高效液相色谱法同时测定清肺抑火丸中13种成分的含量  

Simultaneous determination of 13 components in Qingfei Yihuo Pills by high performance liquid chromatography

作　　者：段营辉 朱樵苏 黄澜 陈惠玲 李玲玲 DUAN Ying-hui;ZHU Qiao-su;HUANG Lan;CHEN Hui-ling;LI Ling-ling(Xiamem Institute for Food and Drug Quality Control,Fujian Xiamen 361012,China)

机构地区：[1]厦门市食品药品质量检验研究院,福建厦门361012

出　　处：《中国医院药学杂志》2022年第14期1399-1404,共6页Chinese Journal of Hospital Pharmacy

基　　金：2021年国家药品抽检项目(编号:2021-83)。

摘　　要：目的:建立高效液相色谱法(HPLC)同时测定清肺抑火丸中芒果苷、栀子苷、盐酸小檗碱、黄芩苷、汉黄芩苷、黄芩素、芦荟大黄素、汉黄芩素、大黄酸、大黄素、白花前胡甲素、大黄酚和大黄素甲醚13种成分含量。方法:采用Dikma Platisil ODS(4.6 mm×250 mm,5μm)色谱柱,乙腈-0.1%甲酸溶液梯度洗脱,检测波长分别为238 nm(栀子苷、盐酸小檗碱),254 nm(芒果苷、芦荟大黄素、大黄酸、大黄素、大黄酚、大黄素甲醚),280 nm(黄芩苷、汉黄芩苷、黄芩素、汉黄芩素),321 nm(白花前胡甲素);柱温:35℃;流速:0.8 mL·min^(-1)。结果:芒果苷、栀子苷、盐酸小檗碱、黄芩苷、汉黄芩苷、黄芩素、芦荟大黄素、汉黄芩素、大黄酸、大黄素、白花前胡甲素、大黄酚和大黄素甲醚线性范围分别为0.231 3~23.13,1.786 8~178.68,0.900 2~90.02,4.913 5~491.35,0.899 0~89.90,0.626 9~62.69,0.213 3~21.33,0.198 8~19.88,0.157 7~15.77,0.210 7~21.07,0.326 1~32.61,0.557 8~55.78,0.235 0~23.50μg·mL^(-1);精密度、稳定性、重复性试验的RSD小于2%;平均回收率(n=6)均大于90%。结论:该方法精确可靠、操作简便快捷,可用于清肺抑火丸中各成分的同时测定。OBJECTIVE To establish a high performance liquid chromatography(HPLC) method for simultaneous determination of 13 components including mangiferin,geniposide,berberine hydrochloride,baicalin,wogonoside,baicalein,aloe-emodin,wogonin,rhein,emodin,praeruptorin A,chrysophanol and physcion in Qingfei Yihuo Pills.METHODS Dikma Platisil ODS column(4.6 mm×250 mm,5 μm) was used with acetonitrile-0.1% formic acid solution as the mobile phase in gradient elution.The detection wavelength was 238 nm(for geniposide,berberine hydrochloride),254 nm(for mangiferin,aloe-emodin,rhein,emodin,chrysophanol,physcion),280 nm(for baicalin,wogonoside,baicalein,wogonin) and 321 nm(for praeruptorin A).In addition,the column temperature was 35 ℃,and the flow rate was 0.8 mL·min^(-1).RESULTS The linear ranges of mangiferin,geniposide,berberine hydrochloride,baicalin,wogonoside,baicalein,aloe-emodin,wogonin,rhein,emodin,praeruptorin A,chrysophanol and physcion were 0.231 3-23.13,1.786 8-178.68,0.900 2-90.02,4.913 5-491.35,0.899 0-89.90,0.626 9-62.69,0.213 3-21.33,0.198 8-19.88,0.157 7-15.77,0.210 7-21.07,0.326 1-32.61,0.557 8-55.78,0.235 0-23.50 μg·mL^(-1),respectively.RSDs of precision,stability and reproducibility tests were less than 2.0%,the average recoveries in sample(n=6) were more than 90%.CONCLUSION The method is accurate,reliable,simple and fast,and can be used for simultaneous determination of multiple components in Qingfei Yihuo Pills.

关 键 词：清肺抑火丸 多组分测定 高效液相色谱-二极管阵列检测 质量评价 

分 类 号：R927.2[医药卫生—药学]