摘要
目的以水杨酸片为考核样品,设计、组织并对能力验证项目NIFDC-PT-004中来自31个省(市)、自治区的40家实验室的水杨酸片溶出度测定结果进行了统计分析,对离群数据进行了技术分析。方法参照CNAS-GL02并结合药物溶出度测定的特点,以篮法、桨法、小杯法分别测定的水杨酸片溶出量为评价指标,对各参加实验室的能力验证结果进行了结果总数、剔除离群值后的平均值、平均值±3倍标准偏差(SD)范围、最小值、最大值、极差、相对标准偏差(RSD)的统计分析。评定标准:溶出度测定结果经Grubbs检验法判定为离群值,为不满意结果;溶出度测定结果-平均值>3SD,为不满意结果;溶出度测定结果-平均值≤3SD为满意结果。结果篮法测得溶出量为满意结果的实验室有38家,占95.0%(n=40);桨法测得溶出量为满意结果的实验室有40家,为100%(n=40);小杯法测得溶出量为满意结果的实验室有34家,占97.1%(n=35)。结论多数实验室的能力验证结果为"满意",从而确保测定结果的准确性和重现性。对于"不满意"结果的实验室应回顾操作过程,查找原因并进行整改。
Objective To design,arrange and evaluate the results obtained ＂from the proficiency testing program NIFDC-PT-004,operated in the 40 laboratories in 30 provinces,＂which was intended to assess the proficiency of the laboratories in determination of dissolution of salicylic acid tablets as testing samples and to conduct technical analysis of the outlier results. Methods According to CNAS-GL02 and features of the determination of dissolution of drugs,dissolutions of salicylic acid tablets which were determined by basket method,paddle method and cup method respectively were set as the evaluation index.Statistical analysis was performed on the results obtained from the laboratories in the proficiency testing program,including the total number,mean（outliers excluded）,mean±3SD,minimum,maximum,range and relative standard deviation（RSD）.Evaluation criteria were as follows.Results of the determination of dissolution were not satisfactory if the values were outliers judged by Grubbs test method;if the determination value of dissolution-mean3SD,the results were unsatisfactory;if the determination value of dissolution-mean≤3SD,the results were satisfactory.Results The results by basket method from 38 laboratories were satisfactory,which accounted for 95.0%（n=40）.By paddle method,results from 40 laboratories were satisfactory,which accounted for 100%（n=40）.The results by cup method from 33 laboratories were satisfactory,which accounted for 97.1%（n=35）.Conclusion The majority of the participant laboratories passed the proficiency test with satisfactory results,which ensured the validity and reproducibility of the results.The laboratories that had unsatisfactory results should carefully review the operation,find the causes and rectify the relevant parts.
出处
《中国药事》
CAS
2014年第12期1327-1330,共4页
Chinese Pharmaceutical Affairs
关键词
能力验证
水杨酸片
溶出度
技术分析
proficiency testing
salicylic acid tablets
dissolution
technical evaluation
