• 대한본초학회지
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• 제28권2호
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• pp.61-65
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• 2013

Objectives : Samchulgeonbi-tang (shenzhujianpi-tang) has been prescribed as one of traditional herbal medicine for treatment of stomach diseases since ancient time in Korea. Samchulgeonbi-tang extract was fermented by Lactobacillus spp. for improving the effect. However, the toxicity and safety of fermented Samchulgeonbi-tang (FS) extract were not confirmed. Therefore, this study was performed to evaluate the acute toxicity and safety of FS extract. Methods : To evaluate the acute toxicity and safety of FS extract, several doses of FS extract, 0, 500, 1000 and 2000 mg/kg, were orally administered to 20 male and 20 female ICR mice, respectively. After treatment with FS extract, we observed mortality, general toxicity, behavior and change of body weight for the 14 days. After 14 days of oral administration, all mice were sacrificed and hematological parameters were analyzed from blood serum. Results : In present study, the toxic signs such as mortality or abnormal behaviors by FS extract were not observed. There are no significant differences between FS-treated group and control group in body weight, organ weights, and hematological parameters. Conclusions : The remarkable adverse effects by FS extract were not observed in ICR mice. Also, any death was not occurred at all treated FS doses, 500, 1000 and 2000 mg/kg. Therefore, the approximate lethal dose (ALD) of FS extract may be more than 2000 mg/kg.

• 한국환경농학회지
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• 제28권1호
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• pp.59-68
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• 2009

유기게르마늄과 무기게르마늄을 첨가하여 양액 재배한 상추의 안전성을 평가하기 위하여 게르마늄 함유 상추의 생쥐(C57BL/6)에 대한 단회 경구 독성시험을 수행하였다. 실험전 기간 동안 사망한 실험동물은 없었으며, 일반증상과 임상증상도 관찰되지 않았고, 부검 결과 어떠한 육안적 병변도 관찰되지 않았다. 그리고 대조군과 시료 투여군 간의 체중 차이도 관찰되지 않았다. 암컷의 사료 소비량과 물 섭취량은 수컷에 비해 약간 적은 것으로 나타났다. 암컷의 경우에 대조군에 비해 각 실험군의 장기 무게가 모두 약간 감소하는 경우(흉선, 오른쪽 난소)와 악간 증가하는 경우(왼쪽 난소)가 있었고, 수컷의 경우에도 흉선, 심장, 오른쪽 신장, 왼쪽 부고환의 무게가 대조군에 비해 모든 실험군에서 약간 감소하였지만 유의한 차이는 아니었고, 왼쪽 신장과 좌우 고환의 무게가 약간 증가하였지만 역시 유의한 차이는 아니었다. 암수 간의 몸무게에 대한 상대적인 장기 무게의 차이는 모두 정상적인 범위내에 속하였다. 혈액 생화학적 검사 결과, 수컷의 경우에는 GPT와 GOT 측정값이 대조군에 비해 $Ge_{132}$를 함유한 상추를 먹인 실험군에서 유의적으로 감소하였고, LDH 측정값이 대조군에 비해 실험군에서 각각 유의적으로 감소하였다. 혈액학적 검사에서는 수컷의 혈소판(PLT) 수치가 대조군에 비해 각 실험군이 증가한 것으로 나타났지만 유의적인 변화는 아니었다. LPS와 Con A 자극에 대해 비장세포의 증식반응과, 비장세포 내 B세포, 보조 T세포, 세포독성 T세포의 비율은 유의한 파이가 없었다. 이상의 실험 결과로 $$GeO_2와 $Ge_{132}$ (60 mg/kg)출 함유한 상추 분말을 식약청 고시에 명시된 최고농도인 2,000 mg/kg을 단회 결구 투여하였을 때, 시료와 관련된 특기할만한 독성증상이 관찰되지 않았다.

