目的 比較自研富馬酸喹硫平片與國外原研藥在4種不同pH的溶出介質(zhì)中的體外溶出行為，為評價自研富馬酸喹硫平片的質(zhì)量及為制劑生產(chǎn)工藝提供參考。方法 采用《中國藥典》2015年版（四部）通則0931第二法（槳法），轉(zhuǎn)速為50 r/min，分別以水、pH 1.0鹽酸溶液、pH 4.5醋酸鹽緩沖液和pH 6.8磷酸鹽緩沖液為溶出介質(zhì)，溶出介質(zhì)體積為900 mL；以紫外-分光光度法測定富馬酸喹硫平含量，并計算累積溶出度，繪制溶出曲線；采用相似因子（f₂）法評價溶出曲線的相似度。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.