Liver and Immunology Research Center, Oriental Medical Collage of Daejeon University, 75, Daedeok-daero 176beon-gil, Seo-gu, Daejeon, 35235, Republic of Korea.
Department of Internal Medicine, Daejeon St. Mary's Hospital of Catholic University, Daejeon, Republic of Korea.
BMC Complement Altern Med. 2019 Jul 8;19(1):166. doi: 10.1186/s12906-019-2588-3.
To evaluate the pharmaceutical safety of Myelophil, an ethanol extract of a mixture of Astragali Radix and Salviae Miltiorrhizae Radix, using both acute and repeated toxicological studies.
A total of 40 beagle dogs (20 each male and female) were fed doses up to 5,000 mg/kg for the acute study and up to 1,250 mg/kg for the 13-week repeated dose toxicological study. Adverse effects were examined intensively by comparing the differences between normal and drug-administered groups using clinical signs, autopsies, histopathological findings, hematology, urinalysis, and biochemical analysis.
No mortality or drug-related clinical signs were observed in the Myelophil-treated groups, except for vomiting due to an excessive dose (5,000 mg/kg). Likewise, in the repeated toxicity test, compound-colored stools in the Myelophil-treated groups and soft stools in all groups, including the control, were observed. No drug-related abnormalities were found in the histopathology, hematology, urinalysis, and biochemical analyses for any doses of Myelophil.
These results support the safety of Myelophil with a no observed adverse effect level (NOAEL) of 1250 mg/kg in beagle dogs, which corresponds to a human equivalent dose (HED) of 694 g/kg.
通过急性和重复毒性研究评估黄芪和丹参混合乙醇提取物 Myelophil 的药物安全性。
将 40 只比格犬（雌雄各 20 只）分别给予高达 5000mg/kg 的剂量进行急性研究，以及高达 1250mg/kg 的剂量进行 13 周重复剂量毒性研究。通过临床症状、尸检、组织病理学发现、血液学、尿液分析和生物化学分析，比较正常组和药物组之间的差异，对不良反应进行了深入检查。
Myelophil 治疗组除因剂量过大（5000mg/kg）导致呕吐外，未见死亡或与药物相关的临床症状。同样，在重复毒性试验中，Myelophil 治疗组出现混合色粪便，所有组（包括对照组）均出现软便。在任何剂量的 Myelophil 进行的组织病理学、血液学、尿液分析和生物化学分析中，均未发现与药物相关的异常。
这些结果支持 Myelophil 的安全性，其在比格犬中的无观察到不良效应水平（NOAEL）为 1250mg/kg，相当于人类等效剂量（HED）为 694g/kg。
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