CN101049339A - Method for preparing injection of astragalus - Google Patents

Method for preparing injection of astragalus Download PDF

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CN101049339A
CN101049339A CN 200710099116 CN200710099116A CN101049339A CN 101049339 A CN101049339 A CN 101049339A CN 200710099116 CN200710099116 CN 200710099116 CN 200710099116 A CN200710099116 A CN 200710099116A CN 101049339 A CN101049339 A CN 101049339A
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injection
water
minutes
radix astragali
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CN100446783C (en
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方同华
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Haerbin Zhenbao Pharmaceutical Co., Ltd.
Heilongjiang ZBD Pharmaceutical Co., Ltd.
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Helongjiang Zhenbaodao Pharmaceutical Co Ltd
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Abstract

A process for preparing the high-purity astragalus injection includes such steps as decocting, chromatography, eluting, depositing in alcohol, etc.

Description

A kind of preparation method of Radix Astragali injection
Technical field
The present invention relates to a kind of preparation method of Radix Astragali injection, belong to field of traditional Chinese.
Background technology
The Radix Astragali is the Chinese medicine resistance and supplementing qi medicine, and now having confirmed has facilitation to body's immunological function.Experiment shows that the Radix Astragali can strengthen the phagocytic function of reticuloendothelial system significantly, and its action intensity and bacillus calmette-guerin vaccine are close, and the Radix Astragali and Radix Codonopsis share, and its effect that strengthens the reticuloendothelial system phagocytic function is particularly remarkable, is strong than bacillus calmette-guerin vaccine.Have cellular immune function potentiation again, can promote the function that healthy human lymphocyte transforms, most of hepatitis B patients SK-SD skin test when obtaining curative effect changes sun and strengthens.Take the Radix Astragali and can obviously improve the function of human leukocytes inducement interferon, and see that the content of IgA and lgG rises in the easy catching a cold patient nose secretion.The Radix Astragali and extract thereof can make mice plasma adenosine cyclophosphate (cAMP) level improve, and this may be relevant with the content of its raising interferon.Visible leukocyte of animal experiment and multinuclear leucocyte increase significantly.
Clinical research shows, Radix Astragali injection can be used for various types of hepatitis patients, especially be applicable to the chronic persistent hepatitis (CPH) of cellular immune function reduction and the patient of chronic active hepatitis (CAH), but appetite stimulator, improve liver function, strengthen cellular immunization, reduce hbs antigen (HBsAg) titre or make it to turn out cloudy.The chronic tracheitis patient who is used for typical insufficiency of the spleen symptom, insufficiency of the spleen doing well,improving in the most patients 20 days.Experimentation shows that the Radix Astragali infects mice I type parainfluenza virus slight protective effect, and testing the conclusive evidence Radix Astragali through the crowd has the anti-effect that cures cold.With Radix Codonopsis compatibility nephritic proteinuria therapeutical effect is arranged.Radix Stephaniae Tetrandrae Siberian cocklebur luxuriant growth soup treatment nephritis commonly used clinically, this may can suppress allergy with it, and is again can the enhancing body resistance relevant.The Radix Astragali also is usually used in leukopenia and thrombocytopenic purpura.
Therefore, the report of relevant Radix Astragali extraction process has much.Such as, patent documentation: 99106225.6, a kind of process for refining astragalus injection of denomination of invention, its get the Radix Astragali by decoct, filter, concentrate, precipitate with ethanol 3 times then, concentration is 70%, 80%, 85%, 0 ℃ of cold preservation is placed a few hours, reclaimed ethanol and concentrate, dilute with water for injection behind each precipitate with ethanol, cold preservation is to 0-4 ℃, place 24 hours, filter, regulate pH value, boil and add active carbon, add 20% sodium hydroxide solution again with 20% sodium hydroxide solution, adjusting pH value, filtration at last, embedding, sterilization, quality inspection, packing form.This application has only adopted precipitate with ethanol, makes gained concentrated solution purity low, and the preparation color is dark, handles though carry out repeatedly precipitate with ethanol, can not well remove impurity significantly.
