齐墩果酸生物黏附型缓释胶囊的稳定性评价  

Stability Evaluation of Oleanolic Acid Bioadhesive Sustained-release Capsules

作　　者：刘跃 唐丽[1] 张晶 郑林 

机构地区：[1]贵州省药物制剂重点实验室,贵阳550004 [2]贵阳医学院药学院/民族药与中药开发应用教育部工程研究中心,贵阳550004

出　　处：《中国药房》2014年第21期1966-1968,共3页China Pharmacy

基　　金：贵州省科技计划项目(No.黔科合SY字〔2013〕3057);贵阳市科技计划项目(No.筑科合同〔2013204〕4-3);贵州省中药现代化科技产业研究开发专项(No.黔科合中药字〔2011〕5081)

摘　　要：目的:研究齐墩果酸生物黏附型缓释胶囊的稳定性。方法:以主药含量、累积释放度、水分、有关物质为指标,对齐墩果酸生物黏附型缓释胶囊进行影响因素试验[高温(避光,60℃)、高湿(25℃,相对湿度90%)、光照(4 500 lx)条件下放置10 d]、加速试验(40℃、相对湿度75%放置6个月)、长期试验(30℃、相对湿度65%放置12个月)。结果:本品在高温、光照条件下和加速试验、长期试验中各指标无明显变化,在高湿条件下胶囊颗粒湿质量增加。结论:本品应放置于干燥、密闭的环境中,其有效期暂定为1年。OBJECTIVE：To study the stability of Oleanolic acid bioadhesive sustained-release capsules.METHODS：Using the content of main component,accumulative release rate,moisture and related substance as index,influential factor test [high temperature（away from light,60 ℃）and humidity（25 ℃,relative humidity of 90%）,light（4 500 lx）,setting for 10 days],accelerated test（40 ℃,relative humidity of 75%,setting for 6 months）and long-term test（30 ℃,relative humidity of 65%,setting for 12 months）.RESULTS：The indexes had no significant change in accelerated test and long-term test under high temperature and light;wet weight of capsule particle increased under high humidity.CONCLUSIONS：The preparation period is tentatively scheduled for one year in dry and closed place.

关 键 词：齐墩果酸 生物黏附型缓释胶囊 含量测定 稳定性 

分 类 号：R927.11[医药卫生—药学] R944.5