Validación de la metodología para cuantificar el fluconazol y sus impurezas orgánicas en materia prima por cromatografía líquida de alta resolución

Introducción. La eficiencia de una metodología para analizar una sustancia farmacológica puede verse afectada por las condiciones reales del laboratorio de cada país, incluyendo el clima. Por esta razón, se requiere validar el método con las pautas recomendadas para ello y optimizar el proceso, para asegurar el éxito y la confianza en los resultados. Objetivo. Validar una metodología para la cuantificación simultánea del fluconazol (materia prima) y sus impurezas orgánicas mediante cromatografía líquida de alta resolución con detector de arreglo de diodos en condiciones de clima tropical y con todos los requisitos normativos. Materiales y métodos. Se hicieron pruebas previas a la validación del método: idoneidad del sistema, estudio de filtros, límite de cuantificación, ausencia del error sistemático, estudios de degradación forzada y estabilidad de las soluciones. Además, se validaron: la especificidad, la linealidad, la exactitud, la precisión y la robustez. Resultados. La pureza espectral del método se logró al obtener la separación de los productos de degradación de los picos de los analitos. La estabilidad de las soluciones no se vio afectada, en la frecuencia evaluada de 24 horas, a temperatura ambiente y de refrigeración. Se obtuvo una linealidad con coeficientes de correlación mayores o iguales a 0,999 para la valoración y mayores o iguales a 0,997 para las impurezas. La recuperación estuvo en el rango de 98 a 102,0 % de fluconazol, con una exactitud entre el 80 y el 120 % para las impurezas. El factor de repetibilidad y reproducibilidad no superó la desviación estándar relativa del 2,0 % para la valoración y, la del 5,0 %, para las impurezas, lo cual mostró una solidez adecuada del método. Además, se obtuvo un tiempo corto de ejecución del análisis, lo que permitió la rápida determinación de la calidad de la materia prima. Conclusión. Se demostró que el método de cuantificación de fluconazol, validado por cromatografía líquida de alta resolución con detector de arreglo de diodos, es lo suficientemente selectivo, preciso, exacto, lineal y robusto; además, es capaz de generar resultados analíticos veraces en condiciones de uso reales, incluyendo el clima tropical de Colombia.

Introduction. The real laboratory conditions of each country, including climate, can affect the method's efficiency in analyzing a pharmacological substance. Thus, it is necessary to validate the process according to the corresponding guidelines and optimize it to ensure success and confidence in the results. Objective. The objective was to validate a methodology for fluconazole and its organic impurities quantification in raw material using high-performance liquid chromatography, with a diode array detector, under tropical climate conditions, and complying with all regulatory requirements. Materials and methods. We performed pre-validation tests of the method consisting of system adequacy, filters study, quantification limit, absence of systematic error, forced degradation studies, and solutions stability. In addition, we validated the specificity, linearity, accuracy, precision, and robustness of the system. Results. Separation of the degradation products from the analyte peaks allowed the achievement of the method's spectral purity. The solution's stability was not affected during the evaluated time (24 hours) at room temperature and under refrigeration. Linearity resulted in correlation coefficients greater than or equal to 0.999 for the evaluation and greater than or equal to 0.997 for impurities. We obtained a fluconazole recovery varying from 98 to 102% with an accuracy between 80 to 120% for impurities detection. The repeatability and reproducibility factor did not exceed a relative standard deviation of 2.0% for the evaluation and of 5.0% for the impurities, demonstrating the adequate robustness of the method. In addition, a short analysis execution time allowed the quick determination of the raw material quality. Conclusion. We demonstrated that the fluconazole quantification method validated by high-performance liquid chromatography is sufficiently selective, precise, exact, linear, and robust to generate accurate analytical results under real conditions, including the tropical climate of Colombia.

