首页|消肿止痛凝胶微生物限度检查方法的建立

消肿止痛凝胶微生物限度检查方法的建立

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

XiaoZhong ZhiTong gelMicrobial limit testSuitability of the test method

郭瑜蓉、黄翠莲、沈麟、杨真真、徐端琼

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泉州市食品药品检验所,福建泉州 362000

泉州市正骨医院,福建泉州 362000

消肿止痛凝胶 微生物限度检查 方法适用性

2021年福建省市场监督管理局科技项目

FJMS2021035

2024

海峡药学
中国药学会福建分会

海峡药学

影响因子:0.643
ISSN:1006-3765
年,卷(期):2024.36(3)
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