用均匀设计合并相关分析优选雄黄胃内漂浮滞留片的处方及制剂工艺

Optimization of formulation matrix proportion and preparation technology of realgar floating tablets for gastric retention by uniform design and correlation analysis

目的:利用均匀设计法及相关分析优选雄黄胃内滞留漂浮片的处方配比。方法:以不同处方配比的羟丙甲基纤维素(HPMC)为骨架材料,采用均匀设计法及相关分析筛选制剂配方并进行体外累积溶出度的测定。结果:体外溶出度符合实验预期要求;释药机制是通过溶蚀和扩散同时完成的。结论:雄黄胃内漂浮滞留片基本达到设计要求,满足缓释、安全的要求。

Objective： To optimize the different components proportions of the Realgar floating tablets for gastric retention by uniform design and correlation analysis. Method： With the different dosage of hydroxypropyl methyl cellulose （HPMC） as the tablets＇ frame matrix, uniform design and correlation analysis were used to optimize the best component proportions of formula, and to measure the dissolution of the tablets in vitro. Result： Dissolution of the tablets in vitro was conformed to the expectation of experiment. The drug-release mechanism was by diffusion and corrosion at the same time. Conclusion：The Realgar floating tablets for gastric retention achieved the goal of design, which demand sustained release and safety.