抗感染重组合异种骨的生物相容性研究

目的 检测抗感染重组合异种骨（ARBX）产品的生物相容性,确保ARBX产品在临床上安全、有效。方法 根据卫生部制定的《生物材料和制品的生物学评价标准》及《相关生物材料和制品的企业标准 Q/JGY001-94》,进行了ARBX急性毒性试验、过敏性试验、熟原试验、骨内埋植试验、肌内埋植试验、溶血试验及细胞毒性试验。结果ARBX未引起小鼠急性毒性反应、豚鼠过敏反应及家兔热原反应。在兔骨内和小鼠肌内埋植,既未产生纤维包膜,也未引起淋巴细胞及炎性细胞浸润。对家兔红细胞溶血率为1.2％,无溶血现象。体外细胞毒性反应指标R=0.25/0,无细胞毒性。结论ARBX的生物相容性符合国家规定的生物材料和制品的生物学标准及企业标准,可试用于临床治疗相关疾病。

Biocompatibility of Anti-infectious Reconstituted Bone Xenograft

Objective To detect the biocompatibility of anti-infectious recombinant bone xenograft (ARBX) and ensure the safety and effectiveness of the pioduct in clinical application. Methods The acute toxicity,hypersensitivity,pyrogen, intraosseous and intramuscular implantation, as well as hemolysis and cyto-toxicity tests were performed on ARBX according to the requirements given in Biological Standards for Biomate-rials and Bioproducts and Business Standards of Relevant Biomaterials and Bioproducts Q/JGY001-94 both issued by The Ministry of Public Health. Results ARBX induced no acute toxicity in mice, allergic reaction in guinea pigs or pyrogen reaction in rabbits. The intraosseous implantation of it in rabbits or intramuscular implantation in mice induced no fibrous capsule formation or lymphocyte or inflammatory cell infiltration. The percentage of erythrocyte hemolysis in rabbit was 1.2% ,and the in vitro cytotoxic index was 0.25% . Conclusion The biocompatibility of ARBX met the requirements in above-mentioned two Standards. It indicated that the ARBX could be used for clinical trial.