• Biomolecules & Therapeutics
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• 제16권1호
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• pp.40-45
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• 2008

The objective of this study was to investigate the single dose and 2-week repeated dose toxicity of Aceporol 330 in ICR mice following single intravenous administration and to compare its toxicity with a commercially available solubilizer of paclitaxel, Cremophor EL. In single dose toxicity test, $LD_{50}$ of Aceporol 330 in mice was estimated to be greater than maximum applicable dose, 4 ml/kg. However, $LD_{50}$ of Cremophor EL in male mice was determined to be 4 ml/kg. Maximum tolerated dose (MTD) of males and females in Aceporol 330-treated group and MTD of females in Cremophor EL-treated group were 3 ml/kg. MTD of males in Cremophor EL-treated group was less than 3 ml/kg. Characteristic toxic symptoms, and hematological and blood chemical changes were not observed after single dose and repeated dose of Aceporol 330 or Cremophor EL. No histopathological abnormalities were found in organs of all animal groups. Based on the linear pharmacokinetic property of paclitaxel and the higher $LD_{50}$ in mice, Aceporol 330 has a potential for use as a safer solubilizer for paclitaxel than Cremophor EL.

• Journal of Acupuncture Research
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• 제38권1호
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• pp.47-59
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• 2021

Background: This study aimed to assess the toxicity of Aconitum sinomontanum Nakai (ASN) pharmacopuncture. Methods: To investigate the toxicity of ASN pharmacopuncture, single and 4-week repeated dose toxicity experiments were conducted on BALB/c mice. In the single-dose toxicity experiment, mice were assigned 1 of 4 groups (5 males, 5 females per group). Then, 31.25, 62.5, and 125 mg/kg of ASN pharmacopuncture were administered to the mice in the experimental groups at acupoint ST36, while 0.2 mL of normal saline was administered to the control group at ST36. After a 4-week repeated dose regimen, the mice were assigned into 4 groups (5 males, 5 females per group). Then, 15.625, 31.25, and 62.5 mg/kg of ASN pharmacopuncture at ST36 were administered to the mice in the experimental groups, while 0.2 mL of normal saline was administered to the control group at ST36. Mortality, morbidity, general body and organ weight changes (after 4 weeks repeated dose), serum hematological and biochemical values, and histopathological changes in the liver and kidney were observed. Results: In both single and 4-week repeated dose toxicity experiments, no deaths or symptoms occurred in any of the groups. There were no significant differences between groups in terms of body and organ weights, serum hematological and biochemical values, and specific organ histopathological changes. Conclusion: ASN pharmacopuncture injection did not demonstrate significant toxicity in BALB/c mice compared with the control group, with a no-observed-adverse-effect level for a single dose of >125 mg/kg, and for 4 weeks repeated dose it was more than 62.5 mg/kg/day.

• 생물정신의학
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• 제18권1호
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• pp.36-45
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• 2011

Objectives : Though a proportion of Alzheimer's disease(AD) patients treated with donepezil have shown positive response on cognition, but the responders' characteristics are still uncertain. This study attempts to identify whether a single oral dose of donepezil(5mg) can change cognition and the relationship between single dose responder items and long-term responder are examined. Methods : Twenty-three AD patients for single donepezil challenge study group and eleven AD patients for controls were participated in the study. Seven days after baseline study for neuropsychological test and EEG, same studies were rechecked after donepezil medication in study group. In donepezil study groups, 12 weeks after donepezil medication, neuropsychological test and EEG were rechecked. Results : After single donepezil challenge, forward digit span, Rey-Osterrieth Complex Figure Test copy, SVLT delayed recall were significantly improved, and beta spectra power in anterior, theta spectra power in posterior field were significantly decreased. According to linear regression analysis, forward digit span after single donepezil challenge was significantly positive correlated with long-term responders. Conclusions : This study suggests that single donepezil medication can significantly change cognitive functions and EEG in AD patients. Among these responsive items, forward digit span was significantly correlated with long-term responder.

