| 王小君 张英明 刘微 杨婧 饶小勇 何雁 陶青.基于近红外光谱技术的六味地黄浓缩丸干燥过程质量控制研究[J].江西中医药大学学报,2026,38(1):72-81. |
| 基于近红外光谱技术的六味地黄浓缩丸干燥过程质量控制研究 |
| Research on Using Near-Infrared Spectroscopy Technology to Monitor the Drying Process Quality of Liuwei Dihuang Concentrated Pills |
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| DOI：10.20140/j.2095-7785.2026.01.16 |
| 中文关键词: 近红外技术；六味地黄浓缩丸；干燥；含量测定；快速检测 |
| 英文关键词: NIR Technology; Liuwei Dihuang Concentrated Pills; Drying; Content Determination; Rapid Test |
| 基金项目:国家自然科学基金项目（82460776）。 |
| 作者 | 单位 | | 王小君1 张英明2 刘微1,3 杨婧3 饶小勇1,3 何雁1 陶青1 | 1 . 江西中医药大学 南昌
330004；2 . 兰州佛慈制药股份有限公司 兰州 730300；3 . 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：利用超高效液相色谱（UPLC）技术同时检测不同热风干燥温度和时间的六味地黄浓缩丸指标成分莫诺苷、马钱苷、
丹皮酚的含量，并通过近红外光谱（NIR）技术对六味地黄浓缩丸指标成分及水分构建定量预测模型，建立干燥过程多指标快
速定量分析方法。方法：采用漫反射方法采集不同干燥条件的六味地黄浓缩丸NIR 数据，UPLC 法测定指标成分含量，烘干法
测定水分含量，对3/4 样品进行偏最小二乘回归分析并分别建立指标成分和水分含量与NIR 数据的校正模型，以1/4 样品进行
模型验证。结果：干燥温度、时间与指标成分含量成反比。采用不同光谱预处理和波长选择方法建立的偏最小二乘回归分析定
量分析模型的预测效果良好，莫诺苷、丹皮酚、水分模型的预测决定系数分别为0.921 7、0.926 2、0.960 0。结论：NIR 技术可
用于六味地黄浓缩丸干燥过程中部分指标成分和水分的快速检测，并提示需均衡考虑丸剂水分及指标成分含量，以确定浓缩丸
干燥终点，保证浓缩丸质量稳定。 |
| 英文摘要: |
| Objective: In order to create a quick and accurate way to analyze the drying process with multiple indexes, the contents of the
index components (Morroniside, Loganin, and Danshi Phenol) of Liuwei Dihuang Concentrated Pills with varying hot air drying temperatures
and times were simultaneously detected using UPLC. Additionally, a quantitative prediction model for the index components and moisture
content of Liuwei Dihuang Concentrated Pills was built using NIR Technique. Methods: The diffuse reflectance method was used to
collect near-infrared spectra of Liuwei Dihuang Concentrated Pills under various drying conditions. UPLC was used to determine the index
component content, and the drying method was used to determine the moisture content. 3/4 of the samples were subjected to partial least
squares regression analysis, and calibration models were created for indicator components and moisture content vs NIR spectra, respectively.
Model validation was done on 1/4 of the samples. Results: Drying temperature and duration were discovered to be inversely related to the
quantity of indicator components. The partial least squares regression analysis quantitative analysis models established using different
spectral pre-processing and wavelength selection methods gave good predictive results, with predictive coefficients of determination for
Morroniside, Danshi Phenol, and moisture content, except for Loganin, being 0.921 7, 0.926 2, and 0.960 0, respectively. Conclusion:
NIR Technique can be used to detect index components and moisture during the drying process of Liuwei Dihuang Pills, and it is suggested
that the drying endpoint of the pills be determined by taking into account the moisture and index component content of the pills, in order to
ensure the stability of the pills' quality. |
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