一测多评法同时测定积雪草总苷及其2种制剂中3种成分  

Simultaneous determination of three constituents in Centella asiatica total glucosides and their two preparations by QAMS

作　　者：陈铭[1] 刘文倩 苗水[1] 周恒[1] 兰岚[1] 李雯婷[1] 季申[1] CHEN Ming;LIU Wen-qian;MIAO Shui;ZHOU Heng;LAN Lan;LI Wen-ting;JI Shen(National Medical Products Administration Key Laboratory for Quality Control of Traditional Chinese Medicine,Shanghai Institute for Food and Drug Control,Shanghai 201203,China)

机构地区：[1]上海市食品药品检验所,国家药品监督管理局中药质量控制重点实验室,上海201203

出　　处：《中成药》2020年第9期2280-2284,共5页Chinese Traditional Patent Medicine

基　　金：国家科技部重点研发计划(2017YFC1700800);上海市科委研发平台专项(18DZ2292200);上海市科委技术标准专项(18DZ2200900);国家药典委员会药品医疗器械审评审批制度改革项目(ZG2016-1)。

摘　　要：目的建立一测多评法同时测定积雪草总苷及积雪苷片、积雪苷霜软膏中3种成分的含有量。方法各样品甲醇提取液的分析采用Eclipse XDB-C18色谱柱(4.6 mm×250 mm,5μm);流动相乙腈-(2 mmol/L羟丙基-β-环糊精)(24∶76);体积流量1.0 mL/min;柱温30℃;检测波长205 nm。以羟基积雪草苷为内标,计算其他2种成分的相对校正因子,测定含有量。结果积雪草苷B、羟基积雪草苷、积雪草苷在各自范围内线性关系良好(r≥0.9998),平均加样回收率97.93%~102.05%,RSD 0.61%~2.06%。一测多评法所得结果与外标法接近。结论该方法稳定可靠,可用于积雪草总苷及其2种制剂的质量控制。AIM To establish a quantitative analysis of multi-components by single-marker(QAMS)method for the simultaneous content determination of three constituents in Centella asiatica total glucosides,Jixuegan Tablets and Jixuegan Cream Ointment.METHODS The analyses of methanol extracts of various samples were performed on a 30℃thermostatic Eclipse XDB-C18 column(4.6 mm×250 mm,5μm),with the mobile phase comprising of acetonitrile-(2 mmol/L hydroxypropyl-β-cyclodextrin)(24∶76)flowing at 1.0 mL/min in a gradient elution manner,and the detection wavelength was set at 205 nm.Madecassoside was used as an internal standard to calculate the relative correction factors of the other two constituents,after which the content determination was made.RESULTS Asiaticoside B,madecassoside and asiaticoside showed good linear relationships within their own rangers(r≥0.9998),whose average recoveries were 97.93%-102.05%with the RSDs of 0.61%-2.06%.The results obtained by QAMS approximated those obtained by external standard method.CONCLUSION This stable and reliable method can be used for the quality control of Centella asiatica total glucosides and their two preparations.

关 键 词：积雪草总苷 积雪苷片 积雪苷霜软膏 积雪草苷B 羟基积雪草苷 积雪草苷 一测多评 

分 类 号：R927.2[医药卫生—药学]