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布托啡诺与氯胺酮联合用于患者自控镇痛输注溶液的长期稳定性研究。

Butorphanol and ketamine combined in infusion solutions for patient-controlled analgesia administration: a long-term stability study.

作者信息

Chen Fuchao, Xiong Hui, Yang Jinguo, Fang Baoxia, Zhu Jun, Zhou Benhong

机构信息

Department of Pharmacy, Dongfeng Hospital, Hubei University of Medicine, Shiyan, Hubei, China (mainland).

Department of Pharmacy, Renmin Hospital, Hubei University of Medicine, Shiyan, Hubei, China (mainland).

出版信息

Med Sci Monit. 2015 Apr 21;21:1138-45. doi: 10.12659/MSM.893138.

Abstract

BACKGROUND

Ketamine in subanesthetic dose added to butorphanol has been reported to give superior pain control when used for intravenous patient-controlled analgesia (PCA) after surgery. However, this admixture is not available commercially and stability data applicable to hospital practice are limited.

MATERIAL/METHODS: The butorphanol-ketamine admixtures were prepared in polyolefin bags and stored in the dark at 4°C, 25°C, or 37°C for 15 days. The initial concentrations were 50-150 microgram/ml for butorphanol and 1-4 mg/ml for ketamine, respectively. The stabilities were determined by visual inspection, pH measurement, and high-pressure liquid chromatography (HPLC) assay of drug concentrations.

RESULTS

Over the 15 days, all solutions were clear in appearance, and no color change or precipitation was observed among the three temperatures. The percentages of initial concentration of each drug were over 95% during the study period, and the pH value did not change significantly.

CONCLUSIONS

The results indicate that the drug mixtures of butorphanol and ketamine in 0.9% sodium chloride injection were stable for 15 days when stored in polyolefin bags at 4°C, 25°C, or 37°C.

摘要

背景

据报道,在术后静脉自控镇痛(PCA)中,将亚麻醉剂量的氯胺酮添加到布托啡诺中可提供更好的疼痛控制。然而,这种混合制剂没有商业供应,适用于医院实际应用的稳定性数据有限。

材料/方法:布托啡诺-氯胺酮混合制剂在聚烯烃袋中配制,并在4℃、25℃或37℃黑暗条件下储存15天。布托啡诺的初始浓度分别为50-150微克/毫升,氯胺酮的初始浓度分别为1-4毫克/毫升。通过目视检查、pH值测量和药物浓度的高压液相色谱(HPLC)测定来确定稳定性。

结果

在15天内,所有溶液外观澄清,在这三个温度下均未观察到颜色变化或沉淀。在研究期间,每种药物的初始浓度百分比均超过95%,且pH值没有明显变化。

结论

结果表明,布托啡诺和氯胺酮的药物混合物在0.9%氯化钠注射液中,于4℃、25℃或37℃下储存在聚烯烃袋中时,15天内是稳定的。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d802/4416463/c7626889c11f/medscimonit-21-1138-g001.jpg

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