메뉴 건너뛰기




Volumn 23, Issue 1, 2013, Pages 1-21

Herbal reference standards: Applications, definitions and regulatory requirements

Author keywords

Brazilian herbal regulations; Dietary and food supplements; Herbal medicinal products; Phytochemical markers; Quality control; Reference substances

Indexed keywords

HERBACEOUS AGENT; PYRROLIZIDINE ALKALOID; STEVIOL;

EID: 84874520857     PISSN: 0102695X     EISSN: None     Source Type: Journal    
DOI: 10.1590/S0102-695X2012005000144     Document Type: Article
Times cited : (28)

References (56)
  • 1
    • 85031159354 scopus 로고    scopus 로고
    • Farmacopeia Brasileira 5a edicão
    • Anvisa, accessed in Dec 2012
    • Anvisa 2010. Farmacopeia Brasileira 5a edicão. Agência Nacional de Vigilância Sanitária, http://www.anvisa.gov.br/hotsite/cd_farmacopeia/index.htm, accessed in Dec 2012.
    • (2010) Agência Nacional De Vigilância Sanitária
  • 3
    • 78651289872 scopus 로고    scopus 로고
    • Anforderungen an Referenzstandards chemisch definierter Substanzen aus regulatorischer Sicht
    • Belz S, Wippo U, Nopitsch-Mai C 2010. Anforderungen an Referenzstandards chemisch definierter Substanzen aus regulatorischer Sicht. Pharm Ind 72: 2037-2042.
    • (2010) Pharm Ind , vol.72 , pp. 2037-2042
    • Belz, S.1    Wippo, U.2    Nopitsch-Mai, C.3
  • 4
    • 85031155457 scopus 로고    scopus 로고
    • Bekanntmachung über die Zulassung von Arzneimitteln durch das Bundesinstitut für Arzneimittel und Medizinprodukte (Neuer Formularansatz für den Antrag auf Zulassung eines Arzneimittels beim Bundesinstitut für Arzneimittel und Medizinprodukte) vom 31. Oktober 1996, Anhang 6
    • Bundesinstitut für Arzneimittel und Medizinprodukte
    • Bundesinstitut für Arzneimittel und Medizinprodukte 1996. Bekanntmachung über die Zulassung von Arzneimitteln durch das Bundesinstitut für Arzneimittel und Medizinprodukte (Neuer Formularansatz für den Antrag auf Zulassung eines Arzneimittels beim Bundesinstitut für Arzneimittel und Medizinprodukte) vom 31. Oktober 1996, Anhang 6. Bundesanzeiger 49: 53.
    • (1996) Bundesanzeiger , vol.49 , pp. 53
  • 5
    • 35948970692 scopus 로고    scopus 로고
    • Quantitative NMR spectroscopy in the quality evaluation of active pharmaceutical ingredients and excipients
    • Diehl BWK, Malz F, Holzgrabe U 2007. Quantitative NMR spectroscopy in the quality evaluation of active pharmaceutical ingredients and excipients. Spectrosc Eur 19: 15-19.
    • (2007) Spectrosc Eur , vol.19 , pp. 15-19
    • Diehl, B.W.K.1    Malz, F.2    Holzgrabe, U.3
  • 6
    • 84886726640 scopus 로고    scopus 로고
    • EFSA Panel on Contaminants in the Food Chain (CONTAM), accessed in Dec 2012
    • EFSA Panel on Contaminants in the Food Chain (CONTAM) 2011. Scientific opinion on Pyrrolizidine alkaloids in Food and Feed. http://www.efsa.europa.eu/de/efsajournal/doc/2406.pdf, accessed in Dec 2012.
    • (2011) Scientific Opinion On Pyrrolizidine Alkaloids In Food and Feed
  • 9
    • 85089116244 scopus 로고    scopus 로고
    • FAQ on CRS of the European Pharmacopopeia
    • Strasbourg, France, accessed in Dece 2012
    • th International Symposium on Pharmaceutical Reference Standards. Strasbourg, France. http://www.edqm.eu/site/session_3_material_management_technology_changes_p1pdf-en-30992-2.html, accessed in Dece 2012.
    • (2012) th International Symposium On Pharmaceutical Reference Standards
    • Egloff, V.1
  • 12
    • 84874551582 scopus 로고    scopus 로고
    • EDQM, European Directorate for the Quality of Medicines & HealthCare, accessed in Dec 2012
    • th Edition (7.5). European Directorate for the Quality of Medicines & HealthCare, http://www.edqm.org, accessed in Dec 2012.
    • (2012) th Edition (7.5)
  • 20
    • 84874514159 scopus 로고    scopus 로고
    • European Parliament and the Council of the European Union, accessed in Dec 2012
    • European Parliament and the Council of the European Union 2004. Directive 2004/9/EC on the Inspection and Verification of Good Laboratory Practice (GLP). http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:050:0028:0043:EN:PDF, accessed in Dec 2012.
    • (2004) Directive 2004/9/EC On the Inspection and Verification of Good Laboratory Practice (GLP)
  • 21
    • 84885078330 scopus 로고    scopus 로고
    • Guidance for Industry
