Study On The Preparation And The Quality Standards Of XiangA-1 Granules

Objective Determined the preparation of XiangA-1 Granules and the quality standards was Established.Methods Using the content of baicalin and extracting ratio as evaluating indexes, we selected the optimum extracting condition by orthogonal design; Using the content of baicalin、absorbance and solids retaining ratio as evaluating indexes, we selected the optimum flocculating condition by single factor compared and orthogonal design; Using the content of baicalin as evaluating indexes, we selected the optimum condition of concentration and frying factor by confrontation; Using the content of volatile oil as evaluating indexes, we selected the optimum inclusion condition by orthogonal design; Using the content of granules as evaluating indexes, we selected the optimum preparative condition by confrontation. TLC Identification used for fritillaria thunbergii miq etc; HPLC used for baicalin, and methods of inspection. Results The optimum extracting condition:fructus amomi rotundus etc were soaked in 10 times water for 0.5h and extracted for 5h, fritillaria thunbergii miq etc were soaked in water for 0.5h, heating, adding baicalensis, heating to extract three times, adding water of 10,8,8 times and extracting for 1.5,1.0, 1.Oh; The optimum flocculating condition:the concentration of extract solution was 1:6, heating to 60℃, stirring in 350r/min, adding dosage of chitosan was 0.8mL/g, stirring for 15 minutes, standing 12 hours; Concentrating, filtering, drying at 70℃; The optimum inclusion condition:adding volatile oil in cyclodextrin of 8 times(grinded by water of 3 times), grinding for 2.0h, filtering, drying at 40℃; The optimum preparative condition:combining medicinal materials and requirements of the dosage form, making soft material, filtering by sieve, drying at 40℃. Established the identification of rhizoma polygoni cuspidati、A、B、C and fritillaria thunbergii miq; baicalin determination feasible, good repeatability, the average recovery was 98.93%, RSD was 2.44%.Conclusion The preparation was reasonable and practical, the quality standards was reliable, can be used for industrial production.