Herbal supplements and methods of use and manufacture thereof

Abstract

The present application provides an herbal supplement and a method for relieving symptoms of gastroesophageal reflux disease (GERD). The herbal supplement includes two or more herbal ingredients selected from the group consisting of atractylodes lancea extract, dandelion root extract, noni extract, hesperidin extract, and lignum extract.

Description

[0001] Related Applications This application claims priority to U.S. Provisional Patent Application No. 63 / 593,045, filed October 25, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This application generally relates to expansionary supplements, and more specifically, to herbal supplements for relieving symptoms of gastroesophageal reflux disease (GERD). Background Technology

[0003] Gastroesophageal reflux disease (GERD) is a common problem treated by physicians. It is estimated that up to 20% of Americans experience symptomatic GERD weekly, and the proportion experiencing heartburn monthly is even higher. Although GERD is a common clinical diagnosis, its pathogenesis is quite complex. The main pathophysiological mechanism of GERD is the reflux of gastric contents, including gastric acid, leading to esophageal mucosal damage, or (even without damage) acid irritation of the esophageal mucosa. However, the pathophysiological features are multifactorial, including factors related to the stomach, the gastroesophageal junction (EGJ), the nervous system, and the esophagus itself. Evidence suggests that LES abnormalities, such as transient LES relaxation (TLESR), decreased LES pressure, delayed gastric emptying, poor esophageal clearance, and impaired esophageal mucosal defense, can all be contributing factors.

[0004] Currently, FDA-approved medications for gastroesophageal reflux disease (GERD) are a class of drugs called proton pump inhibitors (PPIs). These drugs have been linked to certain conditions, such as dementia, osteoporosis, stroke, myocardial infarction, and nutritional deficiencies. There is a pressing need for natural therapies designed to help alleviate GERD symptoms, potentially helping to prevent chronic consequences such as esophageal cancer, without the side effects of pharmacologically selected treatments. Summary of the Invention

[0005] One aspect of this application relates to an herbal supplement comprising two or more herbal ingredients selected from the group consisting of Atractylodes lancea extract, dandelion root extract, noni extract, hesperidin, and aralia extract, wherein the supplement is formulated as an oral preparation to relieve symptoms of gastroesophageal reflux disease.

[0006] Another aspect of this application relates to a method for relieving symptoms of gastroesophageal reflux disease in human patients. The method includes the step of orally administering an effective amount of the herbal supplement of this application to a human patient in need.

[0007] Another aspect of this application relates to a method for preparing the herbal supplement of this application. The method includes: the step of mixing herbal ingredients to form a mixture; and the step of formulating the mixture into unit doses suitable for oral administration. Detailed Implementation

[0008] Although this disclosure will now be described in detail with reference to exemplary embodiments, it is not limited to the specific embodiments shown in the accompanying drawings and numbered paragraphs.

[0009] I. Definition Various terms related to the herbal supplements of this application have been used in the foregoing sections of this document and throughout the specification and claims.

[0010] Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains. All publications and patents specifically mentioned herein are incorporated herein by reference in their entirety for all purposes, including descriptions and disclosures of chemicals, instruments, statistical analyses, and methods reported in such publications that may be used in conjunction with this application. All references cited in this specification should be considered as indications of the level of expertise in the art. Nothing herein should be construed as an admission that this application is not eligible to retroactively claim prior invention rights to such disclosures prior to the date of such publication.

[0011] It should be noted that, as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural references unless the context clearly indicates otherwise. Furthermore, the terms “a” (or “an”), “one or more,” and “at least one” are used interchangeably herein. It should also be noted that the terms “comprising,” “including,” “characterized by,” and “having” are used interchangeably.

[0012] Any percentages mentioned herein shall be considered as weight (w / w) unless otherwise expressly stated to the contrary (e.g., molar ratio, weight-to-volume ratio (w / v), etc.).

[0013] As used herein, the term "herbal composition" refers to any phytochemical substance or mixture thereof obtained, isolated and / or derived from one or more plant materials or plant extracts.

[0014] The term "plant material" refers to any plant material, including but not limited to leaves, bark, stems, flowers, fruits, seeds, roots, and combinations thereof.

[0015] The terms "herbal extract" and "plant extract" are used interchangeably when referring to compositions derived from plants. Herbal extracts can be in the form of dry powder, solution, or oil (such as essential oil). Herbal extracts can contain mixtures of components derived from the original plant material. Herbal extracts can also be in a partially purified form rich in one or more components of the original plant.

[0016] As used herein, the term "extractant ratio" refers to the weight ratio between the raw material and the final extract. A higher extraction ratio indicates a more concentrated extract. For example, an extract with a 10:1 extraction ratio means that 10 parts of raw material are used to prepare 1 part of extract.

[0017] As used herein, the term “substantially free” when used to describe the absence of hydrolyzable tannins in a wood extract means that the component is present as an impurity in the wood extract in trace amounts of less than 1% (w / w) or 0.1% (w / w).

[0018] As used in this article, the terms “treatment” or “management” for GERD are synonymous with relieving GERD symptoms.

[0019] For example, in the list of "nutritionally and health-wise acceptable carriers," the term "nutritionally and health-wise acceptable" refers to carriers that are biologically or otherwise acceptable. Undesirable materials are those that can be added to herbal compositions administered to patients without causing any undesirable biological effects or interacting in a harmful manner with any other component of the composition containing them.

[0020] "Effective dose" refers to a non-toxic but sufficient amount of a composition or plant material to provide the desired systemic or local effect. Effective doses will vary depending on the nature of the composition and its components, the age and physical condition of the end-user, the severity of GERD, the duration of treatment, the nature of concomitant treatments, and the specific nutritionally acceptable carrier used. As used herein, all percentages are by weight unless otherwise expressly stated.

[0021] As used herein, the transitional term “comprising” is synonymous with “including,” “containing,” or “characterized by,” all of which are inclusive or open-ended and do not exclude additional unreferenced elements or method steps, whether used in the preamble or body of a claim. This term further includes the terms “consisting of” and “substantially consisting of.” In the claims and / or description, “comprising” may mean “one,” but is also synonymous with “one or more,” “at least one,” and “one or more.”

[0022] II. Composition One aspect of this application relates to an herbal supplement comprising two or more herbal ingredients selected from the group consisting of Atractylodes lancea extract, dandelion root extract, noni extract, hesperidin extract, and aralia extract, wherein the supplement is formulated for oral administration to relieve symptoms of gastroesophageal reflux disease.

[0023] Atractylodes extract Atractylodes lancea is a flowering plant in the Asteraceae family. In some embodiments, Atractylodes lancea extract is extracted from the rhizomes (roots) of certain varieties of Atractylodes lancea (such as Atractylodes macrocephala, Atractylodes lancea var. chinensis, and Atractylodes macrocephala). In some embodiments, Atractylodes lancea extract is prepared from the rhizomes (roots) of Atractylodes macrocephala, Atractylodes lancea var. chinensis, or Atractylodes macrocephala.

