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首页> 外文期刊>The Canadian journal of hospital pharmacy. >Stability of Cefazolin Sodium in Polypropylene Syringes and Polyvinylchloride Minibags
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Stability of Cefazolin Sodium in Polypropylene Syringes and Polyvinylchloride Minibags

机译：头孢唑林钠在聚丙烯注射器和聚氯乙烯小包装袋中的稳定性

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Background: Cefazolin is a semisynthetic penicillin derivative with a narrow spectrum of activity covering some gram-positive organisms and a few gram-negative aerobic bacteria.Objective: To determine the physical and chemical stability of cefazolin sodium reconstituted with sterile water for injection and stored in polypropylene syringes or diluted with either 5% dextrose in water (D5W) or 0.9% sodium chloride (normal saline [NS]) and stored in polyvinylchloride (PVC) minibags.Methods: Reconstituted solutions of cefazolin (100 or 200 mg/mL) were packaged in polypropylene syringes. More dilute solutions (20 or 40 mg/mL) were prepared in D5W or NS and packaged in PVC minibags. For each concentration-diluent-container combination, 3 containers were designated for each day of analysis (days 7, 14, 21, and 30). Containers were stored under refrigeration (5degC) with protection from light until the designated day of analysis, at which time one 5-mL sample was collected from each the designated container. The designated containers were then stored at room temperature (21degC to 25degC) with exposure to light for an additional 72 h, and additional samples were drawn. The samples were assayed using a validated, stability-indicating high-performance liquid chromatography method. The colour and clarity of the solutions, as well as their pH, were also monitored on each sampling day.Results: All samples remained clear for the duration of the study; they had a slight yellow colour that darkened over time, and there was an increase in pH. Solutions diluted with sterile water for injection and stored in polypropylene syringes retained at least 94.5% of the initial concentration after 30 days of refrigerated storage and at least 92.1% after an additional 72 h at room temperature with exposure to light. Samples diluted in D5W or NS and stored in PVC minibags retained at least 95.8% of the initial concentration after 30 days of refrigerated storage and at least 91.8% after an addi...
机译：背景：头孢唑啉是一种半合成的青霉素衍生物，具有窄谱活性，涵盖一些革兰氏阳性生物和一些革兰氏阴性需氧细菌。目的：确定用注射用无菌水重构并储存在头孢唑林钠中的理化稳定性。聚丙烯注射器或用水（D5W）5％葡萄糖或0.9％氯化钠（生理盐水[NS]）稀释的聚丙烯注射器，并保存在聚氯乙烯（PVC）微型袋中。方法：将头孢唑林的重构溶液（100或200 mg / mL）包装在聚丙烯注射器中。在D5W或NS中制备更多稀释溶液（20或40 mg / mL），并包装在PVC迷你袋中。对于每种浓度-稀释剂-容器组合，每天分析（第7、14、21和30天）指定3个容器。将容器在冷藏（5℃）下避光保存，直到指定的分析日，此时从每个指定的容器中收集5 mL样品。然后将指定的容器在室温（21℃至25℃）下暴露于光下再保存72小时，并抽取其他样品。使用经过验证的，指示稳定性的高效液相色谱法对样品进行分析。在每个采样日还监测溶液的颜色和澄清度以及其pH值。结果：在研究期间所有样品均保持澄清;它们具有淡黄色，随着时间的流逝而变暗，并且pH值增加。用无菌注射用水稀释并保存在聚丙烯注射器中的溶液在冷藏保存30天后保留至少94.5％的初始浓度，在室温下暴露72小时后保留至少92.1％的初始浓度。在D5W或NS中稀释并存储在PVC微型袋中的样品在冷藏存储30天后保留至少95.8％的初始浓度，在添加后至少保留91.8％的初始浓度。

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