红药子质量标准研究  

Study on the quality standard of Rodgersia aesculifolia Batalin

作　　者：张亚杰 海娟 闫巧 李文[1] 周静 贾旭森 张静 张菊 杨平荣 胡芳弟[1] Zhang Ya-jie;Hai Juan;Yan Qiao;Li Wen;Zhou Jing;Jia Xu-sen;Zhang Jing;Zhang Ju;Yang Ping-rong;Hu Fang-di(School of Pharmacy,Lanzhou University,Lanzhou 730000,China;National Engineering Research Center for Gelatin-based Traditional Chinese Medicine,Dong-E-E-Jiao Co.Ltd.,Liaocheng 252201,Shandong,China;Analysis and Test Center,Gansu Institute for Drug Control,Lanzhou 730070,China)

机构地区：[1]兰州大学药学院,甘肃兰州730000 [2]东阿阿胶股份有限公司国家胶类中药工程技术研究中心,山东聊城252201 [3]甘肃省药品检验研究院分析测试中心,甘肃兰州730070

出　　处：《兰州大学学报（医学版）》2021年第1期28-33,41,共7页Journal of Lanzhou University（Medical Sciences）

基　　金：国家重点研究发展项目(2018YFC1706300);甘肃省创新引导专项资金项目(2017ZX-02);兰州市科技计划项目(2017-RC115);甘肃省科技厅科技重大专项项目(17ZD2FA009);中央高校基本业务费重点项目和自由探索项目(lzujbky-2018-k13,lzujbky-2017-205);中央高校基本科研业务费专项资金项目(lzujbky-2020-sp25);兰州市城关区科技计划项目(2018-1-4);兰州市城关区科技局项目(2018KJGG0067)。

摘　　要：目的建立红药子药材的定性定量评价方法。方法采用薄层色谱法建立红药子的定性鉴别方法,采用高效液相色谱法建立红药子中岩白菜素的定量分析方法,参照《中国药典》(2015年)附录相关方法测定红药子中水分、灰分、酸不溶性灰分及浸出物含量。结果建立的薄层色谱法斑点清晰,重复性好,可以特征性地实现12批红药子药材的定性鉴别。红药子中岩白菜素测定的标准曲线为y=6249.8056x+369.11127,线性范围为0.0627~8.03 mg/mL,相关系数为0.9992,日内精密度RSD=0.64%,平均加样回收率为96.20%,RSD=2.97%。12批红药子中岩白菜素、水分、酸不溶性灰分、醇溶性浸出物、水溶性浸出物含量分别为8.94%~12.59%、0.25%~0.95%、27.10%~40.32%、16.06%~26.58%、3.31%~9.45%。结论建立的薄层色谱法可以实现红药子药材的定性鉴别,高效液相色谱法简便、可行,具有较高的精密度和准确性,可用于红药子中岩白菜素的含量测定。Objective To establish qualitative and quantitative methods of Rodgersia aesculifolia Batalin.Methods Thin layer chromatography(TLC)was used for qualitative identification of Rodgersia aesculifolia Batalin.High performance liquid chromatography(HPLC)was used for a quantitative analysis of bergenin in Rodgersia aesculifolia Batalin.At the same time,the water content,total ash,acid-insoloule ash and extractum in the Rodgersia aesculifolia Batalin were determined by following the methods recorded in appendix of the Chinese Pharmacopeia(2015 edition).Results TLC of twelve samples showed clear spots with good reproducibility.The standard curve of bergenin in the Rodgersia aesculifolia Batalin was y=6249.8056x+369.11127,the linear range was 0.0627~8.03 mg/mL,the correlation coefficient was 0.9992,the daily precision RSD was 0.64%,the average recovery rate was 96.20%and the RSD was 2.97%.The content of bergenin,water content,acid-insoluble ash content,alcohol extract content and water extract content in 12 batches of Rodgersia aesculifolia Batalin were 8.94%~12.59%,0.25%~0.95%,27.10%~40.32%,16.06%~26.58%,3.31%~9.45%.Conclusion The established TLC can be used to the qualitative identification of Rodgersia aesculifolia Batalin.The method of HPLC can be used to determine the content of bergenin in Rodgersia aesculifolia Batalin.The above research provides a basis for the establishment of Rodgersia aesculifolia Batalin quality standard.

关 键 词：红药子 岩白菜素 薄层色谱法 高效液相色谱法 质量标准 

分 类 号：R284.1[医药卫生—中药学]