首页|基于4种成分含量测定的小儿化痰止咳颗粒质量评价

基于4种成分含量测定的小儿化痰止咳颗粒质量评价

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目的:基于4种指标成分的含量测定系统评价小儿化痰止咳颗粒的质量.方法:采用末端吸收的高效液相色谱法同时测定盐酸麻黄碱、吐根碱、吐根酚碱、桑皮苷A的含量.结果:盐酸麻黄碱、吐根碱、吐根酚碱、桑皮苷A的线性范围分别为33.0~495.0 μg·mL-1(r2=1.000 0)、9.1~136.2 μg·mL-1(r2=1.000 0)、2.6~39.2 μg·mL-1(r2=0.999 7)、8.2~123.6µg·mL-1(r2=0.997 7);平均回收率分别为 99%(RSD=1.04%)、99%(RSD=1.07%)、96%(RSD=1.42%)、94%(RSD=2.27%).结论:本方法专属性强,准确度高,重现性好,可用于小儿化痰止咳颗粒质量控制.
Study on the Quality Evaluation of Xiaoer Huatan Zhike Granules Based on the Content Determination of Four Indexes Components
Objective:To evaluate the quality of Xiaoer Huatan Zhike granules based on the content determination of 4 index compo-nents.Methods:The contents of ephedrine hydrochloride,emetine,Cephaeline,mulberroside A were determind by HPLC based on termi-nal absorption.Results:The linear ranges of ephedrine hydrochloride,emetine,Cephaeline and mulberroside A were 33.0-495.0 µg·mL-1(r2=1.000 0),9.1-136.2 μg·mL-1(r2=1.000 0),2.6-39.2 µg·mL-1(r2=0.999 7)、8.2-123.6 µg·mL-1(r2=0.997 7),respectively;the average recoveries were 99%(RSD=1.04%),99%(RSD=1.07%),96%(RSD=1.42%),94%(RSD=2.27%)respectively.Conclusion:This method has strong specificity,high accuracy and good reproducibility.It can be used for the quality control for Xiaoer Huatan Zhike granules.

Xiaoer Huatan Zhike granulesHigh performance liquid chromatography(HPLC)Content determinationQuality evaluation

孟庆山、马芳芳、刘雪、楚合法

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威海市食品药品检验检测研究院,山东威海 264210

威海市食品药品质量评价与技术研究重点实验室,山东威海 264210

小儿化痰止咳颗粒 高效液相色谱法 含量测定 质量评价

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(6)