Method and compositions for the use of botanical extracts in the treatment of viral infections, cancer, pain, itch, and inflammation

Abstract

The present disclosure relates generally to the preparation and use of certain botanical extracts and therapeutic compositions for the treatment of viral infections, cancer, pain, itch, and inflammation. The present disclosure generally relates to antiviral compositions, and more specifically to the preparation of botanical extracts and their use in the treatment of viral infections, cancer, pain associated conditions.

What is claimed is: 
     
         1 . A method for preparing a liquid extract from a plant material chosen from  Sarracenia, Nepenthes, Melissa, Lavandula, Glycyrrhiza, Eleutherococcus, Hypericum, Darlingtonia, Heliamphora, Roridula, Drosera, Dionaea, Aldrovanda, Drosophyllum, Triphyophyllum, Catopsis, Brocchinia, Paepalanthus, Utricularia, Genlisea, Pinguicula, Ibicella, Byblis, Philcoxia, Stylidium  and  Cephalotus , said method comprising:
 a. obtaining fresh plant material;   b. washing and air drying said plant material;   c. combining said plant material with a liquid comprising at least one of water, ethanol and glycerol;   d. allowing said liquid to extract said plant material at from about room temperature to simmering temperatures to form said liquid extract; and   e. separating said liquid extract from said plant material.   
     
     
         2 . A method for extracting the roots or leaves from the botanical  Sarracenia purpurea  comprising:
 a. obtaining plant material;   b. washing and air drying said plant material;   c. combining said plant material with a liquid comprising at least one of ethanol, water and glycerol, wherein a ratio of plant material to liquid is from about 1:10 up to about 1:30 grams of plant material to milliliters of liquid, and wherein said ethanol is from about 45% to about 70% of said liquid and said glycerol is from about 0% to about 10% in said liquid;   d. allowing said liquid to extract said plant material at room temperature for 2-60 days, or for 1-3 hours in simmering conditions when said liquid is only water;   e. separating said liquid from said plant material; and   f. optionally filtering said liquid to remove large particulates.   
     
     
         3 . The method of  claim 2  wherein said liquid comprises 63% 190 proof ethanol, 32% water and 5% glycerol. 
     
     
         4 . The method of  claim 2  wherein said liquid comprises from about 50% to about 80% of glycerol, with the remainder being water and no ethanol. 
     
     
         5 . The method of  claim 2 , wherein said liquid consists of only water. 
     
     
         6 . The method of  claim 4  wherein said liquid comprises 25% water and 75% glycerol. 
     
     
         7 . A method of extracting the aerial portions of the botanical  Melissa officinalis  comprising:
 a. removing leaves from stems;   b. washing and air drying said leaves;   c. blending said leaves at a ratio of 1:2-1:5 grams of plant material to milliliters of liquid, said liquid comprising distilled water and glycerol, said glycerol present at from about 50% to about 80% in said liquid;   d. allowing said liquid to extract said leaves for 2 to 40 days at room temperature;   e. separating said liquid from said plant material; and   f. optionally filtering said liquid to remove large particulates.   
     
     
         8 . A method for extracting the flowering stems of the botanical  Lavandula officinalis  comprising:
 a. obtaining fresh  Lavandula officinalis  plants;   b. removing flowers from stems;   c. blending said flowers at a ratio of 1:2-1:5 grams of plant material to milliliters of liquid, said liquid comprising distilled water and glycerol, said glycerol present at from about 50% to about 80% in said liquid;   d. allowing said liquid to extract said leaves for 2 to 40 days at room temperature;   e. separating said liquid from said plant material; and   f. optionally filtering said liquid to remove large particulates.   
     
     
         9 . A method for extracting the flowering stems of the botanical  Hypericum perforatum  comprising:
 a. obtaining fresh  Hypericum perforatum  plants;   b. removing flowers and leaves from stems;   c. blending said flowers and leaves at a ratio of 1:2-1:5 grams of plant material to milliliters of liquid, said liquid comprising 190-proof ethanol, distilled water and glycerol, said ethanol present at from 40% to 70% and said glycerol present at 0% to 5%;   d. allowing said liquid to extract said leaves for 2 to 40 days at room temperature;   e. separating said liquid from said plant material; and   f. optionally filtering said liquid to remove large particulates.   
     
