• The Journal of Korean Medicine
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• v.35 no.2
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• pp.28-33
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• 2014

Background: Samul-tang (Si-Wu-Tang, SMT) is a traditional herbal formula, which has been widely used to treat various diseases such as menstrual irregularity, bleeding and leucorrhea. Although many studies have investigated the pharmacological properties of SMT, its toxicity information has not yet been fully elucidated. Methods: Five Sprague Dawley (SD) rats of each sex were given a single dose (5000 mg/kg) of SMT by gavage; control rats received the vehicle only. After the single administration, mortality, clinical signs, body weight changes and gross findings were monitored for 15 days in accordance with Good Laboratory Practice (GLP) principles. Results: In a single oral dose toxicity study, there was no adverse effect on mortality, clinical sign, body weight change or gross finding in any treatment group. Conclusions: The results indicate that SMT did not induce toxic effects at a dose level up to 5000 mg/kg in rats and its median lethal dose ($LD_{50}$) was considered to be over 5000 mg/kg/day body weight for both genders.

• Journal of Pharmacopuncture
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• v.4 no.3
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• pp.85-92
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• 2001

Objective : This study was purposed to investigate the acute. subacute toxicity of Herbal acupuncture with Juglandis Semen(JsD) in mice and rats. Methods & Results: Balb/c mice were injected intraperitoneally with JsD for $LD_{50}$ and acute toxicity test Sprague-Dawley rats were injected intraperitoneally with JsD for subacute toxicity test. Results: The results obtained were summarized as follows; 1. LD50 was uncountable as could not find the expired of treat group. 2. The clinical signs and body weight changes of mice treated with 0.2cc, 0.4cc JsD were not affected during the acute toxicity test. 3. In acute toxicity test of serum biochemical values of mice, total protein was increased in treat-l group, compared with normal group, and total cholesterol was increased in treat-2 group, compared with normal group.(P<0.05) 4. In subacute toxicity test, main toxic syndrome was not found. 5. The body weight was decreased in treat-2 group, compared with normal group and relative liver weight was decreased in treat-1, 2 group, compared with normal group in subacute toxicity test.(P<0.05) 6. In subacute toxicity test, WBC, MCH, MCHC were decreased in treat-2 group and RBC was increased in treat-2 group, compared with normal group in complete blood count test.(P<0.05) 7. In subacute toxicity test, treat groups were not changed serum biochemical values of rats, compared with normal group.(P<0.05) Conclusions: According to the results, Herbal-acupuncture with Juglandis Semen caused no toxicity.

• Herbal Formula Science
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• v.17 no.2
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• pp.65-72
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• 2009

Objectives : Yukmijihwang-tang (YJT) is known as a tonifying formula for reinforcement of yin deficiency conditions. The present study was carried out to investigate the potential acute toxicity of YJT in ICR male and female mice. Methods : We investigated the acute toxicity about boiling water-extracted YJT. The test article was orally administered once by gavage to 20 male and 20 female mice at dose levels of 0 (control group), 1250, 2500 and 5000 mg/kg body weight. Mortalities, clinical findings, autopsy and body weight changes were monitored daily for the 14 days following the administration according to the Regulation of Korean Food and Drug Administration. Results : We observed survival rates, general toxicity, change of body weight, and autopsy. Single oral administration of YJT with different dosages, no animals died of the test drug. Autopsy of animal revealed no abnormal gross finding. Therefore, $LD_{50}$ value of YJT for ICR mice was more than 5000 mg/kg on oral route. Conclusions : These results suggest that no toxic dose level of YJT in mice is considered to be more than 5000 mg/kg. Consequently, it was concluded that YJT have no effect on acute toxicity and side effect in ICR mice.

• The Journal of Korean Medicine
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• v.28 no.1 s.69
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• pp.1-10
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• 2007

Background : There has been renewed interest in complementary alternative medicine around the world far a decade. On the other hand, the issue of safety of herbal medicine in Korea has been continuously questioned. Issues raised have included not only chemical residue or heavy metals caused by pollution, but also the toxicity of herbal medicine itself. Objectives : The purpose of this study was to review some herbal medicines subject to controversy of toxicity and figure out what kind of problems they evidence. Methods : In this review, PubMed was used to search medical journals. Keywords such as 'herb, or herbal medicine', 'safety, or adverse events, or adverse effect, or toxicity, or liver injury' were applied. Journals were selected by four inclusion criteria, as objectives should be human, researchers should be medical doctors, literature written in the English language, and types of journals should be meta-analysis or practice guideline or reviews. Finally, 9 cases from 60 journals were included in this review. Results : We reviewed 13 herbal medicines for controversy of toxicity such as ephedra(Mahuang), Arisolochia fangchi, Aristolochia manshuriensis, licorice, skullcap , germander, Syo-saiko-to(Xiao-chai-hu-tang), Chelidonium majus, mistletoe, Dictamnus dasycarpus and madder. Conclusions : It suggested that 'who it is prescribed for' is one of the most important factors to identify the causes of toxicity in herbal medicine and dietary supplements, under specific conditions in Korea.

• The Korea Journal of Herbology
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• v.28 no.2
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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.

• The Journal of Korean Obstetrics and Gynecology
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• v.22 no.3
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• pp.135-142
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• 2009

Purpose: Ojeok-san(Wuji-san) is one of the most frequently prescribed traditional medicine. To evaluate acute toxicity, ICR mice were treated with Ojeok-san(Wuji-san) administration. Methods: In this study, we investigated the acute toxicity of water-extracted Ojeok-san(Wuji-san). 0(control group), 1250, 2500, and 5000 mg/kg of Ojeok-san(Wuji-san) were orally administered to 20 male and 20 female for 14 days. We observed survival rates, general toxicity, change of body weight, and autopsy. Results: Compared with the control group, we could not find any toxic alteration in all treated groups (1250, 2500 and 5000 mg/kg). Conclusions: $LD_{50}$ of Ojeok-san(Wuji-san) might be over 5000 mg/kg and it is very safe to ICR mice.

