盐酸可乐定缓释微丸制备工艺的探究  

Investigation of the preparation technique of clonidine hydrochloride sustained-release pellets

作　　者：李见春[1] 张红敏[1] 孙宏张 孙璐璐[1] 赵玉茹[1] 

机构地区：[1]蚌埠医学院药学系,蚌埠233000 [2]合肥合源医药科技股份有限公司,合肥230001

出　　处：《中国新药杂志》2015年第7期827-830,836,共5页Chinese Journal of New Drugs

基　　金：国家级大学生创新训练项目(201210367017)

摘　　要：目的:制备盐酸可乐定缓释微丸,并对其进行质量评价。方法:采用微丸上药包衣技术制备盐酸可乐定缓释微丸,通过控制含药层、隔离层、缓释层等包衣层的增重来调节药物的释放速度。结果:含药层包衣液和隔离层包衣液为5%胃溶型包衣预混剂(欧巴代)水溶液,包衣增重2.5%;缓释层包衣液为乙基纤维素95%的醇溶液,包衣增重约7%,释放曲线和国外同类产品基本类似。结论:盐酸可乐定缓释微丸处方合理,流化床包衣技术具有快速、高效、质量可控的特点,可适合产业化生产。Objective：To prepare sustained release pellets of clonidine hydrochloride and evaluate their quality. Methods：Coating technique was used to prepare the pellets with fluidized bed. By controlling the weights of the medicated layer, isolation layer, and sustained release layer, the drug release rate was adjusted. Results：The medicated layer and isolation layer of the pellets were coated with 5% gastric soluble premix（Obadry） aqueous so- lution to achieve a weight gain of 2.5%. The sustained release layer of the pellets were coated with the alcohol so- lution of ethyl cellulose to achieve a weight gain of about 7%. The releasing curve was similar to those of the same type of products abroad. Conclusion ：The sustained-release pellets of clonidine hydrochloride are obtained by using the fluidized-bed coating technology. The technique is rapid,effective,quality controllable, and suitable for indus- trialized production.

关 键 词：盐酸可乐定 包衣技术 缓释微丸 制备工艺 释放度 

分 类 号：R943.41[医药卫生—药剂学] R972.4[医药卫生—药学]