EP4221734A1 - Compositions with nigella sativa extracts - Google Patents
Compositions with nigella sativa extractsInfo
- Publication number
- EP4221734A1 EP4221734A1 EP21790797.1A EP21790797A EP4221734A1 EP 4221734 A1 EP4221734 A1 EP 4221734A1 EP 21790797 A EP21790797 A EP 21790797A EP 4221734 A1 EP4221734 A1 EP 4221734A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- cov
- sars
- nigella sativa
- treatment
- composition
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
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- 244000090896 Nigella sativa Species 0.000 title claims abstract description 40
- 235000016698 Nigella sativa Nutrition 0.000 title claims abstract description 38
- 239000001711 nigella sativa Substances 0.000 title claims abstract description 38
- 239000000284 extract Substances 0.000 title claims abstract description 18
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- KEQHJBNSCLWCAE-UHFFFAOYSA-N thymoquinone Chemical compound CC(C)C1=CC(=O)C(C)=CC1=O KEQHJBNSCLWCAE-UHFFFAOYSA-N 0.000 claims description 17
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 claims description 15
- MGSRCZKZVOBKFT-UHFFFAOYSA-N thymol Chemical compound CC(C)C1=CC=C(C)C=C1O MGSRCZKZVOBKFT-UHFFFAOYSA-N 0.000 claims description 14
- -1 a-hederin Chemical compound 0.000 claims description 12
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- KCFYEAOKVJSACF-UHFFFAOYSA-N umifenovir Chemical compound CN1C2=CC(Br)=C(O)C(CN(C)C)=C2C(C(=O)OCC)=C1CSC1=CC=CC=C1 KCFYEAOKVJSACF-UHFFFAOYSA-N 0.000 description 1
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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)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
-
- 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
- A61P31/12—Antivirals
- A61P31/14—Antivirals for RNA viruses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
Definitions
- compositions with Nigella sativa extracts Compositions with Nigella sativa extracts
- the present invention relates to compositions comprising Nigella sativa extracts and their use in the treatment of viral infections with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).
- SARS-CoV-2 Severe Acute Respiratory Syndrome Coronavirus 2
- Coronavirus Disease 2019 (COVID-19) has been widely spreading all over the world since the beginning of 2020. Although severe transient restrictions in economic and personal life helped to bring about a slowdown in the spreading of the disease, infections with SARS-CoV-2 are still quite frequently occurring and the number of infections is again rising in most countries. World Health Organization, on January 30, 2020, declared the spread of COVID-19 to be a public emergency of international concern. As of September 30, 2020, 33’692’221 cases and 1 ’008’842 deaths due to COVID-19 have been reported. The disease is transmitted via inhalation or contact with virus-containing droplets. The incubation period ranges from two to fourteen days or even longer. The estimated fatality rate ranges from two to three percent.
- the virus can be detected in respiratory secretions by special molecular tests, such as polymerase chain reaction (PCR) based tests detecting specific sequences in the RNA genome of SARS-CoV-2. Elevated levels of C-reactive protein have been detected in the blood samples of patients, while the white blood cell counts were considered normal.
- PCR polymerase chain reaction
- SARS-CoV-2 is far more infectious than its two ancestors, Severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV), SARS-CoV-2 has a lower mortality rate. To date, the impact of this pandemic is uncertain, and the global research community is working diligently to find a satisfactory therapy.
- SARS-CoV Severe acute respiratory syndrome coronavirus
- MERS-CoV Middle East respiratory syndrome coronavirus
- US 6 841 174 describes complex herbal compositions comprising herbal extracts of numerous plants.
- the composition is prepared in powder form using dried herbs.
- the herbal compositions are used for treating viral infections with hepatitis B and I or hepatitis C.
- the herbal compositions are administered to subjects in need thereof.
- a composition according to the present invention comprises an extract of Nigella sativa.
- the composition is for use in the treatment of a viral infection with SARS-CoV-2.
- Oil extraction may be done by press-extraction of Nigella sativa seeds and can be carried out using screw-less cold press (e.g. IBG Monforts Oekotec GmbH, Mdnchengladbach, Germany). Usually, the press-extraction is a coldpress procedure to utmost preserve the components of Nigella sativa oil.
- screw-less cold press e.g. IBG Monforts Oekotec GmbH, Mdnchengladbach, Germany.
- the press-extraction is a coldpress procedure to utmost preserve the components of Nigella sativa oil.
