A simple and rapid spectrophotometric method for the determination of trans-chalcone in raw-materialand topical formulation / Método espectrofotométrico simples e rápido paradeterminação de trans-chalcona em matéria-primae em formulação tópica

Trans-chalcone (TC) is a flavonoid precursor characterized by a wide spectrum of action, with anti-inflammatory and antioxidant effects. However, no validated methods are available in official compendia for the analysis of this substance. Thus, the aim of this work was to develop and validate a simple, fast, and reproducible spectrophotometric method for the analysis of TC in raw material, and in topical pharmaceutical formulation containing TC. The established conditions were: methanol as extracting solvent, and detection wavelength of 309 nm by UV spectrophotometer. All tests followed the rules of Resolution RDC 166, 2017. The proposed method was selective. Linearity was demonstrated in the concentration range of 1 to 8 µg/mL (r = 0.999). Repeatability and intermediate precision were confirmed by low relative standard deviation values of 1.53% and 2.70% for TC, and of 1.73% and 2.91% for formulation containing TC. Accuracy, evaluated through recovery test, was adequate, with minimum of 98.24% and maximum of 100.23% of recovery. It was observed that the small deliberate modifications done did not interfere with the results, demonstrating the method is robust. The results showed that the method was considered suitable for the intended purpose, inexpensive, easy to apply, selective, linear, precise, accurate, and robust for the determination TC, and pharmaceutical formulation containing TC. Thus, the method developed satisfies the need for an analytical method for the determination of TC, and topical formulation containing TC, being effective, innovative and able to aid in the development of the pharmaceutical field.

Trans-chalcona (TC) é um precursor de flavonoides caracterizado por um amplo espectro de ação, como efeitos anti-inflamatórios e antioxidantes. No entanto, não há método validado disponível em compêndio oficial para análise deste composto. Então, o objetivo deste trabalho foi desenvolver e validar um método espectrofotométrico, simples, rápido e reprodutível para análise de TC em matéria-prima, e em formulação farmacêutica tópica contendo TC. As condições estabelecidas foram: metanol como o solvente de extração, e detecção no comprimento de onda de 309 nm por espectrofotometria no UV. Todos os testes seguiram as normas da RDC 166, 2017. O método proposto foi seletivo. A linearidade foi demonstrada na faixa de concentração de 1 a 8 µg/mL (r = 0.999). A repetibilidade e a precisão intermediária foram confirmadas pelos valores baixos de desvio padrão relativo de 1,53% e 2,70% para a TC, e de 1,73% e 2,91% para a formulação contendo TC. A exatidão, avaliada por meio de testes de recuperação, foi adequada, com mínimo de 98,24% e máximo de 100,04% de recuperação. Observou-se que pequenas modificações no método não interferiram nos resultados, demonstrando que o método é robusto. Os resultados demonstraram que o método foi adequado para a finalidade pretendida, barato, de fácil aplicação, seletivo, linear, preciso, exato e robusto para determinação de TC, e de formulação contendo TC. Então o método desenvolvido satisfaz as necessidades de um método analítico para determinação de TC, e de formulação tópica contendo TC, e é eficaz, inovador e pode contribuir para o desenvolvimento da área farmacêutica.

La gestión de la calidad y la acreditación ISO 15189 en los laboratorios clínicos de Latinoamérica / Quality management and ISO 15189 accreditation in clinical laboratories in Latin America / Gestão da qualidade e acreditação ISO 15189 nos laboratórios clínicos da América Latina

Resumen El presente trabajo fue realizado por el Grupo de Trabajo Gestión de Acreditación de la Confederación Latinoamericana de Bioquímica Clínica (COLABIOCLI) con el objetivo de conocer el estado de los Laboratorios Clínicos (LC) con respecto a la gestión de la calidad y el estatus de la acreditación ISO 15189 en Latinoamérica. La investigación fue de tipo observacional, transversal y descriptiva; se utilizó como herramienta la encuesta y como instrumento el cuestionario. Los resultados se expresaron en frecuencias simples y porcentajes y se analizaron por estadística descriptiva. En las 253 encuestas aceptadas participaron LC de 15 de 16 países integrantes de COLABIOCLI. El 80% de los LC tenían procedimientos de la fase preanalítica y posanalítica. Más del 85% contaba con registros de gestión de la calidad y participaban en programas de evaluación externa de la calidad (PEEC), principalmente en las disciplinas de química clínica (mayor del 80%) y hematología (mayor del 70%). El 7,51% estaban acreditados por ISO 15189 y 10,27% certificados por ISO 9001. La gestión de la calidad y los PEEC presentan un importante avance en los LC de Latinoamérica; sin embargo, es deseable que todas las partes interesadas armonicen intereses, para que este proceso sea introducido paulatinamente y como parte de las normativas y/o regulaciones obligatorias respectivas, lo que podrá contribuir a que más LC se acrediten en base a ISO 15189 en la región.

Abstract The present work was carried out by the Accreditation Management Working Group of the Latin American Confederation of Clinical Biochemistry (COLABIOCLI) with the aim of knowing the status of Clinical Laboratories (LC, for its acronym in Spanish) with respect to quality management and the status of the ISO 15189 accreditation in Latin America. The research was observational, cross-sectional, and descriptive, using the survey as a tool and the questionnaire as an instrument. The results were expressed in simple frequencies and percentages and analysed by descriptive statistics. LCs from 15 of the 16 member countries of COLABIOCLI participated in the 253 surveys accepted. Eighty percent of LCs had pre-analytical and post-analytic procedures, and more than 85% had quality management records and participated in external quality assessment services (EQAS), mainly in the disciplines of clinical chemistry (greater than 80%) and hematology (greater than 70%); 7.51% were ISO 15189 accredited and 10.27% ISO 9001 certified. Although quality management and EQAS represent an important advance in LCs in Latin America, it is desirable that all stakeholders harmonise interests, so that this process is introduced gradually and as part of the respective mandatory standards and/or regulations, thus contributing to more LCs being accredited based on ISO 15189 in the region.

