The Parmaceutical And Pharmacokinetics Research Of Pingxiao Granula

Pingxiao granula,as a novel formula based on the experienced prescription according to TCM principle and clinical trials,consists of ephedrae herba,paeoniae radix alba,pheretima and other eight herbs.As validated in the clinical experiments,the formula has the effects such as"activating YANG and purging lung","dispelling wind and eliminating phlegm","stopping spasm and relieving asthma".Hence it is used to treat or cure asthma,chest stuffiness,expectoration,throat resound and so on.Based on the clinical demand and the properties of herbs in the prescription,the daily dosage form was determined as granunla.Preparation:On the basis of the function and treatment as well as of the main component of the heths,the contents of ephedrine,paeonia,and extract yield were used as indeies in the orthogonal designs of this experiment connected with grading method,in order to get the corresponding optimal processes of water extraetion,aleohol precipitation.The optimum technology was as follows:added 8 times water,decocting for 3 times,1.5 h for each time,the concentration ratio of decoction reaching 1:2(ml:g)and then precipitated by alcohol at the concentration of 80%,the alcohol deposited for 8 hour,filtered,and recycled ethanol from the filtrate.Then The best molding process was preferred by multiple guidelines grading method,using taste,hygroscopic,water-soluble,appearance and operability as indicators.Determined by the best molding process was recover the ethanol in filtrate under reduced pressure and concentrate to a thick extract with a relative density of 1.30(70?),weighed it,then divided into two parts,one of which was added an equal amount of dextrin,plus the sucrose powder to total solids,mixing,granulation,drying,whole,packing.Others was vacuum-dried,crushed(80?100 mesh),adding 2%of aspartame,plus dextrin to total,mixing,granulated with a 40%to 50%ethanol as wetting agent,dried,whole,repackage.Meanwhile middle test enlargement and were finished.Quality specification:The ephedra,paeoniae,pheretima,citrus,glycyrrhiza were identified by TLC.The active ingredient content of ephedra and paeoniae were determinated by HPLC.The content limitation was defined.There are sugar type Pingxiao granula and sugar-free Pingxiao granula containing ephedrine hydrochloride in ephedra,shall be not less than 1.62 mg and 3.27mg per bag,respectively;containing paeoniflorin in paeoniae terms,shall not be less than 4.02 mg and 8.74mg.Then it was examined under the relevant contents of granule in the "China Pharmacopoeia" 2010 edition,and the preliminary quality standards were established for Pingxiao granula.Stability:Examine the long-term stability of samples by observation method at room temperature.Test results show that the three of batches samples's traits,identification,examination and determination all meet the requirements.Pharmacokinetics:The experiment compared the pharmacokinetics of ephedrine hydrochloride,paeoniflorin and albiflorin in rat after oral administration of Pingxiao granules and principal drug extract,illustrated that other flavored herbs in the prescription of herbs have a certain impact on ephedra and paeoniae.The prescription is reasonable.Conclusion:The preparation technology is reasonable and feasible,quality standards is controllable,the quality of the sample is stable,the prescription is reasonable.