US20170100441A1 - Composition for treatment of vitiligo - Google Patents

Composition for treatment of vitiligo Download PDF

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Publication number
US20170100441A1
US20170100441A1 US15/388,514 US201615388514A US2017100441A1 US 20170100441 A1 US20170100441 A1 US 20170100441A1 US 201615388514 A US201615388514 A US 201615388514A US 2017100441 A1 US2017100441 A1 US 2017100441A1
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polarized
composition
scorpion venom
lipoic acid
alpha lipoic
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US15/388,514
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Arthur Mikaelian
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/1767Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from invertebrates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56Materials from animals other than mammals
    • A61K35/63Arthropods
    • A61K35/646Arachnids, e.g. spiders, scorpions, ticks or mites
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/38Heterocyclic compounds having sulfur as a ring hetero atom
    • A61K31/381Heterocyclic compounds having sulfur as a ring hetero atom having five-membered rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/04Immunostimulants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Definitions

  • the present disclosure relates generally to a pharmaceutical or therapeutic composition for treating diseases associated with pigment loss. More specifically, the present disclosure relates to a composition comprising polarized and nanosized blue scorpion venom and polarized and nanosized alpha lipoic acid, a method of manufacture thereof, and a method of administration of that composition for treating Vitiligo.
  • Vitiligo is due to the loss or destruction of melanocytes, which are the cells that produce melanin. Melanin determines the color of an individual's skin, hair, and eyes. If melanocytes cannot form melanin or if the number of melanocytes decreases, skin, hair, and eye color may become progressively lighter.
  • Vitiligo The exact cause of Vitiligo is unknown, but there are three main theories on what might be the cause: 1) the pigment cells are injured by abnormally functioning nerve cells; 2) there is an autoimmune reaction against the pigment cells; or 3) the pigment cells self-destruct.
  • Vitiligo affects 0.5% to 1% of the population, and occurs in all races. It may be more common in certain locations, such as India, with reports of up to 8.8% of the population affected. In about 50% of affected individuals, pigment loss begins before the age of 20 years old, and in about 80% of affected individuals, pigment loss begins before the age of 30 years old. In about 20% of affected individuals, Vitiligo is present in one or more other members of that person's family. Males and females appear to be equally affected by Vitiligo.
  • autoimmune diseases such as diabetes, thyroid disease, pernicious anemia (B12 deficiency), Addison's disease (adrenal gland disease), systemic lupus erythematosus, rheumatoid arthritis, psoriasis, and alopecia areata (round patches of hair loss).
  • the present specification discloses a polarized scorpion venom solution useful for the treatment of Vitiligo and other diseases associated with pigment loss.
  • One embodiment may be a composition for treating vitiligo, the composition comprising: a blue scorpion venom; and an alpha lipoic acid.
  • the blue scorpion venom may be diluted in a distilled water, such that a dilute blue scorpion venom is created.
  • the dilute blue scorpion venom may be polarized, such that a polarized blue scorpion venom is created; and wherein the alpha lipoic acid may be polarized, such that a polarized alpha lipoic acid is created.
  • the polarized blue scorpion venom may be polarized by circulating the dilute blue scorpion venom between at least one set of two paired and aligned magnets; and wherein the alpha lipoic acid is polarized by circulating the alpha lipoic acid between the at least one set of two paired and aligned magnets.
  • Each set of magnets of the at least one set of two paired and aligned magnets may mirror each other, such that the magnets repel each other.
  • the polarized blue scorpion venom and the polarized alpha lipoic acid may be nanosized.
  • a particle size reduction machine may be used to nanosize the polarized blue scorpion venom and the polarized alpha lipoic acid, such that a polarized and nanosized blue scorpion venom is created and a polarized and nanosized alpha lipoic acid is created.
  • the at least one set of two paired and aligned magnets are operatively coupled to a power source, such that a frequency of the at least one set of two paired and aligned magnets is set.
  • the polarized and nanosized blue scorpion venom and the polarized and nanosized alpha lipoic acid may comprise the two active ingredients of the composition, and the composition may be ingested orally by a patient suffering from vitiligo as part of a treatment regimen, such that the patient's skin has an enhanced re-pigmentation as a result of the treatment.
  • the composition may further comprises: one or more vitamins
  • the one or more vitamins may comprise: vitamin B1; vitamin B3; vitamin B6; vitamin B7; vitamin B12; vitamin C; vitamin D3; and vitamin E.
  • the composition may further comprise one or more minerals.
  • the one or more minerals comprise: zinc gluconate; copper gluconate; potassium sorbate; and potassium benzoate.
  • the polarized and nanosized blue scorpion venom may be in an amount from 0.001 to 0.005 percent by weight based on a total weight of the composition.
  • the polarized and nanosized blue scorpion venom is in an amount of 0.003 percent by weight based on a total weight of the composition.
  • the polarized and nanosized alpha lipoic acid may be in an amount from 1.0 to 2.0 percent by weight based on a total weight of the composition.
  • the polarized and nanosized alpha lipoic acid may be in an amount of 1.58 percent by weight based on a total weight of the composition.
  • Another embodiment may be method of treating vitiligo comprising the steps: creating a vitiligo treatment composition comprising: a blue scorpion venom and an alpha lipoic acid; wherein the vitiligo treatment composition is ingested orally by a patient suffering from vitiligo as part of a treatment regimen, such that the patient's skin has an enhanced re-pigmentation.
  • the steps may further comprise: diluting the blue scorpion venom to create a dilute blue scorpion venom; polarizing the dilute blue scorpion venom to create a polarized blue scorpion venom; polarizing the alpha lipoic acid to create a polarized alpha lipoic acid; nanosizing the polarized blue scorpion venom to create a polarized and nanosized blue scorpion venom; and nanosizing the polarized alpha lipoic acid to create a polarized and nanosized alpha lipoic acid.
  • the polarized blue scorpion venom and the polarized alpha lipoic acid may be polarized by a polarization method comprising the steps: providing one or more tubes that are configured to allow the polarized blue scorpion venom or the polarized alpha lipoic acid to circulate through; providing one or more pairs of magnets, wherein each pair of the one or more pairs of magnets are aligned and spaced apart, such that one of the one or more tubes is sandwiched between the one or more aligned pairs of magnets; circulating the diluted blue scorpion venom through the one or more tubes; and circulating the alpha lipoic acid through the one or more tubes.
  • the nanosizing may comprise the steps: providing a particle size reduction machine; adding the polarized blue scorpion venom to the particle size reduction machine, such that a polarized and nanosized blue scorpion venom is created; and adding the polarized alpha lipoic acid to the particle size reduction machine such that a polarized and nanosized alpha lipoic acid is created.
  • the composition may substantially halt the progression of vitiligo, restore melanocytes, and/or restore the normal function of T-cells, such that the T-cells no longer recognize melanocytes as foreign to the body.
  • the composition may comprise active ingredients of alpha lipoic acid and the venom extract of the Rhopalurus princeps scorpion (Blue Scorpion).
  • the active ingredients are polarized and/or nanosized.
  • the alpha lipoic acid is an organosulfur compound that has antioxidant properties, which has been shown to prevent or alleviate symptoms of vitamins A and E deficiencies.
  • Alpha lipoic acid may he used to take up reactive oxygen and nitrogen, which makes alpha lipoic acid an excellent compound to help reduce the oxidative stress in the skin and prevent the destruction of melanocytes by the harmful free radicals.
  • the composition may be mixture of the polarized scorpion venom, the polarized alpha lipoic acid, and various vitamins and supplements.
