热毒宁注射液高效液相色谱指纹图谱研究及多成分定量分析  

The Fingerprint Research and Multi-component Qualitative Analysis of Reduning Injection via HPLC

作　　者：毕宇安[1] 王振中[1] 宋爱华[1] 刘涛[1] 付小环[1] 萧伟[1] 

机构地区：[1]江苏康缘药业股份有限公司,连云港222001

出　　处：《世界科学技术-中医药现代化》2010年第2期298-303,共6页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：国家科技部重大新药创制(2009ZX09313-032):创新中药中试放大研究技术平台;负责人:萧伟

摘　　要：目的:建立热毒宁注射液HPLC-UV指纹图谱测定方法及多指标成分含量测定分析方法。方法:采用高效液相色谱法,以Phenomenex C18(4.6mm×250mm,5μm)色谱柱为分析柱,以甲醇-磷酸水溶液为流动相,梯度洗脱,指纹图谱检测波长为225nm、多指标成分含量测定检测波长为237nm、324nm。结果:在同一色谱条件下,采用不同的检测波长,分别进行指纹图谱的测定、多指标成分(栀子苷、绿原酸、咖啡酸、异绿原酸等9个成分)的含量测定;指纹图谱中确定了14个共有峰,10批热毒宁注射液的指纹图谱平均相似度为0.95以上;含量测定结果表明,10批热毒宁注射液中9个成分的含量均一、稳定。结论:通过系统的方法学验证,该方法能够准确、快捷的测定热毒宁注射液的指纹图谱及多成分含量;该方法分别从定性定量的角度全面的反映热毒宁注射液中的主要成分及其变化情况,提高了热毒宁注射液内在质量控制水平。This study aimed to develop the fingerprint of Reduning Injection by UV-HPLC and establish a method for the multi-component assay. RP-HPLC was performed on a Phenomenex C18 column （4.6 mm×250mm,5μm）. The mobile phase consisted of methanol-0.1% H3PO4 with gradient elution. The fingerprint was detected at 225 nm, and the multi-components were determined at the dual wavelength, k1=237 nm and k2=324 nm. The fingerprints and the muhi-components （containing Geniposide, Chlorogenic acid, etc. ） were simultaneously determined by HPLC in the same chromatographic conditions but at different detection wavelengths. 14 common peaks were observed on the fingerprints of Reduning Injection. The 10 batches of samples all had similarity of more than 95% compared with the control group. The analysis results showed that the contents of the multi-components （Gardenin） were stable. This method is simple and fast, thus it may be used for the fingerprint and multi-component assay of Reduning Injection. It may also qualitatively and quantitatively reflect the content variation of the main ingredients in Reduning Injection, which would be helpful to improving the quality control level of this injection.

关 键 词：热毒宁注射液 高效液相色谱法 指纹图谱 多成分含量测定 

分 类 号：R283[医药卫生—中药学]