- aqueous and ethanolic extracts of Nigella sativa may be made as follows: Nigella sativa seeds were commercially obtained. The seeds were cleaned and dried and powdered using a mechanical grinder. For the aqueous extract, the seed powder (100 g) was added to 1000 mL hotwater, boiled for 15 minutes, and filtered through a cloth. The filtrate was evaporated to dryness under reduced pressure to obtain a viscous residue. The residue was suspended in normal saline solution. For the ethanolic extract, the seed powders (100 g) were defatted with petroleum ether (40° to 60°C) using a Soxhlet apparatus known in the art. Then, the powder was macerated in 800 mL ethanol (80%, v/v) for 72 hours, and the mixture was subsequently filtered and concentrated in vacuo at 40°C. The residue was suspended in saline solution.
- composition comprising the Nigella sativa extract may further comprise a pharmaceutically-acceptable carrier.
- the composition may also be encapsulated in pharmaceutically-acceptable capsules. Such capsules are known in the art and are commercially available.
- composition according to the present invention is very effective for use in the treatment of viral infections with SARS-CoV-2.
- SARS-CoV-2 various symptoms of a SARS-CoV-2 such as fever, (dry) cough, and shortness of breath are significantly alleviated within a few, typically about three days, from the beginning of the treatment.
- a second test on virus particles of SARS-CoV-2 performed twelve days after the first test, yielded a negative result.
- C-reactive protein a clinical parameter, which has been found to undergo significant changes in subject having a severe course of the Corona virus disease 19 (COVID-19) caused by SARS-CoV-2, showed a statistically significant decrease after a few days of treatment with compositions according to the present invention.
- CRP coronavirus protein
- almost no sideeffects were reported due to the intake of the composition according to the present invention.
- the side-effects of compositions according to the present invention for use in the treatment of a viral SARS-CoV-2 infection are minimal.
- the extract of Nigella sativa is further purified and comprises at least one active compound of Nigella sativa.
- the at least one active compound of Nigella sativa is selected from the group consisting of thymoquinone, thymohydroquinone, p-cymene, a-hederin, carvacrol, anethol, 4- terpineol, thymol, alpha-pinene, limonene, nigellidine, and sesquiterpene longifolene.
- the composition may also comprise a mixture of two, three or more active compounds of Nigella sativa.
- the compound thymoquinone of Nigella sativa is a preferred active compound.
- Thymoquinone is a phytochemical compound found in the plant Nigella sativa which can be steam distilled to produce an essential oil. In laboratory experiments in cells and in animals, it has shown anti-inflammatory and antioxidant effects, and it has been studied in models of cardiovascular diseases and diabetes, neurodegenerative diseases and stroke, and cancer.
- p-Cymene is a naturally occurring aromatic organic compound, p- Cymene is insoluble in water, but miscible with organic solvents. It is a constituent of a number of essential oils, most commonly the oil of cumin and thyme.
- a-Hederin (alpha-hederin) is a water-soluble pentacyclic triterpenoid saponin found in the seeds of Nigella sativa. a-Hederin has been shown to enhance the cytotoxicity of an established chemotherapeutic agent, 5- fluorouracil, in an animal model of colon carcinoma.
- Anethole is an organic compound that is widely used as a flavoring substance. It is a derivative of phenylpropene, a type of aromatic compound that occurs widely in nature, in essential oils.
- Thymol also known as 2-isopropyl-5-methylphenol, IPMP
- IPMP 2-isopropyl-5-methylphenol
- Thymol is a natural monoterpenoid phenol derivative of cymene, C10H14O, isomeric with carvacrol, found in oil of thyme, and extracted from Thymus vulgaris (common thyme), and various other kinds of plants as a white crystalline substance of a pleasant aromatic odor and strong antiseptic properties.
- Thymol also provides the distinctive, strong flavor of the culinary herb thyme, also produced from T. vulgaris.
- a-Pinene is an organic compound of the terpene class, one of two isomers of pinene. It is an alkene and it contains a reactive four-membered ring. It is found in the oils of many species of many coniferous trees, notably the pine. It is also found in the essential oil of rosemary (Rosmarinus officinalis) and Satureja myrtifolia.
- Limonene is a colorless liquid aliphatic hydrocarbon classified as a cyclic monoterpene, and is the major component in the oil of citrus fruit peels.
