CN1879687A

CN1879687A - An anti-tumor pharmaceutical composition and preparation method thereof

Info

Publication number: CN1879687A
Application number: CN 200610080536
Authority: CN
Inventors: 李世红
Original assignee: Individual
Current assignee: Li Dongxuan
Priority date: 2006-05-15
Filing date: 2006-05-15
Publication date: 2006-12-20
Anticipated expiration: 2026-05-15
Also published as: CN100548322C

Abstract

The invention relates to a medicinal composition and method for preparation, wherein the medicinal composition is prepared from astragalus root, gen-seng, flavescent sophora root through supersonic extracting, alcohol depositing, water depositing, formulating, loading and freeze-drying. The composition can be used for treating primary liver cancer, lung carcinoma, esophagus cancer, restocarcinoma, malignant lymphoma, gynaecologic carcinoma, leucopenia and chronic hepatitis B.

Description

A kind of antitumor medicine composition and preparation method thereof

Technical field

The present invention relates to a kind of pharmaceutical composition and preparation method thereof, particularly a kind of antitumor medicine composition and preparation method thereof.

Background technology

Motherland's medical science is thought, human body is an organic whole, under the influence of body at certain internal and external factor, caused the dysequilibrium of certain link, will cause whole body pathology, physiological variation, and the whole body pathological change can find expression in the part, and malignant tumor is exactly that systemic disease is in partial performance.It all is key factor that the positive deficiency of vital energy declines in tumorigenic endogenous cause of ill and exopathogenic factor.

Traditional treatment means to malignant tumor mainly is: 3 kinds of chemotherapy, radiotherapy, operation.These three kinds of treatment approach are effective to tumor treatment, but radiotherapy chemotherapy mainly is conceived to the lethal effect to tumor cell, also kill and wound simultaneously normal cell, particularly common to the histiocytic faster toxicity of propagation such as hemopoietic, have bigger toxic and side effects as: bone marrow depression, peripheral hemogram change, immunosuppressant, nausea and vomiting, weak, alopecia etc.

Pass through vast Chinese medicine worker's continuous exploration and effort in recent years, the treatment for cancer means also are greatly improved, particularly to the Study on Modernization of Chinese medicine, the present invention has adopted circulated in countercurrent ultrasound assisted extraction technique, deep layer composite membrane ultrafiltration system and macroporous adsorptive resins.The circulated in countercurrent ultrasound assisted extraction technique is the strong extensional vibration that utilizes ultrasound wave special, high speed impact fragmentation, cavitation effect, physical properties such as stirring and heating are destroyed the extract cellularity, make solvent can infiltrate cell interior, thereby quicken the dissolving of effective ingredient, improve the extraction rate of effective ingredient.It is easy to operate that experimentation proof uses the Reversible Cycle ultrasound assisted extraction technique to have, and extraction time is short, and the extraction ratio height is energy-conservation, need not heating, and effective ingredient is not destroyed, isolating more single, the advantage that purity is high of extracts active ingredients.Medicinal liquid promptly removes thermal source by ultrafiltration system twice and controls particulate matter in the medicinal liquid again, more can guarantee the safety and the quality of stability of medicine.Make effective ingredient purity higher by macroporous adsorbent resin, drug effect is more remarkable.Adopt freeze-dried formulation in transportation, storage, to bring convenience for medicine.

Summary of the invention

The object of the invention is to provide a kind of pharmaceutical composition and preparation method thereof; Another purpose of the present invention is to provide a kind of antitumor medicine composition and preparation method thereof.

The present invention seeks to be achieved through the following technical solutions:

Pharmaceutical composition of the present invention is made by the following method:

Crude drug: Radix Ginseng 50-150 weight portion, Radix Astragali 200-400 weight portion, kurarinone 5-15 weight portion

Processing step: crude drug Radix Ginseng 50-150 weight portion is dropped in the circulated in countercurrent supersound extraction jar, add 4-12 times of weight portion 65-85% ethanol, elder generation's warm macerating is after 6-18 hour, at normal temperatures, mixing speed 100-300r/min, circulated in countercurrent supersound extraction 0.5-105 hour, extracting liquid filtering reclaims the Radix Ginseng clear paste that is evaporated to 60 ℃ of relative density 1.10-1.15 with ethanol;

Crude drug Radix Astragali 200-400 weight portion is dropped in the circulated in countercurrent supersound extraction jar, add for the first time 3-9 and doubly measure purified water elder generation warm macerating after 1-3 hour, at normal temperatures, mixing speed 100-300r/min, circulated in countercurrent supersound extraction 0.5-1.5 hour, extracting solution concentrates with the triple effect concentrator, 70-80 ℃ of concentrator temperature, vacuum 0.03Mpa are imitated in control one, two imitate 60-70 ℃ of concentrator temperature, vacuum 0.06Mpa, 50-60 ℃ of triple effect concentrator temperature, vacuum 0.08Mpa are concentrated into the Radix Astragali clear paste of 60 ℃ of relative density 1.10-1.15;

Above-mentioned Radix Ginseng clear paste and Radix Astragali clear paste are squeezed in the Alcohol-settling tank, added 75-95% ethanol and be stirred to fast and contain the alcohol amount and reach 60-80%, and static after fully stirring, cold preservation 12-36 hour, filter, regulate pH value to 8-9, stir evenly with 10%NaOH solution, more than cold preservation 12-36 hour, filter, filtrate recycling ethanol, controlled pressure is at 0.06-0.1Mpa, temperature 45-55 ℃, vacuum degree control 0.06-0.085Mpa; Medicinal liquid concentrates, and is concentrated into the clear paste 1 of 60 ℃ of relative density 1.10-1.15;

Clear paste 1 is squeezed into Alcohol-settling tank, adding 75-95% ethanol is stirred to the alcohol amount of containing fast and reaches 70-90%, static, cold preservation 12-36 hour, filter, regulate pH value to 8-9 with 10%NaOH solution, stir evenly, more than cold preservation 12-36 hour, filter, filtrate recycling ethanol, concentrate, be concentrated into the clear paste 2 of 60 ℃ of relative density 1.10-1.20;

Clear paste 2 is squeezed into Alcohol-settling tank, adds 95% ethanol and be stirred to fast and contain alcohol amount and reach 75-95%, static, cold preservation 12-36 hour, filter, regulate pH value to 8-9 with 10%NaOH solution, stir evenly, cold preservation filters, filtrate recycling ethanol, be concentrated into and do not have the alcohol flavor, concentrated solution;

With adding the injection water in the concentrated solution to the 5000-15000 parts by volume, regulate pH value to 6.0-7.0 with dilute hydrochloric acid solution, boil, add active carbon 5-15 weight portion, boil after stirring, cooling back filter paper filtering, filtering with microporous membrane is used in cold preservation, hot pressing for the first time 0.1-1.5 hour, filtering with microporous membrane is used in cold preservation, adds the injection water, hot pressing for the second time 0.5 hour, cold preservation was with behind the filtering with microporous membrane hot pressing 0.1-1.5 hour for the third time, cold preservation is filtered, and gets filtered liquid medicine; Get filtered liquid medicine, last macroporous adsorptive resins, the control flow velocity is 0.4-1.2ml/min/cm ²Absorption finishes, and is extremely colourless with the purified water flushing; Resolve with the 65-85% ethanol for preparing, to colourless no flavour of a drug, towards colourless to there not being the alcohol flavor, the control flow velocity is 0.4-1.2ml/min/cm with purified water ², must resolve medicinal liquid; Reclaim under reduced pressure is resolved medicinal liquid, and the alcohol in the medicinal liquid is reclaimed fully, and with the concentrated solution drying, it is standby to get dry powder;

Get crude drug kurarinone 5-15 weight portion, get quantitative powder 1-3 weight portion, add conventional adjuvant, prepared becomes water for injection injection, lyophilized injectable powder or oral solid formulation routinely.

