摘要
目的:建立心可舒系列制剂的UPLC特征图谱,为全面评价其内在质量提供参考。方法:采用Thermo Syncronis C_(18)(2.1mm×150 mm,5μm)色谱柱;以乙腈-0.1%甲酸溶液为流动相,梯度洗脱,流量为0.3 m L·min^(-1);柱温30℃;检测波长287nm。结果:心可舒系列制剂特征图谱共有12个特征峰,采用对照品及质谱信息推断,指认了10个特征峰;采用《中药色谱指纹图谱相似度评价系统(2012版本)》对特征图谱进行相似度分析,以特征峰峰面积为变量,采用SIMCA-P软件进行主成分分析,很好地区分了各剂型与各企业产品。结论:建立的特征图谱专属性强,重现性好,可用于心可舒系列制剂的质量评价。
Objective： To establish a UPLC specific chromatogram of Xinkeshu series preparations to provide reference for the compre- hensive quality control. Methods： The samples were separated on a Thermo Syncronis C18 column （2. 1 mm ×150mm,5μm） and eluted with a gradient elution of acetonitrile - 0. 1% formic acid solution as mobile phase at the flow rate of 0. 3 mL ·min^-1. The col- umn temperature was 30 ℃ and the detection wavelength was set at 287 nm. Results ：The UPLC specific chromatogram of Xinkeshu se- ries preparations was established and showed 12 characteristic peaks, among which 10 peaks were identified by comparison with the ref- erence substances and by ratiocination with MS data. All results were analyzed with Similarity Evaluation System for Chromatographic Fingerprint of TCM （2012）, a common pattern was built and similarity analysis was carried out. According to the SIMCA-P, the sam- ples were classified by cluster analysis and principle component analysis with the peak area for each main chromatographic peak as the variable. Conclusion：The UPLC specific chromatogram has good specificity and reproducibility,which can be applied to the quality control of Xinkeshu series preparations.
出处
《中国药品标准》
CAS
2016年第1期19-23,共5页
Drug Standards of China
基金
国家“重大新药创制”科技重大专项“十二五”计划课题(编号2012ZX09304005-005)
河北省科技支撑计划项目(13272513)
关键词
心可舒系列制剂
特征图谱
超高压液相色谱
葛根
丹参
Xinkeshu series preparations
specific chromatogram
UPLC
Pueraria lobratae radix
Salviae miltiorrhizae radix et rhizoma
