Patent Application
20080057111
The present herb composition is in form of powder, tablet, capsule, which comprises of at least one component, isatis indigotica Fort or its extract. The component takes about 10 to 90% of total weight of the composition. Alternatively, the composition could further comprise of strobilanthes cusia or its extract. Even the herb composition is not necessary to include “strobilanthes cusia extract”, it is preferred to include this indigent in the said herb composition.
Generally, the root of isatis indigotica or the leaf of strobilanthes cusia or herein of the mixture is selected for this preparation. The herb extract is prepared in disinfected facility. The herb plant is washed cleanly, and immersed in 95% aqueous alcoholic solution for 12-72 hours. The said alcoholic solution is ethanol. The mixture of the solution is refluxed at 50-80° C. for three times. The extracted solution is filtered and concentrated with vacuum evaporator. After these processes, the fined product is obtained. Please be alert! The said method for processing the extract is an example, and there is no intention to limit the methods for preparing the herb extract. To a skilled art in this area, the herb extract could be obtained through other methods.
In another embodiment, the composition further composes of vitamin C, which takes 1% to 15% of the total weight of the composition. In another embodiment, the composition also includes vitamin E, and it takes 1% to 15% of the total weight of the composition. The vitamins serve as nutrition supply to improve body immune system. In another embodiment, flavoring, sugar or other artificial sweeteners such as aspartame is added to adjust the flavor of this composition. These conventional addictives are about 01% to 5% of the total weight.
Preferably, the herb composition includes effervescent agents when it is in form of powder, tablet, or capsule. The effervescent agents contain an acid base and a basic base, and they are about 10% to 50% of total weight of the composition. The acid base is selected from the group consisting of an organic acid, for example a carboxylic acid, organic acid salts, organic acid anhydrides, inorganic acids, inorganic acid salts, and mixtures thereof. Preferably, the organic acid, and related salts and anhydrides are selected from carboxylic acids having up to 8 carbon atoms such as, for example acetic, formic, propionic, malic, tartaric, citric, glycolic, maleic, fumaric, adipic, succinic, lactic, gluconic, and butyric acids and their homologs, and sulphamic acid. Examples of inorganic acid or acid salts include boric acid, sodium dihydrogen phosphate, disodium dihydrogen pyrophosphate, and sodium acid sulfite. Among them, citrate or citric acid salt is preferred.
In this composition, the basic component is selected from a group consisting of carbonates, bicarbonates, sequicarbonates and mixtures thereof. Preferably, carbonates, bicarbonates or mixtures thereof are used to make this pharmaceutical composition. When the composition is dissolved into water, the acid base has a chemical reaction with basic base, leading to the production of carbon dioxides. The burst of gas production promotes the disintegration and dissolution of the composition.
Thus, the composition formula mainly consists of:
One example of the pharmaceutical composition, wherein as example A, shows as below: Isatis indigotica Fort extract 50% (w/w); Vitamin C 6% (w/w); Vitamin E 3% (w/w); Monosodium citrate 20% (w/w); Sodium bicarbonate 20% (w/w), aspartame 1% (w/w).
In this example, isatis indigotica Fort extract serves as anti-flu and anti-virus agent. The vitamin C and E are nutrition supplement, and also service as acid base at wet condition. Since the extract of isatis indigotica Fort is slightly bitter, aspartame is added to adjust the flavor of the pharmaceutical composition as sweetener. The monosodium citrate and sodium bicarbonate serve as effervescent agents, and they also serve as binders to plasticize the above composition.
Another example of the pharmaceutical composition, wherein as example B consists of: Isatis indigotica Fort extract 25% (w/w); strobilanthes cusia extract 25% (w/w); Vitamin C 6% (w/w); Vitamin E 3% (w/w); Monosodium citrate 20% (w/w); Sodium bicarbonate 20% (w/w), aspartame 1% (w/w).
Different from example A, example B use isatis indigotica Fort extract and strobilanthes cusia extract as anti-flu and anti-virus agents instead of isatis indigotica Fort extract alone. The said two components share 50% weight of the total pharmaceutical composition, and each of them takes 25% total weight of the herb composition.
In one experiment, the herb composition A and B were diluted into distilled water at the final concentration of 10% (w/w). Sodium chloride solution served as control dose. Japanese rabbits were injected with endotoxin (ET) solution (20 EU/mL) at a dose of 2 ml/kg. Following that, animals were feed with herb composition A or composition B or sodium chloride solution randomly at the dose of 5 ml/kg. The temperature was measured every 0.5 hour for 4 hours. The body temperature in animals treated with herb composition A or herb composition B was significantly lower than animals treated with sodium chloride solution, while herb composition B is better than herb composition A with more animals in low body temperature.