• 한국방사선학회논문지
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• 제17권6호
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• pp.809-817
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• 2023

뇌출혈 진단 방법 중 CT는 비침습적으로 피사체의 3차원 영상을 제공할 수 있다. 그래서 응급실에서 급성인 환자 상대로 많이 사용되고 중요한 역할을 담당하고 있다. 뇌혈관 CT는 다른 혈관 CT에 비해 비교적 촬영 빈도가 높으며 뇌혈관 CT 검사 시 적절한 SNR, 합리적인 유효선량으로 검사를 해야한다. 뇌혈관 CT 검사 시 이중에너지와 단일에너지를 이용하였을 때 실질적으로 어느 것이 유효선량이 적으며, SNR이 차이가 없는지 환자영상과 Phantom영상을 같이 비교하였다. SNR과 CNR의 P값이 0.05이상일 때 통계적으로 차이가 없다고 보았고, 유효선량은 0.05미만일 경우 통계적으로 차이가 있다고 보았다. 실험에서는 병원영상의 환자선량을 비교하였을 때 이중에너지의 유효선량이 53.53% 적게, Phantom의 OLSD 이중에너지 유효선량이 57.94% 적게, Phantom의 Dose Report의 이중에너지 유효선량이 56.04% 적었다. 그래서 뇌혈관조영 CT는 이중에너지를 권장한다.

• 대한한방내과학회지
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• 제32권3호
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• pp.334-344
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• 2011

Objectives : Sipjeondaebo-tang is a medicine traditionally prescribed as a restorative. The aim of this study was to investigate the single oral dose toxicity and safety of extract of fermented Sipjeondaebo-tang in ICR mice. Methods : In single oral dose toxicity study, non-fermented or fermented Sipjeondaebo-tang were administered by oral gavage to ICR mice (5 males, 5 females) at single doses of varying concentrations: 1250, 2500 and 5000 mg/kg. Changes of body weight, general behavior, adverse effects and mortality were determined throughout the experimental period. Hematological parameters, organ weights and necropsy findings were evaluated at the end of the experiment. Results : There were no mortality or signs of toxicity in single oral dose toxicity studies. There were also no significant differences in body weight, organ weight, or hematological parameters between the treatment and control groups. Conclusions : Fermented Sipjeondaebo-tang did not cause remarkable adverse effects in ICR mice. The oral lethal dose of fermented Sipjeondaebo-tang is more than 5000 mg/kg and no-observed-adverse-effect level (NOAEL) of the extract for both male and female mice is 5000 mg/kg.

• Environmental Analysis Health and Toxicology
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• 제21권4호
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• pp.331-335
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• 2006

The single dose toxicity of Buxus microphylla var koreana Nakai was evaluated in ICR mice. Twenty five mice of each sex were randomly assigned to five groups of 5 mice each and were administered singly by gavage at dose of 0, 222, 667, 2,000 and 5,000 mg/kg body weight. After single administration, signs of toxicity were observed every hour for the first 6 hours and every day for 14 days. At the end of 14-day observation period, all animals were sacrificed for gross postmortem examinations. Neither significant toxic signs nor death was observed during the observation period. In addition, no pathological changes were noticed in macroscopic examination at necropsy. These results indicate that the single oral administration of Buxus microphylla var. Koreana Nakai did not cause any toxic effect at the dose of 5,000 mg/kg body weight for both sexes and $LD_{50}$ of Buxus microphylla var. koreana Nakai is greater than 5,000 mg/kg body weight.

• 한방재활의학과학회지
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• 제28권2호
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• pp.61-72
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• 2018

Objectives The purpose of this experiment is to evaluate 4 weeks DRF (Dose Rate Finding) and single oral dose toxicity of ChondroT in rats. Methods In 4-week DRF, male and female Sprague-Dawely rats were treated with ChondroT at oral dose of 0, 500, 1000, and 2000 mg/kg. clinical signs, body weight, food consumption, necropsy findings, organ weight, hematological and blood-chemical parameters, and histological findings were monitored for 4 weeks. Also, after single oral administration of ChondroT, mortality, clinical signs, body weight, and necropsy findings were minitored for 2 weeks. Results In 4-week DRF and single dose oral toxicity study of ChondroT in sprague-Dawley rats, ChondroT did not exhibit any toxicity under the study conditions employed. Conclusions The results suggested a no-observed adverse effects level (NOAEL) was over 2,000 mg/kg/day in SD rats after oral administration, this study could be used as basic study of the repeated dose 13-week oral toxicity study of ChondroT.

