Jeong Yong Joon, Jeon Hyelin, Kim Eun Jeong, Ryu Hyeon Yeol, Song Kyung Seuk, Kang Se Chan
Research Institute, Genencell Co., Ltd., Yongin, Gyeonggi-do 16950 Republic of Korea.
Korea Conformity Laboratories, Incheon, 21999 Republic of Korea.
Toxicol Res. 2021 Mar 5;38(1):69-90. doi: 10.1007/s43188-021-00090-5. eCollection 2022 Jan.
Extracts of and , two traditional herbal medicines, have long been used to treat women's diseases. Our previous studies have confirmed that these extracts could help relieve the symptoms of premenstrual syndrome by inhibiting prolactin release. A mixture of these natural products was named Lomens-P0. In this study, we conducted three genotoxicity tests (bacterial reverse mutation, mammalian chromosome aberration, and mammalian erythrocyte micronucleus studies) and four oral toxicity tests (single-dose, 2-week repeated-dose, and 13-week repeated-dose studies in rodents, and a single-dose dose-escalation toxicity study in a non-rodent model) to confirm the potential toxicity and safety of Lomens-P0. The results of this series of tests indicated Lomens-P0 did not induce genotoxicity, and the NOAEL for the rodent was 2000 mg/kg BW/day. Similarly, no toxic effects were evident in the single-dose-escalation study in the non-rodent model. In conclusion, we confirmed that Lomens-P0 might have potential utility as a raw material for nutraceuticals and natural medicines.
The online version contains supplementary material available at 10.1007/s43188-021-00090-5.
两种传统草药和的提取物长期以来一直用于治疗女性疾病。我们之前的研究证实，这些提取物可通过抑制催乳素释放来帮助缓解经前综合征的症状。这些天然产物的混合物被命名为Lomens-P0。在本研究中，我们进行了三项遗传毒性试验（细菌回复突变试验、哺乳动物染色体畸变试验和哺乳动物红细胞微核试验）以及四项口服毒性试验（啮齿动物单剂量、2周重复剂量和13周重复剂量试验，以及非啮齿动物模型的单剂量剂量递增毒性试验），以确认Lomens-P0的潜在毒性和安全性。这一系列试验的结果表明，Lomens-P0不会诱导遗传毒性，啮齿动物的无观察到有害作用水平（NOAEL）为2000 mg/kg体重/天。同样，在非啮齿动物模型的单剂量剂量递增试验中也未观察到明显的毒性作用。总之，我们证实Lomens-P0作为营养保健品和天然药物的原料可能具有潜在用途。
在线版本包含可在10.1007/s43188-021-00090-5获取的补充材料。
