccharide, astragalus polysaccharides and lycium barbarum polysaccharide combine that the actual content of polysaccharide compound is not less than 50% (w/w) of extract total amount in the said composition.In addition, total polysaccharides can also comprise the compositions that the pure product of above-mentioned polysaccharide adding of the same type pure product that extraction separation comes out from above-mentioned three flavor crude drugs or chemosynthesis are formed according to the proportion of hereinafter describing.The actual content of total polysaccharides also all is not less than 50% (w/w) of total composition in all these active component compositions.
The present composition comprises that above-mentioned total polysaccharides and physiology go up the acceptable pharmaceutical excipient.Wherein the composition of total polysaccharides and preparation method are as follows: extract from Chinese crude drug Radix Codonopsis, the Radix Astragali and Fructus Lycii, separation and purification obtains effective site Radix Codonopsis polysaccharide, astragalus polysaccharides and lycium barbarum polysaccharide, more above-mentioned effective site is combined into total polysaccharides according to a certain percentage.Wherein the amount ranges of three kinds of components is: 30%～60% Radix Codonopsis polysaccharide, 20%～40% astragalus polysaccharides and 10%～40% lycium barbarum polysaccharide, preferable amount is 40%～60% Radix Codonopsis polysaccharide, 30%～40% astragalus polysaccharides and 10%～30% lycium barbarum polysaccharide, and optimum consumption is Radix Codonopsis polysaccharide 40%, astragalus polysaccharides 40% and lycium barbarum polysaccharide 20%.
The preparation method of each effective site and step are as described below in this total polysaccharides:
(1) extraction process of Radix Codonopsis polysaccharide:
1. at first the Radix Codonopsis root is dried, be cut into 2～3cm segment or section then;
2. the water of getting 5～12 times of amounts of above-mentioned Radix Codonopsis root piece adding extracts 2～3 times in 70～100 ℃ of heating extraction of temperature, each 1～3 hour extraction time, merges the water extract;
3. the water extract with gained concentrates, and adds 90% above ethanol stirring and evenly mixing, makes concentration of ethanol reach 65～80%, then with its standing over night;
4. with gained leave standstill liquid filter precipitate, precipitate is water-soluble, add 80%, 75% ethanol more respectively and carry out precipitate with ethanol, filter the gained precipitate, remove albumen (Savage method, protease method etc.), promptly at 60～80 ℃ of following vacuum dryings.
(2) extraction of Astragalus Polysaccharides in Astragalus technology:
1. crude drug is cleaned, dries the back and pulverize, add 6～12 times of water gagings and under 60～100 ℃ of temperature, extract 2～3 times, each 1～3 hour extraction time, filter merging water extract;
2. after the water extract being concentrated, add 90% above ethanol and make its determining alcohol reach 65～80%, fully behind the mixing, left standstill 12～24 hours, inclining supernatant, filters;
3. the gained precipitation is removed soluble impurity with organic solvent washings such as 90% ethanol, 95% ethanol, dehydrated alcohol, reuse removes protein process such as Savage method, protease method etc. are refining, is drying to obtain 60～80 ℃ of reduced vacuum.
(3) extraction process of lycium barbarum polysaccharide:
1. Fructus Lycii is put and dry by the fire 12～24h in the air dry oven under 30～50 ℃ to doing, with 3～8 times of petroleum ether backflow defats 2～3 times, each return time 1～2 hour, filtration.Medicinal residues add 5～12 times of water gagings and extract under 60～100 ℃ temperature 2～3 times, each 1～3 hour extraction time, filter, and extracting solution is merged, concentrate;
2. the ethanol that adds more than 90% in concentrated solution makes its determining alcohol reach 65～80%, fully leaves standstill 24～48 hours behind the mixing, filters;
3. the gained precipitation is removed soluble impurity with organic solvent washings such as 90% ethanol, 95% ethanol, dehydrated alcohol, and it is refining repeatedly that methods such as reuse Savage method, protease method and dialysis are further removed impurity, is drying to obtain 60～80 ℃ of reduced vacuum.
