Basic Research
Copyright ©2006 Baishideng Publishing Group Co., Limited. All rights reserved.
World J Gastroenterol. Dec 14, 2006; 12(46): 7497-7502
Published online Dec 14, 2006. doi: 10.3748/wjg.v12.i46.7497
Toxicological study of the hepatotherapeutic herbal formula, Chunggan extract, in beagle dogs
Woo-Jin Choi, Jang-Woo Shin, Jin-Young Son, Dong-Seok Seo, Hark-Soo Park, Seung-Hyun Han, Ha-Jung Sung, Jung-Hyo Cho, Chong-Kwan Cho, Hwa-Seung Yoo, Yeon-Weol Lee, Chang-Gue Son
Woo-Jin Choi, Jang-Woo Shin, Jin-Young Son, Jung-Hyo Cho, Chong-Kwan Cho, Hwa-Seung Yoo, Yeon-Weol Lee, Chang-Gue Son, East-West Cancer Center, Dunsan Oriental Hospital of Oriental medical Collage of Daejeon University; 1136 Dunsan-dong, Seo-gu, Daejeon 302-122, South Korea
Dong-Seok Seo, Hark-Soo Park, Ha-Jung Sung, Safety Assessment Center, Korea Testing and Research Institute for Chemical Industry, 7-6, Gomak-ri, Wolgot-myeon, Gimpo-si, Kyonggi-do, Korea
Seung-Hyun Han, Department of Oromaxillofacial Infection & Immunity and Dental Research Institute, School of Dentistry, Seoul National University, 28 Yongon-Dong, Chongno-Gu, Seoul 110-749, South Korea
Author contributions: All authors contributed equally to the work.
Correspondence to: Dr. Son CG, East-West Cancer Center, Dunsan Oriental Hospital of Oriental medical Collage of Daejeon University; 1136 Dunsan-dong, Seo-gu, Daejeon 302-122, South Korea. ckson@dju.ac.kr
Telephone: +82-42-4709481 Fax: +82-42-4709005
Received: September 19, 2006
Revised: October 25, 2006
Accepted: September 3, 2006
Published online: December 14, 2006
Abstract

AIM: 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.

CONCLUSION: CGX is supposed to be very safe when used in a clinical application with a wide therapeutic index.

Keywords: Hepatotherapeutics, Herbal remedy, Chunggan extract, Safety, Toxicological study