双波长HPLC法同时测定消炎灵胶囊中四种成分的含量  

Simultaneous Determination of Four Components in Xiaoyanling Capsule by HPLC Dual-wavelength Spectrophotometry

作　　者：张臻锴 郭璐玫 Zhang Zhenkai;Guo Lumei(Guizhou Institute for Food and Drug Control,Guiyang 550004,China)

机构地区：[1]贵州省食品药品检验所,贵州贵阳550004

出　　处：《山东化工》2024年第8期144-149,共6页Shandong Chemical Industry

基　　金：国家药品抽检项目(.国药监药管[2020]33号)。

摘　　要：目的:建立双波长HPLC法同时测定消炎灵胶囊中苦玄参苷Ⅰ_(A)、苦玄参苷Ⅰ_(B)、甘草苷、甘草酸含量,对市售消炎灵胶囊中苦玄参和甘草质量进行研究与评价。方法:使用HPLC,选择Waters Xselect C_(18)色谱柱,以乙腈为流动相A,0.1%磷酸溶液为流动相B进行梯度洗脱,流速1.0 mL/min,柱温30℃,检测波长237 nm(甘草苷、甘草酸)、264 nm(苦玄参苷Ⅰ_(A)、苦玄参苷Ⅰ_(B))。结果:65批消炎灵胶囊4种成分线性关系良好(r=0.9998~1.0000),平均加样回收率为97.6%~98.6%(RSD值均小于1%)。部分企业消炎灵胶囊不同批次间4种成分含量存在较大差异,说明各批次间均一性较差。提示各生产企业加强对药材质量控制。结论:该方法简单快捷,可同时测定4个成分含量,并具有良好精密度、重复性和稳定性,为消炎灵胶囊中苦玄参苷Ⅰ_(A)、苦玄参苷Ⅰ_(B)、甘草苷、甘草酸质量评价提供参考。Objective:To establish a HPLC Dual-wavelength Spectrophotometry method for the determination of picfeltarraeninⅠ_(A),picfeltarraeninⅠ_(B),liquiritin and glycyrrhizic acid in Xiaoyanling capsules,and the quality of Picria felterrae Lour and Glycyrrhiza uralensis Fisch in Xiaoyanling capsules was studied and evaluated.Methods:A Waters Xselect C_(18)column was used for gradient elution with acetonitrile as mobile phase A and 0.1%phosphoric acid solution as mobile phase bat the flow rate of 1.0 mL/min.The column temperature was 30℃.The detection wavelength was 237 nm(liquiritin,glycyrrhizic acid),264 nm(picfeltarraeninⅠ_(A),picfeltarraeninⅠ_(B)).Results:The linear relationship between the four components of 65 batches of Xiaoyanling capsule was good(r=0.9998~1.0000),and the average recoveries were 97.6%~98.6%(RSD values were all less than 1%).The contents of 4 components of Xiaoyanling capsules in different batches of some enterprises are significantly different,indicating poor uniformity among batches.It is suggested that the production enterprises should strengthen the quality control of medicinal materials.Conclusion:The method is simple and rapid,and can be used to determine the contents of 4 components simultaneously,with good precision,repeatability and stability.It can provide reference for the quality evaluation of picfeltarraeninⅠ_(A),picfeltarraeninⅠ_(B),liquiritin and glycyrrhizic acid in Xiaoyanling capsule.

关 键 词：消炎灵胶囊 高效液相色谱法 双波长法 含量测定 苦玄参 甘草 

分 类 号：TQ461[化学工程—制药化工] R284.1[医药卫生—中药学]