本文選題：硫酸亞鐵片 + 硫酸亞鐵緩釋片��； 參考：《中國藥師》2016年11期

【摘要】：目的:考察4個廠家硫酸亞鐵片的溶出度和2個廠家硫酸亞鐵緩釋片的釋放度。方法:采用中國藥典2015年版四部收載的溶出度/釋放度方法,并采用原子吸收分光光度法測定吸光度,分別考察硫酸亞鐵片的溶出度和硫酸亞鐵緩釋片的釋放度,以O(shè)rigin 8軟件求解威布爾分布模型參數(shù)并對其作統(tǒng)計分析。結(jié)果:各廠家樣品的溶出度/釋放度均符合中國藥典規(guī)定,但體外溶出行為存在批間差異,且個別批次的溶出均一性較差。結(jié)論:各廠家的硫酸亞鐵片/緩釋片體外溶出行為差別大,產(chǎn)品質(zhì)量存在一定差異。
[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.
【作者單位】： 寧波市藥品檢驗所;寧波市急救中心;
【基金】：2011年國家藥品評價抽驗項目(編號:86)
【分類號】：R927.1

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本文編號：1867006