海峡药学2024,Vol.36Issue(3) :38-41.

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

郭瑜蓉 黄翠莲 沈麟 杨真真 徐端琼
海峡药学2024,Vol.36Issue(3) :38-41.

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

郭瑜蓉 1黄翠莲 1沈麟 1杨真真 2徐端琼1
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作者信息

  • 1. 泉州市食品药品检验所,福建泉州 362000
  • 2. 泉州市正骨医院,福建泉州 362000
  • 折叠

摘要

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.

Abstract

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

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基金项目

2021年福建省市场监督管理局科技项目(FJMS2021035)

出版年

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
参考文献量2
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