Resumo O presente trabalho foi realizado pelo Grupo de Trabalho de Gestão de Acreditação da Confederação Latino-Americana de Bioquímica Clínica (COLABIOCLI) com o objetivo de conhecer o status dos Laboratórios Clínicos (LC) com relação à gestão da qualidade e o status da acreditação ISO 15189 na América Latina. A pesquisa foi observacional, transversal e descritiva, utilizando a enquete como ferramenta e o questionário como instrumento. Os resultados foram expressos em frequências simples e porcentagens e analisados por estatística descritiva. LCs de 15 dos 16 países membros do COLABIOCLI participaram das 253 pesquisas aceitas; 80% dos LCs tinham procedimentos da fase pré-analítica e pós-analítica, e mais de 85% tinham registros de gestão da qualidade e participavam de programas de avaliação externa da qualidade (PEEC), principalmente nas disciplinas de química clínica (maior de 80%) e hematologia (maior de 70%); 7,51% estavam acreditados pela ISO 15189 e 10,27% certificados pela ISO 9001. Embora a gestão da qualidade e os PEECs apresentem um importante avanço nos LCs da América Latina, é desejável que todas as partes interessadas harmonizem interesses, para que esse processo seja introduzido gradualmente e como parte das respectivas normas e/ou regulações obrigatórias, o que poderá contribuir para que mais LCs sejam acreditados com base na ISO 15189 na região.

Validação da eficácia de desinfetantes após diluição para uso em laboratório farmacêutico oficial / Validation of the efficacy of disinfectants after dilution for use in official pharmaceutical laboratory / Validación de la eficacia de los desinfectantes después de la dilución en un laboratorio farmacéutico oficial

Todos os procedimentos da indústria farmacêutica devem ser validados com a finalidade de garantir que os métodos demonstrem resultados confiáveis e aceitáveis pelo controle de qualidade. Assim, este estudo objetivou validar a eficácia de desinfetantes após diluição para uso em laboratório farmacêutico oficial. Foi elaborado o protocolo de validação e após sua aprovação foi iniciada a diluição dos desinfetantes para os tempos (T) 0, 7, 15 e 30 dias. Foram preparados os meios de cultura, realizada a promoção de crescimento dos microrganismos, preparada a suspensão microbiana e após a incubação foi realizada a diluição seriada de 10-1 a 10-10, o inóculo foi padronizado e a eficácia foi analisada. Os testes de eficácia foram realizados em triplicata, as colônias foram lidas nas placas e os dados planilhados eletronicamente. Do T0 ao T7, todos os microrganismos foram sensíveis aos desinfetantes, exceto Aspergillus brasiliensis, que reprovou três desinfetantes. A partir do T15, os microrganismos Pseudomonas aeruginosa e Bacillus subtilis apresentaram crescimento. No T30, Escherichia coli, Salmonella typhimurium, Staphylococcus aureus e Candida albicans continuaram sem crescimento. Foram aprovados cinco desinfetantes que inibiram o crescimento no período de até 7 dias, sendo definido o prazo de 7 dias como validade para os desinfetantes após diluição.

All procedures in the pharmaceutical industry must be validated to ensure that the methods show reliable and acceptable results according to quality control. This study aimed to validate the efficacy of disinfectants after dilution for use in official pharmaceutical laboratory. The validation protocol was elaborated and, after its approval, the dilution of the disinfectants for the times (T) 0, 7, 15, and 30 days was initiated. The culture media were prepared, the growth of the microorganisms was promoted, the microbial suspension was prepared, and after incubation the serial dilution of 10-1 to 10-10 was performed, the inoculum was standardized, and the efficacy was analyzed. Efficacy tests were performed in triplicates, the colonies were read on the plates, and the data were electronically arranged in spreadsheets. From T0 to T7, all microorganisms were sensitive to disinfectants, except for Aspergillus brasiliensis, which excluded three disinfectants. The microorganisms Pseudomonas aeruginosa and Bacillus subtilis showed growth from T15 onward. At T30, Escherichia coli, Salmonella typhimurium, Staphylococcus aureus, and Candida albicans continued to lack growth. The protocol of this study approved five disinfectants that inhibited growth in a period of up to 7 days and defined 7 days as the validity period for disinfectants after dilution.

Todos los procedimientos de la industria farmacéutica deben ser validados para garantizar que los métodos demuestren resultados confiables y aceptables por el control de calidad. Este estudio tuvo por objetivo validar la eficacia de los desinfectantes diluidos para su uso en laboratorio farmacéutico oficial. Para ello, se elaboró el protocolo de validación y, luego de su aprobación, se inició la dilución de los desinfectantes para los tiempos (T) 0, 7, 15 y 30 días. Se prepararon los medios de cultivo, se promovió el crecimiento de los microorganismos, se preparó la suspensión microbiana, y después de la incubación se realizó la dilución seriada de 10-1 a 10-10, se estandarizó el inóculo y se analizó la eficacia. Las pruebas de eficacia se realizaron por triplicado, las colonias se analizaron en las placas cuyos resultados se pusieron en hojas de cálculo en línea. De T0 a T7, todos los microorganismos fueron sensibles a los desinfectantes, excepto Aspergillus brasiliensis, que falló tres desinfectantes. A partir de T15, los microorganismos Pseudomonas aeruginosa y Bacillus subtilis mostraron crecimiento. En T30, Escherichia coli, Salmonella typhimurium, Staphylococcus aureus y Candida albicans continuaron sin crecimiento. Se aprobaron cinco desinfectantes que inhibieron el crecimiento en un período de hasta 7 días, y se definió un período de 7 días como el período de validez de los desinfectantes después de la dilución.

