复方参芪五味咀嚼片微生物限度检查的方法验证
Validation for determination method of microbacteria limit of compound Shenqi Wuwei chewable tables
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摘要: 目的 对复方参芪五味咀嚼片微生物限度检查方法进行验证。 方法 采用平皿计数法,通过5种阳性对照菌回收率试验进行细菌、霉菌及酵母菌计数方法的验证;采用相同的实验条件,观察大肠埃希菌在试验组、阳性对照组和阴性对照组中的检出情况验证控制菌检查方法。 结果 细菌、霉菌及酵母菌计数用常规法时,各试验菌回收率在70%以上;控制菌检查中,试验组和阳性对照组检出大肠埃希菌,阴性对照组未检出菌。 结论 本方法简便可行,结果准确,适合于微生物限度检查。Abstract: Objective To validate the determination method of microbacteria limit of compound shenqi wuwei chewable tables. Methods Plate counting method was used.The method of counting bacteria and mould was validated by the recovery rates with 5 control trains.The method of checking control bacteria was validated by observing cultivation of Escherichia coli coliform in the test group, positive control group and negetivu control group under the same environment. Results The recovery rate of every trail bacteria was higher than 70% when common methods were used in the counting bacteria and mould;To the examination of control bacteria, Escherichia coli coliform was detected in the test group and positive control group, and hadn't been detected in the negative control group. Conclusion The method was simple, feasible ,reliable and could be used for the examination of microbacteria limit.
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[1] 中国药典.2010年版.一部[S] .2010:附录XIII C:79~88. [2] 中国药品生物制品检定所.中国药品检验标准操作规范[S].北京:中国医药科技出版社,2010:351~368. -
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