【摘要】 目的:建立盐酸氢吗啡酮双层渗透泵片中氢吗啡酮释放度测定的方法。方法:采用带沉降篮的中国药典溶出度测定第3法的仪器装置,释放介质为250mL水;以Ecilpse Plus-C8为固定相的Agilent色谱柱(150mm×4.6mm,5μm),乙腈-缓冲液(含0.09%辛烷磺酸钠、0.4%磷酸二氢钾和0.2%三乙胺水溶液)(15∶85)为流动相,流速为1.0mL·min-1,柱温为50℃,检测波长为225nm。结果:氢吗啡酮在0.051～5.1μg范围内线性关系良好,r=0.9999;在0～24h内释放度测定结果与USP第7法数据一致。结论:本法仪器简便,检测结果较为满意。更多还原

【Abstract】 Objective:To establish a method for the analysis of release of hydromorphone in two layers osmotic pump tablets.Method:ChP dissolution test method Ⅲ with sinker was adopted and used 250 mL water as the release media.Agilent Ecilpse Plus-C8 (150 mm×4.6 mm,5 μm)was adopted at 50 ℃.The mobile phase consisted of acetonitrile and buffer solution (15∶85)at a flow rate of 1.0 mL min-1 and the buffer solutin consisted of 0.09% sodium octanesulfonate,0.4% potassium dihydrogen phosphate and 0.2% triethylamine.The detection wavelength was set at 225 nm.Result:The linear correlation of hydromorphone was observed over the range of 0.051-5.1 μg (r=0.9999).The release of hydromorphone using improved method was identical to which using USP method Ⅶ.Conclusion:The method is fastness and convenience.更多还原