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Freeze-drying composition for injection

A composition and freeze-drying technology, applied in the directions of freeze-dried delivery, drug combination, medical preparations containing active ingredients, etc., can solve the problems of easy change of color and luster, poor solubility of main drugs, and no clear teaching of solutions found.

Inactive Publication Date: 2004-01-14
北京东方天翔医药技术开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, conventional ginkgo extract injections have some quality problems to varying degrees, such as poor stability, solvent irritation and side effects to patients, easy color change, etc.
In addition, in order to solve the shortcomings of poor light stability, the commercially available Ginkgo Damo injection (small water injection) is packaged in brown ampoules, which is not conducive to visual inspection of product quality control; in order to solve the shortcomings of poor solubility of the main drug , also added about 5% ethanol
[0004] For those skilled in the art, when Ginkgo biloba is used in combination with dipyridamole, other quality problems of its compound preparations (especially injection preparations) are even more difficult to predict, and there is no clear definition of related solutions found in the prior art. teach

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Embodiment 1: prepare the lyophilized preparation prescription containing surfactant:

[0025] Ginkgo Biloba Extract 2.0g

[0026] Dipyridamole 0.2g

[0027] Mannitol 15g

[0028] Poloxamer 3g

[0029] Niacinamide 2.5g

[0030] Polyvinylpyrrolidone 2g process:

[0031] (1) drip the sodium hydroxide solution into the ginkgo biloba extract under sufficient stirring, and after dissolving, add poloxamer to adjust the pH value to 5.4;

[0032] (2) Add hydrochloric acid dropwise into dipyridamole under full stirring, and after dissolving, add nicotinamide and polyvinylpyrrolidone successively to adjust the pH value to 5.7;

[0033] (3) Under stirring, add the solution obtained in step (2) dropwise to the solution obtained in step (1), then add the activated carbon-treated mannitol solution, supplement water for injection, and then add an appropriate amount of Activated carbon, stirred for about 15 minutes, while hot, use a 0.8μn microporous membrane for coars...

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Abstract

A freeze-dried composition for injection contains the extract of ginkgo leaf and dipyridamole. The process for prepairing it is also disclosed. Its advantages are better solubility and high stability.

Description

technical field [0001] The invention relates to a freeze-dried pharmaceutical composition, in particular to a freeze-dried pharmaceutical composition for injection containing ginkgo and dipyridamole and a preparation method thereof. Background technique [0002] Modern pharmacological studies have shown that Ginkgo biloba and its active ingredients have a wide range of pharmacological effects, such as lowering blood fat, anti-atherosclerosis, and improving heart and brain microcirculation (Zhuo Bin et al., China Pharmaceutical Industry, 2001, No. 11: pp. 67-69 ; Tang Ling et al., Huaxia Medicine, No. 3, 2001). Simultaneously, people have also carried out in-depth research on the combination of Ginkgo biloba extract and other active substances, and have made certain progress (for example, Lin Jinhua et al., Shi Zhen Guo Yi Guo Yao 2001 No. 9; and CN1262103A etc.). Especially noteworthy is the combination of ginkgo and dipyridamole (Zheng Chunhui, Mod...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4985A61P9/10
Inventor 徐新盛文艳秋
Owner 北京东方天翔医药技术开发有限公司
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