盐酸表柔比星注射液临床前安全性研究

摘要

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.%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。