大豆蛋白基茶碱控释片的制备及稳定性研究

Study on preparation and stability of soybean protein-base theophylline controlled-release tablets

以茶碱为模型药物,大豆蛋白和海藻酸钠作为骨架材料,采用混合压片法制备了不同比例的药物片剂。采用紫外比色法测定释放效果,考察了大豆蛋白与海藻酸钠不同比例以及不同pH释放介质和高湿度对茶碱片稳定性的影响。结果表明:大豆蛋白和海藻酸钠作为骨架材料的片剂释药时间都达到了8h以上,在pH6.8PBS中的释药率相对pH1.2盐酸溶液要快,具有良好的定向控释特性。随着湿度的增加,茶碱释放率略有下降,具有较好的湿度稳定性。通过适度调节大豆蛋白和海藻酸钠的比例可实现不同控释效果。实验结果表明大豆蛋白和海藻酸钠共混物是一种良好的天然药物缓控释骨架材料,其释放过程符合一级动力学特征,是药物扩散和骨架溶蚀二者共同作用的结果。

Using theophylline as a model,the effect of drug delivery system of soybean protein and alginate as nature skeleton materials were studied.Tablets were made according to different formula proportion.The release results of tablets were determined by spectrophotometry.The influence of different proportion and the pH value of release media as well as high relative humidity on the release process and the stability of theophylline controlled-release tablets were studied.The results showed that the release period of soybean protein/alginate tablets lasted above 8h,the release ratio of tablets in the pH1.2 solution was lower than that in the pH6.8 PBS buffer solution.The sogbean protein-base theophylline tablets had good specific-site controlledrelease behavior.The release ratio of theophylline decreased slightly with the increase of relative humidity.The soybean protein-base theophylline tablets had good specific-site controlled-release behavior and humidity-stability.The different effects of controlled-release could be realized by controlling reasonably the weight ratio of soybean protein and alginate in the formula.The experiments results indicated that soybean protein and alginate could be used as a delayed-release skeleton material,and the drug release mechanism was Fickian diffusion and Erosion conforming to first-order model.