대한약침학회지 (Journal of Pharmacopuncture)

  • 제23권2호
  • /
  • Pages.71-78
  • /
  • 2020
  • /
  • 2093-6966(pISSN)
  • /
  • 2234-6856(eISSN)
대한약침학회 (KOREAN PHARMACOPUNCTURE INSTITUTE)
권호 표지
DOI QR코드

DOI QR Code

Development of Hazardous Materials Management Standard for Decoction Type of Personalized Herbal Medicine

  • Jeong, Hye-In (Department of Preventive Medicine, College of Korean Medicine, Woosuk University) ;
  • Kim, Kyeong-Han (Department of Preventive Medicine, College of Korean Medicine, Woosuk University) ;
  • Won, Jae-Hee (Department of Public Infrastructure Operation, National Development Institute of Korean Medicine) ;
  • Sung, Gi-Un (Department of Public Infrastructure Operation, National Development Institute of Korean Medicine) ;
  • Kim, Ji-Won (Department of Korean Medicine Policy, National Development Institute of Korean Medicine) ;
  • Han, Ji-eun (Department of Korean Medicine Policy, National Development Institute of Korean Medicine) ;
  • Sung, Angela Dong-Min (Department of Korean Medicine Policy, National Development Institute of Korean Medicine) ;
  • Park, Eun-Jung (Big Data and Artificial Intelligence Lab, Hana Institute of Technology(Hana TI)) ;
  • Sung, Soo-Hyun (Department of Korean Medicine Policy, National Development Institute of Korean Medicine)
  • 투고 : 2020.06.09
  • 심사 : 2020.06.11
  • 발행 : 2020.06.30
PDF 다운로드
⟨ 이전 논문 다음 논문 ⟩

초록

Objectives: This study was conducted to development of hazardous materials management standards for the decoction type of personalized herbal medicines (PHMs). Methods: This study was conducted in two stages. We searched documents about criteria to use words such as 'Herb', 'Herbal medicine', and 'Botanical Drug' and summarized the results. We organized the committee consisted of seven experts, and held two meetings to reach an agreement on hazardous management standards of the decoction type of PHMs. Results: The seven documents were presented in the literature review and six items related to hazardous management standards of decoction were identified. The second expert meeting brought that a total of six items, including heavy metal, pesticide residues, sulfur dioxide, benzopyrene, mycotoxin, and micro-organism limits, were selected for safety management of decoction type of PHMs. Also, the criteria and test methods for each standard were suggested for monitoring the decoction type of PHMs. Conclusion: The study suggested hazardous material management standards and criteria for the decoction types of PHMs. In the future, it would be necessary to conduct a pilot test to ensure the validity and credibility of the safety management standard and criteria. Furthermore, the government level safety management system should be introduced to verify the safety of decoction medicines.

