WO2012176215A1 - A plant based antiviral composition for the treatment of hiv and hiv related acquired immuno deficiency syndrome - Google Patents

A plant based antiviral composition for the treatment of hiv and hiv related acquired immuno deficiency syndrome Download PDF

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Publication number
WO2012176215A1
WO2012176215A1 PCT/IN2012/000410 IN2012000410W WO2012176215A1 WO 2012176215 A1 WO2012176215 A1 WO 2012176215A1 IN 2012000410 W IN2012000410 W IN 2012000410W WO 2012176215 A1 WO2012176215 A1 WO 2012176215A1
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Prior art keywords
hiv
composition
plant based
present
antiviral composition
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PCT/IN2012/000410
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French (fr)
Inventor
Manohar PUNDALEEKAPPA SHINHASAN
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Pundaleekappa Shinhasan Manohar
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    • 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)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction

Definitions

  • the present invention relates to a plant based antiviral composition and more particularly to a process for preparing an injectable antiviral composition for the treatment of HIV disease and HIV related Acquired Immunodeficiency Syndrome (AIDS).
  • the plant based injectable antiviral composition is effective in treating the infections caused by Human Immunodeficiency Virus (HIV).
  • HIV Human Immunodeficiency Virus
  • the composition of the present invention is effective in relieving symptoms and curing the opportunistic infections of AIDS.
  • the present invention destroys surface antigens as well as HIV Genome by invading into the virus and there by killing HIV.
  • HIV Human Immunodeficiency Virus
  • HIV land HIV 2 Two genetically different but related forms of HIV called HIV land HIV 2 have been isolated from patients with AIDS. HIVl is most common type associated with AIDS in USA, Europe, and Central Africa where as HIV2 causes a similar disease in West Africa and India. Although distinct, HIVl and HIV2 share some antigens. HIV damages the human immune system (lymphoid system) and central nervous system. Profound suppression by severe loss of CD4+T cells as well as impairment in function of surviving helper T-cells occurs. Monocytes, macrophages and dendritic cells are also targets of HIV infection.
  • Envelope glycoprotein gpl20 binds to CD4 molecules through its CXCR4 co-receptors and to macrophages and monocytes through its CCR5 co-receptors.
  • the next step involves conformational changes in gp41. These changes result in insertion of fusion peptide at the tip of gp41 into the cell membrane of target cells. After fusion, the virus core containing the HIV Genome enters the cytoplasm of the cell. Binding of HIV to its co-receptors is important in pathogenesis of AIDS.
  • HIV is the virus that causes AIDS.
  • AIDS is not a single disease but it is a syndrome- a set of diseases, which results from the destruction of the body's defense mechanism.
  • AIDS is the next final stage of HIV infection, which leads to breakdown of the immune system of the human body and makes it unable to fight against infections or the other illness.
  • AIDS is a global problem.
  • HIV had infected 60 million people worldwide and nearly 20 million people have died of the disease.
  • Patients with HIV infection needs long-term or life-long treatment.
  • the now available treatment pattern includes treating not only the virus but. also the opportunistic infections.
  • Antiretroviral drugs are medications preferred for the treatment of infection by retroviruses, primarily HIV.
  • the Antiretroviral drugs used in the treatment of HIV infection generally belongs to the category of Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Non nucleoside Reverse Transcriptase Inhibitors (N RTIs) and Protease Inhibitors (Pis).
  • NRTIs Nucleoside Reverse Transcriptase Inhibitors
  • N RTIs Non nucleoside Reverse Transcriptase Inhibitors
  • Protease Inhibitors Protease Inhibitors
  • HAART Highly Active Anti Retroviral Therapy
  • the common concern about the antiretroviral treatment includes intolerance of the patient to the drugs and development of viral resistance that includes multi drug resistance in the case of patients who were not regular in following the treatment regimen. Another notable concern is regarding the cost of the treatment, which is not affordable by majority of the patients.
  • US5980903 discloses an oral anti viral composition containing Thymol (crystals of Bishop's Weed) and fruit of Chebulic myroblan in addition to Ocimum sanctum.
  • GB2314270 discloses an oral ayurvedic composition
  • an aqueous extract of 42 different herbs including Ocimum sanctum mixed with an aqueous extract of Rasont, Bhasmas, Kalpas, Minerals and.Rudraksh ash.
  • IN243944 reveals an oral herbal composition comprising sixteen herbal ingredients including Ocimum sanctum, to be taken in the form of capsules.
  • US20040156920 patent application reveals an oral composition indicated for conditions including cough, cold, asthma, congestion, sleeplessness and for the human disease concerning nervous, respiratory, digestive and immune system, comprising an . oily extract of a monocotyledonous or dicotyledonous Angiosperm or Gymnosperm plants biomass and other non-plant biomass containing Ocimum sanctum among several other ingredients.
  • US20070122495 patent application reveals an oral herbal preparation indicated to improve psychological functions as an anxiolytic, adaptogenic, antistress, sedative and tranquilizer containing Ocimum sanctum and ten other ingredients.
