Impurities in herbal substances, herbal preparations and herbal medicinal products, I. Microbial contamination;Impuretés des drogues végétales, préparations à base de drogues végétales et médicaments à base de plantes I. Contamination microbienne

S.T.P. Pharma Pratiques

Volumn 17, Issue 4, 2007, Pages 183-208

  Guédon, Didier ^a   Brum, Michèle ^b   Bizet, Danièle ^c   Bizot, Serge ^d   Bourny, Edmond ^b   Compagnon, Pierre Albert ^b   Kergosien, Hélène ^b   Quintelas, Luis Georges ^b   Respaud, Jérôme ^b   Saperas, Olivier ^b   Seigneuret, Jean Marc ^e   Taoubi, Khalil ^b   Urizzi, Pascale ^f  

^a Laboratoires Arkopharma   (France)

^b Laboratoires Boiron ^*

^c Laboratoires Boiron   (France)

^d Indena   (France)

^e Alban Muller   (France)

^f INSTITUT DE RECHERCHE PIERRE FABRE   (France)

Author keywords

Herbal drug preparations; Herbal drugs; Herbal medicinal products; Impurities; Microbial contamination; Quality control; Regulations

Indexed keywords

HERBACEOUS AGENT;

ARTICLE; DRUG MANUFACTURE; HEALTH HAZARD; HERBAL MEDICINE; MICROBIAL CONTAMINATION; SAFETY;

EID: 35148853718     PISSN: 11571497     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (47)

