高效液相色谱-手性拆分法检查消炎镇痛膏非法添加阿托品研究  

Study on the Determination of Atropine Illegally Added in Xiaoyan Zhentong Ointment by HPLC with Chiral Resolution

作　　者：任琦 许妍 袁铭铭 付辉政 罗跃华 马双成[2] REN Qi;XU Yan;YUAN Minmin;FU Huizheng;LUO Yuehua;MA Shuangcheng(Jiangxi Institute for Drug Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Province Engineering Research Center of Drug and Medical Device Quality,Nanchang Jiangxi 330029,China;National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,江西南昌330029 [2]中国食品药品检定研究院,北京100050

出　　处：《药品评价》2023年第9期1070-1073,共4页Drug Evaluation

基　　金：江西省重点研发计划项目(20202BBGL73007)

摘　　要：目的建立消炎镇痛膏非法添加阿托品的高效液相色谱-手性拆分检查方法。方法采用手性色谱柱,对阿托品进行手性拆分。以(+)莨菪碱与(-)莨菪碱峰面积的比值来判定消炎镇痛膏是否存在非法添加阿托品的情况。结果(+)莨菪碱与(-)莨菪碱的峰面积之比值大于0.33时,则判定为添加阿托品;反之,则判定为未添加阿托品。结论该方法能够准确判定消炎镇痛膏是否存在非法添加阿托品情况,也可为其他含颠茄流浸膏的制剂是否存在非法添加阿托品研究提供参考依据。Objective To establish a HPLC chiral separation method for the determination of atropine illegally added in xiaoyan zhentong ointment.Methods The chiral separation of atropine was carried out on a chiral column.The ratio of peak area of(+)and(-)anisodamine was used to determine whether there was illegal addition of atropine in xiaoyan zhentong ointment.Results When the ratio of peak area of(+)and(-)anisodamine was greater than 0.33,atropine was added;otherwise,atropine was not added.Conclusion This method can accurately determine whether there is illegal atropine addition in xiaoyan zhentong ointment,and can also provide reference for the research on the illegal atropine addition in other preparations containing extractum belladonnae liquidum.

关 键 词：消炎镇痛膏 颠茄流浸膏 高效液相色谱法 手性拆分 阿托品 非法添加 

分 类 号：R286.0[医药卫生—中药学]