GC-MS/MS를 이용한 한약재 중 다환방향족탄화수소류 시험법 개선 및 모니터링 = Improvement and Monitoring of Polycyclic Aromatic Hydrocarbons Analytical Method in Herbal Medicine Using GC-MS/MS

다국어 초록 (Multilingual Abstract)

Herbal medicines, being primarily natural products, are susceptible to contamination with polycyclic aromatic hydrocarbons (PAHs), including benzo(a)pyrene(BaP), during processes such as heating, drying, or roasting. This study aims to improve the PAHs analytical method registered in the Korean Pharmacopoeia (KP) to facilitate the quality control of herbal medicines. Also, the study involves monitoring specific herbal medicines, selected by an expert advisory committee, to confirm PAH concentrations. The test methods for PAHs have been improved through the modification of the extraction procedures and GC-MS/MS conditions. Additionally, validation was performed to verify the effectiveness of the improved test methods, and as a result of measuring the accuracy with the recovery rate, it was 72.51% to 112.62%. These results fall within the acceptable range specified in the food and drug test method validation guidelines and the AOAC(Association of Official Analytical Chemists) official methods of analysis guideline. As a result of measuring eight types of PAHs of herbal medicines is conducted by the improved test method, BaP was detected in concentrations ranging from ND (Not Detected) to 3.36 μg/kg, PAH4* from ND to 35.92 μg/kg, and PAH8** from ND to 53.01 μg/kg. In Korea, regulatory limit of BaP in herbal medicines less than 5 μg/kg according to the KP. And European Union (EU) set BaP and PAH4 limits at 10 μg/kg and 50 μg/kg in food respectively. 57 herbal medicines did not exceeded these limits. These results confirm the contamination levels of PAHs, such as BaP, in herbal medicines and provide a scientific basis for regulatory safety. In addition, it can be used as a basis for the regulatory limit of BaP in herbal medicines, such as Mume Fruit, Amomum Tsao-ko Fruit , Rehmannia Root, and Prepared Rehmannia Root. These findings can serve as fundamental data for revising BaP quality control standards and management measures.
*PAH4(Benz(a)anthracene, Chrysene, Benzo(b)fluoranthene, Benzo(a)pyrene,) **PAH8(Benz(a)anthracene, Chrysene, Benzo(b)fluoranthene, Benzo(k)fluoranthene, Benzo(a)pyrene, Indeno(1,2,3-cd)pyrene, Dibenz(a,h)anthracene, Benzo(g,h,i)perylene)

참고문헌 (Reference)

• 1 홍남두, "한약의 품질관리" 신일북스 2-, 2013
• 2 식품의약품안전평가원 식품위해평가부 신종유해물질팀, "식품 중 다환방향족탄화수소료 위해평가" 2018
• 3 식품의약품안전평가원 오염물질과, "숯불조리 방법에 따른 다환방향족탄화수소 생성량 실태조사" 2014
• 4 식품의약품안전평가원, "벤조피렌 등 다환방향족탄화수소류 위해평가" 2016
• 5 Fernández-González, V., "Solid-phase microextraction-gas chromatographic-tandem mass spectrometric analysis of polycyclic aromatic hydrocarbons towards the European union water directive 2006/0129 EC" 1176 : 48-56, 2007
• 6 Shang, D., "Rapid and sensitive method for the determination of polycyclic aromatic hydrocarbons in soils using pseudo multiple reaction monitoring gas chromatography/tandem mass spectrometry" 1334 : 118-125, 2014
• 7 Official Journal of the European Union, "REGULATIONS, COMMISSION REGULATION (EU) 2020/1255"
• 8 Djinovic, J., "Polycyclic aromatic hydrocarbons(PAHs)in different types of smoked meat products from Serbia" 80 : 449-456, 2008
• 9 Guillen, M. D., "Polycyclic aromatic compounds : extraction and determination in food" 11 : 669-684, 1994
• 10 Yu, L., "Isotope dilution-GC-MS/MS analysis of 16 polycyclic aromatic hydrocarbons in selected medicinal herbs used as health food additives" 29 : 1800-1809, 2012
• 11 Veyrand, B., "Innovative method for determination of 19 polycyclic aromatic hydrocarbons in food and oil samples using gas chromatography coupled to tandem mass spectrometry based on an isotope dilution approach" 1149 : 333-344, 2007
• 12 IARC, "IARC Monographs on the evaluation of carcinogenic risks to humans 92"
• 13 Organic Matter, "Environmental Protection Agency"
• 14 Dost, K., "Determination of polycyclic aromatic hydrocarbons in edible oils and barbecued food by HPLC/UV–Vis detection" 133 : 193-199, 2012
• 15 "Agency for Toxic Substances and Disease Registry (ATSDR): Toxicological profile for polycyclic aromatic hydrocarbons (PAHs)"
• 16 식품의약품안전처, "19141생약안205 과제, 한약(생약)안전관리를 위한 시험법 개선 연구" 2021