| 引用本文: | 李辉,周发友,杨晓莉,马仕洪,绳金房.中国药典2020年版抑菌效力检查法修订介绍[J].中国现代应用药学,2021,38(6):655-660. |
| LI Hui,ZHOU Fayou,YANG Xiaoli,MA Shihong,SHENG Jinfang.Introduction to the Revision of the Antimicrobial Effectiveness Testing of Chinese Pharmacopoeia 2020 Edition[J].Chin J Mod Appl Pharm(中国现代应用药学),2021,38(6):655-660. |
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| 中国药典2020年版抑菌效力检查法修订介绍 |
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李辉1,2, 周发友3, 杨晓莉2,4, 马仕洪3, 绳金房2,4
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1.陕西盛德泰林生物安全技术检测有限公司, 西安 710065;2.国家药品监督管理局药品微生物检测技术重点实验室, 西安 710065;3.中国食品药品检定研究院, 北京 100050;4.陕西省食品药品监督检验研究院, 西安 710065
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| 摘要: |
| 目的 介绍中国药典（Chinese Pharmacopoeia，ChP）2020年版抑菌效力检查法修订情况。方法 对比ChP 2020年版与ChP 2015年版抑菌效力检查法内容的主要差异，同时分析ChP、美国药典（USP）、欧洲药典（EP）、英国药典（BP）、日本药局方（JP）等主要药典相关内容的区别与联系。结果 ChP 2020年版抑菌效力检查法在培养体系、测试菌种等方面都做了修订，更适合指导药物制剂中抑菌剂的筛选和抑菌体系的建立。结论 ChP 2020年版抑菌效力检查法进一步获得提高，成为更加完善的方法，既可用于指导药品研发阶段抑菌剂的筛选，也可用于上市药品抑菌剂添加是否科学合理的评价，有利于保证药品安全有效。 |
| 关键词: 抑菌效力 抑菌剂 抑菌效力检查法 中国药典2020年版 药典修订 微生物控制 水分活度 |
| DOI：10.13748/j.cnki.issn1007-7693.2021.06.004 |
| 分类号:R951 |
| 基金项目:陕西省重点研发计划项目（2019SF-062） |
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| Introduction to the Revision of the Antimicrobial Effectiveness Testing of Chinese Pharmacopoeia 2020 Edition |
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LI Hui1,2, ZHOU Fayou3, YANG Xiaoli2,4, MA Shihong3, SHENG Jinfang2,4
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1.Shaanxi Shengde Tailin Biological Safety Technical Testing Co., Ltd., Xi'an 710065, China;2.NMPA Key Laboratory for Testing Technology of Pharmaceutical Microbiology, Xi'an 710065, China;3.National Institutes for Food and Drug Control, Beijing 100050, China;4.Shaanxi Institute for Food and Drug Control, Xi'an 710065, China
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| Abstract: |
| OBJECTIVE To introduce the main revision situation about antimicrobial effectiveness testing of the Chinese Pharmacopoeia(ChP) 2020 Edition. METHODS Compared antimicrobial effectiveness testing of ChP 2020 Edition to the relevant content of the ChP 2015 Edition, the differences and links between the main pharmacopoeias such as ChP, US Pharmacopoeia(USP), European Pharmacopoeia(EP), British Pharmacopoeia(BP), and Japanese Pharmacopoeia(JP) were analyzed at the same time. RESULTS The antimicrobial effectiveness testing of ChP 2020 Edition had been revised in the culture system, test strains, and so on, it was more suitable to guide the screening of antibacterial agents and the establishment of antibacterial systems in the pharmaceutical preparations. CONCLUSION The antimicrobial effectiveness testing has been further improved to become a more complete method, which can be used to guide the screening of bacteriostatic agents in the drug development stage, and can also be used for the scientific and reasonable evaluation of the addition of bacteriostatic agents for listed drugs, which is conducive to ensuring drug safety and effective. |
| Key words: antimicrobial effectiveness antimicrobial agent antimicrobial effectiveness testing Chinese Pharmacopoeia 2020 Edition pharmacopoeia revision microbial control water activity |
