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地塞米松磷酸钠与输注液中5-羟色胺受体拮抗剂的相容性:一项全面研究。

Compatibility of dexamethasone sodium phosphate with 5-HT receptor antagonists in infusion solutions: a comprehensive study.

作者信息

He Guangzhao, Zeng Fan, Lei Kai, Xia Shu, Deng Li, Zhang Chengliang, Liu Dong

机构信息

Department of Pharmacy, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.

Department of Pharmacy, Changzhou Tumor Hospital, Changzhou, Jiangsu, China.

出版信息

Eur J Hosp Pharm. 2017 May;24(3):162-166. doi: 10.1136/ejhpharm-2016-000980. Epub 2016 Jul 14.

Abstract

OBJECTIVES

Patients can benefit from the coadministration of several medications because of the shorter infusion time and more rapid administration. The use of extemporaneously prepared admixtures of dexamethasone sodium phosphate (DSP) and 5-HT receptor antagonists (5-HT3RAs) must be supported by sufficient documentation of their compatibility. The objective of this study was to comprehensively investigate the compatibility of DSP with 5-HT3RAs in infusion solutions.

METHODS

Admixtures of DSP with six different 5-HT3RAs (ondansetron hydrochloride, tropisetron hydrochloride, dolasetron mesylate, azasetron hydrochloride, palonosetron hydrochloride and ramosetron hydrochloride) were prepared in non-polyvinyl chloride (non-PVC) infusion bags filled with 5% glucose or 0.9% NaCl. Bags were stored at ambient temperature (25±2°C) without protection from light. Samples were taken immediately after preparation (0 hour) and at predetermined intervals (12, 24 and 48 hours after preparation). Particulate matter of admixtures was inspected visually and particles were counted with a particle counter. The pH of each sample was also determined. Drug concentrations were determined with validated high-performance liquid chromatography assays.

RESULTS

No visible haze or particulate formation, colour change or gas evolution and no notable changes in pH were observed, and particulate matter was acceptable up to 48 hours. All preparations maintained more than 90.0% of the initial concentration over the study period.

CONCLUSIONS

All the admixtures of DSP and the 5-HT3RAs studied were compatible and stable for at least 48 hours in a 5% glucose injection or a 0.9% NaCl injection stored in non-PVC infusion bags under ambient conditions.

摘要

目的

由于输注时间更短且给药更快,患者可从多种药物的联合给药中获益。地塞米松磷酸钠(DSP)与5-羟色胺受体拮抗剂(5-HT3RAs)的临时配制混合液的使用必须有充分的配伍性文件支持。本研究的目的是全面研究DSP与5-HT3RAs在输液溶液中的配伍性。

方法

在装有5%葡萄糖或0.9%氯化钠的非聚氯乙烯(非PVC)输液袋中制备DSP与六种不同5-HT3RAs(盐酸昂丹司琼、盐酸托烷司琼、甲磺酸多拉司琼、盐酸阿扎司琼、盐酸帕洛诺司琼和盐酸雷莫司琼)的混合液。输液袋在室温(25±2°C)下储存,无避光措施。在配制后立即(0小时)以及预定时间间隔(配制后12、24和48小时)取样。对混合液的颗粒物进行目视检查,并用颗粒计数器计数颗粒。还测定了每个样品的pH值。用经过验证的高效液相色谱法测定药物浓度。

结果

未观察到可见的浑浊或颗粒形成、颜色变化或气体逸出,pH值也无明显变化,且在48小时内颗粒物均可接受。在研究期间,所有制剂的初始浓度均保持在90.0%以上。

结论

在环境条件下,储存在非PVC输液袋中的5%葡萄糖注射液或0.9%氯化钠注射液中,所研究的DSP与5-HT3RAs的所有混合液均配伍且至少48小时稳定。

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