본 연구에서는 인천광역시에서 유통 중인 한약재의 안 전성을 확인하기 위해 24품목의 50건을 대상으로 345종 의 잔류농약을 분석하였다. 잔류농약은 미량으로도 인체 의 건강에 해를 가할 수 있는 유해 물질로 주의가 필요하 다. 기준 규격외 다양한 잔류농약 확인을 위해, QuEChERS 법으로 전처리후 분석한 결과, 7품목 24건(48%)의 한약재 에서 총 22종의 잔류농약이 검출되었으며, 농약이 검출된 한약재는 천궁, 택사, 당귀, 백지 순으로 많았다. 검출 농 약 중 2건을 제외하고는 모두 기준이 설정되어 있지 않은 농약이었으나, 위해 평가 결과 안전한 수준으로 확인되었 다. 또한, 동일 품목에서 다빈도로 검출되는 농약을 확인 하여, 해당 품목의 지속적인 잔류농약 모니터링의 필요성 을 시사하였으며, 대한약전의 전처리법에 따른 비교분석 에서도 동일한 농약이 검출되어, QuEChERS법을 이용한 생약의 잔류농약 분석 가능성을 제시하였다. 결과적으로, 소비자 안전을 위해서 기준규격 잔류농약 항목 외에도, 생 약에 대한 지속적인 잔류농약 모니터링과 신뢰성 높은 고 효율 분석법 개발 연구가 계속 필요할 것이다.

To enhance the bioavailability and bioactivities of mixed herbal medicines (RW), they were fermented with lactic-acid bacteria isolated from kimchi into postbiotics (FRW). Then, from the results of the 16s rRNA sequencing analysis, lactic acid bacteria isolated from kimchi were identified to be of two species, namely Lactobacillus sakei and Leuconostoc mesenteroides. The FRW prepared from the RW were extracted using hot water (HW) and 70% EtOH (EtOH) for comparison of their macrophage-stimulating activities. Based on a comparison of the activities of the FRW extracts, nitric oxide (NO) production of HW was significantly higher than that in EtOH. An analysis of the chemical properties of the extracts showed that HW had higher contents of neutral sugar and uronic acid than EtOH as well as contained a large amount of glucose. In addition, crude polysaccharide (CP) was prepared to enhance the macrophage-stimulating activity. The FRW-CP not only secreted immunostimulatory mediators but also increased the expression of immunostimulatory genes (iNOS, TNF-α, MCP-1, and IL-6). The fractionated FRW-CP contained about 90% neutral sugars, and these sugars were mainly composed of glucose, galacturonic acid, and arabinose. Thus, FRW prepared by fermentation of RW with kimchi lactic acid bacteria were found to be immunostimulatory modulators.

GF-AAS와 수은분석기를 이용하여 납, 비소, 카드뮴 및 수은의 회수율로 정확도를 측정한 결과 92.67-102.56% 범위에서 측정되었고, 정밀도를 측정한 결과 0.21-6.00 RSD%의 재현성을 보였으며, CODEX guideline에서 규정하는 범위에 적합하였다. 또한, FAPAS QC material을 검증결과, 회수율은 96.7-102.0%, 재현성은 0.33-4.93 RSD%로 우수한 결과를 나타냈다. 한약재 430건의 평균 Pb 함량은 254.9 μg/kg (N.D.-2,515.2)이었고, 평균 As 함량은 171.0 μg/kg (N.D.- 2,465.2)이었으며, 평균 Cd 함량은 99.2 μg/kg (N.D.-797.1), 평균 Hg 함량은 6.0 μg/kg (N.D.-83.6)이었다. 분석 결과 우리나라에 유통되는 한약재 20종은 식품의약품안전처에서 규정하는 한약재의 중금속 함량에 대한 허용기준 이내의 결과로 모두 안전한 수준의 한약재로 나타났다. 이를 토대로 한약 규격품 제조업소를 품질관리의 기준으로 하여 유통되기 직전의 가공 포장 과정에서의 한약재 중 납, 비소, 카드뮴 및 수은의 함량을 조사하여 한약재 내 중금속 함량 실태를 파악하고, 국민에게 안전하고 우수한 한약재를 공급하기 위한 기초자료로 활용할 수 있을 것으로 사료된다.

