Chinese Medicine Regulatory Office

Analysis of Chemical Markers in Compound Chinese Medicine Granules

• Introduction
• Organisation Chart
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• Our Laboratories
• HKCMMS
• Research Results
• Upcoming Research Project / Research Project In Progress
• Scientific Publications
• Laboratory Accreditation

Purpose

Compound Chinese medicine granules are a modern dosage form that has rapidly emerged in recent years. They are made from a variety of Chinese herbal medicines through steps like pulverising, decorating, concentrating and etc. Due to their different formulations, their matrices and chemical compositions vary significantly. Consequently, the industry lacks highly versatile testing methods that can be used as technical guidelines or references.

This thematic project aims to establish a comprehensive system for compound Chinese medicine granules of different formulations. This project is based on four main cores of Chinese herbal medicines (Radix Paeoniae Alba (白芍), Radix Ginseng (人參), Radix Angelicae Sinensis (當歸) and Radix Rehmanniae (地黃)) to establish and validate testing methods for each of them. Not only can the testing methods effectively unify and streamline the experimental procedures, but also ensure the specificity, sensitivity and accuracy of the analytical results. The project covers both traditional and advanced techniques to analyse compound Chinese medicine granules of different formulations on the market. This ensures the applicability and effectiveness of the testing methods.

Features

• Cover four main cores of Chinese herbal medicines and establish highly versatile testing methods suitable for compound Chinese medicine granules of different formulations;
• Suit for at least ten different formulations for each main core of Chinese herbal medicines, and propose effective purification procedures to solve the interference problems from matrices or other chemical components, thereby improving the testing efficiency;
• Ensure the analysed chemical markers possess high specificity, effectively represent their main cores of Chinese herbal medicines, thus can be as the technical basis in the proprietary Chinese medicine registration;
• Validate in accordance with the quality control requirements of the Hong Kong Laboratory Accreditation Scheme to ensure the method accuracy and reliability;
• Adopt advanced and traditional instruments to achieve comprehensive and robust analysis.

Testing Methods

• Testing methods