PRODUITS POUR LE SOIN DES ARTICULATIONS

Date

28 mars 2024

Nom(s) propre(s), Nom(s) commun(s), Information(s) d'origine

¹Références: Noms propres : NIHa 2023, RSC 2023, USP-NF 2023, USDA 2023, Martindale 2012, Ph.Eur. 2012, ICIDH 2008, Kralovec et Barrow 2008, Towheed et Anastassiades 2007, IUBMB 1992.

Noms communs: NIHa 2023, USP-NF 2023, USDA 2023, RSC 2023, PPRC 2015, BP 2012, Martindale 2012, Ph.Eur. 2012, Goel et al. 2008, ICIDH 2008, Kralovec et Barrow 2008, Towheed et Anastassiades 2007, Boon et Smith 2004, Wichtl et Anton 2003, Bruneton 1999, Moskowitz 2000, IUBMB 1992, Deodhar et al. 1980.

Informations d'origine: NIH 2023, SITI 2023, RSC 2023, USDA 2023, USP-NF 2023, Froese et Pauly 2018, EMA 2017, PPRC 2015, Martindale 2012, Ph.Eur. 2012, Schauss et al. 2012, Sitanggang et al. 2012, EP 2011, FCC 8 2012, Khan et Abourashed 2010, Evans 2009, Yoshida et al. 2009, Goel et al. 2008, Kalman et al. 2008, Kralovec et Barrow 2008, Sato et Iwaso 2008, Chmielowski et al. 2007, Schrieber et Gareis 2007, Dahiya et al. 2006, Chong et al. 2005, Boon et Smith 2004, Wichtl 2004, Baziwane et He 2003, ESCOP 2003, Barnes et al. 2002, Sato et al. 2002, Blumenthal et al. 2000, BHC 1992, Deodhar et al. 1980.

²Le cartilage doit provenir d'animaux domestiques et en santé utilisés pour la consommation humaine (USP-NF 2023).

³Correspond à l'huile du corps entier d'un ou plus d'espèces des familles listées dans le Tableau 1 dans sa forme naturelle, et/ou sous forme triglycéride/triacylglycérol concentrée et/ou sous forme estérifiée concentrée (BP 2023; Ph.Eur. 2023; Froese et Pauly 2022). Les noms communs des espèces et non pas les familles peuvent être listés sur l'étiquette.

⁴Pour les huiles de poisson incluant des espèces de Gadidae comme matière d'origine, le contenu en vitamine A et D doit être testé afin d'assurer que les doses maximales quotidiennes rencontrent la monographie des Suppléments de multivitamines/minéraux pour chaque groupe d'âge.

⁵Le nom spécifique des organismes utilisés comme matière d'origine doit être clairement indiqué sur le formulaire pour les tissus d'origine animale; le terme « crustacés » n'est pas suffisant.

⁶Le sel stabilisant (i.e. sodium) doit être indiqué si présent dans le produit.

⁷Pour les fins de cette monographie, le collagène hydrolysé ne forme pas de gel et est soluble dans l'eau froide (Schrieber et Gareis 2007; Moskowitz 2000). Le poids moléculaire moyen du collagène hydrolysé est approximativement de 4 kDa (c.-à-d. 2 à 6 kDa) (Moskowitz 2000; Oesser et al. 1999).

Voie d'administration

Orale

Forme(s) posologique(s)

Cette monographie exclut les aliments et les formes posologiques semblables aux aliments tel qu'indiqué dans le document de référence Compendium des monographies.

Les formes posologiques acceptables pour la voie d'administration orale sont indiquées dans la liste déroulante dans le formulaire web de demande de licence de mise en marché pour les demandes officinales.

Usage(s) ou fin(s)

Consulter les tableaux 2 et 3.

