抗癫痫药卡马西平缓释片剂释药机制的研究  

Study on Drug Release Mechanism of Carbamazepine Sustained-release Tablets

作　　者：孙超 秦涛 汤连升 SUN Chao;QIN Tao;TANG Lian-sheng(New Drug Evaluation Center,Shandong Academy of Pharmaceutical Sciences,Jinan 250101,China;Center for Certiflcation and Evaluation,Shandong Food and Drug Administration,Jinan 250101,China)

机构地区：[1]山东省药学科学院新药评价中心,山东济南250101 [2]山东省食品药品监督管理局审评认证中心,山东济南250101

出　　处：《食品与药品》2018年第6期445-448,共4页Food and Drug

摘　　要：目的探讨抗癫痫药卡马西平缓释片剂的释药机制。方法分别在水介质、pH 1.0介质、pH 4.5介质和pH6.8介质中测定自制的3批卡马西平缓释制剂与原研制剂释放曲线并进行对比,对释药行为差异性进行研究。结果3个自制缓释处方在4种释放介质中释放曲线的f2相似因子存在较大差异,处方4可作为最佳处方。结论卡马西平缓释片在不同释放介质中的释药过程是羟丙甲纤维素K4M和甲基丙烯酸共聚物L100-55共同作用的结果,合理掌握羟丙甲纤维素K4M和甲基丙烯酸共聚物L100-55用量比例,可有效控制药物释放过程,实现缓释目的。Objective To explore and study the drug release mechanism of Carbamazepine Sustained-release Tablets. Methods The release curves of 3 batches of self-made Carbamazepine Sustained-release Tablets and the original preparation in water, pH 1, pH 4.5 and pH 6.8 medium were determined and compared, to study the the differences of their release behaviors. Results There were significant differences among the f2 similar factors of 3 self-made formulations in different medium, and formulation 4 showed the best release behaviour. Conclusion The release process of Carbamazepine Sustained-release Tablets in different release medium is the result of interaction of HPMC K4M and Eudragit L100-55. Effective control of the drug release process to achieve the sustained release can be obtained on the basis of suitable dosage ratio of HPMC K4M and Eudragit L100-55.

关 键 词：释药机制 羟丙甲纤维素K4M 甲基丙烯酸共聚物L100-55 缓释片 

分 类 号：R943[医药卫生—药剂学]