A pilot study of mealtime insulin administration and parental stress in youth with new-onset type 1 diabetes.

AIMS: To compare the stress level in parents of children with new-onset type 1 diabetes receiving a fixed insulin dose for a fixed range of carbohydrates (CHOs) to parents of children receiving a precise insulin dose for a precise number of CHOs using an insulin-to-carbohydrate ratio (ICR). METHODS: Twenty-four participants (8-14 years) were randomized to receive a fixed dose of insulin for a fixed range of CHOs (FD group) or a precise dose of insulin for a precise number of carbohydrates using an ICR (ICR group). The primary endpoint was parental stress measured with the parental stress survey (PSS) 1 to 4 months after diagnosis. Secondary endpoints included glycemic variability, glycated haemoglobin (HbA1C ) and safety. RESULTS: Compared to parents of children in the ICR group, those from the FD group reported less stress during the first 4 months after diagnosis (p = 0.022). Glycemic variability and HbA1C were similar in both groups. None of the patients from either group required an emergency department visit or hospitalization. CONCLUSIONS: In comparison to precise insulin dosing using an ICR, fixed insulin dosing for a fixed range of CHOs may be less stressful for parents to learn and employ when initially taught diabetes management skills for their child with new-onset type 1 diabetes.

A homozygous exonic variant leading to exon skipping in ABCC8 as the cause of severe congenital hyperinsulinism.

Congenital hyperinsulinism (CHI) is genetically heterogeneous, caused by pathogenic variants in multiple known genes regulating insulin secretion from the pancreatic ß-cells. The ABCC8 gene encodes the sulfonylurea receptor 1 (SUR1), a key player in insulin secretion, and pathogenic variants in ABCC8 are the most common cause of CHI. With increased application of genetic testing in clinical practice, variants of unknown clinical significance (VUS) are commonly reported. Additional functional investigation for variant pathogenicity is fundamental in establishing definitive molecular diagnosis and in guiding clinical management. However, due to the lack of ubiquitous tissue expression of these genes, obtaining functional studies on affected tissue has been challenging. We present a case of severe congenital hyperinsulinism which required a near-total pancreatectomy. CHI gene sequencing identified a homozygous silent variant in ABCC8 located on the last nucleotide of exon 38, c.4608G>A (p.Ala1536Ala). The total RNA was isolated from pancreas resected at the time of pancreatectomy. RNA sequencing and expression analysis demonstrated exon 38 skipping and decreased RNA expression, which supports the pathogenicity of this variant. This case highlights the feasibility of functional studies of VUS on resected pancreatic tissue. The result expands the mutation spectrum in ABCC8 and allows precise genetic counseling to affected families.

Enhanced translation expands the endo-lysosome size and promotes antigen presentation during phagocyte activation.

The mechanisms that govern organelle adaptation and remodelling remain poorly defined. The endo-lysosomal system degrades cargo from various routes, including endocytosis, phagocytosis, and autophagy. For phagocytes, endosomes and lysosomes (endo-lysosomes) are kingpin organelles because they are essential to kill pathogens and process and present antigens. During phagocyte activation, endo-lysosomes undergo a morphological transformation, going from a collection of dozens of globular structures to a tubular network in a process that requires the phosphatidylinositol-3-kinase-AKT-mechanistic target of rapamycin (mTOR) signalling pathway. Here, we show that the endo-lysosomal system undergoes an expansion in volume and holding capacity during phagocyte activation within 2 h of lipopolysaccharides (LPS) stimulation. Endo-lysosomal expansion was paralleled by an increase in lysosomal protein levels, but this was unexpectedly largely independent of the transcription factor EB (TFEB) and transcription factor E3 (TFE3), which are known to scale up lysosome biogenesis. Instead, we demonstrate a hitherto unappreciated mechanism of acute organelle expansion via mTOR Complex 1 (mTORC1)-dependent increase in translation, which appears to be mediated by both S6Ks and 4E-BPs. Moreover, we show that stimulation of RAW 264.7 macrophage cell line with LPS alters translation of a subset but not all of mRNAs encoding endo-lysosomal proteins, thereby suggesting that endo-lysosome expansion is accompanied by functional remodelling. Importantly, mTORC1-dependent increase in translation activity was necessary for efficient and rapid antigen presentation by dendritic cells. Collectively, we identified a previously unknown and functionally relevant mechanism for endo-lysosome expansion that relies on mTORC1-dependent translation to stimulate endo-lysosome biogenesis in response to an infection signal.

Symptomology following mRNA vaccination against SARS-CoV-2.

