在不同存储条件下,糖甲酸口服溶液烯化合物的长期稳定性
Barbara Bellich1, Martina Franzin1, Debora Curci1
1Institute for Maternal and Child Health, IRCCS "Burlo Garofolo", Via dell'Istria 65/1, 34137 Trieste, Italy.
Pharmaceutics
|August 29, 2024
概括
这项研究评估了口服葡萄糖酸盐溶液的稳定性. 葡萄糖酸盐口服溶液在各种条件下长时间稳定,确保了儿科病治疗的质量.
科学领域:
- 制药化学 制药化学 制药化学
- 药物稳定性研究 药物稳定性研究
- 儿科药理学 儿科药理学
背景情况:
- 葡萄糖酸盐是治疗儿科病的关键肌肉抗剂.
- 了解草甘酸盐口服溶液的稳定性对于维持治疗疗效至关重要.
- 活性药物成分 (API) 的降解会影响药物的安全性和有效性.
研究的目的:
- 为了评估草甘甲酸口服溶液 (0.5 mg/mL) 的化学稳定性.
- 为了研究不同储存容器 (玻璃,PET) 和温度 (室温,4°C,45°C) 对糖烯酸盐稳定性的影响.
- 确保儿童患者用糖酸盐口服剂型的质量和长期可用性.
主要方法:
- 使用高性能液体染色学与紫外线检测 (HPLC-UV) 进行稳定性评估.
- 根据国际协调理事会 (ICH) 的Q2~R2指南验证了分析方法.
- 在受控条件下进行稳定性研究,模拟各种存储场景.
主要成果:
- 在大多数测试条件下,甘酸口服溶液保持稳定 (100±10%的标称度).
- 超过可接受限度的降解仅在2个月后在45°C的玻璃容器中观察到.
- 在玻璃和PET容器中,在室温或4°C下至少210天的稳定性得到证实.
结论:
- 口服液体甘酸剂型在建议的储存条件下表现出极好的稳定性.
- 该药物长时间保持了欧洲药典规定的质量标准.
- 这确保了儿童患者的可靠的治疗覆盖.
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