KR20050033069A - Anti-microbial compositions and methods of using same - Google Patents

Abstract

An anti-microbial composition is provided. The anti-microbial composition includes a first ingredient obtainable from ginger, a second ingredient obtainable from green tea, an optional third ingredient available from turmeric, and, optionally, an acceptable carrier. Also provided are methods of reducing, treating or preventing at least one symptom or adverse effect of microbial infection in a patient. The methods include the step of administering to the patient prior to expected exposure to a microbe, concurrently with exposure to a microbe, or after exposure to a microbe, an effective amount of a composition of the invention.

Description

Antibiotic composition and its use method {ANTI-MICROBIAL COMPOSITIONS AND METHODS OF USING SAME}

A. Field of Invention

The present invention relates to antibiotic compositions and methods of using the same. More particularly, the present invention relates to antibiotic compositions and methods of administering antibiotic compositions useful for treating one or more side effects of microbial infections.

B. Description of the Prior Art

Treatment of microbial infections

The medical literature on antibiotics describes many antibiotics, including large and natural compounds, as well as synthetic or semi-synthetic compounds prepared in the laboratory. Patients often prefer to use natural compounds where they are currently available. Due to concerns about side effects that may be reported side effects in the literature arising in connection with treatment or possible unknown side effects that may result from prolonged use for treatment, many patients are manufactured from natural substances, such as herbs. Particular preference is given to antibiotics with minimal chemical treatment.

Treatment of inflammation

Inflammation can result from microbial infection. In modern non-herb drugs, there are two main types of anti-inflammatory drugs: steroidal and nonsteroidal drugs. Steroidal anti-inflammatory drugs are potent medications based on hormonal substances such as cortisone. Steroidal medications can be administered as pills, injected into the blood, or injected directly into the joint cavity. There are many nonsteroidal anti-inflammatory medications. Acetaminophen, aspirin, iriprofen, and naproxen are the most commonly used nonsteroidal anti-inflammatory drugs.

Nonsteroidal anti-inflammatory drugs have three main functions, all of which are associated with the inhibition of cyclo-oxygenase, which increases the formation of prostanoids. Firstly, anti-inflammatory action can be achieved by reducing the product of vasodilators propaglandin (PGE2, PG12), which means reducing vasodilation and indirectly reducing edema. Secondly, anesthetic effects can be achieved by reducing the production of prostaglandins (decreased sensitization of nerve endings for the inflammation mediators bradykinin and 5-hydroxytrytamine). Third, the antipyretic effect can produce anti-inflammatory action, possibly due to the reduction of the mediator PGE2 produced in response to inflammatory pyrogens as much as interleukin-1.

There are side effects for both of these drug groups. These side effects may include gastric disorders, gastrointestinal bleeding, or ulcers, kidney disorders, hearing disorders, and ankle edema, among other side effects. In addition, steroidal anti-inflammatory medications can have more serious side effects including problems with bone marrow, including decreased bone mass, cataracts, decreased ability to fight infections, edema and weight gain, emotional changes, hypertension and blood cells.

Accordingly, it is an object of certain embodiments of the present invention to provide antibiotic compositions.

A further object of certain embodiments of the invention is to provide antibiotic compositions made from natural products.

Another object of certain embodiments of the present invention is to provide a method of treating a microbial infection by administering an antibiotic composition.

Another object of certain embodiments of the present invention is to provide a method of treating a microbial infection by administering a composition prepared from a natural product.

These and other objects of the present invention will be apparent from the summary and detailed description of the invention described below.

Summary of the Invention

In a first aspect, the present invention provides an antibiotic composition comprising a first component obtainable from ginger, a second component obtainable from green tea, and optionally a suitable carrier, wherein the first component comprises a microorganism prior to the expected exposure to the microorganism. Provided is an antibiotic composition present in the antibiotic composition in an amount effective to reduce, treat or prevent the side effects of microbial infection when administered to a patient simultaneously with or after exposure to the microorganism.

In a further aspect, the present invention provides a first component obtainable from ginger, a second component obtainable from green tea, and optionally, a suitable carrier, prior to the expected exposure to the microorganism, simultaneously with exposure to the microorganism and after exposure to the microorganism. Provided is a method of reducing, treating, or preventing one or more side effects of microbial infection in a patient, comprising administering an amount of a composition comprising a. The composition is effective to reduce, treat or prevent side effects of microbial infections in a patient when administered.

In a first aspect, the present invention relates to an antibiotic composition. The antibiotic composition of the present invention includes components obtainable from ginger and green tea.

The term "flavourant" as used herein includes fruit and vegetable flavors.

The term “sweetener” as used herein includes sugars such as glucose, sucrose, and fructose. Sugars also include high fructose corn syrup solids, invert sugar, sugar alcohols including sorbitol, and mixtures thereof. Artificial sweeteners are also included in the “sweetener” within the scope of the present invention.

As used herein, the term “acceptable” refers to an ingredient that is suitable for use in humans and / or animals without undue side effects and that corresponds to a reasonable risk / benefit ratio.

In addition, the term “safe and effective amount” as used herein is sufficient to produce the desired therapeutic response without undue side effects (eg, toxic, irritant, or allergic reactions), which is reasonable when used in the methods described herein. Represents the amount of the component corresponding to the risk / benefit ratio.

As used herein, the term "inhibiting" microorganisms means removing some or all of the microorganisms from a person or animal to be prevented and / or treated for the reduction or further growth of the microorganisms. Suitable methods for measuring microbial inhibition are described in the Examples.

All active compounds used in the present invention can be obtained from other sources when available. Thus, the term “obtainable from” includes compounds or compositions obtainable from turmeric, ginger, or green tea, as well as synthetic forms of such compounds and / or compositions, as well as such compounds or compositions obtained from other sources. It means to include.

Most preferably, the antibiotic composition of the present invention comprises a first component obtainable from ginger and a second component obtainable from green tea in an amount that is safe and effective to provide one or more beneficial effects described above.

The first component of the antibiotic composition of the present invention can be obtained from ginger (Zingiber officinale, also commonly referred to as ginger root). Ginger from South Asia is a 2- to 4-perennial with grass-like leaves up to one inch wide and up to one foot long. Ginger root, called in a vegetable store, consists essentially of the ground stem of a plant whose shell-like outer shell is peeled off.

Chinese medical literature from the 4th century B.C.E. suggests that ginger is effective in treating nausea, diarrhea, abdominal pain, cholera, toothache, bleeding, and arthritis. Ginger was then used by Chinese doctors to treat various respiratory diseases, including the early stages of coughing and colds.

Ginger's modern use dates back to the early 1880s, when scientist D. D. Mowrey noted that ginger filled capsules relieve nausea during the onset of the flu. Encouraged by this, he carried out his first double blind to ginger. Germany's Commission E subsequently demonstrated ginger as a treatment for dyspepsia and motion sickness. Ginger has been widely accepted for the treatment of nausea. Some conventional medical literature still suggests ginger as a treatment for nausea and vomiting of pregnancy, while others are more cautious.

Ginger relieves muscle pain and pain. Ginger inhibits prostaglandin and leukotriene biosynthesis and histamine release. Thus, ginger acts as an antacid as well as an anti-inflammatory agent. Ginger is a dual inhibitor of lipoxygenase and cycloxygenase systems. Ginger contains about 1 to about 4% essential oils (oleoresins). Fresh ginger, when used alone, is required to be used at substantially high doses (about 50 g per day), which is not only inconvenient but can also act as a stimulant of the gastric mucosa. In the case of a dry form for any significant result, about 7 to about 10 g of dry ginger powder should be consumed per day. Such large amounts of ginger are extremely uncomfortable for the patient and affect the patient's convenience on a daily basis (see Potwardhan, U.S. Patent No. 5,494,668).