[0024] In some embodiments, the Atractylodes lancea extract may contain at least 0.1%, 0.2%, 0.5%, 1%, 2%, 5%, 10%, 15%, 20% (w / w) or more of atractylodesin. In some embodiments, the Atractylodes lancea extract contains 0.1-20%, 0.1-15%, 0.1-10%, 0.1-5%, 0.1-2%, 0.1-1%, 0.1-0.5%, 0.2-20%, 0.2-15%, 0.2-10%, 0.2-5%, 0.2-2%, 0.2-1%, 0.2-0.5%, 0.5-20%, 0.5-15%, 0.5-10%, 0.5-5%, 0.5-2%, 0.5-1%, 1-20%, 1-15%, 1-10%, 1-5%, 1-2%, 2-20%, 2-15%, 2-10%, 2-5%, 5-20%, 5-15%, 5-10%, 10-20%, 10-15%, or 15-20% (w / w) of atractylodes lancea extract. In some embodiments, the Atractylodes lancea extract is in powder form. In some embodiments, the Atractylodes lancea extract has an extraction ratio of 1:1, 2:1, 3:1, 4:1, 5:1, 6:1, 7:1, 8:1, 9:1, 10:1, 15:1, or 20:1. In some embodiments, the Atractylodes lancea extract is a white Atractylodes macrocephala extract with an extraction ratio of 10:1. In some embodiments, the Atractylodes lancea extract is a citronella Atractylodes lancea extract with an extraction ratio of 1:1.

[0025] In some embodiments, the Atractylodes lancea extract is administered at doses of 10-2500 mg, 10-2000 mg, 10-1500 mg, 10-1250 mg, 10-1000 mg, 10-750 mg, 10-500 mg, 10-250 mg, 10-100 mg, 50-2500 mg, 50-2000 mg, 50-1500 mg, 50-1250 mg, 50-1000 mg, 50-750 mg, 50-500 mg, and 50-250 mg per unit. The herbal supplement of this application is present in amounts ranging from 100 to 2500 mg, 100 to 2000 mg, 100 to 1500 mg, 100 to 1250 mg, 100 to 1000 mg, 100 to 750 mg, 100 to 500 mg, 100 to 250 mg, 250 to 2500 mg, 250 to 2000 mg, 250 to 1500 mg, 250 to 1250 mg, 250 to 1000 mg, 250 to 750 mg, or 250 to 500 mg. In some embodiments, the Atractylodes lancea extract is an Atractylodes macrocephala extract with an extraction ratio of 10:1 and is present in the herbal supplement of this application at an amount of 225 mg per unit dose. In some embodiments, the Atractylodes lancea extract is an Atractylodes lancea extract with an extraction ratio of 1:1 and is present in the herbal supplement of this application at an amount of 250 mg per unit dose.

[0026] Dandelion root extract Dandelion is a common name for certain varieties of the genus Taraxacum, a large genus of flowering plants in the Asteraceae family. Dandelion root extract is prepared from the roots of dandelion plants, including but not limited to European dandelion (common dandelion) and red-seeded dandelion.

[0027] In some embodiments, the dandelion root extract comprises at least 1%, 2%, 5%, 10%, 15%, 20%, 25%, or 30% (w / w) or more of taraxasterol. In some embodiments, the dandelion root extract comprises 1-30%, 1-25%, 1-20%, 1-15%, 1-10%, 1-5%, 1-2%, 2-30%, 2-25%, 2-20%, 2-15%, 2-10%, 2-5%, 5-30%, 5-25%, 5-20%, 5-15%, 5-10%, 10-30%, 10-25%, 10-20%, 10-15%, 15-30%, 15-25%, 15-20%, 20-30%, 20-25%, or 25-30% (w / w) of taraxasterol. In some embodiments, the dandelion root extract is in powder form. In some embodiments, the dandelion root extract has an extraction ratio of 1:1, 2:1, 3:1, 4:1, 5:1, 6:1, 7:1, 8:1, 9:1, 10:1, 15:1, or 20:1. In some embodiments, the dandelion root extract has an extraction ratio of 10:1. In some embodiments, the dandelion root extract has an extraction ratio of 5:1.

[0028] In some embodiments, dandelion root extract is administered at unit doses of 50-7500 mg, 50-6000 mg, 50-4500 mg, 50-3000 mg, 50-2000 mg, 50-1000 mg, 50-500 mg, 50-250 mg, 50-150 mg, 100-7500 mg, 100-6000 mg, 100-4500 mg, 100-3000 mg, 100-2000 mg, 100-1000 mg, 100-500 mg, 100-250 mg, 100-150 mg, 150-7500 mg, 150-6000 mg, 150-4500 mg, 150-3000 mg, 150-2 Amounts ranging from 0.00 mg, 150-1000 mg, 150-500 mg, 500-7500 mg, 500-6000 mg, 500-4500 mg, 500-3000 mg, 500-2000 mg, 500-1000 mg, 1000-7500 mg, 1000-6000 mg, 1000-4500 mg, 1000-3000 mg, 1000-2000 mg, 2000-7500 mg, 2000-6000 mg, 2000-4500 mg, 2000-3000 mg, 3000-7500 mg, 3000-6000 mg, or 3000-4500 mg are present in the herbal supplements of this application. In some embodiments, the dandelion root extract has an extraction ratio of 10:1 and is present in the herbal supplement of this application at a dose of 125 mg per unit dose. In some embodiments, the dandelion root extract has an extraction ratio of 5:1 and is present in the herbal supplement of this application at a dose of 1575 mg per unit dose.

[0029] Noni extract Noni, or seashore morinda, is a small evergreen tree found in Pacific islands, Southeast Asia, Australia, and India. In some embodiments, the noni extract is prepared from the noni fruit. In some embodiments, the noni extract is in powder form. In some embodiments, the noni extract has an extraction ratio of 1:1, 2:1, 3:1, 4:1, 5:1, 6:1, 7:1, 8:1, 9:1, 10:1, 15:1, or 20:1. In some embodiments, the noni extract has an extraction ratio of 4:1. In some embodiments, the noni extract has an extraction ratio of 5:1.

[0030] In some embodiments, the noni extract is present in the herbal supplement of this application in amounts ranging from 50 to 5000 mg, 50 to 3000 mg, 50 to 1000 mg, 50 to 500 mg, 50 to 150 mg, 150 to 5000 mg, 150 to 3000 mg, 150 to 1000 mg, 150 to 500 mg, 500 to 5000 mg, 500 to 3000 mg, 500 to 1000 mg, 1500 to 5000 mg, 1500 to 3000 mg, or 3000 to 5000 mg per unit dose. In some embodiments, the noni extract has an extraction ratio of 5:1 and is present in the herbal supplement of this application in an amount of 200 mg per unit dose. In some embodiments, the noni extract has an extraction ratio of 4:1 and is present in the herbal supplement of this application in an amount of 500 mg per unit dose.