Preferably composition and proportioning are as follows by weight for the above-mentioned raw materials medicine:

Radix Ginseng 100 weight portions, the Radix Astragali 300 weight portions, kurarinone 10 weight portions.

Radix Ginseng 60 weight portions, the Radix Astragali 360 weight portions, kurarinone 5 weight portions.

Radix Ginseng 140 weight portions, the Radix Astragali 220 weight portions, kurarinone 15 weight portions.

Above-mentioned processing step is preferably as follows a kind of:

The crude drug Radix Ginseng is dropped in the circulated in countercurrent supersound extraction jar, add 8 times of weight portion 75% ethanol elder generation warm macerating after 12 hours, at normal temperatures, mixing speed 200r/min, circulated in countercurrent supersound extraction 1 hour, extracting liquid filtering reclaims the Radix Ginseng clear paste that is evaporated to 60 ℃ of relative density 1.10-1.15 with ethanol;

The crude drug Radix Astragali is dropped in the circulated in countercurrent supersound extraction jar, add 6 times of amount purified water elder generation warm macerating after 2 hours, at normal temperatures, mixing speed 200r/min, circulated in countercurrent supersound extraction 1 hour, extracting solution concentrates with the triple effect concentrator, 70-80 ℃ of concentrator temperature, vacuum 0.03Mpa are imitated in control one, two imitate 60-70 ℃ of concentrator temperature, vacuum 0.06Mpa, and 50-60 ℃ of triple effect concentrator temperature, vacuum 0.08Mpa are concentrated into the Radix Astragali clear paste of 60 ℃ of relative density 1.10-1.15;

Above-mentioned Radix Ginseng clear paste and Radix Astragali clear paste are squeezed in the Alcohol-settling tank, added 95% ethanol and be stirred to fast and contain alcohol amount and reach 80%, and static after fully stirring, cold preservation 12 hours, filter, regulate pH value to 8-9, stir evenly with 10%NaOH solution, cold preservation is more than 36 hours, filter, filtrate recycling ethanol, controlled pressure is at 0.06-0.1Mpa, temperature 45-55 ℃, vacuum degree control 0.06-0.085Mpa; Medicinal liquid concentrates, and is concentrated into the clear paste 1 of 60 ℃ of following relative density 1.10-1.15;

Clear paste 1 is squeezed into Alcohol-settling tank, adding 95% ethanol is stirred to fast and contains alcohol amount and reach 70%, static, cold preservation 36 hours is filtered, regulate pH value to 8-9 with 10%NaOH solution, stir evenly, cold preservation filtered more than 12 hours, filtrate recycling ethanol, concentrate, be concentrated into the clear paste 2 of 60 ℃ of relative density 1.10-1.20;

Clear paste 2 is squeezed into Alcohol-settling tank, add 95% ethanol and be stirred to fast and contain alcohol amount and reach 95%, static, cold preservation 12 hours is filtered, and regulates pH value to 8-9 with 10%NaOH solution, stirs evenly, and cold preservation filters, filtrate recycling ethanol, be concentrated into and do not have the alcohol flavor, concentrated solution;

With adding injection water to 10000 parts by volume in the concentrated solution, regulate pH value to 6.0-7.0 with dilute hydrochloric acid solution, boil, add active carbon 10 weight portions, boil cooling back filter paper filtering, cold preservation after stirring, use filtering with microporous membrane, hot pressing for the first time 1.2 hours, cold preservation, use filtering with microporous membrane, add the injection water, hot pressing for the second time 0.5 hour, cold preservation, behind filtering with microporous membrane, hot pressing for the third time 0.3 hour, cold preservation is filtered, and gets filtered liquid medicine; Get filtered liquid medicine, last macroporous adsorptive resins, the control flow velocity is 0.8ml/min/cm ²Absorption finishes, and is extremely colourless with the purified water flushing; Resolve with 75% ethanol for preparing, to colourless no flavour of a drug, towards colourless to there not being the alcohol flavor, the control flow velocity is 0.8ml/min/cm with purified water ², must resolve medicinal liquid; Reclaim under reduced pressure is resolved medicinal liquid, and the alcohol in the medicinal liquid is reclaimed fully, and with the concentrated solution drying, it is standby to get dry powder;

Get the crude drug kurarinone, add dry powder 1 weight portion, add appropriate amount of auxiliary materials, prepared becomes water for injection injection, lyophilized injectable powder or oral solid formulation routinely.

The processing step of above-mentioned ejection preparation also can be preferred:

The crude drug Radix Ginseng is dropped in the circulated in countercurrent supersound extraction jar, add for the first time 10 times of weight portion 85% ethanol elder generation warm macerating after 18 hours, at normal temperatures, mixing speed 280r/min, circulated in countercurrent supersound extraction 1.5 hours, extracting liquid filtering reclaims the Radix Ginseng clear paste that is evaporated to 60 ℃ of relative density 1.10-1.15 with ethanol;

The crude drug Radix Astragali is dropped in the circulated in countercurrent supersound extraction jar, add 8 times of amount purified water elder generation warm macerating after 2.5 hours, at normal temperatures, mixing speed 280r/min, circulated in countercurrent supersound extraction 1.5 hours, extracting solution concentrates with the triple effect concentrator, 70-80 ℃ of concentrator temperature, vacuum 0.03Mpa are imitated in control one, two imitate 60-70 ℃ of concentrator temperature, vacuum 0.06Mpa, and 50-60 ℃ of triple effect concentrator temperature, vacuum 0.08Mpa are concentrated into the Radix Astragali clear paste of 60 ℃ of relative density 1.10-1.15;

Above-mentioned Radix Ginseng clear paste and Radix Astragali clear paste are squeezed in the Alcohol-settling tank, added 95% ethanol and be stirred to fast and contain alcohol amount and reach 70%, and static after fully stirring, cold preservation 24 hours, filter, regulate pH value to 8-9, stir evenly with 10%NaOH solution, cold preservation is more than 24 hours, filter, filtrate recycling ethanol, controlled pressure is at 0.06-0.1Mpa, temperature 45-55 ℃, vacuum degree control 0.06-0.085Mpa; Medicinal liquid concentrates, and is concentrated into the clear paste 1 of 60 ℃ of relative density 1.10-1.15;

Clear paste 1 is squeezed into Alcohol-settling tank, adding 95% ethanol is stirred to fast and contains alcohol amount and reach 80%, static, cold preservation 24 hours is filtered, regulate pH value to 8-9 with 10%NaOH solution, stir evenly, cold preservation filtered more than 24 hours, filtrate recycling ethanol, concentrate, be concentrated into the clear paste 2 of 60 ℃ of relative density 1.10-1.20:

Clear paste 2 is squeezed into Alcohol-settling tank, add 95% ethanol and be stirred to fast and contain alcohol amount and reach 85%, static, cold preservation 24 hours is filtered, and regulates pH value to 8-9 with 10%NaOH solution, stirs evenly, and cold preservation filters, filtrate recycling ethanol, be concentrated into and do not have the alcohol flavor, concentrated solution;

With adding injection water to 14000 parts by volume in the concentrated solution, regulate pH value to 6.0-7.0 with dilute hydrochloric acid solution, boil, add active carbon 14 weight portions, boil cooling back filter paper filtering, cold preservation after stirring, use filtering with microporous membrane, hot pressing for the first time 0.5 hour, cold preservation, use filtering with microporous membrane, add the injection water, hot pressing for the second time 0.5 hour, cold preservation, behind filtering with microporous membrane, hot pressing for the third time 0.5 hour, cold preservation is filtered, and gets filtered liquid medicine; Get filtered liquid medicine, last macroporous adsorptive resins, the control flow velocity is 1ml/min/cm ²Absorption finishes, and is extremely colourless with the purified water flushing; Resolve with 75% ethanol for preparing, to colourless no flavour of a drug, towards colourless to there not being the alcohol flavor, the control flow velocity is 1ml/min/cm with purified water ², must resolve medicinal liquid; Reclaim under reduced pressure is resolved medicinal liquid, and the alcohol in the medicinal liquid is reclaimed fully, and with the concentrated solution drying, it is standby to get dry powder;

Get the crude drug kurarinone, add 5 times of parts by volume dissolvings of water for injection, regulate pH value to 6-7 with dilute hydrochloric acid, 100 ℃ of sterilizations of flowing steam 15 minutes, cold preservation gets the kurarinone solution for standby.

