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Abstract A simple, rapid, precise, accurate and sustainable spectrofluorimetric method (SFM) was developed, validated and applied for the determination of 4-aminobenzoic acid and aromatic amino acids (phenylalanine, tryptophan and tyrosine). These compounds are used in biopharmaceutical formulations and therefore must be analyzed by quality control laboratories to meet the criteria established in pharmacopoeias. In general, potentiometric titration (PT) is described in the compendia as the official analytical technique. However, this method showed low sensitivity and selectivity, and moreover was performed with a non-aqueous solvent (acetic acid), which led to higher consumption of reagents and consequently to the formation of residues. Therefore, the SFM was developed in aqueous medium at pH 7.2 using phosphate buffer. It was successfully validated according to the ICH guidelines and showed good linearity range (r>0.999), specificity, accuracy and precision (within and between days) and robustness. The test results were compared between the SFM and PT using raw material samples, while according to the F- and t-tests at 95% confidence level, no statistical difference was found between the methods.
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OBJECTIVE To establish a method for simultaneous determination of the contents of 6 kinds of N-nitrosamines genotoxic impurities in losartan potassium raw material and its formulations. METHODS GC-MS/MS was adopted to determine 6 kinds of N-nitrosamines genotoxic impurities in losartan potassium raw material， Losartan potassium tablet， Losartan potassium capsule and Losartan potassium hydrochlorothiazide tablets， such as N-nitrosodimethylamine （NDMA）， N-nitrosodiethylamine （NDEA）， N-ethyl-N-nitroso-2-propanamine （NEiPA）， N-nitrosodiisopropylamine （NDiPA）， N-nitrosodipropylamine （NDPA） and N-nitrosodibutylamine （NDBA）. The separation was performed on SHIMADZU SH-L-17Sil MS capillary column by temperature- programmed GC， with injector temperature of 250 ℃ ， sample size of 1 μL， carrier gas of helium， and carrier flow rate of 1 mL/min. Electron ionization and multiple reaction monitoring （MRM） data acquisition mode were used， with an ion source temperature of 250 ℃ and solvent delay time of 3.1 min. RESULTS The separation among NDMA， NDEA， NEiPA， NDiPA， NDPA， NDBA and adjacent chromatographic peaks was good， and the separation rate was higher than 3.8； the linear ranges of them were 4.9-486.0， 4.9-488.5， 4.5-451.5， 6.8-683.5， 5.2-525.0 and 5.2-520.0 ng/mL（all r≥0.999 8）. The limits of quantitation were 4.86， 4.88， 4.52， 6.84， 5.25 and 5.20 ng/mL； the limits of detection were 0.97， 0.98， 0.90， 1.37， 1.05 and 1.04 ng/mL. RSDs of repeatability tests were 2.2%-5.6%（n＝6）， those of precision tests were 0.5%-1.4%（n＝6）， and those of stability tests were 1.5%-3.4%（n＝5）， respectively. Average recoveries of low-， medium- and high-concentration solution were 83.4%-103.0% （RSDs were 1.2%-6.3%， n＝3）， respectively. No one among the 6 kinds of N-nitrosamines genotoxic impurities was detected in both losartan potassium raw material and formulations. CONCLUSIONS The method is good in separation effect， highly accurate， sensitive and simple. It can be used in the determination of the 6 kinds of N-nitrosamines genotoxic impurities.
