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Вестник КазНМУ №3-2017
СПИСОК ЛИТЕРАТУРЫ
1 Н. Н. Каркищенко. Основы биомоделирования. - М.: Межакадемическое изд-во., 2005. - 607 с.
2 Н.Н. Каркищенко, С. В. Грачев. Руководство по лабораторным животным и альтернативным моделям в биомедицинских технологиях. - М.: Профиль 2С, 2010. - 358 с.
3 Working Party Report: FELASA recommendations for the health monitoring of mouse, rat, hamster, guinea pig and rabbit colonies in breeding and experimental units, Laboratory Animals, 2014, Vol. 48(3), p. 178-192.
4 FELASA recommendations for the health monitoring of experimental units of calves, sheep, and goats. Report of the Federation of European Laboratory Animal Association (FELASA). Working Group on animal health: Rehbinder C. et. Al. Laboratory animals, 2000, 34 № 4, P. 329-350.
Д. А. Турегелдиева, В. М. Семенюк, А. К. Мухамбетова, И. Б. Утепова, А. М. Исмакова, К. Б. Сармантаева, Л. П. Гениевская
М. Айцымбаев атындагы К,азац карантиндикжэне зооноздыц инфекциялар гылыми орталыгы
ЗЕРТХАНАЛЬЩ ЖАНУАРЛАРДЫН, ДЕНСАУЛЬИЫНЫН, МОНИТОРИНГ1
tywh: Заманауи зертханалар жогары сапалы стандартталган табигаты изогендш SPF - санатты (Specific Pathogen Free) жануарларды пайдаланады. Мундай биологияльщ модельдер микроизоляторлык; технологиясы жагдайында кедерплш жуйейнде усталады жэне генетикалык; мэртебес мен микробиологиялык; мерз1мдшт растауды талап етед! Зертханалык; жануарлардыц денсаулыгыныц сапасын бакылау мыналарды камтиды: жукпалы агенттердщ мониторинг!, тасмалдаушылык;та олар алынып тасталынатыны жэне жануарлардыц жогары санаты сапасына кеп агенттердщ т1збепне жол бершмейтшдШп. TYffiH^ свздер: SPF - санатты зертханалык; жануарлар, денсаулык; мониторинг!, таза уй-жайлар, C57BL/6N желкшдеп жэне CD-1 желкшдеп тышк;андар, Wistar желкшдеп егеук;уйры;тар, NewZeelandWhite желшндеп кояндар.
D. A. Turegeldiyeva, V. M. Semenyuk, A. K. Muchambetova, I. B. Utepova, A. M. Ismakova, K. B. Sarmantayeva, L. P. Geniyevskaya
Kazakh Science Center for Quarantine and Zoonotic Diseases
MONITORING OF HEALTH OF LABORATORY ANIMALS
Resume: Modern laboratories use high-quality standardized isogenic animals of the SPF-category (Specific Pathogen Free). Such biological models are contained in the barrier system under micro-isolation technology and require periodic confirmation of microbiological and genetic status. Control of the health quality of laboratory animals includes the monitoring of infectious agents, the carriage of which is excluded, and the higher the category of animal quality, the greater the list of unacceptable agents.
Keywords: SPF laboratory animals, health monitoring, clean rooms, mice line CD-1 and line C57BL/6N, rats line Wistar, rabbits line New Zeeland White.
ФАРМАЦИЯ И ФАРМАКОЛОГИЯ PHARMACY AND PHARMACOLOGY
УДК: 615, 453,6 - 011 - 012:615.014.21
Z.F. Ibragimov, L.N. Ibragimova, A.Zh. Zhurat, A.K. Aldamzhar, E.Sh. Zhumabiev, M.I. Pak
The Department of technology of drugs with the courses of technological and engineering disciplines, Asfendiyarov Kazakh National Medical University, Almaty, the Republic of Kazakhstan
DEVELOPMENT OF THE COMPOSITION OF "ARPOWER" TABLETS
The article presents the results ofjustifyingrational composition, optimal manufacturing technology, creation of a system of specifications, standardization criteria for tablets under the conventional name "ARPOWER". As an active pharmaceutical ingredient the following substancehas been used: arachidonic acid. As an auxiliary substance magnesium stearate has been justifiedon the basis of its functional characteristics. The optimal way of obtaining tablets has been proved - direct pressing. The pharmaco-technological properties of the active substance have been studied. The criteria of acceptability of technological parameters and quality indicators of raw materials, intermediate products and the finished product have been determined. Based on the data obtained, a laboratory regulation and a draft analytical normative document have been developed.
