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| 中药灭菌方法及典型问题分析 |
| Analysis of sterilization methods and typical problems of traditional Chinese medicine |
| 投稿时间：2024-07-11 修订日期：2024-10-10 |
| DOI： |
| 中文关键词: 中药 灭菌 典型问题 |
| 英文关键词: traditional Chinese medicine sterilization typical problems |
| 基金项目:福建省药品监督管理局2023年度药品安全监管科研项目"已上市中药中等变更的审查标准研究 " |
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| 中文摘要: |
| 目的：为中药生产企业开展中药灭菌研究和药监部门实施相关的监管提供参考。方法：梳理中药灭菌的法规要求和研究思路，并基于中药审评检查案例归纳出典型问题。结果：中药灭菌工艺研究存在灭菌条件选择不合理、研究验证不充分、研究管理不当、过程控制不足等典型问题。结论：建议企业加强物料管理、强化生产过程控制，基于药品特性确定中药灭菌方法，做好变更研究管理工作。 |
| 英文摘要: |
| [Abstract] Objective:In order to provide reference for Chinese medicine production enterprises to carry out Chinese medicine sterilization research and drug supervision departments to implement relevant supervision. Methods:The regulatory requirements and research ideas of traditional Chinese medicine sterilization were sorted out, and typical problems were summarized based on the cases of traditional Chinese medicine review and inspection. Results:There are some typical problems in the research of sterilization process of traditional Chinese medicine, such as unreasonable selection of sterilization conditions, insufficient research verification, improper research management and insufficient process control. Conclusion:It is suggested that enterprises should strengthen material management, strengthen production process control, determine the sterilization method of traditional Chinese medicine based on drug characteristics, and do a good job in change research management. |
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