Study on toxicity of 999 Ganmaoling grain and influence of diet on hepatic toxicity.

Qiu-ping Guo; Ting-ting XU; Yan-qing Chen; Ying-ying Zhen; Yue-fei Zhang; Zu-guang YE; Ruo-min Jin

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Study on toxicity of 999 Ganmaoling grain and influence of diet on hepatic toxicity.

Author: Qiu-Ping GUO ¹ ; Ting-Ting XU ² ; Yan-Qing CHEN ¹ ; Ying-Ying ZHEN ² ; Yue-Fei ZHANG ³ ; Zu-Guang YE ⁴ ; Ruo-Min JIN ²
Author Information

1. Drug Nonclinical Evaluation and Research Center, Guangzhou General Pharmaceutical Research Institute, Guangzhou 510240, China.
2. Drug Safety Evaluation Center, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China.
3. Research Center, Huarun Three Nine Pharmaceutical Limited By Share Ltd., Shenzhen 518110, China.
4. Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Publication Type:Journal Article
Keywords: Ganmaoling grain; acute toxicity; diet; ingredient; liver toxicity; starvation
From: China Journal of Chinese Materia Medica 2016;41(8):1397-1404
CountryChina
Language:Chinese
Abstract: This paper was aimed to compare the acute toxicity of 999 Ganmaoling grain and its different ingredients, and investigate the influence of routine diet on the hepatic toxicity induced by Ganmaoling in mice, so as to provide experimental basis for the clinical safety evaluation. Mice were given a single dose of Ganmaoling grain or its different ingredients respectively by gavage, and then observed for 14 days. LD₅₀ values of Ganmaoling grain or its chemical ingredient and the maximal tolerated dose of its herb ingredient were determined. Mice were divided into starvation and diet group, a single dose of Ganmaoling grain was administered by gavage. LD₅₀ values were estimated after 14 day observation. Mice were divided into starvation and diet group. At the same time,control group was set up for each. A single dose of Ganmaoling grain was given. Serum biochemical indexes were detected, liver weight index was calculated and liver tissue morphological change was observed after 6 h. LD₅₀ values were 4.42, 0.64 g•kg⁻¹ for Ganmaoling grain group and chemical ingredient group, respectively. The maximal tolerated dose of the herb ingredient group was close to 24.24 g•kg⁻¹. The toxic symptom was basically similar in the Ganmaoling grain and the chemical ingredient group. The body weight and food intake were decreased to a certain extent in both groups. There were pathological changes of liver and heart tissue in some of the surviving animals. The animals in the Ganmaoling grain group exhibited a lighter toxicity and recovered faster than that in the chemical ingredient group. LD₅₀ values of Ganmaoling grain were 2.56, 6.93 g•kg⁻¹ for starvation and diet group respectively. TD₅₀ values were 1.29, 6.31 g•kg⁻¹ for starvation and diet group respectively. The toxicity of 999 Ganmaoling was less, which may be related to the reduction of toxicity after the combination of herb and chemical ingredients. Compared with starvation group, the values of LD₅₀ and TD₅₀ of diet group was significantly increased, and toxicity was decreased. From the point of view of safety, it is safer to use Ganmaoling in the absence of hunger or after meal. The above tests provide experimental basis for the clinical safety use of Ganmaoling.