Safety Assessment of Liquid-Type Herbal Preparations

한약제제(액제)의 안전성 평가

  • Jo, Hyun-Ye (Pharmaceutical Chemistry Team, Gyeonggi-do Institute of Health and Environment) ;
  • Jeon, Jong-Sup (Pharmaceutical Chemistry Team, Gyeonggi-do Institute of Health and Environment) ;
  • Kim, Beom-Ho (Pharmaceutical Chemistry Team, Gyeonggi-do Institute of Health and Environment) ;
  • Cho, Sang-Hun (Pharmaceutical Chemistry Team, Gyeonggi-do Institute of Health and Environment) ;
  • Park, Sin-Hee (Pharmaceutical Chemistry Team, Gyeonggi-do Institute of Health and Environment) ;
  • Kim, Young-Sug (Pharmaceutical Chemistry Team, Gyeonggi-do Institute of Health and Environment) ;
  • Yoon, Mi-Hye (Pharmaceutical Chemistry Team, Gyeonggi-do Institute of Health and Environment)
  • 조현례 (경기도보건환경연구원 약품화학팀) ;
  • 전종섭 (경기도보건환경연구원 약품화학팀) ;
  • 김범호 (경기도보건환경연구원 약품화학팀) ;
  • 조상훈 (경기도보건환경연구원 약품화학팀) ;
  • 박신희 (경기도보건환경연구원 약품화학팀) ;
  • 김영숙 (경기도보건환경연구원 약품화학팀) ;
  • 윤미혜 (경기도보건환경연구원 약품화학팀)
  • Received : 2011.04.21
  • Accepted : 2011.05.30
  • Published : 2011.09.30

Abstract

The safety of liquid-type herbal preparations (47 samples) and beverages containing herbal medicines (18 samples), which are distributed in Gyeonggi province was studied by analyzing heavy metals, benzo(a)pyrene, preservatives and sugar content and to explain the differences between medicine and food based on the labeling standards. The herbal preparation is regarded as medicine and can be differentiated from the beverages containing herbal medicine, which is food, based on the fact that the herbal preparation should be labeled with usage, dosage, efficiency and effect. The mean concentrations of Pb, As, Cd, Hg were found to be 0.014 mg/kg, 0.113 mg/kg, 0.004 mg/kg and 0.003 mg/kg in herbal preparation and 0.009 mg/kg, 0.122 mg/kg, 0.003 mg/kg and 0.002 mg/kg in beverages containing herbal medicines, respectively. In 10 cases of herbal preparations and 6 cases of beverages containing Rehmanniae Radix Preparata (Sukjihwang), benzo(a)pyrene was not found. According to preservative test on herbal medicine, dehydroacetic acid was found less than the indicated content in 6 cases out of 37 cases, which labeled with preservatives, and benzoic acid, dehydroacetic acid and methylparaben were contained with 164.0~198.0 mg/kg, 149.8~272.5 mg/kg and 88.4 mg/kg, respectively, in 3 cases out of 10 cases, which was not labeled with preservatives. Among 16 cases of beverages containing herbal medicines, 3 cases of preservative-labeled beverages had the preservatives, and the rest of all, which was not labeled with preservatives, did not show that they contain any preservative, therefore, it was suitable for the labeling standards. As a result of sugar content test, preservative-labeled products were not appreciably different from the others.

