Department of Spinal Surgery, Southern Medical University Orthopedic Research Institute, Third Affiliated Hospital, Guangzhou, China.
Orthop Surg. 2009 Aug;1(3):231-7. doi: 10.1111/j.1757-7861.2009.00036.x.
To evaluate the biocompatibility of a new kind of prosthetic nucleus: a pectin/polyvinyl alcohol composite (CoPP) hydrogel.
According to Chinese national standard GB/-T16886 documents, the toxicity of the CoPP prosthetic nucleus material was examined by cytotoxicity, sensitization, Ames, mice marrow micronucleus, chromosome aberration test of mammalian cell and implantation tests.
Cell growth was similar in the CoPP culture and control groups. No significant difference was found between the CoPP culture and control groups at each time point (P > 0.05). The cell proliferation rate was greater than 100%. In accordance with the relationship between cytotoxicity to proliferation rate, it was confirmed that the cytotoxicity of CoPP was 0 grade. Mice had no allergic reaction when injected with an extract of CoPP. A reverse mutation test with Salmonella typhimurium showed that no significant effect on the number of histidine revertants of TA97, TA98, TA100 and TA102 strains after CoPP was added. The micronucleus rate in bone marrow cells was less than 5%; there was no significant difference compared with the negative control group (P > 0.05). The rate of chromosome aberration was less than 5%; no significant difference was found between the CoPP culture and the control groups. All experimental animal wounds achieved primary healing without exudation, infection or sinus formation. On macroscopic observation, no abscess or hematoma formed at the implantation site.
The CoPP prosthetic nucleus has good biocompatibility and can potentially be used as an implant material.
评价一种新型假体核的生物相容性：果胶/聚乙烯醇复合材料（CoPP）水凝胶。
根据中国国家标准 GB/T16886 文件，采用细胞毒性、致敏、Ames、小鼠骨髓微核、哺乳动物细胞染色体畸变试验和植入试验对 CoPP 假体核材料的毒性进行了检验。
CoPP 培养组与对照组细胞生长情况相似。各时间点 CoPP 培养组与对照组间均无显著差异（P＞0.05）。细胞增殖率均大于 100%。根据细胞毒性与增殖率的关系，证实 CoPP 的细胞毒性为 0 级。CoPP 提取物注射小鼠无过敏反应。用鼠伤寒沙门氏菌回复突变试验表明，CoPP 加入后对 TA97、TA98、TA100 和 TA102 菌株组氨酸回复数无明显影响。骨髓细胞微核率低于 5%；与阴性对照组相比无显著差异（P＞0.05）。染色体畸变率低于 5%；CoPP 培养组与对照组间无显著差异。所有实验动物伤口均达到一期愈合，无渗出、感染或窦道形成。宏观观察，植入部位无脓肿或血肿形成。
CoPP 假体核具有良好的生物相容性，有望作为一种植入材料。
