北京生物醫(yī)學(xué)工程

一種眼鞏膜生物補(bǔ)片的制備及生物相容性研究

Preparation and biocompatibility of an ocular sclera biologicalpatch

作者：柳小軍周小婷周靜張峻梓劉康博周巖徐玉茵王君敏

單位：河南省醫(yī)療器械檢驗(yàn)所（河南省醫(yī)療器械檢驗(yàn)檢測(cè)工程技術(shù)研究中心）（鄭州450000） 鄭州大學(xué)（鄭州  450000） 通信作者：王君敏，講師。E-mail: [email protected]

關(guān)鍵詞：組織工程；生物補(bǔ)片材料；牛心包；毒性反應(yīng)；生物相容性

分類號(hào)：R318.08

出版年·卷·期（頁(yè)碼）：2021·40·5（447-454）

摘要：

目的制備一種適用于眼后鞏膜加固術(shù)的新型生物補(bǔ)片，通過(guò)對(duì)其生物相容性進(jìn)行研究，評(píng)價(jià)其生物安全性。方法首先采用新鮮的牛心包經(jīng)去除表面脂肪組織、脫細(xì)胞、擴(kuò)孔和梳整后，與京尼平進(jìn)行生物交聯(lián)，制備出一種眼鞏膜生物補(bǔ)片。然后進(jìn)行體外細(xì)胞毒性試驗(yàn)、溶血試驗(yàn)、皮內(nèi)反應(yīng)試驗(yàn)、皮膚致敏試驗(yàn)、急性全身毒性試驗(yàn)和植入試驗(yàn)，通過(guò)檢測(cè)細(xì)胞存活率、溶血率、皮內(nèi)反應(yīng)記分、皮膚致敏反應(yīng)等級(jí)、毒性反應(yīng)和植入刺激指數(shù)分析眼鞏膜生物補(bǔ)片的生物相容性。結(jié)果眼鞏膜生物補(bǔ)片無(wú)細(xì)胞毒性反應(yīng)、無(wú)潛在的動(dòng)物皮內(nèi)刺激和肌肉刺激作用、無(wú)皮膚致敏性和無(wú)急性全身毒性反應(yīng)；溶血率符合要求。結(jié)論通過(guò)擴(kuò)孔和梳整工藝等技術(shù)所制備的眼鞏膜生物補(bǔ)片具有良好的生物相容性，符合國(guó)家相關(guān)標(biāo)準(zhǔn)要求，為其在臨床上眼后鞏膜加固術(shù)中的安全應(yīng)用提供參考。

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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