制首乌提取液毒理学研究  

Study on acute and chronic toxicities of polygoni multiflori radix praeparata extracts

作　　者：张思玉[1] 朱晓光[1] 张广平[1] 蒋威[1] 杨海润[1] 陈会丛[1] 翟建英[1] 解素花 

机构地区：[1]北京中研同仁堂医药研发有限公司,中药复方新药开发国家工程研究中心,北京100079 [2]北京同仁堂科技发展股份有限公司

出　　处：《毒理学杂志》2013年第4期261-264,共4页Journal of Toxicology

基　　金：国家高技术研究发展计划(863计划)项目(2010AA023006)

摘　　要：目的研究制首乌提取液急性毒性及长期毒性。方法应用最大耐受量(MTD)测定法,对制首乌提取液进行小鼠急性毒性实验;大鼠长期毒性实验采用连续26周灌胃给药,分别于13和26周每组处死10和20只动物,其余动物停药进行恢复期观察4周,观察大鼠饮食、活动、体重、进食量、外观体征等情况,并进行血液、生化、病理学等检查。结果急性毒性实验未见动物死亡,MTD为144 g/kg,相当于人临床剂量(0.1 g/kg)的1440倍;长期毒性实验结果显示,制首乌提取液高剂量动物出现腹泻及肝毒性,中、低剂量组动物未出现严重中毒表现,各脏器无病理性变化。结论在本试验条件下,长期大剂量服用制首乌提取液对胃肠道具有一定影响,可导致大便稀软,并对肝脏有一定损害,但停药后可恢复。Objective To investigate possible acute and chronic toxicities of Polygoni Muhiflori Radix Praeparata extracts for clinical reference. Methods Maximal tolerated dose （MTD） was established in mice for acute toxicity evaluation. In the chronic toxicological study, rats were treated with intragastrical gavage （ i. g） administration for 26 weeks, then 10 and 20 rats of each dose group were sacrificed in week 13and week 26, and the others were kept for observation in recovery phase for additional 4 weeks. Activity, body weights, food- intake, and external appearance of the treated animals were observed and recorded. Haematologieal and blood biochemical parameters were detected, and pathological examinations performed. Results No death was observed in mouse acute toxicity test. The MTD was 144 g/kg, equivalent to 1440 times of the clinically recommended dose （0. 1 g/kg）. Diarrhea and liver toxicity were observed in high dose group in the long-term evaluation. No severe toxicity was found in middle or low dose group. No organic changes were observed in pathological tests. Conclusion It has some effect on the gastrointestinal tract and the soft stool may occur following prolonged use of high doses of Polygoni Multiflori Radix Praeparata extracts. It may have some liver toxicity and it will recover once stop taking.

关 键 词：制首乌提取液 急性毒性 长期毒性 

分 类 号：R994.6[医药卫生—毒理学]