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A kind of preparation method of ozagrel sodium freeze-dried powder injection

A technology for freeze-dried powder injection and sodium ozagrel, which is applied in the field of preparation of sodium ozagrel freeze-dried powder for injection, can solve the problems of increased content of ineffective ingredients, unstable product quality, limited degree and the like, and achieves improved quality stability. Effect

Active Publication Date: 2018-10-23
HUNAN KELUN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, the existing preparation method is limited in controlling the degradation of ozagrel sodium, which increases the content of ineffective components in the product, so that the obtained product has a higher content of impurities, mainly manifested in unstable product quality.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0025] The invention provides a preparation method of sodium ozagrel freeze-dried powder injection, comprising the following steps:

[0026] a) mixing ozagrel, an alkaline substance containing sodium ions and the first water for injection, and performing pH adjustment and adsorption treatment in sequence to obtain mixed solution A;

[0027] b) mixing the mixed solution A with the second water for injection, freezing and drying in sequence to obtain sodium ozagrel freeze-dried powder injection;

[0028] The volume ratio of the first water for injection to the second water for injection is 6:(3-5).

[0029] In the present invention, the mixed solution A is obtained by mixing ozagrel, an alkaline substance containing sodium ions and the first water for injection, and performing pH value adjustment and adsorption treatment in sequence. In the present invention, ozagrel, an alkaline substance containing sodium ions and the first water for injection are first mixed; the ozagrel is ...

Embodiment 1

[0050] Preparation of 1000 ozagrel sodium freeze-dried powder injections with a specification of 40mg / piece:

[0051] (1) First add 37g ozagrel and 20g sodium hydroxide to 1200mL water for injection, stir to dissolve, then adjust the pH to 8.9-9.0 with 0.5mol / L sodium hydroxide solution, then add 2g activated carbon and stir for 20min, then The titanium rod is decarbonized to obtain mixed solution A.

[0052] (2) After mixing the above-mentioned mixed solution A with 800 mL of water for injection, the 0.45 μm microporous filter element is finely filtered and the 0.22 μm microporous filter element is finely filtered, then filled and semi-pressed; then the product is placed in a vacuum freeze-drying box , freeze at -45°C for 2h, then vacuum to a degree of vacuum less than or equal to 0.15mbar, control the heating rate to be 7°C / h and heat up to 35°C, dry for 3h, stop the vacuum, press plug, unbox, and cover to get Ozagrel sodium freeze-dried powder for injection, the sodium oza...

Embodiment 2

[0060] Preparation of 1000 ozagrel sodium freeze-dried powder injections with a specification of 40mg / piece:

[0061] (1) First, add 37g ozagrel and 15g sodium hydroxide to 1200mL water for injection, stir to dissolve, then adjust the pH value to 8.9-9.0 with 0.5mol / L sodium hydroxide solution, then add 2g activated carbon and stir for 20min, then The titanium rod is decarbonized to obtain mixed solution A.

[0062] (2) After mixing the above-mentioned mixed solution A with 600 mL of water for injection, the 0.45 μm microporous filter element is finely filtered and the 0.22 μm microporous filter element is finely filtered, then filled and half-pressed; then the product is placed in a vacuum freeze-drying box , freeze at -45°C for 2h, then vacuum to a degree of vacuum less than or equal to 0.15mbar, control the heating rate to be 7°C / h and heat up to 35°C, dry for 3h, stop the vacuum, press plug, unbox, and cover to get Ozagrel sodium freeze-dried powder for injection, the sod...

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Abstract

The invention provides a method for preparing a sodium ozagrel freeze-dried powder injection. The method comprises the following steps: a) mixing ozagrel, a sodion-containing alkaline matter and first injection water, and conducting pH value adjustment and adsorption treatment in sequence to obtain a mixed solution A; b) mixing the mixed solution A with second injection water, and conducting refrigeration and drying in sequence so as to obtain the sodium ozagrel freeze-dried powder injection; the volume ratio of the first injection water to the second injection water is 6:(3-5). Compared with the prior art, the provided preparation method can effectively control the content of impurities in the sodium ozagrel freeze-dried powder injection, and can improve the quality stability of the product. Experiment results show that the content of the impurities in the sodium ozagrel freeze-dried powder injection obtained by the provided preparation method is 0.3% or below.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, and more particularly, to a preparation method of ozagrel sodium freeze-dried powder injection. Background technique [0002] Ozagrel sodium is the first thromboxane synthase inhibitor on the market in China. It is mainly used for the treatment of acute thrombotic cerebral infarction and the movement disorder associated with cerebral infarction, and to improve cerebral vasospasm after subarachnoid hemorrhage surgery. Contraction and concurrent cerebral ischemia symptoms. Because sodium ozagrel can not only dissolve thromboprotein, but also have a preventive effect on thrombosis, the clinical application of sodium ozagrel has attracted widespread attention. [0003] At present, sodium ozagrel has been prepared into various pharmaceutical dosage forms for clinical treatment, among which, sodium ozagrel for injection is the most commonly used and has a large market demand. In t...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/4174A61P9/10
Inventor 李全学廖孝曙逯佩荣余泽勇廖国栋黄松生刘志军荣超寻中华陈杨柳
Owner HUNAN KELUN PHARMA
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