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目的建立头孢克肟分散片的微生物限度检查方法,并对其进行方法学验证。方法细菌计数采用薄膜过滤法,霉菌及酵母菌计数采用平皿法,根据中国药典2005年版二部分别使用5种实验菌验证。通过3次独立的平行试验,分别计算各试验菌每次试验的回收率。控制菌检查采用薄膜过滤法。结果各试验菌的回收率均高于70%,稀释液回收率也均高于70%,控制菌检查具有专属性,满足中国药典2005版验证试验的基本要求。结论本品的微生物限度检查方法有效可行,可用于头孢克肟分散片的微生物限度检查。
Objective To establish a limit test method for cefixime dispersible tablets and validate it by methodological method. Methods The bacterial count was measured by membrane filtration method. The counts of molds and yeasts were measured by plate method. According to the Chinese Pharmacopoeia 2005 edition, two kinds of experimental bacteria were used respectively. Through three independent parallel experiments, the recoveries of each test bacteria were calculated separately. Control bacteria used membrane filtration method. Results The recovery rate of each test bacteria was higher than 70%, the diluent recovery rate was higher than 70%, the control bacteria test has the specificity to meet the 2005 Chinese Pharmacopoeia validation test of the basic requirements. Conclusion The microbial limit test method of this product is effective and feasible, which can be used for the limit test of microbe of cefixime dispersible tablets.