球囊式中空赝复体用硅橡胶的生物安全性研究

发布时间：2018-05-13 10:20

本文选题：硅橡胶 + 赝复体　；参考：《华西口腔医学杂志》2014年06期

【摘要】：目的初步评价球囊式中空赝复体用硅橡胶(SRISP)的生物安全性,为后期临床应用提供依据。方法参照国家标准GB/T 16886.10—2005、YY/T 0127.13—2009和GB/T 16886.11—2011规定的方法,采用最大剂量致敏试验、口腔黏膜刺激试验以及短期全身毒性试验(经口途径)评价SRISP的体内生物安全性。结果最大剂量致敏试验:豚鼠腹部移去敷贴24、48、72 h后,无红斑、水肿,致敏率为0,SRISP无潜在致敏性;口腔黏膜刺激试验:金黄地鼠缝合部位黏膜未见出血、肿胀,组织学观察未出现病理性改变,SRISP无口腔黏膜刺激性;短期全身毒性试验:大鼠未见临床毒性体征,体重稳定增长,灌胃前后实验组和对照组大鼠体重与体重相对增长率差异无统计学意义(P0.05),SRISP无短期全身毒性。结论经动物实验表明SRISP具有良好的体内生物安全性,有望用于制作赝复体以修复颌骨缺损。
[Abstract]:Objective to evaluate the biological safety of silicone rubber (SRISP) for balloon hollow prosthesis. Methods according to the national standard GB/T 16886.10-2005 YY / T 0127.13-2009 and GB/T 16886.11-2011, the biosafety of SRISP in vivo was evaluated by maximum dose sensitization test, oral mucosal stimulation test and short-term systemic toxicity test (via oral route). Results the maximum dose sensitization test showed that there was no erythema, edema and no potential sensitization rate of SRISP in guinea pigs after abdominal removal and application for 24 ~ 4872 h, and oral mucosal irritation test showed that there was no bleeding and swelling in the mucosa of golden hamster suture. No pathological changes were observed in SRISP. Short-term systemic toxicity test: no clinical toxicity signs were found in the rats and the body weight increased steadily. There was no significant difference in body weight and body weight relative growth rate between experimental group and control group before and after gastric administration. SRISP had no short-term systemic toxicity. Conclusion SRISP has good biological safety in vivo and is expected to be used in the reconstruction of maxillary defects.
【作者单位】：口腔疾病研究国家重点实验室华西口腔医院修复科(四川大学);
【基金】：四川省科技支撑计划基金资助项目(0040305301409)
【分类号】：R783.1

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