首页|黄芪桂枝五物颗粒的质量控制方法研究

黄芪桂枝五物颗粒的质量控制方法研究

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目的 建立黄芪桂枝五物颗粒的质量控制方法,为该制剂的质量控制研究提供依据。方法 采用薄层色谱法定性鉴别黄芪桂枝五物颗粒中的黄芪和白芍;采用中国药典四部通则方法对黄芪桂枝五物颗粒的粒度、水分和溶化性等性状进行制剂学检查;采用高效液相色谱法对黄芪桂枝五物颗粒中毛蕊异黄酮葡萄糖苷进行含量测定。结果 建立了黄芪桂枝五物颗粒中黄芪、白芍的定性鉴别方法,斑点清晰,阴性对照无干扰;黄芪桂枝五物颗粒的粒度、水分和溶化性等性状检查结果均符合中国药典标准要求;毛蕊异黄酮葡萄糖苷在5~250 mg/L范围内线性关系良好(r=0。999 4),平均回收率为98。9%,6批黄芪桂枝五物颗粒中毛蕊异黄酮葡萄糖苷的含量范围为0。065 9~0。077 0 mg/g。结论 本研究采用的薄层色谱方法、制剂学检查方法和高效液相色谱方法专属性强、重复性好,可为黄芪桂枝五物颗粒的质量控制研究提供依据。
Study on Quality Control Method of Huangqi Guizhi Wuwu Granules
Objective To establish a quality control method of Huangqi Guizhi Wuwu Granules(HGWG),and provide a basis for the qual-ity control research of the preparation.Methods Astragali Radix and Paeoniae Radix Alba in HGWG were qualitatively identified by thin layer chromatography;The particle size,water content and solubility of HGWG granules were examined by the method of general prin-ciples of Chinese Pharmacopoeia(VolumeⅣ);The content of calycosin-7-O-β-D-glucoside in HGWG was determined by high perfor-mance liquid chromatography.Results In this study,the qualitative identification methods of Astragali Radix and Paeoniae Radix Alba in HGWG were established,the spots were clear,and the negative control had no interference;The results of particle size,water content and solubility of HGWG were in line with the requirements of Chinese Pharmacopoeia standards;The linear range of calycosin-7-O-β-D-glucoside was 5-250 mg/L(r=0.999 4),the average recovery was 98.9%and the content range of calycosin-7-O-β-D-glucoside in 6 batches of HGWG was 0.065 9-0.077 0 mg/g.Conclusion The thin layer chromatography method,preparation examination method and high performance liquid chromatography method used in this study have strong specificity and good repeatability,which can provide a ba-sis for the quality control of HGWG.

Huangqi Guizhi Wuwu Granulesquality controlcalycosin-7-O-β-D-glucosidethin layer chromatographyhigh perfor-mance liquid chromatography

刘杨、刘昊、王立和、洪曼、姜雯钰、葛胜宇、关皎、冯波、朱鹤云、金莉莉

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延边大学 药学院,吉林 延吉 133002

吉林医药学院药学院,吉林 吉林 132013

吉林市鹿王制药股份有限公司,吉林 吉林 132013

黄芪桂枝五物颗粒 质量控制 毛蕊异黄酮葡萄糖苷 薄层色谱法 高效液相色谱法

2024

吉林医药学院学报
吉林医药学院

吉林医药学院学报

影响因子:0.459
ISSN:1673-2995
年,卷(期):2024.45(6)