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@#Quercetin, a flavonoid compound which is widely distributed in plants are considered ass beneficial physiologically due to attributed bioactivity such as anti-cancer, immunomodulatory, antidiabetic, and anti-inflammatory. In this study, the quercetin content from the dried Blumea balsamifera L. DC dried leaf was macerated with 95% ethanol and the concentrated extract was purified using Modified Kupchan method and flash chromatography. All fractions were tested for the presence of flavonoids using phytochemical screening and the selected dichloromethane fraction were further purified using another round of flash chromatograph. All resulting fractions and pooled samples were tested for the antioxidant property using the developed Thin Layer Chromatography (TLC)-Bioautography and separated compounds were derivatized with DPPH. Using the optimized TLC-Bioautography method, the quercetin content in the dichloromethane fraction was analyzed and compared with a reversed phase high performance liquid chromatography hyphenated with photodiode array detector (RP-HPLC-PDA). The calculated quercetin content from the pooled sample using TLC-bioautography method is 2.25 mg/ml and from RP-HPLC-PDA is 2.02 mg/ml which was not comparable statistically using unpaired t-test (p<0.05, α=0.05
Subject(s)
QuercetinABSTRACT
Introduction@#According to the manuscript “Imperially commissioned complete record of the body”, the study was selected to clarify the name of the plant, as it is difficult to recognize and translate the medicinal raw materials directly from Manchu, Tibetan, Chinese, Latin, and Sanskrit into Uighur and Mongolian scripts.@*Methods@#We conducted our research using hermeneutic, verification, and checklist methods.@*Results@#“Imperially commissioned complete record of the body” scripture is a rare book based on European anatomical works that combine Western and Eastern medical knowledge. There is reason to believe that European medicine in Mongolia was a witness to the spread of the anthropology of the human body.</br> It is clear from the 6 books that the two volumes are based on the basic tenets of Indian and Chinese medicine, Buddhist philosophy, and the teachings of the five elements and yin-yang. The study included “Ingredients for Correcting Anxiety”, “Ingredients for Correcting Heart Attack,” and “Ingredients for Correcting Depression”. These three ingredients were the basis of the recipes of Oriental medicine in the European medical books. Comparing the taste, potency, and action of all selected medicinal raw materials using traditional medicine, such as “The quintessence Tantras of Tibetan Medicine” and other books, it is clear that the classical European medical tradition differs from the modern medical classification.@*Conclusion@#“Imperially commissioned complete record of the body” manuscript is a documentary scripture used by Mongolian shepherds and herdsmen on the achievements of European medicine, free from religious traditions and taboos. In addition, there found 18 traditional medicinal plants and 7 types of animal medicines used in heart disease.
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The registration system of medical device Master Files is established to solve the problem that the outsourcing suppliers are not willing to cooperate with the device applicants in the process of providing medical device application documents. After a brief introduction of Master Files systems established by foreign regulatory agencies, this article focuses on the research of establishing a medical device Master Files registration system in China. The results show that the establishment of Chinese Master Files registration system can both improve the standardization and convenience of outsourcing activities of medical devices, and satisfy the needs of the development of medical device industry and regulatory system. At the same time, the probability of additional risk caused by the implementation of the system is low. Therefore, it is expected that the benefits of the system to promote public health outweigh the potential risks, which demonstrates that establishment of the system has important application values.
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China , Industry , Reference StandardsABSTRACT
Introduction@#<i>Helianthus tuberosus</i> L. is main source of inuline in pharmaceutical and food industry. Pharmacological studies of the plant have showed some important therapeutic properties such as anti-diabetic, anti-osteoporosis, anti-cancer and strengthening cardiovascular system, immune system.@*Material and method@#<i>Helianthus tuberosus</i> L., which has been cultivated in Botanical Garden of Medicinal Plants of Drug Research Institute, Monos Group, was used as a research raw material. The aerial and below ground parts of the plants were harvested in September 2020. The content of inulin, the main active ingredient in the plant, was determined by spectrophotometry. Raw materials of the plant were processed in several ways and prepared for further use as a pharmaceutical raw material.@*Result@#Inulin content in Sample 1 was 34.5 ± 0.76%, Sample 2 was 70.31 ± 1.25%, Sample 3 was 78.43 ± 0.44% and Sample 4 was 75.36 ± 1.42%. The inulin content and yield were the highest in samples prepared by heat and cold cutting methods. @*Conclusion@#According to the results of appearance, yield, inulin content and moisture contents during the different processings of plant materials, it can be considered that the most suitable method for preparing <i>Helianthus tuberosus</i> L. as a pharmaceutical raw material is the cutting followed by freeze-drying.
