CAJ | 학술논문

目的通过在福建省辖区内组织中成药中厚朴含量的测定(高效液相色谱法)能力验证,评价各参加实验室检测中成药含量的能力. 方法依据CNAS规定的程序进行本次能力验证. 结果采用单因子方差分析对能力验证样品进行了均匀性实验,采用 t检验对样品进行稳定性考察,均符合要求. 采用Z比分数法评价各参加实验室的结果 . 各参加实验室结果的中位值作为指定值,以标准化四分位距( NIQR)作为能力评定标准差. 参加的24个实验室均报告了结果 ,17个实验室获得满意结果 ,4个实验室结果有问题,3个实验室结果不满意. 结论制备均匀性和稳定性符合能力验证的样品,并采用适当的统计方法评价了实验室的高效液相色谱法检测能力.
목적 통과재복건성할구내조직중성약중후박함량적측정(고효액상색보법)능력험증,평개각삼가실험실검측중성약함량적능력. 방법 의거CNAS규정적정서진행본차능력험증. 결과 채용단인자방차분석대능력험증양품진행료균균성실험,채용 t검험대양품진행은정성고찰,균부합요구. 채용Z비분수법평개각삼가실험실적결과 . 각삼가실험실결과 적중위치작위지정치,이표준화사분위거( NIQR)작위능력평정표준차. 삼가적24개실험실균보고료결과 ,17개실험실획득만의결과 ,4개실험실결과 유문제,3개실험실결과 불만의. 결론 제비균균성화은정성부합능력험증적양품,병채용괄당적통계방법 평개료실험실적고효액상색보법검측능력.
OBJECTIVE To evaluate the determination capacity by HPLC of the laboratories which participated in the proficiency-testing.METHODS The study was performed according to procedure of CNAS.RESULTS The one-way ANOVA was used to evaluate the homogeneity of the test samples, whose stability was confirmed with t-tests.All results conformed to the requirements.Z-scores were used to evaluate results from each laboratory with the median of all results as the assigned value;NIQR was used as the standard deviation for proficiency assessment.All 24 1aboratories reported their results,17 laboratories′results were "satisfactory",4 were "questionable",3 were"unsatisfied".CONCLUSION Testing samples are prepared with the homogeneity and stability meeting the re-quirements of proficiency-testing,and the determination capacity by HPLC of the laboratories were evaluated correctly through the suitable statistical method.