EDTAK_(2)抗凝真空采血管质量分析  

Quality analysis of EDTAK_(2) anticoagulant vacuum blood collection tube

作　　者：朱武莲 刘园园 刘磅 颜敏 罗洁 曾思思 ZHU Wu-lian;LIU Yuan-yuan;LIU Pang;YAN Min;LUO Jie;ZENG Si-si(Hunan Institute for Drug Control,Changsha 410001,Hunan,China)

机构地区：[1]湖南省药品检验检测研究院,湖南长沙410001

出　　处：《生物医学工程与临床》2024年第4期474-478,共5页Biomedical Engineering and Clinical Medicine

摘　　要：目的 通过对EDTAK_(2)真空采血管公称液体容量、泄漏、添加剂的实际量3个关键性能的检验,评价真空采血管的质量。方法 实验样品共27批。样品分布在6个省份的10家生产企业,其中山东4批(14.8%),河北1批(3.7%),广东1批(3.7%),湖北1批(3.7%),湖南18批(66.7%),贵州2批(7.4%)。按照行业标准YY/T 0314—2007《一次性使用人体静脉血样采集容器》检测27批真空采血管公称液体容量、泄漏和添加剂的实际量3个关键性能。结果 公称液体容量合格率为85.2%,泄漏合格率为100%,添加剂的实际量合格率为60%。通过产品技术要求与行业标准比对,发现部分企业产品技术要求检验方法存在缺陷或检验方法不具操作性,甚至方法错误,存在不合理、不科学。产品标签上未写明具体添加剂的种类、未明确具体使用海拔等问题。不合格的主要原因有采血管生产中抽真空工艺不稳定、添加剂的配制和添加剂的加注量不准确、质量控制不严、产品技术要求编写不严谨,文件编写审核机制不健全等。结论 部分厂家生产的真空采血管存在质量问题,各方应高度重视真空采血管质量控制因素,提高产品的整体质量。Objective To evaluate the quality of vacuum blood collection tube by testing three key properties of EDTAK_(2)vacuum blood collection tube including nominal liquid capacity,leakage and the actual amount of additives.Methods A total of 27 batches samples were collected,which distributed in 10 production enterprises in 6 provinces,including 4 batches in Shandong(14.8%),1 batch in Hebei(3.7%),1 batch in Guangdong(3.7%),1 batch in Hubei(3.7%),18 batches in Hunan(66.7%),and 2 batches in Guizhou(7.4%).According to standard YY/T 0314-2007 of Disposable human venous blood sample collection container,27 batches of vacuum tube were tested for nominal liquid capacity,leakage and actual amount of additives.Results The qualified rate of nominal liquid capacity was 85.2%,leakage was 100%,and the actual amount of additive was 60%.Compared the product technical requirements with industry standards,it was found that flaws existed in some product technical inspection methods or the methods were non-operatable,even were wrong,unreasonable and unscientific.There was no specific additive type,altitude requirement and other issues on product label.The main reasons for un-qualification were unstable vacuum process in production of blood collection tubes,inaccurate preparation and the filling amount of additives,lax quality control,imprecise product technical requirements and imperfect document review mechanism.Conclusion It is demonstrated that some manufacturers have quality problems in vacuum blood collection tubes,all relevant departments should attach great importance to quality control and improve the overall quality.

关 键 词：EDTAK_(2)抗凝真空采血管 公称液体容量 泄漏 添加剂的实际量 

分 类 号：R318.08[医药卫生—生物医学工程] TH77[医药卫生—基础医学]