活血止痛胶囊的高效液相指纹图谱建立、化学模式识别分析及3种成分的含量测定  

Establishment of HPLC fingerprint,chemical pattern recognition analysis and content determination of three components in Huoxue Zhitong Capsules

作　　者：陈淑丽 孙媛 魏晨旭 刁和芳 赵开军 李伟东[1,2] CHEN Shu-li;SUN Yuan;WEI Chen-xu;DIAO He-fang;ZHAO Kai-jun;LI Wei-dong(School of Pharmacy,Nanjing University of Chinese Medicine,Jiangsu Nanjing210023,China;Key Laboratory of Chinese Medicine Processing in Jiangsu Province,Jiangsu Nanjing210023,China;Jiangsu Hongdian Institute of Chinese Medicine Industry Co.Ltd.,Jiangsu Nanjing 210023,China;Jiangsu Classical Prescriptions Engineering Research Center,Jiangsu Nanjing 210042,China)

机构地区：[1]南京中医药大学药学院,江苏南京210023 [2]江苏省中药炮制重点实验室,江苏南京210023 [3]江苏弘典中药产业研究院有限公司,江苏南京210023 [4]江苏省中药经典名方工程技术研究中心,江苏南京210042

出　　处：《中国医院药学杂志》2022年第3期242-247,共6页Chinese Journal of Hospital Pharmacy

基　　金：国家药典委员会国家药品标准提高研究课题(编号:361,388)。

摘　　要：目的:建立活血止痛胶囊的高效液相色谱(HPLC)指纹图谱及含量测定的方法,结合化学模式识别分析,为其质量评价提供依据。方法:采用Kromasil 100-5-C_(18)(4.6 mm×250 mm,5μm)色谱柱,乙腈-水为流动相,梯度洗脱,流速为1 mL·min^(-1),柱温35℃,检测波长203 nm,测定其3种成分含量并建立指纹图谱。运用“中药色谱指纹图谱相似度评价系统”进行相似度评价,确定共有峰;采用SIMCA14.1统计软件进行化学模式识别分析,对活血止痛胶囊总体质量进行分析评价。结果:建立21批活血止痛胶囊的HPLC指纹图谱,共标定15个色谱峰,各批次的指纹图谱和对照图谱相似度在0.921~0.987之间;聚类分析和主成分分析结果显示3个不同厂家各自聚为一类,正交偏最小二乘法分析筛选出造成各厂家差异的7个色谱峰。21批活血止痛胶囊中三七皂苷R_(1)的线性范围为0.03067~0.30670 mg·mL^(-1),人参皂苷Rg_(1)的线性范围为0.12433~1.24330 mg·mL^(-1),人参皂苷Rb_(1)的线性范围为0.13233~1.32330 mg·mL^(-1)。结论:本研究建立的HPLC含量测定、指纹图谱及化学模式识别分析的方法简便可行,可用于活血止痛胶囊的质量控制和品质评价。OBJECTIVE To establish a method for the HPLC fingerprint and content determination of Huoxue Zhitong Capsules,and combine with chemical pattern recognition analysis to provide basis for its quality evaluation.METHODS The contents of three components were determined and HPLC fingerprint was established on a Kromasil 100-5-C_(18)(4.6 mm×250 mm,5μm)chromatographic column with acetonitrile-water as the mobile phase in a gradient elution manner.The flow rate was 1 mL·min^(-1);the column temperature was 35℃;the detection wavelength was 203 nm.The similarity evaluation was carried out by using the Similarity Evaluation System of Chinese Medicine Chromatographic Fingerprint,and the common peaks were determined.SIMCA14.1 statistical software was used for chemical pattern recognition analysis,and the overall quality of Huoxue Zhitong Capsules was analyzed and evaluated.RESULTS The HPLC fingerprints of 21 batches of Huoxue Zhitong capsules were established,and 15 peaks were calibrated.The similarity between the fingerprint of each batch and the control spectrum was between 0.921 and 0.987.The results of cluster analysis and principal component analysis showed that the three different manufacturers were grouped into one category,and the orthogonal partial least square method was used to screen out 7 chromatographic peaks that caused the differences among the manufacturers.The linear ranges of notoginsenoside R_(1),ginsenoside Rg_(1) and ginsenoside Rb_(1) in 21 batches of Huoxue Zhitong Capsules were 0.03067-0.30670 mg·mL^(-1),0.12433-1.24330 mg·mL^(-1) and 0.13233-1.32330 mg·mL^(-1),respectively.CONCLUSION The methods of HPLC content determination,fingerprint and chemical pattern recognition analysis established in this study are simple and feasible,and can be used for the quality control and evaluation of Huoxue Zhitong Capsules.

关 键 词：活血止痛胶囊 高效液相色谱法 含量测定 指纹图谱 化学模式识别 

分 类 号：R283[医药卫生—中药学]