盐酸环苯扎林缓释微丸的制备及体外释放度考察

发布时间：2018-09-13 07:21

【摘要】：目的:制备盐酸环苯扎林缓释微丸,并考察其体外释放度。方法:采用流化床底喷上药技术制备盐酸环苯扎林载药微丸,再以Surelease~?水分散体作为缓释包衣剂制成盐酸环苯扎林缓释微丸。以包衣时间、包衣效率和微丸粘连率为因变量,通过Box-Behnken响应面法优化包衣工艺中的进风温度、雾化压力、供液速度。利用f2相似因子法对自制制剂和市售制剂(AMRIX~?)在不同介质(水、p H 1.2盐酸水溶液和p H 4.5醋酸盐缓冲液、6.8磷酸盐缓冲液)中的体外释放度进行比较。结果:缓释包衣工艺中包衣增质量为7%,进风温度为55℃,雾化压力为0.36 MPa,供液速度为12.5 ml/min;包衣时间为(47.1±2.1)min,包衣效率为(88.4±1.6)%,微丸粘连率为(2.7±0.3)%,与其相应预测值(44.5 min、90.0%、2.9%)的相对误差分别为5.8%、1.8%、6.9%;在4种介质中自制制剂与市售制剂的f2分别为77.7、85.9、83.5、84.6。结论:制得体外释放较好的盐酸环苯扎林缓释微丸。
[Abstract]:Aim: to prepare cyclbenzalin hydrochloride sustained-release pellets and investigate their release in vitro. Methods: cyclobenzalin hydrochloride pellets were prepared by fluidized bed spray technique, and then Surelease~? was used to prepare the pellets. Water dispersions were used as sustained-release coating agent to prepare cyclobenzalin hydrochloride sustained-release pellets. Based on the dependent variables of coating time, coating efficiency and pellet adhesion rate, the inlet air temperature, atomization pressure and liquid supply rate of coating process were optimized by Box-Behnken response surface method. Using f2 similarity factor method to determine the properties of self-made and marketed preparations (AMRIX~?) The in vitro release rates were compared in different media (aqueous solution of H 1.2 hydrochloric acid and pH 4.5 acetate buffer of 6. 8 phosphate buffer). Results: in the process of slow release coating, the mass increase of coating was 7, and the inlet air temperature was 55 鈩，

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