Notes :

• Tous les produits doivent citer obligatoirement au moins un énoncé concernant les usages ou fins présentés dans le tableau 2.
• Un énoncé concernant les usages ou fins n'est acceptable que si le produit fournit au moins un des ingrédients médicinaux associés à cet énoncé dont la dose est égale ou supérieure à la valeur de la dose minimale présentée dans le tableau 2.
• Les ingrédients médicinaux qui n'atteignent pas la dose minimale quotidienne associée à un énoncé concernant les usages ou fins seront considérés comme ingrédients médicinaux complémentaires dans les formulations de produits.
• Pour les produits à ingrédients multiples :
  • Afin d'empêcher que le produit soit représenté comme une « médecine traditionnelle », toute allégation traditionnelle doit faire référence à/aux ingrédient(s) médicinal(aux) et au système de médecine traditionnelle reconnu d'où l'allégation provient lorsque 1) des allégations à la fois traditionnelles et modernes sont présentes ou 2) lorsque les allégations proviennent de multiples systèmes de médecine traditionnelle (par ex., Le curcuma est utilisé traditionnellement en phytothérapie pour aider à soulager la douleur articulaire).
  • Lorsque TOUS les ingrédients médicinaux (IM) du produit sont utilisés au sein du MÊME système de médecine traditionnelle identifié ET que le produit n'a QUE des allégations traditionnelles, l'inclusion de l'/des ingrédient(s) médicinal(aux) dans l'/les allégation(s) traditionnelle(s) n'est pas requise.

Dose(s)

Sous-population(s)

Adultes 18 ans et plus

Quantité(s)

Consulter les tableaux 2 et 3.

Note: Lorsque 'décoction' ou 'infusion' est listée comme une méthode de préparation acceptable, 'concentré de décoction' ou 'concentré d'infusion' est aussi permis. Ceci s'applique aussi aux méthodes de préparation normalisées.

¹Pour chaque usage ou fin, au moins deux des références suivantes ont été consultées : EMA 2017; Bruyère et al. 2012; Benito-Ruiz et al. 2009; Yoshida et al. 2009; Clark et al. 2008; Winston et Kuhn 2008; Herrero-Beaumont et al. 2007; Mazières et al. 2007; Sontakke et al. 2007; Towheed et Anastassiades 2007; Kim et al. 2006; Mills et Bone 2005; Uebelhart et al. 2004; Usha et Naidu 2004; Braham et al. 2003; ESCOP 2003; Hoffmann 2003; Kimmatkar et al. 2003; Pavelka et al. 2002; Sato et al. 2002; Mazières et al. 2001; Reginster et al. 2001; Thie et al. 2001; Blumenthal et al. 2000; Mills et Bone 2000; Volker et al. 2000; Houpt et al. 1999; Bourgeois et al. 1998; Bucsi et Poor 1998; Uebelhart et al. 1998; Sköldstam et al. 1992; Deodhar et al. 1980.

²Pour chaque dose minimale, au moins une des références suivantes a été consultée : EMA 2017; Bruyère et al. 2012; Benito-Ruiz et al. 2009; WHO 2009; Yoshida et al. 2009; Clark et al. 2008; Kalman et al. 2008; Herrero-Beaumont et al. 2007; Mezieres et al. 2007; Sontakke et al. 2007; Fitzpatrick 2005; Mills et Bone 2005; Boon et Smith 2004; Uebelhart et al. 2004; Usha et Naidu 2004; Wichtl 2004 ; ESCOP 2003; Hoffmann 2003; Kimmatkar et al. 2003; Williamson 2003; Barnes et al. 2002; Pavelka et al. 2002; Mezieres et al. 2001; Reginster et al. 2001; Blumenthal et al. 2000; Volker et al. 2000; Houpt et al. 1999; Bucsi et Poor 1998; Uebelhart et al. 1998; Deodhar et al. 1980.

