首页|复方甘芪止咳颗粒的处方优化和质量评价研究

复方甘芪止咳颗粒的处方优化和质量评价研究

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目的:优化复方甘芪止咳颗粒的处方组成,并建立该制剂质量评价方法.方法:采用HPLC法测定甘草酸铵、甘草苷和黄芪甲苷含量;采用正交实验L9(34)对复方甘芪止咳颗粒处方组成进行优化;参照《中国药典》收载的颗粒剂质量评价项目对其质量进行评价.结果:复方甘芪止咳颗粒的最佳处方组成为1.0%羧甲基纤维素钠(CMC-Na)为粘合剂、淀粉:糊精(1:1,w/w)为填充剂、1.2%干淀粉为崩解剂;薄层色谱可有效监测颗粒中黄芪甲苷和甘草苷;颗粒中黄芪甲苷和甘草苷、甘草酸铵含量约为29.21 μg·g-1、2.45 mg·g-1和10.72 mg·g-1.结论:优化的复方甘芪颗粒处方具备优良的成型性和溶散性;质量评价方法可有效控制该颗粒剂的质量.
Research on Prescription Optimization and Quality Evaluation of Compound Ganqi Anti-cough Granules
Objective:To optimize the prescription composition of Compound Ganqi Anti-cough Granules and to establish a quality evaluation method for this preparation.Methods:The contents of ammonium glycyrrhizinate,glycyrrhizin,and astragaloside A were determined by HPLC.The orthogonal experiment[I9(34)]was used to optimize the prescription composition of Compound Ganqi Anti-cough Granules,and its quality was evaluated regarding the quality evaluation items of granules contained in the Chinese Pharmacopoeia.Results:The optimal formulation of granules was 1.0%sodium carboxymethyl cellulose as adhesive,the mixture of starch:dextrin(1:1,w/w)as filler,and 1.2%dry starch as disintegrator.TLC was used to qualitatively identify astragaloside A and glycyrrhizin in granules,and the content of astragaloside A,glycyrrhizin,and ammonium glycyrrhizinate were about 29.21 μg·g-1,2.45 mg·g-1,and 10.72 mg·g-1.Conclusion:The optimized compound Ganqi Anti-cough granules prescription possesses excellent molding and dissolu-tion properties.The quality evaluation method can effectively control the quality of the granules.

Compound Ganqi Anti-cough granulesFormulation optimizationQuality evaluation

刘晓艳、雷文娟、王萌、韩著、孟敏、史彦斌

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酒钢医院,甘肃嘉峪关 735100

甘肃省人民医院,甘肃兰州 730000

兰州大学,甘肃兰州 730000

甘肃中医药大学,甘肃兰州 730000

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复方甘芪止咳颗粒 处方优化 质量评价

酒钢集团医疗卫生系统科技项目(2020)

JG2020YLKJ21

2024

中国药物评价
国家食品药品监督管理局信息中心

中国药物评价

影响因子:1.09
ISSN:2095-3593
年,卷(期):2024.41(1)
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