摘要
目的:全面了解我国缩宫素效价测定的技术水平,并对参加能力验证实验室测定缩宫素效价的能力进行评价。方法:制备能力验证考核样品,并进行均匀性及稳定性考察。各实验室自愿报名参加,按照中国药典2015年版四部通则1210缩宫素生物测定法测定考核样品的效价,对参加实验室的反馈结果进行统计分析,采用z比分数法评价实验室检测能力。结果:能力验证考核样品经均匀性及稳定性考察合格,满足能力验证计划要求。本次能力验证24家实验室中20家实验室的检测结果评定为"满意",满意率为83.3%。结论:本次能力验证可真实地反映参加实验室的检测水平,大多数参加能力验证的实验室具备检测缩宫素效价的能力。
Objective: To comprehensively understand the technical level of oxytocin potency determination in China,and to evaluate the ability of participating laboratories in the proficiency testing. Methods: The test sample for the proficiency testing was prepared,and the homogeneity and stability were assessed. All laboratories voluntarily registered to participate in the proficiency testing program(PTP). The oxytocin potency determination was performed according to the general principle 1210 in part four of Chinese Pharmacopoeia(2015 edition). The results were statistically analyzed and the determination proficiency of the laboratories was evaluated by z-score. Results: The samples passed the homogeneity and stability assessment,and met the requirements of the PTP. The test results of 20 out of 24 laboratories in this proficiency testing were evaluated as " satisfactory",which accounted for 83.3%. Conclusion: This proficiency testing truly reflected the oxytocin potency determination level of the participating laboratories. Most of the participating laboratories have the ability to determine the potency of oxytocin.
作者
张媛
谭德讲
常艳
赵萌
吴彦霖
高华
Zhang Yuan;Tan Dejiang;Chang Yan;Zhao Meng;Wu Yanlin;Gao Hua(National lnstitutes for Food and Drug Control,Bejing102629,China)
出处
《中国药师》
CAS
2021年第4期777-780,共4页
China Pharmacist
关键词
缩宫素
效价
能力验证
稳健统计
z比分数法
Oxytocin
Potency
Proficiency testing
Robust statistical
z-Score
