• 대한약침학회지
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• 제18권2호
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• pp.67-75
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• 2015

Objectives: This study was carried out to analyze the single-dose toxicity of ShinYangHur (SYH) herbal acupuncture injected into the muscles of Sprague-Dawley (SD) rats. Methods: The SYH herbal acupuncture was made in a clean room at the Korean Pharmacopuncture Institute (KPI, Korea-Good Manufacturing Practice, K-GMP). After the mixing process with sterile distilled water, the pH was controlled to between 7.0 and 7.5. Then, NaCl was added to make a 0.9% isotonic solution by using sterilized equipment. All experiments were conducted at Biotoxtech, an institution authorized to perform non clinical studies under the regulations of Good Laboratory Practice (GLP). SD rats were chosen for the pilot study. Doses of SYH herbal acupuncture, 0.25, 0.5, and 1.0 mL, were administered to the experimental groups, and a dose of normal saline solution, 1.0 mL, was administered to the control group. This study was conducted under the approval of the Institutional Animal Ethics Committee. Results: No deaths or abnormalities occurred in any of the four groups. No significant changes in weight, hematological parameters or clinical chemistry between the control group and the experimental groups were observed. To check for abnormalities in organs and tissues, we used microscopy was used to examine representative histological sections of each specified organ; the results showed no significant differences in any of the organs or tissues. Conclusion: The above outcomes suggest that treatment with SYH herbal acupuncture is relatively safe. Further studies on this subject are needed to yield more concrete evidence.

• Toxicological Research
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• 제19권1호
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• pp.73-82
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• 2003

To evaluate influence of Saposhnikovia divaricata (Turcz.) Schischk extract on rat, Saposhnikovia divaricata (Turcz.) Schischk extract was diluted with 0.9% saline (100 mg/ml/kg, 10 mg/ml/kg, and 1 mg/ml/kg, respectively), and each of diluted test material extract was daily treated subcutaneously for 4 weeks and single-treated subcutaneously for 2 weeks. There were no significances in body weight analysis, urinary analysis, and ophthalmological test. However, in serum biochemical analysis and hematological analysis, we found some significances in high and middle dose group compared with control group. These significances in serum biochemical analysis and hematological analysis may be not induced by test material, because it was not found to be significant from control group in histopathological examination. Therefore, it was concluded that NOEL (No Observed Effect Level) of test material extract may be higher than all treatment doses used in this study, and Saposhnikovia divaricata (Turcz.) Schischk extract may be a non-toxic material.

• 약학회지
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• 제43권5호
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• pp.591-597
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• 1999

The study was carried out on the biochemical characters of Cd-BP(II) after isolation and purification of the protein from the liver of rat ip injection with Cd. A continued study has been doing whether Cd-BP(II) could be induced by Cd or by the other metals such as Zn and Cu. Antisera were made against the antigen of Cd-BP(II) from New Zealand white rabbits. We carried out g-globulin purification, then Ouchterlony test and gel immunodiffusion test. Cd-BP(II) was also found in normal tissues of rat. It was induced up to a considerable level by Cd, whose induced level was higher than that Cu or Zn treatment. The level of induction by Cu or Zn pretreatment plus Cd treatment was lower than that by single treatment of Cu or Zn. Such a result was presumably related to the Cd toxicity.

• 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.

• Journal of Acupuncture Research
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• 제39권4호
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• pp.310-316
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• 2022

Background: Verbenalin is an iridoid glucoside, which is among the active components of some medicinal herbs such as Verbena officinalis Linn, and Cornus officinalis Siebold and Zucc. Previous studies have confirmed the antioxidant activity and neuroprotective potential of verbenalin. To confirm the safety of verbenalin, an approximate lethal dose was determined based on a single oral dose toxicity study. Methods: Institute of Cancer Research mice were randomly assigned to three verbenalin exposure groups (250, 500, and 1,000 mg/kg) and a control group (5% methylcellulose solution). There were (5 male and 5 female mice per group). Mortality, clinical signs, and body weight were monitored for 14 days, and necropsies were conducted. Results: No mortalities were observed in the control group or the verbenalin 250 mg/kg group, whereas mortalities were observed in the 500 mg/kg and 1,000 mg/kg verbenalin groups. During the observation period, stool abnormalities such as mucous stools were observed. Clinical signs such as loss of locomotor activity were observed in the 500 mg/kg and 1,000 mg/kg verbenalin groups. During the study period, significant changes in body weight were observed in the 500 mg/kg and 1,000 mg/kg verbenalin groups; however, no gross abnormalities were observed at necropsy. Overall, no toxicity was found in the 250 mg/kg group. Conclusion: The approximate lethal dose of verbenalin was estimated to be 500 mg/kg. For a more accurate assessment of the safety of verbenalin, other types of studies such as repeated-dose toxicity studies should also be conducted.

