CAJ | 학술논문

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。
목적：연구《중국약전》2010년판제이증보본내위랍평유관물질검사적방법，탐토존재적문제。방법심입부석《중국약전》、《미국약전》화《구주약전》중관우내위랍평적검측방법，실제검측모약엄생산적3개련속비차적내위랍평원료약，비교유관물질검사검측정황。결과안《중국약전》방법검측출3개잡질，안미국、구주약전검측출4개잡질，《중국약전》루검최대적단개잡질。결론증명《중국약전》2010년판제이증보본내위랍평유관물질검사방법，존재루검잡질적정황，건의수정내위랍평유관물질검사방법。
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.