杨立新 冯伟红 夏伯候 林丽美 刘薇薇 苗婉清 甘国锋 邹济高 李春

[摘要]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（46 mm×250 mm，5 μm）进行分离，流动相为乙腈002%甲酸水溶液，梯度洗脱，流速10 mL·min-1，检测波长254 nm，柱温35 ℃，进样量20 μL。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。

[关键词]醒脑静注射液；特征图谱；主成分分析；高效液相色谱法

[Abstract]To establish and analyze the HPLC specific chromatograms of Xingnaojing injection manufactured by different factories The separation was performed on a Thermo BDS Hypersil C18 column （46 mm×250 mm， 5 μm）， with the mobile phase consisting of acetonitrile002% formic acid aqueous solution for gradient elution The flow rate was 10 mL·min-1， and the column temperature was 35 ℃ The detection wavelength was set at 254 nm， and the sample size was 20 μL Eleven chromatographic peaks were identified as characteristic peaks of HPLC specific chromatograms of Xingnaojing injection， after analyzing 29 batches of Xingnaojing injection samples Compared with the reference substances， seven of them were identified as eucarvone， camphor， curcumenone， curcumenol， curdione， curzerenone and germacrone， respectively HPLC specific chromatograms of Xingnaojing injection manufactured by three factories could be easily classified into three categories after investigation with computeraided similarity evaluation system combined with principal component analysis The established HPLC specific chromatograms provide a basis for scientific evaluation and effective control of the quality of Xingnaojing injection

[Key words]Xingnaojing injection； specific chromatograms； principal component analysis （PCA）； highperformance liquid chromatography （HPLC）

doi：10.4268/cjcmm20160912

指紋图谱技术在中药注射剂标准提高中的应用日趋成熟，对保障药品的有效、均一具有重要的意义。2010 年版《中国药典》实施后至2013 年，共新颁布实施了24 个中药注射剂指纹图谱标准，1 个注射用原料标准[1]。2015年版《中国药典》一部正文中明确增加了清开灵注射液和注射用双黄连（冻干）的HPLC特征图谱标准[2]。可见，增加指纹图谱标准是所有中药注射液质量标准提升中必不可少的内容。醒脑静注射液由麝香、冰片、郁金、栀子4味药经水蒸气蒸馏提取而制成，具有清热解毒，凉血活血，开窍醒脑之功，临床上广泛用于多种原因所致脑部疾病，如颅脑外伤、乙型脑炎、脑血管疾病等[3]。……