目的:完善利多瑞-7汤的质量标准。方法:运用薄层色谱法(TLC)针对利多瑞-7汤处方内的川楝子、栀子进行定性鉴别,以处方中的栀子苷含量为指标,通过高效液相色谱法(HPLC)检测并建立含量测定方法,所采用的色谱条件如下:氨基键合硅胶色谱柱,参照《中国药典》(2020版)的方法,柱温设定为30℃,采用流动相为乙腈-水体系进行梯度洗脱,设定检测波长为238nm,流速为1.0mL/min,对蒙药制剂利多瑞-7汤进行检查项目研究。结果:利多瑞-7汤中的栀子苷薄层色谱法鉴别特征明显,阴性对照无干扰,专属性强;利用HPLC法进行对栀子苷总量的含量进行测定,快捷迅速、准确、稳定性、重复性的结果良好,线性结果优良,平均回收率好。结论:本实验所建立的薄层鉴别和含量测定方法,科学可行、灵敏性高、重复性好、精确度高,为完善和提升利多瑞-7汤的质量标准提供确切的科学依据,可用于利多瑞-7汤等蒙药的质量控制。

Objective: To improve the quality standard of Lidorei-7 decoction. Methods: The qualitative identification of Toosendan Fructus and gardenia in Lidorei-7 decoction was carried out by thin Layer chromatography (TLC). The content of geniposide in the formula was determined by high performance liquid chromatography (HPLC). The chromatographic conditions were as follows: amino-bonded silica gel column, according to the method of Chinese Pharmacopoeia (2020 edition), the column temperature was set at 30 ℃, the mobile phase acetonitrile-water system was used for gradient elution, the detection wavelength was set at 238 nm, and the flow rate was 1.00 mL/min. The examination item of Mongolian medicine preparation Lidorei-7 decoction was studied. Results: The characteristics of the identification of gardenoside in Mongolian medicine Lidorei-7-decoction were obvious by thin Layer chromatography, and the negative control had no interference and demonstrating strong specificity. The HPLC method was used to determine the total content of gardenoside, the results were rapid, accurate, stable, repeatable, excellent linear results and good average recovery. Conclusion: The identification, inspection and content determination methods established in this experiment are scientifically feasible, sensitive, reproducible and accurate, which provide a precise scientific basis for establishing the quality standard of Lidori-7 decoction, and can be used for the quality control of Mongolian medicines such as Lidori-7 decoction.