YAKHAK HOEJI (약학회지)

The Pharmaceutical Society of Korea (대한약학회)
권호 표지

Validation and Determination of Glycyrrhizic Acid as a Marker Substance in Bu-Zhong-Yi-Qi-Tang by HPLC/DAD

HPLC/DAD에 의한 보중익기탕 중의 글리시리진산 정량분석법의 확립

  • Baek, Ju-Hyun (College of Pharmacy, Dongduk Women's University) ;
  • Kim, Sun-Min (College of Pharmacy, Dongduk Women's University) ;
  • Ahn, Ji-Won (College of Pharmacy, Dongduk Women's University) ;
  • Cho, Chang-Hee (Herbal Medicinal Products Team, Korea Food & Drug Administration) ;
  • Oh, Mi-Hyune (Herbal Medicinal Products Team, Korea Food & Drug Administration) ;
  • Cho, Jung-Hee (Herbal Medicinal Products Team, Korea Food & Drug Administration) ;
  • Lee, Mi-Kyeong (Institute for Life Science, Elcom Science Co. Ltd.) ;
  • Kim, Hyo-Jin (College of Pharmacy, Dongduk Women's University)
  • 백주현 (동덕여자대학교 약학대학) ;
  • 김선민 (동덕여자대학교 약학대학) ;
  • 안지원 (동덕여자대학교 약학대학) ;
  • 조창희 (식품의약품안전청 생약제제팀) ;
  • 오미현 (식품의약품안전청 생약제제팀) ;
  • 조정희 (식품의약품안전청 생약제제팀) ;
  • 이미경 ((주)엘컴사이언스) ;
  • 김효진 (동덕여자대학교 약학대학)
  • Published : 2008.02.29
Download PDF
⟨ Previous Next ⟩

Abstract

A high performance liquid chromatographic (HPLC) method for the determination of glycyrrhizic acid was developed for the quality control of traditional herbal medicinal preparation Bu-Zhong-Yi-Qi-Tang (BZYQT), which is well-known herbal medicine used as tonic. RP-HPLC analysis was carried out using Capcell pak $C_{18}$ MG column $(5\;{\mu},\;150{\times}4.6\;mm)$ and a mobile phase consisting of acetonitrile and water containing 0.03% phosphoric acid (pH 2.46) at a flow rate of 1.0 ml/min. The optimum wavelength for the detection of the glycyrrhizic acid was found at 250 nm using diode-array UV/VIS detector. The glycyrrhizic acid in BZYQT shows good linearity $(r^2>0.999)$ in the range of $15\;{\mu}g/ml$ to 500 ${\mu}g/ml$. The limit of detection (LOD) was less than 5 ng and R.S.D for intra-day and inter-day reproducibility was less than 7%. The mean recovery of the glycyrrhizic acid was $97.3{\sim}113.0%$. These results suggest that the developed HPLC method is simple and efficient, and could be contributed for the quality control of commercial BZYQT products.

