蒲薏颗粒长期毒性实验研究.docxVIP

蒲薏颗粒长期毒性实验研究 中国编辑。 作者：何迅， 李勇军，王永林，王爱民，兰燕宇，黄勇 【摘要】 　　目的： 观察蒲薏颗粒对大鼠长期给药可能产生的毒性反应,为临床应用提供毒 理学 依据。方法: 120只SD大鼠，随机分为蒲薏颗粒高、中、低剂量组，每组30只，雌雄各半，每日灌胃2次，连续给药26周,观察大鼠的一般状况、体重、摄食量，测定给药第13、26周及停药后2周大鼠的血液生化指标，脏器系数、解剖学及病理组织学改变的情况。对照组给予等容量蒸馏水。结果: 蒲薏颗粒各组动物一般状况良好，体重增长、脏器系数、血常规、血液生化指标、解剖学和主要脏器的病理组织学检查均正常，与对照组比较无明显差异。结论: 蒲薏颗粒在临床剂量范围内毒性小，使用安全。  【关键词】 蒲薏颗粒; 药物毒性; 毒性试验； 慢性；脏器系数； 白细胞计数； 凝血酶； 血红蛋白类  ［Abstract］ Objective: To observe the long-term toxicity of Puyi Granules. Methods: One hundred and twenty SD rats were randomly divided into groups (30 in each group, male:female=1∶1) of which groups orally recEived high, moderate, and low dosages (,.4, and /kg of raw drug equal to0,5, and of those of human dosages) of Puyi granules respectively, and one group recEIved saline as control. The experiment was carried out for consecutiveweeks, and general conditions, body weight and food intake of the animals were observed. The hematological and biochemistry parameters, organ coefficients and histomorphological figures were determined in 1and 1weeks of the experiment and in weeks after the termination. Results: The general conditions of treated rats were normal during and after the experiment. The body weight, organ coefficients, main hemotology and biochemistry indexes of rats in treated groups were basically the same as those of the controls. The urine analysis results and organ histopathological observation showed no significant difference between experimental rats and controls. Conclusion： Puyi Granules has no immediate or delayed toxicity in long-term administration on rats with dosages within clinical range, and is safe for use.  ［Key words］ Piyi granules; drug toxicity; toxicity tests, chronic; leukocyte count; thrombase; hemoglobins; organ coefficients  蒲薏颗粒系由蒲公英、薏苡仁、何首乌、灵芝等药味经提取精制而成的中药制剂，具有清热解毒，活血化瘀，补益气血的功能，用于消化道肿瘤放疗、化疗的辅助 治疗 ，临床适宜病证见皮肤红斑、色素沉着、脱发、恶心、呕吐、口舌生疮、精神疲惫、面色无华、舌红偏紫、舌苔薄腻、脉弦细数等热毒炽盛、血行瘀滞、气血不足者，也可用于消化道肿瘤非放疗、化疗时上述证情者[1，2]。根据中药新药长期毒性实验方法和指导原则