Zhang Yi, Xu Bing, Sun Fei, Wang Xin, Zhang Na, Shi Xin-Yuan, Qiao Yan-Jiang
Research Center of Traditional Chinese Medicine Information Engineering, Beijing University of Chinese Medicine, Beijing 100029, China.
Beijing Key Laboratory for Production Process Control and Quality Evaluation of Traditional Chinese Medicine, Beijing 100029, China.
Zhongguo Zhong Yao Za Zhi. 2016 Jun;41(12):2221-2227. doi: 10.4268/cjcmm20161209.
The physical properties of both raw materials and excipients are closely correlated with the quality of traditional Chinese medicine preparations in oral solid dosage forms. In this paper, based on the concept of the chemical fingerprint for quality control of traditional Chinese medicine products, the method of physical fingerprint for quality evaluation of traditional Chinese medicine extract powders was proposed. This novel physical fingerprint was built by the radar map, and consisted of five primary indexes (i.e. stackablity, homogeneity, flowability, compressibility and stability) and 12 secondary indexes (i.e. bulk density, tap density, particle size<50 μm percentage, relative homogeneity index, hausner ratio, angle of repose, powder flow time, inter-particle porosity, Carr index, cohesion index, loss on drying, hygroscopicity). Panax notoginseng saponins (PNS) extract was taken for an example. This paper introduced the application of physical fingerprint in the evaluation of source-to-source and batch-to-batch quality consistence of PNS extract powders. Moreover, the physical fingerprint of PNS was built by calculating the index of parameters, the index of parametric profile and the index of good compressibility, in order to successfully predict the compressibility of the PNS extract powder and relevant formulations containing PNS extract powder and conventional pharmaceutical excipients. The results demonstrated that the proposed method could not only provide new insights into the development and process control of traditional Chinese medicine solid dosage forms.
原材料和辅料的物理性质与口服固体制剂中药制剂的质量密切相关。本文基于中药产品质量控制的化学指纹图谱概念，提出了中药提取物粉末质量评价的物理指纹图谱方法。这种新型物理指纹图谱由雷达图构建而成，包括五个主要指标（即堆积性、均匀性、流动性、可压性和稳定性）和12个次要指标（即堆密度、振实密度、粒径<50μm百分比、相对均匀性指数、豪斯纳比、休止角、粉末流动时间、颗粒间孔隙率、卡尔指数、内聚指数、干燥失重、吸湿性）。以三七总皂苷（PNS）提取物为例，介绍了物理指纹图谱在PNS提取物粉末来源间和批次间质量一致性评价中的应用。此外，通过计算参数指标、参数轮廓指标和良好可压性指标构建了PNS的物理指纹图谱，以成功预测PNS提取物粉末以及含有PNS提取物粉末和常规药用辅料的相关制剂的可压性。结果表明，所提出的方法不仅能为中药固体制剂的开发和过程控制提供新的思路。
