Safety Toxicology And Evaluation Of Pharynx Function Of Honeysuckle & Qing Guo Multiple Product

Objective: Chronic pharyngitis is a chronic inflammation of the upper respiratory tract.It is diffuse in the pharyngeal mucosa,submucosa and lymphatic tissues.It has high incidence in adults.It has a long duration,is prone to repeated attacks,and is difficult to cure,which has unhealthy impact on people usual life.What’ worse,serious effects increase the economic pressure on patients and society,so to explore better agents to reduce the symptoms of patients becomes much necessary.Honeysuckle,green fruit,bellflower,etc.are common Chinese herbal medicines in mainland China,and have very good curative effects in anti-inflammatory,antibacterial,and anti-tumor performance.In view of this,in this experiment,honeysuckle,green fruit,and bellflower were used as the main raw materials for the research and development of the Qingyan pharynx health care products.The main purpose of this study is:(1)To evaluate the safety of honeysuckle and green fruit products by conducting toxicological tests.(2)Through trials on animals and humans,the main symptoms and other test results were analyzed to evaluate product-clearing effect.Methods: To evaluate the safe toxicology of products,acute toxicity test,genetic toxicity test and 30-day feeding test were used.Mouse ear swelling test,rat paw swelling test,and rat cotton ball implantation test were used to evaluate the anti-inflammatory capacity of the products for animals.Using a randomized,double-blind,and blank control method,from November 2016 to May 2017,101 patients with chronic pharyngitis who met the conditions for inclusion and discharge of a pediatric ENT hospital in Gansu Province were selected for clearance.In the human food trial of pharyngeal function,the duration of the trial was 30 days.All subjects performed symptoms,signs,and biochemical tests before and after the trial.At the very beginning,chest X-ray,ECG examination and abdominal ultrasound were performed on all patients.During the 30-day trial,the dosage of the tablets and the degree of symptoms were recorded.The general conditions,symptoms,physical signs,and biochemical levels required for the statistical test were taken after 30 days according to the dosage of 4.8g/day product.There were 51 cases in the test group and 50 objects in control group,the blank control.The improvement of chronic pharyngitis in patients with products was evaluated.Results: 1.Acute toxicity test: The acute oral MTD of the products in rats was greater than 15g/kg.bw.2.Product genetic toxicity test: Ames test,mouse bone marrow cell micronucleus test and mouse sperm abnormality test all three genetic tests were negative results,products on the test animals without direct or indirect mutagenic effect.3.No abnormal changes in animal health status,biochemical,hematological parameters,and organ tissue morphology were observed during the 30-day feeding test in rats.In the mouse ear swelling test,the ear swelling rate of the 2.4g/kg.bw dose group was significantly lower than that of the control group(P<0.01).In the rat cotton ball implantation test,the net granulose size was significantly lower in the 1.6g/kg.bw dose group than in the control group(P<0.05);in the rat toe swelling test,0.8g/kg.bw Compared with the control group,the swelling rate of the toe volume in the dose group was significantly reduced(P<0.05).5.In the human food trial,the main clinical symptoms and signs of the test food group were 18.00% and 84.00%,sequencely were 0.06% and 38.00% in control group,which had significant differences(P<0.05);The scores of the main clinical symptoms and the scores of the physical signs decreased after the trial,and there was a significant difference between the test group and the control group before and after the test(P<0.05).Conclusion: 1.The product is safe and non-toxic,and it is a non-toxic substance.2.The genotoxicity test did not find that the product had a mutagenic effect.In the 30-day feeding test,the rats showed normal physiological signs,behaviors,urine,defecation,normal weight gain,and normal food use.4.The product was a positive result in animal experimental throat function tests.5.The honeysuckle,green fruit as the main raw material products can improve the human chronic pharyngitis symptoms and signs.