Interpretation of the Revision of Quality Standards for Bovis Calculus in the Chinese Pharmacopoeia 2025 Edition

The Chinese Pharmacopoeia 2025 Edition has carried out systematic revisions to the quality standards for bovis calculus, bovis calculus artifactus, and bovis calculus sativus. Focusing on solving the 3 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. 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.