Literature DB >> 20633626

Evaluation of safety of the herbal formula Ojeok-san: acute and sub-chronic toxicity studies in rats.

Hyekyung Ha1, Jun Kyoung Lee, Ho Young Lee, Chang-seob Seo, Jung-Hoon Kim, Mee-young Lee, Woo Suk Koh, Hyeun Kyoo Shin.   

Abstract

AIM OF THE STUDY: Ojeok-san (OJS; wuji powder in China and goshaku-san in Japan), a widely used herbal formula in traditional Korean medicine and Japanese herbal medicine (Kampo medicine), has been used to treat common cold and illnesses including fatigue and gastrointestinal disorders, but there is very little information on its safety. To provide information on the safety of OJS, we evaluated its acute and sub-chronic toxicity in rats.
MATERIALS AND METHODS: The single and sub-chronic toxicity of OJS was examined using male and female Sprague-Dawley rats. The rats were treated with the OJS extract orally at the highest dose level of 2000 mg/kg/day body weight. After single administration, signs of toxicity were observed every hour for the first 6h and every day for two weeks. In the sub-chronic toxicity study, OJS was administered for 13 weeks. Mortality, clinical signs, body weight changes, food and water consumption, ophthalmologic findings, urinalysis, hematological and biochemical parameters, gross findings, organ weights and histological markers were monitored during the study period.
RESULTS: We found no mortality and no abnormality in clinical signs, body weight, and necropsy findings for any of the animals in the acute and sub-chronic toxicity study following oral administration of OJS.
CONCLUSION: OJS may not have any single dose toxicity. The lethal dose with a 50% mortality rate (LD(50)) was over 2000 mg/kg. The no-observed adverse effects level (NOAEL) was considered to be 2000 and 1000 mg/kg/day for male and female rats, respectively. Crown Copyright 2010. Published by Elsevier Ireland Ltd. All rights reserved.

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Year:  2010        PMID: 20633626     DOI: 10.1016/j.jep.2010.07.011

Source DB:  PubMed          Journal:  J Ethnopharmacol        ISSN: 0378-8741            Impact factor:   4.360


  10 in total

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5.  Cytotoxicity and sub-acute toxicity in Crl:CD (SD) rats of traditional herbal formula Ojeok-san.

Authors:  Soo-Jin Jeong; Jung-Im Huh; Hyeun-Kyoo Shin
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8.  Efficacy and safety of Ojeok-san in Korean female patients with cold hypersensitivity in the hands and feet: study protocol for a randomized, double-blinded, placebo-controlled, multicenter pilot study.

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9.  A Pharmacokinetic Study of Ephedrine and Pseudoephedrine after Oral Administration of Ojeok-San by Validated LC-MS/MS Method in Human Plasma.

Authors:  Sooyoung Lee; Wang-Seob Shim; Heejo Yoo; Sanghee Choi; Jiyoung Yoon; Kwang-Young Lee; Eun-Kyoung Chung; Byung-Cheol Lee; Sung-Vin Yim; Bo-Hyung Kim; Kyung-Tae Lee
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10.  Acute and sub-chronic oral toxicity assessment of the aqueous extract leaves of Ficus glumosa Del. (Moraceae) in rodents.

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  10 in total

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