目的 測(cè)定注射用益氣復(fù)脈（凍干）（YQFM）沖管液安全劑量。方法 以YQFM為研究對(duì)象，以0.9%氯化鈉注射液為稀釋劑和沖管溶液，采用紫外-可見(jiàn)分光光度法測(cè)定沖管液中主藥成分殘留，確定沖管液的安全劑量；收集各段沖管液，在沖管液中加入常用配伍藥物呋塞米注射液，采用紫外-可見(jiàn)分光光度法對(duì)沖管安全劑量進(jìn)行驗(yàn)證；在沖管液中加入注射用環(huán)磷酰胺，采用不溶性微粒檢查法對(duì)沖管液安全劑量進(jìn)行驗(yàn)證。結(jié)果 YQFM 0.9%氯化鈉溶液特征吸收波長(zhǎng)為203和283 nm，濃度-吸收趨勢(shì)擬合顯示線性良好；在0~300 min內(nèi)穩(wěn)定性較好；沖管速度為40滴/min（2 mL/min）時(shí)，YQFM沖管液安全劑量為32.0 mL/min，經(jīng)驗(yàn)證沖管效果符合要求。結(jié)論 為保證臨床用藥的安全性，建議YQFM沖管液用劑量應(yīng)不少于32.0 mL。

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.

R965

天津市科技計(jì)劃項(xiàng)目（18YFCZZC00430）