尼群地平共研粉末及其微丸的制备  

Preparation of nitrendipine co-grinding powder and pellets

作　　者：李新章[1] 唐丽华[1] 游本刚[1] 吴伟华[1] 赵晓丽[1] 周文凤[1] 

机构地区：[1]苏州大学医学部药学院,苏州215123

出　　处：《中国新药杂志》2010年第3期246-249,257,共5页Chinese Journal of New Drugs

基　　金：2007大学生创新性实验计划项目(57315856)

摘　　要：目的:确定尼群地平(nitrendipine,NTD)共研粉末的处方和制备工艺。方法:以体外溶出度试验为手段,通过单因素试验考察共研粉末的处方及工艺。结果:共研粉末的处方和制备工艺为:NTD,MCC和F68三者的比例为1∶2∶2;以400 r.min-1的转速,先将NTD与MCC按处方比例使用4个大球和20个小球共同研磨10 min,再加入处方量的F68(并同时取出4个大球)继续研磨30 min。结论:此处方工艺制备的NTD共研粉末和微丸释药行为稳定,简便可行,易于工业化生产。Objective： To optimaze the formulation and technology of nitrendipine co-grinding powder. Methods ： By means of the single-factor test, formulation and technology factors were investigated by dissolution test. Results：The formulation and technology factors were as follows：the proportion of NTD, MCC and F68 was 1：2： 2; the rotate speed was 400 r·min^-1. In the first 10 minutes,the formulation of NTD and MCC were co-grinded by 4 big balls and 20 small balls. And then 4 big balls were picked out. After that, the formulation of F68 was added and co-grinding lasted 30 minutes. Conclusion：Using this formulation and technology, the drug release from the NTD co-grinding powder and pellets was stable,it was simple and easy to be industrialized.

关 键 词：尼群地平 共研粉末 共研磨法 粉末沉积法 溶出试验 

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