     
         10 . A method for extracting the botanical  Eleutherococcus senticosus  comprising:
 a. obtaining fresh  Eleutherococcus senticosus  plants;   b. blending said plants at a ratio of 1:2-1:5 grams of plant material to milliliters of liquid, said liquid comprising 190-proof ethanol, distilled water and glycerol, said ethanol present at from 25% to 60% and said glycerol present at 0% to 5%;   c. allowing said liquid to extract said leaves for 2 to 40 days at room temperature;   d. separating said liquid from said plant material; and   e. optionally filtering said liquid to remove large particulates.   
     
     
         11 . A method for extracting the botanical  Eleutherococcus senticosus  comprising:
 a. obtaining a powdered extract of  Eleutherococcus senticosus  obtained from a 10:1 ethanol/water extraction;   b. combining said powdered extract at a ratio of 1:10 grams of powdered extract to milliliters of liquid, said liquid comprising 25% to 60% ethanol and 0% to 5% glycerol;   c. mixing for 14 days at room temperature; and   d. filtering said powder from said liquid.   
     
     
         12 . A method for extracting the botanical  Glycyrrhiza glabra  comprising:
 a. obtaining fresh  Glycyrrhiza glabra  plants;   b. blending said plants at a ratio of 1:2-1:5 grams of plant material to milliliters of liquid, said liquid comprising 190-proof ethanol, distilled water and glycerol, said ethanol present at from 10% to 50% and said glycerol present at 0% to 5%;   c. allowing said liquid to extract said leaves for 2 to 40 days at room temperature;   d. separating said liquid from said plant material; and   e. optionally filtering said liquid to remove large particulates.   
     
     
         13 . A method for extracting the botanical  Glycyrrhiza glabra  comprising:
 a. obtaining a powdered extract of  Glycyrrhiza glabra  obtained from a 8:1 ethanol/water extraction;   b. combining said powdered extract at a ratio of 1:10 grams of powdered extract to milliliters of liquid, said liquid comprising 10% to 50% ethanol and 0% to 5% glycerol;   c. mixing for 14 days at room temperature; and   d. filtering said powder from said liquid.   
     
     
         14 . 
     
     
         15 . A therapeutic composition comprising at least one liquid extract from any of  claims 1 - 13 . 
     
     
         16 . An aqueous botanical extract composition comprising: 50% extract of  Sarracenia purpurea  (equating to 50 viral inhibitory units (VIU)/ml); 12%  Melissa officinalis  (equating to 80 viral inhibitory units (VIU)/ml); 20%/o  Lavandula officinalis  (equating to 20 viral inhibitory units (VIU)/ml); 5%  Glycyrrhiza glabra  (equating to 40 viral inhibitory units (VIU)/ml); 5%  Eleutherococcus senticosus  (equating to 40 viral inhibitory units (VIU)/ml); and optionally, 8%  Hypericum perforatum  (equating to 30 viral inhibitory units (VIU)/ml), wherein each of said extracts are prepared by the methods of  claims 1 - 13 . 
     
     
         17 . An aqueous botanical extract composition comprising: 40-100% extract of  Sarracenia purpurea,  5-30%  Melissa officinalis,  5-35%  Lavandula officinalis,  2-30%  Glycyrrhiza  glabra, 2-20%  Eleutherococcus senticosus  and/or 5-20%  Hypericum perforatum.    
     
     
         18 . A synergistic botanical extract composition comprising  Sarracenia purpurea, Melissa officinalis, Lavandula officinalis, Glycyrrhiza glabra, Eleutherococcus senticosus  and/or  Hypericum perforatum.    
     
     
         19 . The use of a therapeutic composition for dermal or epithelial topical therapy, wherein said formulation comprises at least one extract of any one of  claims 1 - 18  suspended in a transdermal base. 
     
     
         20 . The therapeutic composition of  claim 19  wherein said transdermal base is chosen from the group consisting of VERSABASE, LIPODERM, PENTRAVAN, Pluronic Lecithin Organogel, and mixtures thereof. 
     
     
         21 . The use of a therapeutic composition of  claim 19  for transdermal drug delivery on the cervix or vaginal tract of a patient in need of therapy. 
     
     
         22 . A therapeutic composition comprising: at least one extract in accordance with any one of  claims 1 - 13 ; and at least one pharmaceutically acceptable excipient. 
     
     
         23 . The formulation of  claim 22  wherein said at least one extract and said at least one pharmaceutically acceptable excipient are in a ratio of 50/50. 
     
     
         24 . The formulation of  claim 22  wherein said at least one extract and said at least one pharmaceutically acceptable excipient are in a ratio of 75/25. 
     
