Saponins are a class of important active ingredients. Analysis of saponin-containing herbal medicines is a major challenge for the quality control of medicinal herbs in companies. Taking the medicine Astragali radix (AR) as an example, it has been shown that the existing evaporative light scattering detection (ELSD) methods of astragaloside IV (AG IV) has the disadvantages of time-consuming sample preparation and low sensitivity. The universality of ELSD results in an inapplicable fingerprint with huge signals from primary compounds and smaller signals from saponins. The purpose of this study was to provide a practical and comprehensive method for the quality control of the astragalosides in AR. A simple sample preparation method with sonication extraction and ammonia hydrolyzation was established, which shortens the preparation time from around 2 days to less than 2 h. A UPLC-QDA method with the SIM mode was established for the quantification of AG IV in AR. Methanol extract was subjected to UPLC-QDA for fingerprinting analysis, and the common peaks were assigned simultaneously with the QDA. The results showed that with the newly established method, the preparation time for a set of samples was less than 90 min. The fingerprints can simultaneously detect both saponins and flavonoids in AR. This simple, rapid, and comprehensive UPLC-QDA method is suitable for quality assessment of RA and its products in companies, and also provides references for the quality control of other saponin ingredients without UV absorption.

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.