消肿止痛凝胶微生物限度检查方法的建立

Establishment of the Test Method for Microbiological Examination of XiaoZhong ZhiTong Gel

目的建立消肿止痛凝胶2020年版中国药典微生物限度检查方法,并进行方法适用性试验。方法根据《中国药典》2020年版四部的非无菌药品微生物限度检查进行方法适用性试验。结果采用1∶50供试液检查需氧菌总数,采用常规倾注法检查霉菌和酵母菌总数,试验组的回收率均在50%~200%范围内;金黄色葡萄球菌和铜绿假单胞菌检查使用常规法,均能检出相应控制菌。结论消肿止痛凝胶中含抑菌成分,采用1∶50供试液检查需氧菌总数,采用常规法进行霉菌和酵母菌总数和控制菌检查,方法简便,结果可靠。

OBJECTIVE To develop microbiological examination method of the Chinese Pharmacopoeia(Ch.P)2020 Edition for XiaoZhong ZhiTong gel.METHODS The test was carried out according to Ch.P 2020 Edition,microbiological examination of nonsterile products:microbial enumeration tests,tests for specified microorganisms and limit standard.RESULTS It showed that the total number of aerobic bacteria was checked using a 1∶50 test solution,and the total number of mold and yeast was checked using the conventional pouring method.The recovery rates of the experimental group were all within the range of 50%-200%;Staphylococcus aureus and Pseudomonas aeruginosa could be detected by routine method.CONCLUSION XiaoZhong ZhiTong gel contains bacteriostatic ingredients.The total number of aerobic bacteria is checked with 1∶50 test solution,and the total number of mold and yeast and control bacteria are checked with routine method.The method is simple and reliable.