Herbal Drugs for Homoeopathic Preparations
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DEFINITION
Herbal drugs for homoeopathic preparations are mainly whole plants or parts of plants, fragmented or broken, and include algae, fungi or lichens, in an unprocessed state, usually in fresh form. The state, fresh or dried, in which the drug is used, is defined in the individual monograph of the European Pharmacopoeia or, in its absence, in the individual monograph of an official national pharmacopoeia of a member state. In the absence of such a monograph, the state in which the herbal drug is used has to be defined. Certain exudates that have not been subjected to a specific treatment are also considered to be herbal drugs for homoeopathic preparations. Herbal drugs for homoeopathic preparations are precisely defined by the botanical scientific name of the source species according to the binomial system (genus, species, variety and author).
Whole Describes a herbal drug for homoeopathic preparations that has not been reduced in size and is presented, dried or undried, as harvested.
Fragmented Describes a herbal drug for homoeopathic preparations that has been reduced in size after harvesting to permit ease of handling, drying and/or packaging.
Broken Describes a herbal drug for homoeopathic preparations in which the more fragile parts of the plant have broken during drying, packaging or transportation.
For dried herbal drugs for homoeopathic preparations, cut describes size reduction, other than powdering, that reduces the particle size below that which is described in the macroscopic identity of the herbal drug for homoeopathic preparations.
PRODUCTION
Herbal drugs for homoeopathic preparations are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, sorting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs for homoeopathic preparations.
Herbal drugs for homoeopathic preparations are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminants. They do not present signs of decay.
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 for homoeopathic preparations.
Fresh herbal drugs are processed as rapidly as possible after harvesting. Where justified and authorised for transportation or storage purposes, fresh plant material may be deep-frozen; it may also be kept in ethanol (96 per cent) or in ethanol of a suitable concentration, provided the whole material including the storage medium is used for processing.
Adequate measures have to be taken in order to ensure that the microbiological quality of homoeopathic preparations containing 1 or more herbal drugs comply with the recommendations given in general chapter 5.1.4. Microbiological quality of non-sterile pharmaceutical preparations and substances for pharmaceutical use.
IDENTIFICATION
Herbal drugs for homoeopathic preparations are identified using their macroscopic and, where necessary, microscopic descriptions and any further tests that may be required (for example, thin-layer chromatography).
TESTS
The tests for foreign matter and loss on drying should be performed before any further processing of the fresh plant.
Foreign matter (2.8.2)
Where a fresh plant is used as a starting material for the manufacture of homoeopathic preparations, the content of foreign matter is as low as possible; if necessary, the maximum content of foreign matter is indicated in the individual monograph.
Where a dried plant is used as a starting material for the manufacture of homoeopathic preparations, carry out a test for foreign matter, unless otherwise prescribed in the individual monograph. The content of foreign matter is not more than 2 per cent m/m, unless otherwise prescribed or justified and authorised.
Adulteration
A specific appropriate test may apply to herbal drugs for homoeopathic preparations liable to be falsified.
Loss on drying (2.2.32)
Carry out a test for loss on drying on dried herbal drugs for homoeopathic preparations.
If a fresh plant is processed more than 24 h after harvesting, a test for loss on drying should be carried out. The minimum limit is indicated in the individual monograph.
Water (2.2.13)
A determination of water is carried out on herbal drugs for homoeopathic preparations with a high essential oil content.
Pesticides (2.8.13)
Herbal drugs for homoeopathic preparations comply with the requirements for pesticide residues. The requirements take into account the origin and the nature of the plant, where necessary the preparation in which the plant might be used and, where available, knowledge of the complete record of treatment of the batch of the plant. Where justified, the test for pesticides may be performed on the mother tincture according to the requirements of the general monograph Mother tinctures for homoeopathic preparations (2029).
If appropriate, herbal drugs for homoeopathic preparations comply with other tests, such as the following, for example.
Total ash (2.4.16)
Bitterness value (2.8.15)
Heavy metals (2.4.27)
Unless otherwise stated in an individual monograph or unless otherwise justified and authorised:
If justified by the nature or origin of the herbal drug or if required by the competent authority, suitable limits for the content of other heavy metals such as arsenic or nickel are defined.
Where justified, the test for heavy metals may be performed on the mother tincture according to the requirements of the general monograph Mother tinctures for homoeopathic preparations (2029).
Aflatoxin B1 (2.8.18)
Where appropriate, limits for aflatoxins may be required.
Ochratoxin A (2.8.22)
Where appropriate, a limit for ochratoxin A may be required.
Radioactive contamination
In some specific circumstances, the risk of radioactive contamination is to be considered.
ASSAY
Where applicable, herbal drugs for homoeopathic preparations are assayed by an appropriate method.
STORAGE
Store dried herbal drugs protected from light.
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