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Introduction@#Rhodiola rosea L. (R.rosea) is a popular plant in traditional medicine of the Nordic countries, Eastern Europe, and Asia. R.rosea plants are successfully cultivated in Mongolia. The Botanical Garden of Medicinal Plants under the “Monos” Group started to cultivate R. rosea since May 2015. @*Objective@#The aim of this research was to study the salidroside contents of R.rosea collected from Zavkhan and Khuvsgul province, Mongolia, and cultivated in the Botanical Garden of Medicinal Plants, Drug research Institute, Monos group.@*Material and Methods@#The underground parts of wild roseroot plants were collected from April to May 2020 from Jargalant soum, Khuvsgul province, and Nomrog soum, Zavkhan province, 3-years and 4-years-old cultivated R.rosea gathered from the Botanical Garden of Medicinal Plants in April 2020. For comparison, 4-year-old Rhodiola grenulata (R. grenulata) was ordered from Shanxi Zhendong Genuine Medicinal Materials Development Co., Ltd, China, and used for the study. The quantity of the salidroside constituents of the underground parts were compared and the sourcing of roseroot raw material was evaluated. Chemical analysis of roots and rhizome of R. Rosea namely the appearance, identification, moisture, organic impurities, mineral impurities, residue on ignition, water-soluble extractives, fresh weight of roots, and salidroside content were determined according to the National Pharmacopoeia of Mongolia (NPhM) 2011. Microbiological analysis was performed in accordance with the requirements of grade 3b specified in Annex 1 of the Order No. A / 219 of the Minister of Health dated May 30, 2017 to determine the degree of microbiological purity in medicinal products of roots and rhizome raw materials.@*Result@#The content of salidroside, the main biologically active substance of R.rosea plant, was 1.57% in samples collected from Zavkhan province, 1.45% in samples collected from Khuvsgul province, 1.7% in samples grown in China and 0.25% for 3-years-old samples and 1.89% for 4-years-old samples grown in the Botanical Garden of Medicinal Plants, Monos group, Mongolia. In addition, these raw materials meet the general requirements for plant raw materials and microbiological parameters.@*Conclusion@#Samples of underground parts of R.rosea cultivated for 4 years in the Botanical Garden of Medicinal Plants have the highest content (1.89%) of the salidrosde. Therefore, it is suggested that the roots and rhizomes of R.rosea planted in the future can be standardized and used as a raw materials for medicines.
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Objetivo: Avaliar a Atenção Básica quanto aos insumos, imunobiológicos e medicamentos disponibilizados nos serviços de saúde da família de município de Minas Gerais, Brasil. Métodos: Trata-se de pesquisa transversal, analítica, conduzida em 2014, a partir de instrumento ministerial intitulado Autoavaliação para Melhoria do Acesso e da Qualidade da Atenção Básica, de equipes de saúde da família. Oito itens foram considerados, com valores entre zero a 10 pontos, da total inadequação à total adequação da Unidade Básica de Saúde (UBS), ao item avaliado. Classificaram-se as unidades em padrões de qualidade "muito insatisfatório" a "muito satisfatório" e analisou-se conforme localização rural e urbana, nível de significância p<0,05. Resultados: Participaram 75 equipes, que apresentaram expressiva inadequação nos itens: UBS dispor todas as vacinas exigidas no calendário básico, 5,95 (±4,003); possuir insumos e medicamentos para abordagem inicial de urgência/emergência, 2,33 (±2,500); apresentar os medicamentos básicos com regularidade, 3,68 (±3,146). A classificação foi regular para 45,3% das unidades e insatisfatória para 29,3%, sem diferenças quanto à localização urbana ou rural (p=0,479). Conclusão: Evidenciou-se avaliação insatisfatória, com inadequações relativas às vacinas, à abordagem inicial nas situações de urgência e emergência e à disponibilidade dos medicamentos. Tal situação prejudica o elenco de ações e a resolutividade dos serviços, afetando a capacidade da equipe para atender, efetivamente, as demandas de saúde da população
Objective: To evaluate the Basic Care regarding the supplies, immunobiologicals and medicines available in the family health services of the municipality of Minas Gerais, Brazil. Methods: Cross-sectional, analytical research, conducted in 2014, from a ministerial instrument titled Self-Assessment for Improving Access and Quality of Primary Care, of family health teams. Eight items were considered, with values between zero and 10 points, of the total inadequacy to the total adequacy of the Basic Health Unit (UBS), to the evaluated item. The units were classified in quality standards "very unsatisfactory" to "very satisfactory" and analyzed according to rural and urban locations, level of significance p<0.05. Results: 75 teams participated, which presented significant inadequacy in the items: UBS dispose of all the vaccines required in the basic calendar, 5.95 (±4.003); to have supplies and medicines for the initial emergency/emergency approach, 2.33 (±2.500); presenting the basic medicines regularly, 3.68 (±3.146). The classification was regular for 45.3% of the units and unsatisfactory to 29.3%, without differences in urban or rural locations (p=0.479). Conclusion: There was an unsatisfactory evaluation, with inadequacies related to vaccines, the initial approach in emergency and emergency situations and the availability of medicines. Such a situation undermines the list of actions and the resolution of services, affecting the capacity of the team to effectively meet the population's health demands.
