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)
  • A61K36/88—Liliopsida (monocotyledons)
  • A61K36/906—Zingiberaceae (Ginger family)
  • A61K36/9066—Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K33/00—Medicinal preparations containing inorganic active ingredients
  • A61K33/14—Alkali metal chlorides; Alkaline earth metal chlorides
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
  • A61K35/56—Materials from animals other than mammals
  • A61K35/63—Arthropods
  • A61K35/64—Insects, e.g. bees, wasps or fleas
  • A61K35/644—Beeswax; Propolis; Royal jelly; Honey
• • 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
  • 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)
  • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
• • 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)
  • A61K36/70—Polygonaceae (Buckwheat family), e.g. spineflower or dock
• • 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)
  • A61K36/88—Liliopsida (monocotyledons)
  • A61K36/889—Arecaceae, Palmae or Palmaceae (Palm family), e.g. date or coconut palm or palmetto
• • 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)
  • A61K36/88—Liliopsida (monocotyledons)
  • A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
  • A61K36/8962—Allium, e.g. garden onion, leek, garlic or chives
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
  • A61K47/46—Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/0012—Galenical forms characterised by the site of application
  • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
  • A61L26/0057—Ingredients of undetermined constitution or reaction products thereof
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P17/00—Drugs for dermatological disorders
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P17/00—Drugs for dermatological disorders
  • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like

