复方楂金颗粒中试生产及质量评价研究

Study on Pilot Production and Quality Evaluation of Compound Zhajin Granules

关键词:  复方楂金颗粒  中试生产  质量评价

Key words:  Compound Zhajin granules  pilot production  quality evaluation

摘要:

目的 确立复方楂金颗粒中试生产工艺，并进行质量综合评价。方法 以中试规模要求，药材投料量为复方楂金颗粒处方量的10倍，在小试工艺基础上，制备3批复方楂金中试颗粒，对中试工艺的技术参数进行考察，以浸膏得率、流动性、成型率、溶化率、堆密度、吸湿性、含量测定为考察指标；按照颗粒剂相关检查项目对3批中试产品进行粒度、水分、溶化性、装量差异检查，对其制备工艺进行综合评价。结果 复方楂金颗粒中试产品3批，药材投料量60 kg，浸膏得率分别为12.25%，11.31%，9.61%，绿原酸含量分别为0.016 5%，0.017 4%，0.017 1%；采用湿法制粒，浸膏粉∶乳糖∶可溶性淀粉=56∶7∶17(以不含水计算)，混匀，以85%乙醇为润湿剂制软材，乙醇的用量为处方总量的60%~75%，成型率分别为88.25%，89.87%，88.31%，休止角、溶化率、堆密度符合颗粒剂制备要求，平衡吸湿时间分别为140.3，136.5，130.1 h；颗粒剂相关检查均符合规定。结论 复方楂金颗粒中试工艺可靠，连续生产的稳定性好，工艺条件合理可行，符合大生产要求。

Abstract:

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.