通微消痔颗粒单次给药及重复给药毒性研究  

Research on toxicity of Tongwei Xiaozhi Granule after single administration and repeated administration

作　　者：郑海平 苏华[1] 曾宪彪[1] 李燕婧[1] 李开双[1] ZHENG Haiping;SU Hua;ZENG Xianbiao;LI Yanjing;LI Kaishuang(Guangxi Institute of Chinese Medicine and Pharmaceutical Science,Guangxi,Nanning 530022,China)

机构地区：[1]广西中医药研究院,广西南宁530022

出　　处：《中国医药科学》2023年第13期26-29,34,共5页China Medicine And Pharmacy

基　　金：广西科技计划项目(桂科AB18221098)。

摘　　要：目的考察通微消痔颗粒(TWXZ)单次给药和重复给药毒性反应。方法选取40只昆明小鼠按体重分层随机分为空白对照组和TWXZ组,每组各20只,采用最大耐受量试验法考察单次给药毒性。80只SD大鼠按体重分层随机分为空白对照组,TWXZ高、中、低组,每组各20只,每天灌胃给药1次,TWXZ高、中、低剂组按剂量给药(42.0、21.0、10.5 g生药/kg),空白对照组给等体积水,连续30 d,以体重、血生化、血常规、脏器系数、组织病理学检查为指标,评价停药24 h及14 d对大鼠的毒性作用。结果昆明小鼠单次给药毒性试验TWXZ最大耐受量为84 g生药/kg,相当于人日剂量(0.7 g生药/kg)的120倍,给药后小鼠体态、行为、食欲、排便无异常。SD大鼠重复给药毒性试验中,与空白对照组比较,停药24 h和14 d TWXZ高、中、低各剂量组大鼠体重增长和血生化、血常规检查未见异常。摄食量和血常规检查差异在允许范围内,主要器官病理学检查亦未发现明显与药物毒性相关的组织形态学改变。结论拟定的剂量、用法与疗程使用TWXZ安全可靠。Objective To investigate the toxicity of Tongwei Xiaozhi Granule(TWXZ)after single administration and repeated administration.Methods Kunming mice were randomly divided into the blank control group(n=20)and the TWXZ group(n=20)according to body weight stratification.The maximum tolerance dose test was used to investigate the toxicity of single administration.A total of 80 SD rats were randomly divided into the blank control group(n=20),the high TWXZ group(n=20),the medium TWXZ group(n=20)and the low TWXZ group(n=20)according to body weight stratification,and they were administrated intragastrically once a day.The high,medium and low TWXZ groups were administered in doses of(42.0,21.0 and 10.5g crude drug/kg),while the blank control group was given water with equal volume.The treatment lasted for 30 consecutive days,and body weight,blood biochemistry,blood routine,organ index and histopathological examination were considered as indices to evaluate the toxic effects of drug withdrawal for 24 hours and for 14 days on rats.Results The maximum tolerance dose of TWXZ in single administration toxicity test of Kunming mice was 84 g crude drug/kg,which was 120 times of human daily dose(0.7 g crude drug/kg).After administration,the posture,behavior,appetite and defecation of mice were normal.In the repeated administration toxicity test of SD rats,there was no abnormality in the weight gain,blood biochemistry and blood routine examination of rats in the high,medium and low dose TWXZ groups after 24 hours and 14 days of drug withdrawal compared with the blank control group.The differences of food intake and blood routine examination were within the allowable range,and no obvious morphological changes related to drug toxicity were found in the pathological examination of primary organs.Conclusion The use of TWXZ is safe and reliable given that the proposed dose,usage and course of treatment are adopted.

关 键 词：通微消痔颗粒 小鼠 单次给药毒性 大鼠 重复给药毒性 

分 类 号：R285.5[医药卫生—中药学]