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

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.

Screening of quality markers of Jie-Geng decoction based on integration of multiple methods

“…It is widely used in the traceability system of quality process control. Zhao [16] screened Q-markers using the strategy of analyzing the transfer of compounds in shengmai injection, and applied the results for quality control. Moreover, Liao [17] applied chemical analysis and network pharmacology for screening Q-markers of Alisma orientale.…”

Research Progress in Chinese Herbal Medicines for Treatment of Sepsis: Pharmacological Action, Phytochemistry, and Pharmacokinetics

“…Zhao et al identified or partially characterized 87 herbal compounds in SMI and selected 6 bioactive constituents (four ginsenosides (i.e., Rg 1 , Re, Rb 1 , and Rd) and 2 lignans (i.e., schisandrol A and schisandrol B) with high content levels as quality markers (Q-markers). The total content range for these selected Q-markers in 10 batches of SMI was 13.8-22.5 mg/mL [182]. Wu et al identified 92 compounds (i.e., 49 ginsenosides, 31 lignans, 5 steroidal saponins, and 7 homoisoflavanones) in SMP and discovered a class of 25-hydroxyginsenosides for the first time [183].…”

Establishing a chromatographic fingerprint using tandem UV/charged aerosol detection and similarity analysis for Shengmai capsule: A novel method for natural product quality control

“…8,12 In addition, a few studies determined the contents of steroid saponins and saccharides of Shengmai preparations by using an evaporative light scattering detector (ELSD). 13 Quantitative analysis method were mainly focused on the a single marker or a few markers, which is not enough to reflect and control the quality of Shengmai preparations. 12 While fingerprints can comprehensively reflect the overall chemical composition characteristics of traditional Chinese medicine and have been widely used.…”

“…However, only ionized compounds can be detected, and the comparatively high detection cost is the limitation of MS. 12 Furthermore, the HPLC-ELSD technique was also utilized to detect saponins and sugars in the preparations. 13,15 However, the methods could not provide high-efficiency analysis due to low sensitivity and the narrow linear range. 13,16 Moreover, some researchers have used charged aerosol detectors (CADs) to detect the carbohydrates in the Yiqifumai lyophilized injections.…”

“…13,15 However, the methods could not provide high-efficiency analysis due to low sensitivity and the narrow linear range. 13,16 Moreover, some researchers have used charged aerosol detectors (CADs) to detect the carbohydrates in the Yiqifumai lyophilized injections. 17 This detector has outstanding advantages including a high sensitivity, a low limit of detection, and high universality.…”