Objetivo: Evaluar la Atención Básica en cuanto a los insumos, inmunobiológicos y medicamentos disponibles en los servicios de salud de la familia del municipio de Minas Gerais, Brasil. Métodos: Se trata de investigación transversal, analítica, conducida en 2014, a partir de instrumento ministerial titulado Autoevaluación para la mejora del acceso y de la calidad de la atención básica, de los equipos de salud de la familia. Se consideraron ocho ítems, con valores entre cero y diez puntos, de la total inadecuación a la total adecuación de la Unidad Básica de Salud (UBS), al ítem evaluado. Se clasificaron las unidades en estándares de calidad "muy insatisfactorio" a "muy satisfactorio" y se analizó según ubicación rural y urbana, nivel de significancia p<0,05. Resultados: Participaron 75 equipos, que presentaron expresiva inadecuación en los ítems: UBS disponer todas las vacunas requeridas en el calendario básico, 5,95 (±4,003); poseer insumos y medicamentos para el enfoque inicial de urgencia/emergencia, 2,33 (±2,500); presentar los medicamentos básicos con regularidad, 3,68 (±3,146). La clasificación fue regular para el 45,3% de las unidades e insatisfactoria para el 29,3%, sin diferencias en cuanto a la ubicación urbana o rural (p=0,479). Conclusión: Se evidenció una evaluación insatisfactoria, con inadecuaciones relativas a las vacunas, al abordaje inicial en las situaciones de urgencia y emergencia y a la disponibilidad de los medicamentos. Tal situación perjudica el elenco de acciones y la resolutividad de los servicios, afectando la capacidad del equipo para atender efectivamente las demandas de salud de la población.
Subject(s)
Humans , Primary Health Care , Health Evaluation , Pharmaceutical Raw Material , Health Services ResearchABSTRACT
OBJECTIVE： To establish the method for content determination of the related substance in fudosteine raw material and its preparations. METHODS： Fudosteine or its preparations produced by 8 domestic enterprises were taken as samples. HPLC method （external standard） was used to determine the contents of impurities A， B and C. The separation was performed on MGⅡ C18 column with mobile phase consisted of 0.12％ sodium hexane sulfonate solution （pH 2.0） at flow rate of 1.0 mL/min. The detection wavelength was set at 210 nm， column temperature was 35 ℃ and sample size was 20 μL. The contents of impurities E， F， G were determined by HPLC method （principal component self-contrast method with correction factor）. The separation was performed on Altech Altima C18 column with mobile phase consisted of 0.05 mol/L phosphate buffer-acetonitrile- water （gradient elution） at the flow rate of 0.5 mL/min. The detection wavelength was set at 200 nm， and the column temperature was 30 ℃. The sample size was 20 μL. RESULTS： The linear ranges of impurity A， B， C， E， F and G were 0.446-22.291， 0.202-20.158， 0.101-12.082， 0.111 0-11.100， 0.210 4-10.520， 0.221 6-11.080 μg/mL， respectively. The limits of detection were 5.57， 1.01， 1.99， 2.22， 4.21， 4.43 ng， respectively. The limits of quantitation were 11.14， 2.02， 3.98， 4.45， 8.42， 8.85 ng， respectively. The relative correction factors of impurities E， F and G were 0.91， 1.42 and 1.73， respectively； their relative retention time were 0.88， 1.95 and 3.08. RSDs of precision （n＝6） and stability [impurity A （4 h，n＝3）， other impurities （24 h，n＝7）] tests were all lower than 2.0％. The average recoveries were 98.0％， 97.3％， 102.4％， 99.4％， 98.9％， 96.4％， respectively； RSDs were 1.4％， 1.5％， 1.1％， 0.9％， 1.2％， 0.5％ （n＝9）， respectively. Total contents of substances in fudosteine raw material or its preparation produced by 8 enterprises were all lower than 1.1％. CONCLUSIONS： Established method is sensitive and specific. The method can be used for the quantitative study on related substances in fudosteine raw material and its preparations．