In addition, the solvent that is used for extracting or extract in the leaching process of effective site can be water, ethanol, methanol, ethyl acetate, petroleum ether and other organic solvent; Above-mentioned effective site can be extracted respectively, also can mixed extraction, obtain total polysaccharides after refining.In addition, above-mentioned total polysaccharides both can be to derive from plant (Chinese crude drug) to extract, and also can derive from chemosynthesis or semi-synthetic.
The present invention also proposes to go up the Pharmaceutical composition that the acceptable pharmaceutical excipient is formed by above-mentioned " total polysaccharides " and physiology.The dosage form of these Pharmaceutical compositions comprises oral formulations, as various tablets, capsule, pill, oral liquid etc., also can be the parenteral dosage form, as infusion solution, injection, freeze-dried powder injection or powder ampoule agent for injection etc.
Compare with prior art, the present invention has following characteristics: first, we report in conjunction with lot of documents, a large amount of tcm prescriptions have been carried out having the purpose screening, test through the antitumor animal pharmacology of modern Chinese medicine again, carry out actual effect demonstration and Comparison of therapeutic from aspects such as drug effect, The pharmacological results, determined at last to carry out rational compatibility with the effective site polysaccharose substance of above-mentioned three flavor Chinese crude drugs.We think the patient who suffers from tumor, cancer, they have syndromes such as in various degree disharmony between QI and blood, deficiency of both the liver and kidney, weakness of the spleen and stomach, yin and yang imbalance, select for use three medical instruments to make eye bright in the side to calm the nerves, tonifying Qi and lifting yang, benefit defend that consolidating superficial resistance, promoting the production of body fluid to quench thirst and spleen are good for the stomach, nourishing liver and kidney, expelling pus and promoting granulation, inducing diuresis to remove edema, make us effect such as longevity, are the medicines of ancient Chinese medicine doctor tonification commonly used.Therefore with the polyoses extract compatibility of three kinds of medical materials, can give full play to their stronger tonification effects, complementation is short mutually, than single medicinal material better effects if, and has avoided big compound recipe to go into the various drawback of flavour of a drug number.Secondly, except the treatment theory that the tonification of considering the traditional Chinese medical science is nursed one's health, we have also considered the result of study of modern pharmacology simultaneously, as previously mentioned, the modern pharmacological research result of three kinds of medical material polyoses extracts selecting for use shows that they have favorable anti-tumor effect, can the immune stimulatory cell, strengthen cytophagous phagocytic activity, regulate body's immunity from cellular immunization, two aspects of humoral immunization, strengthen patient's body constitution, thus flourishing in the effect that suppresses tumor.The 3rd, the extraction process that we adopt modern Chinese medicine is extracted effective site polysaccharide wherein respectively with three flavor Chinese crude drugs and is made with extra care, and makes wherein the abundant enrichment of effective ingredient to reach content higher effective position, and optimum organization becomes total polysaccharides again.In this compositions, each single effective site: Radix Codonopsis polysaccharide content 〉=50%; Astragalus polysaccharides content 〉=50%; Lycium barbarum polysaccharide content 〉=50%.Total polysaccharides content 〉=50% in the extract, polysaccharide and total polysaccharides all can be by modern analysis methods such as uv analysis methods, carrying out reliable qualitative and quantitative analysis detects, control its content, it is lower to have remedied present compound Chinese medicinal preparation scientific and technological content, active constituent content is low or indeterminate, deficiencies such as difficult quality control.At last, this product had both kept the characteristics of Chinese crude drug treatment disease, treatment disease and nourishing conditioning are synchronously, at antineoplastic simultaneously, can strengthen patient's body constitution, improve patient's quality of life, prolong patient's life, can be used as the adjuvant therapy medicaments behind tumor patient radiotherapy, chemotherapy and the operative treatment, can also demonstrate fully the development characteristic of modern Chinese medicine as the rehabilitation medicine of tumor disease and even other diseases.In addition, because the selected Radix Codonopsis and the Radix Astragali of the present invention is the Chinese crude drug that can be used for health food, the Chinese crude drug Fructus Lycii is that both edible was also pharmaceutically acceptable, therefore, the polysaccharide that is extracted also can be widely used in field of health care food, also can be used as food additive and is applied in the food.