Evaluation of microbial contamination in multi-dose fluorescein eyedrops in a reference eye center / Avaliação da contaminação microbiana em colírios multi-dose de fluoresceína em um centro oftalmológico de referência

ABSTRACT Purpose: To analyze the presence of microorganisms in fluorescein eyedrops used in a reference eye center in Recife-PE. Methods: This real-life and masked study evaluated fluorescein eyedrops used at the Altino Ventura Foundation in May 2019. Cultures were performed according to exposure times; I) three eyedrop bottles were analyzed after one day of use, II) three eyedrop bottles after 4 d of use, III) three eyedrop bottles after 8 d of use, and IV) three unopened bottles used as control. Samples were collected from the bottle's tip, instilled drop, and residual fluid. After incubation, all colonies were analyzed and identified through biochemical tests. Results: The contamination rate of the fluorescein eyedrop bottles in this study was 55.5% (5/9 vials). There was no contamination in the control group. The highest contamination was seen in one day exposed eyedrops, in 100% of the bottles. The bottle's tip had a higher rate of contamination compared to the drop and residual fluid. Gram-positive bacteria were isolated in 7/27 (25.9%) samples. Growth of fungi or gram-negative bacteria was not observed. Conclusion: The identification of gram-positive bacteria predominantly on the tip of the fluorescein eyedrop bottles suggests inadequate handling as the main cause of contamination.

RESUMO Objetivo: Analisar a presença de microrganismos nos colírios de fluoresceína utilizados em um centro oftalmológico de referência em Recife-PE. Métodos: Este estudo de vida real e mascarado avaliou colírios de fluoresceína utilizados na Fundação Altino Ventura em maio/2019. As culturas foram realizadas de acordo com os diferentes tempos de exposição: I - três frascos de colírio foram analisados após 1 dia de uso; II - três frascos de colírio após 4 dias de uso; III - três frascos de colírio após 8 dias de uso; IV - três garrafas fechadas foram usadas como grupo controle. As amostras foram coletadas da ponta do frasco, da gota instilada e do líquido residual interior. Após incubação, todas as colônias foram analisadas e identificadas através de testes bioquímicos. Resultados: A taxa de contaminação dos frascos de colírio de fluoresceína neste estudo foi de 55,5% (5/9 frascos). Não houve contaminação no grupo controle. A maior contaminação foi observada os colírios expostos de um dia - 100% dos frascos. A ponta da garrafa teve uma maior taxa de contaminação em comparação com as culturas de gota e de fluido residual inferior. Bactérias gram-positivas foram isoladas em 7/27 amostras (25,9%). Não houve crescimento de fungos ou bactérias Gram-negativas. Conclusão: A identificação de bactérias Gram-positivas predominantemente na ponta dos frascos de colírio de fluoresceína sugere manuseio inadequado como a principal causa de contaminação de colírios multidose.

Antibacterial effect of lidocaine in various clinical conditions

BACKGROUND: Infection, one of the complications associated with procedures, can cause fatal outcomes for patients. Although the local anesthetic agent we use is less susceptible to infection due to its antibacterial action, we performed this study to check the change in the antibacterial effect of lidocaine in various clinical conditions. METHODS: After exposing lidocaine to five contaminated environments, we checked on whether the bacteria could be cultured in blood agar plate (BAP) media. In each contaminated environment, lidocaine was exposed for 4 h (n = 9) and 8 h (n = 9), and the results were compared. Lidocaine was swabbed with chlorhexidine (group A), brought into contact with saliva (group B), skin (group C), an operating room floor and an outpatient room floor (group D), operating room air for 24 h (group A-a), and outpatient room air for 24 h (group A-b). After exposure, the culture was initiated. RESULTS: In 2 of 9 BAP media where lidocaine was exposed to saliva (group B) for 8 h, growth of a colony was observed. In gram staining, it was found to be Streptococcus viridans. No bacteria were found in any other groups. CONCLUSIONS: Though lidocaine has strong antibacterial activity, it has been found that long-term exposure to a contaminated environment reduces its antibacterial activity and that drug contamination can be heavily affected not only by environmental but also human effects. Therefore, the use of aseptic drugs is necessary, and stopping the reuse of the drug is a way to prevent complications, including infection.

