一种新型生物止血流体膜的生物相容性评价

Evaluation of biocompatibility of a new type of biofluid hemostatic membrane

目的:对一种新型生物止血流体膜从体外细胞毒性和在体皮肤致敏性两方面进行生物相容性评价。方法:将20只豚鼠分为3组,分别为试样组(10只)、阴性对照组(5只)和阳性对照组(5只);采用生物止血流体膜与小鼠成纤维细胞(L-929)间接接触的琼脂扩散试验,在染毒24 h后,评判试样的褪色指数和溶解指数,并根据细胞反应评价试样的体外细胞毒性。制备生物止血流体膜的浸提液,采用最大剂量法试验评价试样对豚鼠的皮肤致敏性。激发后24 h和48 h,根据标准对激发部位皮肤红斑和水肿的反应进行评分并计算致敏率,对试样引起豚鼠产生皮肤致敏的潜在可能作出评价。结果:生物止血流体膜经琼脂扩散,对L-929细胞染毒24 h后,细胞形态正常,贴壁生长良好,胞质内有离散颗粒,可见少量细胞圆缩和悬浮死细胞,细胞间可见间隙,细胞反应为1级,呈现轻度细胞毒性;在激发结束后的各个观察时间点,试样组豚鼠皮肤红斑和水肿记分均为0,未显示有引起皮肤致敏的潜在可能性。结论:在当前试验条件下该生物止血流体膜有良好的体外细胞相容性和体内免疫相容性。

Objective:To evaluate the biocompatibility of a new type of biofluid hemostatic membrane in terms of in vitro cytotoxicity and in vivo skin sensitization.Methods:Twenty guinea pigs were divided into the sample group(n=10),the negative control group(n=5),and the positive control group(n=5).The agar diffusion test that using the biofluid hemostatic membrane in indirect contact with mouse fibroblasts(L-929)was used toevaluatethe discoloration index and lysis index of the sample after 24 hoursof exposure,and the in vitro cytotoxicity of the sample was evaluated according to the response of the cells.An extract of the biofluid hemostatic membrane was prepared,and the maximum dose method test was used to evaluate the sensitization of the sample to the skin of guinea pigs.After 24 and 48 hoursof stimulation,the skin erythema and edema response at the stimulation site was scored and the sensitization rate was calculated,and the potential for skin sensitization of the guinea pig caused by the sample was evaluated.Results:After 24 hours of exposure to the biofluid hemostatic membrane,the morphology was normal and adherent growth was goodof the L-929 cells.There were discrete particles in the cytoplasm.A small amount of cell shrinkage and dead cells were seen.Theintercellular space could be clearly seenbetween the cells,and the cell reaction was level 1,showed mild cytotoxicity.At each observation time point after the stimulation,the skin erythema and edema scores of the sample group were 0,showed no potential to cause skin sensitization.Conclusion:Under the current test conditions,the biofluid hemostatic membrane has good cell compatibility in vitro and immunocompatibility in vivo.