2)法評(píng)價(jià)溶出曲線的相似度。結(jié)果 在4種不同pH的溶出介質(zhì)中,自研和原研富馬酸喹硫平片溶出行為基本一致,30 min時(shí)溶出度均達(dá)到85%以上,f2均大于50。結(jié)論 自研富馬酸喹硫平片在4種溶介質(zhì)中均可以完全釋放,與原研制劑體外溶出行為均相似,能確保二者藥品質(zhì)量的一致性。;Objective To compare the dissolution profiles of elf-prepared and original quetiapine fumarate tablets in 4 kinds of mediums, and that as a reference for evaluating production process and product quality of generic drug.Methods According to the second dissolution method (paddle method) stated in general rule 0931 of Chinese Pharmacopeia (2015 edition Part 4). the rotation speed was 50 r/min with dissolution medium volume of 900 mL. UV was adopted to determine the content of Quetiapine Fumarate in water, pH 1.0 hydrochloride acid, pH 4.5 phosphoric acidand pH 6.8 phosphate buffer solution, calculate the cumulative dissolution and draw dissolution profiles,then similarity factor (f2) was used to evaluate the similarity of dissolution profiles.Results In four different pH solvents, Domestic Quetiapine Fumarate Tablets' dissolve behavior was similar to original drug. In 30 minutes, the dissolution was more than 85% and the f2 was higher than 50 for both domestic and original.Conclusion Domestic Quetiapine Fumarate Tablets could release completely in four solvents and the dissolve behavior was similar to original. That could guarantee the consistency for both qualities."/>

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首頁(yè) > 過刊瀏覽>2018年第41卷第12期 >2018,41(12):2252-2255. DOI:10.7501/j.issn.1674-6376.2018.12.022
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富馬酸喹硫平片在4種溶出介質(zhì)中溶出曲線的比較研究

Comparative study on dissolution profiles of Quetiapine Fumarate Tablets in 4 kinds of dissolution medias

發(fā)布日期:2018-12-17
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