Study On The Preparation Technology And Quality Standard Of Gexie Keli

Objective: Research and develop a new health food with the function of relieving alcohol(Gexie Keli),optimize the preparation process of Gexie Keli,and study its quality standards.Methods: 1.Study on the quality of Allium macrostemon: In this experiment,the best processing method of Allium macrostemon was found by means of microscope,thin layer chromatography,moisture,ash,extract,total saponin content determination and so on,referring to the 2015 Edition(Volume I)of Chinese Pharmacopoeia;The best processing technology was selected by orthogonal test with the content of total saponin and the content of extractive as the index.The best processing technology of Allium macrostemon was selected by TLC,moisture,ash,extractive and the content of total saponin.2.Study on preparation technology of prescription: On the basis of the comprehensive analysis of the effective components of each drug in the prescription,it is carried out in two parts: alcohol extraction and water extraction.The best alcohol extraction and water extraction technology were determined by orthogonal test with the extraction rate of crude drug as the index;Combined with the process and drug properties,the process parameters such as excipients,ethanol concentration and drying time were selected with the indexes such as the difficulty of granulating,the molding rate and the fluidity of particles,so as to determine the best molding process.3.Study on the quality standard of prescription: To ensure the quality of the preparation,this topic from the qualitative identification,particle related inspection the quality standard of the preparation was studied in two aspects,and the quality standard was initially established.Results: 1.Quality screening results of Allium macrostemon: In this experiment,the determination of micro,TLC,moisture,ash and extractive content of scallop raw products,fried products and steamed products are all in accordance with the provisions of Chinese Pharmacopoeia,2015 Edition(Part I);the content of total saponins was higher than0.5%.And the indexes of scallop fried products are superior to those of raw products andsteamed products.The best quality of Allium macrostemon is: selected from Allium macrostemon collected in Linyi,Shandong Province.Stir fry it in high heat for 4min and pour water twice(1ml for every 50 g of Allium macrostemon).2.Preparation process results: The best alcohol extraction process is: alcohol concentration 45%,material liquid ratio 1:12,extraction 3.5h,extraction 3 times;The best water extraction process is: ratio of material to liquid 1:20,extraction for 2 h,extraction for4 times;The best molding process: mix the raw material powder and dextrin according to1:0.8,add appropriate 60% ethanol as the wetting agent,dry at 70℃for 2 h,whole,sub packed.3.Establishment of quality standards: The content of total saponins in Allium macrostemon was determined by UV-spectrophotometry,which was not less than 0.5%.The TLC identification method of all kinds of drugs in Gexie granules was established.Conclusion: In this project,the best quality of Allium macrostemon was selected to form a formula,the preparation process and quality standard of Gexie Keli granules were studied,makes it stable and feasible,and provides a strong basis for ensuring the quality of health products.