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目的建立甘草浸膏胶囊微生物限度检查方法,并对方法进行验证。方法依据《中华人民共和国药典》2010年版一部附录XⅢc微生物限度检查法进行。细菌计数采用培养基稀释法(0.1ml/皿)进行检查,霉菌和酵母菌计数采用常规法进行检查,控制菌采用常规法(培养基:100ml)进行检查。结果在3次独立的平行实验中,5株实验菌回收率均>70%,符合验证要求。结论该方法消除了样品的抑菌性,可用于该品种的微生物限度检查。
Objective To establish a limit test method of licorice extract capsules and validate the method. Methods based on “People’s Republic of China Pharmacopoeia” 2010 edition of an Appendix X Ⅲ c microbial limit test method. The bacterial count was examined by the medium dilution method (0.1 ml / dish), and the count of molds and yeasts was checked by the conventional method. The control bacteria were examined by the conventional method (medium: 100 ml). Results In three independent parallel experiments, the recovery rate of five strains of bacteria was> 70%, which met the validation requirements. Conclusion This method eliminates the bacteriostasis of the sample and can be used for microbial limit testing of this variety.