可注射性胶原生物材料的安全性评价

Evaluation on the Safety of Injectable Collagenous Material

研究可注射性胶原生物材料的急性毒性和三项致突变性作用。测定小鼠经口、经腹腔注射急性毒性试验 ＬＤ＞１００００ ｍｇ／ｋｇ。小鼠骨髓细胞微核试验、小鼠多丸初级精母细胞染色体畸变试验和 Ａｍｅｓ试验均为阴性。说明可注射性胶原对小鼠急性毒性低，且不具有致突变作用。临床上可试作为组织填充剂，具有较大的安全性和可靠性。

Study the acute tocicity and three items of resulting in mutation for the indectable collagenous in mice are studied. The acute toxicity test in mice expressed LD > 10000mg/kg. The results of mice testis primary sepermatogonium chromosame malformation analysis, the mice bone marrow micronucleus test and Ames test are all negative. These results displayed that the acute toxicity of the injectable collagenous mate- rial is low and doesn't cause mutation.