Gamisoyo-san是一种广泛用于治疗心理问题的草药配方,更年期症状,痛经.然而,关于其安全性的信息不足。本研究旨在确认Gamisoyo-san的遗传毒性和急性毒性潜力。我们进行了一系列测试,其中包括使用五种细菌菌株的细菌回复突变测试(Ames测试),使用中国仓鼠肺(CHL)细胞进行的体外染色体畸变试验,小鼠体内微核试验,和人细胞色素P450(CYP450)和UDP-葡糖醛酸基转移酶(UGT)测定。在急性毒性研究中,雄性和雌性大鼠口服给予Gamisoyo-san1000、2000或5000mg/kg,观察14天。使用重组杆体来评估人CYP450和UGT的活性。Gamisoyo-san在五种细菌菌株中没有显示遗传毒性的迹象,CHL细胞,或小鼠骨髓细胞。急性毒性试验表明,Gamisoyo-san在大鼠体内的中位致死剂量(LD50)大于5000mg/kg。Gamisoyo-san抑制CYP1A2,CYP2C19和UGT1A1的活性。总之,Gamisoyo-san在大鼠中的剂量高达5000mg/kg时可能不会产生严重的毒理学事件或遗传毒性作用。
Gamisoyo-san is an herbal formula widely used to treat psychological issues, menopausal symptoms, and dysmenorrhea. However, there is insufficient information on its safety profile. This study aimed to confirm the genotoxic and acute toxic potential of Gamisoyo-san. We performed a battery of tests, which included a bacterial reverse mutation test (Ames test) using five bacterial strains, an in vitro chromosomal aberration test using Chinese hamster lung (CHL) cells, an in vivo micronucleus test in mice, and human Cytochrome P450 (CYP450) and UDP-glucuronosyltransferase (UGT) assays. In the acute toxicity study, male and female rats were orally administered Gamisoyo-san 1000, 2000, or 5000 mg/kg and observed for 14 days. The activities of human CYP450s and UGTs were evaluated using recombinant baculosomes. Gamisoyo-san showed no signs of genotoxicity in the five bacterial strains, CHL cells, or mouse bone marrow cells. The acute toxicity test showed that the median lethal dose (LD50) of Gamisoyo-san was greater than 5000 mg/kg in rats. Gamisoyo-san inhibited the activities of CYP1A2, CYP2C19, and UGT1A1. In conclusion, Gamisoyo-san may not exert severe toxicological events or genotoxic effects at doses up to 5000 mg/kg in rats.