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The incidence of severe mixed hemorrhoids is increasing year by year, and its surgical method has always been the focus in the study of anoenterology. On the basis of anal cushion downward movement theory, anal cushion suspension surgery moves up prolapsed anal cushion by suturing or ligating the mucosa above the dentate line. This not only ensures the effect of surgical treatment, but also protects the structure and function of the canal and anus in the most fine, which is in line with the minimally invasive treatment idea of severe mixed hemorrhoids, and is gradually widely used in clinical practice. As a new surgical method, anal cushion suspension surgery has unique advantages in treating severe mixed hemorrhoids, especially in severe prolapsed hemorrhoids. This paper will analyse the key points of anal cushion suspension surgery combined with procedure for prolapse and hemorrhoids, milligan morgan, hemorrhoidal artery ligation, automatic ligation of hemorrhoids, injection sclerotherapy, laser ablation and mixed surgeries respectively, in order to provide reference for clinicians to operate on severe mixed hemorrhoids.
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Abstract This study aimed to develop and evaluate the stability of sulfadiazine sugar-free extemporaneous oral suspensions, focusing on treating congenital toxoplasmosis. The excipients were carefully chosen to obtain safe products for the pediatric population. Sulfadiazine suspensions (100 mg/ mL) were prepared from the raw material or tablets, stored in amber glass bottles at 5±3ºC, and evaluated at 0, 14, and 30 days. An ultra-performance liquid chromatographic method was developed and validated to assay the drug. The particle size ranged from 29.3 to 50.6 µm, with some variation over the study; pH values around 7.0 and non-Newtonian behavior were observed without modification in the period. Formulations showed a fast dissolution rate (>80% in 15 minutes) without variation over the study. The drug assay was about 100% of the label claimed throughout the study, demonstrating the chemical stability and the preparations' dose homogeneity. The microbiological investigation indicated that both preparations met the requirements for the microbial count and absence of pathogens. In conclusion, the developed formulations can be used for 30 days when stored under refrigeration. The oral suspensions produced are easy to prepare and contain safe components, providing an alternative for congenital toxoplasmosis treatment in children.
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RESUMEN La sedimentación de partículas es un fenómeno común en dispersiones alimentarias, que está asociado con una calidad deficiente y se puede controlar usando diferentes aditivos, dentro de los cuales, se destacan el uso de hidrocoloides. Se evaluó el efecto de la concentración de goma xantano (0,025-0,075%), carboximetilcelulosa sódica (0,025-0,075%) y gel de aloe vera (0,5-1,5%), en las propiedades fisicoquímicas, sensoriales y estabilidad a la sedimentación, en bebidas elaboradas a partir de maíz dulce. No se observó variación significativa en el contenido de sólidos solubles totales, pH, densidad, acidez titulable, potencial ζ, tamaño de partículas, velocidad de sedimentación y parámetros de color con las concentraciones empleadas de hidrocoloides y de aloe vera. El potencial ζ indicó estabilidad ligera en las bebidas (>-30mV) y la floculación de la emulsión, lo que se evidencia en la distribución del tamaño de partícula (1-600μm). La viscosidad y la estabilidad a la sedimentación aumentaron con concentraciones >0,05% de GX y CMC, reflejándose en una mayor valoración sensorial de la apariencia. El aumento en la concentración de aloe vera no mostró efecto en la estabilidad de las bebidas.
ABSTRACT Particle sedimentation is a common phenomenon in food dispersions, which is associated with poor quality and can be controlled using different additives within which the use of hydrocolloids stands out. The effect of the concentration of xanthan gum (0.025-0.075%), sodium carboxymethylcellulose (0.025-0.075%) and aloe vera gel (0.5-1.5%), on physicochemical, sensory properties and sedimentation in beverages made from sweet corn, were evaluated. No significant variation was observed in the content of total soluble solids, pH, density, titratable acidity, ζ potential, particle size, sedimentation index and color parameters with the concentrations of hydrocolloids and aloe vera. The potential ζ indicated slight stability in beverages (> -30mV) and emulsion flocculation, which is evidenced in the particle size distribution (1-600μm). The viscosity and sedimentation stability increased with concentrations >0.05% of GX and CMC, reflected in a higher sensory assessment of appearance. The increase in aloe vera concentration showed no effect on the stability of the beverages.
