Donnelly Ronald F
, MSc(Chem), BSc(Pharm), is the Product Development Pharmacist, Department of Pharmaceutical Services, The Ottawa Hospital (Civic Campus), Ottawa, Ontario.
Can J Hosp Pharm. 2009 Jan;62(1):28-33. doi: 10.4212/cjhp.v62i1.114.
Small amounts of ketamine administered with a narcotic can help to reduce both requirements for and potential adverse effects of the opioid. The use of ketamine in conjunction with morphine has become popular with the Acute Pain Service of the author's hospital. However, the only reported stability data that have been found for this combination stored in syringes were for 6 days at room temperature.
To conduct a compatibility and stability study with the ultimate aim of extending the current expiry date for the concentrations of ketamine and morphine combinations used at the author's institution and thus to allow batch production of mixtures of these drugs without increasing wastage.
Commercial solutions of ketamine (50 mg/mL) and morphine sulphate (50 mg/mL) were combined and further diluted with 0.9% sodium chloride to final concentrations of ketamine 2 mg/mL and morphine 2, 5, or 10 mg/mL; the resulting mixtures were packaged in polypropylene syringes. The syringes were stored at either 23°C or 5°C for 91 days. The following physical compatibility parameters were monitored: clarity, colour, and pH. Chemical stability was determined with a validated stability-indicating high-performance liquid chromatography system.
Over the 91 days, all solutions remained clear and colourless, and the pH did not change significantly. The concentration of each drug in the various solutions remained above 98% of the original concentration for both storage conditions for the duration of the study.
Solutions of ketamine (2 mg/mL) combined with morphine (2, 5, or 10 mg/mL) were physically compatible and chemically stable for 91 days when diluted with normal saline, packaged in polypropylene syringes, and stored at either 23°C or 5°C.
将少量氯胺酮与麻醉剂合用有助于减少阿片类药物的用量及其潜在不良反应。氯胺酮与吗啡联合使用在作者所在医院的急性疼痛服务中已很普遍。然而,已发现的关于该组合储存在注射器中的唯一稳定性数据是在室温下保存6天的情况。
进行一项配伍性和稳定性研究,最终目的是延长作者所在机构使用的氯胺酮和吗啡组合浓度的当前有效期,从而允许批量生产这些药物的混合物而不增加浪费。
将氯胺酮(50 mg/mL)和硫酸吗啡(50 mg/mL)的商业溶液混合,并用0.9%氯化钠进一步稀释至氯胺酮终浓度为2 mg/mL,吗啡终浓度为2、5或10 mg/mL;将所得混合物包装在聚丙烯注射器中。注射器分别在23°C或5°C下储存91天。监测以下物理配伍性参数:澄清度、颜色和pH值。用经过验证的稳定性指示高效液相色谱系统测定化学稳定性。
在91天内,所有溶液均保持澄清无色,pH值无明显变化。在研究期间,两种储存条件下各种溶液中每种药物的浓度均保持在原始浓度的98%以上。
当用生理盐水稀释、包装在聚丙烯注射器中并在23°C或5°C下储存时,氯胺酮(2 mg/mL)与吗啡(2、5或10 mg/mL)的溶液在物理上是配伍的,化学上是稳定的,为期91天。