Patent documentation 03114789.5, denomination of invention Radix Astragali injection and preparation method thereof, the Radix Astragali decocts in water, filters concentrating under reduced pressure filtrate, add ethanol and leave standstill, filter concentrating under reduced pressure, thin up, cold preservation, filter, concentrating under reduced pressure separates with macroporous resin, collects eluent; Dilute with water adds the L-arginine, regulates pH to 7.0~7.5, adds active carbon, filtering decarbonization, and thin up promptly obtains Radix Astragali injection.And but thin up is to 40g Radix Astragali crude drug/250ml, and osmotic pressure is about 300mosm, and the astragaloside amount is not less than 8mg/250ml, fill in the 250ml infusion bottle, blooming gland, sterilization.This application adopts the technology that goes up the resin column eluting behind the first precipitate with ethanol, and the gained concentrated solution can not effectively be removed because of the material that the degradation product of resin and porogen etc. may pollute extract, thereby impurity is also many.
Summary of the invention
The preparation method that the purpose of this invention is to provide a kind of Radix Astragali injection, the extract purity height that this method obtains, application safety.
In order to realize the object of the invention, the preparation method of a kind of Radix Astragali injection of the present invention, it comprises the steps:
1) Radix Astragali section, the water of 4~12 times of amounts of adding crude drug, 45~65 ℃ were soaked 30~60 minutes, boiled 1~3 hour; Leach, add the water of 2~10 times of amounts of crude drug, boiled 0.5~2 hour; Merging filtrate, cooling was left standstill 1~5 hour, filtered, and was cooled to below 30 ℃;
2) going up resin column then soaked 30~60 minutes, cross post absorption with 18~21 liters/minute flow velocity, with the purified water of 3~5 times of amounts of resin towards post, with 20~40% ethanol of 1~3 times of amount of resin towards post, again with the purified water of 1~3 times of amount of resin towards post, 60~85% ethanol with 4~5 times of amounts of resin soaked 30~60 minutes at last, with 15~16.5 liters of/minute flow velocity eluting;
3) collect eluent, filter, reclaim ethanol, and be concentrated into relative density 1.14~1.18 (80 ℃ ± 2 survey) to nothing alcohol flavor; Add high alcohol and make and contain alcohol amount and reach 75~85%, room temperature left standstill 12~24 hours, and membrane filtration reclaims ethanol to there not being the alcohol flavor; Add the injection water and contain crude drug in whole 2~4g to every 1ml, stirring and dissolving, adjust pH to 3.0~4.0, the fill sterilization, be refrigerated to icing, 0~6 ℃ of cold preservation 5~9 days;
4) with cold preservation liquid through filtering with microporous membrane, transfer pH 7.5~9.5, add 0.05~0.5% active carbon and boiled 15~25 minutes, treat that temperature drops to below 50 ℃, filter the fill sterilization; Be refrigerated to freeze after, placed 15~30 days in shady and cool dry place or room temperature;
5) first then coarse filtration again through filtering with microporous membrane, and gets ultrafiltrate after the ultrafiltration; Water for injection after itself and the ultrafiltration below 40 ℃ is merged, adjust pH 7.5~10.0, the water for injection of adding again after the ultrafiltration contains crude drug in whole 2g to every 1ml; Treat that medicinal liquid is cooled to fine straining below 30 ℃, fill is sterilized promptly.