Despite demonstrated efficacy of vaccines against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the causative agent of coronavirus disease-2019 (COVID-19), widespread hesitancy to vaccination persists. Improved knowledge regarding frequency, severity, and duration of vaccine-associated symptoms may help reduce hesitancy. In this prospective observational study, we studied 1032 healthcare workers who received both doses of the Pfizer-BioNTech SARS-CoV-2 mRNA vaccine and completed post-vaccine symptom surveys both after dose 1 and after dose 2. We defined appreciable post-vaccine symptoms as those of at least moderate severity and lasting at least 2 days. We found that symptoms were more frequent following the second vaccine dose than the first (74% vs. 60%, P < 0.001), with >80% of all symptoms resolving within 2 days. The most common symptom was injection site pain, followed by fatigue and malaise. Overall, 20% of participants experienced appreciable symptoms after dose 1 and 30% after dose 2. In multivariable analyses, female sex was associated with greater odds of appreciable symptoms after both dose 1 (OR, 95% CI 1.73, 1.19-2.51) and dose 2 (1.76, 1.28-2.42). Prior COVID-19 was also associated with appreciable symptoms following dose 1, while younger age and history of hypertension were associated with appreciable symptoms after dose 2. We conclude that most post-vaccine symptoms are reportedly mild and last <2 days. Appreciable post-vaccine symptoms are associated with female sex, prior COVID-19, younger age, and hypertension. This information can aid clinicians in advising patients on the safety and expected symptomatology associated with vaccination.

Maternal disability and prenatal oral health experiences: Findings from Pregnancy Risk Assessment Monitoring System.

BACKGROUND: Although disability has associations with poor health and reduced access to health care services, limited research exists on the connection between disability, oral health, and oral health care use. Moreover, to the authors' knowledge, no study has examined the association between disability and oral health around the time of pregnancy. This is an important gap in research, considering that both disability and oral health play a critical role in maternal and infant well-being. METHODS: The authors obtained cross-sectional data from 15 states from 2019 and 2020 from the Pregnancy Risk Assessment Monitoring System (N = 20,189). The authors used multivariable logistic regression analyses to assess the relationship between cumulative disabilities and specific forms of disability (seeing, hearing, walking, remembering, self-care, and communicating) for 6 indicators of oral health experiences during pregnancy. RESULTS: Women reporting multiple forms of disabilities around the time of pregnancy (especially ≥ 3 disabilities) reported lower levels of knowledge of appropriate oral health care during pregnancy, were less likely to undergo dental prophylaxis during pregnancy, were more likely to report needing care for dental health problems, and had more unmet oral health care needs than those without disabilities. CONCLUSIONS: Maternal disability is a risk factor for poorer oral health outcomes and oral health care use during pregnancy. PRACTICAL IMPLICATIONS: Given the potential harms of poor oral health to maternal and infant well-being, the findings of this study suggest the need for increased health promotion efforts to foster improved oral health for pregnant women living with disabilities.

Disparities in Geographic Access to Cardiac Rehabilitation in Los Angeles County.

Background Exercise-based cardiac rehabilitation (CR) is known to reduce morbidity and mortality for patients with cardiac conditions. Sociodemographic disparities in accessing CR persist and could be related to the distance between where patients live and where CR facilities are located. Our objective is to determine the association between sociodemographic characteristics and geographic proximity to CR facilities. Methods and Results We identified actively operating CR facilities across Los Angeles County and used multivariable Poisson regression to examine the association between sociodemographic characteristics of residential proximity to the nearest CR facility. We also calculated the proportion of residents per area lacking geographic proximity to CR facilities across sociodemographic characteristics, from which we calculated prevalence ratios. We found that racial and ethnic minorities, compared with non-Hispanic White individuals, more frequently live ≥5 miles from a CR facility. The greatest geographic disparity was seen for non-Hispanic Black individuals, with a 2.73 (95% CI, 2.66-2.79) prevalence ratio of living at least 5 miles from a CR facility. Notably, the municipal region with the largest proportion of census tracts comprising mostly non-White residents (those identifying as Hispanic or a race other than White), with median annual household income <$60 000, contained no CR facilities despite ranking among the county's highest in population density. Conclusions Racial, ethnic, and socioeconomic characteristics are significantly associated with lack of geographic proximity to a CR facility. Interventions targeting geographic as well as nongeographic factors may be needed to reduce disparities in access to exercise-based CR programs. Such interventions could increase the potential of CR to benefit patients at high risk for developing adverse cardiovascular outcomes.

Temporal variations in the severity of COVID-19 illness by race and ethnicity.

INTRODUCTION: Early reports highlighted racial/ethnic disparities in the severity of COVID-19 seen across the USA; the extent to which these disparities have persisted over time remains unclear. Our research objective was to understand temporal trends in racial/ethnic variation in severity of COVID-19 illness presenting over time. METHODS: We conducted a retrospective cohort analysis using longitudinal data from Cedars-Sinai Medical Center, a high-volume health system in Southern California. We studied patients admitted to the hospital with COVID-19 illness from 4 March 2020 through 5 December 2020. Our primary outcome was COVID-19 severity of illness among hospitalised patients, assessed by racial/ethnic group status. We defined overall illness severity as an ordinal outcome: hospitalisation but no intensive care unit (ICU) admission; admission to the ICU but no intubation; and intubation or death. RESULTS: A total of 1584 patients with COVID-19 with available demographic and clinical data were included. Hispanic/Latinx compared with non-Hispanic white patients had higher odds of experiencing more severe illness among hospitalised patients (OR 2.28, 95% CI 1.62 to 3.22) and this disparity persisted over time. During the initial 2 months of the pandemic, non-Hispanic blacks were more likely to suffer severe illness than non-Hispanic whites (OR 2.02, 95% CI 1.07 to 3.78); this disparity improved by May, only to return later in the pandemic. CONCLUSION: In our patient sample, the severity of observed COVID-19 illness declined steadily over time, but these clinical improvements were not seen evenly across racial/ethnic groups; greater illness severity continues to be experienced among Hispanic/Latinx patients.

