Research on Risk Assessment Methods of Drug Accessories Based on the Network Topology

Abstract

Abstract: 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.

Key words: drug, network topology, risk assessment, related substance

CLC Number:

R994.11

SUN Yi-yuan, WEI Fen-fang, YANG Yue. Research on Risk Assessment Methods of Drug Accessories Based on the Network Topology[J]. Chinese Journal of Pharmacovigilance, 2017, 14(1): 49-53.

References

[1] 赵研,陈丽娜.基于功能一致性和网络拓扑属性预测冠心病致病基因[J]. 生物化学与生物物理进展, 2009, 36(6):781-786.
[2] 王宏,曲晓莉,赵研,等.基于表达及网络拓扑结构挖掘动脉粥样硬化风险疾病基因[J]. 生物化学与生物物理进展, 2010,37(8): 916-922.
[3] 郭浩. 抑郁症静息态功能脑网络异常拓扑属性分析及分类研究[D].太原理工大学, 2013.
[4] 李钦,赵吟,郑晓亮,等.药用注射辅料聚山梨酯80诱发类过敏反应的细胞研究[J]. 中国临床药理学与治疗学, 2011, 16(5):501-505.
[5] 程柏淇. 维生素C对异氟醚引起的细胞毒性及认知功能损伤的作用研究[D].吉林大学, 2015.
[6] 彭琳,刘雁鸣,龙海燕,等. GC-MS法对药用辅料1,2-丙二醇未知杂质的定性研究[J]. 中国药师, 2013, 16(12):1817-1819.
[7] 吕秋军,曹萍. 药用辅料的ADR及其安全性管理[J]. 药物ADR杂志, 2010, 12(6):410-414.
[8] 袁海玲,谢华,陈玉芳,等. 关注含辅料乙醇药品的临床合理用药[J]. 解放军药学报, 2016, 32(1):88-90.
[9] 李钦,赵吟,郑晓亮,等. 药用注射辅料聚山梨酯80诱发类过敏反应的细胞研究[J]. 中国临床药理学与治疗学, 2011, 16(5):501-505.
[10] 孙会敏,杨锐,栾琳,等. 聚山梨酯80质量分析与致敏原探究[J].药物分析杂志, 2011, 31(10):1850-1855.
[11] 吕秋军,曹萍. 药用辅料的不良反应及其安全性管理[J]. 药物不良反应杂志, 2010, 12(6):410-414.
[12] 廖彬,刘雁鸣,龙海燕,等. GC-MS法对药用辅料甘油中未知杂质的研究[J]. 中国药师, 2013, 16(11):1684-1686.
[13] 凌云,张沂. 从二甘醇事件看药用辅料的重要性[J]. 海军总医院学报, 2007, 20(4):228-230.
[14] 谢华,袁海玲,陈玉芳,等. 含辅料注射剂的临床合理用药[J].中国现代应用药学, 2016, 33(4):488-492.
[15] 林鸿恩. 依地酸二钠钙过敏性休克一例报告[J]. 劳动医学,1992,9(1):40.
[16] 张美玉. 静脉用鱼腥草注射剂致敏性评价和比较药理学研究[D].中国中医科学院, 2010.