(4) description of drawings:
Fig. 1 is the process chart of embodiment 4;
Fig. 2 is the process chart of embodiment 5;
Fig. 3 is to mice transplantability S
180The inhibiting experimental result of sarcoma;
Fig. 4 is to mice transplantability H
22The inhibiting experimental result of solid tumor;
Fig. 5 is the experimental result to the influence of EAC ascites tumor mice increase in life span;
Fig. 6 is the experimental result to the influence of tumor-bearing mice peritoneal macrophage phagocytic function;
Fig. 7 is the experimental result to the influence of the carbon clearance ability of tumor-bearing mice reticuloendothelial system (RES);
Fig. 8 is the experimental result to the influence of tumor-bearing mice delayed hypersensitivity (DTH).
The invention will be further described by the following examples, but be not limited in this.
(5) specific embodiment:
The extraction process of embodiment 1 Radix Codonopsis polysaccharide
Get Radix Codonopsis crude drug 40kg, be cut into 2～3cm segment after drying, add the water of 10 times of amounts, put water decoction in the heating kettle, 2 hours extraction times, filter, filter back medicinal residues can repeat above-mentioned technical process 2 times once more, 1.5 hours extraction times, three water extracts are merged, be concentrated into relative density 1.05～1.35, add 95% ethanol stirring and evenly mixing, make concentration of ethanol reach 75%, then with its standing over night; The liquid that leaves standstill of gained is carried out sucking filtration and gets precipitate, precipitate is water-soluble, add 80%, 75% ethanol more respectively and carry out precipitate with ethanol, to filter, precipitate protease method remove impurity is 70 ℃ of following reduced vacuum dryings, promptly.
Embodiment 2 extraction of Astragalus Polysaccharides in Astragalus technologies
20kg Radix Astragali crude drug is cleaned, dries the back pulverize, add 10 times of water gagings and under 100 ℃ of temperature, decoct 3 times, each 2 hours time, filter, merge three times the water extract; The water extract is concentrated into relative density 1.05～1.35, adds 95% ethanol and make pure content reach 70%, fully left standstill 12 hours behind the mixing, inclining supernatant, filters out precipitation; The gained precipitation is used 90% ethanol, 95% ethanol, absolute ethanol washing successively, remove the impurity of solubility, with the further impurity removal and purification of protease method, 70 ℃ of reduced vacuum dryings, promptly.
The extraction process of embodiment 3 lycium barbarum polysaccharide:
Get the 10kg Fructus Lycii put in the air dry oven 40 ℃ down baking 24h pulverize the back with 5 times of petroleum ether backflow defats three times, 2h/ time, filtration to doing.Extraction is 3 times under the temperature that 10 times of water gagings of the air-dry back adding of medicinal residues are 100 ℃, 2 hours extraction times, filters at every turn, three extracting solution is merged be concentrated into relative density 1.05～1.35; The ethanol of adding 95% makes determining alcohol reach 70% in concentrated solution, fully leaves standstill 24 hours behind the mixing, filters; The gained precipitation is successively removed soluble impurity with organic solvent washings such as 95% ethanol, 80% ethanol, 75% ethanol, waves most organic solvent; Further remove impurity with extract obtained with protease method, 70 ℃ of following reduced vacuum dryings, promptly.
Embodiment 4 capsules
Get the total polysaccharides that a certain proportion of Radix Codonopsis polysaccharide, astragalus polysaccharides and lycium barbarum polysaccharide are formed, drying, pulverizing, mistake 80 mesh sieves are crossed 80 mesh sieve mix homogeneously with microcrystalline Cellulose, ethanol system granule with 95%, forced air drying is with 20 mesh sieve granulate, the fill capsule, the polishing packing gets final product.
