WO2021220297A1 - A novel polyherbal pharmaceutical composition exhibiting immunomodulatory and anti-viral activity and method of preparation thereof - Google Patents
A novel polyherbal pharmaceutical composition exhibiting immunomodulatory and anti-viral activity and method of preparation thereof Download PDFInfo
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- WO2021220297A1 WO2021220297A1 PCT/IN2021/050407 IN2021050407W WO2021220297A1 WO 2021220297 A1 WO2021220297 A1 WO 2021220297A1 IN 2021050407 W IN2021050407 W IN 2021050407W WO 2021220297 A1 WO2021220297 A1 WO 2021220297A1
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- amrta
- karuna
- viral infection
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Classifications
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- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
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- A—HUMAN NECESSITIES
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- A61K36/185—Magnoliopsida (dicotyledons)
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- A—HUMAN NECESSITIES
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- 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)
- A61K36/58—Meliaceae (Chinaberry or Mahogany family), e.g. Azadirachta (neem)
-
- 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)
- A61K36/74—Rubiaceae (Madder family)
- A61K36/746—Morinda
-
- 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)
- A61K36/75—Rutaceae (Rue family)
-
- 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)
- A61K36/75—Rutaceae (Rue family)
- A61K36/752—Citrus, e.g. lime, orange or lemon
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Definitions
- the present invention relates to a pharmaceutical composition. More particularly the present invention relates to a novel poly-herbal pharmaceutical composition exhibiting excellent immunomdulatory and anti-viral activity with enhanced bio-availability thereby making as a suitable candidate for treatment of subjects suffering from COVID 19, AIDS, Dengue, H1N1, and H5N1 viral infection and method of preparation of novel poly-herbal pharmaceutical composition thereof.
- Remdesivir Modern system of medicine is based on a medical model that basically offers symptomatic treatment and focuses more on therapy. It emphasizes on the use of drugs, mechanical testing, invasive treatments like surgery, and a passive approach towards the patient. Remdesivir is now being tested in five Covid-19 clinical trials that have been set up at breakneck speed. Remdesivir is an “analog,” designed to mimic the appearance of one of the RNA letters, adenosine. It looks so similar that the polymerase can unknowingly pick it up instead of the real adenosine and insert it into the strand of viral genome that’s being constructed, It’s been delivered through a compassionate use program to some patients, including the first case in the United States.
- CAM complementary and alternative medicine
- the object of the present invention is to formulate a novel polyherbal pharmaceutical composition exhibiting immunomodulatory and anti-viral activity and induces immune system by producing anti bodies against viral infection with enhanced bio-availability and nil side effects, for treating subjects with COVID-19 AIDS, Dengue, H1N1, and H5N1 viral infection.
- Another object of the present invention is to formulate a novel polyherbal pharmaceutical composition
- a novel polyherbal pharmaceutical composition comprising of extract of plant material of Morinda tinctoria, Azadirachta indica, Aegle marmalades, and Tamarindus indica and Citrus limon (L.) along with DM water, preservatives and sweetener.
- Yet another object of the present invention is to formulate a novel polyherbal pharmaceutical composition which does not possess any side effects
- Yet another object of the present invention is to develop a novel process for preparing the novel polyherbal pharmaceutical composition exhibiting exhibiting immunomodulatory and anti-viral activity and induces immune system by producing anti bodies against viral infection with enhanced bio-availability and nil side effects, for treating subjects with COVID-19, AIDS, Dengue, H1N1, and H5N1 viral infection.
- Further object of the present invention is to administer the formulated polyherbal pharmaceutical composition to the subjects for treating COVID-19 AIDS, Dengue, H1N1, and H5N1 viral infection.
- Figure 1 depicts the Cytoprotective effect of Amrta karuna of the present invention.
- FIG. 2 depicts the Kaplan Mayer survival analysis shown WBI (6Gy) with BMSCs following AK treatment improved 75 % survival rate (A). Gaining body weight was observed in the WBI (6Gy) following BMSCs/AK treatments (B). IVIS imaging of the harvested tibia bone marrow shown a DiO labeled BM cells distributed in the AK treatment following 6Gy WBI(C). VE-Cad, Nestin, and CD44 expression significantly increased in the BMSCs/AK treatments compare to WBI alone (D).
- Figure 3 depicts the Histological analysis shown the WBI 6Gy following bone marrow plus AK treatments reduce the apoptotic cells in the mouse bone marrow (A). Arrow shown cluster of dead cells. 600X magnification, scale bar 60 ⁇ m.
- Figure 4 depicts the HIVGKO Virus infection in the SVG pl2cells/Methamphetamine/PBS
- Figure 5 depicts the Cross -reactivity of antisera raised against SARS-Covnsps and structural proteins cross-reacts with corresponding SARS-cov2 protein.
- FISH analysis cells were double labeled with a rabbit antiserum recognizing nsp9(Cyan) and a mouse mAB recognizing dsRNA (Green). Respectively, nuclear DNA was stained with Hoechst 33258(Blue). Scale bar 500 ⁇ m.
- the present invention disclose a novel poly-herbal pharmaceutical composition “Amrta Karuna” exhibiting immunomodulatory and anti- viral activity and induces immune system by producing anti bodies against viral infection with enhanced bio-availability and nil side effects, for treatment of subjects suffering from COVID 19 AIDS, Dengue, H1N1, and H5N 1 viral infection.
- the Amrta Karuna of the present invention comprises of characterized combination of therapeutically and synergistically effective amount of aqueous extracts of Morinda tinctoria, Azadirachta indica, Aegle marmalades, and Tamarindus indica , and fresh fruit juice of Citrus limon (L.) along with DM water, preservatives and sweetener.
- the present invention also discloses a method of preparation of novel poly-herbal pharmaceutical composition “Amrta Karuna” exhibiting immunomodulatory and anti-viral activity and induces immune system by producing anti bodies against viral infection with enhanced bioavailability and nil side effects, for treatment of subjects suffering from COVID 19 AIDS, Dengue, H1N1, and H5N1 viral infection.
- the present invention provides novel combinations of two or more active ingredients being employed together. In some embodiments, a synergistic antiviral effect is achieved.
- the present invention discloses a novel poly-herbal pharmaceutical composition exhibiting immunomodulatory and anti-viral activity and induces immune system by producing anti bodies against viral infection with enhanced bio-availability and nil side effects, thereby making is as a suitable candidate for treatment of subjects suffering from COVID 19 AIDS, Dengue, H1N1, and H5N1 viral infection and method of preparation of novel poly-herbal pharmaceutical composition thereof.
- the poly-herbal pharmaceutical composition of the present invention comprises of Morinda tinctoria, Azadirachta indica, Aegle marmalades, and Tamarindus indica and Citrus limon (L.).
- the poly-herbal pharmaceutical composition is formulated along with DM water, preservatives and sweetener.
- the process of preparation is carried out as follows:
- the manufacturing methods of herbal formulation were prepared by traditional siddha protocols such as Poojas, Subhamukurtha, Panchang, Time metrics.
- the pharmaceutical formulation of the present invention was next subjected to clinical studies to study the antiviral, immunomodulatory and cytotoxicity effects.
- cytotoxicity effect of the composition of the present invention was determined by in vitro cell culture studies. Briefly human normal epithelial(HEK), Human dermal fibroblast (HDF), Human vascular endothelial cells(HUVEC) cells , Human bone marrow stem cells (HBMSCs) were treated with different concentration of Amrta Karuna for 96h. After 96h cell viability was determined by MTT Assay. Prior to evaluating protective effects, the toxicities of Amrta Karuna were established following 96 h exposure to human cells in serum-free, conditions. IC50 concentrations were defined as the extract concentration eliciting a 50% loss of viable cells relative to control cultures. No significant toxicity was observed in all the cells tested which shows cytoprotective effect. Amrta Karuna were well-tolerated by cells, with IC50 concentrations of >500 g/mL, respectively, Fig 1. ANTIVIRAL ACTIVITY:
- composition of the present invention were studied to ascertain its antiviral activity of virus which includes Dengue, H1N1, H5N1 and the like.
- the antiviral activity against Dengue virus was determined on tissue culture using VERO cell line.
- the virus is grown on tissue culture with an overlay of agarose. This will produce plaques. Depending on the time of virus in the inoculums, the number of plaques will be produced. Thereafter the same virus will be mixed with composition of the present invention and again grown and latter counted for reduction in number of plaques. The formulation showed significant inhibition.