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OBJECTIVE： To establish a method for simultaneous determination of residual solvents in phenylbutazone raw material. METHODS： Head-space GC was adopted. The determination was performed on Agilent HP-5 capillary column by temperature programming. The temperature of injector was 200 ℃， and detector was flame ionization detector with temperature of 250 ℃； carrier gas was nitrogen （purity：99.99％） at the flow rate of 2.0 mL/min. The split ratio was 5 ∶ 1. Headspace equilibrium temperature was 60 ℃， and equilibration time was 30 min. The sample size was 1 mL. RESULTS： The linear range was 0.15-4.5 μg/mL for methanol （r＝0.999 9）， 0.25-7.5 μg/mL for ethanol （r＝0.999 7）， 0.25-7.5 μg/mL for isopropyl alcohol （r＝0.999 7）， 0.03-0.9 μg/mL for dichloromethane （r＝0.999 3）， 0.25-7.5 μg/mL for ethyl acetate （r＝0.999 3）， 0.044-1.32 μg/mL for N，N-dimethyl formamide （r＝0.999 3）， respectively. The limits of detection were 0.05， 0.08， 0.08， 0.01， 0.08， 0.015 μg/mL. The limits of quantitation were 0.15， 0.25， 0.25， 0.03， 0.25， 0.044 μg/mL. RSDs of precision test were lower than 2.0％. RSDs of stability and reproducibility tests were lower than 3.0％. The recoveries were 98.75％-100.12％ （RSD＝0.56％， n＝9）， 98.07％-101.20％ （RSD＝1.12％， n＝9）， 98.36％-100.80％ （RSD＝0.92％， n＝9）， 98.33％-101.67％ （RSD＝0.98％， n＝9）， 98.11％-100.40％ （RSD＝0.72％， n＝9） and 98.75％-101.05％ （RSD＝0.89％， n＝9）. CONCLUSIONS： The method is simple， accurate， precise， stable， reproducible and durable， and can be used for simultaneous determination of 6 residual solvents in phenylbutazone raw material.
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OBJECTIVE： To establish method for simultaneous determination of 7 related substances in solifenacin succinate raw material. METHODS： HPLC method was adopted. The determination was performed on Thermo Hypersil ODS C18 column with mobile phase consisted of 0.02 mol/L KH2PO4 （0.02％ triethylamine， pH＝3.0）-acetonitrile （gradient elution） at the flow rate of 1.2 mL/min. The detection wavelength was set at 210 nm， and column temperature was 40 ℃. The sample size was 20 μL. The regression equation of solifenacin succinate and impurity A， C， D， I， J， K， L were drawn. Correction factors of impurities to solifenacin succinate were calculated with slope. The contents of impurities A， C， D， I， J， K and L were determined in 3 batches of solifenacin succinate raw material. RESULTS： The linear ranges of impurity A， C， D， I， J， K and L were 0.148 1-0.740 3， 0.142 9-0.714 5， 0.141 1-0.705 6， 0.148 9-0.744 6， 0.152 0-0.759 9， 0.137 9-0.689 6， 0.020 0-0.100 0 μg/mL （r＝0.999 8， 0.999 9 or 1.000 0）， respectively. The relative correction factors were 0.51， 0.40， 0.41， 0.91， 0.47， 0.85， 1.23. The limits of detection were 0.049 3， 0.047 6， 0.047 0， 0.048 1， 0.050 7， 0.046 0， 0.006 7 μg/mL. The quantification limits were 0.148 1， 0.142 9， 0.141 1， 0.148 9， 0.152 0， 0.137 9， 0.020 0 μg/mL， respectively. RSDs of precision， stability （24 h） and reproducibility tests were all lower than 5.0％ （n＝6）. Average recoveries were 101.09％， 97.58％， 93.77％， 98.56％， 99.68％， 97.07％ and 93.54％； RSDs were 0.75％ ， 0.51％， 0.47％， 0.84％， 0.70％， 0.75％， 1.21％ （n＝9）. The contents of impurity I in 3 batches of solifenacin succinate raw material were 0.015％-0.018％， other impurities were not detected. CONCLUSIONS： The method is sensitive， accurate and reliable， which can be used to determine the related substances of solifenacin succinate raw material.
