兰索拉唑肠溶口崩片的制备与质量评价  

Preparation and quality evaluation of lansoprazole enteric orally disintegrating tablets

作　　者：何燕妮[1,2] 蒋传真 吴秀宁 王东凯 HE Yan-ni;JIANG Chuan-zhen;WU Xiu-ning;WANG Dong-kai(Shenyang Pharmaceutical University,Shenyang 110016,China;Visum Pharmaceutical Co.,Ltd.,Haikou 570311,China)

机构地区：[1]沈阳药科大学,沈阳110016 [2]华益泰康药业股份有限公司,海口570311

出　　处：《中国新药杂志》2025年第4期414-418,共5页Chinese Journal of New Drugs

摘　　要：目的:制备兰索拉唑肠溶口崩片,并对其质量进行考察。方法:采用正交设计法,以脆碎度、崩解时限、黏冲情况、在酸中60 min溶出度的综合评分为指标优化处方。结果:最佳压片处方为微晶纤维素20%、硬脂酸镁2%、交联聚维酮7%、兰索拉唑肠溶微丸15%。3批样品脆碎度、崩解时限、含量和含量均匀度均符合要求;40℃放置6个月脆碎度、崩解时限、含量、有关物质和溶出度均无明显变化。结论:使用正交实验优化处方制备的兰索拉唑肠溶口崩片质量稳定、可控。Objective:To study the preparation and quality evaluation of lansoprazole enteric orally disintegrating tablets.Methods:The formulation was optimized by orthogonal design,using the comprehensive score of friability,disintegration time,and dissolution in acid at 60 min as index.Results:The best formula was composed of microcrystalline cellulose 20%,magnesium stearate 2%,crospovidone 7%,and lansoprazole enteric pellets 15%.The friability,disintegration time,assay and content uniformity of the three batches conformed to the requirements.Samples were put at 40℃condition for 6 months,and there was no significant change in friability,disintegration time,assay,impurity,and dissolution.Conclusion:The lansoprazole enteric orally disintegrating tablets prepared by the optimized method has a flat appearance and stable quality.

关 键 词：兰索拉唑 肠溶口崩片 微丸压片 正交实验 稳定性 

分 类 号：R944.9[医药卫生—药剂学]