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.

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.

Sentinel laboratory compliance with best practices in Burkina Faso's antimicrobial resistance surveillance network

Background: Standardising procedures is the best way to harmonise and strengthen the quality of laboratory-based antimicrobial resistance surveillance. Since 2018, Burkina Faso has developed and disseminated the national manual of procedures for performing antibiotic susceptibility tests in sentinel laboratories within its national antimicrobial resistance surveillance network. Objective: Our study aimed to assess these sentinel laboratories' compliance with good practices for antibiotics susceptibility tests. Methods: Four teams evaluated the antimicrobial resistance sentinel sites laboratories throughout Burkina Faso from 19 to 28 September 2022. Eighteen out of 19 sentinel laboratories were evaluated. A four-member technical committee designed and validated the evaluation tool composed of three Microsoft Excel sheets. The evaluation emphasised quality controls for culture media, antibiotic discs and compliance with antimicrobial susceptibility testing procedures by the laboratories. Excel software was used for data recording and graphs and table design. The free R software version 4.2.0 was used for descriptive statistics. An overall score below 80% was considered noncompliance. Results: Most (83.33%) of the sentinel laboratories conducted at least one quality control activity for culture media, and 66.67% conducted at least one quality control activity for antibiotic discs. Over three-quarters (76.47%) of the laboratories were more than 80% compliant with the modified Kirby Bauer antimicrobial susceptibility testing method. Conclusion: The evaluation revealed the noncompliance of sentinel laboratories with the national procedure manual, particularly in the quality control component. What this study adds: This study has provided baseline data on the sentinel laboratories' compliance with the national antimicrobial susceptibility testing procedures manual, particularly in areas performing quality control checks or meeting quality indicators for culture media and antibiotic discs.

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.

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.

Research progress on clinical application and quality control of sprays / 药学实践杂志

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.

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.

2022 Country Report on Medical Rehabilitation Services, Quality and Safety in Health Care System / 中国康复理论与实践

ObjectiveTo analyze the medical services, quality and safety of rehabilitation medicine departments in general hospitals and rehabilitation hospitals in 2021 in perspectives of structure, segment and outcome quality. MethodsWe analyzed the data from National Clinical Improvement System of the National Health Commission, involving 9 328 hospitals, including all secondary and above general hospitals and rehabilitation hospitals, as well as traditional Chinese Medicine hospitals and integrated traditional Chinese and Western medicine hospitals in 2021. A total of 2 513 sampling hospitals that equipped with rehabilitation wards were included. ResultsAmong the 9 328 general hospitals surveyed this year, only 2 713 had rehabilitation wards. In general hospitals, the average number of physicians per bed in 56.77% hospitals, the average number of rehabilitation therapists per bed in 80.36% hospitals, and the average number of nurses per bed in 53.53% hospitals did not meet the national requirements, and the average number of rehabilitation medical personnel per bed in rehabilitation medicine departments in different regions was significantly different. The rates of early rehabilitation intervention were 13.45%, 20.67% and 29.74% respectively in department of orthopedics, department of neurology and intensive care units in general hospitals. The average improvement rate of activities of daily living of discharged patients was 77.87% in rehabilitation department of general hospitals, and 69.01% in rehabilitation hospitals. ConclusionIn 2021, professional medical services, quality and safety of rehabilitation medicine in China have improved steadily. However, most general hospitals in China still have not configured the rehabilitation wards, and there are problems such as the total number of rehabilitation medical personnel in the country does not meet the requirements, early rehabilitation intervention is significantly insufficient, and the implementation of important evaluation and therapies is deficient. The effect of rehabilitation still needs to improve. It is necessary to continuously promote capacity building of the medical rehabilitation to improve the quality of medical rehabilitation services.

