我国药用辅料蔗糖标准现状及发展建议

Current Status and Suggestions for Future Development of Standards on Sucrose for Pharmaceutical Excipients in China

蔗糖作为一种关键的药用辅料,其在医药领域的应用极为广泛。然而,我国现行的药用辅料蔗糖标准与国际标准之间存在显著差异,这可能影响药品的质量和安全性。本研究旨在深入分析药用辅料蔗糖的基本情况、国内外产品标准的差异、行业发展中存在的问题,并提出相应的发展建议,确立科学合理的药用辅料蔗糖标准对于提升药品质量、保障用药安全具有至关重要的意义。国家药品标准管理部门可进一步细化《中国药典》指标要求,加强指标体系建设;生产企业应加强生产管理,确保生产过程中的质量控制。

As a crucial pharmaceutical excipient,sucrose was extensively utilized in the pharmaceutical field.However,there are significant differences between the current standards for pharmaceutical excipient sucrose in China and those in other countries,which may impact the quality and safety of pharmaceuticals.This paper aims to conduct an in�depth analysis of the basic situation of pharmaceutical sucrose,the discrepancies in domestic and international product standards,and the problems in industry development,and proposes corresponding development recommendations.Establishing a scientifically sound standard for pharmaceutical excipient sucrose is of vital importance for enhancing pharmaceutical quality and ensuring medication safety.The national pharmaceutical standard management department should refine the domestic standard and strengthen the construction of the standards system.The production enterprises should enhance production management to ensure quality control throughout the production process.