摘要
考察颗粒质量、片剂硬度、崩解时限和溶出度等质量指标 ,研究了高效崩解剂、粘合剂 PVP、填充剂微晶纤维素等新型辅料在速释片剂中的作用。结果表明 ,盐酸二甲双胍片剂中加入微晶纤维素、PVP胶浆、以及高效崩解剂交联 PVP、L-HPC、CMS-Na后 ,可在 1min内崩解 ,2 min内药物溶出达 95 %以上。难溶性药物氧氟沙星加入上述辅料后 ,各项质量指标均大为提高 ,崩解时限在 3 min以内 ,10 min以内可溶出 80 %～ 95 %
The water soluble but poor compressible drug metformin hydrochloride and the poor water soluble but good compressible drug ofloxacin were chosen as model drugs for test. The formulations were designed and evaluated using super disintegrants(crosslinking PVP, crosslinking CMC Na, L HPC and CMS Na), new binder PVP, and new filler microcrystalline cellulose. The quality criteria such as granular property, compressibility, disintegration time and dissolution for various formulations indicated that these new excipients could be used satisfactorily in fast release tablets formulation.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2000年第6期257-259,共3页
Chinese Journal of Pharmaceuticals
关键词
盐酸二甲双胍
氧氟沙星
高效崩解剂
速释片
super-disintegrants
microcrystalline cellulose
metformin hydrochloride
ofloxacin
fast-release tablets
