Herbal composition with synergistic component ratio for treating hyperuricemia

Abstract

A composition for administration to a subject for treating hyperuricemia is provided. The composition comprises apium graveolens extract, cichorium intybus extract, lotus extract, potentilla glabra extract and sour cherry extract. In certain embodiments, the composition includes 100 parts by weight of an apium graveolens extract. The composition comprises 65-85 parts by weight of a chicory extract. The composition comprises 30 to 60 parts by weight of a lotus extract. The composition comprises 10 to 25 parts by weight of a potentilla glabra extract. The composition comprises 5 to 20 parts by weight of an acid cherry extract. Related methods and uses are also provided.

Description

Technical Field

[0001] The present invention generally relates to compositions and methods for treating hyperuricemia, and more particularly, to herbal compositions having a synergistic weight ratio of components for reducing uric acid, enhancing uric acid excretion, and / or reducing inflammatory factors in a subject. Related methods are also provided. Background Art

[0002] Hyperuricemia is a condition characterized by abnormally high serum uric acid levels. Uric acid is a product of purine metabolism and is excreted by the kidneys. In healthy subjects, serum uric acid levels are maintained by a balance between production and excretion. Hyperuricemia is associated with gout, kidney stones, and chronic kidney disease.

[0003] In view of the foregoing, there remains an opportunity to provide new and useful treatments for hyperuricemia. Conventional treatments for hyperuricemia include xanthine oxidase inhibitors that reduce uric acid synthesis (e.g., allopurinol and febuxostat), and uricosuric agents that promote renal excretion of uric acid (e.g., probenecid). In addition, herbal compositions for treating hyperuricemia are well known.

[0004] Herbal compositions for treating hyperuricemia have been developed previously. Specifically, various compounds are known to reduce uric acid levels. Although these ingredients exhibit efficacy on their own, it is possible to further reduce uric acid levels by altering their combinations and relative weight loadings. When formulated in specialized ratios, the synergistic effects of specific herbal compounds may enhance their collective impact, potentially enabling improvements in uric acid metabolism beyond those achieved by individual components alone. Well-designed herbal formulations can provide excellent benefits in managing hyperuricemia.

[0005] Regrettably, given the number of components, developing synergistic ratios is challenging considering the numerous permutations of potential ratios of the vast array of herbal components. Accordingly, there remains an opportunity in this field to provide improved compositions, methods, and uses. Summary of the Invention

[0006] A composition for administration to a subject is provided. The composition comprises an extract of Apium graveolens, an extract of Cichorium intybus, an extract of Nelumbo nucifera, an extract of Potentilla glabra var. mandshurica (Maxim), and an extract of Prunus cerasus.

[0007] Provide a first general embodiment of a composition for administration to a subject. The composition comprises 100 parts by weight of Apium graveolens extract. The composition further comprises 65 to 85 parts by weight of Cichorium intybus extract. The composition further comprises 30 to 60 parts by weight of Nelumbo nucifera extract. The composition further comprises 10 to 25 parts by weight of Potentilla acaulis L. extract. The composition further comprises 5 to 20 parts by weight of Prunus cerasus extract.

[0008] Also provide a second general embodiment of a composition for administration to a subject. The composition comprises (i) an extract package and (ii) an additive package. The composition comprises (i) an extract package in an amount of 40 to 99.9% by weight and (ii) an additive package in an amount of 0.1 to 60% by weight. The (i) extract package comprises 34 to 48% by weight of Apium graveolens extract. The (i) extract package further comprises 24 to 37% by weight of Cichorium intybus extract. The (i) extract package further comprises 11 to 25% by weight of Nelumbo nucifera extract. The (i) extract package further comprises 3 to 12% by weight of Potentilla acaulis L. extract. The (i) extract package further comprises 2 to 9% by weight of Prunus cerasus extract. Each component weight % is based on 100% of the total weight of the composition.

[0009] Also provide a third general embodiment of a composition for administration to a subject. The composition comprises (i) an extract package and (ii) an additive package. The composition comprises (i) an extract package in an amount of 40 to 99.9% by weight and (ii) an additive package in an amount of 0.1 to 60% by weight. The (i) extract package comprises 5 to 25% by weight of Apium graveolens extract, 10 to 25% by weight of Cichorium intybus extract, 3 to 35% by weight of Nelumbo nucifera extract, 1 to 10% by weight of Potentilla acaulis L. extract, and 1 to 20% by weight of Prunus cerasus extract. Each weight % is based on 100% of the total weight of the extract package.

[0010] In various embodiments, the composition is an oral composition formulated for oral administration to a subject. In other embodiments, the composition is a topical composition formulated for topical administration to a subject.

[0011] Also provide the use of the composition. The composition can be used to reduce serum uric acid levels, enhance uric acid excretion, and / or reduce inflammatory factors in a subject.

[0012] In addition, provide a method. The method comprises reducing serum uric acid levels, enhancing uric acid excretion, and / or reducing inflammatory factors in a subject. The method comprises administering to the subject an effective amount of the composition as described above.

[0013] Specifically, the present invention discloses the following embodiments:

[0014] Embodiment 1. A composition for administration to a subject, the composition comprising:

[0015] 100 parts by weight of Apium graveolens extract;

[0016] 65 to 85 parts by weight of Cichorium intybus extract;

[0017] 30 to 60 parts by weight of Nelumbo nucifera extract;

[0018] 10 to 25 parts by weight of Potentilla acaulis L. extract; and

[0019] 5 to 20 parts by weight of Prunus cerasus extract.

[0020] Embodiment 2. The composition according to Embodiment 1, wherein the Apium graveolens extract comprises an extract of Apium graveolens seeds, or is optionally an extract of Apium graveolens seeds.

[0021] Embodiment 3. The composition according to Embodiment 1 or Embodiment 2, wherein the Nelumbo nucifera extract comprises an extract of Nelumbo nucifera leaves, or is optionally an extract of Nelumbo nucifera leaves.

[0022] Embodiment 4. The composition according to any one of Embodiments 1 to 3, wherein:

[0023] the Cichorium intybus extract is present in an amount of 70 to 80 parts by weight;

[0024] the Nelumbo nucifera extract is present in an amount of 40 to 50 parts by weight;

[0025] the Potentilla acaulis L. extract is present in an amount of 15 to 20 parts by weight; and

[0026] the Prunus cerasus extract is present in an amount of 5 to 15 parts by weight.

[0027] Embodiment 5. The composition according to Embodiment 4, wherein

[0028] the Cichorium intybus extract is present in an amount of 72.5 to 77.5 parts by weight;

[0029] the Nelumbo nucifera extract is present in an amount of 42.5 to 47.5 parts by weight;

[0030] the Potentilla acaulis L. extract is present in an amount of 17 to 19 parts by weight; and

[0031] the Prunus cerasus extract is present in an amount of 7.5 to 12.5 parts by weight.

[0032] Embodiment 6. The composition according to Embodiment 5, wherein

[0033] the Cichorium intybus extract is present in an amount of approximately 75 parts by weight;

[0034] The lotus extract is present in an amount of about 45 parts by weight;

[0035] The potentilla acaulis extract is present in an amount of about 18 parts by weight; and

[0036] The tart cherry extract is present in an amount of about 10 parts by weight.

[0037] Aspect 7. The composition according to any one of Aspects 1 to 6, wherein the composition further comprises at least one component selected from the following: (a) prebiotics; (b) metabolic absorption regulators; (c) molecular carriers; (d) edible flavors; or (e) combinations thereof.

[0038] Aspect 8. The composition according to any one of Aspects 1 to 7, wherein the composition comprises: resistant starch; erythritol; stevia; silicon oxide; γ-cyclodextrin; and an edible flavor.

[0039] Aspect 9. The composition according to any one of Aspects 1 to 8, wherein the composition has an average particle size of less than 140 μm.

[0040] Aspect 10. A composition for administration to a subject, the composition comprising:

[0041] (i) an extract set in an amount of 40 to 99.9% by weight, which comprises:

[0042] 5 to 25% by weight of an apium graveolens extract;

[0043] 10 to 25% by weight of a cichorium intybus extract;

[0044] 3 to 35% by weight of a lotus extract;

[0045] 1 to 10% by weight of a potentilla acaulis extract; and

[0046] 1 to 20% by weight of a tart cherry extract;

[0047] each based on 100% of the total weight of the extract set; and

[0048] (ii) an additive set in an amount of 0.1 to 60% by weight;

[0049] each based on 100% of the total weight of the composition.

[0050] Aspect 11. A composition for administration to a subject, the composition comprising:

[0051] (i) an extract set in an amount of 40 to 99.9% by weight, which comprises:

[0052] 34 to 48% by weight of Apium graveolens extract;

[0053] 24 to 37% by weight of Cichorium intybus extract;

[0054] 11 to 25% by weight of Nelumbo nucifera extract;

[0055] 3 to 12% by weight of Potentilla acaulis L. extract; and

[0056] 2 to 9% by weight of Prunus cerasus extract;

[0057] each based on 100% of the total weight of the extract set; and

[0058] (ii) an additive set in an amount of 0.1 to 60% by weight;

[0059] each based on 100% of the total weight of the composition.

[0060] Scheme 12. The composition according to any one of Schemes 1 to 11, wherein the composition is further defined as an oral composition formulated for oral administration to a subject.

[0061] Scheme 13. The composition according to Scheme 12, which further comprises a pharmaceutically acceptable additive, optionally wherein the pharmaceutically acceptable additive is not naturally occurring.

[0062] Scheme 14. The composition according to any one of Schemes 1 to 11, wherein the composition is further defined as a topical composition formulated for topical administration to a subject.

[0063] Scheme 15. The composition according to Scheme 14, which further comprises a cosmetically acceptable carrier, optionally wherein the cosmetically acceptable carrier is not naturally occurring.

[0064] Scheme 16. A sachet comprising 2.5 to 7.5 grams of the composition according to any one of Schemes 1 to 13.

[0065] Scheme 17. The sachet according to Scheme 16, which comprises 4.9 to 5.1 grams of the composition.

[0066] Scheme 18. Use of the composition according to any one of Schemes 1 to 15 or the sachet according to Scheme 16 or 17 for reducing serum uric acid levels, enhancing uric acid excretion and reducing inflammatory factors in a subject.

[0067] Scheme 19. A method for reducing serum uric acid levels, enhancing uric acid excretion, and reducing inflammatory factors in a subject, the method comprising administering to the subject an effective amount of a composition, wherein the composition is the composition according to any one of Schemes 1 to 15, or wherein the composition is administered via the pocket according to Scheme 16 or 17.

