补血益母丸遗传毒性研究  

Genotoxicity test of Buxue Yimu Pill

作　　者：吉雅琪 李晓旭 柳清清 韦娜 吴梦瑶 冷其霖 董延生 JI Yaqi;LI Xiaoxu;LIU Qingqing;WEI Na;WU Mengyao;LENG Qilin;DONG Yansheng(School of Life Science and Technology,Central South University of Forestry and Technology,Changsha 410004,China;Zhuzhou Qianjin Pharmaceutical Co.,Ltd.,Zhuzhou 412003,China;SAFE Medical Technology Co.,Ltd.,Langfang 065500,China)

机构地区：[1]中南林业科技大学生命科学与技术学院,湖南长沙410004 [2]株洲千金药业股份有限公司,湖南株洲412003 [3]国科赛赋河北医药技术有限公司,河北廊坊065500

出　　处：《药物评价研究》2023年第3期565-570,共6页Drug Evaluation Research

基　　金：湖南省自然科学基金项目(2021JJ80088)。

摘　　要：目的对补血益母丸干膏粉进行遗传毒性试验,为临床安全用药提供依据。方法采用组氨酸营养缺陷型鼠伤寒沙门氏菌TA97a、TA98、TA100、TA102、TA1535进行细菌回复突变(Ames)试验,采用中国仓鼠肺成纤维(CHL)细胞进行体外染色体畸变试验,采用ICR小鼠进行骨髓细胞微核试验综合评估补血益母丸干膏粉的遗传毒性。其中,Ames试验设50、150、500、1500、5000μg·皿−15个剂量;体外细胞染色体畸变试验设125、250、500μg·mL^(−1)3个剂量;小鼠骨髓细胞微核试验设500、1000、2000 mg·kg^(−1)3个剂量,每天给药1次,连续给药3 d。结果在代谢及非代谢活化条件下(+S9/−S9),Ames试验结果显示,补血益母丸干膏粉对各菌株均无明显或可重复的诱变性及抑菌性;体外CHL细胞染色体畸变试验结果显示,补血益母丸干膏粉对CHL细胞染色体结构畸变率未见有意义的升高;小鼠骨髓细胞微核试验结果显示,补血益母丸干膏粉对ICR小鼠骨髓细胞微核率无明显影响。结论补血益母丸干膏粉未见潜在的遗传毒性。Objective The genotoxicity study of Buxue Yimu Pill dry ointment powder was carried out,and to provide data for clinical safety medication.Methods Bacterial reverse mutation test(Ames test)was performed with histidine auxotrophic Salmonella typhimurium strains TA97a,TA98,TA100,TA102,and TA1535,Chinese hamster lung fibroblasts(CHL cells)were used for in vitro chromosomal aberration test,and ICR small bone marrow cell micronucleus test was performed in mice to comprehensively evaluate the genotoxicity of Buxue Yimu Pill dry ointment powder.Among them,the Ames test set five doses of 50,150,500,1500,and 5000μg·dish−1.The in vitro chromosomal aberration test set three doses of 125,250,500μg·mL^(−1).The mouse bone marrow cell micronucleus test set three doses of 500,1000 and 2000 mg·kg^(−1),administered once a day for 3 consecutive days.Results Under metabolic and non-metabolic activation conditions(+S9/-S9),the Ames test results showed that Buxue Yimu Pills had no obvious or reproducible mutagenicity and bacteriostasis to each strain.The Chromosomal aberrations in CHL cells in vitro test results showed that:Buxue Yimu Pills dry ointment powder did not significantly increase the chromosome structure aberration rate of CHL cells.The results of the mouse bone marrow cell micronucleus test showed that Buxue Yimu Pills had no significant effect on the micronucleus rate of bone marrow cells in ICR mice.Conclusion No significant genetic toxicity was observed in the dry ointment powder of Buxue Yimu Pill.

关 键 词：补血益母丸干膏粉 遗传毒性 AMES试验 染色体畸变试验 微核试验 

分 类 号：R994.2[医药卫生—毒理学]