  • FIG. 1 is an illustration of a particle size reduction machine, such as a Microfluidizer®, for nanosizing polarized blue scorpion venom and polarized alpha lipoic acid.
  • a particle size reduction machine such as a Microfluidizer®, for nanosizing polarized blue scorpion venom and polarized alpha lipoic acid.
  • FIG. 2 is a graph of the raw data displayed in FIG. 3 of an analysis of the particle size ( ⁇ m) of the alpha lipoic acid before particle size reduction.
  • FIG. 3 is an illustration showing the raw data used to create the graph in FIG. 2 .
  • FIG. 4 is a graph of the raw data displayed in FIG. 5 of an analysis of the particle size ( ⁇ m) of the alpha lipoic acid after particle size reduction.
  • FIG. 5 is an illustration showing the raw data used to create the graph in FIG. 4 .
  • FIG. 6 is a graph of the raw data displayed in FIG. 7 of an analysis of the particle size ( ⁇ m) of the escozine (scorpion venom) after particle size reduction.
  • FIG. 7 is an illustration showing the raw data used to create the graph in FIG. 6 .
  • FIG. 8 is a graph of the raw data displayed in FIG. 9 of an analysis of the particle size ( ⁇ m) of the escozine (scorpion venom) before particle size reduction.
  • FIG. 9 is an illustration showing the raw data used to create the graph in FIG. 8 .
  • FIG. 10 is a graph that overlays data showing the overall effectiveness of repigmentation after using a blue scorpion venom composition.
  • FIG. 11 is a graph that overlays data showing the progression of repigmentation after using a blue scorpion venom composition.
  • the terms “approximately” and “about” generally refer to a deviance of within 5% of the indicated number or range of numbers. In one embodiment, the term “approximately” and “about”, may refer to a deviance of between 1-10% from the indicated number or range of numbers.
  • particle size reduction machine generally refers to a machine that reduces the particle size of a homogenized composition.
  • One type of particle size reduction machine is a Microfluidizer®, which uses fluid pressure and shear forces to achieve uniform target nanoparticle size.
  • the present disclosure discloses a scorpion venom composition, a method of manufacture thereof, and a method of administration of that composition for treating Vitiligo.
  • the present disclosure discloses a scorpion venom composition, a method of manufacture thereof, and a method of administration of that composition for treating acne, eczema, hives (urticarial), pityriasis rosea, psoriasis, rosacea, shingles (herpes zoster).
  • the active ingredients of the composition are polarized and nanosized blue scorpion venom and polarized and nanosized alpha lipoic acid.
  • the composition may also be referred to as Adios Vitiligo.
  • Blue scorpion venom is obtained from the venom of Rhopalurus junceus, also referred to as blue scorpion.
  • the venom is preferably extracted from a bioterium of blue scorpions in order to obtain the quantity of venom necessary to produce an organic, natural, and health composition.
  • the blue scorpion venom is a complex mixture of salts, small molecules, peptides, and other proteins.
  • a laboratory may filter the blue scorpion venom using a glass fiber membrane filter that is preferably 0.80 ⁇ m, 25 mm, 1 pk/50 pcs. These parameters may ensure the sterilization and purification of the blue scorpion venom.
  • the blue scorpion venom may be combined with chilled, medical-quality distilled water to achieve a specifically maintained concentration within a sterilized environment.
  • the dilute blue scorpion venom contains 0.0003 ml of venom per 0.9997 ml of distilled water (totaling 1 ml of prepared dilute solution) for treatment of Vitiligo.
  • the dilute blue scorpion venom and alpha lipoic acid are polarized separately.
  • the preferred process for polarizing dilute blue scorpion venom and alpha lipoic acid is the Mikaelian Polarized Liquid Process, named after the current inventor.
  • the first steps in the polarization process preferably, may be to circulate the dilute blue scorpion venom or alpha lipoic acid repeatedly through plastic or glass tubes.
  • the tubes may be one and a half (1.5) centimeters in diameter, but they may be any diameter, and may be made from any malleable or rigid, non-metallic material.
  • the circulation may be performed by one or more small pumps.
  • the next step of the process may be to place, along the pump or tubes, a series of flat magnets.
  • these magnets may be placed in pairs along the opposite sides of the tubes and may be aligned so that the negative poles and positive poles of the magnets mirror one another so that the magnets repel one another.
  • the magnets may be then compressed with one or more non-metallic, preferably wooden, clamps so that the magnets remain in place.
  • the magnets may be compressed to within two millimeters of one another, also compressing the tubes so that the water must flow through a small gap between the magnets. Two millimeters is a preferred compression point, any greater or lesser compression point may be used, so long as the liquid can flow within the tube, without deviating from the scope of the disclosure.
  • the dilute blue scorpion venom or alpha lipoic acid may be circulated through this tube lined with pairs of magnets for an extended period of time.
  • the resulting polarized liquid compared to non-polarized liquid, may be absorbed far more rapidly into the human and may be significantly more bio-available on a cellular level, resulting in significantly improved results.
  • Polarization also called wave polarization, is an expression of the orientation of the lines of electric flux in an electromagnetic field (EM field).
  • EM field electromagnetic field
  • Polarization technology has been widely used in different industries such as radio transmissions, wireless communication systems, food industry, sun glasses, etc. Polarization can be used on many different compounds.
  • a resonance effect can be achieved that can modify the quality of the product without changing its molecular structure.
  • Using a resonance effect can increase and/or decrease the potency of molecules depending on the frequency used.
  • each pair of rare earth magnets may be two BLP2-6120-110 magnets with similar polarities.
  • the north pole of the magnet may be determined, such as with a compass, and marked on the magnet.
  • Each pair of magnets is aligned such that their north poles are in a mirror position, which causes the magnets to repel each other.
  • the magnets may be connected to a power source, such a Chroma® 61501 AC power source. This allows the setting of the frequencies of the magnets.
  • the power source preferably provides 500 VA single-phase, 0-300 VAC or 0-424 VDC output. At full power, the power source may deliver up to 6:1 Crest Factor loads, DC/15 Hz to 1 kHz.
  • the magnets may be electromagnets or permanent rare earth magnets.
  • the polarization may be tested using a polarimeter, such as an Autopol V Plus polarimeter. In this manner the molecular rotation angle may be determined.
  • a liquid polarized using this method is one that is created using intense magnetic resistance (IMR).
  • IMR intense magnetic resistance
  • the IMR uses magnetic repulsion and the fluids circulating through the IMR filed are subject to maolecular polarization that strongly affects the geometric relationships between the molecules the electromagnetic fields surrounding those molecules. This effect is commercially significant.
  • FIG. 1 is an illustration of a particle reduction machine 100 for nanosizing polarized blue scorpion venom and polarized alpha lipoic acid.
  • either polarized blue scorpion venom or polarized alpha lipoic acid may be input into an inlet reservoir 105 that supports high solid content.
  • a high-pressure pump 110 may generate forces up to 40,000 psi (2578 bar) to force the polarized blue scorpion venom or polarized alpha lipoic acid stream into precisely engineered microchannels within a fixed-geometry interaction chamber 115 . Because particle reduction technology has the ability to control shear rates, the smallest pressure required is typically used.
  • the polarized blue scorpion venom or polarized alpha lipoic acid may be exposed to consistent and intense impact and shear forces before it is immediately cooled. This repeatable process may result in tiny particles with a uniform distribution.
  • Table 1 shows the particle size ( ⁇ m) of alpha lipoic acid before particle size reduction.
  • FIG. 2 is a graph of the raw data displayed in FIG. 3 of an analysis of the particle size ( ⁇ m) of the alpha lipoic acid before particle size reduction.