- composition of the present invention has maximum antiviral activity against Dengue virus in the range of 0.1 mg/mL
- the antiviral activity against H1N1 virus was determined on tissue culture using MDCK cell line.
- the virus is grown on tissue culture with an overlay of agarose. This will produce plaques. Depending on the time of virus in the inoculums, the number of plaques will be produced. Thereafter the same virus will be mixed with composition of the present invention and again grown and latter counted for reduction in number of plaques. The formulation showed significant inhibition.
- composition of the present invention has maximum antiviral activity against H1N1 virus in the range of 0.05 mg/mL
- the antiviral activity against H5N 1 virus was determined on tissue culture using VERO cell line.
- the virus is grown on tissue culture with an overlay of agarose. This will produce plaques. Depending on the time of virus in the inoculums, the number of plaques will be produced. Thereafter the same virus will be mixed with composition of the present invention and again grown and latter counted for reduction in number of plaques. The composition showed significant inhibition.
- composition of the present invention has maximum antiviral activity against H5N1 virus in the range of 0.5 mg/mL
- the pharmaceutical formulation of the present invention shows excellent antiviral activity against Dengue, H1N1 and H5N1 virus.
- the formulation of the present invention will also surely efficient to cure COVID19 as it is having excellent anti-viral activity against various viruses
- formulation of the present invention was found to stimulate immunological activity in in vitro cell culture studies. Treatment with five doses of formulation of the present invention was found to enhance the total amount of cytokines production count. Anti inflammatory cytokine such as IL-4, IL-6, IL-10, IFN gamma are produced in significant amount and estimated using quantitative method. These results confirm the immunomodulatory activity of composition of the present invention.
- composition of the present invention is subjected to synergism studies, to Study the effect of the composition of the present invention viz-a-viz its components when individually applied.
- ANTIVIRAL ACTIVITY From Table 1 it is inferred that individual ingredients Morinda tinctoria, or Azadirachta indica or Aegle marmalades or and Tamarindus indica or Citrus limon (L.)can able to inhibit various viruses by only 5-25% whereas the composition of the present invention inhibits 100% thereby proving the synergism of the formulation of the present invention.
- composition of the present invention exhibits superior Immunomodulatory Activity in comparison with individual ingredients Morinda tinctoria, or Azadirachta indica or Aegle marmalades or and Tamarindus indica or Citrus limon (L.) thereby proving the synergism of the compostion of the present invention.
- the tissues and organs recovery from ionizing irradiation is critically dependent on the repopulation of resident stem cells, defined as the subset of cells with self-renewal and differentiation capacity.
- Mobilization of both hematopoietic and mesenchymal stem cell populations can be stimulated by various factors, including cytokines, and the as-yet- unknown soluble factor involved in the radiation bystander effect.
- cytokines cytokines
- stem cell “niches” have recently been shown to be relatively hypoxic.
- BMSCs bone marrow stromal cells
- AK Amrta Karuna
- WBI whole-body irradiation
- Fig 3 protein estimationconfirms the regeneration of hematopoietic stromal cells significantlyincrease the expression of VE-Cadherin, Nestin, and CD44 in the ionizing irradiated bone marrow (Fig 2D).
- Histology confirms the Amrta Karuna improve the mitogens of the transplanted BMSCs whichimproves the migratory response and repair the bone marrow to ionizing irradiation (Fig3).
- HIV infection and METH dependence can have synergistic pathological effects, with preferential involvement of frontostriatal circuits.
- the SARS-CoVnsps specific rabbit or mouse antisera were raised using a synthetic peptide (nsp4, aa 4209-4230 of SARS-Cov ppla).
- Cross-reactivity of antisera to SARS-Cov2 targets was evaluated microscopically byfluorescent in situ hybridization (FISH).
- Vero E6 cells were infected at 12, and 24 hrs post-infection
- Amrta Karuna treated samples were stained with secondary NSP4 and mouse mAB recognizing ds RNA.
- the experiments confirm the Amrta Karuna syrup treatments to Vero E6 cells (Fig 5) revealed a clear difference with SARS-CoV replication inhibited.
- the present invention shall disclose a novel poly-herbal pharmaceutical composition “Amrta Karuna” exhibiting immunomodulatory and anti-viral activity and induces immune system by producing anti bodies against viral infection with enhanced bio-availability and nil side effects, for treatment of subjects suffering from COVID 19 AIDS, Dengue, H1N1, and H5N1 viral infection.
- the Amrta Karuna of the present invention comprises of characterized combination of therapeutically and synergistically effective amount of aqueous extracts of Morinda tinctoria, Azadirachta indica, Aegle marmalades, Tamarindus indica andfresh fruit juice ofCitrus limon (L.) along with DM water, preservatives and sweetener.
- Karuna the aqueous extracts of Morinda tinctoria, Azadirachta indica, Aegle marmalades, Tamarindus indica andfresh fruit juice ofCitrus limon (L.) are present in a ratio comprising of 2: 1 : 1 : 1 :0.5.
- the preservatives are selected from a group comprising of 0.01 % Bronopol, 0.1%Sodium benzoate, 0.01% Citric acid, 1% Ascorbic acid, 1.5% Butylated Hydroxytoluene (3,5- ditertiarybutyl-4-hydroxytoluene)
- the sweetener is selected from a group comprising of Sugar, Sucrose, Aspartame, Sucralose and the like.
- the novel poly-herbal pharmaceutical composition “Amrta Karuna” shall be formulated in a form of syrup, Tablet, Capsule and the like.
- the present invention shall disclose a process of preparation of novel poly-herbal pharmaceutical composition “Amrta Karuna” exhibiting immunomodulatory and anti-viral activity and induces immune system by producing anti bodies against viral infection with enhanced bio-availability and nil side effects, for treatment of subjects suffering from COVID 19 AIDS, Dengue, H1N1, and H5N1 viral infection.
- the process of preparation of Amrta Karuna of the present invention comprises of following steps: a. Collecting shade dried, leaves of Morinda tinctoria, leaves of Azadirachta indica, - leaves of Aegle marmalades, and leaves of Tamarindus indica in a predetermined ratio; b.
- the present invention shall disclose a process of preparation of novel poly-herbal pharmaceutical composition “Amrta Karuna” exhibiting immunomodulatory and anti-viral activity and induces immune system by producing anti bodies against viral infection with enhanced bio-availability and nil side effects, for treatment of subjects suffering from COVID 19 AIDS, Dengue, HINT, and H5N1 viral infection.
- the process of preparation of Amrta Karuna of the present invention comprises of following steps: a) Collecting 200mg of shade dried leaves of Morinda tinctoria, 100mg of shade dried leaves of Azadirachta indica, 100mg of shade dried leaves ofAegle marmalades and 100mg of shade dried leaves of Tamarindus indica', b) Pulverizing the collected shade dried, leaves of Morinda tinctoria, leaves of Azadirachta indica, leaves ofAegle marmalades, and leaves of Tamarindus indica to form a powdered mixture; c) Adding 400 mL of water to the powdered mixture and boiled for 20 min time to form a decoction followed by filtration and addition of 60mL of fresh fruit juice ofCitrus limon (L.) and 0.02% of preservatives to form active ingredient enriched extract; d) Preparing a sugar solution by mixing 50 gms of sugar in 100mL of DM water and boiled for
- the preservatives are selected from a group comprising of 0.01 % Bronopol, 0.1%Sodium benzoate, 0.01% Citric acid, 1% Ascorbic acid, 1.5% Butylated Hydroxytoluene (3,5-ditertiarybutyl-4-hydroxytoluene)
- the present invention shall disclose a novel poly-herbal pharmaceutical composition “Amrta Karuna” exhibiting immunomodulatory and anti-viral activity and induces immune system by producing anti bodies against viral infection with enhanced bio-availability and nil side effects, for treatment of subjects suffering from COVID 19 AIDS, Dengue, H1N1, and H5N1 viral infection, prepared by the process as described above.
- the present invention shall disclose a method of treating viral infection in a subject in need thereof, comprising administering to the subject: (i) effective amount of novel poly-herbal pharmaceutical composition “Amrta Karuna” of the present invention either alone or as an adjuvant, or complementary treatment to an existing and-viral therapy
- the viral infection comprises of COVID 19 AIDS, Dengue, HINT, and H5N1 viral infection or any combination thereof.
- the present invention shall disclose an article of manufacture, comprising: (i) effective amount of novel poly-herbal pharmaceutical composition “Amrta Karuna” of the present invention and (ii) instructions for use in treating viral infection.
