Abstract
Due to the complex nature of traditional medicines, quality control methods need to cover two aspects: compliance of raw materials with quality standards and process control. Astragali radix (AR), the roots of Astragalus mongholicus Bunge, was selected in this study as an example of a widely used traditional medicine in various formulations. Astragaloside IV (AG IV) and calycosin 7-O-β-D-glucoside (CG) are used as the markers for the quality control of AR and its products in the Chinese Pharmacopoeia. However, in the raw materials, malic acid esters of the CG and acetate esters of the astragaloside are easily decomposed into CG and AG IV during storage and processing of AR to make extracts for various preparations. The thermal stability of the isoflavonoids and astragalosides in decoction was studied. The level of CG and astragalosides (AG I/AG II/AG IV) was strongly affected by prolonged heat during processing, while calycosin was stable in the conditions. Also the major astragalosides in AR could fully converted into AG IV which eventually reaches a stable level under certain conditions. With calycosin and AG IV as marker components, practical, reproducible, and precise methods were established and applied to the quality analysis of AR from its raw materials to its intermediates and products. This study demonstrates that a full chemical profiles analysis of the whole manufacturing process (from “raw materials—intermediates/extracts—final product”) is important to identify quality markers (Q-markers) and even to establish proper analysis methods for traditional Chinese medicine products.
Highlights
Astragali radix (AR) (Huang Qi in Chinese) is derived from the dried roots of Astragalus mongholicus or A. membranaceus (Fisch.) Bge (National Commission of Chinese Pharmacopoeia, 2015)
This study demonstrates how to develop quality control methods for to ProductsChinese patent medicines (TCPMs) that are independent of processing in the whole production chain from raw materials to its final products
The results showed that the relative peak area (RPA) of Astragaloside I (AG I), isoastragaloside I (iAG I) and iAG II decreased significantly with heating, while the RPA of Astragaloside IV (AG IV) increased significantly
Summary
Astragali radix (AR) (Huang Qi in Chinese) is derived from the dried roots of Astragalus mongholicus or A. membranaceus (Fisch.) Bge (National Commission of Chinese Pharmacopoeia, 2015). For more than 2,000 years it is one of the most widely used Chinese herbal medicines and functional food for reinforcing “Qi” (vital energy). It’s traditionally used for revitalizing, tonifying, skin reinforcement diuretic, abscess-draining, and tissue-generative purpose (National Commission of Chinese Pharmacopoeia, 2015). Quality Control Markers Form Raw Materials to Products. Chinese patent medicines (TCPMs) containing AR described in the Chinese Pharmacopoeia (2015 version) (National Commission of Chinese Pharmacopoeia, 2015). The manufacturing processes of these products must at least include the extraction of AR pieces with hot water, followed by concentration of the decoction (National Commission of Chinese Pharmacopoeia, 2015). For a proper quality control ensuring reproducible end products, Q-markers are required that have a stable level during the whole production process. The Q-markers should be chemically stable and its levels can be followed during the whole manufacturing process. Whole process (i.e., from “raw materials—intermediates/extracts—final product”) analysis is very necessary to identify Q-markers
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