• 생명과학회지
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• 제26권2호
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• pp.204-211
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• 2016

본 실험에서는 유산균발효 독활의 마우스 단회 경구 투여 독성 자료를 얻기 위해 식품의약품안전청 고시 제 2013-121 “의약품 등의 독성시험 기준”에 의거하여, 설치류 투여 한계 용량인 2,000 mg/kg을 최고 투여군을 설정하고 공비 2로 1,000 및 500 mg/kg 투여군을 중간 및 저용량 투여군으로 설정하여 실험을 실시하였으며, 그 결과는 독활 열수 추출물 2,000 mg/kg 암수 투여군 및 암수 매체 대조군과 비교 평가 하였다. 본 실험의 결과, 설치류 투여한계 용량인 2,000 mg/kg 투여군까지, 유산균발효 독활 열수 추출물 투여와 관련된 사망례, 임상증상, 체중, 장기중량, 육안부검 및 조직병리학적 소견이 인정되지 않았다. 따라서 유산균발효 독활 열수 추출물의 마우스에 대한 단회 경구 투여 반수 치사량 및 개략적 치사량은 암수 각각 2,000 mg/kg이상으로 산출되었으며, 특정 임상증상 및 표적 장기 역시 없는 것으로 판단되어, 유산균발효 독활은 매우 안전한 물질로 판단된다. 또한 독활 열수 추출물 2,000 mg/kg 투여와 관련된 사망례, 임상 증상, 체중, 장기중량, 육안 및 조직병리학적 변화 역시 인정되지 않았다. 이러한 결과는 독활의 활용도를 증대시키는 기초 자료가 될 것으로 사료된다.

• Biomolecules & Therapeutics
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• 제12권1호
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• pp.43-48
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• 2004

The present study was carried out to investigate the potential acute toxicity of CKD-602 by a single intravenous dose in Sprague-Dawley rats. Ten males females were used in each test groups: a vehicle control, 34.7, 4l.7, 50.0, 60.0 and 72.0 mg/kg groups, and were given different single intravenous doses of CKD-602 to the test animals. Mortalities, clinical findings, and body weight changes were monitored for the 14-day period following the administration. At the end of l4-day observation period, all animals were sacrificed and complete gross postmortem examinations were performed. One, 1, 2, 8 and 9 cases of deaths occurred in the male dose groups of 34.7, 41.7, 50.0, 60.0 and 72.0 mg/kg, respectively, and 1, 5 and 9 cases in the female dose groups 50.0, 60.0 and 72.0 mg/kg, respectively. An increase in the incidence of clinical signs such as alopecia, skin pallor skin ulcerations, emaciation and change of fecal material was found in the both sexes of all treatment groups. A decrease or Suppression in the body weight was also observed in a dose-dependent manner. In autopsy, male and/or female rats of the treatment groups showed treatment-related gross findings such as splenomegaly, atrophy of the testis, epididymis, seminal vesicles, ovary, uterus and thymus which were dose-dependent in incidence and severity. Based on these results, it was concluded that a single intravenous injection of CKD-602 to rats caused significant toxicities in gastrointestinal, hematopoietic, and reproductive systems. The $LD_{50}$ value was 53.8 (95% confidence limit: 48.5~60.6) mg/kg for males and 60.l (95% confidence limit: 55.3~65.8) mg/kg for females. The $LD_{10}$ value was 39.9 (95% confidence limit: 3l.7~44.8) mg/kg for males and 50.3 (95% confidence limit: 40.6~54.8) mg/kg for females.

• 한국식품저장유통학회지
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• 제19권2호
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• pp.315-321
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• 2012

