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 E-dition,microbiological examination of nonsterile products:microbial enumeration tests,tests for specified microorgan-isms 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 recov-ery rates of the experimental group were all within the range of 50%-200%;Staphylococcus aureus and Pseudo-monas aeruginosa could be detected by routine method.CONCLUSION XiaoZhong ZhiTong gel contains bacterio-static 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.
关键词
消肿止痛凝胶/微生物限度检查/方法适用性
Key words
XiaoZhong ZhiTong gel/Microbial limit test/Suitability of the test method