Ginger inhibits prostanoid synthesis and also the production of 5-lipoxygenase. The efficacy of ginger extract in the acute inflammatory test appears to be comparable to that shown by acetyl salicylic acid reported in the same study (Mascolo N. et al., Journal of Ethnopharmacology , 1989, 27, 129-140).

One of the hallmarks of inflammation is the increased oxygenation of arachidonic acid, which leads to two enzyme pathways--cyclooxygenase (CO) and 5-lipoxygenase (5-LO), which induce the production of prostaglandins and leukotrienes, respectively. Is metabolized by Srivastava and Mustafa; Medical Hypotheses , 1992, 39 342-348, suggests that one or more of the mechanisms by which ginger exerts its mitigating effect may be involved in the inhibition of prostaglandin and leukotriene biosynthesis, that is, ginger acts as a double inhibitor of eicosanoid biosynthesis. Is presented.

Many chemical studies have been conducted on the composition of essential oils of ginger. All 200 different volatiles have been identified in ginger's essential oils. Ginger's essential oils contain a mixture of various terpenes as well as some other non-terpenoid compounds.

Ginger's active compounds that can be used in the present invention include, but are not limited to, 1,8-cineol, 10-dehydrogingeredione, 10-gingerol, 6-gingeredione, 6-gingerol, 6-shogaol , 8-β-17-epoxy-λ-trans-12-ene-15,16-diol, 8-gingerol, 8-shogaol, 9-oxo-nerolidol, acetaldehyde, acetic acid, alanine, α-linolene Acids, α-linolenic acid, α-phellandrene, α-piene, α-terpinene, α-terpiol, α-gingiberene, ar-curcumin, arginine, ascorbic acid, asparagine, β-bisabolol , β-carotene, β-elemene, β-eudesmol, β-eudesmol, β-ionone, β-mycin, β-phellandrene, β-pinene, β-celinene , β-sesquiphellandrene, β-sitosterol, β-tuzon, bornyl-acetate, boron, caffeic acid, calcium, camphor, camphor, capric acid, caprylic acid, capsaicin, cariophyllene, carbicol , Chlorogenic acid, chrome, citral, citronellal, citronellal, cobalt, copper, Cumin, curcumin, cysteine, delphinidine, δ-cardinene, elemol, ethyl acetate, ethyl-myristate, farnesal, farnesene, ferulic acid, furfural, γ-aminobutyric acid, γ-terpinene, geraniel , Geraniol, Geranyl Acetate, Ginger Lennon, Glutamic Acid, Glycine, Hexahydrocurcumin, Histidine, Isojinzerenone-B, Isoleucine, Camperol, Lecithin, Limonene, Linoleic Acid, Magnesium, Manganese, Methionine, Mufa, Mire Sen, myricetin, myristic acid, neral, nerol, nerolidol, niacin, nickel, oleic acid, oxalic acid, p-comic acid, p-cymene, p-hydroxy-benzoic acid, palmitic acid, pantothenic acid , Paradol, patchoulic alcohol, phenylalanine, quercetin, riboflavin, selenium, schikimic acid, terpinene-4-ol, thiamine, tryptophan, vanillic acid, vanillin, zinc, and gingerology. Also mixtures of two or more of these active compounds can be used.

A first component of the composition of the invention obtainable from ginger is an extract, such as ginger powder extract, ginger juice extract, ginger powder including ginger root powder, and one or more active compounds of ginger, some or all of ginger plants Many different forms can be incorporated into the antibiotic compositions of the present invention, including tinctures thereof and mixtures thereof. Preferably, the first component of the antibiotic composition of the present invention is selected from ginger extract, and ginger root powder.

Each g of the antibiotic composition of the present invention preferably contains about 30 mg to about 150 mg of ginger root powder. Most preferably, each g of the antibiotic composition contains about 50 mg to about 110 mg of ginger root powder. These ranges include Ginger Root Powder from Stryka Botanics in ingestion formulations and Ginger Extract from Calsec, Inc. in Kalamazoo, Michigan in spray formulations. Based on the use of G (Ginger Extract K: Aquaresin Ginger).

The amounts of the various components are described herein with respect to one form of the component, namely ginger root powder. When the component is present in other forms, the amount used is that amount which can provide one or more active compounds in an amount equal to the amount of the component given herein. For example, when ginger tincture is used, the amount of tincture used will be that amount which provides the same amount of one or more active compounds as may be provided by the amount of ginger root powder specified above. This applies to all ingredients given the quantity for one particular type of ingredient.

The second component of the antibiotic composition of the present invention can be obtained from green tea. The second component obtained from green tea may have an antioxidant effect.

Green tea is the dried leaves and leaf buds of Camellia sinensis shrubs. These green teas are mainly produced in China and Japan. Dried green tea leaves consist mainly of phytochemicals known as polyphenols (about 36%), ie mainly flavonols (including catechins), flavonoids and flavonediols. The leaves also contain alkaloids (about 4%), including vegetable caffeine, theobromine and theophylline. Much research on green tea is focused on its effectiveness in preventing cancer. These studies suggest that green tea polyphenols have a chemical protective effect (E. Kaegi, Canadian Medical Association Journal, 1998, 158: 1033-35).

The pharmacological activity of green tea is mainly due to its active compounds. Active compounds of green tea useful in the present invention include, but are not limited to, flavonols, catechins, flavonoids, flavonediols, vegetable alkaloids, caffeine, theobromine, theophylline, phenolic acids, proteins, carbohydrates, and minerals.

Secondary ingredients obtainable from green tea are green tea powder, green tea extracts such as green tea powder extract, green tea extract, and one or more active compounds of green tea, some or all of the green tea plant, green tea leaves, tinctures thereof, or mixtures thereof It may be included in the antibiotic composition in the form of. Preferably, the second component of the antibiotic composition of the present invention is selected from green tea leaves, green tea powder, and green tea extract. More preferably, the second component of the antibiotic composition of the present invention is green tea extract.

Each g of the antibiotic composition of the present invention preferably contains about 5 mg to about 20 mg of green tea extract. More preferably, each g of the antibiotic composition contains about 7 mg to about 15 mg of green tea extract. This range includes Green Tea from Stryka Botanics for ingestion formulations and Green Tea Extract from Phytoway, Inc., Changsha, China, in spray formulations. Extract).

Also preferably, the antibiotic composition of the present invention comprises, as an optional ingredient, one or more ingredients obtainable from turmeric in an amount that is safe and effective to provide one or more beneficial effects described herein.

Turmeric (Curcuma longa, or Haldi in Hindi) is not only very widely used as a medicament but is also a common ingredient in Indian foods. The roots of turmeric are fine powders used in medicine and food.

The anti-inflammatory effects of curcumin isolated from Curcuma longa are described in Srimal and Dhawan, Pharmacology of Diferuloyl Methane, a Non-steroidal Ati-inflammatory Agent, J. Pharm. Pharmac., 25: 447-452 (1973). Significant anti-inflammatory activity against cuminamine compared to phenylbutazone and hydrocortisone was observed by Arora et al. ( Indian Journal of Medical Research, 1971, 59, 1289-1291). Curcumin, ie alkaloids (diferroyl methane), isolated from the alcoholic extract of turmeric has been found to be an effective anti-inflammatory agent. Further studies on anti-inflammatory and anti-arthritis activity have also been performed by Thatte et al. ( Indian Journal of Pharmacology , 1986, 18 (1), 19-21). Turmeric has been shown to exhibit significant anti-inflammatory activity in both acute and chronic models. The therapeutic dose of turmeric for optimal activity when used alone is reported to range from about 5 to about 10 g of dry powder per day (Patwardhan, US Pat. No. 5,494,668). However, these dose levels can cause nausea.