Definitions

• the invention relates to the use of a preparation for treatment of chronic infected wounds
• the wounds include diabetes foot ulcers and gangrene in addition to an antiviral activity.
• Wound healing is a complex biological process that aims to repair damaged tissue (Korblatt et al. 2016). More than 6.5 million Americans suffer from chronic, non-healing wounds, generating annual healthcare costs of more than $25 billion (Sen et al. 2009). These numbers are expected to increase with the growth of high-risk populations, including the increase in number of patients suffering from diabetes and obesity, as well as the elderly. The significant disability and costs to society associated with chronic wounds highlight the inadequacy of our current therapeutic armamentarium (Whittam et al. 2016).
• the composition comprises a mixture of Allium sativum, Ferula assa-foetida, Curcuma longa, Acacia nilotica, Calligonum comosum, Phoenix dactylifera with sodium chloride mixed in honey, and then burnt to form a powdery composition.
• the powdery composition is then mixed with at least one of water, honey, cream, oil or a gel. In one aspect, the preparation has been burnt and afterwards suspended in water.
• the method for the preparation comprises mixing the Allium sativum, Ferula an.na-foetida, Curcuma longa, Acacia nilotica, Calligonum comosum, Phoenix dactylifera with sodium chloride and honey and subsequently burning the mixture to produce a powdery composition.
• the preparation may be used for the treatment of gangrene, skin ulcers, or eczema.
• Figure 1 shows the antibacterial and antifungal activity of the HSAR preparation.
• Figure 2 shows the antiviral activity of the aqueous extract.
• Figures 3A & 3B show a goat udder with deep injury.
• Figure 4A shows a foot with gangrene before treatment.
• Figure 4B shows the foot after treatment.
• Figure 5 shows a diabetic foot ulcer with gangrene after treatment.
• Figure 6 shows the fingers after treatment.
• Figure 7 A shows a varicose vein with ulcer before treatment.
• Figure 7B shows the varicose vein with ulcer during treatment.
• Figures 7C and 7D show the varicose vein with ulcer after treatment.
• Figure 8A shows a hand with eczema before treatment
• Figure 8B shows the hand after treatment with the FIS AR preparation.
• HSAR Preparation The following herbs were cleaned, ground and mixed together in equal proportions: Allium sativum /Garlic/, Ferula assa-foetida (type of dried latex), Curcuma longa (Turmeric), seeds of Acacia nilotica (gum Arabic tree), Aerial parts of Calligonum comosum, Phoenix dactylifera (Dates) together with Salt (NaCl) (lg per kg of the ground herb) were mixed properly with honey (250ml per kg) to form a thick paste.
• the honey as an Acacia honey, but this is not limiting of the invention.
• the paste was then heated over an open fire in air atmosphere (because of the undesired smell of Ferula and garlic) for almost three hours until the paste burned completely and turned to black charcoal.
• the black charcoal was then powdered (called HSAR) and ready to be used.
• the HSAR preparation forms the paste as an emulsion when suspended in honey, oil, cream or a gel.
• the oils can be saturated vegetable oils or animal fats.
• the cream is typically one used as the base of a moisturizing cream.
• the HSAR preparation may be applied as a powder especially in case of wet wounds. All ingredients were purchased from local market in Abu Dhabi.
• Luria-Birtani broth was prepared as follows: Tryptone 10 g /L (HiMedia, India), Yeast extract 5 g /L (HiMedia, India), and sodium chloride 10 g /L (HiMedia, India) at pH 7.2. This medium was used in all the protocols. In case of Luria-Birtani agar (LA) 14 g /L of agar bacteriology No.1 (HiMedia, Mumbai, India) was used for culture maintenance. Bacterial dilutions from 18 h LB cultures grown at 37°C were carried out in phosphate buffered saline (PBS, Oxoid, UK).
• PBS phosphate buffered saline
• the‘soft layer agar’ used was LB prepared in Lambda- buffer [6 mmol /L Tris pH 7.2; 10 mmol/L Mg(S04)2.7H20; 50 mg/L gelatin (Oxoid, UK)] and supplemented with 4 g /L agar bacteriology No. 1 (HiMedia, India). Potato Dextrose Broth and Agar (Fluka, USA) were used to maintain Candida.
• Pseudomonas aeruginosa ATCC 25668 Staphylococcus aureus ATCC 6538, Escherichia coli NTCC 12900 and Candida albicans (Patient isolates from UAE hospitals) were used to evaluate the antimicrobial activity of the composition.
• Pseudomonas aeruginosa ATCC 25668 was used throughout the antibacterial activity as well as antiviral activity investigations. Cultures were stored at -20°C in 15% glycerol. Prior to investigation, a stock culture of the microorganism was maintained on an LA plate.
• Antibacterial and antifungal activity Antimicrobial activity of 10% of the HSAR composition in distilled water (w/v) was evaluated using strains of Pseudomonas aeruginosa ATCC 25668, Staphylococcus aureus ATCC 6538, Escherichia coli NTCC 12900 and Candida albicans. Aliquots of 18 hours broth of each microorganism was mixed with 10% HSAR composition suspension, PBS was used for control, all tubes were incubated for 24 hours at 37 C, Candida albicans was incubated in 30 C. The antimicrobial activities were quantitatively investigated using Miles and Misra method (Miles and Misra, 1938).
• Figure 1 shows the antibacterial and antifungal activity of the HSAR preparation. It can be seen that the HSAR preparation was very effective against P. aeruginosa ATCC 25668 with more than six log reduction, Escherichia coli NTCC 12900 with two log reduction and C. albicans with one log reduction, while did not show any activity against S. aureus ATCC 6538 and C. albicans. This is probably due to differences in the cell walls.
• Bacteriophages The virus that was used in this study was lytic Pseudomonas phage ATCC 14209-B1.
• the phage stocks were prepared on the host strain, P. aeruginosa ATCC 25668, by a plate lysis procedure (Davis and Sinsheimer, 1963; Vidaver, 1973; Sambrook, et al. 1989 ; Ausubel, et al. 1991). Briefly, an aliquot (100 ml) of the phage sample (10-fold serially diluted with Lambda-buffer) was mixed with 100 ml of an overnight LB culture of P.
• aeruginosa ATCC 25668 in a sterile 1.5 ml Eppendorf micro-centrifuge tube (Greiner bio-one) and incubated for 15 min at 37°C to facilitate attachment of the bacteriophage to the host cells.
• the mixture was transferred from the Eppendorf micro-centrifuge tube to a 5 ml Bijou bottle and then 2 ml of soft layer agar was added which had been melted and cooled to 40°C in a water bath. The contents of each bottle were then gently mixed by swirling, poured over the surface of a plate of LA and allowed to set for 15 min at room temperature.
• the plates were incubated for 18 h at 37°C, and a plate showing almost confluent plaques was used to prepare a concentrated phage suspension by overlaying with 5ml of Lambda buffer [titer 10 11 plaque-forming units per ml (pfu /ml)].
• the final purification process used chloroform to separate the bacteriophage from the bacterial cells (Ausubel, et al. 1991).
• the phage stocks, at a titer of 10 11 pfu/ml, were maintained in Lambda- buffer at 4°C.
• phage inactivation was performed as previously described (Adams, 1959). Briefly, an aliquot (100 m ⁇ ) of phage suspension containing 10 10 pfu was added to 900 m ⁇ of 10% HS AR in distilled water (w/v) in an Eppendorf micro-centrifuge tube, the control contained 900 m ⁇ of lambda buffer, all in triplicate. Tubes were kept at room temperature for 18 hours. The number of the survived bacteriophages was measured by enumerating the pfu count.
• Eigure 2 shows the antiviral activity of the aqueous extract, which is determined by enumerating the pfu count of survived phages.
• the HSAR 10% suspension induced 2 log reductions in phage titer (From 10 9 to 10 7 PFU/ml) in 18 hours.
• Such a reduction in the titer of Pseudomonas bacteriophage which is known for its resistance to alcohols, organic acids and alkalines (Jones, 1991) makes the present aqueous extract an absolutely promising antiviral extract.
• Farm animal model Figures 3 A & 3B show a goat udder with deep injury dropping milk
• Figure 3A illustrates the goat udder deep injury before treatment and Figure 3B shows the goat udder after treatment with the HSAR
• FIG. 4A shows the foot with the gangrene before treatment with the HSAR preparation.
• Figure 4B shows the foot after treatment with the HSAR preparation.
• the wound was totally covered by the HSAR preparation in powder form and which sticks to the wet wound. The powder then gradually falls off when the powder become dry and will be replaced by new powder once a day at night for approximately one month until the wound was found to be cured and new healthy skin is generated.
• a second case is gangrene in which amputation was also recommended.
• the patient was male, 53 years, and had a diabetic foot ulcer.
• the patient refused amputation and used the HSAR composition.
• Figure 5 shows the diabetic foot ulcer with gangrene after treatment once a day with the HSAR composition for about one month.
• Figures 7A, 7B, 7C & 7D The patient was a male, 60 years, and did not respond to the provided medical interventions. After one and half year of suffering the patient applied the HSAR preparation.
• Figure 7A shows the varicose vein with ulcer before treatment.
• Figure 7B shows the varicose vein with ulcer during treatment with the HSRA preparation and figures 7C and 7D show the varicose vein with ulcer after two weeks of treatment with the HSAR preparation.
• FIGs 8A & 8B The application to the treatment of eczema is illustrated in Figures 8A & 8B.
• the patient was female, 12 years old, and had had eczema for the last three years on her hand. Treatment once a day was made by the HSAR preparation.
• Figure 8 A shows the hand with eczema before treatment with the HSAR preparation and
• Figure 8B shows the hand after one week of treatment with the HSAR preparation.
• Bacteriophage f6 a lipid-containing virus of Pseudomonas phaseolicola. J. Virol. 11 :799-805

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• 2018
  • 2018-01-30 GB GB1801466.2A patent/GB2570508A/en not_active Withdrawn
• 2019
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  • 2019-01-30 CN CN201980003785.9A patent/CN111065402A/zh active Pending
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