头孢地尔在模拟 Y 型部位给药时与选定的静脉内药物的物理相容性。

ARL Biopharma Inc., Oklahoma City, Oklahoma.

Shionogi Inc., Florham Park, New Jersey.

Int J Pharm Compd. 2021 Jan-Feb;25(1):52-61.

The physical compatibility of cefiderocol for injection (prepared as a diluted 2% cefiderocol solution) with potential co-administration drug products is presented. The compatibility of cefiderocol with a selection of 91 intravenous drugs was tested at clinically relevant concentrations using the admixed volume ratio 1:1. Compatibility of the mixtures was determined by visual observations, turbidity, and particulate-matter measurements. The mixtures were examined immediately after mixing, and then at 1 hour and 4 hours thereafter at room temperature. When using 0.9% sodium chloride or 5% dextrose injection for diluents, solutions of dobutamine hydrochloride, esomeprazole sodium, methylprednisolone acetate, propofol, rocuronium bromide, amiodarone hydrochloride, famotidine, labetalol hydrochloride, mycophenolate mofetil, acyclovir sodium, amphotericin B, caspofungin acetate, doxycycline, posaconazole, diphenhydramine hydrochloride, and phenytoin sodium were found to cause visible cloudiness upon mixing with 2% cefiderocol in both diluents. Solutions of lorazepam, tobramycin sulfate, and vancomycin hydrochloride were determined incompatible by examining the mixtures with the aid of a Tyndall light. These 19 drugs were clearly incompatible with cefiderocol for injection by visual examination. In addition, solutions of iron sucrose and albumin were incompatible with 2% cefiderocol based on sub-visual tests for turbidity and/or particulate matter. Based on sub-visual data, the 0.9% sodium chloride admixture of aminophylline and 2% cefiderocol was incompatible, while inconclusive results were obtained for the 0.9% sodium chloride admixtures of 2% cefiderocol with amikacin sulfate. Similarly, the 5% dextrose admixtures of either ciprofloxacin or polymyxin B sulfate with 2% cefiderocol were incompatible, whereas data for phenylephrine hydrochloride morphine sulfate, or undiluted sodium bicarbonate were inconclusive. Overall, the 2% cefiderocol solution was physically compatible with 63 of 91 drugs challenged at 1:1 volume ratio in both 0.9% sodium chloride and 5% dextrose diluents for at least 4 hours at the concentrations tested in this study.

本研究旨在展示注射用头孢地尔的物理相容性（以 2%头孢地尔稀释液的形式配制），并与潜在的联合用药产品进行比较。在临床相关浓度下，采用 1:1 混合体积比，测试了头孢地尔与 91 种静脉内药物的混合相容性。通过肉眼观察、浊度和颗粒物测量来确定混合物的相容性。混合物在混合后立即进行检查，然后在室温下 1 小时和 4 小时后再次进行检查。当使用 0.9%氯化钠或 5%葡萄糖注射液作为稀释剂时，盐酸多巴酚丁胺、注射用奥美拉唑钠、醋酸甲泼尼龙、丙泊酚、罗库溴铵、盐酸胺碘酮、法莫替丁、盐酸拉贝洛尔、霉酚酸酯、阿昔洛韦钠、两性霉素 B、醋酸卡泊芬净、盐酸多西环素、泊沙康唑、盐酸苯海拉明和苯妥英钠在与两种稀释剂中的 2%头孢地尔混合时，会出现可见的混浊。在借助泰能光检查混合物后，发现盐酸劳拉西泮、硫酸妥布霉素和盐酸万古霉素的溶液不相容。这 19 种药物与注射用头孢地尔在视觉上明显不相容。此外，基于亚视觉浊度和/或颗粒物检测，蔗糖铁和白蛋白与 2%头孢地尔也不相容。根据亚视觉数据，0.9%氯化钠与氨茶碱的混合物与 2%头孢地尔不相容，而 0.9%氯化钠与硫酸阿米卡星的混合物则得到了不确定的结果。同样，5%葡萄糖与 2%头孢地尔的环丙沙星或硫酸多粘菌素 B 的混合物也不相容，而盐酸去氧肾上腺素、硫酸吗啡或未稀释的碳酸氢钠的数据则不确定。总的来说，在本研究的浓度下，在 0.9%氯化钠和 5%葡萄糖稀释剂中，以 1:1 的体积比混合的 91 种药物中，有 63 种药物在至少 4 小时内与 2%头孢地尔保持物理相容。