    • FDA, Food and Drug Administration, accessed in Dec 2012
    • FDA 1999. Guidance for Industry. Validation of Analytical Procedures: Methodology. Food and Drug Administration http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm052379.pdf, accessed in Dec 2012.
    • (1999) Validation of Analytical Procedures: Methodology
  • 22
    • 16444373665 scopus 로고    scopus 로고
    • FDA, Food and DrugAdministration, accessed in Dec 2012
    • FDA 2004. Guidance for Industry - Botanical Drug Products. Food and DrugAdministration, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070491.pdf, accessed in Dec 2012.
    • (2004) Guidance For Industry - Botanical Drug Products
  • 24
    • 0027614205 scopus 로고
    • Stevioside and related sweet diterpenoid glycosides
    • Hansen JR, De Oliviera BH 1993. Stevioside and related sweet diterpenoid glycosides. Nat Prod Reports 10: 301-309.
    • (1993) Nat Prod Reports , vol.10 , pp. 301-309
    • Hansen, J.R.1    de Oliviera, B.H.2
  • 25
    • 68949152534 scopus 로고    scopus 로고
    • Herbal Reference Standards
    • Helliwell K 2006. Herbal Reference Standards. Pharmeuropa 2: 235-238.
    • (2006) Pharmeuropa , vol.2 , pp. 235-238
    • Helliwell, K.1
  • 27
    • 0007177612 scopus 로고    scopus 로고
    • International Organisation for Standardization, ISO copyright office, Geneva, Switzerland
    • International Organisation for Standardization, 2000a. Guide 31 - Reference Materials - Contents of Certificates and Labels. ISO copyright office, Geneva, Switzerland.
    • (2000) Guide 31 - Reference Materials - Contents of Certificates and Labels
  • 28
    • 3142755916 scopus 로고    scopus 로고
    • International Organisation for Standardization, ISO copyright office, Geneva, Switzerland
    • International Organisation for Standardization, 2000b. Guide 33 - Uses of Certified Reference Materials. ISO copyright office, Geneva, Switzerland.
    • (2000) Guide 33 - Uses of Certified Reference Materials
  • 32
    • 84861626007 scopus 로고    scopus 로고
    • JECFA, accessed in Dec 2012
    • JECFA 2010. Steviol Glycosides. http://www.fao.org/ag/agn/jecfa-additives/specs/monograph10/additive-442-m10.pdf, accessed in Dec 2012.
    • (2010) Steviol Glycosides
  • 34
    • 85031154139 scopus 로고    scopus 로고
    • accessed in Dec 2012
    • Ministério da Saúde 2012. Relação Nacional de Medicamentos quase dobra. http://portalsaude.saude.gov.br/portalsaude/noticia/4603/162/relacao-nacional-de-medicamentos-quase-dobra.html, accessed in Dec 2012.
    • (2012) Relação Nacional De Medicamentos Quase Dobra
    • da Saúde, M.1
  • 35
    • 12944265405 scopus 로고    scopus 로고
    • Quantitative H NMR: Development and potential of a method for natural products analysis
    • Pauli G, Jaki B, Lankin D 2005. Quantitative H NMR: development and potential of a method for natural products analysis. J Nat Prod 68: 133-149.
    • (2005) J Nat Prod , vol.68 , pp. 133-149
    • Pauli, G.1    Jaki, B.2    Lankin, D.3
  • 37
    • 0033022295 scopus 로고    scopus 로고
    • New rules for phytopharmaceutical drug registration in Brazil
    • Petrovick PR, Marques LC, De Paula IC 1999. New rules for phytopharmaceutical drug registration in Brazil. J Ethnopharmacol 66: 51-55.
    • (1999) J Ethnopharmacol , vol.66 , pp. 51-55
    • Petrovick, P.R.1    Marques, L.C.2    de Paula, I.C.3
  • 39
    • 34250029171 scopus 로고    scopus 로고
    • Institutional change and political decision-making in the creation of the Brazilian National Health Surveillance Agency
    • Piovesan MF, Labra ME 2007. Institutional change and political decision-making in the creation of the Brazilian National Health Surveillance Agency. Cad Saude Publ 23: 1373-1382.
    • (2007) Cad Saude Publ , vol.23 , pp. 1373-1382
    • Piovesan, M.F.1    Labra, M.E.2
  • 40
    • 68949150539 scopus 로고    scopus 로고
    • The role of chemical reference standards as analytical tools in the quality assessment of botanical materials - A European perspective
    • Reif K, Sievers H, Steffen J-P 2004. The role of chemical reference standards as analytical tools in the quality assessment of botanical materials - A European perspective. Herbal Gram 63: 38-43.
    • (2004) Herbal Gram , vol.63 , pp. 38-43
    • Reif, K.1    Sievers, H.2    Steffen, J.-P.3
  • 41
    • 0028798219 scopus 로고
