• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.14 no.2
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• pp.118-124
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• 2001

The single dose toxicity of Injinhotang, a herbal drug for treatment of hepatic injuries. was evaluated in Sprague-Dawley rats. Injinhotang was once administered to both sexes of rats at the dose levels of 2000, 1000, 500, 250 and 125 mg/kg for oral route. After single administration, clinical signs were observed every day for 14 days and body weights were measured 5 times including initial measurement on day 0 (the days of administration). When observation period was over, the animals were sacrificed and macroscopic examination of major organs was conducted. In addition, the histopathological profiles of these major organs were also conducted. Neither significant clinical signs nor death after administration was observed during the observation periods except for soft feces or diarrhea. In addition, no abnormal necropsy findings, changes of body weight and histopathological profiles were observed at terminal necropsy in both sexes. From these results, it is considered that $LD_{50}$ of Injinhotang is over 2000 mg/kg in oral administration in both sexes of rats.

• The Korea Journal of Herbology
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• v.39 no.2
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• pp.19-25
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• 2024

Objectives : Jeopgoltang (JGT) is a new Korean herbal medicine formulation that is used to treat bone fractures. Although JGT is frequently used in clinical practice, there is a lack of scientific evidence on its safety. This study aimed to evaluate the preclinical toxicity of JGT using a single oral dose toxicity test in Sprague-Dawley (SD) rats. Methods : Five male and female rats per group were orally administered 1,250, 2,500, or 5,000 mg/kg of JGT after fasting for 12 h. Mortality and changes in clinical signs, body weight, and necropsy findings were monitored for 14 days according to the guidelines of the Korean Ministry of Food and Drug Safety and Organisation for Economic Co-operation and Development (OECD). Results : No significant clinical signs or mortality were observed after a single administration of up to 5,000 mg/kg. In addition, no significant necropsy findings related to JGT administration were observed. Conclusions: In conclusion, these results suggest that approximate Lethal Dose (ALD) of JGT on SD rats is over 5,000 mg/kg.

• The Korea Journal of Herbology
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• v.33 no.1
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• pp.71-76
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• 2018

Objectives : This study was performed to investigate the single oral toxicity of HBX-6 in Sprague-Dawley (SD) rats. Methods : Twenty SD rats were randomly assigned to four groups of 5 rats each and were administrated singly to female and male SD rats, as an oral dose of 2000 mg/kg. HBX-6 is a newly combined Korean herbal medicine formula 30 % Ethanol extract derived from The Dongui Bogam. Now we are developing the prescription for the aim of improving benign prostatic hyperplasia (BPH) without undesirable side effects. HBX-6 is composed of nine medicinal herbs: Aconiti Lateralis Radix Preparata, Corni Fructus, Cistanchis Herba, Psoraleae Semen, Dendrobii Herba, Morindae Radix, Cuscutae Semen, Trigonellae Semen, Foeniculi Fructus. Animals were monitored for the mortality and changes in the body weight, clinical signs, gross observation and necropsy findings for the 14 days according to "Standard for Toxicity Study of Pharmaceuticals" of Korea Food and Drug Administration (KFDA) guideline and "Acute Oral Toxicity - Fixed Dose Procedure" of OECD Test Guideline. Results : We could not find any mortality. Compared with the control group, significant weight change was not observed in the experimental group. After administration, the more common symptoms were not observed. There were no gross abnormalities in all cases. Conclusions : Taken together, these results suggest that the approximate lethal dose of HBX-6 in both female and male SD rats were considered as over 2000 mg/kg.

• Journal of Korean Medicine Rehabilitation
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• v.34 no.3
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• pp.89-96
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• 2024

Objectives This study is designed to evaluated the safety of peony root extract tablet in healthy male volunteers. Methods 12 healthy male volunteers were recruited, and this study was conducted by a single center. The safety was evaluated by collecting laboratory test and vital signs of volunteers. As the registration process, 12 subjects were assigned by serial number. To evaluate safety, vital signs were checked and blood samples were collected 4 times during the screening period, pre & post-administration (after 8 hours) and post-administration (after 7 days). The difference in variables was summarized by the mean±standard deviation. The normality test was carried out using the Shapiro-Wilk test and Kolmogorov-Smirnov test. When normality is fulfilled, a paired t-test is applied and the significance level was p<0.05. And the incidence of all adverse effects and serious adverse effects are shown in percentage. Results In the case of vital sign, body temperature (BT) (℃) was 0.06±0.05 ℃ (p=0.008), and there was a statistically significant difference in before and after administration. However, clinical symptoms were not occurred and BT (℃) of all subjects before and after administration showed values within the normal reference value. There was no significant difference from the control group in all other vital signs and laboratory test data. And no side-effects associated to clinical trial drugs were followed. Conclusions The peony root extract tablet was considered to be safe for healthy male volunteers.