- the viral infection comprises of COVID 19, AIDS, Dengue, HINT, and H5N1 viral infection or any combination thereof.
- the present invention shall disclose a kit, comprising: (i) effective amount of novel poly-herbal pharmaceutical composition “Amrta Karuna” the present invention and (ii) instructions for use in treating viral infection.
- the viral infection comprises of COVID 19 AIDS, Dengue, HINT, and H5N1 viral infection or any combination thereof.
- novel poly-herbal pharmaceutical composition of the present invention can be administered at about 0.001 mg/kg to about 100 mg/kg body weight (e.g., about 0.01 mg/kg to about 10 mg/kg or about 0.1 mg/kg to about 5 mg/kg).
- the concentration of a novel poly-herbal pharmaceutical composition of the present invention will vary depending on several factors, including the dosage of the compound to be administered, the pharmacokinetic characteristics of the compound(s) employed, and the route of administration.
- the agent may be administered in a single dose or in repeat doses.
- the dosage regimen utilizing the compounds of the present invention is selected in accordance with a variety of factors including type, species, age, weight, sex and medical condition of the patient; the severity of the condition to be treated; the route of administration; the renal and hepatic function of the patient; and the particular compound or salt thereof employed. Treatments may be once administered daily or more frequently depending upon a number of factors, including the overall health of a patient, and the formulation and route of administration of the selected compound(s). Methods of Treatment:
- a method of treating viral infections in a subject in need of such treatment comprising administering to the subject a therapeutically effective amount of a novel poly-herbal pharmaceutical composition of the present, invention, either alone or as an adjuvant, or complementary treatment to an existing anti -viral therapy.
- a method of treating HIV infections in a subject in need of such treatment comprising administering to the subject a therapeutically effective amount of a novel poly-herbal pharmaceutical composition of the invention, either alone or as an adjuvant, or complementary treatment to an existing anti-viral therapy.
- a method of treating Dengue virus infections in a subject in need of such treatment comprising administering to the subject a therapeutically effective amount of a novel poly-herbal pharmaceutical composition of the invention, either alone or as an adjuvant, or complementary treatment to an existing anti-viral therapy.
- a method of treating HINlinfections in a subject in need of such treatment comprising administering to the subject a therapeutically effective amount of a novel poly-herbal pharmaceutical composition of the invention, either alone or as an adjuvant, or complementary treatment to an existing anti-viral therapy.
- a method of treating HSNlinfections in a subject in need of such treatment comprising administering to the subject a therapeutically effective amount of a novel poly-herbal pharmaceutical composition of the invention, either alone or as an adjuvant, or complementary treatment to an existing anti-viral therapy.
- a method of treating SARS CoV2 infections in a subject in need of such treatment comprising administering to the subject a therapeutically effective amount of a novel poly-herbal pharmaceutical composition of the invention, either alone or as an adjuvant, or complementary treatment to an existing anti-viral therapy.
- formulations comprising the novel poly-herbal pharmaceutical composition of the present invention in combination with a pharmaceutically or nutritionally acceptable carrier(s) or excipient(s).
- novel poly-herbal pharmaceutical composition of the present invention is used during the maintenance phase of the treatment, following an initial viral load reduction phase in which it is used as an adjuvant to conventional anti-viral drug therapy.
- novel poly-herbal pharmaceutical composition of the present invention is used during tire maintenance phase of the treatment, following an initial HIV load reduction phase in which it is used as an adjuvant to conventional anti-viral drug therapy.
- novel poly-herbal pharmaceutical composition of the present invention is used during the maintenance phase of the treatment following an initial Dengue virus load reduction phase in which it is used as an adjuvant to conventional anti-viral drug therapy.
- novel poly-herbal pharmaceutical composition of the present invention is used during the maintenance phase of the treatment, following an initial H1N1 virus load reduction phase in which it is used as an adjuvant to conventional anti-viral drug therapy.
- novel poly-herbal pharmaceutical composition of the present invention is used during the maintenance phase of the treatment, following an initial H5N1 virus load reduction phase in which it is used as an adjuvant to conventional anti-viral drug therapy.
- novel poly-herbal pharmaceutical composition of the present invention is used during the maintenance phase of the treatment, following an initial SARS CoV2 load reduction phase in which it is used as an adjuvant to conventional anti- viral drug therapy.
- the present composition is used for the treatment, prevention or management of immune-supporting system in primates, especially humans comprising administering an effective amount of novel poly-herbal pharmaceutical composition of the present invention.
- novel poly-habal pharmaceutical composition of the present invention include those suitable for oral, nasal, topical (including buccal and sub-lingual), transdermal, or parenteral (including intramuscular, subcutaneous and intravenous) administration.
- the formulations may, where appropriate, be conveniently presented in discrete dosage units and may be prepared by any of the methods well known in the art of pharmaceutical or nutritional formulation. All methods preferably indude the step of bringing into association the active compound with liquid carriers or finely divided solid carriers or both and then, if necessary, shaping the product into the desired formulation.
- novel poly-herbal pharmaceutical composition of the present invention is suitable for oral administration may conveniently be presented as discrete units such as capsules, cachets or tablets each containing a predetermined amount of the active ingredient; as a powder or granules; as a solution, a suspension or as an emulsion.
- the active ingredient may also be presented as a powder or paste or suspension or solutions.
- Tablets and capsules for oral administration may contain conventional excipients such as binding agents, fillers, lubricants, disintegrants. or wetting agents.
- the tablets may be coated according to methods well known in the art.
- Oral liquid preparations may be in the form of, for example, aqueous or oily suspensions, solutions, emulsions, syrups or elixirs, or may be presented as a dry product for constitution with water or other suitable vehicle before use.
- Such liquid preparations may contain conventional additives such as suspending agents, emulsifying agents, non-aqueous vehicles (which may include edible oils), or preservatives.
- novel poly-herbal pharmaceutical composition of the present invention may also be formulated for parenteral administration (e.g., by injection, for example continuous infusion) and may be presented in unit dose form in ampoules, pre-filled syringes, small volume infusion or in multi-dose containers with an added preservative.
- the formulation may take such forms as suspensions, solutions, or emulsions in oily or aqueous vehicles, and may contain agents such as suspending, stabilizing an/or dispersing agents.
- the active ingredients may be in powder form, obtained by aseptic isolation of sterile solid or by lyophilisalion from solution, for constitution with a suitable vehicle, e.g., sterile, pyrogen-free water, before use.
- the novel poly-herbal pharmaceutical composition of the present invention may be formulated as ointments, creams or lotions, or as a transdermal patch.
- Such transdermal patches may contain penetration enhancers such as linalool, carvacrol, thymol, citral, menthol, lecithin, diethylisosorbide, and alkylpyrrolidones.
- Ointments and creams may, for example, be formulated with an aqueous or oily base with the addition of suitable thickening and/or gelling agents.
- Lotions may be formulated with an aqueous or oily base and will in general also contain one or more emulsifying agents, stabilizing agents, dispersing agents, suspending agents, thickening agents, or coloring agents.
- Formulations suitable for topical administration in the mouth include lozenges comprising the active ingredients in a flavored base, usually sucrose and acacia or tragacanth; pastilles comprising the active ingredient in an inert base such as gelatin and glycerin or sucrose and acacia; and mouthwashes comprising the active ingredient in a suitable liquid carrier.
- Articles of manufacture are also provided herein, wherein the article of manufacture comprises a novel poly-herbal pharmaceutical composition of the present invention, in a suitable container,
- the container may be a vial, jar, ampoule, preloaded syringe, or intravenous bag.
- kits for carrying out the methods of the invention.
- the kits may comprise a novel poly-herbal pharmaceutical composition of the present invention as described herein and suitable packaging.
- the kits may comprise one or more containers comprising novel poly-herbal pharmaceutical composition of the present invention described herein.
- a kit includes a novel poly-herbal pharmaceutical composition of the present invention, and a label and/or instructions for use of the compound in the treatment of viral infection described herein.
- the kits may comprise a unit dosage form of the novel poly-herbal pharmaceutical composition of the present invention.
