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The article is devoted to the researches of vocational characteristics of the personnel involved in validation and qualification works at the industrial pharmaceutical enterprises. The authors carry out the analysis of the situation concerning validation works at the Ukrainian pharmaceutical enterprises. The kinds of works which are rational for delegating to validation division on typical pharmaceutical manufacture are defined. The offers on formation of duty regulations of employees of such division (validation department) on an example of the engineer on qualification of the equipment are formulated in the article.
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1. EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use. EudraLex.
The Rules Governing Medicinal Products in the European Union [C " ] / European Commission.–Brussels, 2007. – Vol. 4. : http://www.ec.europa.eu/enterprise/pharmaceuticals.
2. Good Manufacturing Practice for Pharmaceutical Products: Main Principles. – World Heals Organization technical Report Series. – 2003. – 908. – 120 p.
3. Guidance for Industry. Process Validation: General Principles and Practices U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). – 2008. – 20 p.
4. Guidance for Industry. Process Validation: General Principles and Practices. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). – 2008. – 20 p.
5. PIC/S Recommendations PI 006-3 "Validation master plan installation and operational qualification non-sterile process validation; Cleaning validation".–2007.–26 p.
6. Wrigley G. Facility validation: theory, practice and tools / Graham Wrigley. – Boca Raton, Florida: CRC Press LLC, 2004. – 142 p. – ISBN 0-8493-2340-1.
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SUMMARY
Sesame oil can be used as a replacement for olive and almond oils at preparation of ointments, liniments, band- AIDS, oil-in-water emulsions and injection solutions of lipid-soluble drugs. There are, at present, the research of sesame oil in foreign countries. Given that Uzbekistan is rich in vegetal raw materials-including sesame seeds, our goal was to explore the oil of sesame seeds for standardization and subsequent use in medical practice. The object of study was the sesame oil, extracted from the seeds of Sesame (Sesamum indicum l.) growing in Uzbekistan (Samarkand province).
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1. - . 3 " .- .:# , 1997.-52 .
2. A #, & &.+, # C.#. C " " . &. -1990.-5
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4. (! $.&., , &.#., ) (.). . #
" // .: 2&, 2008.-C.146-189.
5. $ 7 .7, 7.I., 7 * // 7 "
.-1999, 4.-#.10-13.
6. J.M.Nzikou, L.Matos, G.Bouanga-Kalou, C.B. Ndangui Chemical Composition on the Seeds and Oil of Sesame (Sesamum indicum L.) Grown in Congo-Brazzaville // Advance Journal of Food Science and Technology.-2009, 1.-P.6-11.
7. Bahki A.H., M.A. Hussain and A.Y. Basahy. Protein and oil composition of sesame seeds (Sesmum indicum, L.) grown in the Gizan area of Saudi Arabia// Int. J. Food Sci. Nutr.-1998, 49.-P. 409-414.
8. 2 # & & . : + . . . -2- . – ( . , 1980. – . 5. – #. 129-
130.
9. Unal, K.M., H.Yalcin. Proximate composition of Turkish sesame seeds and characterization of their oils . Grasas Y Aceites ,59: 23-26.
10. Yoshida, H. Composition and quality characteristics of sesame seed (Sesamum indicum) oil roasted at different temperatures in an electric oven// JSi. Food A gricul-1994. 65.-#.331 -336
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SUMMARY
The results of the researches, which show clinic effectiveness of lipril and it's influence to intracardial hemodinamics during the treatment of 43 people, who were sick of ischemic illness of heart, complicated chronic cardio insufficiency of II- IV were measured, are presented in this article.On the background of therapy with lipril in dose from 2.5 to 20 mg\day positive clinic effect was stated : measurable reduce in manifestation of CHF and authentic increase of
EFof left ventricle after 8 weeks therapy as against ill people of control team.Good transferability of lipril is stated.
Treatment with lipril doesn't show considerable influence on indices of blood count and urine analysis biochemical analysis of blood.
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3175 7
1. 7 A. 1., 7. $., -. 7.// 6 : ",
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2. 7 A. 1.// 6 . – ., 2002. – 136 .
3. # 0 ). +., 7. $.// 1 . 7 " . – .: A ; ,
2002. – 504 .
4. ATLAS of heart failure trials. A brief review of ACE inhibitor studies in heart failure // ZENECA Pharmaceuticals. Alderley House. – 1998. – P. 12.
5. Eichstaedt H. W., Metens D. Ch., Danne O. et al. Effects of lisinopril on LVH-regression in patients treated for essential hypertension// Perfusion. – 1994. – Vol. 7. – P. 426–428.
6. Lancaster S. G., Todd P. A. Lisinopril. A preliminary review of its pharmacodynamic and pharmacokinetic properties, and therapeutical use in hypertension and congestive heart failure// Drugs. – 1988. – Vol. 35. – P.
646–669.