  • 1330/DEL/2004 Indian patent application reveals an oral herbal composition containing nearly 29 ingredients including Ocimum sanctum indicated in the treatment of HIV.
  • ingredients for the plant based antiviral composition comprises of:
  • Distilled water It is another object of the present invention, wherein the plant based antiviral composition is effective in relieving symptoms and curing the opportunistic infections of AIDS.
  • the plant based antiviral composition acts on both HIV surface antigens, namely envelope glycoprotein 41 (gp41), gpl20 and gp36 as well as on HIV Genome.
  • HIV surface antigens namely envelope glycoprotein 41 (gp41), gpl20 and gp36 as well as on HIV Genome.
  • the plant based antiviral composition acts by destroying the surface antigens and make retrovirus unable to get attach with cluster of differentiation four (CD4+T) lymphocytes.
  • the plant based antiviral composition destroys the HIV Genome by invading into the virus and there by kills HIV virus.
  • the plant based antiviral composition is so potent that a single dose through intra venous route eliminates 99% to almost 100% of HIV from blood and body organs.
  • the plant based antiviral composition possess anti viral, anti bacterial , anti oxidant, immuno stimulant, immuno modulator and immune-stabilizing-property, anti-helminthic, anti-lishmanial-activity, anticancer, adaptogenic, diaphoretic, anti genotoxic effects (dose dependent), radio protective property (protection against lipid peroxidation and DNA damage), hepato protective, cardio protective, analgesic, anti emetic, anti spasmodic, anti asthamatic, anti ulcer, anti malarial, larvicidal, anti spermatogenic, anti proliferative, angiogenesis, ameliorative effects, reduces the formation of lipid peroxidases, reactivates antioxidant enzymes restores the level of GSH (Glutathione), calcium attenuating actions, apoptosis inducing property, antistressor effects, anti-hyperlipidemic and membrane stabilizing properties.
  • GSH Glutathione
  • the reported adverse reactions are fever and chills along with atopic type 1, allergic reactions including bronchial asthma and local reactions including pain, tenderness at the site of injection, less frequently phlebitis after intra venous (IV) administration.
  • All initial doses should be given after an Attenuated Test Dose (ATD) of 0.5ml intradermally over ventral part of right/left forearm to find out the sensitivity/allergy of the preparation to the patient. Any flare or redness area of 5mm to 10mm around the site of injection may be considered as sensitive/allergic to the drug.
  • Hydrocartisone hemisuccinate 100 mg (adult dose) injection is the drug of choice to combat any of these drug allergies.
  • the final composition is in powder form and can be used/ reconstituted with or without micronization. It is another object of the present invention, wherein the final composition can be reconstituted by dissolving it in distilled water for administration through deep intramuscular/intra venous or intradermal or subcutaneous route.
  • the recommended concentration of the composition for an average adult is 1 ' to 2 grams of the final composition dissolved in distilled water.
  • the recommended dosage of the composition for an adult isl or 2 doses of the final composition as deep intramuscular (IM) injection followed by a single dose of the said composition as intravenous infusion for 4 to 5 days thereby the total duration of treatment of simple HIV disease is 5 to 7 days.
  • IM deep intramuscular
  • more doses and longer duration may be desired.
  • lower or higher drug concentrations may be used if desired depending on the severity of the disease.
  • ammonium carbonate is commercial ammonium carbonate which is a double salt of ammonium hydrogen carbonate and ammonium amino methanoate (carbamate).
  • the holy basil leaves are selected from the plant species of Ocimum Sanctum and Ocimum Tenniflorum.
  • the final composition is in powder form which may or may not be micronized.
  • composition is reconstituted with distilled water.
  • the reconstituted solution is compatible with dextrose and saline solutions.
  • the crude extract of the composition contains eugenol (1 -hydroxy 2-methoxy 4-allyl benzene), carvacrol, linalool, methyl chavicol, delta cadinene, 3-carene, alfa-humuline, citral, ethyl acetate, hexane, methanol, ursolic acid, rosmarinic acid (phenyl propenoids), boryl-acetate, beta-elemine, neural, camphene, stigmestrol, beta-caryophylline, oleanolic acid, tannins, sapponins, flavonoids (luteolin, apigenin, orietin, vicenin, tangecitin etc) and tri terpenoids. .
  • composition is effective in treating the HIV related AIDS, relieving symptoms and curing the opportunistic infections of AIDS.
  • composition acts on both HIV surface antigens, as well as on HIV Genome.
  • composition destroys the HIV Genome by invading into the virus and there by kills HIV virus.
