摘要
目的 观察和解方颗粒剂对大鼠的长期毒性反应,评价该药物临床应用的安全性.方法 将80只Wistar大鼠随机分为和解方高、中、低剂量组和对照组,每组20只,分别给予50、25、12.5g/kg和解方颗粒剂和等容积蒸馏水,给药体积为20ml/(kg·d),每日2次灌服,连续灌服12周.期间测量大鼠体重,观察一般状况.用药12周末,各组处死10只大鼠,检测血常规、血液生化,计算脏器系数并行脏器组织病理学检查.停药2周后,处死各组剩余大鼠,进行上述检测.结果 各组大鼠体重增长正常,一般状况良好,实验组与对照组比较,实验组间比较脏器系数、血常规和血液生化学指标均无显著性差异(P＞0.05),脏器组织未发现因药物导致的病理学改变.结论 长期应用和解方颗粒剂对大鼠无明显毒性作用,可安全用于临床.
Abstract
Objective To observe the long-term toxicity of Hejie Recipe granule in rat. Methods Eighty Wistar rats were randomly divided into 4 groups with equal males and females in each. The dosage of Hejie Recipe granule administered to the three groups of rats was SO, 25 and 12.5 grams per kilogram twice daily for 12 weeks, while identical volume of distilled water was administered to the control group. 10 rats in each group were sacrificed at the end of the twelveth week, other rats were sacrificed 2 weeks after the stop of granule or distilled water administration. Body weight and general conditions of rats were recorded and blood cell counts, biochemical parameters were tested, and pathological examination were performed. Results The appearance and behavior, weight, general condition, the lab tests in rats administrated with Hejie Recipe granule were not significantly different from those of the control group. Pathological examination showed no significant changes related to drug toxicity and delayed toxicity reactions. Conclusion Hejie Recipe granule has no significant long-term toxicity in rats, so it is safe clinically.
基金项目
国家重大科技专项项目(2009ZX10005-016)
广东省科技计划项目(2009B030801128)
NETL
NSTL
维普
万方数据