Quantitative Analysis of Multi-components in Gnaphalium affine Based on UPLC-Q-Exactive Orbitrap MS / 中国实验方剂学杂志

ObjectiveTo establish a rapid and stable liquid chromatography-mass spectrometry（LC-MS） for simultaneous analysis of 17 chemical components in Gnaphalium affine aboveground parts with flowers， so as to provide experimental basis for improving the quality standard of this herb. MethodUltra performance liquid chromatography-quadrupole/electrostatic field orbitrap mass spectrometry（UPLC-Q-Exactive Orbitrap MS） was used for the quantitative analysis of 17 constituents in 15 batches of G. affine from different origins， the separation was performed on an ACQUITY UPLC® BEH C18 column（2.1 mm×100 mm， 1.7 μm） with the mobile phase of methanol（A）-0.1% formic acid aqueous solution（B） for gradient elution（0-1.0 min， 8%A； 1.0-4.0 min， 8%-26%A； 4.0-9.0 min， 26%A； 9.0-14.0 min， 26%-34%A； 14.0-14.5 min， 34%-45%A； 14.5-15.0 min， 45%-60%A； 15.0-18.0 min， 60%-90%A； 18.0-19.0 min， 90%A； 19.0-19.01 min， 90%-8%A； 19.01-20.0 min， 8%A）， the flow rate was 0.3 mL·min-1， the column temperature was 40 ℃ and the injection volume was 2 μL. And the electrospray ionization was used with full scanning in both positive and negative ion modes， and the scanning range was m/z 100-1 000. ResultThe established method has been verified by the methodology and could be used for the simultaneous quantification of 17 components in G. affine. The content ranges of the 17 components（quinic acid， gallic acid， protocatechuic acid， neochlorogenic acid， chlorogenic acid， cryptochlorogenic acid， caffeic acid， 1，3-O-dicaffeoylquinic acid， isochlorogenic acid A， isoquercitrin， 1，5-O-dicaffeoylquinic acid， apigenin-7-O-glucoside， astragalin， isochlorogenic acid C， luteolin， apigenin and hispidulin） in 15 batches of G. affine samples was 39.60-179.12， 0.17-0.84， 2.41-8.38， 4.33-31.50， 13.63-180.38， 2.43-14.75， 1.16-19.68， 0.49-5.63， 55.77-445.16， 0.23-10.26， 62.04-530.10， 1.11-18.01， 11.36-90.61， 12.22-65.98， 7.22-69.84， 3.37-45.65， 0.30-2.59 μg·g-1， respectively. The content of organic acids was higher than that of flavonoids in G. affine， and the contents of 1，5-O-dicaffeoylquinic acid， isochlorogenic acid A， quinic acid and chlorogenic acid were higher. Meanwhile， the content of flavonoids in the samples from Guizhou was higher than that from Jiangsu， while the content of organic acids in the samples from Jiangsu was higher than that from Guizhou. ConclusionThe established method can be used for the rapid and accurate determination of 17 components in G. affine， which clarifies the content range of the main components in this herb， and can provide a reference for the selection of quality control markers of G. affine.

An analysis of results of 392 times of CT quality control and room radiological protection testing in Guangdong Province, China / 中国辐射卫生

Objective To provide a theoretical basis for radiation health supervision through an analysis of the situation of computed tomography (CT) equipment quality control and CT room radiological protection in Guangdong Province, China in recent years. Methods We collected the data of 392 times of CT quality control and radiological protection testing by a third-party radiological health technical service institution in Guangdong Province from 2019 to 2021. We analyzed the levels of CT-owning hospitals, CT manufacturers, CT quality control test results, and the pass rate of radiation protection tests. Results The examined CT scanners were from different levels of hospitals in Guangdong Province, and were manufactured by nine major CT equipment manufacturers at home and abroad. The pass rate of CT room radiological protection was 99.88%, and the ambient dose equivalent rates of five monitoring points exceeded the limit, with four at the control room door and one at the shield wall of the room. The overall pass rate of CT equipment quality control was 99.49%, and the non-conforming parameters were the accuracy of positioning light and the deviation of reconstructed slice thickness. Conclusion In recent years, CT equipment quality control and room radiation protection in Guangdong Province have been at a high level.

