蜜炼川贝枇杷膏灌胃给药SD大鼠14天毒性探索研究

目的 研究京都念慈庵蜜炼川贝枇杷膏可能的毒性反应，为临床或家庭用药安全性提供参考。方法 采用大鼠14 d重复给药毒性试验，SD大鼠，按体重随机分成对照组、枇杷膏低、中、高剂量组，每组10只，雌雄各半，共40只，给药剂量分别为0、2.5、5、10 ml/（kg·d），给药体积为10 ml/（kg·d），相当于人临床用量的2.5、5、10倍。每天经口灌胃给药1次，连续14 d。第15天测定血液学、血液生化学各指标，同时测定心、肝、脾、肾脏器重量并计算脏器系数。结果 雌雄大鼠各剂量组体重正常增长，与对照组比较，差异无统计学意义（P＞0.05）。雄性大鼠各给药组血液学检测指标与对照组比较，差异无统计学意义（P＞0.05）；雌性大鼠中剂量组MCV偏低，与对照组比较，统计学意义显著（P＜0.01）；雄性大鼠中、高剂量组BUN降低，与对照组比较，统计学意义显著（P＜0.01）；雌性大鼠各给药组血液生化学检测指标与对照组比较，差异无统计学意义（P＞0.05）。雌性、雄性大鼠的脏体比数据中，中剂量组肝系数升高，与对照组比较，差异具有统计学意义（P＜0.05）。结论 蜜炼川贝枇杷膏SD大鼠重复给药14d未提示有明显毒性反应。

Study on Toxicity of Loquat Leaf Extract by Intragastric Administration for 14 days in SD Rats

Abstract:Objective To study the possible toxicity of Nin Jiom Pei Pa Koa loquat leaf extract,and to provide reference for clinical or domestic drug safety.Methods Repeated dose toxicity test in rats for 14 d,SD rats were randomly divided into control group,low, middle and high dosage of loquat leaf extract groups according to body weight.Each group had 10 rats,half male and half female,and total of 40.The dosage was 0,2.5,5,10 ml/(kg·d),and the volume was 10 ml/(kg·d).It is equivalent to 2.5,5 and 10 times of clinical dosage in human.Oral administration was administered once a day for 14 consecutive d.On the 15th day,the indexes of hematology and blood biochemistry were measured,the weight of heart,liver,spleen and kidney were measured,and the coefficients of organs were calculated.Results The weight of the male and female rats in each dose group increased normally,and there was no significant difference compared with the control group(P>0.05).There were no significant differences in the hematological parameters between the male rats and the control group(P>0.05).The MCV of the female rats in the middle dose group was lower than that of the control group,the statistical significance was significant(P<0.01);the BUN of the middle and high dose groups of male rats decreased, compared with the control group,the statistical significance was significant(P<0.01);There were no significant differences in the blood biochemical test indexes between the female rats and the control group(P>0.05).In the visceral ratio data of female and male rats,the liver coefficient of the middle dose group was increased,the difference was statistically significant(P<0.05)compared with the control group.Conclusion The repeated administration of loquat leaf extract for 14d in SD rats did not suggest obvious toxic reaction.