(1) prescription is formed (1000): Radix Codonopsis polysaccharide 60g
Astragalus polysaccharides 40g
Lycium barbarum polysaccharide 40g
Microcrystalline Cellulose 80g
(2) prescription is formed (1000): Radix Codonopsis polysaccharide 30g
Astragalus polysaccharides 20g
Lycium barbarum polysaccharide 10g
Microcrystalline Cellulose 60g
(3) prescription is formed (1000): Radix Codonopsis polysaccharide 40g
Astragalus polysaccharides 30g
Lycium barbarum polysaccharide 10g
Microcrystalline Cellulose 70g
(4) prescription is formed (1000): Radix Codonopsis polysaccharide 60g
Astragalus polysaccharides 40g
Lycium barbarum polysaccharide 30g
Microcrystalline Cellulose 80g
(5) prescription is formed (1000): Radix Codonopsis polysaccharide 40g
Astragalus polysaccharides 40g
Lycium barbarum polysaccharide 20g
Microcrystalline Cellulose 75g
Accompanying drawing 1 is seen in its technological process.
Embodiment 5 tablets
Get the total polysaccharides that a certain proportion of Radix Codonopsis polysaccharide, astragalus polysaccharides and lycium barbarum polysaccharide are formed, drying, pulverizing, mistake 80 mesh sieves are crossed 80 mesh sieve mix homogeneously with microcrystalline Cellulose, carboxymethyl starch sodium, with 5%PVP system granule, forced air drying is with 20 mesh sieve granulate, add magnesium stearate, tabletting.
(1) prescription is formed (1000): Radix Codonopsis polysaccharide 60g
Astragalus polysaccharides 40g
Lycium barbarum polysaccharide 40g
Carboxymethyl starch sodium 7g
Microcrystalline Cellulose 80g
Magnesium stearate 3g
(2) prescription is formed (1000): Radix Codonopsis polysaccharide 30g
Astragalus polysaccharides 20g
Lycium barbarum polysaccharide 10g
Carboxymethyl starch sodium 4g
Microcrystalline Cellulose 55g
Magnesium stearate 1g
(3) prescription is formed (1000): Radix Codonopsis polysaccharide 40g
Astragalus polysaccharides 30g
Lycium barbarum polysaccharide 10g
Carboxymethyl starch sodium 5g
Microcrystalline Cellulose 75g
Magnesium stearate 2g
(4) prescription is formed (1000): Radix Codonopsis polysaccharide 60g
Astragalus polysaccharides 40g
Lycium barbarum polysaccharide 30g
Carboxymethyl starch sodium 5g
Microcrystalline Cellulose 85g
Magnesium stearate 2g
(5) prescription is formed: (1000): Radix Codonopsis polysaccharide 40g
Astragalus polysaccharides 40g
Lycium barbarum polysaccharide 20g
Carboxymethyl starch sodium 5g
Microcrystalline Cellulose 68g
Magnesium stearate 2g
Accompanying drawing 2 is seen in its technological process.
Illustrate its drug action with The pharmacological results below:
One, to S
180, H
22The growth inhibiting influence of solid tumor
Experimental technique:
Selecting body weight for use is the male mice in kunming of 18～22g, with S
180, H
22Tumor cell suspension (1 * 10
5/ ml) to be inoculated in animal forelimb axillary fossa subcutaneous, 0.2ml/ only, each tumor kind is respectively inoculated 70.Weigh after 24 hours and be divided into 7 groups at random: negative control group (giving the equivalent normal saline), model group (giving the equivalent normal saline), be subjected to reagent group (this product 500mg/kg, 250mg/kg), this product (500mg/kg, 250mg/kg) to add cyclophosphamide (CY, 30mg/kg) group and positive control (CY, 30mg/kg) group, every group 10, grouping back administration, be subjected to reagent to irritate stomach, positive drug lumbar injection.Once a day, continuous 10 days, observe every day and respectively organize the mice general state.Each treated animal is weighed next day after the drug withdrawal, puts to death mice and also separates the tumor piece, weighs and calculates tumour inhibiting rate.Win thymus simultaneously and spleen is weighed, be thymus or index and spleen index with likening to of body weight (g) with thymus or spleen weight (mg).
