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Továbbképző közlemények
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[item title=”Hornok Katalin: A GLP szabályozás általános ismertetése, jogszabályok és guideline-ok – II. rész – GYOGAI. 61. 131-137 2017.”]
Irodalom
Az 1-19. sz irodalom az I. rész végén olvasható.
20. 42/2014. (VIII. 19.) EMMI rendelet a helyes laboratóriumi gyakorlat alkalmazásáról és ellenőrzéséről
21. ENV/JM/MONO(99)24 OECD series on principles of good laboratory practice and compliance monitoring N°8, Consensus Document. The role and responsibilities of the study director in GLP studies.
22. ENV/JM/MONO(2002)9 OECD series on principles of good laboratory practice and compliance monitoring N°8, Consensus Document. The Application of the OECD Principles of GLP to the Organisation and Management of Multi-Site Studies.
23. ENV/JM/MONO(99)20 OECD series on principles of good laboratory practice and compliance monitoring N°4, GLP Consensus document. Quality Assurance and GLP.
24. The United Kingdom Good Laboratory Practice Monitoring Authority, Medicines and Healthcare products Regulatory Agency (MHRA): Good Laboratory Practice Regulations 1999, Statutory Instrument 1999 No.3106 as amended by the Good Laboratory Practice (Codification Amendments Etc.) Regulations, 2004, Statutory Instrument 2004, No. 994.
25. ENV/MC/CHEM(98)16 OECD series on principles of good laboratory practice and compliance monitoring N°11, Advisory document, The role and responsibilities of the sponsor in the application of the principles of GLP.
26. ENV/JM/MONO(2016)13 OECD series on principles of good laboratory practice and compliance monitoring N°17, Advisory document, Application of GLP Principles to Computerised Systems.
27. Regulation 1907/2006/EC of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency
28. Regulation 1272/2008/EC of 16 December 2008 on classification, labelling and packaging of substances and mixtures
29. Regulation 440/2008/EC of 30 May 2008 laying down test methods to regulation (EC) No 1907/2006 of the European Parliament and of the Council on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
30. Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes.
31. 40/2013. (II.14.) Korm. rendelet az állatkísérletről.
32. ENV/JM/MONO(2004)26 OECD series on principles of good laboratory practice and compliance monitoring N°14, Advisory document, The Application of the Principles of GLP to in vitro studies.
33. Morgan, F.: GLP-related FDA warning letters – The seven deadly sins, Spring 14(2), 27-33. (2010).
34. ENV/JM/MONO(99)23 OECD series on principles of good laboratory practice and compliance monitoring N°7, Consensus document, The Application of the GLP principles to short term studies.
35. ENV/JM/MONO(2007)10 OECD series on principles of good laboratory practice and compliance monitoring N°15, Advisory document, Establishment and Control of Archives that Operate in Compliance with the Principles of GLP
Hornok, K.: GLP regulations, legislations, guidelines – part II.
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[item title=”Somogyi Aranka, Knausz Márta, Gulyás Beáta: Damoklész kardja: a Clostridium difficile terjedése – GYOGAI. 61. 138-143. 2017.”]
Irodalom
1. Banai J.: IME, 11(4), 32-34 (2012).
2. Bartlett, J.G.: Ann Intern Med, 145, 758 (2006).
3. Terhes, G., Urbán, E., Konkoly-Thege, M., Székely, É., Brazier, J., Kuijper, E., Nagy, E.: Clinical Microbiology and Infection 15(9), 885-886 (2009).
4. European Centre for Disease Prevention and Control. Point prevalence survey of healthcare associated infections and antimicrobial use in European acute care hospitals Stockholm: ECDC; (2013)
5. Országos Epidemiológiai Központ Módszertani Levele A Clostridium difficile fertőzések diagnosztikájáról, terápiájáról és megelőzéséről. Epinfo 18(3) (2011).
6. Országos Epidemiológiai Központ Módszertani Levele A Clostridium difficile fertőzések diagnosztikájáról, terápiájáról és megelőzéséről 2. kiadás https://www.antsz.hu/data/cms76397/OEK_CDI_ML_2016_07_08.pdf (2016)
7. Hall, I.C., O’toole, E.: Am J Dis Child 49(2), 390-402 (1935)
8. Bartlett, J.G., Moon, N., Chang, T.W., Taylor, N.: Gastroenterology 75(5), 778 (1978).
9. Poutanen, S.M., Simor, A.E.: CMAJ, 171, 51-58 (2004)
10. Gulácsi, L., Kertész, A., Kopcsóné, N. I., Banai, J., Ludwig, E., Prinz, Gy., Reményi, P., Strbák, B., Zsoldiné, U. E., Baji, P., Péntek, M., Brodszky, V.: Orv Hetil 154, 1188-1193 (2013).
