HPLC检测中药中非法添加化学降压药物_陈惠玲.docVIP

HPLC检测中药中非法添加化学降压药物 陈惠玲1,封令霞2(1.厦门市药品检验所,福建厦门 361012;2.厦门大学药学院,福建厦门 361000 摘要:目的为打击中药制剂中非法添加化学降压药物现象,建立了HPLC定性检测中药制剂中可能非法添加的15种化学降压药物。方法采用Agilent Extend-C18色谱柱(4.6 mm×250 mm,5 μm,梯度洗脱:流动相A为0.02 mol·L?1醋酸铵溶液,流动相B为甲醇-乙腈(2∶1,检测波长为230 nm,流速为1.0 mL·min?1,柱温为30 ℃。结果15种化学降压药物有很好的分离度、线性及检测灵敏度。检测限为0.01~13 ng,连续5针进样色谱图中各组分保留时间的RSD均0.1%。结论本方法简便灵敏,重复性好,可作为降压类药物的鉴别方法。 关键词:化学降压药物;中药制剂;非法添加;高效液相色谱法 中图分类号:R917.101 文献标志码:B 文章编号:1007-7693(201113-1346-03 Detection of Antihypertensive Agents Illegally Added in Traditional Chinese Medicine by HPLC CHEN Huiling1, FENG Lingxia2(1.Xiamen Institute for Drug Control, Xiamen 361012, China; 2.School of Pharmaceutical Sciences of Xiamen University, Xiamen 361000, China ABSTRACT: OBJECTIVE To hit the phenomenon that antihypertensive agents illegally adulterated in traditional Chinese medicine(TCM preparations, an HPLC method was established for detection of these fifteen kinds of antihypertensive agents. METHODS The chromatography was performed using an Agilent Extend-C18 column(4.6 mm×250 mm, 5 μm and gradient elution with the mobile phase consisting of 0.02 mol·L?1 ammonium acetate solution and methanol-acetonitrile (2∶1 at a flow rate of 1.0 mL·min?1. The detection wavelength was set at 230 nm. The column temperature was set at 30 . ℃RESULTS Under the condition, there was a good resolution among the fifteen kinds of antihypertensive agents and the detectability was 0.01 ng to 13 ng. Repeated 5 injections yielded relative standard deviation less than 0.1% regarding the retention time of each component. CONSLUSION This method is simple and sensitive with good reproduction quality for identifying antihypertensive agents. KEY WORDS: antihypertensive agents; traditional Chinese medicine; illegally additives; HPLC 近年来,在纯中药制剂和保健药品中非法添加化学药物的案件很多,降压类中药制剂中添加西药的现象犹为突出,给人们的健康带来严重威胁。本试验对中药制剂中是否非法添加化学降压药作初步筛查,选择了15种降压药物包含西药中的各类型降压药,采用梯度洗脱的方法对15种化学降压药物进行分离,结果显示该方法简便、灵敏、重复性好,可作为降压类药物的鉴别方法。 1 仪器与试药 1.1 仪器 Agilent 1200 高效液相色谱仪,配有液相四元泵、自动控温的自动进样器及紫外可变波长检测器;Mett