- the novel poly-herbal pharmaceutical composition “Amrta Karuna” exhibiting immunomodulatory and anti-viral activity and induces immune system by producing anti bodies against viral infection with enhanced bio-availability and nil side effects, for treatment of subjects suffering from COVID 19 AIDS, Dengue, H1N1, and H5N1 viral infection, comprises of
- the process of preparation of novel poly-herbal pharmaceutical composition “Amrta Karuna” exhibiting immunomodulatory and anti-viral activity and induces immune system by producing anti bodies against viral infection with enhanced bio-availability and nil side effects, for treatment of subjects suffering from COVID 19 AIDS, Dengue, H1N1, and H5N1 viral infection comprises of following steps: a) Collecting 200mg of shade dried leaves of Morinda tinctoria, 100mg of shade dried leaves of Azadirachta indica, 100mg of shade dried leaves ofAegle marmalades and 100mg of shade dried leaves of Tamarindus indica', b) Pulverizing the collected shade dried, leaves of Morinda tinctoria, leaves of Azadirachta indica, leaves ofAegle marmalades, and leaves of Tamarindus indica to form a powdered mixture; c) Adding 400 mL of water to the powdered mixture and boiled for 20 min time to form a decoction followed by filtration
Abstract
The present invention disclose a novel poly-herbal pharmaceutical composition "Amrta Karuna" exhibiting immunomodulatory and anti-viral activity and induces immune system by producing anti bodies against viral infection with enhanced bio-availability and nil side effects, for treatment of subjects suffering from COVID 19 AIDS, Dengue, H1N1, and H5N1 viral infection. The Amrta Karuna of the present invention comprises of characterized combination of therapeutically and synergistically effective amount of aqueous extracts of Morinda tinctoria, Azadirachta indica, Aegle marmalades, and Tamarindus indica, and fresh fruit juice of Citrus limon (L.) along with DM water, preservatives and sweetener. The present invention also discloses a method of preparation of novel poly-herbal pharmaceutical composition "Amrta Karuna" exhibiting immunomodulatory and anti-viral activity and induces immune system by producing anti bodies against viral infection with enhanced bio-availability and nil side effects, for treatment of subjects suffering from COVID 19 AIDS, Dengue, H1N1, and H5N1 viral infection.
Description
TITLE: A NOVEL POLYHERBAL PHARMACEUTICAL COMPOSITION
EXHIBITING IMMUNOMODULATORY AND ANTI VIRAL ACTIVITY AND METHOD OF PREPARATION THEREOF”
FIELD OF THE INVENTION:
The present invention relates to a pharmaceutical composition. More particularly the present invention relates to a novel poly-herbal pharmaceutical composition exhibiting excellent immunomdulatory and anti-viral activity with enhanced bio-availability thereby making as a suitable candidate for treatment of subjects suffering from COVID 19, AIDS, Dengue, H1N1, and H5N1 viral infection and method of preparation of novel poly-herbal pharmaceutical composition thereof.
BACKGROUND OF THE INVENTION:
The emergence of novel Corona virus has posed a situation that warrants urgent global attention. Though antiviral drugs are available in mainstream medicine for treating symptoms, currently there is no preventive medicine available. Besides the development of drug resistance, emergence of mutant strains of the virus, emergence of a more virulent strain, prohibitive costs of available drugs, time lag between vaccine developments, and mass casualties would pose difficult problems.
Viral infections play an important role in human diseases, and recent outbreaks in the advent of globalization and ease of travel have underscored their prevention as a critical issue in safeguarding public health. Despite the progress made in immunization and drug development, many viruses lack preventive vaccines and efficient antiviral therapies, which are often beset by the generation of viral escape mutants.
Modern system of medicine is based on a medical model that basically offers symptomatic treatment and focuses more on therapy. It emphasizes on the use of drugs, mechanical testing, invasive treatments like surgery, and a passive approach towards the patient. Remdesivir is now being tested in five Covid-19 clinical trials that have been set up at breakneck speed. Remdesivir is an “analog,” designed to mimic the appearance of one of the RNA letters, adenosine. It looks so similar that the polymerase can unknowingly pick it up instead of the real adenosine and insert it into the strand of viral genome that’s being constructed, It’s been
delivered through a compassionate use program to some patients, including the first case in the United States. The first trial results are expected next month, though some analysts have already raised concerns about the prospects based on the drips of data emerging from a small number of patients. Others’ hopes are high for the drug. As of now, there are no approved therapies for any coronavirus infection, and remdesivir is the farthest along in the development process of any candidate. There is no specific treatment, although different experimental treatments with antiviral drugs (Lopinavir/Ritonavir; Remdisivir) and interferon are being used.
In view of the above drawbacks in modem medicine, complementary and alternative medicine (CAM) is only alternative as it offers a plethora of interesting preventive possibilities in patients. Herbs exhibit a diverse array of biological activities and can be effectively harnessed for managing pandemic flu. Thus, identifying novel antiviral drugs is of critical importance and natural products are of excellent source.
Thus there exists an urgent need in the state of art to study the role of CAM for managing novel COVID-19 and the mode of action of natural herbs in an evidence-based approach that can be followed to establish their potential use in the management of corona virus pandemics.
OBJECT OF THE INVENTION:
The object of the present invention is to formulate a novel polyherbal pharmaceutical composition exhibiting immunomodulatory and anti-viral activity and induces immune system by producing anti bodies against viral infection with enhanced bio-availability and nil side effects, for treating subjects with COVID-19 AIDS, Dengue, H1N1, and H5N1 viral infection.
Another object of the present invention is to formulate a novel polyherbal pharmaceutical composition comprising of extract of plant material of Morinda tinctoria, Azadirachta indica, Aegle marmalades, and Tamarindus indica and Citrus limon (L.) along with DM water, preservatives and sweetener.
Yet another object of the present invention is to formulate a novel polyherbal pharmaceutical composition which does not possess any side effects
Yet another object of the present invention is to develop a novel process for preparing the novel polyherbal pharmaceutical composition exhibiting exhibiting immunomodulatory and anti-viral activity and induces immune system by producing anti bodies against viral infection with enhanced bio-availability and nil side effects, for treating subjects with COVID-19, AIDS, Dengue, H1N1, and H5N1 viral infection.
Further object of the present invention is to administer the formulated polyherbal pharmaceutical composition to the subjects for treating COVID-19 AIDS, Dengue, H1N1, and H5N1 viral infection.
BRIEF DESCRIPTION OF DRAWINGS:
Figure 1 depicts the Cytoprotective effect of Amrta karuna of the present invention.
Figure 2 depicts the Kaplan Mayer survival analysis shown WBI (6Gy) with BMSCs following AK treatment improved 75 % survival rate (A). Gaining body weight was observed in the WBI (6Gy) following BMSCs/AK treatments (B). IVIS imaging of the harvested tibia bone marrow shown a DiO labeled BM cells distributed in the AK treatment following 6Gy WBI(C). VE-Cad, Nestin, and CD44 expression significantly increased in the BMSCs/AK treatments compare to WBI alone (D).
Figure 3 depicts the Histological analysis shown the WBI 6Gy following bone marrow plus AK treatments reduce the apoptotic cells in the mouse bone marrow (A). Arrow shown cluster of dead cells. 600X magnification, scale bar 60 μm.
Figure 4 depicts the HIVGKO Virus infection in the SVG pl2cells/Methamphetamine/PBS Figure 5 depicts the Cross -reactivity of antisera raised against SARS-Covnsps and structural proteins cross-reacts with corresponding SARS-cov2 protein. For FISH analysis, cells were double labeled with a rabbit antiserum recognizing nsp9(Cyan) and a mouse mAB recognizing dsRNA (Green). Respectively, nuclear DNA was stained with Hoechst 33258(Blue). Scale bar 500 μm.
SUMMARY OF THE INVENTION:
The present invention disclose a novel poly-herbal pharmaceutical composition “Amrta Karuna” exhibiting immunomodulatory and anti- viral activity and induces immune system by
producing anti bodies against viral infection with enhanced bio-availability and nil side effects, for treatment of subjects suffering from COVID 19 AIDS, Dengue, H1N1, and H5N 1 viral infection. The Amrta Karuna of the present invention comprises of characterized combination of therapeutically and synergistically effective amount of aqueous extracts of Morinda tinctoria, Azadirachta indica, Aegle marmalades, and Tamarindus indica , and fresh fruit juice of Citrus limon (L.) along with DM water, preservatives and sweetener. The present invention also discloses a method of preparation of novel poly-herbal pharmaceutical composition “Amrta Karuna” exhibiting immunomodulatory and anti-viral activity and induces immune system by producing anti bodies against viral infection with enhanced bioavailability and nil side effects, for treatment of subjects suffering from COVID 19 AIDS, Dengue, H1N1, and H5N1 viral infection.