• 대한약침학회지
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• 제15권3호
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• pp.48-52
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• 2012

Objective: This study was performed to analyze the single-dose toxicity of Aconitum kusnezoffii Reichb. pharmacopuncture (AKRP). Methods: All experiments were conducted at the Korea Testing & Research Institute (KTRI), an institute authorized to perform non-clinical studies, under the regulations of Good Laboratory Practice (GLP). Twenty (20) Sprague-Dawley rats were chosen for the pilot study. The animals were divided into four groups of five animals per group: group 1 (G1) being the control group with each animal receiving an injection of 0.3 ml of saline and groups 2, 3, and 4 (G2, G3, and G4) being the experimental groups with each animal receiving an injection of 0.1, 0.2 or 0.3 ml of AKRP, respectively. This study was conducted with the approval of the Institutional Animal Ethics Committee. Results: No deaths occurred in any of the 4 groups, and the $LD_{50}$ of AKRP administered via IV was higher than 1.77 ml/kg. Some changes in the weights of the male rates were observed between the control group and the experimental groups, but no significant differences were noted in the weights of the female rats. To check for abnormalities in organs and tissues, we stained representative sections of each specified organ with Hematoxylin & Eosin for light microscopic examination. The results showed no significant differences in any of the organs or tissues. Conclusions: The above findings suggest that Aconitum kusnezoffii Reichb. pharmacopuncture is a relatively safe treatment. Further studies on the subject should be conducted to yield more concrete evidence.

• Journal of Ginseng Research
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• 제27권4호
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• pp.171-177
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• 2003

Previously we have reported that administration of Korean red ginseng water extract (KRG-WE) plays both preventive and therapeutic roles in testicular toxicity of guinea pigs exposed to 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD). Further study was carried out to verify the beneficial role of Korean red ginseng in TCDD-induced testicular toxicity with different animal species by different route of administration. Korean red ginseng crude saponin (KRG-CS) was prepared by Diaion HP-20 adsorption chromatography. One hundred twenty rats (Sprauge Dawley, 200${\pm}$10 g) were divided into 6 groups. The normal control group (NC) received vehicle (i.p.) and saline (p.o.). Predetermined dosage of TCDD (40 $\mu\textrm{g}$/kg b.w., i.p.) was administered to single TCDD-treated (TT) and test (CS) groups. KRG-CS was admin-istered (p.o.) at daily doses of 5 (CS5), 10 (CS10),20 (CS2O) and/or 40 mg/kg b.w. (CS40) for 5 weeks, starting 1 week before the TCDD-exposure. Body weight gain, organ weights, and sperm quality were investigated. Decrease in body weight gain induced by TCDD was greatly attenuated by KRG-CS in a dose-dependent manner. Testicular weight, sperm head counts and ratio of sperm with progressive movement in TT group decreased significantly but those parameters were improved by the treatment of KRG-CS in a dose-dependent manner. This result led us to conclude that crude saponin might be the active ingredient of Korean red ginseng that attenuates the testicular toxicity induced by TCDD.

• 동의생리병리학회지
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• 제21권5호
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• pp.1118-1126
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• 2007

The purpose of this study was to examine the anti allergic effect in vivo and in vitro, and to observe single and four weeks repeated toxicity in mice of Bangpung-galgeun-tang (BGT). We investigated anti DNP IgE-mediated passive cutaneous anaphylaxis in rodents and compound 48/80-induced active systemic anaphylatic shock in mice after oral administration with BGT of 0.4 g/kg and 0.8 g/kg for 8 days, and also examined MTT assay, ${\beta}-hexosaminidase$ activity, IL-4 and $TNF-{\alpha}$ from RBL-2H3 and $TNF-{\alpha}$ from Raw264.7 after pre-treatment with BGT of 0.25 mg/ml, 0.5 mg/ml, 1 mg/ml and 2 mg/ml. To ascertain safety and toxicity of BGT, we divided into single and four weeks repeated administration test. In single test, three groups were administrated different dosages and routes (2 g/kg/i.p., 4 g/kg/i.p. and 15 g/kg /p.o.) of BGT, and in four weeks repeated test, 0.8 g/kg BGT was administrated. Control groups were administrated with only saline according to on Korean Food and Drug Administration, respectively. We observed attentively motality, abnormal clinical sign, body weight change, organ weight, AST and ALT of mice after BGT administration. BGT inhibited passive cutaneous anaphylaxis and active systemic anaphylatic shock by oral administration. All the concentrations of BGT from 0.25 to 2 mg/ml didn't have an effect on cell viability and cytotoxicity. In RBL-2H3, ${\beta}-hexosaminidase$ release, IL-4 and $TNF-{\alpha}$, and in Raw264.7, $TNF-{\alpha}$ were significantly reduced by treated all concentrations of BGT. During toxicity experiment period, there was no difference in body weight change, organ weight, AST and ALT among different dose groups. Death were found 3 mice from day 2 to day 3 in single test i.p. group. (2 g/kg, 4 g/kg). Several individuals of single test i.p. group were observed that decreased locomotor activity, exophthalmos, bloodshot eyes, loss of eyesight and so on in early period after administration. But there was no difference in clinical signs among p.o. group. These results indicate that BGT have inhibition effects on allergy and suggest that no observable effect level of the test orally administration was considered to be more than 2 g/kg in mice under the conditions employed in this study.

