中成药投料规范性问题分析及质量风险防控策略
Analysis on normative problems of Chinese patent medicine feeding and quality risk prevention and control strategy
投稿时间:2022-05-31  修订日期:2022-08-15
DOI:
中文关键词: 投料  中成药  质量  风险管理
英文关键词: feeding  Chinese patent medicine  Quality  risk management
基金项目:广东省药品监督管理局科技创新项目(2021TDB09) );广东省药品监督管理局药品监管综合改革创新项目《创新中成药质量安全风险“全生命周期”科学监管模式》(2022)
作者单位邮编
严倩茹 梅州市食品药品监督检验所 
邬伟魁 梅州市食品药品监督检验所 514071
宋伟 武汉大学人民医院药学部 
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中文摘要:
      近年来,中成药质量总体向好。但是,由于部分品种的质量标准不够完善,未按标准工艺投料亦可生产出符合规定的产品。中成药质量风险具有客观性,生产环节是全生命周期监管的关键点。为确保中成药质量可控性、使用安全性、治疗有效性,基于投料规范性监测中成药的质量风险迫在眉睫。基于工作实践经验结合文献报道,分析中成药投料规范性问题、探讨风险管理的挑战与策略,旨在提高中成药生产投料规范性,防控质量风险,促进中成药产业高质量发展。
英文摘要:
      In recent years, the quality of Chinese patent medicine(CPM) is generally good. However, due to the imperfect quality standards of some varieties, qualified products can be produced without feeding according to the standard process. The quality risk of CPM is objective, and the production link is the key point of whole life cycle supervision. In order to ensure the quality controllability, use safety and treatment effectiveness of CPM, it is urgent to monitor the quality risk of CPM based on feeding standardization. Based on our work experiences and literature reports, this paper analyzes the problems of feeding, discusses the challenges and strategies of risk management. It is expected that this study will improve the standardization of CPM feeding, prevent quality risks, and promote the high-quality development of CPM industry.
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