对乙酰氨基酚缓释微丸的制备及释放度研究

摘要

Objective In this paper we wanted to prepare paracetamol sustaied-release pellets and to study their release behavior. Methods Cenrifugal granulation method was used to prepare MCC pellets and paracetamol pellets respectively. On that basis Eudragit RS30D/RL30D as a coating material was adopted to coat the paracetamol pellets with a fluid bed spray processor. HPLC method was utilized to determine the release behavior of paracetamol sustained-release pellets. The coating prescription parameters were investigated and optimized with single factor experiments. Results The paracetamol sustained-release pellets coated with 10%coating material sustained released best, and the coating material consisted of Eudragit RS30D/RL30D(15:l,w/w), TEC(25%,w/w) and talc(40%,w/w). Conclusion These showed that paracetamol sustained-release pellets contained a characteristic of sustained-release and the established process and formula were simple and stable.%目的 制备对乙酰氨基酚缓释微丸,考察包衣处方等因素对微丸释放度的影响.方法 采用离心-造粒法制备微晶纤维素空白丸核和对乙酰氨基酚微丸,并在此基础上采用甲基丙烯酸树脂(Eudragit RS30D/RL30D)包衣,制备对乙酰氨基酚缓释微丸.采用HPLC法测定对乙酰氨基酚缓释微丸释放度,单因素筛选包衣处方的优化参数.结果 以Eudragit RS30D/RL30D比例为15:1(w/w),包衣增重为10％,柠檬酸三乙酯占包衣材料量的25％,滑石粉占包衣材料量的40％为包衣液,制备的对乙酰氨基酚释微丸释药曲线具有较好的缓释特性.结论 制备的对乙酰氨基酚缓释微丸具有缓释特性且操作简便、工艺稳定.