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软肝化纤丸的制备工艺及质量控制方法的初步研究
潘赞红1, 宓余强2, 董红筠2, 毕丽萍1
1.天津市第二人民医院制剂科, 天津 300192;2.天津市第二人民医院中西医结合肝病科, 天津 300192
摘要:
[目的] 建立软肝化纤丸的制备工艺、质量控制方法。[方法] 根据药物组成设计制备工艺,采用高效液相色谱法进行定量鉴别。[结果] 以方中所有药味粉碎成细粉加蜜制丸剂,以芍药苷含量测定为定量鉴别项。[结论] 软肝化纤丸制备方法得当,质量稳定,主要成分可控,可以应用于临床。
关键词:  软肝化纤丸  制备  质量控制
DOI:10.11656/j.issn.1672-1519.2014.02.14
分类号:
基金项目:
Preparation technology and quality control of Ruangan Huaxian pills
PAN Zan-hong1, MI Yu-qiang2, DONG Hong-yun2, BI Li-ping1
1.Pharmacy Department, The Second People's Hospital of Tianjin, Tianjin 300192, China;2.Department of Liver Disease by Integrating Traditional and Western Medicine, The Second People's Hospital of Tianjin, Tianjin 300192, China
Abstract:
[Objective] To establish the preparation technology and quality control method of Ruangan Huaxian pills. [Methods] According to the drug components, the preparation technology was designed and HPLC was used to identify the quantity.[Results] All the drugs in the preparation were broken to thin powder the pills were prepared after adding honey. Taking paeoniflorin as the identifying standard the content was determined. [Conclusion] If the preparation technology is correct, the main composition of Ruangan Huaxian pills can be controlled. The quality is stable, and it can be used safely in the clinic to improve patient's symptoms, liver functions, serum hepatic fibrosis and liver fibroscan indexes.
Key words:  Ruangan Huaxian pill  preparation  quality control
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