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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。
Mycobacterial polysaccharide injection (MPS) was studied for acute toxicity and mutagenicity. Results Both intraperitoneal injection of LD_50 male and female mice were greater than 46.4 ml/kg (696μg/kg). No mutagenic effect was found by Ames test and mouse sperm abnormality test. The micronuclear cell rate (4.3‰) in the highest dose group (23.2 ml/kg) of mouse bone marrow micronucleus test was significantly different from that in the negative control group (P<0.01), but it was still within the upper limit of normal value. The group (11.6 ml/kg) has exceeded 1,150 times the clinical application and no increase in the micronuclear cell rate was found. Therefore, it will not cause chromosome damage under the clinical application dose.