Herbal drug preparations

EUROPEAN PHARMACOPOEIA 5.0

or animal matter to be extracted is always covered with the remaining extraction solvent. The residue may be pressed out and the expressed liquid combined with the percolate. TESTS Relative density (2.2.5). Where applicable, the tincture complies with the limits prescribed in the monograph. Ethanol (2.9.10). The ethanol content complies with that prescribed. Methanol and 2-propanol (2.9.11) : maximum 0.05 per cent V/V of methanol and maximum 0.05 per cent V/V of 2-propanol, unless otherwise prescribed. Dry residue (2.8.16). Where applicable, the tincture complies with the limits prescribed in the monograph, corrected if necessary, taking into account any excipient used. STORAGE Protected from light. LABELLING The label states in addition to the requirements listed above : for tinctures other than standardised and quantified tinctures, the ratio of starting material to extraction liquid or of starting material to final tincture, the ethanol content in per cent V/V in the final tincture.

01/2005:1434

HERBAL DRUG PREPARATIONS Plantae medicinales praeparatore

DEFINITION Herbal drug preparations are obtained by subjecting herbal drugs to treatments such as extraction, distillation, expression, fractionation, purification, concentration or fermentation. These include comminuted or powdered herbal drugs, tinctures, extracts, essential oils, expressed juices and processed exudates. Herbal teas comply with the monograph on Herbal teas (1435). Instant herbal teas consist of powder or granules of one or more herbal drug preparation(s) intended for the preparation of an oral solution immediately before use. 01/2005:1433

HERBAL DRUGS Plantae medicinales

DEFINITION Herbal drugs are mainly whole, fragmented or cut, plants, parts of plants, algae, fungi, lichen in an unprocessed state, usually in dried form but sometimes fresh. Certain exudates that have not been subjected to a specific treatment are also considered to be herbal drugs. Herbal drugs are precisely defined by the botanical scientific name according to the binominal system (genus, species, variety and author). PRODUCTION Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations. They are not rotten. If a decontaminating treatment has been used, it is necessary to demonstrate that the constituents of the plant are not affected and that no harmful residues remain. The use of ethylene oxide is prohibited for the decontamination of herbal drugs.

Soft extracts extracta spissa

DEFINITION Soft extracts are semi-solid preparations obtained by evaporation or partial evaporation of the solvent used for extraction. TESTS Dry residue (2.8.16). The soft extract complies with the limits prescribed in the monograph. Solvents. Where applicable, a monograph on a soft extract prescribes a limit test for the solvent used for extraction. STORAGE Protected from light.

Dry extracts extracta sicca

DEFINITION

IDENTIFICATION Herbal drugs are identified using their macroscopic and Dry extracts are solid preparations obtained by evaporation microscopic descriptions and any further tests that may be of the solvent used for their production. Dry extracts usually required (for example, thin-layer chromatography). have a loss on drying or a water content of not greater than TESTS 5 per cent m/m. A test for foreign matter (2.8.2) is carried out, unless TESTS otherwise prescribed in the individual monographs. A specific appropriate test may apply to herbal drugs liable Water (2.2.13). Where applicable, the dry extract complies to be falsified. with the limits prescribed in the monograph. If appropriate, the herbal drugs comply with other tests, for Loss on drying (2.8.17). Where applicable, the dry extract example, total ash (2.4.16), ash insoluble in hydrochloric complies with the limits prescribed in the monograph. acid (2.8.1), extractable matter, swelling index (2.8.4) and Solvents. Where applicable, a monograph on a dry extract bitterness value. prescribes a limit test for the solvent used for extraction. The test for loss on drying (2.2.32) is carried out on herbal drugs, unless otherwise prescribed in the individual STORAGE monographs. A determination of water (2.2.13) is carried In an airtight container, protected from light. out for herbal drugs with a high essential oil content. 572 See the information section on general monographs (cover pages)

