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Method for preparing sodium ozagrel 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, limited degree, unstable product quality and the like, and achieves improved quality stability. Effect

Active Publication Date: 2016-02-03
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 ozagrel sodium freeze-dried powder injection, comprising the following steps:

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

[0027] b) mixing the mixed solution A with the second water for injection, followed by freezing and drying to obtain ozagrel sodium 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, the alkaline substance containing sodium ions and the first water for injection, followed by pH adjustment and adsorption treatment. In the present invention, first, ozagrel, alkaline substances containing sodium ions and the first water for injection are mixed; the ozagrel is the main ingredient,...

Embodiment 1

[0050] Prepare 1000 ozagrel sodium freeze-dried powder injections whose specification is 40 mg / support:

[0051] (1) First, add 37g ozagrel and 20g 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 was decarburized to obtain the mixed solution A.

[0052] (2) After mixing the above-mentioned mixed solution A with 800mL water for injection, fine filter through a 0.45 μm microporous filter element and a 0.22 μm microporous filter element in turn, then fill and half-tamp; then place the product in a vacuum freeze-drying oven , freeze at -45°C for 2 hours, then evacuate until the vacuum degree is less than or equal to 0.15mbar, control the heating rate of 7°C / h to 35°C, dry for 3h, stop the vacuum, press the plug, take out the box, and roll the cap to obtain Ozagrel sodium freeze-dried powder injection, said ozagrel so...

Embodiment 2

[0060] Prepare 1000 ozagrel sodium freeze-dried powder injections whose specification is 40 mg / support:

[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 was decarburized to obtain the mixed solution A.

[0062] (2) After mixing the above-mentioned mixed solution A with 600mL water for injection, fine filter through a 0.45 μm microporous filter element and a 0.22 μm microporous filter element in turn, then fill and half-tamp; then place the product in a vacuum freeze-drying oven , freeze at -45°C for 2 hours, then evacuate until the vacuum degree is less than or equal to 0.15mbar, control the heating rate of 7°C / h to 35°C, dry for 3h, stop the vacuum, press the plug, take out the box, and roll the cap to obtain Ozagrel sodium freeze-dried powder injection, said ozagrel so...

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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, in particular to a preparation method of ozagrel sodium freeze-dried powder injection. Background technique [0002] Sodium ozagrel is the first thromboxane synthetase inhibitor listed in China, mainly used for the treatment of acute thrombotic cerebral infarction and the accompanying motility disorder of cerebral infarction, and for the improvement of cerebral vasospasm after subarachnoid hemorrhage surgery Contraction and concurrent cerebral ischemic symptoms. Because ozagrel sodium can not only dissolve thrombosis protein, but also prevent thrombosis, the clinical application of ozagrel sodium has attracted widespread attention. [0003] At present, ozagrel sodium has been made into various pharmaceutical dosage forms for clinical treatment, among which ozagrel sodium for injection is the most commonly used and has a large market demand. In the production process of pharm...

Claims

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Application Information

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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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