星点设计-效应面法优化脂溶性丹参提取物速释滴丸处方工艺

Optimization of fast release liposoluble Salviae miltiorrhizae Radix et Rhizoma extract dripping pills by central composite design and response surface method

目的采用星点设计-效应面法优化脂溶性丹参提取物速释滴丸的处方工艺。方法在单因素试验的基础上,进一步采用星点设计安排实验,对指标与因素进行数学模型拟合,以效应面法预测优化处方、并验证。结果得到的优化处方中,以PEG 2000-PEG 4000(3.5∶6.5)混合作为载体材料制备脂溶性丹参提取物滴丸,滴丸中丹参提取物的含有量为9%。所制备的滴丸较提取物原料药释药快且完全,在20 min与60 min的累积溶出率分别达53%与83%,分别高出原料药26%与43%。结论采用星点设计-效应面法建立的数学模型预测性良好,实验结果与其函数预测值之间的偏差小于5%。

AIM To optimize the formulation of liposoluble Salviae miltiorrhizae Radix et Rhizoma extract dripping pills characteristic of fast drug release by the central composite design-response surface method.METHODS On the basis of single factor test,central composite design was further adopted to arrange experiments in search of a curve fitting model between factors and effects.The optimal formulation was predicted by response surface method and was verified as well.RESULTS In optimal formulation,PEG2000 and PEG4000 were mixed as carrier materials to prepare liposoluble Salviae miltiorrhizae Radix et Rhizoma extract dripping pills characteristic of fast drug release.The ratio of PEG 2000 to PEG 4000 was 3.5∶ 6.5,and the content of Salviae miltiorrhizae Radix et Rhizoma extract in dripping pills was 9%.The dripping pills released drug fast and completely.The accumulative drug release percentage was 53% and 83% in 20 min and 60 min,respectively,which had 26% and 43% higher cumulants than that of liposoluble Salviae miltiorrhizae Radix et Rhizoma extract.CONCLUSION The mathematical model developed by the central composite design-response surface method shows the perfect prediction with the deviation less than 5% between results and predicted value.