药品、生物制品及相关样品中蔗糖含量分析方法的研究进展

蔗糖是一种常见的辅料，在药品和生物制品中均应用广泛。蔗糖的含量往往对制剂的有效性、稳定性和安全性存在一定影响，因此在质量控制中有必要选用合适的方法对蔗糖进行定量。蔗糖含量的分析方法具有多样性，除了传统的基于氧化还原反应的经典化学方法和旋光法外，目前常用的分析方法包括高效液相色谱法、气相色谱法、近红外光谱法、毛细管电泳法等。不同的检测方式均有各自的应用优势和局限性。本文对蔗糖含量的各类分析方法的原理及应用要点进行综述，同时介绍了不同方法的优缺点和适用条件，以期为实际工作中检测方法的选用提供参考。

Progress on Analytical Methods for Sucrose Determination in Pharmaceuticals, Biological Productions and Associated Samples

Sucrose, a commonly employed excipient in pharmaceuticals and biological products, significantly impacts the efficacy, stability, and safety of formulations. Hence, the adoption of suitable techniques for quantitative analysis of sucrose in quality control becomes imperative. Except for classical chemical methods based on redox reactions and polarimetry, the array of analytical methods for determining sucrose content encompasses high-performance liquid chromatography, gas chromatography, near-infrared spectroscopy, capillary electrophoresis among others. Each detection method exhibits distinct advantages and limitations. This review article elucidates the principles and practical applications of various analytical methods for sucrose, offering an evaluation of the strengths, weaknesses, and applicable conditions associated with each technique, so as to provide guidance for selecting suitable detection methods in practical endeavors.