Curcumin is not only anti-inflammatory, but also has antioxidant, anti-tumor and other useful properties. When used at low concentrations, curcumin can inhibit nitric oxide synthase (NOS), thus inhibiting the production of nitric oxide. See, eg, Bruet et al., Biochem. Biophys. Res. Commun. , 1995, Jan. 17; 206 (2); 533-40 reported that the NOS activity in soluble extracts of activated macrophages for 6 to 24 hours in the presence of curcumin (10 microM) was significantly lower than the NOS activity of macrophages activated without curcumin. did. Norton blot and immunoblotting analysis demonstrated that significantly reduced levels of inducible NOS mRNA and 130-k Da protein were expressed in curcumin activated macrophages compared to macrophages without curcumin activation. Inhibition of NOS induction was greatest when curcumin was added with lipopolysaccharide (LPS) and interferon-gamma (IFN-gamma) and as the interval between curcumin and LPS / IFN-gamma increased to 18 hours Gradually decreased.

The yellow pigment of the root of turmeric consists of three compounds known as curcuminoids. These three curcuminoids are curcumin (diferroylmethane), desmethoxycurcumin (hydroxycinnamoyl feruloylmethane), and bis-desmethoxycurcumin (dihydroxydicinnamoyl methane) Drug Analysis by Chromatography and Microscopy , p. 169, Ann Arbor Science Inc., 1973]. Essential oils of curcumin (curcuma longa) consist mainly of the following compounds: d-camphor (about 1%), cyclo-isoprenmirsen (about 85%), and p-polymethylmethylcarbinol (about 5%) E. Gunther, The Essential Oil , pp. 123-4, Van Nostrand Co., 1955.

Optional components of the composition of the present invention obtained from turmeric are preferably curcuminoids such as curcumin (diferroylmethane), desmethoxycurcumin (hydroxycinnamoyl feruloylmethane), and bis-desmethok Cicurcumin (dihydroxycinnamoyl methane) and mixtures of two or more of these curcuminoids.

Methods for separating curcuminoids from turmeric are known. Janaki and Bose, An Improved Method for the Isolation of Curcumin From Turmeric, J. Indian Chem. Soc. 44: 985 (1967). In addition, curcuminoids for use in the present invention can be prepared by synthetic methods.

Optional ingredients obtainable from turmeric can be incorporated into the compositions of the present invention in a variety of different forms. Such different forms include extracts of turmeric, such as turmeric powder extract, turmeric extract, one or more curcuminoid compounds, and turmeric powder, some or all of the turmeric plant, tinctures thereof, and mixtures thereof. More preferably, any ingredient obtainable from turmeric is turmeric extract.

When any ingredient obtainable from turmeric is used, each g of the antibiotic composition of the present invention contains about 5 to about 20 mg of turmeric powder extract. Most preferably, each g of the antibiotic composition contains about 7 mg to about 15 mg of turmeric powder extract. This range ranges from 95% Turmeric Extract from Pharmline, Inc. in ingestion formulations and Calsec, Inc., Kalamazoo, Mich. In spray formulations. Is based on the use of a tubular root extract (oleoresin tubular) from.

The components of the antibiotic composition of the present invention obtainable from ginger and green tea, and any turmeric, can be used in the form of turmeric powder, ginger powder, and green tea powder, each of which is derived from root of turmeric, ginger root and green tea leaves. Each can be ground. In the case of certain active compounds of ginger, green tea or turmeric, if a synthetic route to them is known, the active compounds can be synthesized. If desired, plant extracts can be prepared as described below. In addition, the turmeric powder, ginger powder, green tea powder and / or one or more active compounds contained in the present invention may be purchased from commercial sources such as Delavau Co., Pa., USA.

Plant extracts that can be used in the compositions of the present invention, such as turmeric extract, ginger extract and green tea extract, can be produced by using conventional extraction methods. Extracts can also be purchased from commercial sources such as Delavau Co., Pa., USA.

One suitable extraction method is usually

1) washing the plant to obtain a pharmacological or biologically active plant extract to remove all foreign substances attached thereto;

2) atomizing the plant to obtain particulate matter having a particle size ranging from 0.001 to about 10 mm ³ ;

3) putting the particulate material in one or more polar and one or more non-polar solvents to obtain individual fractions of the plant extracts soluble in each solvent and mixing the obtained fractions to obtain the beneficial plant extracts according to the invention.

For example, in the case of turmeric, the method

1) washing the roots of turmeric to remove any foreign material thereon;

2) atomizing the roots to obtain particulate matter having a particle size ranging from 0.001 to about 10 mm ³ ;

3) distill the particulate material to obtain any volatile fraction from the particulate material;

4) cooking distilled particulates in polar solvents such as water to solubilize the materials in the distilled particulates to obtain a first solution and a first residue;

5) filtering the first solution from the first residue;

6) evaporate the filtrate obtained from the first solution to remove the solvent and obtain a solute named Fraction A obtained from the particulate material;

7) treating the first residue with a second polar solvent such as 75% to 95% ethanol for 12 to 36 hours to obtain a second solution and a second residue;

8) filtering the second solution from the second residue to obtain a second filtrate;

9) The second filtrate is evaporated to remove its solvent and to obtain a solute named Fraction B obtained from the particulate material;

10) The second residue is treated with a less polar or nonpolar solvent such as petroleum ether for 12 to 36 hours to obtain a third solution and a third residue, and the third solution is filtered from the third residue 3 filtrates are obtained;

11) evaporate the third filtrate to remove its solvent and obtain a solute named Fraction C obtained from the particulate material;

12) uniformly mixing the volatile fraction with fractions A, B and C from the particulate material to obtain a beneficial plant extract.

This method is suitable for preparing pharmacologically or biologically active plant extracts in an easy and administrable dosage form from any of the plants described above.

Solvents useful for extracting turmeric include water, ethanol, propanol, paraffin, hexane, petroleum ether, toluene, acetone, methyl ethyl ketone, and other common organic solvents. Water, ethanol and petroleum ether are preferred solvents for extracting turmeric. Solvents useful for extracting ginger include water, ethanol, propanol, paraffin, petroleum ether, hexane, toluene, acetone, methyl ethyl ketone, and other common organic solvents. Ethanol, water and acetone are preferred solvents for extracting ginger.

Antibiotic compositions of the invention can be used to treat microbial infections because the compositions of the invention have significant antibiotic properties as demonstrated in the Examples herein. The antibiotic compositions of the present invention may also be used as therapeutic compositions to treat one or more symptoms of microbial infections, including throat pain, hyperemia, laryngitis, mucositis, and / or mucosal inflammation, to a patient suffering from one or more of these symptoms or illnesses. have.

Viruses that can be inhibited by the antibiotic composition of the present invention include rhinoviruses, respiratory syncytial virus (RSV), herpes virus, influenza virus, HIV-virus and West Nile virus, among various viruses.

In a preferred embodiment, the viruses that can be inhibited by the antibiotic composition include at least human rhinovirus 16, herpes I virus (HSV-1), influenza A / Moscow / 10/99 (Influenza A / Moscow / 10/99), and B / Guangdong / 120/00 (B / Guangdong / 120/00) is included.

Antibiotic compositions of the invention can also be used to treat bacterial infections, for example, streptococcus infection and fungal infection, for example, yeast, for example, infection by Candida (Candida).

Preferably, the antibiotic composition of the present invention is any suitable dose including, but not limited to, capsules, tablets, georgettes, troches, condensed candies, powders, sprays, gels, elixirs, syrups, and suspensions or solutions. It may be formulated in a form. The antibiotic composition of the present invention may also be formulated in the form of a nutritional supplement, in which case the composition of the invention may be a nutritional supplement or form part of a nutritional supplement containing additional ingredients.

