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稀释腺嘌呤溶液在聚氯乙烯输液袋中的稳定性。

Stability of diluted adenosine solutions in polyvinyl chloride infusion bags.

机构信息

Wal-Mart Pharmacy, Brockport, NY, USA.

出版信息

Am J Health Syst Pharm. 2011 Aug 15;68(16):1533-6. doi: 10.2146/ajhp100573.

Abstract

PURPOSE

The stability of diluted adenosine solutions in polyvinyl chloride infusion bags was studied.

METHODS

Adenosine 50-, 100-, and 220-μg/mL solutions were prepared in 50-mL polyvinyl chloride (PVC) infusion bags containing 0.9% sodium chloride injection or 5% dextrose injection and stored at room temperature (23-25 °C) or under refrigeration (2-8 °C). Each sample of every combination of concentration, diluent, and storage temperature was prepared in triplicate, yielding 36 samples. The samples were assayed using a stability-indicating, reverse-phase high-performance liquid chromatographic method immediately after preparation (time zero) and at 24 hours, 48 hours, 7 days, and 14 days. pH was measured at time zero, 48 hours, 7 days, and 14 days. Time zero concentrations were calculated from the equation produced from a calibration curve of standards ranging from 10 to 500 μg/mL. Samples were also visually inspected against a light background for clarity, color, and the presence of crystalline particulate matter. Stability was defined as retaining at least 90% of the initial adenosine concentration.

RESULTS

After 14 days, all samples retained greater than 98% of the initial adenosine concentration, with no evidence of adsorption, visible precipitation, or considerable change in pH, suggesting minimal to no loss of product due to degradation or adsorption.

CONCLUSION

Adenosine 50-, 100-, and 220-μg/mL solutions in 50-mL PVC infusion bags containing 0.9% sodium chloride injection or 5% dextrose injection stored at room temperature and refrigerated conditions were stable for at least 14 days.

摘要

目的

研究了在聚氯乙烯(PVC)输液袋中稀释的腺苷溶液的稳定性。

方法

在含有 0.9%氯化钠注射液或 5%葡萄糖注射液的 50-mL PVC 输液袋中制备 50、100 和 220-μg/mL 的腺苷溶液,并分别在室温(23-25°C)或冷藏(2-8°C)下储存。每种浓度、稀释剂和储存温度组合的每个样品均制备 3 份,共 36 个样品。使用稳定性指示的反相高效液相色谱法在制备后立即(零时间)和 24 小时、48 小时、7 天和 14 天时对每个样品进行测定。在零时间、48 小时、7 天和 14 天时测定 pH 值。零时间浓度根据标准范围从 10 到 500μg/mL 的校准曲线计算得出。还将样品与背景光进行目视检查,以评估其澄清度、颜色和结晶性微粒物质的存在。稳定性定义为保留至少 90%的初始腺苷浓度。

结果

在 14 天后,所有样品均保留了初始腺苷浓度的 98%以上,没有吸附、可见沉淀或 pH 值发生明显变化的证据,表明由于降解或吸附而导致的产品损失最小或没有。

结论

在室温下和冷藏条件下,0.9%氯化钠注射液或 5%葡萄糖注射液的 50-mL PVC 输液袋中储存的 50、100 和 220-μg/mL 的腺苷溶液在至少 14 天内是稳定的。

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