摘要
目的:研究丹酚酸B注射剂的生殖毒性及遗传毒性。方法:生殖毒性方面研究了丹酚酸B注射剂对SD大鼠胚胎-胎仔发育毒性的影响,于SD大鼠妊娠第6~15天分别连续静脉注射给予29、120、480 mg/(kg·d)的丹酚酸B注射剂,于妊娠第20天剖检,分析其生殖毒性。分别采用Ames试验、中国仓鼠肺细胞(CHL)染色体畸变试验、小鼠骨髓微核试验,观察丹酚酸B注射剂的遗传毒性。结果:胚胎-胎仔发育毒性试验中,丹酚酸B注射剂各剂量组的孕鼠均未出现明显毒性反应,中、高剂量的丹酚酸B注射剂会影响胎鼠发育。遗传毒性的Ames试验、CHL试验和微核试验均为阴性。结论:480 mg/(kg·d)及以下剂量的丹酚酸B注射剂对孕鼠无母体毒性作用。29 mg/(kg·d)的丹酚酸B注射剂对胚胎-胎仔发育无毒性;丹酚酸B注射剂未见明显遗传毒性。
Objective: To study the genetic and reproductive toxicity of Salvianolic acid B injection. Methods: The reproductive toxicity study was studied by investigating the effects of Salvianolic acid B injection on embryo-fetal development toxicity in Sprague-Dawley rats. Pregnant rats were administrated Salvianolic acid B injection at the doses of 29 mg/(kg·d), 120 mg/(kg·d) and 480 mg/(kg·d) at GD6-GD15. The rats were sacrificed and examined reproductive toxicity of Salvianolic acid B injection at GD20. The genotoxicity of Salvianolic acid B injection was examined by the Ames test, Chinese hamster lung fibroblast cell chromosome aberration test and mouse bone marrow micronucleus test. Results: In embryo-fetal development toxicity studies, no obvious toxic reactions were observed in pregnant rats at all the doses groups. Salvianolic acid B injection was found to have effect on rats embryonic development in 120 mg/(kg·d) dose group and 480 mg/(kg·d) dose group. The negative genetic toxicity results were obtained in the Ames test, Chinese hamster lung fibroblast cell chromosome aberration test and mouse bone marrow micronucleus test. Conclusion: Salvianolic acid B injection shows no maternal toxicity on Sprague-Dawley rats when the doses are below 480 mg/(kg·d) and no embryo-fatal toxicity when the doses are below 29 mg·/(kg·d). The results also indicate that Salvianolic acid B for injection has no genotoxic effect under the given conditions.
作者
蔡鸣
王梦
朱敏为
乔红群
刘晶
CAI Ming;WANG Meng;ZHU Min-wei;QIAO Hong-qun;LIU Jing(Jiangsu Institute of Materia Medica, Nanjing Jiangsu 210009, China;Nanjing University of Chinese Medicine, Nanjing Jiangsu 210023, China;Nanjing Tech University, Nanjing Jiangsu 211816. China)
出处
《中医药导报》
2019年第12期35-38,58,共5页
Guiding Journal of Traditional Chinese Medicine and Pharmacy
基金
江苏省政策引导类计划(产学研合作):前瞻性联合研究项目(BY2016005-10)
关键词
丹酚酸B注射剂
遗传毒性
胚胎-胎仔发育毒性
Salvianolic acid B injection: genotoxicity
embryo-fetal development toxicity
