摘要
将盐酸依匹斯汀、预胶化淀粉和微晶纤维素混匀后装填胶囊。考察了原料辅料相容性、胶囊内容物的粉体学性质和溶出度等。初步稳定性考察结果表明,所得盐酸依匹斯汀胶囊在(40±2)℃、相对湿度(75±5)%条件下放置6个月或常温放置12个月,含量和溶出度无明显改变,有关物质略有增加。
The epinastine hydrochloride, pregelatinized starch and microcrystalline cellulose were mixed and then filled into capsules. The drug-excipient compatibility, powder properties of the mixture of drug-excipient with different weight ratio and in vitro dissolution of the product were investigated. The results of preliminary stability test showed that after storage at （40±2） ℃ and relative humidity of （75±5） % for 6 months or at room temperature for 12 months, the content and dissolution did not have significant changes but the amount of related substances had a slightincrease.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2013年第8期774-777,共4页
Chinese Journal of Pharmaceuticals
基金
四川省科技厅科技支撑项目(2011SZ0071)
关键词
盐酸依匹斯汀
胶囊
相容性
体外溶出
稳定性
epinastine hydrochloride
capsule
drug-excipient compatibility
in vitro dissolution
stability