  • composition possess anti viral, anti bacterial , anti oxidant, immuno stimulant, immuno modulator and immune-stabilizing-property, anti-helminthic, anti-lishmanial-activity, anticancer, adaptogenic, diaphoretic, anti genotoxic effects (dose dependent), radio protective property (protection against lipid peroxidation and DNA damage), hepato protective, cardio protective, analgesic, anti emetic, anti spasmodic, anti asthamatic, anti ulcer, anti malerial, larvicidal, anti spermatogenic, anti proliferative, angiogenesis, ameliorative effects, reduces the formation of lipid peroxidases, reactivates antioxidant enzymes restores the level of GSH (Glutathione), calcium attenuating actions, apoptosis inducing property, antistressor effects, anti-hyperlipidemic and membrane stabilizing properties.
  • GSH Glutathione
  • the present invention as discussed hereinbefore relates to a plant based injectable antiviral composition to treat infections caused by HIV and HIV related Acquired Immunodeficiency Syndrome (AIDS) and a process of preparing the same.
  • the plant based antiviral composition is effective in relieving symptoms and curing the opportunistic infections of AIDS.
  • the ingredients required for formulating the plant based antiviral composition of the present invention comprises of:
  • the present invention provides a process for preparing the plant based injectable antiviral composition.
  • the dried leaves of holy basil (Tulasi) Aromatic plant is selected from the species of Ocimum Sanctum/Ocimum tenuiflorum and belongs to the plant Family Lamiaceae.
  • the above boiled leaves of holy basil are again boiled in second water. This decoction is mixed with the decoction obtained after first boiling. Two drops of strong sulfuric acid is added in to the decoction obtained- in the above process. The vegetable matter in the above prepared decoction gets precipitated and clear sherry colored liquor is drawn off with a siphon to a filter.
  • ammonium carbonate is now added to the above clear sherry colored solution.
  • the ammonium carbonate is commercial ammonium carbonate which is a double salt of ammonium hydrogen carbonate (NH 4 HCO 3 ) and ammonium amino methanoate (carbamate) (NH 2 COONH 4 ). Color changes to black and crystals are formed slowly. Keep this preparation for 24 hours without any disturbance. Drain off the supernatant liquid with a siphon after keeping the preparation for 24 hours. The slowly formed and precipitated crystals are allowed to dry on a filter. To decolorize the crystals, about one ounce of spirit of ammonia may be poured on the filter, which washes the coloring matter so that white crystals are formed.
  • the crystals thus obtained are dissolved in boiling ethyl alcohol for purification to obtain the final product, which is a brown powder.
  • This dry powder can be stored at room temperature.
  • the final composition which is in powder form may be micronized or used as such without micronization and mixed with diluents (distilled water).
  • the final composition is not completely soluble in distilled water as it contains minute hard particles in it.
  • This reconstituted solution can be administered wholly through intramuscular or intradermal or subcutaneous route. To administer this composition as intravenous infusion, it is reconstituted with distilled water and allowed to settle down for few minutes to the maximum of half an hour and the clear solution formed after settling down is administered as an intravenous infusion (by intra venous route) over a period of 15 to 30 minutes.
  • the composition in the form of dry powder is reconstituted with distilled water and the whole solution obtained after reconstitution is administered immediately or it can be administered preferably within six hours after the reconstitution as deep intra muscular injection.
  • This reconstituted solution is stable at room temperature of about 25 degree centigrade for 1 to 3 days and is stable for 3 to 10 days if refrigerated at 4 degree centigrade.
  • the solution may vary in color from light brown to light golden yellow color depending on the length of storage and concentration of the composition in the diluents.
  • the recommended concentration range lies between lOmg/ml to 40mg/ml. This is compatible with dextrose and saline solutions.
  • the crude extract contains eugenol (1 -hydroxy 2-methoxy 4-allyl benzene), carvacrol, linalool, methyl chavicol, delta cadinene, 3-carene, alfa-humuline, citral, ethyl acetate, hexane, methanol, ursolic acid, rosmarinic acid (phenyl propenoids), boryl-acetate, beta-elemine, neural, camphene, stigmestrol, beta-caryophylline, oleanolic acid, tannins, sapponins, flavonoids (luteolin, apigenin, orietin, vicenin, tangecitin) and tri terpenoids.
  • the plant based antiviral composition can be used cautiously in children, asthmatics, neonates, and pregnant women.
  • the reported adverse reactions are fever and chills along with atopic type 1, allergic reactions including bronchial asthma.
  • the recommended dosage of the composition for an average adult is an initial 1 to 2 doses of approximately 1 to 2 grams of the preparation as deep intra muscular injection (intragluteal region) followed by 3 to 4 doses of the preparation as intra venOus infusions as single dose per day for a period of five to six days to eliminate HIV completely from the body.
  • concentration and the number of doses used may vary depending on the severity of the miscellaneous infections associated with AIDS as desired.
  • the drug preparation may be given in 12 hours interval in equally divided doses.
  • the initial dose should be administered after an intradermal test dose of 0.5ml given over ventral part of right/left forearm and allergic reactions if any should be ruled out.
  • the plant based antiviral composition is so potent that a single dose eliminates 99% to almost 100% of HIV from blood and body organs.

