| 摘要: |
| 为探讨优化我国兽用生物制品支原体检验方法的可能性,本文从支原体检验方法、培养基种类及培养条件、培养基质量控制和检验操作方法四个方面,对中国、美国和欧盟兽用生物制品支原体检验方法进行系统比较,分析不同方法之间的差异及优劣。结果发现,与美国《联邦法规》第九卷及《欧洲药典》相比《中国兽药典》支原体检验方法有培养基种类及配方成分全面等方面的优势,但在培养基质量控制方法、检验过程控制、检验标准制定等方面还存在不足。正视这些差距与不足,提出改进和验证的方向,可为我国兽用生物制品支原体检验的优化提供参考。 |
| 关键词: 兽用生物制品 支原体检验 中国兽药典 美国《联邦法规》第九卷 欧洲药典 |
| DOI： |
| 投稿时间：2022-11-03修订日期：2023-04-18 |
| 基金项目:兽药行业公益性重点专项(GY202007) |
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| Analysis on Mycoplasma Test of Veterinary Biologics among Chinese Veterinary Pharmacopoeia, U.S. Code of Federal Regulations and European PharmacopoeiaMA Xin, LIU Bo, WEI Jin, WANG Jia, ZHAO Hao-ran, LIU Yan, |
|
| (China Institute of Veterinary Drug Control) |
| Abstract: |
| In order to explore the possibility of optimizing the mycoplasma testing for veterinary biological products in China, this paper systematically compared the mycoplasma testing in China, the United States and the European Union. The differences and advantages and disadvantages were analyzed following the comparison including mycoplasma testing methods, media types and culture conditions, media quality control and testing operation procedures. The results showed that mycoplasma testing in Chinese Veterinary Pharmacopoeia had advantages over the US Code of Federal Regulations, Volume IX and the European Pharmacopoeia in terms of the media types and formulation components, but there were still shortcomings in the media quality control, test process control and test standard development. The study aims to provide a reference for the optimization of mycoplasma testing of veterinary biological products in China. |
| Key words: Veterinary biological products Mycoplasma testing Chinese Veterinary Pharmacopoeia US Code of Federal Regulations, Volume IX European Pharmacopoeia. |
