1、Re、Rb1、Rc、Rb2、Rd和五味子醇甲)的含量變化。結果 YQFM與注射用輔酶A、注射用鹽酸納洛酮配伍后,配伍液中粒徑≥10 μm、≥25μm的微粒數(shù)超出《中國藥典》2015年版規(guī)定范圍;與注射用環(huán)磷酰胺配伍后,配伍液中粒徑≥10 μm的微粒數(shù)超出規(guī)定范圍,且各時間點色譜圖與0 h相比,相似度均小于0.9;與維生素C注射液配伍后pH值變化明顯(RSD=2.12%),相似度均小于0.9;與維生素B6注射液配伍后pH變化明顯(RSD=3.00%),紫外全波段掃描圖譜在340 nm附近發(fā)生顯著變化,相似度均小于0.9;與奧扎格雷鈉注射液配伍后,相似度均小于0.9;與氨茶堿注射液配伍后紫外全波段掃描圖譜在340 nm附近發(fā)生顯著變化,相似度均小于0.9;與呋塞米注射液配伍后pH變化明顯(RSD=3.64%),紫外全波段掃描圖譜在340 nm附近發(fā)生顯著變化,相似度均小于0.9;與注射用泮托拉唑鈉配伍后,溶液顏色變暗,出現(xiàn)絮狀漂浮物,溶液中粒徑≥10 μm、≥25μm的微粒數(shù)均超出規(guī)定范圍;與其他注射劑配伍后各項指標無顯著變化,均符合相關規(guī)定。結論 YQFM與注射用輔酶A、注射用環(huán)磷酰胺、維生素C注射液、維生素B6注射液、奧扎格雷鈉注射液、氨茶堿注射液、呋塞米注射液、注射用鹽酸納洛酮、注射用泮托拉唑鈉配伍后理化性質發(fā)生變化,不可配伍使用;與維生素K1注射液、三磷酸腺苷二鈉注射液、去乙酰毛花苷注射液、胞磷膽堿鈉注射液、碳酸氫鈉注射液、硝酸甘油注射液、地塞米松磷酸鈉注射液、地西泮注射液配伍后理化性質無顯著變化,需進一步考察其在體內(nèi)相互作用情況。;Objective To investigate the compatibility stability of Yiqi Fumai Lyophilized Injection (YQFM) combined with 17 common injections to guide rational drug use. Methods The appearance, pH, insoluble particles and UV absorption spectrum of the compatible solution were observed and determined; the content changes of main compounds including ginsenosides Rg1, Re, Rb1, Rc, Rb2, Rd and schisandrin in YQFM were determined by HPLC at 0, 3, 6, 9, 12 h after mixing. Results After mixed with Coenzyme A for Injection (CAI), Naloxone Hydrochloride For Injection (NHI), the number of particles ≥ 10 and ≥ 25 μm exceeded the scope of Chinese Pharmacopoeia; after mixed with Cyclophosphamide for Injection (CI), the number of particles ≥ 10μm exceeded the scope of Chinese Pharmacopoeia, the similarity of fingerprint was lower than 0.9; after mixed with Vitamin C Injection (VCI), the obvious change was found in pH values (RSD=2.12%), the similarity of fingerprint was lower than 0.9; after mixed with Vitamin B6 Injection (VB6I), the obvious change was found in pH values (RSD=3.00%), UV absorption spectrum changed significantly at 340 nm, the similarity of fingerprint was lower than 0.9; after mixed with Sodium Ozagrel for Injection (SOI), the similarity of fingerprint was lower than 0.9; after mixed with Aminophylline Injection (AI), UV absorption spectrum changed significantly at 340 nm, the similarity of fingerprint was lower than 0.9; after mixed with Furosemide Injection(FI), the obvious change was found in pH values (RSD=3.64%), UV absorption spectrum changed significantly at 340 nm; the similarity of fingerprint was lower than 0.9; after mixed with Pantoprazole Sodium for Injection (PSI), the obvious change was found in the color at 9 h; the number of particles ≥ 10 and ≥ 25 μm exceeded the scope of Chinese Pharmacopoeia. Conclusion After mixed with CAI, NHI, CI, VCI, VB6I, SOI, AI, FI and PSI, the physical and chemical properties change, and cannot be used together. After mixed with Vitamin K1 Injection (VK1I), Adenosine Disodium Triphosphate for Injection (ADTI), Deslanoside Injection (DSI), Sodium Bicarbonate Injection (SBI), Citicoline Sodium Injection (CSI), Nitroglycerin Injection (NI), Dexamethasone Sodium Phosphate Injection (DSPI) and Diazepam Injection (DI), the obvious change was not found, further examination need to be carried out."/>

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首頁 > 過刊瀏覽>2018年第41卷第3期 >2018,41(3):429-438. DOI:10.7501/j.issn.1674-6376.2018.03.014
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注射用益氣復脈(凍干)與17種常用注射劑的配伍穩(wěn)定性考察

Compatibility stability of Yiqi Fumai Lyophilized Injection combined with 17 common injections

發(fā)布日期:2018-03-17
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