摘要
为优化甜橙味维生素A片剂的制备工艺,采用辅料制粒、维生素A后加的总混压片法,在单因素试验的基础上,根据Box-Behnken的原理设计,以制粒时甜橙果粉与微晶纤维素比例、压片压力、硬脂酸镁添加量为自变量,片剂多指标综合评分为响应值,进行维生素A片剂制备工艺的响应面优化实验。结果表明,维生素A片的最佳制备工艺为甜橙果粉∶微晶纤维素2∶1、压片压力25 kN、硬脂酸镁添加量0.66%,在此条件下片剂的综合评分为12.41;制粒过程颗粒均匀,易整粒;所得片剂色泽均一、表面光滑;硬度、脆碎度、崩解时限、维生素A的衰减率等指标均符合要求,工艺稳定可靠,为后期产业化生产提供了参考。
To optimize the preparation process of orange-flavored vitamin A tablets,a total mixing and tabletting method with excipient granulation and post-added vitamin A was employed.Based on single-factor experiments and Box-Behnken design,a response surface optimization experiment was conducted for the preparation process of vitamin A tablets.The independent variables were the ratio of orange powder to microcrystalline cellulose during granulation,tabletting pressure,and the amount of magnesium stearate added,with the comprehensive evaluation score of the tablets as the response value.The results showed that the optimal tabletting process was achieved with an orange powder to microcrystalline cellulose ratio of 2∶1,tabletting pressure of 25 kN,and magnesium stearate addition of 0.66%,the comprehensive evaluation score of 12.41 for the tablets.The resulting tablets had uniform color and a smooth surface,key indicators such as hardness,friability,disintegration time,and vitamin A degradation rate all met the required standards.The process was stable and reliable,providing a reference for subsequent industrial production.
作者
吴洪宾
张振中
宋站立
蔺丽丽
WU Hongbin;ZHANG Zhenzhong;SONG Zhanli;LIN Lili(Shandong Harvey Pharmaceutical Co.,Ltd.,Heze 274000,China)
出处
《中国果菜》
2025年第3期23-27,50,共6页
China Fruit & Vegetable
关键词
维生素A
片剂制备
果味型片剂
响应面实验
Vitamin A
tablet preparation
fruit-flavored tablets
response surface experiment
