通过测量水活动,对散布的粉末原材料进行稳定性研究
Harold A Prada-Ramírez1, Juan Pablo Montes-Tamara2, Eduardo A Rico-Jimenez1
1Laboratorios Coaspharma S.A.S., CL 18A 28A-43, Bogota 111411, Colombia.
Journal of AOAC International
|January 13, 2024
概括
原材料中的水活性低于0.60,可以防止微生物生长,并保持质量. 这项研究证实了水的活性作为一个可靠的指标,药物材料稳定性在持有时间.
科学领域:
- 制药科学 制药科学
- 食品科学 食品科学 食品科学
- 微生物学 微生物学
背景情况:
- 原材料的保留时间对于在制造前保持质量至关重要.
- 水活动 (aw) 是微生物,物理化学和感官稳定的关键指标.
- 低水平的aw抑制了自解和微生物的增殖.
研究的目的:
- 通过使用水活动测量,在8天的持有期内评估粉状原材料的稳定性.
- 为了确定水活动与微生物学,物理化学和感官参数之间的相关性.
- 根据水的活动来确定原材料的最大允许保留时间.
主要方法:
- 粉状原料在受控条件下存储长达8天.
- 在0日,3日和8日使用露点冷却镜法测量了水的活动.
- 在0日和8日进行了微生物学,物理化学和感官评估.
主要成果:
- 在整个8天的持有期内,原材料始终保持水活性低于0.60.
- 随着时间的推移,观察到水活动的统计学意义上的变化 (ANOVA P < 0.05).
- 尽管水活动发生了显著的变化,但所有测试参数都保持在可接受的规格范围内.
结论:
- 低于0.60的水活性有效地阻止微生物生长,并保持有机感和物理化学完整性.
- 水活动是评估原材料微生物负载和化学稳定性的可靠指标.
- 这项研究验证了在药物稳定性研究中使用水活性来监测材料质量.
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