- the D- isomer occurring more commonly in nature as the fragrance of oranges, is a flavoring agent in food manufacturing. It is also used in chemical synthesis as a precursor to carvone and as a renewables-based solvent in cleaning products.
- the less common L-isomer is found in mint oils and has a piny, turpentine-like odor.
- the compound is one of the main volatile monoterpenes found in the resin of conifers, particularly in the Pinaceae, and of orange oil.
- the at least one active compound of the further purified extract of Nigella sativa is thymoquinone.
- thymoquinone may be combined with one or more further active compounds of Nigella sativa.
- further compounds are selected from the group consisting of thymohydroquinone, p-cymene, a-hederin, carvacrol, anethol, 4-terpineol, thymol, alpha-pinene, limonene, nigellidine, and sesquiterpene longifolene.
- composition comprising the extract of Nigella sativa for use in the treatment of a viral infection with SARS-CoV-2 further comprises tocopherol.
- Tocopherols are a class of organic chemical compounds (more precisely, various methylated phenols), many of which have vitamin E activity. Thus, tocopherols are also referred to as vitamin E. Vitamin E exists in eight different forms, four tocopherols and four tocotrienols. All feature a chromane ring, with a hydroxyl group that can donate a hydrogen atom to reduce free radicals and a hydrophobic side chain that allows for penetration into biological membranes. Both the tocopherols and tocotrienols occur in a (alpha), [3 (beta), y (gamma), and 5 (delta) forms, determined by the number and position of methyl groups on the chromanol ring.
- Alpha-tocopherol is the form of vitamin E that is preferentially absorbed and accumulated in humans.
- the measurement of "vitamin E” activity in international units (III) was based on fertility enhancement by the prevention of miscarriages in pregnant rats relative to a-tocopherol.
- Tocotrienols although less commonly known, also belong to the vitamin E family.
- compositions according to the present invention is a-tocopherol.
- the composition according to the present invention for use in the treatment of a viral infection with SARS-CoV-2 further comprises an iron oxide compound.
- Iron oxides are chemical compounds composed of iron and oxygen.
- the iron oxide compound has oxidation state of (II) or (III), examples are Fe2Os and FesC .
- iron oxides There is a number of known iron oxides, the best known of which is rust, a form of iron (III) oxide.
- Iron oxides and oxyhydroxides are widespread in nature and play an important role in many geological and biological processes. They are used as iron ores, pigments, catalysts, and in thermite, and occur in hemoglobin.
- the Nigella sativa extract comprising composition may further comprise an iron comprising compound for use in the treatment of a viral infection with SARS-CoV-2.
- an iron comprising compound is ferrous fumarate.
- Kit of parts that comprises the composition for use in the treatment of a viral infection with SARS-CoV-2 according to the present invention and composition comprising ferrite nanoparticles.
- the ferrite nanoparticles are solubilized or suspended in a solution suitable for intravenous injection.
- the ferrite nanoparticles are selected from the group consisting of magnetite (FesC ) and maghemite (Fe2Os).
- the ferrite nanoparticles may be used in further method of treatment termed magnetic hyperthermia.
- Magnetic hyperthermia or biologically targeted magnetic hyperthermia may be used as an adjuvant treatment in subjects with a viral infection with SARS-CoV-2.
- compositions comprising an extract of Nigella sativa for use in the treatment of viral infections with SARS- CoV-2 magnetic hyperthermia or biologically targeted magnetic hyperthermia amplifies the effect of the Nigella sativa comprising composition.
- the ferrite nanoparticles are biologically targeted such that they accumulate in the desired cells, tissue or biological structure. Targeting may for instance be achieved by way of an appropriate surface coating of the ferrite nanoparticles, e.g.
- such coating may comprise antibodies, parts of antibodies or other ligands the preferentially bind to the desired target cells or biological structure.
- an application of an alternating magnetic field follows to raise the temperature in the target cells or the target tissue.
- hyperthermia the mild elevation of temperature (to 40-43°C) of cells or tissue in a living organism, can induce cell death and enhance the effects of another treatment, for example an antiviral treatment, by enhancing its cytotoxic effects.
- CRP serum C-reactive protein
- CRP Creprivated level of CRP may be a valuable early marker in predicting the possibility of disease progression in non-severe patients with COVID-19, which can help health workers to identify those patients an early stage for early treatment.
- COVID-19 patients with elevated levels of CRP need close monitoring and treatment even though they did not develop symptoms to meet the criteria for the severe disease course.
