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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 dissolution rate of ferrous sulphate tablets from four manufacturers and the release rate of ferrous sulfate sustained-release tablets from two manufacturers. Methods: The dissolution rate / release method of four Chinese Pharmacopoeia (2015 edition) were adopted. The absorbance was measured by atomic absorption spectrophotometry. The dissolution rate of ferrous sulfate tablets and the release rate of ferrous sulfate sustained release tablets were investigated respectively. 8 software to solve Weibull distribution model parameters and make statistical analysis. Results: The dissolution rate and release rate of all the samples were in line with the requirements of the Chinese Pharmacopoeia. However, the in vitro dissolution behavior varied from one batch to another, and the dissolution uniformity of individual batches was poor. Conclusion: Dissolution behavior of ferrous sulfate tablets / sustained-release tablets varies greatly in different manufacturers, and the product quality is different.