서울약령시장과 서울경동시장 등에서 유통되고 있는 식약공용 농·임산물 29품목 171건에 대하여 ICP-MS와 수은 분석기를 이용하여 중금속(납, 카드뮴, 비소, 수은) 함량을 분석하고 위해도를 평가하였다. 납, 카드뮴, 비소, 수은의 검출 범위는 각각 ND-4.719 mg/kg, ND-1.019 mg/kg, 0.002-8.696 mg/kg, ND-0.058 mg/kg로 나타났다. 171건의 검체 중 Artemisiae Capillaris Herba(인진호) 1건과 Actinidiae Ramulus et Fulium et Fructus Vermicultus(목천료) 1건에서 각각 카드뮴과 비소 항목이 허용기준을 초과 하여 부적합 판정을 받았으며 나머지는 모두 허용기준 이내였다. 위해도를 평가 했을 때 비발암위해도지수(HI)가 1을 초과한 품목은 없었고, 발암위해도가 납은 모든 품목에서 10-6 이하였으며 비소는 10-4-10-6 으로 나타나 전반적으로 안전한 수준으로 평가되었다. %PTWI는 납, 카드뮴, 비 소, 수은 모두 100이하로 나타났다. 유통중인 식약공용 농 ·임산물의 중금속(납, 카드뮴, 비소, 수은) 함량을 분석하고 비발암위해도지수(HI), 발암위해도, %PTWI를 평가한 결과 안전한 수준으로 평가되었다.

본고에서는 최근 중국을 중심으로 추진되고 있는 한약재 ISO 국제표준화에 대한 대응을 위해 최신 등재 현황을 소개하고 주요 추진상의 문제점과 대응방안들을 점검해 보았다. 주요 내용을 정리하면 다음과 같다. 1. 국제표준화기구 전통의학 기술위원회(ISO TC249)는 2009년 설립이후 31개의 국가가 참여하여 한약재 국제표준화를 추진하고 있다. 한·중·일은 발의 문건은 90%이상을 차지하여 사실상 아시아의 전통의학 분야를 두고 경쟁하고 있으며 간사국인 중국은 약용작물의 종자 ·종묘에서부터 약재의 생산, 품질 그리고 침구, 의료기술 등에 이르기까지 전 한방분야에서 표준화를 주도하고 있다. 현재 진행되고 있는 약용작물 재배 및 한약재 품질 관련 안건만 약 50여건에 달해 향후 5년 내에 시장 거래량 상위품목들의 국제표준화 작업이 대부분 완료될 것으로 예상된다. 2. 현재 진행되고 있는 안건들은 한약재의 품질이나 품질평가에 관한 안건들이 대부분이다. 이 안건들이 국제표준으로 인정되면 세계 한약재 유통시장에는 새로운 질서와 우열기준이 생기고 유통 한약재의 시장가치 평가에 반영되어 각국 한약재 점유율 변동에도 영향을 줄 수 있다. 이들 안건들은 직접적인 재배생산 표준이 아닌 경우가 대부분이지만 성분이나 성상 등에 대한 표준을 담고 있으므로 대부분 재배생산과도 밀접한 관련이 있다. 만일 중국 중심의 표준화가 계속해서 심화된다면 장기적으로는 국내 생산농가에 부담을 줄 수도 있다. 그러므로 한약재 국제표준화 대응은 향후 국내 생산물이 표준규격을 달성할 수 있는 범위내로 기준을 유도하는 전략을 펴야 할 것이다. 이를 위해 국내 생산물의 특성을 파악하고 선반영 하려는 노력이 필요하다. 3. 한약재 표준화 대응은 중국의 추진안건이 많으므로 분야별 파급영향을 고려한 선별적인 대응이 필요하다. 종자·종묘 등 추가적인 제한 필요성이 낮은 분야보다는 향후 시장에서 한· 중 간 경쟁이 발생할 수 있는 분야에 집중하는 것이 중요하다 . 원산지 변조, 농약 잔류량·이산화황 과다검출 등의 이력이 있는 약재들은 해당 표준을 강화하고 재배환경의 영향을 받을 수 있는 도지약재들의 경우 성상이나 지표성분 등에 대한 국내약재의 특성을 최대한 반영할 필요성이 있다. 곰팡이나 해충관리 등은 아직 각국의 관리규정이나 저온저장 시설 등 현장 인프라 구축이 충분치 않은 점들도 고려되어야 한다. 아직 국제표준을 추진하기 위한 국내의 연구결과들이 충분치 않은 부분들이 많으므로 추가적인 연구와 지원이 필요할 것이다.

