Novel approaches to standardisation of medicinal herb extracts for consistent clinical outcomes


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Phytochemical consistency is pivotal to defining quality of medicinal herb extracts and this in turn influences efficacy outcomes.  Meta-analysis data of clinical trials of commercial medicinal herb preparations and possible phytochemical variations among these preparations illustrates the need to achieve phytochemical consistency.  Awareness of innate, constitutive and induced phytochemical variations as well as manufacturing process influenced variations in medicinal herb preparation is critical in developing processes for phytochemical consistency. Phytochemical profiling of the medicinal herb extract, along with marker assays, provides an insight into the phytochemical consistency and variations.   A true 'holistic' profiling of secondary metabolites in any given extract may be difficult to achieve;  yet use of multiple hyphenated detection techniques in analysis provides a substantial information on secondary metabolite profile characteristics  Application of multi-variate, chemometrics methods, such as Principal Component Analysis and Parallel Factor Analysis (PARAFAC) to  multi-batch profile data provides quantitative information on variation and consistency of medicinal herb preparations. Sourcing 'homogeneous' medicinal herb starting material through Good Agricultural and Collection Practices, application of consistent cGMP in manufacture and utilisation of validated chromatographic techniques are critical to achieve profile consistency. These aspects are discussed with two commercial medicinal herb preparations, AP-Bio┬« (Andrographis paniculata leaf extract) and BacoMind┬« (Bacopa monnieri herb extract) as examples, by providing extract profiles of multiple batches and application of chemometric analysis.  

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