     
         25 . The formulation of  claim 22  wherein said pharmaceutically acceptable excipient is chosen from the group consisting of ammonium acryloyldimethyltaurate/VP Copolymer, aloe vera, allantoin, fatty acids, fatty alcohols, fatty acid esters, monoglycerides, diglycerides, triglycerides, glycerin, lecithin, gums, polymers, sorbitan fatty acid esters, alkoxylated fatty acids, alkoxylated fatty acid esters, and mixtures thereof. 
     
     
         26 . A therapeutic composition comprising an extract of at least one of  Sarracenia, Nepenthes, Melissa, Lavandula, Glycyrrhiza, Eleutherococcus, Hypericum, Darlingtonia, Heliamphora, Roridula, Drosera, Dionaea, Aldrovanda, Drosophyllum, Triphyophyllum, Catopsis, Brocchinia, Paepalanthus, Utricularia, Genlisea, Pinguicula, Ibicella Byblis  and  Cephalotus  genera plant; and a fatty acid component. 
     
     
         27 . The therapeutic composition of  claim 26  comprising a pitcher plant extract and a fatty acid component. 
     
     
         28 . A method for inhibiting the replication of a poxvirus comprising exposing said poxvirus to at least one extract of any one of  claims 1 - 18 . 
     
     
         29 . The method of  claim 28  wherein said poxvirus is chosen from the group consisting of orthopoxvirus, parpoxvirus, avipoxvirus, capripoxvirus, leporipoxvirus, suipoxvirus, molluscipoxvirus and yatapoxvirus. 
     
     
         30 . A method for inhibiting the replication of human poxvirus pathogens comprising exposing said poxvirus pathogen to at least one extract from any one of  claims 1 - 18 . 
     
     
         31 . The method of  claim 30  wherein said poxvirus pathogen is chosen from the group consisting of vaccinia virus, monkeypox virus, variola virus, and molluscum contagiosum virus. 
     
     
         32 . A method of inhibiting the replication of animal poxvirus pathogens comprising exposing said animal poxvirus pathogen to at least one extract of any one of  claims 1 - 18 . 
     
     
         33 . A method of inhibiting the replication of herpes virus family members comprising exposing said herpes virus to at least one extract of any one of  claims 1 - 18 . 
     
     
         34 . The method of  claim 33  wherein said herpes viruses is selected from the group consisting of herpes simplex 1, herpes simplex 2, varicella-zoster virus, Epstein-Barr virus, cytomegalovirus and human herpes 8. 
     
     
         35 . The method of  claim 33  wherein said herpes virus is an animal herpes virus. 
     
     
         36 . The method of  claim 35  wherein said animal herpes virus is equine herpes virus-1. 
     
     
         37 . A method of inhibiting the replication of papilloma and polyomavirus family members comprising exposing said papilloma or polyomavirus family member to at least one extract of any one of  claims 1 - 18 . 
     
     
         38 . A method of inhibiting the replication of human papillomavirus pathogens comprising exposing said human papillomavirus pathogen to at least one extract of any one of  claims 1 - 18 . 
     
     
         39 . The method of  claim 38  wherein said human papillomavirus pathogen is any one of HPV 2, 6, 7, 11, 14, 16, 18, 31, 32, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59 and 63. 
     
     
         40 . A method of inhibiting the replication of human polyomavirus pathogens comprising exposing said polyomavirus pathogen to at least one extract of any one of  claims 1 - 18 . 
     
     
         41 . The method of  claim 40  wherein said pathogen is any one of JC and BK viruses. 
     
     
         42 . A method for inducing cellular senescence and apoptosis in human papillomavirus-induced cancer cells comprising exposing said cancer cells to at least one extract of any one of  claims 1 - 18 . 
     
     
         43 . A method for prophylactic or therapeutic treatment of human poxvirus infections comprising exposing said human poxvirus to any therapeutic composition of any one of  claims 19 , and  22 - 27 . 
     
     
         44 . The method of  claim 43  wherein the viral infection is selected from the group consisting of vaccinia virus, monkeypox virus, variola virus and molluscum contagiosum virus. 
     
     
         45 . A method for prophylactic or therapeutic treatment of animal poxvirus infections comprising exposing said animal poxvirus to any extract of  claims 1 - 18 . 
     
     
         46 . A method for prophylactic or therapeutic treatment of animal poxvirus infections comprising exposing said animal poxvirus to any therapeutic composition of  claims 19 , and  22 - 27 . 
     