This study was carried out to investigate the residual sulfur dioxide residues (SO2) in commercial medicinal herbs in Korea in 2013. Among a total of 116 samples of 11 different kinds of herbs, 71 samples (11 Kinds) were domestic, and 45 samples (10 Kinds) were imported. The residual contents of SO2 in the samples were determinated by a modified Monier-Williams method. Of the 116 samples, 6 samples (5.2%, 4 Kinds) failed to meet the regulations for sulfur dioxide residues of KFDA in medicinal herbs. Among 6 unsuitable samples, 1 samples (1.4%) were domestic, and 5 samples (11.1%, 3 Kinds) were imported. The highest amount of sulfur dioxide residues was 1546.3 mg/kg (Lycii Fructus) in the domestic samples. Regardless of region, SO2 contents were not found at Anemarrhenae Rhizoma, Citri Unshius Pericarpium, Eucommiae Cortex, Forsythiae Fructus, Gardeniae Fructus, Leonuri Herba and Lonicerae Folium et caulis. These data will be used as a basic data for the future legislation on the regulation and control of sulfur dioxide of herbal medicines.

This study was performed to investigate contamination levels of aflatoxins, the secondary metabolites produced by fungi Aspergillus flavus and A. parasiticus, in herbal medicine. Herbs is susceptible to these fungi infections through its growth harvest, transport and storage. This study determine the aflatoxin B₁, B₂, G₁ and G₂levels by HPLC-florescence detector coupled with photochemical enhancement in 558 samples herbal medicine distributed in Korea and China. Also, We checked a transfer ratio of aflatoxins from raw herbal medicines to herbal medicine extract. Hot water extraction of herbal medicines was prepared by air pressure and high pressure condition. The analytical method for aflatoxins was validated in this method. In results recoveries of the analytical method were ranged from 67.4% to 96.2% and, limits of detection and quantitation for aflatoxins were 0.015~0.138 μg/kg and 0.046~0.418 μg/kg, respectively. According to the results of monitoring on aflatoxins in herbal medicine, aflatoxins 1.7 ug/kg B1 and 0.9 ug/kg G₁were detected in only one sample of Strychni Ignatii Semen, and 0.8 ug/kg G₁ in Strychni Semen. About 13.6~51.3% of aflatoxins were transferred to hot water extract. Although the detected levels are under the permitted levels for aflatoxins in herbal medicine, these amounts should be considered in regard to overall daily exposure to mycotoxins.

The study was conducted to estimate the contents of heavy metal in commercial herbal medicines (1047 samples of 132 species) which were collected from markets in Seoul and to analyze the contents of heavy metals of herbal medicines by classifying them by parts. The samples were digested using microwave method. The contents of heavy metal (Pb, Cd, and As) and Hg were determined using Inductively coupled plasma-Mass spectrometer (ICP/MS). And the contents of Hg were obtained by Mercury analyzer. The average values of heavy metal in herbal medicines were as follows [mean (minimum-maximum), mg/kg]; Pb 0.870 (ND-69.200), As 0.148 (ND-2.965), Cd 0.092(ND-2.010), and Hg 0.007 (ND-0.137). And the average values of heavy metal by parts in herbal medicines were as follows [mean (minimum-maximum), mg/kg]; Ramulus 2.046 (0.065-4.474), Herba 1.886 (0.048-10.404), Flos 1.874(0.052-5.393), Cortex 1.377 (0.011-4.837), Radix 1.165 (0.012-70.111), Rhizoma 1.116 (0.016-5.490, Fructus 0.838(0.017-4.527), Perithecium 0.729 (0.013-4.953), Semen 0.646 (0.006-4.416). The average values of heavy metal of imported herbal medicines except Radix were higher than domestic ones. By decoction of herbal medicines exceeding the tolerances, average intake rates of Pb, As, Cd and Hg were obtained as 6.1%, 40.3%, 4.7%, and 2.2%, respectively.