Synthesis of NdAlO3 Nanoparticles and Evaluation of the Catalytic Capacity for Biodiesel Synthesis.

Biodiesel synthesis was carried out via heterogeneous catalysis of canola oil with nanoparticles of a mixed oxide based on rare earths. The catalyst synthesis (NdAlO3) was carried out based on the method proposed by Pechini for the synthesis of nanoparticles. Thermogravimetric analysis-differential thermal analysis (TGA-DTA) analysis was performed on the nanoparticle precursor gel in order to establish the optimum conditions for its calcination, with these being of 800 °C over 24 h. A pure NdAlO3 compound with an approximate size of 100 nm was obtained. The products of the transesterification reaction were analyzed using gas chromatography, FTIR, and NMR. The optimum reaction conditions were determined, namely, the temperature effect, reaction time, methanol:oil mass ratio, and recyclability of the catalyst. These studies showed the following optimal conditions: 200 °C, 5 h, methanol:oil mass ratio of 6:1, and a constant decrease in the catalytic activity of the catalyst was observed for up to six reuses, which later remained constant at around a 50% conversion rate. The maximum biodiesel yield obtained with the optimum conditions was around 75%. Analysis of the reaction products showed that the residual oil showed a chemical composition different from that of the source oil, and that both the biodiesel and glycerol obtained were of high purity.

Validación de una técnica por Cromatografía Líquida de Alta Resolución para la determinación del contenido de Mangiferina en hojas de Mangifera indica L / Validation of a High Performance Liquid Chromatography technique for determination of mangiferin content in Mangifera indica L. leaves

Introducción: la Mangiferina es una glicosilxantona natural presente en varias partes del árbol de Mangifera indica L., a la que se le atribuyen un amplio rango de acciones farmacológicas. Objetivo: establecer un método de determinación del contenido de Mangiferina en las hojas de Mangifera Indica L. por Cromatografia Líquida de Alta Resolución. Métodos: para cuantificar el metabolito en las hojas, previamente secadas y pulverizadas, la separación se realizó a través de una columna cromatográfica Luna RP-18 (5 m) (250 x 4 mm), con detector UV a 254 nm usando un gradiente de fase móvil A compuesta de Acético ácido 0,2 por ciento: acetonitrilo (85:15) y móvil fase B: Acetonitrilo y la cuantificación de este frente a una muestra de referencia utilizando el método del estándar externo. Resultados: la ecuación de la curva de regresión de Mangiferina fue Y = 3,5561 X + 6536,55 (r = 0,999) El porciento de recobrado fue de 99,41 con un coeficiente de variación inferior al 2 por ciento. Los límites de detección y cuantificación fueron de 0.0009 y 0,001 respectivamente. No se observaron diferencias estadísticamente significativas entre las determinaciones realizadas en diferentes días por los diferentes analistas. Conclusión: El método es simple y fiable, el cual puede ser utilizado para el control de la calidad y estudio de estabilidad de las hojas de Mangifera Indica L(AU)

Introduction: Mangiferin is a natural glycosylxanthone present in various parts of the tree Mangifera indica L. which is attributed a wide range of pharmacological properties. Objective: establish a method to determine the content of mangiferin in Mangifera Indica L. leaves by high performance liquid chromatography. Methods: leaves were dried and pulverized before quantification of their metabolite content. Separation was performed using a Luna RP-18 chromatographic column (5 Ám) (250 x 4mm) with a UV detector at 254n and a mobile phase A gradient composed of acetic acid 0.2 percent: acetonitrile (85:15), and a phase B mobile: acetonitrile and its quantification vs. a reference sample applying the external standard method. Results: the regression curve equation for mangiferin was Y=3.5561X +6536.55(r=0.999). Recovery was 99.41 percent with a variation coefficient below 2 percent. Detection and quantification limits were 0.0009 and 0.001, respectively. No statistically significant differences were found between the determinations performed on different days by different analysts. Conclusion: the method is simple and reliable, and may be used for quality control and stability studies about Mangifera Indica L. leaves(AU)

Validación de una técnica por cromatografía líquida de alta resolución para la determinación del contenido de mangiferina en hojas de mangifera indica L / Validation of a high performance liquid chromatography technique for determination of mangiferin content in mangifera indica L. leaves

