伤科消痛酒微生物限度检查方法的适用性试验

Applicability test of microbial limit test for Xiaotong liquor in Department of Traumatology

目的探究伤科消痛酒微生物限度检查方法的适用性试验。方法按照《中华人民共和国药典》2015年版规定,采用薄膜过滤法对需氧菌总计数、霉菌及酵母菌计数及控制菌进行检测。结果薄膜过滤法可使黑曲霉、枯草芽孢杆菌、白色念珠菌、金黄色葡萄球菌、铜绿假单胞菌的回收率比值均高于0.70以上;真菌和酵母菌总数计数适用性试验结果显示,薄膜过滤法可使真菌和酵母菌的回收率比值高于0.70以上;5种验证菌株的菌落数比值均在0.5~2.0,符合验证要求。结论本方法验证结果准确、可靠、重现性好,适用于伤科消痛酒的微生物限度检查。

Objective To explore the applicability of the Department of Traumatology test elimination method for microbial limit test of pain wine.Methods according to the provisions of the ＂Chinese＂ Pharmacopoeia of 2015 edition, the filtration method was used to detect the total count of aerobic bacteria, molds and yeasts and control bacteria.Results the membrane filtration method can make the recovery of Aspergillus niger, Bacillus subtilis,white Candida albicans, Staphylococcus aureus,Pseudomonas aeruginosa and the ratio is higher than 0.70; the total number of fungi and yeasts count applicability test results of membrane filtration method can make the recovery rate of fungus and yeast ratio higher than 0.70; the ratio of colony 5 verification strains were in the range of 0.5 to 2.0,in line with the validation requirements.Conclusion this method is accurate,reliable and reproducible,and is suitable for the microbial limit test of Xiaotong liquor in Department of traumatology.