Study On Prepration Process And Quality Standards Of The Jinchai Shihu Buccal Tablet

Jinchai Shihu Buccal Tablet is a Chinese health products that prepared by the extractsfrom four Chinese herbals, such as Dendrobium nobile, ginseng, Ganoderma lucidum,Momordica grosvenorii. Using the modern pharmaceutical technology, the prescription wasmade into buccal tablet with the guidance of the theories of Traditional Chinese Medicine. Ithas the function of enhancing immunity, and mainly is applicable to the sub-health status.This paper systematically studied for its preparation and quality standards.In this experiment, on the basis of the properties of the effective component of theherbals as well as the function and treatment of the preparation, combining the orthogonalexperiment and single-factor test, the extracting process of the effective component could bedivided into two parts, one part was extracted with ethanol, and the other part was extractedwith water. Taking with the content of total sapoins and total polysaccharides and the yield ofdry extract as indicators, the extracting process for Jinchai Shihu Buccal Tablet wasseparately studied by orthogonal test.Dendrobium nobile, ginseng, Ganoderma lucidum and Momordica grosvenorii weremixed in a predetermined ratio and thoroughly soaking to the heart by85%ethanol. Added12times of85%ethanol and refluxing for2hours, filtered and collected the filtrate. Theextraction process repeated2times, then combined the filtrate, recovering alcohol by vacuumdistillation to afford a residue, concentrated to a relative density of1.10(-0.08MPa~-0.09MPa,60℃). The resulted residue was boiling2times with10times of water, each time1hour, concentrated to a relative density of1.10(-0.08MPa~-0.09MPa,60℃). Then thecream of two parts was coinbined, vacuum drying, grinding, through80mesh screen.Selected the appropriate excipients and screened their ratios, used moist granulation process,coating, then the buccal tablet were gotten. The optimal buccal tablet formulation was asfollows: the extract powder of35.0%, dextrin of38.5%, xylitol of20.0%, citric acid of5.0%,aspartame of0.5%, magnesium stearate of1.0%. Meanwhile, the qualitative identification andquantitative analysis of the buccal tablet were studied. The conditions of prescription herbalsby TLC and content determination method of total sapoins and total polysaccharides, whichare effective ingredient of prescription were determined. Then according to the “ChinaPharmacopoeia”2010Edition, the relevant contents of buccal tablet were examined, and thepreliminary quality standards were established for the buccal tablet.The results indicate that the tablet preparation process is reasonable and feasible, thequality standard of the tablet was controllable, and the quality of the sample was stable on the whole as well.