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目的:建立胆宁分散片的质量标准。方法:用TLC法对处方中药味进行了定性鉴别研究;用HPLC法进行了成品中有效成分水飞蓟宾的含量测定,选用ZORBAX RX-C18(4.6mm×150mm,5μm)色谱柱,甲醇-水-冰醋酸(42∶58∶1)为流动相,流速1.0mL·min-1,检测波长288nm,柱温40℃。结果:建立了胆宁分散片的质量标准,包括人工牛黄、延胡索、大黄的薄层鉴别方法和有效成分水飞蓟宾的含量测定方法。结论:该方法能很好地控制产品的质量,可以作为胆宁分散片的质量标准。
Objective: To establish the quality standard of Danning Dispersible Tablets. Methods: TLC method was used to qualitatively identify the flavor of the prescription. The content of silybin in the finished product was determined by HPLC. ZORBAX RX-C18 (4.6mm × 150mm, 5μm) Water-glacial acetic acid (42:58:1) as mobile phase at a flow rate of 1.0mL · min-1. The detection wavelength was 288nm and the column temperature was 40 ℃. Results: The quality standard of Danning Dispersible Tablets was established, including the method of identifying the thin layer of artificial bezoar, corydalis root and rhubarb and the content determination of silybin. Conclusion: This method can well control the quality of the product, which can be used as the quality standard of Danning Dispersible Tablets.