The antibiotic composition of the present invention may also be formulated with a soluble carrier. Soluble carriers include, but are not limited to, (a) carbohydrates including sweeteners, more preferably fructose, sucrose, sugar, dextrose, starch, lactose, maltose, maltodextrin, solid corn syrup, solid honey Commercially available tablet nutritional supplements such as Emdex ^™ , Mor-Rex ^™ , Royal-T ^™ , Di-Pac ^™ , Sugar-Tab ^™ , Sweet-Rex ^™ , and New-Rab ^™ ; (b) sugar alcohols including mannitol, sorbitol and xylitol; And (c) various relative insoluble excipients, including dicalcium phosphate, calcium sulfate, calcium carbonate, microcrystalline cellulose and other purification components.

The lozenges, tablets, and troches in the present invention may differ in form, size, and manufacturing technology. In the case of oral tablets, the soluble carrier may further include lactose and corn starch. For example, lubricants, including magnesium stearate, sodium lauryl sulfate and talc may also be added to the tablets. Tablets may also contain excipients such as sodium citrate, calcium carbonate, and calcium phosphate. Disintegrants, starch, alginic acid and complex silicates may also be used. Tablets may also include binders such as polyvinylpyrrolidone, gelatin, PEG-8000 and acacia gum.

In the case of oral lozenges, the soluble carrier generally may further comprise a binder such as PE-8000. Preferably, the lozenge is about 0.1 to about 15 g so that it dissolves at a suitable dissolution rate upon oral administration. More preferably, the lozenge is about 1 to about 6 g.

To prepare a compressible lozenge, the active ingredient is added to PEG-8000 processed fructose; The active ingredients of the antimicrobial composition of crystalline fructose and available, and is added to the sweet directly compressing the product, for example, Mendel's Sugar STAB ^TM (Mendell's Sugartab ^TM), Suite Rex ^TM (Sweetrex ^TM), or M. Dex TM (Emdex ^TM) . Sweetening agents such as saccharin may be added if desired, and flavoring agents, glidants such as silicakel, and lubricants such as magnesium stearate may be added if desired. The mixture should remain dry and tableted immediately after mixing. The ingredients are mixed and compressed into lozenges by using conventional pharmaceutical mixing and tableting equipment. The compressive force preferably produces maximum hardness throughout the lozenge to maintain a suitable dissolution rate and maximize the efficacy of the lozenge. Dissolution of lozenges when administered orally should last for a delayed time of about 5 to 60 minutes, preferably about 20 to 30 minutes. The antibiotic composition is preferably stored in sealed containers and cold dark rooms.

Tablets and troches can be prepared by using methods similar to those described above with slight variations in the optimal components. Such changes are within the skill of those skilled in the art.

In addition, the antibiotic compositions of the present invention may be used in a liquid form, such as syrup, mouthwash or spray, in a liquid form, such as syrup, mouthwash or spray, in order to provide repeated delivery of the antibiotic composition to the oral and oropharyngeal mucosa, Optionally with a pharmaceutically acceptable carrier. Preferably, the treatment time is about 5 to 60 minutes, more preferably about 20 minutes to about 30 minutes, such that the antibiotic composition is in long contact with the mouth and throat tissue. The formulations may also be in concentrated form suitable for dilution with water or other substances prior to use.

Antibiotic compositions may also be formulated in chewable forms, such as soft candy, gum drop, liquid filled candy, and chewing gum substrates, or in the form of dental products such as toothpastes and mouthwashes. In use, the chewable composition is preferably held in the mouth for a sustained time of about 5 to 60 minutes, more preferably about 20 to 30 minutes. Dental products can be used in the usual way using such products.

The antibiotic composition of the present invention may be formulated in a capsule form with or without a diluent. For example, useful diluents include lactose and dried corn starch. If a suspension is used, emulsifiers and / or suspending agents may be used in the suspension. In addition, solid compositions comprising one or more components of the lozenges described above can be used in soft and hard gelatin capsules.

The antibiotic composition of the present invention may also be formulated as a nasal aerosol or inhalation composition. Such compositions can be prepared by using known techniques. For these types of formulations, suitable carriers may include the following components: saline containing one or more preservatives, absorption promoters to enhance bioavailability, carbon fluoride, and / or conventional solubilizers or dispersants.

Other materials that may optionally be included in the antibiotic compositions of the invention include resveratrol (trihydroxystilbene), inositol, other B-complex vitamins, and additional anti-inflammatory agents. In addition, ingredients such as sweeteners, flavoring agents, coloring agents, dyes, preservatives, emulsifiers, suspending agents, melting agents, excipients, hygroscopic agents and solvents or diluents such as water, ethanol, propylene glycol, glycerin, and various combinations thereof, It may be included in the antibiotic composition of the present invention.

Any sweeteners that can be used in the antibiotic compositions of the present invention include, but are not limited to, saccharin, aspartame, cyclamite, acesulfame K, neohesperidine dihydrochalcone, other super sweeteners, and their Combinations are included and they may be added to the carrier in a sufficiently small amount so as not to chemically interact with the main components of the antibiotic composition.

Any flavourant that can be used in the antibiotic composition of the present invention includes, but is not limited to, peppermint, peppermint-menthol, eucalypton, wintergreen, licorice, cloves, cinnamon, spearmint, cherry, lemon, orange, lime, menthol, And combinations thereof.

Preferably, the above-mentioned main ingredients which may be derived from ginger and green tea are contained in about 0.5 to about 90% by weight of the total composition. More preferably, the main component is contained in about 20 to about 40 weight percent of the composition.

The non-carrier component of the antibiotic composition comprising the components obtainable from turmeric, ginger, and green tea as described above, does not substantially affect the intended use of the antibiotic composition, while the amount of carrier used in the antibiotic composition. And may be appropriately increased or decreased in the antibiotic composition of the present invention.

In another aspect, the present invention relates to a method of reducing, treating or preventing one or more symptoms or side effects of a microbial infection by administering to a patient infected with the microorganism an antibiotic composition of the present invention comprising an ingredient obtainable from ginger and green tea. It is about.

In this method, the patient can be human, in vitro cells, or animal. Preferably, the patient is a mammal; More preferably, it can be a human. In this method, viruses that can be inhibited by administration of the antibiotic composition of the present invention include rhinovirus, respiratory syncytial virus (RSV), herpes virus, influenza virus, HIV-virus and West Nile virus, among other viruses. In a preferred embodiment, viruses that can be inhibited by administration of antibiotic composition include at least human rhinovirus 16, herpes I virus (HSV-1), influenza A / Moscow / 10/99 (Influenza A / Moscow / 10/99) And B / Guangdong / 120/00.

Antibiotic compositions of the invention can also be used to treat bacterial infections, for example, streptococcus infection and fungal infection, for example, yeast, for example, infection by Candida (Candida).

Symptoms caused by microbial infections that can be treated, reduced or at least partially prevented by the methods of the present invention include one or more of headache, joint pain, fever, cold, sneezing, myalgia, nausea, dry mouth, dizziness, and microbial infection And other symptoms associated with it.

The effective amount of the antibiotic composition depends on the patient being treated, the particular mode of administration, the activity of the particular active ingredient used, age, weight, general health, sex, and the patient's diet, time of administration, excretion rate, characteristics of the ingredient used. It may vary depending on factors such as the formulation, the total content of the main components of the composition, and the severity of the disease or condition. Such amounts are within the skill of the art having regard to these factors.

The antibiotic composition may be administered about 1 to about 15 times per day, more preferably about 2 to about 12 times as needed, and most preferably about 6 to about 10 times per day as needed. Antibiotic compositions of the invention include, but are not limited to, tablets, capsules, lozenges, troches, hard candies, powders, oral sprays, nasal sprays, gels, elixirs, syrups, chewable compositions, dental products, suspensions or It may be administered in any suitable dosage form including a solution.

