Preparation Of Penthorum Chinense Pursh Effervescent Tablet And Its Protective Effect On Liver Damage In Mice

Objective:Penthorum chinense Pursh is a plant in the family Saxifragaceae,it has a good role in protecting and treating liver damage,is a new food raw material,and has a good prospect of both medicine and food.The purpose of this research mainly includes parts as follow:In the first part,study the ratio of raw materials and accessories of Penthorum chinense Pursh effervescent tablet,and optimize the best preparation process then establish a preliminary quality standard evaluation system and study its mass stability;In the second part,the protective effect of Penthorum chinense Pursh effervescent tablets on liver damage caused by carbon tetrachloride and acute alcoholic liver damage.The project aims to develop a health food with the effect of liver protection,to provide an effective scientific basis for the in-depth development and utilization of Penthorum chinense Pursh resources.Methods:1.Total flavonoids were extracted by ethanol reflux,concentrated,dried and ground into dried Penthorum chinense Pursh extractum powder,and the total flavonoids were measured by UV spectrophotometry.2.Using Granulation method by acid-base mixing to compress tablets.The The best accessories was selected by one-factor experiment.The ratio of raw materials and accessories was optimized by the Box-Behnken design and sensory evaluation score.3.Quality analysis of the appearance characteristics,tablet weight difference,hardness,fragility degree,foaming volume,p H value,disintegration time,thin layer chromatography analysis and content determination was performed under the Preparation General Rules of the 2020 Edition of the Chinese Pharmacopoeia.4.Penthorum chinense Pursh effervescent tablet is going to take high temperature,high humidity and high light irradiation experiments and long-term and acceleration experiments to check the appearance characteristics,disintegration time limit and content changes.The factors affecting the stability of Penthorum chinense Pursh effervescent tablets were investigated.5.The study was divided into carbon tetrachloride liver injury experimental group and acute alcoholic liver injury experiment group,with 60Kunming mice in each group,model group,positive drug group(0.15 g·kg^-1)of biphenyl diester drop pill,high,medium and low dose group(8,4,2 g·kg^-1),and10 per group.Each experimental group continuous gavage administration for a period of time,after the last administration except the blank group,the rest of the corresponding liver injury model,die after fasting,measuring mouse liver coefficient,biological indicators and liver tissue section pathological examination,to study Penthorum chinense Pursh effervescent tablet against carbon tetrachloride liver injury and acute alcoholic liver injury.Results:.1.The total flavonoids content obtained in Penthorum chinense Pursh extractum was 31.52%.2.The excipients selected by one-factor experiments were citric acid,sodium bicarbonate,Steviosides,polyethylene glycol 6000,and lactose.Through the response surface design,the ratio of citric acid and sodium bicarbonate is 1.4,the optimal proportion of raw materials and accessories is10.0%Penthorum chinense Pursh extractum powder,Steviosides 5.0%,polyethylene glycol 6000 6.0%,lactose 45.0%.3.According to the best preparation process,the surface of tablets is smooth,uniform color and no loose blade,and the surface is light yellow-green with good taste.Less tablets with incomplete tablets,rough surface,uneven color,deformity,large flower spots or severe foreign matter.The average sheet weight is 0.48 g,weight difference is 2%,gas volume production is 6.5 m L,hardness 33.60 N,brittle degree 1.0%,disintegration time limit 3′43″,p H is between 4.82 and 5.15.4.Temperature,humidity and light conditions are important factors affecting the quality and stability of the Penthorum chinense Pursh effervescent tablet.Near the actual packaging conditions,the acceleration test showed that the temperature is the biggest factor that makes the Penthorum chinense Pursh effervescent tablet ineffective.The long-term test shows that the indexes of the it within 12 months are not obvious,and the quality is stable.5.Carbon tetrachloride experimental group:The liver index of the medium and high-dose group significantly reduced liver damage mice（P<0.01,P<0.05）compared with the model group;the low,medium and high-dose group significantly reduced ALT,AST content（P<0.01）,significantly reduced TNF-αrelease and improved SOD activity（P<0.05）,and decreased MDA activity（P<0.05）.Each dose group has some protective effect on the liver pathological injury caused by CCl₄.Alcohol Experiment Group:Comparing with the model group,each dose group can reduce the liver index,ALT value,and LDL-C content（P<0.01,P<0.05,P<0.01）,medium and high dose groups reduce AST（P<0.05）,low-and medium-dose groups can increase SOD activity（P<0.05,P<0.01）,each dose group can increase the activity of GSH（P<0.05,P<0.01）,medium and high dose groups can reduce TG levels（P<0.05）.Pathological sections showed that each dose group improved hepatocyte morphology and reduced inflammatory infiltration.Conclusion:The results show that the preparation process is simple,efficient and stable,The Penthorum chinense Pursh effervescent tablet is complete and smooth in appearance and tastes comfortable,meeting the requirements under the general principles of the Chinese Pharmacopoeia,and has good quality stability.The pharmacological effect results showed that it has a good protective effect on the acute liver injury and the acute alcoholic liver injury caused by CCl₄.This study provides practical guidance for the production and research and development of Penthorum chinense Pursh effervescent tablet,and provides a direction for the deep research and development of Penthorum chinense Pursh driving.