医疗卫生装备2025，Vol.46Issue(10)：29-35,7.DOI:10.19745/j.1003-8868.2025178
一次性使用血浆病毒灭活输血器材的亚慢性全身毒性研究
Subchronic systemic toxicity of disposable plasma virus-inactivated blood transfusion sets
摘要
Abstract
Objective To evaluate the subchronic systemic toxicity of disposable plasma virus-inactivated blood transfusion sets using hydroxyethyl starch(HES)130/0.4 sodium chloride injection as an extraction medium.Methods Firstly,40 Sprague Dawley(SD)rats including 20 male and 20 female ones were seleted and randomly enrolled into a sample group and a control group by sex,with 20 ones in each group.Secondly,instead of plasma HES 130/0.4 sodium chloride injection was used to leach disposable plasma virus-inactivated blood transfusion sets to prepare the test solution by simulating clinical application such as lighting,adsorption and filtration and storage.Finally,the test solution and HES 130/0.4 sodium chloride injection were injected into the tail vein of the SD rats at a dose of 20 mL/kg for 28 d in the sample group and in the control group respectively,and the subchronic systemic toxicity of disposable plasma virus-inactivated blood transfusion sets and the feasibility of using HES 130/0.4 sodium chloride injection as the extraction medium to assess their subchronic systemic toxicity were evaluated with clinical observation,body mass monitoring,clinical pathology examination,gross necropsy and histopathology examination.Results The sample group and control group had no significant differences in mortality rates,clinical observation results,body mass,gross necropsy results,hematological and coagulation examination results and organ weight(all P>0.05);blood biochemical examinations showed the male rats in the sample group had the cholesterol(CHO)values higher while the creatinine(CR)values lower than those in the control group,with the differences being statistically significant(both P<0.05)and the two indexes within the range of the laboratory's historical reference data,and other blood biochemical indexes were not significantly different(all P>0.05);the sample group had the spleen weight-to-body mass ratios of the female rates lower significantly than those in the control group(P<0.05),and the ratios of other organ weight to body mass had significant differences(all P>0.05);histopathology examination showed slight pathological changes in liver,spleen and kidney of female rats and in spleen and kidney of male rats in the sample group,and the female and male rats in the control group had similar pathological changes found in the sample group,which might be caused by HES metabolites.Conclusion Disposable plasma virus-inactivated blood transfusion sets prove to have no significant subchronic systemic toxicity,and its feasible to use HES 130/0.4 sodium chloride injection as the extraction medium to evaluate the subchronic systemic toxicity of disposable plasma virus-inactivated blood transfusion sets.[Chinese Medical Equipment Journal,2025,46(10):29-35].关键词
输血器材/血浆病毒灭活/亚慢性全身毒性/医疗器械/生物相容性评价Key words
blood transfusion apparatus/plasma virus inactivation/subchronic systemic toxicity/medical device/biocom-patibility evaluation分类
医药卫生引用本文复制引用
屈秋锦,乔春霞,孙令骁,汪晓飞,朱福余,车国喜,许晶,王晓燕,韩乃水,孙晓霞..一次性使用血浆病毒灭活输血器材的亚慢性全身毒性研究[J].医疗卫生装备,2025,46(10):29-35,7.基金项目
山东省重点研发计划项目(2024CXGC010611) （2024CXGC010611）
山东省医疗器械和药品包装检验研究院项目(NB202401) （NB202401）