Keywords: tablets, arachidonic acid, acceptance criteria, technological parameters, quality specification
On the pharmaceutical market of biologically active additives (BAA) of the Republic of Kazakhstan in great demand are products both for professional athletes and amateurs, that help to recover faster after physical exertion, gain muscle mass, increase strength indicators. The analysis of the market has shown that there is no share of domestic sports products, while the price of such pharmaceutical products is high enough and the course of their application has no definite terms, many of them are drunk constantly. There are drugs that are prohibited for use by the Anti-Doping Association and the use of such drugs is undesirable [1].However, the list of banned substances does not include arachidonic acid, which is actively used to restore the body under power loads, as well as to increase muscle mass [2, 3]. Preparations with acid arachidonic, as well as the substance itself are imported from the countries of near and far abroad, mainly from the Russian Federation and the USA. The price of such drugs on our market is more than 6000 tg [4]. The aim of the work is to develop the optimal composition and rational technology of a pharmaceutical product for increasing the strength of athletes and their endurance, accelerating recovery after exercise, and increasing muscle mass. Materials and methods of research. An active substance (Xi'anSonwuBiorech Co., Ltd., China) and excipients (DFE Pharma, India) of pharmacopoeial quality were used in the experiment [9-11].
Manufacture of laboratory samples of tablets was carried out using the following equipment: VT screen analyzer (Erweka, Germany), LK5 mixer (Erweka, Germany), U universal drying
cabinet (Memmer, Germany), single-punch tablet press CPR-6 (DOTT .BONAPACE, Italy).
Reagents and solvents of the category "chc", "chca" and standard samples of pharmacopoeial quality were used for the analysis, as well as the following instruments and equipment: analytical scales SPU 402, tester for disintegration of tablets ZT 222 (ERWEKA, Germany), tablet strength tester (ERWEKA, Germany), tablets abrasiontester (ERWEKA, Germany), tablets solubility tester DT 820 (ERWEKA, Germany), bulk density tester SVM (Erweka, Germany), fluid flow /flowabilitytester VP12A, HPLC of Waters 1525model.
Results and discussion of the results. Among medicinal preparations (MP) and biologically active additives the tableted formis the most common. On the territory of the Republic of Kazakhstan medicines (drugs) registered in the form of tablets are about 43% [5]. In accordance with the requirements of the State Pharmacopoeia of the Republic of Kazakhstan tablets are a solid dosage form (MF) obtained mainly by pressing powders or granules. Uniformity of dosing of active substances, ease of use, portability, the ability to preserve quality for a long time without the use of preservatives, with the correction of taste and odor of active substances were the rationale for choosing tablets as an optimal dosage form.
Arachidonic acid is an organic compound, an omega-6-unsaturated fatty acid, its systematic name is cis-5,8,11,14-eicosatetraenoic acid, the chemical formula is C20H32O2, the structural formula is shown in Figure 1.
,COOH
'CH3
Figure 1 - Struc
Arachidonic acid is widely used in medicine (participation in the synthesis of prostaglandins, prevention of excessive production of hydrochloric acid in the gastrointestinal tract; increased production of mucus, which protects against the occurrence of gastric ulcers and gastric bleeding; stimulation of growth and recovery of muscle fibers, increasing the local content of testosterone in the body, improvement of blood coagulability, increasing susceptibility to insulin, protection of the brain and nerve cells from aging, prevention of senile dementia, and also Alzheimer's disease, improving the functioning of the brain, especially with long-term power loads); in pediatrics (growth and development of cells of the nervous and brain tissues, cognitive development: visual acuity, prevention of neurologic disorders in premature infants, immunological protection of
formula of arachidonic acid
newborns); in sports (increasing stamina, accelerating recovery after exercise, increasing muscle mass), but in all cases it is positioned as a biologically active additive. It is common knowledge that in normal conditions the body needs 5 grams of arachidonic acid per day, naturally its demand increases with active physical exertion. In general, the entry of arachidonic acid into the human body occurs through food: fish, meat, dairy products, legumes, etc. The market research of dietary supplements has shown that the content ofarachidonic acid in a single dose varies within fairly wide limits from 0.5 g to 2 g [4]. For the correct choice of excipients and optimization of the technology for manufacturing any medicinal product it is necessary to take into account the physical, chemical and technological properties of the active substance. In this regard,
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BecTHMK Ka3HMy №3-2017
for the substance "arachidonic acid" the physicochemical and technological parameters have been determined: such as color, taste, odor, particle shape, bulk density and electrical properties, compressibility,- in accordance with the requirements of the GF RK [6-7]. Also such parameters as solubility, wettability, hygroscopicityhave been considered. Particular importance was given to technological parameters, namely, fractional composition, bulk density, porosity, flowability.The content of the active ingredient in the substance is 50%. The substance is nonhygroscopic powder of from white to light yellow color, without taste and smell, itsparticles are not inclined to significant polarization, have good wettability, the dispersion of the powder is uniform, the dominant fraction of the particles is within 0.5 -0.25 mm, the weight is 542 ± 20 kg / m3, the flowability is 3.47 ± 0.5 g / s, the compressibility is 7.5 kg, the disintegration does not exceed 15 min, the abrasion resistance is 98 ± 2%. To remove the electrostatic stress between the particles an antifriction agent of magnesium stearate was used.
