鱼腥草破壁饮片单次和重复给药毒性试验  

Toxicity study on single and repeated dose of Ultrafine Granular Powder of Houttuynia cordata Thunb.

作　　者：雷夏凌 邓雯 陈炜璇 戴锦龙 郭健敏 黄远铿 张前亮 成金乐 杨威 LEI Xialing;DENG Wen;CHEN Weixuan;DAI Jinlong;GUO Jianming;HUANG Yuankeng;ZHANG Qianliang;CHENG Jinle;YANG Wei(Guangdong Provincial Key Laboratory of Drug Non-Clinical Evaluation and Research,TCM Non-clinic Evaluation Branch of National Engineering Research Center for Modernization of Traditional Chinese Medicine,Guangdong Engineering Research Center for Innovative Drug Evaluation and Research,Guangzhou Bay Area Institute of Biomedicine,Guangdong Lewwin Pharmaceutical Research Institute Co.,Ltd.,Guangzhou 510990,China;Zhongshan Zhongzhi Pharmaceutical Group Co.,Ltd.,Zhongshan 528437,China;National Technology Center,Zhongshan 528437,China;National Joint Engineering Research Center for Ultrafine Granular Powder of Chinese Materia Medica,Zhongshan 528437,China)

机构地区：[1]广州湾区生物医药研究院,广东莱恩医药研究院有限公司,广东省药物非临床评价研究企业重点实验室,国家中药现代化工程技术研究中心中药非临床评价分中心,广东省创新药物评价与研究工程技术研究中心,广东广州510990 [2]中山市中智药业集团有限公司,广东中山528437 [3]国家企业技术中心,广东中山528437 [4]中药破壁饮片国家地方联合工程研究中心,广东中山528437

出　　处：《药学研究》2024年第1期19-23,34,共6页Journal of Pharmaceutical Research

基　　金：广东省科技领军人才项目(No.210183503006);广东省重点领域研发计划“新药创制”重点专项(No.2019B020202002);广州市农业和社会发展科技项目(No.2023B03J1227);中山市科技计划项目(No.2017A1033)。

摘　　要：目的研究大鼠单次和重复给予鱼腥草破壁饮片后的毒性反应,为临床研究及应用提供参考的依据。方法鱼腥草破壁饮片和鱼腥草饮片均以7.2 g·kg^(-1)的最大给药量单次灌胃给予大鼠观察毒性反应,并持续观察2周;鱼腥草破壁饮片以1.35、2.70、5.40 g·kg^(-1),鱼腥草饮片1.35、5.40 g·kg^(-1),连续3个月对SD大鼠灌胃给药,恢复期4周,进行临床观察、体重、摄食量、血清生化学、血液学、肾损伤生物标志物及病理学等各项检查。结果鱼腥草破壁饮片、鱼腥草饮片以7.2 g·kg^(-1)对SD大鼠单次灌胃给药,未见明显毒性反应;鱼腥草破壁饮片及鱼腥草饮片重复给药3个月,各剂量组各项检查均未见异常。结论鱼腥草破壁饮片、鱼腥草饮片单次经口给药对SD大鼠的最大耐受剂量(MTD)>7.2 g·kg^(-1)。鱼腥草破壁饮片、鱼腥草饮片对SD大鼠连续灌胃给药3个月的无毒作用剂量(NOAEL)为6.4 g·kg^(-1)。鱼腥草破壁饮片、鱼腥草饮片在相同给药剂量下,SD大鼠毒性反应无明显区别。Objective To study the toxicity of Ultrafine Granular Powder of Houttuynia cordata Thunb.after single and repeated dose in rats,and to provide reference basis for clinical research and application.Methods Both Ultrafine Granular Powder of Houttuynia cordata Thunb.and Houttuynia Decoction Pieces were given by single gavage with the maximum dose of 7.2 g·kg^(-1),and the toxic reactions were observed for 2 weeks;SD rats were given 3-month gavage administration of Ultrafine Granular Powder of Houttuynia cordata Thunb.with 1.35,2.70 and 5.40 g·kg^(-1),and Houttuynia Decoction pieces of 1.35 and 5.40 g·kg^(-1),with 4 weeks recovery period respectively.Clinical observation,body weight,food intake,blood biochemistry,hematology,renal injury biomarkers,and pathology were performed.Results Ultrafine Granular Powder of Houttuynia cordata Thunb.and Houttuynia Decoction Pieces were administered orally in SD rats at a single dose of 7.2 g·kg^(-1),and no obvious toxicity was observed.Moreover,Ultrafine Granular Powder of Houttuynia cordata Thunb.and Houttuynia Decoction Pieces were repeatedly administered for 3 months,and no abnormality was found in each dose group.Conclusion The maximum tolerable dose(MTD)of single oral administration of Ultrafine Granular Powder of Houttuynia cordata Thunb.and Houttuynia Decoction Pieces in SD rats was more than 7.2 g·kg^(-1).The no observed adverse effect level(NOAEL)dose of Ultrafine Granular Powder of Houttuynia cordata Thunb.and Houttuynia Decoction Piece in SD rats by gavage administration for 3 months was 6.4 g·kg^(-1).Thus,at the same dose,there was no significant difference between Ultrafine Granular Powder of Houttuynia cordata Thunb.and Houttuynia Decoction Piece in SD rats.

关 键 词：鱼腥草破壁饮片 鱼腥草饮片 单次给药毒性试验 重复给药毒性试验 肾脏毒性 

分 类 号：R285.1[医药卫生—中药学]