[0068] Scheme 20. The method according to Scheme 19, wherein:

[0069] i) the composition is orally administered to the subject;

[0070] ii) the composition is topically administered to the subject; or

[0071] iii) both i) and ii). Description of the Drawings

[0072] Figure 1 is a graph showing serum uric acid levels of placebo, low-dose, and high-dose treatment regimens over a 12-week study period.

[0073] Figure 2 is a graph showing changes in fractional excretion of uric acid (FEUA) of placebo, low-dose, and high-dose treatment regimens over a 12-week study period.

[0074] Figure 3 is a graph showing changes in tumor necrosis factor α (TNF-α) levels of placebo, low-dose, and high-dose treatment regimens over a 12-week study period. Detailed Description

[0075] Disclosed is a composition for administration to a subject. The composition comprises Apium graveolens extract, Cichorium intybus extract, Nelumbo nucifera extract, Potentilla acaulis extract, and Prunus cerasus extract. The composition is described below, followed by related uses and methods. Each of these extracts is commonly understood in the art and is described, for example, in the applicant's publication CN115300550A, which is incorporated herein by reference in its entirety.

[0076] As will be understood in view of the present disclosure, there are no particular limitations on the composition other than the various extracts, their relative weight loadings, and related uses and methods. Thus, the composition can be formulated as, for example, a topical composition (e.g., a cosmetic composition), or formulated as an oral composition or a health product, medicine, or supplement, and can be used as the sole and independent therapeutic agent or in combination with other compatible therapeutic agents.

[0077] The composition can be used for treating, preventing, and / or ameliorating various conditions, particularly hyperuricemia. Specifically, as will be appreciated in view of the following description and examples, it is believed that the compositions of the present embodiments are capable of reducing uric acid, enhancing uric acid excretion, and / or reducing inflammatory factors in a subject. Thus, at least one of these benefits can be achieved, typically at least two, or more typically all three. In some embodiments, it is also believed that the composition is capable of inhibiting xanthine oxidase.

[0078] Accordingly, the composition can be used for treating (i.e., slowing, preventing, reversing, etc.) hyperuricemia, including related conditions such as gout, ulcers, cancer, ischemia, hypertension, cardiovascular disease, oxidative stress, and oxidative damage. Other related benefits are also contemplated.

[0079] As introduced above, the composition comprises extracts of Apium graveolens, Cichorium intybus, Nelumbo nucifera, Potentilla acaulis, and Prunus cerasus. These compounds are included in the composition at specific relative weight loadings. In various embodiments, the loadings are as follows. Further embodiments are described further below.

[0080] The composition includes 30 to 100, optionally 50 to 100, optionally 70 to 100, or optionally 100 parts by weight of the extract of Apium graveolens. The composition includes 65 to 85, optionally 50 to 100, optionally 70 to 80, optionally 72.5 to 77.5, or optionally about 75 parts by weight of the extract of Cichorium intybus. The composition includes 30 to 60, optionally 30 to 70, optionally 40 to 50, optionally 42.5 to 47.5, or optionally about 45 parts by weight of the extract of Nelumbo nucifera. The composition includes 10 to 25, optionally 10 to 40, optionally 15 to 20, optionally 17 to 19, or optionally about 18 parts by weight of the extract of Potentilla acaulis. The composition includes 5 to 20, optionally 10 to 50, optionally 5 to 15, optionally 7.5 to 12.5, or optionally about 10 parts by weight of the extract of Prunus cerasus.

[0081] The composition can comprise, consist essentially of, or consist of the following: (i) an extract set and (ii) an additive set. (i) The extract set comprises, consists essentially of, or consists of the extracts of Apium graveolens, Cichorium intybus, Nelumbo nucifera, Potentilla acaulis, and Prunus cerasus.

[0082] As used herein, the phrase "consisting essentially of" generally includes the elements / components specifically recited for a particular embodiment. In addition, the phrase "consisting essentially of" generally includes and permits the presence of additional or optional elements / components that do not materially affect the basic and / or novel characteristics of that particular embodiment. In certain embodiments, "consisting essentially of" permits the presence of additional or optional components in an amount of ≤10, ≤5 or ≤1 weight percent (wt.%) based on the total weight of the composition. The above-mentioned extracts may be referred to herein as extracts, actives or active ingredients. Components that generally materially affect the methods / compositions of the present disclosure include active ingredients different from Apium graveolens extract, Cichorium intybus extract, Nelumbo nucifera extract, Potentilla acaulis L. extract and Prunus cerasus extract.

[0083] In certain embodiments, the compositions of the present disclosure do not contain other active ingredients. "Other active ingredients" generally means that the composition does not contain other types of traditional Chinese medicine ("TCM"; or "Chinese medicine") different from Apium graveolens extract, Cichorium intybus extract, Nelumbo nucifera extract, Potentilla acaulis L. extract and Prunus cerasus extract. Other types of TCM are understood in the art. Examples of other types of TCM are generally described as "bioactive substances" in International Publication No. WO2001022934A2, the content of which is incorporated herein by reference in its entirety.

[0084] In some embodiments, the (i) extract set consists of Apium graveolens extract, Cichorium intybus extract, Nelumbo nucifera extract, Potentilla acaulis L. extract and Prunus cerasus extract, such that the extract set does not include any other components.

[0085] The (ii) additive set contains at least one additive. Examples of suitable additives include conventional additives understood in the art. Specific examples are further detailed below.

[0086] The composition may contain the (i) extract set in an amount of 40 to 99.9 weight percent, optionally 50 to 99.9 weight percent, optionally 60 to 99 weight percent, optionally 80 to 99 weight percent, or optionally 90 to 97 weight percent. The composition may contain the (ii) additive set in an amount of 0.1 to 60 weight percent, optionally 0.1 to 50 weight percent, optionally 1 to 40 weight percent, optionally 1 to 20 weight percent, or optionally 3 to 10 weight percent. Generally, the composition is 100 weight percent based on the sum of the (i) extract set and the (ii) additive set.

[0087] In various embodiments, (i) the extract set may include from 5 to 25 wt%, optionally from 10 to 20 wt%, or optionally from 12.5 to 17.5 wt% of Apium graveolens extract. (i) The extract set may include from 10 to 25 wt%, optionally from 15 to 20 wt%, optionally from 16 to 19 wt%, or optionally from 17 to 18 wt% of Cichorium intybus extract. (i) The extract set may include from 3 to 35 wt%, optionally from 7 to 31 wt%, optionally from 11 to 27 wt%, or optionally from 18 to 20 wt% of Nelumbo nucifera extract. (i) The extract set may include from 1 to 10 wt%, optionally from 4 to 7 wt%, or optionally from 5 to 6 wt% of Potentilla acaulis L. extract. (i) The extract set may include from 1 to 20 wt%, optionally from 6 to 15 wt%, optionally from 8 to 13 wt%, or optionally from 9 to 11 wt% of Prunus cerasus extract.

[0088] In other embodiments, (i) the extract set may include from 34 to 48 wt%, optionally from 39 to 43 wt%, or optionally from 40 to 42 wt% of Apium graveolens extract. (i) The extract set may include from 24 to 37 wt%, optionally from 27 to 34 wt%, or optionally from 29 to 32 wt% of Cichorium intybus extract. (i) The extract set may include from 11 to 25 wt%, optionally from 13 to 22 wt%, or optionally from 16 to 20 wt% of Nelumbo nucifera extract. (i) The extract set may include from 3 to 12 wt%, optionally from 6 to 9 wt%, or optionally from 7 to 8 wt% of Potentilla acaulis L. extract. (i) The extract set may include from 2 to 9 wt%, optionally from 4 to 7 wt%, or optionally from 5 to 6 wt% of Prunus cerasus extract.

[0089] In a specific embodiment, the composition has an average particle size of less than 200 μm, optionally less than 150 μm, or optionally less than 140 μm. The particle size can be determined by conventional methods understood in the art.

[0090] In certain embodiments, the composition is further defined as a topical composition formulated for topical administration to a subject. In such embodiments, the composition may also be referred to as a cosmetic composition and generally includes at least one cosmetically acceptable carrier. In a specific embodiment, the cosmetically acceptable carrier is not naturally occurring. In other words, the carrier is not a natural product in these specific embodiments. In other embodiments, the carrier is selected from conventional carriers understood in the art and can be used in conventional amounts.

[0091] In some other embodiments, the composition is further defined as an oral composition formulated to be orally administered to a subject. In such embodiments, the composition may also be referred to as an ingestible composition and generally contains at least one pharmaceutically acceptable additive in addition to (i) the extract set. In a specific embodiment, the pharmaceutically acceptable additive is not naturally occurring. In other words, the pharmaceutically acceptable additive is not a natural product in these specific embodiments. In other embodiments, the pharmaceutically acceptable additive is selected from conventional additives understood in the art and may be used in conventional amounts.

[0092] Apium graveolens

[0093] The composition contains an extract of Apium graveolens, i.e., a material from the flowering plant species Apium graveolens, an extract optionally consisting essentially of material from the flowering plant species Apium graveolens. The Apium graveolens extract is not particularly limited and may comprise or be any extract or combination of extracts from Apium graveolens plants suitable for the embodiments herein.

[0094] Apium graveolens has been reported to contain various bioactive components such as flavonoids, chlorogenic acid, carotenoids, terpenes, coumarins, unsaturated fatty acids, methoxybenzenes, sedanolides, senkyunolides, indoles, tryptophan, and other compounds. Apium graveolens may be abbreviated as A. graveolens, or various other names such as Apium graveolens L., celery, wild celery, Han Qin, Apium graveolens, or celery seed.

[0095] Specific examples of Apium graveolens extracts are known in the art. Thus, Apium graveolens extracts can be purchased or otherwise commercially obtained from various sources, prepared (e.g., using any one or more conventional extraction techniques known in the art, such as any of those described herein), or a combination thereof. In certain embodiments, the extract of Apium graveolens is obtained by water extraction (or aqueous extraction) of the plant material of Apium graveolens. In further or other embodiments, the extract of Apium graveolens is obtained by alcohol extraction (e.g., ethanol extraction) of the plant material of Apium graveolens.

[0096] As will be understood by those skilled in the art, the cultivation of celery is mainly for its plant materials, including but not limited to its stems, leaves, and seeds. Thus, in various embodiments, the celery extract is an extract of celery seeds (Apium graveolens seed). Suitable extractions include those pointed out above, such as water extraction and ethanol extraction of the seeds. The seeds can be from one or more plants and can be fresh, dried, or otherwise aged.