[0031] Hesperidin extract Hesperidin belongs to the flavanone subclass of flavonoids and is primarily found in citrus fruits such as oranges, grapefruits, lemons, and tangerines. In some embodiments, the purity of the hesperidin extract, as determined by HPLC, is 80%, 85%, 90%, or 95%, or a purity greater than these values. As used herein, the term "XX% HPLC purity" refers to a purity of XX% as determined by HPLC analysis. In some embodiments, the hesperidin extract is present in the herbal supplements of this application in amounts ranging from 10 to 1000 mg, 10 to 300 mg, 10 to 100 mg, 10 to 30 mg, 30 to 1000 mg, 30 to 300 mg, 30 to 100 mg, 100 to 1000 mg, 100 to 300 mg, or 300 to 1000 mg per unit dose. In some embodiments, the hesperidin extract is a sour orange fruit extract with 90% purity as determined by HPLC, and is present in the herbal supplement of this application at a dose of 50 mg per unit dose. In some embodiments, the hesperidin extract is present in the herbal supplement of this application at a dose of 100 mg per unit dose.

[0032] hardwood extract Hardwood extracts can be derived from any hardwood tree, including but not limited to Lorenz hardwood ( Schinopsis lorentzii ), Balansajianmu ( Schinopsis balansae ), Brazilian hardwood ( Schinopsis brasiliensis ), Hankwood ( Schinopsis haenkeana ), miscellaneous hardwood ( Schinopsis heterophylla ) and edged-leaved hardwood ( Schinopsis marginata ).

[0033] In some embodiments, the hardwood extract is prepared from the heartwood of the red hardwood tree. In some embodiments, the hardwood extract is substantially free of hydrolyzable tannins. In some embodiments, the hardwood extract is in powder form. In some embodiments, the hardwood extract is in powder form and has a condensed tannin content of at least 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, or 90% (w / w). In some embodiments, the hardwood extract is substantially free of hydrolyzable tannins and has a condensed tannin content of at least 50%, at least 60%, or at least 70%. In some embodiments, the hardwood extract is substantially free of hydrolyzable tannins and has a condensed tannin content of about 73%. In some embodiments, the hardwood extract has an extraction ratio of 1:1, 2:1, 3:1, 4:1, 5:1, 6:1, 7:1, 8:1, 9:1, 10:1, 15:1, or 20:1.

[0034] In some embodiments, the *Pterocarya stenoptera* extract is administered at doses of 25-2500 mg, 25-2000 mg, 25-1500 mg, 25-1250 mg, 25-1000 mg, 25-750 mg, 25-500 mg, 25-250 mg, 25-100 mg, 50-2500 mg, 50-2000 mg, 50-1500 mg, 50-1250 mg, 50-1000 mg, 50-750 mg, 50-500 mg, 50-250 mg, 100-2500 mg, 100-2000 mg, 100-1500 mg, and 100-1250 mg per unit dose. The herbal supplements of this application are present in amounts ranging from g, 100-1000 mg, 100-750 mg, 100-500 mg, 100-250 mg, 250-2500 mg, 250-2000 mg, 250-1500 mg, 250-1250 mg, 250-1000 mg, 250-750 mg, 250-500 mg, 500-2500 mg, 500-2000 mg, 500-1500 mg, 500-1250 mg, 500-750 mg, 1000-2500 mg, 1000-2000 mg, or 1000-1500 mg. In some embodiments, the *Cinnamomum camphora* extract is present in the herbal supplements of this application at a dose of 250 mg per unit dose.

[0035] weight ratio of components In some embodiments, the herbal supplement comprises noni extract and hesperidin in a weight ratio ranging from 40:1 to 2:5, 10:1 to 1:2, 5:1 to 1:1, or 5:1 to 3:1. In some embodiments, the herbal supplement comprises noni extract (5:1 extraction ratio) and hesperidin (90% HPLC) in a weight ratio of 5:1.

[0036] In some embodiments, the herbal supplement comprises noni extract and atractylodes extract in a weight ratio ranging from 10:1 to 1:10, 5:1 to 1:5, 4:1 to 1:4, 3:1 to 1:3, or 2:1 to 1:2. In some embodiments, the herbal supplement comprises noni extract (5:1 extraction ratio) and atractylodes extract (10:1 extraction ratio) in a weight ratio of 8:9.

[0037] In some embodiments, the herbal supplement comprises noni extract and dandelion root extract in a weight ratio ranging from 16:1 to 4:25, 4:1 to 1:5, or 2:1 to 1:2. In some embodiments, the herbal supplement comprises noni extract (5:1 extraction ratio) and dandelion root extract (10:1 extraction ratio) in a weight ratio of approximately 8:5.

[0038] In some embodiments, the herbal supplement comprises hesperidin and Atractylodes lancea extract in a weight ratio ranging from 20:9 to 1:45, 10:9 to 1:25, 5:9 to 1:10, or 1:3 to 1:9. In some embodiments, the herbal supplement comprises hesperidin (90% HPLC) and Atractylodes lancea extract (10:1 extraction ratio) in a weight ratio of 2:9.

[0039] In some embodiments, the herbal supplement comprises hesperidin and dandelion root extract in a weight ratio ranging from 4:1 to 1:25, 2:1 to 1:10, or 1:1 to 1:5. In some embodiments, the herbal supplement comprises hesperidin (90% HPLC) and dandelion root extract (10:1 extraction ratio) in a weight ratio of 2:5.

[0040] In some embodiments, the herbal supplement comprises Atractylodes lancea extract and dandelion root extract in a weight ratio ranging from 18:1 to 9:50, 9:1 to 9:25, or 3:1 to 9:10. In some embodiments, the herbal supplement comprises Atractylodes lancea extract (10:1 extraction ratio) and dandelion root extract (10:1 extraction ratio) in a weight ratio of 9:5.

[0041] In some embodiments, the herbal supplement comprises an extract of *Cinnamomum camphora* and an extract of *Atractylodes lancea* in a weight ratio ranging from 10:1 to 1:10, 5:1 to 1:5, 4:1 to 1:4, 3:1 to 1:3, or 2:1 to 1:2. In some embodiments, the herbal supplement comprises an extract of *Cinnamomum camphora* and an extract of *Atractylodes lancea* in a weight ratio of approximately 1:1.

[0042] In some embodiments, the herbal supplement comprises a red pine extract and a dandelion root extract in a weight ratio ranging from 5:3 to 1:60, 5:6 to 1:30, 1:2 to 1:15, or 1:3 to 1:10. In some embodiments, the herbal supplement comprises a red pine extract and a dandelion root extract in a weight ratio of approximately 1:6.

[0043] In some embodiments, the herbal supplement comprises red ebony extract and noni extract in a weight ratio ranging from 5:1 to 1:20, 5:2 to 1:10, 2:1 to 1:5, or 1:1 to 1:3. In some embodiments, the herbal supplement comprises red ebony extract and noni extract in a weight ratio of approximately 1:2.

[0044] In some embodiments, the herbal supplement comprises a pine extract and a hesperidin extract in a weight ratio ranging from 25:1 to 1:4, 10:1 to 1:2, 5:1 to 1:1, or 5:1 to 5:3.

