Study On Preparation Process And Quality Standards Of Shuanghuang Dispersible Tablets

Shuanghuang dispersible tablet is consisted of Rhizoma Coptidis and Scutellaria. The contents of Rhizoma Coptidis and Scutellaria are antibacterial, anti-virus and indomethacin. In order to adapting clinical demand, its form is designed to dispersible tablet which disintegrates very quickly and drug in it will dissolve faster, meanwhile, the preparation process and the quality control have been studied completely and systematically.The study has determined preparation route according to the effective constituents of two kinds of medicinal substances. By comparing the contents of berberine hydrochloride and total alkaloids, the optimum extraction process was investigated by orthogonal experimental design. The best extracting condition: 70% ethanol, ratio of ethanol to materials is 10, extract 3 times and 1.5 hour of each times. By comparing the contents of baicalin and total flavonoids, the optimum extraction process was investigated by orthogonal experimental design. The best extracting condition: 50% ethanol, ratio of ethanol to materials is 10, extract 3 times and 1.5 hour of each times.By comparing two kinds of methods, macroporous resins were used in purifing total alkaloids. According to the study of macroporous resins, the macroporous resin D101 possessed strong absorption ability and an disadsorption property. According to the orthogonal design, the optimum absorption condition: the weight ratio of solution to raw material 3:1, the ratio of diameter to length 1:7, the weight ratio of raw material to resins 1:1. The procedure of elution is water, 3BV 50% ethanol. The optimum purification process by the single factor test was follows: concentrating the scutellaria extract until the relative density down to 1.02～1.04 (50～60℃) , adjusting to pH 1 by hydrochloric acid, keeping the temperature at 80℃for 1 hour, standing for 24 hours, washing the precipitation by distilled water to pH 5.The contents of total alkaloids and total flavonoids are higher than 70%, the content of berberine hydrochloride is higher than 40%, and the content of baicalin is higher than 50%.The kinds and ratio and adding method of disintegrants and diluents were selected. So the best recipe is: coptidis rhizoma extract 54g, scutellaria extract 19.5g, MCC 88.2g, CMS-Na 29.4g, L-HPC 14.7g, magnesium stearate 1g, pressing to 1000 tablets.In the quality control study of the extracts and the tablets, TLC was used for identification of coptidis rhizoma and scutellaria. Method of HPLC was developed in determining the contents of berberine hydrochloride and baicalin. Method of UV was developed in determining the contents of total alkaloids and total flavonoids. It has good sensitivity, nice specialization and it is easy to carry out. And the tablets' dissolution and disintegration time were limited.As a result, Shuanghuang dispersible tablet can disintegrate within 1.5 minutes and the dissolution of berberine hydrochloride and baicalin is higher than 70% in duration of 15 minutes. Besides, the quality of the product is well controlled by studying the preparation technique, controlling the qualities of the extracts and the tablets.Research result shows, the preparation technique, dosage form and the quality standard guarantee the stabilization of Shuanghuang dispersible tablet.