  • FIG. 3 is an illustration showing the raw data used to create the graph in FIG. 2 .
  • Table 2 shows the particle size ( ⁇ m) of alpha lipoic acid after particle size reduction.
  • FIG. 4 is a graph of the raw data displayed in FIG. 5 of an analysis of the particle size ( ⁇ m) of the alpha lipoic acid after particle size reduction.
  • FIG. 5 is an illustration showing the raw data used to create the graph in FIG. 4 .
  • Table 3 shows the particle size ( ⁇ m) of blue scorpion venom after particle size reduction.
  • FIG. 6 is a graph of the raw data displayed in FIG. 7 of an analysis of the particle size ( ⁇ m) of the escozine (scorpion venom) after particle size reduction.
  • FIG. 7 is an illustration showing the raw data used to create the graph in FIG. 6 .
  • Table 4 shows the particle size ( ⁇ m) of blue scorpion venom before particle size reduction.
  • FIG. 8 is a graph of the raw data displayed in FIG. 9 of an analysis of the particle size ( ⁇ m) of the escozine (scorpion venom) before particle size reduction.
  • FIG. 9 is an illustration showing the raw data used to create the graph in FIG. 8 .
  • Table 5 shows the preferred amount of one or more vitamins and minerals of one embodiment of the composition.
  • the vitamins and minerals may be combined with the active ingredients, polarized and nanosized blue scorpion venom and polarized and nanosized alpha lipoic acid, and/or minerals to create the final composition.
  • Table 5 also lists amount range (g/ml), weight range (%), and preferred weight range (%). This is based on a 450 ml bottle of final product
  • polarization of the active ingredients, alpha lipoic acid and blue scorpion venom may be performed.
  • nanoparticle reduction of the active ingredients may be performed.
  • the polarized and nanosized active ingredients may then be mixed and a final weight recorded and prepared for shipment to a manufacturing facility.
  • the manufacturing facility may prepare the polarized and nanosized active ingredient mixture for identification, sample labeling, and microbiology testing.
  • the inactive ingredients listed in Phase I of Table 5 may be weighed.
  • the alpha lipoic acid and glycerin 99.7% of Phase I may be added to a first mixing vessel and blended until the mixture has become homogenous.
  • Phase I Purified water, potassium sorbate, and potassium benzoate
  • the ingredients from the first mixing vessel and the second mixing vessel may be combined and blended until a final Phase I mixture has become homogenous.
  • the inactive ingredients of Phase II of Table 5 may be weighed. Then all of the ingredients from Phase II, except for the citric acid, may be slowly added the mixing vessel containing the final Phase I mixture, until the final composition is formed. The mixing vessel may be blended until the final composition has become homogenous. At this point, the pH of the final composition is tested by adding the citric acid ingredient from Phase II until a target pH of 3.81 is reached.
  • a bulk version of the composition may be transferred into a sealed, sterilized bulk container and the container then transferred into to a refrigerated environment.
  • the composition is preferably refrigerated and maintained at a range between 12 to 14 C (52 F-58 F). Blue scorpion venom may degrade at an accelerated rate when exposed to bright light and thus the dark refrigerated storage environment should be protected from light and without internal illumination. Further, the composition has tendency to separate from water when suspended in water for an extended period of time.
  • the sealed bulk container is preferably agitated in a back and forth manner for no less than 30 minutes before being transferred into individual containers. During the packaging process the bulk container should be continuously agitated through stirring.
  • the final step of the process is packaging and bottling.
  • the bulk composition is transferred in a sterilized environment into individual one liter bottles, which should include labels, air-tight seals, and opaque containers, which protect the composition from degradation due to inappropriate exposure to light.
  • the containers are pre-sterilized before being filled with the composition.
  • the process of packaging is time sensitive. Undo exposure to air and excessive temperatures will undermine the potency of the composition. As such, time is a sensitive issue with the product. Exposed to room temperature, the process cannot be extended past a few (approximately four) hours from removal from refrigeration to completion of bottling.
  • bottling is done in a highly air conditioned environment (lower than 15 C or 58 F) or if the distilled water used in production is chilled (through prior refrigeration) then the period of production from removal from refrigeration to finalized bottling can be extended. Eight (8) hours for highly chilled distilled water; twelve (12) hours for highly refrigerated environment.
  • bottles of the final composition are to be stored in a dark, refrigerated environment maintained, as preferred, at a temperature between 12 and 14 C (52 F and 58 F) where they will wait until final shipping.
  • the bottle may comprise 450 mL of the final composition.
  • a single dose of the final composition may be a 15 mL dose.
  • the 15 mL dose may comprise 0.00005 to 0.00015 mL of blue scorpion venom. There may be 0.0001 mL blue scorpion venom in the 15 mL dose.
  • the 15 mL dose may comprise 0.04 to 0.06 g of alpha lipoic acid. There may be 0.0527 g of alpha lipoic acid in the 15 mL dose.
  • the 15 mL dose may also comprise:
  • the composition is preferably tested for bacterial contaminants, chemical contaminants, and concentration. Standard microbial and mass spectrometry tests are preferably used. If possible, no product should be shipped to a customer until the batch has undergone testing for purity.
  • Standard testing procedures such as Lowry's method for determining protein concentration should be used to quantitatively evaluate the composition. Other types of procedures, known in the art, may also be used. Batches should be rejected if bacterial or chemical contaminants are found, or if more than 5% of the bottles test for levels of any chemical naturally found within the blue scorpion venom, but at a higher or lower concentration in excess of 10% deviation from the standard concentration per standardized mass spectrometry of the blue scorpion venom.
  • FIG. 10 is a graph 200 which overlays data showing the overall effectiveness of repigmentation in study patients after treatment with the composition.
  • men and women ranging from 5 to 80 years old, who were suffering from Vitiligo were chosen as patients.
  • the patients were monitored once before starting the intake, and then monitored once a month thereafter to evaluate the effectiveness of the composition by observing changes to pigmentation on the patient's skin.
  • FIG. 2 within 30 days of treatment with the composition, 29 individuals had recovery of pigmentation up to 20%. Within 60 days of treatment, 64 individuals had recovery of pigmentation up to 40%.
  • FIG. 11 is a graph 300 which overlays data showing the progression of repigmentation after using the composition.
  • 35 patients reported positive repigmentation results.
  • 85 patients reported positive repigmentation results.
  • 116 patients reported positive repigmentation results.
  • the composition is highly effective at enhancing re-pigmentation and may be used as or part of a treatment regimen for patients suffering for Vitiligo.

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Abstract

A composition for treating vitiligo and a method of making the same, said composition comprising: a blue scorpion venom; and an alpha lipoic acid. Preferably, the blue scorpion venom is diluted, polarized, and nanosized. Preferably the alpha lipoic acid is polarized and nanosized. The composition may also comprise various vitamins and minerals.

