快速筛查检测中成药及保健品中添加的3种双胍类化学降糖药物

Rapid Screening and Detection of 3 Biguanides Added in Traditional Chinese Medicines and Health Products by HPLC-DAD

目的:建立HPLC-DAD法快速筛查检测中成药及保健品中违法添加的盐酸二甲双胍、盐酸丁二胍和盐酸苯乙双胍等3种化学降糖药物。方法:采用高效液相色谱-二极管阵列检测器光谱法,以Zorbax Extend-C18(250 mm×4.6 mm,5μm)为色谱柱;甲醇-0.1%乙酸溶液(含10 mmol·L-1辛烷磺酸钠)(60∶40)为流动相,通过保留时间、DAD紫外吸收光谱以及质谱的分子离子峰和二级碎片信息,对降糖类中成药及保健品中非法添加的3种双胍类降糖药物成分进行鉴定,通过测定235 nm处紫外吸收的峰面积代入线性方程,准确计算出添加物的含量。结果:12批降糖类样品中,5批检出盐酸二甲双胍、5批检出盐酸丁二胍、2批检出盐酸苯乙双胍。结论:本方法简单高效、灵敏度高、结果准确可靠,可同时快速筛查检测中成药及保健品中非法添加的3种双胍类化学降糖药物。

Objective： To establish an HPLC-DAD method for the rapid screening and detection of 3 biguanides, metformin hydro- chloride, bntylbiguanide hydrochloride and phenformin hydrochloride in traditional Chinese medicines and health products. Methods： The HPLC-DAD method employed a Zorbax Extend-Cls （250 mm × 4.6 mm,5 μm）column with the mobile phase consisting of 0.1% aceatic acid solution（ containing 10 mmol · L- 1 sodium octanesulfonate）- methanol （40： 60）. The retention time, DAD ultraviolet ab- sorption spectrum, molecular ions and fragment ions were used to identify the three drugs by comparing with those of reference sub- stances. The added substances were determined according to the chromatograph peaks monitored at 235 nm and the standard curve e- quations. Results： Metformin hydrochloride, butylbiguanide hydrochloride and phenformin hydrochloride were determined in 12 bat- ches of health products and traditional Chinese medicines. Among them, metformin hydrochloride was found in five batches, butylbigu- anide hydrochloride was contained in another five batches, and phenformin hydrochloride was found in two batches. Conclusion： The method is simple, efficient, sensitive and accurate. It can be used as an efficient method for rapid screening and detection of 3 bigua- nides illegally added in traditional Chinese medicines and health products.