[关键词]
[摘要]
目的 测定注射用丹参多酚酸(SAFI)冲管液的安全剂量。方法 以SAFI为研究对象,以0.9%氯化钠注射液为稀释剂和冲管溶液,建立紫外-可见分光光度法测定冲管液中丹参多酚酸(SA)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;在冲管液中加入盐酸左氧氟沙星注射液,采用不溶性微粒检查法对冲管液安全剂量进行验证。结果 SA溶液和SAFI溶液的波长-吸收曲线一致性较好;SA溶液特征吸收波长为285、338和354 nm,3个波长下浓度-吸收趋势拟合显示线性良好;SAFI 0.9%氯化钠溶液在0~240 min内稳定性较好。静滴过程中所用输液器中剩余的静滴液的容积约为13.3 mL,SAFI冲管速度为40滴/min(2 mL/min)时,SAFI的冲管液安全剂量为32.0 mL,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SAFI冲管液用剂量应不少于32.0 mL。
[Key word]
[Abstract]
Objective To determine the safe dosage of flushing fluid for Salvianolic Acids for Injection (SAFI). Methods Taking SAFI as the research object, 0.9% Sodium Chloride Injection as the diluent, the residual SA 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 (levofloxacin Hydrochloride Injection). Results The wavelength absorption curves of SA solution and SAFI solution were in good agreement. The characteristic absorption wavelengths of SA solution are 285, 338 and 354 nm, and the fitting of concentration absorption trend at three wavelengths shows good linearity. SAFI 0.9% sodium chloride solution has good stability in 0-240 min. The volume of the remaining intravenous drip in the infusion set used in the intravenous drip process is about 13.3 mL, 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 SAFI flushing fluid should not be less than 32.0 mL.
[中图分类号]
R965.3
[基金项目]
天津市科技重大专项与工程(18ZXXYSY00120)