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Objective :To fabricate resveratrol nanoemulsions and probe their pharmacokinetics profiles in rats in vivo. Methods The nanoemulsions of resveratrol were tailored by using aethylis oleas as the oil phase, Cremophor RH40 as emulsifiers, absolute alcohol as co-emulsifiers, respectively. The formulation was optimized by pseudo-ternary phase diagrams and their physicochemical properties of nanoemulsions were characterized by particle size distribution, transmission electron microscope (TEM), and Fourier transform infrared spectroscopy (FTIR). The pharmacokinetics experiments were also performed in rats after gavage and the plasm concentration of resveratrol were determined by HPLC as well as the profiles of pharmacokinetic parameters were obtained by Drug and Statistics (DAS) software. Results: The formula of nanoemulsions were as follows: the ratio of resveratrol-aethylis oleas-mixture surfactant- distilled water was 1:10:24:65. The average particle size diameters of prepared resveratrol nanoemulsions were about 40 nm and the droplets of nanoemulsions were in spherical shape observed by TEM. The results of IR disclosed that the active trans-resveratrol presented in the oil droplet of the nanoemulsions. Compared with resveratrol suspensions, the bioavailability of resveratrol nanoemulsions was increased 1.45-fold, and Cmax reached to 1.93-fold. Conclusion : These results indicated that nanoemulsions may be a promising tool for the delivery of resveratrol.
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Este trabalho teve por finalidade desenvolver um método para a caracterização do perfil de dissolução de suspensões de mebendazol (MBZ), discriminatório para as formas polimórficas do fármaco. Pertencendo a classe II do Sistema de Classificação Biofarmacêutica (SCB), além da baixa solubilidade, o MBZ é bastante crítico por apresentar-se comercialmente disponível em duas formas polimórficas (A e C) e misturas destas. Além disso, pouca informação é encontrada acerca de métodos de dissolução de suspensões. O material apresentado está dividido em três capítulos, sendo o primeiro deles uma revisão da literatura sobre a dissolução de suspensões de fármacos que apresentam polimorfismo. Neste capítulo é feita uma abordagem sobre questões relacionadas ao desenvolvimento de métodos, como inserção das amostras na cuba de dissolução, agitação, uso de tensoativos no meio e a quantificação do fármaco. No segundo capítulo é apresentado o desenvolvimento do método de dissolução, com ênfase no estudo da solubilidade das formas polimórficas A e C de MBZ e sua interação com tensoativos. Foram realizados ensaios de solubilidade pelo método do equilíbrio, cálculo de concentração micelar crítica para os tensoativos lauril sulfato de sódio e polissorbato 80, sendo ao final realizado delineamento experimental (DOE) para o desenvolvimento do método. Pela avaliação do DOE, o local de inserção da amostra não influencia a dissolução de MBZ, por outro lado, a presença de tensoativo, assim como a forma polimórfica empregada, exercem efeito nos resultados apresentados. A partir destas informações, o método indicado para avaliação das suspensões de MBZ com potencial discriminatório de suas formas polimórficas foi definido pela utilização do aparato 2 (pá) a 75 rpm, com 2 litros de HCl 0,1 M sem tensoativo, como meio de dissolução. No último capítulo, o método desenvolvido foi utilizado na avaliação de especialidades farmacêuticas adquiridas no Brasil e em alguns países da América Latina, sendo os respectivos perfis de dissolução, comparados por meio de uma análise multivariada de componentes principais, com formulações contendo o MBZ em diferentes proporções de polimorfos. A partir dos resultados, foi possível observar que grande parte das formulações comercializadas não apresentaram perfil de dissolução satisfatório, isso pode estar relacionado com a presença considerável de polimorfo A nas matérias-primas utilizadas, comprometendo assim a sua solubilidade
