HPLC-DAD同时检测乳癖消片（胶囊）中非法掺入醋酸泼尼松.doc

PAGE 3 项目： 国家药品评价性抽验品种 *副主任药师。研究方向：药品检验和质量研究。电话E－maiL:499929857@ 　 HPLC-DAD同时检测乳癖消片（胶囊）中非法掺入醋酸泼尼松等4种 甾体激素类药 本文档由【 HYPERLINK 中文word文档库】 HYPERLINK 提供，转载分发敬请保留本信息；  HYPERLINK 中文word文档库免费提供海量范文、教育、学习、政策、报告和经济类word文档。 a href=/word文档/a 　　　　许亚玲 申璀 罗曼　周兰　（贵州省食品药品检验所 贵州　贵阳550004) 摘要：目的：建立乳癖消片（胶囊）中是否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HPLC检测方法：C18柱(4.6 mm x 200 mm,5 μm)，乙腈-水（24：:76）为流动相，检测波长254 nm，用二极管阵列检测联用技术进行定性鉴定.并模摸拟在未检出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。结果：在同一条件下，测定了3个厂家的96批样品及阳性参比对照，结果阳性参比对照检出醋酸泼尼松、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，可作为监测掺有多种甾体激素类中成药的有效方法。 关键词：高效液相色谱法;二级阵列管;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. HPLC-DAD Ssimultaneously Ddetection ofts pPrednisone Acetate and Oother four Three kKinds of Steriod Hhormone Mmedicines Illegally Mmixed illegally in Rupixiao Ttablets (capsules) by HPLC-DAD XuyaLing shencui Luoman ZhouLan (GuiZhou Province Institute for Food and Drug ControlL, GuiYang, GuiZhou, 550004) ABSTRACT : AIM: To establish the a detection method for determining whether there are illegally mixed method of detecting hormone medicines ( Prednisone Acetate,, Cortisone Acetate, Hycortisone Acetate, Dexamethasone Acetate) whether mixed illegally in Rrupixiao tablets ( capsule) . METHOD: An HPLC method was established: ColLumn : C18 (4.6 mm x 200 mm, 5 μm), thea mobilLe phase of was acetonitrilLe - water (24:76).; Detection wavelength was at 254 nm and Coupled with diode array detector was jointly used for qualitative identification. Simulated A positive control was made by adding appropriate amount of reference substance as a positive control reference substance in to samples of in which four kinds of hormone medicines were not detected as reference substance. RESULTS: Under the same conditions, 96 batches products of samples from 3 factories and positive control reference were determined under the same condition.. Prednisone Acetate, Hydrocortisone Acetate, Cor