IINTRODUCCIÓN: la Mangiferina es una glicosilxantona natural presente en varias partes del árbol de Mangifera indica L., a la que se le atribuyen un amplio rango de acciones farmacológicas. Objetivo: establecer un método de determinación del contenido de Mangiferina en las hojas de Mangifera Indica L.por Cromatografia Líquida de Alta Resolución. MÉTODOS: para cuantificar el metabolito en las hojas, previamente secadas y pulverizadas, la separación se realizó a través de una columna cromatográfica Luna RP-18 (5 m) (250 x 4 mm), con detector UV a 254 nm usando un gradiente de fase móvil A compuesta de Acético ácido 0,2 %: acetonitrilo (85:15) y móvil fase B: Acetonitrilo y la cuantificación de este frente a una muestra de referencia utilizando el método del estándar externo. RESULTADOS: la ecuación de la curva de regresión de Mangiferina fue Y = 3,5561 X + 6536,55 (r = 0,999) El porciento de recobrado fue de 99,41 con un coeficiente de variación inferior al 2 %. Los límites de detección y cuantificación fueron de 0.0009 y 0,001 respectivamente. No se observaron diferencias estadísticamente significativas entre las determinaciones realizadas en diferentes días por los diferentes analistas. CONCLUSIÓN: El método es simple y fiable, el cual puede ser utilizado para el control de la calidad y estudio de estabilidad de las hojas de Mangifera Indica L.

INTRODUCTION: Mangiferin is a natural glycosylxanthone present in various parts of the tree Mangifera indica L. which is attributed a wide range of pharmacological properties. Objective: establish a method to determine the content of mangiferin in Mangifera Indica L. leaves by high performance liquid chromatography. METHODS: leaves were dried and pulverized before quantification of their metabolite content. Separation was performed using a Luna RP-18 chromatographic column (5 µm) (250 x 4mm) with a UV detector at 254n and a mobile phase A gradient composed of acetic acid 0.2 %: acetonitrile (85:15), and a phase B mobile: acetonitrile and its quantification vs. a reference sample applying the external standard method. RESULTS: the regression curve equation for mangiferin was Y=3.5561X +6536.55(r=0.999). Recovery was 99.41 % with a variation coefficient below 2 %. Detection and quantification limits were 0.0009 and 0.001, respectively. No statistically significant differences were found between the determinations performed on different days by different analysts. CONCLUSION: the method is simple and reliable, and may be used for quality control and stability studies about Mangifera Indica L. leaves.

Determinación simultánea de clorhidrato de dorzolamida y maleato de timolol en el colirio / Simultaneous determination of Dorzolamide Chlorhydrate and Timolol Maleate

Objetivo: desarrollar y validar un método analítico por cromatografía líquida de alta resolución, aplicable al control de la calidad y estudio de estabilidad de dorzolamida 2 por ciento y timolol 0,5 por ciento en el colirio. Métodos: para cuantificar simultáneamente los dos principios activos en el producto terminado, la separación se realizó a través de una columna cromatográfica Luna RP-18 (5 µm) (250 x 4 mm), con un detector de arreglo de fotodiodos a 254 y 295 nm, empleando un gradiente con fase móvil A compuesta por acetonitrilo: buffer fosfato pH 2,5: metanol (5:85:10) y fase móvil B: metanol, y la cuantificación de este frente a una muestra de referencia con el método del estándar externo. Resultados: en el estudio de linealidad, los coeficientes de correlación y de determinación obtenidos estuvieron por encima de 0,99 y 0,98 respectivamente. Los porcentajes de recobrado fueron de 99,57 para la dorzolamida y 99,93 para el timolol, con un coeficiente de variación para ambos principios activos inferior al 2 por ciento. En el estudio de repetibilidad realizado, las medias obtenidas fueron de 99,1 por ciento para la dorzolamida y 100,4 por ciento para el timolol, y los coeficientes de variación se encontraron dentro de los límites. En el estudio de precisión intermedia, los valores de p resultaron ser mayores que 0,05, para cada uno de los niveles estudiados Conclusiones: el método analítico desarrollado resulta lineal, preciso, específico y exacto en el rango de concentraciones estudiadas, el cual se establece para el control de la calidad y el estudio de estabilidad del producto terminado ya que no existen métodos analíticos informados para estos fines(AU)

Objective: to develop and validate an analytical high-performance liquid chromatography method applicable to quality control and to stability study of 2 per cent Dorzolamide plus 0.5 per centTimolol eye drops. Methods: to simultaneously quantify both active principles in the finished product, separation was made through a Luna RP-18 (5 µm) (250 x 4 mm) column chromatography, with photodiode array detector at 254 nm an 295nm using a gradient with mobile phase A composed of acetonitrile: phosphate buffer pH 2.5: methanol (5:85:10) and mobile phase B: methanol and the quantification of this front to a reference sample using the external standard method. Results: in the linearity study, the correlation and determination coefficients were above 0.99 and 0.98 respectively. The percentages of having recovered were 99.57 for Dorzolamide and 99.93 for Timolol, with a variation coefficient for both active principles under 2 per cent. In the repeatability study, the means were 99.1 for Dorzolamide and 100.4 per centfor Timolol and the variation coefficients were within the set limits. In the study of intermediate precision, p values were higher than 0.05 for each of the studied levels. Conclusions: the developed analytical method was linear, precise, specific and accurate in the range of study concentrations; it is established for the quality control and stability study of the finished product since there were not analytical methods designed for these aims(AU)

