褐藻胶植物肠溶硬胶囊的制备技术

Preparation of algin enteric-coated capsules

对褐藻胶植物肠溶硬胶囊的制备工艺进行了研究,并对最佳工艺条件下制备得到的胶囊进行成囊性、脆碎性、崩解时限、灼烧残渣等理化指标的测定。根据传统明胶硬胶囊的制备工艺及褐藻胶凝胶特性,实验确定褐藻胶肠溶硬胶囊工艺流程为溶胶、制胚、钙化、干燥、拔壳等,其中钙化过程中使用CaCl2溶液对褐藻胶胶囊毛胚进行直接钙化,使其形成酸不溶性凝胶,从而使褐藻胶胶囊具备肠溶性。通过单因素实验和正交实验确定最佳制备工艺为:以8cP褐藻胶为原料,胶液浓度12%,甘油添加量3%,2%CaCl2溶液钙化15s,胶囊含水量为15%。制备出胶囊的成囊性、脆碎性均符合药典对硬胶囊的要求,且在人工胃液中2h不溶,肠液中崩解时限为43±1min,完全符合药典对肠溶胶囊的要求。

The preparation of algin enteric-coated capsules was studied.Factors affecting preparation yields,such as concentration of alginate sol,calcification,drying,were studied by single and orthogonal experiments. The technological process of algin enteric-coated capsules was sol solution,balnk-making,calcification,drying,shelldrawing,and the optimal process conditions were as follows： the concentration of algin and glycerol was 12% and 3% respectively,and 2% CaCl2 was used for calcification for 15s,and the water content of algin entericcoated capsules was 15% after drying.The disintegration time and combustion remains was （ 43 ±1） min and 26.4% ± 0.99%,while the appearance quality met the requirement of Chinese pharmacopoeia too.