Each dosage form of the antibiotic composition contains a safe and effective amount of the antibiotic composition of the present invention. Amounts effective for each therapeutic administration contain from about 0.1 g to about 1 g of the total, obtainable from ginger and green tea. More preferably, the effective amount of antibiotic composition for each therapeutic administration contains from about 0.2 g to about 0.5 g of the total, obtainable from ginger and green tea. The amounts of the various components of the composition administered according to the methods of the invention are the same as given above for the compositions of the invention.

Preferably, during each oral administration of the antibiotic composition, the composition remains in the mouth for about 5 minutes to about 60 minutes to allow the main component of the antibiotic composition to contact the tissue or throat in the mouth before completely dissolving. More preferably, the antibiotic composition is left in the mouth for about 15 to about 30 minutes.

The following preferred ranges define a composition according to the invention suitable for administration in a spray formulation according to the method of the invention.

Each g of the antibiotic composition administered as a spray according to the method of the present invention preferably contains about 1 mg to about 10 mg of aquaresin ginger. More preferably, each g of the antibiotic composition contains about 3 mg to about 7 mg of aquaresin ginger.

 Each g of the antibiotic composition administered as a spray according to the method of the present invention preferably contains about 1 mg to about 20 mg of green tea leaf extract. More preferably, each g of the antibiotic composition contains about 7 mg to about 15 mg of green tea leaf extract.

When any ingredient from turmeric is used, each g of the antibiotic composition administered as a spray according to the method of the present invention preferably contains about 1 mg to about 12 mg of soluble oleoresin turmeric. More preferably, each g of the antibiotic composition contains about 4 mg to about 9 mg of soluble oleoresin turmeric.

As noted above, the compositions of the present invention include, but are not limited to, tablets, capsules, lozenges, troches, hard candy, powders, oral sprays, nasal sprays, gels, elixirs, syrups, chewable compositions, dental It may be administered in any orally acceptable dosage form, including products, suspensions and solutions.

The invention will be further illustrated by the following examples which are not intended to limit the invention. The scope of the invention is determined by the claims appended hereto.

Example 1-Antibiotic Compositions of the Invention

The antibiotic composition of the present invention formulated in the form of lozenges was prepared by using the method described above. The ingredients of lozenges are listed below:

1g per

Elm Bark 118mg

Turmeric Extract (5% Curcumin) 18mg

Ginger Root 140mg

Horseradish Root 70mg

Green Tea Leaf Extract (30% Catechin & Polyphenol) 14mg

Example 2 Treatment of Sore Throat

Each of the seven patients suffering from sore throat received one lozenge formulated according to Example 1 at two hour intervals, keeping the lozenge in the mouth for about 15-30 minutes until the lozenge was completely dissolved. No patients had more than 10 lozenges on any day of ingestion.

The treated patients showed complete relief of the symptoms of sore throat after ingesting 2-20 lozenges. It has also been found that each lozenge can relieve sore throat by up to six hours.

Example 3 In Vitro Viral Activity Test of Antibiotic Composition

The in vitro virucidal activity test original used in this example is human rhinovirus 16 (hereinafter referred to as "HRV-16") as a target virus, and as a host cell for HRV-16 virus, Jacobs, et al., Characteristics of The MRC-5 cell line associated with human tissue is described as described in Human diploid MRC-5 , Nature (London 0, 227, p168-170 (1970)] Residual virus infectivity after incubation of the test material with the virus Observations were titrated on the MRC-5 cell line for rhinovirus growth by visually recording the cytopathic effect (CPE) induced by viral replication More specifically, CPE was applied to ballooning / rounded cells in MRC-5 culture. Recorded by observation.

In order to measure the virucidal activity, the antibiotic composition of Example 1 (hereinafter “Material 1”) was used diluted to the first 1/20 and then diluted in a series of dilutions in saline. The diluted composition was incubated with HRV-16 for a predetermined time, and then the reaction was terminated by adjusting the cell infection medium to neutral pH. The resulting solution was then titrated on MRC-5 cells diluted 1/10 across the test plate to effect infection of the cells. Each plate was divided into a viral control containing only HRV-16 infected MRC-5 cells and a cell control containing only uninfected MRC-cells.

Plates were further incubated for 4 days after infection. Residual virus infectivity was measured by using the assay described above. All controls on the plates were well treated from the results shown in Tables 1-4.

From the assay, it was found that substance 1 at a 1/20 dilution was effective to produce a HRV-16 virus log reduction (-log 10 TCID50) of 1.50 in 1-minute incubation. Material 1 in a 1/40 dilution of Material 1 produced a log reduction (-log 10 TCID50) of 1.0 in 1-minute incubation. After 2-minute and 5-minute incubation, a 1/2 log reduction in HRV-16 titer was achieved. Thus, these results tend to indicate that the one-minute contact time between substance 1 and HRV-16 produces the most effective viral titer reduction.

Table 1 shows the residual virus titer and log reduction of infectious rhinovirus 16 on MRC-5 cells at one termination point of differently diluted material 1.

Table 1

Dilution PH value of substance 1 in isotonic solution PH value of the terminated solution Virus Control (TCID50)  1 minute incubation Residual Virus Titer (TCID50) Log reduction (TCID50) 1/20 5.03 7.73 3.80 2.30 1.50 1/40 5.13 7.77 3.80 3.30 0.50 1/80 4.98 7.83 3.80 3.80 0.00 1/160 4.98 7.73 3.80 3.80 0.00

Tables 2-4 show the results of residual virus titers and log reduction of infectious HRV-16 on MRC-5 cells at three different termination points of differently diluted material 1.

TABLE 2

Dilution of Substance 1 HRV-16 control titer (TCID50) 1 minute incubation Residual HRV-16 Titer (TCID50) HRV-16 log reduction (TCID50) 1/20 3.30 1.80 1.50 1/40 3.30 2.30 1.00 1/80 3.30 2.80 0.50 1/160 3.30 2.80 0.50 1/320 3.30 2.80 0.50

TABLE 3

Dilution of Substance 1 HRV-16 control titer (TCID50) 2 min incubation Residual HRV-16 Titer (TCID50) HRV-16 log reduction (TCID50) 1/20 3.30 2.80 0.50 1/40 3.30 2.30 0.50 1/80 3.30 2.80 0.50 1/160 3.30 2.80 0.50 1/320 3.30 2.80 0.50

Table 4

Dilution of Substance 1 HRV-16 control titer (TCID50) 5 minutes incubation Residual HRV-16 Titer (TCID50) HRV-16 log reduction (TCID50) 1/20 3.30 2.80 0.50 1/40 3.30 2.80 0.50 1/80 3.30 3.30 0.00 1/160 3.30 2.80 0.50 1/320 3.30 2.80 0.50

Similar virucidal tests are performed on Substance 1, including Herpes I virus (HSV-1) using Vero cells as host cells, Influenza A / Moscow / 10/99, and MDCK cells as host cells. Using other viruses, including B / Guangdong / 120/00. The results for these virucidal tests are summarized in Tables 5-13 below.

Tables 5-7 show the residual viral titer and log reduction of infectious HSV-1 on Vero cells at three different termination points of differently diluted material 1.

Table 5

Dilution of Substance 1 HSV-1 control titer (-log 10 TCID50) 1 minute incubation Residual HSV-1 Titer (-log 10 TCID50) HSV-1 log reduction (-log 10 TCID50) 1/40 3.80 0.00 3.80 1/80 3.80 0.00 3.80 1/160 3.80 2.80 1.00 1/320 3.80 2.80 1.00 1/640 3.80 2.80 1.00

Table 6

Dilution of Substance 1 HSV-1 control titer (-log 10 TCID50) 2 min incubation Residual HSV-1 Titer (-log 10 TCID50) HSV-1 log reduction (-log 10 TCID50) 1/40 3.80 0.00 3.80 1/80 3.80 0.00 3.80 1/160 3.80 1.80 2.00 1/320 3.80 2.80 1.00 1/640 3.80 2.80 1.00

TABLE 7

Dilution of Substance 1 HSV-1 control titer (-log 10 TCID50) 5 minutes incubation Residual HSV-1 Titer (-log 10 TCID50) HSV-1 log reduction (-log 10 TCID50) 1/40 3.80 0.00 3.80 1/80 3.80 0.00 3.80 1/160 3.80 1.80 2.00 1/320 3.80 2.80 1.00 1/640 3.80 2.80 1.00

Tables 8-10 show residual virus titers and log reductions of influenza A / Moscow / 10/99 at three different termination points of differently diluted material 1.