• Herbal Formula Science
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• v.16 no.2
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• pp.183-191
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• 2008

Acetaminophen (N-acety1-p-aminophenol, paracetamol) is widely used as an over-the-counter analgesic and antipyretic drug. Intake of a over dose of acetaminophen may result in severe hepatic necrosis. In this study, we investigated the liver damage in mice using single dose (300 mg/kg) of acetaminophen and the possible protective effects of administration (50-200 mg/kg body weight) of SB-Ex on acetaminophen-induced liver damage in mice. The alanine aminotransferase (ALT), and aspartate aminotransferase (AST) activities were determined in the plasma of mice. The effect of SB-Ex on lipid peroxidation product thiobarbituric reacting substances (TBARS) and some antioxidant enzymes superoxide dismutase (SOD), catalase, d-aminolevulinate dehydratase (${\sigma}$-ALA-D) activities, and gluthathione peroxidase (GPx), were also evaluated in the mouse liver homogenate. Acetaminophen caused liver damage as evident by statistically significant increased in plasma activities of AST and ALT. There were general statistically significant losses in the activities of SOD, catalase, ${\sigma}$-ALA-D, and GPx and an increase in TBARS in the liver of acetaminophen-treated group compared with the control group. However, SB-Ex was able to counteract these effects. These results suggest that SB-Ex can act as hepatoprotectives against acetaminophen toxicity and is a good candidate for further evaluation as an effective chemotherapeutic agent.

• Herbal Formula Science
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• v.7 no.1
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• pp.121-130
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• 1999

Oriental medicine prescription has been used for the treatment of various clinical symptoms associated with cerebral apoplexy. However, single herb drug does not used cerebral apoplexy and there mechanisms of action have not been defined, and it is not yet known what effects they have on the hemodynamics of cerebral circulation. The study was aimed to investigate the effect batryticatus bombycis(BB) on the vascular systems including changes in blood pressure (BP), and regional cerebral blood flow (rCBF) and of male Sprague-Dawely rats. The changes in rCBF were determinated by laser-Doppler flowmetry. 1. Blood pressure was not affected by BB in rats. 2. rCBF was increased by BB in a dose-dependent manner. 3. Pretreatment with methylene blue(1mg/kg), and propranolol(1mg/kg) did not inhibited BB induced increased in rCBF. 4. Pretreatment with propranolol(1mg/kg) was increased by BB in a dose-dependent manner in blood perssure. 5. Pretreatment with ODQ($10{\mu}g/kg$) and L-NNA(1mg/kg) were inhibited BB induced increased in rCBF. 6. Pretreatment with L-NNA(1mg/kg) was increased rCBF in a dose-dependent manner. These results suggest that BB causes a diverse response of blood pressure and regional cerebral blood flow(rCBF). The increased in rCBF is also mediated by nitric oxide synthease and guanylate cyclase.

• The Journal of Korean Medicine
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• v.38 no.2
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• pp.61-72
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• 2017

Objectives: The effects of Gamiondam-tang (GMODT) co-administration within 5min on the pharmacokinetics (PK) of tamoxifen were observed as a process of the comprehensive and integrative medicine, combination therapy of tamoxifen with GMODT to achieve synergic pharmacodynamics and reduce toxicity on the breast cancer. Methods: After 50mg/kg of tamoxifen treatment, GMODT 100mg/kg was administered within 5min. The plasma were collected at 30 min before administration, 30 min, 1, 2, 3, 4, 6, 8 and 24 hrs after end of GMODT treatment, and plasma concentrations of tamoxifen were analyzed using LC-MS/MS methods. PK parameters of tamoxifen (Tmax, Cmax, AUC, $t_{1/2}$ and $MRT_{inf}$) were analysis as compared with tamoxifen single administered rats using noncompartmental pharmacokinetics data analyzer programs. Results: Co-administration with GMODT induced increased trends of plasma tamoxifen concentrations to 1hr after end of administration, and then showed decreased trends of plasma tamoxifen concentrations, and especially significant (p<0.05) increases of plasma tamoxifen concentrations were demonstrated at 0.5hr after end of co-administration with GMODT and also related significant (p<0.05) decreases of $AUC_{0-inf}$ and $MRT_{inf}$ as compared with tamoxifen single formula treated rats, at dosage levels of tamoxifen 10 mg/kg and GMODT 100 mg/kg within 5 min, in this experiment. Conclusion: Based on the results of the present study, it is considered that single co-administration GMODT within 5min significantly inhibited the oral bioavailability of tamoxifen through variable influences on the absorption and excretion of tamoxifen, can be influenced on the toxicity or pharmacodynamic of tamoxifen.

