包衣工艺参数对硫酸沙丁胺醇控释小丸控释膜的影响  

Influences of operating parameters on film of controlled-release salbutamol sulfate coated pellets

作　　者：温新国[1] 锶小希[1] 张霖泽[1] 金辉[2] 何光力[2] 

机构地区：[1]广州市医药工业研究所,广东广州510240 [2]四川大学华西药学院,四川成都610041

出　　处：《华西药学杂志》2005年第2期106-108,共3页West China Journal of Pharmaceutical Sciences

基　　金：国家九.五攻关项目 (No .9690 2 0 2 11)

摘　　要：目的　研究控释膜包衣工艺对硫酸沙丁胺醇控释小丸控释膜性质的影响。方法　以乙基纤维素为包衣材料,在流化床中以不同操作制备硫酸沙丁胺醇控释小丸样品,然后测定小丸的药物释放度并用显微镜观察膜表面特征。结果　雾化压2bar左右,物料温度在33℃～38℃时控释膜质量较好,药物的释放度与控制标准非常接近。结论　工艺参数的设定能明显影响小丸控释膜的质量。因此,在工业生产时,为保证产品批间的释放特性的稳定,须设定相对精确的工艺操作参数范围。OBJECTIVE To study the influence of film coating process on the controlled-release charater of salbutamol sulfate pellets. METHODS The coated pellets were prepared with ethylcellulose dispersion (Surelease) in different coating process, dissolution profiles of the coated pellets were determined by HPLC and the cross section of the films observed with microscopy. RESULTS The films obtained with atomizing pressure 2.0 bar and product temperature 33℃-38℃ could be the best,with dissolution profiles being very close to the dissolution criteria. CONCLUSION The process parameters make a relatively important influence on the quality of coated film. It is necessary to set up a set of precious process parameters for production.

关 键 词：硫酸沙丁胺醇 控释小丸包衣 工艺参数 释放度 

分 类 号：TQ460.6[化学工程—制药化工]