富马酸喹硫平片在4种溶出介质中溶出曲线的比较研究

目的 比较自研富马酸喹硫平片与国外原研药在4种不同pH的溶出介质中的体外溶出行为，为评价自研富马酸喹硫平片的质量及为制剂生产工艺提供参考。方法 采用《中国药典》2015年版（四部）通则0931第二法（桨法），转速为50 r/min，分别以水、pH 1.0盐酸溶液、pH 4.5醋酸盐缓冲液和pH 6.8磷酸盐缓冲液为溶出介质，溶出介质体积为900 mL；以紫外-分光光度法测定富马酸喹硫平含量，并计算累积溶出度，绘制溶出曲线；采用相似因子（f₂）法评价溶出曲线的相似度。结果 在4种不同pH的溶出介质中，自研和原研富马酸喹硫平片溶出行为基本一致，30 min时溶出度均达到85%以上，f₂均大于50。结论 自研富马酸喹硫平片在4种溶介质中均可以完全释放，与原研制剂体外溶出行为均相似，能确保二者药品质量的一致性。

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

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.