阿咖酚散微生物限度检查方法的验证

目的:建立阿咖酚散的微生物限度检查法,并对该法进行方法学验证。方法:采用2005年版《中国药典》附录微生物限度检查法中的3种方法对阿咖酚散进行研究,通过比较回收率来确定适宜的检查方法。结果:平皿法的5种试验菌的回收率均低于70%;薄膜过滤法回收率达85%以上;控制菌采用培养基稀释法可检出试验菌。结论:本品中细菌、霉菌和酵母菌检查宜采用薄膜过滤法,控制菌检查宜采用培养基稀释法。

Validation of Methodology on the Microbial Limit Test for Akafen Powder

OBJECTIVE:To establish a microbial limit test method for Akafen powder and validate the methodology.METHODS:The three methods for microbial limit test in appendices volume Ⅱ of Chinese Pharmacopoeia(2005 Edition)were adopted to study Akafen powder.The optimal test method was obtained by comparing the recovery rates of test organisms.RESULTS:According to the results,the recoveries of five test bacteria of Akafen powder by plating method were less than 70% versus above 85% by membrane-filter procedure.The the test organisms were successfully detected in the control bacteria test by media dilution method.CONCLUSION:Membrane-filter procedure is advisable for the test of bacteria,mould and yeast fungus,while media dilution method is advisable for the control bacteria test.