Quality Control And HPLC Fingerprint Romatography Research Of Glycoprival Huayu Granules

Objective：To explore Glycoprival Huayu Granule, and estimate the quality by qualitativeidentification and content determination; to establish the method of fingerprintchromatogram analysis of Glycoprival Huayu Granule by HPLC.Methods：1. Through studying Orthogonal test for the comprehensive evaluation of theamount of dry extract and caffeic acid as an indicator is used to filter extraction technology;and granules forming, hygroscopicity, melting as an indicator to determine the kind andamount of auxiliary material.2. Through using TLC to identify each single herbs from thepreparations and using HPLC to measure and calculate the content of ginsenosides Rg1,ginsenosides Re and astilbin of the preparations.3. Mobile phase acetonitrile-0.1%phosphoric acid solution gradient elution, the detection wavelength203nm, columntemperature25℃, flow rate1.0mL·min-1.It was analyzed with the Estimating System ofSimilarity of2004A,B Version(the National Pharmacopoeia Committee) on the ChineseMedicine Fingerprint Chromatogram.Results：1. Determining the conditions of boiling decoction with three times plus10timesthe amount of water, respectively, for2.0h,1.5h,1.5h; dextrin dosage for10%andaspartame for0.3%of the amount of dry extract. Parameters of dry granulator equipment:feeding frequency converter rate is22.0; the speedof tabletting inverter is20.5; granulatingfrequency converter rate is21.0.2.Established the method of TLC qualitative identificationof ginseng, radix rhapontici, rhizoma smilacis glabrae, hirudo, radix bupleuri, angelicasinensis, and cattail pollenand radix achyranthis bidentatae.3. Linear relationship ofGinsenoside Rg1in the range of0.326~5.23μg/mL(r=0.9999) was good, averagerecovery was99.38%(RSD0.98%, n=6); linear relationship of Ginsenoside Re in therange of0.118~1.904μg/mL (r=0．9998)was good, average recovery was99.08%(RSD 1.66%, n=6);linear relationship of astilbin in the range of3.2~51.2μg/mL (r=0．9992)wasgood, average recovery was97.23%(RSD2.41%, n=6).The content of ginsenosides Rg1respectively was0.2384、0.2301、0.2485mg/g, the content of ginsenosides Re respectivelywas0.1090,0.1201,0.1147mg/g,and the content of astilbin respectively was0.7371,0.7497,0.7542mg/g in three batches of samples.4. The fingerprint of GlycoprivalHuayu Granules was established by HPLC and21common peaks were found and theresource were determined.10of the common peaks’ composition were confirmed byreference substance contrast method. The similarities of12batches samples were over0.93.Conclusion：The preparation technology is feasible, its quality control method is scientificand reasonable; the established HPLC fingerprint analysis method is simple and accurate,and can be used as a quality evaluation method of Glycoprival Huayu Granule.