[时间域NMR研究评估药物剂量形式的物理性质,用于过程分析]
1Faculty of Pharmaceutical Sciences, University of Toyama.
Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan
|November 1, 2023
概括
时间域NMR (TD-NMR) 有效地评估药物配方的物理性质,如结晶性和可混合性. 这种技术为制药过程分析和质量控制提供了有价值的工具.
科学领域:
- 制药科学 制药科学
- 分析化学 分析化学
- 材料科学 材料科学 材料科学
背景情况:
- 时间域核磁共振 (TD-NMR) 是评估材料特性的一种多功能技术.
- 虽然在食品科学中广泛使用,但其在制药行业的应用仍然有限.
- TD-NMR使用NMR放松测量,主要是用基板低场系统,简化样品处理.
研究的目的:
- 调查TD-NMR对药物配方物理性质的特征的有用性.
- 探索TD-NMR在药品质量控制和过程分析中的潜力.
主要方法:
- 进行了T1和T2放松时间的TD-NMR测量.
- 分析包括将放松曲线与适当的数学模型相匹配,以确定时间常数.
- 研究的重点是固体剂型,二元药物辅助剂混合物和含水量不同的物理混合物.
主要成果:
- T1放松测量成功评估了固体剂型中的药物结晶性.
- 在评估二元混合物中药物辅助剂混合性方面,T1放松也被证明是有效的.
- T2放松测量量定量确定了物理混合物中的药物的固体形式,即使吸附水分.
结论:
- TD-NMR是一种强大的技术,用于评估各种制药配方的物理性质,包括固体和液体形式.
- 该技术显示出在制药过程分析和质量控制中应用的重大前景.
- TD-NMR提供了一种有价值,易于使用的药物表征方法,超出了其在食品科学中的传统用途.
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