同种异体及异种组织修复材料:如何选用适宜的病毒灭活工艺

Allogeneic and xenogeneic tissue repair materials:how to choose a suitable virus inactivation process

背景:为降低医用生物源性组织修复材料感染病毒的风险,确保材料的安全性,在材料制备过程中病毒灭活工序显得尤为重要。目的:阐述同种异体及异种组织修复材料生产过程中的病毒灭活工艺。方法:通过计算机检索PubMed、Elsevier、中国知网、万方数据等数据库中发表的相关文献,英文检索词为"Allogeneic,Xenogeneic,Viral inactivation,Tissue repair biomaterial",中文检索词为"同种异体、异种、病毒灭活、消毒、组织材料",发表时间不限。结果与结论:病毒灭活方法会对生物材料性能造成不同程度的损害,如:热灭活法可能对热敏感材料的性能带来永久性破坏;γ射线照射可能会造成材料力学性能和生物活性物质丧失;酸/碱法对部分不耐受酸、碱材料的性能和结构也可能造成破坏;环氧乙烷、过氧乙酸、过氧化氢等试剂残留对机体造成刺激甚至带入致癌、致畸物质。因此企业和研究机构在选择病毒灭活工序时,应同时考虑该工序对病毒的杀灭效果和对材料性能的损害程度,尽可能采用现有生产工艺进行病毒灭活验证。

BACKGROUND: A proper virus inactivation procedure of medical bio-derived tissue repair material is very important to reduce the risk of virus infection and ensure the safety in the therapeutic process. OBJECTIVE: To elaborate different virus inactivation methods of allogeneic and xenogeneic tissue repair materials. METHODS: PubMed, Elsevier, CNKI, and WanFang databases were searched for relevant articles using the keywords of “allogeneic, xenogeneic, viral inactivation, disinfection, tissue repair biomaterial” in English and Chinese, respectively. RESULTS AND CONCLUSION: Virus inactivation methods can damage the performance of biological materials to different extents. For example, heat inactivation may produce permanent damage to the performance of heat-sensitive materials;γ-ray irradiation may result in the loss of mechanical properties and biologically active substances;acid/alkali method may also destroy the properties and structure of some materials intolerant to acid and alkali corrosion;and some reagent residues such as ethylene oxide, peracetic acid, and hydrogen peroxide may produce irritation to the body and even cause carcinogenic and teratogenic substances. Therefore, in enterprises and research institutions, the virus-killing effect and severity of damage to the material performance should be considered when the virus inactivation process is selected, and the use of existing production processes to verify the virus inactivation is recommended as much as possible.