Microbial monitoring analysis of methylcellulose eye drops during use and storage / 中华实验眼科杂志

Background It is imperative for the microbial monitor after opening the bottle of eyedrops in order to ensure the safety during use of ophthalmic solutions with multi-dose packaging.Objective This study was to research the microbiological properties and sterile duration of methylcellulose (MC) eye drops in three common environmental conditions,including room temperature condition of community,refrigeration condition of community and room temperature condition of hospital.Methods MC eye drops were assigned to the community room temperature group,community refrigeration group and hospital room temperature group,and 200 bottles of MC eye drops with or without ethylparaben were collected in each group,including sealed or unsealed drugs at average.The containers of all the eye drops were opened and the opening times were record.The drugs was admistered 1 drop for 3 times per day,with the opening period for 5-10 seconds.Then the drugs were preserved in different environments based on grouping.Microbial isolation and purification were performed by the same lab technician at 8:00 from 1 through 10 days after opening of drugs with automatic microbial analyzer.Results In the unsealed MC eye drops without ethylparaben,the bacterial positive rates were about 30％ in the community room temperature group,community refrigeration group and hospital room temperature group,but no microbial colony was seen in the sealed eye drops.Ten days after opening of containers,the bacterial cultured rates were 30％,32％ and 36％ in the eye drops without ethylparaben in the community room temperature group,community refrigeration group and hospital room temperature group,and those in the eye drops with ethylparaben were 15％,19％ and 23％,respectively,showing significant differences between the eye drops with and without ethylparaben (x2 =6.452,4.448,4.063,all at P＜0.05).The 95％ confidence interval (CI) of difference values of intergroup bacterial rates were-0.166-0.126,-0.110-0.190 and-0.088-0.208 between the community room temperature group and the community refrigeration group,between the hospital room temperature group and the community refrigeration group,between the hospital room temperature group and the community room temperature group respectively in the unsealed eye drops without ethylparaben,and those in the unsealed eye drops with ethylparaben were-0.159-0.079,-0.089-0.169 and-0.043-0.203 respectively,indicating insignificant differences among the groups.Cultured bacteria were identified as Micrococcus luteus,Acinetobacter lwoffii,Bacillus subtilis,Acinetobacter radioresistens,Myroides and Staptococcus xylosus.Conclusions Ethylparaben can reduce the contamination rate of microorganisms after opening of MC eye drops.Three environmental conditions do not play an influence on microbial contamination of MC eye drops after opening.The bacteria of contaminated eye drops appear to be common microorganisms in atmosphere and soil,rather than eye common pathogens.

Análisis microbiológico de la etnofarmacología empleada por el pueblo Misak / A microbiological analysis of the ethnopharmacological products used by the Misak people

Objetivo Evaluar la presencia, tipo y cantidad de microorganismos en algunos de los principales productos etnofarmacológicos de administración oral, comercializados en el laboratorio Sierra Morena ubicado en el resguardo indígena de Guambia, en el Departamento del Cauca. Materiales y Métodos Se llevó a cabo un estudio observacional, descriptivo, de corte transversal. Se realizó un análisis microbiológico a través de la filtración por membrana de seis muestras escogidas de forma aleatoria que incluyeron el agua y cinco productos etnofarmacológicos listos para la distribución comercial. Resultados Las muestras tomadas fueron no aptas microbiológicamente para el consumo humano debido a la presencia de Escherichiacoli y coliformes. El recuento de UFC (Unidades Formadoras de Colonias)/100ml, (parámetro de referencia 0 UFC/100ml) llegó a ser de hasta 63.000 UFC/100ml en el caso del agua y de 110 UFC/100ml para los etnofármacos. Conclusiones Los resultados cuantitativos revelaron la presencia de organismos patógenos, lo que evidencia un fallo en la infraestructura del abastecimiento rural y purificación del agua. Es necesario un monitoreo continuo de la calidad del agua y una intervención urgente de la elaboración de los etnofármacos debido a que también se encuentran contaminados.(AU)

Objectives Evaluating microorganism presence, type and quantity in some of the most important ethnopharmacological products designed for oral administration currently being distributed by the Sierra Morena laboratory located in the Guambia Indian reservation (Cauca department, Colombia). Materials and Methods This was a cross-sectional descriptive study; it involved microbiological analysis using membrane filtration of six randomly-chosen samples which included the water being used by the laboratory and five of its ethnopharmacological products ready for commercial distribution and sale. Results The samples studied here were not microbiologically suitable for human consumption because they contained Escherichia coli and fecal coliforms. Colony forming unit (CFU) count/100 mL (reference 0 CFU/100 mL) was found to be up to 63,000 CFU/100 mL in water samples and 110 CFU/100 mL in ethnopharmacological samples. Conclusions The quantitative results revealed the presence of pathogens, indicating failure in rural water supply and environmental sanitation infrastructure. On-going monitoring of water quality and an urgent intervention of the laboratory’s ethnopharmacological production is necessary because of the contamination found there.(AU)

