王林波 杨美成 陈祝康 陆明 翟培军 陈桂良 王麟达. 药物中有效成分含量测定能力验证项目介绍J. 药学学报, 2012,47(6): 769-772.
引用本文: 王林波 杨美成 陈祝康 陆明 翟培军 陈桂良 王麟达. 药物中有效成分含量测定能力验证项目介绍J. 药学学报, 2012,47(6): 769-772.
WANG Lin-Bei, YANG Mei-Cheng, CHEN Chu-Kang, LU Ming, ZHAI Pei-Jun, CHEN Gui-Liang, WANG Lin-Da. Study on the proficiency testing program of pharmaceutical preparation analysisJ. 药学学报, 2012,47(6): 769-772.
Citation: WANG Lin-Bei, YANG Mei-Cheng, CHEN Chu-Kang, LU Ming, ZHAI Pei-Jun, CHEN Gui-Liang, WANG Lin-Da. Study on the proficiency testing program of pharmaceutical preparation analysisJ. 药学学报, 2012,47(6): 769-772.

药物中有效成分含量测定能力验证项目介绍

Study on the proficiency testing program of pharmaceutical preparation analysis

  • 摘要:

    为评价全球各主要国家或经济体推荐的药品检测实验室的检测能力, 经亚太实验室认可组织 (APLAC) 的授权, 上海市食品药品检验所 (SIFDC) 和中国合格评定国家认可委员会 (CNAS) 共同组织实施了该能力验证计划 (APLAC T080)。参加实验室采用高效液相色谱法测定复方卡托普利中氢氯噻嗪和卡托普利的含量。实施方采用了0.3σ法对能力验证样品进行了均匀性和稳定性实验, 采用Z比分数法评定了各实验室的结果。以参加实验室测定结果的稳健均值作为氢氯噻嗪和卡托普利含量的指定值, 以稳健标准差作为能力验证评估标准差。在18个国家或经济体推荐的38个实验室中33个实验室按时反馈了结果, 其中24个实验室结果满意; 5个实验室结果可疑; 4个实验室结果不满意。

     

    Abstract:

    his proficiency testing program is established to evaluate the pharmaceutical preparation analysis capacity of laboratories recommended by 18 countries and economies.  It was authorized by Asia Pacific Laboratory Accreditation Cooperation (APLAC), and organized by Shanghai Institute for Food and Drug Control (SIFDC) and China National Accreditation Service for Conformity Assessment (CNAS).  The 0.3σ test is used to evaluate the homogeneity and stability of the proficiency testing sample.  The results of the laboratories were assessed by Z-score.  The robust average and the robust standard deviation of the participants’ results were calculated as assigned value and standard deviation for performance assessment of hydrochlorothiazide and captopril using robust statistics.  Thirty-three of 38 laboratories recommended by 18 countries and economies sent their results back.  Twenty-four laboratories’ results were observed as satisfactory.  Five laboratories were identified as having reported at least one questionable result.  Four laboratories were identified as having reported at least one unsatisfactory result.

     

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