[0097] For example, certain extracts can be obtained where the celery (such as the seeds) is ground in a mill to a uniform size. The resulting powder is then extracted with water or an ethanol solution. The solution is then filtered, and the filtrate can be concentrated under reduced pressure to produce a syrup. The syrup can then be lyophilized to dryness to obtain the extract.

[0098] In various embodiments, the celery extract consists of an extract of celery seeds. In further or other embodiments, the composition is substantially to completely free of components obtained from non-seed-based plant materials of celery. In these embodiments, the non-seed-based plant materials of celery can be, for example, the flowers, leaves, branches, and / or stems of the celery plant. Without being bound by any particular theory, it is believed that the seeds of celery are the most useful in this formulation for reducing serum uric acid levels; while other parts of celery are not.

[0099] In other embodiments, the celery extract can contain materials from any part or combination of parts of the plant and is not limited to seed extracts. For example, the celery extract can contain materials extracted from one or more parts of the celery plant, including its roots, branches, bark, rhizomes, leaves, buds, flowers, seeds, and / or fruits. Additionally, such extracts can be further processed (such as defatted, partially defatted, ground, dried, precipitated, washed, filtered, mesh-sorted, extracted, distilled, concentrated, etc.) to obtain the celery extract. Similarly, the celery plant can be extracted in its original form or processed prior to the extraction of the celery extract (such as used in its original form, suspended form, dehydrated form, concentrated form, etc.). In certain embodiments, the celery extract contains materials obtained from (i.e., extracted from) the seeds of celery.

[0100] In certain embodiments, the composition contains more than one celery extract, such as 2, 3, 4, or more celery extracts. In such embodiments, each celery extract is independently selected, can be the same as or different from any other celery extract, and is each used in the amounts described above.

[0101] The Apium graveolens extract can be used in any form, such as pure (i.e., without solvents, carrier vehicles, diluents, etc.), or placed in a carrier vehicle such as a solvent or a dispersant. The carrier vehicle (if present) can include aqueous solvents (such as water), organic solvents, fluids, or oils, etc., or combinations thereof. When used, the carrier vehicle will be selected based on the specific components of the composition (such as the specific Apium graveolens extract(s) used). It will be appreciated that the Apium graveolens extract can be combined with the carrier vehicle (if used) before, during, or after being combined with any other components of the composition.

[0102] Cichorium intybus

[0103] The composition comprises an extract of Cichorium, i.e., a material derived from the flowering plant species Cichorium, an extract optionally consisting essentially of a material derived from the flowering plant species Cichorium. The Cichorium extract is not particularly limited and can include or be any extract or combination of extracts from Cichorium plants suitable for the embodiments herein.

[0104] Cichorium has been reported to contain various bioactive components such as inulin-type fructans, sesquiterpene lactones, lactucin, lactucopicrin, guaianolid glycosides, hydroxycinnamic acids (such as chicoric acid, chlorogenic acid, and caffeic acid derivatives), flavonoids (such as quercetin and kaempferol derivatives), anthocyanins, and coumarins. Cichorium intybus can be abbreviated as C. intybus, or various other names such as Cichorium intybus L., Chicory, Common Chicory, witloof chicory, blue daisy, blue dandelion, blue sailors, blue weed, bunk, coffeeweed, hendibeh, horseweed, ragged sailors, succory, wild bachelor's buttons, wild endive, Ju Qu, Juju, Cichorii herba, Cichoriiradix, or Chicory.

[0105] Specific examples of chicory extracts are known in the art. Thus, chicory extracts can be purchased or otherwise obtained commercially from a variety of sources, prepared (e.g., using any conventional extraction technique(s) known in the art, such as any of those described herein), or a combination thereof. In certain embodiments, an extract of chicory is obtained by water extraction (or aqueous extraction) of the plant material of chicory. In further or other embodiments, an extract of chicory is obtained by alcohol extraction (e.g., ethanol extraction) of the plant material of chicory.

[0106] As will be understood by those skilled in the art, chicory is cultivated primarily for the whole plant. Thus, in various embodiments, an extract of chicory is an extract of the above-ground parts (e.g., stems, leaves, buds, and / or flowers) of the chicory plant. Suitable extractions include those noted above, such as water extraction and ethanol extraction of the above-ground parts of the plant. The above-ground parts can be from one or more plants and can be fresh, dried, or otherwise aged.

[0107] For example, certain extracts can be obtained in which chicory (e.g., the above-ground parts) is ground in a mill to a uniform size. The resulting powder is then extracted with water or an ethanol solution. The solution is then filtered, and the filtrate can be concentrated under reduced pressure to produce a syrup. The syrup can then be freeze-dried to dryness to obtain the extract.

[0108] In various embodiments, the chicory extract consists of an extract of the above-ground parts of chicory. In further or other embodiments, the composition is substantially to completely free of components obtained from non-above-ground basal plant material of chicory. In these embodiments, the non-above-ground basal plant material of chicory can be, for example, the roots of the chicory plant. Without being bound by any particular theory, it is believed that the above-ground parts of chicory are most useful in promoting the excretion of uric acid in this formulation; while the other parts of chicory are not.

[0109] In other embodiments, the chicory extract can contain materials from any part or combination of parts of the plant and is not limited to above-ground part extracts. For example, the chicory extract can contain materials extracted from one or more parts of the chicory plant, including its roots, stems, bark, rhizomes, leaves, buds, flowers, seeds, and / or fruits. Additionally, such extracts can be further processed (e.g., defatted, partially defatted, ground, dried, precipitated, washed, filtered, sieved, extracted, distilled, concentrated, etc.) to obtain the chicory extract. Similarly, the chicory plant can be extracted in its original form or processed prior to the extraction of the chicory extract (e.g., used in its original form, suspended form, dehydrated form, concentrated form, etc.). In certain embodiments, the chicory extract contains materials obtained from (i.e., extracted from) the above-ground parts of chicory.

[0110] In certain embodiments, the composition comprises more than one chicory extract, such as 2, 3, 4 or more chicory extracts. In such embodiments, each chicory extract is independently selected, can be the same as or different from any other chicory extract, and each is used in the amounts described above.

[0111] The chicory extract can be used in any form, such as pure (i.e., without solvents, carrier vehicles, diluents, etc.), or placed in a carrier vehicle (such as a solvent or dispersant). The carrier vehicle (if present) can comprise an aqueous solvent (e.g., water), an organic solvent, a fluid, an oil, etc., or a combination thereof. When used, the carrier vehicle will be selected based on the specific components of the composition, such as the specific chicory extract(s) used. It will be appreciated that the chicory extract can be combined with the carrier vehicle (if used) before, during, or after being combined with any other components of the composition.

[0112] Lotus

[0113] The composition comprises an extract of lotus, i.e., an extract comprising material from the flowering plant species lotus, optionally consisting essentially of material from the flowering plant species lotus. The lotus extract is not particularly limited and can comprise or be any extract or combination of extracts from lotus plants suitable for the embodiments herein.

[0114] Lotus has been reported to contain various bioactive components, such as alkaloids, steroids, flavonoids, glycosides, triterpenoids, polyphenols, and other compounds. Lotus (Nelumbo nucifera) can be abbreviated as N. nucifera, or various other names such as Lotus (Nelumbo nucifera Gaertn.), East Indian lotus, Hindu lotus, Chinese waterlily, sacred lotus, He Ye, Nelumbinis folium, or lotus leaf.

[0115] Specific examples of lotus extracts are known in the art. Thus, lotus extracts can be purchased or otherwise commercially obtained from various sources, prepared (e.g., using any conventional extraction technique(s) known in the art, such as any of those described herein), or a combination thereof. In certain embodiments, the extract of lotus is obtained by water extraction (or aqueous extraction) of lotus plant material. In further or other embodiments, the extract of lotus is obtained by alcohol extraction (e.g., ethanol extraction) of lotus plant material.

[0116] As will be understood by those skilled in the art, the cultivation of lotus is mainly for its plant materials, including but not limited to its leaves and flowers. Thus, in various embodiments, the lotus extract is an extract of lotus leaves. Suitable extractions include those pointed out above, such as water extraction and ethanol extraction of the leaves.

[0117] The leaves can be from one or more plants and can be fresh, dried or otherwise aged.

[0118] For example, certain extracts can be obtained where the lotus (e.g., the leaves) are ground in a mill to a uniform size. The resulting powder is then extracted with water or an ethanol solution. The solution is then filtered, and the filtrate can be concentrated under reduced pressure to produce a paste. The paste can then be freeze-dried to dryness to obtain the extract.

[0119] In various embodiments, the lotus extract consists of an extract of lotus leaves. In further or other embodiments, the composition is substantially to completely free of components obtained from non-leaf-based plant materials of the lotus. In these embodiments, the non-leaf-based plant materials of the lotus can be, for example, the flowers, seeds and / or rhizomes of the lotus plant. Without being bound by any particular theory, it is believed that the leaves of the lotus are most useful in promoting uric acid excretion in this formulation; while other parts of the lotus are not.

[0120] In other embodiments, the lotus extract can contain materials from any part or combination of parts of the plant and is not limited to leaf extracts. For example, the lotus extract can contain materials extracted from one or more parts of the lotus plant, including its roots, branches, rhizomes, leaves, buds, flowers and / or seeds. Additionally, such extracts can be further processed (e.g., defatted, partially defatted, ground, dried, precipitated, washed, filtered, sieved, extracted, distilled, concentrated, etc.) to obtain the lotus extract. Similarly, the lotus plant can be extracted in its original form or processed prior to the extraction of the lotus extract (e.g., used in its original form, suspended form, dehydrated form, concentrated form, etc.). In certain embodiments, the lotus extract contains a lotus extract containing materials obtained from (i.e., extracted from) lotus leaves.

[0121] In certain embodiments, the composition contains more than one lotus extract, such as 2, 3, 4 or more lotus extracts. In such embodiments, each lotus extract is independently selected, can be the same as or different from any other lotus extract, and each is used in the amounts described above.

[0122] The lotus extract can be used in any form, such as pure (i.e., without solvents, carrier vehicles, diluents, etc.), or placed in a carrier vehicle such as a solvent or a dispersant. The carrier vehicle (if present) can include aqueous solvents (e.g., water), organic solvents, fluids or oils, etc., or combinations thereof. When used, the carrier vehicle will be selected based on the specific components of the composition (such as the specific lotus extract(s) used). It will be recognized that the lotus extract can be combined with the carrier vehicle (if used) before, during, or after being combined with any other components of the composition.

