论文部分内容阅读
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 study the safety of salvianolic acid B and provide a reference for the development of new drugs and safe drug use. Methods The salvianolic acid B was subjected to muscle irritation test, vascular irritation test, in vitro hemolysis and coagulation test, pyrogen test and acute toxicity test in mice. Pyrogen test and abnormal toxicity test were also established. The results showed that salvianolic acid B did not show obvious irritation and hemolysis and coagulation; pyrogen test concentration was 2 mg · m L -1, injection dose was 10 m L · kg -1; LD50 636.89 mg · kg -1, 100 mg · kg -1 could be used as the limit of abnormal toxicity test. Conclusion Salvianolic acid B is safe and reliable.