Department of Laboratory, CHU UCL, Namur, Yvoir, Belgium
Department of Laboratory, CHU UCL, Namur, Yvoir, Belgium.
Eur J Hosp Pharm. 2023 Mar;30(e1):e35-e39. doi: 10.1136/ejhpharm-2021-002940. Epub 2021 Nov 10.
Clonidine is an alpha-2 adrenoreceptor agonist and is frequently combined with opioids (ie, morphine hydrochloride (HCl)) for the management of chronic pain. In palliative care, the administration of clonidine and morphine HCl is recommended in case of tolerance effect. This study aimed to evaluate the physical and chemical stability of this admixture at high and low concentrations in 14 and 48 mL polypropylene syringes.
The stability of a low concentration admixture of clonidine (Catapressan 0.15 mg/mL, Boehringer Ingelheim, Germany) and morphine (morphine HCl 40 mg/mL, Sterop, Belgium) at 0.003 and 0.417 mg/mL, respectively, was evaluated by using five polypropylene syringes of 48 mL. The high concentration admixture consisted of 0.032 mg/mL clonidine and 4.286 mg/mL morphine HCl and was evaluated by using five polypropylene syringes of 14 mL. All syringes were stored for 30 days at 5°C±3°C. Periodic samples were visually and microscopically examined to observe any particle appearance or colour change. pH and absorbance at three wavelengths (350, 410 and 550 nm) were monitored. The concentrations were measured by ultra-high performance liquid chromatography-photodiode array detection.
During the 30 days, there was no change in colour or appearance of opacity, turbidity or precipitation, and pH remained stable. The low and high concentration admixtures were considered chemically stable since the lower limit of the 90% CI remained superior to 90% of the initial concentration. Concentration measurements showed that the degradation rate was less than 1% over 10 days for each component in both admixtures.
The admixture of clonidine and morphine HCl at low and high concentrations in polypropylene syringes appeared to be physically and chemically stable throughout the study period of 30 days at 5°C±3°C. In conclusion, the admixture can be prepared in advance under aseptic conditions by a centralised intravenous additive service in the pharmacy department.
可乐定是一种 α2 肾上腺素受体激动剂，常与阿片类药物（如盐酸吗啡（HCl））联合用于慢性疼痛的治疗。在姑息治疗中，建议在出现耐受效应时使用可乐定和盐酸吗啡。本研究旨在评估高、低浓度下该混合物在 14 和 48 mL 聚丙烯注射器中的物理和化学稳定性。
使用 5 个 48 mL 聚丙烯注射器评估低浓度可乐定（Boehringer Ingelheim，德国生产的 Catapressan 0.15mg/mL）和吗啡（Sterop，比利时生产的盐酸吗啡 40mg/mL）混合物的浓度分别为 0.003 和 0.417mg/mL 的稳定性。高浓度混合物由 0.032mg/mL 可乐定和 4.286mg/mL 盐酸吗啡组成，使用 5 个 14 mL 聚丙烯注射器进行评估。所有注射器在 5°C±3°C 下储存 30 天。定期取样进行目视和显微镜检查，观察任何颗粒外观或颜色变化。监测 pH 值和三个波长（350、410 和 550nm）的吸光度。浓度通过超高效液相色谱-光电二极管阵列检测法测量。
在 30 天内，颜色或不透明、浑浊或沉淀的外观没有变化，pH 值保持稳定。低浓度和高浓度混合物被认为是化学稳定的，因为 90%置信区间的下限仍高于初始浓度的 90%。浓度测量结果表明，在两种混合物中，每个成分的降解率在 10 天内都小于 1%。
在 5°C±3°C 下，30 天的研究期间，低浓度和高浓度的可乐定和盐酸吗啡在聚丙烯注射器中的混合物在物理和化学上似乎是稳定的。总之，该混合物可以由药房部门的中央静脉添加剂服务在无菌条件下预先制备。
