硝苯地平缓释胶囊释放度方法的建立

目的：建立硝苯地平缓释胶囊的释放度检查方法。方法：以盐酸溶液（9→100mL）1000mL溶出介质,转速为60r.min-1,取样时间为1h,4h,8h,采用释放度第一法,溶出度第二法测定。结果：硝苯地平在1.834-22.008μg.mL-1的浓度范围内,线性相关性良好。线性方程为：A=70580.3C-4008.4（r=0.9999）;平均回收率为100.4%,（RSD=1.14%）;6批样品在1h,4h,8h的释放量分别为标示量的15%-40%,30%-65%,50%-80%。结论：本方法便捷、准确、重现性好,可用于硝苯地平缓释胶囊的质量控制。

Stuty on Dissolution Method of Nifedipine Sustained Release Capsules

Objective:To establish a method for deteminiation of dissolution of Nifedipine Sustained Release Capsules.Method:Hydrochloric acid solution(9→100mL)1000mL was taken as solvent with the totating speed at 60r·min-1,and the samoling time was 1h,4h,8h.The dissolution of was determined by dissolution test method 2.Result:The standard curve of Nifedipine Sustained Release Capsules as a good liner relationship in the range of 1.834~22.008μg·mL-1,A=70580.3C-4008.4(r=0.9999);The average recorvery was 100.4%,(RSD=1.14%).The mean cumulative dissolutions of six batches of sample were 15%~40%,30%~65%,50%~80%.Conclusion:The method is simple,accurate and reproducible,and can be used for the quality control of this preparation.