摘要
目的通过建立拓扑网络模型实现对高风险药品辅料的快速筛选,为监管部门重点监测与日常检查提供数据支持。方法采用Cytoscape软件建立中药注射剂-辅料拓扑网络模型,并利用某省2004年1月1日至2015年6月30日收到的涉及中药注射剂的药品不良反应报告数据对模型可行性进行检测。结果中药注射剂-辅料网络拓扑结果显示,聚山梨酯80、甘油、维生素C、亚硫酸氢钠等辅料具有较高的潜在致敏性,其中聚山梨酯80、甘油、维生素C的高风险性已被实验研究证实。结论利用拓扑网络模型对辅料进行风险评估具有一定的可行性,可以减少相关部门检查研究投入,提高风险物质筛选效率。
Objective To establish a network topology model for rapid screening of high-risk pharmaceutical excipients, in order to provide data to support regulatory monitoring and routine inspection. Methods Established network model of the Chinese medicine injection-Accessories topology by Cytoscape software, and detected it by using ADR reporting data related TCM injections from January 1, 2004 to June 30, 2015. Results The traditional Chinese medicine injection-Accessories Network topology results showed, polylobate 80, glycerin, vitamin C, sodium hydrogen sulfite materials had a high potential allergenicity, wherein polylobate 80, glycerin, vitamin C had been confirmed experimentally for high risk. Conclusion The use of the network topology model for materials risk assessment is feasible, which can reduce the relevant departments to check research investment and increase the efficiency of screening for high risk substance.
出处
《中国药物警戒》
2017年第1期49-53,共5页
Chinese Journal of Pharmacovigilance
关键词
药品
网络拓扑
风险评估
相关物质
drug
network topology
risk assessment
related substance