Avaliação in vitro das propriedades antimicrobianas de vasopressores / In vitro evaluation of antimicrobial features of vasopressors / Evaluación in vitro de las propiedades antimicrobianas de vasopresores

Justificativa e objetivo: os medicamentos administrados como perfusão intravenosa podem ser contaminados durante as várias etapas de produção ou preparação. No entanto, estudos sobre os efeitos antibacterianos de vasopressores são muito raros. Este estudo investiga a atividade antimicrobiana in vitro das formas de vasopressores usados clinicamente. Materiais e métodos: atividades antimicrobianas in vitro de substâncias vasopressoras de diferentes concentrações foram investigadas com o uso da técnica de microdiluição. Os microrganismos empregados no teste foram: Escherichia coli ATCC 25922, Yersinia pseudotuberculosis ATCC 911, Pseudomonas aeruginosa ATCC 10145, Listeria monocytogenes ATCC 43251, Enterococcus faecalis ATCC 29212, Staphylococcus aureus ATCC 25923, Bacillus cereus 702 Roma, Mycobacterium smegmatis ATCC607, Candida albicans ATCC 60193 e Saccharomyces cerevisiae RSKK 251. Os ensaios antibacterianos foram feitos em caldo de cultura Mueller-Hinton (pH 7,3) e os ensaios antifúngicos em solução tampão de base nitrogenada para levedura (pH 7,0). Resultados: duas preparações diferentes de dopamina mostraram atividade antimicrobiana. Nenhuma outra substância do estudo mostrou qualquer atividade antimicrobiana. Conclusões: em nossa opinião, os efeitos antibacterianos da dopamina podem ser vantajosos para inibir a propagação de contaminação bacteriana durante a preparação das soluções para perfusão. Contudo, salientamos a importância do seguimento rigoroso das diretrizes de esterilização dos equipamentos e de assepsia durante todos os procedimentos feitos em unidades de terapia intensiva. .

Background: Drugs administered as intravenous infusion may be contaminated during several stages of production or preparation. However studies focusing on antibacterial effects of vasopressor drugs are very rare. This study investigates the in vitro antimicrobial activity of the clinically used forms of vasopressors. Materials and methods: In vitro antimicrobial activities of vasopressor drugs of different concentrations were investigated by using the micro dilution technique. Microorganisms used in the test were Escherichia coli ATCC 25922, Yersinia pseudotuberculosis ATCC 911, Pseudomonas aeruginosa ATCC 10145, Listeria monocytogenes ATCC 43251, Enterococcus faecalis ATCC 29212, Staphylococcus aureus ATCC 25923, Bacillus cereus 702 Roma, Mycobacterium smegmatis ATCC607, Candida albicans ATCC 60193, and Saccharomyces cerevisiae RSKK 251. Antibacterial assays were performed in Mueller-Hinton broth at pH 7.3 and antifungal assays were performed in buffered Yeast Nitrogen Base at pH 7.0. Results: Two different dopamine preparations showed antimicrobial activity. No other study drug showed any antimicrobial activity. Conclusions: In our opinion, dopamine's antibacterial effects may be advantageous for inhibiting the spread of bacterial contamination during the preparation of the infusion solutions. However, it is important that strict guidelines regarding the need for sterile equipment and deliverables be adhered to during all procedures performed in the intensive care units. .