The effect of ballot design for strawberry yogurt analysis using CATA (check-all-that-apply) / Efecto del diseño de la ficha para el análisis de yogurt bebible de fresa por el método CATA (check-all-that-apply)

ABSTRACT Sensory evaluation of food is a constantly evolving field, where recently developed analysis methods are on their way to be consolidated. Check-All-That-Apply (CATA) is a rapid method used to describe sensory characteristics of a product through a personalized selection of terms; however, the format in which these terms are presented is not standardized. This study aimed to assess the effect of the design of four CATA ballots for the analysis of strawberry drinkable yogurt. Fifteen descriptive terms were established with the participation of 97 consumers, with 6 terms relating to texture, 5 to taste, and 2 to both appearance and odor. The four ballot models: a) columns, b) vertical list, c) radial distribution, and d) random distribution, were applied to characterize the same commercial brand of yogurt using 150 consumers for each model. According to Cochran's Q test, significant differences were found for the pink color, acid/sour taste, strawberry odor, creaminess, viscosity, milk odor, and artificial flavor. Among the four ballot models, model C shows less variability in selecting terms. Furthermore, there were found differences among the yogurt samples for physicochemical properties (p-value<0.05) related to instrumental color, pH, titratable acidity, and soluble solids, except for consistency index. Finally, these findings highlight that the ballot design affects consumer responses associated with the visual perception process resulting from the design, as well as the physicochemical characteristics of yogurt derived from the technological process experienced during manufacturing and commercialization.

RESUMEN La evaluación sensorial de alimentos se encuentra en constante evolución, donde los métodos de análisis recientemente desarrollados buscan consolidarse. Check-All-That-Apply (CATA) es un método rápido empleado para describir características sensoriales de un producto mediante una selección personalizada de términos. Sin embargo, el formato en que éstos se presentan no está estandarizado. Este estudio evaluó el efecto del diseño de cuatro fichas CATA para el análisis de yogurt bebible de fresa. Se generaron 15 descriptores con la participación de 97 consumidores; de estos descriptores 6 se relacionaron con la textura, 5 con el sabor y 2 tanto con apariencia como con el olor. Se diseñaron 4 modelos de fichas: a) columnas, b) lista vertical, c) distribución radial y d) distribución aleatoria, que fueron aplicados para caracterizar una misma marca de yogurt comercial, empleando 150 consumidores por cada modelo. La prueba Q de Cochran evidenció diferencias significativas para el color rosado, ácido/agrio, olor a fresa, cremoso, viscoso, olor a leche, y sabor artificial. De las cuatro fichas propuestas, el modelo C mostró menor variabilidad en la selección de términos. Asimismo, los lotes de yogurt presentaron propiedades fisicoquímicas heterogéneas (p-valor<0.05) en relación con el color instrumental, pH, acidez titulable y sólidos solubles con excepción del índice de consistencia. Finalmente, estos hallazgos evidencian que el diseño de la ficha ejerce un efecto significativo en la respuesta de los consumidores asociado al proceso de percepción visual originado por el diseño, así como a características fisicoquímicas inherentes al producto como consecuencia del procesamiento tecnológico y comercialización.

Segurança dos alimentos em casa: desvendando a contaminação em superfícies e ar / Food safety at home: revealing surface and air contamination

A contaminação de superfícies e do ar em cozinhas domésticas representa um grave problema de saúde pública, com microrganismos prejudiciais podendo se alojar em bancadas, utensílios e equipamentos, sendo transferidos através do contato com alimentos crus, resíduos alimentares e sujeira, além de serem dispersos pelo ar, onde os aerossóis podem se espalhar ou se depositar. O objetivo deste estudo foi avaliar a presença de Escherichia coli e Salmonella spp. em superfícies de contato em cozinhas domésticas, bem como a contagem total de microrganismos no ar. Foram coletadas amostras de superfície em seis cozinhas residenciais, utilizando swabs friccionados em maçanetas de geladeira, botões/alças/portas de eletrodomésticos (Airfryer, liquidificador, micro-ondas), portas de armários de mantimentos e gavetas de talheres utilizados no preparo de alimentos. Além disso, a amostragem passiva do ar foi realizada em três períodos de exposição, com os resultados quantificados em Unidades Formadoras de Colônias (UFC). Os resultados indicaram que 72% das amostras estavam contaminadas com bactérias entéricas, sendo 8,3% especificamente contaminadas com Salmonella spp. e E. coli, principalmente na gaveta de talheres e na porta da geladeira. Ficou evidente a importância da limpeza e desinfecção adequadas dessas superfícies para prevenir a contaminação e garantir a segurança dos alimentos. Observou-se também que as superfícies menos higienizadas apresentavam maior contaminação. Ademais, a legislação local em vigor destaca a qualidade microbiológica do ar, considerada de péssima qualidade neste estudo em comparação com os padrões da literatura. Para prevenir a contaminação de superfícies de contato em cozinhas domésticas, é crucial adotar práticas simples, como lavar as mãos com frequência, manter a limpeza e desinfecção regular das superfícies, separar utensílios e equipamentos usados para alimentos crus e cozidos, e armazenar alimentos adequadamente.(AU)

