机构地区:[1]四川省药品检验研究院国家药品监督管理局中成药质量评价重点实验室工业和信息化部产业技术基础公共服务平台,成都611731
出 处:《药物分析杂志》2025年第2期254-264,共11页Chinese Journal of Pharmaceutical Analysis
基 金:四川省药品监督管理局2025年药品科技计划项目(2025001);国家药品监督管理局药品监管科学体系建设重点项目“新技术新方法在中药质量控制中的应用”(RS2024Z006)。
摘 要:目的:多手段结合鉴别4批市售“麦冬”的真伪,探究其韧皮部束超标的原因,为其检验检测提供依据。方法:基于2020年版《中华人民共和国药典》(简称《中国药典》)一部麦冬项下的相关规定,对比麦冬常见混淆品山麦冬,结合传统经验鉴别手段(性状、显微鉴别)及现代分析技术手段(分子生物学ITS2序列),针对正品、混淆品及韧皮部束不合格样本进行数据比较分析。结果:麦冬与山麦冬性状的差异在于表面颜色、纵皱纹的深浅及中柱粗细,显微横切的差异在于韧皮部束个数及内皮层细胞是否全面增厚。4批市售麦冬性状均符合麦冬项下相关规定,显微横切中韧皮部束的个数不合格批次均达40%以上,但样本中内皮层细胞均呈现全面增厚现象。分子生物学研究发现,4批市售“麦冬”与正品麦冬聚为一支,湖北麦冬、短葶山麦冬各独自聚成一支,并表现出明显的条形码间距,综合判定其应均为麦冬。另外,针对韧皮部束的个数与性状的相关量化指标,进行了相关性分析,发现韧皮部束的个数与木心的直径大小呈显著正相关。结论:此4批市售麦冬应为正品基原。结合实验研究推测,韧皮部束的个数不合格原因可能与生长年限有关,中柱粗细可大致推测是否能达到药典规定。判定麦冬是否为基原准确的药材,不能仅凭某一鉴别手段的某一特征下定论,应多手段结合分析,方能准确地进行判定。Objective:To identify the authenticity of four batches of"Ophiopogonis Radix"in the market by means of multiple means,and to explore the reasons for exceeding the limit of its phloem bundles,so as to provide evidence for its inspection and detection.Methods:Based on the relevant provisions of Ophiopogon japonicus(L.f.)Ker-Gawl.,a variety in the 2020 edition of Chinese Pharmacopoeia,comparing the common confused products of Ophiopogon japonicus(L.f.)Ker-Gawl.,Combined with traditional identification methods(character identification,microscopic identification)and modern analysis techniques(molecular biology ITS 2 sequence),the data of genuine products with mixed products and substandard phloem bundle samples were campared and analyzed.Results:The differences between Liriope spicata(Thunb.)Lour.and Ophiopogon japonicus(L.f.)Ker-Gawl.were the surface color,the depth of vertical wrinkles and the thickness of the middle column,and the differences in microscopic cross-sections lay in the number of phloem bundles and whether the inner cortex cells were uniformly thickened.The four batches of"Ophiopogonis Radix"in the market all complied with the relevant regulations under Ophiopogon japonicus(L.f.)Ker-Gawl..The number of unqualified phloem bundled into microscopic cross-sections.was more than 40%,but the inner cortex cells in the samples showed a comprehensive thickening phenomenon.The results of molecular biology study showed that the four batches of"Ophiopogonis Radix"on the market and the Ophiopogon japonicus(L.f.)Ker-Gawl.were clustered into one,the Liriope spicata(Thunb.)Lour.var.prolifera Y.T.Ma and the Liriope muscari(Decne.)Baily were clustered into one,and showed obvious bar code spacing.The number of phloem bundles was obvious positively correlated with the diameter of wood core by correlation analysis of the number of phloem bundles and the quantitative indexes related to traits.Conclusion:These four batches of"Ophiopogonis Radix"on the market are the original of genuine products.Combined with the experimental
关 键 词:麦冬 山麦冬 短葶山麦冬 性状 显微鉴别 分子生物学
分 类 号:R917[医药卫生—药物分析学]
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