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采用紫外分光光度法(λ=333nm)对四批不同厂家的硝苯地平缓释片及控释片进行体外释放度试验。结果表明,本次试验的四批样品的释出符合一级或零级速率过程,其释出参数kr与MDT差异有非常显著性(P<0.01)。其中A与B的缓释作用不稳定,D以恒速释放但释出慢,C既克服释出慢的缺点,又能控制释放。
Four batches of nifedipine sustained release tablets and controlled release tablets from different manufacturers were tested in vitro by UV spectrophotometry (λ = 333 nm). The results showed that the release of four batches of samples in this trial was in accordance with the first order or zero order rate and the difference between kr and MDT was very significant (P <0.01). Which A and B slow release effect instability, D release at a constant speed but slow release, C both overcome the shortcomings of slow release, but also control the release.