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Abstract

The present invention relates to a plant based antiviral composition and more particularly to a process for preparing an injectable antiviral composition comprising holy basil for the treatment of HIV disease and HIV related Acquired Immunodeficiency Syndrome (AIDS). The process comprising boiling the holy basil leaves in distilled water, filtering the boiled mixture, adding strong sulfuric acid to precipitate the vegetable matter, siphoning off the clear solution, adding ammonium carbonate for crystallization of the clear solution, adding spirit of ammonia to decolorize the crystals, and dissolving the decolorized crystals in boiling ethyl alcohol for purification to obtain the final composition. The final composition of the present invention destroys surface antigens as well as HIV Genome by invading into the virus and there by killing HIV.

Description

A PLANT BASED ANTIVIRAL COMPOSITION FOR THE TREATMENT OF HIV AND HIV RELATED ACQUIRED IMMUNO DEFICIENCY SYNDROME
FIELD OF INVENTION
The present invention relates to a plant based antiviral composition and more particularly to a process for preparing an injectable antiviral composition for the treatment of HIV disease and HIV related Acquired Immunodeficiency Syndrome (AIDS). Specifically, the plant based injectable antiviral composition is effective in treating the infections caused by Human Immunodeficiency Virus (HIV). Further, the composition of the present invention is effective in relieving symptoms and curing the opportunistic infections of AIDS. Advantageously, the present invention destroys surface antigens as well as HIV Genome by invading into the virus and there by killing HIV.
DESCRIPTION OF PRIOR ART
Human Immunodeficiency Virus (HIV) is a retrovirus belongs to the Lentivirus family. Two genetically different but related forms of HIV called HIV land HIV 2 have been isolated from patients with AIDS. HIVl is most common type associated with AIDS in USA, Europe, and Central Africa where as HIV2 causes a similar disease in West Africa and India. Although distinct, HIVl and HIV2 share some antigens. HIV damages the human immune system (lymphoid system) and central nervous system. Profound suppression by severe loss of CD4+T cells as well as impairment in function of surviving helper T-cells occurs. Monocytes, macrophages and dendritic cells are also targets of HIV infection. Envelope glycoprotein gpl20 binds to CD4 molecules through its CXCR4 co-receptors and to macrophages and monocytes through its CCR5 co-receptors. The next step involves conformational changes in gp41. These changes result in insertion of fusion peptide at the tip of gp41 into the cell membrane of target cells. After fusion, the virus core containing the HIV Genome enters the cytoplasm of the cell. Binding of HIV to its co-receptors is important in pathogenesis of AIDS.
HIV is the virus that causes AIDS. AIDS is not a single disease but it is a syndrome- a set of diseases, which results from the destruction of the body's defense mechanism. AIDS is the next final stage of HIV infection, which leads to breakdown of the immune system of the human body and makes it unable to fight against infections or the other illness.
AIDS is a global problem. By the year 2002, HIV had infected 60 million people worldwide and nearly 20 million people have died of the disease. There are now more than 42 million people living with HIV/AIDS. Patients with HIV infection, needs long-term or life-long treatment. The now available treatment pattern includes treating not only the virus but. also the opportunistic infections. Antiretroviral drugs are medications preferred for the treatment of infection by retroviruses, primarily HIV. The Antiretroviral drugs used in the treatment of HIV infection generally belongs to the category of Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Non nucleoside Reverse Transcriptase Inhibitors (N RTIs) and Protease Inhibitors (Pis).
The World Health Organization has indicated Standard Highly Active Anti Retroviral Therapy [HAART] consisting of the use of at least three antiretroviral (ARV) drugs to maximally suppress the HIV virus and stop the progression of HIV disease.
The common concern about the antiretroviral treatment includes intolerance of the patient to the drugs and development of viral resistance that includes multi drug resistance in the case of patients who were not regular in following the treatment regimen. Another notable concern is regarding the cost of the treatment, which is not affordable by majority of the patients.
US5980903 discloses an oral anti viral composition containing Thymol (crystals of Bishop's Weed) and fruit of Chebulic myroblan in addition to Ocimum sanctum.
GB2314270 discloses an oral ayurvedic composition comprising an aqueous extract of 42 different herbs including Ocimum sanctum mixed with an aqueous extract of Rasont, Bhasmas, Kalpas, Minerals and.Rudraksh ash.
IN243944 reveals an oral herbal composition comprising sixteen herbal ingredients including Ocimum sanctum, to be taken in the form of capsules. US20040156920 patent application reveals an oral composition indicated for conditions including cough, cold, asthma, congestion, sleeplessness and for the human disease concerning nervous, respiratory, digestive and immune system, comprising an . oily extract of a monocotyledonous or dicotyledonous Angiosperm or Gymnosperm plants biomass and other non-plant biomass containing Ocimum sanctum among several other ingredients.
