目的 測定注射用丹參多酚酸（SAFI）沖管液的安全劑量。方法 以SAFI為研究對象，以0.9%氯化鈉注射液為稀釋劑和沖管溶液，建立紫外-可見分光光度法測定沖管液中丹參多酚酸（SA）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-可見分光光度法對沖管安全劑量進(jìn)行驗證；在沖管液中加入鹽酸左氧氟沙星注射液，采用不溶性微粒檢查法對沖管液安全劑量進(jìn)行驗證。結(jié)果 SA溶液和SAFI溶液的波長-吸收曲線一致性較好；SA溶液特征吸收波長為285、338和354 nm，3個波長下濃度-吸收趨勢擬合顯示線性良好；SAFI 0.9%氯化鈉溶液在0~240 min內(nèi)穩(wěn)定性較好。靜滴過程中所用輸液器中剩余的靜滴液的容積約為13.3 mL，SAFI沖管速度為40滴/min（2 mL/min）時，SAFI的沖管液安全劑量為32.0 mL，經(jīng)驗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SAFI沖管液用劑量應(yīng)不少于32.0 mL。

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.

R965.3

天津市科技重大專項與工程（18ZXXYSY00120）