莫达非尼胶囊的制备及其含量测定  

Preparation and content determination of modafinil capsules

作　　者：黄利 金描真[2] 吕华冲[2] 邓桂兴 王霆 

机构地区：[1]湘北威尔曼制药股份有限公司,长沙410331 [2]广东药学院,广州510006 [3]广州威尔曼新药开发中心,广州510620

出　　处：《中南药学》2012年第8期577-580,共4页Central South Pharmacy

基　　金：湖南科技厅社会发展支撑计划重点项目(编号:2011SK3003)

摘　　要：目的研究莫达非尼胶囊制备工艺并测定其含量。方法通过处方筛选并优化工艺后,将莫达非尼与适宜的辅料制成胶囊,采用HPLC测定其中莫达非尼含量,并进行溶出度检查。结果通过处方筛选和优化后制得的胶囊剂内容物装量差异、溶出度等指标符合胶囊剂的质量要求。所建立的莫达非尼HPLC测定方法在200～600μg·mL-1峰面积与浓度呈线性关系(r=0.999 9),平均回收率为101.4%,RSD为0.023%,采用该方法检验3批胶囊,结果其含量、溶出度等均符合要求。结论该胶囊处方工艺切实可行,所建立的检测方法可作为莫达非尼胶囊的质量控制标准。Objective To study the preparation process and determination method of modafinil capsules.Methods By prescription screening and process optimization,the modafinil capsules were prepared and determined by HPLC,and the dissolution was tested.Results Through prescription screeing and optimization,the load difference,dissolution,and other indicators met the quality requirement of the capsules.Modafinil was linear at 200-600 μg·mL-1（r=0.999 9）,the average recovery was 101.4% and RSD was 0.023%.The dissolution of 3 batches of capsules met the requirement.Conclusion The capsule formulation process is feasible,and the detection method can be used as a quality control standard for modafinil capsules.

关 键 词：莫达非尼 胶囊 制备工艺 含量测定 高效液相色谱法 

分 类 号：R944.5[医药卫生—药剂学] R927.2[医药卫生—药学]