不同厂家硫酸亚铁片及缓释片的体外溶出度比较

发布时间：2018-05-09 18:48

本文选题：硫酸亚铁片 + 硫酸亚铁缓释片　；参考：《中国药师》2016年11期

【摘要】：目的:考察4个厂家硫酸亚铁片的溶出度和2个厂家硫酸亚铁缓释片的释放度。方法:采用中国药典2015年版四部收载的溶出度/释放度方法,并采用原子吸收分光光度法测定吸光度,分别考察硫酸亚铁片的溶出度和硫酸亚铁缓释片的释放度,以Origin 8软件求解威布尔分布模型参数并对其作统计分析。结果:各厂家样品的溶出度/释放度均符合中国药典规定,但体外溶出行为存在批间差异,且个别批次的溶出均一性较差。结论:各厂家的硫酸亚铁片/缓释片体外溶出行为差别大,产品质量存在一定差异。
[Abstract]:Objective: to investigate the dissolution of ferrous sulfate tablets from 4 manufacturers and the release rate of two sustained release ferrous sulfate tablets from 2 manufacturers. Methods: the dissolution / release rate of four parts of Chinese Pharmacopoeia 2015 edition and atomic absorption spectrophotometry were used to determine the dissolution of ferrous sulfate tablets and the release rate of ferrous sulfate sustained release tablets. The parameters of Weibull distribution model are solved by Origin 8 software and analyzed statistically. Results: the dissolution and release rates of samples from different manufacturers were in accordance with the regulations of Chinese Pharmacopoeia, but there were differences in dissolution behavior among batches in vitro, and the dissolution uniformity of individual batches was poor. Conclusion: the dissolution behavior of ferrous sulfate tablets / sustained-release tablets is different in vitro, and the product quality is different.
【作者单位】：宁波市药品检验所;宁波市急救中心;
【基金】：2011年国家药品评价抽验项目(编号:86)
【分类号】：R927.1

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