Residual chemicals that are presented during tissue processing in human tissue banks can be a risk for the allograft recipient. Determine the residual concentrations of the antibiotics and detergent used in the process of human decellularized tissue-engineered heart valves stored in isotonic saline solution up to 18 months. A total of 24 human decellularized allografts were stored in sterile sodium chloride and analyzed immediately after the decellularization process (0 months) and after storage for 6, 12, and 18 months, which includes the use of sodium dodecyl sulfate (SDS) and antibiotics (cefoxitin, vancomycin hydrochloride, lincomycin hydrochloride, polymyxin B sulfate). These valves were used for suitability tests, the zone of inhibition evaluation, and direct contact cytotoxicity assay. The stock solution from 32 valves was used for LC–MS/MS analysis of antibiotics and SDS. Tissue samples from decellularized valves showed a zone of inhibition formation for S. aureus and B. subtilis, suggesting the presence of an inhibitory molecule in the tissue. Cytotoxicity tests were negative. Polymyxin B, vancomycin, and SDS were detected and quantified in human decellularized aortic and pulmonary allografts during all periods of the study. There were no traces of residual cefoxitin and lincomycin in the tissue stock solution. We found residual concentrations of the antibiotics and detergent used in the process of human decellularized tissue-engineered heart valves stored in isotonic saline solution up to 18 months.

人体组织库中组织处理过程中出现的残留化学物质可能会给同种异体移植受体带来风险。确定储存在等渗盐水溶液中长达 18 个月的人类脱细胞组织工程心脏瓣膜过程中使用的抗生素和清洁剂的残留浓度。将总共​​ 24 个人类脱细胞同种异体移植物储存在无菌氯化钠中，并在脱细胞过程（0 个月）和储存 6、12 和 18 个月后立即进行分析，其中包括使用十二烷基硫酸钠（SDS）和抗生素（头孢西丁、盐酸万古霉素、盐酸林可霉素、硫酸多粘菌素 B)。这些阀门用于适用性测试、抑菌圈评估和直接接触细胞毒性试验。来自 32 个阀门的储备溶液用于抗生素和 SDS 的 LC-MS/MS 分析。来自脱细胞瓣膜的组织样本显示抑制区形成S. aureus和B. subtilis，表明组织中存在抑制性分子。细胞毒性试验呈阴性。在研究的所有时期，多粘菌素 B、万古霉素和 SDS 在人类脱细胞主动脉和肺同种异体移植物中被检测和量化。组织原液中没有残留头孢西丁和林可霉素的痕迹。我们发现在人类脱细胞组织工程心脏瓣膜过程中使用的抗生素和清洁剂的残留浓度在等渗盐水溶液中储存长达 18 个月。