    • Medicinal plants in Europe containing pyrrolizidine alkaloids
    • Röder E 1995. Medicinal plants in Europe containing pyrrolizidine alkaloids. Pharmazie 50: 83-98.
    • (1995) Pharmazie , vol.50 , pp. 83-98
    • Röder, E.1
  • 42
    • 79955801725 scopus 로고    scopus 로고
    • The quality of commercially available herbal products
    • Ruparel P, Lockwood B 2011. The quality of commercially available herbal products. Nat Prod Commun 6: 733-744.
    • (2011) Nat Prod Commun , vol.6 , pp. 733-744
    • Ruparel, P.1    Lockwood, B.2
  • 43
    • 77955709559 scopus 로고    scopus 로고
    • Herbal drugs: Standards and regulation
    • Sahoo N, Manchikanti P, Dey S 2010. Herbal drugs: Standards and regulation. Fitoterapia 81: 462-471
    • (2010) Fitoterapia , vol.81 , pp. 462-471
    • Sahoo, N.1    Manchikanti, P.2    Dey, S.3
  • 45
    • 80053572216 scopus 로고    scopus 로고
    • Intended use of reference products & WHO International Standards/Reference Reagents in the development of imilar Biological Products (Biosimilars)
    • Thorpe R, Wadhwa M 2011. Intended use of reference products & WHO International Standards/Reference Reagents in the development of imilar Biological Products (Biosimilars). Biologicals 39: 262-265.
    • (2011) Biologicals , vol.39 , pp. 262-265
    • Thorpe, R.1    Wadhwa, M.2
  • 48
  • 49
    • 0004257069 scopus 로고
    • WHO, World Health Organization, accessed in Dec 2012
    • WHO 1991. Guidelines for the Assessment of Herbal Medicines. World Health Organization, http://whqlibdoc.who.int/hq/1991/WHO_TRM_91.4.pdf, accessed in Dec 2012.
    • (1991) Guidelines For the Assessment of Herbal Medicines
  • 50
    • 0004075491 scopus 로고
    • WHO, World Health Organization, WHO Technical Series, No. 850, 1995, Annex 3, accessed in Dec 2012
    • WHO 1995. Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products. World Health Organization, WHO Technical Series, No. 850, 1995, Annex 3. http://www.nus.edu.sg/irb/Articles/WHO%20GCP%201995.pdf, accessed in Dec 2012.
    • (1995) Guidelines For Good Clinical Practice (GCP) For Trials On Pharmaceutical Products
  • 51
    • 85089113664 scopus 로고    scopus 로고
    • WHO, World Health Organization, accessed in Dec 2012
    • th Report. World Health Organization http://apps.who.int/medicinedocs/en/d/Jh1792e/, accessed in Dec 2012.
    • (1999) th Report
  • 52
    • 85089121349 scopus 로고    scopus 로고
    • WHO, World Health Organization, accessed in Dec 2012
    • th Report. World Health Organization, http://whqlibdoc.who.int/trs/who_trs_952_eng.pdf, accessed in Dec 2012.
    • (2009) th Report
  • 53
    • 0003931628 scopus 로고
    • World Health Organization Research Office for the Western Pacific, accessed in Dec 2012
    • World Health Organization Research Office for the Western Pacific 1993. Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines. http://www.wpro.who.int/publications/docs/Research_Guidelines_Evaluating_the_Safety_and_Efficacy_Herbal_Medicines.pdf, accessed in Dec 2012.
    • (1993) Research Guidelines For Evaluating the Safety and Efficacy of Herbal Medicines
  • 54
    • 38049081642 scopus 로고    scopus 로고
    • Definitionen und Anforderungen an Referenzstandards in der Arzneimittelprüfung
    • Veit M, Wissel S 2007. Definitionen und Anforderungen an Referenzstandards in der Arzneimittelprüfung. Pharm Ind 69: 1475-1480.
    • (2007) Pharm Ind , vol.69 , pp. 1475-1480
    • Veit, M.1    Wissel, S.2
  • 55
    • 39349096670 scopus 로고    scopus 로고
    • Referenzstandards in der Arzneimittelprüfung
    • Veit M, Wissel S 2008. Referenzstandards in der Arzneimittelprüfung. Pharm Ind 70: 135-138.
    • (2008) Pharm Ind , vol.70 , pp. 135-138
    • Veit, M.1    Wissel, S.2
  • 56
    • 68349089383 scopus 로고    scopus 로고
    • Legal requirements for the quality of herbal substances and herbal preparations for the manufacturing of Herbal Medicinal Products in the European Union
    • Vlietinck A, Pieters L, Apers S 2009. Legal requirements for the quality of herbal substances and herbal preparations for the manufacturing of Herbal Medicinal Products in the European Union. Planta Med 75: 683-688.
    • (2009) Planta Med , vol.75 , pp. 683-688
    • Vlietinck, A.1    Pieters, L.2    Apers, S.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.