舒筋定痛片国家药品抽检检测及探索性研究  

Statutory Inspection and Exploratory Research of Shujin Dingtong Tablets Based on National Drug Evaluation Surveillance

作　　者：胡晓茹[1] 党海霞[2] 张南平[1] 周亚楠 郭日新 刘晶晶[1] 郑笑为[1] 张毅 马双成[1] 戴忠[1] 王海南 HU Xiao-ru;DANG Hai-xia;ZHANG Nan-ping;ZHOU Ya-nan;GUO Ri-xin;LIU Jing-jing;ZHENG Xiao-wei;ZHANG Yi;MA Shuang-cheng;DAI Zhong;WANG Hai-nan(National Institutes for Food and Drug Control,Beijing 100050,China;China Academy of Chinese Medical Sciences,Beijing 100700,China;Chongqing Institute for Food and Drug Control,Chongqing 401121,China;National Medical Products Administration,Beijing 100037,China)

机构地区：[1]中国食品药品检定研究院,北京100050 [2]中国中医科学院,北京100700 [3]重庆市食品药品检验检测研究院,重庆401121 [4]国家药品监督管理局,北京100037

出　　处：《中国药学杂志》2021年第13期1091-1098,共8页Chinese Pharmaceutical Journal

摘　　要：目的基于舒筋定痛片的国家药品评价抽检工作,在系统评价其质量现状的基础上,对中成药质量评价方法研究提出建议。方法结合标准检验和探索性研究,从真实性、安全性和有效性方面对舒筋定痛片的质量状况进行系统评价,并对抽检中发现的问题进行总结、分析。结果标准检验显示舒筋定痛片合格率较高;探索性研究结果表明,个别样品和批次存在处方药味掺伪或者混用,原料质量差、工艺不合理,重金属及有害元素超过拟定限度等问题。结论建议在中药质量专属性成分评价、与临床有效性关联的生物效应质量评价及“点-线-面”的全方质量评价模式等方面加强研究,开展中药中矿物药的专项研究,并完善中药中毒性成分检测平台建设和风险评估机制,保障中药的有效性和安全性。OBJECTIVE To evaluate the quality of Shujin Dingtong tablets and give some advice about the quality control of traditional Chinese medicine based on National Drug Evaluation Surveillance.METHODS Statutory inspection and exploratory research can penetrate the quality status of Shujin Dingtong tablets from the authenticity,safety and effectiveness.The quality status revealed the problems were discussed.RESULTS The qualified rate of inspection was 100.0%.There were some defects,such as adulteration or abused use,poor quality of raw materials,insufficient feeding or unreasonable process,heavy metals and harmful elements,and so on.CONCLUSION It is suggested to strengthen the research on the specificity marker of quality control of traditional Chinese medicine,the quality control methods of biological effects related to clinical effectiveness and the“point-line-plane”whole prescription quality control model.Besides these,it is paid attention to improve the quality standard of mineral drugs and perfect the detection platform and safety evaluation of the toxic components of traditional Chinese medicine to ensure the effectiveness and safety of traditional Chinese medicine.

关 键 词：国家药品抽检 中药 质量评价 舒筋定痛片 

分 类 号：R917[医药卫生—药物分析学]