11. Nagy, G.Gy., Várvölgyi, Cs., Balogh, Z., Orosi, P., Paragh, Gy.: Módszertani ajánlás a Clostridium difficile fertőzéshez asszociált hasmenés széklettranszplantációval történő kezeléséhez Orv Hetil 154(1) 10-19 (2013).
12. Crook, D.W., Walker, A.S., Kean, Y., Weiss, K., Cornely, O.A., Miller, M.A., Esposito, R., Louie, T.J., Stoesser, N.E., Young, B.C., Angus, B.J., Gorbach, S.L., Peto, T.E.A.: Clin Infect Dis. 55, 93-103 (2012).
13. Gulyás, B: A Clostridium difficile előfordulási gyakorisága a Petz Aladár Megyei Oktató Kórház immundeficiens betegei között Pécsi Tudományegyetem Egészségtudományi Kar, Egészségfejlesztési- és Népegészségtani Tanszék (2014)
14. Clostridium difficile enteritis infekciókontrolljának eljárásrendje: PAMOKORV_IG-ER-07 (2013).
Somogyi, A., Knausz, M., Gulyás, B.: Sword of Damocles: Clostridium difficile spread
Clostridium difficile infection (CDI) is a severe disease that may result in potentially fatal outcome. The incidence of the disease has increased worldwide in the past few years. The bacterium that causes the illness is the most common enteral nosocomial pathogen worldwide. The increase in the number of cases is a consequence of the inappropriate and unlimited use of antibiotics. Over the recent years, not only the number of CDI cases but the severity of the disease has rising. This can be related to the distribution of the hypervirulent PCR ribotype 027 strains. In the recent years the number of enteritis infectiosa caused by C. difficile has significantly increased in the Aladar Petz County Teaching Hospital too. Outbreaks occurred predominantly in those wards, where patients receive immunosuppressive therapy or elderly subjects are hospitalized. This draws attention to the importance of the topic and inspired the scheme of a study. The aims of this study were to determine the prevalence of Clostridium difficile infections in the internal medicine wards of the hospital, where immune-deficient patients are hospitalized, as well as to study the clinical symptoms in high-risk patient groups, moreover the comparison of the course and outcome of the disease and analysis of the efficacy of the applied antibiotic therapy. Rapid diagnosis, appropriate initial therapy, and strict infection control have great significance among patients with severe underlying disease and more risk-factors.
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[item title=”Pénzes Rita, Boldizsár Imre, Béni Szabolcs, Kéry Ágnes, Alberti Ágnes: Új, a tradicionális kínai gyógyászatban használt gyógynövények a 9. Európai Gyógyszerkönyvben – II. rész – GYOGAI. 61. 144-147 2017.”]
Irodalom
Az 1-49. sz. irodalom az I. rész végén olvasható.
50. http://www.efloras.org/florataxon.aspx?flora_id=1&taxo_id=242100104 (letöltve: 2016. 10. 12.) – 51. http://www.epilepsynaturapedia.com/index.php/Polygonum_orientale (letöltve: 2016. 10. 12.)
52. Liu, Q., Shi, S., Liu, L., Yang, H., Su, W., Chen, X.: J Chromatogr A. 1304, 183-193 (2013).
53. Xie, Z.T., Hu, J.: Zhong Yao Cai. 32, 1397-1399 (2009).
54. Zhou, X.Y., Su, B.H., Zhang, Y.Y., Zhai, Y.J.: Zhong Yao Cai. 35, 540-542 (2012).
55. Jiang, X., Chen, X., Wei, Y.: Lat Am J Pharm. 28, 284-287 (2009).
56. Lee, S.B., Cha, K.H., Selenge, D., Solongo, A., Nho, C.W.: Biol Pharm Bull. 30(6), 1074-9 (2007).
57. Arutyunyan, T.V., Korystova, A.F., Kublik, L.N., Levitman, M.K., Shaposhnikova, V.V., Korystov, Y.N.: Age. 35, 2089–2097 (2013).
58. Yang, J.Y., Wang, J.S., Liu, H.B.: Genet Mol Res. 14, 7671-7679 (2015).
59. http://www.chineseherbshealing.com/cats-claw-gou-teng/ (letöltve: 2016. 10. 12.)
60. https://examine.com/supplements/uncaria-rhynchophylla/ (letöltve: 2016. 10. 12.)