Experimental result:
Behind the inoculated tumour, model group, the movable number of times of positive controls mice obviously reduce, and fur is fluffy, and state is relatively poor.To this product group and to share the activity of cyclophosphamide group mice as usual, fur is smooth, weight increase merely.Positive controls can obviously suppress growth of tumor, but has also suppressed the growth of animal, and weight increase is slow, and state is relatively poor.And the independent use of this product just has inhibition S
180, H
22The tumor growth effect of mice with tumor, tumor control rate is respectively 35.1% and 33.7%; Share the back effect with the chemotherapeutic cyclophosphamide and strengthen, tumor control rate is 72.8% and 63.3%; Cyclophosphamide is to S
180, H
22The suppression ratio of tumor is 62.8% and 59.5%.Simultaneously, this product can also increase the thymus and the index and spleen index of tumor-bearing mice, promotes weight of mice, with tumor matched group and cyclophosphamide group significant difference is arranged more all.Prompting this product has protective effect to the immune organ of chemotherapy tumor-bearing mice, the effect of share efficacy enhancing and toxicity reducing with chemotherapeutic.To S
180The inhibitory action result of sarcoma sees Fig. 3 for details; To H
22Inhibitory action result see for details Fig. 4 (annotate:
*P＜0.05,
*Compare with the tumor matched group P＜0.01;
△P＜0.01,
△ △Compare with the cyclophosphamide group P＜0.01).
Two, to the influence of EAC ascites tumor mice increase in life span
Experimental technique:
Selecting body weight for use is the male mice in kunming of 18～22g, 0.2ml/ EAC tumor liquid of abdominal cavity inoculation.Random packet behind the 24h, grouping and administration are with the solid tumor mice, and positive drug is fluorouracil (5-Fu), intraperitoneal administration 30mg/kg.Behind the administration 10d, the death condition of respectively organizing mice is observed in drug withdrawal every day, calculates increase in life span.
Experimental result:
This product and fluorouracil list improve increase in life span with the life span (P＜0.05, P＜0.01) that all can prolong tumor-bearing mice; The two share the above-mentioned effect in back and obviously strengthens (P＜0.001).Prompting this product also has certain inhibitory action to the ascitic type tumor, with the chemotherapeutic fluorouracil potentiation synergism is arranged.(experimental data sees accompanying drawing 5 for details)
Three, to Immune Effects
1, to the influence of tumor-bearing mice peritoneal macrophage phagocytic function
Experimental technique:
Get 40 of Kunming male mices, body weight 18～22g is divided into 4 groups at random, 10 every group: the normal control group, the tumor matched group is subjected to reagent I group (250mg/kg), is subjected to reagent II group (500mg/kg).Except that the normal control group, all the other respectively organize forelimb axillary fossa subcutaneous vaccination S
180Tumor causes tumor model, every day gastric infusion, 1 time/d * 10d.Behind last administration 30min, every Mus lumbar injection 5%CRBC normal saline suspension 0.2ml puts to death animal behind the 24h, use 2.5mlHank ' s liquid to wash every Mus abdominal cavity, drip about 0.2ml flushing liquor on microscope slide, 37 ℃ of temperature are incubated 30min, wash away cell not adherent on the slide with NS.Methanol is fixed, and Giemsa-PBS liquid dyeing (PH6.5) is dried, and oily mirror is observed 100 macrophages down, and calculates percentage rate and the phagocytic index of engulfing CRBC.
Experimental result:
After causing tumor model, the phagocytic function of the macrophage of matched group obviously reduces, and two dosage groups of this product can improve the phagocytic function of tumor model mice, thereby improves the immunity of body.(experimental data sees accompanying drawing 6 for details)
2, to the influence of the carbon clearance ability of tumor-bearing mice reticuloendothelial system (RES)
Experimental technique:
Get 40 of Kunming male mices, body weight 18～22g is divided into 4 groups at random, 10 every group: the normal control group, the tumor matched group is subjected to reagent I group (250mg/kg), is subjected to reagent II group (500mg/kg).Except that the normal control group, all the other respectively organize forelimb axillary fossa subcutaneous vaccination S
180Tumor causes tumor model, every day gastric infusion, 1 time/d * 10d.30min after the last administration, each organizes the equal iv20% india ink of mice 0.1ml/10g, gets blood 20ul by eye socket respectively in injection back 2min and 12min, is dissolved in 2ml0.1%Na
2CO
3In the solution, wavelength 600nm place measures the optical density value (OD) of each sample, uses 0.1%Na
2CO
3Solution is as blank.After last is got blood, take off cervical vertebra immediately and put to death mice, take out liver, spleen, the record of weighing respectively calculates removing speed (k) and phagocytic index (a).
