【摘要】 目的：考察明胶软胶囊囊壳处方因素对囊壳溶解性能的影响。方法：以柠檬黄为指示剂，按常规方法制备明胶胶块及胶片，以溶出度测定方法，测定了胶片的溶解速率。结果：随着明胶／甘油比例的增加，制得胶片的溶解速率呈不规则变化，胶片经４０℃贮存２１ｄ，各种处方的胶片溶解速率呈不同程度下降。胶块处方中加入高分子材料ＰＶＰ、淀粉可轻微增加明胶的溶解速率。结论：对各种因素的讨论有助于设计各种用途的软胶囊囊壳。并提示明胶胶囊应尽可能在低温保存。更多还原

【Abstract】 OBJECTIVE:To study the relationship between various composition factors and the dissolution rates of the soft gelatin capsule shell.METHOD:The gelatin disk and gelatin shaped mass method were used by the current CP rotating basket dissolution apparatus.The effects of shell compositions on the capsule shell dissolution rate were illustrated and discussed.RESULTS:With the increase in the ratio of gelatin glycerol in soft gelatin shell,the dissolution rate of the shell changed irregularly.After storage of 21 days at 40℃,the dissolution rate of the shell decreased at different extent.The dissolution rate of the shaped gelatin mass increased slightly by adding some polymers (pvp,starch).CONCLUSION:Am investigation of these factors and their influence on dissolution may be of assistance in the formulation of soft gelatin capsule shells for various purposes,THE SOFT gelatin capsules should be stored at relatively low temperature.更多还原