Preferred step is:
1) Radix Astragali section, the water of 4~8 times of amounts of adding crude drug, 50~60 ℃ were soaked 30~50 minutes, boiled 1.5~2 hours; Leach, add the water of 2~6 times of amounts of crude drug, boiled 1~2 hour; Merging filtrate, cooling was left standstill 1~3 hour, filtered, and was cooled to below 30 ℃;
2) going up resin column then soaked 30~50 minutes, cross post absorption with 18~21 liters/minute flow velocity, with the purified water of 3~4 times of amounts of resin towards post, with 30~40% ethanol of 1~2 times of amount of resin towards post, again with the purified water of 1~2 times of amount of resin towards post, 70~85% ethanol with 4~5 times of amounts of resin soaked 30~50 minutes at last, with 15~16.5 liters of/minute flow velocity eluting;
3) collect eluent, filter, reclaim ethanol, and be concentrated into relative density 1.14~1.18 (80 ℃ ± 2 survey) to nothing alcohol flavor; Add high alcohol and make and contain alcohol amount and reach 80~85%, room temperature left standstill 12~18 hours, and membrane filtration reclaims ethanol to there not being the alcohol flavor; Add the injection water and contain crude drug in whole 2g to every 1ml, stirring and dissolving, adjust pH to 3.0~3.5, the fill sterilization, be refrigerated to icing, 0~6 ℃ of cold preservation 7~9 days;
4) with cold preservation liquid through filtering with microporous membrane, transfer pH 8.0~9.0, add 0.1~0.3% active carbon and boiled 15~20 minutes, treat that temperature drops to below 50 ℃, filter the fill sterilization; Be refrigerated to freeze after, placed 15~20 days in shady and cool dry place or room temperature;
5) first then coarse filtration again through filtering with microporous membrane, and gets ultrafiltrate after the ultrafiltration; Water for injection after itself and the ultrafiltration below 40 ℃ is merged, adjust pH 7.5~9.5, the water for injection of adding again after the ultrafiltration contains crude drug in whole 2g to every 1ml; Treat that medicinal liquid is cooled to fine straining below 30 ℃, fill is sterilized promptly.
Wherein, filter membrane adopts the filter membrane in 0.45~0.65 μ m aperture in the step 3).
Microporous filter membrane adopts 0.2~0.45 μ m aperture in the step 4).
Microporous filter membrane adopts 0.2 μ m aperture in the step 5); The ultrafilter of 6000~10000 molecular weight is adopted in ultrafiltration; Fine straining adopts 0.2 μ m microporous filter membrane and cartridge type germ tight filter.
Sterilization can be adopted under 110~120 ℃ of high pressure and handle 20~40 minutes.
The preparation method of Radix Astragali injection of the present invention adopts first upper prop eluting precipitate with ethanol again, can better remove macromole impurity such as tannin, protein, and the resin residue that the degradation product of resin and porogen etc. may pollute extract is removed by precipitate with ethanol, the purity of gained concentrated solution is higher, uses safer.
The specific embodiment
Following examples are used to illustrate the present invention, but are not used for limiting the scope of the invention.
Embodiment 1
Radix Astragali section (thickness is 2-4mm) adds the water of 8 times of amounts of crude drug, and 60 ℃ of warm macerating 30 minutes boiled 1.5 hours.Leach, add the water of 6 times of amounts of crude drug, boiled 1 hour.
Merging filtrate, cooling was left standstill 1 hour, filtered, be cooled to below 30 ℃, last macroporous adsorptive resins soaked 30 minutes, crossed post absorption with 18 liters/minute flow velocity, with the purified water of 3 times of amounts of resin towards post, then with 30% ethanol of 1 times of amount of resin towards post, again with the purified water of 1 times of amount of resin towards post, 70% ethanol with 4 times of amounts of resin soaked 30 minutes at last, with 15 liters of/minute flow velocity eluting.Collect eluent, filter, reclaim ethanol, and be concentrated into relative density 1.16 ± 0.02 (80 ℃ ± 2 survey) to nothing alcohol flavor.
Add high alcohol and make and contain alcohol amount and reach 85%, room temperature left standstill 12 hours, and 0.45 μ m membrane filtration reclaims ethanol to there not being the alcohol flavor.Add the injection water and contain crude drug in whole 2g to every 1ml, stirring and dissolving, adjust pH to 3.2, fill, 115 ℃ of autoclavings 40 minutes, be refrigerated to icing, 0 ℃ of cold preservation 7 days.