Contamination of surfaces and air in household kitchens poses a significant public health concern, as harmful microorganisms can adhere to countertops, utensils, and equipment, and can be transferred through contact with raw food, food waste, and dirt, as well as dispersed through the air, where aerosols can spread or settle. The aim of this study was to assess the presence of Escherichia coli and Salmonella spp. on contact surfaces in domestic kitchens, along with the total count of microorganisms in the air. Surface samples were collected from six residential kitchens, using swabs rubbed on refrigerator handles, buttons/handles/doors of household appliances (Airfryer, blender, microwave), pantry cabinet doors, and cutlery drawers used in food preparation. Additionally, passive air sampling was conducted in three exposure periods, with results quantified in Colony Forming Units (CFU). The findings revealed that 72% of the samples were contaminated with enteric bacteria, with 8.3% specifically contaminated with Salmonella spp. and E. coli, predominantly in the cutlery drawer and on the refrigerator door. The importance of proper cleaning and disinfection of these surfaces to prevent contamination and ensure food safety became apparent. It was also noted that less sanitized surfaces exhibited greater contamination. Furthermore, current local legislation emphasizes the microbiological quality of the air, which was deemed poor in this study compared to literature standards. To mitigate contamination of touch surfaces in home kitchens, it is imperative to adopt straightforward practices such as frequent handwashing, regular cleaning and disinfection of surfaces, segregation of utensils and equipment used for raw and cooked foods, and appropriate food storage.(AU)

Evaluation of the quality of platelet concentrates obtained in a Peruvian hospital / Evaluación de la calidad de concentrados de plaquetas obtenidos en un hospital peruano

INTRODUCTION: Platelet concentrates are blood products obtained from donor's blood, and their conservation must be subject to a strict quality control process to guarantee a safe and high-performance product in treating diseases that require their use. METHODS: We designed a cross-sectional study to determine the total compliance rate in platelet concentrates obtained in the blood bank of the Cayetano Heredia Hospital in Lima during November and December of 2019. The Buffy method Coat obtained the platelet concentrates, and parameters such as platelet count and residual leukocytes, pH, and swirling effect were evaluated according to the National Hemotherapy and Blood Bank Program criteria. RESULTS: The platelet count had a mean of 6.66 ± 3.94 x 10¹°/µL, the platelet concentrates had a mean of 56.30 ± 6.22 mL, and all, without exception, had the presence of the Swirling phenomenon. The pH had a mean of 7.64 ± 0.15, while the leukocyte count had a mean of 4.22 ± 3.51 x 107/µL. Regarding compliance by the parameters evaluated, it was evident that the platelet and leukocyte count had moderate compliance rates of 43.6% and 24.1%, while the pH and swirling effect had rates of 100% in both cases. The total compliance rate was 54.9% (95% confidence interval: 46.0 to 63.5). CONCLUSIONS: The compliance rate of platelet concentrates is moderate, and it is necessary to implement a process of continuous quality improvement in the blood bank.

INTRODUCCIÓN: Los concentrados plaquetarios son hemoderivados obtenidos de la sangre, y su conservación debe estar supeditada a un estricto proceso de control de calidad para garantizar un producto inocuo y de alto rendimiento en el tratamiento de enfermedades que requieran su uso. MÉTODOS: Diseñamos un estudio transversal que tuvo por objetivo determinar la tasa de conformidad total en concentrados plaquetarios obtenidos en el banco de sangre del Hospital Cayetano Heredia de Lima durante los meses de noviembre y diciembre del año 2019. Los concentrados plaquetarios fueron obtenidos por el método de Buffy Coat y se evaluaron parámetros como el recuento de plaquetas y leucocitos residuales, pH y efecto swirling, según criterios del Programa Nacional de Hemoterapia y Bancos de Sangre. RESULTADOS: El recuento de plaquetas tuvo una media de 6.66 ± 3.94 x1010/µL y los concentrados plaquetarios tuvieron una media de 56.30 ± 6.22 mL, y todos sin excepción tuvieron presencia de fenómeno Swirling. El pH tuvo una media de 7.64 ± 0.15, mientras que el recuento de leucocitos tuvo una media de 4.22 ± 3.51 x107/µL. En cuanto al cumplimiento por parámetro evaluado, se evidenció que el recuento de plaquetas y leucocitos tuvieron tasas de conformidad de 43.6% y 24.1%, mientras que el pH y efecto swirling tuvieron tasas del 100% en ambos casos. La tasa de conformidad total fue 54.9% (CI95%: 46.0 a 63.5). CONCLUSIONES: La tasa de conformidad de los concentrados plaquetarios es moderada, y se requiere implementar un proceso de mejora continua de la calidad en el banco de sangre.

Calidad en el servicio mediante la metodología Servqual y satisfacción en pacientes hospitalizados / Quality Service: servqual methodology and patient satisfaction in hospitals

Resumen Objetivo: Determinar la relación existente entre la satisfacción de los pacientes hospitalizados y la calidad en el servicio en un hospital público del Estado de Guanajuato, mediante la metodología SERVQUAL. Materiales y métodos: Estudio de diseño cuantitativo correlacional y de validación de instrumentos de medición. Se contó con la participación de 191 pacientes internados en cuatro servicios de hospital. Resultados: Los resultados comprobaron que el cuestionario utilizado cumple con los parámetros de confiabilidad. Adicionalmente se realizó un análisis de regresión lineal múltiple para identificar los factores del SERVQUAL que influyen en la satisfacción del paciente y se encontró que los factores influyentes son tangibilidad, fiabilidad, seguridad y empatía (F=111.17, p < 0.001), lo que indica una relación altamente significativa. Conclusiones: Las variables del SERVQUAL identificadas como influyentes en la calidad del servicio presentan una asociación positiva (tangibilidad, fiabilidad y empatía). La variable capacidad de respuesta no presenta un valor significativo en la regresión. Sin embargo, la variable seguridad presenta una asociación negativa lo cual implica que el paciente percibe que hace falta comunicación en los procedimientos aplicados por parte del personal y la amabilidad con la cual es atendido.

