hrvatski

Kakvoća biljnog lijeka

A lot of factors such as temperature, light exposure, water availability, nutritients, period and site of collection, age and part of plant collected, method of collection, processing (drying, chemical/radioactive treatment, ...), storage and distribution of starting herbal material, etc., can greatly affect the quality and consequently the therapeutic value of herbal medicines. Therefore, it is essential to produce starting material under Good Agriculture and Collection Practice (GACP) conditions. Because of plant`s genetic and chemical content variations, the site and date should be recorded for each collection. The production of starting materials by cultivation would normally lead to more consistent herbal products due to greater genetic uniformity. Furthermore, cultivation permits monitoring of active constituents and defining of the best period for harvesting. Whether field collected from the wild or produced by cultivation, botanical authentication of plant species and identification by their binomial Latin names are necessary to insure that the correct herbal material is obtained. Also, care must be taken to free the targeted starting material of undesirable plant parts, soil, insects, animal excreta and other contaminants. During post- collection treatments microbial, agrochemical residues and toxic metals contamination should be reduced to a minimum. The harvested starting material must be processed to produce the finished herbal product under Good Manufacture Practices (GMPs) which are similar to those employed for the manufacture of conventional drugs. Frequent variability in the composition of herbally based medicines can be avoided by proper standardization of herbal drugs/preparations and their quality control using pharmacopoeial and/or validated testing methods. In the cases where the active principles are unknown, marker substance(s) should be established for analytical purposes. Independently on traditional use of HMP, all data concerning the quality »from the seeds to the final product« should be provided in the application dossier for marketing authorisation. Post-marketing surveillance by regulatory agencies is further pivotal step in the permanent quality assurance of HMP.

biljni lijek, dobra proizvođačka praksa, patvorenje, zahtjev kakvoće

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