一测多评法同时测定痔舒适洗液中7种成分的含量  

Simultaneous determination of the contents of 7 components in Zhishushi Lotion by QAMS

作　　者：赵志国 姚建华 王婧宁 翟莹莹 ZHAO Zhiguo;YAO Jianhua;WANG Jingning;ZHAI Yingying(Department of Preparation Management,the Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,Shenyang 110032,China;Shenyang Feilong Pharmaceutical Limited Company,Benxi 117004,China)

机构地区：[1]辽宁中医药大学附属医院制剂管理部,沈阳110032 [2]沈阳飞龙药业有限公司,本溪117004

出　　处：《西北药学杂志》2021年第1期14-19,共6页Northwest Pharmaceutical Journal

摘　　要：目的建立能同时测定痔舒适洗液中三叶豆紫檀苷、苦参醇Ⅰ、苦参酮、贝母兰宁、山药素Ⅲ、棕矢车菊素和异泽兰黄素含量的一测多评(QAMS)法。方法色谱柱:Agilent Eclipse XDB-C 18柱(250 mm×4.6 mm,5μm);柱温:25℃;流动相:乙腈-2 mL·L^-1甲酸,梯度洗脱;流速:0.9 mL·min^-1;检测波长:295 nm(检测三叶豆紫檀苷、苦参醇Ⅰ和苦参酮),270 nm(检测贝母兰宁和山药素Ⅲ),330 nm(检测棕矢车菊素和异泽兰黄素)。以苦参酮为内参物,建立其他6种成分的相对校正因子(RCFs),计算各成分含量。结果7种成分的质量浓度分别在1.02~25.50(r 1=0.9991),1.98~49.50(r 2=0.9996),7.66~191.50(r 3=0.9993),1.59~39.75(r 4=0.9997),4.38~109.50(r 5=0.9992),0.62~15.50(r 6=0.9994),1.29~32.25μg·mL^-1(r 7=0.9995)范围内线性关系良好;平均回收率(RSD值)分别为96.94%(1.30%),99.59%(0.74%),100.13%(0.65%),98.42%(1.43%),99.37%(1.26%),97.52%(1.11%),98.50%(0.98%);痔舒适洗液中7种成分的含量QAMS法计算结果与外标法(ESM)实测值无明显差异。结论所建立的QAMS法操作便捷、结果准确,可用于痔舒适洗液的质量控制。Objective To develop a multi-components by single marker(QAMS)for the determination of trifolirhizin,kushenolⅠ,kurarinone,coelonin,batatasinⅢ,jaceosidin and eupatilin in Zhishushi Lotion.Methods The analysis was performed on an Agilent Eclipse XDB-C 18(250 mm×4.6 mm,5μm)column,and the column temperature was set at 25℃.The mobile phase consisted of acetonitrile-2 mL·L^-1 formic acid flowing at 0.9 mL·min^-1 in gradient elution.The detection wavelength were set at 295 nm for trifolirhizin,kushenolⅠand kurarinone,270 nm for coelonin and batatasinⅢ,and 330 nm for jaceosidin and eupatilin.By using kurarinone as an internal standard,the relative correction factors(RCFs)of the other 6 constituents were calculated,and the content determination was made.Results The 7 components showed good linear relationships within the ranges of 1.02-25.50(r 1=0.9991),1.98-49.50(r 2=0.9996),7.66-191.50(r 3=0.9993),1.59-39.75(r 4=0.9997),4.38-109.50(r 5=0.9992),0.62-15.50(r 6=0.9994)and 1.29-32.25μg·mL^-1(r 7=0.9995),and the average recoveries(RSDs)were 96.94%(1.30%),99.59%(0.74%),100.13%(0.65%),98.42%(1.43%),99.37%(1.26%),97.52%(1.11%)and 98.50%(0.98%),respectively.There was no significant difference between the calculated by QAMS method and the measured values by external standard method(ESM).Conclusion The established QAMS method is simple and accurate,which can be used for the quality control of Zhishushi Lotion.

关 键 词：一测多评法 痔舒适洗液 三叶豆紫檀苷 苦参醇Ⅰ 苦参酮 贝母兰宁 山药素Ⅲ 棕矢车菊素 异泽兰黄素 

分 类 号：R927.2[医药卫生—药学]