• 동의생리병리학회지
• /
• 제25권1호
• /
• pp.122-131
• /
• 2011

The object of this study was to evaluate the single dose toxicity of Yukmijihwangtanggamibang (YMJHTGMB), a polyherbal formula have been traditionally used as prevention or treatment agent for various lung diseases including chronic obstructive pulmonary disease (COPD), in male and female mice. Aqueous extracts of YMJHTGMB (Yield = 16.33%) wasadministered to female and male ICR mice as an oral dose of 2,000, 1,000 and 500 mg/kg (body weight) according to the recommendation of Korea Food and Drug Administration (KFDA) Guidelines. Animals were monitored for the mortality and changes in body weight, clinical signs and gross observation during 14 days after dosing, upon necropsy; organ weight and histopathology of 12 principle organs were examined. As results, we could not find any mortality, clinical signs, and changesin the body and organ weight except for soft feces restricted to YMJHTGMB 2,000 mg/kg treated two male mice (2/5; 40%) at 1 day after administration. In addition, no YMJHTGMB-treatment related abnormal gross findings and changes in histopathology of principle organs were detected except for some sporadic accidental findings. The results obtained in this study suggest that the 50% lethal dose and approximate lethal dose of YMJHTGMB aqueous extracts in both female and male mice were considered as over 2,000 mg/kg, the limited highest dosage recommended by KFDA Guidelines.

• 동의생리병리학회지
• /
• 제24권6호
• /
• pp.1019-1026
• /
• 2010

The object of this study was to evaluate the single dose toxicity of Iijintanggami-bang (IJTGMB), a polyherbal formula have been traditionally used as prevention or treatment agent for various digestive disorders including reflux esophagitis, in male and female mice. Aqueous extracts of IJTGMB (Yield = 8.45%) was administered to female and male ICR mice as an oral dose of 2,000, 1,000 and 500 mg/kg (body weight) according to the recommendation of Korea Food and Drug Administration (KFDA) Guidelines. Animals were monitored for the mortality and changes in body weight, clinical signs and gross observation during 14 days after dosing, upon necropsy; organ weight and histopathology of 12 principal organs were examined. As results, we could not find any mortality, clinical signs, and changesin the body and organ weight except for soft feces restricted to IJTGMB 2,000 mg/kg treated two male mice (2/5; 40%) at 1 day after administration. In addition, no IJTGMB-treatment related abnormal gross findings and changes in histopathology of principle organs were detected except for some sporadic accidental findings. The results obtained in this study suggest that the 50% lethal dose and approximate lethal dose of IJTGMB aqueous extracts in both female and male mice were considered as over 2,000 mg/kg, the limited highest dosage recommended by KFDA Guidelines.

• Toxicological Research
• /
• 제27권2호
• /
• pp.119-123
• /
• 2011

In this research, the genotoxic effect of Picrorrhiza Rhizoma (PR) aqueous extract was evaluated using the mouse micronucleus test. PR extract was administered once a day for 2 continuous days by oral gavage to male ICR mice at doses of 2000, 1000 and 500 mg/kg. Cyclophosphamide was used as a known genotoxic agent in a positive control. The appearance of a micronucleus (MN) in polychromatic erythrocyte (PCE) is used as an index for genotoxic potential, and PCE ratio is used as an index of cytotoxicity. Although significant (p < 0.01) increase of the number of PCE with one or more nuclei (MNPCE) was detected in cyclophosphamide treated groups, no significant increases of MNPCE numbers were observed in all three different dosages of PR extracts treated mice with over 0.39 of the individual polychromatic erythrocyte ratio in all mice used in this study. The results obtained indicated that PR extract shows no genotoxicity effects up to 2000 mg/kg dosing levels.

• 대한수의학회지
• /
• 제32권4호
• /
• pp.609-627
• /
• 1992

The study was carried out to obtain the basic data for types, incidence and histopathological features of the spontaneous tumors of the specific pathogen free (SPF) Ktc : ICR mice bred in a barrier system in Technology Research Center, Korea Research Institute of Chemical Technology. One hundred of the mice consisted of 50 males and 50 females were examined for 18 months. 1. The overall incidence rate of spontaneous tumors was 51(51%) of 100 heads tested. The male mice showed slightly higher incidence(28%) than the female(23%), and the incidence rate and the number of affected organs were increased with the increasing age of mice. 2. The incidence rate of primary tumor was 59(59%) of 100 heads tested, consisted of 30 cases (50.8%) of benign tumors and 29 cases(49.2%) of malignant tumors. Among the malignant tumors twenty cases were metastasized to various organs. 3. In tumor incidence rates by systems and organs, the male mice showed the high incidence rate in the liver (18%), hematopoietic system (16% ) and lung (14%), while the female mice, in the hematopoietic system(18%), lung(12%), liver(8%) and uterus(8%). 4. The tumors showing the particularly low incidence rates (<1.0%) were rhabdomyosarcoma in the skeletal muscle, malignant schwannoma in the peripheral nerve, cortical adenoma in the adrenal gland, transitional cell carcinoma in the urinary bladder, tubular cell adenoma in the kidney and adenoma in the pituitary gland and harderian gland.