Mitochondrial Quality Control Affects Diabetic Cardiomyopathy：Based on Theory of Qi Deficiency and Stagnation / 中国实验方剂学杂志

With the increasing incidence of diabetes mellitus in recent years， cardiomyopathy caused by diabetes mellitus has aroused wide concern and this disease is characterized by high insidiousness and high mortality. The early pathological changes of diabetic cardiomyopathy （DCM） are mitochondrial structural disorders and loss of myocardial metabolic flexibility. The turbulence of mitochondrial quality control （MQC） is a key mechanism leading to the accumulation of damaged mitochondria and loss of myocardial metabolic flexibility， which， together with elevated levels of oxidative stress and inflammation， trigger changes in myocardial structure and function. Qi deficiency and stagnation is caused by the loss of healthy Qi， and the dysfunction of Qi transformation results in the accumulation of pathogenic Qi， which further triggers injuries. According to the theory of traditional Chinese medicine （TCM）， DCM is rooted in Qi deficiency of the heart， spleen， and kidney. The dysfunction of Qi transformation leads to the generation and lingering of turbidity， stasis， and toxin in the nutrient-blood and vessels， ultimately damaging the heart. Therefore， Qi deficiency and stagnation is the basic pathologic mechanism of DCM. Mitochondria， similar to Qi in substance and function， are one of the microscopic manifestations of Qi. The role of MQC is consistent with the defense function of Qi. In the case of MQC turbulence， mitochondrial structure and function are impaired. As a result， Qi deficiency gradually emerges and triggers pathological changes， which make it difficult to remove the stagnant pathogenic factor and aggravates the MQC turbulence. Ultimately， DCM occurs. Targeting MQC to treat DCM has become the focus of current research， and TCM has the advantages of acting on multiple targets and pathways. According to the pathogenesis of Qi deficiency and stagnation in DCM and the modern medical understanding of MQC， the treatment should follow the principles of invigorating healthy Qi， tonifying deficiency， and regulating Qi movement. This paper aims to provide ideas for formulating prescriptions and clinical references for the TCM treatment of DCM by targeting MQC.

Progress in quality management and control of donor organ procurement in foreign countries / 器官移植

Since the 20th century, organ transplantation has become a breakthrough technology to effectively save the lives of patients with end-stage organ failure, which has significantly enhanced the quality of life of patients. Organ donation is an important source of organ transplantation. Improving the quality of donor organ procurement is the key to promote the translation of donor organs and improve the prognosis of organ transplantation recipients. The United States, Spain and other countries have put forward a series of policies and standards in the quality management and control of donor organ procurement and achieved positive results. In this article, related concepts of medical quality management and control, advanced strategies and models of international donor organ procurement quality management, and quality control measures of Organ Procurement Organization, donors and donor organs were reviewed, aiming to provide reference for establishing a quality management and control system of donor organs with "Chinese characteristics" and advancing high-speed and high-quality development of donor organ procurement.

Gain deeper insights into traditional Chinese medicines using multidimensional chromatography combined with chemometric approaches / 中草药·英文版

Traditional Chinese medicines (TCMs) possess a rich historical background, unique theoretical framework, remarkable therapeutic efficacy, and abundant resources. However, the modernization and internationalization of TCMs have faced significant obstacles due to their diverse ingredients and unknown mechanisms. To gain deeper insights into the phytochemicals and ensure the quality control of TCMs, there is an urgent need to enhance analytical techniques. Currently, two-dimensional (2D) chromatography, which incorporates two independent separation mechanisms, demonstrates superior separation capabilities compared to the traditional one-dimensional (1D) separation system when analyzing TCMs samples. Over the past decade, new techniques have been continuously developed to gain actionable insights from complex samples. This review presents the recent advancements in the application of multidimensional chromatography for the quality evaluation of TCMs, encompassing 2D-gas chromatography (GC), 2D-liquid chromatography (LC), as well as emerging three-dimensional (3D)-GC, 3D-LC, and their associated data-processing approaches. These studies highlight the promising potential of multidimensional chromatographic separation for future phytochemical analysis. Nevertheless, the increased separation capability has resulted in higher-order data sets and greater demands for data-processing tools. Considering that multidimensional chromatography is still a relatively nascent research field, further hardware enhancements and the implementation of chemometric methods are necessary to foster its robust development.

