Daouphars Mikaël, Hervouët Charles-Henri, Bohn Pierre, Martin Delphine, Rouvet Jean, Basuyau Florence, Varin Rémi
Department of Pharmacy, Cancer Centre Henri Becquerel, Rouen, France.
Department of Pharmacy, University Hospital Charles Nicolle, Rouen, France.
Eur J Hosp Pharm. 2018 Jul;25(4):214-217. doi: 10.1136/ejhpharm-2016-000965. Epub 2016 Oct 17.
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.
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.
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.
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.
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。
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。
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。
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。