中国药事
中國藥事
중국약사
CHINESE PHARMACEUTICAL AFFAIRS
2014年
12期
1331-1334
,共4页
董喆%张会亮%黄湘鹭%冯克然%宋钰%张庆生%曹进%项新华
董喆%張會亮%黃湘鷺%馮剋然%宋鈺%張慶生%曹進%項新華
동철%장회량%황상로%풍극연%송옥%장경생%조진%항신화
能力验证计划%稳健统计%西布曲明%保健食品
能力驗證計劃%穩健統計%西佈麯明%保健食品
능력험증계화%은건통계%서포곡명%보건식품
proficiency testing program%robust statistics%sibutramine%health food
目的:对参加保健食品中西布曲明含量检测能力验证计划实验室的检测能力进行分析和评价。方法通过实施能力验证计划,获得各参加实验室保健食品中西布曲明含量的测定结果,对结果进行稳健统计分析,通过稳健 Z比分数评价实验室检测能力。结果样品通过分析,在P<0.05显著水平,均匀且在3个月内稳定,满足能力验证计划要求。60个实验室参加了本次能力验证计划,满意结果数为54家,满意率为90%;可疑结果数为4家,可疑率为6.67%;不满意结果数为2家,不满意率为3.33%。结论大部分参加实验室检测能力评价为满意,表明保健食品中西布曲明检测水平总体较好。
目的:對參加保健食品中西佈麯明含量檢測能力驗證計劃實驗室的檢測能力進行分析和評價。方法通過實施能力驗證計劃,穫得各參加實驗室保健食品中西佈麯明含量的測定結果,對結果進行穩健統計分析,通過穩健 Z比分數評價實驗室檢測能力。結果樣品通過分析,在P<0.05顯著水平,均勻且在3箇月內穩定,滿足能力驗證計劃要求。60箇實驗室參加瞭本次能力驗證計劃,滿意結果數為54傢,滿意率為90%;可疑結果數為4傢,可疑率為6.67%;不滿意結果數為2傢,不滿意率為3.33%。結論大部分參加實驗室檢測能力評價為滿意,錶明保健食品中西佈麯明檢測水平總體較好。
목적:대삼가보건식품중서포곡명함량검측능력험증계화실험실적검측능력진행분석화평개。방법통과실시능력험증계화,획득각삼가실험실보건식품중서포곡명함량적측정결과,대결과진행은건통계분석,통과은건 Z비분수평개실험실검측능력。결과양품통과분석,재P<0.05현저수평,균균차재3개월내은정,만족능력험증계화요구。60개실험실삼가료본차능력험증계화,만의결과수위54가,만의솔위90%;가의결과수위4가,가의솔위6.67%;불만의결과수위2가,불만의솔위3.33%。결론대부분삼가실험실검측능력평개위만의,표명보건식품중서포곡명검측수평총체교호。
Objective To analyze and evaluate the proficiency of the laboratories participating in the proficiency testing program for the determination of sibutramine in health food.Methods Results of the content of sibutramine in health food were obtained through the proficiency testing program (PTP),data from the results were analyzed by robust statistics and the proficiency of the participant laboratories was evaluated by Z score.Results The analysis showed that samples were homogeneous and stable in the 3-month period at P<0.05 significant level, which met the requirement of the PTP. A total of 60 laboratories participated in the PTP,among which 54 laboratories had satisfactory results,accounting for 90%,4 laboratories (6.67%)had suspicious results,and 2 laboratories (3.33%)had unsatisfactory results.Conclusion The maj ority of the participant laboratories were evaluated to have satisfactory proficiency,indicating that the overall detection level for sibutramine in health food was good.