盐酸二甲双胍药品吸收系数测定的能力验证

The Profi ciency-Testing for Determination of Absorption Coeffi cient of Metformin Hydrochloride

评价参与能力验证实验室的药品吸收系数测定能力。制备了均匀性和稳定性均符合能力验证要求的测试样品,依据ISO13528:2005、国际纯粹与应用化学联合会(IUPAC)能力验证活动的规则以及中国合格评定国家认可委员会(CNAS)规定的程序进行本次能力验证。采用单因子方差分析对制备的测试样品进行均匀性检验,采用t检验对样品进行稳定性考察,均符合要求。采用Z比分数评价各参加实验室的测试结果,以结果的中位值作为测试样品吸收系数的指定值,以标准化四分位距(NIQR)作为变动性度量值(目标标准偏差)。报告检测结果的128家实验室中,101家的结果为"满意",15家的结果"有问题",12家的结果为"不满意"。

The absorption coefficient-determination capacity of the laboratories was evaluated. Testing samples were prepared with homogeneity and stability meeting the requirements of proficiency-testing. The study was performed according to ISO13528：2005, protocol of International Union of Pure and Applied Chemistry （IUPAC） and procedure of China National Accreditation Service for Conformity Assessment （CNAS）. The one-way ANOVA was used to evaluate the homogeneity of the test samples, whose stability was confirmed with t-test. All results conformed to the requirements. Z-scores were used to evaluate results from each laboratory with the median of all results as the indicated value. NIQR was used as the variable metricvalue （target standard deviation）. Among 128 laboratories which reported their results, 101 laboratories＇ results were ＂satisfactory＂, 15 were ＂questionable＂ and 12 were ＂unsatisfied＂.