安立生坦片处方和制备工艺研究
Investigation of Formulation and in-Process Parameters of Ambrisentan Tablets
孙霞 1陈保来 1郭庆明 1萧伟1
作者信息
- 1. 江苏康缘药业股份有限公司,江苏 连云港 222001;中药制药过程新技术国家重点实验室,江苏 连云港 222001
- 折叠
摘要
目的 筛选安立生坦片的最佳处方.方法 通过原料辅料的相容性试验筛选辅料,采用正交试验考察不同处方对颗粒流动性、外观、溶出度的影响,确定最优处方,与市售安立生坦片在4种溶出介质中进行累积溶出曲线对比研究,并考察制剂的加速稳定性.结果 开发出最优处方,产品与市售安立生坦片在4种溶出介质中溶出曲线相似,6个月的加速试验结果与0个月时比较无明显变化.结论 该处方设计合理、制备工艺可靠.
Abstract
OBJECTIVE To optimize the prescription of ambrisentan tablets.METHODS Drug excipients interactions were evaluated to determine the type of excipients,orthogonal design was used to observe the appearance and dissolution of tablets then to determine the optimal prescription,and to compare the dissolution curves in four different pH mediums.And the accelerated stability test was also carried out.RESULTS The optimized rescription of ambrisentan tablets were determined.In various dissolution media with different pH value,the dissolubility curves of ambrisentan tablets between self-prepared preparations and reference VOLIBRS were similar.Result of 6 month accelerated test was not significant different from that of 0 month accelerated test.CONCLUSION The formulation is reasonable,and the preparation is stable.
关键词
安立生坦片/处方研究/溶出曲线/稳定性Key words
ambrisentan tablet/prescription research/dissolubility curves/stability引用本文复制引用
出版年
2015
NETL
NSTL
维普
万方数据