除湿止痒合剂质量控制研究  

Quality control of Chushi Zhiyang Mixture

作　　者：叶泰玮 桑泽春 宋瑜[2] 王新宏[1] 谢燕[1] YE Tai-wei;SANG Ze-chun;SONG Yu;WANG Xin-hong;XIE Yan(Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China)

机构地区：[1]上海中医药大学,上海201203 [2]上海中医药大学附属龙华医院,上海200032

出　　处：《中国新药杂志》2021年第9期831-836,共6页Chinese Journal of New Drugs

基　　金：上海市科委“生物医药领域”科技支撑项目(18401932500);上海市优秀学术带头人计划资助项目(19XD1423700)。

摘　　要：目的:通过对除湿止痒合剂进行薄层鉴别、含量测定等研究,建立合理可行的质量控制方法。方法:参照《中华人民共和国药典》2015年版四部通则相关方法,建立鉴别除湿止痒合剂赤芍、金银花、白鲜皮、地肤子4味饮片的薄层色谱(TLC)鉴别方法;建立HPLC法测定除湿止痒合剂中黄芩苷和芍药苷等指标性成分。结果:TLC鉴别方法专属性强,能够有效鉴别4味饮片;黄芩苷和芍药苷质量浓度分别为1.603~160.250和1.694~211.750μg·mL^(-1),与峰面积呈良好的线性关系,平均加样回收率分别为102.69%(RSD=3.64%)和100.90%(RSD=2.75%)。结论:建立的质量评价方法简便准确、专属性强、重复性好,可对除湿止痒合剂进行有效质量管控。Objective:To establish a reasonable and feasible quality control method of Chushi Zhiyang Mixture using thin layer chromatography(TLC)and high performance liquid chromatography(HPLC).Methods:According to the relevant methods presented in the fourth general rules of Chinese pharmacopoeia(2015 edition),TLC method for identifying four Chinese medicinal materials in Chushi Zhiyang Mixture,including Paeoniae Radix Rubra,Lonicerae Japonicae Flos,Dictamni Cortex,and Kochiae Fructus,and HPLC method for determining the index components of baicalin and paeoniflorin in the mixture were established.Results:The TLC method was specific which could identify the four medicinal materials effectively.The concentrations of baicalin and paeoniflorin were in the range of 1.603~160.250μg·mL-1 and 1.694~211.750μg·mL-1,respectively,which had a good linear relationship with their corresponding peak areas.The average recoveries were 102.69%(RSD 3.64%)and 100.90%(RSD 2.75%),respectively.Conclusion:The established methods for quality evaluation of Chushi Zhiyang Mixture are simple,accurate,specific,and repeatable,which can effectively execute the quality control for Chushi Zhiyang Mixture.

关 键 词：除湿止痒合剂 黄芩苷 芍药苷 薄层色谱 高效液相色谱 

分 类 号：R917[医药卫生—药物分析学]