盐酸沃尼妙林肠溶微丸的研制

Development of valnemulin hydrochloride enteric pellets

沃尼妙林是新一代截短侧耳素（pleuromutilin）类抗生素。试验以丙烯酸树脂水分散体为肠溶包衣材料,单因素与正交试验筛选处方及工艺条件,用流化床包衣技术及挤出-滚圆法制备10%盐酸沃尼妙林肠溶微丸。研制的肠溶微丸外观、含量和释放度在加速试验条件下均保持稳定;以75~150 g/t饲料混饲给药,10%盐酸沃尼妙林肠溶微丸对猪痢疾有良好治疗效果,明显优于痢菌净。研究表明,盐酸沃尼妙林肠溶微丸质量符合药学要求,具有良好的体外肠靶向性,可用于猪肠道疾病的防制。

Valnemulin hydrochloride enteric pellets were developed by extrusion-spheronization and coated by fluid-bed with acrylic acid resin aqueous dispersion.The formulation and technology of valnemulin hydrochloride enteric pellets were selected by single-factor and orthogonal test.Its pharmacodynamics studies were also researched in this paper.The results showed that the coated pellets had smooth roundness,good reproductivity of inter-batch and good enteric-release property in vitro.In summary,the new productration possessed good vitro gut targeting by the optimal formulation and technology,and can be used clinically to prevent and treat swine dysentery.