合成新药SC1001A胺盐的毒性研究

Studies on the Toxicity of a New Synthetic Drus SC1001 - Aminum

SC1001A是一种镇静、安眠及抗癫痫作用的合成新药。作者采用卫生部药检所近年按国际标准建立的药物致突变测试系列以及常规致畸胎试验,检测和评价了该种新药的毒性。结果表明:SC1001A属于低毒类化学物质;体内外测试系统均未发现其致突变性和/或潜在致癌性;也未观察到致畸胎性。

SC1001A is a new sedative, hypnoticand anti-epileptic drug. Screening for pos-sible mutagenicity of the agent consistedof a battery scheme of short-term muta-genic tests with different hereditary de-tecting end points.Three assays were within the scheme; Ames test (for detecting genemutation in vitro), micronucleus test(for detecting chromosomal aberration invivo) and CHL (Chinese hamster lungcell line) test (for detecting chromosomalaberration in vitro). in addition, a rou-tine teratogenicity study on SC1001Awas carried out in mice. They were givendaily at 3-dose levels (exposed to up to33％ of the LD_(50) by gastricincubation fromthe 6th through the 15th day of gesta-tion. SC1001A gave uniformly negative res-ults in all three mutagenic assay systems.Results of the teratogenic experimentshowed tha only the pregnant rate inbred mice in the moderate dose group andthe mean maternal body weight gain ofthe dams during gestation in the lowdose group were significantly lower thanthose in the corresponding control group.A clear dose-response relationship was notdemonstrated. All dose levels of SC1001Aused caused no adverse effects on the nu-mber of survival fetuses per litter, growthor developmeat of the fetal mice. No ma-lformations in the external appearance,of the internal organs and of the skeletalsystems in fetal mice were observed. The above--mentioned results indicatedthat SC1001A induced neither gene muta-tion nor chromosomal damage both invitro and in vivo. There was no evidenceof teratogenesis. Therefore, it is estimatedthat SC1001A is probably comparativelysafe as a pharmaceutical product for hu-man beings in usual dosage.