本文選題：膠原 + 免疫原性��； 參考：《中國(guó)藥品生物制品檢定所》2008年碩士論文

【摘要】： 膠原材料經(jīng)常應(yīng)用于瓣膜、支架、組織修復(fù)等與人體重要部位接觸的體內(nèi)、體外用途,因此使用過(guò)程中是否會(huì)對(duì)人體的免疫系統(tǒng)產(chǎn)生影響是這類(lèi)產(chǎn)品應(yīng)用于臨床的一項(xiàng)重要安全性指標(biāo)。雖然國(guó)家對(duì)此類(lèi)產(chǎn)品提出了免疫原性檢測(cè)的要求,可是到目前為止還沒(méi)有檢測(cè)此類(lèi)產(chǎn)品的具體方法。ASTM相關(guān)標(biāo)準(zhǔn)以及ISO10993—20等一些材料致免疫毒性評(píng)價(jià)實(shí)驗(yàn)有關(guān)的指導(dǎo)原則中也只是給出一些大概的指導(dǎo)和推薦,沒(méi)有給出實(shí)驗(yàn)所需具體方法。因此,對(duì)于試驗(yàn)方法的研究就成了一項(xiàng)緊迫的任務(wù)。 在免疫原性評(píng)價(jià)實(shí)驗(yàn)方法探索中,陽(yáng)性和陰性對(duì)照物對(duì)試驗(yàn)方法的準(zhǔn)確性和可行性起著標(biāo)指作用,因此陽(yáng)性對(duì)照物的選擇是研究的一個(gè)重要組成部分。免疫原性的檢測(cè)可以分為細(xì)胞免疫和體液免疫兩個(gè)部分,本文對(duì)ASTM相關(guān)標(biāo)準(zhǔn)中推薦的陽(yáng)性對(duì)照物BSA作為膠原類(lèi)醫(yī)療器械產(chǎn)品免疫原性檢測(cè)細(xì)胞免疫以及體液免疫陽(yáng)性對(duì)照物的可行性分別作以研究,具體對(duì)其使用劑量,免疫周期及次數(shù)以及免疫效果的檢測(cè)方法進(jìn)行了研究。 另外,本文還以交聯(lián)和未交聯(lián)兩種膠原植入劑為實(shí)驗(yàn)材料,對(duì)材料免疫原性檢測(cè)的檢測(cè)方法進(jìn)行了研究。細(xì)胞免疫方面進(jìn)行了淋巴細(xì)胞增殖實(shí)驗(yàn),流式細(xì)胞術(shù)實(shí)驗(yàn),體液免疫方面進(jìn)行了Ig6,IgM,以及小鼠抗豬Ⅰ型膠原抗體的檢測(cè),另外還進(jìn)行了臟器系數(shù)分析,以及病理切片染色分析。通過(guò)這些實(shí)驗(yàn)數(shù)據(jù)來(lái)分析材料使用劑量,免疫周期、次數(shù)的影響,評(píng)價(jià)實(shí)驗(yàn)用材料的免疫原性,以及初步探索免疫原性檢測(cè)中比較可行且穩(wěn)定可靠的檢測(cè)指標(biāo)。
[Abstract]:Rubber raw materials are often used in valves, scaffolds, tissue repair and other important parts of the human body contact in vivo, in vitro use, Therefore, whether the use of such products will have an impact on the immune system is an important safety index for the clinical application of these products. Although the country has put forward the requirement of immunogenicity test for this kind of product, However, so far, there are no specific methods for testing such products. ASTM related standards, and some materials such as ISO 10993-20 and other materials related to the evaluation of immunotoxicity test guidelines are also given some general guidance and recommendations. No specific method is given for the experiment. Therefore, the study of experimental methods has become an urgent task. In the exploration of immunogenicity evaluation methods, positive and negative controls play a role in marking the accuracy and feasibility of the test methods, so the selection of positive controls is an important part of the study. The detection of immunogenicity can be divided into two parts: cellular immunity and humoral immunity. In this paper, the feasibility of positive control material BSA recommended in ASTM as immunogenicity test of collagen medical device products for cellular immunity and humoral immunopositive control was studied, and the specific dosage of BSA was used. The detection methods of immune cycle and times and immune effect were studied. In addition, two kinds of collagen implants, crosslinked and uncrosslinked, were used as experimental materials to detect the immunogenicity of the materials. Lymphocyte proliferation test, flow cytometry test, humoral immunity test were carried out to detect Ig6 IgM and mouse anti type I collagen antibody in cell immunity, organ coefficient analysis and pathological section staining were also carried out. These experimental data were used to analyze the effects of dosage, immune cycle and times of material use, to evaluate the immunogenicity of experimental materials, and to preliminarily explore the feasible and reliable indicators for the detection of immunogenicity.
【學(xué)位授予單位】：中國(guó)藥品生物制品檢定所
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2008
【分類(lèi)號(hào)】：R392

【引證文獻(xiàn)】

相關(guān)期刊論文 前1條

1 佟剛;雷靜;鐘翠紅;蔡偉信;林雪微;;不同pH與蛋白含量的膠原海綿植入缺損骨組織部位的療效及安全性考察[J];生物醫(yī)學(xué)工程學(xué)雜志;2012年06期

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本文編號(hào)：2069595