Keywords

References

  1. 박영순 : 한방의 약리해설, 제2판, 아카데미서적, 서울 (2002)
  2. 한약처방의 종류 및 조제방법에 관한 규정 보건복지부 고시 제 1995-15호, 1995.3.15
  3. 김호현 : 보중익기탕 합 향사육군자탕이 복수암 유발 생쥐 비장의 세포성 면역활성에 미치는 영향에 관한면역조직화학적 연구. 한의학연구소 논문집 3, 17 (2001)
  4. 안광무 : 보중익기탕 및 소음인 보중익기탕이 S-180에 대한 항종양효과와 cyclophosphamide에 의한 부작용에 미치는 영향. 동의병리학회지 3, 119 (1993)
  5. 류종훈, 김민선, 황영선, 육창수 :　Elevated plus-maze를 이용한 신기환, 보중익기탕 및 사물탕의 항불안 효과. 응용약물학회지 9, 125 (2001)
  6. 엄재원, 정석희, 이종수, 김성수, 신현대 : 보중익기탕과 사물탕이 골다공증에 미치는 임상적 연구. 한국재활의학과학회지 9, 59 (1999)
  7. 박성민 : 보중익기탕과 육미지황탕이 노화촉진생쥐(SAM)의 간장내 항산화작용에 미치는 영향. 대한본초학회지 18, 175 (2003)
  8. Onogi, K., Niwa, K., Tang, L., Yun, W., Mori, H. and Tamaya, T. : Inhibitory effects of Hochu-ekki-to on endometrial carcinogenesis induced by N-methyl-N-nitrosourea and 17beta-estradiol in mice. Oncol. Rep. 16, 1343 (2006)
  9. Kobure, T., Tatsumi, T., Niizawa, A., Fujinaga, H., Shimada, Y. and Terasawa, K. : Population of CD40L-expressing cells was slightly but not significantly decreaseed in lyphoid tissues of collagen-induced arthritic mice treated with Hochu-Ekki-To. Yakugaku Zasshi 127, 547 (2007)
  10. Kiyohara, H., Nagai, T., Munakata, K., Nonaka, K., Hanawa, T., Kim, S. J. and Yamada, H. : Stimulating effect of Japanese herbal (kampo) medicine, hochuekkito on upper respiratory mucosal immune system. Evid Based Complement Alternat Med. 3, 459 (2006)
  11. Tajima, S., Bado, M., Yamasawa, H., Ohno, S., Moriyama, H., Takada, T., Suzuki, E., Gejyo, F. and Sugiyama, Y. : Preventive effect of Hochu-ekki-to on lipopolysaccharide-induced acute lung injury in BALB/c mice. Lung 184, 318 (2006)
  12. Hamazaki, K., Sawazaki, S., Itomura, M., Huan, M., Shibahara, N., Kawakita, T., Kobayashi, S. and Hamazaki, T. : No effect of a traditional chinese medicine, Hochu-ekki-to, on antibody titer after influenza vaccination in man: a randomized, placebocontrolled, double-blind trial. Phytomedicine 14, 11 (2006)
  13. Kuroiwa, A., Liou, S., Yan, H., Eshita, A., Naitoh, S. and Nagayama, A. : Effect of a traditional Japanese herbal medicine, hochu-ekki-to (Bu-Zhong-Yi-Qi-Tang), on immunity in elderly persons. Int. Immunopharmacol. 4, 317 (2004)
  14. 한대양 : 생약학, 10판, 동명사, 서울, p.10 (1998)
  15. 김효진 : 반하백출천마탕에 대한 HPLC 동시정량법 및 TLC 확인 시험법의 확립. 동덕약학연구지 10, 16 (2006)
  16. Gerritsma, K. W. and van der Vijver, L. M. : The determination of glycyrrhizinic acid content in Radix glycyrrhizae and its compounds. Pharm. Weekbl. 101, 733 (1966)
  17. Ogawa, S., Yoshida, A. and Mitani, Y. : Analytical studies on the active constituents in crude drugs. I. Determination of glycyrrhizin in Glycyrrhizae radix by high speed liquid chromatography. Journal of the Pharmaceutical Society of Japan 96, 122 (1976)
  18. Zhong, C., Jin, Y., Wang, Z., Zhou, H. and Li, H. : Determination of polyamine constituents in radix ginseng by HPLC. Zhongguo Zhong Yao Za Zhi 15, 682 (1990)
  19. 의약품등 기준 및 시험방법(식품의약품안전청 고시 제2006-56호, 2006.12.6.) 별표6 한약제제에서의 지표성분 설정 가능한 한약
  20. 의약품등 안전성.유효성 심사규정(식품의약품안전청 고시 제 2003-17호, 2003.4.14.)
  21. ICH Harmonised Tripartite Guideline, Validation of analytical procedures : Text and Methodology Q2(R1), Step 4 version (2005)
  22. 식품의약품안전청 : 의약품등 분석법의 밸리데이션에 대한 가이드라인 (2004)