哌拉西林原料药新版药典微生物限度检查方法的验证

Validation of Microbial Limit Test for Piperacillin Raw Material According to Chinese Pharmacopoeia 2015 Edition

目的:建立哌拉西林原料药微生物限度检查法并进行方法学验证。方法:按《中国药典》2015年版四部制剂通则1105、1106、1107项下要求进行试验。需氧菌总数检查、霉菌和酵母菌检查采用薄膜过滤法(每筒冲洗量500 m L,150万单位青霉素酶),大肠埃希菌检查采用薄膜过滤法(每筒冲洗量500 m L,150万单位青霉素酶),采用上述方法对哌拉西林原料药各试验菌进行回收试验测试及对控制菌检查方法进行验证。结果:需氧菌总数、霉菌和酵母菌总数验证试验中各菌的回收比值均符合《中国药典》2015年版规定,控制菌检查方法可行。结论:该方法适用于哌拉西林原料药的微生物限度检查。

Objective To establish and validate microbial limit test for piperacillin raw material. Methods：The test was carried out according to the requirements of provision 1105, 1106 and 1107 of rules of preparationin volume IV of Chinese Pharmacopoeia 2015 edition. The membrane filtration method was used to detect thetotal viable aerobic bacteria count, total combined yeasts and molds count （500 mL per membrane, 1.5x 106IU penicillinase）. This method was also used to control Escherichia coli （500 mL per membrane, 1.5x 106 IUpenicillinase）. The above-mentioned method was used to test the bacteria, fungi or yeasts in piperacillin rawmaterial and was also validated. ＂Results： The validation results showed that the recovery ratios of all the testedbacteria, fungi or yeasts were in accordance with the acceptance criteria of the Chinese Pharmacopoeia 2015edition and the method for specified bacteria test was reliable. Conclusion： The method is suitable for themicrobial limit test for piperacillin raw material.