Cold preservation liquid through 0.45 μ m filtering with microporous membrane, is transferred pH 9.0 with sodium hydroxide solution, add 0.1% active carbon and boiled 15 minutes, treat that temperature drops to below 50 ℃, filter, through 115 ℃ of sterilizations 40 minutes.Be refrigerated to the back that freezes and in time take out negative catalysis, place two weeks in room temperature.
Filter with 200 order silks,, after 6000 molecular weight ultrafilter ultrafiltration, get ultrafiltrate then through 0.2 μ m filtering with microporous membrane.The water for injection after itself and the ultrafiltration below 40 ℃ is merged, with 10%NaOH adjust pH 9.5, the water for injection of adding again after the ultrafiltration contains crude drug in whole 2g to every 1ml again.Treat that medicinal liquid is cooled to below 30 ℃ through 0.2 μ m microporous filter membrane, cartridge type germ tight filter fine straining, fill is sterilized promptly.
Embodiment 2
Radix Astragali section (thickness is 2-4mm) adds the water of 6 times of amounts of crude drug, and 50 ℃ of warm macerating 60 minutes boiled 1 hour.Leach, add the water of 4 times of amounts of crude drug, boiled 2 hours.
Merging filtrate, cooling was left standstill 2 hours, filtered, be cooled to below 30 ℃, last macroporous adsorptive resins soaked 50 minutes, crossed post absorption with 20 liters/minute flow velocity, with the purified water of 3 times of amounts of resin towards post, then with 30% ethanol of 2 times of amounts of resin towards post, again with the purified water of 2 times of amounts of resin towards post, 60% ethanol with 5 times of amounts of resin soaked 60 minutes at last, with 16.5 liters of/minute flow velocity eluting.Collect eluent, filter, reclaim ethanol, and be concentrated into relative density 1.16 ± 0.01 (80 ℃ ± 2 survey) to nothing alcohol flavor.
Add high alcohol and make and contain alcohol amount and reach 75%, room temperature left standstill 16 hours, and 0.65 μ m membrane filtration reclaims ethanol to there not being the alcohol flavor.Add the injection water and contain crude drug in whole 4g to every 1ml, stirring and dissolving, adjust pH to 3.5, fill, 120 ℃ of autoclavings 30 minutes, be refrigerated to icing, 6 ℃ of cold preservation 5 days.
Cold preservation liquid through 0.2 μ m filtering with microporous membrane, is transferred pH 8.0 with sodium hydroxide solution, add 0.3% active carbon and boiled 20 minutes, treat that temperature drops to below 50 ℃, filter, through 120 ℃ of sterilizations 20 minutes.Be refrigerated to the back that freezes and in time take out negative catalysis, put shady and cool dry place two weeks.
Filter with 200 order silks,, after the ultrafiltration of 8000 molecular weight volume membrane type ultrafilter, get ultrafiltrate then through 0.2 μ m filtering with microporous membrane.Again the water for injection after itself and the ultrafiltration below 40 ℃ is merged, with 10%NaOH adjust pH 7.7, standardize solution.Treat that medicinal liquid is cooled to below 30 ℃ through 0.2 μ m microporous filter membrane, cartridge type germ tight filter fine straining, fill is sterilized promptly.
Embodiment 3
Radix Astragali section (thickness is 2-4mm) adds the water of 4 times of amounts of crude drug, and 65 ℃ of warm macerating 40 minutes boiled 2 hours.Leach, add the water of 2 times of amounts of crude drug, boiled 0.5 hour.
Merging filtrate, cooling was left standstill 5 hours, filtered, be cooled to below 30 ℃, last macroporous adsorptive resins soaked 40 minutes, crossed post absorption with 21 liters/minute flow velocity, with the purified water of 4 times of amounts of resin towards post, then with 20% ethanol of 3 times of amounts of resin towards post, again with the purified water of 3 times of amounts of resin towards post, 85% ethanol with 4 times of amounts of resin soaked 40 minutes at last, with 16 liters of/minute flow velocity eluting.Collect eluent, filter, reclaim ethanol, and be concentrated into relative density 1.16 ± 0.02 (80 ℃ ± 2 survey) to nothing alcohol flavor.
