Toxicological study of the hepatotherapeutic herbal formula, chunggan extract, in beagle dogs.
OBJECTIVE
To evaluate the pharmaceutical safety of a Chinese herbal formula, chunggan extract (CGX), traditionally prescribed as a hepatotherapeutic drug via systemic acute and subacute toxicological study.


METHODS
Twenty male dogs and 20 female dogs were fed doses 50 times and 4 times greater than the clinically-recommended drug dosages in an acute and a subacute toxicological study, respectively. Adverse effects were examined by comparing the differences between normal and drug-administered groups using clinical signs, necropsies, histopathologic findings, haematology, urinalysis, and biochemical analysis.


RESULTS
In the acute study no change in the body weight, diarrhoea, apetite, mortality rate and histopathology of major organs was observed in male or female dogs with a single administration of CGX at 5 g/kg. No drug-induced abnormalities at analysis of histopathology, haematology, urinalysis, and biochemistry were found with any dose of this drug.


CONCLUSIONS
CGX is supposed to be very safe when used in a clinical application with a wide therapeutic index.
Choi
Woo-Jin
WJ
East-West Cancer Center, Dunsan Oriental Hospital of Oriental Medical Collage of Daejeon University, Seo-gu, Daejeon 302-122, South Korea.
Shin
Jang-Woo
JW
Son
Jin-Young
JY
Seo
Dong-Seok
DS
Park
Hark-Soo
HS
Han
Seung-Hyun
SH
Sung
Ha-Jung
HJ
Cho
Jung-Hyo
JH
Cho
Chong-Kwan
CK
Yoo
Hwa-Seung
HS
Lee
Yeon-Weol
YW
Son
Chang-Gue
CG
D000818:Animals; D001835:Body Weight / Q000187:drug effects; D004285:Dogs; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000737:chemistry / Q000627:therapeutic use / Q000633:toxicity*; D004435:Eating / Q000187:drug effects; D005260:Female; D006801:Humans; D007668:Kidney / Q000187:drug effects / Q000473:pathology; D008099:Liver / Q000187:drug effects / Q000473:pathology; D008107:Liver Diseases / Q000188:drug therapy; D008297:Male; D008517:Phytotherapy / Q000009:adverse effects; D012449:Safety
D004365:Drugs, Chinese Herbal