摘要
以盐酸左旋沙丁胺醇为模型药物,丙烯酸树脂水分散体Eudragit NE30D为包衣材料,采用流化床包衣法制备缓释微丸。以释放度和释药性能稳定性为评价指标,考察了不同固化条件对微丸的影响。结果表明,提高固化温度和加湿固化均有助于促进衣膜愈合。60℃固化12 h和60℃、相对湿度(RH)75%固化6 h所得微丸的体外释药均符合设计要求。上述两种固化条件下所得微丸在常温贮存条件下的释药稳定性良好,在较激烈贮存条件下的释药性能则大多发生显著变化,仅后一条件固化微丸敞开于25℃、RH 60%环境中释药性能基本稳定。
The sustained-release pellets loaded with levalbuterol hydrochloride were prepared by fluid-bed coating method with Eudragit NE30D as the coating material. The effects of different curing conditions on pellets were evaluated with in vitro release and stability of release behaviors as indexes. The results showed that both temperature and humidity contributed to the film curing process. Pellets cured under the conditions of 60℃for 12 h and 60 ℃, RH 75% for 6 h showed desired release profile. For both pellets, release behaviors were stable when stored under room temperature; however significant changes were observed when conditions turned harsh; under storage condition of 25 ℃, RH 60 %, only pellets prepared by the latter treatment could remain stable.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2012年第1期25-29,共5页
Chinese Journal of Pharmaceuticals
基金
国家“重大新药创制”科技重大专项(2009ZX09301-007)
上海市科学技术委员会生物医药重点科技攻关项目(09431901500)