Determinación simultánea de clorhidrato de dorzolamida y maleato de timolol en el colirio / Simultaneous determination of Dorzolamide Chlorhydrate and Timolol Maleate

Objetivo: desarrollar y validar un método analítico por cromatografía líquida de alta resolución, aplicable al control de la calidad y estudio de estabilidad de dorzolamida 2 % y timolol 0,5 % en el colirio. Métodos: para cuantificar simultáneamente los dos principios activos en el producto terminado, la separación se realizó a través de una columna cromatográfica Luna RP-18 (5 µm) (250 x 4 mm), con un detector de arreglo de fotodiodos a 254 y 295 nm, empleando un gradiente con fase móvil A compuesta por acetonitrilo: buffer fosfato pH 2,5: metanol (5:85:10) y fase móvil B: metanol, y la cuantificación de este frente a una muestra de referencia con el método del estándar externo. Resultados: en el estudio de linealidad, los coeficientes de correlación y de determinación obtenidos estuvieron por encima de 0,99 y 0,98 respectivamente. Los porcentajes de recobrado fueron de 99,57 para la dorzolamida y 99,93 para el timolol, con un coeficiente de variación para ambos principios activos inferior al 2 %. En el estudio de repetibilidad realizado, las medias obtenidas fueron de 99,1 % para la dorzolamida y 100,4 % para el timolol, y los coeficientes de variación se encontraron dentro de los límites. En el estudio de precisión intermedia, los valores de p resultaron ser mayores que 0,05, para cada uno de los niveles estudiados Conclusiones: el método analítico desarrollado resulta lineal, preciso, específico y exacto en el rango de concentraciones estudiadas, el cual se establece para el control de la calidad y el estudio de estabilidad del producto terminado ya que no existen métodos analíticos informados para estos fines.

Objective: to develop and validate an analytical high-performance liquid chromatography method applicable to quality control and to stability study of 2 % Dorzolamide plus 0.5 % Timolol eye drops. Methods: to simultaneously quantify both active principles in the finished product, separation was made through a Luna RP-18 (5 µm) (250 x 4 mm) column chromatography, with photodiode array detector at 254 nm an 295nm using a gradient with mobile phase A composed of acetonitrile: phosphate buffer pH 2.5: methanol (5:85:10) and mobile phase B: methanol and the quantification of this front to a reference sample using the external standard method. Results: in the linearity study, the correlation and determination coefficients were above 0.99 and 0.98 respectively. The percentages of having recovered were 99.57 for Dorzolamide and 99.93 for Timolol, with a variation coefficient for both active principles under 2 %. In the repeatability study, the means were 99.1 for Dorzolamide and 100.4 % for Timolol and the variation coefficients were within the set limits. In the study of intermediate precision, p values were higher than 0.05 for each of the studied levels. Conclusions: the developed analytical method was linear, precise, specific and accurate in the range of study concentrations; it is established for the quality control and stability study of the finished product since there were not analytical methods designed for these aims.

Diseño de una formulación de ketotifeno 0, 025 por ciento colirio / Design of a Ketotifen formula: 0, 025 percent eyedrops

El colirio de ketotifeno se indica para aliviar los signos y síntomas de las conjuntivitis alérgicas, por ser este un potente antihistamínico H1 que muestra cierta capacidad para inhibir la liberación de histamina y otros mediadores en mastocitos. El objetivo del presente trabajo consistió en realizar el desarrollo tecnológico del colirio de ketotifeno 0,025 por ciento, de producción nacional teniendo en cuenta que es un medicamento muy utilizado en la Operación Milagro, en la cual participa la República de Cuba, para lo que se hace un diseño y los estudios de preformulación. Se estudió ademàs, las especificaciones de calidad de la formulación seleccionada, la estabilidad del producto y el tiempo de vigencia de este. Se realizó el estudio de estabilidad acelerado y por vida de estante, para lo cual se emplearon 3 lotes del producto a escala piloto. El colirio resultó estable física, química y microbiológicamente envasado en frascos de polietileno de baja densidad, por espacio de 12 meses a temperatura ambiente(AU)

The Ketotifen eyedrops is prescribed to relieve the signs and symptoms of allergic conjunctivitis due to it is a powerful H1 antihistaminic with certain ability to inhibit the histamine release and other mediators in the case of mast cells. The aim of present paper was to perform the technological development of 0,025 percent eyedrops Ketotifen of national production considering that it is a drug very used in the Operación Milagro with participation of the Republic of Cuba and with its own design and the pre-formula. Also, we studied the selected formula specifications, the product stability and its expiry date. An accelerated stability study was conducted and by shelf life using 3 batches of pilot scale product. The eyedrops was physically, chemically and microbiologically stable when it is bottling in low-density polyethylene flasks during 12 months at room temperature(AU)

Validación del método analítico para el control de la calidad y estudio de estabilidad de ketotifeno colirio 0, 025 por ciento / Validation of analytical method to quality control and the stability study of 0, 025 percent eyedrops Ketotiphen

