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门诊患者使用的抗生素溶液中氨苄西林和头孢曲松在不同温度下的稳定性。

Ampicillin and Ceftriaxone Solution Stability at Different Temperatures in Outpatient Parenteral Antimicrobial Therapy.

机构信息

Unidad de Farmacia, Hospital Universitario Virgen del Rocío/CSIC/Instituto de Biomedicina de Sevilla (IBiS), Seville, Spain.

Unidad Clínica de Enfermedades Infecciosas, Microbiología y Medicina Preventiva, Hospital Universitario Virgen Macarena/CSIC/Instituto de Biomedicina de Sevilla (IBiS), Seville, Spain.

出版信息

Antimicrob Agents Chemother. 2020 Jun 23;64(7). doi: 10.1128/AAC.00309-20.

Abstract

The inclusion of ampicillin-containing regimens in outpatient parenteral antimicrobial therapy programs (OPAT) depends upon solution stability under conditions similar to those experienced in these programs. Lack of this information could hinder the inclusion in OPAT of patients suffering from infective endocarditis treated with ampicillin plus ceftriaxone. The purpose of this study is to determine the stability of ampicillin and ampicillin plus ceftriaxone solutions in a simulated outpatient setting conditions. Solutions of ampicillin 24 g/liter and ampicillin 24 g/liter combined with ceftriaxone 8 g/liter were stored at 25°C ± 2°C, 30°C ± 2°C and 37°C ± 2°C for 48 h. Chemical and physical stability were evaluated at 20, 24, 30, and 48 h after manufacturing. The solutions were considered stable if the percentage of intact drug was ≥90% and color and clearness remained unchanged. After 24 h of storage at a controlled temperature, ampicillin solution in 0.9% sodium chloride was found to be stable for 30 h at 25 and 30°C and for 24 h at 37°C. In the ampicillin plus ceftriaxone combined solution, both antibiotics were found to be stable after 30 h of storage at 25 and 30°C, but at 37°C, the stability criterion was not met at any time point. Our study offers solid evidence demonstrating that the concentrations of both drugs at two of the tested temperatures (25°C and 30°C) were stable for up to 30 h. Therefore, both ampicillin alone and ampicillin plus ceftriaxone solutions would be appropriate candidates for inclusion in OPAT programs.

摘要

在门诊静脉用抗菌药物治疗计划(OPAT)中加入氨苄西林治疗方案取决于在类似该治疗计划中所经历的条件下溶液的稳定性。缺乏这些信息可能会阻碍患有感染性心内膜炎并接受氨苄西林加头孢曲松治疗的患者纳入 OPAT。本研究的目的是确定模拟门诊环境条件下氨苄西林和氨苄西林加头孢曲松溶液的稳定性。将氨苄西林 24 g/L 和氨苄西林 24 g/L 与头孢曲松 8 g/L 联合的溶液在 25°C ± 2°C、30°C ± 2°C 和 37°C ± 2°C 下储存 48 h。在制造后 20、24、30 和 48 h 时评估化学和物理稳定性。如果药物的完整百分比≥90%且颜色和透明度保持不变,则认为溶液稳定。在受控温度下储存 24 h 后,发现 0.9%氯化钠中的氨苄西林溶液在 25°C 和 30°C 下稳定 30 h,在 37°C 下稳定 24 h。在氨苄西林加头孢曲松联合溶液中,两种抗生素在 25°C 和 30°C 下储存 30 h 后均被发现稳定,但在 37°C 下,任何时间点都未达到稳定性标准。我们的研究提供了确凿的证据,证明在两种测试温度(25°C 和 30°C)下,两种药物的浓度稳定长达 30 h。因此,氨苄西林单独使用和氨苄西林加头孢曲松溶液都可以作为纳入 OPAT 计划的合适候选药物。

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