title: Safety assessment of saponins extract in Dolichos falcatus Klein: Subchronic study in Sprague-Dawley rats.
abstract: BACKGROUND
  Dolichos falcatus Klein (DF), a Chinese Dai ethnic medicine popularly known as "Tuoyeteng" in Yunnan province of China, has been widely used in China to treat fracture, rheumatoid arthritis and soft tissue injuries for a long time. Our previous study showed that saponins in DF (DFS) ameliorated the gouty arthritis induced by MSU crystals in vivo and in vitro. The present study was carried out to evaluate the no-observed-adverse-effect level (NOAEL) of DFS.
  
  
  METHODS
  Sprague-Dawley rats (10/sex/group) were gavaged with DFS at dose level of 0, 50, 100 and 200 mg/kg body weight /day for 90-days.
  
  
  RESULTS
  DFS administration did not result in mortality or show treatment-related changes in clinical signs of toxicity, body weights gain or feed consumption. Similarly, in addition to slightly hemolytic anemia and gastrointestinal tract lesion in males of high-dose treatment group, no toxicologically significant treatment-related changes in hematological, clinical chemistry, urine analysis parameters, organ weights, and macroscopic and microscopic abnormalities were noted during the testing period.
  
  
  CONCLUSIONS
  The results of subchronic toxicity study support the NOAEL for DFS as 200 mg/kg/d in females and as 100mg/kg/d in males. These results provide an important reference for further DFS-related clinical trials or new drug exploration.
authors: School of Pharmacy, Hubei University of Chinese Medicine, Wuhan 430065, PR China. Electronic address: lzlz_84@163.com.
authors: Zhou
authors: Z
authors: Lan
authors: School of Pharmacy, South-Central University for Nationalities, Wuhan 430074, PR China.
authors: Chao
authors: C
authors: Hu
authors: School of Pharmacy, South-Central University for Nationalities, Wuhan 430074, PR China.
authors: Yamin
authors: Y
authors: Huang
authors: School of Pharmacy, South-Central University for Nationalities, Wuhan 430074, PR China. Electronic address: clyhappy05@163.com.
authors: Lvyi
authors: L
authors: Chen
authors: School of Pharmacy, South-Central University for Nationalities, Wuhan 430074, PR China.
authors: Chao
authors: C
authors: Ma
authors: School of Pharmacy, South-Central University for Nationalities, Wuhan 430074, PR China.
authors: Zhinan
authors: Z
authors: Mei
authors: School of Pharmacy, South-Central University for Nationalities, Wuhan 430074, PR China.
authors: Qinxiong
authors: Q
authors: Lin
authors: School of Pharmacy, South-Central University for Nationalities, Wuhan 430074, PR China.
authors: Xianju
authors: X
authors: Huang
authors: School of Pharmacy, South-Central University for Nationalities, Wuhan 430074, PR China.
authors: Xukun
authors: X
authors: Deng
mesh_terms: D000743:Anemia, Hemolytic / Q000139:chemically induced / Q000473:pathology; D000818:Animals; D031294:Dolichos; D004305:Dose-Response Relationship, Drug; D004365:Drugs, Chinese Herbal / Q000302:isolation & purification / Q000633:toxicity*; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced / Q000473:pathology; D008297:Male; D018517:Plant Roots; D051381:Rats; D017207:Rats, Sprague-Dawley; D027343:Rhizome; D012503:Saponins / Q000302:isolation & purification / Q000633:toxicity*; D059550:Toxicity Tests, Subchronic / Q000379:methods*
chemical_list: D004365:Drugs, Chinese Herbal; D012503:Saponins
keywords: Dolichos falcatus Klein; Saponin; Sprague-Dawley rats; Subchronic toxicity