Studie On Preparation Technics, Quality Control Stardards And Stability Of Qingfeiliqi Granule

Objective: Qingfeiliqi granule is based on clinical practice and summarize the clinical experience.It composed of Scutellaria Baicalensis, Gardenia, Tangerine and other traditional Chinese medicine, the clinic function mainly for the treatment of Chronic Bronchitis.In this study we studied the preparation technics and quality standard of the Qingfeiliqi granule and Stability study, so as to establish the foundation for the future widespread clinical application.Methods: In the studies on its preparation technics,first, through orthogonal test optimizing extraction process,selecting optimum route.Then select materials and material proportion.In the studies on its quality standard,the thin layer chromatography(TLC) method was established to identify ten kinds of herbs. Using HPLC method determination of baicalin and geniposide.In the study of stability, we studied accelerated testing and long-term trials, taking TLC, moisture, microbial limit, content determination and so on as the evaluation indexes.Results: The results of the preparation technics:solvent ratio of 10:1(ml/g), decoction time, 90 min, decocting number 3 times, decompression drying to obtain dry extract powder, adding 60% dextrin, granulating.The studies on its quality standard indicated that identifying Baicalensis, Gardenia, Tangerine, Platycodon grandiflorum and Cortex Mori by TLC. When the concentration of baicalin was within the range of 31.50?g/ml–504?g/ml,it had good linear relationship with its peak area.The recovery of baicalin was 97.63%,RSD=1.76%(n=6).When the concentration of geniposide was within the range of 24.88?g/ml–398.00?g/ml,it had good linear relationship with its peak area.The recovery of geniposide was 100.08%,RSD=0.63%(n=6). In the study of stability,we predict the validity,as taking TLC, moisture, microbial limit, content determination and so on as the evaluation indexes.Conclusion:The preparation technics Qingfeiliqi granule are reasonable. the methods of is high sensitivity and repeatability. The quality standard of the preparation is stable and controllable.