Get dry powder 2 weight portions, be dissolved in the water for injection, add above-mentioned kurarinone solution, abundant mixing,, use the microporous filter membrane coarse filtration, again ultrafiltration to particulate matter meet 〉=microgranule of 10 μ m is less than 300, the microgranule of 〉=25 μ m is less than 30 regulation, the ultrafiltration medicinal liquid; The ultrafiltration medicinal liquid is dropped in the Agitation Tank, add water for injection to 1000 parts by volume, regulate pH value and stir evenly to 6.0-7.0, ultrafiltration, prepared becomes lyophilized injectable powder routinely.

The crude drug Radix Ginseng is dropped in the circulated in countercurrent supersound extraction jar, add 6 times of weight portion 65% ethanol elder generation warm macerating after 8 hours, at normal temperatures, mixing speed 150r/min, circulated in countercurrent supersound extraction 0.5 hour, extracting liquid filtering reclaims the Radix Ginseng clear paste that is evaporated to 60 ℃ of relative density 1.10-1.15 with ethanol;

The crude drug Radix Astragali is dropped in the circulated in countercurrent supersound extraction jar, add for the first time 4 times of amount purified water elder generation warm macerating after 1.5 hours, at normal temperatures, mixing speed 150r/min, circulated in countercurrent supersound extraction 0.5 hour, extracting solution concentrates with the triple effect concentrator, 70-80 ℃ of concentrator temperature, vacuum 0.03Mpa are imitated in control one, two imitate 60-70 ℃ of concentrator temperature, vacuum 0.06Mpa, 50-60 ℃ of triple effect concentrator temperature, vacuum 0.08Mpa are concentrated into the Radix Astragali clear paste of 60 ℃ of relative density 1.10-1.15;

Above-mentioned Radix Ginseng clear paste and Radix Astragali clear paste are squeezed in the Alcohol-settling tank, added 95% ethanol and be stirred to fast and contain alcohol amount and reach 60%, and static after fully stirring, cold preservation 36 hours, filter, regulate pH value to 8-9, stir evenly with 10%NaOH solution, cold preservation is more than 12 hours, filter, filtrate recycling ethanol, controlled pressure is at 0.06-0.1Mpa, temperature 45-55 ℃, vacuum degree control 0.06-0.085Mpa; Medicinal liquid concentrates, and is concentrated into the clear paste 1 of (60 ℃) relative density 1.10-1.15;

Clear paste 1 is squeezed into Alcohol-settling tank, adding 95% ethanol is stirred to fast and contains alcohol amount and reach 90%, static, cold preservation 12 hours is filtered, regulate pH value to 8-9 with 10%NaOH solution, stir evenly, cold preservation filtered more than 36 hours, filtrate recycling ethanol, concentrate, be concentrated into the clear paste 2 of 60 ℃ of relative density 1.10-1.20;

Clear paste 2 is squeezed into Alcohol-settling tank, add 95% ethanol and be stirred to fast and contain alcohol amount and reach 75%, static, cold preservation 36 hours is filtered, and regulates pH value to 8-9 with 10%NaOH solution, stirs evenly, and cold preservation filters, filtrate recycling ethanol, be concentrated into and do not have the alcohol flavor, concentrated solution;

With adding injection water to 8000 parts by volume in the concentrated solution, regulate pH value to 6.0-7.0 with dilute hydrochloric acid solution, boil, add active carbon 8 weight portions, boil cooling back filter paper filtering, cold preservation after stirring, use filtering with microporous membrane, hot pressing for the first time 0.3 hour, cold preservation, use filtering with microporous membrane, add the injection water, hot pressing for the second time 0.5 hour, cold preservation, behind filtering with microporous membrane, hot pressing for the third time 1.2 hours, cold preservation is filtered, and gets filtered liquid medicine; Get filtered liquid medicine, last macroporous adsorptive resins, the control flow velocity is 0.6ml/min/cm ²Absorption finishes, and is extremely colourless with the purified water flushing; Resolve with 75% ethanol for preparing, to colourless no flavour of a drug, towards colourless to there not being the alcohol flavor, the control flow velocity is 0.6ml/min/cm with purified water ², must resolve medicinal liquid; Reclaim under reduced pressure is resolved medicinal liquid, and the alcohol in the medicinal liquid is reclaimed fully, and with the concentrated solution drying, it is standby to get dry powder;

Get the crude drug kurarinone and add 4 times of parts by volume dissolvings of water for injection, regulate pH value to 6-7 with dilute hydrochloric acid, 100 ℃ of sterilizations of flowing steam 5 minutes, cold preservation gets the kurarinone solution for standby.

Get dry powder 1 weight portion, be dissolved in the water for injection, add above-mentioned kurarinone solution, fully mixing adds water for injection, uses the microporous filter membrane coarse filtration, again ultrafiltration to particulate matter meet 〉=microgranule of 10 μ m is less than 300, the microgranule of 〉=25 μ m is less than 30 regulation, the ultrafiltration medicinal liquid; The ultrafiltration medicinal liquid is dropped in the Agitation Tank, add water for injection to 1200 parts by volume, regulate pH value and stir evenly to 6.0-7.0, ultrafiltration, prepared becomes the water for injection injection routinely.

Pharmaceutical composition used in the present invention when guaranteeing curative effect of medication, also possesses the purity advantage of higher.The present invention adopts this preparation technology, has saved the energy, and extraction time shortens, the extraction ratio height, and extracts active ingredients more thorough, drug effect is more remarkable, and quality is more stable.Be more suitable for the needs of industrialized great production.

Following experimental example and embodiment are used to further specify but are not limited to the present invention.

Experimental example 1 test experience

1, the check and analysis of Radix Ginseng total saponins

Radix Ginseng total saponins content is in Radix Ginseng Re and Radix Ginseng Rg1, result such as table 1.

2, the check and analysis of Radix Astragali total saponins

Radix Astragali total saponins content is in astragaloside, result such as table 1:

Table 1

Group		Radix Ginseng total saponins is (with Radix Ginseng Re and Radix Ginseng Rg ₁Meter) (mg/ml)	Radix Astragali total saponins (in astragaloside %)
Group			Radix Astragali total saponins (in astragaloside %)	The injection of commercially available Conair injection preparation of pharmaceutical compositions of the present invention	No. 1 No. 2 No. 3 No. 1 No. 2 No. 3	0.08 0.08 0.07 0.12 0.14 0.13	0.033 0.034 0.035 0.051 0.052 0.05

Above experimental data shows drug combination injection of the present invention, through circulated in countercurrent supersound extraction, purification, refining after, can obtain higher ginsenoside of purity and Radix Astragali saponin, composition is simple, has avoided the interference effect between the multicomponent.Guaranteed that clinical drug safety is effective, also can guarantee the stability of the quality of the pharmaceutical preparations simultaneously.

