WO2011134667A2 - Hydrolysats d'extraits végétaux sélectionnés et agent antibactérien contenant ces hydrolysats - Google Patents

Hydrolysats d'extraits végétaux sélectionnés et agent antibactérien contenant ces hydrolysats Download PDF

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Publication number
WO2011134667A2
WO2011134667A2 PCT/EP2011/002150 EP2011002150W WO2011134667A2 WO 2011134667 A2 WO2011134667 A2 WO 2011134667A2 EP 2011002150 W EP2011002150 W EP 2011002150W WO 2011134667 A2 WO2011134667 A2 WO 2011134667A2
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WO
WIPO (PCT)
Prior art keywords
hydrolyzate
aqueous
formulation
antibacterial agent
antibacterial
Prior art date
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PCT/EP2011/002150
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German (de)
English (en)
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WO2011134667A3 (fr
Inventor
Michael Popp
Original Assignee
Bionorica Se
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Publication date
Application filed by Bionorica Se filed Critical Bionorica Se
Publication of WO2011134667A2 publication Critical patent/WO2011134667A2/fr
Publication of WO2011134667A3 publication Critical patent/WO2011134667A3/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents

Definitions

  • the invention relates to a hydrolyzate of at least one extract of at least one plant material selected from Primulae radix, Levisticum radix and Guaiacum officinalis or a mixture or subcombination thereof and a process for the preparation and its use. Furthermore, the
  • Sinupret® is a registered trademark of the applicant Bionorica and has been used as a secretolytic in infections, especially in the upper respiratory tract and especially in over 70 years
  • antibacterial agents consisting of vegetable hydrolysates of unrelated genera are known in
  • Sinusitis can be acute or chronic. Both forms are common, with sinusitis occurring in three out of four cases as a result of an extension of the
  • the nasal sinuses are among the upper respiratory tract.
  • the respiratory tracts extend from the nasal main cavity to the
  • the paranasal sinuses include sinuses, ethmoidal cells, sphenoid sinuses, and maxillary sinuses. All mentioned
  • Ankle cavities are internally lined with mucous membrane and open into the nasal cavity through narrow openings called ostia.
  • Airway is covered, dirt particles and
  • the mucous membrane must have unimpeded protection and cleaning mechanisms. For the removal of the mucus loaded with pathogens, it is essential that the cilia can work unhindered and transport the mucus through their undulating motion. In an infection, the protective and cleaning mechanisms of the mucous membrane are no longer
  • Viruses like rhinoviruses, adenoviruses or coronaviruses
  • Mucosa swells and produces increased mucus. It comes first to aqueous, then to viscous mucus flow. In the course of inflammation of the nasal mucosa, the ostia of the sinuses can swell and mucus can thus no longer drain into the nose. As a result of the swollen mucous membrane and ciliated by viscous mucous cilia, it can be a chronic
  • Ciliated epithelium can be permanently damaged.
  • Staphylococcus aureus Staphylococcus
  • Staphylococcus are ENT-relevant pathogens that invade the mucus
  • MRSA anti-meticillin-resistant Staphylococcus strain
  • Standard antibiotics such as beta-lactam antibiotics, for example, are directed against these bacteria. Oxacillin, penicillin and amoxicillin no effect, so that the pathogen can not be completely killed and resistant MRSA bacterial strains have developed.
  • the invention particularly relates to a hydrolyzate
  • Tonsipret® registered trademark of Tonsipret
  • Lovage root The whole or cut, dried rhizome and the roots of Levisticum officinale Koch (PhEur). The PhEur calls for a minimum content of essential oil.
  • Lovage root is a herbal medicine with a diuretic effect, which is used to treat
  • Urinary tract infections used in indigestion and as a spice.
  • Canephron® (registered trademark of BIONORICA SE) is a well-known blend of three plant drugs, namely Centaurium erythraea (centaury), Levisticum radix (lovage, powder of lovage root), Rosmarinus officinalis
  • Plant materials is provided.
