【摘要】：目的:考察注射用伏立康唑與果糖注射液、轉(zhuǎn)化糖注射液的配伍穩(wěn)定性。方法:參考藥品說(shuō)明書(shū),取注射用伏立康唑200mg經(jīng)注射用水溶解并定容至20 m L后,分別與果糖注射液250 m L、轉(zhuǎn)化糖注射液250 m L配伍。在室溫條件下,分別于配伍后0、1、2、3、4、5 h觀察各配伍液的外觀,測(cè)定其p H和不溶性微粒數(shù),并采用高效液相色譜法測(cè)定伏立康唑的含量。結(jié)果:在上述條件下,各配伍液在5 h內(nèi)外觀和p H均無(wú)明顯變化,粒徑≥10μm和≥25μm的微粒數(shù)均符合2015年版《中國(guó)藥典》標(biāo)準(zhǔn);伏立康唑的相對(duì)百分含量呈下降趨勢(shì)(95.28%~100%),但其變化均在±5%范圍內(nèi)(RSD2%,n=6)。結(jié)論:注射用伏立康唑與果糖注射液、轉(zhuǎn)化糖注射液配伍后,在室溫條件下5 h內(nèi)保持穩(wěn)定。
[Abstract]:Objective: to investigate the compatibility stability of Volconazole, fructose injection and trans sugar injection for injection. Methods: with reference to the drug instruction, 200mg for injection was dissolved in water for injection to 20ml, then mixed with fructose injection 250ml and transforming sugar injection 250ml respectively. At room temperature, the appearance, pH and the number of insoluble particles of each compatibility solution were observed for 5 h after compatibility, and the content of voliconazole was determined by HPLC. Results: under the above conditions, the appearance and pH of each compatibility solution did not change significantly within 5 h, and the number of particles with particle size 鈮，

本文編號(hào)：2307302