芊玖舒胶囊制剂成型颗粒质量对比研究

Qian Jiushu capsules forming comparative study of particle mass

目的：通过对制剂成型颗粒及干膏粉吸湿性和流动性进行对比研究,探索一个制粒成型工艺的质量评价方法,用于芊玖舒胶囊制剂工艺合理性评价.方法：以水提干膏粉及湿法制粒颗粒为研究对象,采用化学试剂配比方法构建梯度湿度环境（30％ ～ 92％）,绘制吸湿曲线,比较吸湿稳定性;以采用供试品休止角测定法,比较其流动性的改善程度;以胶囊的装量差异及含量均一性验证工艺合理性.结果：芊玖舒胶囊制粒后吸湿稳定性及灌装流动性得到明显改善：吸湿率由干膏粉的39％下降为制剂颗粒9％（RH60％,70h）;休止角由干膏粉的42.28＆#176;下降至制剂颗粒休止角为35.95＆#176;.结论：表明本品制备工艺路线设计合理,工艺稳定,质量可控.

Objective： According to compare the hygroscopic of dry paste powder and liquidity about preparation forming particles of QianJiushu capsules, and to explore the granulating molding process of quality evaluation method. Used the method for QianJiushu capsules rationality evaluation. Methods： The granule as a research object, which make by water extract dry extract powder and wet granulation. Based on chemical reagent ratio method to building gradient humidity environment （RH： 30% 92% ） , drew moisture absorption curve, compared of hygroscopic stability, using the angle of repose method to compare liquidity degree of improvement. Used the weight deviation and spray content uni- formity of capsule for validation process were reasonable. Results： The moisture stability and filling liquidity of QianJiushu capsules has been significantly improved： for dry extract powder and particles, moisture rate from 39% down to 9% （60% relative humidity, 70 hours） and the angle of repose from 42.28~ down to 35.95~. Conclusion： QianJiushu capsules produced by above method, which design of process was reasonable, stable and controllable.