MRI造影用钆对比剂及其专利信息分析
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摘要
核磁共振(MRI)已经用于全身各个系统的临床成像诊断,钆对比剂是MRI增强造影最常使用的一类药物,当前全球范围内MRI造影剂上市品种少,研发难度大,而且市售产品仍以前10～20年上市的钆对比剂为主。当前钆对比剂主要集中在纳米、脂质体和聚合物的研究方向,纳米类衍生物产品是当前国内科研院所的研究热点。本文选择钆喷酸葡胺进行专利分析,考察其技术演进过程和未来发展方向。了解钆喷酸葡胺的专利技术主题的申请和专利布局情况,以及目前专利申请中针对减少钆对比剂毒性的相关研究。以上可以为钆对比剂的临床使用和研发立项等工作提供参考依据。
MRI has been used in the clinical imaging diagnosis of patients' whole body,and gadolinium-based contrast agents are the most commonly used in the MRI enhanced imaging. There are few launched MRI contrast agents worldwide,and it is very difficult for the research and development of new products,so the gadolinium-based contrast agents which were launched ten or twenty years ago are now still the major products on the market.At present,the development of gadolinium-based contrast agents mainly focuses on nanometers,lipidosomes,and polymers,and the derivative nanoproduct is the research hotspot in the domestic research institutes. In this article,gadopentetate meglumine is chosen for patent analysis,to be taken a look at the evolution process of technology and the future direction of the development. The technology themes and patent layout of patent applications,and the applications for related research of reducing toxicity of gadopentetate meglumine were reviewed in the article. All of the above analysis can provide reference frame for the clinical application and initialization of research projects of gadolinium-based contrast agents.
MRI has been used in the clinical imaging diagnosis of patients' whole body,and gadolinium-based contrast agents are the most commonly used in the MRI enhanced imaging. There are few launched MRI contrast agents worldwide,and it is very difficult for the research and development of new products,so the gadolinium-based contrast agents which were launched ten or twenty years ago are now still the major products on the market.At present,the development of gadolinium-based contrast agents mainly focuses on nanometers,lipidosomes,and polymers,and the derivative nanoproduct is the research hotspot in the domestic research institutes. In this article,gadopentetate meglumine is chosen for patent analysis,to be taken a look at the evolution process of technology and the future direction of the development. The technology themes and patent layout of patent applications,and the applications for related research of reducing toxicity of gadopentetate meglumine were reviewed in the article. All of the above analysis can provide reference frame for the clinical application and initialization of research projects of gadolinium-based contrast agents.
引文
[1]李文博.磁场对去离子水和溶液冻结过程影响的试验研究[D].青岛:山东大学,2015:3-4.
[2]庞行云.氧化铁纳米粒抗心肌缺血损伤的机制探究[D].南京:东南大学,2014:7.
[3]Clarivate Analytics.Cortellis数据库[EB/OL].(2018-06-19)[2018-06-19].https://www.cortellis.com/intelligence/.
[4]刘哲,程燕南,杨健.磁共振钆对比剂体内分布与沉积研究现状[J].磁共振成像,2017,8(9):716-720.
[5]EMA.EMA's final opinion confirms restrictions on use of linear gadolinium agents in body scans[EB/OL].(2017-07-21)[2018-06-20].http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/07/news_detail_002780.jsp&mid=WC0b01 ac058004d5c1.
[6]FDA Drug Safety Communication.FDA warns that gadoliniumbased contrast agents(GBCAs)are retained in the body;requires new class warnings[EB/OL].(2017-12-19)[2018-06-20].https://www.fda.gov/Drugs/Drug Safety/ucm589213.htm.
[7]国家食品药品监督管理总局药品评价中心,国家药品不良反应监测中心.药品不良反应信息通报(第76期)关注含钆对比剂反复使用引起脑部钆沉积风险[EB/OL].(2017-12-06)[2018-08-03].http://www.cdr-adr.org.cn/xxtb_255/ypblfyxxtb/201712/t20171207_19826.html.
[8]国家食品药品监督管理总局药品评价中心国家药品不良反应监测中心.总局关于修订含钆对比剂说明书的公告(2018年第2号)[EB/OL].(2018-01-15)[2018-08-03].http://www.cdr-adr.org.cn/yxaqjs/gn/201801/t20180116_19883.html.
[9]黄璐,刘哲,许勇.新型免疫调节药来那度胺的专利技术分析[J].中国新药杂志,2016,25(21):2430-2435.
[10]人民网.“香山会议”关注分子探针技术[EB/OL].(2016-03-17)[2018-08-03].http://scitech.people.com.cn/n1/2016/0317/c1007-28206401.html.
[11]国家药品不良反应监测中心.总局提示关注含钆对比剂反复使用引起脑部钆沉积的风险[J].世界临床药物,2018,39(2):1.
[2]庞行云.氧化铁纳米粒抗心肌缺血损伤的机制探究[D].南京:东南大学,2014:7.
[3]Clarivate Analytics.Cortellis数据库[EB/OL].(2018-06-19)[2018-06-19].https://www.cortellis.com/intelligence/.
[4]刘哲,程燕南,杨健.磁共振钆对比剂体内分布与沉积研究现状[J].磁共振成像,2017,8(9):716-720.
[5]EMA.EMA's final opinion confirms restrictions on use of linear gadolinium agents in body scans[EB/OL].(2017-07-21)[2018-06-20].http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/07/news_detail_002780.jsp&mid=WC0b01 ac058004d5c1.
[6]FDA Drug Safety Communication.FDA warns that gadoliniumbased contrast agents(GBCAs)are retained in the body;requires new class warnings[EB/OL].(2017-12-19)[2018-06-20].https://www.fda.gov/Drugs/Drug Safety/ucm589213.htm.
[7]国家食品药品监督管理总局药品评价中心,国家药品不良反应监测中心.药品不良反应信息通报(第76期)关注含钆对比剂反复使用引起脑部钆沉积风险[EB/OL].(2017-12-06)[2018-08-03].http://www.cdr-adr.org.cn/xxtb_255/ypblfyxxtb/201712/t20171207_19826.html.
[8]国家食品药品监督管理总局药品评价中心国家药品不良反应监测中心.总局关于修订含钆对比剂说明书的公告(2018年第2号)[EB/OL].(2018-01-15)[2018-08-03].http://www.cdr-adr.org.cn/yxaqjs/gn/201801/t20180116_19883.html.
[9]黄璐,刘哲,许勇.新型免疫调节药来那度胺的专利技术分析[J].中国新药杂志,2016,25(21):2430-2435.
[10]人民网.“香山会议”关注分子探针技术[EB/OL].(2016-03-17)[2018-08-03].http://scitech.people.com.cn/n1/2016/0317/c1007-28206401.html.
[11]国家药品不良反应监测中心.总局提示关注含钆对比剂反复使用引起脑部钆沉积的风险[J].世界临床药物,2018,39(2):1.