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首页> 外文期刊>Journal of oncology pharmacy practice: official publication of the International Society of Oncology Pharmacy Practitioners >Long-term stability study of clofarabine injection concentrate and diluted clofarabine infusion solutions.
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Long-term stability study of clofarabine injection concentrate and diluted clofarabine infusion solutions.

机译：氯法拉滨注射浓缩液和稀释的氯法拉滨输注溶液的长期稳定性研究。

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The aim of this study was to investigate the physicochemical stability of clofarabine (CAFdA) injection concentrate and ready-to-use CAFdA infusion solutions over a prolonged period of 28 days.To determine the stability of CAFdA infusion solutions, the injection concentrate (Evoltra?, 1 mg/mL, Genzyme) was diluted either with 0.9% sodium chloride or 5% glucose infusion solution. The resulting concentrations of 0.2 mg/mL or 0.6 mg/mL, respectively, were chosen to represent the lower and upper limit of the ordinary concentration range. Test solutions were stored under refrigeration (2-8°C) or at room temperature either light protected or exposed to light. CAFdA concentrations and pH values were determined at different time intervals throughout a 28-day storage period. Compatibility of diluted CAFdA infusion solutions (0.1-0.4 mg/mL) with different container materials (polyvinyl chloride (PVC), glass, and polypropylene/polyethylene (PP/PE)) was tested over a 48-h storage period. CAFdA concentrations were measured by a stability-indicating reversed phase high-performance liquid chromatography (HPLC) assay with ultraviolet detection.CAFdA injection concentrate and CAFdA infusion solutions remained physicochemically stable (>90% CAFdA) for 4 weeks. Results are independent of storage conditions, drug concentrations (0.2, 0.6, and 1.0 mg/mL) and diluents (0.9% sodium chloride, 5% glucose infusion solution). Adsorption of CAFdA to container material can be excluded.CAFdA injection concentrate and diluted infusion solutions in commonly used vehicles are stable for at least 28 days either refrigerated or at room temperature. Physicochemical stability favors pharmacy-based centralized preparation. Due to microbiological reasons, strict aseptic handling and storage of the products under refrigeration is recommended.
机译：这项研究的目的是研究氯法拉滨（CAFdA）注射浓缩液和即用型CAFdA输注溶液在长达28天的时间里的理化稳定性。 （1 mg / mL，Genzyme）用0.9％氯化钠或5％葡萄糖输注溶液稀释。选择所得的0.2 mg / mL或0.6 mg / mL的浓度分别代表普通浓度范围的下限和上限。将测试溶液储存在冷藏（2-8°C）或室温下，避光或暴露于光线下。在整个28天的存储时间内，以不同的时间间隔确定CAFdA浓度和pH值。在48小时的存储期内，测试了稀释的CAFdA输液（0.1-0.4 mg / mL）与不同容器材料（聚氯乙烯（PVC），玻璃和聚丙烯/聚乙烯（PP / PE））的相容性。 CAFdA浓度通过具有紫外检测功能的稳定性指示反相高效液相色谱（HPLC）测定进行测量.CAFdA注射浓缩液和CAFdA输注溶液在理化上保持稳定（> 90％CAFdA）4周。结果与储存条件，药物浓度（0.2、0.6和1.0 mg / mL）和稀释剂（0.9％氯化钠，5％葡萄糖输注溶液）无关。可以排除CAFdA在容器材料上的吸附。在常用车辆中，CAFdA注射浓缩液和稀释的输注溶液在冷藏或室温下至少稳定28天。物化稳定性有利于基于药物的集中制备。由于微生物原因，建议对产品进行严格的无菌处理和冷藏。

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