Similarity Evaluation on the Compound TCM Formulation "Huoling Shengji Granule" and Its Placebo by Intelligent Sensory Evaluation Technologies and the Human Sensory Evaluation Method Based on Critical Quality Attributes.

To evaluate the similarity of Huoling Shengji granule (HLG) and its placebo at both granules and solution status, the innovative methods that consist of intelligent sensory evaluation technologies and human sensory evaluation methods were developed based on critical quality attributes (CQAs) of granule. The CQAs for traditional Chinese medicine (TCM) placebo granule were mainly divided into three categories: formulation attributes, visual attributes, and attributes of taste and smell. In this investigation, the novel intelligent sensory evaluation technologies including the physical property testing apparatus, computer vision system, color card, and electronic tongue (E-tongue) were employed for characterization of CQAs of HLG and its placebo. Meanwhile, human sensory evaluation by test panels was used to description the HLG and its placebo in terms of appearance, color, taste, and smell. On that basis, the similarity of placebo to CQAs of HLG was assessed by calculating the angle cosine values. The intelligent and human sensory evaluation results showed that the similarity values of HLG and its placebo about the CQAs at granule and solution status were all close to 1, which means that the two preparations have high similarities. In this study, the established similarity evaluation methods based on the CQAs were convenient and reliable, which can be utilized to evaluate the similarity of TCM granule and their placebo at granule and solution status, and demonstrated to be well applied in placebo-controlled trials.