摘要
本文建立了复方甘草片的HPLC指纹图谱及吗啡、磷酸可待因、芹糖甘草苷、甘草苷、苯甲酸钠、异甘草苷、甘草酸7成分测定方法。采用50%甲醇水溶液对复方甘草片提取后,用HPLC-UV法进行测定;色谱条件为:Welch Ultimate AQ-C18色谱柱(5μm,4.6 mm×250 mm);乙腈-0.02 mol/L磷酸盐缓冲液(pH4.0)为流动相,梯度洗脱;流速1.0 mL/min;检测波长220、254 nm;柱温35℃;进样量10μL。采用国家药典委员会“中药色谱指纹图谱相似度评价系统”(2012年版)建立18批样品指纹图谱,并同时测定7成分含量。结果显示18批复方甘草片指纹图谱相似度均大于0.95,共有27个共有峰,通过与对照品对照保留时间鉴定了14个共有峰。吗啡、磷酸可待因、芹糖甘草苷、甘草苷、苯甲酸钠、异甘草苷、甘草酸在各自浓度范围内线性关系良好(r>0.9990),平均加样回收率94.73%~104.45%,RSD 0.68%~3.89%。本方法简便、快速、准确,可用于复方甘草片的质量控制。
To establish an HPLC method to generate the fingerprints of compound liquorice tablets and to determine the contents of morphine,codeine phosphate,liquiritinapioside,liquiritin,sodium benzoic isoliquiritin and glycyrrhizic acid simultaneously.Compound liquorice tablets were extracted by 50%methanol and analyzed under the parameters as:column:Welch Ultimate AQ-C18column(5μm,4.6 mm×250 mm);mobile phase:acetonitrile-0.02 mol/L phosphate buffer(pH4.0),gradient elution manner;flow rate:1.0 mL/min;detection wavelength:220 and 254 nm;column temperature:35℃injection volume:10μL.The chromatographic fingerprint evaluation system which was recommended by the State Pharmacopoeia Commission(2012 Edition)was used to establish the fingerprints of 18 batches of samples.The contents of the 7 chemical markers were determined simultaneously.The result showed that similarities of the 18 batches of samples were higher than 0.95,27 peaks were assigned as the common peaks,and 14 peaks were identified by comparing their retention times with those of reference standards.Morphine,codeine phosphate,liquiritinapioside,liquiritin,sodium benzoic,isoliquiritin and glycyrrhizic acid showed good linear relationships within their own ranges(r>0.9990),whose average recoveries were 94.73%-104.45%with RSDs of 0.68%-3.89%.The method is simple,fast,accurate,and could be used for the quality control of compound liquorice tablets.
作者
高小惠
胡燕琴
王洪静
李宁
刘军锋
杨兆祥
GAO Xiao-hui;HU Yan-qin;WANG Hong-jing;LI Ning;LIU Jun-feng;YANG Zhao-xiang(KPC Pharmaceuticals,Inc,Kunming 650100,China;The MOE Key Laboratory for Standardization of Chinese Medicines,Institute of Chinese Materia Medica,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China)
出处
《天然产物研究与开发》
CAS
CSCD
北大核心
2020年第5期734-741,844,共9页
Natural Product Research and Development
基金
2018年研发经费投入补助(昆药集团股份有限公司)(2018YB258)。
关键词
复方甘草片
指纹图谱
含量测定
质量控制
compound liquorice tablets
fingerprint
content determination
quality control
作者简介
通讯作者:李宁,Tel:86-871-68319868-2045,E-mail:mailtolining@gmail.com;通讯作者:刘军锋,E-mail:junfeng.liu@holley.cn。