DETAILED DESCRIPTION OF THE INVENTION:
While the invention will be described in conjunction with the enumerated claims, it will be understood that they are not intended to limit the invention to those claims. On the contrary, the invention is intended to cover all alternatives, modifications, and equivalents, which may be included within the scope of the present invention as defined by the claims.
The present invention provides novel combinations of two or more active ingredients being employed together. In some embodiments, a synergistic antiviral effect is achieved.
The present invention discloses a novel poly-herbal pharmaceutical composition exhibiting immunomodulatory and anti-viral activity and induces immune system by producing anti bodies against viral infection with enhanced bio-availability and nil side effects, thereby making is as a suitable candidate for treatment of subjects suffering from COVID 19 AIDS, Dengue, H1N1, and H5N1 viral infection and method of preparation of novel poly-herbal pharmaceutical composition thereof.
The poly-herbal pharmaceutical composition of the present invention comprises of Morinda tinctoria, Azadirachta indica, Aegle marmalades, and Tamarindus indica and Citrus limon (L.).
The poly-herbal pharmaceutical composition is formulated along with DM water, preservatives and sweetener.
The process of preparation is carried out as follows:
• Morinda tinctoria,- 200mg; Azadirachta indica 100mg; Aegle marmalades 100mg;Tamarindus indica, 100mg; the plants materials were collected and pulverized.
• Add 400ml of water and boil well to obtained the decotion.
• Filter the content and added 60mL of fruit juice of Citrus limon (L.) and preservative as per protocol.
• Take required quantity of sugar and dissolved it in required quantity of DM water under boiling.
• Mix the above two solutions and stir well and pH was adjusted to obtain the polyherbal pharmaceutical composition of the present invention.
The manufacturing methods of herbal formulation were prepared by traditional siddha protocols such as Poojas, Subhamukurtha, Panchang, Time metrics.
The pharmaceutical formulation of the present invention was next subjected to clinical studies to study the antiviral, immunomodulatory and cytotoxicity effects.
CYTOTOXICITY EFFECTS:
The cytotoxicity effect of the composition of the present invention was determined by in vitro cell culture studies. Briefly human normal epithelial(HEK), Human dermal fibroblast (HDF), Human vascular endothelial cells(HUVEC) cells , Human bone marrow stem cells (HBMSCs) were treated with different concentration of Amrta Karuna for 96h. After 96h cell viability was determined by MTT Assay. Prior to evaluating protective effects, the toxicities of Amrta Karuna were established following 96 h exposure to human cells in serum-free, conditions. IC50 concentrations were defined as the extract concentration eliciting a 50% loss of viable cells relative to control cultures. No significant toxicity was observed in all the cells tested which shows cytoprotective effect. Amrta Karuna were well-tolerated by cells, with IC50 concentrations of >500 g/mL, respectively, Fig 1.
ANTIVIRAL ACTIVITY:
Biological activities of the composition of the present invention were studied to ascertain its antiviral activity of virus which includes Dengue, H1N1, H5N1 and the like.
The antiviral activity against Dengue virus was determined on tissue culture using VERO cell line. The virus is grown on tissue culture with an overlay of agarose. This will produce plaques. Depending on the time of virus in the inoculums, the number of plaques will be produced. Thereafter the same virus will be mixed with composition of the present invention and again grown and latter counted for reduction in number of plaques. The formulation showed significant inhibition.
From the experimental results it is inferred that the composition of the present invention has maximum antiviral activity against Dengue virus in the range of 0.1 mg/mL
The antiviral activity against H1N1 virus was determined on tissue culture using MDCK cell line. The virus is grown on tissue culture with an overlay of agarose. This will produce plaques. Depending on the time of virus in the inoculums, the number of plaques will be produced. Thereafter the same virus will be mixed with composition of the present invention and again grown and latter counted for reduction in number of plaques. The formulation showed significant inhibition.
From the experimental results it is inferred that the composition of the present invention has maximum antiviral activity against H1N1 virus in the range of 0.05 mg/mL
The antiviral activity against H5N 1 virus was determined on tissue culture using VERO cell line. The virus is grown on tissue culture with an overlay of agarose. This will produce plaques. Depending on the time of virus in the inoculums, the number of plaques will be produced. Thereafter the same virus will be mixed with composition of the present invention and again grown and latter counted for reduction in number of plaques. The composition showed significant inhibition.
From the experimental results it is inferred that the composition of the present invention has maximum antiviral activity against H5N1 virus in the range of 0.5 mg/mL
From the study it is evident that the pharmaceutical formulation of the present invention shows excellent antiviral activity against Dengue, H1N1 and H5N1 virus. Hence the
formulation of the present invention will also surely efficient to cure COVID19 as it is having excellent anti-viral activity against various viruses
IMMUNOMODULATORY ACTIVITY:
Administration of formulation of the present invention was found to stimulate immunological activity in in vitro cell culture studies. Treatment with five doses of formulation of the present invention was found to enhance the total amount of cytokines production count. Anti inflammatory cytokine such as IL-4, IL-6, IL-10, IFN gamma are produced in significant amount and estimated using quantitative method. These results confirm the immunomodulatory activity of composition of the present invention.
The composition of the present invention is subjected to synergism studies, to Study the effect of the composition of the present invention viz-a-viz its components when individually applied.
SYNERGISM STUDIES.
TABLE 1: ANTIVIRAL ACTIVITY
From Table 1 it is inferred that individual ingredients Morinda tinctoria, or Azadirachta indica or Aegle marmalades or and Tamarindus indica or Citrus limon (L.)can able to inhibit various viruses by only 5-25% whereas the composition of the present invention inhibits 100% thereby proving the synergism of the formulation of the present invention.
From Table 2 it is inferred that the composition of the present invention exhibits superior Immunomodulatory Activity in comparison with individual ingredients Morinda tinctoria, or Azadirachta indica or Aegle marmalades or and Tamarindus indica or Citrus limon (L.) thereby proving the synergism of the compostion of the present invention.
PRECLINICAL ASSESSMENT OF BONE MARROW STROMAL CELLS TRANSPLANTS WITH ADMINISTRATION OF AMRTA KARUNA FOLLOWING IONIZING IRRADIATION.
The tissues and organs recovery from ionizing irradiation is critically dependent on the repopulation of resident stem cells, defined as the subset of cells with self-renewal and differentiation capacity. Mobilization of both hematopoietic and mesenchymal stem cell populations can be stimulated by various factors, including cytokines, and the as-yet- unknown soluble factor involved in the radiation bystander effect. There are precise microanatomic sites in the hematopoietic microenvironment in vivo in which stem cells reside. These stem cell “niches” have recently been shown to be relatively hypoxic. Therefore, in this study, we assessed the bone marrow stromal cells (BMSCs)transplants following Amrta Karuna (AK) treatments in the whole-body irradiation (WBI) promisinglydemonstrated the serial generation of stem cell repopulation capacity identified in the bone marrow of WBI mice.The response of stem cells to irradiation has been the subject of intense investigation. This pilotstudy determined that Amrta Karuna treatment following BMSCs transplants increase the 75% survival of the 6Gy WBI mice (Fig 2A) and improve the body weight (Fig 2B) compare to other mode of treatments groups. Interestingly, IVIS imagining detected signal of the DiO labeled BMSCs following Amrta Karuna treatments (Fig 2C). Further, protein estimationconfirms the regeneration of hematopoietic stromal cells significantlyincrease the expression of VE-Cadherin, Nestin, and CD44 in the ionizing irradiated bone marrow (Fig 2D). In addition, Histology confirms the Amrta Karuna improve the mitogens of the transplanted BMSCs whichimproves the migratory response and repair the bone marrow to ionizing irradiation (Fig3). In conclusion, emerging preliminary data provides that BMSCs with combination of Amrta Karuna promote the BMSCs regeneration following WBI, but still in-depth study required to assess the in-depthmechanism of how Amrta Karuna helps the BMSCs in the WBI and still need to study more vasculature developments and also radioprotective of the Amrta Karuna against hematopoietic syndrome. Statistical analysis: One-way ANOVA with Bonferroni post hoc test performed between WBI 6Gy with other treatment group. *p<0.05 and ** p<0.01
ANTI HIV STUDIES OF AMRTA KARUNA:
HIV infection and METH dependence can have synergistic pathological effects, with preferential involvement of frontostriatal circuits.
Group 1:
HIV latency reactivation in infected in the SVG p 12.
HIVGKO Virus (GFP) positive infection in the SVG pl2 cells/Methamphetamine/PBS. Group 2:
HIV latency reactivation in infected in the SVG p 12.
