Preparation and Quality Control of FOLIUM CRATAEGI Granules

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[Objective]To study the preparation technology of FOLIUM CRATAEGI granules and to establish methods for its quality control.[Method]FOLIUM CRATAEGI was extracted by 50% ethanol.With granules’ angle of repose and hygroscopicity as the indices,the optimal auxiliary materials of prescription were selected.Total flavonoids and hyperin were detected by TLC.UV spectrophotometry was used to determine the content of total flavonoids.[Result]The optimal auxiliary material of prescription was 250 g extract powder,125 g powdered sugar and 125 g dextrin.Under this condition,the angle of repose and the hygroscopicity were both the minimum,which were 33° and 0.65%,respectively.Total flavonoids and hyperin were well isolated from the samples,the TLC spots were clear.The standard curve of total flavonoids was Y =25.455X +0.004 7 with R = 0.999 9.Linear range was between 0.016 and 0.024 mg /ml,the average recovery rate was 100.57%(RSD =0.13%).Moisture content,granularity and dissolvability of granules all met the requirements in Chinese Pharmacopeia.The average content of total flavonoids was 0.412 g /g(RSD = 0.38%).[Conclusion]The preparation process of FOLIUM CRATAEGI granules was simple,feasible and reasonable,and the quality was stable and controllable. [Method] To study the preparation technology of FOLIUM CRATAEGI granules and to establish methods for its quality control. [Method] FOLIUM CRATAEGI was extracted by 50% ethanol. With granules’ angle of repose and hygroscopicity as the indices, the optimal auxiliary materials of prescription were selected.Total flavonoids and hyperin were detected by TLC.UV spectrophotometry was used to determine the content of total flavonoids. [Result] The optimal auxiliary material of prescription was 250 g extract powder, 125 g powdered sugar and 125 g dextrin.Under this condition, the angle of repose and the hygroscopicity were both the minimum, which were 33 ° and 0.65%, respectively.Total flavonoids and hyperin were well isolated from the samples, the TLC spots were clear. The standard curve of total flavonoids was Y = 25.455X +0.004 7 with R = 0.999 9.Linear range was between 0.016 and 0.024 mg / ml, the average recovery rate was 100.57% (RSD = 0.13%). Moisture content, granularity and dissolvability of granules all met the requirements in Chinese Pharmacopeia.The average content of total flavonoids was 0.412 g / g (RSD = 0.38%). [Conclusion] The preparation process of FOLIUM CRATAEGI granules was simple, feasible and reasonable, and the quality was stable and controllable .
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