HPLC-DAD法同时检测镇静安神类中成药及保健食品中非法添加的药物  

Simultaneous determination of the illegally added drugs in tranquilizing Chinese traditional patent medicines and health foods by HPLC-DAD

作　　者：韩东岐[1] 鲁艺[1] 殷果[1] 王珏[1] 胡伟慧 梁莹莹[1] 王铁杰[1] 

机构地区：[1]深圳市药品检验所深圳药品质量标准研究重点实验室,广东深圳518057

出　　处：《中成药》2015年第10期2197-2202,共6页Chinese Traditional Patent Medicine

基　　金：深圳市基础研究项目(JCYJ20120618153944322)

摘　　要：目的建立HPLC-DAD法同时检测镇静安神类中成药及保健食品中非法添加的9种安眠药物。方法样品分析采用Agilent Zorbax SB-Aq色谱柱（4.6 mm×250 mm,5μm）;流动相为含0.1%三乙胺的0.05 mol/L磷酸二氢铵-甲醇溶液,梯度洗脱;体积流量为1.0 m L/min;柱温（35±5）℃;检测波长分别为210 nm（盐酸多塞平、苯妥英钠、司可巴比妥钠、盐酸羟嗪）、220 nm（阿普唑仑、艾司唑仑、劳拉西泮）、254 nm（氯氮卓、盐酸氯丙嗪）,DAD全波长扫描（190~400 nm）。结果在147批药物（镇静安神类中成药87批、保健食品60批）中,11批检出盐酸多塞平,3批检出艾司唑仑,各有1批检出劳拉西泮、阿普唑仑和氯氮卓。结论该方法简便、快速、准确、重复性好,适用于基层药检机构检测非法添加药物。AIM To establish a method for simultaneously determining nine hypnotic drugs illegally added in tranquilizing Chinese traditional patent medicines and health foods by HPLC-DAD. METHODS The analysis of samples was carried out on Agilent Zorbax SB-Aq column（ 4. 6 mm × 250 mm,5 μm）,mobile phase was 0. 05 mol / L ammonium dihydrogen phosphate（ containing 0. 1% triethylamine）-methanol solution with gradient elution,flow rate was 1. 0 m L / min,column temperature was maintained at（ 35 ± 5） ℃,and detection wavelength was set at 210 nm（ doxepin hydrochloride,phenytoin,secobarbital sodium and hydroxyzine hydrochloride）,220nm（ alprazolam,estazolam and lorazepam） and 254 nm（ chlordiazepoxide and chlorpromazine hydrochloride） with DAD full UV wavelength scan（ 190- 400 nm）. RESULTS In 147 batches of drugs（ 87 batches of tranquilizing Chinese traditional patent medicines and 60 batches of health foods）,it was detected that doxepin hydrochloride was illegally added in 11 batches,estazolam in 3 batches,lorazepam,lorazepam and chlordiazepoxide respectively in 1 batch. CONCLUSION This method is simple,rapid,accurate with good reproducibility,which is suitable for local institutes for drug control to detect illegally added drugs.

关 键 词：镇静安神 中成药 保健食品 非法添加 安眠药物 HPLC-DAD 

分 类 号：R927.2[医药卫生—药学]