不同廠家硫酸亞鐵片及緩釋片的體外溶出度比較
發(fā)布時(shí)間:2018-05-09 18:48
本文選題:硫酸亞鐵片 + 硫酸亞鐵緩釋片; 參考:《中國(guó)藥師》2016年11期
【摘要】:目的:考察4個(gè)廠家硫酸亞鐵片的溶出度和2個(gè)廠家硫酸亞鐵緩釋片的釋放度。方法:采用中國(guó)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(cè)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(duì)其作統(tǒng)計(jì)分析。結(jié)果:各廠家樣品的溶出度/釋放度均符合中國(guó)藥典規(guī)定,但體外溶出行為存在批間差異,且個(gè)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(yàn)所;寧波市急救中心;
【基金】:2011年國(guó)家藥品評(píng)價(jià)抽驗(yàn)項(xiàng)目(編號(hào):86)
【分類號(hào)】:R927.1
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2 顏曉,吳韶銘;流動(dòng)注射分析法測(cè)定硫酸亞鐵片的含量[J];藥物分析雜志;2001年01期
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