조위승청탕의 마우스 경구 단회 투여독성 평가
Single Oral Dose Toxicity Test of Choweseuncheng-tang, a Polyherbal Formula in ICR Mice
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초록
The object of this study was to evaluate the single dose toxicity of Choweseuncheng-tang (CWS), a polyherbal formula have been traditionally used as prevention or treatment agent for various diseases as Tae-eumin prescription on Korean medicinal theory, Sasang-euihak, in male and female mice. Aqueous extracts of CWS (yield = 11.00%) was administered to female and male mice as an oral dose of 2,000, 1,000 and 500 mg/kg (body weight) according to the recommendation of Korea Food and Drug Administration (KFDA) Guidelines. Animals were monitored for the mortality and changes in body weight, clinical signs and gross observation during 14 days after dosing, upon necropsy; organ weight and histopathology of 14 principle organs were also examined. As results, we could not find any CWS treatment related mortality and clinical signs, changes in the body and organ weights, gross findings and changes in histopathology of principle organs, except for some dose-independent accidental findings. The results obtained in this study suggest that the 50% lethal dose and approximate lethal dose of CWS aqueous extracts in both female and male mice were considered as over 2,000 mg/kg, the limited highest dosage recommended by KFDA Guidelines, and can be safety used in clinics.
Abstract
The object of this study was to evaluate the single dose toxicity of Choweseuncheng-tang (CWS), a polyherbal formula have been traditionally used as prevention or treatment agent for various diseases as Tae-eumin prescription on Korean medicinal theory, Sasang-euihak, in male and female mice. Aqueous extracts of CWS (yield = 11.00%) was administered to female and male mice as an oral dose of 2,000, 1,000 and 500 mg/kg (body weight) according to the recommendation of Korea Food and Drug Administration (KFDA) Guidelines. Animals were monitored for the mortality and changes in body weight, clinical signs and gross observation during 14 days after dosing, upon necropsy; organ weight and histopathology of 14 principle organs were also examined. As results, we could not find any CWS treatment related mortality and clinical signs, changes in the body and organ weights, gross findings and changes in histopathology of principle organs, except for some dose-independent accidental findings. The results obtained in this study suggest that the 50% lethal dose and approximate lethal dose of CWS aqueous extracts in both female and male mice were considered as over 2,000 mg/kg, the limited highest dosage recommended by KFDA Guidelines, and can be safety used in clinics.
참고문헌 (28)
- 홍순용, "사상의학원론", pp.344~ (1977), 행림출판사
- 이제마, "동의수세보원", pp.116~ (1979), 행림출판사
- 박인상, "동의사상요결", pp.156~ (1991), 소나무
- 유지걸, "生藥 複合製劑의 藥效 硏究 第26報 - 調胃升淸湯의 抗痙攣, 鎭痛, 鎭靜, 摘出腸管, 血管, 血壓 및 呼吸에 對한 影響", 생약학회지, 17(1), pp.12~18 (1986)
- 우주영, "調胃升淸湯이 흰쥐의 방사형 미로 학습과 기억에 미치는 影響", 동의신경정신과학회지, 8(1), pp.69~79 (1997)
- 김형순, "調胃升淸湯 煎湯液이 XO", HX에 의해 損傷된 培養 海馬神經細胞에 미치는 效果, 2002, pp.14(1), 67~78
- 김보균, "알츠하이머형 치매환자에 대한 調胃升淸湯의 효능-청각 ERP 및 K-DRS의 성적 변화를 통하여-", 동의신경정신과학회지, 14(2), pp.43~59 (2003)
- 조성훈, "調胃升淸湯이 초기 Dementia of Alzheimer type 환자의 인지기능 변화에 미치는 효과", 동의신경정신과학회지, 14(1), pp.17~26 (2003)
- 함통일, "浮腫이 발생한 太陰人 中風患者의 調胃升淸湯 合 건율제조탕 치험 1례", 대한한방성인병학회지, 10(1), pp.39~45 (2005)
- 김경욱, "憂鬱症모델 흰쥐에 대한 調胃升淸湯과 St. John's Wort의 抗憂鬱效果에 관한 비교 연구", 동의신경정신과학회지, 15(1), pp.43~64 (2004)
- 류재면, "憂鬱症모델 흰쥐에 대한 調胃升淸湯과 fluoxetine의 抗憂鬱效果 비교", 동의신경정신과학회지, 15(1), pp.27~41 (2004)
- 이재은, "조위승청탕의 알코올 및 熱水 추출물이 지방세포 대사에 미치는 영향", Journal of Pharmacopuncture, 11(1), pp.127~141 (2008), 대한약침학회
- 이미정, "調胃升淸湯의 고지방식이 유도 비만 쥐에서 비만 및 고지혈증에 대한 효과 연구", 대한한의학회지, 32(4), pp.37~47 (2011), 대한한의학회
- 박성식, "調胃升淸湯의 胃粘膜 損傷 防禦效果에 관한 硏究", 사상체질의학회지, 14(1), pp.100~111 (2002)
- 한국식품의약품안전청, "의약품 등의 독성시험기준. 한국식품의약품안전청 고시 제 2009-116호", ~ (2009)
- Irwin, S., "Comprehensive observational assessment: Ia. A systemic, quantitative procedure for assessing the behavioral and physiological state of the mouse", Psychopharmacology, 13(3), pp.222~257 (1968)
- Dourish, C.T., "Experimental Psychopharmacology", pp.325~334 (1987), Humana Press
- Levene, A., "Pathological factors influencing excision of tumours in the head and neck", Clin Otalary, 6(3), pp.145~151 (1981)
- Ludbrook, J., "Update: microcomputer statistics packages. A personal view", Clin Exp Pharmacol Physiol, 24(3), pp.294~296 (1997)
- Hyeung-Sik Lee, "Single Oral Dose Toxicity Studies of Polycan, b-Glucan Originated from Aureobasidium in Mice", 한국독성학회지, 21(4), pp.361~365 (2005), 한국독성학회
- JaeHyun Lee, "Single Subcutaneous Dose Toxicity of Polycan？, a β-Glucan Originated from Aureobasidium in Mice", Laboratory Animal Research, 21(4), pp.299~305 (2005), 한국실험동물학회
- 노성수, "Mouse Single Oral Dose Toxicity Study of DHU001, a Polyherbal Formula", 한국독성학회지, 26(1), pp.53~59 (2010), 한국독성학회
- Won-Ho Lee, "Single Oral Dose Toxicity Test of Platycodin D, a Saponin from Platycodin Radix in Mice", 한국독성학회지, 27(4), pp.217~224 (2011), 한국독성학회
- Plata, E.J., "Growth and hematologic properties of the BALB", wm strain of inbred mice, 1972, pp.22(5), 712~720
- Yamaguchi, C., "Effects of room temperature on reproduction, body weight and organ weights, food and water intakes, and hematology in mice", Exp Anim, 32(1), pp.1~11 (1983)
- Banks, W.J., "Female reproductive system in Applied veterinary histology", pp.506~526 (1986), Williams & Wilkins
- Pineda, M.H., "Female reproductive system in Veterinary endocrinology and reproduction", pp.303~354 (1989), Lea & Febiger
- Health Effects Test Guidelines OPPTS 870.100, Acute Toxicity Testing Background, "US Environmental Protection Agency", US EPA August, ~ (1998)