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Preparation method of stable fleabane extract injection

A technology for breviscapine and injection, which is applied in the field of medicine, can solve the problems of perishable storage, unstable breviscapine, and inability to solve stability problems, etc., and achieves the effects of increasing solubility and good stability.

Inactive Publication Date: 2004-02-25
上海博泰医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The main component of breviscapine, scutellarin, is unstable and easily deteriorates during storage. Currently, all breviscapine injections used clinically have such problems. Therefore, it is urgent to solve the stability problem of breviscapine injections
At present, there is no documented method to solve this problem. Chinese patent CN 1187356A was published in 1998, disclosing a stable prescription of breviscapine injection, using a series of stabilizers, and adjusting the pH value to 7.0-7.8, In fact, it still does not solve the stability problem

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0009] Breviscapine 4.8g

[0010] Glycerin 100ml

[0011] L-Arginine 12g

[0012] Creatinine 100g

[0013] Add water for injection to 20000ml

[0014] Preparation method: Take 100ml of glycerin, heat it in a water bath to 80°C, add the prescribed amount of scutellarin and L-arginine. Stir to dissolve everything, add water for injection to 20,000ml, add creatinine, stir evenly, add 0.1% activated carbon (calculated by volume), decolorize and adsorb for 30 minutes, remove activated carbon, adjust pH to 5.5 with dilute acetic acid, fine filter the solution, potting and sterilize The breviscapine injection was obtained. The content determined by the HPLC method is 98.9%, and the pH is 5.4; after measurement and calculation: the content is 97.8%, and the pH is 5.5 after three years of storage at room temperature in the dark.

Embodiment 2

[0016] Breviscapine 4.8g

[0017] Ethanol 150ml

[0018] L-Arginine 8g

[0019] Boric acid 200g

[0020] Add water for injection to 20000ml

[0021] Preparation method: Take 150ml of ethanol, heat it in a water bath to 70°C, add the prescribed amount of scutellarin and L-arginine. Stir to dissolve all, add water for injection to 20000ml, add boric acid, stir evenly, add 0.1% activated carbon (calculated by volume), decolorize and adsorb for 30min, remove activated carbon, adjust pH to 6.3 with dilute hydrochloric acid, fine filter the solution, potting and sterilize The breviscapine injection was obtained. The content determined by HPLC method is 100.13%, and the pH is 6.3; after measurement and calculation: the content is 98.6%, and the pH is 6.1 after three years of storage at room temperature in the dark.

Embodiment 3

[0023] Breviscapine 4.8g

[0024] Ethanol 50ml

[0025] Glycerin 50ml

[0026] L-Arginine 16g

[0027] Add water for injection to 20000ml

[0028] Preparation method: Take 50ml of ethanol and 50ml of glycerin, heat it in a water bath to 80°C, add the prescribed amount of scutellarin and L-arginine. Stir to dissolve all, add water for injection to 20,000ml, stir evenly, add 0.1% activated carbon (calculated by volume), decolorize and adsorb for 30 minutes, remove activated carbon, adjust pH to 4.8 with citric acid, fine filter the solution, potting and sterilize. Breviscapine injection. The content determined by the HPLC method is 97.6%, and the pH is 4.8; after measurement and calculation: the content is 97.8%, and the pH is 4.6 after three years of storage at room temperature in the dark.

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Abstract

The present invention provides a preparation method of stable breviscapine injection. In the course of preparation the L-arginine can be added, its concentration is 40-80 mg / 100ml, and its pH value is regulated to 4.5-6.5. Said prepared breviscapine injection is stable in quality. It can be stored for above three years.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a preparation method of a stable breviscapine injection. Background technique [0002] Breviscapus is a total flavonoid extracted from the plant Erigron breviscapus (Vaniot) Hand Mazz of Compositae, mainly used in the treatment of cardiovascular and cerebrovascular diseases. At present, it is widely used in clinical practice with definite curative effect, and the total effective rate is more than 90% for coronary heart disease, angina pectoris, cerebral thrombosis, paralysis caused by cerebral infarction and other diseases. The main component of breviscapine, scutellarin, is unstable and easily deteriorates during storage. Currently, all breviscapine injections used clinically have such problems. Therefore, it is urgent to solve the stability problem of breviscapine injections. At present, there is no documented method to solve this problem. Chinese patent CN 118735...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/7048A61K47/16A61P9/10
Inventor 张卫东张川苏娟周耘
Owner 上海博泰医药科技有限公司
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