不同厂家阿司匹林肠溶片中游离水杨酸的考查分析  

Analysis of contents of free salicylic acid in aspirin enteric-coated tablets from different manufacturers

作　　者：苏丹 王巍 陈亚 

机构地区：[1]重庆市涪陵食品药品检验所,重庆408000

出　　处：《天津药学》2017年第4期8-10,共3页Tianjin Pharmacy

摘　　要：目的:考查国内14个不同厂家生产的阿司匹林肠溶片的游离水杨酸,对不同厂家的同一药物制剂的质量进行评价,为临床用药提供参考。方法:根据《中国药典》中阿司匹林肠溶片的检验标准,采用高效液相色谱法测定阿司匹林肠溶片中游离水杨酸的含量并进行方法学考查。结果:14个生产厂家共计44批阿司匹林肠溶片中,有4批次游离水杨酸的限度超过《中国药典》的规定。结论:不同厂家以及部分同一厂家不同批次的的阿司匹林肠溶片,其游离水杨酸含量均存在一定差异。生产企业应筛选合理的处方和制备工艺,运输及经营环节控制好温湿度,以保证药物的质量及稳定性。Objective：To analyse the contents of free salicylic acid in aspirin enteric-coated tablets from 14 different manufacturers in order to provide reference for clinical use.Method：The contents of free salicylic acid in aspirin enteric-coated tablets were determined by high performance liquid chromatography（HPLC） with reference to Chinese Pharmacopoeia.Results：Out of 44 batches of aspirin enteric-coated tablet made by 14 different manufacturers,the contents of salicylic acid in four batches went beyond the limit set in Chinese Pharmacopeia went beyond the limit.Conclusions：The difference exists in the content of free salicylic acid in different batches of aspirin enteric-coated tablets from different manufacturers and the same manufacturer.Production enterprises should select reasonable prescription and preparation process,control the temperature and humidity in transportation and operation,in order to guarantee the quality and stability of the drug.

关 键 词：阿司匹林肠溶片 游离水杨酸 

分 类 号：R927.1[医药卫生—药学]