Study on Preparation ，Quality Standard and Fingerprint of Ganshen Granules / 中国药房

ABSTRACT

OBJECTIVE： To prepare Ganshen granules， formulate its quality standards primarily and establish its HPLC fingerprint. METHODS： Using feeding speed， roller speed， roller pressure and roller clearance as factor， grain forming rate as index， single factor test and orthogonal test were used to optimize the granulation technology of Ganshen granules. According to 2015 edition of Chinese Pharmacopeia （part Ⅳ） （shorted for pharmacopeia）， moisture， granulation and dissolution were determined. TLC was used for the qualitative identification of Lycium barbarum， Astragalus membranaceus， Codonopsis pilosula in the Ganshen granules. HPLC method was used to determine the contents of betaine， calycosin-7-glucoside and lobetyolin in Ganshen granules. Fingerprints of 10 batches of Ganshen granules were drawn. RESULTS： The optimal dry granulation technology of Ganshen granules included that 25 r/min feeding speed， 8 r/min roller speed， 7 MPa roller pressure and 1.1 mm roller clearance， The grain forming rate is 85.83％. The moisture， granulation and solubility of Ganshen granule were all in line with pharmacopeia standard. TLC of L. barbarum， A. membranaceus and C. pilosula showed the same color spots on the corresponding positions of the reference chromatogram. The linear range of sample mass of betaine is 4.32-8.64 μg， and the linear range of mass concentration of calycosin-7-glucoside and lobetyolin were 5-30 and 10-60 μg/mL， respectively. RSDs of precision， reproducibility and stability tests （24 h） were all lower than 2.0％ （n＝5）. Average recoveries were 97.02％， 99.25％ and 101.04％ （all RSD＜1.7％， n＝6 or n＝9）. The contents of them were 4.298、0.054、0.025 mg/g， respectively. The similarity of HPLC fingerprints of 10 batches of Ganshen granules to control fingerprint was higher than 0.95. CONCLUSIONS： The optimal granulation technology of Ganshen granule is stable and feasible， and established quality standard and HPLC fingerprint can provide reference for quality control of Ganshen granule.