星点设计-效应面法优化毛冬青分散片处方工艺

Optimization of Preparation Technology of Maodongqing Dispersible Tablets by Central Composite Designresponse Surface Methodology

目的:优选毛冬青分散片的处方工艺,为毛冬青的临床应用提供新选择。方法:选择毛冬青醇提物为原料,采用单因素试验筛选填充剂、崩解剂及润湿剂;以崩解时限为因变量,采用星点设计-效应面法考察微晶纤维素(MCC)、交联聚维酮(PVPP)及羧甲基淀粉钠(CMS-Na)用量对毛冬青分散片处方工艺的影响。结果:最佳工艺条件为毛冬青醇提物40%,磷酸氢钙27%,18%MCC,9%PVPP,5%CMS-Na,0.2%三氯蔗糖,3%聚维酮,0.8%硬脂酸镁。崩解时限84.7 s,与预测值的偏差3.3%。结论:毛冬青分散片制备工艺简单、崩解时限短、制剂稳定性好,适合工业化生产。

Objective： To optimize preparation process of Maodongqing dispersible tablets. Method：Taking alcohol extract of Ilex pubescens as raw material,fillers,disintegrating and wetting agent were screened by single factor test. With disintegration time linited as index,central composite design-response surface methodology was adopted to optimize formulation process by taking amouts of microcrystalline cellulose（ MCC）,cross-linked povidone（ PVPP） and sodium carboxymethyl starch（ CMS-Na） as factors. Result： The best preparation process was as following： alcohol extract of 40%,calcium hydrogen phosphate of 27%,MCC of 18%,PVPP of 9%,CMS-Na of 5%,PVP of 3%,sucralose of 0. 2%,magnesium stearate of 0. 8%. disintegration time limited was84. 7 s,whose deviation was 3. 3% by comparing with the predictive value. Conclusion： Preparation process of Maodongqing dispersible tablets is simple with short disintegration time limited and good preparation stability,which is suitable for industrial production.