摘要
目的以中成药"消炎利胆片"为考核样品,统计了能力验证项目NIFDC-PT-005中来自30个省(市)、自治区的139家实验室的穿心莲含量测定结果,并对离群数据进行了技术分析。方法依据CNASGL02,以"穿心莲内酯"、"脱水穿心莲内酯"以及"穿心莲内酯加脱水穿心莲内酯"总量为评价指标,对各参加实验室的能力验证结果进行了结果总数、中位数、标准四分位数间距、稳健的变异系数、最小值、最大值、极值、Z比分数的统计分析。评定标准:当|Z|≤2时,为满意结果;当2<|Z|<3时,为可疑结果;当|Z|≥3时,为不满意结果。结果 "穿心莲内酯"、"脱水穿心莲内酯"以及"穿心莲内酯加脱水穿心莲内酯"总量3个指标均为满意结果的实验室有117家,占84.2%。结果可疑或者不满意的原因包括:供试品未去包衣,中性氧化铝的适宜性未验证,色谱分离欠佳,计算错误等。结论多数实验室的能力验证结果为"满意",导致结果 "可疑"或者"不满意"的主要因素为技术因素。
Objective To evaluate the results from the 139 laboratories in 30 provinces obtained in the proficiency testing program NIFDC-PT-005, which was intended to assess the proficiency of the laboratories in the determination of Xiaoyanlidan tablet.Technical analysis was also performed for outlier results. Methods Statistic analysis was performed on the results of andrographolide, dehydroandrographolide （quality-indicating compounds of Xiaoyanlidan tablet）and their total amount, including their total number, median, norm IQR （InterQuartile Range ）, robust CV （coefficient of variation）,minimum,maximum, range and Z-score. Evaluation criteria：if the absolute value of the Z-score is not more than 2 （｜Z｜≤2）,the result is satisfactory;if the ｜Z｜ value is between 2 and 3 （2〈｜Z｜〈3）,the result is questionable;if the ｜Z｜ value is not less than 3 （｜Z｜≥3）,the result is unsatisfactory.Results Among 139 laboratories,117 ones （84.2%）obtained satisfactory results of andrographolide,dehydroandrographolide and their total amount.The possible reasons which caused questionable or unsatisfactory results included improper sample preparation （e.g.the coats of the sample were not removed）,unsuitable chromatographic condition,use of improper neutral aluminum packing material in purification of target compounds,incorrect calculation formula,etc.Conclusion The maj ority＆amp;nbsp;of the participant laboratories passed the proficiency testing program.Most susceptible or unsatisfactory results were caused by technical reasons.
出处
《中国药事》
CAS
2014年第9期981-985,共5页
Chinese Pharmaceutical Affairs