US20070122495 patent application reveals an oral herbal preparation indicated to improve psychological functions as an anxiolytic, adaptogenic, antistress, sedative and tranquilizer containing Ocimum sanctum and ten other ingredients. 1330/DEL/2004 Indian patent application reveals an oral herbal composition containing nearly 29 ingredients including Ocimum sanctum indicated in the treatment of HIV.
1049/MUM/2003 Indian patent application reveals an ayurvedic composition administered in the form of a tablet containing herbal ingredients including Cordifolium, Jack fruit, Kurchi and Holy Basil indicated for treatment of Acquired Immuno Deficiency Syndrome.
2941 /DEL/ 1996 Indian patent application discloses an oral antistress, anti-oxident, immunomodulator and adaptogenic herbal composition for relieving stress in animals, birds and human beings containing Ocimum sanctum and three other ingredients.
744/KOL/2005 Indian patent application provides a herbal composition indicated for increasing the resistance power in humans and enabling a person to be effectively protected against attacks of pathogenic microbodies like virus, bacteria, etc comprising Ocimum Sanctum among several other ingredients.
The complexity of selecting and following a regimen, the severity of the side-effects, and the importance of compliance to the regimen to prevent development of viral resistance and affordability are the factors driving the patients to go for an alternative therapy which is equally effective with minimal side effects, suitable for long term treatment and affordable. The currently known anti-HIV drugs now available are costly and potentially toxic and inaccessible to the majority of HIV infected patients in developing countries. Most of the available herbal anti-viral compositions are only oral preparations. But the injectable preparations are generally preferred over oral preparations for ensuring faster onset of action and better bio availability of the drug in the body fluids. Therefore, all patients need less expensive, less toxic and effective anti-HIV drugs. . Thus, there exists a need for a medication, which posses proven antiviral activity in treating HIV infections and AIDS including the opportunistic infections with minimal side effects and safety profile and better bio availability besides its easy availability and affordability.
OBJECTS OF INVENTION
One or more of the problems of the conventional prior art may be overcome by various embodiments of the present invention.
Accordingly, it is the primary object of the present invention to provide for a plant based antiviral composition to treat infections caused by HIV.
It is another object of the present invention to provide a process for preparing a plant based injectable antivral composition to treat infections caused by HIV.
It is another object of the present invention, wherein the plant based antiviral composition is effective in treating the HIV related AIDS.
It is yet another object of the present invention, wherein the ingredients for the plant based antiviral composition comprises of:
Dried leaves of holy basil (Tulasi, Aromatic plant, Genus: Ocimum, Species: Ocimum Sanctum/Ocimum tenuiflorum [synonyms], Family: Lamiaceae)
Strong sulfuric acid;
Commercial ammonium carbonate;
Ethyl alcohol;
Spirit of ammonia; and
Distilled water. It is another object of the present invention, wherein the plant based antiviral composition is effective in relieving symptoms and curing the opportunistic infections of AIDS.
It is another object of the present invention, wherein the plant based antiviral composition acts on both HIV surface antigens, namely envelope glycoprotein 41 (gp41), gpl20 and gp36 as well as on HIV Genome.
It is another object of the present invention, wherein the plant based antiviral composition acts by destroying the surface antigens and make retrovirus unable to get attach with cluster of differentiation four (CD4+T) lymphocytes.
It is another object of the present invention, wherein the plant based antiviral composition destroys the HIV Genome by invading into the virus and there by kills HIV virus.
It is another object of the present invention, wherein the plant based antiviral composition is so potent that a single dose through intra venous route eliminates 99% to almost 100% of HIV from blood and body organs.
It is another object of the present invention, wherein 4-5 doses of the plant based antiviral composition eliminates HIV completely from the body
It is another object of the present invention, wherein the plant based antiviral composition possess anti viral, anti bacterial , anti oxidant, immuno stimulant, immuno modulator and immune-stabilizing-property, anti-helminthic, anti-lishmanial-activity, anticancer, adaptogenic, diaphoretic, anti genotoxic effects (dose dependent), radio protective property (protection against lipid peroxidation and DNA damage), hepato protective, cardio protective, analgesic, anti emetic, anti spasmodic, anti asthamatic, anti ulcer, anti malarial, larvicidal, anti spermatogenic, anti proliferative, angiogenesis, ameliorative effects, reduces the formation of lipid peroxidases, reactivates antioxidant enzymes restores the level of GSH (Glutathione), calcium attenuating actions, apoptosis inducing property, antistressor effects, anti-hyperlipidemic and membrane stabilizing properties.
It is another object of the present invention, wherein no absolute contra indications are observed for this plant based antiviral composition. It is another object of the present invention, wherein the plant based antiviral composition can be used cautiously in children, asthmatics, neonates, and pregnant women.
