Nội dung được dịch bởi AI, chỉ mang tính chất tham khảo
Các khía cạnh trong việc nghiên cứu ô nhiễm vi sinh vật trong thuốc (Một bài tổng quan)
Tóm tắt
Bài viết xem xét nhiều khía cạnh liên quan đến việc điều tra các vi sinh vật có trong thuốc. Nguồn gốc của sự ô nhiễm trong các loại thuốc không vô trùng được chỉ ra. Các vấn đề liên quan đến sự thay đổi trong các đặc tính cảm quan và chất lượng điều trị của thuốc ô nhiễm, cũng như mối nguy hại của vi sinh vật đối với sức khỏe con người được phân tích. Dữ liệu về thành phần định tính và định lượng của vi sinh vật gây ô nhiễm, được tách chiết từ các loại thuốc khác nhau, được trình bày. Các phương pháp hiệu quả trong việc tách chiết vi sinh vật gây ô nhiễm cũng được mô tả. Các môi trường nuôi cấy hiện đại và các phương pháp để xác định vi khuẩn và nấm trong quá trình kiểm tra chất lượng vi sinh vật của thuốc được trình bày.
Từ khóa
Tài liệu tham khảo
I. R. Berry, R. A. Nash, and A. H. Wachter, Pharmaceutical Process Validation, Marcel Dekker, New York (2003).
L. O. Kailings, F. Ernerfeldt, and L. Silverstolpe, Reports to the National Board of Health, Microbiological Contamination of Medical Preparations, Stockholm (1966).
L. O. Kailings, Contamination in the Manufacture of Pharmaceutical Products, Secretariat of the European Free Trade Association, Geneva, Switzerland (1973), pp. 17 – 23.
The United States Pharmacopeia, XVIII Rev., Bethesda (1970), pp. 848 – 851.
Ceskoslovensky Lekopis, Prague (1954).
RF State Pharmacopoeia, Part 1, Meditsina, Moscow (2007).
Directive EC 2001 / 83 / EC of Nov. 6, 2001, on the Community code relating to medicinal products for human use (2001).
GOST R 52249 – 2004. Manufacturing Rules and Quality Control of Drugs (EC GMP Rules) (2004).
Handbook for the Experimental (Preclinical) Study of New Pharmacological Compounds [in Russian], Remedium, Moscow (2000).
V. V. Beregovykh and A. P. Meshkovskii, Normalization of Pharmaceutical Manufacturing. Product Quality Assurance [in Russian], Remedium, Moscow (2001).
W. Manu-Tawiah, J. Pharm. Sci. Tech., No. 55, 171 – 175 (2001).
Pharmaceutical cGMP for the 21st Century – A Risk-Based Approach, US FDA (2002).
K. Brakht, Chistye Pomeshcheniya Tekhnol. Sredy, No. 4, 22 – 25 (2004).
Sh. Galatovich, Chistye Pomeshcheniya Tekhnol. Sredy, No. 4, 4 – 8 (2003).
W. Whyte, Cleanroom Technology: Fundamentals of Design, Testing and Operation, John Wiley & Sons, Inc., New York (2001).
Microbiological Best Laboratory Practices, Pharm. Forum., 30(5), 17 (2004).
V. A. Golynkin and V. I. Kocherovets, eds., Pharmaceutical Microbiology [in Russian], Arbeniya, Moscow (2003).
V. A. Golynkin, N. A. Zaikina, K. A. Kargamanova, et al., Sanitary-Microbiological Control in the Food and Pharmaceutical Industries [in Russian], St. Petersburg (2004).
G. Morris, J. Hosp. Infect., No. 44, 81 – 92 (2000).
A. D. Durnev and S. B. Seredenin, Mutagens (Screening and Pharmacological Prophylaxis of Effects), Meditsina, Moscow (1999).
K. H. Wallhauzer, Pharm. Ind., No. 42, 6394 – 6400 (1980).
Methodical Instructions MU 2.1.4.1057 – 01. Organization of Internal Quality Control of Sanitary-Microbiological Studies of Water [in Russian], MZ Russia, Moscow (2001).
SanPin 2.1.4.1074-01 of September 26, 2001. Drinking Water. Hygiene Requirements for Water Quality of Centralized Water Supply Systems. Quality Control [in Russian], Minzdrav of Russia, Moscow (2001).
Methodical Instructions MUK 4.2.671-97. Sanitary-microbiological Analytical Methods for Drinking Water [in Russian], Fed. Center of Gossanepidnadzor of Minzdrav of Russia, Moscow (1997).
MUK 4.2.1018-01. Sanitary-Epidemiological Analysis of Drinking Water [in Russian], MZ Russia, Moscow (2001).
