摘要
以Eudragit L30D-55为肠溶衣材料,通过加入Eudragit NE30D调整肠溶衣膜的延展性,以聚乙二醇6000为增塑剂调节最低成膜温度,通过正交试验优化了软胶囊包衣液的处方。3批肠溶软胶囊于(25±2)℃、RH(60±5)%环境放置6个月,均符合中国药典2005年版肠溶制剂的相关标准。
The elongation property of the enteric film of Eudragit L30D-55 could be adjusted with Eudragit NE30D, and its minimum film forming temperature could be decreased with PEG 6000 as plasticizer. The enteric coating formulation of soft gel capsules was optimized by orthogonal design. The qualities of three batches of enteric coating soft gel capsules stored under the condition of （25±2）℃ and RH （60±5） % for 6 months were complied with the enteric specification in ChP 2005.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2008年第6期432-434,共3页
Chinese Journal of Pharmaceuticals
