中药联合益生菌ZY的毒理学安全性评价

Toxicological safety evaluation of Chinese medicine and probiotics ZY

为评价中药联合益生菌ZY临床应用的安全性,选取清洁级昆明小鼠,采用急性毒性和亚急性毒性试验判断其一般毒性,用小鼠骨髓红细胞微核和精子畸形试验判断其特殊毒性。结果表明:急性毒性试验中,中药益生菌ZY对小鼠的最大耐受量为40g/kg,亚急性毒性试验中未见小鼠饮水、采食、精神状态和主要组织器官形态结构有异常变化,中、高剂量组小鼠体重在给药7d后显著高于空白组(P<0.05),高剂量组小鼠体重在给药14d后极显著高于空白组(P<0.01);小鼠骨髓红细胞微核和精子畸形试验中,各试验组小鼠微核率和精子畸形率与空白组相比差异不显著(P>0.05),与阳性组相比差异极显著(P<0.01)。说明中药益生菌ZY安全无毒,能够促进小鼠体重增加,且无体内致突变作用和遗传毒性,这为其临床安全应用提供了有效的依据。

To evaluate the safety of Chinese medicine and probiotics ZY in clinical application, general toxicological safety test of acute toxicity and subacute toxicity, special toxicological safety test of bone marrow micronucleus and sperm abnormality were done in Kunming mice. The results showed that the maximum tolerance dose of ZY was 40 g/kg. ZY had no effect on drinking, feeding and histomorphology. Compared with negative control group, the weight of mice in medium and high dose groups had significant increase after 7 days of administration ( P <0.05), the weight of mice in high dose group had extreme significant increase after 14 days of administration ( P <0.01). The micronucleus rate and sperm deformity rate in bone marrow erythrocyte micronucleus and sperm deformity test of mice in each experimental group were not significantly different from those in the negative control group ( P >0.05), but significantly different from those in the positive control group ( P <0.01). It suggests that ZY is safe and non-toxic, promotes the weight gain and has no mutagenicity and genotoxicity in mice. It provides an effective basis for clinical application of ZY.