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 m L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 C_(18)柱(250 mm×4.6 mm,5μm),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。
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 i 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.
出处
《中国现代应用药学》
CAS
CSCD
2017年第2期272-275,共4页
Chinese Journal of Modern Applied Pharmacy
关键词
去痛片
溶出度测定
高效液相色谱法
compound aminopyrine phenacetin tablets
dissolution test
HPLC
