Box-Behnken响应面法优化地参咀嚼片辅料配比工艺

Optimization of Material Proportioning for Lycopus lucidus Turcz.Chewable Tablets Using Box-Behnken Response Surface Method

为了更好地开发利用地参资源,以地参粉为原料,添加微晶纤维素、硬脂酸镁、羧甲基淀粉钠等辅料,采用直接压片法制备地参咀嚼片,通过单因素试验考察微晶纤维素、硬脂酸镁、羧甲基淀粉钠添加量对地参咀嚼片的片重差异、硬度和脆性的影响,采用Box-Behnken响应面试验结合多指标综合评分法对其辅料配比进行优化。结果表明,微晶纤维素添加量、硬脂酸镁添加量、羧甲基淀粉钠添加量、微晶纤维素和硬脂酸镁添加量交互作用及硬脂酸镁和羧甲基淀粉钠添加量交互作用对地参咀嚼片品质影响显著。地参咀嚼片的最优配比为微晶纤维素添加量17.3%、硬脂酸镁添加量0.7%、羧甲基淀粉钠添加量10.7%,按此配比制备地参咀嚼片的片重差异为1.19%,硬度为98.18 N,脆性为0.37%,多指标综合评分平均值为44.96分。按照优化后辅料配比制备的产品质地结实,表面光滑,色泽均匀,硬度适中,符合咀嚼片的相关要求。

To exploit the resources of Lycopus lucidus Turcz.,chewable tablets were prepared by the direct compression method using Lycopus lucidus Turcz.powder as the main ingredient.Some excipient including magnesium stearate,microcrystalline cellulose,and sodium carboxymethyl starch were added.The effects of the addition of microcrystalline cellulose,magnesium stearate,and sodium carboxymethyl starch on the tablet weight difference,hardness,and brittleness of the Lycopus lucidus Turcz.chewable tablets were investigated through single-factor experiments.The Box-Behnken design combined with a multi-index comprehensive scoring method was used to optimize the excipient ratios.The results showed that the addition of magnesium stearate,microcrystalline cellulose,sodium carboxymethyl starch,the interaction between microcrystalline cellulose and magnesium stearate,and the interaction between magnesium stearate and sodium carboxymethyl starch had a significant impact on the quality of the chewable tablets.The optimal formulation for the Lycopus lucidus Turcz.chewable tablets was 17.3% microcrystalline cellulose,0.7%magnesium stearate,and 10.7% sodium carboxymethyl starch.The chewable tablets prepared according to this ratio exhibited a weight difference of 1.19%,a hardness of 98.18 N,a brittleness of 0.37%,and an average multi-index comprehensive score of 44.96 points.The product prepared according to the optimized excipient ratio demonstrated a solid texture,smooth surface,uniform color,and moderate hardness,aligning with the requisite standards for chewable tablets.