CN1954840A

CN1954840A - Medical composite prepared by Gynostemma pentaphylla, American ginseng and astragalus root

Info

Publication number: CN1954840A
Application number: CN 200610142635
Authority: CN
Inventors: 黄振华
Original assignee: Individual
Current assignee: Haian Su Fu Technology Transfer Center Co Ltd
Priority date: 2005-10-26
Filing date: 2006-10-25
Publication date: 2007-05-02
Anticipated expiration: 2026-10-25
Also published as: CN100548323C

Abstract

A composite medicine for preventing and treating primary liver cancer, lung cancer, rectum cancer, lymph cancer, gynecologic cancers, etc is proportionally prepared from gynostemma pentaphyllum or its extract, American ginseng or its extract, and astragalus root or its extract. Its preparing process is also disclosed.

Description

A kind of pharmaceutical composition of making by Herb Gynostemmae Pentaphylli, Radix Panacis Quinquefolii and the Radix Astragali

1, technical field

The present invention relates to a kind of pharmaceutical composition with antitumor action, be specifically related to a kind of pharmaceutical composition of forming by Herb Gynostemmae Pentaphylli or Herb Gynostemmae Pentaphylli extract, Radix Panacis Quinquefolii or Radix Panacis Quinquefolii extract, the Radix Astragali or Radix Astragali extract and preparation method thereof, and the preparation that contains this pharmaceutical composition, belong to medical technical field.

2, background technology

Since the seventies, China's pathogenesis of cancer and mortality rate are in rising trend always, to the nineties 20 in the period of, cancer mortality rises 29.42%, ageadjusted mortality rate rises 11.56%.Pathogenesis of cancer number in 2000 is about 180～2,000,000, and is dead 140～1,500,000, and cancer is becoming the new century mankind's first killer.Modern medicine mainly is that operative treatment cooperates radiotherapy, chemotherapy to treatment for cancer at present.Though operation can be removed primary lesion, can not fundamentally stop the regeneration and the breeding of cancerous cell; Though put, chemotherapy can kill cancerous cell, simultaneously a large amount of normal tissue cells suffered damage, and brings out gastrointestinal reaction, bone marrow depression and Liver and kidney, impairment of cardiac function.The traditional Chinese medical herbal treatment cancer has long history and has formed some treatment rules of own uniqueness, as rules such as strengthening vital QI to eliminate pathogenic factors, heat-clearing and toxic substances removing, blood circulation promoting and blood stasis dispelling, confirmed that the Chinese medicine cancer has anti-cancer and inhibiting tumor, the human body immunity improving function, reduce the chemicotherapy toxicity, regulate the body equilibrium between yin and yang, improve the outstanding role of band cancer survival rate and life quality, brought into play important effect particularly to the rehabilitation behind the cancer operation, and to the efficacy enhancing and toxicity reducing aspect of chemicotherapy.

Herb Gynostemmae Pentaphylli Gynostemma Pentaphyllum (Thumb.) Makino has another name called Herba Gynostemmatis, has the effect of heat-clearing and toxic substances removing, eliminating phlegm and stopping cough, supplementing QI and nourishing YIN, life lengthening, and the title of " southern Radix Ginseng " is arranged.Pharmacological research shows that Herb Gynostemmae Pentaphylli has multiple pharmacological effect such as defying age, anti-stress and fatigue, antitumor, gonadal hormone and estrogen-like effects, relieving cough and expelling phlegm, blood fat reducing and treatment hepatic disease.The antitumaous effect mechanism of Herb Gynostemmae Pentaphylli is: can directly kill cancerous cell, obviously improve mice plaque forming cells and coagulation antibody and tire, obviously strengthen the delayed hypersensitive reaction of mice, thereby improve the immunity of band tumor animal.Herb Gynostemmae Pentaphylli can increase lymphocyte number, improves the generation and the activity of mice natural killer cell (NK) activity and serum hemolysin, and can strengthen the Turnover of Mouse Peritoneal Macrophages phagocytic function, improves the ability of splenocyte secretory antibody, and Herb Gynostemmae Pentaphylli can also reduce S in addition ₁₈₀The lipid peroxidation of sarcoma mice improves the activity of superoxide dismutase in its blood plasma, and the normal cell of protection body is avoided the too much damage of harmful free radical, thereby reaches restriction tumor growth and invasion and attack effect.

Radix Panacis Quinquefolii is the dry root of Araliaceae Radix Panacis Quinquefolii Panax quinquefolium L., another name Radix Panacis Quinquefolii, Radix Panacis Quinquefolii, panacis quinquefolii radix.Radix Panacis Quinquefolii is cool in nature, and sweet and slightly bitter taste is gone into the heart, lung, kidney three warps.The tonifying the lung pathogenic fire reducing is arranged, and the nourishing the stomach to promote the production of body fluid effect of quenching the thirst is used for the treatment of chronic cough of deficiency lung, loses blood, dry pharynx, thirsty, deficiency-heat, tired tired etc., also can be used for various tumor treatment.Chemical constituent: rhizome contains glycoside, mainly is the ginsenoside, contains volatile oil, resin etc. again.Separate after the total saponins hydrolysis panoxadiol, panaxatriol and oleanolic acid.Modern study shows that the pharmacological action of Radix Panacis Quinquefolii has: (1) anticancer and enhancing human body immunity function: this product can strengthen the T cell and produce the lymphokine ability, can obviously strengthen the activity of mice spleen NKC, and antitumaous effect is arranged; (2) total saponins and ginsenoside have remarkable antifatigue effect, diuresis, oxygen lack resistant function; (3) total saponins influences protein, lipid metabolism, energy blood sugar lowering; (4) saponin has antiarrhythmic effect, and can reduce white mice because of injection central stimulants pentetrazole and the caused convulsions mortality rate of strychnine; (5) brain is had sedation, its sedation is better than Chinese Radix Ginseng.

The Radix Astragali is the dry root of leguminous plant Radix Astagali Astragalus membranaceus (Fisch.) Bge.var.mongholicus (Bge.) Hsiao or Radix Astragali Astragalus membranaceus (Fisch.) Bge., effect with invigorating QI to consolidate the body surface resistance, promoting pus discharge and tissue regeneration strengthening, diuretic, " can control the card of all weakness of QI blood deficiency ".Modern pharmacological research shows that the Radix Astragali removes has significant immunological enhancement, also has good antitumor, antidotal effect.The immunological enhancement of the Radix Astragali mainly shows: the antibody systematic function to normal body has obvious facilitation; inductive T cell proliferative response of ConA and B cellular immune function are obviously strengthened; can promote the activity of NK cells in mice significantly; can obviously improve old people's complement lytic immunity complex (IC) ability; thereby reduce the circulating immune complex level; reduce the IC deposition, the Radix Astragali, astragalus polysaccharides, Radix Astragali saponin all have potentiation to monokaryon-macrophage phagocytic function.The antitumor action of the Radix Astragali mainly shows: the Radix Astragali has protective effect to hemopoietic and immune system, and this radiotherapy to tumor plays positive synergism.

At present, Shang Weijian treats the report of tumor with Herb Gynostemmae Pentaphylli, Radix Panacis Quinquefolii, Radix Astragali three's composition of prescription.

3, summary of the invention

The purpose of this invention is to provide a kind of antitumor medicine composition that is used for, it is mainly made by Herb Gynostemmae Pentaphylli, Radix Panacis Quinquefolii and the Radix Astragali, its parts by weight are: 1～100 part of 1～30 part of Radix Astragali of 0.5～20 part of Radix Panacis Quinquefolii of Herb Gynostemmae Pentaphylli, be preferably: 2～25 parts of 2～6 parts of Radixs Astragali of 1～10 part of Radix Panacis Quinquefolii of Herb Gynostemmae Pentaphylli, the best is: 4 parts of 3 parts of Radixs Astragali of 5 parts of Radix Panacis Quinquefoliis of Herb Gynostemmae Pentaphylli.

Herb Gynostemmae Pentaphylli, Radix Panacis Quinquefolii and Milkvetch Root can be with The suitable solvent respectively or mix through extracting processing and obtain its extract, and total extract is made various preparations with the pharmaceutic adjuvant hybrid process again.Main effective ingredient contained in the total extract is: saponin and/or polysaccharide, and the total content of main effective ingredient is not less than 50% in the total extract.

The invention provides the extraction preparation method of above-mentioned Herb Gynostemmae Pentaphylli, Radix Panacis Quinquefolii and the Radix Astragali, but be not limited only to following technology:

The extraction preparation of Herb Gynostemmae Pentaphylli:

Get the Herb Gynostemmae Pentaphylli medical material, add 75% alcohol reflux secondary, each 2 hours, filter, flow liquid reclaims ethanol to there not being the alcohol flavor, adds water and makes into the solution that every 1ml is equivalent to 2g crude drug amount, stirs evenly, put coldly, standing over night filters, the macroporous resin column of filtrate by having handled well, earlier with the water of 2 times of column volumes towards post, discard water liquid, 60% ethanol of 3 times of column volumes of reuse carries out eluting, collects eluent, reclaims ethanol, be concentrated into relative density and be 1.08～1.10 concentrated solution, spray drying, promptly.The Herb Gynostemmae Pentaphylli extract yield that makes by this technology is 2～4%, and Herb Gynostemmae Pentaphylli total glycosides content is not less than 50%.

Can also extract preparation by the following method:

Method one: get the Herb Gynostemmae Pentaphylli medical material, add 80% alcohol reflux three times, each 2 hours, alcohol adding amount is each 10 times of amounts, filters, and filtrate recycling ethanol is to there not being the alcohol flavor, it is an amount of to add water, stir evenly, put cold, standing over night, filter, it is 1.09～1.10 concentrated solution that filtrate decompression is concentrated into relative density, spray drying, promptly.The Herb Gynostemmae Pentaphylli extract yield that makes by this technology by this technology is 5～7%, and the content of Herb Gynostemmae Pentaphylli total glycosides is not less than 40%.

Method two: get the Herb Gynostemmae Pentaphylli medical material, add 80% alcohol reflux secondary, each 3 hours, add 10 times of amounts of alcohol for the first time, 8 times of amounts for the second time, merge extractive liquid, filters, and filtrate recycling ethanol is to there not being the alcohol flavor, placement is spent the night, and filters, and decompression filtrate recycling ethanol is to the thick paste shape, and spray drying promptly.The Herb Gynostemmae Pentaphylli extract yield that makes by this technology by this technology is 6～10%, and the content of Herb Gynostemmae Pentaphylli total glycosides is not less than 30%.

The extraction preparation of Radix Panacis Quinquefolii:

Get Radix Panacis Quinquefolii, add 10 times of water gagings, soaked 8 hours, leach soak, continuing adds 8 times of amount ordinary waters, decocts 1 hour, and secondary merges lixiviating solution altogether, and being evaporated to density is 1.19～1.25 (60 ℃), and spray drying gets the aqueous extract powder.Add 8,5,5,5 times of amount n-butyl alcohol successively, boiling water bath stirs and extracts 1h, and totally 4 times, merge extractive liquid,, reclaim under reduced pressure n-butyl alcohol, vacuum drying get thick total saponins.Thick total saponins is admixed 20 times of amounts (W/W) D ₁₀₁On the type macroporous resin, closely colourless with the hot water injection to washings, stir the eluting secondary with 4 times of amount 80% ethanol, each 1h merges eluent, reclaims ethanol, and spray drying is promptly.Radix Panacis Quinquefolii extract yield by this prepared is 0.5～2%, and total saponin content is not less than 50%, ginsenoside R _G1, R _B1, R _eContent and be not less than 5%.

Can also extract preparation by the following method:

Method one: get Radix Panacis Quinquefolii, decoct with water three times, each 1.5 hours, amount of water was 12 times of amounts, and collecting decoction filters, and it is 1.20～1.26 (60) that filtrate is concentrated into relative density, filters, and filtrate decompression concentrates, vacuum drying, gets the water extracted immersing paste powder.Add 8,5,5,3 times of amounts 80% successively, boiling water bath stirs and extracts 1h, and totally 4 times, merge extractive liquid,, reclaim under reduced pressure n-butyl alcohol, vacuum drying are promptly.By the Radix Panacis Quinquefolii extract that this technology makes, yield is 1～4%, and total saponin content is not less than 30%, ginsenoside R _G1, R _B1, R _eContent and be not less than 2%.

Method two: get Radix Panacis Quinquefolii, decoct with water three times, each 2 hours, amount of water was 10 times of amounts, and collecting decoction filters, and macroporous resin on the filtrate adopts D101 type macroporous resin, and resin and crude drug ratio are 1: 0.68, with doubling dose 75% ethanol elution.Collect eluent, reclaim ethanol, being concentrated into relative density is 1.18～1.27 (60 ℃), vacuum drying (60 ℃), promptly.By the Radix Panacis Quinquefolii extract that this technology makes, yield is 1～3%, and total saponin content is not less than 40%, ginsenoside R _G1, R _B1, R _eContent and be not less than 3%.

