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Racemic 2-(alpha-hydroxy amyl) benzoate freeze-dried powder injection and preparation method thereof

一种羟基戊基、苯甲酸盐的技术，应用在医药领域，能够解决易发生降解、稳定性差等问题，达到解决质量不稳定、稳定性增加、储运和使用方便的效果

Active Publication Date: 2016-02-24
NANTONG XIE SHENG YUAN PHARM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The present invention provides a racemic 2-(α-hydroxypentyl)benzoate in order to solve the problem that the active ingredient racemic 2-(α-hydroxypentyl)benzoate is easily degraded and has poor stability in the preparation process of a conventional freeze-dried agent. Hydroxypentyl) benzoate freeze-dried powder injection and preparation method thereof

Method used

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  • Racemic 2-(alpha-hydroxy amyl) benzoate freeze-dried powder injection and preparation method thereof
  • Racemic 2-(alpha-hydroxy amyl) benzoate freeze-dried powder injection and preparation method thereof
  • Racemic 2-(alpha-hydroxy amyl) benzoate freeze-dried powder injection and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0035] Prescription composition (1000 sticks, 25mg / stick)

[0036] Racemic 2-(α-hydroxypentyl)sodium benzoate 25g

[0037] Sodium chloride 15g

[0038] Anhydrous disodium hydrogen phosphate 3g

[0039] Preparation method: dissolve the excipients in water for injection, adjust the pH value to 12.0 with aqueous sodium hydroxide solution after dissolving; add the main drug to the above excipient solution with a pH value of 12.0 to dissolve, add water for injection, and adjust the pH value of the solution with sodium hydroxide solution to 12.0, with a final volume of 1000mL; sterilized by passing through a 0.22μm microporous membrane; filling, 1ml / bottle; semi-pressed butyl rubber stoppers, and freeze-drying in a freeze dryer: put the filled medicinal solution in - Pre-freeze at 35°C, and when the temperature of the liquid medicine reaches -35°C, maintain it for 4 hours; raise the temperature to -30°C in 4 hours, maintain it for 20 hours, and keep the vacuum degree <20Pa; raise ...

Embodiment 2

[0041] Prescription composition (1000 sticks, 25mg / stick)

[0042] Racemic 2-(α-hydroxypentyl)sodium benzoate 25g

[0043] Sodium chloride 90g

[0044] Anhydrous disodium hydrogen phosphate 5g

[0045] Preparation method: with embodiment 1.

Embodiment 3

[0047] Prescription composition (1000 sticks, 25mg / stick)

[0048] Racemic potassium 2-(α-hydroxypentyl)benzoate 25g

[0049] Sodium chloride 90g

[0050] Anhydrous disodium hydrogen phosphate 6g

[0051] Preparation method: with embodiment 1.

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Abstract

The invention discloses a racemic 2-(alpha-hydroxy amyl) benzoate freeze-dried powder injection and a preparation method thereof. The racemic 2-(alpha-hydroxy amyl) benzoate freeze-dried powder injection comprises, by weight, 5-95% of racemic 2-(alpha-hydroxy amyl) benzoate and 5-95% of injection excipient. In the preparation method, an alkalization preparation process using pharmaceutically acceptable alkali to adjust pH value to 11.0-13.0 is adopted, so that the problem that racemic 2-(alpha-hydroxy amyl) benzoate serving as an active ingredient is prone to degrading and low in stability in the process of preparing a freeze-dried agent is solved, stability of active ingredients of the racemic 2-(alpha-hydroxy amyl) benzoate freeze-dried powder injection can be improved remarkably, and the preparation method is suitable for preparing the freeze-dried powder injection.

Description

[0001] The application date is March 25, 2013, the application number is: 201310097200.9, and the invention name is "racemic 2-(α-hydroxypentyl) benzoate freeze-dried powder for injection and its preparation method" Divisional application of patent application. technical field [0002] The invention relates to a racemic 2-(α-hydroxypentyl) benzoate freeze-dried powder injection and a preparation method thereof, belonging to the technical field of medicine. Background technique [0003] Racemic 2-(α-hydroxypentyl)benzoate is the drug precursor of racemic butylphthalide, which can be rapidly converted into racemic butylphthalide in the body to exert its drug effect. After intravenous injection of racemic 2-(α-hydroxypentyl)benzoate in dogs and rats, it can be rapidly and completely converted into racemic butylphthalide in vivo, and the exposure value of racemic butylphthalide in plasma Compared with the exposure value of direct intravenous injection of racemic butylphthalide,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/192
Inventor 刘宇航高哲伟韩亚雄
Owner NANTONG XIE SHENG YUAN PHARM TECH CO LTD
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