- a number of pharmaceutical and biological properties have been ascribed to the A/, sativa such as antifungal, antibacterial, antiparasitic, and antiviral activity.
- Thymoquinon has shown efficacy against a variety of diseases, such as neurological and mental illnesses, cardiovascular disorders, cancer, diabetes, inflammatory conditions, and infertility.
- Nigella sativa has also recently gained increasing attention due to its strong antioxidant properties, leading to its frequent use as a dietary supplement.
- thymoquinone has demonstrated synergistic effects with various chemotherapeutic agents, optimizing efficacy and reducing toxicity.
- a composition comprising an extract of Nigella sativa for use in the treatment of a viral infection with SARS-CoV-2 comprises the following ingredients: an extract of Nigella sativa (Nigella sativa oil), vitamin E, and an iron compound.
- the iron compound comprises iron in its Fe 2+ or its Fe 3+ state, i.e. as Fe 2+ or Fe 3+ ion. Fe 2+ ions are preferred.
- iron compounds are iron oxide such as Fe2Os or FesC .
- Another example of an iron compound that may be used is iron(ll) fumarate (ferrous fumarate).
- Nigella sativa oil is in the range of 10OOmg to 2000mg, preferably 1500mg.
- Vitamin E is in the range of 20mg to 40mg, preferably 30mg.
- the iron compound related to the weight of the Fe ion is in the range of 0.5mg to 3mg, preferably in the range of 1.5mg to 2mg, and more preferred 2.0mg.
- the Nigella sativa comprising composition may additionally comprise pharmaceutically acceptable auxiliary compounds.
- the Nigella sativa comprising compound is preferably contained in a capsule which is made of pharmaceutically acceptable compounds.
- Table 2 shows the detailed information and the outcome in those patients with suspected or confirmed COVID-19
- the therapy which has been given to all patients consists of a combine capsule of NS and Vitamin E (ex. Alpinamed Schwarzkummeldl, Schwarzkummel plus capsules) with and without Iron oxide.
- the therapy demonstrated a statistically significant time to improvement (mean time 3days) in clinical and respiratory symptoms and reduction in measured CRP.
- the Nigella sativa extract comprising composition used for the treatment of the COVID-patients had almost no undesired side effects.
- RT-PCR tests are considered the gold standard for detecting many viruses, and quite a number of different tests are commericially available.
- testing conditions and process are far from perfect, and accuracy suffers. It is still unclear what the real-world false positive rate is, but clinical sensitivity of RT-PCR tests ranges from 66% to 80%. That means nearly one in three infected people who are tested will receive false negative results.
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Virology (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Molecular Biology (AREA)
- Organic Chemistry (AREA)
- Alternative & Traditional Medicine (AREA)
- Biotechnology (AREA)
- Botany (AREA)
- Medical Informatics (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Medicines Containing Plant Substances (AREA)
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Abstract
Description
Claims
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP20199971.1A EP3978008A1 (en) | 2020-10-03 | 2020-10-03 | Compositions with nigella sativa extracts |
PCT/EP2021/077207 WO2022069757A1 (en) | 2020-10-03 | 2021-10-03 | Compositions with nigella sativa extracts |
Publications (1)
Publication Number | Publication Date |
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EP4221734A1 true EP4221734A1 (en) | 2023-08-09 |
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EP20199971.1A Withdrawn EP3978008A1 (en) | 2020-10-03 | 2020-10-03 | Compositions with nigella sativa extracts |
EP21790797.1A Pending EP4221734A1 (en) | 2020-10-03 | 2021-10-03 | Compositions with nigella sativa extracts |
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EP20199971.1A Withdrawn EP3978008A1 (en) | 2020-10-03 | 2020-10-03 | Compositions with nigella sativa extracts |
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EP (2) | EP3978008A1 (en) |
WO (1) | WO2022069757A1 (en) |
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US6841174B2 (en) | 2000-09-20 | 2005-01-11 | Zeyad Technologies Llc | Herbal compositions and treatment methods |
-
2020
- 2020-10-03 EP EP20199971.1A patent/EP3978008A1/en not_active Withdrawn
-
2021
- 2021-10-03 WO PCT/EP2021/077207 patent/WO2022069757A1/en unknown
- 2021-10-03 EP EP21790797.1A patent/EP4221734A1/en active Pending
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WO2022069757A1 (en) | 2022-04-07 |
EP3978008A1 (en) | 2022-04-06 |
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