基于AHP-熵权法结合Box-Behnken响应面法优选复方一枝蒿片成型工艺

Based on the AHP-Entropy Weight Method Combined with the Box-Behnken Response Surface Method the Molding Process of Compound Yizhihao Tablets was Optimized

目的:优选复方一枝蒿片的最佳成型工艺,提高片剂可压性,降低中药片剂吸湿性,为后续生产、运输、保存提供科学依据。方法:以五类单因素实验为基础,以休止角、卡尔系数、外观、脆碎度、崩解时限、吸湿性为考察指标,采用AHP-熵权法计算复合权重系数,多指标综合评分结合Box-Behnken响应面设计实验,筛选出最佳成型工艺条件并进行验证。结果:复方一枝蒿片的最佳成型工艺为主药与辅料比例1∶4、润滑剂为硬脂酸镁用量为0.41%、崩解剂羧甲基淀粉钠用量3.59%;填充剂为微晶纤维素。将浸膏粉与过200目筛的辅料进行混合后,再过80目筛,用10.00 mm的冲模进行压片。3次验证试验结果显示,平均吸湿率3.35%,综合评分的平均值为96.83(平均RSD=0.96%,在±3%以内),与预测值接近,说明优选的制剂工艺稳定可行,适用于工业化生产。结论:该试验采用Box-Behnken响应面法设计复方一枝蒿片成型工艺方法稳定性好、重复性高,为复方一枝蒿片后续工业化生产、储存与运输提供强有力的科学依据。

Objective:Optimize the best forming process for compound Yizhihao tablets to enhance compressibility,reduce hygroscopicity,and ensure scientific grounds for production,transportation,and storage.Methods:To optimize and validate the best forming process,an evaluation system based on five single-factor experiments uses AHP-EWM and Box-Behnken response surface design for multi-index scoring.Results:The optimized formulation for Compound Yizhihao Tablets includes a 1∶4 drug-to-excipient ratio,0.41%magnesium stearate as lubricant,3.59%sodium carboxymethyl starch as disintegrant,and microcrystalline cellulose as filler.After blending and sieving,the mixture is compressed into tablets using 10.00 mm punches.Validation trials showed an average moisture absorption of 3.35%,and a comprehensive score of 96.83(RSD 0.96%,within±3%).This process is stable,feasible,and suitable for industrial production.Conclusion:The Box-Behnken response surface method optimized the forming process of Compound Yizhihao Tablets,exhibiting high stability and reproducibility.This ensures a scientific basis for its industrial production,storage,and transportation.