title: Evaluating the safety of phytosterols removed perilla seed oil-based lipid emulsion.
abstract: OBJECTIVE
  The aim of this study was to ascertain the potential toxicity of perilla seed oil-based lipid emulsion (POLE) caused by phytosterols and confirm the efficacy of the technique for removing phytosterols from perilla seed oil, and evaluate the safety of a low phytosterol POLE in a long-term tolerance study in dogs.
  
  
  METHODS
  A comparison between a soybean oil lipid emulsion (Intralipid group A) and POLE with high (group B) versus low (group C) levels of phytosterols was made with regard to their effects on the general condition, hematological and biochemical parameters, urinalysis and histopathological changes in nine dogs receiving daily infusions for four weeks at dosage levels of 6, 6, 9 g fat /kg.
  
  
  RESULTS
  Dogs in group A and group C remained in good condition and gained weight during the infusion period and no diarrhea or gastrointestinal bleeding occurred. Only a moderate degree of anemia was observed, the biochemical parameters changed only slightly and returned to normal after treatment had ceased. However, the dogs in group B exhibited significant symptoms of 'fat overload syndrome'. Vomiting, diarrhoea and blood in the faeces were observed. Moreover, triglyceridemia, cholesteremia, and dark urine as well as microscopic signs of liver and gastrointestinal tract damage and generalized jaundice were clearly seen.
  
  
  CONCLUSIONS
  Phytosterols promote 'fat overload syndrome' in long-term tolerance studies of POLE in dogs by producing cholestatic liver injury and interfering with fat metabolism. And the toxicity of POLE was reduced by removing phytosterols.
authors.affiliation: a Department of Pharmaceutics Science , Shenyang Pharmaceutical University , Shenyang , People's Republic of China.
authors.forename: Zhenhua
authors.initials: Z
authors.lastname: Yang
authors.affiliation: a Department of Pharmaceutics Science , Shenyang Pharmaceutical University , Shenyang , People's Republic of China.
authors.forename: Tianyang
authors.initials: T
authors.lastname: Ren
authors.affiliation: a Department of Pharmaceutics Science , Shenyang Pharmaceutical University , Shenyang , People's Republic of China.
authors.forename: De
authors.initials: D
authors.lastname: Lu
authors.affiliation: a Department of Pharmaceutics Science , Shenyang Pharmaceutical University , Shenyang , People's Republic of China.
authors.forename: Haiyan
authors.initials: H
authors.lastname: Guo
authors.affiliation: a Department of Pharmaceutics Science , Shenyang Pharmaceutical University , Shenyang , People's Republic of China.
authors.forename: Wanqiu
authors.initials: W
authors.lastname: Li
authors.affiliation: a Department of Pharmaceutics Science , Shenyang Pharmaceutical University , Shenyang , People's Republic of China.
authors.forename: Chenglong
authors.initials: C
authors.lastname: Huang
authors.affiliation: a Department of Pharmaceutics Science , Shenyang Pharmaceutical University , Shenyang , People's Republic of China.
authors.forename: Haibing
authors.initials: H
authors.lastname: He
authors.affiliation: a Department of Pharmaceutics Science , Shenyang Pharmaceutical University , Shenyang , People's Republic of China.
authors.forename: Dongchun
authors.initials: D
authors.lastname: Liu
authors.affiliation: a Department of Pharmaceutics Science , Shenyang Pharmaceutical University , Shenyang , People's Republic of China.
authors.forename: Xing
authors.initials: X
authors.lastname: Tang
mesh_terms: D000818:Animals; D004285:Dogs; D004655:Emulsions / Q000737:chemistry; D005217:Fat Emulsions, Intravenous / Q000737:chemistry*; D008099:Liver / Q000378:metabolism; D008297:Male; D010743:Phospholipids / Q000737:chemistry; D010840:Phytosterols / Q000737:chemistry*; D010938:Plant Oils / Q000633:toxicity; D013024:Soybean Oil / Q000737:chemistry; D014280:Triglycerides / Q000097:blood; D017962:alpha-Linolenic Acid / Q000633:toxicity*
chemical_list: D004655:Emulsions; D005217:Fat Emulsions, Intravenous; D010743:Phospholipids; D010840:Phytosterols; D010938:Plant Oils; D014280:Triglycerides; C545823:soybean oil, phospholipid emulsion; D017962:alpha-Linolenic Acid; C058216:perilla seed oil; D013024:Soybean Oil
keywords: IFALD; Long-term tolerance; parenteral lipid emulsion; perilla seed oil; phytosterols; toxicity