胆宁分散片质量标准研究

Study on Quality Control of Danning Dispersible Tablets

摘要:

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(4.6 mm×150 mm,5 μm)色谱柱,甲醇-水-冰醋酸(42 ∶58 ∶1)为流动相,流速1.0 mL ·min^-1,检测波长288 nm,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。

Abstract:

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.