| Objective: Yiqi Qingre prescripion is composed by the four herbs include dandelion, honeysuckle, radix pseudostell and lucidum,to treat physically weak cold.Tablets have easy to take rapid disintegration, rapid absorption, bioavailability, etc.The preparation of tablets is the same to conventional tablets.The process is stable, and it is easy to carry and store.Through the formulation of reform, Yiqi Qingre prescripion is changed from the traditional decoction to dispersible tablets.Yiqi Qingre tablets pharmaceutical research, clinical prepare a convenient administration, rapid onset, and good results of traditional Chinese medicine, Chinese medicine tablet also enriched the variety and speed of traditional Chinese medicine and Chinese medicine tablet preparation craft and quality standards release formulation to provide new ideas and methods.Methods: The extraction rate of chlorogenic acid, caffeic acid extraction rate and the cream rate index, using a single factor test, design- response surface methodology Taguchi experimental design method for the extraction process were studied dandelion and honeysuckle.Transfer rate of chlorogenic acid, caffeic acid transfer rate and cleaning rate as an indicator, the single factor experiment together for dandelion and honeysuckle extract alcohol precipitation process were studied.Chlorogenic acid content, caffeic acid content and flour yield index, with a star design- response surface methodology combined dandelion and honeysuckle extract spray drying process was studied after alcohol precipitation.Crude polysaccharide extraction rate and the cream rate index, using a single factor test and design- response surface method Taizishen and extraction process Ganoderma research.Crude polysaccharide content and impurity rate index, the single factor experiment together for Taizishen and Ganoderma extract ethanol precipitation process were studied and compared the different drying methods.In disintegration, soft material and particle properties and the angle of repose as an index of heat Qi tablet formulation screening, and the use of design- response surface methodology to optimize prescription.Angle of repose, bulk density, and critical relative humidity index, tableting characteristics of Pharmacy to inspect the particles.Qualitative identification by Yiqi Qingre tablets, the content of chlorogenic acid and caffeic acid determination similarity evaluation to establish HPLC fingerprints in characteristic map, Appearance, weight difference, disintegration time, hardness, friability establishing draft quality standards, quality standards Yiqi Qingre tablets were studied.In Appearance, chlorogenic acid and caffeic acid content, disintegration time as index, through stress testing and long-term test,Yiqi Qingre tablets stability studies preliminary.Results: In the extraction process research to determine the extraction process dandelion and honeysuckle is not soaked, 18 times the amount of solvent, extraction of cooking water to cook 2 times 30 min; determining extraction process heterophylla and Ganoderma is soaked 30 min, the solvent 14 times the amount of water to cook cooking method 2 times, each time 120 min.Alcohol precipitation in the study to determine the alcohol precipitation process dandelion and honeysuckle, alcohol precipitation process heterophylla and fungus extracts are combined and concentrated to a relative density of 1.07, and ethanol was added slowly, stirring constantly, until the alcohol concentration reached 80 %, sealed standing 12 h.In the drying process research to determine the dandelion and honeysuckle extract together after the drying process was alcohol precipitation as spray drying, inlet air temperature of 140 ℃, feed rate of 30%, the air flow rate of 750 L · h-1; determining heterophylla and Ganoderma extract combined drying process after alcohol precipitation was vacuum dried at a temperature of 70 ℃, vacuum degree of 0.08 ~ 0.09 MPa.In the process of forming the study to determine the best tablet Qi heat molding process of the powder(content 50%), MCC(content 30%), CCMC-Na(content of 4%) and PVPP(content of 6 %) were well mixed, add the amount of 95% ethanol solution made of soft material, over 24 mesh sieve granulation, 60 ℃ dried, whole, adding CCMC-Na(content of 4%), PVPP(content of 6%) and stearic magnesium(content of 0.3%), mixing, tableting, tableting machine control pressure control in tablet hardness 30 ~ 40 N, each piece weighing about 0.5 g.Yiqi Qingre tablets qualitative identification dispersible tablet can detect heat dandelion and honeysuckle, heterophylla, Ganoderma lucidum. Each tablet contains 3.382% chlorogenic acid, caffeic acid 0.1372%. Fingerprint pattern, established a total of 16 peaks, of which peak on the 5th of chlorogenic acid, caffeic acid 6 peak, the similarity of 15 batches of Qi heat dispersible tablets were greater than 0.9. Qi heat dispersible tablet Appearance, weight variation, disintegration time, hardness, friability are in line with the requirements of tablet.In preliminary stability studies, temperature, humidity and light stability Yiqi Qingre tablets influential, storage and transportation process should be strictly controlled. At a temperature of 25 ℃, relative humidity of 60%,Yiqi Qingre tablets blister pack after heat within six months basically stable.Conclusion: Yiqi Qingre tablets analysis method is novel, specific, sensitive, accurate and reproducible preparation process of scientific, rational, stable, viable, quality standards and stable and controllable, better formulation stability.Key words: CCD-RSM;Taguchi method;dispersible tablets;preparation... |