The extraction preparation of the Radix Astragali

Astragalus polysaccharides and total saponins all have antitumor action, and the preparation method of the two is provided respectively below:

With the astragalus polysaccharides is the preparation of the extract of effective ingredient:

Get Milkvetch Root, add 7 times of amount 70% ethanol extraction secondaries, each 2 hours, extracting solution discards, the slag extracting in water secondary of getting it filled, and extracting solution merges, the ratio that is concentrated into extracting liquid volume and raw medicinal herbs is 1.05: 1, add ethanol precipitation and make and contain the alcohol amount and reach 70%, filter, must precipitate, precipitation 70% washing with alcohol, the dissolving of reuse suitable quantity of water is filtered, and filtrate is crossed macroporous resin, the water eluting, collect water lotion, water lotion is concentrated into medicine liquid volume, add ethanol and make and contain alcohol and measure and reach 70% with the medical material ratio is 1: 2.5, must precipitate, to precipitate with 95% ethanol and washing with acetone dehydration, drying under reduced pressure (60 ℃), promptly.Radix Astragali extract yield by this prepared is 0.5～2%, and the content of astragalus polysaccharides is not less than 50%.

Can also extract preparation by the following method:

Method one: get Milkvetch Root, add the water reflux, extract, three times, each 2 hours, merge extractive liquid, filters, and it is 1.15～1.23 that filtrate decompression is concentrated into relative density, add ethanol and make and contain alcohol amount and reach 80%, left standstill 24 hours, filter, precipitation is dissolved in water, and filters, and adds ethanol again and makes and contain the alcohol amount and reach 85%, left standstill 24 hours, filter, collecting precipitation, vacuum drying are promptly.Radix Astragali extract yield by this prepared is 2～4%, and astragalus polysaccharides content is not less than 40%.

Method two: get Milkvetch Root, add 10 times of amount 80% ethanol extractions 4 hours, extracting solution discards, the slag extracting in water secondary of getting it filled, each 2 hours, add 10 times of amounts of water, extracting solution merges at every turn, filters, filtrate adds ethanol to be made and contains alcohol amount and reach 85%, filter, filtrate decompression is concentrated into the thick paste shape, and spray drying promptly.Radix Astragali extract yield by this prepared is 3～4%, and astragalus polysaccharides content is not less than 35%.

With the total saponins is the preparation of the extract of main component:

Get the Radix Astragali, decoct with water three times, each 1.5 hours, add for the first time 10 times of amounts of water, be 8 times of amounts two, three times, collecting decoction, filter, it is 1.20～1.25 (60 ℃) that filtrate is concentrated into relative density, handles 2 times with ethanol precipitation, containing the alcohol amount in the solution for the first time is 75%, be 85% for the second time, each all cold preservation is placed, and reclaims ethanol and be concentrated into every 1ml to be equivalent to crude drug 10g, be added on the macroporous adsorptive resins of having handled well, earlier with the water of 2 times of volumes towards post, 70% ethanol elution of 4 times of volumes of reuse, collection eluent, concentrating under reduced pressure, vacuum drying, promptly.Radix Astragali extract yield by this prepared is 0.5～2%, and total saponin content is not less than 50%, and wherein Astragaloside content is not less than 2.0%.

Can also extract preparation by the following method:

Method one: get the Radix Astragali and decoct with water three times, each 2 hours, collecting decoction, filter, filtrate is concentrated into relative density 1.20～1.25 (60 ℃), handles 2 times with ethanol precipitation, contains amount of alcohol 60% in the solution for the first time, the second time 85%, each all cold preservation is placed, and reclaims ethanol and be concentrated into every 1ml to be equivalent to crude drug 10g, concentrating under reduced pressure, vacuum drying, promptly.Radix Astragali extract yield by this prepared is 3～5%, and total saponin content is not less than 30%, and wherein Astragaloside content is not less than 1%.

Method two: get the Radix Astragali and decoct with water three times, each 1.5 hours, collecting decoction, filter, it is 1.20～1.25 (60 ℃) that filtrate is concentrated into relative density, handles making that to contain amount of alcohol be 60% for 1 time with ethanol precipitation, cold preservation is placed, reclaim ethanol and be concentrated into every 1ml and be equivalent to crude drug 10g, and concentrating under reduced pressure, vacuum drying, promptly.Radix Astragali extract yield by this prepared is 2～4%, and total saponin content is for being not less than 40%, and wherein Astragaloside content is not less than 1%.

Pharmaceutical composition of the present invention makes except that can above-mentioned medical material feeding intake, can also extract replace medical material directly to feed intake and make.With total glycosides is the Herb Gynostemmae Pentaphylli extract abbreviation Herb Gynostemmae Pentaphylli total glycosides of main effective ingredient, with total saponins is the Radix Panacis Quinquefolii extract abbreviation American ginseng total saponins of main effective ingredient, with total saponins is the Radix Astragali extract abbreviation Radix Astragali total saponins of main effective ingredient, is the Radix Astragali extract abbreviation astragalus polysaccharides of main effective ingredient with polysaccharide.According to the yield 2～4% of Herb Gynostemmae Pentaphylli total glycosides with respect to medical material, American ginseng total saponins is with respect to the yield 0.5～2% of medical material, and astragalus polysaccharides is with respect to the yield 0.5～2% of medical material, and Radix Astragali total saponins calculates with respect to the yield 0.5～2% of medical material, following two kinds of proportionings are arranged, are respectively:

Proportioning 1: 1～80 part of Herb Gynostemmae Pentaphylli total glycosides, 0.5～60 part of American ginseng total saponins, 0.5～200 part of astragalus polysaccharides, preferred: 2～40 parts, 1～12 part, 1～50 part; The best is: 10～20 parts, 1～6 part, 2～8 parts.

Proportioning 2: 1～80 part of Herb Gynostemmae Pentaphylli total glycosides, 0.5～60 part of American ginseng total saponins, 0.5～200 part of Radix Astragali total saponins, preferred: 2～40 parts, 1～12 part, 1～50 part; The best is: 10～20 parts, 1～6 part, 2～8 parts.

In the aforementioned pharmaceutical compositions in the Herb Gynostemmae Pentaphylli total glycosides content of total glycosides be not less than 30%, preferably be not less than 50%; The content of total saponins is not less than 30% in the American ginseng total saponins, preferably is not less than 50%, wherein ginsenoside R _G1, R _B1, R _eContent and be not less than 2%; The content of polysaccharide is not less than 35% in the astragalus polysaccharides, preferably is not less than 50%; The content of total saponins is not less than 30% in the Radix Astragali total saponins, preferably is not less than 50%, and wherein the content of astragaloside is not less than 1%.

More than form to be by weight as proportioning, when producing, can or reduce according to the corresponding proportion increase, as large-scale production can be raw material with the kilogram, or be unit with the ton, small-scale production can be unit with the gram also, weight can increase or reduce, but the constant rate of weight proportion between each composition.If with the kilogram is unit, can make the preparation of 100～10000 consumptions, as injection, can be made into 100～10000,1～10 of each consumption.As tablet, can be made into 100～10000, take 1～10 at every turn.

The ratio of above weight proportion obtains through science screening, and for especial patient, the ratio of can corresponding adjustment forming increases or reduce being no more than 100%.

The application of the further claimed pharmaceutical composition of the present invention of the present invention in preparation treatment antitumor drug.Pharmaceutical composition of the present invention can be grown by anticancer, promotes body's immunity, increases lymphocyte number; protection and improve hemopoietic function of bone marrow improves the regulatory function of endocrine body fluid, improves the body substance metabolism; alleviate put, chemical therapy toxic side effect, strengthen put, the effect of chemotherapy.Be mainly used in primary hepatocarcinoma, pulmonary carcinoma, rectal cancer, malignant lymphoma, gynecologic malignant tumor etc.

Pharmaceutical composition of the present invention can be made clinically any or pharmaceutically acceptable preparation, and preferred oral preparation or injection are applied to the patient who needs this treatment in modes such as oral or parenterals.

When being used for parenteral, can be made into injection, injection means the intravital solution of confession injection, emulsion or the suspension that medicine is made and supplies to face with preceding preparation or be diluted to solution or the sterile preparation of the powder of suspension or concentrated solution, comprises injection, injectable sterile powder and concentrated solution for injection.Injection means that the confession that medicine is made is injected into sterile solution type injection, emulsion-type injection or the suspension type injection of using in the body, it indicates loading amount can be 0.5ml, 1ml, 2ml, 5ml, 10ml, 20ml, 50ml, 100ml, 200ml, 250ml, 500ml etc., and the large volume injection of using for intravenous drip that generally is not less than 100ml also claims venous transfusion.Injectable sterile powder means that confession that medicine is made is faced with the suitable sterile solution of preceding usefulness and is mixed with settled solution or the evenly sterilized powder or the aseptic block of suspension that sterilized powder can make with solvent crystallization, spray drying method or freeze-drying etc.Concentrated solution for injection means that confession that medicine is made faces the aseptic concentrated solution of using for intravenous drip with preceding dilution.

When being used for oral administration, conventional solid preparation be can be made into, tablet, capsule, granule, pill and oral solution etc. comprised.Tablet means disk shape or the special-shaped flaky solid preparation that medicine and the auxiliary materials and mixing compacting that suits form; Tablet is based on oral ordinary tablet, and other has buccal tablet, Sublingual tablet, mouth paster, chewable tablet, dispersible tablet, fuse, effervescent tablet, slow releasing tablet, controlled release tablet and enteric coatel tablets etc.Capsule means medicine or is added with the adjuvant filling in Capsules or be sealed in solid preparation in the soft capsule material; Capsule can be divided into hard capsule (being commonly referred to as capsule), soft capsule (soft gelatin capsule), slow releasing capsule, controlled release capsule and enteric coated capsule according to its dissolving and release characteristics.Granule means that medicine and suitable adjuvant make the dried particles shape preparation with certain particle size; Granule can be divided into soluble particles (being commonly referred to as granule), mix suspension grain, effervescent granule, enteric coated particles, slow-releasing granules and controlled release granule etc.Pill means medicine and suitable adjuvant uniform mixing, the spherical or near-spherical solid preparation made from proper method; Pill comprises drop pill, sugar pill, piller etc.Oral solution means that medicine dissolution makes for oral supernatant liquid preparation in suitable solvent.

The preparation of pharmaceutical composition of the present invention can adopt the conventional method production in the existing pharmaceutical field, can add various pharmaceutically acceptable carriers when needing.Described carrier comprises osmotic pressure regulator, pH value regulator, solubilizing agent, antioxidant, antibacterial, emulsifying agent, suspending agent, filler, binding agent, disintegrating agent, lubricant of pharmaceutical field routine etc.

Pharmaceutical composition of the present invention is when making injection, solvent for use can be aqueous solvent and non-aqueous solvent, also can add suitable additives, as osmotic pressure regulator, pH value regulator, solubilizing agent, antioxidant, antibacterial, emulsifying agent, suspending agent etc. according to the character of medicine.The most frequently used aqueous solvent of aqueous solvent is a water for injection, also available 0.9% sodium chloride solution or other suitable aqueous solutions; The non-aqueous solvent that non-aqueous solvent is commonly used is a vegetable oil, is mainly the injection soybean oil, and other also have the aqueous solution of ethanol, propylene glycol, Polyethylene Glycol etc.Osmotic pressure regulator commonly used comprises sodium chloride, glucose, potassium chloride, magnesium chloride, calcium chloride, sorbitol etc., preferred sodium chloride or glucose; PH value regulator commonly used comprises acetic acid+sodium acetate, lactic acid, citric acid+sodium citrate, sodium bicarbonate+sodium carbonate etc.; Bulking agent commonly used comprises polyoxyethylene sorbitan monoleate, propylene glycol, lecithin, polyoxyethylene castor oil etc.; Antioxidant commonly used comprises sodium sulfite, sodium sulfite, sodium pyrosulfite etc.; Antibacterial commonly used comprises phenol, cresol, chlorobutanol, benzyl alcohol etc.

Pharmaceutical composition of the present invention can add suitable filler, binding agent, disintegrating agent, lubricant etc. when making oral formulations.Filler comprises starch, Icing Sugar, calcium phosphate, calcium sulfate two water things, dextrin, microcrystalline Cellulose, lactose, pregelatinized Starch, mannitol etc.; Binding agent comprises sodium carboxymethyl cellulose, PVP-K30, hydroxypropyl cellulose, starch slurry, methylcellulose, ethyl cellulose, hypromellose, gelling starch etc.; Disintegrating agent comprises dried starch, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose etc.; Lubricant comprises magnesium stearate, Pulvis Talci, sodium lauryl sulphate, micropowder silica gel etc.

Pharmaceutical composition of the present invention has following advantage:

(1) the invention provides a kind of new pharmaceutical composition, satisfied clinical needs with antitumor action.

