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

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.结合工作实践经验和文献报道,分析了中成药投料规范性问题、探讨了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.

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 previous work experiences and literature reports,this paper analyzes the problems of feeding,and discusses the challenges&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.