芪参口服液的毒理学研究

为评价芪参口服液临床用药的安全性,根据毒理学评价程序和方法对其进行了急性毒性试验和长期毒性试验。在急性毒性试验中,将40只昆明小鼠按体重随机分为2组,采用最大给药量法测定小鼠口服芪参口服液的最大耐受剂量;在长期毒性试验中,将80只Wistar大鼠按体重随机分为4组,3个剂量组分别按3.75、7.5、15 g/kg体重给大鼠灌胃,对照组给予同体积生理盐水,1次/d,连续4周。记录每日饮水量、饲料采食量及每周体重,检测给药4周及停药2周血液生化指标、血常规、脏器系数和组织病理学变化。试验结果显示,小鼠口服芪参口服液的最大耐受剂量为生药量40 g/kg,此剂量相当于临床日用量的40倍。部分给药组采食量和饮水量与对照组相比出现显著(P＜0.05)或极显著(P＜0.01)变化,但对平均周增重无显著性影响(P＞0.05);血常规的部分指标出现显著(P＜0.05)或极显著变化(P＜0.01),但停药2周后,所有指标与相应的对照组相比无显著性差异(P＞0.05);给药组血液生化和脏器系数的各项指标与对照组相比,无显著性变化(P＞0.05)。病理组织学检查无明显差异。试验结果表明,在本次试验条件下,该口服液安全无毒。

Study on Toxicology of Qishen Oral Solution

To evaluate clinical safety of Qishen oral solution, tests of acute toxicity and chronic toxicity were made according to toxicological evaluation procedures and methods. During the acute toxicity test, 40 Kunming mice were randomly divided into 2 groups. The maximum tolerable dosage of Qishen oral solution was determined by intragastric administration in mice. During the chronic toxicity test, Wistar rats were randomly divided into 4 groups, and the three experimental groups were given Qishen oral solution in doses of 3.75,7.5,15 g/kg by intragastric administration for 4 weeks, once a day, and observed after stopping administration for 2 weeks.The control group was given the same amount of physiological saline.The chronic toxicity were assessed on rats through recording daily water intake, feed intake and weekly body weight, measuring hematologic and blood biochemical indexes after administration for 4 weeks and withdrawal for 2 weeks. The results showed that the maximum tolerable dosage of Qishen oral solution administration was 40 g/kg in mice.It was equivalent to 40 times of the dosage used in clinic.Daily feed intake and water intake for some administration group showed significant (P＜0.05)or extremly significant (P＜0.01) differences compared with that in the control group, but average weekly gain had no significant changes (P＞0.05); during 4 weeks of intragastric administration, some indexes of hematology appeared significantly (P＜0.05) or extremly significantly (P＜0.01) different from that in the control group, but after 2 weeks, they had no significant changes (P＞0.05); blood biochemistry,viscera index and histological examination had no significant difference (P＞0.05). In conclusion, the clinical medication of the oral liquid was safe under this experimental condition.