不同浸提方法对一次性使用输注器具热原试验的影响  

Effect of Different Extraction Methods of Infusion Sets for Single Use Pyrogen Test

作　　者：刘波 刘宁 洪燕 郑洋滨 LIU Bo;LIU Ning;HONG Yan;ZHENG Yangbin(Jiangxi Institute for Drug Control,Jiangxi Provincial Engineering Research Center for Drug and Medical Device Quality,Jiangxi Nanchang330029,China)

机构地区：[1]江西省药品检验检测研究院,江西省药品与医疗器械质量工程技术研究中心,江西南昌330029

出　　处：《中国医药导刊》2017年第11期1222-1225,共4页Chinese Journal of Medicinal Guide

基　　金：江西省科技厅立项课题(项目编号:20142BBG70020;项目名称:对一次性使用输注器具类医疗器械产品生物安全性评价的研究)

摘　　要：目的:比较一次性使用输注器具产品不同浸提方法所获得的供试液对其热原质检测的影响。方法:参照GB/T14233.2-2005和GB/T16886.12-2005的试验原则,对不同生产企业的58批次不同规格的4个不同品种的一次性使用输注器具产品进行了热原检测。结果:58批次不同规格的一次性使用输注器具产品以0.9%氯化钠注射液为浸提液,按0.2 g:1 mL 121℃保温1h,按家兔体重每公斤注射10 mL,热原检查结果家兔体温升温均小于0.6℃;同批次一次性使用输注器具产品以0.9%氯化钠注射液为浸提液抽取至公称容量37℃保温24 h,按家兔体重每公斤注射10 mL,热原检查结果家兔体温升温均小于0.6℃。从58批次4个不同品种的样品中各抽取3个批次的样品,以含10 EU·mL^(-1)细菌内毒素的0.9%氯化钠注射液为浸提介质,按0.2 g:1mL 121℃保温1 h,按家兔体重每公斤注射10 mL,热原检查结果家兔体温升温均小于0.6℃;同批次一次性使用输注器具产品以含10 EU·mL-1细菌内毒素的0.9%氯化钠注射液抽取至公称容量37℃保温24h,按家兔体重每公斤注射10 mL,热原检查结果每组家兔(3只·组-1)体温升温至少有1只大于0.6℃。结论:当温度升高时,可能导致浸出的热原质降低,从而影响热原实验结果。Objective:To compare the disposable injection apparatus product transport different leaching effect of provided methods for the solution of the pyrogen detection.Methods:According to the experimental principle of GB/T14233.2-2005and GB/T16886.12-2005,the product of4different varieties of different specifications of58batches of different types of production enterprises were tested with thermal original.Results:58batches of different specifications of disposable infusion apparatus is leaching solution with0.9%sodium chloride injection,according to the0.2g:1mL121℃heat preservation for1h,according to the rabbit injected10mL per kilogram weight,rabbit pyrogen inspection results are less than0.6℃temperature warming;disposable infusion apparatus with batch products with0.9%sodium chloride injection for leaching solution extraction to37℃nominal capacity of heat preservation for24h,according to the injected10mL per kilogram weight on rabbit,rabbit pyrogen inspection results are less than0.6℃temperature warming.Samples from58batches of4different varieties were sampled from3batches to contain10EU·mL-1bacterial endotoxin0.9%sodium chloride injection for leaching medium,according to the0.2g:1mL121℃heat preservation for1h,according to the rabbit injected10mL per kilogram weight,rabbit pyrogen inspection results are less than0.6℃temperature warming;the product of the infusion device was used in the same batches to contain10EU·mL-1bacterial endotoxin0.9%sodium chloride injection extraction to37℃nominal capacity of heat preservation for24h,according to the injected10mL per kilogram weight on rabbit,rabbit pyrogen test results for each group(3group only)temperature rising at least one greater than0.6℃.Conclusion:When the temperature rises,it may lead to leaching of pyrogens reduced,thus affecting the pyrogen test.

关 键 词：一次性使用输注器具 浸提方法 热原试验 

分 类 号：TH77[机械工程—仪器科学与技术]