硫酸软骨素和氨基葡萄糖联合制剂的毒理学试验

Toxicological Experiment of Combined Preparation of Chondroitin Sulfate and Glucosamine

目的观察硫酸软骨素片毒性。方法最大耐受量试验(MTD),遗传毒性试验(Ames、骨髓细胞微核及精子畸变试验),30 d喂养试验。结果硫酸软骨素片MTD>10.0 g/kg BW。Ames试验、小鼠精子畸变及骨髓细胞微核试验结果为阴性。30 d喂养试验中雌性和雄性大鼠的高剂量组为6.67 g/kg BW(即人体推荐剂量100倍)时各测定指标与对照组比较无显著性差异。结论本试验条件下,硫酸软骨素片未见明显毒性。

Objective To observe the toxicity on Chondroitin sulfate tablet. Methods MTD; Test of genetic toxicity（Test of Ames, bone marrow cell micronucleus and sperm abnormality ）; 30 days feeding test. Results MTD of chondroitin sulfate tablet was greater than 10.0 g/kg BW to rats and mice. The results were negative in Ames test, mice sperm abnormality test, and mice bone marrow cell micronucleus test. In the 30 days feeding experiment, the test parameters, when the maximum dose group of female and male rats were 6.67 g/kg BW （equal to 100 times of commended dose in human body）, had no significant difference compared with the control group. Conclusion Chondroitin sulfate tablet had no obvious toxicity under this experiment condition.