El colirio de ketotifeno se indica para aliviar los signos y síntomas de las conjuntivitis alérgicas, por ser este un potente antihistamínico H1 que muestra cierta capacidad para inhibir la liberación de histamina y otros mediadores en mastocitos. En este trabajo se desarrolló y validó un método analítico por cromatografía líquida de alta resolución, para el control de la calidad y los estudios de estabilidad del ketotifeno colirio 0,025 por ciento. El método se basó en la separación del principio activo a través una columna cromatográfica Lichrosorb RP-18 (5 µm) (250 x 4 mm), con detección ultravioleta a 296 nm, para lo cual se empleó una fase móvil compuesta por una mezcla desgasificada de metanol:buffer fosfato (75:25; pH 8,5) y se le añadió 1 mL de isopropanol por cada 1 000 mL de la mezcla anterior, con una velocidad de flujo de 1,2 mL/min. El método analítico resultó lineal, preciso, específico y exacto en el intervalo de concentraciones estudiadas(AU)

The Ketotiphen eyedrop is prescribed to relief the signs and symptoms of allergic conjunctivitis due to its potent H1 antihistaminic effect showing some ability to inhibit the histamine release and other mediators in cases of mastocytosis. The aim of present paper was to develop and validate an analytical method for the high-performance liquid chromatography, to quality control and the stability studies of 0.025 percent eyedrop Ketotiphen. Method was based on active principle separation by means of a Lichrosorb RP-18 (5 µm) (250 x 4 mm), with UV detection to 296 nm using a mobile phase including a non-gasified mixture of methanol:buffer-phosphate (75:25; pH 8.5) adding 1 mL of Isopropanol by each 1 000 mL of the previous mixture at a 1.2 mL/min flow velocity. The analytical method was linear, accurate, specific and exact during the study concentrations(AU)

Diseño de una formulación de ketotifeno 0, 025 por ciento colirio / Design of a Ketotifen formula: 0, 025 percent eyedrops

El colirio de ketotifeno se indica para aliviar los signos y síntomas de las conjuntivitis alérgicas, por ser este un potente antihistamínico H1 que muestra cierta capacidad para inhibir la liberación de histamina y otros mediadores en mastocitos. El objetivo del presente trabajo consistió en realizar el desarrollo tecnológico del colirio de ketotifeno 0,025 por ciento, de producción nacional teniendo en cuenta que es un medicamento muy utilizado en la Operación Milagro, en la cual participa la República de Cuba, para lo que se hace un diseño y los estudios de preformulación. Se estudió ademàs, las especificaciones de calidad de la formulación seleccionada, la estabilidad del producto y el tiempo de vigencia de este. Se realizó el estudio de estabilidad acelerado y por vida de estante, para lo cual se emplearon 3 lotes del producto a escala piloto. El colirio resultó estable física, química y microbiológicamente envasado en frascos de polietileno de baja densidad, por espacio de 12 meses a temperatura ambiente.

The Ketotifen eyedrops is prescribed to relieve the signs and symptoms of allergic conjunctivitis due to it is a powerful H1 antihistaminic with certain ability to inhibit the histamine release and other mediators in the case of mast cells. The aim of present paper was to perform the technological development of 0,025 percent eyedrops Ketotifen of national production considering that it is a drug very used in the Operación Milagro with participation of the Republic of Cuba and with its own design and the pre-formula. Also, we studied the selected formula specifications, the product stability and its expiry date. An accelerated stability study was conducted and by shelf life using 3 batches of pilot scale product. The eyedrops was physically, chemically and microbiologically stable when it is bottling in low-density polyethylene flasks during 12 months at room temperature.

Validación del método analítico para el control de la calidad y estudio de estabilidad de ketotifeno colirio 0, 025 por ciento / Validation of analytical method to quality control and the stability study of 0, 025 percent eyedrops Ketotiphen

El colirio de ketotifeno se indica para aliviar los signos y síntomas de las conjuntivitis alérgicas, por ser este un potente antihistamínico H1 que muestra cierta capacidad para inhibir la liberación de histamina y otros mediadores en mastocitos. En este trabajo se desarrolló y validó un método analítico por cromatografía líquida de alta resolución, para el control de la calidad y los estudios de estabilidad del ketotifeno colirio 0,025 por ciento. El método se basó en la separación del principio activo a través una columna cromatográfica Lichrosorb RP-18 (5 µm) (250 x 4 mm), con detección ultravioleta a 296 nm, para lo cual se empleó una fase móvil compuesta por una mezcla desgasificada de metanol:buffer fosfato (75:25; pH 8,5) y se le añadió 1 mL de isopropanol por cada 1 000 mL de la mezcla anterior, con una velocidad de flujo de 1,2 mL/min. El método analítico resultó lineal, preciso, específico y exacto en el intervalo de concentraciones estudiadas

