注射用益气复脉（冻干）冲管液安全剂量测定

目的 测定注射用益气复脉（冻干）（YQFM）冲管液安全剂量。方法 以YQFM为研究对象，以0.9%氯化钠注射液为稀释剂和冲管溶液，采用紫外-可见分光光度法测定冲管液中主药成分残留，确定冲管液的安全剂量；收集各段冲管液，在冲管液中加入常用配伍药物呋塞米注射液，采用紫外-可见分光光度法对冲管安全剂量进行验证；在冲管液中加入注射用环磷酰胺，采用不溶性微粒检查法对冲管液安全剂量进行验证。结果 YQFM 0.9%氯化钠溶液特征吸收波长为203和283 nm，浓度-吸收趋势拟合显示线性良好；在0~300 min内稳定性较好；冲管速度为40滴/min（2 mL/min）时，YQFM冲管液安全剂量为32.0 mL/min，经验证冲管效果符合要求。结论 为保证临床用药的安全性，建议YQFM冲管液用剂量应不少于32.0 mL。

Determination of flushing fluid safe dosage of Yiqi Fumai Lyophilized Injection

Objective To determine the safe dosage of flushing fluid for Yiqi Fumai Lyophilized Injection(YQFM). Methods Taking YQFM as the research object, 0.9% sodium chloride injection as diluent., the residual main components in flushing fluid was determined by ultraviolet-visible spectrophotometry, and the safe dosage of flushing fluid was worked out. The safe dosage of flushing fluid was verified by ultraviolet-visible spectrophotometry with application of furosemide injection and insoluble particle test using an incompatible drug (Cyclophosphamide for Injection). Results The characteristic absorption wavelengths of SA solution are 203 and 283 nm, and the fitting of concentration absorption trend at three wavelengths shows good linearity. YQFM 0.9% sodium chloride injection has good stability in 0-300 min. The safety dosage of flushing fluid was 32.0 mL at the velocity intravenous drip 40 drop/min (2 mL/min). It is verified that the flushing effect meets the requirements. Conclusion In order to ensure the safety of clinical use, it is recommended that the dosage of YQFM flushing fluid should not be less than 32.0 mL.