Mikrobiološka onečišćenja u (tradicionalnim) biljnim lijekovima

Herbal substances, herbal preparations and herbal medicinal products, as well as traditional herbal medicinal products are of natural origin and have a higher risk of microbial contamination compared to chemical drugs. This review addresses microbial contaminants and chemical contaminants as products of microbial presence, referring mainly to mycotoxins. An overview is given on how to ensure suitable microbial quality, considering the importance of preventative measures, manufacturing processes and by applying decontamination processes in the frame of current regulatory aspects. Satisfactory quality regarding microbiological and mycotoxin contamination should be a result of mainly preventive measures, rather than interventions for decreasing the contamination. Evaluation should be based on a case-by-case risk assessment and usually includes tests and limits given in Ph. Eur. (for example TAMC, TYMC, absence of certain specified micro-organisms, testing on mycotoxins) in order to ensure a safe final product for the consumer or patient.