Following embodiment all can realize the described effect of above-mentioned experimental example

The specific embodiment

Embodiment 1: the preparation of lyophilized injectable powder

Radix Ginseng 100kg, Radix Astragali 300kg, kurarinone 10kg

Crude drug Radix Ginseng 100kg is dropped in the circulated in countercurrent supersound extraction jar, add 8 times of weight portion 75% ethanol elder generation warm macerating after 12 hours, at normal temperatures, mixing speed 200r/min, circulated in countercurrent supersound extraction 1 hour, extracting liquid filtering reclaims the Radix Ginseng clear paste that is evaporated to 60 ℃ of relative density 1.10-1.15 with ethanol;

Crude drug Radix Astragali 300kg is dropped in the circulated in countercurrent supersound extraction jar, add 6 times of amount purified water elder generation warm macerating after 2 hours, at normal temperatures, mixing speed 200r/min, circulated in countercurrent supersound extraction 1 hour, extracting solution concentrates with the triple effect concentrator, 70-80 ℃ of concentrator temperature, vacuum 0.03Mpa are imitated in control one, two imitate 60-70 ℃ of concentrator temperature, vacuum 0.06Mpa, and 50-60 ℃ of triple effect concentrator temperature, vacuum 0.08Mpa are concentrated into the Radix Astragali clear paste of 60 ℃ of relative density 1.10-1.15;

Above-mentioned Radix Ginseng clear paste and Radix Astragali clear paste are squeezed in the Alcohol-settling tank, added 95% ethanol and be stirred to fast and contain alcohol amount and reach 70%, and static after fully stirring, cold preservation 24 hours, filter, regulate pH value to 8-9, stir evenly with 10%NaOH solution, cold preservation is more than 24 hours, filter, filtrate recycling ethanol, controlled pressure is at 0.06-0.1Mpa, temperature 45-55 ℃, vacuum degree control 0.06-0.085Mpa; Medicinal liquid concentrates, and is concentrated into the clear paste 1 of 60 ℃ of following relative density 1.10-1.15;

With adding the injection water in the concentrated solution to 10000L, regulate pH value to 6.0-7.0 with dilute hydrochloric acid solution, boil, add active carbon 10kg, boil cooling back filter paper filtering, cold preservation after stirring, use filtering with microporous membrane, hot pressing for the first time 0.5 hour, cold preservation, use filtering with microporous membrane, add the injection water, hot pressing for the second time 0.5 hour, cold preservation, behind filtering with microporous membrane, hot pressing for the third time 0.5 hour, cold preservation is filtered, and gets filtered liquid medicine; Get filtered liquid medicine, last macroporous adsorptive resins, the control flow velocity is 0.8ml/min/cm ²Absorption finishes, and is extremely colourless with the purified water flushing; Resolve with 75% ethanol for preparing, to colourless no flavour of a drug, towards colourless to there not being the alcohol flavor, the control flow velocity is 0.8ml/min/cm with purified water ², must resolve medicinal liquid; Reclaim under reduced pressure is resolved medicinal liquid, and the alcohol in the medicinal liquid is reclaimed fully, and with the concentrated solution drying, it is standby to get dry powder;

Get crude drug kurarinone 10kg and add 4 times of parts by volume dissolvings of water for injection, regulate pH value to 6-7 with dilute hydrochloric acid, 100 ℃ of sterilizations of flowing steam 15 minutes, cold preservation gets the kurarinone solution for standby.

Get dry powder 2kg, be dissolved in the water for injection, add above-mentioned kurarinone solution, fully mixing use the microporous filter membrane coarse filtration, again ultrafiltration to particulate matter meet 〉=microgranule of 10 μ m is less than 300, the microgranule of 〉=25 μ m is less than 30 regulation, must the ultrafiltration medicinal liquid; The ultrafiltration medicinal liquid is dropped in the Agitation Tank, add water for injection, regulate pH value and stir evenly to 6.0-7.0 to 1000L, ultrafiltration, prepared becomes lyophilized injectable powder routinely.

Embodiment 2: the preparation of water for injection injection

Radix Ginseng 100kg, Radix Astragali 300kg, kurarinone 10kg

Crude drug Radix Ginseng 100kg is dropped in the circulated in countercurrent supersound extraction jar, add 10 times of weight portion 85% ethanol elder generation warm macerating 18 hours, at normal temperatures, mixing speed 280r/min, circulated in countercurrent supersound extraction 1.5 hours, back reflux, extract, 3 hours, add for the second time 6 times of weight portions, 75% alcohol reflux 2 hours, add 6 times of weight portions, 75% alcohol reflux 2 hours for the third time, merge extractive liquid, filters, and reclaims the Radix Ginseng clear paste that is evaporated to 60 ℃ of relative density 1.10-1.15 with ethanol;

Crude drug Radix Astragali 300kg is dropped in the circulated in countercurrent supersound extraction jar, add 8 times of amount purified water elder generation warm macerating after 2.5 hours, at normal temperatures, mixing speed 280r/min, circulated in countercurrent supersound extraction 1.5 hours, extracting solution concentrates with the triple effect concentrator, 70-80 ℃ of concentrator temperature, vacuum 0.03Mpa are imitated in control one, two imitate 60-70 ℃ of concentrator temperature, vacuum 0.06Mpa, 50-60 ℃ of triple effect concentrator temperature, vacuum 0.08Mpa are concentrated into the Radix Astragali clear paste of 60 ℃ of relative density 1.10-1.15;

Clear paste 1 is squeezed into Alcohol-settling tank, adding 95% ethanol is stirred to fast and contains alcohol amount and reach 80%, static, cold preservation 24 hours is filtered, regulate pH value to 8-9 with 10%NaOH solution, stir evenly, cold preservation filtered more than 24 hours, filtrate recycling ethanol, concentrate, be concentrated into the clear paste 2 of 60 ℃ of relative density 1.10-1.20;

With adding injection water 14000L in the concentrated solution, regulate pH value to 6.0-7.0 with dilute hydrochloric acid solution, boil, add active carbon 14kg, boil cooling back filter paper filtering, cold preservation after stirring, use filtering with microporous membrane, hot pressing for the first time 0.5 hour, cold preservation, use filtering with microporous membrane, add the injection water, hot pressing for the second time 0.5 hour, cold preservation, behind filtering with microporous membrane, hot pressing for the third time 0.5 hour, cold preservation is filtered, and gets filtered liquid medicine; Get filtered liquid medicine, last macroporous adsorptive resins, the control flow velocity is 1ml/min/cm ²Absorption finishes, and is extremely colourless with the purified water flushing; Resolve with 75% ethanol for preparing, to colourless no flavour of a drug, towards colourless to there not being the alcohol flavor, the control flow velocity is 1ml/min/cm with purified water ², must resolve medicinal liquid; Reclaim under reduced pressure is resolved medicinal liquid, and the alcohol in the medicinal liquid is reclaimed fully, and with the concentrated solution drying, it is standby to get dry powder;

Get crude drug kurarinone 10kg and add 5 times of parts by volume dissolvings of water for injection, regulate pH value to 6-7 with dilute hydrochloric acid, 100 ℃ of sterilizations of flowing steam 15 minutes, cold preservation gets the kurarinone solution for standby.

Get dry powder 2kg, be dissolved in the water for injection, add above-mentioned kurarinone solution, fully mixing use the microporous filter membrane coarse filtration, again ultrafiltration to particulate matter meet 〉=microgranule of 10 μ m is less than 300, the microgranule of 〉=25 μ m is less than 30 regulation, must the ultrafiltration medicinal liquid; The ultrafiltration medicinal liquid is dropped in the Agitation Tank, add water for injection, regulate pH value and stir evenly to 6.0-7.0 to 1000L, ultrafiltration, prepared becomes the water for injection injection routinely.

