复尔康注射液气相色谱指纹图谱研究

STUDY ON THE GC FINGERPRINT OF FUERKANG INJECTION

目的:建立复尔康注射液气相指纹图谱检测标准。方法:采用气相色谱(GC)检测复尔康注射液中所含挥发性化学成分,以樟脑为参照物,按"中药注射剂指纹图谱研究的技术要求"计算相对保留时间及峰面积比值,标定共有指纹峰。结果:在全面方法学研究的基础上,先后对10批复尔康注射液供试品进行检测分析,从而建立了该药品的GC指纹图谱。结论:GC指纹图谱中共有11个共有峰,其相对保留时间及峰面积比值可作为复尔康注射液质量控制的方法之一。

Objective：To establish the GC fingerprint of Fuerkang injection for its quality control. Methods： With camphor as reference material,the volatile chemicals of Fuerkang injection was analyzed by GC. According to the technical requirements of fingerprint on Injection of Chinese traditional medicine, their relative retention time and area ratio of peaks were calculated to determine the common featured peaks of fingerprint. Results： On the basis of systematic methodology, lO batches of sample injection were tested and analyzed,therefore,the GC fingerprint of the injection was established. Conclusion： 11 common featured peaks were found out on GC fingerprint, their retention time and area ratio can be used as important paramefers for the quality control of Fuerkang injection.