[0123] Potentilla glabra

[0124] The composition contains an extract of Potentilla acaulis, i.e., it contains materials (such as flowers or leaves) from the flowering plant species Potentilla acaulis, or an extract optionally consisting essentially of materials (such as flowers or leaves) from the flowering plant species Potentilla acaulis. The Potentilla acaulis extract is not particularly limited and can include or be any flower extract, leaf extract, or a combination of flower and / or leaf extracts from Potentilla acaulis plants suitable for the embodiments herein. More specifically, exemplary Potentilla acaulis flower and / or leaf extracts include those that are capable of inhibiting XO or eliciting / exhibiting any of the other such activities described herein as part of the composition.

[0125] Potentilla acaulis has been reported to contain various bioactive components such as phenolic acids, flavonoids, terpenoids, triterpenes, tannins, polyphenols, saponins, polysaccharides, and other compounds. Potentilla acaulis can be abbreviated as P. glabra, or various other names such as Potentilla glabra Lodd., Potentilla glabra G.Lodd., Dasiphora glabra (G.Lodd.) Soják, Silver Dew Plum, Yinlumei, or Potentilla acaulis. The leaves and flowers of Potentilla acaulis (Potentilla glabra Lodd.) may be called Yaowang tea. In various embodiments, Potentilla acaulis can be the variety Potentilla glabra Lodd. var. mandshurica (Maxim.) Hand.–Mazz, which can be called Manchurian cinquefoil, Baimao Yinlumei, white-haired Potentilla acaulis, or Potentilla acaulis (var.). In many embodiments, Potentilla glabra var. mandshurica (Maxim) is used.

[0126] Specific examples of Potentilla glabra L. var. mandshurica (Maxim.) W. T. Wang & Tsai ex Yu extracts are known in the art. Thus, Potentilla glabra L. var. mandshurica (Maxim.) W. T. Wang & Tsai ex Yu extracts can be purchased or otherwise obtained commercially from various sources, prepared (e.g., using any one or more conventional extraction techniques known in the art, such as any of those described herein), or a combination thereof. In certain embodiments, an extract of Potentilla glabra L. var. mandshurica (Maxim.) W. T. Wang & Tsai ex Yu is obtained by water extraction (or aqueous extraction) of the plant material of Potentilla glabra L. var. mandshurica (Maxim.) W. T. Wang & Tsai ex Yu, including but not limited to flowers and / or leaves. In further or other embodiments, an extract of Potentilla glabra L. var. mandshurica (Maxim.) W. T. Wang & Tsai ex Yu is obtained by alcohol extraction (e.g., ethanol extraction) of the plant material of Potentilla glabra L. var. mandshurica (Maxim.) W. T. Wang & Tsai ex Yu, including but not limited to flowers and / or leaves.

[0127] In certain embodiments, an extract of Potentilla glabra L. var. mandshurica (Maxim.) W. T. Wang & Tsai ex Yu flowers and / or leaves is obtained by water extraction (or aqueous extraction) of the flowers, flower-based plant material, leaves, or leaf-based plant material of Potentilla glabra L. var. mandshurica (Maxim.) W. T. Wang & Tsai ex Yu. In further or other embodiments, an extract of Potentilla glabra L. var. mandshurica (Maxim.) W. T. Wang & Tsai ex Yu flowers and / or leaves is obtained by alcohol extraction (e.g., ethanol extraction) of the flowers, flower-based plant material, leaves, or leaf-based plant material of Potentilla glabra L. var. mandshurica (Maxim.) W. T. Wang & Tsai ex Yu. The flowers and / or leaves can be fresh or dried, typically dried to prevent spoilage. The dried flowers and / or leaves can then be formed into a powder, which can be used as an extract per se, or more typically, the powdered flowers and / or leaves are further processed as described below to form an extract.

[0128] As will be understood by those skilled in the art, Potentilla glabra L. var. mandshurica (Maxim.) W. T. Wang & Tsai ex Yu is cultivated primarily for its flowers and / or leaves. Thus, in various embodiments, an extract of Potentilla glabra L. var. mandshurica (Maxim.) W. T. Wang & Tsai ex Yu is an extract of Potentilla glabra L. var. mandshurica (Maxim.) W. T. Wang & Tsai ex Yu flowers and / or leaves. Suitable extractions include those noted above, such as water extraction and ethanol extraction of the flowers and / or leaves. The flowers and / or leaves can be from one or more plants and can be fresh, dried, or otherwise aged.

[0129] For example, certain extracts can be obtained in which Potentilla glabra L. var. mandshurica (Maxim.) W. T. Wang & Tsai ex Yu (e.g., flowers and / or leaves) is ground in a mill to a uniform size. The resulting powder is then extracted with water or an ethanol solution. The solution is then filtered, and the filtrate can be concentrated under reduced pressure to produce a paste. The paste can then be lyophilized to dryness to obtain an extract.

[0130] In various embodiments, the Potentilla glabra L. var. mandshurica (Maxim.) W. T. Wang & Tsai ex Yu extract consists of an extract of Potentilla glabra L. var. mandshurica (Maxim.) W. T. Wang & Tsai ex Yu flowers and / or leaves. In further or other embodiments, the composition is substantially to completely free of components obtained from non-flower-based plant material and / or non-leaf-based plant material of Potentilla glabra L. var. mandshurica (Maxim.) W. T. Wang & Tsai ex Yu. In these embodiments, the non-flower-based plant material and non-leaf-based plant material of Potentilla glabra L. var. mandshurica (Maxim.) W. T. Wang & Tsai ex Yu can be, for example, the roots, branches, bark, rhizomes, or stems of the Potentilla glabra L. var. mandshurica (Maxim.) W. T. Wang & Tsai ex Yu plant. Without being bound by any particular theory, it is believed that the flowers and leaves of Potentilla glabra L. var. mandshurica (Maxim.) W. T. Wang & Tsai ex Yu are most useful for reducing serum uric acid levels; while other parts of Potentilla glabra L. var. mandshurica (Maxim.) W. T. Wang & Tsai ex Yu are not (as illustrated in the Examples section below).

[0131] In other embodiments, the Potentilla acaulis extract may comprise materials from any part or combination of parts of the plant and is not limited to flower and / or leaf extracts. For example, the Potentilla acaulis extract may comprise materials extracted from one or more parts of the Potentilla acaulis plant, including its roots, branches, bark, rhizomes, leaves, buds, flowers, seeds, and / or fruits. Additionally, such extracts may be further processed (e.g., defatted, partially defatted, ground, dried, precipitated, washed, filtered, sieved, extracted, distilled, concentrated, etc.) to obtain the Potentilla acaulis extract. Similarly, the Potentilla acaulis plant may be extracted in its original form or processed prior to extraction of the Potentilla acaulis extract (e.g., used in its original form, suspended form, dehydrated form, concentrated form, etc.). In certain embodiments, the composition comprises a Potentilla acaulis extract that comprises materials obtained from (i.e., extracted from) the flowers and / or leaves of Potentilla acaulis.

[0132] In certain embodiments, the composition comprises more than one Potentilla acaulis extract, such as 2, 3, 4, or more Potentilla acaulis extracts. In such embodiments, each Potentilla acaulis extract is independently selected, may be the same as or different from any other Potentilla acaulis extract, and is each used in the amounts described above.

[0133] The Potentilla acaulis extract may be used in any form, such as pure (i.e., without solvents, carrier vehicles, diluents, etc.), or placed in a carrier vehicle (such as a solvent or dispersant). The carrier vehicle (if present) may comprise an aqueous solvent (e.g., water), an organic solvent, a fluid, or an oil, etc., or a combination thereof. When used, the carrier vehicle will be selected based on the specific components of the composition (such as the specific Potentilla acaulis extract(s) used). It will be appreciated that the Potentilla acaulis extract may be combined with the carrier vehicle (if used) before, during, or after combination with any other component of the composition.

[0134] Prunus cerasus

[0135] The composition comprises an extract of tart cherry, i.e., an extract that comprises materials from the fruiting plant species tart cherry, optionally consisting essentially of materials from the fruiting plant species tart cherry. The tart cherry extract is not particularly limited and may comprise or be any extract or combination of extracts from a tart cherry plant suitable for the embodiments herein.

[0136] Sour cherries have been reported to contain various bioactive components, such as fatty acids, tocochromanols, tocopherols, tocotrienols, carotenoids, squalene, sterols, polyphenols, flavonoids, cyanidin 3-rutinoside, peonidin 3-glucoside, isorhamnetin, quercetin, ferulic acid, chlorogenic acid, p-coumaric acid, and other compounds. Sour cherry (Prunus cerasus) may be abbreviated as P. cerasus, or various other names such as Prunus cerasus L., sour cherry, tart cherry, dwarf cherry, or acid cherry.

[0137] Specific examples of sour cherry extracts are known in the art. Thus, sour cherry extracts can be purchased or otherwise obtained commercially from various sources, prepared (e.g., using any one or more conventional extraction techniques known in the art, such as any of those described herein), or a combination thereof. In certain embodiments, an extract of sour cherry is obtained by water extraction (or aqueous extraction) of the plant material of sour cherry. In further or other embodiments, an extract of sour cherry is obtained by alcohol extraction (e.g., ethanol extraction) of the plant material of sour cherry.

[0138] As will be understood by those skilled in the art, sour cherries are cultivated primarily for their plant material, including but not limited to their fruits. Thus, in various embodiments, an extract of sour cherry is an extract of sour cherry fruit. Suitable extractions include those noted above, such as water extraction and ethanol extraction of the fruit. The fruit can be from one or more plants and can be fresh, dried, or otherwise aged.

[0139] For example, certain extracts can be obtained in which sour cherries (e.g., the fruit) are ground in a mill to a uniform size. The resulting powder is then extracted with water or an ethanol solution. The solution is then filtered, and the filtrate can be concentrated under reduced pressure to produce a paste. The paste can then be lyophilized to dryness to obtain the extract.

[0140] In various embodiments, the sour cherry extract consists of an extract of sour cherry fruit. In further or other embodiments, the composition is substantially to completely free of components obtained from non-fruit-based plant material of sour cherry. In these embodiments, the non-fruit-based plant material of sour cherry can be, for example, the flowers, leaves, buds, seeds, and / or branches of the sour cherry plant. Without being bound by any particular theory, it is believed that the fruit of sour cherry is most useful for anti-inflammatory effects in this formulation; while the other parts of sour cherry are not.

