骨碎补马鹿茸片毒理学安全性评价

Study on toxicological security of drynaria and deer antler tablets

目的研究东方药林牌骨碎补马鹿茸片(中元片)的毒理安全性。方法应用小鼠、大鼠急性经口毒性实验评价东方药林牌骨碎补马鹿茸片的急性毒性;通过Ames实验、骨髓细胞核实验和小鼠睾丸染色体畸变实验评价其遗传毒性;采用30 d喂养评价亚急性毒性。结果雌、雄大、小鼠急性经口试验的最大耐受量>15 g/kg,毒性等级为无毒级;Ames试验结果为阴性,无致基因突变作用;与对照组比较,各剂量组小鼠细胞微核率、睾丸染色体畸变细胞率差异均无统计学意义(P值均>0.05);30 d喂养实验未见明显的亚急性毒性作用。结论在本实验条件下,东方药林牌骨碎补马鹿茸片无急性毒性、遗传毒性、亚急性毒性,属无毒级物质。

Objective To study the toxicological safety of drynaria and deer antler tablets(Zhongyuan tablets).Methods The acute oral toxicity tests of mice and rats were used to evaluate the acute toxicity of drynaria and deer antler tablets.The genetic toxicities were evaluated by Ames test,bone marrow micronucleus test and mouse testicle cell chromosome aberration test.30 d feeding test was conducted to study subacute toxicity.Results The oral maximal tolerance dose(MTD)was>15 g/kg·bw for both male and female mice,and the toxic level was non-toxic.Ames test showed negative results,and mutagenic effect was not detected.Compared with the control group,bone marrow micronucleus test and testicle cell chromosome aberration test were both negative in Zhongyuan tablet group(P>0.05).No subacute toxicity was observed in rats after 30 day feeding experiment.Conclusion Under this experimental conditions,drynaria and deer antler tablets is safe with no acute toxicity,mutagenic effect and sub-acute toxicity,and it belongs to non-toxic grade.