HPLC法同时检测乳癖消片(胶囊)中是否非法掺入甾体激素类药  

Simultaneous Determination of Steroid Hormone Medicines Illegally Mixed in Rupixiao Tablets(Capsules) by HPLC

作　　者：许亚玲[1] 申璀[1] 罗曼[1] 周兰[1] 

机构地区：[1]贵州省食品药品检验所,贵阳市550004

出　　处：《中国药房》2011年第36期3440-3442,共3页China Pharmacy

摘　　要：目的:建立乳癖消片(胶囊)中非法掺入甾体激素类药(醋酸泼尼松、醋酸可的松、醋酸氢化可的松、醋酸地塞米松)的检测方法。方法:采用高效液相色谱法。色谱柱为Diomaond十八烷基硅烷键合硅胶柱,并加C18预柱,流动相为乙腈-水(24:76),检测波长为254nm,进样量为10μL,流速为1.0mL·min-1,柱温为30℃。在未检出4种甾体激素类药的样品中添加适量对照品作为阳性参比对照,用二极管阵列检测联用技术进行定性检测。结果:在同一测定条件下,3个厂家的96批样品和阳性参比对照结果显示,阳性参比对照均检出醋酸泼尼松、醋酸氢化可的松、醋酸可的松、醋酸地塞米松,96批样品均未检出。结论:所建方法专属性强、灵敏度高、操作方便,可作为检测乳癖消片(胶囊)中是否掺有多种甾体激素类药的有效方法。OBJECTIVE：To establish a detection method for determining whether there are illegally mixed steroid hormone medicines（prednisone acetate,cortisone acetate,hydrocortisone acetate,dexamethasone acetate） in Rupixiao tablets（capsules）.METHODS：HPLC method was established.The determination was performed on Diomaond C18 column with mobile phase consisted of acetonitrile-water（24：76） at flow rate of 1.0 mL·min-1.Detection wavelength was at 254 nm and injection volume was 10 μL.The column temperature was 30 ℃.Diode array detector was jointly used for qualitative identification.A positive control was made by adding appropriate amount of reference substance into samples in which 4 kinds of steroid hormone medicines were not detected.RESULTS：96 batches of samples from 3 factories and positive control reference were determined under the same condition.Prednisone acetate,hydrocortisone acetate,cortisone acetate and dexamethasone acetate were detected in positive control and not detected in the 96 batches of samples.CONCLUSION：The method is specific,sensitive,simple and can be used to detect steroid hormone medicines in Rupixiao tablets（capsule）.

关 键 词：高效液相色谱法 二级管阵列 乳癖消片(胶囊) 醋酸泼尼松 醋酸可的松 醋酸氢化可的松 醋酸地塞米松 

分 类 号：R917[医药卫生—药物分析学]