Adriana Bugno

Occurrence of toxigenic fungi in herbal drugs

O aumento no consumo de produtos naturais transformou seu uso em um problema de Saude Publica devido a possibilidade do acesso a produtos sem adequadas condicoes de uso. A preocupacao com a qualidade dos produtos naturais e devida a potencialidade de contaminacao por fungos e ao risco da presenca de micotoxinas. Noventa e uma amostras de plantas medicinais foram avaliadas quanto a contaminacao fungica e ao potencial micotoxigenico de Aspergillus e Penicillium isolados nestas amostras. Os resultados indicaram que a micoflora predominante esteve distribuida entre 10 generos. Entretanto, 89,9% dos isolados corresponderam aos generos Aspergillus e Penicillium, extremamente importantes do ponto de vista micotoxicologico. Verificou-se que 21,97% dos isolados de Aspergillus e Penicillium demonstraram capacidade para produzir aflatoxinas (42,9%), ocratoxina A (22,4%) e citrinina (34,7%). A presenca de fungos toxigenicos representa risco potencial de contaminacao com micotoxinas e considerando o aumento no consumo de produtos de origem vegetal como alternativa terapeutica, e necessario estabelecer padroes para a presenca de fungos toxigenicos em drogas vegetais a fim de reduzir os riscos a saude do consumidor.

Antimicrobial efficacy of Curcuma zedoaria extract as assessed by linear regression compared with commercial mouthrinses

The antimicrobial activity of Curcuma zedoaria (Christm) Roscoe extract against some oral microorganisms was compared with the antimicrobial activity of five commercial mouthrinses in order to evaluate the potential of the plant extract to be incorporated into formulas for improving or creating antiseptic activity. The in vitro antimicrobial efficacy of plant extracts and commercial products were evaluated against Streptococcus mutans, Enterococcus faecalis, Staphylococcus aureus and Candida albicans using a linear regression method to evaluate the microbial reduction obtained in function of the exposure time, considering as effectiveness a 99.999% reduction in count of standardized microbial populations within 60 seconds. The results showed that the antimicrobial efficacy of Curcuma zedoaria (Christm) Roscoe extract was similar to that of commercial products, and its incorporation into a mouthrinse could be an alternative for improving the antimicrobial efficacy of the oral product.

Avaliação da contaminação microbiana em drogas vegetais

The increasing consumption of natural drugs has made their use a Public Health issue, due to the possibility of accessing products without quality. The concern about quality is mainly due to the potential microbiological contamination of the products, by their natural origin. Ninety-one samples of sixty-five herbal species were evaluated in relation to microbial contamination. Results indicated that 92.3% of the herbal drugs failed to comply with the pharmacopeial parameters of acceptance and therefore, it suggests that regulatory and educational measures are needed in order to guarantee the quality of these products.

ENUMERATION OF HETEROTROPHIC BACTERIA IN WATER FOR DIALYSIS: COMPARISON OF THE EFFICIENCY OF REASONER'2 AGAR AND PLATE COUNT AGAR

Due to the fact the incubation conditions may influence the microbiological evaluation of water for dialysis, the objective of the present study was the comparison of the efficiency of R2A and PCA media in the enumeration of heterotrophic bacteria in 193 samples of water collected in dialysis clinics from 12 cities in São Paulo, between October and December 2007. Results showed counts significantly greater in R2A, suggesting that enumeration should be carried out in R2A, suggesting that enumeration should be carried out in R2A agar associated with longer incubation times, because of the greater sensitivity.

Application of the BacT/ALERTR 3D system for sterility testing of injectable products

Sterility testing as described in the pharmacopoeia compendia requires a 14-day incubation period to obtain an analytical result. Alternative methods that could be applied to evaluating product sterility are especially interesting due to the possibility of reducing this incubation period and thus the associated costs. The aims of this study were to evaluate the performance of the BacT/ALERTR 3D system in detecting microorganisms in large-volume parenteral solutions that were intentionally contaminated and to compare this system to pharmacopoeia sterility testing using the membrane filtration method. The results indicated that there were no significant differences between the methods regarding the ability to detect microbial contamination; however, detection with the BacT/ALERTR 3D system was faster compared to the pharmacopoeia method. Therefore, the BacT/ALERTR 3D system is a viable alternative for assessing the sterility of injectable products.

Avaliação da qualidade microbiológica de produtos saneantes destinados à limpeza

Detergentes e seus congeneres sao produtos destinados a limpeza e higienizacao de objetos inanimados e/ou ambientes. As empresas que produzem ou importam os produtos mencionados devem cumprir as Boas Praticas de Fabricacao e Controle, com a finalidade de garantir a qualidade e a seguranca de uso destes produtos. Este estudo teve por objetivo avaliar a qualidade microbiologica de detergentes e seus congeneres. Cento e quatro amostras foram analisadas no periodo entre Abril de 2001 e Outubro de 2002, sendo que 41% das amostras analisadas apresentaram crescimento microbiano.