The aim of this work was to develop a method for characterization of the dissolution profile of mebendazole (MBZ) suspensions, being discriminatory for the polymorphic forms of the drug. MBZ belongs to class II of the Biopharmaceutics Classification System (BCS), besides its low solubility, it is very critic, being commercially available in two polymorphic forms (A and C) and their mixtures. Moreover, there is low information about dissolution methods for suspensions. The text presented herein is divided into three chapters, the first chapter is a literature review about dissolution of suspensions containing drugs that present polymorphism. In this chapter is made a discussion about the variables of the method, as sample insertion in the dissolution vessel, rotation speed, use of surfactants in the dissolution medium and drug quantification. The development of the dissolution method, focused on the solubility study of MBZ polymorphic forms A and C and their interaction with surfactants is presented in the chapter 2. Some tests were performed: solubility using shake flask method, calculation of micellar critical concentration for the surfactants sodium lauryl sulphate and polysorbate 80, and an experimental design (DOE) was done for developing the method. By DOE evaluation, the sample insertion site does not influence on MBZ dissolution, but the presence of surfactant and the polymorphic form used, show effect on the results. Based on these information, the method indicated for evaluation of MBZ suspensions, with discriminatory power for its polymorphic forms was defined by using apparatus 2 (paddle) at 75 rpm and 2 L of 0.1M HCl without surfactant as dissolution medium. In chapter 3, the method developed was used to evaluate pharmaceutical suspensions from Brazil and from some countries of Latin America. The respective dissolution profiles were compared by means of multivariate analysis of principal components with formulations containing MBZ in different polymorphs ratios. From the results, it was possible to observe that a great part of the commercially available formulations do not presented a satisfactory dissolution profile, and this fact can be related to a considerable amount of the crystalline form A in the raw material, which compromises its solubility
Subject(s)
Suspensions , Dissolution/methods , Mebendazole/analysisABSTRACT
abstract A simple stability-indicating RP-HPLC/UV method was validated for determination of beclomethasone dipropionate (BD) in nanocapsule suspensions. Chromatographic conditions consisted of a RP C18column (250 mm x 4.60 mm, 5 µm, 110 Å), using methanol and water (85:15 v/v) as mobile phase at 1.0 mL/min with UV detection at 254 nm. The calibration curve was found to be linear in the concentration range of 5.0-25.0 µg/mL with a correlation coefficient > 0.999. Precision was demonstrated by a relative standard deviation lower than 2.0%. Accuracy was assessed by the recovery test of BD from nanocapsules (98.03% to 100.35%). Specificity showed no interference from the components of nanocapsules or from the degradation products derived from acid, basic and photolytic conditions. In conclusion, the method is suitable to be applied to assay BD in bulk drug and in nanocapsules, and it can be employed to study stability and degradation kinetics.
resumo Um método simples de CLAE-FR/UV indicativo de estabilidade foi validado para a determinação do dipropionato de beclometasona (BD) em suspensões de nanocápsulas. As condições cromatográficas foram: coluna C18 fase reversa (250 mm x 4,60 mm, 5 µm, 110 Å), usando como fase móvel metanol e água (85:15 v/v) a 1,0 mL/min, com detecção UV a 254 nm. A curva de calibração foi linear no intervalo de 5,0-25,0 µg/mL com coeficiente de correlação >0,999. A precisão foi demonstrada por um desvio padrão relativo menor que 2,0%. A exatidão foi avaliada pelo teste de recuperação do BD a partir das nanocápsulas (98,03% a 100,35%). O teste de especificidade não mostrou interferência dos componentes das nanocápsulas e nem dos produtos de degradação derivados de condições ácidas, básicas e fotolíticas. Em conclusão, o método é adequado para ser aplicado na avaliação do BD puro e em nanocápsulas e pode ser empregado para o estudo de estabilidade e degradação cinética.