  • composition with which one can achieve a sufficient effect for medicinal purposes.
  • This composition is particularly suitable for the treatment of urinary tract infections and has at least anti-inflammatory effects in the urinary tract.
  • the invention also relates to a combination of the hydrolyzate Levisticum radix (Lovage root) with
  • Centaurium erythraea centaury
  • Rosmarinus officinalis (rosemary, powder of rosemary leaves) and their hydrolyzates in the sense of the present invention
  • the plants according to the invention can be obtained, as usual, for the particular plant drug from preferred plant parts, such as leaf, root, etc.
  • a preferred hydrolyzate is characterized in that the extracts by means of an extractant from 40 to 60 vol .-%, in particular 50 vol. -% ethanol and 40 - 60 vol .-%, in particular 50 vol. -% water from the plant material over 24 h with stirring and subsequent vacuum evaporation of the solvent can be produced.
  • a further preferred embodiment of the invention resides in a hydrolyzate which is obtained by hydrolytic treatment of the plant extracts with hydrochloric acid as mineral acid, in particular with hydrochloric acid of a concentration of 1 M to 10 M,
  • ethanol in particular ethanol diluted with water, preferably 50% by volume of ethanol.
  • the displacement of the extracts with the mineral acid can be carried out after removal of the extractant or with the
  • hydrolyzate means an aqueous phase obtained from the extract of the plant according to the invention (ndroge) in which the hydrolysis products are enriched, the hydrolysis preferably taking place under the action of acid such as hydrochloric acid, phosphoric acid, sulfuric acid,
  • the extract in particular dilute mineral acid.
  • the extract can be obtained, for example, by an aqueous / ethanolic extract of a plant (ndroge) by means of
  • aqueous acid are added, evaporated to dryness and then taken up in water.
  • the hydrolysis causes the chemical cleavage of ingredients, formally a hydrogen and a hydroxide are added to the respective cleavage product.
  • the extracts are post-mixed
  • Acid treatment step to dryness preferably in water, a buffer or in dilute ethanol, and optionally with a pharmaceutically acceptable base neutralized.
  • a pharmaceutically acceptable base for this purpose, not as a base, for example, NaOH, Na 2 C0 3 or Na 2 HP0 4 into consideration.
  • hydrolysates according to the invention have an antibacterial effect.
  • hydrolysates of the present invention are known in the
  • the hydrolysates of the present invention can be used to prepare antibacterial agents
  • Streptococcus pneumoniae Streptococcus mutans and / or Gram-negative rod bacteria, in particular Haemophilus influenzae and / or MRSA (methicillin-resistant
  • Staphylococcus aureus The hydrolysates were tested in the context of the present invention against the following pathogens relevant to ENT and respiratory tract: Staphylococcus aureus (ATCC 25923), Staphylococcus epidermidis (ATCC 12228), Streptococcus pneumoniae (DSMZ 20566), Streptococcus pyogenes (DSMZ 20565), Streptococcus mutans (ATCC 35668), Haemophilus influenzae (DSMZ 4690), Klebsiella pneumoniae (ATCC 13883), and
  • VRE Enterococcus casseliflavus
  • DSMZ 20680 the intestinal bacteria Escherichia coli
  • VRE Enterococcus faecalis
  • Pseudomonas aeruginosa Pseudomonas aeruginosa
  • Burkholderia cepacia Pseudomonas aeruginosa
  • Hydrolysates of the present invention can be used to prepare an antibacterial agent.
  • Antibacterial agents may protect and / or
  • Treatment of infections are preferably used orally or topically on skin and mucous membranes, palates in the form of a galenic formulation corresponding to their application.
  • Antibacterial agents of the present invention are characterized by comprising the oral formulations such as dragees, tablets, coated tablets, powders, capsules or liquid dilutions, in particular drops, juices or syrups.
  • Gum deposits, tamponades, tonsillar brush solutions, gargling solutions or rinsing solutions for nose and ear are also suitable for dental applications.
  • Rinse solutions for the nose and ear are beneficial in combination with physiological or hyperosmolar
  • a preparation present as a lyophilisate has many advantages, in particular during storage and long-term stability.
