一测多评法测定双黄连注射液中4种成份的含量  

Determination of Four Components in Shuanghuanglian Injection by QAMS

作　　者：王奎鹏[1,3] 徐兴敏 方清朝 王均伟 王祖红 WANG Kui-peng;XU Xing-min;FANG Qing-chao;WANG Jun-wei;WANG Zu-hong(The First Affiliated Hospital of the Henan University of Traditional Chinese Medicine,Zhengzhou 450000,China;The College of Forensic Medicine,Henan University of Science and Technology,Louyang 471000,China;Henan Fusen Pharmaceutical Co.,Ltd.,Nanyang 474450,China)

机构地区：[1]河南中医药大学第一附属医院,郑州450000 [2]河南科技大学法医学院,洛阳471000 [3]河南福森药业有限公司,南阳474450

出　　处：《中国合理用药探索》2022年第1期114-120,共7页Chinese Journal of Rational Drug Use

基　　金：河南省自然科学基金(182300410168);河南省高等学校重点科研项目(17A150008)。

摘　　要：目的:建立一测多评法(QAMS)同时测定双黄连注射液中绿原酸、咖啡酸、黄芩苷、连翘苷4种成份的含量。方法:采用YMC-C18色谱柱(150mm×4.6mm,5μm),以乙腈-0.2%甲酸为流动相进行梯度洗脱,流速为1.0 ml/min,柱温35℃,检测波长为324nm(0~13min检测绿原酸、咖啡酸)和280nm(13~35min检测黄芩苷、连翘苷)。以连翘苷为内标参照物,计算绿原酸、咖啡酸、黄芩苷的相对校正因子f_(s/i),建立QAMS并测定各成份的含量。与外标法(EMS)测定结果比较,验证QAMS的准确性和可行性。结果:绿原酸、咖啡酸、黄芩苷的f_(s/i)分别为0.2169、0.1260、0.1856,在不同实验条件下重现性良好;QAMS与EMS测定结果无明显差异。结论:本研究所建立的QAMS可用于双黄连注射液的质量控制。Objective:To establish quantitative analysis of multi-components by single marker(QAMS)to simultaneously determine the contents of chlorogenic acid,caffeic acid,baicalin and forsythin in Shuanghuanglian injection.Method:The column YMC-C18(150 mm×4.6 mm,5µm)was used,the mobile phase were gradient elution with acetonitrile–0.2%formic acid;the flow rate was 1.0 ml/min;the column temperature was 35℃;the detection wavelengths were 324 nm(0~13 min,detection of chlorogenic acid and caffeic acid)and 280 nm(13~35 min,detection of baicalin and forsythin).Using forsythin as an internal reference,calculate its relative correction factor f_(s/i) with chlorogenic acid,caffeic acid,and baicalin,establish QAMS and determine the content of each sample.Compare with measurement results of the external standard method(EMS)to verify the accuracy and feasibility of QAMS.Results:The f_(s/i) of chlorogenic acid,caffeic acid,and baicalin were 0.2169,0.1260 and 0.1856,respectively,and the reproducibility was good under different experimental conditions;there was no significant difference between the results of QAMS and EMS.Conclusion:The QAMS established in this experiment can be used for the quality control of Shuanghuanglian injection.

关 键 词：双黄连注射液 绿原酸 咖啡酸 黄芩苷 连翘苷 一测多评 高效液相色谱法 

分 类 号：R286.0[医药卫生—中药学]