Clean Analysis Not to Use Harmful Solvent for TLC Identification Test of the Herbal Medicine

생약의 확인시험법에 대한 유해용매 대체시험법 설정

  • Received : 2010.01.23
  • Accepted : 2010.05.26
  • Published : 2010.06.30

Abstract

This study was carried out to utilize non-toxic solvents instead of harmful solvents for the TLC(Thin Layer Chromatography) identification test of herbal medicines. It is recommended not to use harmful solvent such as chloroform at a viewpoint of clean analysis. In this study, we revised the identification test of 10 items in the Korea Pharmacopoeia(KP) and the Korean Herbal Pharmacopoeia(KHP) such as Cornus officinalis S. containing the harmful solvents on the developing solvent and established identification test that is utilized non-toxic solvents by HPTLC(High Performance Thin Layer Chromatography).

Keywords

References

  1. WHO Western Pacific Regional Forum on Harmonization of Herbal Medicines Activity Report (2006).
  2. WHO Western Pacific Regional Forum on Harmonization of Herbal Medicines Activity Report (2008).
  3. 대한약전 제9개정 (2007) 식품의약품안전청, 서울.
  4. 대한약전외한약(생약)규격집 (2007) 식품의약품안전청, 서울
  5. 의약품잔류용매기준지침 (2007) 식품의약품안전청, 서울
  6. Proceedings of International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Guideline Q3B Impurities in New Drug Products (1997), 스위스.
  7. David, J. K. and McGovern, T. (2007) Toxicological overview of impurities in pharmaceutical products. Advanced Drug Delivery Reviews 59(1): 38-42. https://doi.org/10.1016/j.addr.2006.10.007
  8. WHO Western Pacific Regional Forum on Harmonization of Herbal Medicines Activity Report (2009).
  9. Heipieper, H. J., Weber, F. J., Sikkema, J. and Keweloh, H. (1994) Mechanism of resistance of whole cells to toxic organic solvents. Trends in Biotechnology 12(10): 409-415. https://doi.org/10.1016/0167-7799(94)90029-9
  10. Branch, S. K. (2005) Guidelines from the international conference on harmonisation(ICH). Journal of Pharmaceutical and Biomedical Analysis 38(5): 798-805. https://doi.org/10.1016/j.jpba.2005.02.037
  11. Witschi, C. and Doelker, E. (1997) Residual solvents in pharmaceutical products: acceptable limits, influences on physicochemical properties, analytical methods and documented values. Eur. J. Pharm. Biopharm. 43: 215-242. https://doi.org/10.1016/S0939-6411(96)00037-9
  12. Camarasu, C., Madichie, C. and Williams, R. (2006) Recent progress in the determination of volatile impurities in pharmaceuticals. TrAC, Trends anal. Chem. 25: 768-777. https://doi.org/10.1016/j.trac.2006.05.013
  13. Boehlert, J. P. (2000) Regulatory aspects: ICH and pharmacopoeial perspectives. Progress in Pharmaceutical and Biomedical Analysis 4:48-66.
  14. Branch, S. K. (2005) Guidelines from the International Conference on Harmonisation (ICH). Journal of Pharmaceutical and Biomedical Analysis 38(5): 798-805. https://doi.org/10.1016/j.jpba.2005.02.037