Abstract Objective: Determine the relationship between the satisfaction of hospitalized patients and the quality of service in a public hospital in the State of Guanajuato, through the SERVQUAL methodology. Materials and methods: Correlational quantitative design study and validation of measurement instruments. 191 patients of four hospital service were interviewed. Results: The results confirmed that the questionnaire used meets the reliability parameters. Additionally, a multiple linear regression analysis was carried out to identify the SERVQUAL factors that influence patient satisfaction and it was found that the influential factors are tangibility, reliability, security and empathy (F=111.17, p < 0.001), which indicates a highly significant relationship. Conclusions: The SERVQUAL variables identified as influencing service quality present a positive association (tangibility, reliability and empathy). The responsiveness variable does not present a significant value in the regression. However, the security variable presents a negative association which implies that the patient perceives that there is a lack of communication in the procedures applied by the staff and the kindness with which he is cared for.

Assessing and Achieving Quality in Qualitative Research: Clues for Researchers in Training* / Valorar y lograr la calidad de la investigación cualitativa: claves para investigadores en formación / Avaliar e alcançar a qualidade da pesquisa qualitativa: chaves para pesquisadores em formação

This article deals with the particularities of the quality of qualitative research, under the double lens of valuing it and ensuring it. While achieving the quality of qualitative research concerns only those who have opted for this methodology, assessing it is everyone's business because researchers in training will encounter, in the literature reviews, qualitative studies on which they must reflect and estimate their quality. Appreciating the quality of a research work is a complex activity as it is situated within a context and conducted by individuals who use any of the means available to do so. The means they use are criteria as evaluation guides and criteria checklists. For researchers in training, I suggest some guiding criteria to evaluate qualitative publications and ensure quality during the research process, key issues that they must address.

Este artículo trata sobre las particularidades de la calidad de la investigación cualitativa, bajo la doble lente de valorarla y asegurarla. Mientras que alcanzar la calidad de una investigación cualitativa atañe solo a los que han optado por esta metodología, valorarla es asunto de todos, ya que los investigadores en formación se encontrarán en las revisiones bibliográficas con estudios cualitativos sobre los cuales deberán reflexionar y estimar su calidad. Apreciar la calidad de un trabajo de investigación es una actividad compleja ya que está situada en un contexto y llevada a cabo por personas que usan alguno de los medios disponibles para hacerlo. Los medios que usan son los criterios como guías de evaluación y los listados de verificación de criterios. Para los investigadores en formación sugiero unos criterios guía para la valoración de publicaciones cualitativas y para asegurar la calidad durante el proceso de investigación, unas cuestiones claves a las que deben atender.

Este artigo trata das particularidades da qualidade da pesquisa qualitativa, sob a dupla lente de valorizá-la e garanti-la. Embora alcançar a qualidade da pesquisa qualitativa seja do interesse de quem optou por esta metodologia, Avaliar é tarefa de todos, pois os pesquisadores em formação se encontrarão em revisões bibliográficas com estudos qualitativos, sobre os quais deverão refletir e estimar sua qualidade. Avaliar a qualidade de um trabalho de investigação é uma atividade complexa, pois está situada num context e é realizada por pessoas que utilizam qualquer um dos meios disponíveis para o fazer. Os meios que utilizam são critérios como guias de avaliação e listas de verificação de critérios. Aos pesquisadores em formação, sugiro alguns critérios norteadores para avaliar publicações qualitativas e para garantir a qualidade durante o processo de pesquisa, questões chaves que devem ser abordadas.

El laboratorio de fertilidad masculina, su evolución en los últimos 20 años / The male fertility laboratory, its evolution over the last 20 years / O laboratório de fertilidade masculina, sua evolução ao longo dos últimos 20 anos

Resumen La mayor accesibilidad a los tratamientos de reproducción asistida (RA) y los avances de la criobiología produjeron cambios en los laboratorios de andrología. El objetivo de este trabajo fue analizar la demanda y evolución de las variables seminales en las últimas dos décadas, caracterizar el laboratorio andrológico actual, evaluar el impacto de la incorporación del aseguramiento de la calidad y la inclusión de los sistemas computarizados (CASA). Se utilizaron datos de las medias mensuales del control de calidad interno (n=22 528) y encuestas a profesionales de laboratorios andrológicos (n=65) y a médicos especialistas en fertilidad (n=33). La demanda global se redujo significativamente con el aumento de las solicitudes de primera vez. El volumen y recuento, variables dependientes de andrógenos, disminuyeron con los años. El criterio estricto en morfología disminuyó el porcentaje de normales; la mitad de los médicos encuestados recibieron resultados entre 0 y 10% y el 40% consideró que ponía en riesgo el valor clínico de la variable. El sistema CASA permitió objetivar la cinética espermática e incrementar el porcentaje de progresivos rápidos, pero pocos laboratorios lo incorporaron. El 66% de los médicos resuelven el factor andrológico severo por tratamientos clínicos y el 95% utiliza técnicas de RA. El análisis de semen es ejecutado fundamentalmente por bioquímicos especializados, con baja adhesión a la automatización y acreditación del laboratorio, pero con participación en programas de evaluación externa de calidad. La demanda disminuyó como consecuencia del aumento del tratamiento por RA. La reducción del porcentaje de formas normales compromete su utilidad clínica.

