复方胆囊炎胶囊对比格犬灌胃给药急性毒性试验

Acute toxicity test of compound cholecystitis capsule in beagle dogs by intragastric administration

目的考察比格犬以灌胃给药接受过量受试物复方胆囊炎胶囊后可能出现的急性毒性反应。方法取8只检疫合格的健康Beagle犬,按体质量随机分为受试物组6只和溶媒对照组2只,雌雄各半,雌性无孕。受试物组给予复方胆囊炎混悬液,单次给药剂量为6 250 mg/kg,24 h内给药两次,累计给药剂量为12 500 mg/kg。溶媒对照组以相同给药频率给予同体积的0.5%羧甲基纤维素钠溶液。给药后对受试动物进行症状观察,并检测其心电、体温、体重、血液生化、血凝、血液细胞学和尿常规等指标,在观察期结束后进行大体剖检观察。结果受试物组4只动物在给药后出现短暂的干呕症状,其余未见异常。受试物组剩余动物及对照组动物未见明显毒性症状。将受试物组动物的心电、体温、体质量、血液生化、血凝、血液细胞学和尿常规等指标进行给药前后自身比较,差异无统计学意义(P>0.05)。观察期结束后麻醉放血处死动物,经大体剖检未见明显异常。结论复方胆囊炎胶囊对Beagle犬灌胃给药急性毒性试验是临床上人拟用量的130倍,给药后未见明显的毒性症状。

Objective To investigate the possible acute toxic reaction after beagle dogs accepted excessive amount of compound cholecystitis capsule by intragastric administration. Methods A total of 8 healthy beagle dogs were randomly divided into two groups： the experimental group（n=6） and the control group（n=2）, with non-pregnant female and male each half. The dogs in the experimental group were treated with compound cholecystitis suspension, at the dosage of 6 250 mg/kg, with a cumulative dosage of 12 500 mg/kg within 24 h. The control group was given the same volume of 0.5% sodium carboxymethyl cellulose solution at the same frequency. After the treatment, the symptoms of the dogs were observed, and electrocardiogram（ECG）, body temperature, body weight, blood biochemistry, blood coagulation, blood cytology and urine routine were measured. After the end of the observation period, the gross dissection was observed. Results Four beagle dogs in the experimental group had transient retch symptoms after administration,and the rest did not show any abnormality. There were no obvious toxic symptoms in the remaining dogs in the experimental group and dogs in the control group. There was no significant difference in the ECG, body temperature, body weight, blood biochemistry, blood coagulation, blood cytology and urine routine between before and after the intragastric administration（P〈0.05）. At the end of the observation period, digs were sacrificed by anesthesia and bloodletting,and no significant abnormality was observed by general autopsy. Conclusion The beagle dogs were treated with compound cholecystitis suspension by intragastric administration, which is 130 times of clinical dosage contemplated for human. There is no obvious toxicity of the symptoms after administration.