Embodiment 3: the preparation of capsule

Radix Ginseng 100kg, Radix Astragali 300kg, kurarinone 10kg

Crude drug Radix Ginseng 100kg is dropped in the circulated in countercurrent supersound extraction jar, add 6 times of weight portion 65% ethanol elder generation warm macerating after 8 hours, at normal temperatures, mixing speed 150r/min, circulated in countercurrent supersound extraction 0.5 hour, extracting liquid filtering reclaims the Radix Ginseng clear paste that is evaporated to 60 ℃ of relative density 1.10-1.15 with ethanol;

Crude drug Radix Astragali 300kg is dropped in the circulated in countercurrent supersound extraction jar, add for the first time 4 times of amount purified water elder generation warm macerating after 1.5 hours, at normal temperatures, mixing speed 150r/min, circulated in countercurrent supersound extraction 0.5 hour, extracting solution concentrates with the triple effect concentrator, 70-80 ℃ of concentrator temperature, vacuum 0.03Mpa are imitated in control one, two imitate 60-70 ℃ of concentrator temperature, vacuum 0.06Mpa, 50-60 ℃ of triple effect concentrator temperature, vacuum 0.08Mpa are concentrated into the Radix Astragali clear paste of 60 ℃ of relative density 1.10-1.15;

With adding the injection water in the concentrated solution to 8000L, regulate pH value to 6.0-7.0 with dilute hydrochloric acid solution, boil, add active carbon 8kg, boil cooling back filter paper filtering, cold preservation after stirring, use filtering with microporous membrane, hot pressing for the first time 0.5 hour, cold preservation, use filtering with microporous membrane, add the injection water, hot pressing for the second time 0.5 hour, cold preservation, behind filtering with microporous membrane, hot pressing for the third time 0.5 hour, cold preservation is filtered, and gets filtered liquid medicine; Get filtered liquid medicine, last macroporous adsorptive resins, the control flow velocity is 0.6ml/min/cm ²Absorption finishes, and is extremely colourless with the purified water flushing; Resolve with 75% ethanol for preparing, to colourless no flavour of a drug, towards colourless to there not being the alcohol flavor, the control flow velocity is 0.6ml/min/cm with purified water ², must resolve medicinal liquid; Reclaim under reduced pressure is resolved medicinal liquid, and the alcohol in the medicinal liquid is reclaimed fully, and with the concentrated solution drying, it is standby to get dry powder;

Get dry powder 2kg, kurarinone 10kg adds appropriate amount of auxiliary materials, and technology is made capsule routinely.

Embodiment 4: the preparation of lyophilized injectable powder

Radix Ginseng 60kg, Radix Astragali 360kg, kurarinone 5kg

Crude drug Radix Ginseng 60kg is dropped in the circulated in countercurrent supersound extraction jar, add 8 times of weight portion 75% ethanol elder generation warm macerating after 12 hours, at normal temperatures, mixing speed 200r/min, circulated in countercurrent supersound extraction 1 hour, extracting liquid filtering reclaims the Radix Ginseng clear paste that is evaporated to 60 ℃ of relative density 1.10-1.15 with ethanol;

Crude drug Radix Astragali 360kg is dropped in the circulated in countercurrent supersound extraction jar, add 6 times of amount purified water elder generation warm macerating after 2 hours, at normal temperatures, mixing speed 200r/min, circulated in countercurrent supersound extraction 1 hour, extracting solution concentrates with the triple effect concentrator, 70-80 ℃ of concentrator temperature, vacuum 0.03Mpa are imitated in control one, two imitate 60-70 ℃ of concentrator temperature, vacuum 0.06Mpa, and 50-60 ℃ of triple effect concentrator temperature, vacuum 0.08Mpa are concentrated into the Radix Astragali clear paste of 60 ℃ of relative density 1.10-1.15;

Above-mentioned Radix Ginseng clear paste and Radix Astragali clear paste are squeezed in the Alcohol-settling tank, added 95% ethanol and be stirred to fast and contain alcohol amount and reach 60%, and static after fully stirring, cold preservation 36 hours, filter, regulate pH value to 8-9, stir evenly with 10%NaOH solution, cold preservation is more than 12 hours, filter, filtrate recycling ethanol, controlled pressure is at 0.06-0.1Mpa, temperature 45-55 ℃, vacuum degree control 0.06-0.085Mpa; Medicinal liquid concentrates, and is concentrated into the clear paste 1 of 60 ℃ of relative density 1.10-1.15;

With adding the injection water in the concentrated solution to 10000L, regulate pH value to 6.0-7.0 with dilute hydrochloric acid solution, boil, add active carbon 10kg, boil cooling back filter paper filtering, cold preservation after stirring, use filtering with microporous membrane, hot pressing for the first time 0.3 hour, cold preservation, use filtering with microporous membrane, add the injection water, hot pressing for the second time 0.5 hour, cold preservation, behind filtering with microporous membrane, hot pressing for the third time 1.2 hours, cold preservation is filtered, and gets filtered liquid medicine; Get filtered liquid medicine, last macroporous adsorptive resins, the control flow velocity is 0.8ml/min/cm ²Absorption finishes, and is extremely colourless with the purified water flushing; Resolve with 75% ethanol for preparing, to colourless no flavour of a drug, towards colourless to there not being the alcohol flavor, the control flow velocity is 0.8ml/min/cm with purified water ², must resolve medicinal liquid; Reclaim under reduced pressure is resolved medicinal liquid, and the alcohol in the medicinal liquid is reclaimed fully, and with the concentrated solution drying, it is standby to get dry powder;

Get crude drug kurarinone 5kg and add 4-5 times of parts by volume dissolving of water for injection, regulate pH value to 6-7 with dilute hydrochloric acid, 100 ℃ of sterilizations of flowing steam 5 minutes, cold preservation gets the kurarinone solution for standby.

Get dry powder 3kg, be dissolved in the water for injection, add above-mentioned kurarinone solution, fully mixing adds water for injection, uses the microporous filter membrane coarse filtration, again ultrafiltration to particulate matter meet 〉=microgranule of 10 μ m is less than 300, the microgranule of 〉=25 μ m is less than 30 regulation, the ultrafiltration medicinal liquid; The ultrafiltration medicinal liquid is dropped in the Agitation Tank, add water for injection, regulate pH value and stir evenly to 6.0-7.0 to 800L, ultrafiltration, prepared becomes lyophilized injectable powder routinely.

Embodiment 5: the preparation of water for injection injection

Radix Ginseng 140kg, Radix Astragali 220kg, kurarinone 15kg

Crude drug Radix Ginseng 140kg is dropped in the circulated in countercurrent supersound extraction jar, add 10 times of weight portion 85% ethanol elder generation warm macerating 18 hours, at normal temperatures, mixing speed 280r/min, circulated in countercurrent supersound extraction 1.5 hours, back reflux, extract, 3 hours, add for the second time 6 times of weight portions, 75% alcohol reflux 2 hours, add 6 times of weight portions, 75% alcohol reflux 2 hours for the third time, merge extractive liquid, filters, and reclaims the Radix Ginseng clear paste that is evaporated to 60 ℃ of relative density 1.10-1.15 with ethanol;

Crude drug Radix Astragali 220kg is dropped in the circulated in countercurrent supersound extraction jar, add 8 times of amount purified water elder generation warm macerating after 2.5 hours, at normal temperatures, mixing speed 280r/min, circulated in countercurrent supersound extraction 1.5 hours, extracting solution concentrates with the triple effect concentrator, 70-80 ℃ of concentrator temperature, vacuum 0.03Mpa are imitated in control one, two imitate 60-70 ℃ of concentrator temperature, vacuum 0.06Mpa, 50-60 ℃ of triple effect concentrator temperature, vacuum 0.08Mpa are concentrated into the Radix Astragali clear paste of 60 ℃ of relative density 1.10-1.15;

With adding the injection water in the concentrated solution to 14000L, regulate pH value to 6.0-7.0 with dilute hydrochloric acid solution, boil, add active carbon 14kg, boil cooling back filter paper filtering, cold preservation after stirring, use filtering with microporous membrane, hot pressing for the first time 0.3 hour, cold preservation, use filtering with microporous membrane, add the injection water, hot pressing for the second time 0.5 hour, cold preservation, behind filtering with microporous membrane, hot pressing for the third time 1.2 hours, cold preservation is filtered, and gets filtered liquid medicine; Get filtered liquid medicine, last macroporous adsorptive resins, the control flow velocity is 1ml/min/cm ²Absorption finishes, and is extremely colourless with the purified water flushing; Resolve with 75% ethanol for preparing, to colourless no flavour of a drug, towards colourless to there not being the alcohol flavor, the control flow velocity is 1ml/min/cm with purified water ², must resolve medicinal liquid; Reclaim under reduced pressure is resolved medicinal liquid, and the alcohol in the medicinal liquid is reclaimed fully, and with the concentrated solution drying, it is standby to get dry powder;

Get crude drug kurarinone 15kg and add 4 times of parts by volume dissolvings of water for injection, regulate pH value to 6-7 with dilute hydrochloric acid, 100 ℃ of sterilizations of flowing steam 5 minutes, cold preservation gets the kurarinone solution for standby.