[0141] In other embodiments, the tart cherry extract may comprise materials from any part or combination of parts of the plant and is not limited to fruit extracts. For example, the tart cherry extract may comprise materials extracted from one or more parts of the tart cherry plant, including its roots, branches, bark, rhizomes, leaves, buds, flowers, seeds, and / or fruit. Additionally, such extracts may be further processed (e.g., defatted, partially defatted, ground, dried, precipitated, washed, filtered, sieved, extracted, distilled, concentrated, etc.) to obtain the tart cherry extract. Similarly, the tart cherry plant may be extracted in its original form or processed prior to extraction of the tart cherry extract (e.g., used in its original form, suspended form, dehydrated form, concentrated form, etc.). In certain embodiments, the composition comprises a tart cherry extract that comprises materials obtained from (i.e., extracted from) the fruit of the tart cherry.

[0142] In certain embodiments, the composition comprises more than one tart cherry extract, such as 2, 3, 4, or more tart cherry extracts. In such embodiments, each tart cherry extract is independently selected, may be the same as or different from any other tart cherry extract, and is each used in the amounts described above.

[0143] The tart cherry extract may be used in any form, such as pure (i.e., no solvent, carrier vehicle, diluent, etc. present), or placed in a carrier vehicle (such as a solvent or dispersant). The carrier vehicle (if present) may comprise an aqueous solvent (e.g., water), an organic solvent, a fluid, an oil, etc., or a combination thereof. When used, the carrier vehicle will be selected based on the particular components of the composition (such as the particular tart cherry extract(s) used). It will be appreciated that the tart cherry extract may be combined with the carrier vehicle (if used) before, during, or after combination with any other components of the composition.

[0144] Additive

[0145] Optionally, the composition may include one or more additional components, such as additives. In other aspects, in embodiments having an (ii) additive kit, the composition includes at least one additive.

[0146] It will be appreciated that the additives will vary and the topical and oral compositions each contain additives suitable for the particular application. Suitable additives include those understood in the art, including but not limited to preservatives, solvents, vehicles, carriers, disinfectants, antiseptics, active pharmaceutical ingredients, analgesics, neurogenic pain compounds, antioxidants, circulation promoters, antidepressants, anxiolytics, anti-stress compounds, other types of additives known to those skilled in the art, and combinations thereof. Particularly suitable additives for topical embodiments include humectants, emollients, emulsifiers, surfactants, oils, complementary plant extracts, skin protectants, sunscreens, insect repellents, exfoliants, fragrances, and colorants. These additives can be used alone or in combination. Generally, optional additives can be of any type used in personal care products and cosmetic products.

[0147] Excipients can be further classified as other components. Specifically, excipients for oral solid dosage forms have been classified into the following groups based on their functions: such as diluents, disintegrants, binders, compression aids, granulating agents, glidants, lubricants, controlled-release polymers, stabilizers (such as antioxidants, chelating agents, and pH regulators), film coating polymers, coating agents, vehicles, plasticizers, surfactants, colorants, sweeteners, and flavoring agents. Diluents are used to increase volume and allow for more convenient dosing units. Non-exhaustive examples include microcrystalline cellulose (MCC), wood cellulose, starches (corn starch, dry starch, modified starches), lactose, mannitol, sorbitol, dextrose, sucrose, calcium phosphate, calcium sulfate, kaolin, sodium chloride. Binders are used to provide cohesion to powdered components to ensure composition integrity and granule formation. Non-exhaustive examples include starches, gelatin, sucrose, glucose, lactose, molasses, natural and synthetic gums (such as gum arabic, sodium alginate), cellulose derivatives (such as methylcellulose, ethylcellulose), PVP, microcrystalline cellulose. Disintegrants are used to facilitate the breakdown of the dosing unit after ingestion. Non-exhaustive examples include sodium starch glycolate, starch, MCC, cross-linked PVP. Lubricants are used to improve the flow of the granules of the composition to prevent sticking during the compression process. Non-exhaustive examples include magnesium stearate, stearic acid, calcium stearate, talc, zinc stearate, PEG, hydrogenated vegetable oil, wax, sodium stearyl fumarate, light anhydrous silicic acid. Glidants are used to enhance the powder flowability of the composition. Non-exhaustive examples include colloidal silicon dioxide, talc, and starch. Flavoring agents (or flavorants or flavors) improve the palatability of the composition. Non-exhaustive examples include synthetic and natural flavorings, perfumes, sweeteners (such as saccharin, aspartame, stevia), and acidulants (such as citric acid, malic acid).

[0148] In various embodiments, the composition comprises at least one component selected from binders, lubricants, glidants, and combinations thereof. In certain embodiments, the composition includes one or more compounds including, but not limited to, methylcellulose, hydroxypropyl methylcellulose, ethylcellulose, cellulose acetate phthalate, gum arabic, gums, waxes, glyceryl monostearate, acrylic polymers and copolymers, methacrylic acid, methyl acrylate, ethyl acrylate, methyl methacrylate, ethyl methacrylate, lactose, calcium sulfate, calcium hydrogen phosphate, sugars, microcrystalline cellulose (MCC), starch, sodium starch glycolate, polyvinylpyrrolidone, polyethylene glycol, and magnesium stearate. Combinations of these components can be used, and these components and other components used in conventional tablets are known in the art.

[0149] As used herein, a "diluent" can be an inert substance added to increase the volume of a composition so that a tablet reaches a practical size for compression. Thus, they can also be referred to as fillers. Commonly used diluents include, but are not limited to, microcrystalline cellulose (MCC), wood cellulose, corn starch, modified corn starch, tricalcium phosphate, calcium sulfate, lactose, kaolin, mannitol, sodium chloride, dry starch, (powdered) sugar, dextrose, mannitol, sorbitol, etc. Diluents / fillers can be used alone or in various mixtures and in any amount known in the art for oral compositions.

[0150] As used herein, a "flavorant" is a compound intended to impart a more palatable taste to a composition. Flavorants vary widely in their chemical structure, from simple esters, alcohols, and aldehydes to carbohydrates and complex volatile oils. Synthetic flavorants of almost any desired type are now available and are well known in the art. If the astringency, sourness, or bitterness derived from the raw materials can be suppressed by flavoring or aromatizing, acidulants (such as citric acid, tartaric acid, malic acid, ascorbic acid, etc.), sweeteners (such as sodium saccharin, dipotassium glycyrrhizinate, aspartame, stevia, thaumatin, etc.), or flavor essences (such as various fruit essences containing lemon oil, orange oil, or strawberry, as well as yogurt, mint, menthol, etc.) can be included in the composition. Flavorants can be used alone or in various mixtures and in any amount known in the art for oral compositions.

[0151] As used herein, "lubricant" is a material that performs many functions related to a composition. In certain embodiments, such as in tablet manufacturing, a lubricant performs one or more functions, such as improving the flow rate of tablet granulation, preventing the tablet material from adhering to the surfaces of dies and punches, reducing inter-particle friction, and facilitating the ejection of tablets from the die cavity. Examples of suitable lubricants include, but are not limited to, zinc stearate, gum arabic powder, cocoa butter, carnauba wax, calcium carboxymethyl cellulose, sodium carboxymethyl cellulose, caropeptide, aqueous silica, dried aluminum hydroxide gel, glycerin, magnesium silicate, light anhydrous silicic acid, light liquid paraffin, crystalline cellulose, hardened oil, synthetic aluminum silicate, sesame oil, flour starch, white beeswax, magnesium oxide, dimethylpolysiloxane, sodium potassium tartrate, sucrose fatty acid ester, glycerol fatty acid ester, silicone resin, aluminum hydroxide gel, stearyl alcohol, stearic acid, aluminum stearate, calcium stearate, polyoxylstearate, magnesium stearate, cetyl alcohol, gelatin, talc, magnesium carbonate, precipitated calcium carbonate, corn starch, lactose, stearin, sucrose, potato starch, hydroxypropyl cellulose, fumaric acid, sodium stearyl fumarate, polyethylene glycol, polyoxyethylene polyoxypropylene glycol, polysorbate, beeswax, magnesium aluminometasilicate, methyl cellulose, Japan wax, glycerol monostearate, sodium lauryl sulfate, calcium sulfate, magnesium sulfate, liquid paraffin, phosphoric acid, palmitic acid, and hydrogenated vegetable oils and fats. Lubricants can be used alone or in various mixtures and in any amount known in the art for oral compositions.

[0152] As used herein, "adhesive" is a reagent used to impart cohesiveness to powder materials. Adhesives, or what they are sometimes called "granulating agents", impart cohesiveness to tablet formulations, which ensures that the tablets remain intact after compression and also improves the free-flow properties by formulating particles of the desired hardness and size. Materials commonly used as adhesives include starches such as corn starch and pregelatinized starch; gelatin; sugars such as sucrose, glucose, dextrose, molasses, and lactose; natural and synthetic gums such as gum arabic, sodium alginate, Irishmoss extract, panwar gum, ghattigum, mucilage of isapol husks, carboxymethyl cellulose, methyl cellulose, polyvinylpyrrolidone (PVP), magnesium aluminum silicate (Veegum), microcrystalline cellulose, microcrystalline dextrose, amylose, larch arabinogalactan, ethyl cellulose, cellulose acetate, etc. Adhesives can be used alone or in various mixtures and in any amount known in the art for oral compositions.

[0153] As used herein, "colorant" is a reagent that imparts a more pleasant appearance to the composition, and in addition helps the manufacturer to control the product during its preparation and helps the user to identify the product. Any approved certified water-soluble FD&C dye, its mixture, or its corresponding lake can be used to color the tablets. A lake is obtained by adsorbing a water-soluble dye onto a combination of hydrated oxides of heavy metals, resulting in an insoluble form of the dye. The colorants can be used alone or in various mixtures and in any amount known in the art for oral compositions.

[0154] Other conventional ingredients that may optionally be present in the composition include preservatives, stabilizers, anti-adhesion agents or silica flow regulators or glidants (such as silica). These ingredients can be used alone or in various mixtures and in any amount known in the art for oral compositions.

