ABSTRACT
O método de difusão em ágar tem sido utilizado na avaliação da atividade antimicrobiana desde a descoberta da penicilina. Apesar disso, pouco avanço ocorreu no sentido de reduzir o tempo necessário para a determinação dos halos de inibição de crescimento. O objetivo deste projeto foi desenvolver, otimizar e validar métodos microbiológicos rápidos (MMRs) para a avaliação da potência de agentes antimicrobianos, além de identificar, quantificar e avaliar as principais fontes de incerteza associadas à determinação da potência. O projeto foi dividido em quatro etapas: 1) influência da composição do meio de cultura na formação dos halos de inibição; 2) estudo da incerteza de medição associada à determinação da potência de agentes antimicrobianos; 3) desenvolvimento, otimização e validação de métodos microbiológicos rápidos (MMRs) para determinação da potência de agentes antimicrobianos e 4) determinação dos parâmetros envolvidos na formação dos halos de inibição de crescimento e estudo dos mecanismos de difusão e crescimento microbiano. Os resultados deste projeto possibilitaram a redução do tempo necessário para a determinação do tamanho dos halos de inibição. Adicionalmente, contribuiu com a elucidação dos mecanismos de difusão e crescimento microbiano, possibilitando identificar e quantificar as principais fontes de incerteza de medição associadas à formação dos halos de inibição
Agar diffusion method has been used in the evaluation of antimicrobial activity since the discovery of penicillin. Nevertheless, little progress has occurred in order to reduce the time required for the determination of growth inhibition zones. The goal of this project was to develop, optimize and validate rapid microbiological methods (RMMs) for evaluation of potency of antimicrobials, as well as to identify, quantify and assess the main sources of uncertainty associated with potency. The project was divided into four steps: 1) influence of culture medium composition on inhibition zones; 2) study of measurement uncertainty associated with antimicrobials potencies; 3) development, optimization and validation of rapid microbiological methods (RMMs) for the determination of antimicrobials potencies and 4) determination of the parameters involved in the formation of inhibition zones and study of mechanisms of diffusion and microbial growth. The results of this project allowed the reduction of the time required for the determination of inhibition zone sizes. Additionally, it contributed to the elucidation of the mechanisms of diffusion and microbial growth, making it possible to identify and quantify the main sources of measurement uncertainty associated with formation of inhibition zone sizes
Subject(s)
Agar/administration & dosage , Uncertainty , Methods , Anti-Infective Agents/analysis , Penicillins/administration & dosage , Growth and Development , Diffusion , Process Optimization/classificationABSTRACT
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.
.Subject(s)
Bacteria/isolation & purification , Fungi/isolation & purification , Microbiological Techniques/methods , Quality Control , Sterilization , Bacterial Load , Bacteria/growth & development , Filtration/methods , Fungi/growth & developmentABSTRACT
OBJECTIVE:To explore the differences of plasma concentration of norvancomycin by HPLC and microbiological method. METHODS:Microbiological method and HPLC were used to detect the plasma concentration of norvancomycin,and clinical test result of both techniques was retrospectively analyzed. RESULTS:There were no significant differences in the plasma concentra-tion of norvancomycin by microbiological method and HPLC(y=0.992 7x+0.155 8,r=0.997 6)(P>0.05). CONCLUSIONS:Both microbiological method and HPLC are more effective and reliable for the plasma concentration detection of norvancomycin. The hospi-tals can choose corresponding method according to their condition when determining plasma concentration of norvancomycin.
ABSTRACT
OBJECTIVE:To estimate the uncertainty in the content determination of azithromycin granules by microbiological method.METHODS:The origin and degree of uncertainty in the content determination of azithromycin granules by microbiological method were analyzed and evaluated in accordance with the standard given in JJF1059-1999 "Evaluation and Expression of Uncertainty in Measurement".RESULTS:The expanded uncertainty was 5 420.0 IU/bag,and the results of the determination can be expressed as(103 838.0?5 420.0)IU/bag.The uncertainty was chiefly originated from method design,followed by solution dilution.CONCLUSIONS:The degree of uncertainty for the content determination of antibiotic drugs by microbiological method can be effectively reduced by suitable method design and reducing the times of dilution.
ABSTRACT
AIM:To develop a microbiological method for determining plasma doxycyclineMETHODS:Plasma concentration of doxycycline was detected with Staphylococcus aureus ATCC 26003 and Micrococcus luteus ATCC 28001 strains in a variety of culture media and pHsRESULTS:Linear scope of doxycycline(016～100mg/L,r=09 985) could be achieved with using a microbiological method,which consisted of staphylococcus aureus and bovine heart soup culture medium at pH 50CONCLU_SION:This method can be used in study of pharmacokinetics and bioavailability of doxycycline
ABSTRACT
OBJECTIVE: To study the pharmacokinetics of infusion Etimicin in the patients with respiratory tract infec- tions. METHODS: Ten patients were infused with 200mg Etimicin and the concentrations of drug in the plasma, urine and sputurn were determined by microbiological method. RESULTS & CONCLUSlON: The peak concentration of plasma was 17.74?g/ml. The concentration of 0.29?g/ml maintained 12h after administration. Pharmacokinetics parameters conformed to two - compartment model. The pharmacokinetics parameters were, T1/2?= 0. 257h, T1/2? = 2. 22h, Vc = 34. 32L, K2l = 2.14h~(-1), K12 = 0. 48h~(-1), K10 = 0.39h~(-1). The cumulative percentage of renal excretion was 21.37% within 12h, Ke =0. 027h~(-1), K = 0. 431h~(-1). The drug concentration in sputum reached the peak of 2.09?g/ml 2h after infusion.
ABSTRACT
Objective: To establish microbiological method for determining biotin in foods and feeds. Methods: Using biotin dependent microorganisms Lactobacillus plantarum(ATCC 8014), the biotin content was detected indirectly by the growth of cultrued bacteria spectrophotometrically.Results: The detection limit was 0.03 ng. The relative standard deviations(RSD) of within and between run assays were 2.2%-3.8%,2.1%-5.3% respectively. The recovery of added biotin was 93.4%-104.6%, and RSD was 3.1%-4.1%. Conclusion: This assay is sufficiently accurate and repoducible for determining biotin in foods and feeds.