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目的:建立检测中药降糖制剂中非法掺入的苯乙双胍和格列齐特专属性方法。方法:采用液相色谱-串联四极杆质谱联用法。通过相对分子质量、二级质谱碎片信息、液相色谱保留时间3方面信息,对中药降糖制剂的提取液进行液相色谱-串联四极杆质谱分析。通过与对照品的色谱及质谱行为相比较,对中药降糖制剂中非法掺入的合成降糖药进行定性鉴别。结果:在4种受试中药降糖制剂中,1种被检测到同时掺有苯乙双胍和格列齐特,1种被检测到掺有苯乙双胍。结论:该方法选择性强,灵敏度高,可作为分析中药降糖制剂中非法掺人苯乙双胍和格列齐特的有效检测方法。
OBJECTIVE: To establish a specific method for the detection of illegal incorporation of phenformin and gliclazide in Chinese herbal hypoglycemic agents. Method: Using liquid chromatography-tandem mass spectrometry. According to the information of molecular weight, mass spectrometry (MS/MS) fragmentation, and retention time of liquid chromatography (HPLC), the extracts of traditional Chinese medicine hypoglycemic agents were analyzed by liquid chromatography-tandem mass spectrometry. By comparing with the chromatogram and mass spectrometry behaviors of the reference substance, qualitative identification was made on the synthetically hypoglycemic drug illegally incorporated in the traditional Chinese medicine hypoglycemic agent. RESULTS: Among the 4 Chinese herbal hypoglycemic agents tested, 1 was detected with phenformin and gliclazide at the same time, and 1 was detected with phenformin. Conclusion: This method is highly selective and sensitive. It can be used as an effective method for the analysis of the illegal incorporation of phenformin and gliclazide in Chinese traditional medicine for reducing blood glucose.