不同厂家硫酸亚铁片及缓释片的体外溶出度比较  

Comparison of in vitro Dissolution of Ferrous Sulfate Tablets and Sustained-release Tablets from Different Manufacturers

作　　者：章燕 陈长水[2] 

机构地区：[1]宁波市药品检验所,浙江宁波315048 [2]宁波市急救中心

出　　处：《中国药师》2016年第11期2144-2147,共4页China Pharmacist

基　　金：2011年国家药品评价抽验项目(编号:86)

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。Objective： To investigate the in vitro dissolution of ferrous sulfate tablets from four different manufacturers and ferrous sulfate sustained-release tablets from two different manufacturers. Methods： Referring to the method described in Chinese Pharmacopoeia （2015 edition, volume Ⅳ）, the dissolution tests on ferrous sulfate tablets and sustained-release tablets were carried out. The ab- sorbance was measured by atomic absorption spectrophotometry. The Weibull distribution parameters were calculated by Origin 8 curve fit toolbox and analyzed by a statistical method. Results： The dissolution of all samples from different manufacturers was in accordance with the provisions of Chinese Pharmacopoeia. However, the in vitro dissolution behavior had lots of differences among the batches, and the dissolution uniformity in the individual batches was poor. Conclusion： There are significant differences in the dissolution parameters of ferrous sulfate tablets and sustained-release tablets from different manufacturers.

关 键 词：硫酸亚铁片 硫酸亚铁缓释片 溶出度 威布尔分布模型 原子吸收分光光度法 

分 类 号：R917[医药卫生—药物分析学]