骨痨敌注射液HPLC指纹图谱研究

HPLC fingerprint study of Gu laodi injection

目的 建立中药复方制剂骨痨敌注射液的HPLC指纹图谱分析方法,对制剂的质量进行控制。方法 采用ECOSIL C_（18）柱（250 mm×4.60 mm,5μm）,以乙腈-水为流动相进行梯度洗脱,流速：1.0 mL/min,柱温：30℃,检测波长：203 nm,进样量：10μL。结果 通过对25批制剂进行指纹图谱分析,标定出9个共有峰。采用对照品指认了毛蕊异黄酮葡萄糖苷、柚皮苷、三七皂苷R1、人参皂苷Rg1和人参皂苷Rb1 5个色谱峰。并运用“中药指纹图谱计算机辅助相似度计算软件”,计算25批注射液的相似度在0.985~0.997之间。结论 所建立的HPLC指纹图谱分析方法专属性强、重复性良好,可用于骨痨敌注射液的质量评价。

Objective To establish an HPLC fingerprints analysis method for the quality control of the compound Chinese medicine Gu laodi injection.Methods The separation was performed on a ECOSIL C_（18） column（250 mm×4.60 mm,5μm） by gradient elution with acetonitrile-water as the mobile phase,the flow rate at 1.0 mL/min,the column temperature at 30 ℃,the detection wavelength at 203 nm and the injection volume at 10μL.Results By the fingerprint analysis of 25 batches of injection,we had pinpointed 9 common peaks.The peaks of calycosin-7-glucoside,naringin,notoginsenoside R1,ginsenoside Rg1 and ginsenoside Rb1 were identified.The similarity of 25 batches of injection was about 0.985 to 0.997 by using traditional Chinese medicine chromatographic fingerprint similarity calculation software.Conclusion The HPLC fingerprints analysis method is specific and reproducible,and it can be used to assess the quality of Gu laodi injection.