Jhunjhunwala V P, Bhalla H L
Am J Hosp Pharm. 1981 Dec;38(12):1922-4.
The compatibility and stability of mephentermine sulfate with hydrocortisone sodium succinate or aminophylline in 5% dextrose injection were studied. Mephentermine sulfate injection (equivalent to mephentermine 300 mg) was added to both hydrocortisone sodium succinate injection (equivalent to hydrocortisone 100 mg--admixture I) and aminophylline injection 250 mg (admixture II), each in 5% dextrose injection 400 ml. The solutions were stored in sealed USP type I containers and stored at 0-4 degrees C, 30 +/- 2 degrees C, and 45 +/- 1 degree C. Aliquots were drawn initially and at 4 and 24 hours for pH, drug content, and degradation product determinations. Mephentermine sulfate content was analyzed by a spectrophotometric method involving ion-pair extraction with tropaeolin 00. Hydrocortisone sodium succinate and aminophylline were analyzed by color reaction with isoniazid and UV spectrophotometry, respectively. The content of mephentermine and total hydrocortisone showed no change in admixture I under all test conditions. Hydrocortisone sodium succinate ester hydrolyzed slowly, but not more than 5% after 24 hours at 45 degrees C. There was no appreciable loss of mephentermine sulfate or aminophylline potency in admixture II. The pH of the solutions did not change over the period of study. The results indicate that both admixtures were compatible and stable under the tested storage conditions for at least 24 hours.
研究了硫酸美芬丁胺与氢化可的松琥珀酸钠或氨茶碱在5%葡萄糖注射液中的配伍性和稳定性。将硫酸美芬丁胺注射液（相当于美芬丁胺300mg）分别加入氢化可的松琥珀酸钠注射液（相当于氢化可的松100mg——混合液I）和氨茶碱注射液250mg（混合液II）中，每种均加入400ml 5%葡萄糖注射液。溶液储存于密封的USP I型容器中，分别在0 - 4℃、30±2℃和45±1℃下保存。最初以及在4小时和24小时抽取等分试样，用于测定pH值、药物含量和降解产物。硫酸美芬丁胺含量采用分光光度法分析，该方法涉及用金莲橙00进行离子对萃取。氢化可的松琥珀酸钠和氨茶碱分别采用与异烟肼的显色反应和紫外分光光度法进行分析。在所有测试条件下，混合液I中美芬丁胺和总氢化可的松的含量均无变化。氢化可的松琥珀酸钠酯水解缓慢，在45℃下24小时后水解不超过5%。混合液II中硫酸美芬丁胺或氨茶碱的效价没有明显损失。在研究期间，溶液的pH值没有变化。结果表明，在测试的储存条件下，两种混合液至少24小时内都是配伍稳定的。
