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。
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.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2009年第7期532-535,共4页
Chinese Journal of Pharmaceuticals
基金
上海市科委重大科技攻关项目(05DZ19347)
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
recombinant human insulin
dry powder inhalation
RP-HPLC
relevant protein
determination
