소복축어탕의 마우스 경구 단회투여 독성 평가
Single Oral Dose Toxicity Test of Sobokchuko-tang, a Polyherbal Formula in ICR Mice
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Objectives: This study was to evaluate the single dose toxicity of Sobokchuko-tang(SBC) in male and female mice. Methods: Aqueous extract of SBC (yield=6.60%) was administered to femaleand male mice as an oral dose of 2,000, 1,000 and 500 mg/kg (body weight) accordingto the recommendation of Korea Food and Drug Administration (KFDA) Guidelines. Animals were monitored for the mortality and changes in body weight, clinicalsigns and gross observation during 14 days after dosing, upon necropsy; organweight and histopathology of 14 principle organs were also examined. Results: we could not find any SBC treatment related mortality and clinicalsigns, changes in the body and organ weights, gross findings and changes in histopathologyof principle organs, except for pharmacological immunomodulatory effects relatedfindings including significant increases of submandibular lymph node weights,hypertrophy and hyperplasia of lymphoid cells in the submandibular lymph nodesrestrictly detected in 2,000 mg/kg treated female and male mice with some sporadicaccidental findings. Conclusions: The results obtained in this study suggest that the 50% lethaldose and approximate lethal dose of SBC aqueous extracts in both female and malemice were considered as over 2,000 mg/kg, the limited highest dosage recommendedby KFDA Guidelines, and can be safety used in clinics.
Abstract
Objectives: This study was to evaluate the single dose toxicity of Sobokchuko-tang(SBC) in male and female mice. Methods: Aqueous extract of SBC (yield=6.60%) was administered to femaleand male mice as an oral dose of 2,000, 1,000 and 500 mg/kg (body weight) accordingto the recommendation of Korea Food and Drug Administration (KFDA) Guidelines. Animals were monitored for the mortality and changes in body weight, clinicalsigns and gross observation during 14 days after dosing, upon necropsy; organweight and histopathology of 14 principle organs were also examined. Results: we could not find any SBC treatment related mortality and clinicalsigns, changes in the body and organ weights, gross findings and changes in histopathologyof principle organs, except for pharmacological immunomodulatory effects relatedfindings including significant increases of submandibular lymph node weights,hypertrophy and hyperplasia of lymphoid cells in the submandibular lymph nodesrestrictly detected in 2,000 mg/kg treated female and male mice with some sporadicaccidental findings. Conclusions: The results obtained in this study suggest that the 50% lethaldose and approximate lethal dose of SBC aqueous extracts in both female and malemice were considered as over 2,000 mg/kg, the limited highest dosage recommendedby KFDA Guidelines, and can be safety used in clinics.
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