It is another object of the present invention, wherein the reported adverse reactions are fever and chills along with atopic type 1, allergic reactions including bronchial asthma and local reactions including pain, tenderness at the site of injection, less frequently phlebitis after intra venous (IV) administration. All initial doses should be given after an Attenuated Test Dose (ATD) of 0.5ml intradermally over ventral part of right/left forearm to find out the sensitivity/allergy of the preparation to the patient. Any flare or redness area of 5mm to 10mm around the site of injection may be considered as sensitive/allergic to the drug. Hydrocartisone hemisuccinate 100 mg (adult dose) injection is the drug of choice to combat any of these drug allergies.
It is another object of the present invention, wherein the final composition is in powder form and can be used/ reconstituted with or without micronization. It is another object of the present invention, wherein the final composition can be reconstituted by dissolving it in distilled water for administration through deep intramuscular/intra venous or intradermal or subcutaneous route.
It is another object of the present invention, wherein the recommended concentration of the composition for an average adult is 1 'to 2 grams of the final composition dissolved in distilled water.
It is another object of the present invention, wherein the recommended dosage of the composition for an adult isl or 2 doses of the final composition as deep intramuscular (IM) injection followed by a single dose of the said composition as intravenous infusion for 4 to 5 days thereby the total duration of treatment of simple HIV disease is 5 to 7 days. Incase of serious miscellaneous infections of HIV associated with AIDS, more doses and longer duration may be desired. However lower or higher drug concentrations may used if desired depending on the severity of the disease.
It is another object of the present invention, wherein high clinical efficacy is observed after administering a single dose of the final composition through IM/IV route. It is another object of the present invention, wherein after administration the plant based antiviral composition, is widely distributed in various tissues and body fluids.
The details of the novel plant based injectable antiviral composition its objects and advantages explained hereunder is to be understood that the composition, as fully described herein is not intended to be limited by the objects mentioned herein.
SUMMARY OF INVENTION
Thus according to the basic aspect of the present invention there is provided a process for preparing a plant based injectable antiviral composition of holy basil, the method comprising: boiling the holy basil leaves in distilled water;
filtering the boiled mixture;
adding strong sulfuric acid to precipitate the vegetable matter;
siphoning off the clear solution;
adding ammonium carbonate for crystallization of the clear solution;
adding spirit of ammonia to decolorize the crystals;
dissolving the decolorized crystals in boiling ethyl alcohol for purification to obtain the final composition,
wherein the ammonium carbonate is commercial ammonium carbonate which is a double salt of ammonium hydrogen carbonate and ammonium amino methanoate (carbamate).
In the above said process, the holy basil leaves are in dried form.
Also, the holy basil leaves are selected from the plant species of Ocimum Sanctum and Ocimum Tenniflorum.
It is another aspect of the present invention, wherein the final composition is in powder form which may or may not be micronized.
It is further aspect of the present invention, wherein the composition is reconstituted with distilled water.
It is another aspect of the present invention, wherein clear solution formed after reconstitution can be administered through intravenous route. It is another aspect of the present invention, wherein solution formed after reconstitution can be administered through deep intra muscular route.
It is another aspect of the present invention, wherein the reconstituted solution is stable at room temperature.
It is another aspect of the present invention, wherein the reconstituted solution is stable under refrigerated conditions.
It is another aspect of the present invention, wherein the reconstituted solution varies in colour depending upon the period of storage and concentration of the said final composition in the distilled water.
It is another aspect of the present invention, wherein the reconstituted solution is compatible with dextrose and saline solutions.
It is another aspect of the present invention, wherein the crude extract of the composition contains eugenol (1 -hydroxy 2-methoxy 4-allyl benzene), carvacrol, linalool, methyl chavicol, delta cadinene, 3-carene, alfa-humuline, citral, ethyl acetate, hexane, methanol, ursolic acid, rosmarinic acid (phenyl propenoids), boryl-acetate, beta-elemine, neural, camphene, stigmestrol, beta-caryophylline, oleanolic acid, tannins, sapponins, flavonoids (luteolin, apigenin, orietin, vicenin, tangecitin etc) and tri terpenoids. .
It is another aspect of the present invention, wherein the composition is effective in treating the HIV related AIDS, relieving symptoms and curing the opportunistic infections of AIDS.
It is another aspect of the present invention, wherein the composition acts on both HIV surface antigens, as well as on HIV Genome.
It is another aspect of the present invention, wherein the composition destroys the HIV Genome by invading into the virus and there by kills HIV virus.
It is another aspect of the present invention, wherein the composition possess anti viral, anti bacterial , anti oxidant, immuno stimulant, immuno modulator and immune-stabilizing-property, anti-helminthic, anti-lishmanial-activity, anticancer, adaptogenic, diaphoretic, anti genotoxic effects (dose dependent), radio protective property (protection against lipid peroxidation and DNA damage), hepato protective, cardio protective, analgesic, anti emetic, anti spasmodic, anti asthamatic, anti ulcer, anti malerial, larvicidal, anti spermatogenic, anti proliferative, angiogenesis, ameliorative effects, reduces the formation of lipid peroxidases, reactivates antioxidant enzymes restores the level of GSH (Glutathione), calcium attenuating actions, apoptosis inducing property, antistressor effects, anti-hyperlipidemic and membrane stabilizing properties.
