摘要
对研制的那格列奈片进行质量评价与研究。观察高温、高湿度及光照条件下处方中主药的含量变化 ,判断处方的筛选结果及工艺的可行性。所制那格列奈片呈类白色 ,硬度、崩解度、溶出度合格 ,含量准确、均匀 ,片重差异小 ,质量可靠 ,各项指标均符合要求 ,三批样品结果表明其具有良好的稳定性。研制的那格列奈片质量可靠、工艺具有生产可行性 。
To study and evaluate the quality of Nateglinide tablets the formulation is screened. The feasibility of its technics is investigated according to the content changes of Nateglinide in different formulations under high temperarature, high humidity and strong light conditions. A reasonablely designed formulation with feasible technics was selected. Nateglinide tablets made of this formulation and technics measured up to the expected standard. The formulation and technics of Nateglinide tablets are feasible in practice and its quality criteria can effectively control.
出处
《科学技术与工程》
2004年第1期21-23,共3页
Science Technology and Engineering
基金
军事医学科学院基金 ( 980 5 10 6)资助
关键词
那格列奈片
质量评价
糖尿病
药物
Nateglinide tablets quality evaluation stability