[0045] In some implementations, the herbal supplement comprises a pine extract and a hesperidin extract in a weight ratio of approximately 5:2.

[0046] In some embodiments, the herbal supplement comprises extracts of *Cinnamomum camphora*, *Atractylodes lancea*, and *Taraxacum mongolicum* root, in a weight ratio in the range of 1:1:6.

[0047] In some embodiments, the herbal supplement comprises extracts of scleroderma, Atractylodes lancea, and Noni in a weight ratio of 1:1:2.

[0048] In some embodiments, the herbal supplement comprises extracts of *Atractylodes lancea*, *Atractylodes lancea*, and hesperidin in a weight ratio of 5:5:2.

[0049] In some embodiments, the herbal supplement comprises extracts of hardwood, dandelion root, and noni in a weight ratio of 1:6:2.

[0050] In some embodiments, the herbal supplement comprises a hardwood extract, a dandelion root extract, and a hesperidin extract in a weight ratio of 5:30:2.

[0051] In some embodiments, the herbal supplement comprises a pine extract, a noni extract, and a hesperidin extract in a weight ratio of 5:10:2.

[0052] In some embodiments, the herbal supplement comprises Atractylodes lancea extract, dandelion root extract, and noni extract in a weight ratio in the range of 1:6:2. In some embodiments, the herbal supplement comprises Atractylodes lancea extract (10:1 extraction ratio), dandelion root extract (10:1 extraction ratio), and noni extract (5:1 extraction ratio) in a weight ratio in the range of 9:5:8.

[0053] In some embodiments, the herbal supplement comprises Atractylodes lancea extract, dandelion root extract, and hesperidin extract in a weight ratio in the range of 5:30:2. In some embodiments, the herbal supplement comprises Atractylodes lancea extract (10:1 extraction ratio), dandelion root extract (10:1 extraction ratio), and hesperidin extract (90% HPLC) in a weight ratio in the range of 9:5:2.

[0054] In some embodiments, the herbal supplement comprises dandelion root extract, noni extract, and hesperidin extract in a weight ratio in the range of 15:5:1. In some embodiments, the herbal supplement comprises dandelion root extract (10:1 extraction ratio), noni extract (5:1 extraction ratio), and hesperidin extract (90% HPLC) in a weight ratio in the range of 5:8:2.

[0055] In some embodiments, the herbal supplement comprises red pine extract, atractylodes extract, dandelion root extract and noni extract in a weight ratio in the range of 1:1:6:2.

[0056] In some embodiments, the herbal supplement comprises red pine extract, atractylodes extract, dandelion root extract and hesperidin extract in a weight ratio of 5:5:30:2.

[0057] In some embodiments, the herbal supplement comprises red pine extract, atractylodes extract, noni extract and hesperidin extract in a weight ratio of 5:5:10:2.

[0058] In some embodiments, the herbal supplement comprises red pine extract, dandelion root extract, noni extract, and hesperidin extract in a weight ratio of 5:30:10:2.

[0059] In some embodiments, the herbal supplement comprises Atractylodes lancea extract, dandelion root extract, Noni extract, and hesperidin extract in a weight ratio of 5:30:10:2.

[0060] In some embodiments, the herbal supplement comprises Atractylodes lancea extract (10:1 extraction ratio), Taraxacum mongolicum root extract (10:1 extraction ratio), Noni extract (5:1 extraction ratio), and hesperidin extract (90% HPLC) in a weight ratio in the range of 9:5:8:2.

[0061] In some embodiments, the herbal supplement comprises red pine extract, atractylodes extract, dandelion root extract, noni extract, and hesperidin extract in a weight ratio of 5:5:30:10:2.

[0062] In some embodiments, the herbal supplement comprises 1-25 parts by weight of *Rhizoma Chamaecyparis* extract, 1-25 parts by weight of *Rhizoma Atractylodis* extract, and 6-150 parts by weight of *Radix Taraxaci* root extract. In some embodiments, the herbal supplement comprises 2-15 parts by weight of *Rhizoma Chamaecyparis* extract, 2-15 parts by weight of *Rhizoma Atractylodis* extract, and 10-90 parts by weight of *Radix Taraxaci* root extract. In some embodiments, the herbal supplement comprises 4-10 parts by weight of *Rhizoma Chamaecyparis* extract, 4-10 parts by weight of *Rhizoma Atractylodis* extract, and 20-60 parts by weight of *Radix Taraxaci* root extract. As used herein, the term "part by weight" refers to a unit of weight relative to the weight of another component in the same composition. For example, a herbal composition comprising 1 gram of *Rhizoma Chamaecyparis* extract, 1 gram of *Rhizoma Atractylodis* extract, and 6 grams of *Radix Taraxaci* root extract may be described as having 1 part by weight of *Rhizoma Chamaecyparis* extract, 1 part by weight of *Rhizoma Atractylodis* extract, and 6 parts by weight of *Radix Taraxaci* root extract.

[0063] In some embodiments, the herbal supplement comprises 1-25 parts by weight of red ebony extract, 1-25 parts by weight of Atractylodes lancea extract, and 2-50 parts by weight of noni extract. In some embodiments, the herbal supplement comprises 2-15 parts by weight of red ebony extract, 2-15 parts by weight of Atractylodes lancea extract, and 4-30 parts by weight of noni extract. In some embodiments, the herbal supplement comprises 4-10 parts by weight of red ebony extract, 4-10 parts by weight of Atractylodes lancea extract, and 8-20 parts by weight of noni extract.

[0064] In some embodiments, the herbal supplement comprises 1-25 parts by weight of *Rhizoma Chamaecyparis* extract, 1-25 parts by weight of *Rhizoma Atractylodis* extract, and 0.4-10 parts by weight of hesperidin extract. In some embodiments, the herbal supplement comprises 2-15 parts by weight of *Rhizoma Chamaecyparis* extract, 2-15 parts by weight of *Rhizoma Atractylodis* extract, and 0.8-6 parts by weight of hesperidin extract. In some embodiments, the herbal supplement comprises 4-10 parts by weight of *Rhizoma Chamaecyparis* extract, 4-10 parts by weight of *Rhizoma Atractylodis* extract, and 1.6-4 parts by weight of hesperidin extract.

[0065] In some embodiments, the herbal supplement comprises 1-25 parts by weight of red ebony extract, 6-150 parts by weight of dandelion root extract, and 2-50 parts by weight of noni extract. In some embodiments, the herbal supplement comprises 2-15 parts by weight of red ebony extract, 12-90 parts by weight of dandelion root extract, and 4-30 parts by weight of noni extract. In some embodiments, the herbal supplement comprises 4-10 parts by weight of red ebony extract, 24-60 parts by weight of dandelion root extract, and 8-20 parts by weight of noni extract.

[0066] In some embodiments, the herbal supplement comprises 1-25 parts by weight of red pine extract, 6-150 parts by weight of dandelion root extract, and 0.4-10 parts by weight of hesperidin extract. In some embodiments, the herbal supplement comprises 2-15 parts by weight of red pine extract, 12-90 parts by weight of dandelion root extract, and 0.8-6 parts by weight of hesperidin extract. In some embodiments, the herbal supplement comprises 4-10 parts by weight of red pine extract, 24-60 parts by weight of dandelion root extract, and 1.6-4 parts by weight of hesperidin extract.

