米非司酮片溶出速率的研究

Dissolution Study of RU_(486) Tablets

采用平衡溶解实验法测定了米非司酮(RU_(436))在不同pH条件下的溶解度,并采用转篮法对RU_(436)市售片和自制片在不同pH条件下的溶出进行了测试。实验证明,RU_(436)在pH 3.0以上的水中难溶,在pH 1.2,pH 2.0,pH 3.0的条件下,自制片的溶出速率显著快于市售片。但无论市售片还是自制片在pH>3.0的溶出介质中,溶出速率均显著下降。

Equilibrium solubility of RU_(486) in different pH value buffer was detected. Dissolution rates of RU_(486) tablets were determined in different pH value by rotary basket method (100r/min, 37.0±0.5℃). It was found that RU_(486) was not water-soluble in pH>3.0 buffer and the dissolution rates of both commercial RU_(486) tablets and new formulation RU_(486) tablets in pH4.0 and pH5.0 buffer were much slower than those in pH<3.0 buffer. So it was suggested that RU_(486) tablets should be taken in at least two hours before or after meals.