A Strategy for Selecting "Q-Markers" of Chinese Medical Preparation via Components Transfer Process Analysis with Application to the Quality Control of Shengmai Injection.

Zheng Li,Peiqi Miao,Chunxia Zhao,Houen Wang,Huan Liu,Heshui Yu,Chunhua Wang

doi:10.3390/molecules24091811

Zheng Li, Peiqi Miao + Show 5 more

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https://doi.org/10.3390/molecules24091811

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Abstract

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.

Highlights

Due to the diversity of chemical components in traditional Chinese medicine (TCM), the complexity of its mechanism of action, and the variability of the preparation process, the quality assurance is more difficult than chemical and biological drugs and necessitated the establishment of a unique quality and bioactivity evaluation system to ensure the safety and effectiveness of TCMs [1,2,3].Professor Liu Changxiao introduced a new concept on the quality marker (Q-marker) for quality assessment and process control of TCMs [4]
The representative based peak intensity (BPI) chromatograms of Shengmai injection (SMI) illustrated in Figure 1 and the negative ion BPI chromatogram of reference standards of ginsenosides illustrated in Molecules 2019, 24, x
(R2 satisfactory reproducibility which would be adopted for the quality assessment and control of SMI

Summary

Introduction

Due to the diversity of chemical components in traditional Chinese medicine (TCM), the complexity of its mechanism of action, and the variability of the preparation process, the quality assurance is more difficult than chemical and biological drugs and necessitated the establishment of a unique quality and bioactivity evaluation system to ensure the safety and effectiveness of TCMs [1,2,3].Professor Liu Changxiao introduced a new concept on the quality marker (Q-marker) for quality assessment and process control of TCMs [4]. Due to the diversity of chemical components in traditional Chinese medicine (TCM), the complexity of its mechanism of action, and the variability of the preparation process, the quality assurance is more difficult than chemical and biological drugs and necessitated the establishment of a unique quality and bioactivity evaluation system to ensure the safety and effectiveness of TCMs [1,2,3]. The Q-marker is designed for quality assessment and production process control of TCM products with transitivity and traceability [4,5]. It is an important job and a great challenge to select appropriate Q-markers for quality assessment and process control of Chinese medical preparation (CMP). Jiang et al constructed a novel strategy of “Spider-web” mode to identify

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Results

Conclusion