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Acute and subchronic toxicity as well as evaluation of safety pharmacology of Galla chinensis solution

Author:
Xiang, Fa, Peng, Lianci, Yin, Zhongqiong, Jia, Renyong, Hu, Zhiqiang, Li, Zhengwen, Ni, Xueqin, Liang, Xiaoxia, Li, Lixia, He, Changliang, Yin, Lizi, Su, Gang, Lv, Cheng
Source:
Journal of ethnopharmacology 2015 v.162 pp. 181-190
ISSN:
0378-8741
Subject:
Oriental traditional medicine, acute toxicity, adverse effects, body weight, cardiovascular system, central nervous system, dysentery, inflammation, lethal dose 50, necrosis, oral administration, pharmacology, poisoning, rats, respiratory system, specific pathogen-free animals, subchronic toxicity, toxicity testing
Abstract:
Galla chinensis has been popularly used in traditional Chinese medicine which is beneficial for the treatment of various diseases, such as inflammation, dysentery, toxicosis and sore. However, it has not previously been evaluated for safety through systematic toxicological studies. In the present study, acute and subchronic oral toxicity studies and safety pharmacology evaluation of Galla chinensis solution (GCS) were conducted in specific pathogen-free (SPF) Sprague–Dawley (SD) rats. Acute administration of GCS was done as single dose from 3333mg to 6912mg per kg/bodyweight (bw) and subchronic toxicity study for 30 days was done by daily oral administration of GCS at doses of 500, 1500 and 2500mg/kg body weight in SPF SD rats. The acute toxicity study showed the LD50 of GCS was greater than 5000mg/kg. The results of sunchronic toxicity study showed that the no-observed effect level of GCS was lesser than 1500mg/kgbwday, which suggested three times higher than that of recommended dose for clinical applications (500mg/kgbwday). The dose at 2500mg/kgbwday of GCS may slow down the growth of rats and lead to degeneration and necrosis of tissue cells to some extent. In the safety pharmacology study, GCS did not produce any side effects to rats in central nervous system, cardiovascular system and respiratory system. Therefore, from the results of the study presented herein, it could be concluded that the use of appropriate levels (one to three times of recommended dose for clinical applications) of GCS as a topical preparations is considered safe.
Agid:
6045842