The Ketotiphen eyedrop is prescribed to relief the signs and symptoms of allergic conjunctivitis due to its potent H1 antihistaminic effect showing some ability to inhibit the histamine release and other mediators in cases of mastocytosis. The aim of present paper was to develop and validate an analytical method for the high-performance liquid chromatography, to quality control and the stability studies of 0.025 percent eyedrop Ketotiphen. Method was based on active principle separation by means of a Lichrosorb RP-18 (5 µm) (250 x 4 mm), with UV detection to 296 nm using a mobile phase including a non-gasified mixture of methanol:buffer-phosphate (75:25; pH 8.5) adding 1 mL of Isopropanol by each 1 000 mL of the previous mixture at a 1.2 mL/min flow velocity. The analytical method was linear, accurate, specific and exact during the study concentrations

Metabolitos secundarios en los extractos secos de Passiflora incarnata L., Matricaria recutita L. y Morinda citrifolia L. / Secondary metabolites in Passiflora incarnate L., Matricaria recutita L. and Morinda citrifolia L. dry extracts

INTRODUCCIÓN: resulta de interés establecer una tecnología propia para la elaboración y el establecimiento de especificaciones de calidad en diversas formulaciones sólidas de extractos secos de Passiflora incarnata L. (pasiflora), Matricaria recutita L. (manzanilla) y Morinda citrifolia L. (noni). OBJETIVOS: realizar los estudios fitoquímicos y analizar parámetros de control de calidad de los extractos secos de Passiflora incarnata L., Matricaria recutita L. y Morinda citrifolia L. MÉTODOS: para el estudio fitoquímico por cromatografía en capa delgada se emplearon técnicas simples, rápidas, selectivas y con equipamiento mínimo para determinados compuestos. Para el análisis de los parámetros de calidad, se aplicaron los ensayos descritos en la Norma Ramal del Ministerio de Salud Pública (NRSP 309). RESULTADOS: se comprobó la presencia de flavonoides, aminoácidos, aminas, azúcares y oligosacaridos en los 3 extractos secos estudiados. En el de M. citrifolia se observó además la presencia de compuestos antraquinónicos y terpenos, mientras que en M. recutita se identificó la presencia de coumarinas. CONCLUSIONES: los resultados obtenidos demostraron que los 3 extractos se encuentran dentro de los límites establecidos para su empleo como principio activo de origen natural(AU)

INTRODUCTION: it is interesting to develop our own technology to work out and to set quality specifications for different solid formulations of Passiflora incarnata L. ((passiflora), Maricaria recutita L. (chamomile) and Morinda citrifolia L. (noni) dry extracts. OBJECTIVES: to conduct phytochemical studies on and to examine the quality control parameters of Passiflora incarnata L. Maricaria recutita L. and Morinda citrifolia L. (noni) dry extracts. METHODS: for the phytochemical study based on thin layer chromatography, quick, simple and selective techniques were used, and minimal amount of equipment was employed for certain compounds. The analysis of the quality control parameters included the assays described in the Branch Standard of the Ministry of Public Health known as NRSP 309. RESULTS: flavonoids, aminoacids, amines, sugars and oligosaccharides were found in the three dry extracts under study. Antraquninone compounds and terpens were observed in the M. citrifolia extract whereas coumarins were present in the M. recutita leaf extract. CONCLUSIONS: the results proved that the three extracts are within the set limits for their use as natural active principle(AU)

Metabolitos secundarios en los extractos secos de Passiflora incarnata L., Matricaria recutita L. y Morinda citrifolia L. / Secondary metabolites in Passiflora incarnate L., Matricaria recutita L. and Morinda citrifolia L. dry extracts

INTRODUCCIÓN: resulta de interés establecer una tecnología propia para la elaboración y el establecimiento de especificaciones de calidad en diversas formulaciones sólidas de extractos secos de Passiflora incarnata L. (pasiflora), Matricaria recutita L. (manzanilla) y Morinda citrifolia L. (noni). OBJETIVOS: realizar los estudios fitoquímicos y analizar parámetros de control de calidad de los extractos secos de Passiflora incarnata L., Matricaria recutita L. y Morinda citrifolia L. MÉTODOS: para el estudio fitoquímico por cromatografía en capa delgada se emplearon técnicas simples, rápidas, selectivas y con equipamiento mínimo para determinados compuestos. Para el análisis de los parámetros de calidad, se aplicaron los ensayos descritos en la Norma Ramal del Ministerio de Salud Pública (NRSP 309). RESULTADOS: se comprobó la presencia de flavonoides, aminoácidos, aminas, azúcares y oligosacaridos en los 3 extractos secos estudiados. En el de M. citrifolia se observó además la presencia de compuestos antraquinónicos y terpenos, mientras que en M. recutita se identificó la presencia de coumarinas. CONCLUSIONES: los resultados obtenidos demostraron que los 3 extractos se encuentran dentro de los límites establecidos para su empleo como principio activo de origen natural.

