CN1543976A - Astragaloside injection preparation and its preparing process - Google Patents
Astragaloside injection preparation and its preparing process Download PDFInfo
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- CN1543976A CN1543976A CNA2003101089141A CN200310108914A CN1543976A CN 1543976 A CN1543976 A CN 1543976A CN A2003101089141 A CNA2003101089141 A CN A2003101089141A CN 200310108914 A CN200310108914 A CN 200310108914A CN 1543976 A CN1543976 A CN 1543976A
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- astragaloside
- ethanol
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- propylene glycol
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Abstract
The invention discloses an astragaloside IV injection preparation (small injection, powder injection, glucose fluid infusion and sodium chloride fluid infusion), and the process for its preparation, wherein the auxiliary solvent and solvent assisting deflocculating agent are screened, which has proved that propylene glycol, ethanol, glycerin, polyethylene glycol, benzyl benzoate and acetic acid dimethylamide has solubilization function for astragaloside IV.
Description
Technical field
The invention belongs to medical technical field, be specifically related to a kind of pharmaceutical preparation of astragaloside, more specifically to a kind of astragaloside injection (comprising small-volume injection, injectable powder, glucose infusion liquid and sodium chloride transfusion), the invention still further relates to the preparation method of said preparation simultaneously.
Background technology
The Radix Astragali is the Chinese medicine of traditional simply invigorating QI to consolidate the body surface resistance, diuresis poison holding, evacuation of pus, expelling pus and promoting granulation.A large amount of studies show that, the Radix Astragali the active main effective ingredient of cardiovascular system is arranged is astragaloside.The traditional Chinese medical science thinks that qi depression to blood stasis is a main cause of cardiovascular and cerebrovascular disease morbidity, and is with astragaloside treatment qi depression to blood stasis cardiovascular and cerebrovascular disease, evident in efficacy.
The Radix Astragali injection of present clinical use mostly is Radix Astragali extract and makes, and wherein Astragaloside content is not high, and differs greatly, and drug effect is wayward; Simultaneously not high because of content, impurity is more, and the untoward reaction after patient's medication is more, and particularly during injecting drug use, it is particularly outstanding that this problem just seems.
Because the water solublity of astragaloside is relatively poor, when its injection of preparation (small-volume injection, injectable powder, glucose infusion liquid and sodium chloride transfusion), be difficult for making stable, satisfactory preparation.
Summary of the invention
The object of the present invention is to provide that a kind of content is clear and definite, quality controllable, the astragaloside injection of stable performance and preparation method thereof, product is injecting medicine-feeding form (as small-volume injection, injectable powder, glucose infusion liquid and sodium chloride transfusion).
Astragaloside is a kind of triterpene saponin, be insoluble in water, but structure is more stable, be difficult for destroyed, decompose, so need not add protective agent such as antioxidant, and very stable under pH2～10 conditions.But select suitable solvent most important to the preparation astragaloside injection.The present invention studies the dissolubility of astragaloside, has solved the poorly soluble problem of astragaloside.
The astragaloside injection that the present invention proposes (comprising small-volume injection, injectable powder, glucose infusion liquid and sodium chloride transfusion), contain the active ingredient astragaloside in its medicinal liquid, and be equipped with pharmaceutic adjuvant, pharmaceutic adjuvant comprises diluent, osmotic pressure regulator, excipient etc., and wherein the content of effective ingredient astragaloside is 1～100mg/ bottle.Here bottle is a packing unit.For example, a packing unit of small-volume injection can be 10ml, and the packing unit of glucose infusion liquid or sodium chloride transfusion can be for 100ml etc.
The raw material of the used astragaloside of the present invention gets through extracting purification, and through quality analysis, wherein the weight concentration of astragaloside is 90-100%.
The structure of astragaloside is as follows:
Among the present invention, when preparation small-volume injection injection, cosolvent, diluent can adopt one or more in propylene glycol, ethanol, glycerol, Polyethylene Glycol, benzyl benzoate, the dimethyl acetylamide, dilute astragaloside in the proper ratio.In these diluent, be good with propylene glycol and alcohol mixeding liquid especially, both weight proportions are 0.5: 1 ~ 1: 0.5.
Among the present invention, the preparation injectable powder generally can adopt conventional freeze-drying, as solvent, the steps include: to get astragaloside with water, adds excipient, adds the water heating for dissolving, filtration sterilization, and packing, lyophilizing, gland is promptly.Used excipient comprises mannitol, lactose, gelatin hydrolysate, glucose, dextran etc.
