双黄连粉针中间体与制剂UPLC-MS指纹图谱相关性  

Correlational research of UPLC-MS fingerprinting system of intermediates and preparation of SHL powder injection

作　　者：石朗[1] 顾媛媛[2] 焦丁宁[2] 苏德龙 王英昕 董培良[2] 陈大忠[2] 

机构地区：[1]黑龙江中医药大学附属第一医院,哈尔滨150040 [2]黑龙江中医药大学中医药研究院,哈尔滨150040 [3]哈药集团中药二厂,哈尔滨150078

出　　处：《哈尔滨商业大学学报（自然科学版）》2015年第6期671-674,共4页Journal of Harbin University of Commerce：Natural Sciences Edition

基　　金：黑龙江省应用技术研究与开发计划项目(GC13C109);"重大新药创制"科技重大专项-双黄连粉针剂技术改造(2011ZX09201-201-15)

摘　　要：为建立双黄连粉针中间体的UPLC-MS指纹图谱.采用ACQUITY UPLCTM BEH C18Column(1.7μm,2.1×50 mm,Waters Corp,Milford USA)作为色谱柱;乙腈-0.1%甲酸为流动相,梯度洗脱,流速为0.3 m L/min,柱温40℃.建立了13批双黄连粉针中间体的UPLC指纹图谱共有模式,特征图谱有26个共有峰,以对照品为对照,指认了3个主要色谱峰,各色谱峰有较好的分离效果.对13批双黄连粉针剂中间体的特征图谱进行聚类分析,并采用"中药色谱指纹图谱相似度评价系统(2004A版)"对其质量进行评价.本方法快速、高效,可用于双黄连粉针剂中间体的质量控制,同时与成品制剂之间具有良好的相关性.To establish SHL powder injection intermediates UPLC-MS ACQUITY UPLCTM BEH C18 Column （1.7 μm, 2.1 × 50 mm, Waters as column, mobile phase of acetonitrile and 0.1% formic acid, gradi fingerprinting. Using Corp, Milford USA） ent elution, the flow rate was 0.3 mL/min, and the column temperature was 40 ℃. A total of 13 batches of UP- LC fingerprint pattern of SHL powder injection intermediates were established. There were 26 common peaks in the characteristic maps. Three main peaks were identified with reference substances for comparison, and each peak has a better separation. A cluster analysis for characteristic spectra of 13 batches SHL intermediate was done, and the ＂Chinese medicine chromatographic fingerprint evaluation system （2004A Edition）＂ was used to evaluate their quality. The method was rapid, efficient and can be used for quality control of SHL injection intermediates, while between FPP and had a good correlation.

关 键 词：双黄连粉针中间体 指纹图谱 UPLC—MS 相关性 

分 类 号：R286[医药卫生—中药学]