非洛地平缓释制剂体外释放度比较

Study on the in vitro dissolution of felodipine sustained release preparations

目的:对不同厂家非洛地平缓释制剂的体外释放度进行比较。方法:按照非洛地平的部颁标准,采用桨法测定非洛地平缓释制剂的释放度,通过选用数学模型线性拟合,求出参数,进行方差分析。结果:B样品释放度的均一性和重现性均好于A样品,A样品同一样品不同批号间释放度差异极具显著性(P<0.01),B样品有2个批号间差异具显著性(P<0.05)。结论:两个厂家的产品的释放度均符合部颁标准规定,B样品释放度好于A样品。

OBJECTIVE To compare the in vitro drug release of felodipine release preparations manutactured by different pharmaceutical factories. METHODS The drug release was tested by paddle method according to the national drug standards. RESULTS The uniformity and repeatability of sample B is better than that of sample A. The drug releases of different batches of sample A were significant (P < 0.01) . CONCLUSIONS Although the samples from two factories meet the requirement, the sample B is better than sample A in the respect of drug release.