Table 8

Dilution of Substance 1 A / Moscow virus titer (-log 10 TCID50) 1 minute incubation Residual A / Moscow Titer (-log 10 TCID50) A / Moscow log reduction (-log 10 TCID50) 1/10 2.80 0.00 2.80 1/20 2.80 0.00 2.80 1/40 2.80 1.80 1.00 1/80 2.80 1.80 1.00 1/160 2.80 1.80 1.00 1/320 2.80 1.80 1.00 1/640 2.80 1.80 1.00 Citrate Buffer 2.80 1.80 1.00

Table 9

Dilution of Substance 1 A / Moscow virus titer (-log 10 TCID50) 2 min incubation Residual A / Moscow Titer (-log 10 TCID50) A / Moscow log reduction (-log 10 TCID50) 1/10 2.80 0.00 2.80 1/20 2.80 0.00 2.80 1/40 2.80 1.80 1.00 1/80 2.80 1.80 1.00 1/160 2.80 1.80 1.00 1/320 2.80 1.80 1.00 1/640 2.80 1.80 1.00 Citrate Buffer 2.80 1.80 1.00

Table 10

Dilution of Substance 1 A / Moscow virus titer (-log 10 TCID50) 5 minutes incubation Residual A / Moscow Titer (-log 10 TCID50) A / Moscow log reduction (-log 10 TCID50) 1/10 2.80 0.00 2.80 1/20 2.80 0.00 2.80 1/40 2.80 1.80 1.00 1/80 2.80 1.80 1.00 1/160 2.80 1.80 1.00 1/320 2.80 1.80 1.00 1/640 2.80 1.80 1.00 Citrate Buffer 2.80 0.00 2.80

Tables 11-13 show residual virus titers and log reductions of influenza B / guangdong / 120/00 at three different termination points of differently diluted material 1.

Table 11

Dilution of Substance 1 B / Guangdong Virus Titer (-log 10 TCID50) 1 minute incubation Residual B / Guangdong Titer (-log 10 TCID50) B / Guangdong log reduction (-log 10 TCID50) 1/10 1.80 0.00 1.80 1/20 1.80 0.00 1.80 1/40 1.80 1.80 0.00 1/80 1.80 1.80 0.00 1/160 2.30 1.80 0.50 1/320 2.30 1.80 0.50 1/640 1.80 2.30 -0.50 Citrate Buffer 1.80 0.00 1.80

Table 12

Dilution of Substance 1 B / Guangdong Virus Titer (-log 10 TCID50) 2 min incubation Residual B / Guangdong Titer (-log 10 TCID50) B / Guangdong log reduction (-log 10 TCID50) 1/10 1.80 0.00 1.80 1/20 1.80 0.00 1.80 1/40 1.80 1.80 0.00 1/80 1.80 1.80 0.00 1/160 2.30 1.80 0.50 1/320 2.30 1.80 0.50 1/640 1.80 2.80 -1.00 Citrate Buffer 1.80 0.00 1.80

Table 13

Dilution of Substance 1 B / Guangdong Virus Titer (-log 10 TCID50) 5 minutes incubation Residual B / Guangdong Titer (-log 10 TCID50) B / Guangdong log reduction (-log 10 TCID50) 1/10 1.80 0.00 1.80 1/20 1.80 0.00 1.80 1/40 1.80 1.80 0.00 1/80 1.80 1.80 0.00 1/160 2.30 1.80 0.50 1/320 2.30 1.80 0.50 1/640 1.80 2.80 -1.00 Citrate Buffer 1.80 0.00 1.80

TCID50 = -log 10 TCID50 in Tables 1-13.

As can be seen from the above results, substance 1 is effective in inhibiting or extinct influenza virus and human rhinovirus. As a result, substance 1 will be effective in treating influenza and common colds.

Example 4 In Vitro Viral Activity Test of Antibiotic Compositions

The in vitro virucidal activity test original used in this test is human linovirus 16 (HRV-16) as a target virus, and as a host cell for HRV-16 virus, Conant et al., Basis for a numbering system. I. Hela cells for propagation and serologic procedure , J. Immunol., 100, p107-113 (1968)] was used for the rhinovirus sensitized Hela cell line associated with human tissue.

The antibiotic composition of Example 1, namely substance 1, was dissolved in the infection medium at the following dilution rates: 1/20, 1/40, 1/80, 1/160 and 1/320. These dilutions were incubated at 37 ° C. (5% CO ₂ ) for 30 minutes on MRC-5 cell plates. After incubation, 1 dilution of the substance containing MRC-5 in the wells of the plate was added to HRV-16 of 2.30 known titer (-log 10 TCID50). Each plate was divided into a virus control (Hella cells infected with HRV-16 virus but without substance 1), a cell control (only HeLa cells) and a differently diluted test compound control (Hella cells with test compounds only). All other samples on the plate contained HeLa cells infected with HRV-16 virus and material 1 diluted differently. Plates were incubated for an additional 4 days after infection.

Residual viral infectivity after incubation of substance 1 with virus was titrated on the HeLa cell line for rhinovirus growth, which was titrated by measuring the cytopathic effect (CPE) induced by the virus using the following procedure.

The remaining viable HeLa cells after incubation with material 1 were stained with crystal violet solution. Excess crystal violet was washed off and crystal violet stained cells were lysed using a mixture of methanol and acetic acid. The solution was measured for absorbance at 540 nm with an ELISA plate reader. The level of virus induced CPE was inversely proportional to absorbance.

The results from the crystal violet assay yielded an equation for the toxicity and effective concentration of substance 1, i.e., y = mx + c, where x is the concentration of substance 1 and y is the percent of substance 1 to the cell. It was possible to measure by constructing. From this equation, TC50 (the concentration at which substance 1 is 50% toxic to cells) is the case for 1/571 dilution of substance 1.

These results correlate with the percentage of cell viability of various concentrations of substance 1 measured using crystal violet as shown in Table 14 below.

Table 14

Dilution of Substance 1 without Virus Survival Cell% 1/320 89.7 1/160 94.6 1/80 97.6 1/40 109.3 1/20 168.2

Using the same equation where x is still the concentration of substance 1 and y is the percent efficiency of substance 1 in the presence of the virus, the EC50 (the concentration at which the test substance shows 50% efficacy in the presence of the virus) is equal to 1/91 dilution of substance 1. It was determined to be the case. These results correlate with the percentage of viable cells in various substances 1 measured by using a crystal violet assay as shown in Table 15 below.

Table 15

Dilution of substance 1 and virus % Viable cells 1/320 + HRV-16 79.3 1/160 + HRV-16 62.3 1/80 + HRV-16 39.0 1/40 + HRV-16 15.9 1/20 + HRV-16 -220.0

In Table 14 and Table 15,% viable cells = (only compound / only cells) × 100; And% viable cells = (only cell-compound + virus) / (only cell-only virus) × 100.

"Only compound" shows measurement results for wells containing only HeLa cells and Constantly Diluted Material 1.

“Only cells” refers to the measurement results for wells containing only uninfected HeLa cells.

"Compound + virus" represents the measurement results for wells containing HeLa cells infected with HRV-16 virus and substance 1 that was constantly diluted.

"Only virus" shows measurement results for wells containing HeLa cells infected with HRV-16 only.