[0155] It is to be recognized that certain components or additives may be classified under different technical terms, and just because a component or additive is classified under that term does not mean that it is limited to that function. If used, the (one or more) additives may be present in the composition in various amounts. For example, when applicable for topical or oral administration, additional ingredients optionally used in the composition are described in U.S. Patent Nos. 5,747,006; 5,980,904; 6,994,874; 7,060,304; 7,247,321; 7,348,034; 7,364,759; 7,700,110; 7,722,904; 8,202,556; 8,916,212; 9,445,975; 9,801,809; 10,307,366; 10,532,024; and 10,537,516; and U.S. Publications 2006 / 0257509; 2007 / 0224154; 2008 / 0081082; 2008 / 0124409; 2013 / 0302265; 2017 / 0252293; 2017 / 0281666; 2018 / 0200285; 2019 / 0083566; 2019 / 0160117; 2020 / 0171117; 2020 / 0383898; 2021 / 0017240; and 2021 / 0212926; the disclosures of which are hereby incorporated by reference in their entireties.

[0156] In some embodiments, the composition comprises at least one component selected from the following: (a) prebiotics; (b) metabolic absorption regulators; (c) molecular carriers; (d) flavorants; or (e) combinations thereof. As used herein, a "prebiotic" is a reagent of indigestible food components that serves as a nutrient source for beneficial gut bacteria to promote their growth and activity. Probiotics improve gut health and digestion by selectively stimulating the growth of beneficial microorganisms in the digestive system.

[0157] As used herein, a "metabolic absorption regulator" is a reagent that affects the absorption of nutrients, drugs, or other compounds in the body by regulating metabolic processes. These regulators can affect the rate, efficiency, and extent of the absorption of substances into the bloodstream, typically through mechanisms including enzyme regulation, transporter influence, hormonal control, pH alteration, and gut microbiota interaction. As used herein, a "molecular carrier" is a reagent that facilitates the transport, delivery, or controlled release of other molecules, including drugs, nutrients, or biomolecules. Molecular carriers are effective in stabilizing the transported molecules, protecting the transported molecules, or targeting the transported molecules to specific locations. Molecular carriers can include solubilizers and stabilizers.

[0158] In a specific embodiment, the composition comprises resistant starch, L-arabinose, γ-cyclodextrin, and flavorants. (a) The prebiotic can comprise resistant starch, optionally consisting essentially of resistant starch, optionally consisting of resistant starch. (b) The metabolic absorption regulator can comprise L-arabinose, optionally consisting essentially of L-arabinose, optionally consisting of L-arabinose. (c) The molecular carrier can comprise γ-cyclodextrin, optionally consisting essentially of γ-cyclodextrin, optionally consisting of γ-cyclodextrin.

[0159] In certain embodiments, the composition comprises resistant starch; erythritol; stevia; silicon oxide; γ-cyclodextrin; and flavorants.

[0160] Sachet

[0161] The composition can be placed in a sachet. A sachet is a sealed package made of paper, plastic, foil, fabric, or a combination of materials that contains a measured amount of the product, typically in the form of a powder, granule, gel, or liquid. The sachet allows for the convenient transportation and administration of the composition and typically corresponds to a single dose of the composition.

[0162] In some embodiments, the sachet contains 2.5 to 7.5 grams, optionally 4.9 to 5.1 grams, or optionally about 5 grams of the composition. In some embodiments, one sachet corresponds to one daily dose of the composition. In an alternative embodiment, two sachets correspond to one daily dose of the composition.

[0163] Definition

[0164] For a clear and consistent understanding of this specification and the claims, the following definitions are provided.

[0165] The term "composition" or "preparation" refers to a product that treats, improves, promotes, increases, manages, controls, maintains, optimizes, modifies, reduces, inhibits, or prevents a particular condition associated with a natural state, biological process, or disease or disorder. For example, the composition or preparation improves, minimizes, inhibits, or prevents at least one of hyperuricemia, gout, ulcers, cancer, ischemia, and hypertension.

[0166] The terms composition and preparation include, but are not limited to, pharmaceuticals (i.e., drugs), over-the-counter (OTC) drugs, cosmetics, foods, food ingredients, or dietary supplement compositions, which include an effective amount of an extract, at least one of its components, or a mixture thereof. Exemplary compositions and / or preparations include creams, cosmetic lotions, packs, or powders, or as emulsions, lotions, liniment foams, tablets, plasters, granules, or ointments. Typical compositions are formulated for topical administration / application and for oral administration / ingestion.

[0167] As used herein, the terms "effective amount" or "therapeutically effective amount" of a pure compound, composition, extract, extract mixture, component of an extract, and / or active agent or ingredient or combination thereof refer to an amount that is effective within a dose and time period sufficient to achieve the desired result. For example, an "effective amount" or "therapeutically effective amount" refers to an amount of a pure compound, composition, extract, plant extract, extract mixture, plant extract mixture, component of an extract, and / or active agent or ingredient or combination thereof of the present invention that is sufficient to effect treatment, such as improving, minimizing, inhibiting, or preventing at least one of hyperuricemia, gout, ulcers, cancer, ischemia, and hypertension, when administered to a subject (e.g., a mammal, such as a human). The amount of the composition, extract, plant extract, extract mixture, plant extract mixture, component of an extract, and / or active agent or ingredient of the present disclosure that constitutes an "effective amount" or "therapeutically effective treatment" will vary depending on the active agent or compound, the condition being treated and its severity, the mode of administration, the duration of treatment, or the age of the subject being treated, but can be determined by one of ordinary skill in the art in accordance with their own knowledge and in a conventional manner based on the present disclosure.

[0168] The term "pharmaceutically acceptable" refers to those drugs, agents, extracts, or inert ingredients that are suitable for use in contact with the tissues of humans and lower animals without undue toxicity, incompatibility, instability, irritation, etc., and that are commensurate with a reasonable benefit / risk ratio.

[0169] The terms "administering" and "administration" are defined as providing a composition to a subject by a route known in the art, including but not limited to topical, intravenous, intra-arterial, oral, parenteral, buccal, transdermal, rectal, intramuscular, subcutaneous, intraosseous, transmucosal or intraperitoneal administration routes. In a preferred embodiment, the topical and / or oral administration routes of the composition are suitable.

[0170] The terms "minimize", "reduce", "prevent", "lower" and / or "inhibit" mean a decrease or reduction in serum uric acid levels in the presence of a botanical (or plant) ingredient or plant extract as described herein, compared to the serum uric acid levels in the absence of the botanical (or plant) ingredient or plant extract as described herein (e.g., in a control sample), by increasing uric acid excretion, reducing inflammatory factors, inhibiting xanthine oxidase and / or its downstream effects. The extent of the decrease in serum uric acid levels by increasing uric acid excretion, reducing inflammatory factors, inhibiting xanthine oxidase and / or its downstream effects will vary with the nature and amount of the botanical ingredient or plant extract present, but will be visibly apparent, for example, as a detectable decrease in serum uric acid levels; the degree of decrease is desirably greater than about 5%, about 10%, about 15%, about 20%, about 25%, about 50%, about 75%, about 90%, about 95% or about 99% (or any degree of decrease within the range of about 5% to about 99%) compared to the serum uric acid levels in the absence of the botanical ingredient or plant extract. For example, the composition can minimize or lower serum uric acid levels.

[0171] As used herein, the terms "subject" or "individual" include mammals to which a composition can be administered. Non-limiting examples of mammals include humans, non-human primates, rodents (including transgenic and non-transgenic mice), and the like. In some embodiments, the subject is a mammal, and in some embodiments, the subject is a human.

[0172] Use

[0173] The use of the composition is further disclosed. Specifically, the composition or sachet can be used to lower uric acid, enhance uric acid excretion and / or reduce inflammatory factors in a subject (generally, all three). In some embodiments, the composition or sachet is used as an agent for treating hyperuricemia. In certain embodiments, the composition or sachet can be used to inhibit xanthine oxidase.

[0174] Method

[0175] Further disclosed is a method for reducing uric acid, enhancing uric acid excretion and / or reducing inflammatory factors (generally, all three) in a subject. The method comprises administering an effective amount of the composition or sachet to the subject. In some embodiments, the composition is administered orally to the subject. In certain embodiments, the composition is administered topically to the subject. In some embodiments, the method further inhibits xanthine oxidase.

[0176] The composition can be administered or dosed daily, several times a day, or according to any suitable regimen as needed to achieve the desired effect. In the methods of the present disclosure, the frequency of administration (e.g., oral ingestion) can depend on several factors, including the desired uric acid level, uric acid excretion, and inflammatory factor level. In some embodiments, the composition inhibits xanthine oxidase. Generally, the regimen includes ingesting the composition one or two times a day, including administration in the morning and / or in the evening. The dosage and / or frequency of administration of the composition can depend on several factors, including the level of the desired outcome and the specific composition.

[0177] Improved XO inhibition, uric acid reduction, increased uric acid excretion, and inflammatory factor reduction can be achieved by administering the formulations of the present invention externally, internally, or some combination thereof. Generally, the formulations of the present invention are administered with an acceptable carrier. For example, the formulations of the present invention can be administered externally in the form of a gel, lotion, cream, tonic, emulsion, etc. with an acceptable carrier. As a further example, the formulations of the present invention can be administered internally in the form of a pill, tablet, powder, bar, beverage, etc. with an acceptable carrier. Thus, the formulations described herein can be used in a wide variety of finished products, including pharmaceutical, food, and beverage compositions. Generally, the product can be used to provide XO inhibition to a mammal.

[0178] When the formulations of the present invention are administered orally in liquid form, the liquid can be water-based, milk-based, tea-based, juice-based, or some combination thereof. Solid and liquid formulations for internal administration according to the present invention can further comprise thickeners, including xanthan gum, carboxymethyl cellulose, carboxyethyl cellulose, hydroxypropyl cellulose, methyl cellulose, microcrystalline cellulose, starch, dextrin, fermented whey, tofu, maltodextrin, polyols, including sugar alcohols (e.g., sorbitol and mannitol), carbohydrates (e.g., lactose), propylene glycol alginate, gellan gum, guar gum, pectin, tragacanth gum, acacia gum, locust bean gum, gum arabic, gelatin, and mixtures of these thickeners. These thickeners are generally included in the formulations of the present invention at a content of up to about 0.1%, depending on the specific thickener involved and the desired viscosity effect.

[0179] The solid and liquid (food and beverage) preparations of the present invention may contain, and will generally contain, an effective amount of one or more sweeteners, including carbohydrate sweeteners and natural and / or artificial non / low-calorie sweeteners. The amount of sweetener used in the preparations of the present invention varies, but generally depends on the type of sweetener used and the desired intensity of sweetness.

[0180] In another example, the preparations of the present invention are topically applied in the following forms: solutions, gels, lotions, creams, ointments, oil-in-water emulsions, water-in-oil emulsions, sticks, sprays, pastes, mousses, tonics, foundations or other cosmetic and topically suitable forms.