Justificativa y objetivo: Los medicamentos administrados como perfusión intravenosa pueden ser contaminados durante las diversas etapas de producción o preparación. Sin embargo, son muy raros los estudios existentes sobre los efectos antibacterianos de los vasopresores. Este estudio investiga la actividad antimicrobiana in vitro de las formas de vasopresores usados clínicamente. Materiales y métodos: Actividades antimicrobianas in vitro de sustancias vasopresoras de diferentes concentraciones fueron investigadas con el uso de la técnica de microdilución. Los microrganismos usados en el test fueron: Escherichia coli ATCC 25922, Yersinia pseudotuberculosis ATCC 911, Pseudomonas aeruginosa ATCC 10145, Listeria monocytogenes ATCC 43251, Enterococcus faecalis ATCC 29212, Staphylococcus aureus ATCC 25923, Bacillus cereus 702 Roma, Mycobacterium smegmatis ATCC607, Candida albicans ATCC 60193 y Saccharomyces cerevisiae RSKK 251. Los ensayos antibacterianos se hicieron en un caldo de cultivo Mueller-Hinton (pH 7,3) y los ensayos antifúngicos en una solución tapón de base nitrogenada para levadura (pH 7,0). Resultados: Dos preparaciones diferentes de dopamina mostraron actividad antimicrobiana. Ninguna otra sustancia del estudio mostró alguna actividad antimicrobiana. Conclusiones: En nuestra opinión, los efectos antibacterianos de la dopamina pueden ser ventajosos para inhibir la propagación de la contaminación bacteriana durante la preparación de las soluciones para perfusión. Sin embargo, destacamos la importancia del seguimiento riguroso de las directrices de esterilización de los equipos y de asepsia durante todos los procedimientos realizados en las unidades de cuidados intensivos. .

Erros farmacológicos na prática anestésica: quatro casos de morbidades não fatais / Drugs errors in anaesthesia practice: four cases of non-fatal morbidity / Errores de medicación en la práctica de la anestesia: cuatro casos de morbilidad no fatal

Justificativa e objetivos: Os anestesistas estão se preocupando mais em garantir segurança aos pacientes, enfatizando o desfecho cirúrgico e qualidade do atendimento no centro cirúrgico e em outras áreas do hospital. Na prática, não existe nenhum aspecto da Anestesiologia que seja mais importante no manuseio seguro dos pacientes do que a administração correta de fármacos. Erros farmacológicos representam uma pequena percentagem dos problemas anestésicos, mas apresentam potencial de morbidade grave e consequências legais. O objetivo deste relato foi descrever quatro casos de erros medicamentosos (EM) raros no centro cirúrgico, sem consequências danosas para os pacientes e como sua análise e identificação evitaram o desenvolvimento de danos mais graves. Relato dos casos: Quatro casos de sobredoses acidentais no centro cirúrgico antes da indução anestésica. A mesma seringa foi usada para preparar e diluir dois medicamentos diferentes. Portanto, esse erro foi causado pela presença do segundo medicamento. A toxicidade se manifestou com depressão respiratória e sedação temporárias, havendo necessidade de ventilação assistida, mas sem desfechos adversos. Conclusões: Explicou-se como os medicamentos envolvidos e quando o erro cometido foram identificados para melhorar a prática clínica, reduzindo os erros medicamentosos. Enfatizamos a importância da informação e educação dos profissionais de saúde sobre novos medicamentos e seu processo de preparação, pois foi prática inaceitável em 2009.

Background and objectives: Anesthesiologists became more concerned about ensuring patient safety by a greater emphasis on outcome, quality patient care both in operation theatre and elsewhere in hospital. In the clinical practice, there is no aspect of Anesthesia that occupies a more important place in the safe management of the patients than the accurate drug administration. Medication errors represent a small part of anesthesia problems but still have potential for serious morbidity and legal consequences. The objective of this report was to describe four cases of unusual medical errors (ME) in the operation theatre, without harm to the patient, and how their analysis and identification had prevented more serious damage occurrence. Case reports: Four cases of inadvertent overdose in operation theatre previous to induction anesthesia. The same syringe was used to prepare and dilute two different drugs. This error was therefore caused by the presence of the second drug. Toxicity was manifested as brief respiratory depression and sedation, and assisted ventilation was required but no adverse outcomes happened. Conclusions: We explain how we identified the drug involved, the point at which the error occurred in order to improve clinical practice reducing medication errors. We focus on providing more information and education to each health care professional about new drugs and their preparation process, because this is should not be an acceptable practice in 2009.

