| 赖淼 夏梦棋 杨世林.尼泊尔黄堇药材的质量标准研究[J].江西中医药大学学报,2026,38(1):82-87. |
| 尼泊尔黄堇药材的质量标准研究 |
| Study on Quality Standard of Corydalis Hendersonii |
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| DOI：10.20140/j.2095-7785.2026.01.17 |
| 中文关键词: 尼泊尔黄堇；质量标准；薄层鉴别；含量测定；原阿片碱 |
| 英文关键词: Corydalis Hendersonii; Quality Standard;TLC; Content Determination; Protopine |
| 基金项目:国家重点研发计划项目（2019YFC1712302，2019YFC1712304） |
| 作者 | 单位 | | 赖淼1 夏梦棋2 杨世林2 | 1 . 江西中医药大学 南昌 330004；2 . 中药固体制剂制造技术国家
工程研究中心 南昌 330006 |
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| 中文摘要: |
| 目的：依据《中华人民共和国药典》2020 版四部通则，对藏药尼泊尔黄堇开展质量研究，为尼泊尔黄堇质量控制提
供科学依据。方法：采用显微鉴别对尼泊尔黄堇粉末特征进行描述；以一批尼泊尔黄堇作为对照药材，建立薄层色谱法进行
鉴别；按照四部通则对尼泊尔黄堇药材中的水分、总灰分、酸不溶性灰分和醇溶性浸出物含量进行检测；利用高效液相色谱
法测定其中主要活性成分原阿片碱的含量。结果：尼泊尔黄堇的性状特征和显微特征明显，薄层色谱斑点清晰且分离度良好。
经检测21 批样品，初步拟定水分含量不高于10.00%，总灰分含量不高于14.00%，酸不溶性灰分含量不高于5 .00%，醇溶性
浸出物含量不低于23 .00%，原阿片碱含量不低于0.125%。结论：建立的质量标准可有效控制尼泊尔黄堇的质量，为其临床
应用和进一步开发提供保障。 |
| 英文摘要: |
| Objective: Based on the General Principles of the fourth part of the Chinese Pharmacopoeia in 2020, conduct quality
research on the Tibetan medicine Corydalis hendersonii, to provide a scientific basis for the quality control of Corydalis hendersonii.
Methods: Microscopic identification was used to describe the powder characteristics of Corydalis hendersonii. A thin-layer
chromatography method was established for identification with a batch of Corydalis hendersonii as the reference material. The
content of moisture, total ash, acid-insoluble ash and alcohol-soluble extract in Corydalis hendersonii was detected according to the
general principles of the fourth part. The content of the main active ingredient protopine was determined by high performance liquid
chromatography. Results: The characteristics and microscopic features of Corydalis hendersonii were obvious, and the thin-layer
chromatographic spots was clear with good separation degree. After testing 21 batches of samples, it was preliminarily determined that
the moisture content was not higher than 10.00%, the total ash content was not higher than 14.00%, the acid-insoluble ash content was
not higher than 5.00%, the alcohol-soluble extract content was not lower than 23.00%, and the protopine content was not lower than
0.125%. Conclusion: The quality standard established in this study can effectively control the quality of Corydalis hendersonii and
provide aguarantee for its clinical application and further development. |
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