中国药物警戒 ›› 2015, Vol. 12 ›› Issue (6): 321-324.

• 基础及临床研究 •    下一篇

盐酸表柔比星注射液临床前安全性研究

刘奋1,徐欣昌1,赵涛1,吕金钢1,姚景春1,薛芳喜1*   

  1. 1鲁南制药集团股份有限公司新药安评中心，山东 临沂 273400;
    2枣庄矿业集团中心医院药学部，山东 枣庄 277000
  • 收稿日期:2015-04-25 出版日期:2015-06-08 发布日期:2015-07-27
  • 通讯作者: 薛芳喜，女，工程师，药理毒理实验研究。
  • 作者简介:刘奋，男，硕士，工程师，药理毒理实验研究。

Preclinical Safety Research of Epirubicin Hydrochloride Injection

LIU Fen1,XU Xin-chang2,ZHAO Tao1,LV Jin-gang1,YAO Jing-chun1,XUE Fang-xi1*   

  1. 1Center for New Drug Safety Evaluation of Lunan Pharmaceutical Group Corporation, Shandong Linyi 273400, China;
    2Department of Pharmacy, Central Hospital of Zaozhuang Mining Group, Shandong Zaozhuang 277000, China
  • Received:2015-04-25 Online:2015-06-08 Published:2015-07-27

PDF (PC)

406

摘要： 目的 评价盐酸表柔比星注射液的安全性，为临床安全用药提供理论依据。方法 通过血管刺激性试验、膀胱黏膜刺激性试验、体外溶血性试验、主动全身过敏试验(ASA)，评价盐酸表柔比星注射液的安全性。结果 盐酸表柔比星注射液无明显血管和膀胱黏膜刺激性，无过敏反应，有溶血反应。结论 盐酸表柔比星注射液临床使用时可能会出现溶血现象，建议稀释后使用。

关键词: 表柔比星, 血管刺激性, 膀胱黏膜刺激性, 溶血性, 主动全身过敏

Abstract: Objective To study the safety of epirubicin hydrochloride injection and provide theoretical evidence for clinical application. Methods The safety of epirubicin hydrochloride injection was observed through vascular and bladder mucosa irritation test, hemolytic test in vitro and active systemic anaphylaxis(ASA). Results Epirubicin hydrochloride injection had no obvious vascular and bladder mucosa irritation, no allergic reaction, however it had hemolytic reaction. Conclusion The hemolysis phenomenon may occur when epirubicin hydrochloride injection is used in clinic, and dilution is recommended.

Key words: epirubicin, vascular irritation, bladder mucosa irritation, hemolytsis, active systemic anaphylaxis(ASA)

中图分类号: