Phytopharmaceutical

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A phytopharmaceutical ( Greek : φυτόν phyton (plant) and φάρμακον pharmakon (medicine)) is a finished medicinal product used in phytotherapy , the active components of which are exclusively of herbal origin. A phytopharmaceutical consists of one or more herbal active ingredients , whereby the herbal active ingredients are mostly themselves multicomponent mixtures of different plant ingredients.

Classification

Depending on the evidence for their effectiveness, a distinction is made between rational and traditionally used herbal medicinal products:

  • If the application is based on rational, scientifically verifiable data, for example from clinical studies , one speaks of rational phytopharmaceuticals.
  • The use of traditional phytopharmaceuticals, on the other hand, is based on their many years of application experience.

The transcultural phytopharmaceuticals include, for example, preparations from Ayurvedic medicine and traditional Chinese medicine . Homeopathic and anthroposophic medicinal products , on the other hand, are generally not regarded as phytopharmaceuticals. An assignment of homeopathic low potencies or mother tinctures to the phytopharmaceuticals, as well as the inclusion of natural substance mixtures, is controversially discussed.

Accordingly, there are various options for market access for phytopharmaceuticals. In EU countries, authorization must be applied for for rationally used herbal medicinal products. If it is a "generally medicinally used" medicinal product, other "scientific evidence" (e.g. literature data) can be submitted instead of own clinical studies. For traditionally used phytopharmaceuticals, a simplified procedure for obtaining a marketing permit is possible in the EU countries, called "registration" in Germany.

composition

A phytopharmaceutical consists of one or more active substances within the meaning of the substance term in pharmaceutical law . These in turn usually represent a complex mixture of different plant constituents. A distinction can be made between main constituents, key substances , accompanying substances and builders. The main ingredients are those plant ingredients that have an effect-determining or effect-co-determining character. The main ingredients that clearly determine the effect, such as the anthranoids of senna leaves , are also referred to as effectors. Key substances are plant constituents that are used in analysis for phytochemical identification. Accompanying substances, also known as coeffectors, are not directly involved in the effect of the phytopharmaceutical, but can indirectly influence the effect of the main ingredients , for example by influencing the pharmacokinetics . Plant constituents from the cellular or extracellular matrix, which were responsible for the structure and stability of the plant, are called builders. In addition, phytopharmaceuticals can also contain non-herbal auxiliaries that are important for the manufacture of a finished medicinal product.

Many herbal medicines contain dried plant parts or simple extracts made from them . So-called special extracts, on the other hand, are produced using a complex, multi-stage extraction and purification process. This removes unwanted ingredients and enriches the desired substances that determine the effectiveness. The use of special extracts has several advantages. In this way, the concentration of active ingredients in the special extract can be increased. Smaller amounts of a substance are required for the same effect. Unwanted by-products are removed during the extraction, the phytopharmaceutical is better tolerated. The composition and amount of the ingredients are standardized. This guarantees consistent quality.

Market in Germany

Sales of herbal medicinal products increased by 3.2 percent to 1.7 billion euros in 2017. Sales amounted to 175 million packs and were down slightly. The share of over-the-counter phytopharmaceuticals and homeopathic medicines in the pharmacy market (including mail order) made up 31 percent of sales with over-the-counter medicines.

Preparations of the phytopharmaceuticals sold in 2017 (in million packs) are respiratory / cold remedies (57), stomach and digestive aids ( 14), sedatives and sleeping pills (8), urological and urinary system drugs (7), and muscle and joint pain relievers (5), laxatives (4), blood circulation- enhancing (3) and other cardiovascular agents (3).

The use of herbal medicinal products is widespread in Germany among children and adolescents between the ages of 0 and 17 and is higher than in other countries by international standards. This was the result of an analysis of the data from the KiGGS study for children and adolescents.

See also

literature

Individual evidence

  1. ↑ a b c Heinz Schilcher , Susanne Kammerer, Tankred Wegener: Guide to Phytotherapy. 3. Edition. Elsevier, Urban & Fischer, Munich / Jena 2007, ISBN 978-3-437-55342-4 , chapter Fundamentals of rational phytotherapy. Pp. 1-30.
  2. ↑ PW Elsinghorst u. a .: The thermal and enzymatic taxifolin-alphitonin rearrangement. In: Journal of Natural Products . Vol. 74, No. 10, October 28, 2011, pp. 2243-2249. PMID 21992235 .
  3. ↑ a b The drug market in Germany. Facts and figures, 2017. According to the Federal Association of Drug Manufacturers .
  4. ↑ Y. Du, IK Wolf, W. Zhuang, S. Bodemann, W. Knöss, H. Knopf: Use of herbal medicinal products among children and adolescents in Germany. In: BMC Complement Altern Med. 14, Jul 2, 2014, p. 218. PMID 24988878 .