磁朱丸质量评价与研究  

Quality evaluation and study of Cizhu Wan

作　　者：闫海霞[1] 李铮[1] 范妙璇[1] 常增荣[1] 陈有根[1] 傅欣彤[1] YAN Hai-xia;LI Zheng;FAN Miao-xuan;CHANG Zeng-rong;CHEN You-gen;FU Xin-tong(Beijing Institute for Drug Control,Beijing Center for Health Food and Cosmetics Control,IS MPA Key Laboratory for Quality Evaluation of Traditional Chinese Medicine(Traditional Chinese Patent Medicine),Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,Beijing 102206,China)

机构地区：[1]北京市药品检验所,北京市保健食品化妆品检验中心,国家药品监督管理局中成药质量评价重点实验室中药成分分析与生物评价北京市重点实验室,北京102206

出　　处：《中国新药杂志》2020年第5期565-570,共6页Chinese Journal of New Drugs

基　　金：国家药典委员会国家药品标准提高2020年版《中华人民共和国药典》科研项目(394)。

摘　　要：目的:调研市场上磁朱丸的质量情况,优化并完善磁朱丸的质量控制方法,为监管工作提供建议。方法:通过市场和问卷调研、检验数据和文献查阅相结合,明确磁朱丸质量和标准现状,同时提出解决方案。结果:市场抽检合格率为84. 78%,发现磁朱丸质量标准存在欠缺,且存在朱砂染色现象,通过标准检验和探索性研究,完善并修订了磁朱丸的质量标准。结论:依据现行标准检验,磁朱丸质量基本合格,但染色及低限投料的情况依然存在,严重影响用药安全。应从源头管控原料药质量,规范药品生产,确保朱砂采用水飞工艺、磁石应为煅磁石、六神曲按照标准生产和炒制,才能真正保障药品质量安全。Objective: To investigate the quality of Cizhu Wan in local market and optimize and improve the quality control method to provide proposals for drug administration. Methods: By combination of survey of market and questionnaire,inspection data and literature review,the present situation of quality and standard of Cizhu Wan was clarified and the solution was proposed. Results: The qualification rate of sampling was 84. 78%according to the legal standard,indicating the quality standard still exists drawback. Dyeing of cinnabaris was detected in some batches. The quality standard of Cizhu Wan was revised and improved on the basis of legal test and exploratory research. Conclusion: The quality of Cizhu Wan was evaluated as average;however,staining and minimum batch charging still exist in some batches,making threaten to medication security. In order to ensure the security of pharmaceutical quality,drug quality should be controlled at beginnings,and pharmaceutical production,such as,should be normalized.

关 键 词：磁朱丸 朱砂 磁石 六神曲 质量 

分 类 号：R931[医药卫生—生药学] R943[医药卫生—药学]