Seki Jack T, Wang Tian Q, Yip Paul M, Mazzulli Tony, Minden Mark D
1 Department of Pharmacy, Princess Margaret Cancer Centre, University Health Network, Toronto, Canada.
2 Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Canada.
J Oncol Pharm Pract. 2018 Apr;24(3):198-200. doi: 10.1177/1078155217694493. Epub 2017 Feb 20.
Background Dysfunctional central venous catheter prohibits the administration of potential life-saving chemotherapy and the delivery of essential supportive care needs to patients. Sodium bicarbonate injection has been shown to impede against fibrin clot formation and prolong prothrombin time and thrombin clotting time. Sodium bicarbonate injection has been tried as a second-line agent with good results in a small number of patients (internal data not published) when alteplase failed. We assessed whether the pre-filled sodium bicarbonate injection in 5 mL syringes would not only preserve sterility and retain its pH and concentration but also amount to the potential cost savings for future use when stored in a refrigerated environment. Methodology Twelve pre-filled 5 mL syringes were prepared aseptically, of which four each were tested for pH, sodium bicarbonate injection concentration and sterility when stored in refrigerated temperature over a six-week period. A standard pH meter, enzymatic carbon dioxide analyzer, and a 14-day incubation for microbial detection were employed for this study. Results Sodium bicarbonate concentration measured in the form of carbon dioxide ranged from 923 mmol/L or (1846 mosol/L) to 1006 mmol/L or (2012 mosmol/L), and pH ranged from (7.88 to 8.05) were reported over the duration of the study period. The 14-day incubation period resulted in no microbial growth. Conclusion Our study results have indicated that the pH and sodium bicarbonate injection concentration values were stable and within range, comparable to those reported by the manufacturer within the study period. The contents of the subdivided sodium bicarbonate injection 5 mL syringes retained sterility over a 14-day incubation period.
背景 功能失调的中心静脉导管会妨碍对患者进行可能挽救生命的化疗以及提供必要的支持性护理。已证明碳酸氢钠注射液可阻止纤维蛋白凝块形成，并延长凝血酶原时间和凝血酶凝结时间。当阿替普酶治疗失败时，碳酸氢钠注射液已作为二线药物进行尝试，在少数患者中取得了良好效果（内部数据未发表）。我们评估了预填充在5毫升注射器中的碳酸氢钠注射液在冷藏环境中储存时，是否不仅能保持无菌状态并维持其pH值和浓度，还能在未来使用时节省潜在成本。方法 无菌制备12支预填充5毫升注射器，其中4支在冷藏温度下储存六周期间分别进行pH值、碳酸氢钠注射液浓度和无菌性测试。本研究采用标准pH计、酶促二氧化碳分析仪以及为期14天的微生物检测培养。结果 在研究期间，以二氧化碳形式测得的碳酸氢钠浓度范围为923 mmol/L（或1846 mosol/L）至1006 mmol/L（或2012 mosmol/L），pH值范围为（7.88至8.05）。14天的培养期未出现微生物生长。结论 我们的研究结果表明，pH值和碳酸氢钠注射液浓度值稳定且在范围内，与制造商在研究期间报告的值相当。预分装的5毫升碳酸氢钠注射液在14天培养期内保持无菌状态。
