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Study applicability decontamination process of medicinal drugs through ethylene oxide

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Author(s):
Lucilia Cristina Satomi
Total Authors: 1
Document type: Master's Dissertation
Press: São Paulo.
Institution: Universidade de São Paulo (USP). Conjunto das Químicas (IQ e FCF) (CQ/DBDCQ)
Defense date:
Examining board members:
Terezinha de Jesus Andreoli Pinto; Nádia Araci Bou Chacra; Hérida Regina Nunes Marona
Advisor: Terezinha de Jesus Andreoli Pinto
Abstract

The consumption of medicinal plants has significantly increased in Brazil in the last decades. Data from the World Health Organization estimate that 80% of the world population use medicinal plants as a therapeutic alternative. However, little information is available about their components and their potential risks to human health. Thus every subject related to the quality of those drugs is of fundamental importance. Due to their natural origin, the bioburden detected in vegetal drugs often be considered high, what is a potencial risk to their consumers. These can have their safety assure; however, through the evaluation of the drugs microbial quality and the use of decontamination processes. Therefore the aim of this work was the determination of the microbial contamination levels and the research of pathogenics microorganisms; besides the efficacy of a 30 to 60 minutes exposure to ethylene oxide of bacteria, moulds and yeasts and also the determination of toxic residues and the verification of possible alterations in the leveIs of marker compounds in samples of Matricaria recutita L., Cynara scolimus L., Paulinia cupana H.B.K. and Ginkgo biloba L., deriving from three different suppliers. All the analyzed medicinal plants presented high levels of bacteria, moulds and yeasts, around 105 ufc/g, and pathogenic microorganisms have also been detected in the samples. However after their exposure ethylene oxide exposition for 30 and 60 minutes, an elimination of about 90% and 99,8%, respectively, was observed. The presence of the pathogenic microorganisms was completely eliminated after 30 minutes of exposure to gas. The residual leveis of ethylene oxide in the analyzed medicinal plants were reduced to acceptable levels after 14 days of environmental aeration. As for the ethylene glicol and ethylene chlorhidrin levels, these were within the sensibility limits of the adopted method. No alteration was observed in chamomile, ginkgo biloba and guaraná, regarding the marker compounds concentration, even after a 60 minutes cycle exposure to ethylene oxide gas. The results led us to the conclusion that microbial decontamination methods are necessary in order to provide safer products to consumers, as they are often consumed by sick people, among which several elders and children. We can also conclude that the decontamination process of medicinal drugs through ethylene oxide is an effective and safe process, provided the necessary safety requirements are adopted, what doesn\'t always happen. (AU)