The Study On Preparation Process And Quality Standard Of Gehuang Tablets

Objective:To study the Gehuang Tablets preparation process and quality standard.Method:(1)Using single factor test method combined with central composite design,Based on the content of puerarin,the content of total polysaccharide and the score of alpha glucosidase,Optimization of extraction process of Gehuang Tablets.(2)Study on the best molding technology of Gehuang tablets.(3)Establish the quality standard for Gehuang tablets: Using thin layer chromatography Identify the Gehuang tablets effective components of Trichosanthin,Huangjing,radix puerariae,Radix Scrophulariae,using high performance liquid chromatography method for determining the content of puerarin in preparationsand the methodology was investigated,UV spectrophotometry was used to determine the composition of total polysaccharide in the preparation.Result:(1)Single factors determine the time range for the 90~150 min entered the star test,determine multiples 8~12 times by adding water into the star test,determine the times for two,soak time is 30 min,to determine the best water extraction process is 10 times,the amount of water for continuous reflux extraction of 2 times,each time 120 min;(2)Comprehensive scoring method diluent type and amount determined for microcrystalline cellulose thinner types,is 25% the best.Disintegrating dosage and join filter determines to join is 2% of polyvinyl pyrrolidone K30,added ways for internal and external additions.Selection of wetting agent concentration of ethanol 75% ethanol as the best wetting agent concentration,determined according to the above test are within range of Star testing as thinner,microcrystalline cellulose,20%~30%,PvP K30 disintegrants polyethylene 1%~3%,wetting agent concentration for 70%~80%.The best molding process:70%ethanol as wetting agent,30% Microcrystalline cellulose as diluents,2%K30 as disintegrating agent;(3)For the herbs by thin-layer chromatography,finally using thin layer chromatography Identify the Gehuang tablets of Trichosanthin,Huangjing,radix puerariae,Radix Scrophulariae,using high performance liquid chromatography method for determining the content of puerarin in preparations,chromatographic conditions were as follows,carbinol:0.2% ortho-phosphoric acid(22:78),detection wavelength of UV detector is 250,Column temperature was 30 ℃,Flow rate was 1.0 mL/min,UV spectrophotometry was used to determine the content of total polysaccharide in the preparation,detection wavelength was 486 nm.Conclusion: Gehuang tablets production process reasonable and feasible,good accuracy and reproducibility of quality standards,it can effectively control the quality of the preparation.