Chinese medical preparation has complicated chemical constituents. Consequently, the proper quality control methods for these Chinese medical preparations have been great challenges to the traditional Chinese medicine modernization and internationalization. What components should be chosen for quality control is a big challenge in the development of traditional Chinese medicine. A new concept of “Quality Marker” was proposed by Liu et al. to solve this problem and established a new research paradigm for traditional Chinese medicine quality study. Several strategies were proposed by the researchers in traditional Chinese medicine, here, we used Shengmai injection as an example to discuss a strategy for selecting “Quality Markers” of Chinese medical preparation by the components transfer process analysis in the Shengmai injection manufacturing process. Firstly, a total of 87 compounds were identified or partially characterized in shengmai injection. Secondly, referenced to the quality control method in China pharmacopeia and considered the biomarkers in the original medicines and representative components in the manufacturing process, four ginsenosides in Panax ginseng (Hongshen), two compounds in Schisandra chinensis (Wuweizi), and a sugar from Ophiopogon japonicas (Maidong) were quantified. As a result, these seven representative compounds exhibited an acceptable transitivity throughout the Shengmai injection manufacturing process. Finally, combined with the active ingredients, components transfer process analysis, and comprehensive evaluation by “Spider-web” analysis, six compounds were selected as the quality markers for the quality control of Shengmai injection. Through this strategy of optimization for quality markers of Shengmai injection, we found that these six compounds could represent the main bioactive substances and be easily detected in the whole process of production. Furthermore, the quality control method was developed for quality assessment and control of these six quality markers in the Shengmai injection. The total content range of the selected quality markers in the 10 batches of the Shengmai injection is 13.844-22.557 mg/mL.
A machine vision system based on a convolutional neural network (CNN) was proposed to sort Amomum villosum using X-ray non-destructive testing technology in this study. The Amomum villosum fruit network (AFNet) algorithm was developed to identify the internal structure for quality classification and origin identification in this manuscript. This network model is composed of experimental features of Amomum villosum. In this study, we adopted a binary classification method twice consecutive to identify the origin and quality of Amomum villosum. The results show that the accuracy, precision, and specificity of the AFNet for quality classification were 96.33%, 96.27%, and 100.0%, respectively, achieving higher accuracy than traditional CNN under the condition of faster operation speed. In addition, the model can also achieve an accuracy of 90.60% for the identification of places of origin. The accuracy of multi-category classification performed later with the consistent network structure is lower than that of the cascaded CNNs solution. With this intelligent feature recognition model, the internal structure information of Amomum villosum can be determined based on X-ray technology. Its application will play a positive role to improve industrial production efficiency.