HPLC检测中药中非法添加化学降压药物.pdf

HPLC 检测中药中非法添加化学降压药物 1 2 陈惠玲 ，封令霞 (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(2011)13-1346-03 Detection of Antihypertensive Agents Illegally Added in Traditional Chinese Medicine by HPLC 1 2 CHEN Huiling , FENG Lingxia (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