[0067] In some embodiments, the herbal supplement comprises 1-25 parts by weight of red ebony extract, 2-50 parts by weight of noni extract, and 0.4-10 parts by weight of hesperidin extract. In some embodiments, the herbal supplement comprises 2-15 parts by weight of red ebony extract, 4-30 parts by weight of noni extract, and 0.8-6 parts by weight of hesperidin extract. In some embodiments, the herbal supplement comprises 4-10 parts by weight of red ebony extract, 8-20 parts by weight of noni extract, and 1.6-4 parts by weight of hesperidin extract.

[0068] In some embodiments, the herbal supplement comprises 1-25 parts by weight of Atractylodes lancea extract, 6-150 parts by weight of Taraxacum mongolicum root extract, and 2-50 parts by weight of Noni extract. In some embodiments, the herbal supplement comprises 2-15 parts by weight of Atractylodes lancea extract, 12-90 parts by weight of Taraxacum mongolicum root extract, and 4-30 parts by weight of Noni extract. In some embodiments, the herbal supplement comprises 4-10 parts by weight of Atractylodes lancea extract, 24-60 parts by weight of Taraxacum mongolicum root extract, and 8-20 parts by weight of Noni extract.

[0069] In some embodiments, the herbal supplement comprises 1-25 parts by weight of Atractylodes lancea extract, 6-150 parts by weight of Taraxacum mongolicum root extract, and 0.4-10 parts by weight of hesperidin extract. In some embodiments, the herbal supplement comprises 2-15 parts by weight of Atractylodes lancea extract, 12-90 parts by weight of Taraxacum mongolicum root extract, and 0.8-6 parts by weight of hesperidin extract. In some embodiments, the herbal supplement comprises 4-10 parts by weight of Atractylodes lancea extract, 24-60 parts by weight of Taraxacum mongolicum root extract, and 1.6-4 parts by weight of hesperidin extract.

[0070] In some embodiments, the herbal supplement comprises 6-150 parts by weight of dandelion root extract, 2-50 parts by weight of noni extract, and 0.4-10 parts by weight of hesperidin extract. In some embodiments, the herbal supplement comprises 12-90 parts by weight of dandelion root extract, 4-30 parts by weight of noni extract, and 0.8-6 parts by weight of hesperidin extract. In some embodiments, the herbal supplement comprises 24-60 parts by weight of dandelion root extract, 8-20 parts by weight of noni extract, and 1.6-4 parts by weight of hesperidin extract.

[0071] In some embodiments, the herbal supplement comprises 1-25 parts by weight of red ebony extract, 1-25 parts by weight of Atractylodes lancea extract, 6-150 parts by weight of dandelion root extract, and 2-50 parts by weight of noni extract. In some embodiments, the herbal supplement comprises 2-15 parts by weight of red ebony extract, 2-15 parts by weight of Atractylodes lancea extract, 10-90 parts by weight of dandelion root extract, and 4-30 parts by weight of noni extract. In some embodiments, the herbal supplement comprises 4-10 parts by weight of red ebony extract, 4-10 parts by weight of Atractylodes lancea extract, 20-60 parts by weight of dandelion root extract, and 8-20 parts by weight of noni extract.

[0072] In some embodiments, the herbal supplement comprises red pine extract, atractylodes extract, dandelion root extract and hesperidin extract in a weight ratio of 5:5:30:2.

[0073] In some embodiments, the herbal supplement comprises 1-25 parts by weight of *Rhizoma Chamaecyparis* extract, 1-25 parts by weight of *Rhizoma Atractylodis* extract, 6-150 parts by weight of *Radix Taraxaci* root extract, and 0.4-10 parts by weight of hesperidin extract. In some embodiments, the herbal supplement comprises 2-15 parts by weight of *Rhizoma Chamaecyparis* extract, 2-15 parts by weight of *Rhizoma Atractylodis* extract, 10-90 parts by weight of *Radix Taraxaci* root extract, and 0.8-6 parts by weight of hesperidin extract. In some embodiments, the herbal supplement comprises 4-10 parts by weight of *Rhizoma Chamaecyparis* extract, 4-10 parts by weight of *Rhizoma Atractylodis* extract, 20-60 parts by weight of *Radix Taraxaci* root extract, and 1.6-4 parts by weight of hesperidin extract.

[0074] In some embodiments, the herbal supplement comprises 1-25 parts by weight of red ebony extract, 1-25 parts by weight of Atractylodes lancea extract, 2-50 parts by weight of noni extract, and 0.4-10 parts by weight of hesperidin extract. In some embodiments, the herbal supplement comprises 2-15 parts by weight of red ebony extract, 2-15 parts by weight of Atractylodes lancea extract, 4-30 parts by weight of noni extract, and 0.8-6 parts by weight of hesperidin extract. In some embodiments, the herbal supplement comprises 4-10 parts by weight of red ebony extract, 4-10 parts by weight of Atractylodes lancea extract, 8-20 parts by weight of noni extract, and 1.6-4 parts by weight of hesperidin extract.

[0075] In some embodiments, the herbal supplement comprises 1-25 parts by weight of red ebony extract, 6-150 parts by weight of dandelion root extract, 2-50 parts by weight of noni extract, and 0.4-10 parts by weight of hesperidin extract. In some embodiments, the herbal supplement comprises 2-15 parts by weight of red ebony extract, 12-90 parts by weight of dandelion root extract, 4-30 parts by weight of noni extract, and 0.8-6 parts by weight of hesperidin extract. In some embodiments, the herbal supplement comprises 4-10 parts by weight of red ebony extract, 24-60 parts by weight of dandelion root extract, 8-20 parts by weight of noni extract, and 1.6-4 parts by weight of hesperidin extract.

[0076] In some embodiments, the herbal supplement comprises Atractylodes lancea extract, dandelion root extract, Noni extract, and hesperidin extract in a weight ratio of 5:30:10:2.

[0077] In some embodiments, the herbal supplement comprises 1-25 parts by weight of Atractylodes lancea extract, 6-150 parts by weight of Taraxacum mongolicum root extract, 2-50 parts by weight of Noni extract, and 0.4-10 parts by weight of hesperidin extract. In some embodiments, the herbal supplement comprises 2-15 parts by weight of Atractylodes lancea extract, 12-90 parts by weight of Taraxacum mongolicum root extract, 4-30 parts by weight of Noni extract, and 0.8-6 parts by weight of hesperidin extract. In some embodiments, the herbal supplement comprises 4-10 parts by weight of Atractylodes lancea extract, 24-60 parts by weight of Taraxacum mongolicum root extract, 8-20 parts by weight of Noni extract, and 1.6-4 parts by weight of hesperidin extract.

