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用于患者自控镇痛的羟考酮-氯胺酮溶液在聚丙烯注射器和聚氯乙烯袋中的物理化学稳定性。

Physicochemical stability of oxycodone-ketamine solutions in polypropylene syringe and polyvinyl chloride bag for patient-controlled analgesia use.

作者信息

Daouphars Mikaël, Hervouët Charles-Henri, Bohn Pierre, Martin Delphine, Rouvet Jean, Basuyau Florence, Varin Rémi

机构信息

Department of Pharmacy, Cancer Centre Henri Becquerel, Rouen, France.

Department of Pharmacy, University Hospital Charles Nicolle, Rouen, France.

出版信息

Eur J Hosp Pharm. 2018 Jul;25(4):214-217. doi: 10.1136/ejhpharm-2016-000965. Epub 2016 Oct 17.

Abstract

OBJECTIVES

The study evaluated the stability of three combinations of oxycodone and ketamine diluted in normal saline (NS) after storage for 7 days at 23°C and exposed to light.

METHODS

The stability of three mixtures of oxycodone and ketamine (oxycodone 0.4 mg/mL+ketamine 40 mg/mL, oxycodone 10 mg/mL+ketamine 0.1 mg/mL and oxycodone 10 mg/mL+ketamine 40 mg/mL) in NS stored in a polypropylene syringe and a polyvinyl chloride (PVC) bag was studied. The physical characteristics, including pH, colour and precipitation, were evaluated. The samples were analysed in triplicate by a stability-indicating high-performance liquid chromatography method.

RESULTS

There was no significant change in the pH values of any solution. No precipitation or change in colour was observed. All formulations maintained more than 95% of the initial concentration of each drug on day 7. No trace of degradation products was detected.

CONCLUSIONS

Ketamine (0.1-40 mg/mL) combined with oxycodone (0.4-10 mg/mL) is physically compatible and chemically stable for 7 days when diluted with NS, packaged in polypropylene syringe or PVC bag and stored at 23°C.

摘要

目的

本研究评估了三种将羟考酮和氯胺酮稀释于生理盐水(NS)中的组合在23°C下储存7天并暴露于光照后的稳定性。

方法

研究了羟考酮和氯胺酮的三种混合物(羟考酮0.4mg/mL + 氯胺酮40mg/mL、羟考酮10mg/mL + 氯胺酮0.1mg/mL以及羟考酮10mg/mL + 氯胺酮40mg/mL)在聚丙烯注射器和聚氯乙烯(PVC)袋中储存于NS中的稳定性。评估了包括pH值、颜色和沉淀在内的物理特性。采用稳定性指示高效液相色谱法对样品进行了三次分析。

结果

任何溶液的pH值均无显著变化。未观察到沉淀或颜色变化。所有制剂在第7天均保持了每种药物初始浓度的95%以上。未检测到降解产物痕迹。

结论

氯胺酮(0.1 - 40mg/mL)与羟考酮(0.4 - 10mg/mL)混合,用NS稀释后,包装在聚丙烯注射器或PVC袋中并在23°C下储存时,在物理上是相容的,化学上是稳定的,为期7天。

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