Quantitative Analysis of Glycine Semen Nigra and Eucommiae Cortex for Standardization of GCSB-5 Preparation

생약복합제 GCSB-5의 품질 표준화를 위한 흑두 및 두충의 함량 분석

  • Lee, Eun-Hee (Department of Pharmaceutical Engineering, College of Health Sciences, Sangji University) ;
  • Cha, Bae-Cheon (Department of Pharmaceutical Engineering, College of Health Sciences, Sangji University)
  • 이은희 (상지대학교 보건과학대학 제약공학과) ;
  • 차배천 (상지대학교 보건과학대학 제약공학과)
  • Published : 2009.03.31

Abstract

GCSB-5 preparation is a purified extract from a mixture six herbal medicines (Acanthopanacis Cortex, Achyranthis Radix, Saposhnikoviae Radix, Cibotii Rhizoma, Glycine Semen Nigra, Eucommiae Cortex) that have been widely used in traditional medicine to treat various bone disorders. This study was carried out to obtain the HPLC analysis method that can be used to establish quantitative analysis of Glycine Semen Nigra and Eucommiae Cortex for standardization of GCSB-5 preparation. HPLC analysis methods for the simultaneous determination of genistin (Glycine Semen Nigra) and geniposide (Eucommiae Cortex) were established for the quality control of herbal medicinal raw material and preparation. And validation of HPLC analysis methods were conformed for verification of HPLC methods by check to specificity, linearity, intra-day precision, inter-day precision and accuracy following ICH guideline. As the result of quantitative analysis, the contents of genistin and geniposide in the raw material of GCSB-5 preparation were 0.0426-0.0427 mg/g and 0.431-0.432 mg/g. And GCSB-5 preparation contained genistin of 0.0202-0.0203 mg/capsule and geniposide of 0.211-0.212 mg/capsule, respectively.

Keywords

References

  1. Shimizu, M., Hashimoto, T., Ishikawa, S. and Morita, N. (1979) Analysis of constituents in crude drug by high-speed liquid chromatography I. Yakugaku Zasshi 99: 432-436 https://doi.org/10.1248/yakushi1947.99.4_432
  2. Hayakawa, J., Noda, N., Yamada, S. and Uno, K. (1984) Studies on physical and chemical evaluation of crude drugs preparation II. Yakugaku Zasshi 104: 57-62 https://doi.org/10.1248/yakushi1947.104.1_57
  3. Park, J. H., Jung, J. H., Kim, J. S. and Park, H. J. (1997) Studies on quality control of crude drugs preparations, chemical analysis of 'Gal Gun Tang'. Kor. J. Pharmacogn. 28: 42-47
  4. Ohtake, N., Nakai, Y., Yamamoto, M., Sakakibara, I., Takeda, S., Amagaya, S. and Aburada, M. (2004) Separation and isolation methods for analysis of the active principles of Shosaiko-to (SST) oriental medicine. J. Chromatogr. B. 812: 135-148 https://doi.org/10.1016/S1570-0232(04)00547-1
  5. Ye, M., Guo, G. H., Han, J. and Guo, D. (2006) Simultaneous determination of cytotoxic bufadienolides in the Chinese medicine ChanSu by high-performance liquid chromatography coupled with photodiode array and mass spectrometry detections. J. Chromatogr. B. 838: 86-95 https://doi.org/10.1016/j.jchromb.2006.04.042
  6. Lee, C. H., Kim, S. H., Lee, J. S., Cho, K. H., Kim, J. S., Cho, S. H. and Lee, S. M. (2005) Evaluation of the antinociceptive properties of GCSB-5, a herbal formulation. Kor. J. Pharmacogn. 36: 299-304
  7. Lee, E. H. and Cha, B. C. (2008) Quantitative analysis of Acanthopanacis Cortex and Achyranthis Radix for standardization of GCSB-5 preparation. Kor. J. Pharmacogn. 39: 316-323
  8. Fukutake, M., Takahashi, M., Ishida, K., Kawamura, H., Sugimura, T. and Wakabayashi, K. (1996) Quantification of genistein and genistin in soybeans and soybean products. Food Chem. Toxicol. 34: 457-461 https://doi.org/10.1016/0278-6915(96)87355-8
  9. Kim, K. S., Kim, M. J., Park, J. S., Sohn, H. S. and Kwon, D. Y. (2003) Compositions of functional components of traditional korean soybeans. Food Sci. Biotechnol. 12: 157-160
  10. Son, K. H., Lee, J. M., Chang, S. Y. and Lee, K. S. (2001) Isolation and quantitative determination of geniposide from Eucommia ulmoides Oliver. Kor. J. Pharmacogn. 32: 89-92
  11. 의약품평가부 (2004) 의약품 등 분석법의 밸리데이션에 대한 가이드라인. 식품의약 품안전청, 5-12
  12. 식품의약품안전청 (2002) 대한약전 제8개정. 약업신문, 1654-1656
  13. Lee, Y. W., Kim, J. D., Zheng, J. and Row, K. H. (2007) Comparisons of isoflavones from Korean and Chinese soybean and processed products. Biochem. Eng. J. 36: 49-53 https://doi.org/10.1016/j.bej.2006.06.009
  14. Wu, H. K., Chuang, W. C. and Sheu, S. J. (1998) Separation of nine iridoids by capillary electrophoresis and high-performance liquid chromatography. J. Chromatogr. A. 803: 179-187 https://doi.org/10.1016/S0021-9673(97)01227-2
  15. Ran, X., Liang, Q., Luo, G., Liu, Q., Pan, Y., Wang, B. and Pang, C. (2006) Simultaneous determination of geniposide, baicalin, cholic acid and hyodeoxycholic acid in rat serum for the pharmacokinetic investigations by high performance liquid chromatography–tandem mass spectrometry. J. Chromatogr. B. 842: 22-27 https://doi.org/10.1016/j.jchromb.2006.05.001
  16. 안덕균 (1998) 원색 한국본초도감, 403. (주)교학사, 서울
  17. 한의학대사전편찬위원회 (1998) 한의학대사전, 1820. 도서출판사정담, 서울
  18. 김창민, 신민교, 안덕균, 이경순 (1999) 중약대사전, 5147. 도서출판사정담, 서울
  19. Wang, H. and Murphy, P. A. (1994) Isoflavone content in commercial soybean foods. J. Agric. Food Chem. 42: 1666-1673 https://doi.org/10.1021/jf00044a016
  20. 김재길 (1984) 원색 천연물대사전, 439. 남산당, 서울
  21. Hong, N. D., Rho, Y. S., Kim, J. W., Won, D. H., Kim, N. J. and Cho, B. S. (1988) Studies on the general pharmacological activities of Eucommia ulmoides Oliver. Kor. J. Pharmacogn. 19: 102-110
  22. Takeshi, D. (1983) The constituents of Eucommia ulmoides Oliv. I. Isolation of (+)-medioresinol-di-O-$\beta$-D-glucopyranoside. Chem. Pharm. Bull. 31: 2993-2997 https://doi.org/10.1248/cpb.31.2993