The case for 'quality by design' botanical testing

Review outlines the need for a unique approach for each botanical material and provides an overview of useful analytical technologies.

Having invoked the concept of building quality into a system instead of testing for it, this review covers the basic steps in botanical quality assurance, beginning with an accurate identity determination of plant material by a taxonomist. It then follows with descriptions of classical pharmacognosy techniques (macroscopic, microscopic, organoleptic) for evaluating crude herbs, discusses genetic fingerprinting, and progresses into a discussion of analytical techniques that mentions the difficulty and complexity involved in obtaining pure standard marker compounds from plant material and the subsequent validation of methods of analysis for those constituents. The review focuses on the need for a unique approach for each botanical material and provides an overview of useful analytical technologies, including high-performance thin-layer chromatography and general advances in liquid chromatography. "Holistic" chemometric techniques are discussed, where characteristic fingerprint-type information can be gleaned and identification determinations made with the proviso that some technologies, such as near-infrared spectroscopy, simply compare samples with "a compiled population of authenticated reference samples."

Journal of Natural Products
August 31, 2012; doi:10.1021/np300434j
“Implementing a "Quality by Design" Approach to Assure the Safety and Integrity of Botanical Dietary Supplements”

Natural products have provided a basis for health care and medicine to humankind since the beginning of civilization. According to the World Health Organization (WHO), approximately 80% of the world population still relies on herbal medicines for health-related benefits. In the United States, over 42% of the population claimed to have used botanical dietary supplements to either augment their current diet or to "treat" or "prevent" a particular health-related issue. This has led to the development of a burgeoning industry in the U.S. ($4.8 billion per year in 2008) to supply dietary supplements to the consumer. However, many commercial botanical products are poorly defined scientifically, and the consumer must take it on faith that the supplement they are ingesting is an accurate representation of what is listed on the label, and that it contains the purportedly "active" constituents they seek. Many dietary supplement manufacturers, academic research groups, and governmental organizations are progressively attempting to construct a better scientific understanding of natural products, herbals, and botanical dietary supplements that have co-evolved with Western-style pharmaceutical medicines. However, a deficiency of knowledge is still evident, and this issue needs to be addressed in order to achieve a significant level of safety, efficacy, and quality for commercial natural products. The authors contend that a "quality by design" approach for botanical dietary supplements should be implemented in order to ensure the safety and integrity of these products. Initiating this approach with the authentication of the starting plant material is an essential first step, and in this review several techniques that can aid in this endeavor are outlined.


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