DETAILED DESCRIPTION OF THE INVENTION
The present invention as discussed hereinbefore relates to a plant based injectable antiviral composition to treat infections caused by HIV and HIV related Acquired Immunodeficiency Syndrome (AIDS) and a process of preparing the same. The plant based antiviral composition is effective in relieving symptoms and curing the opportunistic infections of AIDS.
The ingredients required for formulating the plant based antiviral composition of the present invention comprises of:
Dried leaves of holy basil;
Strong sulfuric acid;
Ammonium carbonate;
Ethyl alcohol;
Spirit of ammonia; and
Distilled water.
In another aspect, the present invention provides a process for preparing the plant based injectable antiviral composition.
The process is as follows:
One pound of dried leaves of holy basil is boiled in distilled water sufficient to cover them for 2 hours and the decoction is drained off through a course cloth into a large precipitating jar. The dried leaves of holy basil (Tulasi) Aromatic plant, is selected from the species of Ocimum Sanctum/Ocimum tenuiflorum and belongs to the plant Family Lamiaceae. The above boiled leaves of holy basil are again boiled in second water. This decoction is mixed with the decoction obtained after first boiling. Two drops of strong sulfuric acid is added in to the decoction obtained- in the above process. The vegetable matter in the above prepared decoction gets precipitated and clear sherry colored liquor is drawn off with a siphon to a filter. Ammonium carbonate is now added to the above clear sherry colored solution. The ammonium carbonate is commercial ammonium carbonate which is a double salt of ammonium hydrogen carbonate (NH4HCO3) and ammonium amino methanoate (carbamate) (NH2COONH4). Color changes to black and crystals are formed slowly. Keep this preparation for 24 hours without any disturbance. Drain off the supernatant liquid with a siphon after keeping the preparation for 24 hours. The slowly formed and precipitated crystals are allowed to dry on a filter. To decolorize the crystals, about one ounce of spirit of ammonia may be poured on the filter, which washes the coloring matter so that white crystals are formed. The crystals thus obtained are dissolved in boiling ethyl alcohol for purification to obtain the final product, which is a brown powder. This dry powder can be stored at room temperature. The final composition which is in powder form may be micronized or used as such without micronization and mixed with diluents (distilled water).The final composition is not completely soluble in distilled water as it contains minute hard particles in it. This reconstituted solution can be administered wholly through intramuscular or intradermal or subcutaneous route. To administer this composition as intravenous infusion, it is reconstituted with distilled water and allowed to settle down for few minutes to the maximum of half an hour and the clear solution formed after settling down is administered as an intravenous infusion (by intra venous route) over a period of 15 to 30 minutes. To administer the composition through intra muscular route the composition in the form of dry powder is reconstituted with distilled water and the whole solution obtained after reconstitution is administered immediately or it can be administered preferably within six hours after the reconstitution as deep intra muscular injection. This reconstituted solution is stable at room temperature of about 25 degree centigrade for 1 to 3 days and is stable for 3 to 10 days if refrigerated at 4 degree centigrade. The solution may vary in color from light brown to light golden yellow color depending on the length of storage and concentration of the composition in the diluents. The recommended concentration range lies between lOmg/ml to 40mg/ml. This is compatible with dextrose and saline solutions. However initial dose should be given after an intradermal test dose of 0.5 ml of drug at ventral part of right/left fore arm. The crude extract contains eugenol (1 -hydroxy 2-methoxy 4-allyl benzene), carvacrol, linalool, methyl chavicol, delta cadinene, 3-carene, alfa-humuline, citral, ethyl acetate, hexane, methanol, ursolic acid, rosmarinic acid (phenyl propenoids), boryl-acetate, beta-elemine, neural, camphene, stigmestrol, beta-caryophylline, oleanolic acid, tannins, sapponins, flavonoids (luteolin, apigenin, orietin, vicenin, tangecitin) and tri terpenoids.
Clinical trials have been conducted to observe the efficacy of the above mentioned plant based antiviral composition. The details are given below:
In vitro and in vivo tests were conducted to ascertain the antiviral activity of the plant based antiviral composition. The antiviral composition is widely distributed in various tissues and body fluids. The in vitro tests reveal that the plant based antiviral composition acts on surface antigens namely gp 41, gp 160, and gp 36. The case study were conducted on human volunteer who has HIV with AIDS (clinical stage 4, base line CD4+count 11 1, 18%) associated with right sided pleural effusion. The in vivo tests conducted on HIV 1 RNA PCR after one week of giving the plant based antiviral composition reveals that value not detected, i.e., negative (A negative result indicates that absence of HIV or presence of virus below detection limits) and base line CD4+ count is 181 cells per micro liter (26.2%). ("Viral load and blood CD4+ counts" is the strongest indicators of clinical condition of HIV related disease). It also reveals that the right sided pleural effusion is completely resolved, fever disappeared, appetite improved, severe general weakness recovered, body weight is regained back from 46kg to his previous normal weight of 61kg and the person has completely regained his normal life and activities in just two months of time after the treatment.