In another study, Kunming strain mice were randomly divided into control, herb composition group A and herb composition B group. All animals were pretreated with lipopolysaccharides (LPS) at the dose of 0.2 mL/20 g. All herb compositions were dissolved into distilled water at final concentration of 10% (w/w), and fed animals at the 1 ml/20 g. The control animals were treated with sodium chloride with the same dose as the herb composition solution. The death rate of all mice was observed over 72 hours. The death rate is 70% in animals treated with sodium chloride, while the death rate in herb composition A treated group and composition B treated group was 30% and 20% respectively. The improvement is significantly in herb treated animals, and herb composition B is slightly better than herb composition A.
The anti-virus effect of herb composition A and B were studied in cultured human epithelial cells. The epithelial cells were infected with influenza virus B, and the cells were treated with composition A or composition B. In culture condition, the applied herb compositions were dissolved in DMEM medium, and applied in cultured cells at final concentration 1% (w/v). The cytokines including RANTES (regulated on activated normal T cell expression and secreted), MCP-1 (monocyte chemoattractant protein-1), MIP-1α (Macrophage inflammatory protein 1α) were studied. Both herb composition A and herb composition B had an inhibitory effect on cytokines production in influenza infected cells, and the inhibitory effect of herb composition A is stronger than herb composition B.
In addition, the time to dissolve herb composition A and herb composition B was studied in experiment. Once the composition touches the water, the effervescent agents have a chemical reaction, and carbon dioxides are released out to disintegrate the composition. As respected, there was no significant difference in carbon dioxide release in comparison with the two herb compositions, and it takes the same amount of time for these two herb composition of these two herb composition generally.
When the composition is in form of solution, the effervescent agents are not necessary to be included in this formula.
Preferably, the herb composition could be in form of gum, wherein gum base is a must, and takes about 5% to 95% total weight of the herb composition. The gum base generally comprises elastomer, resins, fats and oils, waxes, softeners and inorganic fillers. To a skilled art in this area, the elastomer may be polyisobutylene, isobutylene-isoprene copolymer and styrene butadiene rubber, as well as natural latexes such as chicle. Resins may include other materials such as polyvinylacetate and terpene resins. To give some example materials here just wants to clarify the definition of some science terms, and does not mean the limitation of the resource. To one skilled art in this area, there are more materials should be included as gum base.
In another embodiment, the herb composition further comprises of isatis indigotica Fort extract or strobilanthes cusia extract or therein mixture. The herb extract is about 10-90% of total weight. The ratio of isatis indigotica Fort extract and strobilanthes cusia extract is from 1:9 to 9:1, or the herb extract only, for example isatis indigotica Fort or strobilanthes cusia extract alone. In another embodiment, the herb composition also includes vitamin C, vitamin E, some flavoring and sweeteners. The sweeteners may be sugar, saccharin, aspartame, sucrlose, neotame, and acesulfame potassium et al. The flavorings may include a group of molecules such as glycin salt, guanylic acid salts, inosinic acid salts, 5′-ribonucleotides, malic salt and tartaric salt The listed sample materials do not mean the limitation of the resource, and to the knowledge of a killed art in this field, there are more substances in this category. The flavoring and sweeteners is about 0.1-5% of total weight. Vitamin C is in amount of about 1 to 15% of total weight, and vitamin E is in amount of about 1% to 15% of total weight.
In the process of produce, the gum base is melted to a soluble liquid. Herb extracts, vitamin C, vitamin E, some flavoring and sweeteners are slowly added to the gum base until the liquid cools down like dough. To a skilled art in this area, the dough is shaped, and cut into stick for package.
Please be alert that in the description of this patent, the numerical value with the word “about” or “proximally” in the specification just states the proximal range in this invention although the below and up value is indicated, unless otherwise it is specified. In this manner, a slight up or below the indicated value is allowed, and there is no significant difference in their effect with the formula specified in this specification and the slight modification. For example, when the range is about between 20% and 60%, a modification, for example 10% or 80%, is still allowed. In this disclosure, the range of the numerical value continuously covers all the number between the minimum and maximum values.
In addition, “such as”, “about”, “preferred”, “preferably” in this patent is to illustrate the content of the disclosure, there is no intention to limit the scope of the claims. In this patent, some examples are also intended to clarify the content of the dislosure. It dose not mean the limitation of scope of the claim in this patent.
