Study On Prearation Technology, Quality Control And Preliminary Pharmacodynamic Of Yang He Pingchuan Granules

Objective： YangHePingChuan Granules is a praeparatum of the First AffiliatedHospital, Anhui universtiy of Chinese Medicine, mostly apply to cure BronchinalAsthma disease. However, its pharmaceutical research is relatively weak,this topic aimto optimize process by combing Modern Extraction and separation technology; set upreliability and exact method of Quality control, in order to provide experimentalevidence for the optimized preparation process understand pharmacodynamic effectcharacteristics. It will also establish a basic step to be a new drug of Chinese traditionalMedicine.Methods:1.The arranging presacriptions are extracted by ethylahohol ruflux. Select fourfactors and three levels orthogonal experiment method, taking the contents ofHydrochloride and Schisandrin and sinapine thiocyanate and the yield of extraction asthe evaluating indexes，to inspect concentration of alcohol，alcohol volume，extractiontime and times，and taking the multiple guidelines grading method to optimizealcohol extraction technology,and validate the stability of extract method.2.Category and ratio of accessories were investigated by taking moistureabsorption percentage as index；Optimum molding technology were screened bymolding rate of granule as indexes. and investigated angle of repose， moistureabsorption percentage and critical relative humidity of granule.3.On the study of the quality standard, Ephedrae herba，Morindae officinalisradix，Rehmanniae radix praeparata，Angelicae sinensis radix，Schisandraechinensis fructus， Inulae flos，Sinapis semen and Descurainiae semen wereidentified by thin layer chromatography. The contents of Ephedrine Hydrochloride andSchisandrin and Sinapine Thicoyanate were determined by UPLC method.Control thequality by combing method of nature and quantity identify. 4. Pharmacodynamics Experiments, build the model of rat asthma by Sensitizationand Allergen Challenge. Had done some experimental study on the pharmacodynamics,such as lung tissue, the concentration of NO and ET-1in serum and the expression ofiNOS in lung.Results:1.The best alcohol extraction technology was as follows：add80%concentrationalcohol and8times volume,extracting2times per1.5hour.Filtration and merge thefiltrate,the filtrate to concentrate without alcohol by decompression. Transferred to thevacuum drying oven,70℃dry vacunm drying to get loose,shattered extract powder.2.To selsct the Microcrystalline cellulose and β-Cyclodextrin as excipients asexcients, and the steviosin should be used in granule product，with95%alcohol tomake granule and to dry under60℃.3. Identify of Ephedrae herba, Morindae officinalis radix,Rehmanniae radixpraeparata and so on by TLC. The separation of the stains is apparent，and themethod was simple and accurate，and the negative contrast showed no disturbed.Average content of Ephedrine hydrochloride is0.762mg·g-1, Average content ofSchisandrin is0.403mg·g-1,Average content of Sinapine thicoyanate is2.181mg·g-1.And the method were sensitive，specificity and reproducible.4. Successfully reproduce the rat model of asthma and the treatment group canimprove the general condition of rats. Dose group can significantly alleviatepathological damage, reduce the content of NO and ET-1in serum, reduce the level ofiNOS in lung.Conclusion：The production process of YangHePingChuan Granules is reasonable andpracticable；the quality control method is accuracy,and feasible，strong specificity, andcan effectively control the drug quality.The result of Pharmacodynamics show that thenew process can reduce the content of NO and ET-1in rat serum, reduce the express of iNOS, ameliorate the lung tissue infiltration of inflammatory cells, can do effect to lungprotect and treatment.