复合水凝胶人工角膜裙边支架材料的生物相容性评价

Biocompatibility of a hydrogel skirt scaffold in artificial cornea

背景:β-磷酸三钙/聚乙烯醇复合水凝胶具有高含水量、良好柔软性优点,有利于成纤细胞生长及胶原沉积,适用于做人工角膜裙边支架材料。目的:评价β-磷酸三钙/聚乙烯醇复合水凝胶人工角膜裙边支架材料的生物相容性。方法:①迟发型超敏反应:在豚鼠脊柱两侧皮内由头到尾分别注射A液(完全弗氏佐剂与生理盐水等体积混合液)、B液(β-磷酸三钙/聚乙烯醇复合水凝胶浸提液或生理盐水或2-巯基苯并噻唑)、C液(A液与B液等体积混合稳定性乳化剂),并进行局部诱导及激发。②急性全身性毒性实验:由昆明小鼠尾静脉分别注射生理盐水与β-磷酸三钙/聚乙烯醇复合水凝胶浸提液。③体外细胞毒性实验:分别以β-磷酸三钙/聚乙烯醇复合水凝胶浸提液、细胞培养液及含苯酚的细胞培养液培养MRC-5细胞。④皮内反应:在兔脊柱皮内分别注射β-磷酸三钙/聚乙烯醇复合水凝胶生理盐水(或芝麻油)浸提液、生理盐水及芝麻油。结果与结论:β-磷酸三钙/聚乙烯醇复合水凝胶人工角膜裙边支架材料的迟发型超敏反应分级为0-1级,急性全身毒性实验结果为正常无症状,体外细胞毒性均为0级或1级,皮内反应为极轻微。表明β-磷酸三钙/聚乙烯醇复合水凝胶人工角膜裙边支架材料生物相容性指标达到生物植入医用材料的要求。

BACKGROUND： Beta-tricalcium phosphate/poly （vinyl alcohol） hydrogel （13-TCP/PVA-H） composite is a material with high water content, good softness, which is beneficial to the fibroblasts growth and collagen deposition.OBJECTIVE： To study the biocompatibility of β-TCP/PVA-H composite as an artificial cornea skirt material.METHODS： Delayed-type hypersensitivity： Both sides of the spinal skin of the guinea pig from beginning to end were injected with A solution （the mixture of complete Freund＇s adjuvant and normal saline）, B solution （extraction of β-TCP/PVA-H composite or normal saline or 2-Mercaptobenzothiazole）, C solution （mixture of A and B solutions at equal volume）, followed by local induction and inspire. The acute systemic toxicity test： Kunming mouse tail vein was injected with normal saline and 13-TCP/PVA-H composite extraction. In vitro cytotoxicity assays： MRC-5 cells were cultured by β-TCP/PVA-H composite extraction, cell culture medium and phenol-containing cell culture medium.Intradermal reaction： The extracts of β-TCP/PVA-H composite, normal saline was injected intradermally into the rabbit spine by normal saline （or sesame oil）, normal saline and sesame oil,RESULTS AND CONCLUSION： The biocompatibility experiments of ^-TCP/PVA-H composite showed that delayed-type hypersensitivity was graded 0-1, acute systemic toxicity test showed no symptoms, in vitro cytotoxicity was graded 0 or 1, and skin irritations were very slight. The experiments are agreed with the relative national standards, and β-TCP/PVA-H composite skirt as artificial cornea scaffold is a qualified medical material.