人血白蛋白的蛋白质含量测定能力验证结果与分析  

Results and Analysis of Proficiency Test of Human Albumin Protein Content Measurement

作　　者：王敏力[1] 王箐舟[1] 刘雅丹[1] 徐苗[1] 侯继锋[1] Wang Minli Wang Qingzhou Liu Yadan Xu Miao Hou Jifeng(National Institutes for Food and Drug Control, Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, Beijing 100050, China)

机构地区：[1]中国食品药品检定研究院,卫生部生物技术产品检定方法及标准化重点实验室,北京100050

出　　处：《中国药事》2017年第7期754-759,共6页Chinese Pharmaceutical Affairs

摘　　要：目的:对全国血液制品批签发授权药检机构及相关生产企业或单位实验室的人血白蛋白蛋白质含量检测能力进行评价。方法:选择符合要求的人血白蛋白产品作为原料进行合并、除菌、分装。制备后按照《中国药典》2015年版三部蛋白质含量(凯式定氮)测定,组织协作标定后确立指定值。均一性和稳定性监测合格后按能力验证要求发放样品。以多中心协作标定结果作为评价参加者能力验证结果的依据。结果:能力验证样品确立的指定值及其参考范围为(193.30±5.08)g·L^(-1),参加本次能力验证的药检机构或企业实验室共13家,10家实验室结果为优秀,1家实验室为合格,2家实验室为不满意。整体满意率为84.6%,优秀率76.9%,不合格率15.4%。结论:国内血液制品的7家批签发授权药检机构能力验证结果均为优秀,部分企业实验室能力验证结果为满意,但也有个别实验室测定结果出现偏差,参加者应调查并改进。Objective： To evaluate the proficiency of the human albumin protein content measurement of the authorized blood products batch issued by institutes for drug control and other relevant enterprises or laboratories. Methods： Qualified human albumin products were selected as raw materials to be mixed, sterilized and subpackaged. The samples were distributed to eleven laboratories to determine the protein content according to the method of Kjeldahl determination of China Pharmacopeia（2015 edition, part III） for cooperative calibration and establishment of verification value. The samples were handed out according to the requirement of proficiency test and the results of cooperative calibration were used as the reference to evaluate the proficiency of the participants. Results： The verification value and reference（193.30±5.08） g.L^（-1） of the samples for proficiency test were established. Among the 13 participants, 10 laboratories were excellent, 1 laboratory was satisfactory, and 2 laboratories were unsatisfactory. The overall satisfactory rate was 84.6%, excellent rate was 76.9%, and the failure rate was 15.4%. Conclusion： The proficiency test results of 7 blood products batch issued by institutes for drug control were excellent. The proficiency test results of some enterprise laboratories were satisfactory. But the testing results of few laboratories were unsatisfactory and needed to be investigated and improved.

关 键 词：能力验证 人血白蛋白 血液制品 蛋白质含量测定 凯式定氮法 实验室质量管理 

分 类 号：R95[医药卫生—药学]