液质联用分析中药降糖制剂中掺入的西药成分

Detection of Synthetical Compounds Illegally Mixed into Traditional Chinese Medicine Antidiabetic Preparations by Liquid Chromatography-Mass Spectrometry

采用液相色谱-离子阱质谱联用技术检测中药降糖制剂中非法掺入的西药成分.选用MGII C18色谱柱,以甲醇、水和甲酸(三者的体积比为80.0∶20.0∶0.1)为流动相,对中药降糖制剂的提取液进行液相色谱-离子阱质谱分析.通过与对照品的色谱和质谱行为比较,对中药降糖制剂-荞芪胶囊中非法掺入的合成降糖药进行定性鉴别和初步定量分析.结果表明:该荞芪胶囊中分别检测到苯乙双胍2.6 mg/粒,格列本脲2.0 mg/粒;液相色谱-离子阱质谱联用技术快速、准确,可作为分析检测中药降糖制剂中非法掺入合成药的有效方法.

Liquid chromatography-mass spectrometry was used to detect synthetical compounds illegally mixed into traditional Chinese medicine antidiabetic preparations. The organic extract of the traditional Chinese medicine antidiabetic capsule was analyzed through a Cl8 column with a mobile phase of methanol-formic acid （ 80.0 ： 20.0 ： 0.1 ） . Two components illegally added into the traditional Chinese medicine antidiabetic capsule were identified according to the chromatographic behavior and mass spectral data by comparison with those of reference substances. As a result, each capsule （ 400 mg ） for oral administration was quantited to contain 2.6 mg phenformin and 2.0 mg glibenclamide. The conclusion is that liquid chromatography-mass spectrometry can be used as a selective and sensitive instrumentality to detect compounds illegally mixed into the traditional Chinese medicine antidiabetic preparations.