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目的 :探讨 1,6 二磷酸果糖钙盐 (FDP Ca2 )单次或多次给药后动物出现的毒性反应及其性质和程度 ,寻找主要的靶器官、无毒反应剂量及药物的安全范围 ,以推断人的临床用量。方法 :按照新药临床前安全性评价的要求进行狗急性毒性和长期毒性研究。结果 :狗经口急性毒性试验各剂量组未见明显中毒症状 ,各剂量组化验检查指标也未见明显异常 ;长期毒性试验以 15 0 0mg·kg-1给药 12周 ,狗的血肌酐值与对照组比较差异有显著性 (P <0 .0 5 ) ,其它未见明显异常 ,恢复期后实验组与对照组各项指标比较差异均无显著性 (P >0 .0 5 )。结论 :FDP Ca2 临床治疗量为 2 5～ 5 0mg·kg-1·d 1,仅为狗急性毒性试验安全量的1/2 0 0 ,5 0 0mg·kg-1为FDP Ca2 狗长期毒性试验的无毒反应剂量 ,此剂量为临床实际用量的10～ 2 0倍 ,因而推断FDP Ca2 在临床长期口服 (治疗量为 2 5～ 5 0mg·kg-1·d 1)是安全的。
OBJECTIVE: To investigate the toxicity and the nature and extent of animals after single or multiple administration of FDP Ca2, and to find out the main target organs, non-toxic dose and drug safety range, To infer the clinical dosage. Methods: The acute toxicity and long-term toxicity of dogs were studied according to the requirements of preclinical safety evaluation of new drugs. Results: There were no obvious symptoms of poisoning in each dose of oral acute toxicity test in dogs. There was no obvious abnormality in each dose group. Long-term toxicity test was given at 15 0 mg · kg-1 for 12 weeks. Serum creatinine Compared with the control group, the difference was significant (P <0.05), no obvious abnormalities in other groups. There was no significant difference between the experimental group and the control group after recovery (P> 0.05). CONCLUSION: The clinical therapeutic dose of FDP Ca2 is 25 ~ 50mg · kg-1 · d1, only the safe dose of 1/2 0 0, 500 mg · kg-1 is the long-term toxicity test of FDP Ca2 Of the non-toxic dose, the dose of 10 to 20 times the actual clinical dosage, and therefore concluded that FDP Ca2 in clinical long-term oral (therapeutic dose of 25 ~ 50mg · kg -1 · d 1) is safe.