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Objective: To establish a method for the determination of related substances in dexmetomidine hy- drochloride gels,and investigate the compatibility of dexmedetomidine hydrochloride and excipients in the dexmetomi- dine hydrochloride gels. Methods: HPLC was performed on an octadecylsilane bonded silica gel column by a gradient elution with acetonitrile/0.008 mol/L NaH2PO4 solution as mobile phase. Flow rate was 1.0 ml/min. Column temperature was 30℃. Injection volume was 50 μl. Detection wavelength was 210 nm. According to the Basic Technical Guidelines for the Research of Chemical Drug Preparations,dexmetomidine hydrochloride was mixed with excipients in a certain propor- tion,and the mixtures were treated as test sample at the conditions of high temperature(60℃)and strong light(4500± 500)Lx irradiation. Sampling was performed on the 0,10th and 30th day of treatment,respectively. The appearance of the test samples was examined,and related substances in the samples were determined by the established HPLC method. Results: The established HPLC method showed a good specificity and durability,which could be used to accurately and effectively determine the changes of related substances. The appearance of the test samples the mixtures of dexmetomi- dine hydrochloride and excipients showed no changes in the full course of treatment at the tested conditions,and the re- lated substances were also not increased under the same conditions. Conclusion: The selected excipients(HPMC,pro- pylene glycol,methylparaben,sodium benzoate,and benzyl alcohol)all showed a good compatibility with dexmetomi- dine hydrochloride,and the tested mixture samples with the excipients and dexmetomidine hydrochloride were stable un- der the conditions of high temperature and strong light irradiation. These excipients could be used for the formulation screening for the dexmedetomidine hydrochloride gel development.
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A qualidade do leite é definida por sua composição, características físico-químicas, propriedades organolépticas e higiene. Os teores de proteínas, gorduras, sais minerais, vitaminas e água são influenciados pela raça, idade, alimentação, manejo, fatores ligados ao nível de estresse e escore corporal. A legislação exige que o leite de animais que estão sendo submetidos a tratamento com antibiótico seja descartado, propiciando assim a obtenção de um alimento de qualidade, seguro para o consumo e livre de resíduos químicos. Neste trabalho realizou-se um estudo para detecção de resíduos de antibióticos no leite cru, pasteurizado e UAT comercializados na região do Gama-DF. Foram analisadas 30 amostras, utilizando o Kit BALLYA Bio BT Sensor®. Obteve-se resultado positivo para presença de Betalactâmicos em uma amostra de leite UHT, sendo em nível superior ao LMR apresentado pelo fabricante, indicativo de risco para consumo humano. No teste de Lactofermentação, de 10 amostras de leite cru, 5 (cinco) resultaram em coágulo Esponjoso, o qual se refere às más condições de higiene das mãos do ordenhador e utensílios durante a ordenha, o que afeta a qualidade do leite e derivados, aumentando o índice de contaminação do leite
Milk quality is defined by its composition, physico-chemical characteristics, organoleptic properties and hygiene. The levels of protein, fat, minerals, vitamins and water are influenced by race, age, diet, management, factors related to stress level and body score. Legislation requires that the milk of animals being treated with antibiotics be discarded, thus providing a quality food, safe for consumption and free of chemical residues. In this work a study was carried out to detect residues of antibiotics in raw, pasteurized and UAT milk commercialized in the Gama-DF region. Thirty samples were analyzed using the BALLYA Bio BT Sensor® Kit. A positive result was obtained for the presence of Betalactams in a UHT milk sample, being higher than the MRLs presented by the manufacturer, indicative of risk for human consumption. In the Lactofermentation test, from 10 samples of raw milk, 5 (five) resulted in a spongy clot, which refers to poor hygiene of the milker's hands and utensils during milking, where it will affect the quality of milk and milk products, increasing the rate of milk contamination
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A qualidade do leite é definida por sua composição, características físico-químicas, propriedades organolépticas e higiene. Os teores de proteínas, gorduras, sais minerais, vitaminas e água são influenciados pela raça, idade, alimentação, manejo, fatores ligados ao nível de estresse e escore corporal. A legislação exige que o leite de animais que estão sendo submetidos a tratamento com antibiótico seja descartado, propiciando assim a obtenção de um alimento de qualidade, seguro para o consumo e livre de resíduos químicos. Neste trabalho realizou-se um estudo para detecção de resíduos de antibióticos no leite cru, pasteurizado e UAT comercializados na região do Gama-DF. Foram analisadas 30 amostras, utilizando o Kit BALLYA Bio BT Sensor®. Obteve-se resultado positivo para presença de Betalactâmicos em uma amostra de leite UHT, sendo em nível superior ao LMR apresentado pelo fabricante, indicativo de risco para consumo humano. No teste de Lactofermentação, de 10 amostras deleite cru, 5 (cinco) resultaram em coágulo Esponjoso, o qual se refere às más condições de higiene das mãos do ordenhador e utensílios durante a ordenha, o que afeta a qualidade do leite e derivados, aumentando o índice de contaminação do leite.