Description

    CROSS-REFERENCE TO RELATED APPLICATIONS
  • This U.S. Non-Provisional Patent Application is a Continuation-in-Part Patent Application of U.S. Non-Provisional patent application Ser. No. 14/632,973, filed on Feb. 26, 2015, titled “Polarized Scorpion Venom Solution and a Method for Making Polarized Scorpion Venom Solution,” by sole inventor Arthur Mikaelian, the contents of which are expressly incorporated herein by this reference as though set forth in their entirety, and to which priority and benefit are claimed. U.S. Non-Provisional patent application Ser. No. 14/632,973 is a Continuation Application of U.S. Non-Provisional patent application Ser. No. 13/849,008, filed on Mar. 22, 2013, titled “Polarized Scorpion Venom Solution and a Method for Making Polarized Scorpion Venom Solution,” by sole inventor Arthur Mikaelian, the contents of which are expressly incorporated herein by this reference as though set forth in their entirety. U.S. Non-Provisional patent application Ser. No. 13/849,008 is a Continuation Application of U.S. Non-Provisional patent application Ser. No. 13/323,669, filed on Dec. 12, 2011, titled “Polarized Scorpion Venom Solution and a Method for Making Polarized Scorpion Venom Solution,” by sole inventor Arthur Mikaelian, the contents of which are expressly incorporated herein by this reference as though set forth in their entirety. U.S. Non-Provisional patent application Ser. No. 13/323,669 is a Continuation Application of U.S. Non-Provisional patent application Ser. No. 12/270,664, now U.S. Pat. No. 8,097,284, filed on Nov. 13, 2008, titled “Polarized Scorpion Venom Solution and a Method for Making Polarized Scorpion Venom Solution,” by sole inventor Arthur Mikaelian, the contents of which are expressly incorporated herein by this reference as though set forth in their entirety. U.S. Non-Provisional patent application Ser. No. 12/270,664 claims priority from and benefit of U.S. Provisional Patent Application No. 60/987,756, filed on Nov. 13, 2007, titled “Analgesic, Antiinflammatory, Immunity Boosting, Antitumoral, and Cancer Preventing and Treating Methodology Using Organic, Modified, and Magnetically Polarized Scorpion Venom and Synthetics Thereof,” by sole inventor Arthur Mikaelian, the contents of which are expressly incorporated herein by this reference as though set forth in their entirety.
  • FIELD
  • The present disclosure relates generally to a pharmaceutical or therapeutic composition for treating diseases associated with pigment loss. More specifically, the present disclosure relates to a composition comprising polarized and nanosized blue scorpion venom and polarized and nanosized alpha lipoic acid, a method of manufacture thereof, and a method of administration of that composition for treating Vitiligo.
  • BACKGROUND
  • Vitiligo is due to the loss or destruction of melanocytes, which are the cells that produce melanin. Melanin determines the color of an individual's skin, hair, and eyes. If melanocytes cannot form melanin or if the number of melanocytes decreases, skin, hair, and eye color may become progressively lighter.
  • The exact cause of Vitiligo is unknown, but there are three main theories on what might be the cause: 1) the pigment cells are injured by abnormally functioning nerve cells; 2) there is an autoimmune reaction against the pigment cells; or 3) the pigment cells self-destruct.
  • Vitiligo affects 0.5% to 1% of the population, and occurs in all races. It may be more common in certain locations, such as India, with reports of up to 8.8% of the population affected. In about 50% of affected individuals, pigment loss begins before the age of 20 years old, and in about 80% of affected individuals, pigment loss begins before the age of 30 years old. In about 20% of affected individuals, Vitiligo is present in one or more other members of that person's family. Males and females appear to be equally affected by Vitiligo.
  • Even though most individuals with Vitiligo are in good health, they may face a greater risk of autoimmune diseases such as diabetes, thyroid disease, pernicious anemia (B12 deficiency), Addison's disease (adrenal gland disease), systemic lupus erythematosus, rheumatoid arthritis, psoriasis, and alopecia areata (round patches of hair loss).
  • Currently, there is no cure for Vitiligo but several treatment options are available. An affected individual may use applied steroids and ultraviolet light (phototherapy). However, due to the high risk of skin cancer associated with phototherapy, the United Kingdom's National Health Service suggests that phototherapy only be used if primary treatments are ineffective. Lesions located on the hands, feet, and joints are typically the most difficult to repigment and those on the face are easiest to return to the natural skin color.
  • Thus, there exists the need for an effective solution to treat Vitiligo and other diseases associated with pigment loss.
  • SUMMARY
  • To minimize the limitations in the cited references, and to minimize other limitations that will become apparent upon reading and understanding the present specification, the present specification discloses a polarized scorpion venom solution useful for the treatment of Vitiligo and other diseases associated with pigment loss.
  • One embodiment may be a composition for treating vitiligo, the composition comprising: a blue scorpion venom; and an alpha lipoic acid. The blue scorpion venom may be diluted in a distilled water, such that a dilute blue scorpion venom is created. The dilute blue scorpion venom may be polarized, such that a polarized blue scorpion venom is created; and wherein the alpha lipoic acid may be polarized, such that a polarized alpha lipoic acid is created. The polarized blue scorpion venom may be polarized by circulating the dilute blue scorpion venom between at least one set of two paired and aligned magnets; and wherein the alpha lipoic acid is polarized by circulating the alpha lipoic acid between the at least one set of two paired and aligned magnets. Each set of magnets of the at least one set of two paired and aligned magnets may mirror each other, such that the magnets repel each other. The polarized blue scorpion venom and the polarized alpha lipoic acid may be nanosized. A particle size reduction machine may be used to nanosize the polarized blue scorpion venom and the polarized alpha lipoic acid, such that a polarized and nanosized blue scorpion venom is created and a polarized and nanosized alpha lipoic acid is created. The at least one set of two paired and aligned magnets are operatively coupled to a power source, such that a frequency of the at least one set of two paired and aligned magnets is set. The polarized and nanosized blue scorpion venom and the polarized and nanosized alpha lipoic acid may comprise the two active ingredients of the composition, and the composition may be ingested orally by a patient suffering from vitiligo as part of a treatment regimen, such that the patient's skin has an enhanced re-pigmentation as a result of the treatment. The composition may further comprises: one or more vitamins The one or more vitamins may comprise: vitamin B1; vitamin B3; vitamin B6; vitamin B7; vitamin B12; vitamin C; vitamin D3; and vitamin E. The composition may further comprise one or more minerals. The one or more minerals comprise: zinc gluconate; copper gluconate; potassium sorbate; and potassium benzoate. The polarized and nanosized blue scorpion venom may be in an amount from 0.001 to 0.005 percent by weight based on a total weight of the composition. The polarized and nanosized blue scorpion venom is in an amount of 0.003 percent by weight based on a total weight of the composition. The polarized and nanosized alpha lipoic acid may be in an amount from 1.0 to 2.0 percent by weight based on a total weight of the composition. The polarized and nanosized alpha lipoic acid may be in an amount of 1.58 percent by weight based on a total weight of the composition.
  • Another embodiment may be method of treating vitiligo comprising the steps: creating a vitiligo treatment composition comprising: a blue scorpion venom and an alpha lipoic acid; wherein the vitiligo treatment composition is ingested orally by a patient suffering from vitiligo as part of a treatment regimen, such that the patient's skin has an enhanced re-pigmentation. The steps may further comprise: diluting the blue scorpion venom to create a dilute blue scorpion venom; polarizing the dilute blue scorpion venom to create a polarized blue scorpion venom; polarizing the alpha lipoic acid to create a polarized alpha lipoic acid; nanosizing the polarized blue scorpion venom to create a polarized and nanosized blue scorpion venom; and nanosizing the polarized alpha lipoic acid to create a polarized and nanosized alpha lipoic acid. The polarized blue scorpion venom and the polarized alpha lipoic acid may be polarized by a polarization method comprising the steps: providing one or more tubes that are configured to allow the polarized blue scorpion venom or the polarized alpha lipoic acid to circulate through; providing one or more pairs of magnets, wherein each pair of the one or more pairs of magnets are aligned and spaced apart, such that one of the one or more tubes is sandwiched between the one or more aligned pairs of magnets; circulating the diluted blue scorpion venom through the one or more tubes; and circulating the alpha lipoic acid through the one or more tubes. The nanosizing may comprise the steps: providing a particle size reduction machine; adding the polarized blue scorpion venom to the particle size reduction machine, such that a polarized and nanosized blue scorpion venom is created; and adding the polarized alpha lipoic acid to the particle size reduction machine such that a polarized and nanosized alpha lipoic acid is created.