Subject(s)
Beclomethasone/pharmacokinetics , Chromatography, High Pressure Liquid/methods , Nanocapsules , Nanoparticles , Chromatography, Reverse-PhaseABSTRACT
The patient package inserts (PPIs) should contain all the required information for the patient. It must be clear and understandable. There are several problems with the PPIs including the wrong information, readability and comprehensibility. Thus the pharmacists have to take an active role in making sure that patient is aware of important instruction including correct storage. Five antibiotics namely Erythromycin ethylsuccinate, Amoxicillin, Cefdinir, Flucloxacillin sodium and Clarithromycin powder for suspensions, were selected for this study, these antibiotic were reconstituted as directed on the label and tested initially and after 7 days when stored at room temperature and in refrigerator. Several chemical and physical pharmacopeial tests were performed. The results showed that two of the antibiotic oral suspensions namely erythromycin ethyl succinate and flucloxacillin sodium failed the accepted shelf life specification limits when stored at room temperature while both passes these limits when stored in refrigerator. Erythromycin ethylsuccinate has failed the tests of taste and odour while the flucloxacillin sodium has failed the assay test. Clarithromycin has failed some tests as viscosity, taste and pouring test when stored in refrigerator while passes all the tests when stored at room temperature. The study showed the vital role of the pharmacist to reiterate the important patient package insert instructions specially those concerned with the storage condition of the drug.
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El cultivar de plátano 'FHIA - 25' (AAB), posee excelente rendimiento y alta resistencia a "Sigatoka negra", pero con la limitante del bajo contenido de azúcar en su fruto, lo cual hace que sea necesario disponer de un método de regeneración de plantas a nivel celular como la embriogénesis somática, que se complemente a técnicas biotecnológicas de transformación genética para mejorar la calidad del fruto. El presente trabajo se realizó con el objetivo de establecer una metodología de regeneración vía embriogénesis somática a partir del explante inicial ápices de brotes axilares establecidos directamente en medio de cultivo líquido. Se obtuvieron suspensiones celulares embriogénicas homogéneas a partir del explante antes mencionado. Se lograron las mayores tasas de multiplicación a la densidad celular de 3,0%. La incubación de los embriones somáticos durante 30 días en el medio de cultivo de maduración permitió incrementar la germinación de los mismos. Durante la fase de aclimatización las plantas provenientes de los embriones somáticos, así como las plantas regeneradas por organogénesis, mostraron un alto porcentaje de supervivencia (98 y 97 %, respectivamente), sin la presencia de variación somaclonal.
Plantain cultivar 'FHIA - 25' (AAB) shows high yielding qualities and high resistance to Black Sigatoka disease, but its sugar content in the fruit is low, so a regeneration method at cell level is necessary, such as somatic embryogenesis supported by biotechnological tools to improve fruit quality. This work was performed with the aim of establishing a plant regeneration method via somatic embryogenesis using initial explants of shoot apices from axillary buds in liquid culture medium. Homogenous embryogenic cell suspensions were obtained from mentioned explants. The highest cellular multiplication rates were achieved at 3,0% density. The incubation of somatic embryos during 30 days in the maturation culture medium permitted to increase germination. During the acclimatization stage, plants regenerated from somatic embryos, as well as plants from organogenesis, showed a high survival percentage (98 and 97 respectively), without somaclonal variation.
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This paper reports the development, characterization and
O trabalho reporta o desenvolvimento, caracterização e estudo
Subject(s)
Humans , Chemistry, Pharmaceutical , Sulfasalazine/administration & dosage , Sulfasalazine/pharmacokinetics , Sulfasalazine/pharmacology , Drug Delivery Systems , Gastroenteritis/drug therapyABSTRACT
The laboratory control of diseases frequently receives powders for oral suspension of amoxicillin, with reports of therapeutic ineffectiveness and problems in reconstituting suspensions. The compendial analyzes not shows quality deviations. This fact motivated the study to assess the quality and stability of oral suspensions amoxicillin in the period of use corresponding to the first and seventh days after reconstitution. Six generic drugs were tested along with the referential drug during its intake period, from the first to the seventh day after powder reconstitution for suspension by high performance liquid chromatographic method. The reconstitution of all samples resulted in suspensions with homogeneous aspect. Both pH assay and amoxicillin identification complied with the product’s specification. The amoxicillin rates were determined in the 1th and 7th days after the reconstitution of samples through a method for stability detection, developed and validated before. At the 1th day, a generic drug sample presented 78% of the rate declared, below the lowest-value specification (90%). In the 7th day, 3 generic drug samples presented rates below 87%, 83% and 68.1% of the declared value, lower than the minimal specification, thus evidencing pharmacotechnical flaws in the product because of its lack of stability. Percent degradation rates of 3.5%, 4.0%, 6.0%, 9.9%, and 15% amoxicillin in 5 of the generic formulations studied are significant. The present study about amoxicillin oral suspension provides information about the stability during the using period, described for manufacturers. Even though the degradation products have not been identified, they can compromise their safe use, meaning potential risks to the users because of possible toxicity and/or therapeutic inefficacy.
