| 摘要: |
| 为分析影响无菌检验结果的因素，探寻无菌检验方法优化的思路，对中国、欧盟国家、美国兽用生物制品无菌检验方法进行了全面比较。结果发现，《中国兽药典》中，兽用生物制品通用的无菌检验无论是从培养基种类、培养条件、培养基质量控制还是操作方法均与欧洲药典及美国《联邦法规》第九卷中方法存在差异，对这些差异进行进一步比对验证，可为我国兽用生物制品无菌检验的优化提供借鉴。 |
| 关键词: 兽用生物制品 无菌检验 中国兽药典 欧洲药典 美国《联邦法规》第九卷 |
| DOI： |
| 投稿时间：2021-08-03修订日期：2021-09-13 |
| 基金项目:中国兽医药品监察所“兽药行业工艺性重点专项”-常用细菌类活疫苗活菌计数等培养基质量控制方法研究(GY202010) |
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| Analysis on Sterility Test of Veterinary Biologics among Chinese Veterinary Pharmacopoeia, European Pharmacopoeia and U.S. Code of Federal Regulations |
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| (China Institute of Veterinary Drug Control) |
| Abstract: |
| In order to analyze factors influencing test results and to explore thoughts on sterility test optimization, a thorough comparison of sterility test was made among Chinese Veterinary Pharmacopoeia, European Pharmacopoeia and U.S. Code of Federal Regulations Title 9. The results showed that sterility test in Chinese Veterinary Pharmacopoeia was different from that abroad in culture media, cultural condition, media quality control and method. Comparison and verification of these differences could lay foundation for the optimization of sterility test. |
| Key words: veterinary biologics sterility test Chinese Veterinary Pharmacopoeia European Pharmacopoeia U.S. Code of Federal Regulations title 9 |
