The German Pharmacopoiea ( Deutsches Arzneibuch , or DAB ) contains monographs on the quality and standards of many herbal drugs, medicinal plant preparations, and natural substances (e.g., essential oils) sold in Germany. As is customary in pharmacopoeial standards monographs, the approved medicinal uses of the herb are not listed, but instead they contain the standards for assuring the proper identity and purity of the herbal drug. This section contains six monographs as examples of the level of quality control measures required for manufacturers of phytomedicines in Germany. Included are monographs taken from DAB 8, DAB 9, and DAB 10: Hawthorn fluidextract DAB 10 (Crataegi extractum fluidum), Hawthorn leaf with flower (Crataegi folium cum flore), Horse Chestnut seed (Hippocastani semen), Standardized Horse Chestnut seed extract (Hippocastani semen extractum siccum normatum), Lemon Balm DAB 10 (Melissae folium), and Milk Thistle fruit (Cardui mariae fructus). When the work of Commission E was terminated in 1994, DAB 10 was valid; currently DAB 1997 is valid (Schilcher, 1997b). ABC received permission to reprint translations of these monographs from the publisher , Deutscher Apotheker Verlag in Stuttgart, Germany. Consistent with European harmonization efforts, current work on updating the monographs for the DAB is being conducted in concert with the European Pharmacopoeia (Koerner, 1997).

We are grateful to Dr. A. Artiges of the European Pharmacopoeia Commission of the European Department for the Quality of Medicines, the Council of Europe, Strasbourg, France, for permission to include several samples of the monographs for herbal drugs. These monographs represent quality and identity standards and test methods for many herbal drugs sold in Europe and are included in this book as examples of monographs produced to help ensure proper identity and quality of herbal drugs. Monographs for the European Pharmacopoeia are produced by a joint effort of scientists and health professionals from many countries in Western Europe.

We have included sections explaining methods for formulation of leading dosage forms: Extracta (extracts), Pulveres (powders), and Tincturae (tinctures). These sections include definitions of the dosage forms and instructions in their preparation. We also include the following six monographs on herbal drugs: Hamamelidis Folium (Witch Hazel leaf), Matricariae Flos (German Chamomile flower), Sennae Folium (Senna leaf), Sennae Fructus Acutifoliae (Alexandrian Senna pods), Sennae Fructus Angustifoliae (Tinnevelly Senna pods), and Valerianae Radix (Valerian root). These monographs do not include therapeutic information found in those produced by Commission E; they include only pharmaceutical quality parameters and methods, including methods to determine identity, and descriptions of tests and assay methods to determine purity, including the types of reagents and related chemicals required.

In 1975 the European Economic Community (EEC) published Directive 75/318/EEC dealing with the special problems associated with herbal medicines (e.g., multiple chemical compounds and the variability of these compounds). In particular, the directive attempts to clarify distinctions between herbs and conventional drugs ("chemically defined active ingredients"). The directive notes, "Consistent quality for products of vegetable origin can only be assured if the starting materials are defined in a rigorous and detailed manner, including the specific botanical identification of the plant material used. It is also important to know the geographical source and conditions under which the vegetable drug is obtained in order to ensure material of a consistent quality." (EEC, 1975.) This section includes guidelines for qualitative and quantitative details of the constituents, descriptions of the method of preparation, quality control of the herbal preparations (if different from the dried herb, e.g., analysis of the starting material, tests for microbiological quality, detection of pesticide residues, fumigants, solvents, radioactivity, heavy metals, etc.), and other control tests that must be conducted during the manufacturing process.