中国药房2013，Vol.24Issue(33)：3126-3128,3.DOI:10.6039/j.issn.1001-0408.2013.33.19
伏立诺他胶囊的制备及其稳定性考察
Investigation of the Preparation and Stability of Vorinostat Capsule
陈钦伟 1归小龙 1安富荣 1崔岚 1王勤1
作者信息
- 1. 上海交通大学医学院附属仁济医院药剂科,上海200001
- 折叠
摘要
Abstract
OBJECTIVE:To prepare Vorinostat capsules and to investigate its stability.METHODS:Vorinostat micropowder was prepared with grinding.The particle size of micropowder was determined.The crystal forms were tested by DSC and XRD.Bulk density and angle of repose of micropowder were tested to investigate the flowability of micropowder.The vorinostat micropowder,microcrystalline cellulose,sodium carboxymethyl starch and magnesium stearate were mixed and filled into capsules.The contents of main component,related substance and accumulative dissolution within 60 min were determined by HPLC.The stability of the product was investigated in some intensive conditions such as temperature of 60 ℃,relative humidity of 92％ and light of 4500 lx for 10 days,respectively.RESULTS:After grinding,the particle size of vorinostat decreased from 11 μm to 3 μm; endothermic peak disappeared at 126 ℃,and crystal form changed; bulk density increased from 0.24 g/ml to 0.31 g/ml and angle of repose decreased from 40° to 36° ; average amount of each capsule was 215 mg,and RSD of amount deviation of each capsule was 3.96％ (n=20); the content of capsule was (100.17 ± 1.48)％,and relevant substance was (0.41 ± 0.08)％; accumulative dissolution was 90％ within 60 min,and the index had no significant change under high temperature,high moisture and high light.CONCLUSIONS:Vorinostat capsule has been prepared by grinding successfully with good stability.关键词
制备/伏立诺他/胶囊/稳定性/研磨/溶出度Key words
Preparation/ Vorinostat/ Capsule/ Stability/ Grinding/ Dissolution rate分类
医药卫生引用本文复制引用
陈钦伟,归小龙,安富荣,崔岚,王勤..伏立诺他胶囊的制备及其稳定性考察[J].中国药房,2013,24(33):3126-3128,3.
