胶原类医疗器械产品的免疫原性研究

发布时间：2018-06-26 07:02

本文选题：胶原 + 免疫原性　；参考：《中国药品生物制品检定所》2008年硕士论文

【摘要】： 胶原材料经常应用于瓣膜、支架、组织修复等与人体重要部位接触的体内、体外用途,因此使用过程中是否会对人体的免疫系统产生影响是这类产品应用于临床的一项重要安全性指标。虽然国家对此类产品提出了免疫原性检测的要求,可是到目前为止还没有检测此类产品的具体方法。ASTM相关标准以及ISO10993—20等一些材料致免疫毒性评价实验有关的指导原则中也只是给出一些大概的指导和推荐,没有给出实验所需具体方法。因此,对于试验方法的研究就成了一项紧迫的任务。在免疫原性评价实验方法探索中,阳性和阴性对照物对试验方法的准确性和可行性起着标指作用,因此阳性对照物的选择是研究的一个重要组成部分。免疫原性的检测可以分为细胞免疫和体液免疫两个部分,本文对ASTM相关标准中推荐的阳性对照物BSA作为胶原类医疗器械产品免疫原性检测细胞免疫以及体液免疫阳性对照物的可行性分别作以研究,具体对其使用剂量,免疫周期及次数以及免疫效果的检测方法进行了研究。另外,本文还以交联和未交联两种胶原植入剂为实验材料,对材料免疫原性检测的检测方法进行了研究。细胞免疫方面进行了淋巴细胞增殖实验,流式细胞术实验,体液免疫方面进行了Ig6,IgM,以及小鼠抗猪Ⅰ型胶原抗体的检测,另外还进行了脏器系数分析,以及病理切片染色分析。通过这些实验数据来分析材料使用剂量,免疫周期、次数的影响,评价实验用材料的免疫原性,以及初步探索免疫原性检测中比较可行且稳定可靠的检测指标。
[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.
【学位授予单位】：中国药品生物制品检定所
【学位级别】：硕士
【学位授予年份】：2008
【分类号】：R392

【引证文献】