丹酚酸B的安全性研究

Study on the safety of salvianolic acid B

目的研究丹酚酸B的安全性,为新药研发和安全用药提供参考。方法对丹酚酸B进行肌肉刺激性试验及血管刺激性试验、体外溶血与凝聚试验、热原试验及小鼠急性毒性试验,并建立热原和异常毒性检查方法。结果丹酚酸B未见明显刺激性及溶血与凝聚作用;其热原检查浓度为2 mg·m L^(-1),注射剂量为10 m L·kg-1;半数致死量(LD50)为636.89 mg·kg^(-1),可采用100 mg·kg^(-1)作为异常毒性检查限值。结论丹酚酸B安全可靠。

OBJECTIVE To observe the safety of salvianolic acid B , and to provide a reference for the development of new drugs. METHODS The muscle stimulation test,vessel stimulation test,haemolytic test,pyrogen test and acute toxicity test in mice were used to study the safety of salvianolic acid B. And the methods of pyrogen test and abnormal toxicity test were established. RESULTS Salvianolie acid B had no stimulation to muscle and ear vein of rabbit and no hemolytic reaction. The concentration of pyrogen test was 2 mg·mL^-1 and the dosage was 10 mL·kg^-1. LDs0 was 636.89 mg·kg^-1 and the limit value of abnormal toxicity was 100 mg·kg^-1. CONCLUSION Salvianolie acid B is safe and reliable based on the animal experiment.