Example 5 Antibiotic Lozenges of the Invention

Antibiotic lozenges were prepared according to the formulations described below.

1) Textose 865.0mg

2) Elm Bark 150.0mg

3) stearic acid 75.0mg

4) Ginger root 105.0 mg (child) or 140.0 mg (adult)

5) Horseradish Root 70.0mg

6) Natural Honey Flavor 40.0mg

7) Turmeric Extract (5% Curcumin) 15.0mg

8) Green Tea Leaf Extract (36% C & P) 14.0mg

9) Silicon Dioxide 14.0mg

10) Magnesium Stearate 12.0mg

11) Sucrose / Splenda 4.0mg

Tablet weight: 1364.0 mg

Note: The term C & P as used above means "catechol and phenol".

Example 6 Antibiotic Spray of the Invention

Antibiotic sprays were prepared according to the formulations described below.

(1) Elm Bark Extract 18.52mg

(2) Oleoresin turmeric, soluble (approximately 8.5% curcumin) 8.82 mg

(3) Aqua resin ginger 7.0mg

(4) Horseradish Flavoring Agent WONF 0.62mg

(5) Green tea leaf PE 50% chromaticity 14.0mg

(6) Natural Honey Flavor 40.0mg

(7) Ethanol (95%) @ 5% 68.2 mg

(8) Glycerin 603.42mg

(9) 603.42mg of distilled water

Total weight: 1364.0mg

Example 7 In Vitro Antibiotic Lozenge Test

The antibiotic lozenge of Example 5 influenza virus of strain A / NewCaledonia / 20/99 (H ₁ N ₁ ), A / Panama / 2007/99 (H ₃ N ₂ ) and B / Guangdong / 120/00 We tested for virucidal and antiviral for infection of MDCK.

In measuring live virus, lozenges were tested diluted at 1/10, 1/20, 1/40, 1/80, 1/160, 1/320, and 1/640. Lozenges were diluted with isotonic saline solution (Normasol). Each dilution was tested at the end point 1, 2 and 5 minutes after lozenge contacted each virus. The reaction was terminated with 1.8 ml of 0% FBS cell medium.

The log reduction in this example is reported as -log 10 TCID50 and calculated with the Karber equation.

Table 16-Residual viral titers and log reduction of infectious A / New Caletonia / 20/99 (H1N1) virus after 1 minute termination at different dilutions

Dilution A / New Caledonia virus titer (-log 10 TCID50) 1 minute incubation Residual Influenza Station (-log 10 TCID50) Virus log reduction (-log 10 TCID50) 1/10 2.80 0.00 2.80 1/20 2.80 2.30 0.50 1/40 2.80 1.80 1.00 1/80 2.80 2.30 0.50 1/160 2.80 1.80 1.00 1/320 2.80 1.80 1.00 1/640 2.80 1.80 1.00 Citrate Buffer 2.80 1.80 1.00

Table 17-Residual viral titers and log reduction of infectious A / New Caletonia / 20/99 (H1N1) virus after 2 min termination point with different dilutions

Dilution A / New Caledonia virus titer (-log 10 TCID50) 2 min incubation Residual Influenza Station (-log 10 TCID50) Virus log reduction (-log 10 TCID50) 1/10 2.80 0.00 2.80 1/20 2.80 1.80 1.00 1/40 2.80 1.80 1.00 1/80 2.80 1.80 1.00 1/160 2.80 1.80 1.00 1/320 2.80 1.80 1.00 1/640 2.80 1.80 1.00 Citrate Buffer 2.80 1.80 1.00

Table 18-Residual viral titers and log reduction of infectious A / New Caletonia / 20/99 (H1N1) virus after 5 minutes termination at different dilutions

Dilution A / New Caledonia virus titer (-log 10 TCID50) 5 minutes incubation Residual Influenza Station (-log 10 TCID50) Virus log reduction (-log 10 TCID50) 1/10 2.80 0.00 2.80 1/20 2.80 1.80 1.00 1/40 2.80 1.80 1.00 1/80 2.80 1.80 1.00 1/160 2.80 1.80 1.00 1/320 2.80 1.80 1.00 1/640 2.80 1.80 1.00 Citrate Buffer 2.80 1.80 1.00

Table 19-Residual viral titers and log reduction of infectious A / Panama / 2007/99 (H3N2) virus after 1 minute termination at different dilutions

Dilution A / Panama virus titer (-log 10 TCID50 1 minute incubation Residual Influenza Station (-log 10 TCID50) Virus log reduction (-log 10 TCID50) 1/10 4.80 3.80 1.00 1/20 4.80 3.80 1.00 1/40 4.80 4.80 0.00 1/80 4.80 4.30 0.50 1/160 4.80 4.80 0.00 1/320 4.80 4.80 0.00 1/640 4.80 4.80 0.00 Citrate Buffer 4.80 0.00 4.80

Table 20-Residual viral titers and log reduction of infectious A / Panama / 2007/99 (H3N2) virus after 2-minute termination at different dilutions

Dilution A / Panama Virus Titer (-log 10 TCID50) 2 min incubation Residual Influenza Station (-log 10 TCID50) Virus log reduction (-log 10 TCID50) 1/10 4.80 3.80 1.00 1/20 4.80 4.30 0.50 1/40 4.80 4.80 0.00 1/80 4.80 4.30 0.50 1/160 4.80 4.80 0.00 1/320 4.80 4.80 0.00 1/640 4.80 4.80 0.00 Citrate Buffer 4.80 2.30 2.50

Table 21-Residual viral titers and log reduction of infectious A / Panama / 2007/99 (H3N2) virus after 5-minute termination at different dilutions

Dilution A / Panama Virus Titer (-log 10 TCID50) 5 minutes incubation Residual Influenza Station (-log 10 TCID50) Virus log reduction (-log 10 TCID50) 1/10 4.80 3.80 1.00 1/20 4.80 4.30 0.50 1/40 4.80 4.80 0.00 1/80 4.80 4.80 0.00 1/160 4.80 4.80 0.00 1/320 4.80 4.80 0.00 1/640 4.80 4.80 0.00 Citrate Buffer 4.80 2.80 2.00

Table 22-Residual Virus Titers and Log Reduction of Infectious B / Guangdong / 120/00 Viruses After 1-Minute Termination with Different Dilutions

Dilution A / Guangdong virus titer (-log 10 TCID50) 1 minute incubation Residual Influenza Station (-log 10 TCID50) Virus log reduction (-log 10 TCID50) 1/10 3.30 1.30 2.00 1/20 3.30 1.80 1.50 1/40 3.30 2.80 0.50 1/80 3.30 2.80 0.50 1/160 3.30 2.80 0.50 1/320 3.30 2.80 0.50 1/640 3.30 2.80 0.50 Citrate Buffer 3.30 0.00 3.30

Table 23-Residual Virus Titers and Log Reduction of Infectious B / Guangdong / 120/00 Viruses After 2-Minute End point at Different Dilutions

Dilution A / Guangdong virus titer (-log 10 TCID50) 2 min incubation Residual Influenza Station (-log 10 TCID50) Virus log reduction (-log 10 TCID50) 1/10 3.30 1.80 1.50 1/20 3.30 1.80 1.50 1/40 3.30 2.80 0.50 1/80 3.30 2.80 0.50 1/160 3.30 2.80 0.50 1/320 3.30 2.80 0.50 1/640 3.30 2.80 0.50 Citrate Buffer 3.30 0.00 3.30

Table 24-Residual viral titers and log reduction of infectious B / Guangdong / 120/00 virus after 5-minute termination at different dilutions

Dilution A / Guangdong virus titer (-log 10 TCID50) 5 minutes incubation Residual Influenza Station (-log 10 TCID50) Virus log reduction (-log 10 TCID50) 1/10 3.30 1.80 1.50 1/20 3.30 1.80 1.50 1/40 3.30 2.80 0.50 1/80 3.30 2.80 0.50 1/160 3.30 2.80 0.50 1/320 3.30 3.30 0.00 1/640 3.30 1.80 1.50 Citrate Buffer 3.30 0.00 3.30

In virucidal assays, known titers of influenza viruses are used as virus controls; This control proceeded to the same procedure as the test compound, QR-435. Influenza titers on all plates were consistent with virus control titers greater than 2.5 (-log 10 TCID50).

