title: A 4-week Repeated dose Oral Toxicity Study of Mecasin in Sprague-Dawley Rats to Determine the Appropriate Doses for a 13-week, Repeated Toxicity Test.
abstract: OBJECTIVE
  In this study, we investigated the 4-week repeated-dose oral toxicity of gami-jakyak gamcho buja decoction (Mecasin) to develop safe treatments.
  
  
  METHODS
  In order to investigate the 4-week oral toxicity of Mecasin, we administered Mecasin orally to rats. Sprague-Dawley (SD) rats were divided into four groups of five male and five female animals per group: group 1 being the control group and groups 2, 3, and 4 being the experimental groups. Doses of Mecasin of 500, 1,000, and 2,000 mg/kg of body weight were administered to the experimental groups, and a dose of normal saline solution of 10 mL/kg was administered to the control group. We examined the survival rate, weight, clinical signs, and gross findings for four weeks. This study was conducted under the approval of the Institutional Animal Ethics Committee.
  
  
  RESULTS
  No deaths occurred in any of the four groups. No significant changes in weights or food consumption between the control group and the experimental groups were observed. Serum biochemistry revealed that some groups showed significant decrease in inorganic phosphorus (IP) (P < 0.05). During necropsy on the rats, one abnormal macroscopic feature, a slight loss of fur, was observed in the mid dosage (1,000 mg/ kg) male group. No abnormalities were observed in any other rats. In histopathological findings, the tubular basophilia and cast of the kidney and extramedullary hematopoiesis of the spleen were found. However, those changes were minimal and had occurred naturally or sporadically. No other organ abnormalities were observed.
  
  
  CONCLUSIONS
  During this 4-week, repeated, oral toxicity test of Mecasin in SD rats, no toxicity changes due to Mecasin were observed in any of the male or the female rats in the high dosage group. Thus, we suggest that the doses in a 13-week, repeated test should be 0, 500, 1,000, and 2,000 mg/kg respectively.
authors.affiliation: Department of Acupuncture & Moxibustion Medicine, Wonkwang University Gwangju Korean Medical Hospital, Gwangju, Korea; Nervous & Muscular System Disease Clinical Research Center of Wonkwang University Gwangju Korean Medical Hospital, Gwangju, Korea.
authors.forename: Eunhye
authors.initials: E
authors.lastname: Cha
authors.affiliation: Department of Acupuncture & Moxibustion Medicine, Wonkwang University Gwangju Korean Medical Hospital, Gwangju, Korea; Nervous & Muscular System Disease Clinical Research Center of Wonkwang University Gwangju Korean Medical Hospital, Gwangju, Korea.
authors.forename: Jongchul
authors.initials: J
authors.lastname: Lee
authors.affiliation: Department of Acupuncture & Moxibustion Medicine, Wonkwang University Gwangju Korean Medical Hospital, Gwangju, Korea; Nervous & Muscular System Disease Clinical Research Center of Wonkwang University Gwangju Korean Medical Hospital, Gwangju, Korea.
authors.forename: Seongjin
authors.initials: S
authors.lastname: Lee
authors.affiliation: Department of Acupuncture & Moxibustion Medicine, Wonkwang University Gwangju Korean Medical Hospital, Gwangju, Korea; Nervous & Muscular System Disease Clinical Research Center of Wonkwang University Gwangju Korean Medical Hospital, Gwangju, Korea.
authors.forename: Manyong
authors.initials: M
authors.lastname: Park
authors.affiliation: Department of Nursing, Gwang-Ju Womens University, Gwangju, Korea.
authors.forename: Inja
authors.initials: I
authors.lastname: Song
authors.affiliation: Department of Neurology, Inam Neuroscience Research Center, Sanbon Medical Center, College of Medicine, Wonkwang University, Iksan, Korea.
authors.forename: Ilhong
authors.initials: I
authors.lastname: Son
authors.affiliation: Department of Internal Medicine, Wonkwang University Gwangju Korean Medical Hospital, Gwangju, Korea.
authors.forename: Bong-Keun
authors.initials: BK
authors.lastname: Song
authors.affiliation: Department of Internal Medicine, Wonkwang University Gwangju Korean Medical Hospital, Gwangju, Korea.
authors.forename: Dongwoung
authors.initials: D
authors.lastname: Kim
authors.affiliation: Department of Radiology, College of Korean Medicine, Wonkwang University, Iksan, Korea.
authors.forename: Jongdeok
authors.initials: J
authors.lastname: Lee
authors.affiliation: Department of Acupuncture & Moxibustion Medicine, Wonkwang University Gwangju Korean Medical Hospital, Gwangju, Korea; Nervous & Muscular System Disease Clinical Research Center of Wonkwang University Gwangju Korean Medical Hospital, Gwangju, Korea.
authors.forename: Sungchul
authors.identifier: 0000-0003-3580-5290
authors.initials: S
authors.lastname: Kim
keywords: four week repeated toxicity test; gami jakyak gamcho buja decoction (mecasin); herbal medicine; sprague-dawley rat