MUK 4.2.734-99. Microbiological Monitoring of Manufacturing Medium [in Russian], Moscow (1999).
G. Temprano, PDA J. Pharm. Sci. Tech., No. 58, 215 – 221 (2004).
J. W. Lengeler, G. Drews, and H. G. Schlegel, Biology of the Prokaryotes, Thieme, Stuttgart, New York (1999).
W. E. Horner, Air-and Dustborne Mycoflora in Houses Free of Water Damage and Fungal Growth, Marietta, GA, USA (2004).
Technology of Purity. Report of the XIIIth Symposium on Microcontamination Control [in Russian], ASINKOM, No. 1, 10 – 13 (1997).
A. P. In?kov, Chistye Pomeshcheniya Tekhnol. Sredy, No. 4, 10 – 15 (2002).
P. Koger, Chistye Pomeshcheniya Tekhnol. Sredy,No. 2,21 – 23 (2003).
S. N. Fursov, Chistye Pomeshcheniya Tekhnol. Sredy, No. 2, 30 – 38 (2003).
Methodical Recommendations MU-45-116. Determination of Cleanliness Class of Manufacturing Rooms and Workplaces. Instruments and Methods [in Russian], Inform.-izd. Tsentr Minzdrava Rossii, Moscow (1997).
GOST R ISO 14644-5-2005. Cleanrooms and Controlled Media Related to them [in Russian], Part 5. Operation (2005).
B. Reinmuller and B. Ljungqvist, Eur. J. Parenteral Sci., 5(3), 55 – 58 (2000).
R. Williams, Appl. Environ. Microbiol., No. 67, 2453 – 2459 (2001).
R. M. Maier, J. L. Peper, and C. P. Gerba, Environmental Microbiology, New York (2002). [Q. Rev. Biol., 77(2), 222 (2002)]
Instruction “Procedure for Performing Control of Air Parameters in Cleanrooms and Method of Measuring them During Drug Manufacturing” RDI 42-505-00 [in Russian], Minzdrav of Russia, Moscow (2000).
A. Myuller, Chistye Pomeshcheniya Kontrol. Sredy, No. 4, 18 – 26 (2002).
E. Graf, R. Scheer, and I. Schollborn, Pharm. Ind., 51(9), 1041 – 1045 (1989).
E. J. Plumpton, J. T. F. Foil, and P. Gilbert, Microbios Lett., No. 27,7–15 (1982).
C. A. Mims, Medical Microbiology, Mosby Europe, London (1993).
B. Reinmüller and B. Ljungqvist, Cleanroom Technique and GMP Rules, Moscow (2003), pp. 53 – 68.
A. Yu. Popov, Chistye Pomeshcheniya Tekhnol. Sredy, No. 1, 5 – 6 (2003).
E. G. Beveridge, Microbiological Aspects of Deteriorating Materials, London (1975), pp. 213 – 235.
E. Lyuk and M. Yagen, Preservatives in the Food Industry [in Russian], St. Petersburg (2003).
R. Churner and R. Cunningham, Ann. Ophthalmol., 15(8), 724 – 729 (1983).
S. I. Butrus and S. A. Klotz, Curr. Eye Res., 5(10), 745 – 748 (1986).
E. Pitsigavdaki and M. Spiropoulou, Acta Microbiol. Hell., No. 35, 341 – 348 (1990).
A. Pinna, Ophthalmology, No. 108, 1830 – 1834 (2001).
S. S. Purohit, A. K. Saluja, and H. N. Kakrany, Pharmaceutical Microbiology, Agrobios Jodpur (2003).
K. A. Bruck, S. Nash, F. D. Fooley, et al., Arch. Surg., No. 102, 476 – 482 (1972).
T. Lund, M. L. De Buyser, and P. E. Granum, Mol. Microbiol., No. 38, 254 – 261 (2000).
K. J. Ryan, An Introduction to Infectious Diseases, Appleton and Lange, Norwalk, Connecticut (1994).
M. V. Gusev and L. A. Mineeva, Microbiology [in Russian], Akademiya, Moscow (2006).
M. T. Madigan, J. M. Martinko, and J. Brock, Biology of Micro-organisms, Prentice Hall, New Jersey (1997).
T. I. Ushakova, Development History of Presentations of Metabolic Syndrome [in Russian], G. E. Roitberg, ed., MEDpress-inform, Moscow (2007).
B. A. Shenderov, Functional Food and Its Role in Prevention of Metabolic Syndrome [in Russian], LeLi print, Moscow (2008).
