扶正解毒颗粒对小鼠血液指标影响的研究

Impact of Fuzhengjiedu Granule on Blood Index of Mice

为考察长期使用扶正解毒颗粒的毒性,选取体重(18±2)g昆明小鼠160只,雌雄各半,随机分为4组(对照组及高、中、低3个剂量药物组),每组雌雄小鼠各20只,分笼饲养。根据毒理学评价标准及相关参考文献,其中高剂量为推荐临床用药量(即4 g/L饮水)的20倍,中剂量为推荐临床用药量的10倍,低剂量为推荐临床用药量的5倍。给药周期为90 d,将药物混于饮水中自由饮用,采食不限。主要从一般指标、增重及饲料利用、血液学常规、血液生化检查等方面研究该制剂对昆明小鼠的慢性毒性反应。结果显示:无论30 d末还是90 d末,受试药物的3个剂量组的上述各项指标测定结果均与对照组无显著差异(P>0.05),表明该新制剂无明显毒性,在临床上长期应用是安全的。

This research was aimed to investigate the toxicity of Fuzhengjiedu Granule for long-term use.One hundred and sixty Kunming mice with half males and half females weighed（18 ± 2） g were randomly divided into four groups as high-,medium-and low-dose groups and control group respectively.Every group had 20 male and 20 femal mice,and they were housed in cages separately.According to the toxicological evaluation criteria and relevant references,high dose was 20 times of recommended clinical dosage（4 g/L water）,medium dose was 10 times of recommended clinical dosage,and low dose was 5 times of recommended clinical dosage.The drug was used for 90 days through mixed in drinking water freely and feeding without limitation.Its chronic toxicity to Kunming mice was analyzed from general indexes,weight gain and feed utilization,routine hematology and blood chemistry.The results showed that either in the end of 30 days or 90 days,there were no significant differences in these indicators between drug groups and control group.It indicated that the drug showed no significant toxicity,and it was safe for clinical application.