  • in one embodiment, the composition may substantially halt the progression of vitiligo, restore melanocytes, and/or restore the normal function of T-cells, such that the T-cells no longer recognize melanocytes as foreign to the body.
  • In one embodiment, the composition may comprise active ingredients of alpha lipoic acid and the venom extract of the Rhopalurus princeps scorpion (Blue Scorpion). Preferably, the active ingredients are polarized and/or nanosized. The alpha lipoic acid is an organosulfur compound that has antioxidant properties, which has been shown to prevent or alleviate symptoms of vitamins A and E deficiencies. Alpha lipoic acid may he used to take up reactive oxygen and nitrogen, which makes alpha lipoic acid an excellent compound to help reduce the oxidative stress in the skin and prevent the destruction of melanocytes by the harmful free radicals.
  • In a preferred embodiment, the composition may be mixture of the polarized scorpion venom, the polarized alpha lipoic acid, and various vitamins and supplements.
  • It is an object of the present disclosure to overcome the limitations of the prior art.
  • Additional embodiments of the disclosure will be understood from the detailed description of the disclosure.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • The drawings show illustrative embodiments, but do not depict all embodiments. Other embodiments may be used in addition to or instead of the illustrative embodiments. Details that may be apparent or unnecessary may be omitted for the purpose of saving space or for more effective illustrations. Some embodiments may be practiced with additional components or steps and/or without some or all components or steps provided in the illustrations. When different drawings contain the same numeral, that numeral refers to the same or similar components or steps.
  • FIG. 1 is an illustration of a particle size reduction machine, such as a Microfluidizer®, for nanosizing polarized blue scorpion venom and polarized alpha lipoic acid.
  • FIG. 2 is a graph of the raw data displayed in FIG. 3 of an analysis of the particle size (μm) of the alpha lipoic acid before particle size reduction.
  • FIG. 3 is an illustration showing the raw data used to create the graph in FIG. 2.
  • FIG. 4 is a graph of the raw data displayed in FIG. 5 of an analysis of the particle size (μm) of the alpha lipoic acid after particle size reduction.
  • FIG. 5 is an illustration showing the raw data used to create the graph in FIG. 4.
  • FIG. 6 is a graph of the raw data displayed in FIG. 7 of an analysis of the particle size (μm) of the escozine (scorpion venom) after particle size reduction.
  • FIG. 7 is an illustration showing the raw data used to create the graph in FIG. 6.
  • FIG. 8 is a graph of the raw data displayed in FIG. 9 of an analysis of the particle size (μm) of the escozine (scorpion venom) before particle size reduction.
  • FIG. 9 is an illustration showing the raw data used to create the graph in FIG. 8.
  • FIG. 10 is a graph that overlays data showing the overall effectiveness of repigmentation after using a blue scorpion venom composition.
  • FIG. 11 is a graph that overlays data showing the progression of repigmentation after using a blue scorpion venom composition.
  • DETAILED DESCRIPTION
  • In the following detailed description of various embodiments of the disclosure, numerous specific details are set forth in order to provide a thorough understanding of various aspects of one or more embodiments of the disclosure. However, one or more embodiments of the disclosure may be practiced without some or all of these specific details. In other instances, well-known methods, procedures, and/or components have not been described in detail so as not to unnecessarily obscure aspects of embodiments of the disclosure.
  • While multiple embodiments are disclosed, still other embodiments of the present disclosure will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the disclosure. As will be realized, the disclosure is capable of modifications in various obvious aspects, all without departing from the spirit and scope of the present disclosure. Accordingly, the figures, and the detailed descriptions thereof, are to be regarded as illustrative in nature and not restrictive. Also, the reference or non-reference to a particular embodiment of the disclosure shall not be interpreted to limit the scope of the disclosure.
  • As used herein, the terms “approximately” and “about” generally refer to a deviance of within 5% of the indicated number or range of numbers. In one embodiment, the term “approximately” and “about”, may refer to a deviance of between 1-10% from the indicated number or range of numbers.
  • As used herein, the term “particle size reduction machine” generally refers to a machine that reduces the particle size of a homogenized composition. One type of particle size reduction machine is a Microfluidizer®, which uses fluid pressure and shear forces to achieve uniform target nanoparticle size.
  • The present disclosure discloses a scorpion venom composition, a method of manufacture thereof, and a method of administration of that composition for treating Vitiligo.
  • The present disclosure discloses a scorpion venom composition, a method of manufacture thereof, and a method of administration of that composition for treating acne, eczema, hives (urticarial), pityriasis rosea, psoriasis, rosacea, shingles (herpes zoster).
  • The active ingredients of the composition are polarized and nanosized blue scorpion venom and polarized and nanosized alpha lipoic acid. The composition may also be referred to as Adios Vitiligo.
  • Blue scorpion venom is obtained from the venom of Rhopalurus junceus, also referred to as blue scorpion. The venom is preferably extracted from a bioterium of blue scorpions in order to obtain the quantity of venom necessary to produce an organic, natural, and health composition.
  • The blue scorpion venom is a complex mixture of salts, small molecules, peptides, and other proteins. A laboratory may filter the blue scorpion venom using a glass fiber membrane filter that is preferably 0.80 μm, 25 mm, 1 pk/50 pcs. These parameters may ensure the sterilization and purification of the blue scorpion venom. After filtration, the blue scorpion venom may be combined with chilled, medical-quality distilled water to achieve a specifically maintained concentration within a sterilized environment. Preferably, the dilute blue scorpion venom contains 0.0003 ml of venom per 0.9997 ml of distilled water (totaling 1 ml of prepared dilute solution) for treatment of Vitiligo.
  • Polarization of the Dilute Blue Scorpion Venom and Alpha Lipoic Acid. Preferably, the dilute blue scorpion venom and alpha lipoic acid are polarized separately. The preferred process for polarizing dilute blue scorpion venom and alpha lipoic acid is the Mikaelian Polarized Liquid Process, named after the current inventor. The first steps in the polarization process, preferably, may be to circulate the dilute blue scorpion venom or alpha lipoic acid repeatedly through plastic or glass tubes. Preferably, the tubes may be one and a half (1.5) centimeters in diameter, but they may be any diameter, and may be made from any malleable or rigid, non-metallic material. The circulation may be performed by one or more small pumps. The next step of the process may be to place, along the pump or tubes, a series of flat magnets. Preferably these magnets may be placed in pairs along the opposite sides of the tubes and may be aligned so that the negative poles and positive poles of the magnets mirror one another so that the magnets repel one another. The magnets may be then compressed with one or more non-metallic, preferably wooden, clamps so that the magnets remain in place. The magnets may be compressed to within two millimeters of one another, also compressing the tubes so that the water must flow through a small gap between the magnets. Two millimeters is a preferred compression point, any greater or lesser compression point may be used, so long as the liquid can flow within the tube, without deviating from the scope of the disclosure. Preferably, the dilute blue scorpion venom or alpha lipoic acid may be circulated through this tube lined with pairs of magnets for an extended period of time. The resulting polarized liquid, compared to non-polarized liquid, may be absorbed far more rapidly into the human and may be significantly more bio-available on a cellular level, resulting in significantly improved results.