     
         47 . A method for prophylactic or therapeutic treatment of human herpes virus infections comprising exposing said human herpes virus to any extract of  claims 1 - 18  or any therapeutic composition of  claims 19 , and  22 - 27 . 
     
     
         48 . The method of  claim 47  wherein the viral infection is selected from the group consisting of herpes simplex virus-1 (HSV1), herpes simplex virus-2 (HSV2), herpes varicella-zoster, Epstein-Barr virus, cytomegalovirus and human herpes 8. 
     
     
         49 . A method for prophylactic or therapeutic treatment of animal herpes virus infections comprising exposing said animal herpes virus to any extract of  claims 1 - 18  or any therapeutic composition of  claims 19 , and  22 - 27 . 
     
     
         50 . The method of  claim 49  wherein the viral infection is equine herpes virus-1. 
     
     
         51 . A method for prophylactic or therapeutic treatment of human papillomavirus infections comprising exposing said human papillomavirus to any extract of  claims 1 - 18  or any therapeutic composition of  claims 19 , and  22 - 27 . 
     
     
         52 . The method of  claim 51 , wherein the viral infection is at least one of human papillomaviruses HPV 2, 6, 7, 11, 14, 16, 18, 31, 32, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59 and 63. 
     
     
         53 . A method for prophylactic or therapeutic treatment of human polyomavirus infections comprising exposing said human polyomavirus to any extract of  claims 1 - 18  or any therapeutic composition of  claims 19 , and  22 - 27 . 
     
     
         54 . The method of  claim 53 , wherein the viral infection is one of human JC and BK viruses. 
     
     
         55 . A method for prophylactic or therapeutic treatment of pre-cancer or cancer, wherein the pre-cancer or cancer is actinic keratosis or squamous cell carcinoma, comprising exposing said pre-cancer or cancer to any extract of  claims 1 - 18  or any therapeutic composition of  claims 19 , and  22 - 27 . 
     
     
         56 . A method for prophylactic or therapeutic treatment of pre-cancer or cancer, wherein the pre-cancer or cancer is cervical dysplasia or cervical cancer, comprising exposing said pre-cancer or cancer to any extract of  claims 1 - 18  or any therapeutic composition of  claims 19 , and  22 - 27 . 
     
     
         57 . A method for prophylactic or therapeutic treatment of cancer, wherein the cancer is anal cancer, comprising exposing said cancer to any extract of  claims 1 - 18  or any therapeutic composition of  claims 19 , and  22 - 27 . 
     
     
         58 . A method for prophylactic or therapeutic treatment of cancer, wherein the cancer is oropharyngeal cancer, laryngeal papillomas, or oral papillomas, comprising exposing said cancer to any extract of  claims 1 - 18  or any therapeutic composition of  claims 19 , and  22 - 27 . 
     
     
         59 . A method for prophylactic or therapeutic treatment of warts, wherein the warts include plantar warts, common warts and anogenital warts, comprising exposing said warts to any extract of  claims 1 - 18  or any therapeutic composition of  claims 19 , and  22 - 27 . 
     
     
         60 . A method for prophylactic or therapeutic treatment of cancer, wherein the cancer is Kaposi's Sarcoma, comprising exposing said cancer to any extract of  claims 1 - 18  or any therapeutic composition of  claims 19 , and  22 - 27 . 
     
     
         61 . A method for prophylactic or therapeutic treatment of pre-cancer or cancer associated with herpes virus infections, comprising exposing said pre-cancer to any extract of  claims 1 - 18  or any therapeutic composition of  claims 19 , and  22 - 27 . 
     
     
         62 . The method of  claim 61 , wherein the viral-induced cancer is one of Epstein-Barr virus and Human herpes 8 virus. 
     
     
         63 . A method for prophylactic or therapeutic treatment of pre-cancer or cancer associated with papillomavirus infections comprising exposing said pre-cancer or cancer to any extract of  claims 1 - 18  or any therapeutic composition of  claims 19 , and  22 - 27 . 
     
     
         64 . The method of  claim 63 , wherein the viral-induced cancer is associated with any one of human papilloma viruses HPV 16, 18, 31 and 45. 
     
     
         65 . A method for therapeutic treatment of itching (anti-pruritic) in a patient in need thereof, comprising administering to said patient a therapeutically effective amount of a botanical extract of any one of  claims 1 - 18 . 
     
