Guo Tao, Feng Wei-Hong, Liu Xiao-Qian, Gao Hui-Min, Wang Zhi-Min, Gao Liang-Liang
Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China; National Engineering Laboratory for Quality Control Technology of Chinese Herbal Medicines, Beijing 100700, China; School of Life Science and Engineering, Lanzhou University of Technology, Lanzhou 730050, China.
Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China; National Engineering Laboratory for Quality Control Technology of Chinese Herbal Medicines, Beijing 100700, China.
J Pharm Biomed Anal. 2016 May 10;123:16-23. doi: 10.1016/j.jpba.2015.11.021. Epub 2015 Dec 1.
The granule of Chinese medicine (GCM) is prepared by water-soluble extract of single yinpian (WESY) of herbal medicine, and used as a drug ingredient for clinical formulation. The WESY content or corresponding yinpian amount is the most important parameter in evaluating the quality of GCM. Low WESY content reflects poor GCM. Classical quantitative methods, such as HPLC, cannot fully detect the adulteration by adding characteristic ingredients and less WESY production. GCM is composed of WESY and a high content of specific excipient. The WESY content in the GCM may be indirectly analyzed using mid-infrared spectroscopy (MIR). In this paper, a quantitative method to evaluate the quality of Danshen (Salvia miltiorrhiza) granule (DG) was developed using MIR combined with chemometrics. Appropriate characteristic quantitative regions (CQR) were extracted by selecting the spectral regions corresponding to altered excipient content in DG. The best model of dextrin content determination in DG with low RMSEC of 1.97, low RMSEP of 2.07, and excellent RPD of 5.03 (>5.0) was obtained using partial least-squares (PLS) regression, and validated using accepted values of precision and recovery. The results suggest that FT-MIR combined with PLS is a rapid and valuable analytical tool to determine the WESY in DG based on excipient content. The model enabling indirect calculation of WESY content in GCM represents a reference standard for rapid analysis of other WESYs in GCM industry.
中药颗粒（GCM）由中药材单味饮片的水溶性提取物（WESY）制备而成，用作临床制剂的药物成分。WESY含量或相应饮片量是评估GCM质量的最重要参数。WESY含量低反映GCM质量差。经典的定量方法，如高效液相色谱法（HPLC），无法完全检测出添加特征成分和WESY产量较低时的掺假情况。GCM由WESY和高含量的特定辅料组成。可使用中红外光谱（MIR）间接分析GCM中的WESY含量。本文采用MIR结合化学计量学方法建立了一种评估丹参颗粒（DG）质量的定量方法。通过选择与DG中辅料含量变化相对应的光谱区域，提取了合适的特征定量区域（CQR）。采用偏最小二乘法（PLS）回归获得了DG中糊精含量测定的最佳模型，其RMSEC低至1.97，RMSEP低至2.07，RPD优异，为5.03（>5.0），并使用精密度和回收率的公认值进行了验证。结果表明，傅里叶变换红外光谱（FT-MIR）结合PLS是一种基于辅料含量测定DG中WESY的快速且有价值的分析工具。该能够间接计算GCM中WESY含量的模型代表了GCM行业中其他WESY快速分析的参考标准。