Add high alcohol and make and contain alcohol amount and reach 80%, room temperature left standstill 20 hours, and 0.55 μ m membrane filtration reclaims ethanol to there not being the alcohol flavor.Add the injection water and contain crude drug in whole 3g to every 1ml, stirring and dissolving, adjust pH to 3.0, fill, 110 ℃ of autoclavings 30 minutes, be refrigerated to icing, 0 ℃ of cold preservation 9 days.
Cold preservation liquid through 0.35 μ m filtering with microporous membrane, is transferred pH 9.5 with sodium hydroxide solution, add 0.5% active carbon and boiled 25 minutes, treat that temperature drops to below 50 ℃, filter, through 115 ℃ of sterilizations 40 minutes.Be refrigerated to the back that freezes and in time take out negative catalysis, room temperature was placed 20 days.
Filter with 200 order silks,, after 10000 molecular weight ultrafilter ultrafiltration, get ultrafiltrate then through 0.2 μ m filtering with microporous membrane.Again itself and the water for injection after the ultrafiltration below 40 ℃ are merged, with 10%NaOH adjust pH 7.5, standardize solution.Treat that medicinal liquid is cooled to below 30 ℃ through 0.2 μ m microporous filter membrane, cartridge type germ tight filter fine straining, fill is sterilized promptly.
Embodiment 4
Radix Astragali section adds the water of 12 times of amounts of crude drug, and 45 ℃ of warm macerating 30 minutes boiled 1 hour; Leach, add the water of 10 times of amounts of crude drug, boiled 2 hours.
Merging filtrate, cooling was left standstill 3 hours, filtered, be cooled to below 30 ℃, last macroporous adsorptive resins soaked 60 minutes, crossed post absorption with 18 liters/minute flow velocity, with the purified water of 5 times of amounts of resin towards post, then with 40% ethanol of 2 times of amounts of resin towards post, again with the purified water of 1 times of amount of resin towards post, 65% ethanol with 5 times of amounts of resin soaked 50 minutes at last, with 15 liters of/minute flow velocity eluting.Collect eluent, filter, reclaim ethanol, and be concentrated into relative density 1.16 ± 0.01 (80 ℃ ± 2 survey) to nothing alcohol flavor.
Add high alcohol and make and contain alcohol amount and reach 75%, room temperature left standstill 24 hours, and 0.45 μ m membrane filtration reclaims ethanol to there not being the alcohol flavor.Add the injection water and contain crude drug in whole 2g to every 1ml, stirring and dissolving, adjust pH to 4.0, fill, 115 ℃ of autoclavings 40 minutes, be refrigerated to icing, 2 ℃ of cold preservation 7 days.
Cold preservation liquid through 0.20 μ m filtering with microporous membrane, is transferred pH 7.5 with sodium hydroxide solution, add 0.05% active carbon and boiled 15 minutes, treat that temperature drops to below 50 ℃, filter, through 120 ℃ of sterilizations 30 minutes.Be refrigerated to the back that freezes and in time take out negative catalysis, put shady and cool dry place 30 days.
Filter with 200 order silks,, after 80000 molecular weight ultrafilter ultrafiltration, get ultrafiltrate then through 0.2 μ m filtering with microporous membrane.Again the water for injection after itself and the ultrafiltration below 40 ℃ is merged, with 10%NaOH adjust pH 10.0, standardize solution.Treat that medicinal liquid is cooled to below 30 ℃ through 0.2 μ m microporous filter membrane, cartridge type germ tight filter fine straining, fill is sterilized promptly.
Experimental example
This test example is to study the purity and the safety of Radix Astragali injection.
1) inspection of tannin: get Radix Astragali injection 2ml, add the physiological sodium chloride solution 5ml that contains 1% Ovum Gallus domesticus album of new preparation, placed 15 minutes, do not become turbid.
2) proteinic inspection: get Radix Astragali injection 1ml, add 30% sulfosalicylic acid solution 1ml of new preparation, mixing was placed 5 minutes, did not become turbid.
