Studies On The Quality Control Standard Of Compound Aster Granule

Objective:To identify the quality of medicine in the prescription and select the excellent crude drugs;To study the quality standard of Compound granule aster and provide the scientific basis for controlling the quality of the preparation and researching the drug.Methods:(1)Refer to Chinese Pharmacopoeia,qualitative analysis Aster,coltsfoot flower,blackberry lily,rhizoma zingiberis and tenuifolia in the prescription.And determined the content of the index components of each herb by HPLC.Identified gallic acid that is the index components in mango nucler.Determined the content of gallic acid in Mango seed by HPLC.The separation was performed on a Welch C18(4.6mm×250mm,5μm)column;The gallic acid was determined at 290nm detection wavelength with acetontrile-0.05%phosphoric acid(4:96)as mobile phase;The column temperature was 25℃,and the velocity of flow was 1.0ml/min.And determined the gallic acid of mango seed in different part and origin.(2)TLC identification method was used to identify the aster,coltsfoot fiower,blackberry lily,rhizoma zingiberis,mango seed in the granule.(3)Established the HPLC method for the determination of aster ketone in the compound aster granule.The separation was performed on a Elite C18(4.6mm×200mm,5μm)column;The aster ketone was determined at 200nm detection wavelength with acetontrile-water(95:5)as mobile phase;The column temperature was 40℃ and the velocity of flow was 1.0ml/min.Established the HPLC method for the determination of gallic acid in the compound aster granule.The separation was performed on a Welch C18(4.6mm×250mm,5μm)column;The gallic acid was determined at 290nm detection wavelength with acetontrile-0.05%phosphoric acid(3:97)as mobile phase;The column temperature was 25℃ and the velocity of flow was 1.0ml/min.(4)With reference to the Chinese pharmacopoeia 2010 edition I appendix C granules rule,we researched the compound aster granule.Results:(1)Aster,coltsfoot fiower,blackberry lily,rhizoma zingiberis and tenuifolia in the compound aster granule are up to the mustard of the Chinese pharmacopoeia 2010 edition.(2)TIC map of mango seed is clear,the spots can be well separated,and the method is simple and convenient and has good repratability.It can be used to distinguish the gallic acid in mango seed.By high performance liquid chromatographic,determine gallic acid content in compound aster granule,gallic acid in 0.168～2.016μg(r=0.9999)range of peak area into a good sample weight linear relationship,and the average recovery was 101.47%,RSD%=1.80.(3)TIC map of Aster,coltsfoot flower,blackberry lily,rhizoma zingiberis and mango seed is clear,the spots can be well separated,the negative control is without interference and the method has a strong specificity.It is involves in quality standard draft of compound aster granule.(4)By high performance liquid chromatographic,determine aster ketone content in compound aster granule,aster ketone in 0.10～0.60μg(r=0.9995)range of peak area into a good sample weight linear relationship,and the average recovery is 100.92%,RSD%=3.27.The compound aster granule in preparations contain aster ketone amount of not less than 2.52mg/d.(5)By high performance liquid chromatographic,determine gallic acid content in compound aster granule,gallic acid in 0.336～2.016μg(r=0.9999)range of peak area into a good sample weight linear relationship,and the average recovery is 98.62%,RSD%=2.17.The compound aster granule in preparations contain gallic acid amount of not less than 38.66mg/d.(6)As the China pharmacopoeia 2010 version of a IC granules of appendix genral under grain size,moisture,dissolve sex,loaded quantity differences,heavy metals,arsenic salt and microbiological.And the results are in line with granules requirements.Conclusion:The study determinines the quality standarads of mango seed and the compound aster granule,and the methods are stable and have stong specificity,good repeatability and can effectively control the quality of the compound aster granule.