7. Manufacturers’ recommendations. Guidelines for the treatment of heart failure// Eur. Heart J. – 1997. – Vol.
18. – P. 736–753.
8. Nielsen F. S., Rossing P., Gall M. A. et al. Lisinopril improves endothelial dysfunction in hypertensive NIDDM subjects with diabetic nephropathy// Scand. J. Clin. Lab. Invest. – 1997. – Vol. 57. – P. 427–434.
9. Opie L. //Angiotensin converting enzyme inhibitors: The advance continues. – New York: Authors Publishing House, 1999. – 275 p.
10. Packer M., Poole-Wilson P., Armstrong P. et al. Comparative effects of low-dose versus high-dose lisinopril on survatal and major events in chronic heart failure: the Assessment of Treatment with Lizinopril and Survival study (ATLAS)// Eur. Heart J. – 1998. – Vol. 19. – P. 142.
11. Remuzzi G., Ruggenenti P., Benigni A. Understanding the nature of renal disease progression// Kidney Int. – 1997. – Vol. 51. – P. 2–15.
12. Task Force for the diagnosis and treatment of chronic heart failure, European Society of Cardiology.
Guidelines for the diagnosis and treatment of chronic heart failure// Eur. Heart J. – 2001. – Vol. 21. – P. 1527–
1560.
13. Terpestra W. F., May I. F., Smit A. I. et al. Long-term evaluation of long-term effects of amlodipine and lisinopril on left ventricular mass and diastolic function in elderly, previously untreated hypertensive patients (the ELDERA trial)// Eur. Heart J. – 1999. – Vol. 19. – P. 596.
14. Thind G. S. Angiotensin converting enzyme inhibitors: comparative structure, pharmakokinetics and pharmakodynamics// Cardiovasc. Drugs Therapy. – 1990. – Vol. 4. – P. 199–206.
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SUMMARY
During the treatment of patients with GOLD it's nesessary to use drugs, which can improve or facilitate the separation of a patalogically changed bronchial secretion, prevent mukostase and improve mucociliary clearance. One of the main factors of reversible bronchial obstruction is opted out with the facility of a separation of secretion.
Moreover, possibility of microbal colonization of breathing ways is redused. It is achieved in a high degree, due to using of mucolytic(mucoregulatoric) drugs.
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The clinical results of the drug aerius used in the combined treatment of 50 patients with allergic dermatoses are assessed. Twenty patients with eczema and 30 patients with atopic dermatitis were followed up. The authors experience has indicated the efficacy and good tolerance of this drug, which permits its use in dermatological practice in the out inpatient settings.
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Recent data on the of fluroguinolones for the treatment of urogenital clamydiasis are reviewed with special reference to the indications for loxof therapy.High therapeutic of loxof is illustrated by successful treatment of 26 patients with urogenital clamydiasis.
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45 children with hypoxic and ischemic defeat of the central nervous system are surveyed. High effeiciency of application of Instenon treatment of this children pathology is revealed.
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1. Edwards A.D., Brock lehurst P, Gunn A.J., Holliday. Neurological outcomes at 18 months of age after moderate hupothermia for perinatal hypoxic ischaemic encephalopathy: synthesis and meta – analysis of trial data. BMJ 2010; 340:
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The purpose of this work is to study of Encefaboli in childrens with nevrologikal simtoms terapy by )ncefaboli reduced teirm in other medicaments.
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An update on intestinal microenvironmental disorder is s assocated with the use of antibiotics. Based on their own findings the authors have drawn a valid conclusion that it is useful to use Lineks in the therapy of infants with antibiotics –associated dia rrhea
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20 children from 6 months to 3 years old with pnevmonia were discovered. The drug Tireodin shows high effect in treatment of children with pneumonia.
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Efficacy and safity of Bronhipret in treatment of acute respiratory infection (ARI) acute obstructive and acute obstructive bronchitis were studied in 40 children aged 6-11 years.ARJ monoterapy by Bronchipret reduced teirm in other medicaments. The study proved Bronchipret safety in outpatient treatment of pediatric ARJ.
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Last years calcipotriol was widely used in dermatologic practice for curing psoriasis. The article shows there is an the experience of using Akerat in case of psoriasis.
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Introduction of international standards GMP will positively affect quality of made medicines.
Keywords: the Warehouse zone, organizational structure, conditions and technics of storage, introduction of standards, quality of a medicine.
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Creating a system of material management in health care organizations is the foundation of a stable and harmonious treatment process to ensure drugs. This article reflects the main areas of difficulty of the system of drug provision of medical organizations.
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The article reflects the modern aspects of external treatment of atopic dermatitis, and describes the technology of treatment of dermatosis with aelica cream.
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48 males with fresh anterior gonorrtal uretritis were followed up; 48 patients received Zetamax retard. Zetamax retard may be used as reserve antibacterial agent in uncomplicated gonorrea.
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