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目的:检测辛伐他汀片在4种溶出介质中的不同时间的溶出度,绘制溶出曲线,确定溶出介质,建立溶出度检测方法。方法:在不同的溶出介质中,分别在5、10、15、20、30、40分钟取样,测定溶出度,绘制出溶出曲线,比较在不同介质中的溶出结果。结果:最终选择含0.5%十二烷基硫酸钠的0.01mol/L磷酸二氢钠缓冲液为溶出介质。结论:辛伐他汀片在不同溶出介质中的溶出度与其自身理化性质有直接关系。
OBJECTIVE: To determine the dissolution rate of simvastatin tablets at different time in four dissolution media, draw the dissolution curve, determine the dissolution media, and establish the dissolution detection method. Methods: In different dissolution media, samples were taken at 5, 10, 15, 20, 30 and 40 minutes respectively to measure the dissolution rate. The dissolution curves were drawn and the dissolution results in different media were compared. Results: 0.01mol / L sodium dihydrogen phosphate buffer containing 0.5% sodium dodecyl sulfate was selected as dissolution medium. Conclusion: The dissolution of simvastatin tablets in different dissolution media is directly related to its physico-chemical properties.