目的 考察不同溫度及光照條件下，注射用益氣復(fù)脈（凍干）（YQFM）與0.9%氯化鈉注射液的配伍穩(wěn)定性，為臨床用藥提供參考。方法 模擬臨床應(yīng)用，以0.9%氯化鈉注射液為溶媒，按說明書要求與YQFM進行混合，考察配伍溶液在室溫、高溫、光照、暗處條件下，6 h內(nèi)溶液顏色及性狀、pH、不溶性微粒及人參皂苷Rg₁、Re、Rb₁和五味子醇甲含量以及指紋圖譜的變化。結(jié)果 YQFM與0.9%氯化鈉注射液配伍后6 h內(nèi)，室溫、高溫、光照、暗處條件下，配伍液顏色及外觀、pH變化不明顯，溶液中粒徑≥ 10 μm、≥ 25 μm的微粒數(shù)均符合《中國藥典》規(guī)定范圍；人參皂苷Rg₁、Re、Rb₁和五味子醇甲含量變化RSD<2.50%；且各時間點指紋圖譜與0 h相比，相似度均大于0.997。結(jié)論 YQFM與0.9%氯化鈉注射液配伍后6 h內(nèi)，在室溫、高溫、光照、暗處條件下，溶液均較穩(wěn)定。

Objective To investigate the compatibility stability of Yiqi Fumai Lyophilized Injection (YQFM) combined with 0.9% sodium chloride injection under different temperature and light conditions to provide reference for clinical medication. Methods We mixed YQFM with 0.9% sodium chloride injection according to the requirements of the instructions. The color, pH, and insoluble particles were observed and determined. The content changes of main compounds including ginsenosides Rg₁, Re, Rb₁, and schisandrin in YQFM were determined by HPLC at 0, 2, 4, 6 h after mixing. Results Within 6 hours after YQFM and 0.9% sodium chloride injection were mixed, there is no obvious change in color and pH value. The number of particles (≥ 10 and ≥ 25 μm) met the requirements of Chinese Pharmacopoeia. There is no change was found in ginsenosides Rg₁, Re, Rb₁, and schisandrin values (RSD< 2.50%). The similarity of fingerprint was larger than 0.997. Conclusion Within 6 hours after YQFM and 0.9% sodium chloride injection were mixed, the solution was stable under room temperature, high temperature, light, and dark conditions.

R965.3

天津市科技計劃項目（18YFCZZC00430）