| 引用本文: | 赵海鹏,齐衍超,祁立新,杨丽蓉,陈燕,徐玉文.市售复方甘草片的质量评价[J].中国现代应用药学,2022,39(13):1737-1743. |
| ZHAO Haipeng,QI Yanchao,QI Lixin,YANG Lirong,CHEN Yan,XU Yuwen.Quality Evaluation of Compound Liquorice Tablets in Market[J].Chin J Mod Appl Pharm(中国现代应用药学),2022,39(13):1737-1743. |
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| 市售复方甘草片的质量评价 |
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赵海鹏1,2, 齐衍超1, 祁立新1, 杨丽蓉1, 陈燕1, 徐玉文2,3,4
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1.潍坊市检验检测中心, 山东 潍坊 261200;2.国家药品监督管理局仿制药研究与评价重点实验室, 济南 250101;3.山东省食品药品检验研究院, 济南 250101;4.山东省仿制药一致性评价工程技术研究中心, 济南 250101
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| 摘要: |
| 目的 对市售复方甘草片的质量进行分析评价。方法 依据现行法定标准对17个生产企业的60批复方甘草片进行检验，并针对性地建立气相色谱法对样品中樟脑、反式茴香脑进行检测（标准中缺少针对挥发性组分的质量控制指标）。结果 按照法定标准检验60批复方甘草片，合格率为100%；60批样品每片含樟脑含量为0.073~1.393 mg，均未达到理论限度值（每片1.54~2.30 mg）；每片含反式茴香脑含量为0.000~1.569 mg，26批达到理论限度值（每片1.28~1.92 mg）。结论 60批复方甘草片均符合法定标准，总体质量良好；但各厂家的复方甘草片中樟脑、反式茴香脑含量存在较大差异，现行标准无法较好地反映出该品种的实际质量优劣，建议相关部门加强监管并修订完善质量标准。 |
| 关键词: 复方甘草片 樟脑 反式茴香脑 气相色谱法 聚类分析 质量评价 |
| DOI：10.13748/j.cnki.issn1007-7693.2022.13.012 |
| 分类号:R284.1 |
| 基金项目: |
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| Quality Evaluation of Compound Liquorice Tablets in Market |
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ZHAO Haipeng1,2, QI Yanchao1, QI Lixin1, YANG Lirong1, CHEN Yan1, XU Yuwen2,3,4
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1.Weifang Inspection and Testing Center, Weifang 261200, China;2.NMPA Key Laboratory for Research and Evaluation of Generic Drugs, Jinan 250101, China;3.Shandong Institute for Food and Drug Control, Jinan 250101, China;4.Shandong Research Center of Engineering and Technology for Consistency Evaluation of Generic Drugs, Jinan 250101, China
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| Abstract: |
| OBJECTIVE To evaluate the quality of Compound Liquorice Tablets in market. METHODS According to the mandatory standard, 60 batches of Compound Liquorice Tablets from 17 production enterprises were tested, and GC was established to detect camphor and trans-anethole in samples(there was no quality control index for volatile components in the standard). RESULTS According to the mandatory standard, 60 batches of Compound Liquorice Tablets were tested, and the qualified rate was 100%. The content of camphor in each tablet of 60 batches of products was 0.073-1.393 mg, which did not reach the theoretical limit value(1.54-2.30 mg per tablet). The content of trans-anethole in each tablet was 0.000-1.569 mg, and 26 batches reached the theoretical limit value(1.28-1.92 mg per tablet). CONCLUSION The 60 batches of Compound Liquorice Tablets meet the mandatory standards with good overall quality. However, the contents of camphor and trans-anethole in Compound Liquorice Tablets from different production enterprises are quite different, and the current standards cannot well reflect the actual quality of the variety. It is advised relevant department should to enhance the supervision and management, meanwhile to revise and improve the quality standard. |
| Key words: Compound Liquorice tablets camphor trans-anethole GC cluster analysis quality evaluation |
