The Study On Preparation And Quality Standards Of Mabaixuanfeihuatan Granules

Objective:to research the technology of preparation and establish the quality standards of the granules.Methods:(1)Use the single factor combined with orthogonal experiment design method,determine the contents of ephedrine hydrochloride and pseudoephedrine hydrochloride,the content of baicalin and the content of the total polysaccharides as the index,select the top radix Chinese ephedra,Scutellaria baicalensis et.medical materials to sure the water extraction technology parameter;(2)Use the single factor combined with orthogonal experiment design method,determine the contents of total flavonoid and the content of orange peel glucoside as the index,select the top radix Salisburia adiantifolia,Tangerine Peel et.medical materials to sure the aqueous alcohol extraction technology parameter;(3)Research the moulding technology of Mabaixuanfeihuatan granules;(4)Qualitative test with thin-layer chromatography was performed on Mabaixuanfeihuatan granules,with all species of medical materials,use the method of HPLC to measure the contents of ephedrine hydrochloride and pseudoephedrine hydrochloride,and the content of orange peel glucoside,to make out the quality standard.Results:(1)The optimum water extraction procedure was adding 10 times amount of water extracted three times,each time one hour;(2)The optimum ethanol extraction procedure was adding 10 times amount of 80%ethanol,extracted two times,each time one hour;(3)The granules' moulde technology was using 12%new fritillaria fine powder,8%dextrin as supplementary material,0.4%sweet chrysanthemum as taste masking agent and 85%?90%ethanol as bond to make granules;(4)Established the qualitative differentiation with the method of TLC of Chinese ephedra,Scutellaria baicalensis and Tangerine peel,the contents of ephedrine hydrochloride and pseudoephedrine hydrochloride,and the content of orange peel glucoside were detected by HPLC,respectively for the mobile phases:acetonitrile-0.4%H3PO4(3:97)and acctonitrile-0.1%H3PO4(19:81),detect wavelength:290nm and 323nm,column temperature:30?,flow rate:1.0mL/min.Conclusions:The extraction technology was stable,simple and feasible.The quality standards were reliable and accurate,and can effectively control the quality of the preparations.