摘要
目的研究囊壳处方中明胶、甘油比例的改变及加入不同添加剂对舒胸软胶囊溶解性的影响。方法制备明胶胶皮模拟软胶囊囊壳,测定胶皮中柠檬黄的溶出速率常数,以此结果为指标,通过改变舒胸软胶囊囊壳的处方组成,在不同条件下,观察对囊壳溶解性的影响。结果在不同条件下,囊皮溶解性能随明胶、甘油比例的增加而降低,不同添加剂的加入能有效地改善囊皮的溶解性。温度升高将延长囊皮的溶解时间。结论囊壳处方对舒胸软胶囊的溶散有较大影响,当明胶、甘油选用质量比为1∶0.5的处方配比时,在其中添加质量分数为5%的聚乙二醇400,并在低温贮存时可以有效地改善囊壳的溶解性能。
Objective To study the effects of different additives and the ratio of gelatin and glycerol on the dissolvability of Shuxiong(traditional Cinese medicines) Soft Gelatin Capsule shells.Method Gelatin disks were prepared to measure the dissolution-rate constant of lemon yellow in shells by rotating-basket dissolution method.The result was regarded as the index to test the effect of shell composition on the solubility indirectly in different conditions.Result The dissolvability of capsule shell was decreased with increasing the ratio of gelatin and glycerol.It was also changed markedly by adding different additives.The dissolution time was prolonged after storage at high store temperature.Conclusion The dissolvability of Shuxiong soft gelatin capsule shells was influenced by the composition considerably.The best ratio of gelatin and glycerol in shells was 1:0.5(w).The dissolvability could be improved by adding 5%(w) PEG 400 and being stored at low temperature.
出处
《中国药剂学杂志(网络版)》
2005年第4期249-254,共6页
Chinese Journal of Pharmaceutics:Online Edition
关键词
药剂学
舒胸软胶囊
囊皮
柠檬黄
溶出速率
添加剂
pharmaceutics
Shuxiong soft gelatin capsules
capsule shells
lemon yellow
dissolution rates
additives