[0078] In some embodiments, the herbal supplement comprises 1-25 parts by weight of red ebony extract, 1-25 parts by weight of Atractylodes lancea extract, 6-150 parts by weight of dandelion root extract, 2-50 parts by weight of noni extract, and 0.4-10 parts by weight of hesperidin extract. In some embodiments, the herbal supplement comprises 2-15 parts by weight of red ebony extract, 2-15 parts by weight of Atractylodes lancea extract, 12-90 parts by weight of dandelion root extract, 4-30 parts by weight of noni extract, and 0.8-6 parts by weight of hesperidin extract. In some embodiments, the herbal supplement comprises 4-10 parts by weight of red ebony extract, 4-10 parts by weight of Atractylodes lancea extract, 24-60 parts by weight of dandelion root extract, 8-20 parts by weight of noni extract, and 1.6-4 parts by weight of hesperidin extract.

[0079] In some embodiments, the herbal supplement comprises 0.9-90 parts by weight of Atractylodes lancea extract, 0.5-50 parts by weight of Taraxacum mongolicum root extract, 0.8-80 parts by weight of Noni extract, and 0.2-20 parts by weight of hesperidin extract. In some embodiments, the herbal supplement comprises 3-30 parts by weight of Atractylodes lancea extract, 2-20 parts by weight of Taraxacum mongolicum root extract, 4-20 parts by weight of Noni extract, and 0.2-20 parts by weight of hesperidin extract. In some embodiments, the herbal supplement comprises 3-15 parts by weight of Atractylodes lancea extract, 3-8 parts by weight of Taraxacum mongolicum root extract, 4-12 parts by weight of Noni extract, and 1-3 parts by weight of hesperidin extract. In some embodiments, the Atractylodes lancea extract has a 10:1 extraction ratio, the Taraxacum mongolicum root extract has a 10:1 extraction ratio, the Noni extract has a 5:1 extraction ratio, and the hesperidin extract has 90% HPLC purity.

[0080] In some embodiments, the herbal supplement comprises 0.9-90 parts by weight of Atractylodes lancea extract, 0.5-50 parts by weight of Taraxacum mongolicum root extract, and 0.8-80 parts by weight of Noni extract. In some embodiments, the herbal supplement comprises 3-30 parts by weight of Atractylodes lancea extract, 2-20 parts by weight of Taraxacum mongolicum root extract, and 4-20 parts by weight of Noni extract. In some embodiments, the herbal supplement comprises 3-15 parts by weight of Atractylodes lancea extract, 3-8 parts by weight of Taraxacum mongolicum root extract, and 4-12 parts by weight of Noni extract. In some embodiments, the Atractylodes lancea extract has a 10:1 extraction ratio, the Taraxacum mongolicum root extract has a 10:1 extraction ratio, and the Noni extract has a 5:1 extraction ratio.

[0081] In some embodiments, the herbal supplement comprises 0.9-90 parts by weight of Atractylodes lancea extract, 0.5-50 parts by weight of Taraxacum mongolicum root extract, and 0.2-20 parts by weight of hesperidin extract. In some embodiments, the herbal supplement comprises 3-30 parts by weight of Atractylodes lancea extract, 2-20 parts by weight of Taraxacum mongolicum root extract, and 0.2-20 parts by weight of hesperidin extract. In some embodiments, the herbal supplement comprises 3-15 parts by weight of Atractylodes lancea extract, 3-8 parts by weight of Taraxacum mongolicum root extract, and 1-3 parts by weight of hesperidin extract. In some embodiments, the Atractylodes lancea extract has a 10:1 extraction ratio, the Taraxacum mongolicum root extract has a 10:1 extraction ratio, and the hesperidin extract has 90% HPLC purity.

[0082] In some embodiments, the herbal supplement comprises 0.9-90 parts by weight of Atractylodes lancea extract, 0.8-80 parts by weight of Noni extract, and 0.2-20 parts by weight of hesperidin extract. In some embodiments, the herbal supplement comprises 3-30 parts by weight of Atractylodes lancea extract, 4-20 parts by weight of Noni extract, and 0.2-20 parts by weight of hesperidin extract. In some embodiments, the herbal supplement comprises 3-15 parts by weight of Atractylodes lancea extract, 4-12 parts by weight of Noni extract, and 1-3 parts by weight of hesperidin extract. In some embodiments, the Atractylodes lancea extract has a 10:1 extraction ratio, the Noni extract has a 5:1 extraction ratio, and the hesperidin extract has 90% HPLC purity.

[0083] In some embodiments, the herbal supplement comprises 0.5-50 parts by weight of dandelion root extract, 0.8-80 parts by weight of noni extract, and 0.2-20 parts by weight of hesperidin extract. In some embodiments, the herbal supplement comprises 2-20 parts by weight of dandelion root extract, 4-20 parts by weight of noni extract, and 0.2-20 parts by weight of hesperidin extract. In some embodiments, the herbal supplement comprises 3-8 parts by weight of dandelion root extract, 4-12 parts by weight of noni extract, and 1-3 parts by weight of hesperidin extract. In some embodiments, the dandelion root extract has a 10:1 extraction ratio, the noni extract has a 5:1 extraction ratio, and the hesperidin extract has 90% HPLC purity.

[0084] In some embodiments, the herbal supplement comprises 0.9 to 90 parts by weight of Atractylodes lancea extract and 0.5 to 50 parts by weight of Taraxacum mongolicum root extract. In some embodiments, the herbal supplement comprises 3 to 30 parts by weight of Atractylodes lancea extract and 2 to 20 parts by weight of Taraxacum mongolicum root extract. In some embodiments, the herbal supplement comprises 3 to 15 parts by weight of Atractylodes lancea extract and 3 to 8 parts by weight of Taraxacum mongolicum root extract. In some embodiments, the Atractylodes lancea extract has a 10:1 extraction ratio, and the Taraxacum mongolicum root extract has a 10:1 extraction ratio.

[0085] In some embodiments, the herbal supplement comprises 0.9 to 90 parts by weight of Atractylodes lancea extract and 0.8 to 80 parts by weight of Noni extract. In some embodiments, the herbal supplement comprises 3 to 30 parts by weight of Atractylodes lancea extract and 4 to 20 parts by weight of Noni extract. In some embodiments, the herbal supplement comprises 3 to 15 parts by weight of Atractylodes lancea extract and 4 to 12 parts by weight of Noni extract. In some embodiments, the Atractylodes lancea extract has an extraction ratio of 10:1, and the Noni extract has an extraction ratio of 5:1.

[0086] In some embodiments, the herbal supplement comprises 0.9 to 90 parts by weight of Atractylodes lancea extract and 0.2 to 20 parts by weight of hesperidin extract. In some embodiments, the herbal supplement comprises 3 to 30 parts by weight of Atractylodes lancea extract and 0.2 to 20 parts by weight of hesperidin extract. In some embodiments, the herbal supplement comprises 3 to 15 parts by weight of Atractylodes lancea extract and 1 to 3 parts by weight of hesperidin extract. In some embodiments, the Atractylodes lancea extract has a 10:1 extraction ratio, and the hesperidin extract has 90% HPLC purity.