³Pour chaque dose maximale, au moins une des références suivantes a été consultée : EMA 2017; Bruyère et al. 2012; Benito-Ruiz et al. 2009; WHO 2009; Clark et al. 2008; Sato et Iwaso 2008; Herrero-Beaumont et al. 2007; Sontakke et al. 2007; Hathcock et Shao 2006; Kim et al. 2006; Mills et Bone 2005; Boon et Smith 2004; Wichtl 2004; Braham et al. 2003; ESCOP 2003; Kimmatkar et al. 2003; Williamson 2003; Barnes et al. 2002; Pavelka et al. 2002; Sato et al. 2002; Reginster et al. 2001; Blumenthal et al. 2000; Bourgeois et al. 1998; US FDA 1997; BHC 1992; Deodhar et al. 1980.

⁴Curcuma : Consultez la monographie de curcuma pour plus d'information sur les extraits natifs.

⁵Huile de poisson : Le ratio AEP:ADH pour l'huile de poisson doit se situer entre 0,5:1 et 2:1 (Volker et al. 2000; Sköldstam et al. 1992) et l'activité doit être exprimée en quantité (mg) et/ou en pourcentage (%) d'AEP et d'ADH (% poids/poids) par rapport à la quantité totale d'huile de poisson.

*Note: Pour la griffe du diable et le curcuma, les solvants permis pour la méthode de préparation « Extraits non-normalisés (extrait sec) » au sein de cette monographie sont l'éthanol et/ou l'eau uniquement.

Les allégations suivantes sont seulement acceptables en plus d'au moins une allégation listées dans le tableau 2 ci-dessus. Un produit de soin des articulations ne peut pas contenir uniquement des ingrédients et allégations du tableau 3.

¹Pour chaque usage ou fin, au moins deux des références suivantes ont été consultées : SC 2018; Hunt CD 2012; FDA 2008; Tang et al. 2007; IOM 2006; NAMS 2006; Shils et al. 2006; Devirian et Volpe 2003; Brown et Josse 2002; Walker et al. 2002; ; NIH 2001; Groff et Gropper 2000; Blumenthal 1998; IOM 1997; Nielsen et al. 1987.

²Pour chaque dose minimale, au moins une des références suivantes a été consultée : SC 2018; Hunt CD 2012; IOM 2006; Walker et al. 2002; Blumenthal 1998.

³Pour chaque dose maximale, au moins une des références suivantes a été consultée : SC 2018; Hunt CD 2012; IOM 2006; Kerkhoffs et al. 2004; Singer et al. 2001.

⁴Bore : Règle spécifique pour les produits fournissant plus de 0,7 mg de bore par jour. Consultez la section 'Notes' ci-dessous.

⁵Bromélaïne de fruit/Bromélaïne de tige : Une unité FCC de papaïne (PU) est définie comme étant la quantité d'enzymes qui libère l'équivalent d'1 microgramme de tyrosine par heure dans les conditions du test (FCC 8 2012).Une unité de dissolution de gélatine (UDG) est approximativement équivalente à 15 000 unité FCC de papaïne (1 UGD ≈ 15 000 FCC PU). L'information sur la dose peut inclure les quantités de la préparation enzymatique ainsi que son activité enzymatique. L'activité enzymatique peut être indiquée dans le champ de Quantité/Unité et la quantité de la préparation d'enzymes en mg ou en ml dans le champ Quantités/Unités supplémentaires.

Notes :

• Les usages ci-dessus peuvent être combinés sur l'étiquette du produit s'ils proviennent du même système de médecine traditionnelle ou non-traditionnelle (par ex., Aide au maintien d'articulations saines et à réduire la douleur articulaire associée à l'arthrose).
• Règle spécifique pour les produits fournissant plus de 0,7 mg de bore par jour: afin d'assurer un profil risque-bénéfice favorable, un produit fournissant du bore élémentaire à des doses au-dessus de 0,7 mg et jusqu'à la limite maximale de 3,36 mg par jour doit :
  • être un produit pour les soins des articulations;
  • contenir au moins un ingrédient médicinal du Tableau 2;
    et
  • faire uniquement les allégations pour la douleur ou de santé articulaire spécifiées dans le Tableau 2. En plus, l'allégation associée au bore 'Aide à maintenir un métabolisme du calcium sain' peut être incluse.