Experimental result:
Tumor mice in control group RES function after modeling significantly reduces, and shows as removing speed and the phagocytic index decline of RES to carbon granules; Two dosage groups of this product and tumor matched group compare, and the carbon clearance ability is significantly strengthened, and prompting this product can improve the RES function of tumor-bearing mice.(experimental data sees accompanying drawing 7 for details)
3, to the influence of tumor-bearing mice delayed hypersensitivity (DTH)
Experimental technique:
Get 40 of Kunming male mices, body weight 18～22g is divided into 4 groups at random, 10 every group: the normal control group, the tumor matched group is subjected to reagent I group (250mg/kg), is subjected to reagent II group (500mg/kg).Except that the normal control group, all the other respectively organize forelimb axillary fossa subcutaneous vaccination S
180Tumor causes tumor model.Use 1%DNFB acetone solution 50ul simultaneously, be applied to and respectively organize the mouse web portion sensitization of skin of depilation in advance.Administration next day (water), 1 time/d * 10d.30min after the last administration, being applied to each ear both sides, a Mus left side with 1%DNFB acetone solution 10ul attacks, put to death animal behind the 24h, cut left and right sides auricle, the auricle that sweeps away equal size with the card punch of 8mm is weighed, with the interaural difference value as index, between organizing relatively, get spleen simultaneously and thymus is weighed, try to achieve organ index.
Experimental result:
Two dosage groups of this product all can improve the delayed hypersensitivity of tumor-bearing mice, with the tumor matched group significant difference (P＜0.05, P＜0.01) are arranged relatively.(experimental data sees accompanying drawing 8 for details)
Claims (9)
1, a kind of compositions of Chinese medicine extract, it is made up of active component and/or pharmaceutically acceptable carrier, it is characterized in that described active component is the compositions of the polysaccharide compound of 30%～60% Radix Codonopsis polysaccharide, 20%～40% astragalus polysaccharides and 10%～40% lycium barbarum polysaccharide composition.
2, according to the described polysaccharide composition of claim 1, the preferable amount that it is characterized in that active component is 40%～60% Radix Codonopsis polysaccharide, 30%～40% astragalus polysaccharides and 10%～30% lycium barbarum polysaccharide.
3, polysaccharide composition according to claim 1 and 2 is characterized in that the content of described Radix Codonopsis polysaccharide, astragalus polysaccharides and lycium barbarum polysaccharide is not less than 50% of extract.
4, the poor method of polysaccharide preparation of compositions according to claim 1 and 2, it is to adopt conventional extracting method, it is characterized in that: with Chinese crude drug Radix Codonopsis, the Radix Astragali and Fructus Lycii is raw material, medical material is carried through adding hydro-thermal after the pre-treatment respectively, extracting solution is concentrated, and the alcohol that adds suitable concentration carries out precipitate with ethanol, filters, drying precipitate, dry thing mixing promptly gets the polysaccharide compositions.
5, polysaccharide preparation of compositions method according to claim 4, its feature are that also the precipitation that the precipitate with ethanol after-filtration goes out also can remove soluble impurity through solvent wash, and/or remove deproteinize with Savage method or protease method and make with extra care.
6, the preparation method of polysaccharide compound according to claim 4 is characterized in that it being to be prepared as follows to form:
(1) above-mentioned Chinese crude drug Radix Codonopsis root is dried, be cut into 2～3cm segment or section then; Radix Astragali crude drug cleans, pulverize the oven dry back; Baking 12～24h is extremely dried down at 30～50 ℃ for Fructus Lycii, with 3～8 times of petroleum ether backflow defats 2～3 times;
(2) water that adds 6～10 times of amounts in the medical material after the processing extracts 2～3 times in 70～100 ℃ of heating extraction of temperature, each 1～3 hour extraction time, merge the water extract, and the water extract of gained is concentrated;
(3) in concentrated solution, add 90% above ethanol stirring and evenly mixing, make concentration of ethanol reach 65～80%, then with its standing over night, filter precipitate;
(4) precipitate carries out precipitate with ethanol once more or uses organic solvent washing, removes soluble impurity, removes Deproteinization with Savage method or protease method;
(5) gains at 60～80 ℃ of following vacuum dryings promptly.