B. A. Shenderov, Otraslevoe Pitanie, No. 1, 24 – 29 (2006).
B. A. Shenderov, Medicinal Microbial Ecology and Functional Food. Vol. I: Human and Animal Microflora and Its Functions [in Russian], Izd. GRANT, Moscow (1998).
B. A. Shenderov, Medicinal Microbial Ecology and Functional Food. Vol. II: Social-Ecological and Clinical Consequences of Misbalance of Human and Animal Microbial Ecology [in Russian], Izd. GRANT, Moscow (1998).
B. A. Shenderov, Probiotics, Prebiotics and Synbiotics. General and Selected Sections of the Problem. Food Ingredients. Raw Material and Additives [in Russian], No. 2, 23 – 26 (2005).
S. R. Gill, M. Pop, R. T. DeBoy, et al., Science, 312, 1355 – 1359 (2006).
G. I. Novik, A. A. Samartsev, N. L. Astapovich, et al., Appl. Biochem. Microbiol., 42(2), 166 – 172 (2006).
K. E. Scholz-Ahrens, P. Ade, B. Marten, et al., J. Nutr., 137, 838 – 846 (2007).
F. Negretti and S. I. M. A. Su Convegno, Norme di igiene nella produzione alimentare farmaceutica e cosmetica, Milan (1977), pp. 78– 98.
Y. Sagath, J. Babik, and R. Martincova, Zbb. Pharm., 113(6), 571 – 576 (1974).
M. Soad and Abu El-Souad, Indian J. Pharm. Sci., 47(6), 197 – 200 (1985).
J. E. Martinez, Pharm. Technol., Feb., 58 – 70 (2002).
A. J. Fontana, Pharm. Formulation Quality, 7(4), 66–68 (2005).
A. J. Fontana and J. Mumford, Pharm. Formulation Quality, 7(6), 63 – 66 (2005).
A. J. Fontana, Pharm. Microbiol. Forum, Newsletter, 12(10), 10 (2006).
W. D. Grunt, “Life at Low Water Activity,” Philos. Trans. R. Soc. London, 1249 – 1267 (2004).
D. Wenter, Pharmeuropa, 12(3), 373 – 375 (2000).
A. R. Fassihi and M. S. Parker, Int. Biodeterior. Bull., No. 13, 75 – 80 (1977).
GOST 26670–91. Food Products. Methods for Cultivating Microorganisms [in Russian], Moscow (1991).
GOST R 51446–1999 (ISO 7218–96). Microbiology. Food Products. General Rules for Microbiological Investigations [in Russian], Izd. Standartov, Moscow (1999).
GOST 10444.12-94. Food Products. Methods for Determining Yeast and Mold Fungi [in Russian], Izd. Standartov, Moscow (1994).
GOST 10444.15-94, Food Products. Methods for Determining the Amount of Mesophilic Aerobic and Facultative-Anaerobic Microorganisms [in Russian], Izd. Standartov, Moscow (1994).
GOST R 50474–93. Food Products. Method for Isolating and Determining the Amount of Colibacillus Bacteria [in Russian], Izd. Standartov, Moscow (1993).
GOST 30705–2000. Dairy Products for Children’s Food. Method for Determining Mesophilic Aerobic and Facultative-Anaerobic Microorganisms [in Russian], Izd. Standartov, Moscow (2000).
GOST 30706–2000. Dairy Products for Children. Method for Determining Yeast and Mold Fungi [in Russian], Izd. Standartov, Moscow (2000).
GOST 30726–2001. Food Products. Methods for Isolating and Determining the Amount of E. coli Bacteria [in Russian], Izd. Standartov, Moscow (2001).
R. L. Merker, ed., Media and Reagents, Appendix 3, in: Food and Drug Administration Bacteriological Analytical Manual, AOAC International, Gaithersburg, MD (1998).
G. G. Onishchenko, V. I. Efremenko, I. S. Tyumentseva, et al., Zh. Mikrobiol. Epidemiol. Immunol., Suppl. No. 6, 88 (2003).
V. V. Kartsev, L. V. Belova, and V. P. Ivanov, Sanitary Microbiology of Food Products, GMA im. I. I. Mechnikova, St. Petersburg (2000).
D. Roberts and M. Greenwood, eds., Practical Food Microbiology, Technology, Bodmin, UK (2003).
C. Collins, H. Lyne, and M. Patricia, Micribiological Methods, Butterworths, London (1985).
E. J. Rhodehamel and S. M. Harmon, Bacillus cereus, Ch. 14, in: Food and Drug Administration Bacteriological Analytical Manual, Gaithersburg (1998).