• 대한한방내과학회지
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• 제32권4호
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• pp.599-609
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• 2011

Objectives : The aim of this study was to evaluate the single oral dose toxicity and safety of Bojungikgi-tang (Buzhongyiqi-tang) and fermented Bojungikgi-tang (Buzhongyiqi-tang) extracts in male and female ICR mice. Methods : In the single oral dose toxicity study, non-fermented and fermented Bojungikgi-tang (Buzhongyiqi-tang) were administered to male and female ICR mice as an oral dose of 1250, 2500 and 5000 mg/kg. Changes of body weights, general behaviors, adverse effects and mortality were determined throughout the experimental period. Hematological parameters, serum chemistry, organ weights and necropsy findings were evaluated at the end of the experiment. Results : There was no mortality or sign of toxicity in the single oral dose toxicity study. There were also no significant differences in body weights, organ weights, and hematological parameters, serum chemistry values between treatment and control groups. Conclusions : The results obtained in this study suggest that the 50% lethal dose of fermented Bojungikgi-tang (Buzhongyiqi -tang) in both female and male mice can be considered as well over 5,000 mg/kg, so these medicines can be safe in clinics.

• Toxicological Research
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• 제20권2호
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• pp.143-151
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• 2004

This study was to investigate single and repeated-dose toxicities of CJ-11555, an anticirrhotic agent, in Sprague-Dawley (SO) rats. In single-dose oral toxicity study, the test article were administered once by gavage to males and females at dose levels of 0 and 2,000 mg/kg. No dead animals and abnormal necropsy findings were found in control and CJ-11555 treated group. Therefore, the approximate lethal dose of CJ-11555 was considered to be higher than 2,000 mg/kg in rats. In the 4-week repeated oral toxicity study, the test article was administered once daily by gavage to male and female rats at dose levels of 0, 10, 50 and 200 mg/kg/day for 4-weeks. In clinical signs, yellow-colored urine and yellow hair coat were observed in the 50 and 200 mg/kg male and female groups. In hematology, erythrocyte count and hemoglobin were significantly decreased in the 200mg/kg male and female groups. In serum biochemistry, total cholesterol was significantly increased and aspartate aminotransferase (AST) was significantly decreased in the 50 or 200 mg/kg male and female groups. In histopathological examinations, centrilobular hepatocellular hypertrophy in the liver, congestion and pigmentation in the spleen, hyaline droplets in the kidney were observed in the 50 and 200 mg/kg male and female groups. In toxicokinetic study, CJ-11555 was dose-dependent in systemic exposure and showed better absorption in female with minimum accumulation after multidosing. Based on these results, it was concluded that the 4-week repeated oral dose of CJ-11555 resulted in the suppression of AST activity and centrilobular hepatocellular hypertrophy in both sexes at a dose level of 50 or 200 mg/kg/day. The target organ was estimated to be liver, spleen and male's kidney. The no-observed-adverse-effect level (NOAEL) for CJ-11555 in rats following gavage for at least 4-week is 10 mg/kg/day.

• 대한약학회:학술대회논문집
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• 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.1
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• pp.181.2-182
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• 2003

Single and 28-day repeated dose toxicity studies of botulinum toxin type A(BTA) were carried out in ICR mice and SD rats. respectively. In the single dose toxicity study. BTA was injected intraperitoneally to male and female mice at a single dose of 40, 59, 89, 133 and 200 ng/kg. All animals died from 59 ng/kg. Some clinical signs were observed in most of both sexes from 59 ng/kg, but no signs were seen in all animals at 40 ng/kg. (omitted)