6厂家吲哚美辛肠溶片体外溶出试验比较

    Comparison of in vitro dissolution results of the enteric-coaled tablets of indometacin from 6 pharmaceutical factories

    • 摘要: 目的: 考察6厂家吲哚美辛肠溶片的体外溶出度。方法: 采用转篮法进行体外溶出度试验,用紫外分光光度法检测溶出介质中药物浓度,计算累积释放量,以威布尔分布拟合溶出参数,并对溶出参数进行统计分析。结果: 6家药厂生产的吲哚美辛肠溶片在酸性介质(0.1 mol/L的盐酸)中的溶出度均符合规定,有一家药厂生产的吲哚美辛肠溶片在pH 6.8的磷酸盐缓冲液中的溶出度不符合中国药典的要求。结论: 6厂家的吲哚美辛肠溶片溶出度参数差异有显著性。

       

      Abstract: Objective: To investigate the in vitro dissolution results of enteric-coaled tablets of indometacin probided by 6 different drug manufacturers.Methods: The dissolution tests were carried out with the rotating basket.The ultraviolet spectrometric assay was used to determine the concentration of indometacin in dissolution media.The cumulative dissolution percent of the labeled amount was calculated and the Weibull's equation was used to model the main dissolution parameters according to the dissolution data.The differences between different groups were statistically analysed.Results: The dissolution data of the indometacin tablets produced by different manufacturers meet the requirements of pharmacopoeia in the dissolution test with acidic medium(0.1 mol/L HCL),but one kind of indometacin tablet failed to meet the requirements of pharmacopoeia in the dissolution test with pH 6.8 phosphate buffer solution.Conclusions: The dissolution parameters of the enteric-coated tablets of indometacin from 6 different manifactures differ greatly.

       

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