• Journal of Pharmacopuncture
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• v.5 no.1 s.8
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• pp.27-42
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• 2002

Objective: The purpose of this study was to investigate the acute and subacute toxicity and sarcoma- 180 anti-cancer effects of Herbal acupuncture with Triglii Semen in mice and rats. Method: Balble mice were injected intraperitoneally with Triglii semen Herbal acupuncture for $LD_{50}$ and acute toxicity test. Sprague Dawley rats were injected intraperitoneally with Triglii semen Herbal acupuncture for subacute toxicity test. The Triglii semen Herbal acupuncture was injected on Chung-wan(CV12) of mice with S-180 cancer cell line. Results: 1. In acute toxicity test, the $LD_{50}$ value was $7.49{\times}10^3$ml, 0.30ml/kg.2. The body weights of mice treated with Triglii semen Herbal acupuncture increased during the acute toxicity test. 3. In acute toxicity test of serum biochenrical values of mice, total protein was decreased in treatment groups I, 2 and 3, albunrin was decreased in treatment groups 2 and 3 compared to the control group. GOT was increased in treatment group I and Alk. Phosphatase was increased in treatment groups 1,2 and 3 compared to the normal group(p<0.05). 4.ln subacute toxicity test, severe tissue injury was found in lung and liver. 5. In subacute toxicity test, the body weight was decreased in treatment groups I and 2 compared to the normal group and the weight of liver. lung and kidney were increased in treatment groups 1, 2 and 3 compared to the normal group.(p<0.05) 6. In subacute toxicity test, RBC, HGB and HCT were decreased in treatment groups 1 and 2 compared to the normal group. MCV was increased in treatment group1 compared to the normal group, MCH was increased in treatment groups 1 and 2 compared to the control group in complete blood count test.(p<0.05) 7. In subacute toxicity test, total protein was decreased in treatment groups 1 and 2 compared to the nonnal group, BUN was increased in treatment groups 1 and 2 compared to the nonnal group, creatinine and uric acid were decreased in treatment groups 1 and 2 compared to the normal group, glucose was increased in treatment group 2 compared to the nonnal group, triglycelide was decreased in treatment groups I and 2 compared to the normal group, total cholesterol was increased in treatment groups 1 and 2 compared to the control group. GOT was decreased in treatment group 2 compared to the normal and control group, AIk. Phosphatase was increased in treatment group 1 compared to the normal and control group.(p<0.05) 8. Median survival time was 17days in treatment group 2 for S- 180 cancer cell treated with Triglii semen Herbal acupuncture. 9. Natural killer cell activity was insignificant for S-180 cell treated with Triglii semen Herbal acupuncture.(p<0.05) 10. lnterieukin-2 productivity was decreased for S-180 cell treated with Triglii semen Herbal acupuncture compared to the normal and control group.(p<0.05) Conclusion: According to the results, we can conclude Herbal-acupuncture with Triglii semen caused toxicity, and caused no effects in S-180 cancer cell.

• Korean Journal of Clinical Pharmacy
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• v.11 no.2
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• pp.68-77
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• 2001

Herbal medicines have been used since ancient times as medicines to treat and relieve the symptoms of many different human diseases. However, so far, relatively few herbal medicines have been evaluated scientifically to prove their safety, potential benefits and effectiveness. This study was conducted to provide the groundwork for improving the current registration regulations for herbal medicines in distinction from synthetic medicines. The study was performed based on the literature research and individual interviews with 5 experts who had extensive experience in registration of herbal medicines. When compared with synthetic drugs, herbal medicines exhibit some marked differences, namely the active principles are frequently unknown, standardization, stability and quality control are not easy, they are usually mixtures of complex compounds. Second, the current regulations for herbal medicines are reviewed by comparison of foreign regulation systems like the one in China. The regulation requirements of herbal medicine in China are in distinction from synthetic drugs. The authors conclude that new registration requirements for the herbal medicines should be changed as follows; the toxicity and efficacy data should be submitted as mixed herbal preparation and the documents and other research on the reproduction and generation toxicity need to be shown for the proof of reproduction and generation toxicity, if needed.

• Journal of Pharmacopuncture
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• v.5 no.2
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• pp.6-24
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• 2002

This experiment was carried out to study on the safety assessment of Bos tures$^{\circ}{\S}Ursus thibetanus^{\circ}{\S}$Moschus extract solution(BUM) for Herbal-acupuncture. SD rats and ICR mice were used for acute toxicity test. the results were summerized as follows; 1. In rats and mice, LD50 value could not be measured. 2. There were no abnormal finding in acute toxicity test treated BUM for Herbal-acupuncture

• Herbal Formula Science
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• v.20 no.2
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• pp.93-102
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• 2012

Objectives : Traditional medicine Gumiganghwal-tang (GT) has been used in Asia to treat inflammatory diseases including common cold, pain, fever, and algor. In this study we investigated the acute toxicity and safety of GT and fermented GT (FGT). Methods : Acute toxicity and safety were evaluated in male and female ICR mice orally administered 0 (control) and 2,000 mg/kg of GT and FGT. After the administration of GT and FGT, we observed mortality, body weight, clinical symptoms. After necropsy, organ weights were measured and blood analysis was performed. Results : There was no mortality and clinical symptoms according to the administration of GT and FGT. Comparing with control group, there were no significant alterations on the organ weight, complete blood cell count and biochemical parameters. Conclusions : Median lethal dose of GT and FGT considered to be over 2,000 mg/kg in both male and female mice, and recognized as safe with no toxicity.