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《Chinese Journal of Hospital Pharmacy》 2015-13
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Long-term toxicity study on Gualou Xiebai dropping pills

ZOU Chun-cai;YAN Hai-yan;WEI Mei-ling;GAO Zheng-zheng;YANG Yang;Pharmacy School of Wannan Medical College;  
OBJECTIVE To observe long-term toxicity of Gualou Xiebai dropping pills in rats,and provide reference for clinical safety of medication.METHODS A total of 120 healthy rats SPF grade were divided into blank control group and Gualou Xiebai dropping pills low,medium and high dose groups(15,45,135 g·kg-1·d-1,equivalent to Gualou Xiebai crude drug)and control group(same volume of distilled water),and the daily doses were 5.71,17.13 and 51.39 times of adult dose(0.42g·kg-1 crude drug),respectively.Drugs were administered by gavages for 90 days(1/d).Rats were observed daily for general physiological indicators.After rats were gavaged for 30 days and 90 days,received for 15 days,8 male and female rats in each group were taken and killed with abdominal aortic blood collected,blood and blood chemistry cytology examination were performed,major organs(heart,liver,spleen,lung,kidney,brain,adrenal gland,ovary,testis)were removed for viscera index calculation and pathological examination.RESULTS After gavage for 30 and 90 days,low,medium and high dose groups were compared with control group.There were abnormal changes of individual indexes,such as NEUT#,LYM#,MCH and MCHC decreased,GLU increased,but all were recovered to be normal after 15 days.Other indicators were not statistically significant(P0.05).No pathological changes were associated with drug action.CONCLUSION Gualou Xiebai dropping pills have no long term toxicity under our experimental conditions,and are safe and reliable at specified doses.
【Fund】: 安徽省科技攻关项目(编号:12010402089);; 皖南医学院“国家级大学生创新创业训练计划”项目(编号:201310368042 201410368013);; 皖南医学院重点培育基金项目(WK2014Z04)
【CateGory Index】: R285.5
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