瓜蒌薤白滴丸的长期毒性实验

目的:观察瓜蒌薤白滴丸对大鼠长期毒性作用,为临床安全用药提供参考依据.方法:健康SPF级大鼠120只分为空白对照组和瓜蒌薤白滴丸低、中、高剂量组(15,45,135 g·kg^-1·d^-1,相当于瓜蒌薤白生药),日剂量分别为成人用量(0.42 g 生药·kg^-1)的5.71,17.13,51.39倍,灌胃给药,连续90 d(1次/天).每天观察大鼠一般生理指标.并于给药30,90 d,停药恢复15 d后,各组分别取雌雄大鼠各5只,腹主动脉取血后处死动物,进行血液细胞学与血液生化学检查,取主要脏器(心、肝、脾、肺、肾、脑、肾上腺、卵巢、睾丸)计算脏器指数,并进行组织病理学检查.结果:给药30,90 d,低、中、高3个给药组与空白组比较,出现个别指标如NEUT^＃降低,LYM^＃降低,MCH降低、MCHC降低、GLU升高等异常,其他各项指标均无显著性差异(P >0.05),且均在停药15 d后恢复正常,并未见与药物作用有关的病理变化.结论:瓜蒌薤白滴丸在本实验条件下未发现长期毒性反应,在规定剂量下服用较安全.

Long-term toxicity study on Gualou Xiebai dropping pills

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 (0.42 g·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 (P >0.05). 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.