Treatment of Traditional Chinese Medicine for Diabetic Peripheral Neuropathy Based on Mitochondrial Quality Control： A Review / 中国实验方剂学杂志

Diabetic peripheral neuropathy（DPN） is a neurodegenerative disease of diabetes mellitus involving peripheral nervous system damage， which is characterized by axonal degenerative necrosis， Schwann cell apoptosis and demyelination of nerve myelin sheath as the main pathological features， this disease is highly prevalent and is a major cause of disability in diabetic patients. Currently， the pathogenesis of DPN may be related to oxidative stress， inflammatory response， metabolic abnormality， and microcirculation disorder. The treatment of DPN in modern medicine mainly starts from controlling blood glucose， nourishing nerves and improving microcirculation， which can only alleviate the clinical symptoms of patients， and it is difficult to fundamentally improve the pathological damage of peripheral nerves. Mitochondrial quality control refers to the physiological mechanisms that can maintain the morphology and functional homeostasis of mitochondria， including mitochondrial biogenesis， mitochondrial dynamics， mitochondrial oxidative stress and mitochondrial autophagy， and abnormal changes of which may cause damage to peripheral nerves. After reviewing the literature， it was found that traditional Chinese medicine（TCM） can improve the low level of mitochondrial biogenesis in DPN， maintain the balance of mitochondrial dynamics， inhibit mitochondrial oxidative stress and mitochondrial autophagy， and delay apoptosis of Schwann cells and neural axon damage， which has obvious effects on the treatment of DPN. With the deepening of research， mitochondrial quality control may become one of the potential targets for the research of new anti-DPN drugs， therefore， this paper summarized the research progress of TCM in treating DPN based on four aspects of mitochondrial quality control， with the aim of providing a theoretical research basis for the discovery of new drugs.

Construction of Chinese Herbal Medicine Traceability System Based on Influencing Factors of Chinese Herbal Medicine Quality / 中国实验方剂学杂志

As a Chinese saying goes， "good Chinese medicinal material makes good medicine"， the quality of Chinese herbal medicines is related to the development prospect of Chinese medicine industry in China. With the rapid development of new technologies such as traceability methods and monitoring instruments， it is imperative to integrate and innovate traditional Chinese herbal medicines with new-generation information technology in view of the quality problems existing in the current production and circulation of Chinese herbal medicines， and it is of great significance for the construction of traceability system to ensure the quality and safety of Chinese herbal medicines and to promote the industry of Chinese herbal medicines to move towards high-quality development. This paper reviews the development history of the traceability system of Chinese herbal medicines in China， takes the influencing factors of the quality of Chinese herbal medicines as the entry point， and proposes that the construction of the traceability system should satisfy the traceability requirements of the characteristics of Chinese herbal medicines and their traditional medication experience. By analyzing the influencing factors of the quality of Chinese herbal medicines， it is pointed out that focusing on the influencing factors to build a traceability system is of great significance for targeting the problematic links at a later stage and exploring the interrelationship between environmental factors and the quality of Chinese herbal medicines. Based on the previous explorations， the author summarizes the system framework， functional modules and practical applications of the traceability system of Chinese herbal medicines， and looks forward to the development of a traceability system with risk early warning function and expert decision-making function in its functional development. Finally， based on the factors affecting the quality of Chinese herbal medicines， the author puts forward several thoughts on construction of the traceability system， and makes an in-depth analysis and puts forward a solution for the current situation that a unified， standardized and universal traceability system has not yet been built， with a view to providing ideas and references for the construction of traceability system of Chinese herbal medicines.

