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

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.