LACTOFERIN IN THE PROBLEM OF ANTI-INFECTIOUS PROTECTION OF BABIES IN THEIR FIRST YEAR OF LIVING

The author  summarizes  the  results  of research  of the  antibacterial,  antiviral  and  antifungal  properties  of multifunctional  human protein  — lactoferrin,  in order  to determine  the prospects  for its use in the prevention  and  treatment  of infectious  diseases  of children in their first year of life. The mechanisms of anti-infectious effect of this protein with breastfed children have been described. Basic differences between human lactoferrin and cattle lactoferrin have been shown. Biotechnology of obtaining recombinant human lactoferrin from the milk of genetically engineered dairy animals (goat-producers) has been described. According to the studies, both by physical and chemical parameters and biological activity, human lactoferrin, obtained from milk-producing  goats, corresponds to its natural counterpart

ВОЗМОЖНОСТИ ПРИМЕНЕНИЯ ЛАКТОФЕРРИНА У ДЕТЕЙ ПЕРВОГО ГОДА ЖИЗНИ

The author  summarizes  the  results  of research  of the  antibacterial,  antiviral  and  antifungal  properties  of multifunctional  human protein  — lactoferrin,  in order  to determine  the prospects  for its use in the prevention  and  treatment  of infectious  diseases  of children in their first year of life. The mechanisms of anti-infectious effect of this protein with breastfed children have been described. Basic differences between human lactoferrin and cattle lactoferrin have been shown. Biotechnology of obtaining recombinant human lactoferrin from the milk of genetically engineered dairy animals (goat-producers) has been described. According to the studies, both by physical and chemical parameters and biological activity, human lactoferrin, obtained from milk-producing  goats, corresponds to its natural counterpart.В статье обобщены результаты исследований, посвященных изучению антибактериальных, противовирусных и противогрибковых свойств многофункционального белка человека — лактоферрина, для определения перспектив его применения с целью профилактики и лечения инфекционной патологии у детей первого года жизни. Описаны механизмы противоинфекционного действия этого белка у детей, находящихся на грудном вскармливании. Показаны основные различия между лактоферрином человека и лактоферрином крупного рогатого скота. Описана биотехнология получения рекомбинантного лактоферрина человека из молока генно-инженерных молочных животных (коз-продуцентов). Согласно проведенным исследованиям, как по физико-химическим параметрам, так и по биологической активности лактоферрин  человека, выделенный из молока коз-продуцентов, соответствует его природному аналогу

The role of pharmacopoeia in the context of globalization of world economies and its development prospects

The article reviews the process of development and the role of national and regional pharmacopoeias in the context of globalization of world economies. Three major paths of globalization identified are: enlargement of national pharmacopoeias’ area of influence, formation of supranational (regional and supraregional) pharmacopoeias and harmonization of pharmacopoeias. The article draws a conclusion on interrelation of national and regional pharmacopoeias that aim to contribute to each other’s development. Harmonization of pharmacopoeias should follow the path of alignment of test methods and analytical procedures and at the same time accommodate national factors and priorities of countries that are involved in harmonization

Роль фармакопеи в условиях глобализации экономики стран и пути ее развития

The article reviews the process of development and the role of national and regional pharmacopoeias in the context of globalization of world economies. Three major paths of globalization identified are: enlargement of national pharmacopoeias’ area of influence, formation of supranational (regional and supraregional) pharmacopoeias and harmonization of pharmacopoeias. The article draws a conclusion on interrelation of national and regional pharmacopoeias that aim to contribute to each other’s development. Harmonization of pharmacopoeias should follow the path of alignment of test methods and analytical procedures and at the same time accommodate national factors and priorities of countries that are involved in harmonization.В статье рассмотрены процессы развития и роль национальных и региональных фармакопей в условиях глобализации мировой экономики. Выделены три основных направления развития процессов глобализации: расширение территории влияния национальных фармакопей, создание наднациональных (региональных и надрегиональных) фармакопей и гармонизация фармакопей. Сделан вывод о взаимосвязи национальных и региональных фармакопей, которые должны способствовать развитию друг друга. Гармонизация фармакопей должна идти по пути унификации методов и методик анализа, но в то же время учитывать национальные факторы и приоритеты стран-участниц гармонизации

Major challenges in evaluating the quality of pharmaceutical substances (the assay)

Common topical issues of the quality assessment of pharmaceutical substances in terms of «Assay», are related to the compliance of actual test results to assay requirements as well as to the proper elaboration of normative documents (completeness, accuracy of the descriptions of analytical methods) and the appropriate test conditions validation with the materials in the scope of the mentioned regulatory documents. It was shown that an objective assessment of the quantitative content of an active ingredient in pharmaceutical substance of synthetic or mineral origin depends largely on the choice of the analytical method, use of the appropriate techniques considering the materials included in the monographs of the State Pharmacopoeia the Russian Federation and leading foreign pharmacopoeias

Development and Validation of Pomalidomide Determination in Human Plasma by HPLC-MS/MS Method

