盐酸青藤碱微球制备工艺及体外性质研究  

Preparation Process and Extracorporeal Properties Study on Sinomenine Hydrochloride Microspheres

作　　者：卿勇军[1] 刘文[1] 杜平[1] 姚晓艳[1] 金阳[1] 张建锋 Qing Yongjun;LiuWen;DuPing;Yao Xiaoyan;JinYang;Zhang Jianfeng(Guiyang College of Traditional Chinese Medicine, Guiyang 550002, China;Sinopharm group （Guizhou） Pharmaceutical Co. ltd,Guiyang 550000,China)

机构地区：[1]贵阳中医学院,贵州贵阳550002 [2]国药集团同济堂(贵州)制药有限公司,贵州贵阳550014

出　　处：《亚太传统医药》2018年第6期34-38,共5页Asia-Pacific Traditional Medicine

基　　金：贵州省贵阳中医学院院士工作站(黔科合院士站[2014]3013号);贵阳中医学院研究生创新计划项目(ZYYCX14031)

摘　　要：目的:优选盐酸青藤碱明胶微球的制备工艺,并对其外观、粒径及体外释放等性质进行考察。方法:采用乳化-化学交联法制备盐酸青藤碱微球,并对微球的载药量、包封率、产率、表征、粒径分布等质量评价指标进行考察。结果:盐酸青藤碱微球的最优工艺处方为明胶浓度质量分数为15%,水相与油相的体积比为1∶6,药物与载体质量比为1∶6,乳化剂的用量为1.5%。制得的微球外观呈圆球形、表面光滑、未出现粘连现象,平均粒径为12.15μm,平均载药量为12.36%,包封率为69.33%,产率为85.76%。结论:以最佳工艺处方制备盐酸青藤碱明胶微球工艺合理、稳定,综合质量评价结果表明该微球质量较好,具有明显的缓释作用,可为后期新制剂的开发研究提供依据。Objective：To optimize the preparation process of chloranine hydrochloride gelatin microspheres and to investigate its appearance,particle size and in vitro release.Methods：The microspheres were prepared by emulsification-chemical cross linking method,and the quality evaluation indexes such as the dosage,encapsulation rate,yield,characterization and particle size.Results：The optimal prescription of the sinomenine hydrochloride microspherewas 15% of the gelatin solubility quality,the volume ratio of water phase to oil phase was 1∶6,the quality ratio of drug to carrier was 1∶6,and the amount of emulsifying agent was 1.5%.The microsphere has a spherical shape,smooth surface and no adhesion phenomenon.The average particle size is 12.15μm,the average load is12.36%,the packet seal rate is 69.33%,and the yield is 85.76%.Conclusion：The optimum prescription preparation technology of sinomenine hydrochloride gelatin microspheres is reasonable and stable.Comprehensive quality assessment results show that microspheres quality is good,and it has obvious sustained release effect,so this technology can provide the basis for the later study of new products.

关 键 词：盐酸青藤碱 微球 制备工艺 体外释放 

分 类 号：R283[医药卫生—中药学]