INTRODUCTION: it is interesting to develop our own technology to work out and to set quality specifications for different solid formulations of Passiflora incarnata L. ((passiflora), Maricaria recutita L. (chamomile) and Morinda citrifolia L. (noni) dry extracts. OBJECTIVES: to conduct phytochemical studies on and to examine the quality control parameters of Passiflora incarnata L. Maricaria recutita L. and Morinda citrifolia L. (noni) dry extracts. METHODS: for the phytochemical study based on thin layer chromatography, quick, simple and selective techniques were used, and minimal amount of equipment was employed for certain compounds. The analysis of the quality control parameters included the assays described in the Branch Standard of the Ministry of Public Health known as NRSP 309. RESULTS: flavonoids, aminoacids, amines, sugars and oligosaccharides were found in the three dry extracts under study. Antraquninone compounds and terpens were observed in the M. citrifolia extract whereas coumarins were present in the M. recutita leaf extract. CONCLUSIONS: the results proved that the three extracts are within the set limits for their use as natural active principle.

Choque cardiogénico en síndrome coronario agudo: causas, criterios diagnósticos, tratamiento y mortalidad en el Instituto Nacional del Corazón en Lima, Perú / Cardiogenic shock in coronary acute syndrome: Causes, diagnostic criteria, treatment and mortality at the Instituto Nacional del Corazón in Lima, Peru

Objetivo: Determinar las causas, criterios diagnósticos, tratamiento y mortalidad del choque cardiogénico (ChC) como complicación del síndrome coronario agudo (SCA) en el Instituto Nacional del Corazón, en Lima – Perú. Material y métodos: Se realizó un estudio observacional, descriptivo tipo serie de casos de fuentes secundarias en pacientes con diagnóstico de ChC por SCA del Instituto Nacional del Corazón desde febrero 2004 hasta 31 diciembre 2005. Para seleccionar los pacientes, se utilizaron las palabras clave: choque cardiogénico, balón intraaórtico (BIA) e infarto de miocardio agudo (IMA) más muerte. Los datos obtenidos de las historias clínicas seleccionadas, fueron procesados en el programa SPSS. Resultados: Se encontraron 24 pacientes. Veinte tuvieron ecocardiografía y 70,0%, presentaron disfunción ventricular izquierda (DVI) como causa de ChC, las demás fueron por complicaciones mecánicas. El 95% de pacientes tuvieron criterios clínicos (hipotensión o signos de hipoperfusión tisular); 11 tuvieron estudio hemodinámico, y cumplieron el criteriohemodinámico de choque. El tratamiento fue con vasopresores en 95,8% de los pacientes, inotrópicos en 66,7%, BIA en50%. Trece pacientes tuvieron cinecoronariografia siendo revascularizados el 69,2%. Todos los pacientes fallecieron. Conclusiones: La causa principal de ChC fue DVI. El diagnóstico fue predominantemente clínico. El tratamiento en su mayoría fue médico y la tasa de mortalidad fue del 100%. Estos datos concuerdan con los descritos en otros estudios excepto que la mortalidad fue mayor en nuestro estudio.

Objective: To determine causes, diagnostic criteria, treatment and mortality of cardiogenic shock complicating coronary acute syndrome (CSCCAS), at the Instituto Nacional del Corazón Lima – Peru. Material and methods: Observational – descriptive (case series) study of secondary sources was conducted on patients with CSCCAS. To select patients we used key words: cardiogenic shock, intraaortic balloon pumping (IABP), myocardial infarction plus death. Data of clinic charts was analyzed in SPSS program. Results: We got 24 patients, 20 of them had echocardiographic study and 70% showed left ventricular dysfunction (LVD) as a cause of cardiogenic shock owing to coronary acute syndrome (myocardial infarction) and the rest were mechanical complications. 95% filled clinical criteria (including hypotension or signs of end organ hypoperfusion); 11 patients had hemodynamic study and all of them filled hemodynamic criteria. Treatment consisted on vasopressors in 95.8% of patients, inotropics in 66.7%, IABP in 50%. 13 patients had coronary angiographic study and 69.2% of them were revascularized. All the patients died. Conclusions: LVD was the main cause of CS. Diagnosis was predominantly clinical. Medical treatment were used in the majority of cases. Our results were similar to other studies except in mortality that was higher (100%).

Validación del ensayo de disolución de las tabletas de propiltiuracilo 50 mg / Validation of the dissolution assay of propylthiouracil 50 mg

Se validó un método para evaluar la disolución de las tabletas de propiltiuracilo 50 mg por espectrofotometría, con detección ultravioleta a 274 nm. Se evaluaron los parámetros de especificidad, linealidad, precisión e influencia de la filtración. La curva de linealidad se realizó en el rango de 3,32 a 7,75 µg/mL con un coeficiente de correlación igual a 0,99984; la prueba estadística para el intercepto y la pendiente se consideró no significativa. En el estudio de la influencia de la filtración se demostró que en la filtración no se adsorbe el principio activo ni se aportan interferencias al filtrado, por lo que es posible su empleo.

A method to evaluate the dissolution of propylthiouracil tablets 50 mg by spectrophotometry, with ultraviolet detection of 274 nm, was validated. Specificity, linearity, precision and filtration influence were the evaluated parameters. The linearity curve was made at the range from 3.32 to 7.75 µg/mL with a correlation coefficient equal to 0.99984. The statistical test for the interval and the slope was not significant. In the study of filtration influence it was proved that the active principle was not absorbed in the filtration and that there were no interferences in the filtration, which made its use possible.