祛瘀通经片制备工艺与稳定性研究

目的为了进一步提高药品质量和疗效,优化祛瘀通经片的制备工艺。方法以芍药苷、小檗碱含量为评价指标,考察风机频率、稠膏相对密度、雾化压力、喷雾速度、辅料量等制粒条件对颗粒效果的影响。结果优选工艺经三批中试生产放大验证一步制粒所生产的颗粒流动性好,压制的片剂崩解、溶出速度快,芍药苷、小檗碱含量合格。结论该制备工艺简单合理可行,重现性好,有利于提高祛瘀通经片的质量和稳定性,降低生产成本,提高药品临床疗效,为实际生产提供科学依据。

Research on processing techniques and stability of Blood Stasis Activating Tablets

Objective To further improve the quality and effect of Blood Stasis Activating Tablets,and optimize the preparation process of it.Methods The evaluation indicator were determined,those were the content of paeoniflorin and berberine,investigated the fan frequency,the relative density of thick paste,atomization pressure,spray rate and excipients and so on for granulation conditions,which influenced on the particle effect.Results The optimum process was proved through three batches of production.The granulation produced good fluidity particle,fast disintegration and dissolution of pressed tablet,paeoniflorin and berberine content were up to the standard.Conclusion The preparation process is simple,reasonable and feasible with good reproducibility,it is benefit for improving the quality and stability of blood stasis activating tablets,reducing production cost,improving the clinical efficacy of Blood Stasis Activating Tablets and provides a scientific basis for the practical production.