61. Wagner, H., Bauer, R., Melchart, D., Xiao, P.G., Staudinger, A.: Chromatographic Fingerprint Analysis of Herbal Medicines: Thin-layer and High Performance Liquid Chromatography of Chinese Drugs. Springer, Wien
New York: pp. 347-353. (2011).
62. Szántay, Cs., Blaskó, G., Honty, K., Dörnyei, G.: Corynantheine, yohimbine, and related alkaloids in: The Alkaloids: Chemistry and Pharmacology. Vol. 27., Academic Press, pp. 131-268. (1987).
63. Kim, K.S., Pham, T.N.N., Jin, C.J., Umeyama, A., Shoji, N., Hashimoto, T., Takei, M.: Biomark Insights. 6, 27–38 (2011).
64. Shi, J.S., Yu, J.X., Chen, X.P., Xu, R.X.: Acta Pharmacol Sin. 24, 97-101 (2003).
65. Kuramochi, T., Chu, J., Suga, T.: Life Sci. 54, 2061-2069 (1994).
66. Shi, J.S., Huang, B., Wu, Q., Ren, R.X., Xie, X.L.: Zhongguo Yao Li Xue Bao. 14, 114-117 (1993).
67. Hsieh, C.L., Tang, N.Y., Chiang, S.Y., Hsieh, C.T., Lin, J.G.: Life Sci. 65, 2071-2082 (1999).
68. Fujiwara, H., Iwasaki, K., Furukawa, K., Seki, T., He, M., Maruyama, M., Tomita, N., Kudo, Y., Higuchi, M., Saido, T.C., Maeda. S,, Takashima, A., Hara, M., Ohizumi, Y., Arai, H.: J Neurosci Res. 84, 427-433 (2006).
69. Shi, J.S., Liu, G.X., Wu, Q., Huang, Y.P., Zhang, X.D.: Effects of rhynchophylline and isorhynchophylline on blood pressure and blood flow of organs in anesthetized dogs. Zhongguo Yao Li Xue Bao. 13, 35-38. Erratum in: Chung Kuo Yao Li Hsueh Pao 13, 306 (1992).
70. Zhu, Y.: Zhongguo Zhong Yao Za Zhi. 18, 745-747 (1993).
71. Shimada, Y., Goto, H., Itoh, T., Sakakibara, I., Kubo, M., Sasaki, H., Terasawa, K.: J Pharm Pharmacol. 51, 715-722 (1999).
72. Matsumoto, K., Morishige, R., Murakami, Y., Tohda, M., Takayama, H., Sakakibara, I., Watanabe, H.: Eur J Pharmacol. 517, 191-199 (2005).
Pénzes, R., Boldizsár, I., Béni, Sz., Kéry, Á., Alberti, Á.: New Traditional Chinese Medicine herbal drug Monographs in the 9th edition of the European Pharmacopoeia part I.
The number of studies regarding herbs used in Traditional Chinese Medicine (TCM) is increasing considerably. Due to the numerous scientific results obtained, new monographs of Traditional Chinese Medicinal plants have been adopted in the new editions of the European Pharmacopoeia, making it possible to ensure and control the quality of these herbal remedies and to assure safety and efficacy. Herein we provide an overview of the available literature data on several new TCM herbal drugs official in the 9th edition of the European Pharmacopoeia, including Paeoniae radix alba, Paeoniae radix rubra, Polygoni cuspidati rhizoma et radix (part I.), Polygoni orientalis fructus and Uncariae rhynchophyllae ramulus cum uncis (part II.).
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[item title=”Dános Béla, László-Bencsik Ábel, Boldizsár Imre: Farmakobotanikai tanulmányút ősszel, az erdők hetében – GYOGAI 61. 149-159. 2017.”]
trip at the Week of the Forests
The „Week of the Forests” is the initiative of the National Forestry Association of Hungary. So it was timely to recall the immense importance of forests: maintaining biodiversity, protection our living habitats, adequate quality assurance of the athmosphere, protection against the erosion and destructive flooding. Therefore along our last way, from Normafa (see Gyógyszerészet 2015/2) to Anna-rét, Csacsi-rét, Makkosmária and – in the end – Csillebérc (these are all famous places of Buda Hills) primarily we are all concerned for living trees and shrubs. Thus thing worth mentioning the diversity of the fruit-types of the beech, maple, horse chestnut, hawthorne and roses (the last ones are herbal drugs too). The pharmacists are interested in the knowledge of toxic plants, namely Physalis, nightshade, lily of the valley, Solomons-seal and their substances (alkaloids, cardenolides). By good fortune, after the last reaping can be found some flowering plants, thus the meadow and lilac sage, common agrimony, yarrow and the common tansy. – Along the descent to Makkosmária via Csacsi-rét frequently occured the bladder campion, small-flowered touch-me-not, ivy, black horehound, lesser periwinkle, greater (edible) burdocks (the last four are medicinal plants). Finally, the last section of our trips, between Makkosmária and Csillebérc (bus stop) we visited the small stone quarry with considerable geological rarity of dolomite formations, in other hand, afterward under the more dense canopy of mixed oak-hornbeam association surprisingly some polypore mushroom species with medical properties apparented for us (Trametes versicolor, Ganoderma lucidum).
