可吸收性材料CPP生物安全性评价  

Biological security evaluation of an absorbable CPP material

作　　者：杨团民[1] 张庆华 薛金山[1] 贺增良[1] 李毅[1] 焦宁[1] 张文[1] 

机构地区：[1]西安市红十字会医院骨科,陕西西安710054 [2]西安北环医院,陕西西安710032

出　　处：《第四军医大学学报》2006年第17期1573-1576,共4页Journal of the Fourth Military Medical University

摘　　要：目的评价CPP材料的生物安全性.方法采用聚磷酸钙(CPP)材料萃出液腹腔注射(IP)最大允许剂量,进行了该材料最大耐受量测定,并用IP最大耐受量进行了小鼠骨髓细胞微核试验、小鼠精子畸变试验、小鼠骨髓细胞染色体畸变试验、致畸试验等毒理学试验,评价其安全性;同时采用体内肌肉包埋法,观测其对对周围组织的反应,对CPP材料生物相容性进行评价.结果CPP材料萃出液的最大耐受量大于40mL/kg,最大耐受量的CPP对小鼠骨髓细胞微核率(1.36±0.27)‰,小鼠骨髓细胞染色体畸变率(1.94±0.46)%和小鼠精子畸变率(1.51±0.37)%,致畸试验畸发率(1.84±0.55)%和对照组比差异无统计学意义(P>0.05),CPP材料肌肉包埋后组织反应不明显.结论CPP材料是一种安全而理想的可吸收性生物医用材料.AIM： To evaluate the biological security of a new kind of absorbable CPP material used for internal fixation of fracture. METHODS ： Maximal tolerant dose of CPP was determined by intraperitoneal （ip） injection of its extractives to mice, and micronucleus test of bone marrow cells, spermatic aberration test, chromosomal aberration test, and teratogenic test were done by ip injection of maximal tolerant dose of CPP to evaluate its biological security. CPP intramuscular implantation was performed to observe its surrounding tissue reaction and evaluate its biological compatibility. RESULTS： Maximal tolerant dose of CPP extractives was above 40 mL/kg, and this dose did not have any obvious effects on micronucleus rate of bone marrow cells （1. 36 ± 0.27 ） ‰, chromosomal aberration rate （ 1.94 ± 0.46 ） % , spermatie aberration rate （ 1. 51 ± 0. 37 ）% and teratogenie rate （ 1.84 ± 0.55 ） % when compared with controls. CPP intramuscular implantation also did not cause obvious surrounding tissue inflammatory reaction. CONCLUSION： CPP is a new safe medical material with good tissue compatibility.

关 键 词：聚磷酸钙纤维 可吸收性植入物 毒理学 安全性 

分 类 号：R318.17[医药卫生—生物医学工程]