  Les autres produits de santé tels que les suppléments de multivitamines et minéraux ne doivent pas fournir plus que la limite maximale de 0,7 mg de bore élémentaire par jour.

Mode(s) d'emploi

¹Pour les modes d'emploi, les références suivantes ont été consultées: Bore: Devirian et Volpe 2003; Zittermann 2003; Calcium: Sweetman 2007; IOM 2011, ASHP 2005; MSM: Kim et al. 2006.

Règles pour les associations

• Pour les produits à ingrédients multiples qui contiennent de la bromélaïne de fruit et de la bromélaïne de tige, l'activité protéolytique combinée ne doit pas dépasser l'activité protéolytique maximale de 130 000 000 FCC PU par jour et 45 000 000 FCC PU par dose unique.
• La même règle d'association s'applique lors de l'association de la bromélaïne de fuit et/ou la bromélaïne de tige avec la papaïne.
• Le produit fini ne doit pas dépasser une quantité totale de curcuminoïdes de 500 mg par dose et 1 500 mg par jour.
• Le produit fini ne doit pas dépasser une quantité totale de curcumine de 400 mg par dose et 1 200 mg par jour.
• La dose quotidienne de chlorhydrate de glucosamine combinée avec le sulfate de glucosamine est limitée selon le critère suivant : la somme des pourcentages des doses quotidiennes individuelles maximales ne doit pas être supérieure à 120% [(par ex., un produit fournissant une dose quotidienne de 2 000 mg de chlorhydrate de glucosamine (100% de la dose quotidienne maximale de 2 000 mg) + 300 mg de sulfate de glucosamine (20% de la dose quotidienne maximale de 1 500 mg) serait acceptable (100% + 20% = 120%)].

Durée(s) d'utilisation

Notes

• Un énoncé de durée d'utilisation minimum est requis dans le cas des produits concernant les usages ou fins associé(e)s au boswellia, au sulfate de chondroïtine, à la griffe du diable, à la glucosamine (sulfate ou chlorhydrate/hydrochlorure), au collagène hydrolysé ou au méthylsulfonylméthane (MSM).
• Si un produit requiert plus d'une durée d'utilisation, l'énoncé ayant la plus courte durée d'utilisation doit apparaître sur la demande de licence de mise en marché et l'étiquette. Par exemple, un produit ayant des énoncées concernant les usages pour le sulfate de chondroïtine et le chlorhydrate de glucosamine doit avoir l'énoncé de durée d'utilisation suivant sur l'étiquette : « Utiliser pendant au moins 1 mois afin de constater les effets bénéfiques ».
• Un énoncé de durée d'utilisation maximum est requis pour tous les produits contenant de la bromélaïne ou de l'écorce de saule. Si la durée d'utilisation maximale est de plus courte durée que la durée d'utilisation minimale pour constater les effets bénéfiques, l'allégation associée ne peut pas être incluse.

Durée(s) d'utilisation minimum

¹ Pour chaque énoncé de durée d'utilisation, au moins une des références suivantes a été consultée : Bruyère et al. 2012; Benito-Ruiz et al. 2009; Calrk et al. 2008; Bjordal et al. 2007; Mehta et al. 2007; Sontakke et al. 2007; Kim et al. 2006; Usha et Naidu 2004; ESCOP 2003; Kimmatkar et al. 2003; Houpt et al. 1999; Qiu et al. 1998.

Durée(s) d'utilisation maximum

Produits contenant de la bromélaïne

Consulter un praticien de soins de santé/fournisseur de soins de santé/professionnel de la santé/docteur/médecin pour une utilisation prolongée.

Produits contenant de l'écorce de saule

Consulter un praticien de soins de santé/fournisseur de soins de santé/professionnel de la santé/docteur/médecin si l'utilisation se prolonge au-delà de 6 semaines (Beer et Wegener 2008; Biegert et al. 2004).

