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

Objective:Weiyankang granule is based on clinical practice and summarize the clinical experience.It composed of Chinese Codonopsis pilosula, Atractylodes, Radix Aucklandiae and other traditional Chinese medicine, the clinic function mainly for the treatment of Chronic superficial gastritis.In this study we studied the preparation technics and quality standard of the compound preparation 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 the response surface experiment optimizing extraction process,selecting optimum route.Then through contrast test to select materials and material proportion.In the studies on its quality standard,the thin layer chromatography (TLC) method was established to identify pericarpium citri reticulatae, corydalis tuber, Mangnolia officinalis, Rhizoma Atractylodis Macrocephalae and Costustoot. The high performance liquid chromate graphy(HPLC) method was established to determine the content of hesperidin in pericarpium citri reticulatae and the content of honokiol and magnolol in Mangnolia officinalis. In the study of stability, according to the "Chinese Pharmacopoeia" 2010 edition and"Anhui Province medical establishment preparation research technical guidelines",we studied accelerated testing and long-term trials with three pilot products, taking TLC, moisture, microbial limit, content determination and so on as the evaluation indexes.Results:The results of the preparation technics:solvent ratio of 14:1 (mL/g), decoction time,110 min, decocting number 3 times, decompression drying to obtain dry extract powder, adding 80% dextrin, spray drying, granulating.The studies on its quality standard indicated that the TLC for identifying pericarpium citri reticulatae, corydalis tuber, Mangnolia officinalis, Rhizoma Atractylodis Macrocephalae and Costustoot is simple and practicable,and negative control sample has no interference in TLC.When the concentration of hesperidin was within the range of 24.88μg/mL-398μg/mL,it had good linear relationship with its peak area (r=0.9991).The recovery of hesperidin was 98.02%,RSD=1.47%(n=6).When the concentration of honokiol was within the range of 5.025μg/mL-100.5μg/mL,it had good linear relationship with its peak area (r=0.9998).The recovery of honokio was 98.41%, RSD=1.61%(n=6). When the concentration of magnolol was within the range of 2.625μg/mL-52.5μg/mL, it had good linear relationship with its peak area (r=0.9995).The recovery of magnolol was 96.92%, RSD=0.99%(n=6). In the study of stability, we predict 24 months as the preparation of validity, taking TLC, moisture, microbial limit, content determination and so on as the evaluation indexes.Conclusion:The preparation technics Weiyankang granule are reasonable. the methods of is high sensitivity and repeatability. The quality standard of the preparation is stable and controllable.