黄河倩 徐俊 陈欢 曹丹婧 肖李钱

    [摘要] 目的 建立瑞舒伐他汀钙固体分散体颗粒溶出度的测定方法。 方法 运用固体分散体技术制备瑞舒伐他汀钙固体分散体颗粒，采用紫外分光光度法测定其溶出度，紫外检测波长为241 nm，并进行方法学考察，主要包括考察精密度、稳定性以及重现性、回收率。 结果 在6.0～22.0 mg/L，瑞舒伐他汀钙浓度与吸光度的线性关系良好，线性回归方程为Y=0.032X+0.0292(r = 0.999 95)，平均回收率为99.77%，RSD为0.94%，重现性的RSD为0.33%，溶出度达到90%以上。 结论 本方法可用于瑞舒伐他汀钙固体分散颗粒溶出度的测定。

    [关键词] 瑞托伐他汀钙;溶出度;固体分散体;颗粒;紫外分光光度法

    [中图分类号] R927.2? ? ? ? ? [文献标识码] A? ? ? ? ? [文章编号] 1673-7210(2019)08(a)-0038-04

    [Abstract] Objective To establish a method for the determination of dissolution rate of Rosuvastatin Calcium Solid Dispersion Granules. Methods Rosuvastatin Calcium Solid Dispersion Granules were prepared by solid dispersion technology. The dissolution rate was determined by ultraviolet spectrophotometry. The ultraviolet detection wavelength was 241 nm. Methodological investigation was carried out， including precision， stability， reproducibility and recovery. Results At 6.0-22.0 mg/L， the linear relationship between the concentration of Rosuvastatin Calcium and absorbance was good. The linear regression equation was Y=0.032X+0.0292 (r = 0.999 95). The average recovery rate was 99.77% ......