Milk quality is defined by its composition, physico-chemical characteristics, organoleptic properties and hygiene. The levels of protein, fat, minerals, vitamins and water are influenced by race, age, diet, management, factors related to stress level and body score. Legislation requires that the milk of animals being treated with antibiotics be discarded, thus providing a quality food, safe for consumption and free of chemical residues. In this work a study was carried out to detect residues of antibiotics in raw, pasteurized and UAT milk commercialized in the Gama-DF region. Thirty samples were analyzed using the BALLYA Bio BT Sensor® Kit. A positive result was obtained for the presence of Betalactams in a UHT milk sample, being higher than the MRLs presented by the manufacturer, indicative of risk for human consumption. In the Lactofermentation test, from 10 samples of raw milk, 5 (five) resulted in a spongy clot, which refers to poor hygiene of the milker's hands and utensils during milking, where it will affect the quality of milk and milk products, increasing the rate of milk contamination.
Subject(s)
Anti-Bacterial Agents , Chemical Contamination , Milk , Fermentation , Food QualityABSTRACT
Experiencing challenges of modern medicine, globe is shifting towards the Ayurvedic theory of health management. In the treatment of disease use of medicine is practiced rampantly. This increased the demand of raw material exponentially. But, growth in production is still linear in nature. Fast depletion of resources is creating the major trouble. To meet the deficit, practices of adulteration and substitution are going on wildly. This adulteration and substitution became burning problem in industry threatening the integrity of Ayurveda. The deforestation, extinction or evolution of many species, insufficient knowledge, unauthenticated practices about identification, collection, storage and transport of raw material collectively resulted in adulteration. Strategic planning and integrated approach towards mass production, supply chain management, IEC, proper advocacy and knowledge sharing is needed to trim down the gravity of adulteration. “Prevention of Food Adulteration act 1954” describes technical definitions and guidelines for quality maintenance. Government is enforcing quality maintenance by implementation of “The Drug and Cosmetics Act 1940” For quality assurance, proper pharmacovigillance monitoring of raw materials and processes is very necessary. The concept of substitution is known in Ayurveda as it is enlightened prominently in Bhavprakash and Yogratnakar. However in scenario of crises, selection of substitute drugs may have upper edge over adulteration of the raw material. Scope of this article advocates that how adulteration and substitution are creating problems with respect to production of inferior quality medicines.
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Background: Pretreatment of lignocellulosic biomass is essential for using it as a raw material for chemical and biofuel production. This study evaluates the effects of variables in the chemical pretreatment of the Arundo biomass on the glucose and xylose concentrations in the final enzymatic hydrolysate. Three pretreatments were tested: acid pretreatment, acid pretreatment followed by alkaline pretreatment, and alkaline pretreatment. Results: The amounts of glucose and xylose released by the enzymatic hydrolysis of the Arundo biomass obtained from acid pretreatment ranged from 6.2 to 19.1 g/L and 1.8 to 3.1 g/L, respectively. The addition of alkaline pretreatment led to a higher yield from the enzymatic hydrolysis, with the average glucose concentration 3.5 times that obtained after biomass hydrolysis with an acid pretreatment exclusively. The use of an alkaline pretreatment alone resulted in glucose and xylose concentrations similar to those obtained in the two-step pretreatment: acid pretreatment followed by alkaline pretreatment. There was no significant difference in 5-hydroxymethylfurfural, furfural, or acetic acid concentrations among the pretreatments. Conclusion: Alkaline pretreatment was essential for obtaining high concentrations of glucose and xylose. The application of an alkaline pretreatment alone resulted in high glucose and xylose concentrations. This result is very significant as it allows a cost reduction by eliminating one step.
Subject(s)
Ethanol/metabolism , Poaceae/chemistry , Acids/chemistry , Xylose/analysis , Cellulose/chemistry , Biomass , Biofuels , Glucose/analysis , Hydrolysis , LigninABSTRACT
Objetivos: Determinar la tasa de uso de materiales dentales en procedimientos de operatoria dental, cirugía bucal, impresión dental, cementación dental, base cavitaria, prevención, cementación en endodoncia, cementación de bandas ortodónticas en la Clínica Odontológica de la Unidad Académica de Salud y Bienestar de la Universidad Católica de Cuenca, Ecuador. Material y métodos: Se analizaron 31 materiales dentales y 7 insumos, en una clínica dental docente de Odontología en Ecuador. Se pesó el envase lleno, luego el envase vacío y se determinó la cantidad del peso real del producto en gramos, después se determinó el peso de cada porción y se calculó la tasa de uso (cantidad de porciones). Para los insumos se dividió la cantidad total de unidades entre el uso por intervención para hallar la tasa de uso, en ambos casos la tasa de uso sirvió para calcular el costo por unidad. Resultados: Las tasas de uso del componente líquido y del polvo del ionómero de restauración posterior son diferentes, superando uno al otro en una proporción de 2,04 a 1,00. Respecto a la silicona, el activador posee una tasa de 165; teniendo una proporción de 1,89 a 1,00 entre activador y silicona pesada. Conclusiones: La tasa de uso de materiales odontológicos ayudará a conocer el rendimiento exacto de los materiales que se emplearán para la práctica odontológica, y establecerán costos propios que van a variar dependiendo de la cantidad de materiales usados y calidad de servicio que brindemos.
