我们之前的研究显示玉米醇溶蛋白具有良好的生物相容性和机械特性。由玉米醇溶蛋白多孔支架制成的第一个产品——一种可吸收的骨替代物，已经通过了国家食品药品监督管理总局医疗器械的生物学评价(ISO 10993)。然而，作为一种三类医疗器械，在其进入市场前需要进行质量监控，这些监控包括原材料的质量监控、灭菌方法的选择和生物相容性的评价。在本文中，我们通过氨基酸分析(AAA) 和十二烷基硫酸钠–聚丙烯酰氨凝胶电泳(SDS-PAGE) 研究了四种玉米醇溶蛋白，来监控其组成和纯度，以控制原材料的质量。我们用SDS-PAGE 研究了三种灭菌方式对玉米醇溶蛋白多孔支架的影响，并比较了在不同γ 射线剂量下SDS-PAGE 图谱的变化。我们发现在剂量20~30 kGy 范围内，γ 射线灭菌过程中玉米醇溶蛋白的肽链没有发生断裂或聚合，这表明γ 射线灭菌对于玉米醇溶蛋白多孔支架是适用的。对于细胞相容性，我们发现使用MTT 实验和CCK-8 实验来评估玉米醇溶蛋白膜上细胞的增殖是有区别的，由于在CCK-8 实验中背景的吸光度差异较小，我们认为CCK-8 实验更为适合。

Our previous studies have shown that zein has good biocompatibility and good mechanical properties. The first product from a porous scaffold of zein, a resorbable bone substitute, has passed the biological evaluation of medical devices (ISO 10993) by the China Food and Drug Administration. However, Class III medical devices need quality monitoring before being placed on the market, and such monitoring includes quality control of raw materials, choice of sterilization method, and evaluation of biocompatibility. In this paper, we investigated four sources of zein through amino acid analysis (AAA) and sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE) in order to monitor the composition and purity, and control the quality of raw materials. We studied the effect of three kinds of sterilization method on a porous zein scaffold by SDS-PAGE. We also compared the changes in SDS-PAGE patterns when irradiated with different doses of gamma radiation. We found that polymerization or breakage did not occur on peptide chains of zein during gamma-ray (γ-ray) sterilization in the range of 20–30 kGy, which suggested that γ-ray sterilization is suitable for porous zein scaffolds. Regarding cell compatibility, we found a difference between using a 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide (MTT) assay and a cell-counting kit-8 (CCK-8) assay to assess cell proliferation on zein film, and concluded that the CCK-8 assay is more suitable, due to its low background optical density.