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KMID : 0861020180330010071
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Korea Journal of Herbology
2018 Volume.33 No. 1 p.71 ~ p.76
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Single Oral Dose Toxicity Test of HBX-6 in Sprague-Dawley Rat
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Jin Bo-Ram
Seo Dong-Wook
Kim Myoung-Seok
Lee Kwang-Ho
Yoon Il-Joo
Kim Chang-Eun
An Hyo-Jin
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Abstract
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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 ㎎/㎏. 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 ㎎/㎏.
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KEYWORD
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HBX-6, single oral dose toxicity, SD rats, safety
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