키워드

참고문헌

  1. Korea Ministry of Food and Drug Safety. Korean Pharmacopoeia, 11th edition. Korea Ministry of Food and Drug Safety (Osong); 2017.
  2. World Health Organization. General guidelines for methodologies on research and evaluation of traditional medicine. World Health Organization (Geneva); 2000.
  3. Pan SY, Litscher G, Gao SH, Zhou SF, Yu ZL, Chen HQ, et al. Historical perspective of traditional indigenous medical practices: the current renaissance and conservation of herbal resources. Evid Based Complement Alternat Med. 2014;2014:1-20.
  4. Pittler MH, Ernst E. Systematic review: hepatotoxic events associated with herbal medicinal products. Aliment Pharmacol Ther. 2003;18(5):451-71. https://doi.org/10.1046/j.1365-2036.2003.01689.x
  5. Cheon CH, Park JS, Park SJ, Kweon KT, Shin YC, Ko SG. Necessity of adverse event reporting system through the trend of internet news about safety of herbal medicine. Kor J Oriental Preventive Medical Society. 2011;15(2):131-43.
  6. Yun YJ, Shin BC, Lee MS, Cho SI, Park JH, Lee HJ. Systematic review of the cause of drug-Induced liver injuries in Korean literature. J Korean Oriental Med. 2009;30(2):30-45.
  7. Choi DW, Kim JH, Cho SY, Kim DH, Chang SY. Regulation and quality control of herbal drugs in Korea. Toxicology. 2002;181-182:581-6. https://doi.org/10.1016/S0300-483X(02)00487-0
  8. Ciociola AA, Cohen LB, Kulkarni P. How drugs are developed and approved by the FDA: Current Process and Future Directions. Am J Gastroenterol. 2014;109(5):620-3. https://doi.org/10.1038/ajg.2013.407
  9. Pusan National University. A study on establishment of foundation for strengthening the health insurance coverage of herbal medicine (decoction). National Health Insurance Service (Wonju); 2018.
  10. Ryu JY, Park JY, Sung ADM, Sung SH. The utilization of traditional herbal medicine for treatment in traditional Korean medicine clinics. IntechOpen (London); 2019.
  11. Korea Ministry of Health and Welfare, National Development Institute of Korean Medicine, Gallup Korea. 2017 years national survey for usage and consumption of traditional herbal medicine. National Development Institute of Korean Medicine (Seoul); 2018.
  12. Korea Ministry of Food and Drug Safety. 2016 Ministry of Food and Drug Safety white paper. Ministry of Food and Drug Safety (Osong); 2015.
  13. Association of Traditional Korean Medicine. Development and implementation of the safety management strategies for non-medicinal herbs. National Development Institute of Korean Medicine (Gyeongsan); 2019.
  14. Kim TK, Jung WS, Park SW, Cho KW, Kim YB. Comparison of efficacy and safety between Chunghyul-dan (HH-333) and Atorvastatin (Lipitor). Korean J Orient Int Med. 2003;24(4):837-45.
  15. Kim YM, Choi HY, Kim JD. Studies on oral toxicity of Eumcheonyijin-tang in rats. J Korean Oriental Med. 2000;21(3):199-208.
  16. World Health Organization. Guidelines for the regulation of herbal medicines in the South-East Asia region: developed at the regional workshop on the regulation of herbal medicines. Regional office for South East Asia (New Delhi); 2003.
  17. World Health Organization. National policy on traditional medicine and regulation of herbal medicines, Report of a WHO global survey. World Health Organization (Geneva); 2005.
  18. Korea Ministry of Food and Drug Safety. Korean Herbal Pharmacopoeia, 4th edition. Korea Ministry of Food and Drug Safety (Osong); 2013.
  19. Korea Ministry of Food and Drug Safety. A quality control guideline for herbal or botanical medicine extracts. Korea Ministry of Food and Drug Safety (Osong); 2015.
  20. Pharmacopoeia Committee of China Ministry of Health. Pharmacopoeia of the People's Republic of China, 16 edition. China Medical Science Press (Beijing); 2015.
  21. Japan Ministry of Health, Labor and Welfare. Japanese Pharmacopoeia, 16th edition. Ministry of Health, Labor and Welfare (Tokyo); 2016.
  22. Japan Ministry of Health, Labor and Welfare. Japanese standards for non-pharmacopoeial crude drugs. Ministry of Health, Labor and Welfare (Tokyo); 2015.
  23. Council of Europe. European Pharmacopoeia, 18th edition. Council of Europe (Strasbourg); 2015.
  24. US Center for Drug Evaluation and Research. Botanical Drug Development Guidance for Industry. US Center for Drug Evaluation and Research (Silver Spring); 2016.
  25. Jang IS, Yang CS, Lee SD, Han CH. A review of herbal medicinal products associated with toxic events in Korea. J Korean Oriental Med. 2007;28(1):1-10.
  26. Man SC, Durairajan SSK, Kum WF, Lu JH, Huang JD, Cheng CF, et al. Systematic review on the efficacy and safety of herbal medicines for Alzheimer's disease. Journal of Alzheimer's Disease. 2008;14(2):209-23. https://doi.org/10.3233/JAD-2008-14209
  27. Seoul National University. Risk management of sulfur dioxide residue in herbal medicine. Korea Ministry of Food and Drug Safety (Osong); 2004.
  28. Cho YK, Kim JS, Yoon SH, Ryu BH, Ryu KW. The effects of Strychni Ignatii Semen on toxicity levels and gastrointestinal tract. Korean J Orient Int Med. 2002:23(1):107-16.