在短期冷藏和环境温度储存期间,二甲醇5w/v%水溶液的稳定性
Masakazu Dohi1, Kayoko Ueda1, Yoshinori Yamagiwa1
1Central Research Laboratories, Research & Development Division, Senju Pharmaceutical Co. Ltd., Kobe, Hyogo, Japan.
Veterinary medicine and science
|October 26, 2024
概括
非药品级丁巴比特 (PBNa) 水溶液在短时间内作为注射麻醉剂使用时表现出稳定性. 这一发现提供了一个可行的替代品,当药品等级的选择是不可用的.
科学领域:
- 兽医药理学 兽医药理学
- 药物稳定性研究 药物稳定性研究
背景情况:
- 由于COVID-19的流行,日本的动物研究中药品级注射麻醉剂的供应受到干扰.
- 对必要麻醉剂的有限获取需要探索替代配方.
研究的目的:
- 评估非药品级巴比特 (PBNa) 水溶液作为潜在的麻醉替代品的稳定性和物理化学特性.
- 评估PBNa 5% 水溶液 (PBNa 5% AS) 适合短期使用的情况.
主要方法:
- 使用非药品级的PBNa和水制备了PBNa 5% AS.
- 样品在25°C和5°C下储存了15天.
- 通过监测视觉外观,pH值,度和PBNa含量 (试剂和相关物质) 来评估稳定性.
主要成果:
- 在测试条件下,PBNa 5% AS在视觉外观,pH或度上没有显著变化.
- 测试和相关物质水平保持稳定,在25°C时,杂质的增加可以忽略不计.
- 配方的pH值保持在10.0以下,表明可以接受的刺激水平.
结论:
- 非药品级PBNa 5% AS显示出足够的稳定性和可接受的物理化学特性,适用于短期使用.
- 这种配方可以作为一种实用的替代麻醉剂,当药品级产品无法获得时.
- 需要进一步评估生物可用性和长期稳定性.
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