番石榴叶质量标准提升研究 点击下载
| 论文标题： | 番石榴叶质量标准提升研究 |
| 英文标题： | |
| 中文摘要： | 目的 提高和完善番石榴叶的质量标准。方法以24批番石榴叶为样品，观察其外观性状、粉末显微特征，并对其进行薄层鉴别；按照2025年版《中国药典》（四部）中相应方法，测定样品中杂质、水分、总灰分、酸不溶性灰分、水溶性浸出物，以及铅、镉、铜、砷、汞及47种禁用农药残留；建立高效液相色谱（HPLC）法，测定番石榴叶中番石榴苷含量；建立番石榴叶的HPLC指纹图谱，并对样品进行相似度评价和聚类分析。结果番石榴叶药材性状符合相关质量标准；药材粉末的非腺毛、草酸钙晶体、导管、气孔等显微特征显著；薄层鉴别结果显示，在供试品色谱中，与番石榴苷对照品色谱相应位置上显相同颜色的荧光斑点。24批样品中杂质、水分、总灰分、酸不溶性灰分和水溶性浸出物测定范围分别为0.3%～2.8%、5.1%～10.7%、5.3%～7.2%、0.4%～1.8%、11.8%～26.3%，重金属及有害元素、禁用农药残留检测结果均符合《中国药典》的限量要求。含量测定和指纹图谱的方法学考察结果均符合相关要求。24批样品中番石榴苷含量范围为0.14%～0.28%。24批样品HPLC指纹图谱的相似度为0.828～0.997；共标定出15个共有峰，指认出其中6个共有峰；24批样品被划分为两大类，类群归属与样品来源高度一致。结论本研究优化了番石榴叶的薄层鉴别方法，新增了含量测定和指纹图谱等质控项目，并拟定番石榴叶药材中水分不得过12.0%、总灰分不得过8.0%、水溶性浸出物不得少于10.0%、番石榴苷含量不得少于0.14%（以干燥品计算）的质量标准。 |
| 英文摘要： | Abstract OBJECTIVE To upgrade and perfect the quality standard of Psidii Guajavae Folium. METHODS A total of 24 batches of Psidii Guajavae Folium samples were adopted in this study. The macroscopic traits and powder microscopic features of the medicinal materials were observed， and thin-layer chromatography （TLC） identification was carried out. In accordance with corresponding methods documented in Volume Ⅳ of the 2025 edition of the Chinese Pharmacopoeia， multiple indexes were determined， including foreign matter， moisture， total ash， acid-insoluble ash， water-soluble extractives， heavy metals （lead， cadmium， copper， arsenic， mercury） as well as residues of 47 prohibited pesticides. A high-performance liquid chromatography （HPLC） method was established to quantify guaijaverin in Psidii Guajavae Folium. Meanwhile， the HPLC fingerprint of the herb was constructed， followed by similarity evaluation and cluster analysis of all samples. RESULTS The macroscopic traits of Psidii Guajavae Folium complied with relevant specifications of quality standards. Distinct microscopic characteristics were observed in medicinal powder， including non-glandular hairs， calcium oxalate crystals， vessels and stomata. TLC results revealed identical fluorescent spots at positions corresponding to the guaijaverin reference substance on chromatograms of test samples. Among the 24 batches of samples， the detection ranges were 0.3%-2.8% for foreign matter， 5.1%-10.7% for moisture， 5.3%-7.2% for total ash， 0.4%-1.8% for acid-insoluble ash， and 11.8%-26.3% for water-soluble extractives. The test results of heavy metals， harmful elements and prohibited pesticide residues all satisfied the Chinese Pharmacopoeia limit criteria. Methodological validation of content determination and fingerprint analysis met relevant validation requirements. The guaijaverin content of the 24 batches ranged from 0.14% to 0.28%. The HPLC fingerprint similarity values of all samples fluctuated between 0.828 and 0.997； fifteen common peaks were calibrated， six of which were chemically identified. The 24 batches were divided into two major clusters， and cluster classification showed high consistency with sample origins. CONCLUSIONS This research optimizes the TLC identification protocol of Psidii Guajavae Folium and supplements new quality control items including quantitative assay and chromatographic fingerprint. Tentative quality limits are proposed as follows： moisture ≤12.0%， total ash ≤8.0%， water-soluble extractives ≥10.0%， and guaijaverin content ≥0.14% （calculated based on dry products）. |
| 期刊： | 2026年第37卷第15期 |
| 作者： | 郭丁丁；王涵；荆然；刘聪；王越欣；吕绍伟 |
| 英文作者： | GUO Dingding，WANG Han，JING Ran，LIU Cong，WANG Yuexin，LYU Shaowei |
| 关键字： | 番石榴叶；质量标准；薄层色谱法；重金属；农药残留；高效液相色谱法；番石榴苷；指纹图谱 |
| KEYWORDS： | Psidii Guajavae Folium； quality standard； TLC method； heavy metals； pesticide residues； HPLC method； guaijaverin； fingerprint |
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