苁蓉连翘合剂质量标准研究  

Study on Quality Standards of Cistanches Herba and Forsythiae Fructus Mixture

作　　者：刘娟[1] 韩文均[1] 范伟 时扣荣[1] 张春燕[1] 辛蓓玮 顾伟鹰[1] 朱建勇[1] LIU Juan;HAN Wenjun;FAN Wei;SHI Kourong;ZHANG Chunyan;XIN Beiwei;GU Weiying;ZHU Jianyong(Seventh People's Hospital,Shanghai University of TCM,Shanghai,China 200137)

机构地区：[1]上海中医药大学附属第七人民医院,上海200137

出　　处：《中国药业》2022年第8期80-83,共4页China Pharmaceuticals

基　　金：上海市卫生健康委员会科研项目[20214Y0280];上海市浦东新区卫生健康委员会优秀青年医学人才培养计划[PWRq2020-48]。

摘　　要：目的建立苁蓉连翘合剂的质量标准。方法采用薄层色谱(TLC)法对样品中肉苁蓉、连翘、佛手进行定性鉴别;采用高效液相色谱(HPLC)法测定样品中松果菊苷的含量,色谱柱为Agilent Zorbax Eclipse XDB-C_(18)柱(250 mm×4.6 mm,5μm),流动相为甲醇-0.1%甲酸溶液(梯度洗脱),流速为1.0 mL/min,检测波长为330 nm,柱温为30℃。结果肉苁蓉、连翘、佛手的TLC斑点清晰,分离度好,阴性对照无干扰。松果菊苷进样量在1.0~20.0μg范围内与峰面积线性关系良好(r=0.9999,n=6);精密度、稳定性、重复性试验的RSD均小于1.1%,平均加样回收率为98.76%,RSD为2.05%(n=9)。结论所建立的方法简便易行,专属性强,准确可靠,可用于苁蓉连翘合剂的质量控制。Objective qualitative identification of Cistanches Herba,Forsythiae Fructus and Citri Sarcodactylis Fructus in samples were identified by thin-layer chromatography(TLC).The content of echinacoside was determined by high-performance liquid chromatography(HPLC)method,the chromatographic column was Agilent Zorbax Eclipse XDB-C_(18) column(250 mm×4.6 mm,5μm),the mobile phase was methanol-0.1% formic acid solution(gradient elution),the flow rate was 1.0 mL/min,the detection wavelength was 330 nm,the column temperature was 30℃.ResultsThe TLC spots of Cistanches Herba,Forsythiae Fructus and Citri Sarcodactylis Fructus were clear and well separated,and the negative sample had no interference.The injection volume of echinacoside showed a good relationship with the peak area in the range of 1.0-20.0μg(r=0.9999,n=6).The RSDs of precision,stability and repeatability tests were less than 1.1%,the average recovery was 98.76%with RSD of 2.05%(n=9).Conclusion with strong specificity is simple,accurate,reliable,and it can provide a reference for the quality control of Cistanches Herba and Forsythiae Fructus mixture.

关 键 词：苁蓉连翘合剂 薄层色谱法 高效液相色谱法 松果菊苷 质量标准 

分 类 号：R932[医药卫生—生药学] R284.1[医药卫生—药学]