Studies On Echinacea Herb Powder Of Safety Evaluation

Echinacea is grown for the natural medicinal plants from America civilized over the world,it has the function of immunological enhancement,anti-inflammatory, antibacterial, antiviral effect and so on. According to reports,the active ingredients of Echinacea herbs, which include chicoric acid, polysaccharide, alkyl amide and coffee acid derivatives, have significant pharmacological effect on animals. To evaluate the toxicity of natural echinacea herbs, and study the safety of the drug and provide a scientific basis for further clinical use, acute toxicity、 subchronic toxicity、 mutagenicity assay and teratogenicity test were conducted.1. Acute Toxicity Test.To evaluate the safety of Echinacea Herb Powder,20SD rats,half of male and female,were orally treated with Echinacea Herb Powder.The results show that Echinacea Herb Powder through the mouth, LD50greaters than5000mg/kg. According to WTO relevant about chemicals acute toxicity grading standards to evaluate, There is no significant toxicity in SD rats treated with Echinacea Herb Powder.2. Subchronic Toxicity Test. Eighty rats were randomly divided into4groups with20rats in each group and orally given at a dose of0mg/kg (Ⅰ group),250mg/kg (Ⅱ group),500mg/kg (Ⅲgroup) and1000mg/kg (IV group) of Echinacea Herb once a day for90days to test the safety and if the drug have toxic or side effects. The results showed that subchronic toxicity test were not significantly different from the control group. The drug had no poisonous effects on normal activities, physiological, pathologica and biochemical index of rats after45days and90days, the test suggested that Echinacea Herb Powder is no genotoxicity.3. Mutagenicity Assay3.1Micronucleus Test. Select50ICR male and female mice on the base of preliminary experiment, the selected mice were divided into five groups trabantly, there are10mice in each group. The ICR male and female mice were exposed to Echinacea Herb Powder through oral use at a dose of2500mg/kg、1250mg/kg、625mg/kg, there are also cytoxan positive control group and0.9%N.S. negative control group. The mice were killed by cervical dislocation after24h after oral use, The number of micronucleus cells per1000polychromatic erythrocytes (PCE) from stermum bone marrow was counted and the figures were analysed. The result showed that micronucleus test were not significantly different from the control group. The micronucleus test is negative.3.2Ames Test. The experiment was conducted with a view to evaluate the potential mutagenicity of Echinacea Herb Powder. Suspension of echinacea herb was prepared for Ames test. In the flat-plate incorporation test of Salmonella typhimurium, the average number of spontaneous revertants of TA97, TA98, TA100, and TA102at four concentrations was calculated after incubation at37℃for48hours. The results showed that whether adding S9or not, the number of induced revertants did not increase significantly compared to that of spontaneous revertants. The Ames test was negative. It indicated that Echinacea Herb Powder did not cause the increase of the back mutation in murine typhoid Salmonella and could not cause gene mutation.3.3Sperm deformity Test. Select50ICR male and female mice on the base of preliminary experiment, the selected mice were divided into five groups trabantly, there are10mice in each group. The ICR male and female mice were exposed to Echinacea Herb Powder through oral use at a dose of2500mg/kg、1250mg/kg、625mg/kg, there are also cytoxan positive control group and negative control group. The groups were given Echinacea Herb Powder seven times for continually.Then killed all mice on the35th day after the first exposure,and the rates of sperm deformity were detected. The result of each dose group were no significant difference as compared with control group (p>0.05) Echinacea Herb Powder can not cause sperm deformity.4. Teratogenicity Test. The animals were divided into negative control, positive control and three experiment groups, and Echinacea Herb Powder was administered by gavage during gestation day7to day16in doses of1000mg/kg,500mg/kg and50mg/kg, respectively. The body weight gain of pregnant rats, the body weight, body length and tail length of live fetus and some other parameters of embryonic development were measured. The result showed that the frequency of live fetus of each dose group were no significant difference as compared with control group (p>0.05).These results indicated that Echinacea Herb Powder is no maternal toxicity and embryotoxicity.