评估两种市售的可携式弹性储药输液帮浦（Baxter 的 Infusor LV 与 Woo Young Medical 的 Accufuser）中，柠檬酸缓冲氟氯西林注射剂在储存时的稳定性：符合英国国民保健署黄色封面文件（NHS Yellow Cover Document，YCD）需求的研究。
Assessment of the stability of citrate-buffered flucloxacillin for injection when stored in two commercially available ambulatory elastomeric devices: INfusor LV (Baxter) and Accufuser (Woo Young Medical): a study compliant with the NHS Yellow Cover Document (YCD) requirements.
机构信息
Biopharma Stability Testing Laboratory, BioCity Nottingham, Nottingham, UK.
Pharmacy Department and OPAT Service, Nottingham University Hospitals NHS Trust, Nottingham, UK.
出版信息
Eur J Hosp Pharm. 2020 Mar;27(2):90-94. doi: 10.1136/ejhpharm-2018-001515. Epub 2018 Sep 18.
OBJECTIVES
To investigate the effect of pH and buffers on the degradation rate of flucloxacillin and to determine if flucloxacillin can be stabilised using a buffered diluent for up to 14 days when stored at 2°C-8°C including a 24-hour infusion period at 32°C in two elastomeric devices (Accufuser and INfusor LV) filled to 240 mL. Testing as per the NHS Pharmaceutical Quality Assurance Committee Yellow Cover Document (YCD) requirements.
METHODS
A validated stability indicating high-performance liquid chromatography method was used for assessing the stability of flucloxacillin diluted in 0.3% w/v citrate-buffered saline pH 7.0 when stored at 2°C-8°C in two ambulatory devices (Accufuser and INfusor LV). Flucloxacillin at 10 and 50 mg/mL diluted in 0.3% w/v citrate-buffered saline pH 7.0 to a final volume of 240 mL and stored at 2°C-8°C, including 24 hours at 32°C, was tested from two batches in replicate (n=3) at five time points for up to 14 days according to the requirements of the YCD.
RESULTS
Greater than 95% of the zero-time concentration of flucloxacillin at 10 and 50 mg/mL remained when stored at 2°C-8°C after 14 days including 24 hours at 32°C in both Accufuser and INfusor LV devices.
CONCLUSIONS
Flucloxacillin sodium stability was improved, and complied with UK national standards, by using a diluent of 0.3% w/v citrate-buffered saline pH 7 in both Accufuser and INfusor LV ambulatory devices when filled to 240 mL. The data support assigning a shelf-life of up to 14 days (13 days stored at 2°C-8°C and 24 hours at 32°C). Flucloxacillin may now be used appropriately as a continuous 24-hour infusion in outpatient parenteral antimicrobial therapy services, providing further opportunity to avoid or shorten patient hospital stays, as well as support ideal antimicrobial stewardship principles.
目的
研究 pH 值和缓冲液对氟氯西林降解速率的影响，并确定氟氯西林是否可以在 2°C-8°C 下使用缓冲稀释剂稳定 14 天，其中包括在两个弹性装置（Accufuser 和 INfusor LV）中输注 24 小时，每个装置填充至 240ml。按照英国国家医疗服务体系（NHS）药物质量保证委员会黄色封面文件（YCD）的要求进行测试。
方法
使用经验证的高灵敏度高效液相色谱法评估氟氯西林在 0.3%w/v 柠檬酸盐缓冲盐水 pH7.0 中的稳定性，该药物在两个流动输液装置（Accufuser 和 INfusor LV）中于 2°C-8°C 下储存。氟氯西林以 10mg/ml 和 50mg/ml 的浓度在 0.3%w/v 柠檬酸盐缓冲盐水 pH7.0 中稀释至 240ml 的最终体积，于 2°C-8°C 下储存，包括在 32°C 下 24 小时，然后在两个批次中各重复（n=3）测试 5 个时间点，最长达 14 天，根据 YCD 的要求进行。
结果
在 2°C-8°C 下储存 14 天后，包括在 32°C 下 24 小时，氟氯西林的浓度均大于初始浓度的 95%，10mg/ml 和 50mg/ml 两种浓度在 Accufuser 和 INfusor LV 装置中均如此。
结论
在 Accufuser 和 INfusor LV 流动输液装置中使用 0.3%w/v 柠檬酸盐缓冲盐水 pH7.0 作为稀释液，可提高氟氯西林钠的稳定性，并符合英国国家标准。当装置填充至 240ml 时，可将氟氯西林的有效期延长至 14 天（在 2°C-8°C 下储存 13 天，在 32°C 下储存 24 小时）。氟氯西林现在可作为门诊患者的连续 24 小时输注药物，适当用于肠外抗菌治疗服务，这进一步提供了避免或缩短患者住院时间的机会，同时也支持理想的抗菌药物管理原则。
Zotero 插件