人工生物瓣抗钙化性能检测中阳性对照样品限值的研究  

Study on limits of positive controls in biological valve anti-calcification test

作　　者：付海洋[1] 于秋航 杨柳 王召旭[1] 陈丹丹[1] 付步芳[1] FU Hai-yang;YU Qiu-hang;YANG Liu;WANG Zhao-xu;CHEN Dan-dan;FU Bu-fang(National Institute of Food and Drug Control(NIFDC),Bejing 102629;Yantai University,Yantai 264005,Shandong,China)

机构地区：[1]中国食品药品检定研究院,北京10262 [2]烟台大学,山东烟台264005

出　　处：《生物医学工程与临床》2022年第5期545-548,共4页Biomedical Engineering and Clinical Medicine

基　　金：国家重点研发计划资助项目(2020YFC1107901)。

摘　　要：目的 探索大鼠皮下检测生物瓣抗钙化性能实验中阳性对照样品的限值范围。方法 阳性对照样品为来自不同厂家12批次未经抗钙化工艺处理的牛或猪心包材料。SPF级3周刚断乳Wistar雄性大鼠384只,体质量45~55 g。将12批次384个阳性对照样品植入SPF级3周刚断乳Wistar雄性大鼠背部,8周后取材。干燥至恒质量后用火焰原子分光光度法检测样品的钙含量,运用统计分析的方法分析阳性对照样品钙含量数据及其分布特征,并计算出阳性对照样品钙含量的95%参考区间。结果 384个阳性对照样品钙含量最大值29.8%,最小值6.3%,极差23.5%,分组数20,分组组距1.1,均值19.6%,标准差4.3%,符合正态分布,钙含量95%参考区间为11%~28%。结论 建议应用大鼠皮下植入模型以阳性对照8周时钙含量11%为可接受的最低限。Objective To explore limit range of positive control in anti-calcification test of biological valve using rat subcutaneous implantation model. Methods Positive control samples were 12 batches bovine or porcine pericardial materials without anti calcification treatment from different manufacturers, which were implanted into the back of 384 SPF grade 3-week weaned male Wistar rats(body mass of 45-55 g). The samples were taken after 8 weeks, dried to constant mass and calcium content of samples was detected by flame atomic spectrophotometry. The distribution characteristics of positive control sample calcium content data were analyzed by statistical analysis method, and the 95 % reference interval of calcium content in positive control group was calculated. Results The maximum value of calcium content in 384 positive controls was 29.8 %, the minimum value was 6.3 %, the range was 23.5 %, the number of groups was 20, group distance was 1.1, mean value was19.6 %, and standard deviation was 4.3 %, which conformed to normal distribution. The 95 % reference interval of calcium content was 11 %-28 %. Conclusion It is demonstrated that 11 % calcium content in positive control at 8-week is the acceptable minimum value in rat subcutaneous implantation model, so as to control the reliability of experimental system.

关 键 词：生物瓣 抗钙化 参考区间 阳性对照 

分 类 号：R318.08[医药卫生—生物医学工程]