     
         66 . A method for therapeutic treatment of pain (analgesic) in a patient in need thereof, comprising administering to said patient a therapeutically effective amount of a botanical extract of any one of  claims 1 - 18 . 
     
     
         67 . The method of  claim 1  wherein said plant is selected from the group consisting of  S. elata, S. flava, S. leucophylla  and  S. rubra.    
     
     
         68 . The method of  claim 1  wherein said plant is selected from the group consisting of  N. veitchii, N. spectrabilis×ventricosa, N. eymae, N. Judith Finn, N. chaniana, N. fusca  and  N. macrophylla.    
     
     
         69 . The method of  claim 1  wherein said plant is selected from the group consisting of  Drosera  spp.,  Dioneae  spp.,  Darlingtonia  spp., and  Pinguicula  spp. 
     
     
         70 . A topical therapeutic composition comprising an extract of  claims 1 - 18  or a therapeutic composition of  claims 19 , and  22 - 27 . 
     
     
         71 . An oral formulation comprising an extract of  claims 1 - 18  or a therapeutic composition of  claims 19 , and  22 - 27 . 
     
     
         72 . A suppository comprising an extract of  claims 1 - 18  or a therapeutic composition of  claims 19 , and  22 - 27 . 
     
     
         73 . A method for administering an extract of  claims 1 - 18  or a therapeutic composition of  claims 19 , and  22 - 27  consisting of administering said extract or therapeutic composition through at least one of oral, buccal, rectal, intranasal, parenteral, intraperitoneal, intradermal, subcutaneous, intramuscular, transdermal, inhalation and intratracheal routes. 
     
     
         74 . A method for the standardization of botanical extracts for antiviral activity and therapeutic value comprising a determination and measurement of the antiviral units per milliliter. 
     
     
         75 . An aqueous mixture comprising: 50% extract of  Sarracenia purpurea  (equating to 50 viral inhibitory units (VIU)/ml); 12%  Melissa officinalis  (equating to 80 viral inhibitory units (VIU)/ml); 20%  Lavandula officinalis  (equating to 20 viral inhibitory units (VIU)/ml); 5%  Glycyrrhiza glabra  (equating to 40 viral inhibitory units (VIU)/ml); 5%  Eleutherococcus senticosus  (equating to 40 viral inhibitory units (VIU)/ml); and optionally, 8%  Hypericum perforatum  (equating to 30 viral inhibitory units (VIU)/ml). 
     
     
         76 . A composition comprising at least one of a Genus Extract. 
     
     
         77 . A composition comprising at least one of a Genus II Extract. 
     
     
         78 . A composition comprising at least one of a Species Extracts. 
     
     
         79 . A composition comprising at least one of a Species II Extract. 
     
     
         80 . 
     
     
         81 . The composition of  claim 79 , further comprising a pharmaceutically acceptable excipient. 
     
     
         82 . The composition of  claim 79 , further comprising a gel carrier. 
     
     
         83 . The composition of  claim 79 , wherein the composition is aqueous. 
     
     
         84 . A composition comprising at least one of the following botanical extract pairs:
   Melissa  and  Sarracena; Melissa  and  Glycyrrhiza; Melissa  and  Eleutherococcus; Sarracenia  and  Eleutherococcus; Sarracenia  and  Glycyrrhiza; Sarracenia  and  Hypericum; Sarracenia  and  Lavandula; Eleutherococcus  and  Glycyrriza; Glycyrhizza  and  Lavandula; Eleutherococcus  and  Hypericum ; and  Eleutherococcus  and  Lavandula.      
     
     
         85 . The composition of  claim 84 , further comprising a pharmaceutically acceptable excipient. 
     
     
         86 . The composition of  claim 84 , further comprising a gel carrier. 
     
     
         87 . The composition of  claim 84 , wherein the composition is aqueous. 
     
     
         88 . A composition comprising at least one of a Genus III Extract. 
     
     
         89 . A method for therapeutic treatment of inflammation in a patient in need thereof, comprising administering to said patient a therapeutically effective amount of a botanical extract of any one of  claims 1 - 18 . 
     
     
         90 . The method of  claim 89 , wherein the botanical extract decreases a cellular gene expression level of a pro-inflammatory cytokine. 
     
     
         91 . The method of  claim 90 , wherein the pro-inflammatory cytokine is selected from the group consisting of macrophage inflammatory protein-la, tumor necrosis factor-α, interleukin-8, interleukin-5, interleukin-1ß, interleukin-2, interleukin-10, interferon-γ, and interleukin-6.