Among the present invention, the preparation injectable powder also can adopt spray drying method, and with ethanol as solvent, the steps include: to get astragaloside, add excipient, add dissolve with ethanol, filtration sterilization, spray drying, aseptic subpackaged, gland promptly.
Among the present invention, preparation glucose infusion liquid or sodium chloride transfusion need to add cosolvent.Cosolvent can adopt one or more in propylene glycol, ethanol, glycerol, Polyethylene Glycol, benzyl benzoate, the dimethyl acetylamide, and dilutes astragaloside in the proper ratio.
Among the present invention, in order to control the quality of the pharmaceutical preparations, we have set up the HPLC content assaying method of astragaloside.Because astragaloside does not have uv absorption, so adopted evaporat light scattering (ELSD) detector.Astragaloside content is up to specification in the preparation, and all other indexs all meet officinal regulation.The room temperature result of the test that keeps sample for a long time shows that the quality of the pharmaceutical preparations made is stable in addition, and commercially available back does not have quality problems in following 2 years.
The specific embodiment
Further introduce the present invention below by embodiment.
Embodiment 1 (small-volume injection);
Component amount (g/ bottle)
Astragaloside 0.005
Ethanol 0.50
Propylene glycol 0.50
Glycerol 0.10
Preparation technology is:
Get astragaloside, add ethanol, glycerol and propylene glycol dissolving, filtration sterilization, the packing embedding, sterilization is promptly.Wherein the content of astragaloside is 97% of labelled amount in the astragaloside raw material.
Embodiment 2 (injectable powder);
Component amount (g/ bottle)
Astragaloside 0.01
Mannitol 0.03
Preparation technology is:
Get astragaloside, add mannitol, add water 20ml, heating for dissolving claims the heat filtering degerming, and packing, lyophilization are promptly.Wherein the content of astragaloside is 95% of labelled amount in the astragaloside raw material.
Embodiment 3 (injectable powder)
Component amount (g/ bottle)
Astragaloside 0.03
Lactose 0.05
Preparation technology is:
Get astragaloside, lactose adds ethanol 10ml, dissolving, and filtration sterilization, spray drying, aseptic subpackaged, gland is promptly.Wherein the content of astragaloside is 100% of labelled amount in the astragaloside raw material.
Embodiment 4 (sodium chloride transfusion)
Component amount (g/ bottle)
Astragaloside 0.08
Ethanol 5.0
Propylene glycol 3.0
Glycerol 2.0
Polyethylene Glycol 2.0
Sodium chloride 0.90
Water for injection 100
Preparation technology is:
Get astragaloside, add ethanol, propylene glycol, glycerol, Polyethylene Glycol dissolving, add sodium chloride, water for injection, dissolving, mixing, filtration sterilization, the packing embedding, sterilization is promptly.Wherein the content of astragaloside is 96% of labelled amount in the astragaloside raw material.
5) embodiment 5 (glucose infusion liquid);
Component amount (g/ bottle)
Astragaloside 0.10
Ethanol 1.0
Propylene glycol 4.0
Polyethylene Glycol 1.0
Glucose 25.0
Water for injection 500
Preparation technology is:
Get astragaloside, add ethanol, propylene glycol, Polyethylene Glycol dissolving, add glucose, water for injection, dissolving, mixing, filtration sterilization, the packing embedding, sterilization is promptly.Wherein the content of astragaloside is 100% of labelled amount in the astragaloside raw material.
The above-mentioned various astragaloside injection preparations that make, the effective component content of its astragaloside is clear and definite, controlled, and properties of product are very stable, and result of use is good.Room temperature 2 years steady qualities that keep sample for a long time under the commercially available back, every index is up to specification.
Claims (6)
1, a kind of astragaloside injection, it is characterized in that containing in the medicinal liquid active ingredient astragaloside, and be equipped with pharmaceutic adjuvant and form, pharmaceutic adjuvant comprises diluent, cosolvent, osmotic pressure regulator, excipient, the weight concentration of astragaloside is 90-100% in the used astragaloside raw material, and the content of astragaloside is 1～100mg in every bottle of injection.
2, astragaloside injection according to claim 1 is characterized in that cosolvent, diluent adopt one or more in propylene glycol, ethanol, glycerol, Polyethylene Glycol, benzyl benzoate, the dimethyl acetylamide.
3, astragaloside injection according to claim 1 is characterized in that the hydrotropy diluent adopts propylene glycol and ethanol, and both weight proportions are 0.5: 1-1: 0.5.
