| 魏引平,闫花丽.从高质量发展谈中药制剂原料的监管[J].中国药事,2023,(1):18-22 |
| 从高质量发展谈中药制剂原料的监管 |
| Discussion on Supervision of Raw Material of Traditional Chinese Medicine Preparation from High Quality Development |
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| DOI：10.16153/j.1002-7777.2023.01.002 |
| 中文关键词: 药品 高质量发展 中药制剂 原料 |
| 英文关键词: drug high quality development traditional Chinese medicine preparation raw material |
| 基金项目: |
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| 摘要点击次数: 841 |
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| 中文摘要: |
| 目的：为中药制剂监管检查更好地服务于行业高质量发展提供参考。方法：归纳中药制剂原料质量控制存在的问题，分析产生问题的原因。结果：现行GMP没有完全对焦中药制剂主要矛盾，对高质量发展关注不够。结论：中药制剂应该探索均一化投料，完善原料质量控制，加强原料供应保障，建议完善GMP中药制剂相关内容，强化投料前质量控制，细化内控质量标准要求，加强原料供应体系审计要求，突出原料供应的稳定性和保障能力，建立基础数据库，助力中药行业发展。 |
| 英文摘要: |
| Objective: To provide references for the supervision and inspection of Chinese medicine preparations to better serve the high-quality development of the industry. Methods: The problems of quality control of raw materials of traditional Chinese medicine preparations, and analyze the reasons for the problems were summarized. Results: The current GMP does not fully focus on the main contradictions of traditional Chinese medicine preparations, and does not pay enough attention to high-quality development. Conclusion: Traditional Chinese medicine preparations should explore uniform feeding, improve the quality control of raw materials, and strengthen the guarantee of raw material supply. It is recommended to improve the relevant content of GMP Chinese medicine preparations, strengthen the quality control before feeding, refi ne standard requirements of the internal control quality, strengthen the audit requirements of the raw material supply system, highlight the stability and support capability of raw material supply, establish a basic database, and help the development of the traditional Chinese medicine industry. |
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