生物降解左旋-18甲基长效避孕埋植剂载体材料的生物相容性研究  

Study on Biocompatibilities of Poly(ε-caprolactone-b-DL lactide) for Biodegradable Long-Acting Contraceptive Implant Releasing Levonorgestrel.

作　　者：顾忠伟 丁训诚 杨纪元 杜福胜 谷昭 朱蓬弟 

机构地区：[1]国家计划生育委员会科学技术研究所,北京100081 [2]上海市计划生育科学技术研究所

出　　处：《中国计划生育学杂志》1997年第3期135-141,共7页Chinese Journal of Family Planning

基　　金：国家计生委资助的"八五"国家重点攻关课题

摘　　要：采用生物降解的嵌段型聚己内酯丙交酯(CL-b-LA)高分子材料为载体制成的左旋-18甲长效避孕埋植剂是一种新型的皮下埋植剂。为尽快在临床推广使用,按照中国药品生物制品鉴定所等单位制定的标准对这一材料进行了详细的生物相容性研究,包括皮肤刺激试验、皮肤致敏试验、体外溶血试验、急性毒性试验、细胞毒性试验、鼠伤寒沙门氏菌回复突变试验-Ames试验、哺乳动物培养细胞染色体畸变试验、小鼠骨髓多染红细胞微核试验、致畸胎试验和肌内长期埋植试验等。所有结果表明,生物降解左旋-18甲长效避孕埋植剂载体材料CL-b-LA是可以植入体内的,无任何毒副作用的,具有良好生物相容性的医用高分子材料。Biodegradable long-acting contraceptive implant releasing levonorgestrel is a new type of sub-dermal implant. Block copolymer of ε-caprolactoneand DL--lactide, CL-b-LA, is used as drug carriermaterial of the implant. In order to develop thebiodegradable levonorgestrel subdermal implant intoclinical trial,a serial of biocompatible tests of thematerial was conducted, including skin irritationtest,skin sensitivity test,hemolysis test,systemic a-cute toxicity test, cell toxicity test, dominant lethaltest of styphimurium in mice-Ames test, chromo-some aberration assay in mammalian cell culture,micronecleus test of polychromatic erythrocytes ofmarrow in mice,teratogenicity test and test of long-term implantation in muscle. All results of the testsshowed that the biodegradable block copolymer ofε--caprolactone and DL--lactide is a nontoxic biomedical polymer material, causes, no side-effects andwith good biocompatibility when used as a contra-ceptive implant.

关 键 词：生物降解 长效 避孕埋植剂 生物相容性 载体材料 

分 类 号：R979.21[医药卫生—药品] R169.41[医药卫生—药学]