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中国药物评价 ›› 2022, Vol. 39 ›› Issue (1): 32-35.

• 评价技术与方法 • 上一篇    下一篇

复方白及液微生物限度检查方法适用性研究

苑艳飞,申应德2*,李伟栋3   

  1. 1.泰安市食品药品检验检测研究院,山东 泰安 271000;  2. 临沂市检验检测中心,山东 临沂 276001; 3.山东省泰山医院,山东 泰安 271000
  • 收稿日期:2021-09-02 修回日期:2021-11-10 出版日期:2022-02-28 发布日期:2022-02-28

Study on Suitability of Microbial Limit Test Method of Compound Baiji Enema

  1. 1. Taian Institute for Food and Drug Control, Shandong Taian 271000, China;  2. Linyi Center for Inspection and Testing, Shandong Linyin276001, China;  3. Shandong Provincial Taishan Hospital, Shandong Taian 271000, China
  • Received:2021-09-02 Revised:2021-11-10 Online:2022-02-28 Published:2022-02-28

摘要: 目的:对复方白及液微生物限度检查方法适用性进行研究,建立该产品的微生物限度检查方法。方法:按照《中国药典》2020年版要求,分别采用培养基倾注法、薄膜过滤法,进行微生物计数方法适用性试验。采用常规法、薄膜过滤法、培养基稀释法进行控制菌检查方法适用性试验。结果:微生物计数方面,培养基倾注法不能满足要求,采用薄膜过滤法,需氧菌总数、霉菌及酵母菌总数各实验菌株回收比值均在0.5~2.0的范围内。控制菌检查方面,金黄色葡萄球菌检查采用分膜过滤联合培养基稀释法,铜绿假单胞菌检查采用培养基稀释法,试验组菌株均生长良好。结论:薄膜过滤法和培养基稀释法可消除样品抑菌活性,适用于复方白及液微生物限度检查。

关键词: font-size:medium, ">复方白及液;微生物限度检查;薄膜过滤法;抑菌活性

Abstract: Objective:To establish the microbial limit test method of Compound Baiji Enema,the suitability of microbial limit test method was studied. Methods:Accordingto ChP2020, The plate pouring method and the membrane filtration method were used for the tests of total count(aerobic microbial,yeasts and molds).The direct inoculation method,the membrane filtration and the medium dilution method were used for the detection of control bacteria test.Results: The plate pouring method couldn′t met the requirement of the recovery ratio.Using membrane filtration method, the recovery ratio of validation strains was in 0.5~2.In control bacteria test,S.aureuswas determined by membrane filtration method and medium dilution method, P.aeruginosacan be determined by the medium dilution method. Conclusion:The membrane filtration and medium dilution method were used to remove the antimicrobial activity,that was suitable for the microbial limit test method of Compound Baiji Enema.

Key words: Compound Baiji Enema, Microbial limit test, Membrane filtration method, Antimicrobial activity

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