Objective  The purpose of the experiment was to probe into the animal’s toxicity reaction,its nature and degree after receiving calcium fructose-1,6-diphosphate(FDP?Ca  2) once or repeatedly,look for the main target organ,nonpoisonous response dosage and safety range of the drug,and infer a clinical safety dosage.Methods  The experiment was conducted according to the preclinical safety evaluation for new drugs.Results   No obvious signs of toxicity and abnormality of laboratory parameters were found in all tested groups for acute toxicity experiment   per os  .In the long  term toxicity experiment,the creatinine levels were significantly higher in 1?500?mg·kg    -1   group at week 12,than those of control group(  P  <0.05).No significant difference in regard to the indexes studied was found between the experimental and control groups after recovery.Conclusions  At present,the treatment dosage of FDP?Ca  2 is 25～50?mg·kg    -1  ·d    -1   body weight,which amounts to 1/200 of the safety dosage in acute toxicity,and nonpoisonous response dosage for long  term toxicity experiment.We may ,therefore,reasona~bly conclude that it is safe to take FDP?Ca  2 orally over a long period of time at the dose of 25～50?mg·kg    -1  ·d    -1  .