Challenges in the Quality Control of Chinese Herbal Products

In order to guarantee efficacy and safety of Chinese herbal products it is necessary to produce them in a consistent high quality. Methods for testing identity, purity, and content are usually established in monographs of the pharmacopoeias [1]. However, already a clear botanical definition and identification of the plant material may be challenging. Often anatomical and morphological characters are not sufficient for authentication, and methods for chromatographic fingerprint analysis [2] or genetic analysis [3] have to be developed. Many Chinese herbs, like aconite, need to be properly processed in order to degrade toxic constituents. Others need to be processed to generate the active constituents. For such procedures (“paozhi”), detailed conditions need to be specified and analytical endpoints need to be defined.

By quality control also the absence of toxic constituents like aristolochic acids or pyrrolizidine alkaloids must be guaranteed. Limit tests have to be established and corresponding methods have to be developed. In order to establish relevant assays, more research is needed for the identification of the active principles. Chromatographic fingerprint analysis and principle component analysis may be a future appropriate approach in order to respect the complexity of the constituents. Correlation of metabolic profiles and pharmacological activity may be a promising strategy for quality control concepts in the future.