摘要
目的:制备滑石粉分散片并优选其处方工艺。方法:以崩解时限、分散均匀性或软材成型情况为指标,通过单因素试验筛选滑石粉分散片的辅料种类;选取滑石粉、崩解剂、填充剂用量为考察因素,以崩解时限、分散均匀性和混悬稳定性为综合评价指标,采用综合评分法和D-最优混料设计优选滑石粉分散片处方。结果:最佳制备工艺为以微晶纤维素为填充剂,含羟丙基甲基纤维素(HPMC)的30%乙醇溶液为黏合剂,交联聚乙烯吡咯烷酮(PVPP)为崩解剂,最优处方比例为滑石粉-微晶纤维素-PVPP(0.447∶0.400∶0.123)。结论:优选的制备工艺稳定可行;D-最优混料设计可用于滑石粉分散片处方的优化,建立的数学模型具有良好预测性。
Objective： To prepare Talci Pulvis dispersible tablets and optimized its prescription process. Method： Wtih disintegration time,dispersible uniformity or soft material molding conditions as indexes,excipients species of Talci Pulvis dispersible tablets were screened by single factor tests;With the amount of Talci Pulvis,disintegrating agents and stuffing bulking agents as factors,comprehensive scoring method and D-optimal mixture design were adopted to optimize prescription of Talci Pulvis dispersible tablets by taking disintegration time,dispersible uniformity and suspension stability as indicators. Result： Optimal preparation technology was as following：with microcrystalline cellulose（MCC） as a filler,30% ethanol configured hydroxy propyl methyl cellulose（HPMC） as a binder,cross-linked polyvinylpyrrolidone（PVPP） as a disintegrating agent;The best proportion of prescriptions was Talci Pulvis-MCC-PVPP （0.447：0.400：0.123）. Conclusion： Optimized preparation tehcnology was stable and feasible; Established mathematical model of D-optimal mixture design had good predictability which could be used to optimize prescription of Talci Pulvis dispersible tablets.
出处
《中国实验方剂学杂志》
CAS
北大核心
2013年第24期13-16,共4页
Chinese Journal of Experimental Traditional Medical Formulae
基金
国家中医药管理局项目(201007011-09)
关键词
滑石粉
分散片
单因素试验
综合评分法
D-最优混料设计
Talci Pulvis
dispersible tablets
single factor test
comprehensive evaluation method
D-optimal mixture design
