摘要
目的:对药物注射用针尖和注射器内壁加工用新型免溶剂硅油产品开展生物安全性评价。方法:在GB/T 16886系列标准方法的指导下,通过细胞毒性试验、致敏试验、皮内刺激试验、急性全身毒性试验和溶血试验全面评价免溶剂硅油产品应用于医疗器械产品的安全性。结果:在该试验条件下,试验样品细胞毒性试验结果为1级、样品检测液没有导致致敏反应、皮内刺激反应、溶血反应、小鼠死亡或引起全身毒性反应的迹象。结论:新型药物注射润滑用免溶剂硅油产品具有较高的生物安全性,将有望替代传统溶剂型硅油产品,在一次性医疗器械生产中应用。
Objective： To evaluate the biological safety of the new solvent free silicone oil products used in the needles and syringes for injection; Methods： Through cytotoxicity test, sensitization test, intradermal irritation test, acute systemic toxicity test and hemolysis test, the safety of solvent free silicone oil products used in medical instruments was evaluated under the guidance of GB/T 16886 standards; Results： Under these conditions, the cytotoxieity grade of the test sample was 1, and the sample did not lead to sensitization, intradermal stimulation, hemolysis, death of the mice or signs of systemic toxicity. Conclusion： The new solvent-free silicone oil for the lubrication of drug injection has high biological safety and will be expected to replace traditional solvent silicone oil products and be used in the disposable medical devices.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2017年第9期1710-1715,共6页
Chinese Journal of Pharmaceutical Analysis
基金
国家重点研发计划:新一代生物材料质量控制关键技术研究(2016YFC1103200)
关键词
药物注射
免溶剂硅油
医疗器械
生物安全性
drug injection
solvent-free silicone oil
medical device
biological safety
