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目的探讨对半夏止咳糖浆进行微生物限度检查进行验证的方法。方法采用常规法或培养基稀释法对本品的细菌、霉菌及酵母菌计数方法进行验证。结果通过人工污染5种代表菌株的回收率试验,以常规法测定半夏止咳糖浆大肠埃希菌、金黄色葡萄球菌、白色念珠菌和黑曲霉的回收率皆在80%以上,而对枯草芽孢杆菌则低于70%,改以培养基稀释法测定,其回收率达90%以上。结论确定对大肠埃希菌、金黄色葡萄球菌、白色念珠菌和黑曲霉能以常规法进行微生物限度检查验证;而对枯草芽孢杆菌则应以培养基稀释法进行验证。
Objective To explore the method of verifying the limit microbiological examination of Pinellia cough syrup. Methods The method of bacterial, mold and yeast count was verified by conventional method or medium dilution method. RESULTS: The recovery rate of artificially contaminated five representative strains was used to determine the recoveries of E. coli, Staphylococcus aureus, Candida albicans, and Aspergillus niger in the Pinellia tuberculosis cough syrup by more than 80%. Bacillus was less than 70%, changed to the medium dilution method, the recovery rate of more than 90%. Conclusions The determination of the microbial limit test for Escherichia coli, Staphylococcus aureus, Candida albicans, and Aspergillus niger can be routinely performed; for Bacillus subtilis, the media dilution method should be used for validation.