叶黄素酯肠溶微囊的制备工艺研究及性能考察

Preparation of lutein ester enteric microencapsulation

文章采用单凝聚法制备叶黄素酯肠溶微囊,并对其性质进行评价。首先以明胶为囊材采用单凝聚法通过超声辅助制备叶黄素酯微囊,然后通过扫描电子显微镜(scanning electron microscope,SEM)和Beckman Coulter LS 230激光粒度仪表征微囊表面形态及粒径,通过线性回归的方法对其包封率和载样量进行测定,依据药典测其在肠中的溶出度,并进行药物动力学和生物利用度考察。通过单因素法与正交试验确定优化处方和工艺,经考察,最终处方和工艺如下:温度55℃,搅拌速度为400r.min-1,叶黄素酯与明胶的质量比为1∶6。通过本次研究考察,制备得到的微囊具有较好的耐酸性与肠溶性能,平均粒径约为70μm。

Using the single coacervation method,the work was aimed to optimize the enteric encapsulation process and investigated physicochemical properties of microcapsules.The enteric microencapsulation of lutein ester were prepared by single coacervation method with the assistance of ultrasonic using the enteric material gelatin.The shape and diameter of microcapsules were observed by SEM and laser diameter instrument（Beckman Coulter LS 230）,the coating rate and sample loads were measured through linear regression method.According to the pharmacopoeia test its dissolution in the intestine,pharmacokinetic and relative bioavailability were also assessed.Single factor method and orthogonal test were applied to determine the optimized prescription and technique.The optimized formulation was： temperature（55℃）,stirring speed（400r.min-1）,Lutein ester/gelatin ratio（1：6）.The research found that the microencapsulation with the mean size of 70μm had good resistance to acid and enteric performance.