Development of blood transfusion external quality assessment program at national scale

Introduction: External quality assessment is a crucial component in ensuring the quality of blood transfusion testing laboratories. Objectives: To develop a procedure for generating external quality assessment items for blood transfusion testing to evaluate participants' performance. Methods: Experimental research was conducted at Quality Control Center for Medical laboratory- University of Medicine and Pharmacy at Ho Chi Minh City, Vietnam. Three items, including red blood cell, serum, and atypical antibody serum samples, were assessed for homogeneity and stability; 5 assessment areas, including ABO grouping, Rh grouping, compatible cross matches, Coombs test, and screening of atypical antibodies, were utilized to evaluate the performance of 38 participants in the 2020-2021 period. Results: Red blood cell and serum samples maintained quality for a specific period at controlled temperatures, while serum samples with atypical antibodies showed stability at different temperatures. The participants demonstrated high satisfactory performance in ABO grouping, Rh grouping, Coombs test, and screening for atypical antibodies. However, the most unsatisfactory performance was reported in crossmatching, with 15% of participants unsatisfactory results. Conclusion: The procedure of production of proficiency testing items has been successfully developed, and its application at the national level is suggested to improve the quality of blood transfusion laboratories.

Introducción: La evaluación externa de calidad es esencial para asegurar la calidad de los laboratorios de pruebas de transfusión sanguínea. Objetivos: Desarrollar un procedimiento para generar elementos de evaluación externa de calidad y evaluar el rendimiento de los participantes en pruebas de transfusión sanguínea. Métodos: Estudio experimental realizado en el Centro de Control de Calidad para Laboratorios Médicos de la Universidad de Medicina y Farmacia en la Ciudad de Ho Chi Minh, Vietnam. Se evaluaron muestras de glóbulos rojos, suero y suero con anticuerpos atípicos para homogeneidad y estabilidad. Se utilizaron 5 áreas de evaluación, incluida la agrupación ABO, la agrupación Rh, las coincidencias cruzadas compatibles, la prueba de Coombs y la detección de anticuerpos atípicos, para evaluar el desempeño de 38 participantes, en el período 2020-2021. Resultados: Las muestras de glóbulos rojos y suero mantuvieron la calidad durante un período específico a temperaturas controladas, mientras que las muestras de suero con anticuerpos atípicos mostraron estabilidad a diferentes temperaturas. Los participantes obtuvieron un alto rendimiento en algunas áreas, como la agrupación ABO y Rh, la prueba de Coombs y la detección de anticuerpos atípicos. Sin embargo, las pruebas de compatibilidad reportaron un rendimiento insatisfactorio en un 15% de los participantes. Conclusión: El procedimiento desarrollado cumple con los criterios de calidad, y se sugiere su aplicación a nivel nacional para mejorar la calidad de los laboratorios de transfusión sanguínea.

Aseguramiento y control de la calidad de los datos en un estudio de cohorte en Colombia

Introducción: La calidad de los datos facilita garantizar la fiabilidad de los estudios observacionales. Objetivo: Describir el aseguramiento y el control de calidad para mantener la fiabilidad y la validez del dato en un estudio de cohorte. Métodos: Presentar el manejo de datos implementado dentro de un seguimiento de enfermos renales crónicos cuya exposición fue un programa de protección renal comparado con el tratamiento convencional y su asociación con desenlaces clínicos. Se evaluó el cambio en la frecuencia de errores después de implementar el plan y la reproducibilidad del ingreso de registros a las bases de datos. Resultados: Se documentó una disminución progresiva en los errores cometidos en la captación de datos. El valor de Kappa entre los recolectores de la información para las variables clínicas más importantes fue 0,960 para la depuración de creatinina 150 mg/dL; 0,730 para la alteración del sedimento urinario; 0,956 para la asignación de estadio al ingreso. Los coeficientes de correlación intraclase para la identificación de las cifras de presión arterial sistólica fue 0,996; para la de presión arterial diastólica 0,993 y para los niveles de creatinina sérica al diagnóstico 0,995. Discusión: La calidad de los datos comienza con el reconocimiento de los retos y dificultades que implica su responsable captación, de ahí el aporte de la estandarización de los procesos y el personal que los lleve a cabo en forma idónea. Estudios evidencian que muchos procesos de mejora surgen en el desarrollo de la investigación sin protocolos preestablecidos. Conclusión: La reducción en la proporción y el tipo de error durante el proceso de captación de datos se debe a su identificación temprana y la corrección de instructivos, del instrumento de control de diligenciamiento y de la capacitación continua del personal. El análisis mostró una buena concordancia interevaluador.

