基于国家药品抽检的血竭饮片的质量问题分析  

Quality Analysis of Draconis Sanguis Based on National Drug Sampling Inspection

作　　者：张明童 刘志荣 李冬华 宋平顺 马潇 杨玲霞 Zhang Mingtong;Liu Zhirong;Li Donghua;Song Pingshun;Ma Xiao;Yang Lingxia(Gansu Institute for Drug Control,Gansu Inspection and Testing Technical Engineering Laboratory for Chinese Herbal and Tibetan Medicine,NMPA Key Laboratory for Quality Control of TCM,Lanzhou 730070,China)

机构地区：[1]甘肃省药品检验研究院,甘肃省中藏药检验检测技术工程实验室,国家药品监督管理局中药材及饮片质量控制重点实验室,兰州730070

出　　处：《中国药事》2024年第3期312-319,共8页Chinese Pharmaceutical Affairs

基　　金：中药材及饮片质量控制重点实验室项目(编号2022GSMPA-KL12,2022GSMPA-KL10);甘肃省药品科研项目(编号2022GSMPA0017,2022GSMPA0075);兰州市科技计划项目资助(编号2022-3-41)。

摘　　要：目的:通过开展血竭饮片的国家抽检工作,提升现行标准,全面掌握血竭的质量问题,为血竭的监管提供技术支持,保障公众用药安全。方法:依据法定标准进行检验,从影响药品的安全性、有效性及标准完善等方面开展探索性研究。结果:共抽检47批血竭饮片,按现行质量标准检验并结合探索性研究,其不合格率为70.2%。改进了薄层色谱和含量测定方法,针对血竭中掺龙血竭问题,建立了补充检验方法。结论:血竭饮片质量较差,非法掺入龙血竭现象严重,应加强监管;检验标准仍需进一步完善,建议修订薄层色谱鉴别和含量测定方法,制订血竭中龙血竭成分检查的补充检验方法。Objective:To improve the current standards,fully grasp the quality problems of Draconis Sanguis,provide technical support for the supervision of Draconis Sanguis and ensure the safety of the public medication,the national drug evaluation sampling inspection of Draconis Sanguis was carried out.Methods:According to the legal standards,exploratory research was carried out in terms of infl uencing the safety,eff ectiveness and standard perfection of drugs.Results:A total of 47 batches of Draconis Sanguis were sampled,and according to the current quality standard inspection combined with exploratory research,the unqualifi ed rate was 70.2%.The TLC method and content determination method were improved.Aiming at mixing Resina Draconis in the Draconis Sanguis,supplementary testing method was established.Conclusion:The quality of Draconis Sanguis is poorer.The phenomenon of illegal adulteration of Resina Draconis is serious,so supervision should be strengthened and the inspection standards still need to be further improved.It is recommended to revise the TLC identifi cation and content determination methods,as well as develop supplementary testing methods for detecting the components of Resina Draconis.

关 键 词：血竭 龙血竭 质量分析 问题 建议 

分 类 号：R95[医药卫生—药学]