AHP-EWM混合加权法结合Box-Behnken响应面法优化蒲黄滴丸的制备工艺
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篇名: AHP-EWM混合加权法结合Box-Behnken响应面法优化蒲黄滴丸的制备工艺
TITLE: Optimization of preparation process of Pollen Typhae dripping pills by AHP-EWM hybrid weighting method combined with Box-Behnken response surface methodology
摘要: 目的 优化蒲黄滴丸的制备工艺。方法以外观形态、圆整度、拖尾现象、粘连情况、脆碎度以及蒲黄总黄酮含量为评价指标,运用层次分析法-熵权法混合加权法确定各指标权重系数并计算综合评分作为响应值。通过单因素实验及Box-Behnken响应面法分别考察基质种类与配比、药物与基质配比、冷凝温度等对滴丸成型工艺的影响,筛选最优工艺并进行验证。测定蒲黄滴丸150min内的累积溶出度,并与蒲黄总黄酮提取物进行比较。结果蒲黄滴丸最优工艺为PEG4000与PEG6000配比2∶1,药物与基质配比1∶2,冷凝温度17.5℃;以此条件制备的滴丸综合评分实测平均值为9.208(RSD=0.91%,n=3),与预测值9.285相比的相对误差为0.83%。蒲黄滴丸释放机制为Fickian扩散控制型减速释放,初期溶出速率较快,中后期溶出速率下降;蒲黄总黄酮提取物在溶出初期释放较快,且很快进入平台期,二者的最大溶出度分别为95.96%和84.07%。结论优化所得的蒲黄滴丸成型工艺稳定可靠;按优化工艺制备的蒲黄滴丸溶出度较蒲黄总黄酮提取物有所提升。
ABSTRACT: OBJECTIVE To optimize the preparation process of Pollen Typhae dripping pills.METHODS Using appearance morphology, roundness, tailing phenomenon, adhesion condition, friability, and total flavonoids content of Pollen Typhae as evaluation indicators, the analytic hierarchy process-entropy weight method (AHP-EWM) hybrid weighting method was employed to determine the weight coefficients of each indicator and calculate the comprehensive score as the response value. The effects of matrix type and ratio, drug-to-matrix ratio, and condensation temperature on the forming process of dripping pills were respectively investigated, through single-factor experiments and Box-Behnken response surface methodology and the optimal process was optimized and validated. The cumulative dissolution rate of Pollen Typhae dripping pills within 150 min was determined and compared with that of total flavonoid extract from Pollen Typhae .RESULTS The optimal preparation process for Pollen Typhae dripping pills was determined as follows: the ratio of PEG4000 to PEG6000 was 2∶1, the drug-to-matrix ratio was 1∶2, and the condensation temperature was 17.5 ℃. The measured average comprehensive score of dripping pills prepared under these conditions was 9.208 (RSD=0.91%, n =3), with a relative error of 0.83% compared to the predicted value of 9.285. The release mechanism of Pollen Typhae dripping pills was Fickian diffusion controlled deceleration release. The initial dissolution rate was fast, and the dissolution rate decreased in the middle and later stages. The total flavonoid extract from Pollen Typhae was released rapidly in the initial dissolution stage and quickly entered the plateau phase. Their maximum dissolution rates were 95.96% and 84.07%, respectively.CONCLUSIONS The optimized preparation process for Pollen Typhae dripping pills was stable and reliable. The dissolution rate of Pollen Typhae dripping pills prepared by optimized process was higher than that of the total flavonoid extract from Pollen Typhae .
期刊: 2026年第37卷第18期
作者: 朱芙琴;石露萍;马佳怡;蔡玲娜;余琰
AUTHORS: ZHU Fuqin,SHI Luping,MA Jiayi,CAI Lingna,YU Yan
关键字: 蒲黄滴丸;层次分析法-熵权法混合加权法;Box-Behnken响应面法;蒲黄总黄酮;工艺优化
KEYWORDS: Pollen Typhae dripping pills;AHP-EWM hybrid weighting method;Box-Behnken response surface method;total flavonoids from Pollen Typhae ;Process optimization
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