Abstract Increasing availability to assisted reproduction (AR) treatments in Argentina and advances in cryobiology resulted in changes in andrology laboratories. The aim of this study was to evaluate the demand and evolution of seminal variables in the last two decades, characterise the current andrology laboratory, evaluate the impact of the incorporation of quality assurance and the introduction of computer assisted semen analysis (CASA). Data were taken from internal quality control (IQC) monthly means (n=22 528) and professionals in charge of laboratories (n=65) and fertility physicians' (n=33) surveys. Overall demand decreased significantly while first-time orders increased. Sperm volume and sperm count -androgen dependent parameters- decreased over the years. Strict morphology criteria reduced the percentage of normal results; half of the physicians received results between 0 and 10% and 40% considered that it compromised the clinical value of the variable. The CASA system made it possible to objectify sperm kinetic, increasing the percentage of fast progressives, but few laboratories have incorporated it. Sixty-six percent of physicians resolve severe andrological factor by clinical treatments and 95% use AR techniques in those cases. Semen analysis is mainly performed by specialised biochemists, with low adherence to laboratory automatisation and accreditation, but with participation in external quality assessment programmes. The demand decreased because of the increase in AR treatment. The lower percentage of normal forms compromises their clinical utility.

Resumo O aumento do acesso aos tratamentos de reprodução assistida (RA) e os avanços na criobiologia levaram a mudanças nos laboratórios de andrologia. O objetivo deste trabalho foi analisar a demanda e a evolução das variáveis de sêmen nas últimas duas décadas, caracterizar o laboratório de andrologia atual, avaliar o impacto da incorporação da garantia da qualidade e a inclusão dos sistemas computadorizados (CASA). Foram utilizados dados das médias mensais do controle de qualidade interno (n= 22 528) e pesquisas a profissionais de laboratórios andrológicos e a médicos especialistas em fertilidade (n=33). A demanda geral diminuiu significativamente com o aumento das solicitações de primeira vez. O volume e a contagem de esperma, parâmetros dependentes de andrógenos, diminuíram ao longo dos anos. O critério morfológico rigoroso diminuiu a porcentagem de normais; metade dos médicos entrevistados recebeu resultados entre 0 e 10% e 40% considerou que isso comprometía o valor clínico do parâmetro. O sistema CASA, permitiu objetivar a cinética espermática e aumentar o percentual de progressões rápidas, mas poucos laboratórios o incorporaram. 66% dos médicos resolvem o fator andrológico grave por tratamentos clínicos e 95% utilizam técnicas de RA nesses casos. A análise do sêmen é realizada principalmente por bioquímicos especializados, com baixa aderência à automação e acreditação laboratorial, mas com participação em programas de avalação externa de qualidade. A demanda diminuiu como consequência do aumento do tratamento por RA. A diminuição em percentagem de formas normais compromete sua utilidade clínica.

Controles de calidad externos en el diagnóstico molecular de enfermedades genéticas. Impacto sobre la calidad de los estudios genéticos / External quality controls in the molecular diagnosis of genetic diseases. Impact on the quality of the genetic studies / Controles de qualidade externos no diagnóstico molecular de doenças genéticas. Impacto na qualidade dos estudos genéticos

Resumen La participación en programas de evaluación externa de la calidad (PEEC) dirigidos al diagnóstico de enfermedades genéticas permite obtener una medida objetiva del desempeño técnico y analítico de los laboratorios y es un requisito para la acreditación de los laboratorios clínicos bajo la norma ISO 15189. El objetivo de este estudio fue evaluar retrospectivamente el desempeño en los esquemas EMQN (European Molecular Genetics Quality Network) y CF Network (Cystic Fibrosis European Network) en el período 2014-2022. Se participó en un total de 88 esquemas. Se recolectó la información de nuestros puntajes y las medias de los laboratorios participantes en las categorías genotipificación, interpretación y exactitud de la información del paciente/informe. Se informó en forma completa el 90,9% (n=80) de los esquemas. El desempeño en genotipificación mostró puntajes superiores a la media en el 89,3% de los esquemas; 0,8% de los informes correspondieron a falsos negativos. En interpretación, el 66,7% de los esquemas evidenció un desempeño superior a la media y el 33,3% debajo de la media. La exactitud de la información del paciente/informe presentó puntajes superiores a la media en el 97,6% de los esquemas. Se observó una diferencia estadísticamente significativa en el porcentaje de esquemas con puntaje por encima de la media en el año 2022 (10/12 esquemas) respecto al año 2014 (1/6 esquemas) en la categoría interpretación (p=0,0128). En conclusión, la participación regular en PEEC tuvo impacto positivo en la calidad de los estudios y permite realizar mejoras continuas a partir de las recomendaciones sugeridas por estos programas.

Abstract Participation in external quality assessment programmes focused on rare genetic diseases makes it possible to assess the laboratory technical and analytical performance and it is a prerequisite for accreditation according to ISO 15189. The objective of this study was to perform a retrospective evaluation of our performance in the EMQN (European Molecular Genetics Quality Network) and the CF Network (Cystic Fibrosis European Network) programmes in the 2014-2022 period. The laboratory performance on genotyping, interpretation and clerical accuracy and patient identifiers in a total of 88 schemes were assessed. The information of our scores and the mean scores of all participating laboratories in the three categories were collected. A total of 90.9% of the schemes were fully completed. The performance in genotyping showed scores above the mean scores in 89.3% of the schemes; 0.8% of the reports correspond to false negative results. Regarding interpretation category, 66.7% of the schemes presented scores above the mean scores and 33.3% below the mean scores. The clerical accuracy and patient identifiers were above the mean scores in 97.6% of the schemes. A statistically significant difference in the percentage of schemes with a score above the mean for the interpretation category in the year 2022 (10/12 schemes) was observed compared to the year 2014 (1/6 schemes) (p=0.0128). In conclusion, regular participation in external quality assessment programmes had a positive impact on the quality of the studies and allows for continuous improvements based on the recommendations suggested by these programmes.