EUROPEAN PHARMACOPOEIA 5.0

Immunosera for human use, animal

Herbal drugs comply with the requirements for pesticide residues (2.8.13). The requirements take into account the nature of the plant, where necessary the preparation in which the plant might be used, and where available the knowledge of the complete record of treatment of the batch of the plant. The content of pesticide residues may be determined by the method described in the annex to the general method. The risk of contamination of herbal drugs by heavy metals must be considered. If an individual monograph does not prescribe limits for heavy metals or specific elements such limits may be required if justified. Recommendations on the microbiological quality of products consisting solely of one or more herbal drugs are given in the text on Microbiological quality of pharmaceutical preparations (5.1.4. Category 4). Where necessary limits for aflatoxins may be required. In some specific circumstances, the risk of radioactive contamination is to be considered. ASSAY Unless otherwise justified and authorised herbal drugs are assayed by an appropriate method. STORAGE Store protected from light.

mass of the contents by more than the percentage deviation shown in the table below and none deviates by more than twice that percentage.
Average mass less than 1.5 g 1.5 g to 2.0 g included more than 2.0 g Percentage deviation 15 per cent 10 per cent 7.5 per cent

STORAGE Store protected from light. 01/2005:0084

IMMUNOSERA FOR HUMAN USE, ANIMAL Immunosera ex animale ad usum humanum

HERBAL TEAS Plantae ad ptisanam

DEFINITION Animal immunosera for human use are liquid or freeze-dried preparations containing purified immunoglobulins or immunoglobulin fragments obtained from serum or plasma of immunised animals of different species. The immunoglobulins or immunoglobulin fragments have the power of specifically neutralising or binding to the antigen used for immunisation. The antigens include microbial or other toxins, human antigens, suspensions of 01/2005:1435 bacterial and viral antigens and venoms of snakes, scorpions and spiders. The preparation is intended for intravenous or intramuscular administration, after dilution where applicable.

PRODUCTION GENERAL PROVISIONS The production method shall have been shown to yield DEFINITION consistently immunosera of acceptable safety, potency in Herbal teas consist exclusively of one or more herbal man and stability. drugs intended for oral aqueous preparations by means Any reagent of biological origin used in the production of of decoction, infusion or maceration. The preparation is immunosera shall be free of contamination with bacteria, prepared immediately before use. fungi and viruses. The method of preparation includes a Herbal teas are usually supplied in bulk form or in sachets. step or steps that have been shown to remove or inactivate known agents of infection. The herbal drugs used comply with the appropriate individual European Pharmacopoeia monographs or in their Methods used for production are validated, effective, absence to the general monograph on Herbal drugs (1433). reproducible and do not impair biological activity of the product. Recommendations on the microbiological quality of herbal The production method is validated to demonstrate that the teas (5.1.4. Category 4) take into account the prescribed product, if tested, would comply with the test for abnormal preparation method (use of boiling or non-boiling water). toxicity for immunosera and vaccines for human use (2.6.9). IDENTIFICATION Reference preparation. A batch shown to be suitable in The identity of herbal drugs present in herbal teas is checked clinical trials, or a batch representative thereof, is used as the reference preparation for the tests for high molecular by botanical examinations. mass proteins and purity. TESTS ANIMALS The animals used are of a species approved by the The proportion of herbal drugs present in herbal teas is competent authority, are healthy and exclusively reserved checked by appropriate methods. for production of immunoserum. They are tested and Herbal teas in sachets comply with the following test : shown to be free from a defined list of infectious agents. Uniformity of mass. Determine the average mass of twenty The introduction of animals into a closed herd follows specified procedures, including definition of quarantine randomly chosen units as follows : weigh a single full measures. Where appropriate, additional specific agents are sachet of herbal tea, open it without losing any fragments. Empty it completely using a brush. Weigh the empty sachet considered depending on the geographical localisation of the establishment used for the breeding and production of and calculate the mass of the contents by subtraction. the animals. The feed originates from a controlled source Repeat the operation on the nineteen remaining sachets. and no animal proteins are added. The suppliers of animals Unless otherwise justified not more than two of the twenty are certified by the competent authority. individual masses of the contents deviate from the average General Notices (1) apply to all monographs and other texts 573