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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：2024-11-07 |
| DOI： |
| 中文关键词: 中药 灭菌 典型问题 审评 检查 变更 |
| 英文关键词: traditional Chinese medicine sterilization typical problem review inspection change |
| 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（编号 2023023） |
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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提出建议，为药监部门实施相关监管提供参考。方法：梳理中药灭菌的法规要求和常规中药灭菌工艺，并基于中药审评检查案例归纳、分析典型问题。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，确保变更的合理性和合规性。 |
| 英文摘要: |
| Objective: In order to provide suggestions for Chinese medicine manufacturers to carry out research
on sterilization of traditional Chinese medicine, and to provide reference for the implementation of relevant
supervision by the pharmaceutical supervision department. Methods: The regulatory requirements of traditional
Chinese medicine sterilization and the conventional sterilization process of traditional Chinese medicine were
sorted out, and typical problems were summarized and analyzed based on the cases of traditional Chinese
medicine review and inspection. Results: There were 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 and management to ensure the rationality and compliance of changes. |
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