止血纤维素材料亚慢性毒性实验研究 王春仁.docxVIP

止血纤维素材料亚慢性毒性实验研究 王春仁 止血纤维素材料亚慢性毒性实验研究lowbar;王春仁 中国药事2021年第21卷第9期695 止血纤维素材料亚慢性毒性实验研究 王春仁, 王召旭, 宋谊萍, 彭新杰, 奚廷斐 (中国药品生物制品检定所, 北京 100050) 摘要: 按照GB/疗器械生物学评价第11部分全身毒性试验的方法, 观察了止血纤维素材料对大鼠的全身亚慢性毒性反应, 其目的是找出止血纤维素材料毒副反应的靶器官, 确定是否有潜在的毒性反应, 研究发现止血纤维素材料试验液高、中、低三剂量组连续大鼠腹腔注射给样13周, 大鼠一般状况良好, 体重增加。给供试品后高、中、低剂量大鼠肝脏和脾脏系数与对照组比较有显著性差异。病理组织学检查各剂量组试验液对大鼠肝脏和脾脏均有不同的病理改变, 各试验动物脾脏被大量吞噬泡沫细胞充斥, 脾小结及红髓减少; 多数肝脏也见灶状泡沫细胞浸润, 汇管区尤甚, 伴淋巴细胞、窦内皮细胞增生。因此止血纤维素材料毒性可能的靶器官主要是肝脏和脾脏, 提示止血纤维素可能不完全降解而在体内蓄积所致。 关键词: 止血; 亚慢性毒性; 纤维素; 不良反应 中图分类号:R95 文献标识码:A 文章编号:1002-7777(2021) 09-0695-04The Subchronic Systemic Toxicity Investigation of Haemostatic Cellulose Wang Chunren, W ang Zhao xu, So ng Yiping, Peng Xinjie and Xi Tingfei (National Institute for the Co ntro l of Phar maceutical and Bio logical Pr oducts, Beijing 100050) ABSTRAC T The subchronic systemic toxicity of haemo static cellulose w as investigated based o n the method described in the GB/iolog ical Evaluation of M edical Devices Part 11:Systemic Tox icity fo r finding possible target org an of the cellulose w hich po tentially cause to xic and side effect 1The determ ination o f tox icity w as based upo n clinical observatio n, animal/or gan w eights, haematolog ical parameter s and serum bio chemical analysis, necropsy observation and histopatholog ical assessment of selected tissues from animals ex posed to the test article extracts and co ntro l animals exposed to vehicle 1The results sho w ed the animals in test and contro l g roup did no t exhibit significant sig ns of clinical observatio n over the course of the study 1Necropsy fo und that the spleen enlarg em ent in the test g roups and spleen or gan index in the test g roups w as sig nificantly difference from the contro l g roups 1The histo patholog ical observation also fo und a lot of fo am y cells infiltr ated in the spleen and hepatic tissue 1The study co ncluded that the potential tox ic targ et o rgan of the haemostatic cellulose w