Get dry powder 1kg, be dissolved in the water for injection, add above-mentioned kurarinone solution, fully mixing adds water for injection, uses the microporous filter membrane coarse filtration, again ultrafiltration to particulate matter meet 〉=microgranule of 10 μ m is less than 300, the microgranule of 〉=25 μ m is less than 30 regulation, the ultrafiltration medicinal liquid; The ultrafiltration medicinal liquid is dropped in the Agitation Tank, add water for injection, regulate pH value and stir evenly to 6.0-7.0 to 1200L, ultrafiltration, prepared becomes the water for injection injection routinely.

Embodiment 6: the preparation of granule

Radix Ginseng 140kg, Radix Astragali 220kg, kurarinone 15kg

Crude drug Radix Ginseng 140kg is dropped in the circulated in countercurrent supersound extraction jar, add 6 times of weight portion 65% ethanol elder generation warm macerating after 8 hours, at normal temperatures, mixing speed 150r/min, circulated in countercurrent supersound extraction 0.5 hour, extracting liquid filtering reclaims the Radix Ginseng clear paste that is evaporated to 60 ℃ of relative density 1.10-1.15 with ethanol;

Crude drug Radix Astragali 220kg is dropped in the circulated in countercurrent supersound extraction jar, add for the first time 4 times of amount purified water elder generation warm macerating after 1.5 hours, at normal temperatures, mixing speed 150r/min, circulated in countercurrent supersound extraction 0.5 hour, extracting solution concentrates with the triple effect concentrator, 70-80 ℃ of concentrator temperature, vacuum 0.03Mpa are imitated in control one, two imitate 60-70 ℃ of concentrator temperature, vacuum 0.06Mpa, 50-60 ℃ of triple effect concentrator temperature, vacuum 0.08Mpa are concentrated into the Radix Astragali clear paste of 60 ℃ of relative density 1.10-1.15;

With adding the injection water in the concentrated solution to 8000L, regulate pH value to 6.0-7.0 with dilute hydrochloric acid solution, boil, add active carbon 8kg, boil cooling back filter paper filtering, cold preservation after stirring, use filtering with microporous membrane, hot pressing for the first time 1.2 hours, cold preservation, use filtering with microporous membrane, add the injection water, hot pressing for the second time 0.5 hour, cold preservation, behind filtering with microporous membrane, hot pressing for the third time 0.3 hour, cold preservation is filtered, and gets filtered liquid medicine; Get filtered liquid medicine, last macroporous adsorptive resins, the control flow velocity is 0.6ml/min/cm ²Absorption finishes, and is extremely colourless with the purified water flushing; Resolve with 75% ethanol for preparing, to colourless no flavour of a drug, towards colourless to there not being the alcohol flavor, the control flow velocity is 0.6ml/min/cm with purified water ², must resolve medicinal liquid; Reclaim under reduced pressure is resolved medicinal liquid, and the alcohol in the medicinal liquid is reclaimed fully, and with the concentrated solution drying, it is standby to get dry powder;

Get crude drug kurarinone 15kg, add dry powder 1kg, add appropriate amount of auxiliary materials, prepared becomes granule routinely.

Claims

1, a kind of antitumor medicine composition is characterized in that this pharmaceutical composition is to be made by following method:

Crude drug: Radix Ginseng 50-150 weight portion Radix Astragali 200-400 weight portion kurarinone 5-15 weight portion

Processing step: crude drug Radix Ginseng 50-150 weight portion is dropped in the circulated in countercurrent supersound extraction jar, add 4-12 times of weight portion 65%-85% ethanol elder generation warm macerating after 6-18 hour, at normal temperatures, mixing speed 100-300r/min, circulated in countercurrent supersound extraction 0.5-1.5 hour, extracting liquid filtering reclaims the Radix Ginseng clear paste that is evaporated to 60 ℃ of relative density 1.10-1.15 with ethanol;

Crude drug Radix Astragali 200-400 weight portion is dropped in the circulated in countercurrent supersound extraction jar, add 3-9 and doubly measure purified water elder generation warm macerating after 1-3 hour, at normal temperatures, mixing speed 100-300r/min, circulated in countercurrent supersound extraction 0.5-1.5 hour, extracting solution concentrates with the triple effect concentrator, 70-80 ℃ of concentrator temperature, vacuum 0.03Mpa are imitated in control one, two imitate 60-70 ℃ of concentrator temperature, vacuum 0.06Mpa, 50-60 ℃ of triple effect concentrator temperature, vacuum 0.08Mpa are concentrated into the Radix Astragali clear paste of 60 ℃ of relative density 1.10-1.15;

With adding the injection water in the concentrated solution to the 5000-15000 parts by volume, regulate pH value to 6.0-7.0 with dilute hydrochloric acid solution, boil, add 5-15 weight portion active carbon, boil after stirring, cooling back filter paper filtering, filtering with microporous membrane is used in cold preservation, hot pressing for the first time 0.1-1.5 hour, filtering with microporous membrane is used in cold preservation, adds the injection water, hot pressing for the second time 0.5 hour, cold preservation was with behind the filtering with microporous membrane hot pressing 0.1-1.5 hour for the third time, cold preservation is filtered, and gets filtered liquid medicine; Get filtered liquid medicine, last macroporous adsorptive resins, the control flow velocity is 0.4-1.2ml/min/cm ²Absorption finishes, and is extremely colourless with the purified water flushing; Resolve with the 65-85% ethanol for preparing, to colourless no flavour of a drug, towards colourless to there not being the alcohol flavor, the control flow velocity is 0.4-1.2ml/min/cm with purified water ², must resolve medicinal liquid; Reclaim under reduced pressure is resolved medicinal liquid, and the alcohol in the medicinal liquid is reclaimed fully, and with the concentrated solution drying, it is standby to get dry powder;

Get crude drug kurarinone 5-15 weight portion, get quantitative powder 1.5-4.5 weight portion, add conventional adjuvant, prepared becomes water for injection injection, lyophilized injectable powder or oral solid formulation routinely.