[0181] Generally, the preparations of the present invention suitable for topical application are mixed with an acceptable carrier. The acceptable carrier can variously act as a solvent, carrier, diluent or dispersant for the components of the composition and allows the components to be uniformly applied to the skin surface at an appropriate dilution. The acceptable carrier can also facilitate the penetration of the composition into the skin.

[0182] In one example of the preparation for topical application, the acceptable carrier constitutes from about 70% to about 99.99% by weight of the total composition. In other examples, the acceptable carrier will constitute from about 85% to 99.99% by weight of the total composition. The acceptable carrier can also constitute from about 90% to about 99.99% of the total composition; or from about 99.95% to about 99.999% of the total composition. The acceptable carrier can constitute the balance of the composition in the absence of other cosmetic adjuvants or additives.

[0183] The various components used to practice the present invention may or may not be soluble in the acceptable carrier. If all the components of the preparation are soluble in the acceptable carrier, then the vehicle acts as a solvent. However, if all or some of the components of the preparation are insoluble in the acceptable carrier, then these components are dispersed in the vehicle, for example, by means of suspensions, emulsions, gels, creams or pastes.

[0184] Thus, it will be obvious to those skilled in the art that the range of possible acceptable carriers is very wide. For example, the acceptable carrier can be an emulsion, lotion, cream or tonic. The acceptable carrier can contain water, ethanol, butylene glycol or other various solvents that contribute to skin penetration. Some examples of suitable vehicles are described in U.S. Patent Nos. 6,184,247 and 6,579,516, the entire contents of which are incorporated herein by reference.

[0185] In certain embodiments, acceptable carriers for practicing the present invention comprise water and ethanol. Optionally, the acceptable carrier further contains butylene glycol. For example, the acceptable carrier may comprise 2-5% by weight of butylene glycol based on the weight of the composition. In the practice of the present invention, such an acceptable carrier may be mixed with 2% by weight of the preparation of the present invention that constitutes the total composition. In other examples, the acceptable carrier is mixed with 0.001% to 30% by weight, 1% to 5% by weight, 0.01% to 15% by weight, or 0.5% to 1.0% by weight of the total composition of the preparation of the present invention.

[0186] However, in general, acceptable carriers according to the present invention may include, but are not limited to, any of the following examples: water; castor oil; ethylene glycol monobutyl ether; diethylene glycol monoethyl ether; corn oil; dimethyl sulfoxide; ethylene glycol; isopropyl alcohol; soybean oil; glycerin; soluble collagen; safflower oil; meadowfoam seed oil; mineral oil; squalene; shea butter; borage oil; or rice bran oil; polyquaternium-10; methylparaben; PEG-8; sodium lauroamphodiacetate; sodium laureth sulfate; hexylene glycol; sodium methyl cocoyl taurate; triethanolamine lauryl sulfate; lauryl betaine; sodium myristoyl sarcosinate; PEG-150 distearate; anhydrous citric acid; sodium citrate dihydrate; diazolidinyl urea; disodium EDTA; propylparaben; polysorbate 60; isopropyl palmitate; octyl palmitate; C12-15 alkyl benzoate; dipropylene glycol dibenzoate; PPG-15 stearyl ether benzoate; isododecane; isoeicosane; squalane; jojoba oil; polydimethylsiloxane; glyceryl stearate; PEG-100 stearate; cetyl alcohol; butylene glycol; chlorphenesin; fragrance; polyacrylamide; C13-14 isoparaffin; laureth-7; aloe powder; aloe gel, hydroxyethyl acrylate; acryloyldimethyl taurate copolymer; behenyl alcohol; tocopheryl acetate; isodecyl neopentanoate; glyceryl trioctanoate; cetearyl alcohol; cetearyl glucoside; chamomile flower extract; biosaccharide gum-1; pentadecanolide; dipropylene glycol; cyclomethicone; PEG / PPG-18 / 18 dimethicone; cyclopentasiloxane; distearyldimonium hectorite; SD alcohol 40; phenoxyethanol; ethylparaben; trimethylsilyoxysilicate; triethoxysilane; microcrystalline titanium dioxide; titanium dioxide; zinc oxide; iron oxides (yellow; red; black; etc.); octyl silane; sodium chloride; diisopropyl dimer dilinoleate; aluminum hydroxide; stearic acid; polyethylene beads; C12-15 alkyl benzoate; acrylate / C10-30 alkyl acrylate; xanthan gum; sorbitan laurate; panthenol; petrolatum; isopropyl isostearate; polydimethylsiloxane; arginine; phenoxyethanol; acryloyldimethyl taurate copolymer; isocetane; polysorbate 80; hydroxyethyl acrylate; acryloyldimethyl taurate copolymer; octyl methoxycinnamate; oxybenzone; dioctyl ether; isodecyl neopentanoate; cetearyl alcohol; cetearyl glucoside; benzyl alcohol; HDI / trimetylolhexyl lactone crosslinked polymer; silica; isodecyl neopentanoate; cocoyl glucoside; C20-22 alkyl phosphate; C20-22 alcohol; palmitoyl proline; magnesium palmitoyl glutamate;Sodium palmitoyl sarcosinate; C30-45 alkyl cetearyl crosslinked polymer; Polyacrylate-13; Polyisobutene; Polysorbate 20; Iodopropynyl butylcarbamate; Sodium magnesium silicate; Methyl gluceth-20; Dimethyl isosorbide; Silicon dioxide; SD alcohol 40-B; Salicylic acid; Ceteth-20; Fragrance; or Witch hazel.;

[0187] In addition, acceptable carriers for use in the present invention may optionally include one or more humectants, including but not limited to: dibutyl phthalate; soluble collagen; sorbitol; or sodium 2-pyrrolidone-5-carboxylate. Other examples of humectants that can be used to practice the present invention can be found in the CFTA Cosmetic Ingredient Handbook, the relevant portions of which are incorporated herein by reference.

[0188] In addition, acceptable carriers in the present invention may optionally include one or more emollients, including but not limited to: butane-1,3-diol; cetyl palmitate; dimethicone; glyceryl monocastorate; glyceryl monostearate; isobutyl palmitate; isocetyl stearate; isopropyl palmitate; isopropyl stearate; butyl stearate; isopropyl laurate; hexyl laurate; decyl oleate; isopropyl myristate; lauryl lactate; octadecane-2-ol; triglyceride caprylic acid; triglyceride capric acid; polyethylene glycol; propan-1,2-diol; triethylene glycol; sesame oil; coconut oil; safflower oil; isopentyl laurate; nonoxynol-9; panthenol; hydrogenated vegetable oil; tocopheryl acetate; tocopheryl linoleate; allantoin; propylene glycol; peanut oil; castor oil; isostearic acid; palmitic acid; isopropyl linoleate; lauryl lactate; myristyl lactate; decyl oleate; or myristyl myristate. Other examples of emollients that can be used to practice the present invention can be found in the CFTA Cosmetic Ingredient Handbook, the relevant portions of which are incorporated herein by reference.

[0189] In addition, acceptable carriers for use in the present invention may optionally include one or more penetration enhancers, including but not limited to: pyrrolidones, such as 2-pyrrolidone; alcohols, such as ethanol; alkanols, such as decanol; diols, such as propylene glycol, dipropylene glycol, butylene glycol; surfactants; or terpenes.

[0190] Other acceptable carriers that can be used to practice the present invention will be apparent to those skilled in the art and are included within the scope of the present invention.

[0191] For example, an acceptable vehicle can be a topically applied lotion. The lotion can contain Carbomer 981, water, glycerin, isopropyl myristate, mineral oil, shea butter, stearic acid, ethylene glycol stearate, cetyl alcohol, dimethicone, preservatives, TEA, and various components of the preparation of the present invention.

[0192] The preparation of the present invention can also contain various known and conventional cosmetic adjuvants, provided that they do not detrimentally affect the desired improvement provided by the preparation. For example, the preparation of the present invention can further include one or more additives or other optional ingredients well-known in the art, which can include but are not limited to fillers (such as solids, semi-solids, liquids, etc.); vehicles; diluents; thickeners; gelling agents; vitamins, retinoids, and retinol (such as vitamin B3, vitamin A, etc.); pigments; fragrances; chemical sunscreens and physical sunblocks; antioxidants and free radical scavengers; organic hydroxy acids; exfoliants; skin conditioners; moisturizers; ceramides, ceramide-like substances, phospholipids, sphingolipids, cholesterol, glucosamine, pharmaceutically acceptable penetrants (such as decyl methyl sulfoxide, lecithin organogel, tyrosine, lysine, etc.); preservatives; antimicrobial agents; amino acids such as proline, pyrrolidone carboxylic acid and its derivatives and salts, saccharide isomerate, panthenol, buffers with bases (such as triethanolamine or sodium hydroxide); waxes such as beeswax, ozokerite, paraffin wax; plant extracts such as aloe vera, cornflower, witch hazel, elderflower, or cucumber, and combinations thereof. Other suitable additives and / or adjuvants are described in U.S. Patent No. 6,184,247, the entire content of which is incorporated herein by reference.

[0193] The preparation can include additional inactive ingredients, including but not limited to surfactants, co-solvents, and excipients. Surfactants, such as hydrophilic and hydrophobic surfactants, can be included in the preparation. Specific surfactants can be used based on the overall composition of the preparation and the intended delivery of the preparation. Available surfactants include polyethoxylated (PEG) fatty acids, PEG-fatty acid diesters, PEG-fatty acid monoester and diester mixtures, polyethylene glycol glycerol fatty acid esters, alcohol-oil transesterification products, polyglycerolated fatty acids, propylene glycol fatty acid esters, mixtures of propylene glycol esters-glycerol esters, glycerol monoesters and glycerol diesters, sterols and sterol derivatives, polyethylene glycol sorbitan fatty acid esters, polyethylene glycol alkyl ethers, polysaccharide esters, polyethylene glycol alkyl phenols, polyoxyethylene-polyoxypropylene block copolymers, sorbitan fatty acid esters, lower alcohol fatty acid esters, ionic surfactants, and mixtures thereof.

[0194] The preparation may also include cosolvents such as alcohols and polyols, polyethylene glycol ethers, amides, esters, other suitable cosolvents, and mixtures thereof. The preparation may also include excipients or additives such as sweeteners, edible flavors, colorants, antioxidants, preservatives, chelating agents, viscosity regulators, tonicifiers, odorants, emulsifying agents, suspending agents, binders, and mixtures thereof.

