HPLC同时测定清肺抑火片中14种成分的含量  

Simultaneous Determination of 14 Components in Qingfei Yihuo Tablets by HPLC

作　　者：徐维二 范秀春 罗廷顺 缪明锦 董坤 杨怀镜 XU Wei'er;FAN Xiuchun;LUO Tingshun;MIAO Mingjin;DONG Kun;YANG Huaijing(Dali Institute for Food and Drug Control,Dali 671000,China)

机构地区：[1]大理州食品药品检验所,云南大理671000

出　　处：《中国现代应用药学》2024年第8期1084-1090,共7页Chinese Journal of Modern Applied Pharmacy

基　　金：云南省药品监督管理局评价抽检计划项目(云药监办<2022>7号)。

摘　　要：目的建立HPLC同时测定清肺抑火片中栀子苷、芒果苷、黄芩苷、盐酸小檗碱、汉黄芩苷、黄芩素、芦荟大黄素、大黄酸、汉黄芩素、大黄素、白花前胡甲素、大黄酚、大黄素甲醚、白花前胡乙素14种成分含量的方法。方法采用Titank C18(250 mm×4.6 mm,5μm)色谱柱;以0.1%磷酸溶液(A)-乙腈(B)为流动相,梯度洗脱;检测波长:栀子苷为238 nm,芦荟大黄素、大黄酸、大黄素、大黄酚、大黄素甲醚、芒果苷为254 nm,盐酸小檗碱为265 nm,黄芩苷、汉黄芩苷、黄芩素、汉黄芩素为280 nm,白花前胡甲素、白花前胡乙素为321 nm;流速为1.0 mL·min^(-1);柱温为35℃;进样量为10μL。结果栀子苷、芒果苷、黄芩苷、盐酸小檗碱、汉黄芩苷、黄芩素、芦荟大黄素、大黄酸、汉黄芩素、大黄素、白花前胡甲素、大黄酚、大黄素甲醚、白花前胡乙素的线性范围分别为4.96~223.17,0.84~42.22,18.76~938.16,4.46~223.17,4.86~243.10,1.59~79.32,0.76~38.17,1.03~51.49,1.59~79.40,1.21~60.72,1.80~90.06,0.91~45.48,1.04~51.83,0.86~43.23μg·mL^(-1),r均≥0.9999。仪器精密度、稳定性、重复性试验的RSD均<2%,平均加样回收率(n=6)均>90%,RSD<3%。结论该方法操作简单,重复性好,可为完善清肺抑火片的质量标准提供科学依据。OBJECTIVE To establish a high-performance liquid chromatography method for the simultaneous determination of 14 components including geniposide,mangiferin,baicalin,berberine hydrochloride,wogonoside,baicalein,aloe-emodin,rhein,wogonin,emodin,praeruptorin A,chrysophanol,physcion and praeruptorin B in Qingfei Yihuo tablets.METHODS Titank C18(250 mm×4.6 mm,5μm)column was used;0.1%phosphoric acid solution(A)-acetonitrile(B)was used as the mobile phase with gradient elution;detection wavelengths:geniposide at 238 nm,aloe-emodin,rhein,emodin,chrysophanol,physcion and mangiferin at 254 nm,berberine hydrochloride at 265 nm,baicalin,wogonoside,baicalein,and wogonin at 280 nm,praeruptorin A and praeruptorin B at 321 nm.The flow rate was 1.0 mL·min^(-1)and the column temperature was 35℃;the injection volume was 10μL.RESULTS The linear ranges of geniposide,mangiferin,baicalin,berberine hydrochloride,wogonoside,baicalein,aloe-emodin,rhein,wogonin,emodin,praeruptorin A,chrysophanol,physcion and,praeruptorin B were 4.96−223.17,0.84−42.22,18.76−938.16,4.46−223.17,4.86−243.10,1.59−79.32,0.76−38.17,1.03−51.49,1.59−79.40,1.21−60.72,1.80−90.06,0.91−45.48,1.04−51.83 and 0.86−43.23μg·mL^(-1),with r all≥0.9999.The RSDs of instrument precision,stability and reproducibility tests were<3%,and the average recoveries in sample(n=6)were>90%,with the RSDs<3%.CONCLUSION The method is simple and reproducible and can provide a scientific basis for improving the quality standard of Qingfei Yihuo tablets.

关 键 词：清肺抑火片 高效液相色谱法-二极管阵列检测器 含量测定 质量控制 

分 类 号：R917.101[医药卫生—药物分析学]