• Journal of Acupuncture Research
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• 제33권1호
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• pp.1-7
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• 2016

Objectives : This study was conducted to analyze the single dose toxicity of Mecasin (Gami-Jakyak Gamcho buja Decoction) herbal acupuncture administered in the vein of Sprague-Dawley rats. Methods : All experiments were performed at the Medvill, an institution licensed to conduct nonclinical studies, under the Good Laboratory Practice (GLP) regulations. Sprague-Dawley rats were chosen in this pilot study. In the experiment, Sprague-Dawley rats were divided into four groups of five male and five female animals per group. Doses of Mecasin herbal acupuncture, at 0, 500, 1,000, and 2,000 mg/kg, were given to the experimental groups, and a dose of normal saline solution, at 2 ml/kg, was administered to the control group. Mecasin herb acupuncture and normal saline were injected into the vein at once, and we observed mortality, clinical signs, weights, and gross findings for 14 days after injection. This study was conducted under the approval of the Institutional Animal Ethics Committee. Results : There is no death or abnormality in any of the four groups. All groups put on weights favorably. There are no significant gross findings in necropsy examinations. Conclusions : The above results showed that intravenous injection of 500-2,000 mg/kg of Mecasin herb acupuncture did not cause any changes in weight or, in the results of necropsy examinations, in mortalities. Therefore, the toxicity of Mecasin herb acupuncture was not confirmed, and the presumptive lethal dose of Mecasin herb acupuncture was higher than 2,000 mg/kg. The outcomes suggest that treatment with Mecasin herbal acupuncture is relatively safe. Further evaluations on this subject are needed to yield more concrete evidence.

• 생명과학회지
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• 제26권10호
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• pp.1207-1213
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• 2016

오미자(Schisandrae Fructus)와 상엽(Mori folium)은 한국, 중국, 일본을 포함한 아시아 지역에서 오랫동안 식품자원 및 전통 의약제로 광범위하게 사용되어 왔다. 최근 연구에 따르면 오미자와 상엽은 항균, 항염증, 항산화, 면역기능 조절 및 혈관신생억제 등과 같은 많은 효능을 가지는 것으로 알려져 있다. 그러나 오미자(SF), 상엽(MF) 에탄올 단독추출물 및 복합추출물(medicinal herber mixture, MHMIX)에 대한 독성 및 안전성에 대해서는 거의 알려져 있지 않은 실정이다. 따라서 본 연구에서는 SF, MF 및 MHMIX가 유발하는 급성독성 및 안전성을 확인하였다. 이를 위하여 ICR mice를 대상으로 SF, MF 및 MHMIX 5,000 mg/kg을 최고농도로 설정하여 단회 경구 투여하였으며, 투여 후 14일 동안의 치사율, 체중 변화, 임상증상, 음수율 및 사료섭취량과 함께 부검 소견, 장기무게 변화, 혈액학 및 혈액생화학적 검사를 실시하였다. 결과에서 나타난 바와 같이 SF, MF 및 MHMIX의 투여 후 치사율, 임상증상, 체중 및 부검 소견 상의 유의적인 변화는 관찰되지 않았다. 또한 SF, MF 및 MHMIX 투여에 따른 각 장기의 무게, 혈액학적 및 혈청학적 임상 화학적 지표에도 유의적인 변화는 관찰할 수 없었다. 따라서 SF, MF 및 MHMIX는 단회 경구 투여에 따른 치사량이 5,000 mg/kg 이상일 것으로 추정되어 ICR 마우스에 대하여 급성독성이 없는 비교적 안전한 물질이라는 것을 알 수 있었으며, 향후 천연물 소재로서의 효능 규명을 통한 활용이 기대된다.

