马来酸卡比沙明树脂复合物包衣缓释系统的制备工艺研究  

Study on preparation technology of carbinoxamine maleate-resin complex coating sustained-release system

作　　者：李金龙 王甜甜 王艳娇[1] 唐星[1] LI Jinlong;WANG Tiantian;WANG Yanjiao;TANG Xing(School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016,China)

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016

出　　处：《中国药剂学杂志》2020年第2期79-92,共14页Chinese Journal of Pharmaceutics

摘　　要：目的制备马来酸卡比沙明缓释混悬制剂,并考察其体外释放。方法通过离子交换反应,制备马来酸卡比沙明树脂复合物,并通过流化床粉末包衣技术,制备缓释颗粒,最终加入基质溶液制备成缓释混悬液制剂。研究中考察了缓释颗粒的释药机制,并比较自制制剂和参比制剂的体外释放行为。结果制得的药物树脂复合物混悬液的释放度与参比制剂一致。包衣药物树脂复合物的释放过程受化学交换反应、药物及反离子的扩散,以及缓释层阻滞三者综合作用的影响。结论树脂复合物缓释制剂制备工艺的关键为树脂的微粉包衣过程,树脂中药物与反离子的交换作用与缓释衣膜的阻滞作用共同导致药物的缓释释放行为的发生。Objective To prepare a sustained-release suspension of carbinoxamine maleate and investigate the release of drug in vitro.Methods Carbinoxamine maleate resin complex was prepared by ion exchange reaction,then the sustained-release granules were prepared by fluidized bed microparticle-coating techniques.Finally,the blank matrix solution was applied to prepare a sustained-release suspension.The drug release mechanism of sustained-release granules was investigated.In vitro release behaviors of the test formulation and the reference formulation were compared.Results The release behavior of the prepared resin complex suspension was consistent with the release of the reference formulation.The release process of coated resin was influenced by ion exchange reaction,diffusion of drug and counter ion,and retardation of sustained-release layer.Conclusions The key to the preparation process of resin complex sustained-release suspension is the microparticle-coating.The exchange effect between the drug and counter ion in the resin and the retardation of the sustained-release coating film together contributed to the sustained release behavior of the drug.

关 键 词：药剂学 马来酸卡比沙明 树脂复合物 粉末包衣 液体缓释制剂 

分 类 号：R94[医药卫生—药剂学]