The Reaserch On Pharmaceutical And Acute Toxicity Of Shuang Gan Qing Yan Tablet

Objective: The reaserch on mangiferin,mogroside and menthol contributes to the anti-inflammatory effect of Shuang Gan Qing Yan Tablet(SGQY tablet),in ordert to selecting the optimal prescription of the tablet.Optimize the preparation process of SGQY tablet,and screening out the best preparation technology.Establish quality control standard of SGQY tablet.Study on the stability of SGQY tablet according to preliminary stability study test,understanding the factors affecting its stability and Changes in the composition,so that Provide basis for formulation design,process screening,selection of packaging materials and containers,determination of storage conditions,and related substances control.Evaluate the safety of SGQY tablet by i.g SGQY tablet to mice acute toxicity test,so that provide basis for clinical medication.Methods:(1)By central composite design-response surface methodology(CCD-RSM)optimization test,we titrated the dosage of mangiferin,mogroside and menthol,and determined their therapeutic effects on xylene-induced auricle tumefaction and impaired abdominal capillary permeability in mice.(2)Putting mogroside powder into the pure water,and put the sweet agent to join them,and absorption of the solution with other drugs and accessories.In order to make better particles,which tablet made of good taste,as well as quality inspects requirement.(3)The standard establish for quality control of SGQY tablet,which includes: character,identification,quality inspection,content determination.(4)The preliminary stability study: Packaging methods to be listed,put 3 batches of samples under constant temperature and humidity incubator scale which at of conditions 40?,RH75%,and accelerate the test,sampling is detected during the first 0,1,2,3,6 months of the test.(5)The acute toxicity test of i.g SGQY tablet to the mice,the maximum dose is used in the pre experiment,If there is no animal death,then maximum dose will used to carry out a formal experiment.The experimental results using SPSS20.0 statistical software,t test was used in each group,as *P < 0.05 for a statistical significance.Results:(1)During the formulation optimization experiment of SGQY tablet,The primary and secondary order of the effect of three kinds of main drugs on the anti-inflammatory effect is: mangiferin> mogroside > menthol;in the preliminary study,the orthogonal test method was used to optimize the prescription,the results(accounting for heavy pieces of plain tablets): mangiferin10.40%,mogroside 9.40%,and menthol0.30%,This experiment adopted CCD-RSM optimization test formulation optimization results: mangiferin is 13.00%,mogroside is 9.75% and menthol is 0.30%.(2)Optimization of preparation process of SGQY tablet,put sweetener and mogroside dissolved into the pure water,at the same time as the binder,increase the ratio of powder to particles,so better mobility.The tablet has good taste and quality inspects the requirements.(3)This experiment establishes the quality standard of SGQY tablet,the method is simple and convenient.method investigates the precision,repeatability,stability,sample recovery,linear relationship.The experimental results are accurate and stable.(4)Preliminary stability study,the results of the experiments are stable during the first 0,1,2,3,6 months of sampling detection,the preliminary judgment of SGQY tablet is stable.(5)The acute toxicity test of i.g SGQY tablet to the mice,the experimental results show that the maximum dose,there is no significant difference between the group and the control group(*P >0.05),it shows that the security is high.Conclusions: This experiment uses CCD-RSM optimizes prescription,in the preliminary study,the orthogonal test is used to optimize the prescription,the results are similar,the two prescription optimization research,although the method used is different,but gets the similar results,and the results confirm each other.In this experiment,we optimizes the preparation process,improve the taste and quality of the tablets,and quality inspects the requirements,therefore preparation process of optimized SGQY tablet is feasible.Set up the quality standard of SGQY tablet,the experimental results are accurate and stable.Study on the initial stability of double g SGQY tablet,accelerated test results over a period of 6 months are more stable,so the shelf life is tentatively scheduled for 18 months.The acute toxicity test of i.g SGQY tablet to the mice,the high security of SGQY tablet,is safe for clinical application.