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

作　　者：张聪子[1] 张金玲 杜光[2] 王维武 姜琼[1] 夏松柏[1] 陈辉[1] 甘露珍[1] 徐金军[1] 章登政 傅勃 饶志威[1] ZHANG Congzi;ZHANG Jinling;DU Guang;WANG Weiwu;JIANG Qiong;XIA Songbai;CHEN Hui;GAN Luzhen;XU Jinjun;ZHANG Dengzheng;FU Bo;RAO Zhiwei(Department of Pharmacy,the First Affiliated Hospital of Hubei University of Science and Technology,Xianning Central Hospital,Xianning 437100,China;Department of Pharmacy,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China;Department of Spleen and Stomach Diseases,the First Affiliated Hospital of Hunan University of traditional Chinese Medicine,Changsha 410000,China)

机构地区：[1]咸宁市中心医院、湖北科技学院附属第一医院药学部,咸宁437100 [2]华中科技大学同济医学院附属同济医院药学部,武汉430030 [3]湖南中医药大学第一附属医院脾胃病科,长沙410000

出　　处：《医药导报》2022年第9期1346-1350,共5页Herald of Medicine

基　　金：湖北省自然科学基金面上项目(2020CFB868)。

摘　　要：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.

关 键 词：复方肺毒清颗粒 制备工艺 薄层色谱 高效液相色谱法 质量标准 

分 类 号：R286[医药卫生—中药学] R943[医药卫生—中医学]