创新链/学科链/研发链/产业链

新药研发前沿动态 / 医药领域趋势进展

脂质药用辅料氧化指标的研究现状与挑战

Research Status and Challenges of Oxidation Indexes of Lipid-Based Pharmaceutical Excipients

  • 摘要: 脂质药用辅料的氧化监测对于确保药品的质量和安全性至关重要。目前各国药典已收载的适用于脂质药用辅料的氧化指标包含过氧化值、甲氧基苯胺值和总氧化值,各国药典未收载但相关行业标准已收载或文献研究报道的氧化指标包含共轭二烯值、硫代巴比妥酸值和羰基值。综述脂质药用辅料氧化指标的研究现状,分析其适用性和局限性及面临挑战,以期为脂质药用辅料的氧化监测提供参考。

     

    Abstract: The oxidation monitoring of lipid-based pharmaceutical excipients is crucial for ensuring the quality and safety of pharmaceutical products. The oxidation indexes applicable to lipid-based pharmaceutical excipients currently included in the pharmacopoeias of various countries encompass the peroxide value, anisidine value, and total oxidation value. Additionally, indexes such as the conjugated diene value, thiobarbituric acid value, and carbonyl value, which are not officially included in the pharmacopoeia but have been documented in relevant industry standards and literature, are also used to assess the oxidative status of lipid-based pharmaceutical excipients. This review examines the current research on these oxidation indexes for lipid-based pharmaceutical excipients, and analyzes their applicability, limitations, and challenges, aiming to provide some reference for the oxidation monitoring of lipid-based pharmaceutical excipients.

     

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