In accordance with the properties of the active substance the direct compression method has been chosen as the optimal one;it significantly reduces the time of the technological cycle due to the minimum number of operations and stages, minimizes the amount of the equipment used, reduces the operating areas involved, which consequently leads to a reduction in energy and labor costs, in the cost of finished products. The technological process for the production of tablets consists of the following stages: the preparation of raw materials, mixing, tabletting, dedusting, packaging; it is shown in Figure 2. The quality of the finished product was determined according to the following quality indicators in accordance with the requirements of the State Pharmacopoeia of the Republic of Kazakhstan and the regulatory documentation of regulatory bodies [6-9]: description, identification, mass and homogeneity of the mass, related impurities, strength, abrasion, disintegration, dissolution, microbiological purity.
Packingofcapsules
Figure 2 - Technological scheme of manufacturing tablets "ARPOWER"
Thus, the rational composition of "ARPOWER" tablets, the optimal manufacturing technology, the specification of the quality of the finished product, and the criteria for its standardization have been determined. As an active pharmaceutical ingredient the substance "arachidonic acid" has been chosen; based on the experimentally determined
pharmaco-technological properties of the active substance the use of magnesium stearate as an auxiliary substance has been justified, the direct compression method as the optimal one has been chosen. Based on the data obtained, a laboratory regulation and a draft analytical normative document have been developed.
REFERENCE
1 TheWorld Anti-Doping Code. International Standard. The banned list of year 2017.— P. 39 — 48.
2 Biochemistry:A Textbook for High Schools / Ed. E.S. Severin. - GEOTAR-Media, 2003. -P. 371, 372, 417, 418. -ISBN 5-9231-0254-4.
3 Fundamentalsof biochemistry: in 3 volumes, V.2 / A. White, F. Hendler, E. Smith, R. Hill, I. Lehman. -Mir, 1981. - P.766.
4 Center for Medical and Pharmaceutical Information. Electronic resource. http://mpi.kz/index.php/reestr-food
5 State Register of medicines, medical devices and MT of the Republic of Kazakhstan. Electronic resource. http://www.dari.kz / category/Gosudarstvennyi_reesttr
6 State Pharmacopoeia of the Republic of Kazakhstan. V.1. - Almaty: Zhibek Zholy, Publishing House, 2008. — P. 198 — 215.
7 State Pharmacopoeia of the Republic of Kazakhstan. V.2. - Almaty: Zhibek Zholy, Publishing House, 2009.— P. 486 — 510.
8 State Pharmacopoeia of the Republic of Kazakhstan. V.3. - Almaty: Zhibek Zholy, 2014.— P. 141 — 155.
9 Order754 of 19.11.2009 "On approval of the Rules for drawing up, approval and examination of the regulatory and technical document on the control of the quality and safety of medicinal products" of the MH RK.
З.Ф. Ибрагимов, Л.Н. Ибрагимова, А.Ж. Журат, А.К. Алдамжар, Е.Ш. Жумабиев, М.И. Пак
Дэрлер технологиясы кафедрасы мен технологиялыц пэндер курсы жэне инженерл!к пэндер курсы, С.Ж. Асфендияров атындагы К,азац ¥лттыц Медициналыц УниверситетI, Алматы ц.,К,азак,стан Республикасы
«ARPOWER» ТАБЛЕТКАЛАРЫНЬЩ К¥РАМЫН ЖАСАУ
ТYЙiн: Ма;алада «ARPOWER» таблеткаларын стандарттау критерийлерь утымды курылымын зерттеу нэтижелер1, спецификация жуйесш ;уру,оцтайлы внд1р1стш технологиясы усынылган.Белсенд1 фармацевтикалы; ингредиент ретшде келей субстанциялар ;олданылды: арахидон кышкылы.Функционалды касиеттерше непзделе отырып комекш1 зат ретшде магний стеараты крлданылды.Тшелей пресстеу -таблетканы алудыц оцтайлы эдга болып непзделдъ Белсенд заттыц фармако-технологиялы; ;асиеттер1 зерттелдъ Шигазаттыц, аралы; ошмнщ, дайын ошмнщ сапа корсетгаштер1 жэне технологиялы; параметрлердщ колайлылы; критерийлер1 аньщталды.Алынган мэл1меттерге суйене отырып зертханалы; регламент жэне аналитикалы; нормативт ;ужаттыц жобасы жасалды.