  • the antibacterial agents of the present invention may, of course, be
  • the hydrolysates according to the invention show a broad, partially pronounced antibacterial action against skin, respiratory and ENT-relevant pathogens, which in tests were considerably more pronounced on their antibacterial activity than was the case with unhydrolysed extracts.
  • antibacterial susceptibility testing with the Mueller-Hinton agar diffusion assay (Mueller, H. J. and Hinton, J. (1941): A protein-free medium for primary Isolation of the Gonococcus and Meningococcus. Proc. Soc.
  • Agar diffusion test showed virtually no antibacterial activity against the tested bacterial reference panel. Furthermore, MIC90 tests were performed as outlined in the examples.
  • the preparations of the invention are also characterized by a good compatibility in the
  • the antibacterial agent of the present invention is particularly effective against the following pathogens, especially against Gram positive cocci such as Staphylococcus aureus,
  • the present invention also relates to the use of the hydrolysates and antibacterial agents according to the invention for the manufacture of a medicament for the treatment of infections, in particular respiratory tract and ENT infections caused by pathogens and ENT-relevant pathogens.
  • the invention relates to a process for the preparation of hydrolysates obtainable from at least one aqueous / ethanolic extract
  • the invention also relates to a process for the preparation of an antibacterial agent, wherein from at least one plant according to the invention (ndroge) in a first step
  • aqueous / ethanolic extract is prepared and added in a second step, the extract obtained with an aqueous acid and the aqueous fractions are collected and optionally. Dried.
  • the hydrolyzates obtained can be converted into a dry mass.
  • a dry mass In a preferred embodiment, a
  • drying methods are also usable.
  • the invention relates to a corresponding antibacterial agent or the use of the hydrolysates according to the invention as an antibacterial agent.
  • the invention also relates to a medicament consisting of a hydrolyzate according to the invention
  • infection covers all diseases caused by the invasive invasion of bacteria in or on the
  • Infectious disease is caused by the infectious (transmissibility or Kontagiostician, adhesiveness or tenacity, Penetration or invasiveness, proliferation and vitality) and pathogenic properties of the bacterium (pathogenicity) significantly determined.
  • infectious transmissibility or Kontagiostician, adhesiveness or tenacity, Penetration or invasiveness, proliferation and vitality
  • pathogenic properties of the bacterium pathogenicity significantly determined.
  • parenteral percutaneous (over the skin), permucous (via the mucous membranes), inhalation infection; b) enteral (via the
  • Intestine c) over a wound; d) directly from human or mammal to human or mammal, e.g. B. as a droplet infection,
  • Intermediate carriers or intermediate hosts such as. an infection chain; with gradients like a) foudroyant (faster
  • Respiratory infections covers all forms of inflammation and / or respiratory infections caused by bacteria, especially tonsillitis, sinusitis and rhinitis.
  • “Respiratory tract” means the respiratory tract to the alveoli; the upper respiratory tract includes the nasal cavity with its sinuses and the pharynx where the airway crosses the food pathway. The lower respiratory tract begins with the
  • the invention relates to a pharmaceutical
  • antibacterial agents may take the form of
  • a single dose preferably contains the amount of active ingredient which is administered in one application and which usually corresponds to a whole, a half, a third or a quarter of a daily dose.
  • Carriers are solid, semi-solid or liquid
  • Preferred pharmaceutical formulations are in
  • Extender e.g. Starches, lactose, cane sugar, glucose, mannitol and silicic acid
  • binders e.g.
  • Polyvinylpyrrolidone c) humectants, e.g. Glycerine, d) disintegrants, e.g. Agar-agar, calcium carbonate and
  • Sodium carbonate e) dissolution inhibitor, e.g. Paraffin and f) absorption enhancer, e.g. quaternary ammonium compounds, g) wetting agents, e.g. Cetyl alcohol, glycerol monostearate, h) adsorbents, e.g. Kaolin and bentonite and i)
