七味参地胶囊微生物限度检查方法学验证

Validation of microbial limit test method for seven flavored ginseng capsules

目的建立七味参地胶囊微生物限度检查法.方法采用《中国药典》2015年版四部规定的常规法及培养基稀释法测定该药品对5株验证菌的回收率,同时验证控制菌的检验方法.结果可用常规法进行七味参地胶囊的微生物检查,5株控制菌的回收率均达到70%以上,各控制菌试验中,阴性菌对照组未检出对照菌,试验组检出试验菌,符合验证要求.结论采用常规法(平皿法)不会对七味参地胶囊可能存在的各类微生物产生抑制作用,可用常规法进行七味参地胶囊的微生物限度检查.

Objective To establish a microbial limit test method for Qiwei Shendi capsule.Methods the recovery rate of 5 validation bacteria was determined by the conventional method and culture medium dilution method specified in the fourth part of Chinese Pharmacopoeia(2015 Edition),and the test method of control bacteria was verified.Results Routine method can be used for microbial inspection of qi wei shen di capsule,the recovery rate of 5 control bacteria reached more than 70%.In each control bacteria test,no control bacteria were detected in the negative bacteria control group,and the test bacteria were detected in the experimental group,which met the verification requirements.Conelusion the conventional method(plate method)can not inhibit all kinds of microorganisms in Qiwei Shendi capsule,but can be used for microbial limit test of Qiwei Shendi capsule.