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    水杨酸片溶出度测定的不确定度及Z比分数研究

    Study on the Uncertainty and the Z Score for the Determination of Dissolution Rate of Salicylic Acid Tablets

      摘要
    • 摘要: 目的 比较、分析水杨酸片溶出度测定的不确定度及Z比分数法。方法 按照中国药典2010年版溶出度测定法先对溶出仪进行性能确认，再分别对水杨酸片A、B样进行溶出度蓝法和浆法的测定。考察各影响因素，计算不确定度，取包含因子k=2(对应的置信水平为95%)，得扩展不确定度。用Z比分数法统计参加此次能力验证的205家实验室的结果。结果 A样蓝法和浆法溶出度分别为23.75%，23.65%；B样蓝法和浆法溶出度分别为23.49%，24.46%。Z比分数法统计结果满意。结论 通过2种方法的比较，可以对溶出度有更全面的认识。

       

      Abstract: OBJECTIVE To compare and analyze the uncertainty and the Z score for the determination of dissolution rate of salicylic acid tablets. METHODS To confirm the performance of dissolution tester according to the dissolution method of Ch.P 2010 Vol Ⅱ. To test the dissolution of salicylic acid tablets A and B using dissolution method 1 and 2. The factors influenced upon the measurement were inspected and the uncertainty of each factor was calculated, then the expanded uncertainty was obtained by using a coverage factor k=2(confidence of approximately 95%). Analyzed the results of 205 labs participating in this ability verification by the use of the Z score. RESULTS The dissolution of salicylin acid tablets A using dissolution method basket and paddle was 23.75, 23.65%. The dissolution of salicylin acid tablets B using dissolution method basket and paddle was 23.49%, 24.46%. The statistical results of the Z score were satisfying. CONCLUSION By comparing these two methods, more comprehensive knowledge about the dissolution can be get.

       

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