新型淋巴示踪剂—示踪用盐酸米托蒽醌注射液  

A novel self-assembly lymphatic tracer——"mitoxantrone hydrochloride injection for tracing"

作　　者：郎罡 李馨颐 王淑君[3] LANG Gang;LI Xin-yi;WANG Shu-jun(Shenzhen China Resources Gosun Pharmaceuticals Co.,Ltd,Shenzhen 518049,Guangdong Province,China;Rollins School of Public Health,Emory University,Georgia 30322,US;Department of Pharmaceutics,School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 117004,Liaoning Province,China)

机构地区：[1]深圳华润九新药业有限公司,深圳广东518049 [2]埃默里大学罗琳斯公共卫生学院,美国佐治亚州30322 [3]沈阳药科大学药学院药剂学系,沈阳辽宁117004

出　　处：《中国临床药理学杂志》2024年第4期615-618,共4页The Chinese Journal of Clinical Pharmacology

基　　金：国家“十三五”重大新药创制科技重大专项成果转化。

摘　　要：规范的淋巴结清扫是恶性肿瘤根治性手术的关键,但目前国内的淋巴示踪剂选择有限。沈阳药科大学王淑君团队经过多年研发,创新性研发了全球首个生物自主装纳米晶淋巴靶向示踪剂——示踪用盐酸米托蒽醌注射液。该药经过了临床前动物研究以及Ⅰ~Ⅲ期临床研究,2021年6月在国内获批上市。目前该药已广泛应用于甲状腺癌淋巴清扫术和乳腺癌前哨淋巴结活检术中,其示踪效果和安全性得到了临床验证。本文从药物的作用机制、使用方法、有效性与安全性、药代动力学、与传统化疗药米托蒽醌的区别等方面进行阐述,为示踪用盐酸米托蒽醌注射液的临床应用提供参考。Standardized lymph node dissection is the key to radical surgery for malignant tumors.However,the choice of lymphatic tracers in China is limited at present.After years of research and development,the team of Shujun Wang from Shenyang Pharmaceutical University has innovatively developed the first biological self-assembly nanocrystal lymphatic targeted tracer——mitoxantrone hydrochloride injection for tracing.After preclinical animal studies and phase Ⅰ-Ⅲ clinical studies,the drug was approved for marketing in China in June 2021 and it has been widely used in lymph node dissection for thyroid cancer and sentinel lymph node biopsy for breast cancer.Its efficacy and safety have been clinically verified.This article expounds the mechanism of action,method of application,efficacy and safety,pharmacokinetics,and differences from traditional mitoxantrone used in chemotherapy,so as to provide a reference for the clinical application of mitoxantrone hydrochloride injection for tracing.

关 键 词：示踪用盐酸米托蒽醌注射液 纳米晶体 淋巴示踪剂 乳腺癌 甲状腺癌 

分 类 号：R97[医药卫生—药品]