G. Bornet, Microbiologiques Analysis dans la Securitee Systeme, Rev. Med. Vet. (France), 151, No.8–9, 805–812 (2000).
W. Hewitt, Microbiological Assay for Pharmaceutical Analysis: A Rational Approach, Interpharm / CRC, Boca Raton, FL, USA (2003).
M. H. Rubinstein and C. G. Wilson, Handbook of Microbiological Quality Control: Pharmaceutical and Medical Devices, London (2000).
M. C. Easter, ed., Rapid Microbiological Methods in Pharmaceutical Industry, Medical, Boca Raton, FL, USA (2003).
W. P. Olson, ed., Automated Microbial Identification and Quantitation. Technologies for the 2000s, Boca Raton, FL, USA (1996).
M. J. Miller, ed., Encyclopedia of Rapid Microbiological Methods, Vol. III, DHI Publishing, River Grove, IL (2006).
European Pharmacopoeia, 5th Ed., Strasbourg (2005).
The United States Pharmacopeia, XXXI Rev., Rockville (2008).
Japanese Pharmacopeia, JP XIV, Suppl. II, Ch. 47 (2001).
D. A. A. Mossel and K. E. Dijkmann, Media and Methods for Growing Yeasts, Utrecht (1998), pp. 279 – 288.
A. D. Ring, J. I. Pitt, L. R. Beuchat, and J. E. L. Corry, Methods for Mycological Examination, Plenum Press NATO Scientific Affairs Division, New York, London (1984).
J. W. Hastings, W. Y. J. Tsai, and L. B. Bullerman, J. Agric. Res. Div., No. 16, 47 – 49 (1987).
V. Prigione, Appl. Environ. Microbiol., No. 70, 1365 – 1365 (2004).
S. Sutton, Pharm. Microbiol. Forum Newsletter, 12, 4–9 (2006).
S. Sutton, Pharm. Microbiol. Forum Newsletter, 12(4), 2–8 (2006).
S. Sutton, Pharm. Microbiol. Forum Newsletter, 13(1), 4– 14 (2007).
D. Y. C. Fung, Rapid Microbiol. News, 3,4–5 (2002).
O. L. Startseva, E. B. Smirnova, L. S. Katunina, et al., in: Abstracts of the Proceedings of the International Scientific-Practical Conf. “Development and Manufacture of Diagnostic Dry Culture Media and Microsystems” [in Russian], Makhachkala (2001), p. 7.
Z. Z. Sultanov, A. Z. Aliev, E. A. Kakulina, et al., in: Abstracts of the Proceedings of the International Scientific-Practical Conf. “Development and Manufacture of Diagnostic Dry Culture Media and Microsystems” [in Russian], Makhachkala (2002), pp. 40 – 41.
V. A. Golynkin, N. A. Zaikina, and V. I. Kocherovets, Culture Media for Microbiological Quality Control of Drugs and Food Products, Handbook [in Russian], V. A. Golynkina and V. I. Kocherovets, eds., Prospekt Nauki, St. Petersburg (2006).
Pharmaceutical Microbiological Manual, HiMedia Laboratories, Pvt. Limited, India (2006).
R. M. Atlas, ed., Handbook of Microbiological Media, CRC Press, Boca Raton, London, New York, Washington (2004).
M. S. Polyak, V. I. Sukharevich, and M. E. Sukharevich, Culture Media for Medicinal Microbiology [in Russian], St. Petersburg (2003).
T. I. Osokina, Z. A. Isaeva, L. A. Astarkhanova, et al., in: Abstracts of the Proceedings of the International Scientific-Practical Conf. “Development and Manufacture of Diagnostic Dry Culture Media and Microsystems” [in Russian], Makhachkala (2003), pp.9–10.
L. D. Gaziumarova, in: Abstracts of the Proceedings of the International Scientific-Practical Conf. “Development and Manufacture of Diagnostic Dry Culture Media and Microsystems” [in Russian], Makhachkala (2003), pp. 18 – 19.
HiMedia Catalog, Dry Culture Media and Additives, Mumbai, India (2003).
Bio-Rad Laboratories Catalog, Moscow (2002).
A. S. Labinskaya and E. G. Volina, eds., Handbook of Medicinal Microbiology. General and Sanitary Microbiology [in Russian], Book 1, BINOM, Moscow (2008), pp. 989 – 1011.
V. I. Bilai and E. Z. Koval’, Aspergilli: A Key [in Russian], Naukova Dumka, Kiev (1988).
N. M. Pidoplichko, Fungi – Parasites of Cultivated Plants: A Key [in Russian], Naukova Dumka, Kiev (1977).
M. Manafi, J. Food Microbiol., No. 60, 205 – 218 (2003).