• Journal of Korean Medicine Rehabilitation
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• v.31 no.4
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• pp.157-166
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• 2021

Objectives This study is designed to evaluate the safety of Bojungikgi-tang soft extract in healthy male volunteers. Methods 12 healthy male volunteers were recruited and this study was carried out by a single center. Laboratory test results, vital signs of the volunteers were collected to evaluate safety. According to registration order, the 12 subjects were allocated by serial number. To evaluate safety, blood samples were taken and vital signs were checked 4 times - screening, pre administration, post administration and follow up-during the whole trial. The difference between pre (before medication [0 hr]) and post-administration (after medication [48 hr]) variables was summarized as mean±standard deviation. The normality test was performed using the Kolmogorov-Smirnov test and Shapiro-Wilk test. When the normality is satisfied, the paired t-test is applied. Otherwise, the non-parametric method, Wilcoxon signed rank test is applied. The significance level was p<0.05. The incidence of all adverse effects are shown in percentage. Results In the case of red blood cell, hemoglobin, hematocrit, lymphocytes, neutrophils, protein, γ-glutamyl transpeptidase values, the normality test result of the variable for the difference value before and after the dosing has a significance level <0.05. But most of values did not deviate from the normal range, and the deviation from the normal range could not be regarded as the significance associated with this clinical trial. And adverse event wasn't observed associated with the clinical trial drug. Conclusions Bojungikgi-tang soft extract were considered to be safe for healthy male volunteers.

• Korean Journal of Pharmacognosy
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• v.41 no.3
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• pp.196-203
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• 2010

Black sesame (Sesami semen nigrum) has been used to treat dizziness, earnoise, constipation in the traditional Chinese medicine. In the present study, we assessed memory enhancing properties of 70% ethanolic extract of black sesame (EBS70) and its ameliorating activities on learning and memory impairments induced by scopolamine. Drug-induced amnesia was made by scopolamine treatment (1 mg/kg, i.p.). Single EBS70 (200 mg/kg, p.o.) administration significantly enhanced cognitive function and attenuated scopolamine-induced cognitive impairments as determined by the passive avoidance and Y-maze tasks (P<0.05) and also reduced escape-latency on the Morris water maze task (P<0.05). In addition, EBS70 increased BDNF expression in hippocampus 4 h after its administration (P<0.05). These results suggest that EBS70 enhances learning and memory in normal state and attenuates amnesic state caused by cholinergic dysfunction.

• Journal of Oriental Neuropsychiatry
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• v.22 no.4
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• pp.185-199
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• 2011

In the present study, we assessed the effect of the PPA (Polygala japonica Houtt., Polygala tenuifolia WILLD. and Acorus gramineus SOLAND. mixed preparation), a traditional herbal prescription, on the learning and memory impairments induced by scopolamine. The cognition-enhancing effect of PPA was investigated using a passive avoidance test, Y-maze test and the Morris water maze test in mice. Drug-induced amnesia was induced by treating animals with scopolamine (1 mg/kg, i.p.). A single PPA (400 and 800 (mg/kg)) administration significantly reversed the scopolamine-induced cognitive impairments in the passive avoidance test (P<0.05). On the Y-maze test, PPA (400 and 800 (mg/kg)) also significantly reversed scopolamine-induced cognitive impairments in mice (P<0.05). PPA also improved escape latencies in training trials and increased swimming times and distances within the target zone of the Morris water maze (P<0.05). These results suggest that PPA attenuates amnesic state induced by scopolamine and that these Effect are mediated by enhancing the cholinergic dysfunction.