摘要
目的通过分析不同检验方法的偏差结果,调查探讨药品检验结果产生偏差的原因,然后针对原因制定相应的质量控制方案并逐项落实。方法收集某检验所2018年1月—2019年6月时间段内的药品检验样本,并从这些样品中随机选取300份进行该次研究,采用紫外分光光度法和高效液相色谱法对选取的样品作药品检验,对不同方法的检验结果进行对比,探讨分析偏差原因。结果紫外分光光度法检验中成药≤2.0%的药品有65份(92.86%),西药≤1.5%的药品有217份(94.35%),高效液相色谱法检验中成药≤2.0%的药品有65份(92.86%),西药≤1.5%的药品有217份(94.35%),两种方法检验结果比较差异无统计学意义(P>0.05);从紫外分光光度法着手,观察质控前后偏差发生率,结果显示质量控制前,紫外分光光度法有18份发生结果偏离;质量控制后,有4份发生结果偏离,差异有统计学意义(P<0.05)。结论造成检验结果偏离的原因主要有人为因素、设备因素以及物料因素,针对这些原因制定相应的质量管理控制方案并予以落实,可以大大提高检验结果的准确度。
Objective By analyzing the deviation results of different inspection methods,investigate and explore the reasons for the deviation of drug test results,and then formulate corresponding quality control plans for the reasons and implement them item by item.Methods Collected the drug test samples of a laboratory from January 2018 to June 2019,and randomly selected 300 copies from these samples for this study,and use ultraviolet spectrophotometry and high performance liquid chromatography to compare the selected samples.The samples are tested for drugs,the test results of different methods are compared,and the reasons for the analysis deviation are discussed.Results Ultraviolet spectrophotometry detected 65(92.86%)of Chinese patent medicines with≤2.0%,217(94.35%)Western medicines with≤1.5%,and HPLC examination of Chinese patents with≤2.0%65,217 copies(94.35%)of western medicines≤1.5%,and there was no statistically significant difference between the two methods(P>0.05);starting from the UV spectrophotometry,observe the occurrence of deviations before and after quality control.The results showed that before the quality control,there were 18 results of UV spectrophotometry deviation;after the quality control,there were 4 deviations,the difference was statistically significant(P<0.05).Conclusion The main reasons for the deviation of the inspection results are human factors,equipment factors and material factors.For these reasons,the corresponding quality management control plan and implementation can greatly improve the accuracy of the inspection results.
作者
曹鲁娜
CAO Lu-na(Heze Institute of Food and Drug Inspection and Testing,Heze,Shandong Province,274000 China)
出处
《中国卫生产业》
2020年第36期139-141,共3页
China Health Industry
关键词
药品
检验
结果偏离
原因
Drugs
Inspection
Deviation of results
Reasons
