王秋悦 吴晨璐 赵静 李正

摘要 药用辅料油在中药制药过程中常具赋形、充当载体、提高稳定性、增溶、助溶等重要功能，是可能会影响到制剂的质量、安全性和有效性的重要成分。药用辅料油品种的多样性，成分的相似与不同，品质的好坏都关乎着制剂的有效性与安全，对药用辅料油的品质质量进行研究具有必要性。而近红外光谱是检测药品和食品的重要的技术，具有快速、无损、良好的鉴别能力，能够实现样品快速准确地分析。因此，对近红外光谱用于药用辅料油的品类检测如种类鉴别、掺假分析和品质检测如成品油质量指标检测、成品油化学成分检测、储存油、煎炸油质量检测方面进行了综述评价。

关键词 近红外光谱技术;辅料油;品种鉴别;掺假;定量检测

A Review on Quality Control of Excipient Oil for Chinese Medicinal Based on Near Infrared Spectroscopy

WANG Qiuyue1，WU Chenlu1，ZHAO Jing1，2，LI Zheng1，2

（1 College of Pharmaceutical Engineering of Traditional Chinese Medicine，Tianjin University of Traditional Chinese Medicine，Tianjin 301617，China; 2.State Key Laboratory of Traditional Chinese Medicine，Tianjin 301617，China）

Abstract Pharmaceutical excipient oil has many important functions in the pharmaceutical process of Traditional Chinese medicine，such as forming，acting as carrier，improving stability，solubilizing and helping to dissolve，which may affect the quality，safety and effectiveness of the preparation.The variety of pharmaceutical excipient oil，the similarity and difference of composition，and the quality are all related to the effectiveness and safety of the preparation，so it is necessary to study the quality of pharmaceutical excipient oil.And near infrared spectroscopy is an important technology for the detection of drugs and food，with rapid，non-destructive，good identification ability，can achieve rapid and accurate sample analysis.Therefore，this paper reviews the application of NIR spectroscopy in the detection of pharmaceutical excipient oils，such as category identification，adulteration analysis and quality detection，such as product oil index determination，chemical composition content determination，storage oil and frying oil quality detection.

Keywords NIR spectroscopy; Excipient oil; Variety identification; Adulteration; Quantitative detection

中圖分类号：R283.2文献标识码：Adoi：10.3969/j.issn.1673-7202.2021.23.005

随着药品质量的提高，药用辅料的质量也不断需要得到提升。药用辅料是指生产药品调配处方时使用的赋形剂和添加剂，是除活性成分外，在安全性方面已进行了合理的评估，且包含在药物制剂中的物质。药用辅料虽然不是影响药物发挥疗效的核心成分，但它具有赋形、充当载体、提高药品稳定性、增溶、助溶等重要功能，作为药物制剂处方重要组成部分，由于辅料并不是完全惰性，有些辅料也会对疾病的治疗起到协同作用[1]，而且辅料的质量会直接影响制剂的质量、稳定性和疗效，因此，药用辅料的品质对药物的质量具有重要的作用。

油脂类药用辅料源于食品，现在不仅作为食用油食用，也被用于制药行业和药用化妆品行业。……