Resumo A participação em programas de avaliação externa da qualidade (PEECs) voltados para o diagnóstico de doenças genéticas permite obter uma mensuração objetiva do desempenho técnico e analítico dos laboratórios e é requisito para a acreditação dos laboratórios clínicos sob a norma ISO 15189. O objetivo desse estudo foi avaliar retrospectivamente o desempenho nos esquemas EMQN (European Molecular Genetics Quality Network) e CF Network (Cystic Fibrosis European Network) no período 2014-2022. Participou-se em um total de 88 esquemas. Foram coletadas informações de nossos escores e das médias dos laboratórios participantes nas categorias genotipagem, interpretação e precisão da informação do paciente/laudo. 90,9% (n=80) dos esquemas foram informados em sua totalidade. O desempenho na genotipagem apresentou escores acima da média em 89,3% dos esquemas; 0,8% dos laudos corresponderam a falsos negativos. Na interpretação, 66,7% dos esquemas apresentaram desempenho acima da média e 33,3% abaixo da média. A precisão das informações do paciente/laudo apresentou escores acima da média em 97,6% dos esquemas. Observou-se diferença estatisticamente significativa no percentual de esquemas com pontuação acima da média no ano de 2022 (10/12 esquemas) em relação ao ano de 2014 (1/6 esquemas) na categoria interpretação (p=0,0128). Em conclusão, a participação regular em PEECs teve um impacto positivo na qualidade dos estudos e permite fazer melhorias contínuas com base nas recomendações sugeridas por esses programas.

Enzyme-linked Immunosorbent Assay in Quality Control of Chinese Medicines： A Review / 中国实验方剂学杂志

In the quality control of Chinese medicine， the detection of active components and toxic and harmful components are two important links. Although conventional methods such as high performance liquid chromatography and liquid chromatography-mass spectrometry can accurately quantify the above substances， they have shortcomings such as complicated operation， high costs， inability of detection at any time， difficult detection of insoluble and macromolecular substances. Enzyme-linked immunosorbent assay （ELISA） can adsorb antigens or antibodies on the surface of solid carriers and realize qualitative or quantitative analysis of targets by using the specific reactions of antigens and antibodies. This method is praised for the simple operation， high sensitivity， strong specificity， simple requirements for experimental equipment， a wide application range， and low costs. In recent years， ELISA has been widely used in the quality control of Chinese medicine， especially in the content determination of mycotoxins represented by aflatoxin and the qualitative and quantitative analysis of active components. ELISA plays an increasingly important role with its unique advantages， providing new methods and ideas for the rapid quality examination of large quantities of Chinese medicines. This paper reviews the research progress in ELISA for the quality control of Chinese medicine in recent years and prospects its technical development and application prospects， aiming to provide reference and research ideas for further using this method to ensure the quality， safety， and controllability of Chinese medicine.

Trend analysis of hemagglutinin and ovalbumin content for influenza virus split vaccines in 2021 / 中国生物制品学杂志

@#Objective To analyze the trend of the hemagglutinin(HA) and ovalbumin contents in the lot release of influenza virus split vaccines in 2021,and evaluate the quality and quality control level of the vaccines.Methods The HA and ovalbumin content data of influenza virus split vaccines from two domestic enterprises in 2021 were collected and collated. The mean value and standard deviation were calculated according to the first 40 batches of data of the enterprise in the year,and the warning limit and action limit were established. The trend analysis of the above indexes was carried out to evaluate the stability and consistency of the product quality of the enterprise. Statistical data comparison and consistency analysis were made between the test results of the batch inspected by the lot release institution and the results of the enterprise.Results Through the retrospective data analysis of quadrivalent influenza virus split vaccines from two vaccine enterprises A and B,it was found that the content of H1N1 subtype HA and ovalbumin in the two enterprises and the content of Bv HA in the B enterprise had out of trend(OOT)situations,while the trend of other items was stable. The results of paired student's t test or Wilcoxon signed-rank test of the samples inspected by the lot release institution showed that except Bv subtype HA(t = 1. 094 and 0. 742 respectively)and ovalbumin(w =-64 and 36 respectively)contents showed no statistically significant difference(P > 0. 05),the HA contents of H1N1(t = 3. 862,w = 232),H3N2(t = 8. 225 and3. 473 respectively)and By(t = 5. 616 and 4. 934 respectively)of the two enterprises had significant differences(P <0. 05). The results of enterprises were generally higher than the lot release institution. Bland-Altman test analysis found that the consistency between the test data of enterprise A's HA content and the data of the lot release institution was better than that of enterprise B.Conclusion The stability and consistency of data trends of active ingredients and main impurity ingredients of quadrivalent influenza virus split vaccine batches in 2021 were generally good. The trend analysis can identify potential problems in vaccine production,and enterprises should carefully implement trend analysis and effectively monitor the product quality of vaccines.

Development and verification of whole column imaging detection-capillary isoelectric focusing method for determination of isoelectric point of pertactin / 中国生物制品学杂志

@#Objective To develop and verify a whole column imaging detection-capillary isoelectric focusing(WCID-CIEF)method for the determination of isoelectric point(pI)of pertactin(PRN).Methods The WCID-CIEF method for the determination of PRN antigen was developed by optimizing the parameters such as the focusing time and final concentration of samples in the WCID-CIEF process,and verified for the specificity,accuracy,repeatability,intermediate precision,durability and inter-batch consistency.Results The optimal focusing time of WCID-CIEF for the determination of PRN antigen pI was 1 min at 1 500 V and 3 min at 3 000 V. The optimal final concentration of PRN antigen was 300 μg/mL. The PRN antigen pI was about 6. 035,and the blank matrix showed no interference peak in the position of each peak of antigen. The method had good specificity,accuracy,repeatability,intermediate precision,durability and consistency among batches.Conclusion The developed WCID-CIEF method is suitable for the pI detection and charge heterogeneity analysis of PRN antigen,which can provide basis for the characterization of PRN antigen and reference for the quality control in the process of development and production of related vaccines.