[0087] In some embodiments, the herbal supplement comprises 0.5 to 50 parts by weight of dandelion root extract and 0.8 to 80 parts by weight of noni extract. In some embodiments, the herbal supplement comprises 2 to 20 parts by weight of dandelion root extract and 4 to 20 parts by weight of noni extract. In some embodiments, the herbal supplement comprises 3 to 8 parts by weight of dandelion root extract and 4 to 12 parts by weight of noni extract. In some embodiments, the dandelion root extract has a 10:1 extraction ratio, and the noni extract has a 5:1 extraction ratio.

[0088] In some embodiments, the herbal supplement comprises 0.5 to 50 parts by weight of dandelion root extract and 0.2 to 20 parts by weight of hesperidin extract. In some embodiments, the herbal supplement comprises 2 to 20 parts by weight of dandelion root extract and 0.2 to 20 parts by weight of hesperidin extract. In some embodiments, the herbal supplement comprises 3 to 15 parts by weight, 3 to 8 parts by weight of dandelion root extract, and 1 to 3 parts by weight of hesperidin extract. In some embodiments, the dandelion root extract has a 10:1 extraction ratio, and the hesperidin extract has 90% HPLC purity.

[0089] In some embodiments, the herbal supplement comprises 0.8 to 80 parts by weight of noni extract and 0.2 to 20 parts by weight of hesperidin extract. In some embodiments, the herbal supplement comprises 4 to 20 parts by weight of noni extract and 0.2 to 20 parts by weight of hesperidin extract. In some embodiments, the herbal supplement comprises 4 to 12 parts by weight of noni extract and 1 to 3 parts by weight of hesperidin extract. In some embodiments, the noni extract has a 5:1 extraction ratio, and the hesperidin extract has 90% HPLC purity.

[0090] Additional ingredients In some embodiments, the herbal supplement of this application further comprises additional ingredients selected from the group consisting of: Satsuma mandarin orange peel extract, ginseng extract, jujube extract, glycyrrhizic acid glycyrrhizinate (DGL), and carob (…). Ceratonia siliqua Extract.

[0091] In some embodiments, the herbal supplements of this application further comprise a nutritionally acceptable carrier.

[0092] III. Preparation Method The herbal supplement of this application is prepared by mixing suitable plant extracts and ingredients to form a mixture, and then formulating the mixture into a suitable dosage form. In some embodiments, the herbal supplement is in tablet or capsule form.

[0093] The extracts used in this application can be prepared from plant tissues / parts that can be extracted using water, polar solvents, or petroleum solvents used to treat irritable bowel syndrome. The extracts can be prepared using extraction processing procedures well known in the art, such as organic solvents like lower alcohols, alkyl esters, alkyl ethers, alkyl ketones, chloroform, petroleum ether, hexane, and / or inorganic solvents like water. Furthermore, the extracts can be prepared using cold extraction techniques employing a variety of different extraction solvents, including but not limited to water, fatty solvents (e.g., olive oil), and alcoholic solvents (e.g., 70% ethanol). Cold extraction techniques can be applied to softer plant parts (e.g., leaves and flowers) or when the desired plant active ingredient is heat-labile.

[0094] Alternatively, the aforementioned solvents can be used to prepare extracts of the desired plant using thermal extraction techniques, wherein the solvent is heated to a high temperature, the exact value of which depends on the properties of the selected solvent, and is maintained at that temperature throughout the extraction process. Thermal extraction techniques are more commonly used for the harder, tougher parts of plants, such as bark, tree branches, and larger roots.

[0095] In some cases, continuous extraction can be carried out in more than one solvent and at different temperatures.

[0096] Standard operating procedures for preparing plant extracts (including hot extraction, cold extraction, and other techniques) are well known in the art. Supplements preferably contain one or more plant extracts prepared in powder form.

[0097] In some embodiments, the supplement may comprise herbal extracts in the form of essential oils. As used herein, the term "essential oil" refers to an oil obtained from herbs or other plants by steam distillation or cold pressing. Essential oils may be mixed with vegetable oils or water and, according to this disclosure, may be taken orally for use.

[0098] In some cases, leaves from a particular plant species can be steam-distilled to prepare essential oils derived from that plant species. The name of an essential oil prepared from a specific tree species can be used interchangeably with the name of the plant species, as well as the name of an essential oil prepared from the leaves and other components of that plant species. The same applies to extracts derived from a given plant species.

[0099] Herbal supplements can be provided in any nutritionally acceptable form. Herbal supplements are preferably formulated for oral administration, such as, but not limited to, powders, crystals, granules, microparticles (including micrometer-sized particles, such as microspheres and microcapsules), microparticles (including millimeter-sized particles), beads, microbeads, clumps, pills, microtablets, compressed tablets or lozenges, molded tablets or lozenges, and capsules, which may be hard or soft and contain the composition in the form of powder, granules, beads, solution, or suspension.

[0100] Herbal supplements can also be formulated for oral administration as solutions or suspensions in aqueous liquids, liquids added to capsules, or any other convenient formulations for administration, or as suppositories, enemas, or other convenient forms for rectal administration. Additionally, the compositions of this application can also be provided as controlled-release systems.

[0101] Herbal supplements may further comprise any nutritionally acceptable excipients, carriers, or mixtures thereof. As used herein, the term "nutritionally acceptable excipient or carrier" refers to a non-toxic, inert solid, semi-solid, diluent, encapsulating material, or any type of formulation excipient. Exemplary excipients include, but are not limited to, diluents or fillers such as dextrose, dicalcium phosphate, calcium sulfate, lactose, cellulose, kaolin, mannitol, sodium chloride, dry starch, sorbitol, sucrose, inositol, powdered sugar, bentonite, microcrystalline cellulose, or hydroxypropyl methylcellulose may be added to inhibitor molecules to increase the volume of the composition. Binders can also be added to supplements, such as, but not limited to, starch, gelatin, sucrose, glucose, D-glucose, molasses, lactose, gum arabic, sodium alginate, carrageenan extract, panvoi gum, solanum gum, psyllium husk mucus, carboxymethyl cellulose, methyl cellulose, polyvinylpyrrolidone, magnesium aluminum silicate, starch-arabinogalactan, polyethylene glycol, ethyl cellulose, and waxes to enhance their cohesive quality. Additionally, lubricants can be added to supplements, such as, but not limited to, talc, magnesium stearate, calcium stearate, stearic acid, hydrogenated vegetable oil, polyethylene glycol, sodium benzoate, sodium acetate, sodium chloride, leucine, carbowax, sodium lauryl sulfate, and magnesium lauryl sulfate. Flow aids can also be added, such as, but not limited to, colloidal silica or talc, to improve the flow properties of powdered supplements. Finally, disintegrants may also be added to facilitate the disintegration of the supplement in the intestine, such as, but not limited to, starch, clay, cellulose, alginate, gum, cross-linked polymers (e.g., cross-linked carboxymethyl cellulose, cross-linked polyvinylpyrrolidone, and sodium carboxymethyl starch), magnesium aluminum silicate, methyl cellulose, agar, bentonite, cellulose and wood products, natural sponges, cation exchange resins, alginate, guar gum, citrus pomace, carboxymethyl cellulose, or sodium dodecyl sulfate containing starch.

