胆宁分散片质量标准研究

Study on Quality Control of Danning Dispersible Tablets

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 a quality control method for Danning Dispersible Tablets.Method：TLC and HPLC were used.Result：Calculus Bovis Antifactus,Rhizoma Corydalis,Radix et Rhizoma Rhei were identified by TLC.Silybin was determined by HPLC.ZORBAX RX-C18 （4.6 mm×150 mm,5 μm） column was used and the column temperature was set at 40 ℃ .The mobile phase was consisted with methanol-water-acetic acid （42：58：1） and the flow rate was 1.0mL·min-1.The detection wavelength was at 288 nm.Conclusion：The method established can be used to control the quality of Danning Dispersible Tablets.