Statistical Quality Control of Herbal Drugstuffs Distributed in Seoul Area - Centering around Ash, Acid-insoluble Ash, Loss on Drying and Hazardous Heavy Metals -

서울지역 유통한약재의 통계적 품질관리 - 회분, 산불용성회분, 건조감량, 유해중금속을 중심으로 -

  • Kim, Dong-Gyu (Herbal Medicines Inspection Team, Seoul Metropolitan Government Research Institute of Public Health and Environment) ;
  • Kim, Bog-Soon (Herbal Medicines Inspection Team, Seoul Metropolitan Government Research Institute of Public Health and Environment) ;
  • Han, Chang-Ho (Herbal Medicines Inspection Team, Seoul Metropolitan Government Research Institute of Public Health and Environment) ;
  • Kim, Eun-Ju (Herbal Medicines Inspection Team, Seoul Metropolitan Government Research Institute of Public Health and Environment) ;
  • Choi, Byung-Hyun (Herbal Medicines Inspection Team, Seoul Metropolitan Government Research Institute of Public Health and Environment) ;
  • Park, Seung-Kook (Institute of Life Science and Resources, Kyung Hee University)
  • 김동규 (서울시보건환경연구원 한약재검사팀) ;
  • 김복순 (서울시보건환경연구원 한약재검사팀) ;
  • 한창호 (서울시보건환경연구원 한약재검사팀) ;
  • 김은주 (서울시보건환경연구원 한약재검사팀) ;
  • 최병현 (서울시보건환경연구원 한약재검사팀) ;
  • 박승국 (경희대학교 생명과학대학)
  • Received : 2009.05.19
  • Accepted : 2009.07.06
  • Published : 2009.10.31

Abstract

To survey the status of quality control of major ingredients of 'Ssanghwatang (Oriental medicine used for fatigue)', we analyzed 1,024 samples (9 kinds) of medical herbs to determine amounts of ashes, acid-insoluble ashes, loss on drying that are major elements to ensure basic quality of herbal drugstuffs. After ash analysis, Paeoniae Radix (from China) failed to meet the herbal standard criterion. After yielding Z-score(indicating the probability of exceeding its criterion) Zizyphi Fructus, Zingiberis Rhizoma, Paeoniae Radix, Rehmanniae Radix Preparata became objects of intense quality control (=IQC). Analysis on loss on drying shows Cinnamomi Cortex was unsuitable and was put under the IQC. In case of respective heavy metals, Angelicae Gigantis Radix, Cnidii Rhizoma, Cinnamomi Cortex exceeded the maximum permissible range for Cd. The 3 kinds of sub-standards were put to the IQC. Statistic figures showed a significant correlation (t-test, p<0.01) between country-of-origin and sub-quality rates. Compared to domestic one, imported medicinal herbs were less suitable in regard of acid-insoluble ash, loss on drying and Pb/Hg content. Meanwhile, amounts of Acid-insoluble ash showed positive relation with amounts of Pb (r=0.202) and As (r=0.243) among heavy metals leading to an inference that herbs of which root/rhizome is used for medical purposes attribute its high heavy metal content to the fine earth/sand being stuck to its root stalk.

