Combining UHPLC with DAD and MS/MS for Quality Evaluation of Chinese Allergy Pill


Xinyi Biyan is a Chinese patent medicine with significant therapeutic effects, widely used clinically to treat acute and chronic rhinitis or allergic rhinitis.

All different types of seasonal allergies are either ramping up or peaking at this time of the spring, but how can you tell if the rhinitis you may be experiencing is of the allergic or non-allergic variety, and what can you do to treat it?

Chinese herbal medicine selection on calligraphy background | Image Credit: © zhikun sun -

Chinese herbal medicine selection on calligraphy background | Image Credit: © zhikun sun -

A study recently appearing in the Journal of Pharmaceutical and Biomedical Analysis touted the benefits of the Xinyi Biyan Pill (XBP, also stylized elsewhere as Xin Yi Bi Yan), which is a classical Chinese patent medicine (CPM) clinically identified as an herbal treatment for acute and chronic rhinitis, as well as allergic rhinitis, within the field of traditional Chinese medicine (TCM) (1).

Allergic rhinitis, specifically, is characterized by sneezing, nasal itching, runny nose, and congestion following inflammation of nasal mucosa when exposed to allergens, according to the Encyclopedia of Respiratory Medicine (2). It is related to sinusitis but can also be associated with such conditions as asthma or conjunctivitis, and even in the Encyclopedia’s 2006 entry on the subject, nearly two decades ago, allergic rhinitis was said to have grown to epidemic levels.

The 10 authors of this more recent study—a collaboration of researchers from Chengdu University of Traditional Chinese Medicine in Chengdu, China, Shenzen Technology University in Shenzen, China, Southwest Medical University in Luzhou, China, Guangzhou Baiyunshan Zhongyi Pharmaceutical Co., and the State Key Laboratory of Quality Research in Chinese Medicine—identified 13 Chinese herbal medicines (CHMs) in XBP: Magnoliae Flos, Menthae Haplocalycis Herba, Perillae Folium, Glycyrrhizae Radix et Rhizoma, Pogostemonis Herba, Xanthii Fructus, Centipeda Herba, Isatidis Radix, Angelicae Dahuricae Radix, Saposhnikoviae Radix, Houttuyniae Herba, Chrysanthemi Flos and Melicope Pteleifolia (1).

What, then, can be learned by further breaking apart XBP at the molecular level? The researchers endeavored to do that by combining ultrahigh-pressure liquid chromatography (UHPLC) with a diode array detector (DAD) for a fingerprint analysis and quality evaluation of 12 batches of XBP, which were then further analyzed for chemical markers by UHPLC coupled to tandem mass spectrometry (MS/MS) (1).

The results of the first leg of the analysis yielded 141 compounds of XBP either preliminarily characterized or outright identified in both positive and negative ion modes, when coupled with a hybrid linear ion trap-Orbitrap mass spectrometer (1). In the subsequent UHPLC–MS/MS process, 10 chemical markers were simultaneously determined within 15 min, and applied to the overarching analysis of the 12 batches of XBP.

The researchers concluded that the combination of these methods could be useful as a reference for future overall quality consistency evaluations of CPMs. They reported that, relative to the findings they sought, these approaches based on UHPLC were sufficiently precise, accurate, reliable and repeatable (1). Moreover, they found consistency among the 12 samples of XBP, lending credence to its effectiveness in treating rhinitis in all its forms.


(1) Lu, Y.; He, Z.; Wang, Q.; et al. An Advanced Strategy for Quality Evaluation of Xinyi Biyan Pill by UPLC-DAD Fingerprinting Combined with Multi-Components UPLC-MS/MS Analysis. J. Pharm. Biomed. Anal. 2024, 239, 115858. DOI: 10.1016/j.jpba.2023.115858

(2) van Cauwenberge, P.; Watelet, J.- B.; Van Zele, T.; Van Hoecke, H. Allergy | Allergic Rhinitis. In Encyclopedia of Respiratory Medicine; Laurent, J. G., Shapiro, S. D., Eds.; Academic Press, 2006; pp 80–92. DOI: 10.1016/B0-12-370879-6/00023-5

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