Objectives: Determine the rate of use of dental materials in procedures of dental surgery, oral surgery, dental impression, dental cementation, cavitary base, provisional, prevention, cementation in endodontics, cementation of bands at the Dental Clinic of the Academic Unit of Health and Welfare from the Catholic University of Cuenca, Ecuador. Materials and methods: 31 dental materials and 7 supplies were analyzed in a dental dentistry teaching clinic in Ecuador. The filled container was weighed, then the empty container and the amount of the actual weight of the product in grams was determined, then the weight of each portion was determined and the usage rate (number of portions) was calculated. For the inputs, the total number of units was divided between the use by intervention to find the rate of use, in both cases the rate of use was used to calculate the cost per unit. Results: The rates of use of the liquid component and the dust of the posterior restoration ionomer are different, exceeding each other in a ratio of 2.04 to 1.00. Regarding the silicone, the activator has a rate of 165; having a ratio of 1.89 to 1.00 between activator and heavy silicone. Conclusions:The rate of use of dental materials will help to know the exact performance of the materials that will be used for dental practice, and will establish own costs that will vary from the quantity of materials used and quality of service that we provide.
ABSTRACT
Ginkgo diterpene lactone raw material, as a raw material for ginkgo diterpene lactone meglumine injection, is extracted and purified from ginkgo leaf. ¹H-NMR content determination method and fingerprint analysis method were respectively established for ginkgo diterpene lactone raw material. Content determination was conducted in 3 batches of samples by using ¹H-qNMR, and then the results were basically consistent with the results in HPLC method. Twenty-four proton peaks were identified as common fingerprint peaks, and the fingerprint peaks were identified by using the control product and NMR information. Furthermore, 10 batches of samples were analyzed by ¹H-NMR fingerprint. The similarities were all higher than 0.99 and the common peaks were identified with the reference standards. This method is easy, fast, with good precision, stability and repeatability and could provide basis and new ideas for quality evaluation of ginkgo diterpene lactone raw material and its preparations.
Subject(s)
Chromatography, High Pressure Liquid , Diterpenes/analysis , Drugs, Chinese Herbal/analysis , Ginkgo biloba/chemistry , Lactones/analysis , Proton Magnetic Resonance Spectroscopy , Quality ControlABSTRACT
In this work, we obtained the quality information of Panax notoginseng with near infrared spectroscopy in an efficient way. By combining the quality information of raw materials with process parameters in experimental design, quantitative relationship models were established between material quality information, process parameters and product quality of P. notoginseng, thus realizing the feedforward control of the alcohol extraction process. The quantitative models established have high robustness and satisfactory forecasting ability. With new batches of P. notoginseng introduced for the alcohol extraction process, the quality information of raw materials was rapidly obtained. Based on the established models, the process parameters were optimized according to the expected critical quality attributes (CQA), thereby reducing the fluctuation of product quality caused by raw material variation.
ABSTRACT
Ginkgo diterpene lactone raw material, as a raw material for ginkgo diterpene lactone meglumine injection, is extracted and purified from ginkgo leaf. ¹H-NMR content determination method and fingerprint analysis method were respectively established for ginkgo diterpene lactone raw material. Content determination was conducted in 3 batches of samples by using ¹H-qNMR, and then the results were basically consistent with the results in HPLC method. Twenty-four proton peaks were identified as common fingerprint peaks, and the fingerprint peaks were identified by using the control product and NMR information. Furthermore, 10 batches of samples were analyzed by ¹H-NMR fingerprint. The similarities were all higher than 0.99 and the common peaks were identified with the reference standards. This method is easy, fast, with good precision, stability and repeatability and could provide basis and new ideas for quality evaluation of ginkgo diterpene lactone raw material and its preparations.