复方肺毒清颗粒的制备工艺及质量标准

Preparation and the Quality Standard of Compound Feiduqing Granules

目的建立复方肺毒清颗粒的制备方法和质量标准。方法按小试规模要求,处方量的30倍药材投料,制备复方肺毒清颗粒,对颗粒剂粒度、吸湿性、溶化率、堆密度、休止角进行相关检查,并对其制备工艺进行综合评价;采用薄层色谱法对处方中柴胡进行定性鉴别;采用高效液相色谱法对处方中柴胡皂苷a进行含量测定。结果复方肺毒清颗粒剂成型率96.31%,颗粒剂相关检查均符合规定;柴胡的薄层色谱中可检出特征斑点;柴胡皂苷a在0.06~0.98 mg·mL^(-1)线性关系良好。结论复方肺毒清颗粒制备工艺合理,可行,质量可控。

Objective To establish the preparation method and quality standard of compound Feiduqing granules.Methods According to the requirements of small-scale production,30 times the prescription amount of medicinal materials were used to prepare compound Feiduqing granules.The qualitative identification of bupleurum in the prescription was carried out by thin-layer chromatography,and the content of saikosaponin A in the prescription was determined by high performance liquid chromatography.Results The molding ratio of compound Feiduqing granules was 96.31%,and the relevant inspections of the granules are in compliance with the regulations.Characteristic spots could be detected in the thin layer chromatography of bupleurum.Saikosaponin A in 0.06—0.98 mg·mL^(-1) has a good linear relationship.Conclusion The extraction process of compound Feiduqing granules is reasonable and feasible,and the quality standard of this preparation has been formulated.