| 中药粉体物理指纹图谱研究进展 |
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| 基金项目:国家自然科学基金项目(82074033);中华中医药学会青年人才托举工程项目(2019-QNRC2-C11);北京中医药大学青年教师项目(2019-JYB-JS-015) |
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| 中文摘要:中药(TCM)粉体是中药口服固体制剂的重要中间体或产品，粉体的物理性质不仅影响制剂成型，而且直接或间接影响产品质量。中药粉体种类众多、尺度各异，采用物理指纹图谱可从物理状态层面整体评价中药粉体质量，并可将其作为对中药粉体含量测定或HPLC指纹图谱评价的补充，这为中药粉体全面质量控制提供了新的工具和思路。该文系统梳理了中药粉体物理指纹图谱的规范化建立方法，包括指标体系的设计、二级指标的测试或计算，以及二级指标标准化处理和图谱展示。总结了物理指纹图谱在中药破壁粉、中药浸膏粉、中药颗粒、药用辅料、制剂成型工艺全过程质量评价和制剂处方设计中的应用。指出了开展物理指纹图谱和物性分析方法验证，确保物理指纹图谱数据可靠，同时结合模式识别和人工智能方法拓展物理指纹图的应用场景，支持中药质量一致性评价、产品和工艺的设计与持续改进，将是中药粉体物理指纹图谱未来的研究方向。 |
| 中文关键词:中药粉体 物理指纹图谱 物性表征 一致性评价 质量源于设计 |
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| Physical Fingerprint of Traditional Chinese Medicine Powders:A Review |
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| Abstract:Traditional Chinese medicine(TCM) powders are important intermediates or products of oral solid preparations of traditional Chinese medicines.The physical properties of the powders not only affect the formation techniques,but also impact the quality of the products directly or indirectly.There are many types of traditional Chinese medicine powders with different scales.Physical fingerprints,as a complementary method for the content determination of traditional Chinese medicine powders or HPLC fingerprint evaluation,are used to evaluate the quality of traditional Chinese medicine powders from the physical properties,which provide a new way for the overall quality control of traditional Chinese medicine powders.A standardized establishment method of the physical fingerprints for traditional Chinese medicine powders is systematically described in this paper,including design of the index system,test or calculation of the secondary indexes,and standardized processing and map display of the secondary indexes.Application of physical fingerprints in the whole process quality evaluation of Chinese medicine wall broken powders,Chinese medicine extract powders,Chinese medicine granules,pharmaceutical excipients,dosage forming process and formulation design is summarized.Carrying out physical fingerprints and physical property analysis method verification to ensure the reliability of the data of the physical fingerprints,combining pattern recognition with artificial intelligence methods to expand the application scenarios of physical fingerprints,supporting the quality consistency evaluation and the design and continuous improvement of the prescription and process of Chinese medicine preparations are the main directions of the future research. |
| Key Words:traditional Chinese medicine powders physical fingerprint physical characterization quality consistency evaluation quality by design |
| 引用本文：张煜皓,王雅雯,宿军慧,戴胜云,乔延江,罗赣,徐冰.中药粉体物理指纹图谱研究进展[J].分析测试学报,2021,40(1):139-148. |
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