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HPTLC를 이용한 표준생약의 안정성 평가 연구

Stability Evaluation Study for Reference HPTLC of Herbal Medicine

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한국약용작물학회 (The Korean Society of Medicinal Crop Science)
초록

Background : Recently, there has been an increase in the use of herbal drugs for healthcare. The reference standards of herbal medicine is used to quality control for herbal medicines. It have been produced and re-evaluated by Ministry of Food and Drug Safety, starting from 2002. In this study, we re-tested the quality of a variety of Herbal Reference Standards (HRS). We analyze the HRSs with identification test by High Performance Thin Layer Chromatography (HPTLC). All test is based on experimental method of the Korean Pharmacopoeia, the Korea Herbal Pharmacopoeia.
Methods and Results : To check the stability of reference standards of herbal medicine, we annually performe real-time monitoring under storage condition (4℃). The aim of this study is to perform a stability testing for 200 national reference standards to ensure the reliability of standards. For example, there are reference standards of Osterici Radix, Polygoni Multiflori Radix, Lithospermi Radix etc. It was achieved by comparing the colors and Rf values of the bands in TLC with those of the marker compounds using High Performance Thin Layer Chromatography (HPTLC). Tests for each item are based on experimental methods of the official compendium or the previous study on establishment of HRSs. Through re-test system, we confirm stability and reliability of HRSs condition. Also, based on the results, these HRSs will be continuously supplied as Herbal Reference Standards of MFDS.
Conclusion : As the result, the HPTLC results showed the same TLC patterns as compared with previous reports. Based on the all results that we will update the each certificate of analysis. We want to contribute for quality control of herbal medicines.

저자
  • 이지선(식품의약품안전평가원 생약연구과) | Ji Sun Lee
  • 이민지(식품의약품안전평가원 생약연구과) | Min Ji Lee
  • 박혜영(식품의약품안전평가원 생약연구과) | Hye Young Park
  • 강일현(식품의약품안전평가원 생약연구과) | Il hyun Kang
  • 강주혜(식품의약품안전평가원 생약연구과) | Ju Hye Kang Corresponding author