分枝杆菌多糖毒理学安全性评价研究

对分枝杆菌多糖注射液(MPS)进行了急性毒性和致突变性的研究。结果腹腔注射LD_50雌、雄小鼠均大于46.4 ml/kg(696μg/kg)。经Ames试验及小鼠精子畸形试验均未发现有致突变作用。小鼠骨髓微核试验最高剂量组(23.2 ml/kg)的微核细胞率(4.3‰)与阴性对照组相比较,有显著性差异(P<0.01),但仍属于正常值上限,中剂量组(11.6 ml/kg)已超过临床应用量1150多倍,并未发现微核细胞率的增高。因此,在临床应用剂量下将不至于导致染色体的损伤。

The Evaluation of Toxicological Safety of Mycobacterial Polysaccharides

We have studied the acute toxicity and mutagenicity of mycobacterial polysaccharide (MPS) injection.The LD₅₀ was higher than 46.4 ml/kg when intraperitoneal injection to both sexes of mice was made.No mutagenie effects were found in Ames' test and in analysis of sperm abervation of mice.While in micronucleus test of mice bone marrow, the proportion of micronucleus cell in group of high dose was singnificantly higher than that in group of negative control(P<0.01 ), but it was only 4.3‰ and still within the upper limit of normal-ity.Meanwhile, no increase of the proportion of micronucleus cell was found in group of middle dose (11.6 ml/kg), which was 1150 times more than that used in clinic.Thus, we think that MPS may have no risk leading to injury of chromosome in actual use.