颈复康颗粒剂的毒理学实验

Toxicologic Study on Jingfukang Granules

目的:观察动物口服颈复康颗粒剂的急性毒性和长期毒性。方法:以最大浓度、最大体积的颈复康灌服小鼠,测定1日最大给药量。以高、中、低3个剂量的颈复康灌服大鼠连续180d,观察大鼠给药90,180d时的生长发育、血液学、血液生化学、脏器系数、组织病理学变化及停药后30d上述指标的变化。结果:小鼠2次/d灌服颈复康的最大给药量>220.80g生药/kg。长期毒性实验中,连续给药90d时,高剂量组血清肌酐比对照组明显增高(P<0.05),肝、肾的重量系数比对照组明显增大(P<0.001和P<0.01);给药180d时,血清肌酐高剂量组比对照组显著增高(P<0.01),肝脏的重量系数三个剂量组均比对照组明显增高,肾脏的重量系数仅高剂量组比对照组增大;病理学检查,高剂量组1只大鼠肾脏近曲小管上皮细胞水肿;停药恢复30d后,大鼠体重、摄食量、活动、血液学、生化指标检查、脏器重量系数、病理学检查均正常。结论:颈复康颗粒在规定剂量下服用是安全可靠的。

Objective: To observe the acute toxicity of Jingfukang(JFK) in mice and its long-period toxicity in rats. Methods: The maximal tolerance dose was tested by gastric infusion of two times oral dose of JFK. Three groups of rats (in high,medium and low dosage of JFK) were administered with repeated gastric infusion of JFK for 180 days. Body weight, hema-tological and hematobiochemical parameters, coefficient and histomorphological figure of organs (the heart, liver, spleen, Lungs, kidneys, adrenals, testes, prostate, pancreas uterus, brain, thymus) were examined in 90 days, 180 days and 30 days after the cessation of JFK. Results: The oral maximal tolerance of JFK in mice was more than 220.80 (crude drugs) g/kg (equal to 194 times of clinical dose). In the long-period toxicity test, after adminisered repeatedly for 90 days the grea and the coefficient of livers and kidneys were increased in high-dosage group. After administered repeatedly for 180 days, the grea increased in high-dosage group and the coefficient of liver increased in high, medium and low-dosage. Kidneys of one rat occurred the following pathological changes: the epithelial cell of proximal convoluted tubules swelling. The changes of hematobiochemical, pathological and coefficient of organs could completely recover in 30 days after stopping the drug. Conclusion: JFK administration by long-period might slightly injure the renal function of rats, but the injury was reversible. It is safe to administer the prescribed dose of JFK.