摘要
采用湿法制粒压片法制备苯妥英钠素片,以外观、硬度、片重差异为指标,对片芯的填充剂种类、黏合剂种类进行考察.以累计释放度为指标,筛选包衣液的成膜材料种类、包衣质量分数、致孔剂种类及用量、包衣增重.最优处方为:填充剂为可压性淀粉与微晶纤维素比例1∶[KG-*3]1,黏合剂为10%PVP K30乙醇溶液,成膜材料为醋酸纤维素,包衣质量分数为6%,致孔剂为PEG-4000且用量为30%,包衣增重为5%,在12 h内累计释放量为78.02%.本实验制备的苯妥英钠微孔膜缓释片可减少给药次数,延长作用时间,提高患者的依从性.
To prepare phenytoin sodium microporous membrane sustained-release tablets.Phenytoin sodium tablets were prepared by wet granulation tableting method.The appearance,hardness,and tablet weight were used as indexes to investigate the filler types and adhesive types of the cores.The cumulative release rate was used as an index to select the type of film-forming material for the coating liquid,the concentration of the coating,the type and amount of the porogen,and the weight gain of the coating.The optimal prescription was as follows:the filler was a 1∶1 ratio of compressible starch to microcrystalline cellulose,the binder was 10%PVP K30 ethanol solution,the film-forming material was cellulose acetate,and the coating concentration was 6%.The porogen was PEG-4000 with a dosage of 30%and the coating weight gain was 5%.The phenytoin microporous membrane controlled release tablets prepared using the optimal prescription have a smooth and smooth appearance,and the RSD of the hardness was less than 2.0%.The cumulative release within 12 h was 78.02%.Phenytoin sodium microporous membrane sustained release tablets can reduce the number of administration,prolong the action time,and improve patient compliance.
作者
李燕珍
钟美玲
谢竟
杨晓雯
王小月
马晓星
LI Yan-zhen;ZHONG Mei-ling;XIE Jing;YANG Xiao-wen;WANG Xiao-yue;MA Xiao-xing(School of Pharmaceutical,Qiqihar Medical University,Qiqihar 161006,China)
出处
《哈尔滨商业大学学报（自然科学版）》
CAS
2019年第6期645-650,共6页
Journal of Harbin University of Commerce：Natural Sciences Edition
基金
黑龙江省大学生创新创业训练计划项目(No.201711230059)
关键词
苯妥英钠
微孔膜缓释片
释放度
湿法制粒压片
醋酸纤维素
微晶纤维素
phenytoin sodium
microporous membrane sustained-release tablets
cumulative release rate
wet process compression method
cellulose acetate
microcrystalline cellulose
