Linking Chemical and Biological Characteristics in Assuring the Quality of Chinese Medicinal Materials and OTC Products

摘要

Several news-catching episodes in developed and developing communities indicate adverse effects allegedly arisen consequential to the use of complementary medicine and herbal products from various ethnic groups. Since the early 1990s, the increasing interest in Chinese medicine (CM) outside China has created several headlines on the issues of the practice and use of CM in the West. The quality control (QC) and assurance (QA), safety and efficacy assessment of herbal products present several difficulties. These OTC products contain numerous chemical compounds whose identities, structures and bioactivities are often unrelated or unknown. Focusing on Lingzhi (Ganoderma species) as an example, this paper proposes how we can produce good quality products from setting up standard operating procedures for Good Agricultural Practice (GAP) to obtain crude materials with acceptable constancy to finished products with QC/QA assessment. It is proposed that fingerprinting and pattern recognition techniques can be used as important steps to characterise the chemical and biological properties of herbal medicines and Lingzhi products for their QC/QA.