消癌平注射液指纹图谱研究

Research of Fingerprint Chromatogram of Xiaoaiping Injection by HPLC

目的:建立消癌平注射液的HPLC指纹图谱。方法:选择Shim-packVP-ODS柱,流动相为A:50mM磷酸盐缓冲液(磷酸调pH=3);B:甲醇;流速1mL/min,检测波长330nm,参比波长390nm,柱温25℃,进样量20μL,记录时间为70min。梯度洗脱程序为,0min,B为5%;10min,B为5%;30min,B为20%;70min,B为45%。结果:根据13批次供试品的检测结果,选择了各批样品共有的、峰面积较大且保留时间以及峰面积相对稳定的8个色谱峰作为消癌平注射液指纹图谱的共有峰,其峰面积之和占总峰面积大于95%。测定了通关藤药材、中间体及注射液的指纹图谱,结果表明消癌平注射液与其中间体及通关藤药材之间有较好的相关性。结论:该方法简单可靠,可作为消癌平注射液的质量控制指标。

Objective： To establish the fingerprint chromatogram of Xiaoaiping Injection （Caulis Marsdeniae Tenacissimae） by HPLC. Methods： The HPLC method was established by Shim-pack VP-ODS column, with gradient elution by mobile phase A： 50mM phosphate buffer （pH=3）; B： methanol. The detection wavelength was set at 330nm with reference wavelength 390nm. Results： According to the results of thirteen lots sample analysis, eight peaks were relatively stable and marked on the HPLC fingerprint of Xiaoaiping Injection. The sum of the eight peaks area was over 95 percent of the total peak area. And the fingerprint chromatogram of injection was traceable to intermediate and medicinal materials. Conclusion： The method is simple with good reproducibility and can be used as a quality control method for Xiaoaiping Injection.