人参鹿鞭牡蛎肽片(压片糖果)配方设计及制备工艺

Formula Design and Preparation Technology of Ginseng,Deer Whip and Oyster Peptide Tablets(Pressed Candy)

基于中医药理论基础及现代药理学研究结果,以人参粉、鹿鞭粉、牡蛎肽为主要原料,麦芽糖醇、山梨糖醇、微晶纤维素等为备选辅料,优化配方,筛选适宜的片剂制剂工艺。利用单因素试验与正交试验设计,考察辅料种类及用量、环境湿度等对制剂品质的影响,确认最佳制备工艺。结果表明,最佳辅料是麦芽糖醇,硬脂酸镁适宜添加用量是0.6 g/kg,30%以下为适宜环境湿度。按以上组方及工艺参数获得的产品片面光滑,色泽均匀,硬度适宜。

Based on the theoretical foundation of traditional Chinese medicine and modern pharmacology research results,ginseng powder,deer whip powder and oyster peptide were used as the main raw materials,with maltitol,sorbitol,microcrystalline cellulose,etc.as alternative excipients,to optimize the formula and to screen suitable tablet preparation processes.By combining single factor horizontal and orthogonal experiments,the effects of excipient types,dosage and environmental humidity on product quality were studied to confirm the optimal preparation process.The results showed that maltitol was the optimal excipient,with a magnesium stearate addition of 0.6 g/kg and an environmental humidity of below 30%,resulting in the highest sensory score.The tablets prepared with this formula and process had a smooth surface,uniform color,and moderate hardness.