通宣理肺片微生物限度检查方法适用性验证

Applicability Validation of Microbial Limit Test for Tongxuan Lifei Tablet

目的:按照《中华人民共和国药典》2020年版对通宣理肺片进行微生物限度检查方法适用性试验研究并建立其方法。方法:本研究依据《中国药典》2020年版四部通则1105及1106,对通宣理肺片进行计数方法和控制菌检查方法的适用性试验。结果:通宣理肺片采用倾注法1∶100稀释级验证需氧菌总数、霉菌和酵母菌总数,回收率在0.5~2范围内;采用常规法验证大肠埃希菌、耐胆盐革兰阴性菌、沙门菌,检出阳性菌,阴性对照未检出。结论:本次验证方法可作为通宣理肺片微生物限度的检查方法。

Objective To establish a microbial limit test and the applicability test for Tongxuan Lifei Tablet based on Chinese Pharmacopoeia in 2020.Methods The applicability of counting method and controlling bacteria methodwere testedaccording to Chinese Pharmacopoeia in 2020(Part IV)General Principles 1105 and 1106.Results The Tongxuan Lifei Tablet was validated by pouring method at 1∶[KG-3/5]100 dilution level for total aerobic bacteria,total molds and yeasts.Besides,the recoveries were in the range of 0.5~2.The conventional method was used to validate the Escherichia coli,bile salt-resistant gram-negative bacteria and Salmonella,and the positive bacteria were detected,while the negative control was not detected.Conclusion Thisvalidated method can be used as a method for checking the microbial limit of Tongxuan Lifei Tablet.