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Related Experiment Videos

Pharmaceutical prerequisites for a multi-target therapy.

U Kroll1, C Cordes

  • 1Steigerwald Arzneimittelwerk GmbH, Darmstadt, Germany. kroll@steigerwald.de

Phytomedicine : International Journal of Phytotherapy and Phytopharmacology
|July 22, 2006
PubMed
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Ensuring phytomedicine quality requires rigorous control from herbal drug cultivation to finished product manufacturing. This involves pharmacognostic methods, fingerprint chromatograms, and marker substance quantification for multi-component preparations like Iberogast.

Area of Science:

  • Pharmacognosy and Phytomedicine Quality Control
  • Herbal Drug Standardization and Analysis
  • Good Manufacturing Practice (GMP) in Herbal Products

Background:

  • Phytomedicine quality hinges on herbal drug sourcing, preparation manufacturing, and final product characteristics, adhering to Good Manufacturing Practice (GMP).
  • Quality control integrates pharmacognostic methods, fingerprint chromatograms, marker substances, physicochemical properties, and microbiological monitoring.
  • Multi-component herbal preparations demand stringent quality assurance for all constituents and their combined effect, as seen with Iberogast (STW 5).

Purpose of the Study:

  • To detail the pharmaceutical prerequisites for ensuring the quality of individual components and the combined preparation of a multi-component phytomedicine.
  • To illustrate the necessary investigations for quality control using Iberis amara extract as an example.

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  • To demonstrate the importance of Good Agricultural Practice (GAP) and advanced analytical methods for standardization.

    • Main Methods:

    • Cultivation of plant material under Guidelines for Good Agricultural Practice (GAP) to ensure high-quality raw material.
    • Identification of characteristic compounds within extracts.
    • Development and application of analytical methods, including High-Performance Liquid Chromatography (HPLC), for standardized extracts and the finished product.

    Main Results:

    • Variability in plant material from natural habitats necessitates defined cultivation and analytical controls.
    • Identification of characteristic compounds and exemplary chromatograms are crucial for fingerprint evaluation and quantification.
    • Analytical data supports the characterization of the active substance profile in the finished product.

    Conclusions:

    • Comprehensive quality control, from cultivation (GAP) to manufacturing (GMP), is essential for consistent and effective phytomedicines.
    • Standardized extracts and defined marker substances are critical for ensuring the quality of multi-component herbal preparations.
    • Robust analytical methodologies, like HPLC, are indispensable for characterizing and quantifying active compounds in herbal medicines.