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阿糖胞苷、甲氨蝶呤钠和氢化可的松琥珀酸钠混合液的稳定性。

Stability of cytarabine, methotrexate sodium, and hydrocortisone sodium succinate admixtures.

作者信息

Cheung Y W, Vishnuvajjala B R, Flora K P

出版信息

Am J Hosp Pharm. 1984 Sep;41(9):1802-6.

PMID:6496516
Abstract

A high-performance liquid chromatographic (HPLC) method was developed for simultaneous determination of cytarabine, methotrexate sodium, and hydrocortisone sodium succinate, and the stability of the three drugs mixed together in four infusion fluids was assessed. Solutions were prepared with two concentrations of the three drugs similar to those administered intrathecally. Admixtures were prepared in Elliott's B solution, 0.9% sodium chloride injection, 5% dextrose injection, and lactated Ringer's injection. and lactated Ringer's injection. Solutions were filtered and kept in a disposable syringe in a 25 degrees C water bath for 24 hours. An HPLC assay capable of separating the three drugs and their degradation products was developed and validated. With one exception, all three drugs were stable in all four solutions for 24 hours. Hydrocortisone sodium succinate concentrations decreased to less than 90% of initial concentration in one of the admixtures with Elliott's B solution. No precipitation was noted in any admixture during the first eight hours of storage, but longer storage led to precipitation of unknown substances in some solutions. Admixtures of these three drugs in the four solutions tested are stable for at least 10 hours at 25 degrees C. However, intrathecal and administration of such admixtures within several hours of preparation is encouraged since none contains antibacterial preservatives.

摘要

建立了一种高效液相色谱(HPLC)法,用于同时测定阿糖胞苷、甲氨蝶呤钠和氢化可的松琥珀酸钠,并评估了这三种药物在四种输液中混合后的稳定性。用与鞘内给药相似的两种浓度的这三种药物配制溶液。在艾略特B液、0.9%氯化钠注射液、5%葡萄糖注射液和乳酸林格氏注射液中制备混合液。溶液经过过滤后保存在一次性注射器中,置于25℃水浴中24小时。开发并验证了一种能够分离这三种药物及其降解产物的HPLC分析方法。除了一个例外,这三种药物在所有四种溶液中24小时内均稳定。在与艾略特B液的一种混合液中,氢化可的松琥珀酸钠浓度降至初始浓度的90%以下。在储存的前8小时内,任何混合液中均未观察到沉淀,但储存时间延长会导致某些溶液中出现未知物质沉淀。在测试的四种溶液中,这三种药物的混合液在25℃下至少稳定10小时。然而,由于均不含抗菌防腐剂,建议在制备后数小时内进行鞘内给药和使用此类混合液。

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