Box-Behnken中心组合设计优化复方一枝蒿滴丸成型工艺

Optimization of molding technology for Compound Yizhihao Dropping Pills by Box-Behnken central composite design

目的优化复方一枝蒿滴丸成型工艺。方法采用Box-Behnken中心组合设计,以基质配比、提取物与基质配比、滴速为自变量,丸质量差异、总评归一化值(OD)为因变量,利用响应曲面法分析自变量对因变量的影响,确定较优条件进行验证试验。通过体外溶出试验比较颗粒剂与滴丸剂的溶出差异。结果复方一枝蒿滴丸最佳成型工艺条件为聚乙二醇4000与聚乙二醇6000比例为3.8∶1,提取物与基质配比为1∶2.5,滴速为28滴/min;在此条件下,预测值和测定值偏差绝对值均<5%,与模型拟合程度较高。滴丸剂的溶出速率明显高于颗粒剂。结论本研究系统优化了复方一枝蒿滴丸的成型工艺,方法科学、简便可行。

Objective To optimize the molding technology for Compound Yizhihao Dropping Pills. Methods Box-Behnken central composite design was adopted; The matrix ratio, the ratio of extract to matrix, and dropping speed were taken as the independent variables; The weight variation of pills and general normalized value were taken as dependent variables. The response surface methodology （RSM） was used to estimate the relationship between the dependent and independent variables and to validate the optimal formulation. Then the differences of dissolution behaviors between the granule and dropping pills were investigated by in vitro dissolution test. Results The optimized conditions were as follows extracts to matrix was l ： 2.5, the dropping speed was 28 drops/rain the ratio of PEG 4000 to PEG 6000 was 3.8 ： 1, the ratio of Under these conditions, the measured value was consistent with the predicated value with RSD 〈 5%. The dissolution rates of dropping pills was significantly higher than those of the granule Conclusion The molding technology of dropping pills is optimized, which is simple and feasible.