RP-HPLC法测定鼻用重组人胰岛素粉雾剂中的相关蛋白质.pdfVIP

532 Chinese Journal of Pharmaceuticals 2009, 40 7 · · 中国医药工业杂志 ( ) RP-HPLC法测定鼻用重组人胰岛素粉雾剂中的相关蛋白质 1 2 石劲敏 ，金 方 (1. 上海市食品药品检验所，上海 201203 ；2 . 上海医药工业研究院，创新药物与制药工艺国家重点实验室，上海 200437) 摘要：分别采用并比较中国药典 2005 年版中重组人胰岛素中相关蛋白质测定的洗脱程序及改进后的洗脱程序考察胰岛 素原药及其粉雾剂的相关蛋白含量。结果表明，采用改进法测得的胰岛素出峰时间恒定，柱效明显提高，主药峰与杂质 峰分离更好，相关蛋白质检出量更高。 关键词：重组人胰岛素；粉雾剂；反相液相色谱法；相关蛋白质；测定 + + TQ460.7 2 O657.7 2 A 1001-8255 2009 07-0532-04 中图分类号： ； 文献标志码： 文章编号： ( ) Determination of Relevant Protein in Recombinant Human Insulin Intranasal Dry Powder Inhalation by RP-HPLC 1 2 SHI Jing-min , JIN Fang 1. Shanghai Institute for Food and Drug Control, Shanghai 201203; ( 2. State Key Lab. of New Drug Pharmaceutical Process, Shanghai Institute of Pharmaceutical Industry, Shanghai 200437) ABSTRACT: The relevant protein of recombinant human insulin and its intranasal dry powder inhalation were comparatively determined by gradient elution RP-HPLC method in ChP 2005 ed and the improved gradient elution ( ) RP-HPLC method. The results showed that the latter method could determine more impurities and the retention time of insulin peak was stable——indicative of the better column efficiency and resolution of main peak and impurity peaks. Key Words: recombinant human insulin; dry pow