(2) traditional Chinese medical science thinks that it is one of main etiology and pathology of malignant tumor that pyretic toxicity pents up.The effect of method of dissipating heat and detoxifying treatment existing direct inhibition of tumor or killing tumor cell can improve body's immunological function again and reaches therapeutic effect.Clinically see that the carcinoma patient is the card of heat stagnation fire-toxin more, no matter excess-fire (heat), asthenic fire (heat), all calorific potential an inferior horses open, and illustrates that tumor develops, to the method for this carcinoid tumor patient when plan heat-clearing and toxic substances removing, nourishing YIN to lower pathogenic fire.The present invention adopts Herb Gynostemmae Pentaphylli, Radix Panacis Quinquefolii, Radix Astragali compatibility, the Herb Gynostemmae Pentaphylli heat-clearing and toxic substances removing, and the Radix Panacis Quinquefolii nourishing YIN to lower pathogenic fire, Radix Astragali temperature compensation Tuoli, strengthening vital QI to eliminate pathogenic factors, compatibility is reasonable.

(3) studies have shown that by pharmacodynamic experiment first: pharmaceutical composition of the present invention is compared with Herb Gynostemmae Pentaphylli with single, lotus SRS-82 sarcoma mice there is remarkable tumor-inhibiting action, can significantly strengthen lotus SRS-82 sarcoma immune function of mice, to rat liver cancer (HePA)) solid tumor growth has remarkable tumor-inhibiting action, can significantly improve the lethality and the lymhocyte transformation rate of lotus H22 NK cells in mice, suppress the Mice Bearing Lewis Lung Cancer lung and shift, reach with radiotherapy medicine 5-fluorouracil ⁶⁰The coupling of Co chemotherapy has potentiation, and the curative effect of its best proportioning and positive control drug KANGLAITE ZHUSHEYE, the therapeutic equivalence of cyclophosphamide, toxicity are little, and this is that those of ordinary skills institute is beyond thought.

(4) the present invention has drawn the best proportioning of Herb Gynostemmae Pentaphylli, Radix Panacis Quinquefolii and the Radix Astragali by pharmacological testing.

(5) Herb Gynostemmae Pentaphylli, Radix Panacis Quinquefolii and Radix Astragali drug combination are synergism, and dosage reduces relatively.

Below routine by experiment beneficial effect of further setting forth pharmaceutical composition of the present invention, these experimental examples comprise the pharmacodynamics and the stability experiment of pharmaceutical composition of the present invention.

Herb Gynostemmae Pentaphylli extract (Herb Gynostemmae Pentaphylli total glycosides) used in the following experimental example derives from embodiment 1; Radix Panacis Quinquefolii extract (American ginseng total saponins) derives from embodiment 2; Astragalus polysaccharides derives from embodiment 3; Radix Astragali total saponins derives from embodiment 4.The pharmaceutical composition of Herb Gynostemmae Pentaphylli or Herb Gynostemmae Pentaphylli total glycosides, Radix Panacis Quinquefolii or American ginseng total saponins, the Radix Astragali (is main effective ingredient with polysaccharide) or astragalus polysaccharides is hereinafter to be referred as compositions A, and the pharmaceutical composition of Herb Gynostemmae Pentaphylli or Herb Gynostemmae Pentaphylli total glycosides, Radix Panacis Quinquefolii or American ginseng total saponins, the Radix Astragali (is main effective ingredient with total saponins) or Radix Astragali total saponins is hereinafter to be referred as compositions B.

Experimental example 1 pharmaceutical composition of the present invention is tested the tumor that presses down of lotus SRS-82 sarcoma mice

Laboratory animal: ICR kind mice, body weight 18～22g, 8 ages in week, male and female half and half, totally 380,10 every group.

The SRS-82 cell strain, Shanghai cell biological institute.

Test sample: positive control medicine: KANGLAITE ZHUSHEYE, 100ml:10g, Zhejiang Kanglaite Pharmaceutical Co., Ltd;

Gynostemma pentaphyllum total glycoside injection liquid: self-control, specification: 2ml;

American ginseng total saponins injection: self-control, specification: 2ml;

Astragalin injection: self-control, specification: 2ml;

Radix Astragali total saponins injection: self-control, specification: 2ml;

The Different Weight proportioning group of pharmaceutical composition A injection of the present invention, self-control;

The Different Weight proportioning group of pharmaceutical composition B injection of the present invention: self-control.

Table 1 present composition compares the tumour inhibiting rate of lotus SRS-82 sarcoma mice

Group	Medical material proportioning (g)	Dosage (mg/kg)	Tumor heavy (g)	Tumour inhibiting rate (%)
Group	Medical material proportioning (g)	Dosage (mg/kg)	Tumor heavy (g)	Tumour inhibiting rate (%)	Blank group positive controls American ginseng total saponins group astragalus polysaccharides group Radix Astragali total saponins group Herb Gynostemmae Pentaphylli total glycosides group	- - - - - -	- - 80 80 80 80	2.44±0.56 0.96±0.49 ^** 1.82±0.34 ^* 1.91±0.42 ^* 1.89±0.39 ^* 1.74±1.64 ^*	- 60.66 19.67 25.41 24.18 27.05
Compositions A	0.5+1+1 0.5+6+25 0.5+30+100 1+2+3 5+2+3 10+2+3 1+3+4 5+3+4 10+3+4 1+6+10 5+6+10 10+6+10 10+30+100 20+1+1 20+6+100 20+30+100	80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80	1.48±0.52 ^#△☆ 1.42±0.46 ^#△☆ 1.37±0.33 ^#△☆ 1.29±0.57 ^{##△△☆☆} 1.25±0.59 ^{##△△☆☆} 1.18±0.64 ^{##△△☆☆} 1.14±0.38 ^{##△△☆☆} 0.91±0.45 ^{##△△☆☆} 1.12±0.52 ^{##△△☆☆} 1.26±0.61 ^{##△△☆☆} 1.21±0.56 ^{##△△☆☆} 1.06±0.61 ^{##△△☆☆} 1.37±0.58 ^#△☆ 1.32±0.64 ^#△☆ 1.37±0.42 ^#△☆ 1.43±0.55 ^*#△☆	42.76 45.54 49.36 54.80 58.67 61.49 64.18 68.70 56.10 58.36 51.41 56.56 49.43 48.25 43.52 46.67		- - - - - -	- - 80 80 80 80		- 60.66 19.67 25.41 24.18 27.05
Compositions A		80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80			Compositions B	0.5+1+1 0.5+6+25 0.5+30+100 1+2+3 5+2+3 10+2+3 1+3+4 5+3+4 10+3+4 1+6+10 5+6+10 10+6+10 10+30+100 20+1+1 20+6+100 20+30+100	80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80	1.32±0.63 ^#△& 1.47±0.66 ^#△& 1.34±0.32 ^#△& 1.25±0.49 ^##△△&& 1.04±0.54 ^##△△&& 1.15±0.58 ^##△&& 1.29±0.62 ^##△△&& 0.94±0.38 ^##△△&& 1.26±0.46 ^##△△&& 1.25±0.57 ^##△△&& 1.21±0.60 ^##△△&& 1.19±0.52 ^##△△&& 1.35±0.66 ^#△& 1.33±0.57 ^#△& 1.40±0.63 ^#△& 1.38±0.72 ^*#△&	43.87 45.26 49.36 54.55 57.38 52.87 57.63 61.48 50.36 54.62 50.41 53.03 46.47 48.32 44.79 47.28

Annotate: compare with the blank group, ^*P＜0.05, ^*P＜0.01; Compare with the Herb Gynostemmae Pentaphylli group, ^#P＜0.05, ^##P＜0.01; Compare with the Radix Panacis Quinquefolii group, ^△P＜0.05, ^{△ △}P＜0.01; Compare with the astragalus polysaccharides group, ^☆P＜0.05, ^{☆ ☆}P＜0.01; Compare with the Radix Astragali total saponins group, ^﹠amp;P＜0.05, ^{﹠amp; ﹠amp;}P＜0.01.

Experimental technique: mice group: mice is divided into 38 groups: blank group, positive controls, American ginseng total saponins group, astragalus polysaccharides group, Radix Astragali total saponins group, Herb Gynostemmae Pentaphylli total glycosides group, the different proportioning groups of present composition injection.

Tumor inoculation: with behind the SRS-82 cell inoculation kunming mice of cultivating the 8th day, extract the about 15ml of ascites in 4 mouse peritoneals respectively, being diluted to cell number with normal saline is 1.0 * 10 ⁷Behind/the ml (30ml altogether), every mice left side groin subcutaneous injection 0.2ml (2.0 * 10 ⁶/ only).

Administering mode and time: every mouse peritoneal injection (ip) administration, KANGLAITE ZHUSHEYE is not diluted direct ip administration, the beginning administration in the 2nd day behind inoculated tumour, 1 time/day, totally 10 days.

Tumour inhibiting rate: in postvaccinal the 12nd day, take off cervical vertebra execution and respectively organize mice, peel off tumor mass, take by weighing tumor weight, and calculate tumour inhibiting rate as follows: tumour inhibiting rate=(model group average tumor weight-administration group average tumor weight)/model group average tumor weight * 100%.

Experimental result and conclusion: the results are shown in Table 1.Compare with the blank group, each administration group has obvious inhibitory action (p＜0.05 to lotus SRS-82 tumor mouse tumor, p＜0.01), wherein compositions A, B curative effect in the ratio range of 1～10 part of Herb Gynostemmae Pentaphylli, 2～6 parts of Radix Panacis Quinquefoliis, 3～10 parts of the Radixs Astragali all is better than single Herb Gynostemmae Pentaphylli total glycosides, American ginseng total saponins, astragalus polysaccharides and Radix Astragali total saponins used, and prompting Herb Gynostemmae Pentaphylli, Radix Panacis Quinquefolii, the Radix Astragali have share synergistic function.Wherein remarkable with Herb Gynostemmae Pentaphylli+Radix Panacis Quinquefolii+Radix Astragali (5g+3g+4g) dosage group curative effect, and with positive control drug KANGLAITE ZHUSHEYE therapeutic equivalence, show that anti-tumor activity is strong.

Experimental example 2 pharmaceutical compositions of the present invention are to lotus SRS-82 sarcoma effect of immunologic function

Laboratory animal: ICR kind mice, body weight 18～22g, 8 ages in week, male and female half and half.

Tumor kind and reagent: mice SRS-82 cell strain is available from Shanghai cell biological institute

Interleukin II (1L-2) injection, Ke Xing biotech company in Shenzhen produces;

IL-2 and α-Zhong Liuhuaisiyinzi (TNF-α) test kit; Concanavalin A (Con-A) is available from crystalline substance U.S. bio-engineering corporation.

Herb Gynostemmae Pentaphylli injection: self-control;

Pharmaceutical composition A of the present invention, self-control (seeing embodiment 8 aqueous injection prescription 1), main effective ingredient is Herb Gynostemmae Pentaphylli total glycosides, American ginseng total saponins, astragalus polysaccharides (being equivalent to Herb Gynostemmae Pentaphylli 5g, Radix Panacis Quinquefolii 3g, Radix Astragali 4g);

Pharmaceutical composition B of the present invention, self-control (seeing embodiment 8 aqueous injection prescription 2), main effective ingredient is Herb Gynostemmae Pentaphylli total glycosides, American ginseng total saponins, Radix Astragali total saponins (being equivalent to Herb Gynostemmae Pentaphylli 5g, Radix Panacis Quinquefolii 3g, Radix Astragali 4g).

Experimental technique: mice group: mice is divided into that blank group, positive controls, present composition injection A are organized basic, normal, high dosage group, present composition injection B organizes basic, normal, high dosage group.

2.1 quantity of leucocyte of the present invention changes: solid tumor mice the 11st day behind inoculated tumour, eye socket rear vein beard about 100 μ l that take a blood sample, respectively organize the leukocyte count of mice with Japanese F-800 hemocyte automatic analyzer detection.

2.2 the macrophages in vitro phagocytic function detects: each organizes white mice in the cold DMEM culture medium of experiment the 11st day difference intraperitoneal injection 5ml, and peritoneal fluid is extracted in soft abdominal cavity out behind the 10min, and the centrifugal 10min of 1000r/min abandons the part supernatant, stays about 2ml.Add 1% Sanguis Gallus domesticus ball 2ml then behind the mixing.Put in the constant incubator behind the 60min, the mixing smear, Wright's staining calculates 100 macrophage phagocytic percentage rate (what cytophagies erythrocyte) and phagocytic index (having engulfed what erythrocyte altogether).

2.3 tumor-bearing mice serum is than IL-2 and TNP Determination on content: behind tumor inoculation the 12nd day, take a blood sample by the eye socket posterior vein, the centrifugal 10min separation of serum of 3000r/min is with mice IL-2 and the TNF-α kit measurement serum il-2 and the TNF-alpha levels of brilliant U.S. bio-engineering corporation.

