摘要
目的筛选硝酸异山梨酯缓释微丸的处方。方法采用离心法制备硝酸异山梨酯骨架型缓释微丸,以体外溶出度为考察指标对药物原料进行处方筛选,以粒径分布、休止角、堆密度、收率等为考察指标,对黏合剂种类进行考察。结果原料药经固体分散体技术处理后,体外溶出速率明显降低,在药物:硬脂酸=1:3时,可达理想缓释效果。以10%PVPK30作为黏合剂,在一定的工艺参数下可制备出缓释效果好,收率高,机械强度及体外释放均符合要求的骨架缓释微丸。结论该筛选的处方合理,工艺简便,适宜工业化生产。
Objective To prepare the sustained release pellets of isosorbide dinitrate and optimize the formulation. Methods The sustained release pellets were prepared by centrifugal granulation method, the drug in vitro release was used to screen drug raw materials formulation, the particle size distribution, bulk density, angle of repose, and the yield were used to study the types of adhesive. Results The rate of drug in vitro release decreased obviously when processed by solid dispersion technique,when drug： stearic acid at a ratio of 1：3, the sustained-release result is good.With 10% PVPK30 as an adhesive, sustained release pellets can be prepared with characteristics such as： sustained-release result is good; yield is high; mechanical strength and in vitro release were all meet the requirements. Conclusion The prescription is reasonable and feasible, and the process is simple and suitable for industrialized oroduction.
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
2014年第8期615-619,共5页
Chinese Journal of Antibiotics
关键词
骨架型微丸
处方筛选
释药机制
硝酸异山梨酯
Matrix sustained-release pellet
Prescription screening
Mechanism of drug release
Isosorbide dinitrate