Introduction. B-cell malignancies of the plasma cell leads to the second most spread hematological malignancy disease, called multiple myeloma. Pomalidomide is used in case of previous multiple myeloma ineffective treatment. Pomalidomide is a thalidomide synthetic derived, approved as immunomodulatory drug by the Food and Drug Administration (FDA). Nowadays, detection of pomalidomide in blood plasma by high performance liquid chromatography tandem mass spectrometry (HPLC-MS/MS) is not spread. Moreover, the detection and the experimental setting accumulated data are varying greatly. This investigation provides development and validation of pomalidomide aiming to determine human blood plasma by HPLC-MS/MS method. The samples were processed by methanol protein precipitation.Aim. The aim of this study is to develop a method for the pomalidomide in human plasma by HPLC-MS/MS for pharmacokinetic studies.Materials and methods. Determination of pomalidomide in plasma by HPLC-MS/MS. The samples were processed by methanol protein precipitation.Results and discussion. This method was validated by next parameters: selectivity, matrix effect, calibration curve, accuracy, precision, spike recovery, lower limit of quantification, detection limit, carry-over and stability.Conclusion. The method of the determination of pomalidomide in human plasma was developed and validated by HPLC-MS/MS. The linearity in plasma sample was achieved in the concentration range of 1,00 – 500,00 ng/ml. Method could be applied to pomalidomide determination in plasma for PK and BE studies

Основные проблемы экспертизы качества фармацевтических субстанций (оценка количественного содержания)

Common topical issues of the quality assessment of pharmaceutical substances in terms of «Assay», are related to the compliance of actual test results to assay requirements as well as to the proper elaboration of normative documents (completeness, accuracy of the descriptions of analytical methods) and the appropriate test conditions validation with the materials in the scope of the mentioned regulatory documents. It was shown that an objective assessment of the quantitative content of an active ingredient in pharmaceutical substance of synthetic or mineral origin depends largely on the choice of the analytical method, use of the appropriate techniques considering the materials included in the monographs of the State Pharmacopoeia the Russian Federation and leading foreign pharmacopoeias.Общие проблемные вопросы, возникающие при экспертизе качества фармацевтических субстанций по показателю «Количественное определение», связаны с соответствием фактически полученных величин предусмотренным нормам количественного содержания, а также уровнем подготовки представленных нормативных документов (полнота, правильность изложения методик анализа) и соответствием условий проведения испытаний с валидационными материалами по данному разделу нормативной документации. Показано, что объективность оценки количественного содержания действующего вещества в фармацевтической субстанции синтетического или минерального происхождения во многом определяется выбором метода анализа, приведением соответствующих методик с учетом материалов, включенных в фармакопейные статьи Государственной фармакопеи Российской Федерации и монографии ведущих зарубежных фармакопей

A mice model of amyotrophic lateral sclerosis expressing mutant human FUS protein

BACKGROUND AND ОBJECTIVE: Loss of conformation and function of sufficient number of proteins with high aggregation capacity plays an important role in the pathogenesis of many neurodegenerative disorders (NDD). Due to a recent discovery of new array of proteins with the capacity to form aggregates of nonamyloid type, new NDD models as well as a new level of understanding in vivo models which are already exist is needed. DNA/RN A binding proteins - FUS and TDP-43 play a crucial role in the pathogenesis of some forms of amyotrophic lateral sclerosis (ALS) and frontotemporal dementia. The objective of the study was to develop a new ALS transgenic model. MATERIAL AND METHODS: In cell culture experiments, we studied mutant FUS proteins capable to form intracellular deposits morphologically similar to those observed in the autopsy material of ALS patients. RESULTS AND CONCLUSION: We created a transgenic mice line, in which a pathogenic form of human FUS protein was expressed in the nervous system. That led to the aggregation of FUS protein in spinal cord and motor neurons with the following degeneration and development of a phenotype, similar to the human ALS disease phenotype, in young grown-up animals. This neurodegenerative phenotype corresponds to a great number of clinical manifestations of human ALS and is an adequate transgenic model of the disease

A mice model of amyotrophic lateral sclerosis expressing mutant human FUS protein

BACKGROUND AND ОBJECTIVE: Loss of conformation and function of sufficient number of proteins with high aggregation capacity plays an important role in the pathogenesis of many neurodegenerative disorders (NDD). Due to a recent discovery of new array of proteins with the capacity to form aggregates of nonamyloid type, new NDD models as well as a new level of understanding in vivo models which are already exist is needed. DNA/RN A binding proteins - FUS and TDP-43 play a crucial role in the pathogenesis of some forms of amyotrophic lateral sclerosis (ALS) and frontotemporal dementia. The objective of the study was to develop a new ALS transgenic model. MATERIAL AND METHODS: In cell culture experiments, we studied mutant FUS proteins capable to form intracellular deposits morphologically similar to those observed in the autopsy material of ALS patients. RESULTS AND CONCLUSION: We created a transgenic mice line, in which a pathogenic form of human FUS protein was expressed in the nervous system. That led to the aggregation of FUS protein in spinal cord and motor neurons with the following degeneration and development of a phenotype, similar to the human ALS disease phenotype, in young grown-up animals. This neurodegenerative phenotype corresponds to a great number of clinical manifestations of human ALS and is an adequate transgenic model of the disease