鸦胆子油自微乳化颗粒对大鼠长期毒性实验

摘要

目的 考察鸦胆子油自微乳化颗粒对大鼠的长期毒性. 方法 将120只斯泼累格·多雷( SD)大鼠随机分为空白对照组、鸦胆子油自微乳化颗粒大剂量组、中剂量组、小剂量组,每组30只. 鸦胆子油自微乳化颗粒大、中、小剂量组分别按照144,72,36倍人体服用剂量给药,并同时进行空白对照. 于给药前、给药3,6个月及停药后4周进行大鼠体质量、血液学、血液生化学、脏器指数、病理组织学检查. 结果 一般观察指标及体质量均未见显著变化:血液学指标:3个月时与空白对照组比较,大剂量组淋巴细胞比率( LY)降低、单核细胞比率( MO)升高,中剂量组MO、嗜碱性细胞比率( BA)均显著升高( P0.05). 血液生化学指标:3个月时与空白对照组比较,大剂量组总蛋白(TP)、球蛋白(G)、丙氨酸氨基转移酶(ALT),中剂量组TP均显著升高( P0.05).In blood biochemical indexes, the levels of total protein (TP), albumin (G), glutamic-pyruvic transaminase ( ALT) in high dose group and TP in medium dose group were significantly higher than those in blank control group (P<0.05).Glutamic-oxalacetic transaminase (AST) in high dose group was very significantly higher than that in blank control group (P<0.01) after 3 months.After 6 months treatment , compared with blank control group, the level of glutamic-oxalacetic transaminase (AST) in high dose group was higher while trilaurate glycerin (TG) was lower(P<0.05).The level of creatine kinase (CK) was lower(P<0.05) and the level of TG was very significantly lower (P<0.01).The level of glucose ( Glu) was very significantly lower ( P<0. 01 ) . Those changed indexes recovered to be blank on the 4th week after withdrawal.In haematological indexes,delayed enlargements of liver and testis occurred after withdrawal.No rat died in the process of experiment.No obvious histopathologic changes of organs of rats were observed . Conclusion Self-microemulsifying granules of Brucea javanica oil have no apparent toxicity.It is worthy of further research.