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目的探讨蛞蝓胶囊是否具有致畸和致突变的毒理作用。方法本研究采用大鼠致畸胎、艾姆斯(Ames)试验、小鼠骨髓细胞微核试验、体外细胞染色体畸变试验检测的蛞蝓胶囊致畸胎、致突变性。结果蛞蝓胶囊各剂量对孕鼠体重、胚胎早期发育、胚胎生长发育、以及胎鼠的骨骼发育和内脏器官发育等均无不良影响。无论加与不加S9,各剂量组诱变TA98、TA100种菌落数均未超过自然回变菌落数,与阴性对照组比较均无显著性差异(P>0.05)。与对照组相比,各剂量组对小鼠的微核率无明显的影响(P>0.05)。蛞蝓胶囊对培养的哺乳动物体细胞染色体结构无致畸变作用。结论蛞蝓胶囊各剂量均无致畸和致突变的作用,说明在临床应用剂量范围内是安全的。
Objective To investigate if the capsule has teratogenic and mutagenic toxicological effects. Methods This study used teratogenic, Ames test, micronucleus test of bone marrow cells, and chromosome aberration test in vitro to detect teratogenicity and mutagenicity. RESULTS: Each dose of Radon Capsules had no adverse effects on body weight, embryonic development, embryonic development, fetal rat bone development, and visceral organ development. With or without S9, the number of TA98 and TA100 colonies induced by mutagenesis in each dose group did not exceed the number of natural retrograded colonies, and there was no significant difference compared with the negative control group (P>0.05). Compared with the control group, each dose group had no significant effect on the micronucleus rate of mice (P>0.05). Qi capsule has no distortion effect on the chromosome structure of cultured mammalian somatic cells. Conclusion There are no teratogenic and mutagenic effects in each dose of Fuling Capsule, which indicates that it is safe in the clinical application dose range.