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该研究采用高效液相色谱法建立并分析了不同厂家生产醒脑静注射液的特征图谱。采用Thermo BDS Hypersil C18色谱柱(4.6 mm×250 mm,5μm)进行分离,流动相为乙腈-0.02%甲酸水溶液,梯度洗脱,流速1.0 m L·min~(-1),检测波长254nm,柱温35℃,进样量20μL。通过对29批醒脑静注射液的HPLC特征图谱研究,共标定了11个特征峰。经与对照品对比,指认出其中7个特征峰的结构,分别为优香芹酮、樟脑、姜黄烯酮、莪术烯醇、莪术二酮、莪术酮和吉马酮。运用计算机辅助相似性评价系统及主成分分析对所建29批醒脑静注射液的HPLC特征图谱进行分析比较,结果显示不同厂家生产的醒脑静注射液能明显分为3类。该文所建立的HPLC特征图谱为科学评价和有效控制醒脑静注射液质量提供了依据。
This study established and analyzed the characteristic map of Xingnaojing injection by different manufacturers by HPLC. The sample was separated on a Thermo BDS Hypersil C18 column (4.6 mm × 250 mm, 5 μm) using acetonitrile-0.02% formic acid as the mobile phase with gradient elution at a flow rate of 1.0 mL · min-1 and a detection wavelength of 254 nm. Temperature 35 ℃, injection volume 20μL. Through the study of 29 batches of Xingnaojing injection HPLC characteristic map, a total of 11 characteristic peaks were calibrated. Compared with the reference substance, the structures of seven characteristic peaks were identified, which are excellent carvone, camphor, curcumin, curcumol, curdione, curcumerone and gemcitabine. Using computer-aided similarity assessment system and principal component analysis of 29 batches Xingnaojing injection HPLC profiles were compared and analyzed, the results show that different manufacturers of Xingnaojing injection can be clearly divided into three categories. The HPLC profiles established in this paper provide the basis for scientific evaluation and effective control of the quality of Xingnaojing injection.