《中国药典》2025年版牛黄类药材质量标准修订解读

Interpretation of the Revision of Quality Standards for Bezoars in the 2025 Edition of the Pharmacopeia of the People's Republic of China

关键词:  《中国药典》2025年版  牛黄  人工牛黄  体外培育牛黄  质量标准  修订

Key words:  Chinese Pharmacopoeia 2025 Edition  BOVIS CALCULUS  BOVIS CALCULUS ARTIFACTUS  BOVIS CALCULUS SATIVUS  quality standard  revision

摘要:

《中国药典》2025年版对牛黄、体外培育牛黄及人工牛黄的质量标准进行了系统性的修订,聚焦解决原标准存在的专属性不足、掺伪难识别、内在质量评价不精准三大核心问题,通过广泛引入高效液相色谱法等分析技术,建立了以胆酸类和胆红素类成分为核心的专属质控体系。重点增设了游离胆酸检查项目,优化了胆红素和胆酸类成分含量测定方法,并针对不同品种特性完善了质控标准。这些修订内容显著提升了牛黄类药材的质量控制水平,为有效防控市场掺伪掺杂、保障牛黄类药材及其制剂的安全性与有效性、推动行业规范化及高质量发展奠定了基础。

Abstract:

ABSTRACT: The 2025 Edition of the Pharmacopoeia of the People""s Republic of China has carried out systematic revisions to the quality standards for bezoar, in vitro cultivated bezoar, and artificial bezoar. Focusing on solving the three core problems existing in the original standards, namely insufficient specificity, difficulty in identifying adulteration, and inaccurate evaluation of intrinsic quality, it has established an exclusive quality control system centered on cholic acid and bilirubin components by widely introducing analytical technologies such as high-performance liquid chromatography (HPLC). Key revisions include the addition of free cholic acid inspection, optimization of the content determination methods for bilirubin and cholic acids, and improvement of quality control indicators according to the characteristics of different varieties. These amendments have significantly enhanced the quality control level of bezoar-related medicinal materials, laying a foundation for effectively preventing market adulteration, ensuring the safety and efficacy of bezoar-related medicinal materials and their preparations, and promoting the standardized and high-quality development of the industry.