盐酸坦洛新缓释胶囊制备工艺及其体外释放度的考察研究

An Exploring Research about Preparation Technology and Released Effect of Tamsulosion Hydrochloride Sustained-Released Capsules

目的研究盐酸坦洛新缓释胶囊的制备工艺并对其体外释放度进行考察。方法采用蔗糖空白丸芯作为载药基质,用苏丽丝和雅克宜作为包衣缓释材料、以羟丙甲纤维素E6作为致孔剂,用流化床底喷溶液上药法制备载药微丸,并进行缓释包衣。以释放度作为评价指标,通过单因素实验对处方影响因素进行考察,并对自制盐酸坦洛新缓释胶囊与市售制剂释放曲线进行比较。结果本试验所述制剂工艺可靠,能顺利制备盐酸坦洛新缓释胶囊,其体外释放与市售制剂相似,批间及批内重复性较好。结论本试验制得的盐酸坦洛新缓释胶囊具有良好的缓释效果,制备工艺合理,简单易行,可适合工业化生产。

OBJECTIVE To study the preparation technology of tamsulosion hydroehloride sustained-release capsules and investi- gate the release degree in vitro. METHODS The pellets containing tamsulosin hydrochloride were prepeared in the fluid-bed using bottom gush medicine. Then, it was coated with ethylcellulose aqueous dispersion （surelease） , and in the following procedures, water- based acrylic resin enteric system （ Acryl-EZE ） was used as coating material, hydroxypropylmethylcellulose E6 （ HPMC E6） was considered as porous agent by fluid-bed. Based on the release degree in vitro, prescription influence factors were evaluated, as well as drug releases curve was compared, according to the single factor experiment. RESULTS The preparation technology referred in our research was available to make tamsulosin hydrochloride sustained-release capsules, and drug release curve of self-made sustained-re- lease capsules was similar to the commercial one. Additionally, the products reproducibility of intra-batch and inter-batch was excel- lent. CONCLUSION The tamsulosin hydrochloride sustained-release capsules prepared in this study exhibited ideal sustained-re- lease characteristics in vitro. The formulation is reasonable and feasible. It is suitable for industrial production.