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目的:探讨泮托拉唑钠与酚磺乙胺混合后变色的原因。方法:考察泮托拉唑钠和酚磺乙胺分别加至不同pH值磷酸盐缓冲液中,放置0、1、2h后的外观和pH值变化;另同等条件下制备泮托拉唑钠(0.16mg.mL-1)+0.9氯化钠注射液(NS)、酚磺乙胺(4mg.mL-1)+NS、泮托拉唑钠(0.08mg.mL-1)+酚磺乙胺(2mg.mL-1)+NS、少量酚磺乙胺(0.08mg.mL-1)+泮托拉唑钠(0.16mg.mL-1)+NS、少量泮托拉唑钠(0.0032mg.mL-1)+酚磺乙胺(4mg.mL-1)+NS、NS等溶液,观察上述溶液室温放置0、1、2h后的外观和pH值变化。结果与结论:当pH>7.0时,酚磺乙胺发生变色;当pH<7.0时,泮托拉唑钠发生变色。二者配伍可能生成醌式结构,当pH达到6.7时,发生变色。
Objective: To investigate the causes of discoloration after mixing pantoprazole sodium and phenylethanolamine. Methods: To investigate the appearance and pH value of pantoprazole sodium and phenylethanolamine added to different pH value phosphate buffer respectively, put it aside for 0, 1 and 2 hours, then prepare pantoprazole sodium ( 0.16 mg.mL-1) +0.9 Sodium Chloride Injection (NS), Etostamine (4 mg.mL-1) + NS, Pantoprazole sodium (0.08 mg.mL-1) (2mg.mL-1) + NS, a small amount of psoralen (0.08mg.mL-1) + pantoprazole sodium (0.16mg.mL-1) + NS, a small amount of pantoprazole sodium (0.0032mg. mL-1) + ethanesulfonamide (4mg.mL-1) + NS, NS, etc. The appearance and pH of the solution were observed after 0, 1, 2h at room temperature. RESULTS AND CONCLUSION: When pH> 7.0, phenylethylamine was discolored. When pH was less than 7.0, pantoprazole sodium discolored. Compatibility between the two may generate quinone structure, when the pH reaches 6.7, discoloration occurs.