【摘要】：目的:考察注射用兩性霉素B與不同廠家的5%葡萄糖注射液配伍的穩(wěn)定性影響因素,為注射用兩性霉素B選擇合適的溶劑載體提供可靠的依據(jù)。方法:注射用兩性霉素B與不同廠家(A、B、C、D、E廠家)的5%葡萄糖注射液配伍后,在避光條件下,室溫(25℃)放置0、1、2、4、6、8 h,采用高效液相色譜(HPLC)法,測定樣品中兩性霉素B的含量變化,同時觀察樣品溶液的性狀、澄明度、p H值變化。結(jié)果:隨著放置時間的延長,兩性霉素B與p H4.2的5%葡萄糖注射液配伍均出現(xiàn)不溶性雜質(zhì),主藥含量明顯下降。只有A廠家的5%葡萄糖注射液符合與兩性霉素B的配伍要求。結(jié)論:兩性霉素B與5%葡萄糖注射液的配伍穩(wěn)定性與溶劑的p H值密切相關(guān),建議溶劑生產(chǎn)廠家在藥品說明書中注明其p H值,以便臨床在使用類似藥品時選擇合適的溶劑,安全用藥。
[Abstract]:Objective: to investigate the factors affecting the stability of amphotericin B for injection and 5% glucose injection from different manufacturers, and to provide reliable basis for selecting suitable solvent carrier for amphotericin B for injection. Methods: amphotericin B for injection was combined with 5% glucose injection from different manufacturers (A, B, D, E). Under the condition of avoiding light, placing at room temperature (25 鈩，

本文編號：2519274