본 연구는 김치에서 분리한 항진균 및 항세균 활성을 나타내는 $Lb.$ $plantarum$ AF1을 분리하여 이 균의 천연 식품보존제 및 사료보존제로서 사용 적합성 및 안전성을 평가하고자 단회 급성독성시험을 실시하였다. 급성독성시험을 위하여 경구 혹은 복강으로 1회 시험물질을 최고 용량(경구: 5,000 mg/kg, 복강: 2,500 mg/kg)으로 하여 ICR계통 암 수 마우스에게 용량별 각 군당 10마리씩 투여한 후 14일간의 일반증상, 사망률, 체중, 임상증상 및 육안적 소견을 관찰하였다. 단회 경구투여 혹은 복강주사한 후 모든 시험군에서 사망례가 관찰되지 않았으며, 시험동물은 시험 종료 시까지 계속 생존하여 평균치사량을 산출할 수 없었다. 복강 혹은 경구투여한 후 마우스의 체중변화에 있어서도 암 수 모두 대조군과 시료물질 투여군 사이에 유의성 있는 차이는 보이지 않았으며, 용량 의존적인 차이도 볼 수 없었다. 경구구투여 혹은 복강주사 단회 투여한 후 시험 종료한 다음 생존동물 모두를 부검하여 주요 장기의 육안적 소견을 관찰한 결과 대조군과 시료투여군 모두에서 외관상이나 내부장기에 어떠한 이상소견이나 병변이 관찰되지 않았다. 이상의 결과로부터 시험물질인 $Lb.$ $plantarum$ AF1는 경구투여 혹은 복강주사 시 ICR계통 암 수 마우스에서 독성학적인 변화가 관찰되지 않았으며, $LD_{50}$은 복강주사가 2,500 mg/kg, 경구투여가 5,000 mg/kg 이상인 저독성의 안전한 물질로 사료된다.

• 한국약용작물학회지
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• 제22권4호
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• pp.276-288
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• 2014

The six polysaccharide fractions were prepared by chromatographic procedure from the hot water extracts of the aboveground parts of Astragalus membranaceus. These six polysaccharides from aboveground parts of Astragalus membranaceus Bunge were tested for gut-mucosal immune activity and acute toxicity. In a view of molecular weight, the six fractions were estimated to be 75000, 88000, 129000 and 345000 Da, respectively. Component sugar analysis indicated that these fractions were mainly consisted of galactose (46.3 ~ 11.8%) and arabinose (35.4 ~ 9.9%) in addition to glucose, rhamnose, fucose, arabinose, xylose, mannose, glucuronic acid and galacturonic acid. Among the six major purified polysaccharides, AMA-1-b-PS2 showed highest bone merrow cell proliferation and lymphocyte of Peyer's patch stimulating activity. It may be concluded that intestinal immune system modulating activity of aboveground parts from Astragalus membranaceus Bunge is caused by polysaccharides having a polygalacturonan moiety with neutral sugars such as arabinose and galactose. In single oral dose toxicity study, no differences were observed between control and treated groups in clinical signs. The results indicated that lethal dose 50 ($LD_{50}$) of water extracts from Astragalus membranaceus-aboveground parts was found to be higher than 5000 mg/kg/day in this experiment. From the above results, we may suggest that Astragalus membranaceus-aboveground parts might have useful as a safe material for functional food and pharmaceutics.

• 한국식품영양과학회지
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• 제36권5호
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• pp.527-533
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• 2007

건강효능이 우수한 고품질 유색미 과피의 안전성 규명을 목적으로 ICR계 마우스 암수 각각 10마리를 이용하여 적진주벼, 흑진주벼 및 흑향벼 과피를 80% EtOH로 추출한 농축물을 1회 경구투여 후 14일 동안 실시한 급성독성 평가 결과는 다음과 같다. 시험물질을 1회 경구투여한 경우, 총 14일의 실험기간 동안 모든 시료투여군의 암수 동물에서 정상적인 체중증가가 관찰되었으며, 체중증가는 유의적인 차이를 나타나지 않았으며, 시료투여군의 경우 용량의존적인 체중변화도 관찰되지 않았다. 시험물질 투여 14일 후 부검결과, 암수 모든 실험군의 간장, 신장(좌, 우), 비장, 심장, 폐 및 뇌에서 시험물질 투여에 따른 어떤 육안적 이상 소견도 발견되지 않았다. 치사시킨 동물의 혈액 생화학적 검사 결과, 모든 시료 투여군의 ALT와 AST 활성도가 정상 수치를 나타냈으며, 본 실험의 최고 용량인 10.0 g/kg투여에도 정상치를 나타내는 것으로 보아, 유색미 과피 추출물을 10.0 g/kg 이하 섭취할 경우에는 어떠한 간독성도 나타내지 않음을 확인할 수 있었다. 이상의 실험결과를 통해 고품질 유색미인 적진주벼, 흑진주벼 및 혹향벼 과피 추출물의 단회 경구투여에 의한 독성시험 시, 시험물질 투여에 의한 표적 장기가 관찰되지 않았으며, 어떠한 독성학적인 변화도 관찰되지 않는 것으로 보아, 무해 용량은 암수 모두 10.0 g/kg을 상회할 것으로 추정할 수 있었다.