  • Polarization, also called wave polarization, is an expression of the orientation of the lines of electric flux in an electromagnetic field (EM field). Polarization technology has been widely used in different industries such as radio transmissions, wireless communication systems, food industry, sun glasses, etc. Polarization can be used on many different compounds. By finding the specific molecular frequency, using the Mikaelian method, a resonance effect can be achieved that can modify the quality of the product without changing its molecular structure. Using a resonance effect can increase and/or decrease the potency of molecules depending on the frequency used.
  • In the present methods and compositions, each pair of rare earth magnets may be two BLP2-6120-110 magnets with similar polarities. The north pole of the magnet may be determined, such as with a compass, and marked on the magnet. Each pair of magnets is aligned such that their north poles are in a mirror position, which causes the magnets to repel each other. Once the magnets are placed so as to sandwich a tube for circulating a fluid, the magnets may be connected to a power source, such a Chroma® 61501 AC power source. This allows the setting of the frequencies of the magnets. The power source preferably provides 500 VA single-phase, 0-300 VAC or 0-424 VDC output. At full power, the power source may deliver up to 6:1 Crest Factor loads, DC/15 Hz to 1 kHz. The magnets may be electromagnets or permanent rare earth magnets.
  • After the venom and alpha lipoic acid are polarized, the polarization may be tested using a polarimeter, such as an Autopol V Plus polarimeter. In this manner the molecular rotation angle may be determined.
  • A liquid polarized using this method is one that is created using intense magnetic resistance (IMR). The IMR uses magnetic repulsion and the fluids circulating through the IMR filed are subject to maolecular polarization that strongly affects the geometric relationships between the molecules the electromagnetic fields surrounding those molecules. This effect is commercially significant.
  • FIG. 1 is an illustration of a particle reduction machine 100 for nanosizing polarized blue scorpion venom and polarized alpha lipoic acid. As shown in FIG. 1, either polarized blue scorpion venom or polarized alpha lipoic acid may be input into an inlet reservoir 105 that supports high solid content. A high-pressure pump 110 may generate forces up to 40,000 psi (2578 bar) to force the polarized blue scorpion venom or polarized alpha lipoic acid stream into precisely engineered microchannels within a fixed-geometry interaction chamber 115. Because particle reduction technology has the ability to control shear rates, the smallest pressure required is typically used.
  • Once inside the interaction chamber 115, the polarized blue scorpion venom or polarized alpha lipoic acid may be exposed to consistent and intense impact and shear forces before it is immediately cooled. This repeatable process may result in tiny particles with a uniform distribution.
  • Table 1 shows the particle size (μm) of alpha lipoic acid before particle size reduction.
  • TABLE 1
    D(v, 0.1): 5.13235 (μm)
    D(v, 0.5): 7.67725 (μm)
    Result File Name Alpha Lipoic Acid D(v, 0.9): 11.35496 (μm)
    Transmittance (R) 93.2%
    Transmittance (B) 93.5%
    Refractive index (R) 1.54-0.00i(1.33)
    [1.54-0.00(1.540-0.000i),
    1.33 (1.333)]
    Distribution Base Volume
    Ultrasound 00:15 (1)
    Circulation speed  5
    Agitation speed  2
    Convergence factor 15
    Algorithm General Mode
  • FIG. 2 is a graph of the raw data displayed in FIG. 3 of an analysis of the particle size (μm) of the alpha lipoic acid before particle size reduction.
  • FIG. 3 is an illustration showing the raw data used to create the graph in FIG. 2.
  • Table 2 shows the particle size (μm) of alpha lipoic acid after particle size reduction.
  • TABLE 2
    D(v, 0.1): 1.59409 (μm)
    Alpha Lipoic D(v, 0.5): 3.99677 (μm)
    Result File Name Acid (Nanosized) D(v, 0.9): 7.60579 (μm)
    Transmittance (R) 96.6%
    Transmittance (B) 95.3%
    Refractive indecx 1.54-0.00i(1.33)
    (R) [1.54-0.00(1.540-0.000i),
    1.33 (1.333)]
    Distribution Base Volume
    Ultrasound 00:27 (1)
    Circulation speed  5
    Agitation speed  2
    Convergence 15
    factor
    Algorithm General Mode
  • FIG. 4 is a graph of the raw data displayed in FIG. 5 of an analysis of the particle size (μm) of the alpha lipoic acid after particle size reduction.
  • FIG. 5 is an illustration showing the raw data used to create the graph in FIG. 4.
  • Table 3 shows the particle size (μm) of blue scorpion venom after particle size reduction.
  • TABLE 3
    D(v, 0.1): 0.05961 (μm)
    Escozine (0.003) D(v, 0.5): 0.07907 (μm)
    Result File Name (Nanosized) D(v, 0.9): 0.11126 (μm)
    Transmittance (R) 98.2%
    Transmittance (B) 86.5%
    Refractive index (R) 1.54-0.00i(1.33)
    [1.54-0.00(1.540-0.000i),
    1.33 (1.333)]
    Distribution Base Volume
    Ultrasound Off
    Circulation speed
     5
    Agitation speed  2
    Convergence factor 15
    Algorithm General Mode
  • FIG. 6 is a graph of the raw data displayed in FIG. 7 of an analysis of the particle size (μm) of the escozine (scorpion venom) after particle size reduction.
  • FIG. 7 is an illustration showing the raw data used to create the graph in FIG. 6.
  • Table 4 shows the particle size (μm) of blue scorpion venom before particle size reduction.
  • TABLE 4
    D(v, 0.1): 6.33306 (μm)
    Escozine (0.003) D(v, 0.5): 67.38076 (μm)
    Result File Name (Non-Nanosized) D(v, 0.9): 144.79427 (μm)
    Transmittance (R) 98.1%
    Transmittance (B) 95.2%
    Refractive indecx 1.54-0.00i(1.33)
    (R) [1.54-0.00(1.540-0.000i),
    1.33 (1.333)]
    Distribution Base Volume
    Ultrasound Off
    Circulation speed
     5
    Agitation speed  2
    Convergence 15
    factor
    Algorithm General Mode
  • FIG. 8 is a graph of the raw data displayed in FIG. 9 of an analysis of the particle size (μm) of the escozine (scorpion venom) before particle size reduction.
  • FIG. 9 is an illustration showing the raw data used to create the graph in FIG. 8.
