Central Research Laboratories, Research & Development Division, Senju Pharmaceutical Co. Ltd., Kobe, Hyogo, Japan.
Vet Med Sci. 2024 Nov;10(6):e70066. doi: 10.1002/vms3.70066.
The COVID-19 pandemic made it difficult to obtain pharmaceutical-grade injectable anaesthetics used in animal experiments in Japan. To address this problem, it is worth the effort to evaluate whether the use of non-pharmaceutical-grade sodium pentobarbital (PBNa) water solution can be an alternative one from the perspective of stability, physicochemical properties, bioavailability and so on. In this article, as a first step, we examined the stability of PBNa 5w/v% aqueous solution (PBNa 5% AS). PBNa 5% AS sample was prepared simply by dissolving non-pharmaceutical-grade PBNa into water and was stored at 25°C and 5°C for 15 days. Visual appearance, pH, osmolality and assay (contents of PBNa and related substances) were tested. The stability test results indicated that there was no profound change in these test items of the PBNa 5% AS under either storage condition, suggesting that the formulation was sufficiently stable in such a short term. The only observable change was an increase of an impurity under 25°C storage; however, it was at a negligible level. Moreover, as the pH of the formulation remained <10.0 throughout the storage period in both conditions, the irritant level of the pH is considered to be acceptable. Therefore, from the viewpoint of the stability and physicochemical properties, PBNa 5% AS can be an alternative injectable anaesthetic when access to pharmaceutical-grade anaesthetics is limited, as long as used in short-term from its preparation.
新型冠状病毒病大流行使得在日本难以获得用于动物实验的医药级注射用麻醉剂。为了解决这个问题，从稳定性、物理化学性质、生物利用度等方面评估是否可以使用非医药级戊巴比妥钠（PBNa）水溶液替代具有一定的价值。在本文中，作为第一步，我们检查了 5w/v%戊巴比妥钠水溶液（PBNa 5% AS）的稳定性。PBNa 5% AS 样品通过将非医药级 PBNa 溶解于水中简单制备，并在 25°C 和 5°C 下储存 15 天。测试了外观、pH 值、渗透压和含量分析（PBNa 和相关物质的含量）。稳定性测试结果表明，无论在何种储存条件下，该 PBNa 5% AS 的这些测试项目均无明显变化，表明在如此短的时间内配方足够稳定。唯一可观察到的变化是在 25°C 储存条件下杂质增加，但处于可忽略水平。此外，由于在两种条件下，制剂的 pH 值均保持在<10.0，因此认为 pH 值的刺激性水平是可以接受的。因此，只要从制备之日起短期使用，在获得医药级麻醉剂受到限制的情况下，PBNa 5% AS 可以作为替代注射用麻醉剂。
