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喘舒片质量分析

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目的 对2022年山东省内生产及流通的喘舒片的质量进行评价.方法 对抽取的70批喘舒片样品,按法定标准检验;对合并相同批号后的44批有效批数的喘舒片样品进行探索性研究,包括:采用高效液相色谱(HPLC)进行盐酸双氯醇胺的含量均匀度检查和含量测定,采用显微观察法对大黄粉进行显微鉴别及异性有机物检查,采用薄层色谱(TLC)进行土大黄苷的检查,采用HPLC进行黄芩提取物的鉴别,采用TLC进行止咳平喘类化学药物的非法添加及金胺O非法染色的检查.结果 按现行法定标准检验,样品全部合格,但通过探索性研究,发现盐酸双氯醇胺含量均匀度检查及含量测定合格率偏低.结论 省内生产流通的喘舒片符合现行法定标准要求,但现行法定标准不统一且存在缺陷,建议尽快提高并统一喘舒片的质量标准,多指标,全方位地控制喘舒片的质量.
Quality Analysis of Chuanshu Tablets
Objective To evaluate the quality of Chuanshu Tablets produced and circulated in Shandong Province in 2022.Methods In this study,70 batches of Chuanshu Tablets were tested according to the statutory standards.Exploratory research was conducted on 44 batches of effective batches of Chuanshu Tablets after merging the same batch number,including:HPLC was adopted for the content uniformity inspection and content determination of clenbuterol hydrochloride;microscopic observation was used for microscopic identification and foreign organic matter examination of Rhei Radix et Rhizoma powder;TLC was used for the check of rhaponticin;HPLC was used for identification of Scutellariae Radix extract,and TLC was used for the check of illegal addition of cough and asthma relieving chemical drugs and illegal staining of auramine O.Results According to the current statutory standards,all samples are qualified.However,according to the exploratory research,the qualification rates of content uniformity inspection and content determination of clenbuterol hydrochloride were low.Conclusion Chuanshu Tablets produced and circulated in Shandong province meet the requirements of the current statutory standards.However,the current statutory standards are not uniform and have defects.It is suggested that the quality standard of Chuanshu Tablets should be improved and unified as soon as possible,and the overall and multi-index quality control of Chuanshu Tablets should be carried out.

Chuanshu Tabletsquality analysisexploratory research

张秋红、李敏、齐红、于姗姗、窦传浩

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济南市食品药品检验检测中心,山东济南 250102

山东中医药大学,山东济南 250355

喘舒片 质量分析 探索性研究

2024

食品与药品
山东省生物药物研究院

食品与药品

CSTPCD
影响因子:0.537
ISSN:1672-979X
年,卷(期):2024.26(6)