北京生物医学工程

一种眼巩膜生物补片的制备及生物相容性研究

Preparation and biocompatibility of an ocular sclera biologicalpatch

作者：柳小军周小婷周静张峻梓刘康博周岩徐玉茵王君敏

单位：河南省医疗器械检验所（河南省医疗器械检验检测工程技术研究中心）（郑州450000） 郑州大学（郑州  450000） 通信作者：王君敏，讲师。E-mail: wangjunmin@zzu.edu.cn

分类号：R318.08

出版年·卷·期（页码）：2021·40·5（447-454）

摘要：

目的制备一种适用于眼后巩膜加固术的新型生物补片，通过对其生物相容性进行研究，评价其生物安全性。方法首先采用新鲜的牛心包经去除表面脂肪组织、脱细胞、扩孔和梳整后，与京尼平进行生物交联，制备出一种眼巩膜生物补片。然后进行体外细胞毒性试验、溶血试验、皮内反应试验、皮肤致敏试验、急性全身毒性试验和植入试验，通过检测细胞存活率、溶血率、皮内反应记分、皮肤致敏反应等级、毒性反应和植入刺激指数分析眼巩膜生物补片的生物相容性。结果眼巩膜生物补片无细胞毒性反应、无潜在的动物皮内刺激和肌肉刺激作用、无皮肤致敏性和无急性全身毒性反应；溶血率符合要求。结论通过扩孔和梳整工艺等技术所制备的眼巩膜生物补片具有良好的生物相容性，符合国家相关标准要求，为其在临床上眼后巩膜加固术中的安全应用提供参考。

Objective To prepare a new biological patch suitable for scleral reinforcement of posterior eyes and evaluate its biological safety by studying its biocompatibility. Methods With fresh bovine pericardium as raw material, after removing surface adipose tissue, acellular treatment, reaming and mask comb combing, one kind of ocular sclera biological patch was developed through biological cross-linking with Genipin. Then the in vitrocytotoxicity, hemolysis test, intradermal reaction test, skin sensitization test, cute systemic toxicity and implantation test were performed and the biocompatibility of eye sclera patches was analyzed by detecting the cell survival rate, the hemolysis rate, intradermal reaction score, skin sensitization reaction level, toxic reaction and stimulated index. Results There was no cytotoxicity, potential intracutaneous irritation and muscle stimulation, skin sensitization or acute systemic toxicity in the ocular sclera biological patch. Moreover, the hemolysis rate met the requirements. Conclusions The ocular scleral biological patch prepared with pore broadening and combing techniques has good biocompatibility and conforms to relevant national standards, providing a reference for its safe application in clinical scleral reinforcement.

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