Justificativas y objetivos: Los anestesiólogos están cada vez más preocupados sobre la seguridad de los pacientes, haciendo un gran énfasis en los resultados, en la cualidad de los cuidados en la salud, como también en el quirófano o en cualquier otro lugar dentro del hospital. En la práctica clínica, no existe un aspecto de la anestesia que sea más crucial en el aspecto del cuidado de la seguridad de los pacientes, que no sea la correcta administración de los fármacos. Los errores en la medicación representan una pequeña parte de los problemas de la anestesia pero todavía son un serio problema para la morbilidad, como también traen serias consecuencias legales. El objetivo de este artículo, fue describir cuatro casos de unos inusuales errores médicos (EM) en el quirófano, sin perjudicar al paciente y verificando cómo sus análisis e identificaciones pueden prevenir daños más serios. Reporte de casos: Cuatro casos de sobre dosis inadvertida en quirófano antes de la inducción de anestesia. Se usó la misma jeringuilla para la preparación y la dilución de dos fármacos diferentes. Por lo tanto, el error fue causado por la presencia del segundo fármaco. La toxicidad se manifestó con depresión y sedación temporales, necesitando ventilación asistida, no habiendo sido registrados resultados adversos. Conclusiones Hemos explicado cómo identificar los fármacos involucrados, y el punto en que ocurrió el error, en el sentido de perfeccionar la práctica clínica reduciendo los errores médicos. Nos concentramos en proveer más información y más educación de literatura médica sobre los nuevos fármacos y sobre sus procesos de preparación a cada médico, porque ésa no es una práctica aceptable en el 2009.

Influence of Different Methods of Cutting Ampules on Drug Contamination by Glass Flakes from the Ampule / 기본간호학회지

PURPOSE: This study was done to examine how medication contamination in a single-dose glass ampule is affected by minute glass flakes generated in different methods of cutting the ampule. METHOD: Sixty medicationcontaining glass ampules were randomly assigned to two groups. The number of glass flakes, resulting from two different cutting methods (with cotton and without cotton), were counted under the microscope. Contamination was evaluated by extracted the medication with a syringe and culturing it in E. coli, coliform, and aerobic bacteria culture media. Result: Fewer glass flakes were found in the ampules when the ampule was cut with cotton. The use of cotton, however, did not significantly change the degree of drug contamination. CONCLUSION: Although minute glass flakes generated in the ampule cutting operation did not significantly contaminate the medication and the use of cotton decreased the number of glass flakes in the ampules, glass flakes injected into the blood and tissues of the patient remain a risk factor. Therefore, pre-filled syringes or syringes with filters would be alternative methods and safeguards against the possible injection of glass flakes generated while cutting the ampule.

Uso ocular de água boricada: condições de manuseio e ocorrência de contaminação / Use conditions of boric acid solution in the eye: handling and occurrence of contamination

OBJETIVOS: Avaliar as condições de uso de água boricada e verificar a contaminação dos frascos e seu conteúdo. MÉTODOS: Foram selecionados, por critério de conveniência, quarenta e dois pacientes, usuários de água boricada, que compareceram ao Pronto-Socorro de Oftalmologia do Hospital São Paulo, em fevereiro e março de 2003. Foi colhido material para cultura do saco conjuntival, da superfície interna da borda do frasco, da superfície interna da tampa, além de 1 ml de solução do frasco. RESULTADOS: Dos 42 recipientes de água boricada, 17 (40,5 por cento) apresentavam contaminação, sendo 1 (2,4 por cento) no conteúdo liquido, 17 (40,5 por cento) na parte interna da tampa e 6 (14,3 por cento) na parte interna da borda do frasco. Dos 17 frascos contaminados, 10 (58,8 por cento) tiveram suas tampas manuseadas de maneira inadequada e 13 (76,5 por cento) frascos já haviam sido usados em outras ocasiões. Os microrganismos mais encontrados nas tampas e bordas foram Staphylococcus sp (69,6 por cento) e bacilos Gram-positivos (26,1 por cento). Dezesseis (38,1 por cento) frascos foram abertos há mais de um mês e, destes, 5 (31,3 por cento) apresentaram contaminação. A instrução de uso nos rótulos dos frascos era inconsistente. A utilização de água boricada foi por conta própria, por indicação de amigos ou parentes em 26 (61,9 por cento) casos; indicação de farmacêuticos em 8 (19,0 por cento); de oftalmologistas em 5 (11,9 por cento) e de clínicos gerais em 3 (7,1 por cento). CONCLUSÃO: A indicação de uso tópico oftálmico de água boricada foi feita, na maioria, por leigos. Os frascos, em geral, eram manipulados de maneira inadequada, apresentando contaminação em uma proporção de casos muito maior do que a contaminação do líquido. Essa porcentagem menor de contaminação do conteúdo provavelmente está associada às características anti-sépticas do produto.

