中药制剂复方薏蓝颗粒的生产工艺分析

Analysis of production technology of traditional Chinese medicine preparation Compound Yilan Particles

目的分析建立复方薏蓝颗粒制剂的生产工艺。方法通过对复方薏蓝颗粒制剂的处方分析,根据药物组成成分的不同性质,选择确定不同的精提工艺;同时通过对制剂的中试生产及中试成品的质量检查,以评价复方薏蓝颗粒的制剂质量。结果生产的复方薏蓝颗粒外观性状好,粒度及溶化性均符合《中国药典》2010年版颗粒剂项下的要求。结论复方薏蓝颗粒的生产工艺合理,制剂质量稳定。

Objective To analyze and establish the production technology of Compound Yilan Particle preparation. Methods Through the prescription analysis of compound Yilan Particle preparation, different extraction technologies were select- ed according to different nature of drug components. At the same time, through pilot production of the preparation and quality check of the pilot production, the quality of compound Yilan Particle preparation was evaluated. Results The shape and property of the produced Compound Yilan Particles were good and their particle sizes and dissolubility both accorded with the requiremetits under the granular preparation item of Chinese Pharmacopoeia 2010 edition. Conclusion Compound Yilan Particles has reasonable production technology and stable preparation quality.