基于国家药品抽检的骨刺片质量分析  

Quality analysis of Guci tablets based on national drug evaluation sampling

作　　者：刘静[1] 刘燕[1] 郑笑为[1] 汪祺[1] 何风艳[1] 王菲菲[1] 王亚丹[1] 何轶[1] 聂黎行[1] 胡晓茹[1] 戴忠[1] 马双成[1] LIU Jing;LIU Yan;ZHENG Xiaowei;WANG Qi;HE Fengyan;WANG Feifei;WANG Yadan;HE Yi;NIE Lixing;HU Xiaoru;DAI Zhong;MA Shuangcheng(National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国药物警戒》2023年第3期292-295,共4页Chinese Journal of Pharmacovigilance

基　　金：国家科技重大专项重大新药创制(2018ZX09735-006)。

摘　　要：目的通过骨刺片国家药品抽检,对全国骨刺片质量状况进行综合考察与分析。方法通过开展标准检验与探索性研究工作,特别是根据标准检验过程中发现的问题,同时结合处方中含4味毒性药材以及大处方的主要特点,重点围绕药品安全性与有效性等方面进行深入研究,对骨刺片的质量现状进行深入而全面地分析。结果骨刺片标准检验合格率为98.1%,不合格样品2批次,为士的宁含量测定项不符合规定。探索性研究发现部分批次样品存在砷、汞超标,存在一定安全性风险;部分批次样品可能存在原料药材投料质量差或未按处方投料的问题。结论上述研究发现的安全性与有效性相关问题应予以关注与重视。建议生产企业进一步加强源头控制,同时应加强投料生产过程控制,严把质量关,从而更好地保障药品安全性与有效性。Objective To evaluate the quality of Guci tablets based on national drug evaluation sampling.Methods This quality analysis was based on inspections of standards and research.Since the prescription involved four toxic crude drugs,in-depth research on safety and effectiveness was carried out by targeting the problems found during inspections of standards.Results The qualified rate of inspections of standards was 98.1%.There were 2 batches of unqualified samples and their contents of strychnine fell short of the standard.Research indicated that arsenic and mercury exceeded standard limits in some samples.High concentrations of arsenic and mercury posed a risk to safety.In addition,some crude drugs might have been of poor quality or crude drugs were not used according to the prescriptions.Conclusion Importance should be attached to the safety and effectiveness of drugs.It is recommended that manufacturers strengthen the control over the source of drugs and production processes in order to ensure the safety and effectiveness of medicines.

关 键 词：骨刺片 国家药品评价抽检 乌头碱 士的宁 马钱子碱 重金属 黄曲霉素 质量分析 

分 类 号：R917[医药卫生—药物分析学]