- Plants are complex multicomponent mixtures and their composition depends on many external factors.
- Starting materials need to be correctly authenticated and must be free of adulterants and contaminants.
- The production process of herbal medicinal products needs to be strictly monitored and standarized.
- For valid and reproducible pharmacological and toxicological studies, products must be characterized.
- Knowledge on ADME characteristics of the bioactive constituents is essential.
As all medicines, herbal medicinal products are expected to be safe, effective, and of appropriate quality. However, regulations on herbal medicinal products vary from country to country, and herbal preparations do occur not only in the form of medicinal products but also as less strictly regulated product groups like dietary supplements. Therefore, it is not always easy for the consumers to discriminate high-quality products from low-quality products. On the other hand, herbal medicines have many special features that distinguish them from conventional medicinal products. Plants are complex multicomponent mixtures; in addition, their phytochemical composition is not constant because of inherent variability and a plethora of external influences.
Therefore, the production process of an herbal medicinal product needs to be strictly monitored. First of all, the starting materials need to be correctly authenticated and free of adulterants and contaminants. During plant growth, many factors like harvest season and time, developmental stage, temperature, and humidity have a strong impact on plant metabolite production. Also, postharvest processing steps like drying and storage can significantly alter the phytochemical composition of herbal material. As the production of many phytopharmaceuticals includes an extraction step, the extraction solvent and conditions need to be optimized in order to enrich the bioactive constituents in the extract. The quality of finished preparations needs to be determined either on the basis of marker constituents or on the basis of analytical fingerprints. Thus, all production stages should be accompanied by appropriate quality assessment measures. Depending on the particular task, different methods need to be applied, ranging from macroscopic, microscopic, and DNA-based authentication methods to spectroscopic methods like vibrational spectroscopy and chromatographic and hyphenated methods like HPLC, GC–MS and LC–MS.
Also, when performing pharmacological and toxicological studies, many features inherent in herbal medicinal products need to be considered in order to guarantee valid results: concerning in vitro studies, difficulties are often related to lacking knowledge of ADME characteristics of the bioactive constituents, nuisance compounds producing false positive and false negative results, and solubility problems. In in vivo animal studies, the route of administration is a very important issue. Clinical trials on herbal medicinal products in humans very often suffer from a poor reporting quality. This often hampers or precludes the pooling of clinical data for systematic reviews. In order to overcome this problem, appropriate documentation standards for clinical trials on herbal medicinal products have been defined in an extension of the CONSORT checklist.
This article is part of a Special Issue entitled “Botanicals for Epilepsy”.
- AAS, atomic absorption spectrometry;
- CAD, charged aerosol detector;
- CE, capillary electrophoresis;
- CZE, capillary zone electrophoresis;
- DAD, diode array detector;
- DSHEA, Dietary Supplement Health and Education Act;
- ELSD, electric light scattering detector;
- EMA, European Medicines Agency;
- FID, flame ionization detector;
- GACP, good agricultural and collection practice;
- GC, gas chromatography;
- GMP, good manufacturing practice;
- HILIC, hydrophilic interaction chromatography;
- HPLC, high-performance liquid chromatography;
- HR-MS, high-resolution mass spectrometry;
- ICP-OES, inductively coupled plasma-optical emission spectrometry;
- IR, infrared;
- MEKC, micellar electrokinetic chromatography;
- MIR, mid-infrared;
- MS, mass spectrometry;
- NIR, near-infrared;
- NMR, nuclear magnetic resonance;
- TCM, traditional Chinese medicine;
- TLC, thin layer chromatography;
- UHPLC, ultrahigh-pressure liquid chromatography;
- WHO, World Health Organization;
- XRFS, X-ray fluorescence spectroscopy
- Herbal medicinal products;
- Quality control
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