广东省医疗机构中药制剂使用紫河车药材相关问题的监管思考  

The Regulatory Considerations on Related Issues of Placenta Hominis of Traditional Chinese Medicine Preparations in Medical Institutions of Guangdong Province

作　　者：陈家润 曾祥卫 沈小莉[2] 江映珠 吴雪龙 Chen Jiarun;Zeng Xiangwei;Shen Xiaoli;Jiang Yingzhu;Wu Xuelong(Center for Evaluation and Certifi cation,Guangdong Medical Products Administration,Guangzhou 510080,China;Guangdong Food and Drug Vocational College,Guangzhou 510520,China)

机构地区：[1]广东省药品监督管理局审评认证中心,广州510080 [2]广东食品药品职业学院,广州510520

出　　处：《中国药事》2023年第7期772-775,共4页Chinese Pharmaceutical Affairs

基　　金：广东省药品监督管理局科技创新项目(编号2022TDB08);广东省食品药品监督管理局科技创新项目(编号2018TDZ10)。

摘　　要：目的:为解决医疗机构中药制剂使用紫河车药材可能影响产品安全性的问题提供思路,促进医疗机构中药制剂的发展。方法:针对广东省现有医疗机构中药制剂使用紫河车药材可能影响产品安全性的问题,通过查阅文献、研究技术指导原则来寻找解决问题的方法。结果:提出加强紫河车来源管理、提高紫河车质量标准、变更制剂工艺及制剂说明书标示警示语4种解决思路。结论:4种解决思路的提出,解决了使用紫河车药材所引起可能影响产品安全性问题的不足,可为支持医疗机构中药制剂的发展提供新的思路。Objective:To provide ideas for solving the issues that may affect the safety of products caused by the using Placenta Hominis of traditional Chinese medicine preparations in medical institutions,and lay a foundation for the rapid development of traditional Chinese medicine preparations in medical institutions.Methods:In view of the issues that may affect the safety of the product caused by using Placenta Hominis of traditional Chinese medicine preparations in medical institutions in Guangdong province,a solution was identifi ed by referring to the literature and researching on the technical guidelines.Results:Four solutions were proposed:to strengthen the management of the source of Placenta Hominis,improve the quality standard of Placenta Hominis,change the preparation technology,and label warning words in the instructions.Conclusion:The proposed four solutions could solve the issues that may affect the safety of products caused by using Placenta Hominis,and provid new ideas to support the development of traditional Chinese medicine preparations in medical institutions.

关 键 词：医疗机构中药制剂 紫河车 安全性 思考 药品监管 

分 类 号：R95[医药卫生—药学]