一种含醇搽剂微生物限度检查方法学研究

Study on Microbial Limit Inspection Methods for Alcohol Containing Liniment

建立一种含有醇类的吲哚美辛搽剂微生物限度检查方法,为药品检验机构和药品生产企业提供参考。按《中国药典》2020年版四部“非无菌产品微生物限度检查:微生物计数法、控制菌检查法”规定,测定吲哚美辛搽剂对金黄色葡萄球菌、铜绿假单胞菌、枯草芽孢杆菌、白色念珠菌和黑曲霉5种试验菌株的回收率,进行需氧菌、霉菌和酵母菌总数计数方法的适用性试验,并进行控制菌金黄色葡萄球菌和铜绿假单胞菌检查方法的适用性试验。吲哚美辛搽剂可采用薄膜过滤法,pH 7.0无菌氯化钠-蛋白胨缓冲液冲洗3次,每次100 mL,测定其需氧菌、霉菌和酵母菌以及控制菌。方法学验证表明,所建立方法可有效去除抑菌成分醇类的干扰,能为吲哚美辛搽剂的微生物限度检查提供可靠依据。

To establish microbial limit inspection methods of indometacin liniment,which can provide references for drug inspection and control institutions and manufacturers,according to“microbial limit test of non-sterile products:microbial count method,control bacteria test method”in Chinese Pharmacopoeia(2020 edition,Vol.IV),the recovery rates of 5 test strains,including of Staphylococcus aureus,Pseudomonas aeruginosa,Bacillus subtilis,Candida albicans and Aspergillus niger,were measured for validation of the methods for counting of total aerobic bacteria,molds and yeasts,and applicability test of control bacteria Staphylococcus aureus and Pseudomonas aeruginosa was also validated.The membrane-filter procedure was used for the microbial limit inspection methods of indometacin liniment,pH 7.0 sterile sodium chloride peptone buffer as washing liquid,washing volume:100 mL/film,3 times in total,the above method can count total aerobic bacteria,molds and yeasts,and detect control bacteria.Methodology validation indicates that the established method can effectively remove the interference of antibacterial components such as alcohols,and provide a reliable basis for the microbial limit test of indometacin liniment.