青银注射液指纹图谱实验研究

目的 :建立青银注射液指纹图谱检测标准。方法 :采用气相 (GC)、液相 (HPLC)色谱法 ,分别检测青银注射液所含挥发性及非挥发性化学成分 ,以樟脑、绿原酸对照品为参照物 ,按“中药注射剂指纹图谱的技术要求”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 13批注射液供试品进行检测分析 ,从而建立了该注射液的GC ,HPLC指纹图谱。结论 :GC指纹图 15个共有峰、HPLC指纹图 6个共有峰的相对保留时间及峰面积比值 ,可作为青银注射液质量评价的重要依据之一。

Study on chromatogrqphic fingerprint of Qingying injection

Objective: To establish the fingerprint detecting standard of Qingyin injection. Method: By adopting GC and HPLC,camphor and chlorogenic acid were used as reference material. To analyze separatly Qingyin injection which contains volatile and non-volatile chemials. According to the technical requirements of fingerprint on Injection of Chinese traditional medicine,we calculated their bn relative retention time and area proportionality of peaks to detemine the common peaks of fingerprint. Result: On the basis of systematic methodalogy,we tested and analyzed 13 batches of sample injection so as to establish GC and HPLC fingerprint of the injection. Conclusion: 15 common peaks on GC and 6 common peaks as well as their retention time and area proportionality on HPLC can be used as the important paramefers of the quality control for Qingyin injecttion.