Research progress on clinical application and quality control of sprays / 药学实践与服务

Sprays have gained significant attention and widespread use due to their numerous advantages, including rapid action, safety, and convenience. They are widely used in various fields such as dermatology, respiratory disease treatment, wound repair, and central nervous system targeted drug delivery. With the in-depth research of new drugs and modern pharmaceutics, the development ideas of sprays are more diverse, and the application scenarios are increasingly extensive. In this review the clinical application status of sprays and the latest research progress were summarized. Then the quality control parameters were briefly introduced，which provided reference for the research and development of sprays.

Research progress and existing problems in the industrialization of stem cell drugs / 中国药科大学学报

@#Abstract: Stem cells, which are a type of primitive cells with multipotent differentiation potential and self-renewal ability, have the potential to regenerate various tissues and organs. Stem cell drug development is a frontier research field in life sciences. Extensive clinical trials involving stem cells have been conducted for different complicated diseases. Some stem cells have been approved as drugs for some indications, indicating their broad industrial prospects. This review introduces the progress of stem cell drugs around the world, especially in China, and discusses the main problems in the industrialization of stem cell drugs, such as their effectiveness, quality control and safety, so as to provide some reference and insight for the development and rapid industrialization of stem cell drugs.

Application Progress of Electrochemical Methods in Quality Control of Traditional Chinese Medicine / 分析化学

The quality control of traditional Chinese medicine(TCM)is the core issue to ensure the modernization,industrialization and internationalization of TCM.Compared with other detection methods,electrochemical analysis method has many advantages such as high sensitivity,fast detection speed and low cost,making it an important means of quality control for TCM and having broad development prospects.This article reviewed the research progress of electrochemical methods in quality control of TCM in recent years,discussed the application of electrochemical fingerprinting technique in identification of TCM,and comprehensively summarized the application of electrochemical technology in analyzing effective components and harmful substances in TCM,including flavonoids,alkaloids,quinones,glycosides,heavy metals and pesticide residues.Finally,the development prospects of electrochemical methods in the field of quality control of TCM were discussed.

Analysis on the quality of wild and different cultivation methods of Sanghuang porus vaninii (Ljub.) L.W. Zhou & Y.C. Dai / 国际中医中药杂志

Objective:To compare and evaluate the quality of wild and different cultivation methods of Sanghuang porus vaninii (Ljub.) L.W. Zhou & Y.C. Dai through analysis on UPLC characteristic atlas and multi-component content determination results. Methods:UPLC was used to establish the characteristic chromatogram and multi-component content determination method of Sanghuang porus vaninii (Ljub.) L.W. Zhou & Y.C. Dai, and clustering analysis, orthogonal partial least squares - discriminant analysis method were used for chemical pattern recognition analysis. Results:The results showed that there were 10 common peaks in 18 batches of Sanghuang porus vaninii (Ljub.) L.W. Zhou & Y.C. Dai. Five components were identified, erythrothioneine(peak 1), protocatechuic acid (peak 2), protocatechualdehyde (peak 3), caffeic acid (peak 4) and Hispidin (peak 5). HCA and OPLS-DA could distinguish Sanghuang porus vaninii (Ljub.) with different cultivation methods. Conclusion:Sanghuang porus vaninii (Ljub.) L.W. Zhou & Y.C. Dai in wood is closer to wild Sanghuang porus vaninii (Ljub.) L.W. Zhou & Y.C. Dai than in substitute cultivation. The UPLC characteristic atlas and multi-component content determination method established in this study can provide reference for the quality evaluation of Sanghuang porus vaninii (Ljub.) L.W. Zhou & Y.C. Dai.

Study on quality evaluation of Buddleja officinalis from different habitats based on HPLC fingerprint and content determination / 国际中医中药杂志

Objective:To establish UPLC fingerprint method and 2 contents determination methods of Buddleja officinalis; To provide a reference for improving the quality control standard and evaluation of Buddleja officinalis from different habitats.Methods:UPLC method was used to establish the fingerprints of 17 batches of Buddleja officinalis. The similarity evaluation, clustering analysis, principal component analysis and orthogonal partial least squares discriminant analysis were used to compare the quality differences of Buddleja officinalis from different habitats. The contents of acteoside and linarin in Buddleja officinalis were determined.Results:There were 12 common peaks in UPLC fingerprints of Buddleja officinalis, six of which were identified as echinacoside, acteoside, cynaroside, isoacteoside, linarin, and apigenin. The fingerprint similarity of 17 batches of Buddleja officinalis was more than 0.9; Buddleja officinalis from different habitats were classified into 2 groups. Five differential markers were determined by OPLS-DA analysis. The order of significance was acteoside > peak 3 > echinacoside > isoacteoside > linarin. Edgeworthia chrysantha was identified by the method of fingerprint as counterfeit. The results of content determination showed that the content of Buddleja officinalis in Hubei and Sichuan was the high and stable.Conclusion:The method can effectively analyze the differences of Buddleja officinalis from different habitats, and provide reference for the quality control of Buddleja officinalis.

Research progress in mitochondrial quality control in schizophrenia / 中南大学学报(医学版)

Mitochondria are the main site of energy metabolism within cells,generating a substantial amount of ATP to supply energy to the human body.Research has shown that alterations in mitochondrial structure and function exist in individuals with schizophrenia,suggesting their potential impact on the onset of psychiatric disorders and clinical treatment efficacy.Therefore,understanding the research progress on the genetic mechanisms,pathological processes,image manifestations of schizophrenia and mitochondrial quality control,and summarizing the relevant evidence of mitochondrial-related targets as potential therapeutic targets for schizophrenia,can provide references for further research.