| As a traditional Chinese medicine,Pseudostellaria heterophylla has a long history of application.It is a dry root of the caryophyllaceous plant Pseudostellaria heterophylla(Miq.)Pax ex Pax et Hoffm.,which has the effects of nourishing qi and strengthening the spleen and regenerating lungs.It is often used to treat the symptoms of spleen deficiency,body fatigue,inappetence,weakness after illness,deficiency of Qi and Yin,self perspiration and thirst,dry lung cough,etc.Pseudostellaria heterophylla is mainly produced in Fujian,Guizhou,Anhui,Zhejiang,Shandong,Jiangsu and other places.Shibing County,Guizhou is the largest production area of Pseudostellaria heterophylla,accounting for about half of the country's total output.Although Pseudostellaria heterophylla has a history of being used as a food ingredient in Guizhou and other places,it has not yet been included in the list of new food ingredients.Therefore,Pseudostellaria heterophylla is mainly used as a raw material for the development of medicines and health foods.The product form is relatively simple,which greatly limits the development of the Pseudostellaria heterophylla industry.At present,there are many research reports on the chemical composition and pharmacological effects of Pseudostellaria heterophylla,but there is a lack of systematic safety toxicology evaluation.This topic intends to conduct a comprehensive and systematic study on the safety of Pseudostellaria heterophylla in accordance with the relevant provisions of the "New Food Raw Material Safety Review Management Measures" and "Food Safety Toxicology Evaluation Procedures and Methods".Study on the pharmacodynamics of Pseudostellaria heterophylla for strengthening the spleen and anti-inflammatory.The research of this topic can provide research foundation and technical support for the inclusion of Pseudostellaria heterophylla in the national new food material list,which is beneficial to extending the industrial chain of Pseudostellaria heterophylla and expanding the market of it.The main work of this paper includes the following three aspects:1.Safety Evaluation of Pseudostellaria heterophylla:The acute toxicity test,three genotoxicity tests(mouse bone marrow polychromatic erythrocytes micronucleus test,mouse sperm deformity test,Ames test)and 90 day feeding test were used to study and evaluate the safety toxicology of Pseudostellaria heterophylla produced in Guizhou.(1)Acute toxicity test,the maximum tolerable dose method was used for poisoning.The water extract and alcohol extract of Pseudostellaria heterophylla were 60 g/kg·bw,respectively,which were administered to KM mice by gavage within one day,and the dose was 200 times higher than the recommended dose for human,and there was no poisoning and death in mice.The results showed that Pseudostellaria heterophylla belonged to the non-toxic range.(2)Three genetic tests: 1)Micronucleus test of mouse bone marrow cells was carried out by oral gavage twice every 24 hours.The dosage of water extract and alcohol extract were 20,10 and 5 g/kg·bw in high,middle and low dose groups,respectively.Meanwhile,cyclophosphamide in 40 mg/kg·bw was used as positive control and distilled water as negative control.The results showed that mouse micronucleus test was negative.The micronucleus test of mouse bone marrow cells was conducted by oral gavage twice every 24 h.The high,medium and low dose groups of Pseudostellaria heterophylla water extract and alcohol extract were 20,10 and 5 g/kg·bw,respectively,with cyclophosphamide at a dose of 40 mg/kg·bw as a positive control and distilled water as a negative control.The results showed that the mouse cell micronucleus test was negative.2)In the sperm abnormality test of mice,the water extract and alcohol extract of Pseudostellaria heterophylla were gavaged to KM mice for five consecutive days.The high,medium and low dose groups were 20,10 and 5 g/kg·bw respectively.At the same time,the 40 mg/kg·bw cyclophosphamide was used as the positive control and the distilled water as the negative control.The results showed that the sperm abnormality test of mice was negative.3)In the Ames test,the mutant strains of Salmonella typhimurium TA97 a,TA98,TA100,TA102 and TA1535 were selected,and the five dose groups of ginseng ginseng water extract were 5000,1000,200,40 and 8 ?g/dish respectively.The control group,with or without activation system S9,showed that the Ames test was negative.(3)90-day feeding test: Wistar rats were fed with water extracts of Pseudostellaria heterophylla for 90 consecutive days.The high,medium,and low dose groups were 100 times,50 times,and 25 times the recommended doses,respectively,and blank control groups were established.The test results show that there is no significant difference in the body weight and food utilization of the experimental group compared with the blank group.There were no significant lesions in the pathological sections of some organs in the experimental group and the blank group.In addition,there was no difference between the experimental group and the blank group in terms of Hematology and serum biochemical indexes.2.Study on the Effect of Pseudostellaria heterophylla on Strengthening the SpleenThe spleen deficiency model of rats was established by using the classical rhubarb,bitter cold and purgative function.The high,medium and low dose groups of Pseudostellaria heterophylla water extract were 10 times,5 times and 1 times of the recommended dose respectively,and the blank control group was set up.The results showed that the body mass and spleen coefficient of the model group were significantly lower than those of the blank group,but after treatment,the body mass and spleen coefficient of the drug group,especially the high dose group and the positive drug group were significantly different from those of the model group.Moreover,compared with the blank group,the model group showed significant changes in AMS,D-Xylose,Gas and VIP.Compared with the model group,the experimental group,especially the high dose group and the positive drug group,which had significant difference.It shows that the water extract of Pseudostellaria heterophylla has a good effect on Invigorating the spleen,and in a certain dose range,the higher the dose,the better the effect.3.Study on the anti-inflammatory effect of Pseudostellaria heterophyllaThe model of lung deficiency in rats was established by combining smoking with LPS for one month and dexamethasone as the positive drug.The administration concentration of the high,middle and low dose groups of the water extract of Pseudostellaria heterophylla was 10 times,5 times and 1 times of the recommended dose taken by humans respectively,and a blank control group was also established.The results showed that the body mass and lung coefficient of the model group were significantly lower than those of the blank group,but after treatment,the body mass and lung coefficient of the high dose group and the positive drug group were significantly different from those of the model group.The pathological section of the lungs of rats showed that the model group had significant lesions,while the administration group had mild lesions,especially the positive drug group and the high-dose group.Judging from the indexes of inflammatory factors in serum,the inflammatory factors in the model group are significantly different from the blank group.Compared with the model group,the inflammatory factors in the drug administration group,especially the positive drug group and the high-dose group,are significantly different.It shows that the water extract of Pseudostellaria heterophylla has good lung-invigorating and anti-inflammatory effects,and within a certain dose range,the higher the dose,the better the effect.In summary,the acute oral toxicity test and the 90-day feeding test showed that Pseudostellaria heterophylla was safe and non-toxic.The three genetic tests(mouse bone marrow polychromatic erythrocyte micronucleus test,mouse sperm deformity test,Ames test)were all negative,indicating that Pseudostellaria heterophylla has no mutagenic effect and has the potential to become a new food material.Pharmacodynamic studies have shown that Pseudostellaria heterophylla has good spleen and anti-inflammatory effects.Through the research of this project,it will provide research basis and data support for further listing the Pseudostellaria heterophylla as a national new food raw material. |
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