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苁蓉连翘合剂质量标准研究

Study on Quality Standards of Cistanches Herba and Forsythiae Fructus Mixture

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【作者】 刘娟韩文均范伟时扣荣张春燕辛蓓玮顾伟鹰朱建勇

【Author】 LIU Juan;HAN Wenjun;FAN Wei;SHI Kourong;ZHANG Chunyan;XIN Beiwei;GU Weiying;ZHU Jianyong;Seventh People′s Hospital,Shanghai University of TCM;

【通讯作者】 朱建勇;

【机构】 上海中医药大学附属第七人民医院

【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-C18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=0.999 9,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。

【Abstract】 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-C18column(250 mm × 4. 6 mm,5 μm),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. 0 μg(r = 0. 999 9,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.

【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]
  • 【文献出处】 中国药业 ,China Pharmaceuticals , 编辑部邮箱 ,2022年08期
  • 【分类号】R286.0
  • 【下载频次】130
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