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The present study describes the development and validation of an in vitro dissolution method for evaluation to release diclofenac potassium in oral suspension. The dissolution test was developed and validated according to international guidelines. Parameters like linearity, specificity, precision and accuracy were evaluated, as well as the influence of rotation speed and surfactant concentration on the medium. After selecting the best conditions, the method was validated using apparatus 2 (paddle), 50-rpm rotation speed, 900 mL of water with 0.3% sodium lauryl sulfate (SLS) as dissolution medium at 37.0 ± 0.5°C. Samples were analyzed using the HPLC-UV (PDA) method. The results obtained were satisfactory for the parameters evaluated. The method developed may be useful in routine quality control for pharmaceutical industries that produce oral suspensions containing diclofenac potassium.
O presente estudo descreve o desenvolvimento e validação de um método de dissolução in vitro para avaliação da liberação de diclofenaco potássico suspensão oral. O teste de dissolução foi desenvolvido e validado de acordo com as diretrizes internacionais. Parâmetros como linearidade, especificidade, precisão e exatidão foram avaliados, bem como a influência da velocidade de rotação e a concentração de tensoativono meio. Depois de selecionar as melhores condições, o método foi validado usando o aparato 2 (pás), velocidade de rotação de 50 rpm, 900 mL de água com 0,3% de lauril sulfato de sódio (LSS) como meio de dissolução a 37,0 ± 0,5 ºC. As amostras foram analisadas pelo método de CLAE-UV (PDA). Os resultados obtidos foram satisfatórios para os parâmetros avaliados. O método desenvolvido pode ser útil na rotina de controle de qualidade para as indústrias farmacêuticas que produzem suspensões orais contendo diclofenaco potássico.
Subject(s)
Diclofenac/classification , Chromatography, High Pressure Liquid/methods , Validation Study , Quality Control , Dissolution/methodsABSTRACT
Objective To study the efficacy and safety of oral calcium carbonate suspension and proton pump inhibitors (PPI) in symptoms relief of acid related diseases.Methods The multi-center,randomized and controlled study was carried out.A total of 400 acid-related diseases patients from 14 to 70 years old with at least one of moderate or severe symptoms such as acid regurgitation,epigastric pain,epigastric discomfort,upper abdominal burning or distension were equally divided into two groups and treated with oral calcium carbonate suspension or omeprazole enteric-coated tablets.The onset of symptoms relief of all patients of the first time after taking medicine was observed.The relief of clinical symptoms at the third day and seventh day after taking medicine was also observed.The adverse events were recorded.Analysis of variance was performed for statistical analysis.Results The onset of symptoms relief of oral calcium carbonate suspension group in acid regurgitation,epigastric pain,epigastric discomfort,upper abdominal burning or distension of the first time after taking medicine were significantly faster than those of PPI group (F=4.866,8.142,41.366,6.955,35.252; all P＜0.05).At the third day after taking medicine,the treatment efficiency of oral calcium carbonate suspension group and PPI group were 69.50％ and 72.50％,and at the seventh day the treatment efficiency of oral calcium carbonate suspension group and PPI group were 92.00％ and 96.50％.There was no significant difference in treatment efficiency and comprehensive efficacy between two groups at day three and seven after taking medicine (both P＞ 0.05).There were 14 cases of mild adverse events and two cases of moderate adverse events in oral calcium carbonate suspension group.There were 10 cases of mild adverse events in PPI group.There was no significant difference between two groups (P＞0.05).Conclusion Oral calcium carbonate suspension provides faster symptom relief than PPI and can effectively improve the symptoms of acid-related diseases.
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A two dimensional colloidal suspension subject to a periodic substrate evolves into a colloidal molecular crystal under situationsofstrongconfinement. Wefocusonthelongrangeorientationalordertherebyemerging, inthegroundstate. We study by simulations the situations where in each trap lies a pair of identical colloids, or alternatively a pair of oppositelychargedmacroions. We consider square or triangular geometries for the periodic confinement, together with less symmetric distorted lattices.
