Study On Preparation Process And Quality Standard Of Sheganmahuang Granules

Sheganmahuangtang from the eastern han zhang zhongjing’s theory of typhoid miscellaneous diseases,from rhizoma belamcandae and ephedra,ginger,asarum,phlegm,coltsfoot flower,big jujube,pinellia,fructus schisandrae nine taste of traditional Chinese medicine,has the effect of releasing lungs melt,cold drink cough,sputum for ease,reversed flow of qi to cough and gasp the certificate,the original party and add and subtract party has widely used in modern clinical,and records in many version of pharmacology teaching.This topic in Chinese medicine theory as the instruction,check a large number of literature,and connecting with the practical application of drugs,as well as the technical requirements of new drug of TCM,the party developed into granules,the preparation process,quality standard,stability,etc,were studied.Preparation technology research:according to the square of the various kinds of physical and chemical properties,pharmacological action and clinical application,the original decoction method comparing with the results of modern refluxing extraction to extract,formulate reasonable technology route.Through the single factor test,the water absorption of medicinal materials was investigated,and the optimal soaking time was determined.Through the orthogonal test of L9(34),the water content,the number of extraction times and the extraction time were investigated,and the optimum extraction conditions were determined.Through concentrated drying test,the relative density and concentrated drying method,temperature and pressure were investigated,and the appropriate concentration drying conditions and degree were determined.Study on molding process,discuss and inspect different correctives,and optimize the appropriate auxiliary materials and dosage.The type of this preparation,on the package of the independent bag,direct or water use.The test of forming process was carried out to verify the experiment,and the whole process was smooth,scientific,reasonable and stable.Quality standards research:to ensure the quality of granules stable and controllable,this topic by using modern methods and precision instruments correlation dry ephedra soup granules quality standards are studied,using thin layer chromatography(TLC)for the preparation of rhizoma belamcandae and ephedra,coltsfoot flower,fruit of Chinese magnoliavine four taste traditional Chinese medicine(TCM)to establish the TLC identification;By high performance liquid chromatography(HPLC)each other in the gentleman medicine mahuang ephedrine hydrochloride and pseudoephedrine hydrochloride for determination of total content,investigates methodology established shoot dry ephedra soup granules quality control system.Preliminary stability study:according to the technical requirement in the drug registration management measures ",the granules agent has carried on the preliminary stability test for a period of 6 months,respectively,at 0,1 month,2 months,3 months,6 months on a regular basis in accordance with the "Chinese pharmacopoeia" 2015 version of four granules agent under the general principles of the(0104)inspection items for inspection,the results show that the inspection indexes had no statistical difference,comply with the provisions.