  • Table 5 shows the preferred amount of one or more vitamins and minerals of one embodiment of the composition. The vitamins and minerals may be combined with the active ingredients, polarized and nanosized blue scorpion venom and polarized and nanosized alpha lipoic acid, and/or minerals to create the final composition. Table 5 also lists amount range (g/ml), weight range (%), and preferred weight range (%). This is based on a 450 ml bottle of final product
  • TABLE 5
    Amount Preferred Wt/Wt % Preferred
    Ingredient Range Amount Range Wt/Wt %
    Phase I
    Purified Water 0.10-4.0 ml 2.01 ml   0.01-2.0 0.43
    Potassium Sorbate .05-3.0 g 0.85 g   0.01-2.0 0.18
    Glycerin (99.7%) 50-120 g 86.09 g    1.0-40 18.20
    Potassium Benzoate 0.02-2.0 g 0.47 g   0.01-2.0 0.10
    Alpha Lipoic Acid 0.01-5.0 g 1.58 g   0.01-2.0 0.33
    Phase II
    Fructose Crystalline 20-200 g 103.11 g    1.0-40 21.80
    Glutathione 1.0-20 g 9.46 g   0.01-5.0 2.00
    Vitamin C Ascorbic 0.3-10 g 3.15 g   0.01-5.0 0.67
    Acid
    Vitamin B1 0.3-10 g 1.89 g   0.01-5.0 0.40
    Thiamine HCl
    Vitamin B6 0.3-10 g 3.15 g   0.01-5.0 0.67
    Pyridoxal-
    5-Phosphate
    Vitamin B12 0.001-1.0 g 0.03 g  0.001-5.0 0.01
    Cyanocobalamin
    Vitamin B12 0.001-1.0 g 0.03 g  0.001-5.0 0.01
    Hydroxocobalmin
    Vitamin B12 0.001-1.0 g 0.05 g  0.001-5.0 0.01
    Methylcobalamin
    Vitamin E 0.1-50 g 11.47 g   0.01-5.0 2.42
    Tocopheryl
    1,100 IU/gm
    Vitamin 0.01-5.0 g 0.32 g  0.001-2.0 0.07
    D3 1000,000
    IU/gm
    LoHan Guo Extract 0.01-5.0 g 0.57 g  0.001-2.0 0.12
    Zinc Gluconate 10% 0.3-10 g 3.15 g  0.001-3.0 0.67
    Copper 0.01-5.0 g 0.16 g  0.001-2.0 0.3
    Gluconate 10%
    Vitamin H/Vitamin 0.1-20 g 7.88 g  0.001-5.0 1.67
    B7 Biotin 1%
    Vitamin B3 0.3-10 g 3.15 g  0.001-3.0 0.67
    Niacinamide
    Orange Pineapple 0.3-10 g 1.18 g 0.0001-0.2 0.25
    Flavor
    Grape Concentrate 1.0-50 g 14.19 g  0.001-9.0 3.00
    Cherry Concentrate 1.0-50 g 14.19 g  0.001-9.0 3.00
    Citric Acid 0.01-5.0 g 0.61 g  0.001-5.0 0.13
    Xanthan Gum 0.01-5.0 g 0.71 g  0.001-5.0 0.15
    Resveratrol 0.3-10 g 3.15 g  0.001-5.0 0.67
    Hyaluronic Acid 0.3-10 g 1.89 g  0.001-5.0 0.40
    Purified Water 50-400 ml 198.49 ml   0.1-80 41.96
  • In one embodiment, polarization of the active ingredients, alpha lipoic acid and blue scorpion venom, may be performed. Next, nanoparticle reduction of the active ingredients may be performed. The polarized and nanosized active ingredients may then be mixed and a final weight recorded and prepared for shipment to a manufacturing facility. The manufacturing facility may prepare the polarized and nanosized active ingredient mixture for identification, sample labeling, and microbiology testing. Next, the inactive ingredients listed in Phase I of Table 5 may be weighed. Then the alpha lipoic acid and glycerin 99.7% of Phase I may be added to a first mixing vessel and blended until the mixture has become homogenous. Next, the remaining ingredients of Phase I, purified water, potassium sorbate, and potassium benzoate, may be added to a second mixing vessel and blended until the mixture has become homogenous. The ingredients from the first mixing vessel and the second mixing vessel may be combined and blended until a final Phase I mixture has become homogenous.
  • Next, the inactive ingredients of Phase II of Table 5 may be weighed. Then all of the ingredients from Phase II, except for the citric acid, may be slowly added the mixing vessel containing the final Phase I mixture, until the final composition is formed. The mixing vessel may be blended until the final composition has become homogenous. At this point, the pH of the final composition is tested by adding the citric acid ingredient from Phase II until a target pH of 3.81 is reached.
  • A bulk version of the composition may be transferred into a sealed, sterilized bulk container and the container then transferred into to a refrigerated environment. The composition is preferably refrigerated and maintained at a range between 12 to 14 C (52 F-58 F). Blue scorpion venom may degrade at an accelerated rate when exposed to bright light and thus the dark refrigerated storage environment should be protected from light and without internal illumination. Further, the composition has tendency to separate from water when suspended in water for an extended period of time. To achieve consistent concentration of the composition, the sealed bulk container is preferably agitated in a back and forth manner for no less than 30 minutes before being transferred into individual containers. During the packaging process the bulk container should be continuously agitated through stirring.
  • The final step of the process is packaging and bottling. The bulk composition is transferred in a sterilized environment into individual one liter bottles, which should include labels, air-tight seals, and opaque containers, which protect the composition from degradation due to inappropriate exposure to light. The containers are pre-sterilized before being filled with the composition. The process of packaging is time sensitive. Undo exposure to air and excessive temperatures will undermine the potency of the composition. As such, time is a sensitive issue with the product. Exposed to room temperature, the process cannot be extended past a few (approximately four) hours from removal from refrigeration to completion of bottling. However, if bottling is done in a highly air conditioned environment (lower than 15 C or 58 F) or if the distilled water used in production is chilled (through prior refrigeration) then the period of production from removal from refrigeration to finalized bottling can be extended. Eight (8) hours for highly chilled distilled water; twelve (12) hours for highly refrigerated environment.
  • Once the bottling procedure is complete, bottles of the final composition are to be stored in a dark, refrigerated environment maintained, as preferred, at a temperature between 12 and 14 C (52 F and 58 F) where they will wait until final shipping.
  • The bottle may comprise 450 mL of the final composition. A single dose of the final composition may be a 15 mL dose. The 15 mL dose may comprise 0.00005 to 0.00015 mL of blue scorpion venom. There may be 0.0001 mL blue scorpion venom in the 15 mL dose. The 15 mL dose may comprise 0.04 to 0.06 g of alpha lipoic acid. There may be 0.0527 g of alpha lipoic acid in the 15 mL dose. The 15 mL dose may also comprise:
  • TABLE 6
    Range One Embodiment
    Component of 15 mL dose (in grams) (in grams)
    Biotin    0.2-0.5 0.2628
    Cherry Flavoring    0.3-0.6 0.4730
    Citric Acid   0.01-0.04 0.0205
    Copper Gluconate  0.003-0.007 0.0053
    Crystalline Fructose   3.2-3.6 3.4371
    Glutathione   0.2-0.4 0.3153
    Glycerin   2.5-3.2 2.8695
    Grape Flavoring   0.4-0.5 0.4730
    Hyaluronic Acid   0.04-0.08 0.0631
    LoHan Guo Extract   0.01-0.03 0.0189
    Orange Pineapple Flavoring   0.01-0.05 0.0394
    Potassium Benzoate   0.01-0.25 0.0158
    Potassium Sorbate   0.02-0.04 0.0284
    Purified Water    12-13 mL 12.7208 mL
    Resveratrol   0.05-0.2 0.1051
    Vitamin B1   0.04-0.08 0.0631
    Vitamin B12 0.0005-0.0018 0.0011
    (cyanobalamin)
    Vitamin B12 0.0005-0.0018 0.0011
    (hydroxocobalmin)
    Vitamin B12  0.001-0.0025 0.0016
    (methylcobalamin)
    Vitamin B3  0.05-0.2 0.1051
    Vitamin B6  0.05-0.2 0.1051
    Vitamin C  0.05-0.2 0.1051
    Vitamin D3  0.005-0.020 0.0105
    Vitamin E   0.3-0.6 0.3822
    Xanthan Gum  0.01-0.04 0.0237
    Zinc Gluconate  0.05-0.25 0.1051
  • The composition is preferably tested for bacterial contaminants, chemical contaminants, and concentration. Standard microbial and mass spectrometry tests are preferably used. If possible, no product should be shipped to a customer until the batch has undergone testing for purity.
  • Standard testing procedures, such as Lowry's method for determining protein concentration should be used to quantitatively evaluate the composition. Other types of procedures, known in the art, may also be used. Batches should be rejected if bacterial or chemical contaminants are found, or if more than 5% of the bottles test for levels of any chemical naturally found within the blue scorpion venom, but at a higher or lower concentration in excess of 10% deviation from the standard concentration per standardized mass spectrometry of the blue scorpion venom.