Uma suspensão bidimensional coloidal sujeita a um substrato periódico evolui para um cristal coloidal molecular em situações de forte confinamento. Nós focamos na ordem de orientação emergindo a partir do estado fundamental. Fazendo uso de simulações, estudamos as situações onde em cada armadilha reside um par de colóides idênticos ou, alternativamente, um par de macro-íons de cargas opostas. Consideramos geometrias quadradas ou triangulares para o confinamento periódico com arranjos simétricos com menor distorção.
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1.The mean range was 2.54 on the hands.CONCLUSIONS These results show that Medilox has a quick and highly effective bactericidal action.
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Objective To study the effects of phase change material (cooling agent) on the quality of blood after long-distant transportation.Methods A total of 12 bags, packed with pre-chilled phase change materials, were put into regular blood transportation kit, and the new blood transportation kit, which was developed by our hospital. In each kit there were 54 U of red blood cell suspensions. The temperatures in the kit were recorded during the transportation at different times.Results The temperature in the kit was kept between 1—7℃ during the 72h transportation. The temperature met the needs of red blood cell transportation.Conclusion Phase change material could be used as an effective cooling agent for long distance blood transportation.
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Se estudió la viscosidad de suspensiones, en función del contenido de sólidos, de una bentonita procedente del Valle del Cauca, en estado natural en agua y modificada con iones bencildimetiltetradecil amonio en mezclas etanol-glicerina, a 25 °C. Para la bentonita natural la función: viscosidad frente a%de sólidos es lineal, mientras que para la organofílica es parabólica. La función matemática: viscosidad específica /%de sólidos frente a % de sólidos es un polinomio de grado dos, tanto para las suspensiones de la bentonita natural como para las de la organofílica. En ninguno de estos dos casos se cumple la ecuación de Einstein, de DoughertyKreiger o de Farris.
It was studied the suspensions viscosity of a bentonite, from the CaucaValley, related to the solids content, in natural state with water and modified with benzyldimethyltetradecylammonium ions with ethanol- glycerine mixture at 25 °C. For the natural bentonite the function : Viscosity vs. % of solids is lineal, but for the organophilic bentonite is parabolic. The mathematical function: Specific viscosity /%of solids vs,%of solids is a polynomial of grade two as the suspensions of the natural bentonite as well as the organophilic one. None of theses cases the Einstein, Dougherty-Kreiger or Farris ecuations is followed.
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Objectives To study the effect of highway transportation on the quality of red blood cells. Methods Highway transportation environment was simulated by random vibration test. Red blood cell suspensions and whole blood were vibrated for 120 minutes based upon GB/T 4857.23-2003 with the RMSVA of 0.38 and 0.52grms, as well as GJB 2711-1996 with the RMSVA of 1.04grms and weight loading of 60kg. Five ml of specimen were taken before the testing (as Control Group), and after the testing at 30mins' intervals (as Testing Group). K+, FHb and red blood cell osmotic fragility were tested. Results The red blood cell osmotic fragility of whole blood increased in 0.38grms, 90min and 0.52grms, 60min specimens (P
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Objective:To study anti-tumor activity of Xidan Suspensions in vivo.Methods: The mice were transported by armpit or intraperitoneum injection of H22,EC or P388 tumor cells.Results: Xidan Suspensions inhibited markedly the growth of H22,EC or P388 tumor cells(P
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Objective:To study acute toxicity of Xidan suspensions in mice.Methods:To measure the LD50 and to observe the response to machinery stimulation and the autonomic activity of the experimental animals when Xidan suspensions is taken orally into the mice.Results:The LD_(50) of Xidan suspensions is 148.08g(crude medicinal materials)/kg in the mice by ig.When it is taken orally(ig)into the mice at the dosage of LD_(50) or more [180g(crude medicinal materials)/kg],it is found that the response to machinery stimulation,the autonomic activity the muscle tone and the regulation of balance ability decreased obviously.Conclusion:It is indicated that Xidan suspensions could be toxic to the nervous system of mice.