[1] YANG XS, GAO HY, WANG D, et al.The degraded products and toxicity of potassium sodium pehydroandrographolide succinate for injection[J]. Progress of Anatomical Sciences(解剖科学进展), 2019, 25(4): 417-421. [2] WEI JT, BAN BK, SUN R, et al.Analysis of adverse drug reactions reports of potassium sodium pehydroandroandrographolide succinate for injection[J]. Chinese Journal of Ethnomedicine and Ethnopharmacy(中国民族民间医药), 2016, 25(18): 100-102. [3] LI WL, DING ZD, WANG TS, et al.Research on relationship between dosing and effect of andrographis reproductive toxicity[J]. Journal of Harbin University of Commerce(Natural Sciences Edition) [哈尔滨商业大学学报(自然科学版)], 2013, 29(3): 257-261. [4] DAI WJ.Reproductive toxicity and antifertility of andrographolide in male rats-The effect on sperm in testis and epididymis tail[J]. World Phytomedicines[国外医药(植物药分册)], 2001(5): 216-217. [5] LI WL.Correlation between Andrographis paniculata chemical molecular groups and reproductive toxicity based on in vivo process[D]. Harbin: Harbin University of Commerce(哈尔滨商业大学), 2013. [6] WANG HP, WANG EL, XU JY, et al.Genetic toxicity of Tongguan San[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2020, 17(12): 861-866. [7] OECD guideline for the testing ofchemicals 471, bacterial reverse mutation test[S]. Adopted: 21 July 1997. [8] HOUY, LIU J, QIAO HQ.Genetoxic study of Sanqisu injection[J].Journal of Clinical Rational Drug Use(临床合理用药杂志), 2017, 10(32): 94-95. [9] OECD guideline for the testing of chemicals 473, in vitro mammalian chromosomal aberration test[S]. 2016. [10] GAO M, MA H, CHEN K, et al.Genetoxicity evaluation of (R)-(+)-rabeprazole sodium for injection[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2020, 17(9): 559-563. [11] OECD guideline for the testing of chemicals 474, mammalian erythrocyte micronucleus test[S]. 2016. [12] HU YP, SONG J, LI B.Collecting historica data in bacterial reverse mutation test[J]. Chinese Jounal of New Drugs, 2009, 18(22): 2110-2112. [13] WEN HR, WANG YN, SONG J, et al.Standarization and historical data collection of mammalian cell chromosome aberration test[J].Drug Evaluation Research(药物评价研究), 2018, 41(5): 727-733. [14] WEN HR, SONG J, MAO ZH, et al.Standardized methods for bone marrow micronucleus test in rodents and historical data collection[J]. Drug Evaluation Research(药物评价研究), 2017, 40(5): 638-647. [15] Center for Drug Evaluation, State Food and Drug Admnistration.The research group of Guidance on genotoxicity study for pharmaceutical(药物遗传毒性研究技术指导原则)[S]. 2018: 4-7. [16] ZHONG ZN, XING CF, LIANG LZ, et al.Genotoxicity verification test[C]. 2013 (3rd) annual meeting of Chinese pharmacotoxicology and forum on non clinical safety evaluation of drugs, 2013. [17] LIU ZG, HU YM, YI XC, et al.Experimental study on toxicological safety evaluation of extractive from Anoectochilus roxburghii leaves[J]. Pract Prev Med, 2020, 27(9): 1072-1076. [18] HAN JY, YI Y, LIANG AH, et al.Genotoxicity research thought and method on traditional Chinese medicine[J]. China Journal of Chinese Materia Medica, 2015, 40(14): 2696-2700. |