The influence of table 2 pharmaceutical composition SRS-82 of the present invention lotus sarcoma murine interleukin quantity

Group	Number of animals	Dosage (mg/kg)	Leukocyte count (* 10 ⁹/L)
Group	Number of animals	Dosage (mg/kg)	Leukocyte count (* 10 ⁹/L)	Dosage group composition B low dose group among the dosage group composition A low dose group composition B high dose group composition B among the blank positive controls gynostemma pentaphylla group composition A high dose group composition A	10 10 10 10 10 10 10 10 10	- - 80 80 60 40 80 60 40	7.07±0.85 11.24±1.22 ^*## 7.13±0.71 ^ 11.88±1.48 ^## 10.99±1.35 ^## 9.11±1.12 ^# 11.92±1.44 ^## 11.01±1.38 ^## 9.24±1.17 ^#

Annotate: compare with the blank group, ^*P＜0.05, ^*P＜0.01; Compare with the Herb Gynostemmae Pentaphylli group, ^#P＜0.05, ^##P＜0.01.

The influence of table 3 pharmaceutical composition SRS-82 of the present invention lotus sarcoma macrophage phagocytosis of mice

Group	Number of animals	Dosage (mg/kg)	Phagocytic index
Group	Number of animals	Dosage (mg/kg)	Phagocytic index	Dosage group composition B low dose group among the dosage group composition A low dose group composition B high dose group composition B among the blank positive controls gynostemma pentaphylla group composition A high dose group composition A	10 10 10 10 10 10 10 10 10	- - 80 80 60 40 80 60 40	0.59±0.20 1.29±0.23 ^*## 0.79±0.20 ^ 1.32±0.39 ^## 1.13±0.31 ^## 0.98±0.25 ^# 1.34±0.39 ^## 1.18±0.32 ^## 0.97±0.21 ^#

Table 4 pharmaceutical composition of the present invention is to the influence of SRS-82 tumor-bearing mice serum TNF, IL-2 level

Group	Number of animals	Dosage (mg/kg)	TNF-α	IL-2
Group	Number of animals	Dosage (mg/kg)	TNF-α	IL-2	Dosage group composition B low dose group among the dosage group composition A low dose group composition B high dose group composition B among the blank positive controls gynostemma pentaphylla group composition A high dose group composition A	10 10 10 10 10 10 10 10 10	- - 80 80 60 40 80 60 40	0.030±0.017 0.058±0.013 ^## 0.024±0.014 0.059±0.031 ^## 0.052±0.027 ^*## 0.041±0.023 ^# 0.060±0.029 ^## 0.053±0.026 ^## 0.042±0.021 ^*#	0.065±0.018 0.107±0.028 ^*## 0.069±0.020 ^ 0.112±0.032 ^## 0.097±0.027 ^## 0.083±0.023 ^# 0.109±0.030 ^## 0.094±0.026 ^## 0.085±0.021 ^#

Experimental result and conclusion: the results are shown in Table 2,3,4.All can make lotus tumor SRS-82 mice blood leukocytes number rising (p＜0.05, p＜0.01) by table 2 result pharmaceutical composition A of the present invention as can be seen, B and Herb Gynostemmae Pentaphylli.All can make lotus tumor SRS-82 macrophage phagocytosis of mice strengthen (p＜0.05, p＜0.01) by table 3 result pharmaceutical composition A of the present invention as can be seen, B and Herb Gynostemmae Pentaphylli.All can make the TNF and the TL-2 level rising (p＜0.05, p＜0.01) of lotus tumor SRS-82 mice serum by table 4 result pharmaceutical composition A of the present invention as can be seen, B and Herb Gynostemmae Pentaphylli.With the Herb Gynostemmae Pentaphylli ratio, pharmaceutical composition A of the present invention, B respectively organize particularly significantly (p＜0.05 of curative effect, p＜0.01), wherein compositions A, B high dose group curative effect are better than positive control medicine KANGLAITE ZHUSHEYE, and prompting Herb Gynostemmae Pentaphylli, Radix Panacis Quinquefolii, the Radix Astragali three medicines have share the synergistic antitumor effect.

Experimental example 3 pharmaceutical compositions of the present invention are to the influence of rat liver cancer (HePA) solid tumor growth

Test sample: positive control medicine: cyclophosphamide Injection;

Herb Gynostemmae Pentaphylli injection: self-control;

Pharmaceutical composition A of the present invention, self-control (seeing embodiment 9 injectable powder prescription 1): main effective ingredient is Herb Gynostemmae Pentaphylli total glycosides, American ginseng total saponins, astragalus polysaccharides (being equivalent to Herb Gynostemmae Pentaphylli 5g, Radix Panacis Quinquefolii 3g, Radix Astragali 4g);

Pharmaceutical composition B of the present invention, self-control (seeing embodiment 9 injectable powder prescription 2): main effective ingredient is Herb Gynostemmae Pentaphylli total glycosides, American ginseng total saponins, Radix Astragali total saponins (being equivalent to Herb Gynostemmae Pentaphylli 5g, Radix Panacis Quinquefolii 3g, Radix Astragali 4g).

Experimental technique: get the equal subcutaneous vaccination hepatocarcinoma of mice (HePA) tumor liquid (2 * 10 ⁷/ ml) 0.2ml/, next day, grouping was weighed.Each organizes intraperitoneal injection, positive controls administration cyclophosphamide.Inoculation tumor mice begins intraperitoneal injection next day, and totally 10 days, drug withdrawal was weighed next day, put to death mice and also peeled off the subcutaneous tumors piece, claimed tumor heavy, and calculated tumour inhibiting rate.

Experimental result and conclusion: the results are shown in Table 5.Compare with the blank group, all growth has remarkable inhibitory action (p＜0.05, p＜0.01) to rat liver cancer (HePA) tumor for cyclophosphamide, Herb Gynostemmae Pentaphylli, pharmaceutical composition A of the present invention, B group.Wherein compositions A, B curative effect obviously are better than single Herb Gynostemmae Pentaphylli (P＜0.01) of using, and the high dose group curative effect is close with positive control medicine cyclophosphamide curative effect, and prompting Herb Gynostemmae Pentaphylli, Radix Panacis Quinquefolii, the Radix Astragali three medicines have share synergistic function.

Table 5 pharmaceutical composition of the present invention is to the influence of rat liver cancer (HePA) solid tumor growth

Group	Number of animals	Dosage (mg/kg)	Tumor heavy (g)	Tumour inhibiting rate (%)
Group	Number of animals	Dosage (mg/kg)	Tumor heavy (g)	Tumour inhibiting rate (%)	Dosage group composition B low dose group among the dosage group composition A low dose group composition B high dose group composition B among the blank group endoxan group gynostemma pentaphylla group composition A high dose group composition A	10 10 10 10 10 10 10 10 10	- 80 80 80 60 40 80 60 40	2.25±0.68 0.76±0.32 ^*## 1.55±0.64 ^ 0.84±0.35 ^## 0.98±0.42 ^## 1.22±0.46 ^# 0.82±0.39 ^## 0.97±0.44 ^## 1.18±0.53 ^#	- 66.22 31.11 62.67 56.44 45.78 63.56 56.89 47.56

Experimental example 4 pharmaceutical compositions of the present invention are to the influence of lotus H22 NK cells in mice activity and lymhocyte transformation rate

Laboratory animal: ICR kind mice, female, 18～22g, totally 80,10 every group.

The tumor kind: Bel7402 SMMC-7721, rat liver cancer cell line H22, Jilin Province's treatment and prevention of tumour institute provides.

Test sample: Herb Gynostemmae Pentaphylli total glycosides granule: self-control;

American ginseng total saponins granule: self-control;

Astragalus polysaccharide particles agent: self-control;

Radix Astragali total saponins granule: self-control;

Pharmaceutical composition A Different Weight proportioning group of the present invention, self-control (seeing embodiment 7 granules prescription 1);

Pharmaceutical composition B Different Weight proportioning group of the present invention, self-control (seeing embodiment 7 granules prescription 2).

Each medicine becomes required solution with physiological saline solution.

Experimental technique: be inoculated in the 7th day H22 ascites of kunming mice, be mixed with tumor cell suspension, viable count is 1 * 10 ⁶Individual/ml, the ascites tumour cell is finished inoculation in mouse peritoneal in the back 1h that exsomatizes, every Mus inoculation 0.1ml (containing 105 cells). each administration group gastric infusion, and the blank group gives with the volume normal saline, once a day, continuous 10 days.

The NK cytoactive is observed: 1d puts to death mice after the drug withdrawal, aseptic excision spleen, and the preparation splenocyte suspension, transferring splenocyte content is 4 * 10 ⁶P/ml adds 96 well culture plates, every hole 100 μ l, and every mouse boosting cell is established 3 multiple holes, the trophophase K562 cell of taking the logarithm, transferring cell content is 2 * 10 ⁵/ ml, every hole adds 100 μ l, and making every hole imitate the target ratio is 20: 1, and parallel laying effect cell control well is pressed the MTT method and is added reagent, calculates NK cell killing rate.

Lymhocyte transformation rate is observed: preparation splenocyte suspension (4 * 10 ⁶/ ml) adding 96 well culture plates, 200 μ l/ holes add ConA15mg/L in the experimental port, and control wells adds equal-volume normal saline, 37 ℃, 5%CO ₂After cultivating 48h, add MTT10 μ l/ hole, counting lymphocyte transformation index.

Table 6 pharmaceutical composition of the present invention is to the influence of lotus H22 NK cells in mice activity and lymhocyte transformation rate

Group	Medical material proportioning (g)	Dosage (mg/kg)	NK cytoactive (%)	Lymhocyte transformation rate (%)
Group	Medical material proportioning (g)	Dosage (mg/kg)	NK cytoactive (%)	Lymhocyte transformation rate (%)	Blank group American ginseng total saponins group astragalus polysaccharides group Radix Astragali total saponins group Herb Gynostemmae Pentaphylli total glycosides group	- - - - -	- 80 80 80 80	19.37±3.19 31.54±9.34 ^* 29.42±9.57 ^* 31.29±10.23 ^* 32.83±11.55 ^*	3.32±1.19 5.52±1.63 ^* 5.27±1.42 ^* 5.50±2.02 ^* 5.62±1.98 ^*
Compositions A	0.5+1+1 0.5+6+25 0.5+30+100 1+2+3 5+2+3 10+2+3 1+3+4 5+3+4 10+3+4 1+6+10 5+6+10 10+6+10 10+30+100 20+1+1 20+6+100 20+30+100	80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80	36.21±10.05 ^#&☆ 37.53±10.25 ^#&☆ 38.36±9.54 ^#&☆ 40.24±10.18 ^##&&☆☆ 42.59±9.76 ^##&&☆☆ 43.21±9.42 ^##&&☆☆ 44.88±10.08 ^##&&☆☆ 45.94±11.25 ^##&&☆☆ 44.68±9.57 ^##&&☆☆ 42.94±11.01 ^##&&☆☆ 43.21±8.52 ^##&&☆☆ 41.87±9.83 ^##&&☆☆ 37.42±10.32 ^#&☆ 38.02±10.81 ^#&☆ 36.58±8.67 ^#&☆ 37.19±9.36 ^#&☆	6.20±1.65 ^#&△☆ 6.16±1.47 ^#&△☆ 6.23±1.69 ^#&△☆ 6.69±1.77 ^{##&&△△☆☆} 6.62±1.52 ^{##&&△△☆☆} 6.76±1.63 ^{##&&△△☆☆} 6.80±2.29 ^{##&&△△☆☆} 6.96±2.32 ^{##&&△△☆☆} 6.85±2.13 ^{##&&△△☆☆} 6.71±1.90 ^{##&&△△☆☆} 6.66±1.72 ^{##&&△△☆☆} 6.62±1.56 ^{##&&△△☆☆} 6.25±2.10 ^#&△☆ 6.31±1.95 ^#&△☆ 6.29±1.85 ^#&△☆ 6.04±1.66 ^#&△☆		- - - - -	- 80 80 80 80
Compositions A		80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80			Compositions B	0.5+1+1 0.5+6+25 0.5+30+100 1+2+3 5+2+3 10+2+3 1+3+4 5+3+4 10+3+4 1+6+10 5+6+10 10+6+10 10+30+100 20+1+1 20+6+100 20+30+100	80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80	36.54±10.43 ^#△☆ 38.77±9.82 ^#a△☆ 37.68±9.58 ^#△☆ 41.69±11.16 ^{##△△☆☆} 42.32±9.54 ^{##△△☆☆} 43.79±9.53 ^{##△△☆☆} 44.21±10.11 ^{##△△☆☆} 46.09±11.17 ^{##△△☆☆} 45.95±9.64 ^{##△△☆☆} 44.72±11.06 ^{##△△☆☆} 42.44±9.63 ^{##△△☆☆} 42.87±8.85 ^{##△△☆☆} 37.98±9.65 ^#△☆ 38.95±11.74 ^#△☆ 37.38±9.91 ^#△☆ 36.26±8.18 ^#△☆	6.13±1.27 ^#&△☆ 6.27±1.62 ^#&△☆ 6.30±1.77 ^#&△☆ 6.63±1.47 ^{##&&△△☆☆} 6.77±1.42 ^{##&&△△☆☆} 6.80±1.71 ^{##&&△△☆☆} 6.86±1.94 ^{##&&△△☆☆} 6.95±2.25 ^{##&&△△☆☆} 7.11±2.15 ^{##&&△△☆☆} 6.88±1.86 ^{##&&△△☆☆} 6.71±1.63 ^{##&&△△☆☆} 6.80±1.35 ^{##&&△△☆☆} 6.22±1.77 ^*#&△☆ 6.28±1.75 ^#&△☆ 6.31±1.36 ^#&△☆ 6.10±1.78 ^#&△☆

Annotate: compare with the blank group, ^*P＜0.05, ^*P＜0.01; Compare with the Radix Panacis Quinquefolii group, ^#P＜0.05, ^##P＜0.01; Compare with the astragalus polysaccharides group, ^﹠amp;P＜0.05, ^{﹠amp; ﹠amp;}P＜0.01; Compare with the Radix Astragali total saponins group, ^△P＜0.05, ^{△ △}P＜0.01; Compare with the Herb Gynostemmae Pentaphylli group, ^☆P＜0.05, ^{☆ ☆}P＜0.01.

