茶碱缓释片的制备及与参比制剂的体外溶出相似性评价  

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

作　　者：黎德南 韦伟宁 LI De'nan;WEI Weining(College of Pharmacy,Guilin Life and Health Career Technical College,Guangxi,Guilin 541100,China;Guangxi Hongshantang Biotechnology Co.,Ltd.,Guangxi,Nanning 530000,China)

机构地区：[1]桂林生命与健康职业技术学院药学院,广西桂林541100 [2]广西弘山堂生物科技有限公司,广西南宁530000

出　　处：《中国医药科学》2021年第23期82-85,共4页China Medicine And Pharmacy

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。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,hydroxyethyl cellulose as the backbone material,cetostearyl alcohol as the blocking agent,povidone K30 as the binder,talc and magnesium stearate as the lubricant,and adopting the process of wet granulation followed by tablet compression.With reference to the testing method under the Dissolution of theophylline extended-release tablets in JP,the in vitro dissolution similarity was evaluated by testing the dissolution rate of the self-made preparation and the reference preparation using four dissolution media,respectively.Results The in vitro dissolution rate of the self-made preparation remains constant.The dissolution curve similarity factor f2 between the reference preparation and the self-made preparation was more than 50,with similar in vitro dissolution.Conclusion The prescription and process of the self-made preparation are of great significance to ensure the bioequivalence of theophylline extended-release tablets and the reference preparation,and can improve the safety and effectiveness of clinical medication of theophylline extended-release tablets.

关 键 词：茶碱 缓释片 参比制剂 释放度 生物等效性 

分 类 号：R284.1[医药卫生—中药学]