羧甲基壳聚糖水凝胶亚慢性全身毒性试验植入剂量探讨  

Discussion on implantation dose of carboxymethyl chitosan hydrogel in subchronic systemic toxicity test

作　　者：贾莉芳[1,2] 孙吉 梁洁 袁暾[1] 连欢[2] 马静 郑利萍 JIA Li-fang;SUN Ji;LIANG Jie(National Engineering Research Center for Biomedical Materials,Sichuan University,Chengdu 610064,China)

机构地区：[1]四川大学国家生物医学材料工程技术研究中心,610064 [2]四川医疗器械生物材料和制品检验中心,610064

出　　处：《中国实用医药》2020年第30期1-6,共6页China Practical Medicine

基　　金：四川省重点研发项目(项目编号:2020YFS0039);国家重点研发计划(项目编号:2018YFC1106800)。

摘　　要：目的采用不同植入剂量,对羧甲基壳聚糖(CMC)水凝胶亚慢性全身毒性试验剂量的选择进行探讨。方法设置5 ml/kg和50 ml/kg的植入剂量,综合临床观察、血液学、临床生化、大体尸检和组织病理学检查结果,对CMC水凝胶亚慢性全身毒性进行比较研究。结果植入剂量为50 ml/kg时,实验动物初期皮肤刺激损伤明显,试验终期临床生化指标及组织病理指标提示受试物在该剂量条件下有潜在的亚慢性全身毒性。而植入剂量为5 ml/kg时未见明显的亚慢性全身毒性。结论生物材料器械亚慢性毒性评价应遵循个体化原则,根据产品的预期使用目的、使用方式、临床最大使用剂量及前期的研究资料,在动物可耐受的情况下,设计科学合理的试验方案对其进行全面评价。Objective To discuss the implant dose of carboxymethyl chitosan(CMC)hydrogel in subchronic systemic toxicity test.Methods The implantation doses of 5 ml/kg and 50 ml/kg were set,and the results of clinical observation,hematology,clinical biochemistry,autopsy and histopathology were integrated to compare the subchronic systemic toxicity of CMC hydrogel.Results The skin irritation injury was obvious in the experimental animals at the initial stage.The clinical biochemical indexes and histopathological indexes at the end of the experiment indicated that the test material had potential subchronic systemic toxicity at the dose of 50 ml/kg.However,there was no obvious subchronic systemic toxicity at the dose of 5 ml/kg.Conclusion The subchronic toxicity evaluation of biomaterials and devices should follow the principle of individualization.According to the expected use purpose,use mode,clinical maximum dosage and previous research data,scientific and reasonable test scheme should be designed to comprehensively evaluate the toxicity of biomaterials and devices under the condition that animals’toleration.

关 键 词：羧甲基壳聚糖 亚慢性全身毒性 植入剂量 

分 类 号：R318.08[医药卫生—生物医学工程]