【摘要】 目的 :解决软胶囊崩解迟缓、崩解不合格的问题。方法 :从更换明胶、添加加速溶出辅料、抗氧剂三方面改进囊皮 ,应用胶片溶解速率法筛选囊皮处方 ,并进行软胶囊留样考察。结果 :加入 L-半胱氨酸、柠檬酸 ,选用优质明胶均有明显的增溶效果 ,选用优质明胶可解决软胶囊崩解迟缓、崩解不合格的问题。结论 :不同厂家生产的明胶质量存在较大差异 ,选用优质明胶是改善软胶囊崩解迟缓、崩解不合格问题的关键所在。更多还原

【Abstract】 Object: To solve the problems of prolonged disintegration and disqualified disintegration of soft capsules. Methods: Three methods are considered to modify the quality of the soft capsule shells, using different gelatin, adding additives that can facilitate dissolution and adding antioxidant agents. Gelatin film dissolution rate was used as the indicator for the optimization of the formulation of capsule shells. Soft capsules were taken for further observation. Results: Adding L-cysteine or citric acid, or using high quality gelatin can significantly increase the dissolution rate. Using high quality gelatin alone was enough to solve the problems of prolonged disintegration and disqualified disintegration of soft capsules. Conclusion: Gelatins from different manufacturers are greatly different in quality. Using high quality gelatin is a very effective method to solve the problem of prolonged disintegration and disqualified disintegration of soft gelatin capsules.更多还原