  • dissolution inhibitor e.g. Paraffin
  • absorption enhancer e.g. quaternary ammonium compounds
  • wetting agents e.g. Cetyl alcohol, glycerol monostearate
  • adsorbents e.g. Kaolin and bentonite and i)
  • Lubricants eg talc, calcium and magnesium stearate and solid polyethylene glycols or mixtures of the substances listed under a) to i).
  • the tablets, dragees, capsules, pills and granules can be mixed with the usual, optionally opacifying
  • the active ingredient (s) may optionally also be incorporated with one or more of the excipients listed above
  • microencapsulated form is a microencapsulated form.
  • Suppositories may contain, besides the active ingredient (s), the usual water-soluble or water-insoluble excipients, e.g. Polyethylene glycols, fats, e.g. Cocoa fat and higher esters (e.g., C14 alcohol with C16 fatty acid) or
  • Ointments, pastes, creams and gels may contain, in addition to the active substance (s), the usual excipients, e.g.
  • Powders and sprays may contain, in addition to the active substance (s), the usual excipients, e.g. Lactose, talc, silicic acid, aluminum hydroxide, calcium silicate and
  • Sprays may additionally contain the usual propellants.
  • Solutions and emulsions may contain, in addition to the active substance (s), the customary carriers such as solvents, solubilizers and emulsifiers, e.g. Water, ethyl alcohol, isopropyl alcohol, ethyl carbonate, ethyl acetate, benzyl alcohol, benzyl benzoate, propylene glycol, 1,3-butylene glycol, dimethylformamide, oils, in particular cottonseed oil, peanut oil, corn oil, olive oil, castor oil and sesame oil, glycerol, glycerol formal,
  • solvents e.g. Water, ethyl alcohol, isopropyl alcohol, ethyl carbonate, ethyl acetate, benzyl alcohol, benzyl benzoate, propylene glycol, 1,3-butylene glycol, dimethylformamide, oils, in particular cottonseed oil, peanut oil, corn oil, olive oil, castor oil and sesame
  • Tetrahydrofurfuryl alcohol polyethylene glycols and Fatty acid esters of sorbitan or mixtures of these substances.
  • Suspensions may contain, in addition to the active substance (s), the usual excipients such as liquid diluents, e.g. Water, ethyl alcohol, propylene glycol, suspending agent, e.g. ethoxylated isostearyl alcohols, polyoxyethylene sorbitol and sorbitan esters, microcrystalline cellulose,
  • liquid diluents e.g. Water, ethyl alcohol, propylene glycol
  • suspending agent e.g. ethoxylated isostearyl alcohols, polyoxyethylene sorbitol and sorbitan esters, microcrystalline cellulose
  • Formulations may also include colorants,
  • Preservatives and odor and flavor improving additives e.g. Peppermint oil and eucalyptus oil and sweeteners, e.g. Saccharin, included.
  • the MIC (or MIC) of the cultured bacteria is after
  • the minimum inhibitory concentration, or MIC for short, is the smallest active ingredient concentration of an antimicrobial substance (e.g., an antibiotic) containing the
  • MIC90 / MIC90 Minimum inhibitory concentration for 90% of strains tested. Based on the minimum inhibitory concentration can be one
  • Plate diffusion test or E-test is usually given in ⁇ g / ml.
  • the agar dilution test was applied: 10 milliliters of Brain Heart Infusion (BHI) or Fildes Broth (for H.
  • BHI Brain Heart Infusion
  • Fildes Broth for H.
  • Influenza were infected with 5 colonies of bacterial strains
  • Bacterial suspension was subcultured in the culture for 2.5 hours at 36 +/- 1 degree Celcius. Subsequently, the
  • Bacterial strain was added to the extract test solution in 96 well microtiter plates. Positive growth controls of bacterial strains in the extract test solutions were performed with basal medium.
  • MIC 90 values were determined by counting colonies according to DIN59049-7, 2 hours after incubation, with slight modifications, as follows: 100
  • Microliters of a bacterial culture were added in a test tube with 1 ml of a sterile 0.9% sodium chloride solution, followed by a 10-fold dilution, namely 10 1 , 10 2 and 10 3 . Thereafter, 100 microliters were removed and opened streaked twice on an agar plate, with an exposure time of 18 - 24 hours at 36 +/- 1 degrees Celsius in the presence of room air or CO2 for Streptococcus sp.
  • MRSA Ulti-Resistant Staphylococcus Aureus
  • VRE 2 vancomycin-resistant enterococcus