Experimental result and conclusion: the results are shown in Table 6.Compare with the blank group, Radix Panacis Quinquefolii, astragalus polysaccharides, Radix Astragali total saponins, Herb Gynostemmae Pentaphylli significantly raise NK cytoactive, lymhocyte transformation rate (p＜0.05), present composition A, B extremely significantly raise NK cytoactive, lymhocyte transformation rate (p＜0.01); Compare with Radix Panacis Quinquefolii, astragalus polysaccharides, Radix Astragali total saponins, Herb Gynostemmae Pentaphylli group, pharmaceutical composition A of the present invention, B significantly raise NK cytoactive, lymhocyte transformation rate (p＜0.05, p＜0.01), the curative effect that pharmaceutical composition A of the present invention, B are described is better than single Herb Gynostemmae Pentaphylli of using, and prompting Herb Gynostemmae Pentaphylli, Radix Panacis Quinquefolii, the Radix Astragali three medicines have share synergistic function.

The influence that experimental example 5 pharmaceutical compositions of the present invention shift the Mice Bearing Lewis Lung Cancer lung

Laboratory animal: ICR kind mice, female, 18～22g, totally 90,10 every group.

Test sample: the strain of Lewis lung cancer tumor is provided by Shanghai Pharmaceutical Inst., Chinese Academy of Sciences tumor chamber;

Ginseng stilbene Kingcon capsule: be made up of the Radix Astragali, Radix Ginseng, Rhizoma Curcumae Longae, Radix Sophorae Flavescentis, Herba Agrimoniae, Bombyx Batryticatus, Bulbus Fritillariae Thunbergii 13 flavor medicines, Beijing Rui Puda tumour medicine institute provides lot number 030803;

Herb Gynostemmae Pentaphylli capsule: self-control;

Pharmaceutical composition A of the present invention, self-control (seeing embodiment 6 capsules prescription 1): main effective ingredient is Herb Gynostemmae Pentaphylli total glycosides, American ginseng total saponins, astragalus polysaccharides (being equivalent to Herb Gynostemmae Pentaphylli 5g, Radix Panacis Quinquefolii 3g, Radix Astragali 4g);

Pharmaceutical composition B of the present invention, self-control (seeing embodiment 6 capsules prescription 2): main effective ingredient is Herb Gynostemmae Pentaphylli total glycosides, American ginseng total saponins, Radix Astragali total saponins (being equivalent to Herb Gynostemmae Pentaphylli 5g, Radix Panacis Quinquefolii 3g, Radix Astragali 4g);

Each medicine becomes required solution with physiological saline solution.

Experimental technique: mice is divided into 9 groups at random, blank group, ginseng stilbene Kingcon group, Herb Gynostemmae Pentaphylli group, the high, medium and low dosage group of present composition A, the high, medium and low dosage group of present composition B, 10 every group.Intramuscular inoculation Lewis lung cancer (cancerous cell homogenate in 1: 3) 0.2ml/ respectively of mice, the continuous gastric infusion of each treated animal next day 21 days was put to death in experiment on the 22nd day, got lung and shifted and the metastasis number with pressed disc method counting lung.

Table 7 drug regimen of the present invention is to the inhibitory action of the spontaneous transfer of Mice Bearing Lewis Lung Cancer

Group	Dosage (mg/kg)	The lung rate of transform (%)	Lung metastasis number (x ± s, individual)	Metastasis is counted suppression ratio (%)
Group	Dosage (mg/kg)	The lung rate of transform (%)	Lung metastasis number (x ± s, individual)	Metastasis is counted suppression ratio (%)	Dosage group composition B low dose group among the dosage group composition A low dose group composition B high dose group composition B among the blank group ginseng stilbene Kingcon group gynostemma pentaphylla group composition A high dose group composition A	- 80 80 80 60 40 80 60 40	100 82.6 ^* 84.5 ^* 76.8 ^#$ 76.6 ^#$ 76.5 ^#$ 76.7 ^#$ 76.6 ^#$ 76.4 ^#$	4.56±1.38 1.74±1.36 ^* 2.23±1.25 ^* 1.35±1.21 ^#$$ 1.54±1.45 ^#$$ 1.65±2.04 ^$$ 1.33±2.02 ^#$$ 1.57±1.62 ^#$$ 1.68±1.44 ^$$	- 45.0 38.1 58.7 52.8 49.3 58.4 52.2 48.7

Annotate: with blank group ratio, ^*P＜0.05, ^*P＜0.01; With ginseng stilbene Kingcon group ratio, ^#P＜0.05; With Herb Gynostemmae Pentaphylli group ratio, ^$P＜0.05, ^$$P＜0.01.

Experimental result and conclusion: the results are shown in Table 7.With the blank group relatively, ginseng stilbene Kingcon, Herb Gynostemmae Pentaphylli, pharmaceutical composition A of the present invention, B can significantly suppress lung cancer metastasis, significantly suppress lung cancer metastasis kitchen range number (p＜0.05, p＜0.01); Compare with ginseng stilbene Kingcon, pharmaceutical composition A of the present invention, B can both significantly suppress the lung rate of transform (p＜0.05, p＜0.01), illustrate that pharmaceutical composition A of the present invention, B have reasonable inhibitory action for the transfer of pulmonary carcinoma.With the Herb Gynostemmae Pentaphylli ratio, pharmaceutical composition A of the present invention, B are better than single Herb Gynostemmae Pentaphylli of using for the inhibitory action of lung cancer metastasis, and prompting Herb Gynostemmae Pentaphylli, Radix Panacis Quinquefolii, the Radix Astragali three medicines have share synergistic function.

The potentiation that experimental example 6 pharmaceutical compositions of the present invention and 5-fluorouracil (5-Fu) share

Laboratory animal: ICR kind mice, body weight 18～22g, 8 ages in week, male and female half and half, totally 90.

Test sample: positive control medicine: 5-fluorouracil injection, Zizhu Pharmaceutical Co., Ltd., Beijing;

Herb Gynostemmae Pentaphylli injection: self-control;

Pharmaceutical composition A of the present invention, self-control (seeing embodiment 8 aqueous injection prescription 1): main effective ingredient is Herb Gynostemmae Pentaphylli total glycosides, American ginseng total saponins, astragalus polysaccharides (being equivalent to Herb Gynostemmae Pentaphylli 5g, Radix Panacis Quinquefolii 3g, Radix Astragali 4g);

Pharmaceutical composition B of the present invention, self-control (seeing embodiment 8 aqueous injection prescription 2): main effective ingredient is Herb Gynostemmae Pentaphylli total glycosides, American ginseng total saponins, Radix Astragali total saponins (being equivalent to Herb Gynostemmae Pentaphylli 5g, Radix Panacis Quinquefolii 3g, Radix Astragali 4g).

Experimental technique: get mice, all subcutaneous vaccination S ₁₈₀Tumor liquid (2 * 10 ⁷/ ml) 0.2ml/, next day, grouping was weighed.Except that the blank group, all the other respectively organize equal lumbar injection 5-fluorouracil (5-Fu) 60mg/kg.Each organizes intraperitoneal injection, blank group administration normal saline, positive controls administration cyclophosphamide.Totally 10 days.Drug withdrawal is weighed next day, puts to death mice and peels off the subcutaneous tumors piece, claims tumor heavy, calculates tumour inhibiting rate and potentiation rate.

Potentiation rate (%)=(it is heavy that chemotherapy adds the average tumor of water group average tumor weight-chemotherapy dosing group)/chemotherapy adds the average tumor of water group heavy * 100%

Table 8 pharmaceutical composition of the present invention and the anti-S of 5-fluorouracil ₁₈₀The potentiation of tumor

Group	Number of animals	Dosage (mg/kg)	Tumor heavy (g)	Tumour inhibiting rate (%)	Potentiation rate (%)
Group	Number of animals	Dosage (mg/kg)	Tumor heavy (g)	Tumour inhibiting rate (%)	Potentiation rate (%)	Dosage group 5-Fu+ composition B low dose group 5-Fu group among the dosage group 5-Fu+ composition A low dose group 5-Fu+ composition B high dose group 5-Fu+ composition B among the blank group 5-Fu+ gynostemma pentaphylla group 5-Fu+ composition A high dose group 5-Fu+ composition A	10 10 10 10 10 10 10 10 10	- 80 80 60 40 80 60 40 -	2.58±0.74 1.12±0.56 ^* 0.54±0.42 ^## 0.66±0.51 ^## 0.75±0.56 ^# 0.52±0.38 ^## 0.66±0.44 ^## 0.78±0.52 ^# 1.33±0.64 ^**	- 56.59 79.07 74.42 70.93 79.84 74.42 69.77 48.45	- 15.79 59.40 50.38 43.61 60.90 50.38 41.35 -

Annotate: compare with the 5-Fu group, ^*P＜0.05, ^*P＜0.01; Compare with 5Fu+ Herb Gynostemmae Pentaphylli group, ^#P＜0.05, ^##P＜0.01.

Experimental result and conclusion: the results are shown in Table 8.Compare with the blank group, Herb Gynostemmae Pentaphylli, pharmaceutical composition A of the present invention, B all have synergistic function (p＜0.05 with 5-fluorouracil, p＜0.01), wherein compositions A, B potentiation are better than single Herb Gynostemmae Pentaphylli of using, compositions A, B high dose group curative effect potentiation the strongest (p＜0.01), prompting Herb Gynostemmae Pentaphylli, Radix Panacis Quinquefolii, the Radix Astragali three medicines share the collaborative effect that increases the drug effect of antitumor drug.

Experimental example 7 pharmaceutical compositions of the present invention are to the potentiation of radiotherapy

Laboratory animal: ICR kind mice, body weight 18～22g, 8 ages in week, male and female half and half, 10 every group, totally 90.

Test sample: Herb Gynostemmae Pentaphylli injection: self-control;

Pharmaceutical composition B of the present invention, self-control (seeing embodiment 9 injectable powder prescription 1): main effective ingredient is Herb Gynostemmae Pentaphylli total glycosides, American ginseng total saponins, Radix Astragali total saponins (being equivalent to Herb Gynostemmae Pentaphylli 5g, Radix Panacis Quinquefolii 3g, Radix Astragali 4g).

Experimental technique: get mice, all subcutaneous vaccination S ₁₈₀Tumor liquid (2 * 10 ⁷/ ml) 0.2ml/, next day, grouping was weighed.All the other respectively organize all the 3rd, the 6th day usefulness after inoculation except that the blank group ⁶⁰Co total irradiation, exposure dose are 0.05Gy/min.Each organizes intraperitoneal injection, blank group administration normal saline, positive controls administration cyclophosphamide.Administration is 10 days altogether, and drug withdrawal is weighed next day, puts to death animal.Peel off the subcutaneous tumors piece, claim tumor heavy, calculate tumour inhibiting rate and potentiation rate.

Table 9 pharmaceutical composition of the present invention and the anti-S of fluorouracil ₁₈₀The potentiation of tumor

Group	Dosage (mg/kg)	Tumor heavy (g)	Tumour inhibiting rate (%)	Potentiation rate (%)
Group	Dosage (mg/kg)	Tumor heavy (g)	Tumour inhibiting rate (%)	Potentiation rate (%)	The blank group ⁶⁰Co+ Herb Gynostemmae Pentaphylli group ⁶⁰Co+ compositions A high dose group ⁶⁰Dosage group among the Co+ compositions A ⁶⁰Co+ compositions A low dose group ⁶⁰Co+ compositions B high dose group ⁶⁰Dosage group among the Co+ compositions B ⁶⁰Co+ compositions B low dose group ⁶⁰Co 0.05Gy/min	- 80 80 60 40 80 60 40 -	2.56±0.65 1.77±0.58 ^* 1.56±0.39 ^## 1.68±0.41 ^## 1.75±0.56 ^# 1.53±0.36 ^## 1.67±0.42 ^## 1.73±0.53 ^# 2.08±0.59	- 30.86 39.06 34.38 31.64 40.23 34.77 32.42 18.75	- 14.90 25.00 19.23 15.87 26.44 19.71 16.83 -

Annotate: with ⁶⁰Co organizes relatively, ^*P＜0.05, ^*P＜0.01; With ⁶⁰Co+ Herb Gynostemmae Pentaphylli group compares, ^#P＜0.05, ^##P＜0.01.

