鸦胆子油微囊的制备及体外释放性能研究  

Preparation of Brucea Javanica Oil Microcapsule and Investigation of Its in Vitro Release Mechanism

作　　者：丁乐 林金海[2] 申音 钟斌[2] 杨建琼[2] 陈芳辉[2] 杨人泽[2] Ding Le;Shen Yin;Zhong Bin;Yang Jianqiong;Chen Fanghui;Yang Renze;Lin Jinhai(Ganzhou Maternal and Child Health Hospital, Ganzhou, Jiangxi, China 341000;The First Affiliated Hospital of Gannan Medical University,Ganzhou, Jiangxi, China 341000)

机构地区：[1]江西省赣州市妇幼保健院,江西赣州341000 [2]赣南医学院第一附属医院,江西赣州341000

出　　处：《中国药业》2017年第24期8-11,共4页China Pharmaceuticals

基　　金：江西省卫生和计划生育委员会立项科技计划项目[20154051]

摘　　要：目的探讨鸦胆子油微囊的制备工艺和质量控制方法,并研究其稳定性及体外释药特性,为开发新剂型奠定基础。方法以阿拉伯胶、明胶为囊材,采用复凝聚法制备鸦胆子油微囊,采用正交试验设计优化制备工艺并进行验证。考察所制得的鸦胆子微囊粒径分布和体外药物释放率。结果最优处方工艺为,囊心(鸦胆子油)与囊材(阿拉伯胶和明胶)质量比为1∶4,囊材质量分数为1.50%,搅拌速率为500 r/min,成囊温度为53℃。所得微囊鸦胆子油的包封率为94.60%,载药量为49.70%;最优工艺获得鸦胆子微囊外形圆整光滑,无黏连,粒径均匀,主要分布在60~90μm;30 min的累积释药率达92.00%。结论采用复凝聚法制备鸦胆子油微囊方法简便、易行,鸦胆子油微囊稳定,在人工胃液中有理想的溶出度,且此方法操作简单,适合工业化生产。To investigate the preparation technology and quality control method of Brucea javanica oil microcapsule(BOM),then study its stability and in vitro drug releasing properties,in order to lay the foundation for the development of the new dosage form of BOM.Methods With gum arabic and gelatin as capsule materials,BOM was prepared by the complex agglutination method,the preparationtechnology was optimized and validated by orthogonal design test,and afterwards the particle size distribution of the prepared BOM and the rate of in vitro drug release were studied.Results The optimal preparation process was as follows:core materials(Brucea javanica oil)-capsule materials(gum arabic and gelatin)(l-4),the mass fraction of capsule material was1.50%,the stirring velocity was500r/m in,and the temperature of encapsulation was53XI.The encapsulation efficiency of BOM was94.60%,the drug loading was49.70%.BOM was prepared by optimal technology,which had rounded smooth surface without adhesions and uniform particle size.The average particle size was distributed in60-90(xm,and the dissolution of the microcapsules at30min was about92.00%.Conclusion The complex agglutination method for preparing BOM is simple and convenient BOM has good stability and ideal dissolution in the artificial gastric acid fluid.This method is easy to operate and is suitable for industrial production.

关 键 词：鸦胆子 油微囊 制备 体外释放 

分 类 号：R283.3[医药卫生—中药学] R285.5[医药卫生—中医学]