Safety of Children’s Traditional Chinese Medicine Decoction Pieces in Clinical Application and Children’s Drug Development

doi:10.19803/j.1672-8629.20240704

Abstract

Abstract: Objective To give tips about the clinical application and development of traditional Chinese medicine decoction pieces for children based on the 2020 edition of the Pharmacopoeia of the People's Republic of China (ChP 2020). Methods The children’s decoction pieces specified in the ChP 2020 were categorized before safety risks were analyzed. Results The ChP 2020 covered a total of 616 types of traditional Chinese medicine decoction pieces, 26 of which were specifically related to children. Among them, one type had both indications and dosage for children, 23 had indications for children only, one had only dosage for children, and one was prohibited for children. Among the 24 herbal medicines with indications for children, the most commonly used indication was infantile malnutrition, and a total of 3 drugs were labeled as “toxic” and 2 as “slightly toxic”. Conclusion It is recommended that basic research on pharmacy and toxicology related to indications and TCM decoction pieces, adverse drug reactions in children be reported, and related standards be improved so as to facilitate safe medication and drug development.

Key words: Children, Traditional Chinese Medicine Decoction Pieces, Safety, Pharmacopoeia of the People’s Republic of China, Drug Development

CLC Number:

R985
994.11

JIA Zhichao, HU Siyuan, LI Ruiben, XU Yaqian. Safety of Children’s Traditional Chinese Medicine Decoction Pieces in Clinical Application and Children’s Drug Development[J]. Chinese Journal of Pharmacovigilance, 2025, 22(3): 324-328.

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https://zgywjj.magtechjournal.com/EN/Y2025/V22/I3/324

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