Abstract

The herbal decoction process is generally inconvenient and unpleasant. To avoid using herbal medicine decoctions, various high-quality industrial and pharmaceutical herbal decoction products have been used in clinical applications for more than ten years in Taiwan. However, the consistency and standardization of the quality of these herbal medicines are goals that remain to be achieved. The aim of study was to develop a validated liquid chromatography-tandem electrospray ionization mass spectrometry (LC-MS/MS) method to determine the biomarkers astragaloside I, astragaloside IV, formononetin, cinnamic acid, paeoniflorin and gingerol in the herbal preparation known as Huangqi-Guizhi-Wuwu (HGW). To investigate the physical quality of HGW, methods such as scanning electron microscopy, light microscopy with Congo red and potassium iodine staining, solubility measurements, swelling power tests, and crude fiber analysis were used to identify additives in commercial pharmaceutical products. The optimal LC-MS/MS multiple reaction-monitoring system included a gradient program using 5 mM ammonium acetate buffer with 0.05% formic acid/methanol. The results demonstrate deviations in biomarker content across different brands. In addition to the herbal extract, starch and excipients in the pharmaceutical granule, and crushed crude herb powder was added to the pharmaceutical products to increase their herbal ingredient content. In conclusion, a rigorous examination should be performed to certify the quality of the herbal products.

Highlights

  • IntroductionTraditional Chinese Medicine is one of the most important medical sources for human medicines

  • Traditional Chinese Medicine is one of the most important medical sources for human medicines.The frequency and the cost of Traditional Chinese Medicine treatments have grown dramatically in recent years [1,2]

  • HGW is recorded in the Synopsis of Prescriptions of the Golden Chamber (Jingui Yaolue), a classic traditional Chinese medicine treatise with ancient and contemporary case studies

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Summary

Introduction

Traditional Chinese Medicine is one of the most important medical sources for human medicines. The frequency and the cost of Traditional Chinese Medicine treatments have grown dramatically in recent years [1,2]. Quality controls for these herbal products still do not demonstrate batch-to-batch production consistency even for those from the same industrial pharmaceutical company. Huangqi-Guizhi-Wuwu (HGW) decoction is a popular traditional Chinese prescription that ameliorates peripheral diseases such as diabetic peripheral neuropathy. This herbal formulation is combined with acupuncture for the treatment of lymphedema [3]. HGW is recorded in the Synopsis of Prescriptions of the Golden Chamber (Jingui Yaolue), a classic traditional Chinese medicine treatise with ancient and contemporary case studies

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