Mention(s) de risque

Précaution(s) et mise(s) en garde

Produits fournissant plus de 2,8 g de collagène hydrolysé par jour ou tout autre ingrédient médicinal du Tableau 2 à toute dose (sauf les produits contenant de l'écorce de saule qui requièrent une contre-indication)

Consultez un praticien de soins de santé/fournisseur de soins de santé/professionnel de la santé/docteur/médecin avant l'utilisation si vous êtes enceinte ou si vous allaitez.

Douleur (articulaire et l'enflure) associées à l'arthrose ou à l'arthrite rhumatoïde

Consultez un praticien de soins de santé/fournisseur de soins de santé/professionnel de la santé/docteur/médecin si les symptômes s'aggravent.

Inflammation des articulations/anti-inflammatoire/douleur, de l'enflure et de l'inflammation mineures

Consultez un praticien de soins de santé/fournisseur de soins de santé/professionnel de la santé/docteur/médecin si les symptômes persistent ou s'aggravent.

Produits contenant les ingrédients médicinaux suivants

¹Les références suivantes ont été consultées pour les précautions et mises en garde : bêta-Carotène: Touvier et al. 2005; Omenn et al. 1996; ATBC 1994; Bore: Usuda et al. 1996; Nielsen et al. 1992; Bromélaïne de fruit/tige: Martindale 2011; Brinker 2010; Blumenthal et al. 2000; Curcumine: Brinker 2010; Mills et Bone 2005; ESCOP; McGuffin 2003; McGuffin et al. 1997; Curcuma : Brinker 2010; ESCOP;McGuffin 2003; McGuffin et al. 1997; Huile de poisson et écorce de saule combinés: Block et al. 2012, 2013; Larson al. 2008; Manganèse : IOM 2006; IOM 2001; Krieger et al. 1995; Écorce de saule : EMA 2017; Vitamine K : ASHP 2005; Franco et al. 2004; IOM 2001; Hansten et al. 1997.

Contre-indications(s)

Produits contenant de l'écorce de saule

• Ne pas utiliser si vous êtes enceinte ou si vous allaitez (EMA 2017; Brinker 2010; Wichtl 2004; ESCOP 2003; Barnes et al. 2002; Blumenthal et al. 2000).
• Ne pas utiliser si vous êtes allergique aux salicylates (EMA 2017; Brinker 2010; Wichtl 2004; ESCOP 2003; Barnes et al. 2002; Blumenthal et al. 2000).

Réaction(s) indésirable(s) connue(s)

Produits contenant du boswellia et/ou de la bromelaïne

Cessez l'utilisation si une hypersensibilité/allergie se manifeste (Martindale 2011; Brinker 2010; WHO 2009; Murray et Pizzorno 2006; Blumenthal et al. 2000; Baur et Fruhmann 1979).

Produits contenant du boswellia, de la bromelaïne, du collagène hydrolysé, du méthylsulfonylméthane et/ou de l'écorce de saule

Lorsque vous utilisez ce produit, vous pourriez souffrir souffrir d'inconfort gastro-intestinal/de troubles gastro-intestinaux (EMA 2017; Martindale 2011; Brinker 2010; Sontakke et al. 2007; Brien et al. 2006;Wichtl 2004; ESCOP 2003; Kimmatkar et al. 2003; Barnes et al. 2002; Blumenthal et al. 2000; McGuffin 2000).

Produits fournissant plus de 350 mg de magnésium par jour

Lorsque vous utilisez ce produit, vous pourriez souffrir de diarrhée (IOM 2006; IOM 1997).

Ingrédients non médicinaux

Doivent être choisis parmi ceux de la version actuelle de la Base de données sur les ingrédients des produits de santé naturels (BDIPSN) et respecter les restrictions mentionnées dans cette base de données.

