高效液相色谱-蒸发光散射法测定肤痒颗粒中薯蓣皂苷元的含量  

Content Determination of Diosgenin in Fuyang Granules by High Performance Liquid Chromatography-Evaporative Light Scattering Detection

作　　者：施文禧 欧贝丽 邹燕 龚秋翼 SHI Wenxi;OU Beili;ZOU Yan;GONG Qiuyi(Jiaxing Food,Drug and Product Quality Inspection and Testing Institute,Zhejiang Jiaxing 314000,China)

机构地区：[1]嘉兴市食品药品与产品质量检验检测院,浙江嘉兴314000

出　　处：《中国医药导刊》2023年第10期1014-1017,共4页Chinese Journal of Medicinal Guide

基　　金：浙江省药品监管系统科技计划项目[项目编号:2022012;项目名称:肤痒颗粒质量标准提升与质量标志物(Q-marker)的预测]。

摘　　要：目的:建立一种准确测定肤痒颗粒中薯蓣皂苷元含量的方法。方法:以白英中薯蓣皂苷元为检测指标,采用高效液相色谱-蒸发光散射法测定肤痒颗粒中薯蓣皂苷元的含量。色谱柱为Eclipse XDB-C 18柱(250 mm×4.6 mm,5μm),流动相为甲醇-水(95∶5),流速为1.0 mL·min^(-1),柱温为30℃,进样量为20μL;采用Alltech 3300 ELSD蒸发光散射检测器。肤痒颗粒供试品溶液的制备采用酸水解提取,水浴回流3 h,用石油醚(60~90℃)萃取4次,回收石油醚至干,用甲醇溶解得到供试品溶液进行测定。结果:薯蓣皂苷元在20.82~104.10μg·mL^(-1)浓度范围内线性关系良好。平均回收率为92.97%(n=6),RSD=4.8%。测定14个厂家肤痒颗粒中薯蓣皂苷元含量,发现含量相差较大。结论:本方法准确,专属性强,能客观地反映肤痒颗粒中薯蓣皂苷元的含量。不同厂家肤痒颗粒中薯蓣皂苷元含量参差不齐,应加强质量控制。Objective:To establish a method for accurate determination of the content of diosgenin in Fuyang granules.Methods:High performance liquid chromatography is used with Alltech 3300 ELSD evaporative light scattering detector.The chromatographic column is Eclipse XDB-C 18 column(250 mm×4.6 mm,5μm).The mobile phase is methanol-water(95∶5).The velocity of flow is 1.0 mL·min^(-1).The column temperature is 30℃.The injection volume is 20μL.Acid hydrolysis extraction was used for the preparation of Fuyang granule test solution.Water bath reflux for 3 hours,extract 4 times with petroleum ether(60-90℃),recover petroleum ether to dryness,and dissolve in methanol to obtain the test solution for content determination.Results:The linear relationship of diosgenin was good in the concentration range from 20.82 to 104.10μg·mL^(-1).The average recovery was 92.97%(n=6),RSD=4.8%.The diosgenin content in Fuyang granules from 14 manufacturers was determined and it was found that the content varied greatly.Conclusion:The method established is accurate and specific,which can objectively reflect the content of diosgenin in Fuyang granules.The content of diosgenin in Fuyang granules from different manufacturers varied,so the quality control should be strengthened.

关 键 词：肤痒颗粒 薯蓣皂苷元 高效液相色谱 蒸发光散射 

分 类 号：R927.2[医药卫生—药学]