Development of a comprehensive method combining UHPLC-CAD fingerprint, multi-components quantitative analysis for quality evaluation of Zishen Yutai Pills: A step towards quality control of Chinese patent medicine.

Zishen Yutai Pills (ZYP) is a well-known Chinese patent medicine which has been used to prevent recurrent miscarriage and treat threatened abortion in China. In this study, a comprehensive strategy combining ultrahigh performance liquid chromatography coupled with charged aerosol detector (UHPLC-CAD) fingerprint and multi-components quantitative analysis was developed and validated for quality evaluation of ZYP. For fingerprint analysis, a total of 52 characteristic peaks were selected to evaluate the similarities of 16 batches of ZYP. In addition, combining the chemical fingerprint profile with an advanced hybrid LTQ-Orbitrap mass spectrometer, 281 compounds were identified or tentatively identified in ZYP based on chemical standards, accurate mass and fragmentation information. Moreover, 18 chemical markers were simultaneously determined within 13 min by ultra-performance liquid chromatography couple to tandem mass spectrometry (UPLC-MS/MS) with positive-negative conversion multiple reaction monitor (+/-MRM) technique. This method has been validated and exhibited satisfactory sensitivity, precision, reproducibility and accuracy. The validated quantitative method was successfully applied to the analysis of 16 batches of ZYP samples. The combination of UHPLC-CAD fingerprint and multi-components quantification has been proved to be an efficient and reliable strategy for quality control of ZYP and could be considered as a reference for quality evaluation of Chinese patent medicine.

Multiple fingerprint profiling for quality evaluation of polysaccharides and related biological activity analysis of Chinese patent drugs: Zishen Yutai Pills as a case study.

ETHNOPHARMACOLOGICAL RELEVANCE: Zishen Yutai Pills (ZYP), a famous traditional Chinese patent medicine, has been widely applied to avoid recurrent miscarriage and treat threatened abortion. Polysaccharides of ZYP (ZYPPs) play an essential role in the theraprutic effects of ZYP. However, the complex compositions of ZYP and the complicated structure of ZYPPs have posed great challenges and barriers to the quality evaluation of ZYP. AIM OF THE STUDY: To identify and characterize the ZYPPs for better quality control of ZYP, a reliable and valid quality control system was established in this study. MATERIALS AND METHODS: A multi-fingerprint profile strategy based on HPSEC-MALL-RID, FT-IR, and HPLC (complete acid digested fingerprint, partial acid digested fingerprint and enzymatically digested fingerprint) was established to identify and discriminate the chemical structure of ZYPPs. Besides, the purpose of revealing the relationships between structure and biological activity of ZYPPs, their chemical characteristics, in vitro antioxidant and anti-glycation activities were investigated and discussed. RESULTS: The similarity evaluation of ZYPPs indicated ZYPPs from different batches showed a high similarity based on the correlation coefficient values of multi-fingerprints. Furthermore, ZYPPs exhibited remarkable antioxidant and antiglycation properties, which might be attributed to their molecular weights and the content of uronic acids. CONCLUSIONS: These results indicated that the multiple fingerprint technique was reliable and effective for the improvement of quality control of ZYPPs, suggesting the multiple fingerprint technique could also be potentially applied as a valid and feasible strategy to control the quality of polysaccharide-enriched herbal medicines.

[Rapid determination of puerarin in Xiaoke pill powder by near-infrared spectroscopy].

OBJECTIVE: To determine the content of puerarin in Xiaoke pill powder rapidly by near-infrared spectroscopy. METHOD: Near-infrared diffuse reflectance spectroscopy technology was used to collect NIR spectra of Xiaoke pills powder. With HPLC analysis values as reference, the fast determination method of puerarin was established with partial least squares (PLS). RESULT: The R2, RMSECV and RPD of the calibration model for puerarin were 0.980 1, 0.131 and 7.09. The average relative deviation of the predication set was 3.2%. CONCLUSION: The method is accurate, fast and simple, which could be generalized to the on-line quality control of Xiaoke pill powder production.