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  本文選題：膠原 + 免疫原性�。� 參考：《中國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,因此使用過程中是否會對人體的免疫系統(tǒng)產(chǎn)生影響是這類產(chǎn)品應(yīng)用于臨床的一項重要安全性指標(biāo)。雖然國家對此類產(chǎn)品提出了免疫原性檢測的要求,可是到目前為止還沒有檢測此類產(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價實驗有關(guān)的指導(dǎo)原則中也只是給出一些大概的指導(dǎo)和推薦,沒有給出實驗所需具體方法。因此,對于試驗方法的研究就成了一項緊迫的任務(wù)。 在免疫原性評價實驗方法探索中,陽性和陰性對照物對試驗方法的準(zhǔn)確性和可行性起著標(biāo)指作用,因此陽性對照物的選擇是研究的一個重要組成部分。免疫原性的檢測可以分為細胞免疫和體液免疫兩個部分,本文對ASTM相關(guān)標(biāo)準(zhǔn)中推薦的陽性對照物BSA作為膠原類醫(yī)療器械產(chǎn)品免疫原性檢測細胞免疫以及體液免疫陽性對照物的可行性分別作以研究,具體對其使用劑量,免疫周期及次數(shù)以及免疫效果的檢測方法進行了研究。 另外,本文還以交聯(lián)和未交聯(lián)兩種膠原植入劑為實驗材料,對材料免疫原性檢測的檢測方法進行了研究。細胞免疫方面進行了淋巴細胞增殖實驗,流式細胞術(shù)實驗,體液免疫方面進行了Ig6,IgM,以及小鼠抗豬Ⅰ型膠原抗體的檢測,另外還進行了臟器系數(shù)分析,以及病理切片染色分析。通過這些實驗數(shù)據(jù)來分析材料使用劑量,免疫周期、次數(shù)的影響,評價實驗用材料的免疫原性,以及初步探索免疫原性檢測中比較可行且穩(wěn)定可靠的檢測指標(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】：中國藥品生物制品檢定所
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2008
【分類號】：R392

【引證文獻】

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：2069595