阿咖酚散微生物限度检查方法的验证

Validation of Methodology on the Microbial Limit Test for Akafen Powder

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。

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.