Keywords

References

  1. Park, H. M., K. H. Choi, J. Y. Jung and S. D. Lee.: Metal exposure through consumption of herbal medicine, and estimation of health risk among Korean population. Kor. J. Env. Health. 32, 186-191 (2006).
  2. Park, M. K., S. Y. Kim, and H. U. Hwang.: A study on the heavy metal contents in herbal medicines.-Cultivated herbal medicines at north Gyeongbuk area-. J. of the Environmental Sciences 13, 1117-1122 (2004). https://doi.org/10.5322/JES.2004.13.12.1117
  3. Park, G. H. Pb, Cu, Zn contaminants and their correlation of soil, leave and bark of ginkgo. B and ambient air adjacent to a heavy traffic road side. Kor. J. Env. Health. 18, 19-25 (1992).
  4. Hong, S. U. and S. H. Park.: Studies on the pollution of heavy metal in soil and vegetable. Kor. J. Env. Health. 10, 33-45 (1984).
  5. Rhee, S. J., S. O. Kim, and W. K. Choe.: Effect of cadmium dose injection on peroxidative damage in rat liver in Korean. J. Korean Soc. Food Sci. Nutr 21, 601-607 (1992).
  6. Rabinowits, M. B. and G. W.: Weatherill. Lead metabolism in the normal human; stable isotope studies. Science. 185, 275 (1973).
  7. Choi, S. I., J. H. Lee, and S. R. Lee.: Effect of green teabeverage for the removal of cadmium and lead by animal experiments in Korean. Korean J. Food Sci. Technol. 26, 745-749 (1994).
  8. Choi, S. I., J. B. Hwang, J. H. Kwon, and H. K. Kim.: Suppressong Effect of Medicinal Plants on the Intestinal Absorption of heavy metals Korean. J. Food Sci. Technol. 30, 456-460 (1998).
  9. Agency for Toxic Substances and Disease Registry (ATSDR), Toxicological profile for polycyclic aromatic hydrocarbons (PAHs), U. S. Department of health and human services, public health service (1995).
  10. IARC Monographs on the evaluation of carcinogenic risks to humans, 92(2006).
  11. E. J. Lee, S. O. Ro, and C. H. Lee.: A Survey on the consumer attitude toward health food in korea (II) Consumer perception on health foods. Korean J. Dietary Culture 11(4), 487-495 (1996).
  12. The pharmaceutical affairs law, Ministry of Health and Welfare (2010).
  13. Food sanitation law, Ministry of Health and Welfare (2010).
  14. WHO. Environmental health criteria 3 - Lead, 44-54 (1997).
  15. KFDA. Notice No. 2010-75, Specification and test method for heavy metals in oriental medicines (2010).
  16. KFDA. Korean Food Standards Codex. pp. 282 (2010).
  17. Yoshida, T., Yamauchi, H., and Fan, S.G.: Chronic health effects in people exposed to arsenic- viathe drinking water: doseresponse relationships inreview, Toxicol. Appl. Pharm. 198, 243- 252. (2004). https://doi.org/10.1016/j.taap.2003.10.022
  18. J. S. Bae, J. P. Park, Y. U. Kim, and M. K. Park.: Contcentration of Heavy metals in Granuls, Globular and Liquid types of Herbal Medicines. KSBB Journal 25, 91-96 (2010).
  19. U.S. FDA. Total Diet Study. Food & Drug Administration, USA (1999).
  20. ANZFA. The Australian Market Basket Survey. Australia New Zealand Food Anthority, Australia (1996).
  21. M. K. Paik, W. I. Kim, J. H. Yoo, J. K. Kim, G. J. Im, M. K. Hong and A. S. Om.: Risk assessment for Arsenic in Agricultural Commodities. Ensuring Agro-Food Safety International Symposium. (2009).
  22. Roberte, W.D. and Arthur, D.M.: Survey of lead, cadmium, flouride, nickel, and cobalt in food composites and estimation of dietary intakes of these elementts by Canadians in 1986-1988. J. AOAC Int. 78, 897-909 (1995).
  23. Fribery, L. and Nordbery, G.F.: A toxicological and epidemiological appraisal in : Miller. M. W and Clarson. T. W. ed. Mercury, mercurials and mercaptans, G,C. Thomas. 5 (1973).
  24. KFDA. Notice No. 2008-76, Specification and test method for preservatives. (2008).
  25. Jeong IH, Kim JH, Jeon JS, Cho SH, Park SH, Jo HY, Kim YS.: Safety Assessment of Oriental Medicines and Their Preparations. J. Fd Hyg. Safety. 25(3), 232-237 (2010).
  26. WHO. Benzoic acid and sodium benzoate. Concise International Chemical Assessment Document 26. World Health Organization, Geneva, Switzerland (2000).
  27. Oishi S.: Effects of propyl paraben on the male reproductive system.. Food Chem. Toxicol. 40, 1807-1813 (2002). https://doi.org/10.1016/S0278-6915(02)00204-1
  28. E. R. Park, S. K. Lee, H. S. Hwang, C. S. Mun, I. S. Gwak, O. H. Kim, and K. H. Lee.: Monitoring of Natural Preservative Levels in Food Products. J Korean Soc Food sci Nutr 37(12), 1640- 1646 (2008). https://doi.org/10.3746/jkfn.2008.37.12.1640
  29. KFDA. Study on food additives (preservatives) identified as Natural Compound in Food materials. The annual report of KFDA (2006).
  30. Yamaguchi, N., Koyama, Y., and Fujimaki, M.: Fractionation and antioxidative activity of browning reaction products between D-xylose and glycine. 5: 429-439 Prog. Food Ntr. Sci., 5, 429 (1981).
  31. Einarson, H., Snygg, B.G., and Eriksson, C.: Inhibition of bacterial growth by Maillard reaction products, J. Agri. Food Chem. 55(3), 201-206 (1983).
  32. M.H. Choi, K. I. Kwon, J. Y. Kim, J. S. Lee, J. W. Kim, H. K. Park, M. C. Kim, G. H. Kim.: Monitoring of total sugar contents in processed foods and noncommercial foodservice foods. Korean J. Food Sci. Technol. 40(3), 337-342 (2008).