Toxicological study on MUNOPHIL, water extract of Panax ginseng and Hericium erinaceum in rats.
OBJECTIVE
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
The data could provide satisfactory preclinical evidence of safety to launch clinical trials on standardized formulation of plant extracts.
Park
Il-Dong
ID
East-West Cancer Center, Dunsan Oriental Hospital of Daejeon University, 1136 Dunsan-dong, Seo-gu, Daejeon, South Korea.
Yoo
Hwa-Seung
HS
Lee
Yeon-Weol
YW
Son
Chang-Gue
CG
Kwon
Min
M
Sung
Ha-Jung
HJ
Cho
Chong-Kwan
CK
D000818:Animals; D001487:Basidiomycota / Q000737:chemistry*; D001835:Body Weight / Q000187:drug effects; D064420:Drug-Related Side Effects and Adverse Reactions; D009929:Organ Size / Q000187:drug effects; D005894:Panax / Q000737:chemistry*; D004364:Pharmaceutical Preparations / Q000008:administration & dosage; D010936:Plant Extracts / Q000008:administration & dosage / Q000009:adverse effects*; D051381:Rats; D017207:Rats, Sprague-Dawley
D004364:Pharmaceutical Preparations; D010936:Plant Extracts