目的 考察注射用益氣復(fù)脈（凍干）與胰島素注射液聯(lián)合用藥的配伍穩(wěn)定性，為臨床合理用藥提供參考。方法 取同一批次注射用益氣復(fù)脈（凍干）8瓶，用5%葡萄糖注射液250 mL溶解后，分別加入8 U胰島素注射液混合均勻，考察配伍后溶液在0、4、8 h內(nèi)溶液顏色及性狀、pH值、不溶性微粒和紫外光譜的變化，采用HPLC法測定注射用益氣復(fù)脈（凍干）中主要化學(xué)成分人參皂苷Rg₁、Re、Rb₁及指紋圖譜變化和配伍的胰島素含量變化情況，以評估其配伍后藥液的穩(wěn)定性。結(jié)果 注射用益氣復(fù)脈（凍干）與8 U胰島素注射液在5%葡萄糖注射液中配伍后，8 h內(nèi)外觀無明顯變化；pH值和紫外吸收無明顯變化；配伍液中粒徑≥ 10 μm、≥ 25 μm的微粒數(shù)均符合《中國藥典》規(guī)定范圍；主要化學(xué)成分人參皂苷Rg₁、Re、Rb₁含量情況均無顯著變化，指紋圖譜相似度大于0.993，配伍藥液胰島素含量無顯著變化。結(jié)論 注射用益氣復(fù)脈（凍干）用5%葡萄糖注射液溶解后，再加入8 U胰島素注射液混合后的藥液在8 h內(nèi)配伍穩(wěn)定性良好。

Objective To investigate the compatibility stability of YiqiFumai Lyophilized Injection (YQFM) combined with insulin, and to provide reference for clinical medication. Methods Eight bottles of YiqiFumai Lyophilized Injection in same production batch were taken and dissolved with 250 mL 5% glucose injection, and then 8 units of insulin injection were added to mix. HPLC was used to determine ginsenosides Rg₁, Re and Rb₁ and the changes of fingerprint of YQFM and insulin content for evaluating the stability of the solution. Results There was no significant change in the internal and external view after the compatibility of YQFM and insulin for injection in 5% glucose injection for 8 hours, and the particle size ≥ 10 μm and ≥ 25 μm in the compatibility solution were within the range specified in the Chinese Pharmacopoeia. There was no significant change in pH value. The contents of ginsenoside Rg₁, ginsenoside Re, and ginsenoside Rb₁ was not significantly changed and the similarity of fingerprints was more than 0.993. There was no significant change in insulin content of the compatibility liquid. Conclusion When 250 mL 5% glucose injection was used for dissolution and 8 bottles of YQFM and 8 units of insulin injection were added to mix evenly, the compatibility stability of the solution was good within 8 hours.

R286.02

天津市科技計劃項目（18YFCZZC00430）