The authors respectfully offer this arcticle for memory of Professor Szabolcs Nyiredy, who died ten years ago. He as the former executive of Hungarian Society of Pharmaceutical Sciences initiated and keenly supported our botanical trips.
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Gyógyszerésztörténeti közlemények
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[item title=”Tatár, Gy.: Európában rendezett nemzetközi gyógyszerész kongresszusok célkitűzései a XIX. század második felében – 1. rész – GYOGAI 61. 160-166. 2017.”]
Irodalom
1. Zboray B.: Adatok a Budai és Pesti Gyógyszerész-Grémium történetéhez. Orvostörténeti Közlemények, Medicina, Budapest 1986.
2. Hvezda K.: Gyógyszerész Hetilap 734 (1865).
3. Bugát Pál Internet 2016.
4. Gyógyszerészi Hetilap, Tárca 587 (1865).
5. Gyógyszerészi Hetilap, Tárca 539 (1865).
6. Gyógyszerészi Hetilap, Tárca 43 (1866).
7. Gyógyszerész Hetilap, Tárca 58 (1866).
8. Gyógyszerészi Hetilap, Tárca 73 (1866).
9. Gyógyszerész Hetilap, Tárca 92 (1866).
10. Gyógyszerészi Hetilap, Tárca 508 (1867).
11. Dr. pharm et med. Mikó Gyula egyetemi magántanár: IV. Magyar Gyógyszerkönyv Kommentárja. Pannónia Könyvnyomda Vállalat, Debrecen, 1936.
12. Gyógyszerészi Hetilap, Tárca 665 (1867).
13. Gyógyszerészi Hetilap, Tárca 680 (1867).
14. Gyógyszerészi Hetilap, Tárca 795 (1867).
15. Gyógyszerészi Hetilap, Tárca 807 (1867).
16. Gyógyszerészi Hetilap, Tárca 823 (1867).
17. Gyógyszerészi Hetilap, Tárca 175 (1869).
18. Gyógyszerészi Hetilap, Tárca 293 (1870).
Tatár, Gy.: The aims of the international pharmaceutical cong-resses organised in the second half of the 19th century. Part I.
The pharmaceutical societies of the European pharmacists organised nine international congresses at which members of oversees pharmaceutical societies also participated. The first congress was in Braunschweig (1865), the second in Paris (1867), the third in Vienna (1869), the fourth in Saint Petersburg (1874), the fifth in London (1881), the sixth in Brussels (1885), the seventh was cancelled, the eighth was organised in Brussels (1897) and the ninth in Paris (1900).
The above pharmaceutical congresses established a future direction for the development of pharmaceutics. The decisions taken and the recommendations approved at the congresses as a result of democratic debates were sent to the governments of the participating countries for legislative purposes. Sooner or later all countries implemented the decisions taken and the recommendations approved at the congresses. The most important ones are as follows: prohibition of curing with so called “secret” drugs, the foundation of the chambers of pharmacists to encourage their official representation, authorisation of pharmacies based on population figures, improving the standards of pharmacy education, introduction of the European Pharmacopoeia, adoption of decrees specifying the conditions of trade and practice of pharmacies, the unification of the dosage of medicines having strong effect, the unification of the names of medicines registered in the national Pharmacopoeias.
Despite the decreasing interest and the lower participation at the last international pharmaceutical congresses, overall such congresses established the right direction for the development of pharmaceutics not only in Europe but also in the other continents.
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Aktuális oldalak
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[item title=”Hankó Zoltán: Az állami gyógyszerészettől a függetlenségig – GYOGAI 61. 167-174. 2017.”]
Hankó Z.: From the state pharmacy to the indepen-dent pharmacy
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Hírek
Ízelítő Londonból: A Mitofusin-2 mutáns sejtek nyomában – Hírek Szegedről – Posgayné
Dr. Kovács Edit 1926-2017 – Dr. Dénes Lajos 1915-2017 – Dr. Dredán Judit (1952-2016)
Tallózó
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Somogyi Aranka, Knausz Márta, Gulyás Beáta: Damoklész kardja: a Clostridium difficile terjedése
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