不同厂家硝苯地平控释片体外溶出度的比较

Comparison of the dissolution of nifedipine control relay tablet

目的:考察不同厂家硝苯地平控释片的质量,并为临床用药提供可靠的指导性依据。方法:参考中国药典2005版溶出度测定法的条件,以人工胃液为溶出介质进行四种硝苯地平控释片的体外溶出试验,采用UV吸收光谱法测定样品液的浓度,计算累积溶出量。结果:不同厂家药物的溶出度之间存在显著差异。结论:与国外样品相比,B样品与C样品的控释效果较好;A样品的控释效果较差.说明B样品与C样品的制剂已达到国外先进水平,A样品需要改进其制剂工艺。

Objective： To investigate the quality of Nifedipine Control Relay Tablet （NFCRT） from the different plants and provide reliable and direct basis for clinical medication.Methods：The experiment of NFCRT dissolution rate was according to experimental condi- tion of dissolution rate test of China Pharmacopoeia （2005 version） by UV sepectrophotomatry.Results：The analysis of dissolution rate showed different effect among the four samples. Conclusion：Controlling effect of B and C were the same as the external sample.The dissolution rate of A was worse than the other three samples,so,we can give the company some advice to improve their technology.