7,, it is characterized in that the application in preparing adjuvant therapy medicaments of tumor or health food, food additive according to the application of the described polysaccharide composition of claim 1.
8, the application of polysaccharide composition according to claim 7 is characterized in that being mainly used in auxiliary treatment and the medicine of rehabilitation or the application in the health food behind tumor radiotherapy, chemotherapy and the operative treatment.
9, the preparation of polysaccharide composition according to claim 1, it is characterized in that said dosage form is mainly oral formulations and comprises tablet such as ordinary tablet, controlled release tablet, slow releasing tablet, oral cavity disintegration tablet etc. and hard capsule, soft capsule, pill, granule etc., also can be the parenteral that suits with dosage form such as injection, lyophilized injectable powder, infusion solution etc.
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102000106A (en) * | 2010-11-12 | 2011-04-06 | 新乡医学院 | Medicinal composition for preventing and treating vascular injury caused by organic phosphorous pesticide and preparation method thereof |
| CN102872209A (en) * | 2012-10-11 | 2013-01-16 | 重庆市中药研究院 | Fumaiding medicine extractive composition and preparation method and application thereof |
| CN104119575A (en) * | 2014-06-19 | 2014-10-29 | 无限极（中国）有限公司 | Radix codonopsis and lycium barbarum compound polysaccharide capable of regulating tumor microenvironment as well as preparation method and application thereof |
| CN104116025A (en) * | 2014-06-19 | 2014-10-29 | 无限极（中国）有限公司 | Application of codonopsis pilosula polysaccharides to preparation of functional food with effect of helping to inhibit prostate cancer |
| CN106620195A (en) * | 2016-10-27 | 2017-05-10 | 无限极（中国）有限公司 | Chinese herbal medicine polysaccharide composition and application thereof |
| CN110585233A (en) * | 2019-10-18 | 2019-12-20 | 青岛市妇女儿童医院（青岛市妇幼保健院、青岛市残疾儿童医疗康复中心、青岛市新生儿疾病筛查中心） | Anti-tumor composition and pharmaceutical application thereof |
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2005
- 2005-04-20 CN CNA200510038967XA patent/CN1864718A/en active Pending
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102000106A (en) * | 2010-11-12 | 2011-04-06 | 新乡医学院 | Medicinal composition for preventing and treating vascular injury caused by organic phosphorous pesticide and preparation method thereof |
| CN102000106B (en) * | 2010-11-12 | 2011-12-21 | 新乡医学院 | Medicinal composition for preventing and treating vascular injury caused by organic phosphorous pesticide and preparation method thereof |
| CN102872209A (en) * | 2012-10-11 | 2013-01-16 | 重庆市中药研究院 | Fumaiding medicine extractive composition and preparation method and application thereof |
| CN104119575A (en) * | 2014-06-19 | 2014-10-29 | 无限极（中国）有限公司 | Radix codonopsis and lycium barbarum compound polysaccharide capable of regulating tumor microenvironment as well as preparation method and application thereof |
| CN104116025A (en) * | 2014-06-19 | 2014-10-29 | 无限极（中国）有限公司 | Application of codonopsis pilosula polysaccharides to preparation of functional food with effect of helping to inhibit prostate cancer |
| CN104116025B (en) * | 2014-06-19 | 2016-08-31 | 无限极（中国）有限公司 | Radix Codonopsis polysaccharide application in preparation has the functional food of auxiliary suppression carcinoma of prostate effect |
| CN106620195A (en) * | 2016-10-27 | 2017-05-10 | 无限极（中国）有限公司 | Chinese herbal medicine polysaccharide composition and application thereof |
| CN110585233A (en) * | 2019-10-18 | 2019-12-20 | 青岛市妇女儿童医院（青岛市妇幼保健院、青岛市残疾儿童医疗康复中心、青岛市新生儿疾病筛查中心） | Anti-tumor composition and pharmaceutical application thereof |
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