Experimental result and conclusion: the results are shown in Table 9.With the blank group relatively, Herb Gynostemmae Pentaphylli, pharmaceutical composition A of the present invention, B all with ⁶⁰Co radiotherapy has synergistic function (p＜0.05, p＜0.01), wherein compositions A, B potentiation are better than single Herb Gynostemmae Pentaphylli of using, compositions A, the potentiation of B high dose group curative effect be (p＜0.01) significantly, and prompting Herb Gynostemmae Pentaphylli, Radix Panacis Quinquefolii, the Radix Astragali three medicines share the collaborative effect that increases chemotherapeutic efficacy.

Experimental example 8 pharmaceutical composition aqueous injection specific safety of the present invention experiments

1, anaphylaxis experiment

Laboratory animal: Cavia porcellus, 24, body weight 280～310g, the male and female dual-purpose is divided at random for reagent A group, for four groups of reagent B group, negative control and positive controls, 6 of every big groups.

Test sample: pharmaceutical composition A of the present invention, specification: 5ml derives from embodiment 5;

Pharmaceutical composition B of the present invention, specification: 5ml derives from embodiment 5;

Negative control: sodium chloride injection, Shandong Huaxin Pharmaceutical Co., Ltd.;

Positive control drug: 5% ovalbumin normal saline solution, self-control.

Dosage: priming dose 0.5ml/ only; The sensitization number of times: the next day lumbar injection 1 time, continuous 3 times; Challenge dose 1ml/, intravenous injection.

Experimental technique: the above-mentioned medicinal liquid 0.5ml of lumbar injection next day of giving Cavia porcellus respectively by above-mentioned grouping, inject three times altogether.Then every big group Cavia porcellus is divided into two groups, 3 of every groups again.The first group Cavia porcellus after first time sensitization 14 days, second group carried out antigen in 14 days and attacks every above-mentioned medicinal liquid 1ml of the equal intravenous injection of Cavia porcellus after first time sensitization.Observe and write down the performance of attacking Cavia porcellus in the 15min of back.

Experimental result and conclusion: all do not find anaphylaxis for reagent group and negative control medicine group Cavia porcellus, and the ovalbumin group produces anaphylaxis and dead.Show that composite injection does not have obvious sensitization.

2, hemolytic experiment

Experimental animal: male rabbit, 2, body weight 2.5kg.

Test sample: pharmaceutical composition A of the present invention, dosage form: liquid drugs injection, specification: 5ml derives from embodiment 5;

Pharmaceutical composition B of the present invention, dosage form: liquid drugs injection, specification: 5ml derives from embodiment 5;

Negative control: sodium chloride injection, Shandong Huaxin Pharmaceutical Co., Ltd..

Experimental technique: it is standby to prepare 2% erythrocyte normal saline suspension.Get 7 of clean tube, number and be arranged on the test tube rack, according to the form below operation in tandem, incubation in the rearmounted 37 ℃ of water-baths of mixing, the result of observed and recorded 15min, 30min, 45min, 1h, 2h, 3h.

Test tube number	1	2	3	4	5	6	7
Test tube number	1	2	3	4	5	6	7	Composite injection (ml) normal saline (ml) distilled water (ml) 2% red cell suspension (ml)	0.1 2.4 - 2.5	0.2 2.3 - 2.5	0.3 2.2 - 2.5	0.4 2.1 - 2.5	0.5 2.0 - 2.5	- 2.5 - 2.5	- - 2.5 2.5

Experimental result and conclusion: each pipe of test sample 0.1～0.5ml haemolysis and hemagglutination all do not occur at 15min, 30min, 45min, 1h, 2h, 3h.Show that composite injection does not have obvious hemolytic.

3, blood vessel irritation experiment

Laboratory animal: rabbit, body weight 2.1～2.3kg, male and female dual-purpose.

Test sample: pharmaceutical composition A of the present invention, dosage form: liquid drugs injection, specification: 5ml derives from embodiment 8;

Pharmaceutical composition B of the present invention, dosage form: liquid drugs injection, specification: 5ml derives from embodiment 8;

Contrast medicine sodium chloride injection, Shandong Huaxin Pharmaceutical Co., Ltd..

Quiet dosage of dosage rabbit is 100ml/kg.

Experimental technique: get 9 of healthy rabbits, be divided at random for reagent A group, for reagent B group and 0.9% sodium chloride injection matched group, 3 every group, dosage is 20ml/kg.Rabbit is put in the fixed case before the administration, instils respectively for reagent and 0.9% sodium chloride injection by above-mentioned grouping in auricular vein, drip speed and be 1ml/min (20/min), the 24h injection site has or not hyperemia, edema, hemorrhage, downright bad after the observation administration.Successive administration 3 days, 24h does pathological examination getting the rabbit ear 10% formalin fixed away from the entad end of injection site 1cm after the last administration.

Experimental result and conclusion: perusal and pathologic finding show that administration group and matched group do not have significant difference, and the blood vessel of agents area and surrounding tissue there is no hyperemia, edema, hemorrhage, downright bad, and pathologic finding is no abnormal.Show that quiet of composite injection vein is to the blood vessel nonirritant.

Experimental example 9 medicine composition injection stability experiments of the present invention

Sample: pharmaceutical composition A of the present invention, dosage form: liquid drugs injection, specification: 5ml derives from embodiment 8;

Investigation project: character, pH value, clarity;

Long-time stability experimental technique and result: this product is put under the condition of 25 ℃ ± 2 ℃ of temperature, relative humidity 60% ± 10% and placed 6 months, 12 months, every index has no significant change, experimental result show composite injection long-term place basicly stable.

4, the specific embodiment

The specific embodiment of form is described in further detail foregoing of the present invention by the following examples.But this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following embodiment.All technology that realizes based on foregoing of the present invention all belong to scope of the present invention.The adjuvant of each dosage form can be replaced with acceptable accessories in following examples, perhaps reduces, increases.

The preparation of embodiment 1 Herb Gynostemmae Pentaphylli total glycosides

Get the Herb Gynostemmae Pentaphylli medical material, add 75% alcohol reflux secondary, each 2 hours, filter, flow liquid reclaims ethanol to there not being the alcohol flavor, adds water and makes into the solution that every 1ml is equivalent to 2g crude drug amount, stirs evenly, put coldly, standing over night filters, the macroporous resin column of filtrate by having handled well, earlier with the water of 2 times of column volumes towards post, discard water liquid, 60% ethanol of 3 times of column volumes of reuse carries out eluting, collects eluent, reclaims ethanol, be concentrated into relative density and be 1.08～1.10 concentrated solution, spray drying, promptly.

Make three batches of Herb Gynostemmae Pentaphylli total glycosides respectively, extract yield and content see Table 10.

Assay

The preparation precision of reference substance solution takes by weighing in that 3 hours gypenoside of 60 ℃ of drying under reduced pressure-the A reference substance is an amount of, adds dissolve with methanol, makes the solution that every 1ml contains 2mg.

The preparation precision of need testing solution takes by weighing this product 50mg, adds dissolve with methanol, makes the solution that every 1ml contains 2mg.

Accurate reference substance solution and each the 100 μ l of need testing solution of drawing of algoscopy, put respectively in the 15ml tool plug test tube, the accurate mixed liquor 2ml that contains 5% vanillin glacial acetic acid solution and perchloric acid (2: 8) that adds new preparation, shake up, close plug, put in 60 ℃ of water-baths and heated 15 minutes, take out, put into frozen water cooling 2 minutes immediately, the accurate glacial acetic acid 10ml that adds, shake up, make blank with reagent,, measure trap at 555 ± 5nm wavelength place according to spectrophotography (51 pages of appendix of Chinese Pharmacopoeia nineteen ninety version) test, calculate, promptly.

This product is pressed dry product and is calculated, and contains Herb Gynostemmae Pentaphylli total glycosides with gypenoside-A (C ₅₃H ₉₀O ₂₁) meter, must not be less than 50.0%.

Used Herb Gynostemmae Pentaphylli total glycosides in following examples is in the present embodiment and prepares.

The yield and the content of table 10 Herb Gynostemmae Pentaphylli extract total saponins

Batch	Medical material (kg)	Extract (kg)	Yield (%)	Total glycosides content (%)
Batch	Medical material (kg)	Extract (kg)	Yield (%)	Total glycosides content (%)	123 is average	100 100 100 -	2.12 2.48 3.08 -	2.12 2.48 3.08 2.56	69.87 60.12 52.33 60.77

The preparation of embodiment 2 American ginseng total saponins

Get Radix Panacis Quinquefolii, add 10 times of water gagings, soaked 8 hours, leach soak, continuing adds 8 times of amount ordinary waters, decocts 1 hour, and secondary merges lixiviating solution altogether, and being evaporated to density is 1.19～1.25 (60), and spray drying gets the aqueous extract powder.Add 8,5,5,5 times of amount n-butyl alcohol successively, boiling water bath stirs and extracts 1h, and totally 4 times, merge extractive liquid,, reclaim under reduced pressure n-butyl alcohol, vacuum drying get thick total saponins.Thick total saponins is admixed 20 times of amounts (W/W) D ₁₀₁The type macroporous resin, closely colourless with the hot water injection to washings, stir the eluting secondary with 4 times of amount 80% ethanol, each 1h merges eluent, the reclaim under reduced pressure n-butyl alcohol, spray drying, promptly.

The discriminating of American ginseng total saponins

Get this product powder 0.5g, add methanol 25ml, reflux 1 hour, Fang Leng, filter, filtrate evaporate to dryness, residue add water 20ml makes dissolving, extract 2 times with the ether jolting, each 10ml discards ether solution, water layer extracts 3 times with saturated n-butyl alcohol jolting, and each 15ml merges n-butanol extracting liquid, wash with water 2 times, each 10ml divides and gets n-butyl alcohol liquid, evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution.Other gets Radix Panacis Quinquefolii control medicinal material 1g, shines medical material solution in pairs with legal system.Get anthropomorphic body saponin F again ₁₁Reference substance, ginsenoside Rb ₁Reference substance, personal saponin Re reference substance, personal saponin Rg ₁Reference substance adds methanol and makes the solution that every 1ml contains 2mg, in contrast product solution.Drawing above-mentioned six kinds of each 5ul of solution puts respectively on same silica gel g thin-layer plate, (15: 40: 22: 10) 5～10 ℃ of lower floor's solution of placing 12 hours were developing solvent with chloroform-ethyl acetate-methanol-water, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to the speckle colour developing at 105 ℃, puts respectively under daylight and the sub-ultra-violet lamp (365nm) and inspects.In the test sample chromatograph, with control medicinal material chromatograph and the corresponding position of reference substance chromatograph on, show the speckle or the fluorescence speckle of same color respectively.

Make three batches of American ginseng total saponins respectively, extract yield and content results see Table 12.

The American ginseng total saponins assay

The reference substance solution precision takes by weighing American ginseng total saponins reference substance 4mg, puts in the 2ml measuring bottle, adds methanol to scale, shakes up, in contrast product solution (every 1ml contains American ginseng total saponins 2mg).

The need testing solution precision takes by weighing this product 1g, adds methanol extraction 4 times (50,40,40,40ml), extracts 30min at every turn.Merge extractive liquid,, reclaim under reduced pressure is to doing.The adding distil water dissolving also is transferred in the 50ml measuring bottle, divides washing container for several times with distilled water, and washing liquid and aqueous solution merge, and adding distil water shakes up to scale.The accurate aqueous solution 20ml that draws puts in the separatory funnel, with water saturated n-butanol extraction 4 times (20,15,15,15ml), extract with the saturated water 20ml washing of n-butyl alcohol after, put in the water-bath reclaim under reduced pressure to dried.Residue adds dissolve with methanol and is transferred in the 10ml measuring bottle, and with methanol washing container repeatedly, washing liquid is incorporated measuring bottle into, adds methanol to scale and shakes up, promptly.

The standard curve precision is measured reference substance solution 20,40,60,80,100ul, put respectively in the 10ml tool plug test tube, put and volatilize solvent in the water-bath, take out precision immediately and add 5% vanillin, one glacial acetic acid liquid 0.2ml, perchloric acid 0.8ml, shake up, put in 60 ℃ of water-baths and heat 15min, take out, with circulating water cooling 2min, precision adds glacial acetic acid 5ml, shakes up immediately.With the reagent corresponding is blank, measures trap in 550nm wavelength place, is ordinate with the trap, and the ug number of American ginseng total saponins is an abscissa drawing standard curve, calculates regression equation.

The accurate respectively need testing solution 20ul that draws of algoscopy puts in the 10ml tool plug test tube.In water-bath, volatilize solvent.All the other steps are with the preparation of standard curve.The place records trap at the 550nm wavelength, is gone out the amount of total saponins by regression equation calculation.

The ginsenoside Rg ₁, Rb ₁, Re assay

According to high performance liquid chromatography

Chromatographic condition and system suitability test are filler with the octadecyl silane; With the second eyeball is mobile phase A, is Mobile phase B with 0.1% phosphoric acid solution, and the regulation in the according to the form below is carried out gradient elution; The detection wavelength is 203nm; 40 ℃ of column temperatures.Number of theoretical plate is pressed Radix Ginseng Rb ₁The peak calculates and is not less than 4000.

