丹酚酸B注射剂的胚胎-胎仔发育毒性与遗传毒性

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英文篇名：Embryos-Fetus Developmental Toxicity and Genotoxity of Salvianolic Acid B Injection 作者：蔡鸣 ; 王梦 ; 朱敏为 ; 乔红群 ; 刘晶 英文作者：CAI Ming;WANG Meng;ZHU Min-wei;QIAO Hong-qun;LIU Jing;Jiangsu Institute of Materia Medica;Nanjing University of Chinese Medicine;Nanjing Tech University; 关键词：丹酚酸B注射剂 ; 遗传毒性 ; 胚胎-胎仔发育毒性 英文关键词：Salvianolic acid B injection;;genotoxicity;;embryo-fetal development toxicity 中文刊名：HNZB 英文刊名：Guiding Journal of Traditional Chinese Medicine and Pharmacy 机构：江苏省药物研究所;南京中医药大学;南京工业大学; 出版日期：2019-06-30 出版单位：中医药导报 年：2019 期：v.25;No.334 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) 语种：中文; 页：HNZB201912010 页数：5 CN：12 ISSN：43-1446/R 分类号：39-42+62

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.

引文

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