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  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
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  • Epidemiology (AREA)
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  • Communicable Diseases (AREA)
  • Oncology (AREA)
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  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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Abstract

L'invention concerne un hydrolysat d'au moins un extrait d'au moins une matière végétale, choisie parmi Primulae radix, Levisticum radix et Guaiacum officinalis, ou un mélange ou une sous-combinaison de ceux-ci, ainsi qu'un procédé de préparation et l'utilisation de cet hydrolysat. L'invention concerne en outre un agent antibactérien pouvant être obtenu à partir de cet hydrolysat ainsi que des médicaments, destinés en particulier au traitement de maladies infectieuses.
PCT/EP2011/002150 2010-04-29 2011-04-29 Hydrolysats d'extraits végétaux sélectionnés et agent antibactérien contenant ces hydrolysats WO2011134667A2 (fr)

Applications Claiming Priority (2)

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DE102010018835 2010-04-29
DE102010018835.2 2010-04-29

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WO2011134667A3 WO2011134667A3 (fr) 2011-12-29

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023124920A1 (fr) * 2021-12-31 2023-07-06 上海纳米技术及应用国家工程研究中心有限公司 Procédé de préparation d'un liquide antifongique modifié à partir de plantes naturelles et produit associé

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0753306B1 (fr) 1995-07-10 1998-08-05 Plantamed Arzneimittel GmbH Procédé d'obtention de préparations pharmaceutiques à haute teneur en huiles essentielles et phénols
EP1368605B1 (fr) 2001-03-12 2005-11-09 Bionorica AG Procede permettant de produire des extraits secs sans les alterer
WO2009056316A1 (fr) 2007-10-31 2009-05-07 Bionorica Ag Hydrolysats d'extraits végétaux et agent anti-bactérien les contenant
WO2010049542A2 (fr) 2008-10-31 2010-05-06 Bionorica Ag Hydrolysats issus d'extraits végétaux et agent antibactérien contenant ces hydrolysats
WO2010125171A2 (fr) 2009-04-29 2010-11-04 Bionorica Se Composition cosmétique ou dermatologique contenant des hydrolysats d'extraits végétaux

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102009041753A1 (de) * 2009-09-16 2011-03-24 Bionorica Se Wasch-, Reinigungs- oder Desinfektionsmittel enthaltend Hydrolysate aus Pflanzenextrakten
DE102009050407A1 (de) * 2009-10-22 2011-06-22 Bionorica SE, 92318 Entzündungshemmendes Mittel enthaltend Hydrolysate aus Pflanzenextrakten

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0753306B1 (fr) 1995-07-10 1998-08-05 Plantamed Arzneimittel GmbH Procédé d'obtention de préparations pharmaceutiques à haute teneur en huiles essentielles et phénols
EP1368605B1 (fr) 2001-03-12 2005-11-09 Bionorica AG Procede permettant de produire des extraits secs sans les alterer
WO2009056316A1 (fr) 2007-10-31 2009-05-07 Bionorica Ag Hydrolysats d'extraits végétaux et agent anti-bactérien les contenant
WO2010049542A2 (fr) 2008-10-31 2010-05-06 Bionorica Ag Hydrolysats issus d'extraits végétaux et agent antibactérien contenant ces hydrolysats
WO2010125171A2 (fr) 2009-04-29 2010-11-04 Bionorica Se Composition cosmétique ou dermatologique contenant des hydrolysats d'extraits végétaux

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
MUELLER, H.J., HINTON, J.: "A protein-free medium for primary isolation of the Gonococcus and Meningococcus", PROC. SOC. EXPT. BIOL. MED., vol. 48, 1941, pages 330 - 333, XP055070290, DOI: doi:10.3181/00379727-48-13311

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023124920A1 (fr) * 2021-12-31 2023-07-06 上海纳米技术及应用国家工程研究中心有限公司 Procédé de préparation d'un liquide antifongique modifié à partir de plantes naturelles et produit associé

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