| 摘要: |
| 马缨丹药材为马鞭草科植物马缨丹（Lantana camara L.）的干燥茎叶，具有消肿解毒、散瘀止痛等功效，在海南黎族地区使用较广范。然而，因其药材质量标准缺失，不能作为药材在临床上使用，也缺乏药材质量监管的依据，亟需制定马缨丹药材质量标准。依据《中国药典》（2020年版）和《国家药品标准工作手册》质量标准研制的要求，通过性状观察法、显微鉴别法对马缨丹药材的性状和显微结构特征进行研究，对药材的检查项（水分、总灰分）、浸出物等进行测定。明确了马缨丹药材性状和显微结构特征，建立了专属性薄层色谱鉴别方法，规定马缨丹药材水分不得超过13.0%、总灰分不得超过13.0%、水溶性浸出物不得少于14.0%。研究制定的马缨丹药材质量标准，可为其临床用药及质量监管提供技术支撑。 |
| 关键词: 马缨丹 黎药 质量标准 |
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| 基金项目:海南省重点研发专项（ZDYF2025SXLH015） |
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| Study on quality standard for Lantana camara L.a native traditional medicine in Hainan |
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| Abstract: |
| Lantana camara L. is derived from the dried stems and leaves of the plant Lantana camara L. (Verbenaceae). It is used in Li ethnic communities in Hainan for its therapeutic effects, including reducing swelling, detoxifying, dispelling blood stasis, and alleviating pain. However, the absence of established quality standards prevents its formal clinical application and hinders regulatory oversight. Therefore, developing quality standards for this medicinal material is urgently needed.Following the guidelines of the Chinese Pharmacopoeia (2020 Edition) and the National Drug Standard Working Manual, this study characterized the macroscopic and microscopic features of Lantana camara L. using morphological and microscopic identification. Analytical tests such as moisture content, total ash, and extractives were also performed.The characteristics and microstructures of Lantana camara L. were identified, and an exclusive thin layer-chromatography identification method for Lantana camara L. was established. The crude drug of Lantana camara L. is provided for to contain no more than 13.0% of water, no more than 13.0% of total ash and no less than 14.0% of water soluble extract .The quality standards developed in this research will provide technical support for the clinical application and quality supervision of Lantana camara L. medicinal material. |
| Key words: Lantana camara L. Li medicine quality standards |