Purpose : The prescriptions of Dongyisoosebowon (東醫壽世保元) are so different to those of existing Korean medicine(韓醫學). Because Lee Jema (李濟馬, 1837-1900, the author of Dongyisoosebowon) has classified herbal medicines(本草) by the four Sasang constitutions(四象體質). But he has not explained his method in detail. Therefore we make a plan to analyze the herbal medicine of the Dongyisoosebowon prescription by Sung․M i․Guikyung(性․味․歸經), the essential elements of the herbal medicines, to get a idea how Lee Jema has classified the herbal medicines by four Sasang constitutions. Methods : The herbal medicines are chosen from Dongmuyugo(東武遺藁) and Dongyisoosebowon. And they are rearranged by Sung․Mi․Guikyung from Shinnongbonchokyung(神農本草經), Tangaekboncho(湯液本草) Dongyibogam(東醫寶鑑) and Imsangbonchohak(臨床本草學, Clinical Herbology). Result : The herbal medicines classified by Lee Jema have a characteristic trend by their Sung․Mi․Guikyung. In the herbal medicines of Soumin (少陰人), 81.8% of them is characterised in Warm and hot medicine (溫熱藥材) and 68.2% has its action to Bi(脾). In those of Soyangin, 75% of them is characterised in Cool and cold medicine (寒凉藥材) and 60% to Sin(腎), 25.7% to Bangkwnag(膀胱). In those of Taeumin, 63% of them is characterised in Warm and hot medicine, 47.8% in Cool and cold medicine. In all of their classifications, the result of Yakmi(藥味, taste of herbal medicine) analysis is not characteristic. Conclusion : The herbal medicines classified by Lee Jema have a characteristic trend by their Sung․Guikyung.

With the implementation of the internationalization strategy of traditional Chinese medicine (hereinafter referred to as “TCM”) and the increasing recognition of TCM in the world, the export trade of traditional Chinese medicinal materials has shown an overall positive trend. With the rapid development of the global economy, people's pursuit of wealth has gradually accelerated, and at the same time, they have paid much more attention to pollution-free and health and green environmental protection than before. A new measure to protect the domestic ecological environment has emerged internationally - green trade barriers. Based on the analysis of the general situation of green trade barriers and the status quo of the industry, this paper expounds the performance and reality of the green trade barriers encountered in China’s export of Chinese herbal medicines, and then provides four countermeasures: firstly, spread and promote screening and classification standards of regions and material origins for medicines; secondly, resolutely promote industrial production standards to ensure the quality of traditional Chinese medicinal products; thirdly, accelerate the cultivation of international TCM trade talents to help better predicting and responding to the green trade barriers; and lastly, strengthen the overall management of the traditional Chinese medicine industry.

This study was conducted to investigate the residual contents of sulfur dioxide (SO2) in commercial medicinal herbs in Korea in 2012. Among a total of 136 samples of 16 different kinds of herbs, 86 samples (15 Kinds) were domestic, and 50 samples (14 Kinds) were imported. Sulfur dioxide in the samples was measured by a modified Monier-Williams method. Of the 136 samples, 17 samples (12.5%, 6 Kinds) failed to meet the regulations for sulfur dioxide residues of KFDA in medicinal herbs. Among 17 unsuitable samples, 7 samples (8.1%, 3 Kinds) were domestic, and 10 samples (20.0%, 6 Kinds) were imported. The highest amount of sulfur dioxide residues was 3,167.94 mg/kg (Lycii Fructus) in the domestic samples. The detection frequency of sulfur dioxide by medicinal herb parts used, Rhizoma 25.7%, Flos 20.0%. Cortex 12.5%, Radix 15.3%, Fructus 7.6%, p-value 0.011. This results will be used as a basic data for the future legislation on the quality estimation and safety of medicinal herbs.

This study was conducted to determine the contents of heavy metal in commercial herbal medicines. The monitoring of lead, arsenic, cadmium and mercury was carried out on 100 samples with 10 kinds of herbal medicines. The contents of heavy metal were measured by inductively coupled plasma atomic emission spectrometry (ICP-AES) and mercury analyzer. The mean values of heavy metal contents for herbal medicines were Pb 1.87 mg/kg, As 0.39 mg/kg, Cd 0.26 mg/kg and Hg 0.021 mg/kg. Of the total samples, 19 samples (19%, 4 types) were violated the KFDA regulatory guidance of heavy metal in herbal medicines (9 samples on Pb, 10 samples on Cd). Among these 19 unsuitable samples, 16 samples were domestic and 3 samples were imported. Therefore, we need continuously monitoring to ensure confidence and safety for these herbal medicines.