1. EMEA Guideline on quality of herbal medicinal products/traditional herbal medicinal products (CPMP/QWP/2819/00 Rev 1).
2. EMEA Guideline on specifications: tests procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products (CPMP/QWP/2820/00 Rev 1).
3. EMEA/HMPC Guideline on good agricultural and collection practices (GACP) for starting materials of herbal origin (EMEA/HMPC/246816/05).
4. LUTOMSKI J, KEDZIA B. Mycoflora of crude drugs. Estimation of mould contaminations and their toxicity. Planta Med 1980;40:212-7.
5. YDE M, VAN RILLAER W, DE MAYER-CLEEMPOEL S. Mikrobiologisch onderzoek van thee en kruidenthee's. Arch Belg Med Soc 1981;39:488-97.
6. SCHILCHER H. Rückstände und Verunreinigungen bei Drogen und Drogenzubereitungen. 19.Mitteilung : Zur Wertbestimmung und Qualitä tsprüfung von Drogen. Planta Med 1982;44:65-77.
7. CORTEZ Y, PERSONNE JC, ESTEVE G. Etude comparative de la contamination de plantes médicinales. Plantes Méd Phytother 1986;20:236-50.
8. HÄRTLING C. Beitrag zur Frage des mikrobiellen Zustandes pflanzlicher Drogen-Fakten und Folgerungen. Pharm Ztg 1987;132:643-4.
9. FRANK B. Mikroorganismen in Drogen. Der mikrobiologische Status von Drogen und Drogenzubereitungen und seine Beurteilung. Dtsch Apoth Ztg 1989;129:617-23
10. THONKE M, KHANG ND, DRESSEL H. Zum Keimgehalt pflanzlicher Drogen. Pharmazie 1991;46:284-6.
11. FAVET J. Etude de la contamination microbienne d'une vingtaine de drogues végétales. Pharm Acta Helv 1992;67:250-8.
12. BRANTNER A, LÜCKE W. Influence of physical parameters on the germ-reducing effect of microwave irradiation on medicinal plants. Pharmazie 1995;50:762-6.
13. KABELITZ L. Mikrobiologische Belastung an Heil- und Gewü rzpflanzendrogen. Arznei- und Gewürzpflanzendrogen 1996;1:9-16.
14. KABELITZ L. Are the current requirements regarding the microbiological purity of medicinal plant drugs practicable? Pharmeuropa 1997;9:585-90.
15. KOLB N. Microbiological status of untreated herbal materials. Dtsch Lebensmittel-Rundschau 1999;95:263-9.
16. CZECH E, KNEIFEL W, KOPP B. Microbiological status of commercially available medicinal herbal drugs - A screening study. Planta Med 2001;67:263-9.
17. LEIMBECK R. Teedrogen-Wie steht es mit der mikrobiologischen Qualität? Dtsch Apoth Ztg 1987;127:1221-6.
18. SCHNEIDER E. Keimbesiedlung von frischen Arzneipflanzen und von Drogen. Veränderungen der Keimzahlen von Drogen während der Gewinnung und Verarbeitung. Dtsch Apoth Ztg 1987;127:1683-6.
19. ROCKLAND LB, BEUCHAT LR. Water activity: theory and applications to food. New York: Marcel Dekker,1987.
20. BEUCHAT LR. Microbial stability as affected by water activity. Cereals Foods World 1981;26:345-9.
21. BECKMANN G, KROTH E, BOMBLIES L, LEIMBECK R, SONNENSCHEIN B. An investigation into the microflora of medicinal plants during growth and harvesting - the plant-associated microflora of melissa, valerian and parsley include enterobacteria. Pharmeuropa 2003;15:303-10.
22. LENOBLE M, FOURNIAT J, BOURLIOUX P, PARIS M, MAGHAMI P, GERMAN A. Contrôle de la qualité microbiologique d'échantillons de Mentha piperita de diverses origines géographiques. Ann Pharm Fr 1980;38:333-42.
23. BERNARD J. Contamination microbiologique des plantes médicinales. Act Pharm 1983;196:32-4.
24. KNEIFEL W, CZECH E, KOPP B. Microbial contamination of medicinal plants - A review. Planta Med 2002;68:5-15.
25. KATUSIN-RAZEM B, MATIC SJ, RAZEM D, MIHOKOVIC V. Radiation decontamination of tea herbs. J Food Sci 1988;53:1120-6.
26. ALEXANDER RG, WILSON DA, DAVIDSON AG. Medicines Control Agency investigation of the microbial quality of herbal products. Pharm J 1997;259:259-61.
27. KABELITZ L, SIEVERS H. Contaminants of medicinal and food herbs with a view to EU regulations. Innov Food Technol 2004 Nov: 25-7.
28. MARTINS HM, MARTINS ML, DIAS MI, BERNARDO F. Evaluation of microbiological quality of medicinal plants used in natural infusions. Int J Food Microbiol 2001;68:149-53.
29. McKEE LH. Microbial contamination of spices and herbs: a review. Lebensm-Wiss u Technol 1995;28:1-11.
30. CANDLISH AAG, PEARSON SM, AIDOO KE, SMITH JE, KELLY B, IRVINE H. A survey of ethnic foods for microbial quality and aflatoxin content. Food Addit Contam 2001;18:129-36.
31. ROBERTS D, WATSON GN, GILBERT RJ. Contamination of food plants and plant products with bacteria of public health significance. Soc Appli Bact Symp Ser 1982;10:169-95.
32. VIJ V, AILES E, WOLYNIAK C, ANGULO FJ, KLONTZ KC. Recalls of spices due to bacterial contamination monitored by the US Food and Drug Administration: the predominance of salmonellae. J Food Prot 2006;69:233-7.
33. BUTZLER JP, OOSTEROM J. Campylobacter: pathogenicity and significance in foods. Int J Food Microbiol 1991;12:1-8.
34. RABSCH W, PRAGER R, KOCH J, STARK K, ROGGENTIN P, BOCKEMÜHL J, BECKMANN G et al. Molecular epidemiology of Salmonella enterica serovar Agona: characterization of a diffuse outbreak caused by aniseed-fennel-caraway infusion. Epidemiol Infect 2005;133:837-44.
35. Centers for Disease Control. Outbreak of Salmonella Oranienburg infection-Norway Morb Mortal Wkly Rep 1982;31:655-6.
36. LEHMACHER A, BOCKEMÜHL J, ALEKSIC S. Nationwide outbreak of human salmonellosis in Germany due to contaminated paprika and paprika-powdered potato chips. Epidemiol Infect 1995;115:501-11.
37. ROGGENTIN P, KOLB N, BOCKEMÜHL J. Influence of brewing temperature and brewing period on the microbial kinetics in herbal infusions. Arch Lebensmittelhygiene 2005;56:100-4.
38. VAN DOORNE H, BOSCH EH, ZWAVING JH, ELEMA ET. Gamma irradiation of sennae folium. Microbiological and phytochemical studies. Pharm Weekbl Sci Ed 1988;10:217-20.
39. ICH Harmonised tripartite guideline. Specifications: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances. Q6A (6 October 1999).
40. The United States Pharmacopeia. The National Formulary. United States Pharmacopeial Convention, Rockville.
41. NF ISO 7402. Microbiology. General guidance for the enumeration of Enterobacteriaceae without resuscitation. MPN technique and colony count technique. December 1993.
42. NF V 08-054. Microbiology of food and animal feeding stuffs. Enumeration of the enterobacteria by colony count technique at 30°C. Routine method. February 1999.
43. Directive 2004/24/EC of the European parliament and of the council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the community code relating to medicinal products for human use. Official Journal of the European Union 2004:L 136/85 (30 April).
44. WHO. Quality control methods for medicinal plant material. 1998. WHO, Geneva.
45. KNEIFEL W, BERGER E. Microbiological criteria of random samples of spices and herbs retailed on the Austrian market. J Food Protect 1994;57:893-901.
46. KRÄMER J. Veröffentlichte mikrobiologische Richt- und Warnwerte zur Beurteilung von Lebensmitteln (Stand: Januar 2002) - Eine Empfehlung der Fachgruppe Lebensmittelmikrobiologie und Lebensmittelhygiene der Deutschen Gesellschaft für Hygiene und Mikrobiologie (DGHM). Der Lebensmittelbrief 2002; Iss. 3/4:S40-2 (www.lm-mibi.uni-bonn.de/DGHM.html).
47. Commission Regulation 2073/2005/EC of 15 November 2005 on microbiological criteria for foodstuffs. Official Journal of the European Communities 2005:L338/1-26 (22 December).