Preparation And Quality Standards Of The Winter Yellow Granules

Donghuang granules prescription comes from clinical experience recipe, which consist of Exocarpium Benincasae, Ophiopogon japonicus and Coptis.It has hypoglycemic effect ,so can be used to treat diabetes. With the guidance of the theories of traditional Chinese medicine, Donghuang granules was studied with modern pharmaceutical technology. On the basis of differernces of effective parts as welt as different characters of them,traditional decoction was transformed into granules by the optimum extracting and processing technologies. This research studied on the preparing technology of Donghuang granules. Orthogonal design is applied to research the best extracting conditions of polysaccharide in Ophiopogon Japonicus, polysaccharide in Exocarpium Benincasae and alkaloid in Coptis. The optimum processing technology was selected by orthogonal design which used several assessing norms to research factors of excipients,etc. Meanwhile middle test enlargement and quality standard of Donghuang granules were performed.The content determination of Berberine has been carried out by reversed-phase HPLC (with C₁₈ chemical bonded silica gel as a solid phase, acetonitrile-0.05 mol/L KH₂PO₄ (28:72) as a mobile phase ,UV detection wavelength at 429nm and column temperature at 35℃).Morever, Coptis was identified by TLC. Then the preliminary stability was fulfilled on the basis of controllable quality standard, the result showed that the product was steady in the observation period of 6 months. This research indicated that the technology of preparation was reasonable and practical, the standard of quality was controllable and the quality of the sample was steady as well. The results of this study could establish stable foundation for developing new traditional Chinese medicine for curing diabetes.