Table 11 gradient elution proportion of mobile phase table

Time (minute)	Mobile phase A (%)	Mobile phase (%)
Time (minute)	Mobile phase A (%)	Mobile phase (%)	0～25 25～60 60～90 90～100	19-＞20 20-＞40 40-＞55 55-＞60	81-＞80 80-＞60 60-＞45 45-＞40

Reference substance solution must prepare precision and take by weighing the ginsenoside Rg ₁Reference substance, ginsenoside Re's reference substance, Radix Ginseng Rb ₁Reference substance is an amount of, adds methanol and makes every 1ml and contain the ginsenoside Rg ₁Reference substance 0.1mg, ginsenoside Re's reference substance 0.4mg, ginsenoside Rb ₁1mg,

The about 1g of this product powder (crossing sieve No. three) is got in the preparation of need testing solution, the accurate title, decide, put in the tool plug conical flask, the water saturated n-butyl alcohol 50ml of accurate adding claims to decide weight, put in the water-bath heating and refluxing extraction 1.5 hours, put coldly, claim again to decide weight, supply with water saturated n-butyl alcohol and subtract weight loss, shake up, filter.Precision is measured subsequent filtrate 25ml, puts in the evaporating dish, and evaporate to dryness, residue add 50% methanol to scale, shakes up, and filters, and gets subsequent filtrate, promptly.

Accurate respectively reference substance solution and each the 20 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure, promptly.Used American ginseng total saponins in following examples is in the present embodiment and prepares.

The yield of table 12 American ginseng total saponins and content

Batch	Medical material (kg)	Extract (kg)	Yield (%)	Total saponin content (%)	The ginsenoside Rg ₁、 Rb ₁, Re content (%)
Batch	Medical material (kg)	Extract (kg)	Yield (%)	Total saponin content (%)	The ginsenoside Rg ₁、 Rb ₁, Re content (%)	123 is average	50 50 50 -	0.515 0.625 0.870 -	1.03 1.25 1.74 1.34	62.4 58.9 54.2 58.5	6.1 7.2 6.8 6.7

The preparation of embodiment 3 astragalus polysaccharidess

Get Milkvetch Root, add 7 times of amount 70% ethanol extraction secondaries, each 2 hours, extracting solution discards, the slag extracting in water secondary of getting it filled, and extracting solution merges, the ratio that is concentrated into extracting liquid volume and raw medicinal herbs is 1.05: 1, add ethanol precipitation and make and contain the alcohol amount and reach 70%, filter, must precipitate, precipitation 70% washing with alcohol, the dissolving of reuse suitable quantity of water is filtered, and filtrate is crossed macroporous resin, the water eluting, collect water lotion, water lotion is concentrated into medicine liquid volume, add ethanol and make and contain alcohol and measure and reach 70% with the medical material ratio is 1: 2.5, must precipitate, to precipitate with 95% ethanol and washing with acetone dehydration, drying under reduced pressure (60 ℃), promptly.

Make three batches of astragalus polysaccharidess respectively, extract yield and content results see Table 13.

The discriminating of astragalus polysaccharides

(1) gets the about 0.2g of this product, after adding water 5ml dissolving, add 5 of alkaline cupric tartrate test solutions, heating promptly produces red precipitate, cooling, filter, get filtrate add 1 of hydrochloric acid make acid, heating in water bath 10 minutes, put cold, regulate pH value to neutral, add alkaline cupric tartrate test solution 0.5ml, heating in water bath promptly produces red copper oxidule precipitation.

(2) get the about 0.2g of this product, add water 2ml dissolving after, add 5% alpha-Naphthol alcoholic solution 0.5ml and shake up, slowly add sulphuric acid 3ml, two liquid level intersection displaing amaranth rings.

The astragalus polysaccharides assay

105 ℃ of glucose 100mg that are dried to constant weight are got in the preparation of standard solution, and accurate the title decides, and puts in the 100ml measuring bottle, is dissolved in water, and is diluted to scale, shakes up.Precision is measured 10ml, puts in the 100ml measuring bottle, adds water to scale, shakes up, and is standby.

Standard curve drafting precision is measured totally 6 parts of standard solution 0.1ml～0.6ml, put respectively in the 25ml measuring bottle, add water to 2.0ml, and add phenol solution and (get phenol 300g, aluminium flake 0.3g, sodium bicarbonate 0.15g, mix distillation, collect 182 ℃ of fractions, be mixed with 5% aqueous solution) 1.0ml, shake up, drip concentrated sulphuric acid 5.0ml rapidly, shake up, place 5min, put and heat 15min in the water-bath, take out, be cooled to room temperature rapidly, in addition with the same operation repetitive of 2.0ml water as blank, measure absorption value at 490nm wavelength place, calculate regression equation.

Assay method is got Radix Astragali extract 0.5g and is put in the 25ml measuring bottle, and the method under the sighting target directrix curve drafting item is measured absorption value, according to the content of regression equation calculation polysaccharide from " adding water to 2.0ml " in accordance with the law.

Used astragalus polysaccharides in following examples is in the present embodiment and prepares.

The yield of table 13 astragalus polysaccharides and content

Batch	Medical material (kg)	Extract (kg)	Yield (%)	Polyoses content (%)
Batch	Medical material (kg)	Extract (kg)	Yield (%)	Polyoses content (%)	123 is average	40 40 40 -	0.416 0.272 0.608 -	1.04 0.68 1.52 1.08	58.9 65.2 60.1 61.4

The preparation of embodiment 4 Radix Astragali total saponinss

Get Milkvetch Root, decoct with water three times, each 1.5 hours, collecting decoction filters, and it is 1.20～1.25 (60 ℃) g that filtrate is concentrated into relative density, handle 2 times with ethanol precipitation, containing the alcohol amount in the solution for the first time is 75%, is 85% for the second time, each all cold preservation is placed, and reclaims ethanol and be concentrated into every 1ml to be equivalent to crude drug 10g, is diluted to every 1ml with water for injection and is equivalent to crude drug 1g, cold preservation was placed 12 hours, filter, filtrate decompression concentrates, vacuum drying, promptly.

Make three batches of Radix Astragali total saponins extracts respectively, extract yield and content results see the following form 14.

The Radix Astragali total saponins discrimination test

Discrimination test one is got this product 0.01g, adds methanol 20ml, reflux 1 hour, filter, filtrate is added on neutral alumina post (100～120 orders, 5g, on the internal diameter 10～15mm), with 40% methanol 100ml eluting, collect eluent, evaporate to dryness, residue adds water 30ml makes dissolving, extract 2 times with water saturated n-butyl alcohol jolting, each 20ml merges n-butyl alcohol liquid; Wash each 20ml with water 2 times; Discard water liquid, n-butyl alcohol liquid evaporate to dryness, residue add methanol 0.5ml makes dissolving, as need testing solution.Other gets the astragaloside reference substance, adds methanol and makes the solution that every 1ml contains 1mg, in contrast product solution.Drawing each 2 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, is developing solvent with lower floor's solution of chloroform-methanol-water (13: 7: 2), launch, take out airing, spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to the speckle colour developing at 105 ℃.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, daylight shows down identical sepia speckle; Ultra-violet lamp (365nm) shows identical orange-yellow fluorescence speckle down.

Discrimination test two is got this product 0.01g, adds ethanol 30ml, reflux 20 minutes, filter, filtrate adds 0.3% sodium hydroxide solution 15ml makes dissolving, filters, and filtrate is regulated pH value to 5～6 with dilute hydrochloric acid, extract with ethyl acetate 15ml jolting, divide and get ethyl acetate liquid, filter the filtrate evaporate to dryness with the filter paper that is covered with anhydrous sodium sulfate, residue adds ethyl acetate 1ml makes dissolving, as need testing solution.Other gets Radix Astragali control medicinal material 2g, shines medical material solution in pairs with legal system.Draw each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate,, launch as developing solvent with chloroform-methanol (10: 1), take out, airing is put in the ammonia steam and is inspected under the smoked rearmounted ultra-violet lamp (365nm).In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence principal spot of same color.

The Radix Astragali total saponins assay

The assay of total saponins

The preparation precision of reference substance solution takes by weighing the about 10mg of astragaloside reference substance that is dried to constant weight in 105 ℃, puts in the 100ml measuring bottle, adds dissolve with methanol and is diluted to scale, shakes up, and promptly gets (every 1ml contains astragaloside dry product 0.1mg).

This product 0.1g is got in the preparation of need testing solution, and accurate the title decides, and adds water 25ml and makes dissolving, move in the separatory funnel, extract 4 times, each 20ml with water saturated n-butyl alcohol jolting, merge n-butyl alcohol liquid, with the saturated water washing twice of n-butyl alcohol, each 10ml, discard water liquid, n-butyl alcohol evaporate to dryness to the water-bath, residue adds dissolve with methanol, move in the 25ml measuring bottle, and add methanol and be diluted to scale, shake up, filter, get subsequent filtrate, promptly.

The algoscopy precision is measured reference substance solution, each 1ml of need testing solution, puts 25ml Na Shi color comparison tube, puts evaporate to dryness in the water-bath, put coldly, add freshly prepared 5% vanillin-glacial acetic acid solution 0.4ml, perchloric acid 1.6ml, shake up, placed 5 minutes, put in the boiling water bath and developed the color 15 minutes, take out, put immediately and be cooled to room temperature in the ice bath, add the 8ml glacial acetic acid, shake up, measure absorbance at 538nm wavelength place, calculate, promptly.

The assay of astragaloside

Chromatographic condition and system suitability test are filler with the octadecyl silane; With second eyeball-water (32: 68) is mobile phase; Evaporative light scattering detector.Number of theoretical plate calculates with the astragaloside peak and is not less than 4000.

It is an amount of that the preparation precision of reference substance solution takes by weighing the astragaloside reference substance, adds methanol and make the solution that every 1ml contains 0.5mg, promptly.

The preparation precision of need testing solution takes by weighing this product 0.04g, and accurate the title decides, and puts in the apparatus,Soxhlet's, first methanol 40ml, cold invading spent the night, and it is an amount of to add methanol again, reflux 4 hours, extracting solution reclaim solvent and are concentrated into driedly, and residue adds water 10ml, slight fever makes dissolving, extracts 4 times with water saturated n-butyl alcohol jolting, each 40ml, merge n-butyl alcohol liquid, use ammonia solution thorough washing 2 times, each 40ml, discard ammoniacal liquor, n-butyl alcohol liquid evaporate to dryness, residue add water 5ml makes dissolving, Fang Leng is by D101 type macroporous adsorptive resins (internal diameter 1.5cm, long 12cm), with water 50ml eluting, discard water liquid, reuse 40% ethanol 30ml eluting, discard eluent, continue with 70% ethanol 80ml eluting, collect eluent, evaporate to dryness, with dissolve with methanol and be transferred in the 5ml measuring bottle, add methanol and be diluted to scale, shake up, promptly.

Accurate respectively reference substance solution 10 μ l, 20 μ l and the need testing solution 20 μ l of drawing of algoscopy inject chromatograph of liquid, measure, and calculate with 2 logarithmic equations of external standard, promptly.

Used Radix Astragali total saponins in following examples is in the present embodiment and prepares.