Example 8 In Vivo Antibiotic Spray Test

Five minutes before infection with the influenza virus of strain A / Sydney / 5/97 (H3N2), six groups of live pellets were administered nasal dosage form experimental or control compositions. Negative control group was treated with Tamiflu ^TM (Tamiflu ^TM) (See La Roche Laboratories in New Jersey, USA Material of press wrong (oseltamivir phosphate (oseltamivir phosphate) available from Roche Laboratories of Nutley)). One test group was treated with the nasal spray of Example 6 and the other group was treated with a similar nasal spray containing no green tea extract. After the initial challenge, the pellets were administered in their assigned composition twice a day.

The pellets in the PBS treated controls all exhibited symptoms typical for influenza A infected pellets, including weight loss, fever, increased inflammatory cell numbers, and viral release on the first day after infection. Pellets in the Tamiflu ^™ treated control group had no weight loss and virus release, a decrease in inflammatory cell count, and no recessive disease.

Similar nasal sprays, including the test formulation of Example 6 and no green tea extracts, induced low levels of intermittent inflammatory cell counts, prevention of the development of recessive diseases, and delayed virus release that could indicate viral inhibition. . However, the pellets treated with the nasal spray according to Example 6 showed some weight loss. Pellets treated with nasal sprays according to Example 6 were more active than pellets treated with Tamiflu ^™ .

There may be variations in the composition of the invention and in carrying out the methods of the invention described above without departing from the spirit and scope of the invention. All matters included in the above description are intended to illustrate the present invention and thus are not intended to limit the present invention. The scope of the invention should be determined by the claims appended hereto.

Claims (31)

A first component obtainable from ginger; A second component obtainable from green tea; And an soluble carrier, wherein the first component and the second component are admixed so as to be administered to the patient prior to the expected exposure to the microorganism, concurrently with exposure to the microorganism, or after exposure to the microorganism. An antibiotic composition present in the antibiotic composition in an amount effective to reduce, treat, or prevent side effects. The method according to claim 1, wherein the first component is selected from the group consisting of ginger powder extract, ginger juice extract, ginger powder, at least a portion of the whole ginger plant, ginger tincture, one or more compounds contained in ginger, and mixtures thereof, An antibiotic composition, characterized in that the second component is selected from the group consisting of green tea powder, green tea powder extract, green tea liquid extract, at least some of the green tea plants, green tea tincture, one or more compounds contained in green tea, and mixtures thereof. 2. The antibiotic composition of claim 1 wherein the first component comprises ginger root powder and the second component comprises green tea extract. 4. The antibiotic composition of claim 3, wherein each g of the composition contains about 5 mg to about 20 mg of green tea extract. The antibiotic composition of claim 4 wherein each gram of the composition contains about 30 mg to about 150 mg ginger root powder. 4. The antibiotic composition of claim 3 wherein each g of the composition contains about 7 mg to about 15 mg of green tea extract. 7. The antibiotic composition of claim 6 wherein each gram of the composition contains about 50 mg to about 110 mg of ginger root powder. The antibiotic composition of claim 1 further comprising a component obtainable from turmeric. 9. The component of claim 8 wherein the component obtainable from turmeric is turmeric powder extract, turmeric extract, turmeric extract, one or more curcuminoid compounds, one or more other compounds contained in turmeric, turmeric powder, at least some of the turmeric plant, turmeric Antibiotic composition, characterized in that it is selected from the group consisting of tinctures, and mixtures thereof. 10. The composition of claim 9 wherein the component obtainable from turmeric comprises turmeric extract. The antibiotic composition of claim 10 wherein each g of the composition comprises from about 5 mg to about 20 mg of turmeric powder extract. The antibiotic composition of claim 10 wherein each g of the composition comprises from about 7 mg to about 15 mg of turmeric powder extract. The antibiotic composition of claim 1, further comprising resveratrol. Turmeric extract; Ginger root powder; Green tea extract; And an soluble carrier, wherein the ginger root powder, green tea extract and turmeric extract are mixed to be administered to the patient prior to the expected exposure to the microorganism, simultaneously with or after the exposure to the microorganism. An antibiotic composition present in the antibiotic composition in an amount effective to reduce, treat, or prevent the side effects of. 15. The composition of claim 14 further comprising resveratrol. 15. The method of claim 14 wherein each g of the composition contains from about 5 mg to about 20 mg of green tea extract, from about 30 mg to about 150 mg of ginger root powder, and from about 5 mg to about 20 mg of turmeric powder extract. Antibiotic composition. A first component obtainable from ginger before the expected exposure to the microorganism, concurrently with or after the exposure to the microorganism; A second component obtainable from green tea; And administering an amount of the composition effective to reduce, treat, or prevent the side effects of microbial infection when administered to a patient as a composition comprising an soluble carrier, How to treat or prevent. 18. The method of claim 17, wherein the microorganism to be infected is selected from the group consisting of herpes virus, HIV-virus, AIDS virus, Streptococcus bacteria, influenza virus, rhinovirus, and respiratory syncytial virus. 18. The method of claim 17, wherein the composition is administered in a form selected from the group consisting of tablets, capsules, lozenges, troches, hard candy, chewable compositions, and dental products. 18. The method of claim 17, wherein the composition is administered by nasal spray or throat spray. 18. The method of claim 17, wherein the first component is selected from the group consisting of ginger powder extract, ginger juice extract, ginger powder, at least a portion of the entire ginger plant, ginger tincture, one or more compounds contained in ginger, and mixtures thereof, And wherein the second component is selected from the group consisting of green tea powder, green tea powder extract, green tea liquid extract, at least a portion of the green tea plant, green tea tincture, one or more compounds contained in green tea, and mixtures thereof. 18. The method of claim 17, wherein the first component comprises ginger root powder and the second component comprises green tea extract. 18. The method of claim 17, wherein each g of the composition contains about 5 mg to about 20 mg of green tea extract, and about 30 mg to about 150 mg of ginger root powder. 18. The method of claim 17, further comprising a component obtainable from turmeric. 25. The turmeric powder of claim 24, wherein the component obtainable from turmeric is turmeric powder extract, turmeric extract, turmeric extract, one or more curcuminoid compounds, one or more other compounds contained in turmeric, turmeric powder, at least some of the turmeric plant, turmeric Tincture, and mixtures thereof. 25. The method of claim 24, wherein the component obtainable from turmeric comprises turmeric extract. 27. The method of claim 26, wherein each g of the composition comprises from about 5 mg to about 20 mg of turmeric powder extract. 18. The method of claim 17, wherein the composition further comprises resveratrol. Turmeric extract, to the patient prior to the expected exposure to the microorganism, concurrently with or after the exposure to the microorganism; Ginger root powder; Green tea extract; And administering a predetermined amount of the composition in an amount effective to reduce, treat, or prevent the side effects of microbial infection when the ginger root powder, green tea extract, and turmeric extract are mixed and administered to a patient as a composition comprising an soluble carrier. Including, reducing, treating, or preventing the side effects of microbial infection in a patient. 30. The method of claim 29, wherein the composition further comprises resveratrol. 30. The method of claim 29, wherein each g of the composition contains about 5 mg to about 20 mg green tea extract, about 30 mg to about 150 mg ginger root powder, and about 5 mg to about 20 mg turmeric powder extract. .