文章摘要
刘 波,洪燕,郑洋滨,刘宁.不同浸提方法对一次性使用输注器具热原试验的影响[J].中国医药导刊,2017,19(11):1222-1225.
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
投稿时间:2016-11-23  修订日期:2017-03-14
DOI:
中文关键词: 一次性使用输注器具  浸提方法  热原试验
英文关键词: Disposable infusion apparatus  Extraction method  Pyrogen test
基金项目: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)
作者单位E-mail
刘 波 江西省药品检验检测研究院 2647563963@qq.com 
洪燕 江西省药品检验检测研究院  
郑洋滨 江西省药品检验检测研究院  
刘宁 江西省药品检验检测研究院 liuning008@sohu.com 
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中文摘要:
      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:1 mL 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。
英文摘要:
      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/T14233.2-2005 and GB/T16886.12-2005,the product of 4 different varieties of different specifications of 58 batches of different types of production enterprises were tested with thermal original. Results: 58 batches of different specifications of disposable infusion apparatus is leaching solution with 0.9% sodium chloride injection, according to the 0.2 g: 1 mL 121 ℃ heat preservation for 1 h, according to the rabbit injected 10 mL per kilogram weight, rabbit pyrogen inspection results are less than 0.6 ℃ temperature warming; disposable infusion apparatus with batch products with 0.9% sodium chloride injection for leaching solution extraction to 37 ℃ nominal capacity of heat preservation for 24 h, according to the injected 10 mL per kilogram weight on rabbit, rabbit pyrogen inspection results are less than 0.6 ℃ temperature warming. Samples from 58 batches of 4 different varieties were sampled from 3 batches to contain 10 EU·mL-1 bacterial endotoxin 0. 9% sodium chloride injection for leaching medium, according to the 0.2 g: 1 mL 121 ℃ heat preservation for 1 h, according to the rabbit injected 10 mL per kilogram weight, rabbit pyrogen inspection results are less than 0.6 ℃ temperature warming; the product of the infusion device was used in the same batches to contain 10 EU·mL-1 bacterial endotoxin 0. 9% sodium chloride injection extraction to 37 ℃ nominal capacity of heat preservation for 24 h,according to the injected 10 mL per kilogram weight on rabbit, rabbit pyrogen test results for each group(3 group only) temperature rising at least one greater than 0.6 ℃.Conclusion: When the temperature rises, it may lead to leaching of pyrogens reduced,thus affecting the pyrogen test.
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