• 한국식품영양과학회지
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• 제44권1호
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• pp.24-28
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• 2015

청국장에서 분리한 항균활성이 우수한 Bacillus subtilis JNS의 probiotics로서의 활용성을 검증하기 위해 단기투여에 의한 안전성을 확인하고자 실험을 실시하였다. 경구투여용 존데를 이용하여 임상적용 경로인 경구로 투여하였으며, 최고투여용량은 2,000 mg/kg으로 설정하였다. ICR계 암수 마우스에서 14일간 관찰한 결과 일반증상, 사망률, 체중, 임상증상 및 육안적 소견 등에서 무처리 대조군과 비교해서 유의성 있는 차이를 보이지 않았다. 부검 후의 주요 장기에 대한 육안적 검사에서 또한 대조군과 비교하여 이상소견이나 병변이 관찰되지 않았다. 이상의 결과로부터 시험물질인 B. subtilis JNS는 경구투여 시 ICR계 암수 마우스에서 독성학적인 변화가 관찰되지 않았으며, 경구투여가 2,000 mg/kg 이상인 저독성의 안전한 물질로 사료된다.

• Natural Product Sciences
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• 제26권3호
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• pp.252-258
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• 2020

This study investigated the biochemical and histological changes associated with the co-administration of cisplatin and methanolic extract of Portulaca oleracea (MEPO) in adult Wistar rats. Twenty-four (24) adult female Wistar rats were randomly divided into six (6) groups (A-F) (n = 4). Group A served as the control group for the experiment and received no treatment. Group B was given a single dose of cisplatin and served as the cisplatin control group. Group C and D received 400 mg/kg and 800 mg/kg of MEPO 6 hours after a single dose cisplatin injection respectively. Group E and F received 400 mg/kg and 800 mg/kg of MEPO 6 hours before cisplatin injection. The cisplatin injection was 2 mL/kg given intraperitoneally for all groups. There was a significant increase in the serum levels of ALT, ALP, AST, total bilirubin, and conjugated bilirubin following cisplatin treatment (p = 0.000, 0.000, 0.039, 0.000, 0.004 respectively) with a consequent reversal due to MEPO administration across all treated groups (p = 0.000, 0.000, 0.000, and 0.000) in a dose-dependent fashion. Cisplatin caused the expansion of the red and white pulp in the spleen which was attenuated by MEPO. MEPO demonstrated a protective effect against cisplatin-induced liver and spleen toxicity.

• 보존과학회지
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• 제33권4호
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• pp.255-266
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• 2017

국내 문화재 생물피해 방제는 농약에서 유래한 화학적 약제를 사용하여 왔다. 그러나 인체와 환경에 대한 유해성 문제로 인하여 사용이 점차 제한되고 있으며, 새로운 방제약제의 탐색과 안전성 연구에 대한 관심이 지속적으로 증가되고 있다. 개발된 천연 생물방제제의 안전성은 동물실험을 통한 독성평가로 확인하고 있으며, 치사량과 자극성 평가를 위하여 경구독성, 경피독성, 안점막자극 및 피부자극 시험법을 이용하여 안전성을 평가한다. 독성평가를 위해 실험용 쥐와 토끼를 이용하며, 쥐에 대해 단회 경구독성과 경피독성 시험을 실시하고, 토끼에 대해 안점막자극시험 및 피부자극 시험을 시행한다. 본 시험에 이용한 천연 생물방제물질은 목재부후균과 흰개미에 대한 항진균활성 및 살충활성이 조사된 족두리풀 추출물을 적용하였다. 쥐에 대한 단회 경구투여한 결과 $LD_{50}$ 값이 수컷 4,000 mg/kg 이상, 암컷 2,000 mg/kg 이상으로 판정되었으며, 단회 경피 투여한 결과 $LD_{50}$ 값이 암수 모두 10,000 mg/kg 이상으로 판정되었다. 토끼의 눈에 대한 자극시험에서는 무자극성으로 판정되었으며, 피부에 대해서는 약한 자극성이 있는 물질로 판단되었다. 본 연구를 통해 천연 생물방제물질인 족두리풀 추출물의 안전성을 동물실험으로 확인함으로써 화학 물질의 안전성 검증을 위한 기본적인 유해성 평가 방법으로 제시하고자 한다.