| Jian Wei chewable tablet is a compound formula prescription,made up by gegen and sanqi, and has the function of supplementing Qi and stomach,clearing away the heat to alleviate a hangover,promoting fluid production to quench thirst.Thus it can be used in stomach-yin deficiency,dry mouth and throat,hunger without appetite,crimson tongue with little fluid, especially after alcohol and distraught and thirst due to drunkenness.Under the guidance of the theory of the Traditional Chinese Medicine,in combination with the action of this prescription and the physicochemical property of the drugs,systematic researches have been carried out for the preparatory techniques,quality standard and the initial stability. Indicated by the content of the kakkonein and the solid yield,single factor test and othogonal test were adopted to select the optimum technique,which was:gegen and shihu soaked in the water for 1 hour,then extracted with water for 3 times,0.5 hour for each time; the decoction integrated,filtrated and then concentrated to 1g/ml;ethanol added till the concentration of which reached 55%;the supernate separated after 16 hour settlement,the ethanol recycled and the leftovers concentrated to 1.25(60℃).Then the dense extract was vacuum dried and pulverized.Sanqi was mingled with the powdered extract after super-micronized and 24.7%manicol,0.3%gum acacia,3%Aspartame,1%citric acid was mixed in evenly.After granulation,sieving and tabletting came the end item.In the quality standard study,the identification of gegen and sanqi was established and also the assaying of kakkonein,the baseline of which was defined.In the stability study was done to the 3 batches of semi-works production for 3 months.And every indicator accorded with the defination.The results shows that the technique is scientific,reasonable,stable and feasible;the quality standard is controllable and the property of the tablet is stable. |
