黎德南 韦伟宁

    [摘要]目的阐述茶碱缓释片的制备方法及与参比制剂的释放度相似性评价。方法本研究以茶碱为原料，以羟乙基纤维素为骨架材料、十六十八醇为阻滞剂、聚维酮 K30为粘合剂，滑石粉、硬脂酸镁为润滑剂，采用湿法制粒后压片的工艺，制得茶碱缓释片。参照 JP 中茶碱缓释片溶出度项下的检测方法，分别以4种溶出介质，检测自研制剂与参比制剂的释放度，以评价其体外溶出相似性。结果自研制剂的体外释放速度恒定，与参比制剂比较，溶出曲线相似因子 f2>50，具有体外溶出相似性。结论自研制剂处方、工艺对确保茶碱缓释片与参比制剂生物等效有重大意义，可提高茶碱缓释片临床用药的安全性与有效性。

    [关键词]茶碱;缓释片;参比制剂;释放度;生物等效性

    [中图分类号] R284.1? [文献标识码] A? [文章编号]2095-0616(2021)23-0082-04

    Preparation? of theophylline? extended -release? tablets? and evaluation of in vitro dissolution similarity with the reference preparation

    LI? De'nan? WEI? Weining

    1. College of Pharmacy， Guilin Life and Health Career Technical College， Guangxi， Guilin 541100， China;2. Guangxi Hongshantang Biotechnology Co.， Ltd.， Guangxi， Nanning 530000， China

    [Abstract] Objective To describe the preparation method of theophylline extended-release tablets and the evaluation of dissolution similarity with the reference preparation. Methods This research described that the theophylline extended-release tablets were prepared by taking theophylline as raw material ......