Conditions d'entreposage

Doivent être établies conformément aux exigences décrites dans le Règlement sur les produits de santé naturels.

Produits contenant de l'huile de poisson, sauf ceux encapsulés

Réfrigérer après ouverture (Wille et Gonus 1989).

Produits contenant de l'huile de poisson (information pour l'industrie; pas pour l'étiquetage)

À être emballé dans un contenant hermétique à l'abri de la lumière (Ph.Eur. 2023; USP-NF 2023).

Produits contenant du collagène hydrolysé (information pour l'industrie; facultatif pour l'étiquetage selon l'emballage)

À entreposer à l'abri de la chaleur et de l'humidité (Ph.Eur. 2023).

Spécifications

• Les spécifications du produit fini doivent être établies conformément aux exigences décrites dans le Guide de référence sur la qualité des produits de santé naturels de la Direction des produits de santé naturels et sans ordonnance (BDIPSN)
• L'ingrédient médicinal doit être conforme aux exigences mentionnées dans la BDIPSN.
• Ingrédients provenant de tissus bovins

  Afin d'atténuer le risque de maladies du type encéphalopathie spongiforme transmissible (EST) provenant de produits dont la matière d'origine est de source bovine, les demandeurs de licence de mise en marché doivent posséder un certificat d'un vétérinaire et doivent s'assurer que les critères suivants ont été respectés (Ph.Eur. 2023):

  1. L'animal source est propre à la consommation humaine;
  2. La matière d'origine peut être retracée au troupeau ou à l'animal;
  3. La contamination croisée avec des tissus à fort potentiel infectieux est évitée lors de l'obtention de la matière d'origine;
  4. Les pratiques de fabrication réduisant le potentiel infectieux sont mises en application (p. ex. les pratiques conforment à celles énoncées au chapitre 5.2.8 de la Pharmacopée européenne 2012 'Réduction du risque de transmission des agents des encéphalopathies spongiformes animales par les médicaments à usage humain et vétérinaire').
• Huile de poisson
  1. Les niveaux de peroxyde, d'anisidine et les niveaux totaux d'oxydation de l'huile de poisson et des dérivés d'acides gras oméga-3 provenant de l'huile de poisson doivent respecter les normes établies par l'Association of Analytical Community (AOAC) et/ou les méthodes analytiques des pharmacopées. Ces spécifications assureront la résistance à l'oxydation de l'huile de poisson et des acides gras oméga-3 provenant de l'huile de poisson (SC 2015). Le niveau maximal de l'indice de peroxyde (IP) doit être 5 mEq/kg, le niveau maximal de l'indice d'anisidine (IA) doit être 20 tandis que le niveau maximal du total d'oxydation doit être 26 (calculé selon la formule : 2 X IP + IA).
  2. Les dioxines polychlorodibenzo-para-dioxines (PCDD) et polychlorodibenzofuranes (PCDF), les polychlorobiphényles de type dioxine (PCBTD) et les polychlorobiphényles (PCB) sont des contaminants présents dans les huiles marines. Des analyses pour détecter ces contaminants sont obligatoires. Tel que mentionné dans le Guide de référence sur la qualité des produits de santé naturels, il convient d'utiliser des méthodes d'analyse appropriées, comme la méthode n° 1613 (révision B) pour les PCDD et les PCDF et la méthode no 1668B pour les congénères de biphényles chlorés de l'EPA. Pour plus d'information, il est conseillé aux titulaires d'une licence de mise en marché de consulter les documents de la Commission européenne sur les dioxines et les PCB de type dioxine dans les huiles marines. Consultez le Guide de référence sur la qualité des produits de santé naturels pour obtenir plus d'informations sur les limites acceptables de dioxines et de PCB de type dioxine.
  3. Pour les huiles de poisson incluant des espèces de Gadidae comme matière d'origine, le contenu en vitamine A et D doit être testé afin d'assurer que les doses maximales quotidiennes rencontrent la monographie des Suppléments de multivitamines/minéraux pour chaque groupe d'âge.
• Bromélaïne
  1. Les détails de fabrication de l'enzyme à l'étape de la matière première doivent être fournis et doivent comprendre le milieu de fermentation et le procédé d'isolement des ingrédients médicinaux.
  2. Les spécifications doivent présenter l'analyse de l'activité enzymatique de l'ingrédient médicinal aux stades appropriés de la formulation et du procédé de fabrication conformément à l'épreuve décrite dans la version actuelle du Food Chemicals Codex (FCC) : PLANT PROTEOLYTIC ACTIVITY
  3. Lorsque les méthodes publiées ne sont pas appropriées, le fabriquant fera preuve de diligence raisonnable afin de s'assurer que les enzymes demeurent actives jusqu'à la fin de la période de conservation indiquée sur l'étiquette du produit.
• Sulfate de chondroitine