ТYЙiндi сездер: таблеткалар, арахидон к;ышк;ылы,колайлылык критерийлер1, технологиялы; параметрлер,сапа спецификациясы
З.Ф. Ибрагимов, Л.Н. Ибрагимова, А.Ж. Журат, А.К. Алдамжар, Е.Ш. Жумабиев, М.И. Пак
Кафедра технологии лекарств с курсом технологических дисциплин и курсом инженерных дисциплин, Казахского Национального Медицинского Университета имени С.Д. Асфендиярова, г. Алматы, Республика Казахстан
РАЗРАБОТКА СОСТАВА ТАБЛЕТОК «ARPOWER»
Резюме: В статье представлены результаты обоснования рационального состава, оптимальной технологии производства, создания системы спецификаций, критериев стандартизации таблеток под условным названием «ARPOWER». В качестве активных фармацевтических ингредиентов использованы субстанции: кислота арахидоновая. В качестве вспомогательных веществ на основании функцинальных характеристик обоснован магния стеарат. Обоснован оптимальный способ получения таблеток-прямое прессование. Исследованы фармако-технологические свойства активной субстанции. Определены критерии приемлемости технологических параметров и показателей качества сырья, полупродуктов и готового продукта. На основании полученных данных разработаны лабораторный регламент и проект аналитического нормативного документа.
Ключевые слова: таблетки, кислота арахидоновая, критерии приемлемости, технологические параметры, спецификация качества
УДК: 615.4:615.772-65.9(5к)21
Г.М. Кадырбаева, М.Е. Амантаева, А. Турлыбекова
С.Ж. Асфендияров атындагы Казак ¥лттыц медицина университетi
ТУЙМЕДАК СЬИЫНДЫСЫ KOCbWFAH ДЭР1Л1К К¥РАЛДАРДЫН, КР ФАРМАЦЕВТИКАЛЫК HAPbIFbIHAAFbl МАРКЕТИНГТ1К
ТАЛДАУЫ
Мацалада курамында туймедац сыгындысы бар дэршк цуралдардыц Казахстан Республикасы фармацевтикалыц нарыrындаrымаркетингтiк талдауыныц нэтижелерi керсетыген.Туймедац сыгындысы негiзiнде жасалынган дэршк куралдардыц цабынуга царсы жэне антисептик ретшде кещнен цолданылады.
TYÜiHÖi сездер: маркетингтiк талдау, туймедац сыгындысы, дэршк заттардыц реестрiхамазулен.
Халы; арасында ауыз нуысыныц шырышты ;абатыныц, пародонт тшшщ ;абыну аурулары ;аз!рп уа;ытта ^рнындап есуде. БДДС¥ мэл1мет1 бойынша пародонт тшшщ ай;ын деструктивт1 езгерга кобше 35-44 жас аралыгындагы адамдарда - 65%-98%, ал 13 пен 19 жас аралыгындагыларда 55%-95% жшлште кездесед1. Т1с жулудыц 80%-ына -пародонт ауруы себеп болады.
Осыган байланысты фармацевтика ;ауымдастыгы ;абынуга ;арсы тек синтетикалы; емес, оймдш тектес дэртк заттардыда ;олданады.Дэр1л1к препараттардыц 40%-нан астамы оймдштерден алынады. К^аз1рп ;ез;арас бойынша ес1мд1ктект1 дэр1 - бул белсенд1 эсер етет1н заттары бар, екшшШк метаболиттер1, протеиндер1, эфир майлары, хлорофилл, бейорганикалы; туздары, дэрумендер1 бар биогенетикалы; кешен.
Фитопрепараттардыц жумса; эсер1, фармакологиялы; ;асиетшщ кецд1г1, жанама эсер1н1ц минимумдыгы кушт1 эсерл1 синтетикалы; препараттардан кем ;алган емес.
Дэр1ханальщ туймеда; - пародонтоз ауруында ;олданылатын дэр1л1к заттыц б!р! болып табылады. Туймеда;тыц эсер етуш1 заты - хамазулен эфир майы болып табылады.
Ауыз нуысын емдеуде фармацевтикалы; онд1рк эфир майлары бар эртурл1 ндлыптар шыгаруда. Бурыш жалбыз майы бар тк тамшылары, пульпит, периодонтиттерд1 емдеуде ;олданылатын пасталар ;урамында гвоздика, лаванда, эвкалипт, жалбыз майлары бар. Олар ауруды басатын, бактериостатикалы; жэне дезодорирлейтш ;асиетке ие.
Туймеда; сыгындысы нег1з1ндег1 дэрШк заттар ;абынуга ;арсы жэне антисептик ретшде кецшен ;олданылады. Дэр1л1к туймеда;тыц гулдер1н1ц ;урамында 0,2-0,8% дей1н кек туст1 эфир майы бар, эфир майыныц ец бастыкомпоненттер1 матрицин мен матрикарин, осы ;осылыстардан 7% жуы; хамазулен туз1лед1.