[0195] Generally, the preparation of the present invention is administered topically or orally at least once a day for a period of time sufficient to bring about the desired level of improvement in uric acid levels. The topical administration or oral administration of the preparation of the present invention may continue for any suitable period of time. More specifically, within a few hours to a few days after the initial administration or ingestion, the user may notice improvement in the symptoms of hyperuricemia, gout, ulcers, cancer, ischemia, or hypertension. It should be recognized that the frequency of administration or ingestion of the preparation of the present invention will vary depending on the desired level of improvement. In particular, the degree of symptom relief will vary directly with the total amount of the composition used.

[0196] Useful dosage forms can be prepared by methods and techniques well understood by those skilled in the art and may include the use of additional ingredients in the production of tablets, capsules, or liquid dosage forms.

[0197] Examples

[0198] The Apium graveolens seed water extract was prepared by performing a water extraction of Apium graveolens seeds. The Cichorium intybus water extract was prepared by performing a water extraction of Cichorium intybus. The Nelumbo nucifera leaf water extract was prepared by performing a water extraction of Nelumbo nucifera leaves. The Potentilla acaulis water extract was prepared by performing a water extraction of Potentilla acaulis. The Prunus cerasus water extract was prepared by performing a water extraction of Prunus cerasus.

[0199] Approximately 2 grams of the Apium graveolens seed water extract, approximately 1.5 grams of the Cichorium intybus water extract, approximately 0.9 grams of the Nelumbo nucifera leaf water extract, approximately 0.3 grams of the Potentilla acaulis water extract, 0.2 grams of the Prunus cerasus water extract, trace amounts of resistant starch, trace amounts of L - arabinose, trace amounts of γ - cyclodextrin, and trace amounts of edible flavor were combined to obtain a polyherbal composition. The Apium graveolens seed water extract, Cichorium intybus water extract, Nelumbo nucifera leaf water extract, Potentilla acaulis water extract, and Prunus cerasus water extract are all present in the polyherbal composition at a weight ratio of 100:75:45:18:10, respectively. The polyherbal composition was finely blended with a particle size of <134 μm.

[0200] Evaluate the efficacy of the compound herbal composition in reducing uric acid. Compared with the placebo, low-dose (1 sachet / day) and high-dose (2 sachets / day) interventions for 12 weeks showed significant effects in reducing uric acid levels, improving uric acid excretion, and reducing inflammatory cytokines.

[0201] Measure uric acid levels during the 12-week intervention. As Figure 1 shown, when compared with the placebo, for both low-dose and high-dose treatment regimens, uric acid levels continued to decline. Compared with the placebo, the P-value measured for the high-dose regimen at week 4 was P < 0.0001, and the P-values measured between the placebo and the high-dose regimen and between the placebo and the low-dose regimen at week 12 were P < 0.0001. The P-value measured between the low-dose and high-dose regimens at the two measurements at week 4 and week 12 was P < 0.0001.

[0202] Measure the fractional excretion of uric acid (FEUA) during the 12-week intervention. As Figure 2 shown, the high-dose treatment regimen generally showed higher uric acid excretion, while the low-dose treatment regimen showed higher uric acid excretion than the placebo but less than the high-dose treatment regimen. Higher uric acid excretion was observed at week 12 than at week 4. The P-value measured between the high-dose treatment regimen and the placebo at week 4 was P < 0.01. The P-values measured between the low-dose treatment regimen and both the high-dose treatment regimen and the placebo at week 12 were P < 0.0001.

[0203] Measure the change in tumor necrosis factor α (TNF-α) levels during the 12-week intervention. As Figure 3 shown, the high-dose and low-dose treatment regimens were generally associated with a decrease in tumor necrosis factor levels during the 12-week intervention. The P-value measured between the high-dose treatment regimens at week 4 and week 12 was P < 0.01.

[0204] The disclosure of CN115300550A is hereby incorporated by reference in its entirety. Generally, the examples of CN115300550A are incorporated herein as comparative examples. It will be recognized that, compared with the comparative examples, when administered to subjects during a 12-week clinical study, this example showed excellent reduction in uric acid levels, uric acid excretion, and reduction of tumor necrosis factor α.

[0205] The terms “comprising” are used in their broadest sense herein to encompass the concepts of “including,” “consisting essentially of,” and “consisting of.” The use of “for example,” “such as,” and “including” to list illustrative examples is not limited to the examples listed. Thus, “for example” or “such as” means “for example but not limited to” or “such as but not limited to” and encompasses other similar or equivalent examples. The term “about” as used herein is intended to reasonably encompass or describe minor variations in values measured by instrumental analysis or caused by sample handling. Such minor variations can be about ±0 - 10, ±0 - 5, or ±0 - 2.5% of the value. In addition, when associated with a numerical range, the term “about” applies to both values. Further, even if not explicitly stated, the term “about” may apply to a numerical value.

[0206] Generally, as used herein, the hyphen “-” or en dash “–” in a numerical range is “to” or “through”; “>” is “above” or “greater than”; “≥” is “at least” or “greater than or equal to”; “<” is “below” or “less than”; and “≤” is “at most” or “less than or equal to.” On an individual basis, each of the above patent applications, patents, and / or patent application publications is hereby expressly incorporated by reference in its entirety in one or more non-limiting embodiments.

[0207] It is to be understood that the appended claims are not limited to the specific and particular compounds, compositions, or methods described in the detailed description, and they may vary between specific embodiments that fall within the scope of the appended claims. With respect to any Markush group of specific features or aspects relied upon herein to describe various embodiments, it is recognized that different, special, and / or unexpected results can be obtained by each member of the Markush group independently of all other Markush members. The members of the Markush group can be relied upon individually and / or in combination and provide adequate support for specific embodiments within the scope of the appended claims.

[0208] It is also to be understood that any range and sub - ranges used to describe various embodiments of the present invention independently and collectively fall within the scope of the appended claims, and are understood to describe and contemplate all ranges including integral and / or fractional values therein, even if such values are not explicitly written herein. Those skilled in the art will readily recognize that the recited ranges and sub - ranges are sufficient to describe and implement various embodiments of the present invention, and such ranges and sub - ranges can be further delineated into related 1 / 2, 1 / 3, 1 / 4, 1 / 5 and the like. By way of example only, the range of "0.1 to 0.9" can be further delineated into the lower 1 / 3, i.e., 0.1 to 0.3, the middle 1 / 3, i.e., 0.4 to 0.6, and the upper 1 / 3, i.e., 0.7 to 0.9, which independently and collectively fall within the scope of the appended claims and can independently and / or collectively provide sufficient support for specific embodiments within the scope of the appended claims. Further, with respect to words that define or modify a range, such as "at least", "greater than", "less than", "not greater than", etc., it is to be understood that such words include sub - ranges and / or upper or lower limits. As another example, the range of "at least 10" inherently includes sub - ranges of at least 10 to 35, at least 10 to 25, 25 to 35, and the like, and can independently and / or collectively rely on each sub - range and provide sufficient support for specific embodiments within the scope of the appended claims. Finally, the independent numerical values within the disclosed range can be relied upon and provide sufficient support for specific embodiments within the scope of the appended claims. For example, the range of "1 to 9" includes various independent integers such as 3, and independent numerical values (or fractions) with a decimal point, such as 4.1, which can be relied upon to provide sufficient support for specific embodiments within the scope of the appended claims.

[0209] The present invention has been described in an exemplary manner, and it is to be understood that the terms used are descriptive rather than restrictive. Many modifications and variations of the present invention are possible in light of the above teachings. The invention may be practiced differently from the specific description within the scope of the appended claims. All combinations of the subject matter of the independent and dependent claims (including single and multiple dependent claims) are explicitly contemplated herein.

Claims

1. A composition for administration to a subject, the composition comprising: 100 parts by weight of Apium graveolens extract; 65 to 85 parts by weight of Cichorium intybus extract; 30 to 60 parts by weight of Nelumbo nucifera extract; 10 to 25 parts by weight of Potentilla acaulis L. extract; and 5 to 20 parts by weight of Prunus cerasus extract.

2. The composition according to claim 1, wherein the Apium graveolens extract comprises an extract of Apium graveolens seeds, or optionally is an extract of Apium graveolens seeds.

3. The composition according to claim 1 or claim 2, wherein the Nelumbo nucifera extract comprises an extract of Nelumbo nucifera leaves, or optionally is an extract of Nelumbo nucifera leaves.

4. The composition according to any one of claims 1 to 3, wherein: the Cichorium intybus extract is present in an amount of 70 to 80 parts by weight; the Nelumbo nucifera extract is present in an amount of 40 to 50 parts by weight; the Potentilla acaulis L. extract is present in an amount of 15 to 20 parts by weight; and the Prunus cerasus extract is present in an amount of 5 to 15 parts by weight.

5. The composition according to claim 4, wherein: the Cichorium intybus extract is present in an amount of 72.5 to 77.5 parts by weight; the Nelumbo nucifera extract is present in an amount of 42.5 to 47.5 parts by weight; the Potentilla acaulis L. extract is present in an amount of 17 to 19 parts by weight; and the Prunus cerasus extract is present in an amount of 7.5 to 12.5 parts by weight.

6. The composition according to claim 5, wherein: the Cichorium intybus extract is present in an amount of approximately 75 parts by weight; the Nelumbo nucifera extract is present in an amount of approximately 45 parts by weight; the Potentilla acaulis L. extract is present in an amount of approximately 18 parts by weight; and the Prunus cerasus extract is present in an amount of approximately 10 parts by weight.

7. The composition according to any one of claims 1 to 6, wherein the composition further comprises at least one component selected from the following: (a) prebiotic; (b) metabolic absorption regulator; (c) molecular carrier; (d) edible flavor; or (e) a combination thereof.

8. The composition according to any one of claims 1 to 7, wherein the composition comprises: resistant starch; erythritol; stevia; silicon oxide; γ-cyclodextrin; and edible flavor.

9. The composition according to any one of claims 1 to 8, wherein the composition has an average particle size of less than 140 μm.

10. A composition for administration to a subject, the composition comprising: (i) an extract set in an amount of 40 to 99.9% by weight, which comprises: 5 to 25% by weight of Apium graveolens extract; 10 to 25% by weight of Cichorium intybus extract; 3 to 35% by weight of Nelumbo nucifera extract; 1 to 10% by weight of Potentilla acaulis L. extract; and 1 to 20% by weight of Prunus cerasus extract; each based on 100% of the total weight of the extract set; and (ii) an additive set in an amount of 0.1 to 60% by weight; each based on 100% of the total weight of the composition.

Images