灵通颗粒微生物限度检查方法学验证  

Methodology validation of Microbial Limit Test of Lingtong Grain

作　　者：沈婷婷[1] 李世芳[1] 刘瑾[1] 蒋洁莹[1] 

机构地区：[1]上海中医药大学附属曙光医院,上海200021

出　　处：《海峡药学》2015年第1期45-46,共2页Strait Pharmaceutical Journal

摘　　要：目的建立灵通颗粒的微生物限度检查方法。方法按《中国药典》2010版附录微生物限度检查法的指导原则,采用常规法对灵通颗粒的三个批号进行微生物限度检查。细菌、霉菌及酵母菌采用平皿法计数。控制菌采用比照法检验。结果各试验菌的回收率大于70%,控制菌检查中试验组检出试验菌。结论建立的灵通颗粒微生物限度检查方法准确可靠,可行性强,能有效地对其进行微生物限度的测定。OBJECTIVE To establish a method of microbial limit test of Lingtong grain. METHODS According to the China Pharmacopoeia 2010 Edition appendix of microbial limit test method guideline,the routine method was used to determine the microbial limits of Lingtong grain. The plating method can be used to take the number of bacterial,mould,saccharomycetes. The antithesis method was taken for the test of control bacteria. RESULTS The recovery of the strain rate was more than 70%,the experimental group were verified by test bacteria in the control bacteria detection. CONCLUSION The established Lingtong grain of microbial limit test method is accurate,reliable,feasible,and can carry out the measurement of microbial limit effectively.

关 键 词：灵通颗粒 常规法 方法学验证 

分 类 号：R927.2[医药卫生—药学]