洛萨坦酸液体配方用于儿童医院使用:发展和稳定性评估评估
Augusto César Corte1, Caren Gobetti1, Graciela Carlos1
1Programa de Pós-Graduação em Ciências Farmacêuticas, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.
概括
开发了一种新的液态洛萨坦制剂,用于儿科. 抗高血压糖在冷藏下在PET和玻璃包装中表现为21天的稳定性.
科学领域:
- 制药科学 制药科学
- 药物的配方 药物的配方
- 稳定性研究 稳定性研究
背景情况:
- 洛沙坦是一种用于高血压的血管素II受体对抗剂.
- 儿科患者需要适合年龄和口感的药物形式.
- 医院的日常工作可以通过稳定,准备好使用的液体配方来简化.
研究的目的:
- 为了开发一个稳定的液体口服配方的洛萨坦.
- 评估不同储存条件下的配方的初步稳定性.
- 确保儿科治疗的遵守,并促进医院管理.
主要方法:
- 准备了一种含有洛萨坦 (1.0 和 2.5 毫克/毫升) 的糖和标准辅助剂.
- 在珀色PET和玻璃瓶中的包装配方.
- 在室温 (15-30°C),冷藏 (2-8°C) 和烤箱温度 (40°C) 下保存样品28天.
- 开发并验证了一种稳定性指示HPLC方法用于药物定量.
主要成果:
- 该HPLC方法在线性,准确性,精度和稳定性方面得到了验证.
- 在室温下储存的配方在7天内保持了90-110%的药物含量.
- 冷藏样品 (2-8°C) 保持稳定 (90-110%含量) 和均21天.
- pH 值保持稳定,粘度在两种瓶类型的可接受范围内.
结论:
- 成功开发了一种简单,经济的液态洛萨坦制剂.
- 该配方在冷藏下存储21天后显示出足够的稳定性.
- 无论是PET包装还是玻璃包装都适合冷藏液体配方.
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