HIVGKO Virus (GFP) positive infection in the SVG pl2 cells/Methamphetamine/AK. CONCFUSION (Fig 4)
1. Based on the DNMT1 in situ fish hybridization result it was found that Amrta Karuna totally reduce the methamphetamine abuse in the HIV positive astroglial cells.
2. Interestingly, it was found that the Amrta Karuna treatment reduce the effect of meth abuse and also reduce the proliferation on the HIV infected human SVG pl2 astroglia cells.
Anti SARSCOV-2 activity of Amrta Karuna:
The SARS-CoVnsps specific rabbit or mouse antisera were raised using a synthetic peptide (nsp4, aa 4209-4230 of SARS-Cov ppla). Cross-reactivity of antisera to SARS-Cov2 targets was evaluated microscopically byfluorescent in situ hybridization (FISH). Vero E6 cells were infected at 12, and 24 hrs post-infection Amrta Karuna treated samples were stained with secondary NSP4 and mouse mAB recognizing ds RNA. However, the experiments confirm the Amrta Karuna syrup treatments to Vero E6 cells (Fig 5) revealed a clear difference with SARS-CoV replication inhibited. Interestingly post 12 hours shows 60% and 24 hours shows 100% propagation of SARS-CoV infection in the Vero cell line. However, SARS-CoV infected Vero cell line treated with Amrta Karuna syrup significantly reduce the propagation of the SARS-CoV virus protein expression.
As many viruses remain without preventive vaccines and effective antiviral treatments, eradicating these viral diseases appears difficult. Nonetheless, herbal products serve as an excellent source of biodiversity of formulating novel antivirals, revealing new structure-activity relationships, and developing effective protective/therapeutic strategies against viral infections. The antiviral and Immunomodulatory activity of a drug is important to fight against any virus. This study has shown that the polyherbal pharmaceutical composition of the present invention, exhibits excellent antiviral and Immunomodulatory activity which could form a good basis for the development of new and useful antiviral drugs for the prevention and treatment of those highly virulent viruses that have hitherto been very difficult to control with orthodox drugs particularly due to rapid occurrence of drug resistant virus strains in particular SARS Co V 2.
In one of the preferred embodiment, the present invention shall disclose a novel poly-herbal pharmaceutical composition “Amrta Karuna” exhibiting immunomodulatory and anti-viral activity and induces immune system by producing anti bodies against viral infection with enhanced bio-availability and nil side effects, for treatment of subjects suffering from COVID 19 AIDS, Dengue, H1N1, and H5N1 viral infection. The Amrta Karuna of the present invention comprises of characterized combination of therapeutically and synergistically effective amount of aqueous extracts of Morinda tinctoria, Azadirachta indica, Aegle marmalades, Tamarindus indica andfresh fruit juice ofCitrus limon (L.) along with DM water, preservatives and sweetener.
According to the invention, in the novel poly-herbal pharmaceutical composition “Amrta
Karuna”, the aqueous extracts of Morinda tinctoria, Azadirachta indica, Aegle marmalades, Tamarindus indica andfresh fruit juice ofCitrus limon (L.) are present in a ratio comprising of 2: 1 : 1 : 1 :0.5.
As per the invention, in the novel poly-herbal pharmaceutical composition “Amrta Karuna”, the preservatives are selected from a group comprising of 0.01 % Bronopol, 0.1%Sodium benzoate, 0.01% Citric acid, 1% Ascorbic acid, 1.5% Butylated Hydroxytoluene (3,5- ditertiarybutyl-4-hydroxytoluene)
In accordance with the invention, in the novel poly-herbal pharmaceutical composition “Amrta Karuna”, the sweetener is selected from a group comprising of Sugar, Sucrose, Aspartame, Sucralose and the like.
According to the invention, the novel poly-herbal pharmaceutical composition “Amrta Karuna”, shall be formulated in a form of syrup, Tablet, Capsule and the like.
In another preferred embodiment, the present invention shall disclose a process of preparation of novel poly-herbal pharmaceutical composition “Amrta Karuna” exhibiting immunomodulatory and anti-viral activity and induces immune system by producing anti bodies against viral infection with enhanced bio-availability and nil side effects, for treatment of subjects suffering from COVID 19 AIDS, Dengue, H1N1, and H5N1 viral infection. The process of preparation of Amrta Karuna of the present invention comprises of following steps: a. Collecting shade dried, leaves of Morinda tinctoria, leaves of Azadirachta indica, - leaves of Aegle marmalades, and leaves of Tamarindus indica in a predetermined ratio; b. Pulverizing the collected shade dried, leaves of Morinda tinctoria, leaves of Azadirachta indica, leaves of Aegle marmalades, and leaves of Tamarindus indica to form a powdered mixture; c. Adding predetermined amount of water to the powdered mixture and boiled for predetermined time to form a decoction followed by filtration and addition of predetermined amount of fresh fruit juice ofCitrus limon (L.) and preservatives to form an active ingredient enriched extract; d. Preparing a sugar solution by mixing predetermined amount of sugar in DM water and boiled for predetermined period of time; e. Homogeneously mixing the active ingredient enriched extract and the sugar solution followed by adjusting pH to predetermined value to form the Amrta Karuna.
In yet another preferred embodiment, the present invention shall disclose a process of preparation of novel poly-herbal pharmaceutical composition “Amrta Karuna” exhibiting immunomodulatory and anti-viral activity and induces immune system by producing anti bodies against viral infection with enhanced bio-availability and nil side effects, for treatment of subjects suffering from COVID 19 AIDS, Dengue, HINT, and H5N1 viral infection. The
process of preparation of Amrta Karuna of the present invention comprises of following steps: a) Collecting 200mg of shade dried leaves of Morinda tinctoria, 100mg of shade dried leaves of Azadirachta indica, 100mg of shade dried leaves ofAegle marmalades and 100mg of shade dried leaves of Tamarindus indica', b) Pulverizing the collected shade dried, leaves of Morinda tinctoria, leaves of Azadirachta indica, leaves ofAegle marmalades, and leaves of Tamarindus indica to form a powdered mixture; c) Adding 400 mL of water to the powdered mixture and boiled for 20 min time to form a decoction followed by filtration and addition of 60mL of fresh fruit juice ofCitrus limon (L.) and 0.02% of preservatives to form active ingredient enriched extract; d) Preparing a sugar solution by mixing 50 gms of sugar in 100mL of DM water and boiled for 10 min; e) Homogeneously mixing the active ingredient enriched extract and the sugar solution followed by adjusting pH to 5-6 to form the Amrta Karuna
According to the invention, in the process discussed above, the preservatives are selected from a group comprising of 0.01 % Bronopol, 0.1%Sodium benzoate, 0.01% Citric acid, 1% Ascorbic acid, 1.5% Butylated Hydroxytoluene (3,5-ditertiarybutyl-4-hydroxytoluene)
In further preferred embodiment, the present invention shall disclose a novel poly-herbal pharmaceutical composition “Amrta Karuna” exhibiting immunomodulatory and anti-viral activity and induces immune system by producing anti bodies against viral infection with enhanced bio-availability and nil side effects, for treatment of subjects suffering from COVID 19 AIDS, Dengue, H1N1, and H5N1 viral infection, prepared by the process as described above.
In another preferred embodiment the present invention shall disclose a method of treating viral infection in a subject in need thereof, comprising administering to the subject: (i) effective amount of novel poly-herbal pharmaceutical composition “Amrta Karuna” of the present invention either alone or as an adjuvant, or complementary treatment to an existing and-viral therapy
As per the invention, in the method described above, the viral infection comprises of COVID 19 AIDS, Dengue, HINT, and H5N1 viral infection or any combination thereof.
In another preferred embodiment, the present invention shall disclose an article of manufacture, comprising: (i) effective amount of novel poly-herbal pharmaceutical composition “Amrta Karuna” of the present invention and (ii) instructions for use in treating viral infection.
In accordance with the invention, in the article of manufacture, the viral infection comprises of COVID 19, AIDS, Dengue, HINT, and H5N1 viral infection or any combination thereof.
In further preferred embodiment, the present invention shall disclose a kit, comprising: (i) effective amount of novel poly-herbal pharmaceutical composition “Amrta Karuna” the present invention and (ii) instructions for use in treating viral infection.
According to the invention, in the kit, the viral infection comprises of COVID 19 AIDS, Dengue, HINT, and H5N1 viral infection or any combination thereof.
