中药制剂及保健品中添加的10种抗高血压药物监测  

Monitoring of Ten Kinds of Anti-hypertensive Drugs Added in Traditional Chinese Medicine Preparations and Health Products

作　　者：吴毅 刘绪平 王栋 彭绪玲 谢二磊 

机构地区：[1]江西省食品药品检验所,南昌330029 [2]江西省药品与医疗器械质量工程技术研究中心 [3]江西省新药评审中心

出　　处：《中国药事》2014年第5期495-500,共6页Chinese Pharmaceutical Affairs

基　　金：国家"十二五"科技重大专项"重大新药创制"子课题"原料药;制剂和药用辅料的近红外和拉曼光谱及药品光谱-色谱数据的研究"项目(编号2011ZX09303-001)

摘　　要：目的建立抗高血压药物盐酸可乐定、氢氯噻嗪、酒石酸美托洛尔、盐酸哌唑嗪、盐酸普萘洛尔、苯磺酸氨氯地平、利血平、硝苯地平、尼群地平、尼莫地平10种化合物的HPLC快速检测方法。方法采用GRACE Prevail C18色谱柱;梯度洗脱方式;利用相对容量因子和紫外光谱相似度双指标进行定性;相对容量因子法进行定量分析。结果建立了同时测定10种抗高血压药物的HPLC方法;采用双指标进行定性,增加了HPLC定性的准确性;相对校正因子的含量测定法,有效减少对照品的使用,加快HPLC的分析速度。结论本文建立了双指标定性、相对校正因子测定含量的HPLC方法,可以同时测定10种抗高血压药物,适用于中药制剂及保健品非法添加的快速监测。Objective To establish a fast HPLC detection method for ten compound anti-hypertensive drugs, namely clonidine hydrochloride, hydrochlorothiazide, metoprolol tartrate, prazosin hydrochloride, propranolol hydrochloride, amlodipine besylate, reserpine, nifedipine, nitrendipine and nimodipine. Methods The GRACE Prevail C18 column was applied using a gradient elution mode. The relative capacity utilization factor and ultraviolet spectral similarity pairs were used as the qualitative indicators for qualitative analysis; the relative capacity factor method was applied for quantitative analysis. Results The method for simultaneous determination of 10 kinds of anti-hypertensive drugs by HPLC was established. Dual qualitative indicators increased the accuracy of qualitative HPLC. Relative correction factor determination method effectively reduced the use of reference and accelerated the speed of HPLC analysis. Conclusion This paper established the HPLC method with double qualitative indexes and relative correction factor for content determination of 10 kinds of anti-hypertensive drugs. The method was suitable for rapid detection of illegal additives in the traditional Chinese medicine preparations and health products.

关 键 词：抗高血压药物 非法添加监测 盐酸可乐定 氢氯噻嗪 酒石酸美托洛尔 盐酸哌唑嗪 盐酸 普萘洛尔 苯磺酸氨氯地平 利血平 硝苯地平 尼群地平 尼莫地平 HPLC法快速检测 

分 类 号：R917[医药卫生—药物分析学]