The yield of table 14 Radix Astragali total saponins and content

Batch	Medical material (kg)	Extract (kg)	Yield (%)	Total saponin content (%)	Astragaloside content (%)
Batch	Medical material (kg)	Extract (kg)	Yield (%)	Total saponin content (%)	Astragaloside content (%)	123 is average	40 40 40 -	0.324 0.488 0.568 -	0.81 1.22 1.42 1.15	69.8 60.1 52.3 60.7	2.2 2.8 3.5 2.8

The preparation of embodiment 5 pharmaceutical composition tablets of the present invention

Prescription 1:

Herb Gynostemmae Pentaphylli extract 128.0g (being equivalent to Herb Gynostemmae Pentaphylli 5kg)

Radix Panacis Quinquefolii extract 40.2g (being equivalent to Radix Panacis Quinquefolii 3kg)

Astragalus polysaccharides 43.2g (being equivalent to Radix Astragali 4kg)

Starch 120.0g

Microcrystalline Cellulose 40.0g

The 2%HPMC aqueous solution is an amount of

Magnesium stearate 2.0g

Carboxymethylstach sodium 10.0g

Prepare 1000 altogether

Prescription 2:

Radix Astragali total saponins 46.0g (being equivalent to Radix Astragali 4kg)

Starch 120.0g

Microcrystalline Cellulose 40.0g

The 2%HPMC aqueous solution is an amount of

Magnesium stearate 2.0g

Carboxymethylstach sodium 10.0g

Prepare 1000 altogether

Prescription 3:

Herb Gynostemmae Pentaphylli extract 12.8g (being equivalent to Herb Gynostemmae Pentaphylli 0.5kg)

Radix Panacis Quinquefolii extract 13.4g (being equivalent to Radix Panacis Quinquefolii 1kg)

Astragalus polysaccharides 10.8g (being equivalent to Radix Astragali 1kg)

Starch 120.0g

Microcrystalline Cellulose 40.0g

The 2%HPMC aqueous solution is an amount of

Magnesium stearate 2.0g

Carboxymethylstach sodium 10.0g

Prepare 1000 altogether

Prescription 4:

Radix Astragali total saponins 11.5g (being equivalent to Radix Astragali 1kg)

Starch 120.0g

Microcrystalline Cellulose 40.0g

The 2%HPMC aqueous solution is an amount of

Magnesium stearate 2.0g

Carboxymethylstach sodium 10.0g

Prepare 1000 altogether

Prescription 5:

Herb Gynostemmae Pentaphylli extract 512.0g (being equivalent to Herb Gynostemmae Pentaphylli 20kg)

Radix Panacis Quinquefolii extract 402.0g (being equivalent to Radix Panacis Quinquefolii 30kg)

Astragalus polysaccharides 1080.0g (being equivalent to Radix Astragali 100kg)

Starch 120.0g

Microcrystalline Cellulose 40.0g

The 2%HPMC aqueous solution is an amount of

Magnesium stearate 2.0g

Carboxymethylstach sodium 10.0g

Prepare 5000 altogether

Prescription 6:

Radix Astragali total saponins 1150.0g (being equivalent to Radix Astragali 100kg)

Starch 120.0g

Microcrystalline Cellulose 40.0g

The 2%HPMC aqueous solution is an amount of

Magnesium stearate 2.0g

Carboxymethylstach sodium 10.0g

Prepare 5000 altogether

Prescription 7:

Herb Gynostemmae Pentaphylli extract 256.0g (being equivalent to Herb Gynostemmae Pentaphylli 10kg)

Radix Panacis Quinquefolii extract 80.4g (being equivalent to Radix Panacis Quinquefolii 6kg)

Astragalus polysaccharides 270.0g (being equivalent to Radix Astragali 25kg)

Starch 120.0g

Microcrystalline Cellulose 40.0g

The 2%HPMC aqueous solution is an amount of

Magnesium stearate 2.0g

Carboxymethylstach sodium 10.0g

Prepare 5000 altogether

Prescription 8:

Radix Astragali total saponins 287.5g (being equivalent to Radix Astragali 25kg)

Starch 120.0g

Microcrystalline Cellulose 40.0g

The 2%HPMC aqueous solution is an amount of

Magnesium stearate 2.0g

Carboxymethylstach sodium 10.0g

Prepare 5000 altogether

Preparation technology:

Raw material and starch, microcrystalline Cellulose add 2%HPMC aqueous solution system soft material, granulate then, drying, add magnesium stearate, carboxymethylstach sodium granulate, and abortion product check back determines that sheet weighs, tabletting, pack finished product.

The preparation of embodiment 6 medicament composition capsule agent of the present invention

Prescription 1:

Astragalus polysaccharides 43.2g (being equivalent to Radix Astragali 4kg)

Starch 60.0g

Microcrystalline Cellulose 20.0g

The 2%HPMC aqueous solution is an amount of

Magnesium stearate 1.0g

Prepare 1000 altogether

Prescription 2:

Radix Astragali total saponins 46.0 (being equivalent to Radix Astragali 4kg)

Starch 60.0g

Microcrystalline Cellulose 20.0g

The 2%HPMC aqueous solution is an amount of

Magnesium stearate 1.0g

Prepare 1000 altogether

Prescription 3:

Radix Panacis Quinquefolii extract 26.8g (being equivalent to Radix Panacis Quinquefolii 2kg)

Astragalus polysaccharides 21.6g (being equivalent to Radix Astragali 2kg)

Starch 60.0g

Microcrystalline Cellulose 20.0g

The 2%HPMC aqueous solution is an amount of

Magnesium stearate 1.0g

Prepare 1000 altogether

Prescription 4:

Radix Astragali total saponins 23.0g (being equivalent to Radix Astragali 2kg)

Starch 60.0g

Microcrystalline Cellulose 20.0g

The 2%HPMC aqueous solution is an amount of

Magnesium stearate 1.0g

Prepare 1000 altogether

Prescription 5:

Astragalus polysaccharides 10.8g (being equivalent to Radix Astragali 1kg)

Starch 60.0g

Microcrystalline Cellulose 20.0g

The 2%HPMC aqueous solution is an amount of

Magnesium stearate 1.0g

Prepare 1000 altogether

Prescription 6:

Radix Astragali total saponins 11.5g (being equivalent to Radix Astragali 1kg)

Starch 60.0g

Microcrystalline Cellulose 20.0g

The 2%HPMC aqueous solution is an amount of

Magnesium stearate 1.0g

Prepare 1000 altogether

Prescription 7:

Astragalus polysaccharides 43.2g (being equivalent to Radix Astragali 4kg)

Starch 60.0g

Microcrystalline Cellulose 20.0g

The 2%HPMC aqueous solution is an amount of

Magnesium stearate 1.0g

Prepare 1000 altogether

Prescription 8:

Radix Astragali total saponins 46.0 (being equivalent to Radix Astragali 4kg)

Starch 60.0g

Microcrystalline Cellulose 20.0g

The 2%HPMC aqueous solution is an amount of

Magnesium stearate 1.0g

Prepare 1000 altogether

Preparation technology:

Raw material and starch, microcrystalline Cellulose add 2%HPMC aqueous solution system soft material, granulate then, drying, add the magnesium stearate granulate, the definite loading amount in abortion product check back, encapsulated, pack finished product.

The preparation of embodiment 7 medicament composition granule agent of the present invention

Prescription 1:

Astragalus polysaccharides 43.2g (being equivalent to Radix Astragali 4kg)

Icing Sugar 2000.0g

Correctives is an amount of

The 2%HPMC50% alcoholic solution is an amount of

Prepare 1000 bags altogether

Prescription 2:

Radix Astragali total saponins 46.0 (being equivalent to Radix Astragali 4kg)

Correctives is an amount of

Icing Sugar 2000.0g

The 2%HPMC50% alcoholic solution is an amount of

Prepare 1000 bags altogether

Prescription 3:

Herb Gynostemmae Pentaphylli extract 25.6g (being equivalent to Herb Gynostemmae Pentaphylli 1kg)

Astragalus polysaccharides 21.6g (being equivalent to Radix Astragali 2kg)

Icing Sugar 2000.0g

Correctives is an amount of

The 2%HPMC50% alcoholic solution is an amount of

Prepare 1000 bags altogether

Prescription 4:

Radix Astragali total saponins 23.0g (being equivalent to Radix Astragali 2kg)

Correctives is an amount of

Icing Sugar 2000.0g

The 2%HPMC50% alcoholic solution is an amount of

Prepare 1000 bags altogether

Preparation technology: raw material and Icing Sugar add 2%HPMC50% alcoholic solution system soft material, and granulation, drying are determined loading amount after the check of abortion product then, and packing gets finished product.

The preparation of embodiment 8 pharmaceutical composition aqueous injection of the present invention

Prescription 1:

Astragalus polysaccharides 43.2g (being equivalent to Radix Astragali 4kg)

Tween-80 100ml

Water for injection adds to 5000ml

Prepare 1000 altogether

Prescription 2:

Radix Astragali total saponins 46.0 (being equivalent to Radix Astragali 4kg)

Tween-80 100ml

Water for injection adds to 5000ml

Prepare 1000 altogether

Prescription 3:

Astragalus polysaccharides 270.0g (being equivalent to Radix Astragali 25kg)

Tween-80 100ml

Water for injection adds to 5000ml

Prepare 1000 altogether

Prescription 4:

Tween-80 100ml

Water for injection adds to 5000ml

Prepare 1000 altogether

Prescription 5:

Astragalus polysaccharides 21.6g (being equivalent to Radix Astragali 2kg)

Tween-80 100ml

Water for injection adds to 5000ml

Prepare 1000 altogether

Prescription 6:

Radix Astragali total saponins 23.0g (being equivalent to Radix Astragali 2kg)

Tween-80 100ml

Water for injection adds to 5000ml

Prepare 1000 altogether

Preparation technology:

Supplementary material dissolves dosing with water for injection, makes finished product through activated carbon adsorption processing after-filtration, standardize solution, smart worry, the inspection of semifinished product, embedding, sterilization, leak detection, lamp inspection, packing.

The preparation of embodiment 9 pharmaceutical composition injectable powder of the present invention

Prescription 1:

Astragalus polysaccharides 43.2g (being equivalent to Radix Astragali 4kg)

Tween-80 100ml

Mannitol 300g

Sterile water for injection adds to 5000ml

Prepare 1000 altogether

Prescription 2:

Radix Astragali total saponins 46.0 (being equivalent to Radix Astragali 4kg)

Tween-80 100ml

Mannitol 300g

Sterile water for injection adds to 5000ml

Prepare 1000 altogether

Preparation technology:

Supplementary material sterile water for injection dosing is handled after-filtration, standardize solution, smart worry, the inspection of semifinished product, fill, lyophilizing, tamponade, rolls lid, is packed and make finished product through activated carbon adsorption.

The preparation of embodiment 10 pharmaceutical composition glucose injections of the present invention

Prescription 1:

Astragalus polysaccharides 43.2g (being equivalent to Radix Astragali 4kg)

Tween-80 100ml

Glucose 5000g

Water for injection adds to 100000ml

Prepare 1000 bottles altogether

Prescription 2:

Radix Astragali total saponins 46.0 (being equivalent to Radix Astragali 4kg)

Tween-80 100ml

Glucose 5000g

Water for injection adds to 100000ml

Prepare 1000 bottles altogether

Preparation technology:

Supplementary material dissolves dosing with water for injection, through activated carbon adsorption handle after-filtration, standardize solution, smart worry, the inspection of semifinished product, fill, jump a queue, roll lid, sterilization, leak detection, lamp inspection, packing make finished product.

Claims

1, a kind of antitumor medicine composition is characterized in that, makes the consisting of of crude drug of the contained active ingredient of this pharmaceutical composition: 0.5～20 part of Herb Gynostemmae Pentaphylli, 1～30 part of Radix Panacis Quinquefolii, 1～100 part of the Radix Astragali.

2, pharmaceutical composition as claimed in claim 1 is characterized in that, makes the consisting of of crude drug of the contained active ingredient of this pharmaceutical composition: 1～10 part of Herb Gynostemmae Pentaphylli, 2～6 parts of Radix Panacis Quinquefoliis, 2～25 parts of the Radixs Astragali.

3, pharmaceutical composition as claimed in claim 2 is characterized in that, makes the consisting of of crude drug of the contained active ingredient of this pharmaceutical composition: 5 parts of Herb Gynostemmae Pentaphylli, 3 parts of Radix Panacis Quinquefoliis, 4 parts of the Radixs Astragali.

As the described arbitrary pharmaceutical composition of claim 1-3, it is characterized in that 4, crude drug wherein can singly be carried or mix to obtain through refining and obtain extract fully with The suitable solvent and method, total extract is made arbitrary preparation with mixing acceptable accessories again.

5, pharmaceutical composition as claimed in claim 4 is characterized in that, main effective ingredient contained in the total extract is: saponin and/or polysaccharide, the total content of main effective ingredient is not less than 50% in the total extract.

6, pharmaceutical composition as claimed in claim 1 is characterized in that, said composition can also be made by following bulk drugs, and its weight proportion is: 1～80 part of Herb Gynostemmae Pentaphylli total glycosides, 0.5～60 part of American ginseng total saponins, 0.5～200 part of astragalus polysaccharides; Perhaps be: 1～80 part of Herb Gynostemmae Pentaphylli total glycosides, 0.5～60 part of American ginseng total saponins, 0.5～200 part of Radix Astragali total saponins.

7, pharmaceutical composition as claimed in claim 6 is characterized in that, said composition can also be made by following bulk drugs, and its weight proportion is: 2～40 parts of Herb Gynostemmae Pentaphylli total glycosides, 1～12 part of American ginseng total saponins, 1～50 part of astragalus polysaccharides; Perhaps be: 2～40 parts of Herb Gynostemmae Pentaphylli total glycosides, 1～12 part of American ginseng total saponins, 1～50 part of Radix Astragali total saponins.

8, pharmaceutical composition as claimed in claim 7 is characterized in that, the content of total glycosides is not less than 30% in the Herb Gynostemmae Pentaphylli total glycosides; The content of total saponins is not less than 30% in the American ginseng total saponins, wherein ginsenoside R _G1, R _B1, R _eContent and be not less than 2%; The content of polysaccharide is not less than 35% in the astragalus polysaccharides; The content of total saponins is not less than 30% in the Radix Astragali total saponins, and wherein the content of astragaloside is not less than 1%.

9, as claim 1,2,3,6,7 described arbitrary pharmaceutical compositions, it is characterized in that this pharmaceutical composition can add acceptable accessories and make any preparation.

10, pharmaceutical composition as claimed in claim 9 is characterized in that, this pharmaceutical composition can be made injection or oral formulations.