4, astragaloside injection according to claim 1 is characterized in that used excipient comprises mannitol, lactose, gelatin hydrolysate, glucose, dextran, makes injectable powder by freeze-drying.
5, astragaloside injection according to claim 1 is characterized in that used solvent is water, ethanol, or its mixture, makes injectable powder by spray drying method.
6, astragaloside injection according to claim 1 is characterized in that cosolvent adopts one or more in propylene glycol, ethanol, glycerol, Polyethylene Glycol, benzyl benzoate, the dimethyl acetylamide, makes the transfusion of glucose infusion liquid or sodium chloride.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2003101089141A CN1543976A (en) | 2003-11-27 | 2003-11-27 | Astragaloside injection preparation and its preparing process |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2003101089141A CN1543976A (en) | 2003-11-27 | 2003-11-27 | Astragaloside injection preparation and its preparing process |
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| CN1543976A true CN1543976A (en) | 2004-11-10 |
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| CNA2003101089141A Pending CN1543976A (en) | 2003-11-27 | 2003-11-27 | Astragaloside injection preparation and its preparing process |
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Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100366260C (en) * | 2005-04-01 | 2008-02-06 | 江苏正大天晴药业股份有限公司 | Astragalus glycoside fatty emulsion and its preparation technology |
| WO2009046620A1 (en) | 2007-09-13 | 2009-04-16 | Tianjin Institute Of Pharmaceutical Research | Cycloastragenol monoglucoside, preparation, pharmaceutical composition and application thereof |
| CN100534440C (en) * | 2005-09-02 | 2009-09-02 | 天津药物研究院 | Astragaloside injection and preparation thereof |
| CN101507747B (en) * | 2009-03-21 | 2010-12-01 | 山西振东泰盛制药有限公司 | Preparation method of astragalus total-saponin sodium chloride injector |
| CN101007013B (en) * | 2006-01-23 | 2010-12-01 | 天津药物研究院 | Liposome of astragaloside IV and its medicinal preparation |
| CN107753313A (en) * | 2017-12-04 | 2018-03-06 | 胡江宇 | A kind of method that ultrasonic assistant prepares Astragaloside IV bath foam |
| CN107753306A (en) * | 2017-12-04 | 2018-03-06 | 胡江宇 | A kind of method that microwave radiation technology prepares Astragaloside IV bath foam |
| CN107789215A (en) * | 2017-12-04 | 2018-03-13 | 胡江宇 | A kind of preparation method of Astragaloside IV bath foam |
| CN108478525A (en) * | 2018-04-02 | 2018-09-04 | 青岛科技大学 | One kind having highly-water-soluble and high stable type Astragaloside IV eye drops and preparation method thereof |
-
2003
- 2003-11-27 CN CNA2003101089141A patent/CN1543976A/en active Pending
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100366260C (en) * | 2005-04-01 | 2008-02-06 | 江苏正大天晴药业股份有限公司 | Astragalus glycoside fatty emulsion and its preparation technology |
| CN100534440C (en) * | 2005-09-02 | 2009-09-02 | 天津药物研究院 | Astragaloside injection and preparation thereof |
| CN101007013B (en) * | 2006-01-23 | 2010-12-01 | 天津药物研究院 | Liposome of astragaloside IV and its medicinal preparation |
| WO2009046620A1 (en) | 2007-09-13 | 2009-04-16 | Tianjin Institute Of Pharmaceutical Research | Cycloastragenol monoglucoside, preparation, pharmaceutical composition and application thereof |
| CN101507747B (en) * | 2009-03-21 | 2010-12-01 | 山西振东泰盛制药有限公司 | Preparation method of astragalus total-saponin sodium chloride injector |
| CN107753313A (en) * | 2017-12-04 | 2018-03-06 | 胡江宇 | A kind of method that ultrasonic assistant prepares Astragaloside IV bath foam |
| CN107753306A (en) * | 2017-12-04 | 2018-03-06 | 胡江宇 | A kind of method that microwave radiation technology prepares Astragaloside IV bath foam |
| CN107789215A (en) * | 2017-12-04 | 2018-03-13 | 胡江宇 | A kind of preparation method of Astragaloside IV bath foam |
| CN108478525A (en) * | 2018-04-02 | 2018-09-04 | 青岛科技大学 | One kind having highly-water-soluble and high stable type Astragaloside IV eye drops and preparation method thereof |
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