  L'ingrédient médicinal doit : i. Être conforme aux spécifications énoncées dans les monographies Chondroitin Sulfate Sodium publiées dans les pharmacopées britannique (BP) ou européenne (Ph. Eur.) ou, ii. Faire partie d'un fichier principal de produit de santé naturel (FP-PSN) approuvé par la DPSN. Une lettre d'autorisation d'accès du propriétaire enregistré du FP-PSN doit être fournie par le demandeur

• Acide hyaluronique
  
  1. L'information sur le poids moléculaire de l'acide hyaluronique pour la caractérisation doit être fournie sur demande (p. ex. certificat d'analyse, feuille de données techniques, information sur le produit, etc). Le poids moléculaire moyen de l'acide hyaluronique obtenu à partir de Gallus gallus comb doit être 800 kDa. Le poids moléculaire moyen de l'hyaluronate de sodium à obtenu à partir de Streptococcus equi doit être 900 kDa.
  2. L'information sur la méthode de préparation doit être fournie sur demande.
  3. Pour tous les produits obtenus par fermentation microbienne, les espèces de Streptococcus utilisées doivent être fournies sur demande et doivent être appuyées par des preuves. L'information sur les procédés de fabrication pour réduire ou éliminer les composantes pyrogéniques ou inflammatoires de la paroi cellulaire doit être fournie sur demande.
  4. Le contenu en glycosaminoglycanes sulfatés, en acides nucléiques, en protéines, et la contamination microbienne provenant de cet ingrédient doit respecter les méthodes indiquées dans la Pharmacopée européenne :
     • Glycosaminoglycanes sulfatés : maximum 1%, si l'ingrédient est extrait de la crête de Gallus gallus
     • Acides nucléiques : l'absorbance de la solution à 260 nm est au maximum 0,5
     • Protéines : maximum 0,3%
     • Contamination microbienne : Microorganismes aérobies totaux de 10² CFU/g.
• Collagène hydrolysé
  1. Pour les fins de cette monographie, le collagène hydrolysé ne forme pas de gel et est soluble dans l'eau froide (Schrieber et Gareis 2007; Moskowitz 2000).
  2. Le poids moléculaire moyen du collagène hydrolysé est approximativement de 4 kDa (c.-à-d. 2 à 6 kDa) (Moskowitz 2000; Oesser et al. 1999).

EXEMPLE D'INFO-PRODUIT :

Veuillez consulter la ligne directrice, Étiquetage des produits de santé naturels pour plus de détails.

Références citées

• ASHP 2005: American Society of Health-System Pharmacists. American Hospital Formulary Service (AHFS) Drug Information. Philadelphia (PA): Lippincott Williams and Wilkins; 2005.
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• Barnes J, Anderson LA, Philipson JD. Herbal Medicines: A Guide for Healthcare Professionals. 2nd edition. London (GB): The Pharmaceutical Press; 2002.
• Baur X, Fruhmann G. Allergic reactions, including asthma, to the pineapple protease bromelain following occupational exposure. Clinical Allergy 1979;9(5):443-450.
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