3) inspection of D-101 macroporous adsorbent resin organic solvent residual: adopt headspace gas chromatography to detect, do not detect residues such as normal hexane, benzene, toluene, xylol, o-Dimethylbenzene, styrene and divinylbenzene.
4) undue toxicity checks: get 5 of mices, every mouse mainline Radix Astragali injection 0.5ml.5 mices are not dead in 48 hours after administration.
5) haemolysis is checked with cohesion: check (an appendix XVIII of Chinese Pharmacopoeia version in 2005 B), no haemolysis and coacervation take place in accordance with the law.
The extract purity that adopts preparation method of the present invention to obtain is higher, uses safer.
Though above the present invention is described in detail with a general description of the specific embodiments, on basis of the present invention, can make some modifications or improvements it, this will be apparent to those skilled in the art.Therefore, these modifications or improvements all belong to the scope of protection of present invention without departing from theon the basis of the spirit of the present invention.

Claims (7)

1. the preparation method of a Radix Astragali injection is characterized in that, it comprises the steps:
1) Radix Astragali section, the water of 4~12 times of amounts of adding crude drug, 45~65 ℃ were soaked 30~60 minutes, boiled 1~3 hour; Leach, add the water of 2~10 times of amounts of crude drug, boiled 0.5~2 hour; Merging filtrate, cooling was left standstill 1~5 hour, filtered, and was cooled to below 30 ℃;
2) going up resin column then soaked 30~60 minutes, cross post absorption with 18~21 liters/minute flow velocity, with the purified water of 3~5 times of amounts of resin towards post, with 20~40% ethanol of 1~3 times of amount of resin towards post, again with the purified water of 1~3 times of amount of resin towards post, 60~85% ethanol with 4~5 times of amounts of resin soaked 30~60 minutes at last, with 15~16.5 liters of/minute flow velocity eluting;
3) collect eluent, filter, reclaim ethanol, and be concentrated into relative density 1.14~1.18 (80 ℃ ± 2 survey) to nothing alcohol flavor; Add high alcohol and make and contain alcohol amount and reach 75~85%, room temperature left standstill 12~24 hours, and membrane filtration reclaims ethanol to there not being the alcohol flavor; Add the injection water and contain crude drug in whole 2~4g to every 1ml, stirring and dissolving, adjust pH to 3.0~4.0, the fill sterilization, be refrigerated to icing, 0~6 ℃ of cold preservation 5~9 days;
4) with cold preservation liquid through filtering with microporous membrane, transfer pH 7.5~9.5, add 0.05~0.5% active carbon and boiled 15~25 minutes, treat that temperature drops to below 50 ℃, filter the fill sterilization; Be refrigerated to freeze after, placed 15~30 days in shady and cool dry place or room temperature;
5) first then coarse filtration again through filtering with microporous membrane, and gets ultrafiltrate after the ultrafiltration; Water for injection after itself and the ultrafiltration below 40 ℃ is merged, adjust pH 7.5~10.0, the water for injection of adding again after the ultrafiltration contains crude drug in whole 2g to every 1ml; Treat that medicinal liquid is cooled to fine straining below 30 ℃, fill is sterilized promptly.