Performance Survey and Comparison Between Rapid Sterility Testing Method and Pharmacopoeia Sterility Test

The sterility test described in pharmacopoeial compendia requires a 14-day incubation period to obtain a valid analytical result. Therefore, the use of alternative methods to evaluate the sterility of pharmaceuticals, such as the BacT/Alert® 3D system, is particularly interesting, because it allows a reduced incubation period and lower associated costs. Considering that the BacT/Alert® 3D system offers several culture media formulations developed for this microbial detection system, the present study was aimed to evaluate and compare the performance of BacT/Alert® 3D with the pharmacopoeial sterility test. There was no significant difference between the ability of the culture media to allow detection of microbial contamination. However, the rapid sterility testing method allowed a more rapid detection of the challenge microorganisms, which indicates that the system is a viable alternative for assessing the sterility of injectable products.

Informal Trade of Psychoactive Herbal Products in the City of Diadema, SP, Brazil: Quality and Potential Risks

The present study aimed to assess the quality and risks involved in the consumption of psychoactive herbal products (PHs) that are available through informal commerce in the city of Diadema, SP, Brazil. Methods of ethnography were used to conduct the fieldwork during which four dealers were selected to record the collection, handling, packaging, types of PHs marketed, and their therapeutic purposes. In addition, lots of the PHs selected were purchased from the dealers and analyzed using microbiology and pharmacognosy techniques. 217 PHs were recorded and categorized into two main groups: stimulants (67%) and depressants (27%) of the central nervous system; sixteen of them were selected, and their 52 lots were acquired. The deficiencies observed in handling and packaging these lots by dealers were confirmed by microbiological analysis; 80.8% of them presented risk according to the indicators defined by the Brazilian Pharmacopoeia. The pharmacognostic analysis confirmed the authenticity of only 9 to 16 PHs analyzed. In addition, descriptions of contraindications, adverse reactions, and drug interactions were found in the literature for the PHs. The results of this study allow the observation of the priorities for the sanitary adequacy of the popular trade of herbs.

Avaliação do teor de Atenolol em comprimidos divididos com faca caseira e aparelho cortador

Objective: To evaluate whether the content of Atenolol on fragments of tablets in dosages of 100 mg, 50 mg and 25 mg broken into four parts with the aid of homemade knife and cutter unit tablets is different, depending on how the division is performed. Methods: The intact tablets were divided with a knife and with a homemade pill cutter device, and the concentrations of Atenolol were determined in all fragments. Results: No significant difference existed between the levels of Atenolol obtained after splitting the tablets with the homemade knife or the pill cutter device, although the division led to severe levels of dispersal among fragments. When divided in half, the dispersion of results was between 7% and 12.1%, and when divided into four parts, it was between 9.2% and 21.1%, indicating the possibility of compromising the effectiveness of treating patients regardless of how the division was made. Conclusion: The results indicated a greater dispersion than would be acceptable to guarantee a uniform dose received at each drug administration, regardless of the way the division was performed, either by phone or homemade knife cutter pills.Objective: To evaluate whether the content of Atenolol on fragments of tablets in dosages of 100 mg, 50 mg and 25 mg broken into four parts with the aid of homemade knife and cutter unit tablets is different, depending on how the division is performed. Methods: The intact tablets were divided with a knife and with a homemade pill cutter device, and the concentrations of Atenolol were determined in all fragments. Results: No significant difference existed between the levels of Atenolol obtained after splitting the tablets with the homemade knife or the pill cutter device, although the division led to severe levels of dispersal among fragments. When divided in half, the dispersion of results was between 7% and 12.1%, and when divided into four parts, it was between 9.2% and 21.1%, indicating the possibility of compromising the effectiveness of treating patients regardless of how the division was made. Conclusion: The results indicated a greater dispersion than would be acceptable to guarantee a uniform dose received at each drug administration, regardless of the way the division was performed, either by phone or homemade knife cutter pills.

Evaluation of an Amplified ATP Bioluminescence Method for Rapid Sterility Testing of Large Volume Parenteral

The sterility test described in pharmacopeial compendia requires a 14-day incubation period to obtain a valid analytical result. Therefore, the use of alternative methods to evaluate the sterility of pharmaceuticals, such as the Celsis AKuScreen™ Advance™ system, is particularly interesting because it allows a reduced incubation period and higher efficiency. The present study was aimed to evaluate and compare the performance of Celsis AKuScreen™ Advance™ system with the pharmacopeial sterility test. There was no significant difference between the ability of detection of microbial contamination observed within pharmacopeial method and test method. The Celsis AKuScreen™ Advance™ system allowed a faster detection of the challenge microorganisms, which indicates that the system is a viable alternative for assessing the sterility of injectable products.