| 摘要: |
| 无菌检查法是无菌兽药制剂重要的质量检查方法。根据目前国内外相关文献的研究报道,分别从无菌检查法的特点、替代方案以及兽药制剂特殊性等方面进行论述，以期最大程度降低无菌检查法缺点的影响，规范我国兽药制剂的无菌检查方法，为兽药无菌检查的研究提供参考和依据。 |
| 关键词: 兽药制剂 无菌检查 局限性 替代方法 参数放行 |
| DOI： |
| 投稿时间：2023-02-24修订日期：2023-07-14 |
| 基金项目: |
|
| Discussion on Problems of Sterility Test Method for Veterinary Drug Preparations |
|
| (Beijing Veterinary Drug and Feed Monitoring Center) |
| Abstract: |
| Sterility test is an important method of quality inspection for sterile veterinary drug preparations. According to the domestic and foreign literatures, this paper summaried the characteristics, alternatives of sterility test method and the particularity of veterinary drug preparations, to minimize the impact of the sterility test method and standardize the sterility test method of veterinary drug preparations in China. The purpose is to provide reference and basis for the study of sterility test in veterinary drug. |
| Key words: veterinary drug preparations sterility test limitations alternative methods parametric release |
