氧化苦参碱肠溶包衣微丸的制备

Preparation of Oxymatrine Enteric-coated Pellets

目的:制备氧化苦参碱肠溶包衣微丸。方法:采用单因素试验考察包衣锅转速、包衣锅温度和喷枪压力对包衣条件的影响,并比较各种树脂包衣液的性质,选出适宜的包衣材料;采用包衣锅法制备微丸;以体外释放度评价包衣效果。结果:包衣条件为包衣锅转速50r.min-1、包衣温度30℃、喷枪压力0.10MPa;包衣材料为湖州Ⅲ号聚丙烯酸树脂;制备的微丸体外释放度符合2005年版《中国药典》(二部)要求。结论:所选方法可制备出体外释放良好的氧化苦参碱肠溶包衣微丸。

OBJECTIVE： To prepare Oxymatrine enteric- coated pellets. METHODS： The coating conditions such as the rotation speed, the coating temperature as well as the pressure of spray gun were optimized through single factor experiment; the properties of different coating solutions of resins were compared to optimize the coating material. The enteric - coated pellets were prepared by bed coating technology. The coating effect was evaluated by the dissolution in vitro. RESULTS： The optimal coating conditions were as follows： the rotation speed of the coating pan was 50 r · min^ -1, the coating temperature was 30 ℃, the pressure of spray gun was 0.10 MPa; the coating material was polyacrylic resin （Huzhou Ⅲ ） . The in vitro dissolution of the entericcoated pellets prepared by the bed coating technology met the requirements specified in the Chinese Pharmacopeia（2005 edition） .CONCLUSION： By using the bed coating technology, the entericcoated pellets with good dissolution in vitro can be obtained.