2. the preparation method of Radix Astragali injection according to claim 1 is characterized in that, it comprises the steps:
1) Radix Astragali section, the water of 4~8 times of amounts of adding crude drug, 50~60 ℃ were soaked 30~50 minutes, boiled 1.5~2 hours; Leach, add the water of 2~6 times of amounts of crude drug, boiled 1~2 hour; Merging filtrate, cooling was left standstill 1~3 hour, filtered, and was cooled to below 30 ℃;
2) going up resin column then soaked 30~50 minutes, cross post absorption with 18~21 liters/minute flow velocity, with the purified water of 3~4 times of amounts of resin towards post, with 30~40% ethanol of 1~2 times of amount of resin towards post, again with the purified water of 1~2 times of amount of resin towards post, 70~85% ethanol with 4~5 times of amounts of resin soaked 30~50 minutes at last, with 15~16.5 liters of/minute flow velocity eluting;
3) collect eluent, filter, reclaim ethanol, and be concentrated into relative density 1.14~1.18 (80 ℃ ± 2 survey) to nothing alcohol flavor; Add high alcohol and make and contain alcohol amount and reach 80~85%, room temperature left standstill 12~18 hours, and membrane filtration reclaims ethanol to there not being the alcohol flavor; Add the injection water and contain crude drug in whole 2g to every 1ml, stirring and dissolving, adjust pH to 3.0~3.5, the fill sterilization, be refrigerated to icing, 0~6 ℃ of cold preservation 7~9 days;
4) with cold preservation liquid through filtering with microporous membrane, transfer pH 8.0~9.0, add 0.1~0.3% active carbon and boiled 15~20 minutes, treat that temperature drops to below 50 ℃, filter the fill sterilization; Be refrigerated to freeze after, placed 15~20 days in shady and cool dry place or room temperature;
5) first then coarse filtration again through filtering with microporous membrane, and gets ultrafiltrate after the ultrafiltration; Water for injection after itself and the ultrafiltration below 40 ℃ is merged, adjust pH 7.5~9.5, the water for injection of adding again after the ultrafiltration contains crude drug in whole 2g to every 1ml; Treat that medicinal liquid is cooled to fine straining below 30 ℃, fill is sterilized promptly.
3. the preparation method of Radix Astragali injection according to claim 1 and 2 is characterized in that, filter membrane adopts the filter membrane in 0.45~0.65 μ m aperture in the step 3).
4. according to the preparation method of any described Radix Astragali injection of claim 1-3, it is characterized in that microporous filter membrane adopts 0.2~0.45 μ m aperture in the step 4).
5. according to the preparation method of any described Radix Astragali injection of claim 1-4, it is characterized in that microporous filter membrane adopts 0.2 μ m aperture in the step 5).
6. according to the preparation method of any described Radix Astragali injection of claim 1-5, it is characterized in that the ultrafilter of ultrafiltration employing 6000~10000 molecular weight in the step 5).
7. according to the preparation method of any described Radix Astragali injection of claim 1-6, it is characterized in that fine straining adopts 0.2 μ m microporous filter membrane and cartridge type germ tight filter.
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Cited By (4)

* Cited by examiner, † Cited by third party
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CN106256338A (en) * 2016-07-25 2016-12-28 湖北梦阳药业股份有限公司 A kind of raw white kalgan lamb skin takes liquid production line
CN106619794A (en) * 2016-12-27 2017-05-10 神威药业集团有限公司 Refining method of high-stability radix astragali seu hedysari injection solution and radix astragali seu hedysari injection solution
CN106806348A (en) * 2015-11-30 2017-06-09 湖南恒生制药股份有限公司 The preparation method of Breviscapine
CN113730346A (en) * 2021-09-15 2021-12-03 大理药业股份有限公司 Method for improving stability of radix astragali injection

Family Cites Families (1)

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Publication number Priority date Publication date Assignee Title
CN1515295A (en) * 2003-01-08 2004-07-28 上海盛平医药科技有限公司 Astragalus root extract injection and its preparation method

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106806348A (en) * 2015-11-30 2017-06-09 湖南恒生制药股份有限公司 The preparation method of Breviscapine
CN106256338A (en) * 2016-07-25 2016-12-28 湖北梦阳药业股份有限公司 A kind of raw white kalgan lamb skin takes liquid production line
CN106619794A (en) * 2016-12-27 2017-05-10 神威药业集团有限公司 Refining method of high-stability radix astragali seu hedysari injection solution and radix astragali seu hedysari injection solution
CN106619794B (en) * 2016-12-27 2020-08-21 神威药业集团有限公司 Refining method of high-stability astragalus injection and astragalus injection
CN113730346A (en) * 2021-09-15 2021-12-03 大理药业股份有限公司 Method for improving stability of radix astragali injection

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