去痛片溶出度测定方法的研究

Study of Method for Dissolution Test of Compound Aminopyrine Phenacetin Tablets

摘要: 目的建立去痛片中氨基比林、非那西丁、咖啡因和苯巴比妥的溶出度测定方法。方法采用浆法，以0.1 mol·L^-1盐酸溶液900 mL为溶出介质，转速为50 r·min^-1。应用高效液相色谱法，色谱柱为Kromasil C₁₈柱（250 mm×4.6 mm，5 μm），磷酸二氢钾溶液-甲醇（60：40）为流动相，检测波长为215 nm，测定去痛片的溶出量。结果不同厂家去痛片的溶出曲线存在明显差异。结论所建方法可为提高去痛片的质量标准，建立合理的溶出度测定方法提供依据。

Abstract: OBJECTIVE To establish the dissolution test method for the compound aminopyrine phenacetin tablets.METHODS The established dissolution was the paddle method. 900 mL 0.1 mol·L^-1 hydrochloride acid was used as the dissolution medium, the rotation speed was 50 r·min^-1. HPLC was used for detection. A Kromasil C₁₈ column (250 mm×4.6 mm, 5 μm) was used. Mobile phase consisted of a mixture of monopotassium phosphate solution-methanol (60:40), and UV detection wavelength was 215 nm.RESULTS Obvious difference of dissolution curves between different companies was observed.CONCLUSION The developed method provided a scientific basis for improving the quality control standards, and establishing a reasonable dissolution test method for compound aminopyrine phenacetin tablets.