2010年版《中国药典》奈韦拉平有关物质检查存在问题的探讨  

Study on the nevirapine-related substances test method in Chinese Pharmacopoeia of 2010

作　　者：王宏亮 陈盼盼 何计龙 

机构地区：[1]临海市食品药品检测中心,临海317000 [2]玉环县食品药品检验检测中心,台州317600

出　　处：《国际药学研究杂志》2015年第4期524-526,530,共4页Journal of International Pharmaceutical Research

摘　　要：目的研究《中国药典》2010年版第二增补本奈韦拉平有关物质检查的方法,探讨存在的问题。方法深入剖析《中国药典》、《美国药典》和《欧洲药典》中关于奈韦拉平的检测方法,实际检测某药厂生产的3个连续批次的奈韦拉平原料药,比较有关物质检查检测情况。结果按《中国药典》方法检测出3个杂质,按美国、欧洲药典检测出4个杂质,《中国药典》漏检最大的单个杂质。结论证明《中国药典》2010年版第二增补本奈韦拉平有关物质检查方法,存在漏检杂质的情况,建议修订奈韦拉平有关物质检查方法。Objective To research the nevirapine-related substances method in the second supplement of Chinese Pharma-copoeia（Ch.P） 2010 edition, and explore the existing problems. Methods In-depth comparison of the nevirapine-related substances test method in Ch.P, United States Pharmacopoeia（USP） and European Pharmacopoeia（EP）;three consecutive batches of nevirapine produced at a pharmaceutical factory were detected, and inspection situation of the related substances was compared. Results According to the Ch.P method we detected three impurities, while according to the other two pharmacopoeias we detected four impu-rities. ＂Ch.P＂ leaves out the biggest single impurity. Conclusion We proved that the second supplement of Ch.P 2010 edition has the problem of residual impurities in the nevirapine-related substances test method, and propose to revise the nevirapine-related sub-stances method.

关 键 词：中国药典 奈韦拉平 高效液相色谱法 

分 类 号：R927[医药卫生—药学]