The Quality Standard And Fingerprint Of Chinese Compound Zhenyuan Granules

The prescription of Zhenyuan granules was derived from AnRen Chinesemedicine hospital of Tianjin, which was applied to the clinic for more than20years.Our lab have transformed from a traditional decotion into a new kind of granulesusing modern technology, such as microwave drying and dry-rolling granulation.Thetarget of this study was to establish a quality standard draft and the Chinesefingerprint of Zhenyuan graunles using TLC and HPLC in order to improve thequality and guarantee the efficacy. The main work lays the foundation of Zhenyuangranules’research and development, which was stated as follows:1, The Angelica sinenisi, Artemisia annua L., Saposhnikovia divaricata(Trucz.)Schischk., Glycyrrhiza uralensis Fisch. were identified and the content ofaconitine were limited by TLC, which was a simple and sensitive way. We carried outthe methodological inspection and the results of TLC showed that the spots were clear,specific and could be well separated without interference. The established qualitativeand quantitative methods can be effectively used for the quality control of Zhenyuangranules.2, We analyzed the content of the active ingredient glycyrrhizic and carried outthe methodological evaluation using HPLC with Agilent SB C18(4.6×250mm,5μm)chromatographic column. The mobile phase was0.5%phosphoric acid aqueoussolution (40:60) with flow rate at0.8mL/min and the detective wavelength was250nm; The column temperature was kept at30℃and the injection volume was10μL.As a result, the content of glycyrrhizic acid has a good linearity within the range of4.406~234.1μg/mL (r=0.9994) and the optimal sample concentration is0.02g/mL.The RSD of precision, repeatability and stability test was0.86%,1.01%and1.89%respectively. The sample was stable within24hours. The average recovery rate was100.3%and RSD was2.16%(n=9). This established method with high specificity issimple, accurate, reliable and reproducible.3, The fingerprint of Zhenyuan granules was established using HPLC-DAD withAgilent SB C18(4.6×250mm，5μm) chromatographic column. The mobile phase was1%formic acid acetonitrile(A)-0.1%formic acid aqueous solution(B)and the gradientelution mode was applied in chromatographic separation:0-5min,5%A-5%A; 5-60min,5%A-15%A;60-80min,15%A-18%A;80-90min,18%A-22%A;90-140min,22%A-35%A;140-160min,35%A-37%A;160-170min,37%A-50%A;170-175min,50%A-5%A;175-180min,5%A-5%A; The flow rate was1.0mL/min, the detectivewavelength was set at254nm and the column temperature was30℃.26commonpeaks were identified in the fingerprint of10batches of Zhenyuan graunles. The RSDof precision, stability and repeatability test was less than3%. The similarity of10batches of Zhenyuan granules was more than0.99, which represents the uniform andstable of Zhenyuan granules. The method is found to be simple and accurate forcontrol and assessment of the products quality.