Park Il-Dong, Yoo Hwa-Seung, Lee Yeon-Weol, Son Chang-Gue, Kwon Min, Sung Ha-Jung, Cho Chong-Kwan
East-West Cancer Center, Dunsan Oriental Hospital of Daejeon University, 1136 Dunsan-dong, Seo-gu, Daejeon, South Korea.
J Acupunct Meridian Stud. 2008 Dec;1(2):121-7. doi: 10.1016/S2005-2901(09)60032-7.
As data on the safety profile of Panax ginseng and Hericium erinaceum is lacking, the safety of these two compounds was examined in a series of toxicological studies.
MUNOPHIL, the water extract mixture of Panax ginseng and Hericium erinaceum was tested in an oral subchronic 28-day toxicity study in rats at doses of 1250, 2500 and 5000 mg/kg/day.
In repeated dose toxicity studies, no mortality was observed when varying doses of the extracts were administered once daily for a period of 28 days. There were no significant differences in body weight, absolute and relative organ weights between controls and treated rats of both sexes. Hematological analysis showed no differences in most parameters examined. In the biochemistry parameter analysis, no significant change occurred. Pathologically, neither gross abnormalities nor histopathological changes were observed. Therefore, MUNOPHIL appears to be safe and non-toxic in these studies and a no-observed adverse effect level in rats was established at 5000 mg/kg/day.
The data could provide satisfactory preclinical evidence of safety to launch clinical trials on standardized formulation of plant extracts.
由于缺乏人参和猴头菇安全性概况的数据，在一系列毒理学研究中对这两种化合物的安全性进行了检测。
人参和猴头菇的水提取物混合物MUNOPHIL在大鼠口服亚慢性28天毒性研究中，以1250、2500和5000毫克/千克/天的剂量进行测试。
在重复剂量毒性研究中，当每天一次给予不同剂量提取物，持续28天时，未观察到死亡情况。对照组和各处理组的雌雄大鼠在体重、绝对和相对器官重量方面均无显著差异。血液学分析显示，所检测的大多数参数均无差异。在生化参数分析中，未发生显著变化。在病理学上，未观察到大体异常或组织病理学变化。因此，在这些研究中，MUNOPHIL似乎是安全无毒的，并且在大鼠中确定的无观察到不良反应水平为5000毫克/千克/天。
这些数据可为开展植物提取物标准化制剂的临床试验提供令人满意的临床前安全性证据。