In various aspects, the novel poly-herbal pharmaceutical composition of the present invention, can be administered at about 0.001 mg/kg to about 100 mg/kg body weight (e.g., about 0.01 mg/kg to about 10 mg/kg or about 0.1 mg/kg to about 5 mg/kg).
The concentration of a novel poly-herbal pharmaceutical composition of the present invention will vary depending on several factors, including the dosage of the compound to be administered, the pharmacokinetic characteristics of the compound(s) employed, and the route of administration. The agent may be administered in a single dose or in repeat doses. The dosage regimen utilizing the compounds of the present invention is selected in accordance with a variety of factors including type, species, age, weight, sex and medical condition of the patient; the severity of the condition to be treated; the route of administration; the renal and hepatic function of the patient; and the particular compound or salt thereof employed. Treatments may be once administered daily or more frequently depending upon a number of factors, including the overall health of a patient, and the formulation and route of administration of the selected compound(s).
Methods of Treatment:
Provided herein are also methods of treating a viral infection in a human in need thereof, comprising administering the novel poly-herbal pharmaceutical composition of the present invention.
In another aspect, there is provided a method of treating viral infections in a subject in need of such treatment comprising administering to the subject a therapeutically effective amount of a novel poly-herbal pharmaceutical composition of the present, invention, either alone or as an adjuvant, or complementary treatment to an existing anti -viral therapy.
In another aspect, there is provided a method of treating HIV infections in a subject in need of such treatment comprising administering to the subject a therapeutically effective amount of a novel poly-herbal pharmaceutical composition of the invention, either alone or as an adjuvant, or complementary treatment to an existing anti-viral therapy.
In another aspect, there is provided a method of treating Dengue virus infections in a subject in need of such treatment comprising administering to the subject a therapeutically effective amount of a novel poly-herbal pharmaceutical composition of the invention, either alone or as an adjuvant, or complementary treatment to an existing anti-viral therapy.
In another aspect, there is provided a method of treating HINlinfections in a subject in need of such treatment comprising administering to the subject a therapeutically effective amount of a novel poly-herbal pharmaceutical composition of the invention, either alone or as an adjuvant, or complementary treatment to an existing anti-viral therapy.
In another aspect, there is provided a method of treating HSNlinfections in a subject in need of such treatment comprising administering to the subject a therapeutically effective amount of a novel poly-herbal pharmaceutical composition of the invention, either alone or as an adjuvant, or complementary treatment to an existing anti-viral therapy.
In another aspect, there is provided a method of treating SARS CoV2 infections in a subject in need of such treatment comprising administering to the subject a therapeutically effective amount of a novel poly-herbal pharmaceutical composition of the invention, either alone or as an adjuvant, or complementary treatment to an existing anti-viral therapy.
In another aspect, there is provided formulations comprising the novel poly-herbal pharmaceutical composition of the present invention in combination with a pharmaceutically or nutritionally acceptable carrier(s) or excipient(s).
In another aspect, the novel poly-herbal pharmaceutical composition of the present invention is used during the maintenance phase of the treatment, following an initial viral load reduction phase in which it is used as an adjuvant to conventional anti-viral drug therapy.
In another aspect, novel poly-herbal pharmaceutical composition of the present invention is used during tire maintenance phase of the treatment, following an initial HIV load reduction phase in which it is used as an adjuvant to conventional anti-viral drug therapy.
In another aspect novel poly-herbal pharmaceutical composition of the present invention is used during the maintenance phase of the treatment following an initial Dengue virus load reduction phase in which it is used as an adjuvant to conventional anti-viral drug therapy.
In another aspect, novel poly-herbal pharmaceutical composition of the present invention is used during the maintenance phase of the treatment, following an initial H1N1 virus load reduction phase in which it is used as an adjuvant to conventional anti-viral drug therapy.
In another aspect, novel poly-herbal pharmaceutical composition of the present invention is used during the maintenance phase of the treatment, following an initial H5N1 virus load reduction phase in which it is used as an adjuvant to conventional anti-viral drug therapy.
In another aspect, novel poly-herbal pharmaceutical composition of the present invention is used during the maintenance phase of the treatment, following an initial SARS CoV2 load reduction phase in which it is used as an adjuvant to conventional anti- viral drug therapy.
In another aspect, the present composition is used for the treatment, prevention or management of immune-supporting system in primates, especially humans comprising administering an effective amount of novel poly-herbal pharmaceutical composition of the present invention.
The novel poly-habal pharmaceutical composition of the present invention include those suitable for oral, nasal, topical (including buccal and sub-lingual), transdermal, or parenteral (including intramuscular, subcutaneous and intravenous) administration. The formulations may, where appropriate, be conveniently presented in discrete dosage units and may be prepared by any of the methods well known in the art of pharmaceutical or nutritional formulation. All methods preferably indude the step of bringing into association the active compound with liquid carriers or finely divided solid carriers or both and then, if necessary, shaping the product into the desired formulation.
The novel poly-herbal pharmaceutical composition of the present invention is suitable for oral administration may conveniently be presented as discrete units such as capsules, cachets or tablets each containing a predetermined amount of the active ingredient; as a powder or granules; as a solution, a suspension or as an emulsion. The active ingredient may also be presented as a powder or paste or suspension or solutions. Tablets and capsules for oral administration may contain conventional excipients such as binding agents, fillers, lubricants, disintegrants. or wetting agents. The tablets may be coated according to methods well known in the art. Oral liquid preparations may be in the form of, for example, aqueous or oily suspensions, solutions, emulsions, syrups or elixirs, or may be presented as a dry product for constitution with water or other suitable vehicle before use. Such liquid preparations may contain conventional additives such as suspending agents, emulsifying agents, non-aqueous vehicles (which may include edible oils), or preservatives.
The novel poly-herbal pharmaceutical composition of the present invention may also be formulated for parenteral administration (e.g., by injection, for example continuous infusion) and may be presented in unit dose form in ampoules, pre-filled syringes, small volume infusion or in multi-dose containers with an added preservative. The formulation may take such forms as suspensions, solutions, or emulsions in oily or aqueous vehicles, and may contain agents such as suspending, stabilizing an/or dispersing agents. Alternatively, the
active ingredients may be in powder form, obtained by aseptic isolation of sterile solid or by lyophilisalion from solution, for constitution with a suitable vehicle, e.g., sterile, pyrogen-free water, before use.
For topical administration to the epidermis, the novel poly-herbal pharmaceutical composition of the present invention may be formulated as ointments, creams or lotions, or as a transdermal patch. Such transdermal patches may contain penetration enhancers such as linalool, carvacrol, thymol, citral, menthol, lecithin, diethylisosorbide, and alkylpyrrolidones. Ointments and creams may, for example, be formulated with an aqueous or oily base with the addition of suitable thickening and/or gelling agents. Lotions may be formulated with an aqueous or oily base and will in general also contain one or more emulsifying agents, stabilizing agents, dispersing agents, suspending agents, thickening agents, or coloring agents.
Formulations suitable for topical administration in the mouth include lozenges comprising the active ingredients in a flavored base, usually sucrose and acacia or tragacanth; pastilles comprising the active ingredient in an inert base such as gelatin and glycerin or sucrose and acacia; and mouthwashes comprising the active ingredient in a suitable liquid carrier.
When desired the above-described formulations adapted to give sustained release of the active ingredient may be employed.
Articles of Manufacture
Articles of manufacture are also provided herein, wherein the article of manufacture comprises a novel poly-herbal pharmaceutical composition of the present invention, in a suitable container, The container may be a vial, jar, ampoule, preloaded syringe, or intravenous bag.
The present disclosure further provides kits for carrying out the methods of the invention. The kits may comprise a novel poly-herbal pharmaceutical composition of the present invention as described herein and suitable packaging. The kits may comprise one or more containers comprising novel poly-herbal pharmaceutical composition of the present invention
described herein. In one aspect, a kit includes a novel poly-herbal pharmaceutical composition of the present invention, and a label and/or instructions for use of the compound in the treatment of viral infection described herein. The kits may comprise a unit dosage form of the novel poly-herbal pharmaceutical composition of the present invention.
The following examples are provided to illustrate various embodiments of the present invention and shall not be considered as limiting in scope.
Example 1:
The novel poly-herbal pharmaceutical composition “Amrta Karuna” exhibiting immunomodulatory and anti-viral activity and induces immune system by producing anti bodies against viral infection with enhanced bio-availability and nil side effects, for treatment of subjects suffering from COVID 19 AIDS, Dengue, H1N1, and H5N1 viral infection, comprises of
• 200mg of Morinda tinctoria present as aqueous extract of shade dried leaf
• 100mg of Azadirachta indica present as aqueous extract of shade dried leaf
• 100mg of Aegle marmalades present as aqueous extract of shade dried leaf
• 100mg of Tamarindus indica present as aqueous extract of shade dried leaf
• 60mL of fresh fruit juice of Citrus limon (L.)