Introduction: Data quality makes it easier to ensure that observational studies are reliable. Objective: To describe assurance and quality control to maintain data reliability and validity in a cohort study. Methodology: We present the data management strategies implemented in a study that followed patients of chronic kidney disease who were in a renal protection program and compared them with those undergoing conventional treatment to observe its association with clinical outcomes. We assessed the changes in error frequency after implementing the plan along with the reproducibility of the strategies for entering records into the databases. Results: We documented a progressive decrease of data collection errors. The Kappa values among data collectors for the most important variables were: 0.960 for creatinine clearance 150 mg/dl; 0.730 for urinary sediment alteration and 0.956 for stage allocation upon admission. The intraclass correlation coefficient for the identification of systolic blood pressure was 0.996; for diastolic blood pressure, the coefficient was 0.993 and for serum creatinine levels at diagnosis, the value was 0.995. Discussion: Data quality begins with the recognition of the challenges and difficulties involved in responsible data collection, hence the contribution of standardized processes and personnel to carry them out in a suitable manner. Studies show that many improvement processes arise in the development of research without pre-established protocols. Conclusion: The reduction in error ratio and type during the data collection process are the result of the early identification of erroneously entered or missing data, the correction of the guidelines for completing forms as well as of the instruments for detecting errors and continuous training of the staff. The analysis showed good inter-rater reliability.

Análisis retrospectivo del diferimiento quirúrgico a un año de la pandemia COVID-19 / Retrospective analysis of the one-year surgical deferral of the COVID-19 pandemic

Resumen: Introducción: El diferimiento quirúrgico desde el inicio de la pandemia COVID-19 representa un riesgo para la salud de los pacientes y un reto para las instituciones sanitarias. La métrica de indicadores de productividad en quirófano, como la tasa de diferimiento quirúrgico, nos brindará información para planear estrategias basadas en evidencia científica que nos permitan mejorar la calidad de la atención. Objetivo: Determinar la tasa de diferimiento quirúrgico durante la pandemia COVID-19. Material y métodos: Se realizó un estudio, retrospectivo, descriptivo y transversal en el que se analizaron 297 pacientes cuyas cirugías fueron diferidas durante el período comprendido del 11 de marzo de 2020 al 10 de marzo de 2021. Para el análisis de variables se efectuó estadística descriptiva, utilizando medidas de tendencia central y dispersión, frecuencias simples y proporciones. Adicionalmente se realizó un diagrama de Pareto. La información fue procesada con SPSS v-25.0. Resultados: La proporción de diferimiento fue de 7.34%; 20.92% de las causas fueron atribuidas al paciente, 31.65% a causas médicas y 47.49% fueron logístico-administrativas. Conclusión: Las causas de diferimiento quirúrgico establecidas son evitables y revelan fracasos en los procesos logístico-administrativos que requieren planes de mejora continua.

Abstract: Introduction: Surgical deferral since the beginning of the COVID-19 pandemic represents a risk to the health of patients and a challenge for health institutions. The metric of productivity indicators in the operating room, such as the surgical deferral rate, will provide us with information to plan strategies based on scientific evidence that allow us to improve the quality of care. Objective: To determine the surgical deferral rate during the COVID-19 pandemic. Material and methods: A retrospective, descriptive and cross-sectional study was carried out in which 297 patients whose surgeries were deferred during the period from March 11, 2020 to March 10, 2021 were analyzed. Descriptive statistics were employed, using measures of central tendency and dispersion, simple frequencies and proportions. Additionally, a Pareto diagram was made. The information was processed with SPSS v-25.0. Results: The deferral rate was 7.34%. 20.92% of the causes were attributed to the patient, 31.65% to medical causes and 47.49% logistic-administrative. Conclusion: The established causes of surgical deferral are avoidable and reveal failures in the logistical-administrative processes that require continuous improvement plans.