2, pharmaceutical composition as claimed in claim 1 is characterized in that crude drug wherein is:

3, pharmaceutical composition as claimed in claim 1 is characterized in that crude drug wherein is:

4, pharmaceutical composition as claimed in claim 1 is characterized in that crude drug wherein is:

5, as the arbitrary described pharmaceutical composition of claim 1-4, the processing step that it is characterized in that ejection preparation wherein is: the crude drug Radix Ginseng is dropped in the circulated in countercurrent supersound extraction jar, add 8 times of weight portion 75% ethanol elder generation warm macerating after 12 hours, at normal temperatures, mixing speed 200r/min, circulated in countercurrent supersound extraction 1 hour, extracting liquid filtering reclaims ethanol the Radix Ginseng clear paste that is evaporated to 60 ℃ of relative density 1.10-1.15;

With adding injection water 10000 parts by volume in the concentrated solution, regulate pH value to 6.0-7.0 with dilute hydrochloric acid solution, boil, add 10 weight portion active carbons, boil cooling back filter paper filtering, cold preservation after stirring, use filtering with microporous membrane, hot pressing for the first time 0.5 hour, cold preservation, use filtering with microporous membrane, add the injection water, hot pressing for the second time 0.5 hour, cold preservation, behind filtering with microporous membrane, hot pressing for the third time 0.5 hour, cold preservation is filtered, and gets filtered liquid medicine; Get filtered liquid medicine, last macroporous adsorptive resins, the control flow velocity is 0.8ml/min/cm ²Absorption finishes, and is extremely colourless with the purified water flushing; Resolve with 75% ethanol for preparing, to colourless no flavour of a drug, towards colourless to there not being the alcohol flavor, the control flow velocity is 0.8ml/min/cm with purified water ², must resolve medicinal liquid; Reclaim under reduced pressure is resolved medicinal liquid, and the alcohol in the medicinal liquid is reclaimed fully, and with the concentrated solution drying, it is standby to get dry powder;

Get the crude drug kurarinone, add 5 times of parts by volume dissolvings of water for injection, regulate pH value to 6-7 with dilute hydrochloric acid, 100 ℃ of sterilizations of flowing steam 15 minutes, cold preservation gets the kurarinone solution for standby;

Get dry powder 3 weight portions, be dissolved in the water for injection, add above-mentioned kurarinone solution, abundant mixing,, use the microporous filter membrane coarse filtration, again ultrafiltration to particulate matter meet 〉=microgranule of 10 μ m is less than 300, the microgranule of 〉=25 μ m is less than 30 regulation, the ultrafiltration medicinal liquid; The ultrafiltration medicinal liquid is dropped in the Agitation Tank, add water for injection to 1000 parts by volume, regulate pH value and stir evenly to 6.0-7.0, ultrafiltration, prepared becomes lyophilized injectable powder routinely.

6, as the arbitrary described pharmaceutical composition of claim 1-4, the processing step that it is characterized in that ejection preparation wherein is: the crude drug Radix Ginseng is dropped in the circulated in countercurrent supersound extraction jar, add 10 times of weight portion 85% ethanol elder generation warm macerating after 18 hours, at normal temperatures, mixing speed 280r/min, circulated in countercurrent supersound extraction 1.5 hours, extracting solution reclaim the Radix Ginseng clear paste that is evaporated to 60 ℃ of relative density 1.10-1.15 with ethanol;

Clear paste 1 is squeezed into Alcohol-settling tank, adding 95% ethanol is stirred to fast and contains alcohol amount and reach 90%, static, cold preservation 12 hours is filtered, regulate pH value to 8-9 with 10%NaOH solution, stir evenly, cold preservation filtered more than 36 hours, filtrate recycling ethanol, concentrate, be concentrated into the clear paste 2 of 60 ℃ of relative density 1.10-1.20:

With adding injection water 14000 parts by volume in the concentrated solution, regulate pH value to 6.0-7.0 with dilute hydrochloric acid solution, boil, add 14 weight portion active carbons, boil cooling back filter paper filtering, cold preservation after stirring, use filtering with microporous membrane, hot pressing for the first time 0.3 hour, cold preservation, use filtering with microporous membrane, add the injection water, hot pressing for the second time 0.5 hour, cold preservation, behind filtering with microporous membrane, hot pressing for the third time 1.2 hours, cold preservation is filtered, and gets filtered liquid medicine; Get filtered liquid medicine, last macroporous adsorptive resins, the control flow velocity is 1ml/min/cm ²Absorption finishes, and is extremely colourless with the purified water flushing; Resolve with 75% ethanol for preparing, to colourless no flavour of a drug, towards colourless to there not being the alcohol flavor, the control flow velocity is 1ml/min/cm with purified water ², must resolve medicinal liquid; Reclaim under reduced pressure is resolved medicinal liquid, and the alcohol in the medicinal liquid is reclaimed fully, and with the concentrated solution drying, it is standby to get dry powder;

Get the crude drug kurarinone and add 4 times of parts by volume dissolvings of water for injection, regulate pH value to 6-7 with dilute hydrochloric acid, 100 ℃ of sterilizations of flowing steam 5 minutes, cold preservation gets the kurarinone solution for standby;

7, as the arbitrary described pharmaceutical composition of claim 1-4, it is characterized in that processing step wherein is: the crude drug Radix Ginseng is dropped in the circulating ultrasonic extraction pot, add 6 times of weight portions, 65% ethanol warm macerating after 8 hours, at normal temperatures, mixing speed 150r/min, 0.5 hour extracting liquid filtering of circulated in countercurrent supersound extraction reclaims the Radix Ginseng clear paste that is evaporated to 60 ℃ of relative density 1.10-1.15 with ethanol;

The crude drug Radix Astragali is dropped in the circulating ultrasonic extraction pot, adds 4 times of amount purified water warm macerating after 1.5 hours,, at normal temperatures, mixing speed 150r/min, circulated in countercurrent supersound extraction 0.5 hour; Extracting solution concentrates with the triple effect concentrator, 70-80 ℃ of concentrator temperature, vacuum 0.03Mpa are imitated in control one, two imitate 60-70 ℃ of concentrator temperature, vacuum 0.06Mpa, 50-60 ℃ of triple effect concentrator temperature, vacuum 0.08Mpa are concentrated into the Radix Astragali clear paste of 60 ℃ of relative density 1.10-1.15;

With adding injection water 8000 parts by volume in the concentrated solution, regulate pH value to 6.0-7.0 with dilute hydrochloric acid solution, boil, add 8 weight portion active carbons, boil cooling back filter paper filtering, cold preservation after stirring, use filtering with microporous membrane, hot pressing for the first time 1.2 hours, cold preservation, use filtering with microporous membrane, add the injection water, hot pressing for the second time 0.5 hour, cold preservation, behind filtering with microporous membrane, hot pressing for the third time 0.3 hour, cold preservation is filtered, and gets filtered liquid medicine; Get filtered liquid medicine, last macroporous adsorptive resins, the control flow velocity is 0.6ml/min/cm ²Absorption finishes, and is extremely colourless with the purified water flushing; Resolve with 75% ethanol for preparing, to colourless no flavour of a drug, towards colourless to there not being the alcohol flavor, the control flow velocity is 0.6ml/min/cm with purified water ², must resolve medicinal liquid; Reclaim under reduced pressure is resolved medicinal liquid, and the alcohol in the medicinal liquid is reclaimed fully, and with the concentrated solution drying, it is standby to get dry powder;

8, a kind of preparation method of antitumor medicine composition is characterized in that this method is:

Processing step: crude drug Radix Ginseng 50-150 weight portion is dropped in the circulated in countercurrent supersound extraction jar, add 4-12 times of weight portion 65-85% ethanol, after warm macerating 6-18 hour, at normal temperatures, mixing speed 100-300r/min, circulated in countercurrent supersound extraction 0.5-1.5 hour, extracting liquid filtering, ethanol is reclaimed, be evaporated to the Radix Ginseng clear paste of 60 ℃ of relative density 1.10-1.15;

Crude drug Radix Astragali 200-400 weight portion is dropped in the circulated in countercurrent supersound extraction jar, add 3-9 and doubly measure the purified water warm macerating after 1-3 hour, at normal temperatures, mixing speed 100-300r/min, circulated in countercurrent supersound extraction 0.5-1.5 hour, extracting solution concentrates with the triple effect concentrator, 70-80 ℃ of concentrator temperature, vacuum 0.03Mpa are imitated in control one, two imitate 60-70 ℃ of concentrator temperature, vacuum 0.06Mpa, 50-60 ℃ of triple effect concentrator temperature, vacuum 0.08Mpa are concentrated into the Radix Astragali clear paste of 60 ℃ of relative density 1.10-1.15;

9, preparation of drug combination method as claimed in claim 8 is characterized in that crude drug is in this method: Radix Ginseng 100 weight portions, the Radix Astragali 300 weight portions, kurarinone 10 weight portions.

