Comparative Analysis of Quality Requirements for Medicines Based on Horse-Chestnut Seeds

Abstract

Scientific relevance. When harmonising conditions for qualitative and quantitative analysis of bioactive compounds in herbal medicines, the Institute of Pharmacopoeia and Medicinal Product Standardisation has discovered that horse-chestnut products lack national quality standards.Aim. This study aimed to review international quality standards in order to identify the most promising testing methods for the main groups of bioactive compounds in horse-chestnut seeds and draw upon these methods when drafting national pharmacopoeial monographs for horse-chestnut seed products.Discussion. The authors compared the requirements established by leading world pharmacopoeias for the identification and assay of herbal drugs and herbal drug preparations derived from horse-chestnut seeds.Conclusions. The study results show that, predominantly, identification tests are based on thin-layer chromatography, assays rely on spectrophotometry, and aescin is used as a pharmacopoeial reference standard. The authors drafted a pharmacopoeial monograph for the medicinal product Horse-Chestnut Seed Dry Extract + Thiamine Hydrochloride, Oral Solution, which requires using thin-layer chromatography and spectrophotometry for qualitative and quantitative testing.