复方卡托普利脉冲缓释微丸的制备及释放度考察  

Preparation and release degree investigation of compound captopril pulsed sustained release pellets

作　　者：李武营[1] 樊轻亚[2] 游国叶[2] 

机构地区：[1]河南大学学报编辑部,河南开封475000 [2]信阳职业技术学院药学院,河南信阳464000

出　　处：《河南大学学报（医学版）》2014年第1期24-29,共6页Journal of Henan University:Medical Science

基　　金：河南省自然科学基金项目(052442004)

摘　　要：目的制备卡托普利脉冲微丸及氢氯噻嗪缓释微丸,考察制剂体外释放度影响因素;方法依据时控爆破系统原理,利用底喷式流化床包衣设备,通过调节脉冲微丸溶胀层增重、控释层增重、致孔剂用量及缓释微丸包衣膜增重及熟化处理时间等因素,考查微丸释放度影响因素。结果脉冲微丸以L-HPC为溶胀层,Surelease为控释层,分别增重为16.20%和22.84%;以HPMCE3为致孔剂,用量为水分散体固含物量的5.52%,体外释放时滞约为5h;缓释微丸以Eudragit NE30D为包衣材料,缓释层增重为10%,致孔剂乳糖用量为1.5%(聚合物的1.5%);后处理时间为12h;两主药体外释放过程均接近一级。结论该方法制备的复方脉冲缓释微丸符合脉冲释放制剂要求,外观光滑圆整,衣膜致密,工艺操作简便、可控。Objective To prepare captopril pulsed pellets, and Hydrochlorothiazide sustained-release pellets, inspect the influencing factors on release of formulation in vitro. Methods According the principle of blasting system theory, using the bottom gush type fluidized coating equipment, through adjust the pulsed pellet＇s swelling layer weight gain, controlled release layer weight gain, amount of poermaking agent, while the HCTZsustained release pellet adjust the coating gained weight and maturation processing time and other factors. Results Pulsed pellet with LHPC for swelling layer, Surelease for controlled release layer, weight gain respectively is 16.20% and 22.84%; To HPMCE3 for poermaking agent, dosage is for moisture medium solid content 5.52%, the lag time is 5 h; Suatained release pellet with Eudragit NE30D as coating material, increase weight for 10%, send pore agent lactose dosage for 1.5% （polymer 1.5%）; Post processing time for 12 h; Two main medicine in vitro release process are close to first level. Conclusion This method of the preparation of compound pulse slow-release micro pill apply with the requirements of pulsed release preparation, exterior is smooth and rounder, garment membrane density, process operation is simple and controllable.

关 键 词：卡托普利 氢氯噻嗪 脉冲 缓释微丸 释放度 

分 类 号：R944.9[医药卫生—药剂学]