摘要
目的:制备复方磺胺嘧啶分散片并考察处方、工艺的稳定性。方法:以溶出度为指标,采用正交设计法优选最佳处方,通过初步稳定性试验考察该制剂的质量。结果:以最佳处方制得分散片在60 s内完全崩解,分散均匀度测定能通过2号筛网,体外溶出度优于胶囊剂,初步稳定性显示制剂质量稳定。结论:自制复方磺胺嘧啶分散片处方合理,制备工艺稳定,为大生产提供了依据。
Objective：To prepare compound sulfadiazine dispersible tablets and study the stability of the formula and preparation process.Method：The optimal formula was screened by orthogonal experiment using dissolution rate as the index.The quality of compound sulfadiazine dispersible tablets was evaluated by the preliminary stability test.Result：The disintegration time of the dispersible tablets was in 60 seconds and could pass through No.2 sieve.The dissolution rate of the dispersible tablets was much better than that of the capsules,and the quality of the dispersible tablets was promising in the stability test.Conclusion：The formula screened out for compound sulfadiazine dispersible tablets is reasonable and stable,and suitable for the mass production.
出处
《中国药师》
CAS
2013年第3期357-360,共4页
China Pharmacist
基金
湖北医药学院研究生启动基金资助项目(编号:2007QDJ3)
关键词
磺胺嘧啶
分散片
正交试验
制备工艺
Sulfadiazine
Dispersible tablets
Orthogonal design
Preparation process
