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.
作者
何燕妮
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)
出处
《中国新药杂志》
北大核心
2025年第4期414-418,共5页
Chinese Journal of New Drugs
关键词
兰索拉唑
肠溶口崩片
微丸压片
正交实验
稳定性
lansoprazole
enteric orally disintegrating tablets
pellets compression
orthogonal test
stability