The plant based antiviral composition can be used cautiously in children, asthmatics, neonates, and pregnant women. The reported adverse reactions are fever and chills along with atopic type 1, allergic reactions including bronchial asthma.
The recommended dosage of the composition for an average adult is an initial 1 to 2 doses of approximately 1 to 2 grams of the preparation as deep intra muscular injection (intragluteal region) followed by 3 to 4 doses of the preparation as intra venOus infusions as single dose per day for a period of five to six days to eliminate HIV completely from the body. The concentration and the number of doses used may vary depending on the severity of the miscellaneous infections associated with AIDS as desired. The drug preparation may be given in 12 hours interval in equally divided doses. The initial dose should be administered after an intradermal test dose of 0.5ml given over ventral part of right/left forearm and allergic reactions if any should be ruled out. The plant based antiviral composition is so potent that a single dose eliminates 99% to almost 100% of HIV from blood and body organs.
The scope of the invention should therefore be determined not with reference to the above description but should be detennined with reference to appended claims along with full scope of equivalents to which such claims are entitled.

Claims

I CLAIM:
1. A process for preparing a plant based injectable antiviral composition of holy basil, the method comprising:
boiling the holy basil leaves in distilled water;
filtering the boiled mixture;
adding strong sulfuric acid to precipitate the vegetable matter;
siphoning off the clear solution;
adding ammonium carbonate for crystallization of the clear solution;
adding spirit of ammonia to decolorize the crystals;
dissolving the decolorized crystals in boiling ethyl alcohol for purification to obtain the final composition,
wherein the ammonium carbonate is commercial ammonium carbonate which is a double salt of ammonium hydrogen carbonate and ammonium amino methanoate (carbamate).
2. The process as claimed in claim 1, wherein the holy basil leaves are in dried form.
3. The process as claimed in claim 2, wherein the holy basil leaves are selected from the plant species of Ocimum Sanctum and Ocimum Tenniflorum.
4. The process as claimed in claim 1, wherein the final composition is in powder form which may or may not be micronized.
5. The process as claimed in claim 4, wherein the composition is reconstituted with distilled water.
6. The process as claimed in claim 5, wherein clear solution formed after reconstitution can be administered through intravenous route.
7. The process as claimed in claim 5, wherein solution formed after reconstitution can be administered through deep intra muscular route.
8. The process as claimed in claim 5, wherein the reconstituted solution is stable at room temperature.
9. The process as claimed in claim 5, wherein the reconstituted solution is stable under refrigerated conditions.
10. The process as claimed in claim 5, wherein the reconstituted solution varies in colour depending upon the period of storage and concentration of the said final composition in the distilled water.
1 1. The process as claimed in claim 5, wherein the reconstituted solution is compatible with dextrose and saline solutions.
12. The process as claimed in claim 1, wherein the crude extract of the composition contains eugenol (1 -hydroxy 2-methoxy 4-allyl benzene), carvacrol, linalool, methyl chavicol, delta cadinene, 3-carene, alfa-humuline, citral, ethyl acetate, hexane, methanol, ursolic acid, rosmarinic acid (phenyl propenoids), boryl-acetate, beta-elemine, neural, camphene, stigmestrol, beta-caryophylline, oleanolic acid, tannins, sapponins, flavonoids (luteolin, apigenin, orietin, vicenin, tangecitin) and tri terpenoids.
13. The process as claimed in claim 1, wherein the final composition is effective in treating the HIV related AIDS, relieving symptoms and curing the opportunistic infections of AIDS.
14. The process as claimed in claim 13, wherein the composition acts on both HIV surface antigens, as well as on HIV Genome.
15. The process as claimed in claim 14, wherein the composition destroys the HIV Genome by invading into the virus and there by kills HIV virus.
16. The process as claimed in claim 1, wherein the composition possess anti viral, anti bacterial , anti oxidant, immuno stimulant, immuno modulator and immune-stabilizing-property, anti- helminthic, aiiti-lishmanial-activity, anticancer, adaptogenic, diaphoretic, anti genotoxic effects (dose dependent), radio protective property (protection against lipid peroxidation and DNA damage), hepato protective, cardio protective, analgesic, anti emetic, anti spasmodic, anti asthamatic, anti ulcer, anti malarial, larvicidal, anti spermatogenic, anti proliferative, angiogenesis, ameliorative effects, reduces the formation of lipid peroxidases, reactivates antioxidant enzymes restores the level of GSH (Glutathione), calcium attenuating actions, apoptosis inducing property, antistressor effects, anti-hyperlipidemic and membrane stabilizing properties.
PCT/IN2012/000410 2011-06-20 2012-06-11 A plant based antiviral composition for the treatment of hiv and hiv related acquired immuno deficiency syndrome WO2012176215A1 (en)

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