• 0.02% of 0.01 % Bronopol
• 50 gms of sugar
• 1L of DM water Example 2:
The process of preparation of novel poly-herbal pharmaceutical composition “Amrta Karuna” exhibiting immunomodulatory and anti-viral activity and induces immune system by producing anti bodies against viral infection with enhanced bio-availability and nil side
effects, for treatment of subjects suffering from COVID 19 AIDS, Dengue, H1N1, and H5N1 viral infection, comprises of following steps: a) Collecting 200mg of shade dried leaves of Morinda tinctoria, 100mg of shade dried leaves of Azadirachta indica, 100mg of shade dried leaves ofAegle marmalades and 100mg of shade dried leaves of Tamarindus indica', b) Pulverizing the collected shade dried, leaves of Morinda tinctoria, leaves of Azadirachta indica, leaves ofAegle marmalades, and leaves of Tamarindus indica to form a powdered mixture; c) Adding 400 mL of water to the powdered mixture and boiled for 20 min time to form a decoction followed by filtration and addition of 60mL of fresh fruit juice ofCitrus limon (L.) and 0.02% of 0.01 % Bronopol to form active ingredient enriched extract; d) Preparing a sugar solution by mixing 50 gms of sugar in 100mL of DM water and boiled for 10 min; e) Homogeneously mixing the active ingredient enriched extract and the sugar solution followed by adjusting pH to 5-6 to form the Amrta Karuna
Although the invention has now been described in terms of certain preferred embodiments and exemplified with respect thereto, one skilled in art can readily appreciate that various modifications, changes, omissions and substitutions may be made without departing from the spirit thereof. It is intended therefore that the present invention be limited solely by the scope of the following claims.
Claims
1. A novel poly-herbal pharmaceutical composition “Amrta Karuna” exhibiting immunomodulatory and anti- viral activity and induces immune system by producing anti bodies against viral infection with enhanced bio-availability and nil side effects, for treatment of subjects suffering from COVID 19 AIDS, Dengue, H1N1, and H5N1 viral infection, the claimed Amrta Kanina comprises of characterized combination of therapeutically and synergistically effective amount of aqueous extracts of Morinda tinctoria, Azadirachta indica, Aegle marmalades, Tamarindus indica andfresh fruit juice ofCitrus limon (L.) along with DM water, preservatives and sweetener.
2. The novel poly-herbal pharmaceutical composition “Amrta Karuna” as claimed in claim 1 wherein the said aqueous extracts of Morinda tinctoria, Azadirachta indica, Aegle marmalades, Tamarindus indica andfresh fruit juice ofCitrus limon (L.) are present in a ratio comprising of 2: 1 : 1 : 1 :0.5.
3. The novel poly-herbal pharmaceutical composition “Amrta Karuna” as claimed in claim 1 wherein the said preservatives are selected from a group comprising of 0.01 % Bronopol, 0.1%Sodium benzoate, 0.01% Citric acid, 1% Ascorbic acid, 1.5% Butylated Hydroxytoluene (3,5-ditertiarybutyl-4-hydroxytoluene)
4. The novel poly-herbal pharmaceutical composition “Amrta Karuna” as claimed in claim 1 wherein the said sweetener is selected from a group comprising of Sugar, Sucrose , Aspartame, Sucralose and the like.
5. The novel poly-herbal pharmaceutical composition “Amrta Karuna” as claimed in claim 1 shall be formulated in a form of syrup, Tablet, Capsule and the like.
6. A process of preparation of novel poly-herbal pharmaceutical composition “Amrta Karuna” exhibiting immunomodulatory and anti-viral activity and induces immune system by producing anti bodies against viral infection with enhanced bio-availability and nil side effects, for treatment of subjects suffering from COVID 19 AIDS, Dengue, H1N1, and H5N1 viral infection, the claimed process of preparation of Amrta Karuna comprises of following steps:
a. Collecting shade dried, leaves of Morinda tinctoria, leaves of Azadirachta indica, - leaves of Aegle marmalades, and leaves of Tamarindus indica in a predetermined ratio; b. Pulverizing the collected shade dried, leaves of Morinda tinctoria, leaves of Azadirachta indica, leaves of Aegle marmalades, and leaves of Tamarindus indica to form a powdered mixture; c. Adding predetermined amount of water to the said powdered mixture and boiled for predetermined time to form a decoction followed by filtration and addition of predetermined amount of fresh fruit juice ofCitrus limon (L.) and preservatives to form an active ingredient enriched extract; d. Preparing a sugar solution by mixing predetermined amount of sugar in DM water and boiled for predetermined period of time; e. Homogeneously mixing the said active ingredient enriched extract and the said sugar solution followed by adjusting pH to predetermined value to form the said Amrta Karuna.
7. A process of preparation of novel poly-herbal pharmaceutical composition “Amrta Karuna” exhibiting immunomodulatory and anti-viral activity and induces immune system by producing anti bodies against viral infection with enhanced bio-availability and nil side effects, for treatment of subjects suffering from COVID 19 AIDS, Dengue, H1N1, and H5N1 viral infection, the claimed process of preparation of Amrta Karuna comprises of following steps: a. Collecting 200mg of shade dried leaves of Morinda tinctoria, 100mg of shade dried leaves of Azadirachta indica, 100mg of shade dried leaves of Aegle marmalades and 100mg of shade dried leaves of Tamarindus indica', b. Pulverizing the collected shade dried, leaves of Morinda tinctoria, leaves of Azadirachta indica, leaves of Aegle marmalades, and leaves of Tamarindus indica to form a powdered mixture; c. Adding 400 mL of water to the said powdered mixture and boiled for 20 min time to form a decoction followed by filtration and addition of 60mL of fresh
fruit juice ofCitrus limon (L.) and 0.02% of preservatives to form active ingredient enriched extract; d. Preparing a sugar solution by mixing 50 gms of sugar in 100mL of DM water and boiled for 10 min; e. Homogeneously mixing the said active ingredient enriched extract and the said sugar solution followed by adjusting pH to 5-6 to form the said Amrta Karuna
8. The process as claimed in claim 6 and 7 wherein the said preservatives are selected from a group comprising of 0.01 % Bronopol, 0.1%Sodium benzoate, 0.01% Citric acid, 1% Ascorbic acid, 1.5% Butylated Hydroxytoluene (3,5-ditertiarybutyl-4- hydroxy toluene) .
9. A novel poly-herbal pharmaceutical composition “Amrta Karuna” exhibiting immunomodulatory and anti-viral activity and induces immune system by producing anti bodies against viral infection with enhanced bio-availability and nil side effects, for treatment of subjects suffering from COVID 19 AIDS, Dengue, H1N1, and H5N1 viral infection, prepared by the process as claimed in claim 7 and 8.
10. A method of treating viral infection in a subject in need thereof, comprising administering to the subject: (i) effective amount of novel poly-herbal pharmaceutical composition “Amrta Karuna” of any one of claims 1-5 and 9 either alone or as an adjuvant, or complementary treatment to an existing anti-viral therapy.
11. The method of claim 10, wherein the said viral infection comprises of COVID 19 AIDS, Dengue, HINT, and H5N1 viral infection or any combination thereof.
12. An article of manufacture, comprising: (i) effective amount of novel poly-herbal pharmaceutical composition “Amrta Karuna” of any one of claims 1-5 and 9 and (ii) instructions for use in treating viral infection.
13. The article of manufacture of claim 12, wherein the said viral infection comprises of COVID 19, AIDS, Dengue, HINT, and H5N1 viral infection or any combination thereof.
14. A kit, comprising: (i) effective amount of novel poly-herbal pharmaceutical composition “Amrta Karuna” of any one of claims 1-5 and 9 and (ii) instructions for use in treating viral infection.
15. The kit of claim 35, wherein the said viral infection comprises of COVID 19 AIDS, Dengue, H1N1, and H5N1 viral infection or any combination thereof.
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KURU, PINAR: "Tamarindus indica and its health related effects", ASIAN PACIFIC JOURNAL OF TROPICAL BIOMEDICINE, vol. 4, no. 9, 2014, pages 676 - 681, XP002742978, DOI: 10.12980/APJTB.4.2014APJTB-2014-0173 * |
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