Safety Evaluation Of Coptis Chinensis Franch Radix As A Traditional Chinese Medicine

Rhizoma Coptidis (Huanglian in chinese) is a widely used traditional Chinese medicine, which was related to the heart, liver, spleen, gall bladder, stomach, and large intestine channels, bitter in flavor and cold in nature. It has a history of thousands of years for the treatment of heat-clearing and detoxifying and firstly described in Shen Nong Ben Cao Jing. Rhizoma Coptidis was also named Coptis chinensis Franch, the roots of which would yield a large number of adventitious roots when harvesting, which could be collected, cleaned and dried to Coptis chinensis Franch radix. Many studies have demonstrated that Coptis chinensis Franch radix contains the same constituents as Coptis chinensis Franch, including berberine, coptisine, jatrorrhizine, palmatine, epiberberine and other alkaloids, whereas, the content is only one-third of Coptis chinensis Franch. Coptis chinensis Franch radix would be developed into a new drug with a very broad application prospects attributing to its low price.In recent years adverse event have occurred frequently in chinese medicine. Though Coptis chinensis Franch radix has a variety of pharmacological activities as the same as Coptis chinensis Franch, under no circumstance should the safety issues of herbal medicine be neglected. Therefore, this dissertation was carried out to evaluate the safety of Coptis chinensis Franch radix as a traditional Chinese medicine according to the standard of new drugs.The main contents of this study are as follows:(1) The acute toxicity of Coptis chinensis Franch radixThe acute toxicity of Coptis chinensis Franch radix was tested in mice, which were fed three times within24h and the maximum dose reached21g/kg. However, the mean body weight of mice was slightly lower than the control group within5days after the oral administration of Coptis chinensis Franch radix. Moreover, there was no difference of autopsy between the treatment groups and control group at the end of the experiment (two weeks). The results indicated that there was not obvious toxicity associated with Coptis chinensis Franch radix.(2) The sub-chronic toxicity of Coptis chinensis Franch radixIn the sub-chronic toxicity study, the rats were divided into four groups, including control group, low-dose group (0.94g/kg, the highest dose in clinic), middle-dose group (1.88g/kg, twice as much as the highest dose in clinic) and high-dose group (3.76g/kg, four times as much as the highest dose in clinic). Mortality, clinical signs, body weight changes, organ weights, urinalysis and hematological parameters, gross findings and histopathology were monitored during the study period. Furthermore, there were no treatment-related toxicological changes following the administration of Coptis chinensis Franch radix for90-day compared with the control group.(3) The three-induced toxicity of Coptis chinensis Franch radixIn the Salmonella typhimurium reverse mutation assay, the Coptis chinensis Franch radix powder showed no mutagenicity in the range of5～0.005mg. In the mouse bone marrow micronucleus and sperm morphology test, the mice were divided into four groups, including negative (solvent) control group, low-dose group (625mg/kg), middle-dose group (1250mg/kg) and high-dose group (2500mg/kg), respectively, there were no significant difference between the treatment group and control group. In the traditional teratogenicity test, the mice were administrated by three dose levels (low-dose group (125mg/kg), middle-dose group (500mg/kg) and high-dose group (2000mg/kg)), the appearance malformations, visceral malformations and skeletal deformities of fetal indicated that Coptis chinensis Franch radix had not any teratogenic effects to fetal mice.