中药保健品中非法掺入格列本脲的检测

Identification and Determination of Illegal Adding of Glibenclamide in Traditional Chinese Medicine for Health Care

目的:建立中药保健品中非法掺入化学成分格列本脲的定性、定量检测方法,为药监、药检部门提供参考。方法:采用薄层色谱法、高效液相色谱法对怀疑掺有格列本脲的荞芪胶囊的提取物进行分离分析,并采用高效液相色谱-二级管阵列检测法及直接电喷雾四级杆质谱技术对其进行定性鉴别,另采用高效液相色谱法测定其中格列本脲的含量。结果:供试品荞芪胶囊A、荞芪胶囊B均检出格列本脲,其含量分别为1·51、0·55mg/粒。结论:本方法专属性强、灵敏度高、操作简便,可作为监测掺有格列本脲中药保健品的有效方法。

OBJECTIVE：To establish a method for identification and determination of illegal adding of chemical substance glibenclamide in traditional Chinese medieine（TCM） for health care, and to provide the reference for the governmental department of drug surveillance and drug inspection.METHODS： TLC and HPLC were employed to isolate and analyze the extract from Qiaoqi capsule suspected of illegal addition of glibenclamide.Glibenclamide was identified by HPLC-DAD spectrography and ESI-MS technology, and the content determination was made by HPLC, RESULTS： Both capsule sample A and B were detected to contain glibenclamide, the concentrations of which were 1,51mg per capsule and 0.55mg per capsule respectively .CONCLUSION：The established method is specific, sensitive, and convenient, and can be used efficiently for control and surveillance of illegal adding of chemical substance glibenelamide in TCM for health care.