The Study On Processing Technology And Quality Standards Of New Hypoglycemic Granules

Purpose: To determine the preparation process of new hypoglycemic granules,study the quality standard of the new Jiangtang granule,and lay the foundation for the study of the quality control of the new hypoglycemic granuleMethods: Based on the guidance of traditional Chinese medicine theory,we use the orthogonal test to investigate the extraction process,take the dry extract yielding rate and the content of catalpol as the evaluation indexes by Rehmannia and Scrophulariaceae,evaluate the selected factors,and design the extraction method of the compound medicine.Through the combination of the reference literature and experimental results,we make a general appraisal of the selection and proportion of auxiliary materials,to determine the molding process parameters and establish the preparation method of the new drug hypoglycemic granules.We use the high performance liquid chromatography(HPLC)to measure the content of the major material,catalpol;We use the thin-layer chromatography(TLC)to do qualitative discrimination for the materials in the prescription,namely,Rehmannia,Codonopsis and Anemarrhena;Through the preliminary investigation of the stability,we determine the effective shelf life of the new hypoglycemic granules.Results: The extraction process of the compound medicine goes as follows: Add 8 times of water and immerse it in 1L container for 2 hours.Do reflux extraction by heating for 3 times,and the interval for each extraction is 1 hours.Combine the liquids,filter it,and condense it by reduced pressure.Prepare the dry extract by the 65 ℃ reduced pressure method,crush it,and screen it through the 60-mesh sieve.Mix the materials together.The mixing ratio is: dry extract powder: dextrin: soluble starch = 1: 0.6: 0.4.Use water as the wetting agent,and make the granules through drying under reduced pressure.Thus,we have established the preparation method of the new drug hypoglycemic granules.Thin-layer chromatography(TLC)can detect the characteristic spots of Radix Rehmanniae,Codonopsis and Anemarrhena in the compound;the content of catalpol in the new drug hypoglycemic granules measured through the high performance liquid chromatography(HPLC)can not be less than 1.50 mg / g.Thus,preliminary study on the quality control of new Jiangtang granule.From the preliminary stability test results,we can know: each indicator of the new drug hypoglycemic granules can meet the requirements after being placed at room temperature within six monthsConclusions: We have established the preparation technology of the new drug hypoglycemic granules,and set the quality standard of the new hypoglycemic granules.The experiment has proved that the method is simple and feasible,and can effectively control the quality of the new hypoglycemic granules.