Study on Pilot Production and Quality Evaluation of Compound Zhajin Granules

OBJECTIVE To establish the pilot production process of Compound Zhajin granules(CZJG) and make the quality comprehensive evaluation. METHODS In pilot scale requirements, the inventory rating of medicinal materials was 10 times of the prescribed amount of CZJG. On the basis of small pilot process, prepared 3 batches of CZJG in the pilot product, assessed the key technical parameters of pilot process, with dry extract rate, mobility, forming rate, melting rate, bulk density, moisture absorption and chlorogenic acid content as index; according to inspection items of granules, particle size, moisture content, melt resistance and load difference examination were determined to give a comprehensive evaluation of the preparation. RESULTS Produced 3 batches of CZJG in the pilot production, the crude drug inventory rating was 60 kg, the extract yield was 12.25%, 11.31% and 9.61%, and chlorogenic acid content was 0.016 5%, 0.017 4% and 0.017 1%; using wet granulation, extract powder∶lactose∶soluble starch = 56∶7∶17 (calculated with no water), mixed with 85% ethanol as a wetting agent to make the soft material, the total amount of ethanol as a prescription of 60%-75%, the forming rates were 88.25%, 89.87% and 88.31%, angle of repose, melting rate and bulk density were in compliance with the requirements of granules, equilibrium moisture absorption time was 140.3, 136.5 and 130.1 h; granules relevant checks were conformed to the stipulation. CONCLUSION The pilot process is reliable, continuous production is stable, and process conditions are reasonable and feasible, meeting the requirements of large-scale production.