• 한국한의학연구원논문집
• /
• 제16권3호
• /
• pp.149-154
• /
• 2010

Objective : Ssanghwa-tang has been used as herbal medine, favorite beverage or health beverage. This study was performed to evaluate the acute toxity and safety of fermented Ssanghwa-tang extract in ICR mice. Methods : 0(control group), 1250, 2500 and 5000 mg/kg of Ssanghwa-tang and fermented Ssanghwa-tang extracts were orally administered to 35 male and 35 female ICR mice. After single administration, we observed number of death, clinical signs, changes of body weight for 14 days. After 14 day of administration, all mice were sacrificed and major organ were observed. Results : Compared with the control group, we could not find any toxic alteration in all treated groups (1250, 2500 and 5000 mg/kg). Conclusions : These results suggest that Sssanghwa-tang fermented with nuruk extracts might be safe to ICR mice.

• 대한한의학회지
• /
• 제28권2호통권70호
• /
• pp.200-204
• /
• 2007

Objectives : The purpose of this study was to investigate acute toxicity of orally-treated Sagunja-tang(Sijunzi-tang) in ICR mice. Methods : In this study, we investigated the acute toxicity of water-extracted Sagunja-tang(Sijunzi-tang). Twenty-five mice completed 14 days of oral Sagunja-tang(Sijunzi-tang) at respective doses of 0 (control group), 2560, 3200, 4000 and 5000 mg/kg. Results : We observed survival rates, clinical signs of male ICR mice with acute toxicity, change of body weight and autopsy. Conclusions : Compared with the control group, we could not find any toxic alteration in anytreated groups (2560, 3200, 4000 and 5000mg/kg). LD50 of Sagunja-tang(Sijunzi-tang) was over 5000 mg/kg and it is very safe for ICR mice.

• 대한한방내과학회지
• /
• 제34권2호
• /
• pp.155-164
• /
• 2013

Objectives : This study aimed to evaluate the single oral dose toxicity of Jaeumganghwa-tang (Ziyinjianghuo-tang) and Jaeumganghwa-tang (Ziyinjianghuo-tang) fermented with Lactobacillus acidophyllus in male and female ICR mice. Methods : In this single oral toxicity study, non-fermented and fermented Jaeumganghwa-tang (Ziyinjianghuo-tang) were administered to male and female ICR mice as an oral dose of 500, 1000 and 2000 mg/kg. After single administration, body weight changes, general behavior, adverse effects and mortality were determined for 14 days. Serum chemistry, organ weights and necropsy findings were evaluated at the end of the experiment. Results : There were no mortality or signs of toxicity for 14 days. There were also no significant differences in body weights, organ weights, or serum chemistry values between treatment and control groups. Conclusions : These results indicate that the 50% lethal dose of Jaeumganghwa-tang (Ziyinjianghuo-tang) fermented with Lactobacillus acipophullus may be over 2000 mg/kg. This finding can be expected to provide scientific evidence for the safety of Jaeumganghwa-tang (Ziyinjianghuo-tang) fermented with Lactobacillus acidophyllus.

• Mass Spectrometry Letters
• /
• 제3권4호
• /
• pp.104-107
• /
• 2012

Mollugin isolated from Rubia cordifolia is known to have anti-inflammatory, anti-cancer, and anti-viral activities. In the present study, a cocktail probe assay and LC-MS/MS were used to investigate the modulating effect of mollugin on cytochrome P450 (CYP) enzymes in male ICR mice. After mollugin was orally administrated to mice at the 20, 40, or 80 mg/kg for 3 days, the activities of CYP in hepatic S-9 fractions were investigated. Unlike the selective inhibitory effect of mollugin on CYP1A2-catalyzed phenacetin O-deethylation in vitro, mollugin only significantly inhibited the activity of CYP2E1-catalyzed chlorzoxazone 6-hydroxylase in vivo. The activities of other CYPs were only slightly altered by mollugin. The results of this study suggest that mollugin might cause herb-drug interactions via the selective inhibition of CYP2E1 in vivo.

• 한국한의학연구원논문집
• /
• 제15권3호
• /
• pp.93-98
• /
• 2009

In this research, the acute toxicity of fermented Yukmijihwangtang extract was examined using male and female ICR mice, To evaluate the acute toxity and safety, 0(control group), 1250, 2500 and 5000 mg/kg of fermented Yukmijihwangtang extract were orally administered to male and female ICR mice. After single administration, we observed survival rates, general toxicity, changes of body weight for the 14 days and autopsy at 1 day following the administration according to the Regulation of Korean Food and Drug Administration. Compared with the control group, we could not find any toxic alteration in all treated groups (1250, 2500 and 5000 mg/kg). $LD_{50}$ of fermented Yukmijihwangtang extract might be over 5000 mg/kg and it is very safe to ICR mice.

• Biomolecules & Therapeutics
• /
• 제15권2호
• /
• pp.127-132
• /
• 2007

The object of this study was to evaluate the acute toxicity of lyophilized water extract of Radix Araliae Cordatae (RA) in male and female mice. The extract was administered to female and male ICR mice as an oral dose of 2000 mg/kg (body wt.) according to the recommendation of KFDA Guidelines. Animals were monitored for the mortality and changes in body weight, clinical signs and gross observation during 14 days after dosing, upon necropsy, organ weight and histopathology of 12 principle organs were examined. As results, we could not find any mortality, clinical signs, changes in the body weight and gross findings except for increases of hypertrophy of lymph nodes in male RA extracts-dosing group. In addition, no RA extracts-treatment related abnormal changes in the organ weight and histopathology of principle organs except for some sporadic accidental findings. The results obtained in this study suggest that the RA extracts does not cause any toxicological signs. The LD$_{50}$ and approximate LD of RA extracts in both female and male mice were considered as over 2000 mg/kg.