利用兽药典方法对青霉素钾工业盐和原料药的检测比较

Comparing Study on Benzylpenicillin potassium industry salt and Benzylpenicillin potassium active pharmaceutical ingredient according to Chinese Veterinary Pharmacopoeia 2010 Version

关键词:  青霉素钾  工业盐  原料药  中国兽药典（2010年版）

Key words:  Benzylpenicillin Potassium  industry salt  active pharmaceutical ingredient  Chinese Veterinary Pharmacopoeia (2010 Version)

摘要:

为了辨别青霉素钾工业盐和青霉素钾原料药，依据《中国兽药典》（2010年版）中青霉素钾的质量标准，对四家青霉素原料药生产企业提供的4批青霉素钾工业盐和4批青霉素钾原料药进行了检测，项目包括性状、鉴别、吸光度、结晶性、溶液澄清度与颜色、青霉素聚合物、干燥失重、不溶性微粒、酸碱度、有关物质、细菌内毒素、可见异物、无菌和含量测定。结果表明，8批样品均符合现行兽药典青霉素钾标准中各项规定，但结果无法用以区分青霉素钾工业盐和青霉素钾原料药。本实验结果提示注射用青霉素的质量控制方法需进一步加强。

Abstract:

In order to distinguish between Benzylpenicillin potassium industry salt and benzylpenicillin potassium active pharmaceutical ingredient, 4 bathes of industry salt samples and 4 bathes of active pharmaceutical ingredient samples offered by 4 different veterinary drug manufacturers respectively were identified according to quality standards in Chinese Veterinary Pharmacopoeia 2010 Version, including….. Results of those 8 batches of samples were all in compliance with the standards, however, finding no distinguishable differences between industry salt and active pharmaceutical ingredient, which might indicate that quality control method of Benzylpenicillin for injection need to be updated.