10, preparation of drug combination method as claimed in claim 8 is characterized in that crude drug is in this method: Radix Ginseng 60 weight portions, the Radix Astragali 360 weight portions, kurarinone 5 weight portions.

11, preparation of drug combination method as claimed in claim 8 is characterized in that crude drug is in this method: Radix Ginseng 140 weight portions, the Radix Astragali 220 weight portions, kurarinone 15 weight portions.

12, as the arbitrary described preparation of drug combination method of claim 8-11, the processing step that it is characterized in that the ejection preparation in this method is: the crude drug Radix Ginseng is dropped in the circulated in countercurrent supersound extraction jar, add for the first time 8 times of weight portion 75% ethanol elder generation warm macerating after 12 hours, at normal temperatures, mixing speed 200r/min, circulated in countercurrent supersound extraction 1 hour, extracting liquid filtering, ethanol is reclaimed, be evaporated to the Radix Ginseng clear paste of 60 ℃ of relative density 1.10-1.15;

The crude drug Radix Astragali is dropped in the circulated in countercurrent supersound extraction jar, add for the first time 6 times of amount purified water warm macerating after 2 hours, at normal temperatures, mixing speed 200r/min, circulated in countercurrent supersound extraction 1 hour, extracting solution concentrates with the triple effect concentrator, 70-80 ℃ of concentrator temperature, vacuum 0.03Mpa are imitated in control one, two imitate 60-70 ℃ of concentrator temperature, vacuum 0.06Mpa, and 50-60 ℃ of triple effect concentrator temperature, vacuum 0.08Mpa are concentrated into the Radix Astragali clear paste of 60 ℃ of relative density 1.10-1.15;

With adding injection water to 10000 parts by volume in the concentrated solution, regulate pH value to 6.0-7.0 with dilute hydrochloric acid solution, boil, add 10 weight portion active carbons, boil cooling back filter paper filtering, cold preservation after stirring, use filtering with microporous membrane, hot pressing for the first time 0.5 hour, cold preservation, use filtering with microporous membrane, add the injection water, hot pressing for the second time 0.5 hour, cold preservation, behind filtering with microporous membrane, hot pressing for the third time 0.5 hour, cold preservation is filtered, and gets filtered liquid medicine; Get filtered liquid medicine, last macroporous adsorptive resins, the control flow velocity is 0.8ml/min/cm ²Absorption finishes, and is extremely colourless with the purified water flushing; Resolve with 75% ethanol for preparing, to colourless no flavour of a drug, towards colourless to there not being the alcohol flavor, the control flow velocity is 0.8ml/min/cm with purified water ², must resolve medicinal liquid; Reclaim under reduced pressure is resolved medicinal liquid, and the alcohol in the medicinal liquid is reclaimed fully, and with the concentrated solution drying, it is standby to get dry powder;

13, as the arbitrary described preparation of drug combination method of claim 8-11, the processing step that it is characterized in that the ejection preparation in this method is: the crude drug Radix Ginseng is dropped in the circulated in countercurrent supersound extraction jar, add for the first time 10 times of weight portion 85% ethanol elder generation warm macerating after 18 hours, at normal temperatures, mixing speed 280r/min, circulated in countercurrent supersound extraction 1.5 hours, extracting liquid filtering reclaims the Radix Ginseng clear paste that is evaporated to 60 ℃ of relative density 1.10-1.15 with ethanol;

The crude drug Radix Astragali is dropped in the circulated in countercurrent supersound extraction jar, add 8 times of amount purified water elder generation warm macerating after 2.5 hours, at normal temperatures, mixing speed 280r/min, circulated in countercurrent supersound extraction 2.5 hours, extracting solution concentrates with the triple effect concentrator, 70-80 ℃ of concentrator temperature, vacuum 0.03Mpa are imitated in control one, two imitate 60-70 ℃ of concentrator temperature, vacuum 0.06Mpa, and 50-60 ℃ of triple effect concentrator temperature, vacuum 0.08Mpa are concentrated into the Radix Astragali clear paste of 60 ℃ of relative density 1.10-1.15;

With adding injection water to 14000 parts by volume in the concentrated solution, regulate pH value to 6.0-7.0 with dilute hydrochloric acid solution, boil, add active carbon 14 weight portions, boil cooling back filter paper filtering, cold preservation after stirring, use filtering with microporous membrane, hot pressing for the first time 0.3 hour, cold preservation, use filtering with microporous membrane, add the injection water, hot pressing for the second time 0.5 hour, cold preservation, behind filtering with microporous membrane, hot pressing for the third time 1.2 hours, cold preservation is filtered, and gets filtered liquid medicine; Get filtered liquid medicine, last macroporous adsorptive resins, the control flow velocity is 1ml/min/cm ²Absorption finishes, and is extremely colourless with the purified water flushing; Resolve with 75% ethanol for preparing, to colourless no flavour of a drug, towards colourless to there not being the alcohol flavor, the control flow velocity is 1ml/min/cm with purified water ², must resolve medicinal liquid; Reclaim under reduced pressure is resolved medicinal liquid, and the alcohol in the medicinal liquid is reclaimed fully, and with the concentrated solution drying, it is standby to get dry powder;

14, as the arbitrary described preparation of drug combination method of claim 8-11, it is characterized in that the processing step in this method is: the crude drug Radix Ginseng is dropped in the circulated in countercurrent supersound extraction jar, add for the first time 6 times of weight portion 65% ethanol elder generation warm macerating after 8 hours, at normal temperatures, mixing speed 150r/min, circulated in countercurrent supersound extraction 0.5 hour, extracting liquid filtering reclaims the Radix Ginseng clear paste that is evaporated to 60 ℃ of relative density 1.10-1.15 with ethanol;

With adding injection water 8000 parts by volume in the concentrated solution, regulate pH value to 6.0-7.0 with dilute hydrochloric acid solution, boil, add active carbon 8 weight portions, boil cooling back filter paper filtering, cold preservation after stirring, use filtering with microporous membrane, hot pressing for the first time 1.2 hours, cold preservation, use filtering with microporous membrane, add the injection water, hot pressing for the second time 0.5 hour, cold preservation, behind filtering with microporous membrane, hot pressing for the third time 0.3 hour, cold preservation is filtered, and gets filtered liquid medicine; Get filtered liquid medicine, last macroporous adsorptive resins, the control flow velocity is 0.6ml/min/cm ²Absorption finishes, and is extremely colourless with the purified water flushing; Resolve with 75% ethanol for preparing, to colourless no flavour of a drug, towards colourless to there not being the alcohol flavor, the control flow velocity is 0.6ml/min/cm with purified water ², must resolve medicinal liquid; Reclaim under reduced pressure is resolved medicinal liquid, and the alcohol in the medicinal liquid is reclaimed fully, and with the concentrated solution drying, it is standby to get dry powder;

Get the crude drug kurarinone, add medicated powder 1 weight portion, add appropriate amount of auxiliary materials, prepared becomes water for injection injection, lyophilized injectable powder or oral solid formulation routinely.

15, as the application of pharmaceutical composition as described in the claim 1,2,3 or 4 in preparation treatment anti-tumor drug.

16, as the application of pharmaceutical composition as described in the claim 5 in preparation treatment anti-tumor drug.

17, as the application of pharmaceutical composition as described in the claim 6 in preparation treatment anti-tumor drug.

18, as the application of pharmaceutical composition as described in the claim 7 in preparation treatment anti-tumor drug.