This study is an endeavor to evaluate the risk assessment of hazardous(aflatoxin B1) in medicines from oriental medical prescription which are circulated much recently. For that, twelve globular and granule types, seven liquid types of herbal medicine were bought to compare and analyze the content of aflatoxin B1, which are harmful to human body. Woo Hwang Cheong Sim Hwan of Aflatoxin B1 concentration lower than the standard accepted by all the products have been detected, B company(tradition) is the concentration of 1.24 ㎍/kg, C company 1.04 ㎍/kg, A company(tradition) and B company did not detect. And the general pill of aflatoxin B1 concentration lower than the standard accepted by all the products have been detected, S-1 is the concentration of 1.8 ㎍/kg, S-2 of 1.04 ㎍/kg, S-3 of 0.88 ㎍/kg, S-4 of 9.32 ㎍/kg, S-6 of 7.8 ㎍/kg, S-5 did not detect. All the products eundan allowed in the concentration of aflatoxin B1 levels were lower than detection, D company of 0.96 ㎍/kg, E company concentration was not detected. The liquid product of aflatoxin B1 concentration was found liwer than the standard accepted by all the product, L-3 concentration of 0.8 ㎍/kg, K-4 was detected in the 1.16 ㎍/kg, L-1 and L-2 is not detected, L-5 concentration of 15 ㎍/kg, L-7 is detected as 1.08 ㎍/kg and, L-6 was not detected.

This study is an endeavor to evaluate the safety of medicines from heavy metals, prescribed on the basis of herbal medicinal system and oriental medical prescription which are circulated much recently. For that, three globular types, four extract granular types and four liquid types of herbal medicine were bought to compare and analyze the content of heavy metals, such as As, Pb, Cd and Hg, which are harmful to human body. The concentration of Pb was found to be 0.552 ppm in Sachiltang, 2.552 ppm in Anjungjogiwhan and 1.735 ppm in Cheongsangbohwawhan in case of pill type herbal medicine, and liquid type herbal medicine, Maekmundongtang was 0.002 ppm, Galgeuntang was 0.003 ppm, Sangwhatang was 0.004 ppm, 20jeon Daebotang was 0.0185 ppm. And the concentration of Pb was found to be 0.322 ppm in Banhasasimtang, 0.47 ppm in Eungjosan, 0.29 ppm in Yukmijihwangtang, 0.64 ppm in Socheongryongtang in case of granular type. It was found that the liquid types herbal medicines were relatively safer than three pill types of, four granular types of and four liquid types herbal medicines were tested for concentration of heavy metals. It is considered that is required in the stage of raw material treatment, manufacturing and packaging because those herbal medicines are directly taken in and absorbed into human body through the final treatment process.

We studied concentration of heavy metals in Sagunjatang. In this experiment was analyzed the concentration of heavy metals of boiled Sagunjatang, decoction and its ingredient herbal medicines. The concentration of heavy metals(As, Pb, and Cd) were analysed using ICP-AES, and Hg was analysed by mercury analyzer. The average concentration of heavy metals in Sagunjatang were as follows : In all ingredient herbal medicines (Glycyrrhizae Radix, Atractylodes Macrocephala, Poria Cocos and Jinseng) of Sagunjatang, As(arsenite) contents in all samples was in the range of 0.369-0.723ppm, Cd(cadmium) was in the range of 0.000-0.085ppm, Pb(lead) was in the range of 0.059-0.871ppm and Hg(mercury) was in the range of 0.001-0.004ppm. In boiled Sagunjatang, the concentration of heavy metals(As, Pb, Cd and Hg) was in the range of 0.000-0.016ppm, respectively. In the decoction of herbal medicines after boiled, the concentration of heavy metals was in the range of 0.004-0.387ppm. These results suggest that Sagunjatang which we take is less harmful than herbal medicine itself, and there are more significant for using the decoction of herbal medicines.

We were carried out to monitor pesticide residues in herbal medicine. In Korea Pharmacy, these are no critics for pesticides except 5 kinds of organic chlorines (BHC, DDT, Aldrin, Endrin, Dieldrin) and heavy metals. We analysed 53 kinds of pesticides consisted of 14 kinds of organochlorines, 20 kinds of organophosphoruses, and 19 kinds of pesticides estimated endocrine disruptor on 373 samples consisted with 30kinds of herbal medicine. In this study, Domestic, Chinese and Japanese herbal medicines were tested with GC/ECD, GC/NPD and then confirmed with GC/MSD. Recoveries were 75～110% in ECD detector and 76～97% in NPD detector. Detection limits were 0.004～0.064ppm in ECD detector and 0.006～0.094ppm in NPD detector. Organochlorines and others were not detected in samples.