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[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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[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 ...
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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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