氟苯尼考肠溶缓释包衣微粒的制备及体外评价

摘要

The sustained -released particles prepared by wet granulation were coated by fluidized bed. Orthogonal experiment design was used to optimize parameters of coating formulation and fluidized bed conditions, and the dissolution test was done to determine the release characteristics of particles. Results showed that there was little dissolved in the specified acidic stage and not less than 80% dissolved in the buffer stage. The design of the formula was reasonable with simple production technology and provided the basis for the pharmaceutical optimization.%采用湿法制粒、流化床包衣制备肠溶缓释微粒，正交法进行微粒处方、工艺参数的筛选，通过溶出度试验对其释放特性进行考察，筛选最佳工艺处方。在此优选处方和工艺条件下制得的微粒体外释放特性良好，在人工胃液中几乎不溶，而在人工肠液中释放达80％以上。本品处方合理，制备工艺简单，达到了肠溶缓释的目的，为氟苯尼考制剂的优化提供了依据。