PURPOSE: To evaluate use conditions and detect contamination in bottles of boric acid solution. METHODS: A convenience sample of 42 recruited patients using boric acid solution came to the Ophthalmology Emergency Room of the São Paulo Hospital from February to March of 2003. Cultures were taken from material of the conjunctival sac, inner surface of bottle edge, inner part of cap and from 1 ml of boric acid solution of each bottle. RESULTS: Of the 42 boric acid solution bottles, 17 (40.5 percent) showed contamination: 1 (2.4 percent) in the solution, 17 (40.5 percent) in the inner cap and 6 (14.3 percent) in the inner part of the bottle edge. Of the 17 contaminated bottles, 10 (58.8 percent) were handled inappropriately and 13 (76.5 percent) of the bottles were not discharged after first use. The most common microorganisms found in the caps and edges of the bottles were Staphylococcus sp (69.6 percent), followed by Gram-positive bacillus (26.1 percent). Sixteen bottles (38.1 percent) had been opened more than a month ago and 5 (31.3 percent) of those showed contamination. The boric acid solution bottle directions shown on the labels were incomplete and not clear. The use of boric acid solution was on recommendation of their own, friends or relatives in 26 (61.9 percent) cases; pharmacists in 8 (19.0 percent) cases, ophthalmologists in 5 (11.9 percent) cases and general practitioners in 3 (7.1 percent) cases. CONCLUSION: In most cases, the topic use of boric acid solution was recommended by non-physicians. The bottles, in general, were handled inappropriately, and hence presented a much higher level of contamination that did the boric acid solution inside. The lower level of contamination in the solution is possibly associated with the anti-septic characteristics of the boric acid solution.

An Outbreak of Acute Febrile Reaction Developed after the Administration of Teicoplanin

An outbreak of acute febrile reaction which developed after the administration of teicoplanin was identified in seven patients. Fever, with hypotension in some, developed during or soon after infusion and persisted for several hours. Laboratory abnormalities including leukocytosis and elevation of liver enzymes and creatine phosphokinase in serum were observed for two or three days. Contamination of the drug with endotoxins was identified.

An Outbreak of Acute Febrile Reaction Developed after the Administration of Teicoplanin

An outbreak of acute febrile reaction which developed after the administration of teicoplanin was identified in seven patients. Fever, with hypotension in some, developed during or soon after infusion and persisted for several hours. Laboratory abnormalities including leukocytosis and elevation of liver enzymes and creatine phosphokinase in serum were observed for two or three days. Contamination of the drug with endotoxins was identified.

In-vitro Antibacterial Effect and Sterility Test of Danshen Injection / 中药新药与临床药理

Objective To investigate the in-vitro antibacterial effect and sterility test of Danshen injection(DI). Methods Three kinds of in-vitro antibacterial and bacteriostatic methods were used to investigate the in-vitro antibacterial effect of DI and to establish its sterility test according to the results of the antibacterial effects. By validation test, the validity of its sterility test was evaluated. Results The results of doubling dilution test showed that the minimum bacteriostatic concentration of DI is 0.098 mg/mL, and its minimum bactericidal concentration is 1. 563 mg/mL in ethanolsulfate medium and 0.195 mg/mL in nutrient meat soup medium. Rate of recovered bacterium was much more than 80% by membrane filtration method. Conclusion DI has strong in-vitro bacteriostatie effects for staphylococcus aureus and the effectual method of its sterility test is membrane filtration method.