Keywords

References

  1. 한국의약품수출입협회 한국의약품시험연구소 : 한약재감별주해. 대영, p. 3 (2003)
  2. 식품의약품안전청 : 한약재표준제조공정지침(I, II). 발간등록번호 11-147000-001652-14, 서울 (2008)
  3. 한국보건산업진흥원 : 한약품질 및 유통관리제도 조사연구, 보건의료기술 연구개발사업보고서, p. 2 (2000)
  4. Choi, S. M., Chung, H. J., Yoon, Y. S., Lee, M. Y., Choi, H. S. and Sung, H. J. : Studies on the administration of the quality of herbal medicine. J. Korean Oriental Med. 21, 99 (2000)
  5. Kim, H. K., Chun, J. M., Lee, A. Y., Choi, J. H., Jang, S. and Ko, B. S. : Quality monitoring of oriental medicines. J. Korean Oriental Med. 11, 155 (2005)
  6. Kim, K. S. and Kim, H. C. : Review on original plants of oriental medicines used in Korea. Korean J. Crop Sci. 48, 79 (2003)
  7. Hong, Y. J., Park, W. H., Ko, S. K., Yu, I. S., Kang, H. G. and Kim, M. H. : Quantitative analysis of commercial herbal medicines and study on identification method by LC/MSD. Report of Seoul Institute of Health and Enviroment 40, 242 (2004)
  8. 김욱희 : 고속액체크로마토그래피를 이용한 쌍화탕 원료 지표성분의 동시분석. 단국대학교 박사학위 논문, 서울 (2008)
  9. Hwang, J. B., Yang, M. O. and Shin, H. K. : Survey for approximate composition and mineral content of medicinal herbs. Korean J. Food Sci. Technol. 29, 671 (1997)
  10. Kim, J. H., Yang, J. Y. and Moon, Y. S. : The risk assessment of residual pesticides and heavy metals in rehmanniae radix preparata. J. of the Environmental Sciences 16, 1287 (2007) https://doi.org/10.5322/JES.2007.16.11.1287
  11. Cha, Y. Y., Hea, S. K., Cha, B. C. and Sea, S. H. : Determination of heavy metals and residual pesticides in oriental medical materials. Korean J. Oriental Physiology & Pathology 21, 226 (2007)
  12. Jung, D. H. and Park, M. K. : The content of heavy metals in manufactured herbal medicines. J. of the Environmental Sciences 17, 129 (2008) https://doi.org/10.5322/JES.2008.17.1.129
  13. Kim, M. K., Hur, M. H., Lee, C. H., Jin, J. S., Jin, S. K. and Lee, Y. J. : Monitoring of residual sulfur dioxide in herbal medicines. Korean J. Pharmacogn 35, 276 (2004)
  14. Sin, Y. M., Kim, J. I., Kim, W. S., Park, K. S., Kim, J. M., Chae, R. C., Cho, D. H., Kim, D. B. and Kim, O. H. : Studies on the residual contents of sulfur dioxide in herbal medicines distributed at domestic. Korean J. Oriental Physiology & Pathology 21, 1039 (2007)
  15. Lee, S. H., Choi, H. Y. and Park, C. H. : Determination of heavy metal contents in oriental medical materials and the effect of washing. Korean J. Biotechnol. Bioeng. 18, 90 (2003)
  16. Kim, J. S., Hwang, S. W., Kim, J. M. and Ma, J. Y. : Monitoring research for heavy metals as endocrine disruptors in sibjeondaebotang and its ingredients herbal medicines (II). Yakhak Hoeji 45, 448 (2001)
  17. 저자미상 : 방약합편, 일원서각, p. 76 (2006)
  18. 한국약학대학 약전분과회 : 대한약전 해설서, 문성사, p. 117 (1999)
  19. 박창호, 강신인 : 한약재 포제기술. 청문각, p. 32 (2006)
  20. 서부일, 이제현, 최호영, 권동렬, 부영민 : 한약본초학. 영림사, p. 27 (2006)
  21. 식품의약품안전청 : 대한약전-제9개정. 신일북스, 서울 (2008)
  22. 식품의약품안전청 : 대한약전외한약(생약)규격집, 서울 (2007)
  23. 식품의약품안전청 고시 제2006-17호 '생약등의중금속허용기준및 시험방법' (2006)
  24. 식품의약품안전청 고시 제2008-25호 '검사능력관리규정' (2008)
  25. Niesink, R. J. M., De Vries, J. and Hollinger, M. A. : Toxicology : Principles and applications. CRC Press, Inc., Florida, USA (1996)
  26. Yu, I. S. and Hong, Y. J. : Analysis of heavy metals in medicinal plants. Report of Seoul Institute of Health and Environment 42, 62 (2006)