  • FIG. 10 is a graph 200 which overlays data showing the overall effectiveness of repigmentation in study patients after treatment with the composition. In this study, men and women, ranging from 5 to 80 years old, who were suffering from Vitiligo were chosen as patients. As part of the treatment regimen, each patient orally ingested two milliliters (2 cc) of the composition, twice a day, over the course of 90 days. The patients were monitored once before starting the intake, and then monitored once a month thereafter to evaluate the effectiveness of the composition by observing changes to pigmentation on the patient's skin. As shown in FIG. 2, within 30 days of treatment with the composition, 29 individuals had recovery of pigmentation up to 20%. Within 60 days of treatment, 64 individuals had recovery of pigmentation up to 40%. Within 90 days of treatment, 23 individuals had recovery of pigmentation up to 60%. Further, within 90 days of treatment, only 4 individuals did not see any results. Overall, most patients began experiencing an increase in pigmentation ranging from 15% to 60% within the first three months of treatment. No signs of allergic reactions or negative side effects were observed in any of the patients. Further, the patients showed adequate tolerance to the composition and did not develop any complications.
  • FIG. 11 is a graph 300 which overlays data showing the progression of repigmentation after using the composition. As shown in FIG. 3, within 30 days of treatment with the composition, 35 patients reported positive repigmentation results. Within 60 days of treatment, 85 patients reported positive repigmentation results. And within 90 days of treatment, 116 patients reported positive repigmentation results. Thus, it may be concluded that the composition is highly effective at enhancing re-pigmentation and may be used as or part of a treatment regimen for patients suffering for Vitiligo.
  • Unless otherwise stated, all measurements, values, ratings, positions, magnitudes, sizes, locations, and other specifications that are set forth in this specification, including in the claims that follow, are approximate, not exact. They are intended to have a reasonable range that is consistent with the functions to which they relate and with what is customary in the art to which they pertain.
  • The foregoing description of the preferred embodiment has been presented for the purposes of illustration and description. While multiple embodiments are disclosed, still other embodiments will become apparent to those skilled in the art from the above detailed description. These embodiments are capable of modifications in various obvious aspects, all without departing from the spirit and scope of protection. Accordingly, the detailed description is to be regarded as illustrative in nature and not restrictive. Also, although not explicitly recited, one or more embodiments may be practiced in combination or conjunction with one another. Furthermore, the reference or non-reference to a particular embodiment shall not be interpreted to limit the scope of protection. It is intended that the scope of protection not be limited by this detailed description, but by the claims and the equivalents to the claims that are appended hereto.
  • Except as stated immediately above, nothing that has been stated or illustrated is intended or should be interpreted to cause a dedication of any component, step, feature, object, benefit, advantage, or equivalent, to the public, regardless of whether it is or is not recited in the claims.

Claims (20)

What is claimed is:
1. A composition, said composition comprising:
a blue scorpion venom; and
an alpha lipoic acid.
2. The composition of claim 1, wherein said blue scorpion venom is diluted in a distilled water, such that a dilute blue scorpion venom is created;
wherein said dilute blue scorpion venom is polarized, such that a polarized blue scorpion venom is created; and
wherein said alpha lipoic acid is polarized, such that a polarized alpha lipoic acid is created.
3. The composition of claim 2, wherein said polarized blue scorpion venom is polarized by circulating said dilute blue scorpion venom between at least one set of two paired and aligned magnets; and
wherein said alpha lipoic acid is polarized by circulating said alpha lipoic acid between said at least one set of two paired and aligned magnets.
4. The composition of claim 3, wherein each set of magnets of said at least one set of two paired and aligned magnets mirror each other, such that said magnets repel each other.
5. The composition of claim 4, wherein said polarized blue scorpion venom and said polarized alpha lipoic acid are nanosized.
6. The composition of claim 5, wherein a particle size reduction machine is used to nanosize said polarized blue scorpion venom and said polarized alpha lipoic acid, such that a polarized and nanosized. blue scorpion venom is created and a polarized and nanosized alpha lipoic acid is created.
7. The composition of claim 6, wherein said at least one set of two paired and aligned magnets are operatively coupled to a power source, such that a frequency of said at least one set of two paired and aligned magnets is set.
8. The composition of claim 7, wherein said polarized and nanosized blue scorpion venom and said polarized and nanosized alpha lipoic acid comprise two active ingredients of said composition, and
wherein said composition is ingested orally by a patient suffering from vitiligo as part of a treatment regimen, such that said patient's skin has an enhanced re-pigmentation.
9. The composition of claim 8, wherein said composition further comprises:
one or more vitamins.
10. The composition of claim 9, wherein said one or more vitamins comprise:
vitamin B1;
vitamin B3;
vitamin B6;
vitamin B7;
vitamin B12;
vitamin C;
vitamin D3; and
vitamin E.
11. The composition of claim 8, further comprising:
one or more minerals.
12. The composition of claim 11, wherein said one or more minerals comprise:
zinc gluconate;
copper gluconate;
potassium sorbate; and
potassium benzoate.
13. The composition of claim 8, wherein said polarized and nanosized blue scorpion venom is in an amount from 0.00005 to 0.00015 mL in an approximately 15 mL dose of said composition.
14. The composition of claim 13, wherein said polarized and nanosized blue scorpion venom is in an amount of 0.0001 mL in an approximately 15 mL dose of said composition.
15. The composition of claim 8, wherein said polarized and nanosized alpha lipoic acid is in an amount from 0.04 to 0.06 g in an approximately 15 mL dose of said composition.
16. The composition of claim 15, wherein said polarized and nanosized alpha lipoic acid is in an amount of 0.06 g an approximately 15 mL dose of said composition.
17. A method of treating a condition comprising the steps:
creating a condition treatment composition comprising: a blue scorpion venom and an alpha lipoic acid;
wherein said condition treatment composition is ingested orally by a patient suffering from vitiligo as part of a treatment regimen, such that said patient's skin has an enhanced re-pigmentation.
18. The method of claim 17, further comprising the steps:
diluting said blue scorpion venom to create a dilute blue scorpion venom;
polarizing said dilute blue scorpion venom to create a polarized blue scorpion venom;
polarizing said alpha lipoic acid to create a polarized alpha lipoic acid.
19. The method of claim 18, further comprising the steps:
nanosizing said polarized blue scorpion venom to create a polarized and nanosized blue scorpion venom;
nanosizing said polarized alpha lipoic acid to create a polarized and nanosized alpha lipoic acid;
20. The method of claim 19, wherein said polarized blue scorpion venom and said polarized alpha lipoic acid are polarized by a polarization method comprising the steps:
providing one or more tubes that are configured to allow said polarized blue scorpion venom or said polarized alpha lipoic acid to circulate through;
providing one or more pairs of magnets, wherein each pair of said one or more pairs of magnets are aligned and spaced apart, such that one of said one or more tubes is sandwiched between said one or more aligned pairs of magnets;
circulating said diluted blue scorpion venom through said one or more tubes; and
circulating said alpha lipoic acid through said one or more tubes;
wherein said nanosizing comprises the steps:
providing a particle size reduction machine;
adding said polarized blue scorpion venom to said particle size reduction machine, such that a polarized and nanosized blue scorpion venom is created; and
adding said polarized alpha lipoic acid to said particle size reduction machine such that a polarized and nanosized alpha lipoic acid is created.
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US13/849,008 US20130216587A1 (en) 2007-11-13 2013-03-22 Polarized scorpion venom solution and a method for making polarized scorpion venom solution
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