摘要:
为了评价苦参功劳颗粒的安全性,为临床用药提供参考,试验将80只Wistar大鼠随机分为4组,分别为苦参功劳颗粒低、中、高剂量组和空白对照组,苦参功劳颗粒高、中、低剂量组分别按体重8.1,5.4,1.8 g/kg的剂量给药,连续给药30 d,观察试验期内大鼠的临床表现,试验结束后统计各组大鼠的增重、饲料利用率,测定各组大鼠的血常规指标、血清生化指标、脏/体比,观察内脏器官(肝脏、肾脏、脾脏、胃、十二指肠、睾丸/卵巢)病变。结果表明:苦参功劳颗粒各剂量组大鼠精神状态、行为表现、采食量、生长发育等均正常。试验期间苦参功劳颗粒各剂量组与空白对照组相比,每周增重、饲料利用率及血常规指标、血清生化指标均差异不显著(P>0.05)。苦参功劳颗粒各剂量组大鼠心脏、肝脏、脾脏、肺脏、肾脏、胃肠、卵巢/睾丸的脏/体比与空白对照组相比无显著差异(P>0.05)。剖检未见明显病变,内脏器官发育正常,病理组织学检查无异常。说明苦参功劳颗粒的安全浓度大于8.1 g/kg(相当于大鼠临床用量的19.3倍,鸡用量的40.5倍),苦参功劳颗粒长期给药毒副作用小,安全性良好,临床拟用剂量安全。
Abstract:
In order to evaluate the safety of Kushen Gonglao granules and to provide reference for clinical medication, 80 Wistar rats were randomly divided into 4 groups: Kushen Gonglao granules low-dose, medium-dose, high-dose group, and blank control group, respectively. Kushen Gonglao granules high-dose, medium-dose and low-dose groups were given 8.1 g/kg, 5.4 g/kg and 1.8 g/kg, respectively, for continuous 30 days.The clinical manifestations of the rats were observed during the trial period. After the trial, the weight gain and feed utilization rate of the rats in each group were counted, the blood routine indexes, serum biochemical indexes, viscera/body ratio of the rats in each group were measured, and the lesions of internal organs（liver, kidney, spleen, stomach, duodenum, testis/ovary） were observed. The results showed that the mental state, behavior, feed intake, growth and development of the rats in each dose group were normal. Compared with the blank control group, there were no significant differences in weight gain, feed utilization rate per week, blood routine indexes and blood biochemical indexes in each dose groups of Kushen Gonglao granules（P＞0.05）. There were no significant differences in heart, liver, spleen, lung, kidney, gastrointestinal, ovary/testis viscera/body ratio in each dose groups of Kushen Gonglao granules compared with the blank control group（P＞0.05）. No obvious lesions were found at necropsy, the development of internal organs was normal, and no abnormalities were found in histopathology. These results indicate that the safe concentration of Kushen Gonglao granules is greater than 8.1 g/kg body weight（equivalent to 19.3 times of the clinical dose of rats and 40.5 times of the clinical dose of chickens）. The long-term administration of Kushen Gonglao granules has little toxic and side effects, good safety, and the clinical dose is safe, so it can be used for clinical application.
百度学术
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