[0102] In some embodiments, one or more components of the supplement may be formulated to protect the component from degradation due to the acidic conditions present in the stomach and from interaction with proteins (such as pepsin) present in the stomach. Such formulations may include pH-dependent enteric coatings to prevent release until the stomach is empty. Thus, in some embodiments, one or more components or the entire supplement is enteric-coated. However, in other embodiments, no component of the supplement is enteric-coated.

[0103] Enteric-coated components or supplements can be formulated as enteric-coated tablets, beads, or granules, which may optionally contain a lubricant, such as, but not limited to, magnesium stearate. The enteric coating may contain one or more pH-dependent polymers. The pH-dependent polymers are intact at pH values ​​less than about 4.0 and soluble at pH values ​​greater than 40, preferably greater than 50, and most preferably about 6.0. Exemplary pH-dependent polymers include, but are not limited to, methacrylic acid copolymers, methacrylic acid-methyl methacrylate copolymers (e.g., EUDRAGIT® L100 (Type A), EUDRAGIT® S100 (Type B), Rohm GmbH, Germany); methacrylic acid-ethyl acrylate copolymers (e.g., EUDRAGIT® L100-55 (Type C) and EUDRAGIT® L30D-55 copolymer dispersions, Rohm GmbH, Germany), methacrylic acid-methyl methacrylate and methyl methacrylate copolymers (EUDRAGIT® FS), trimers of methacrylic acid, methacrylate and ethyl acrylate, hydroxypropyl methylcellulose phthalate (HPMCP) (e.g., HP-55, HP-50, HP-55S, ShinEtsu Chemical, Japan), and polyvinyl acetate phthalate (PVAP) (e.g., COATERIC®, OPADRY®). Enteric-coated white (OY-P-7171)); polyvinyl butyral acetate; cellulose acetate succinate (CAS); hydroxypropyl methyl cellulose acetate succinate (HPMCAS), such as HPMCAS LF, MF, and HF grades, including AQOAT® LF and AQOAT® MF (ShinEtsu Chemical, Japan); shellac (e.g., MARCOAT™ 125 & MARCOAT™ 125N); vinyl acetate-maleic anhydride copolymer; styrene-maleic acid monoester copolymer; carboxymethyl ethyl cellulose (CMEC, Freund Corporation, Japan); cellulose acetate phthalate (CAP) (e.g., AQUATERIC®); cellulose acetate trimellitate (CAT); and mixtures of two or more of these in a weight ratio of about 2:1 to about 5:1, such as EUDRAGIT® in a weight ratio of about 3:1 to about 2:1. A mixture of L100-55 and EUDRAGIT® S100, or a mixture of EUDRAGIT® L30 D-55 and EUDRAGIT® FS in a weight ratio of about 3:1 to about 5:1.

[0104] pH-dependent polymers may be added in amounts ranging from about 10% to 90%, preferably from about 20% to 80%, and most preferably from about 30% to 70% by weight of the dosage unit or supplement. The polymers may be added to the formulation before or after granulation, or they may be added to the supplement as a dry material, or they may be dispersed or dissolved in a suitable solvent and dispersed during granulation.

[0105] Enteric-coated components or supplements may include enteric-coated beads in capsules, enteric-coated microspheres in capsules, enteric-coated microspheres provided in suspension or mixed with food (which is particularly convenient for pediatric administration), and enteric-coated compressed tablets. Capsules may be hard-shell gelatin capsules or cellulose capsules. In particular, the component or herbal supplement may be formulated as enteric-coated capsules.

[0106] In some embodiments, the component and / or supplement may be directly compressed into tablets or other herbal supplements with or without any excipients, exhibiting nutritionally acceptable hardness and brittleness. Directly compressible herbal supplements are preferably compressed into tablets with a hardness greater than 4 kp (kilogram-force), preferably 8 to 14 kp, and more preferably 10 to 13 kp. Directly compressible components may be compressed into tablets with a brittleness loss of no more than 1% by weight, preferably less than 0.8% by weight, and more preferably less than 0.5% by weight.

[0107] IV. Method of Use (Treatment Method) Another aspect of this application relates to a method for preventing, treating, or alleviating GERD symptoms. The method includes the step of administering an effective amount of the herbal supplement of this application to a patient in urgent need of such treatment. In some embodiments, the patient is a human patient. In some embodiments, the patient has one or more GERD symptoms. In some embodiments, the patient has been diagnosed with GRED. In some embodiments, the patient has been treated with proton pump inhibitors (e.g., omeprazole, lansoprazole, pantoprazole, rabeprazole, esomeprazole, and dexlansoprazole) and / or H2 blockers (e.g., Pepcid® and Zantac®). In some embodiments, the patient has GERD-associated esophagitis.

[0108] GERD symptoms are well known in the field. Typical GERD symptoms include, but are not limited to, heartburn (also known as stomach upset), upper abdominal pain, regurgitation, chest pain, difficulty swallowing (also known as dysphagia), sour / bitter taste in the mouth, vomiting, bloating, dry cough or throat clearing, sore throat, hoarseness or laryngitis, shortness of breath, excessive salivation, intolerance to certain foods and liquids, and halitosis.

[0109] In some embodiments, the herbal composition is administered orally. The unit dose and frequency of administration can be varied. In some embodiments, the herbal composition is administered twice daily, once daily, every two days, every three days, every four days, or once weekly. In some embodiments, the duration of administration of the herbal composition is one week, two weeks, three weeks, one month, two months, or three months.

[0110] The present application is further illustrated by the following embodiments, which should not be construed as limiting. All references, patents, and published patent applications cited throughout this application are incorporated herein by reference.

[0111] Example Example 1: The herbal supplement of this application can effectively relieve GERD symptoms. A test batch (test supplement) of the herbal supplement of this application was prepared by mixing Atractylodes lancea extract, dandelion root extract, noni extract and hesperidin in a weight ratio of 9:5:8:2 to form a mixture, and filling capsules with this mixture. Each capsule contained 225 mg of Atractylodes lancea extract (extraction ratio 10:1), 125 mg of dandelion extract (extraction ratio 10:1), 200 mg of noni fruit extract (extraction ratio 5:1) and 50 mg of hesperidin extract (90% HPLC).

[0112] The trial supplement was administered to a 52-year-old man with a prominent hiatal hernia who had suffered from severe GERD for over 30 years. During this time, he would respond to each proton pump inhibitor for a period, then become resistant to their effects. Prescription medications used included omeprazole, lansoprazole, pantoprazole, rabeprazole, and esomeprazole, eventually responding only to an expensive drug called dexlansoprazole. He had attempted to gradually wean off the medication multiple times over the years, but this only resulted in severe symptoms, including heartburn, severe chest pain, and jaw pain. The weaning process was methodical and involved a combination of over-the-counter H2 blockers (Pepcid / Zantac) and various "natural" remedies. He successfully weaned off the prescription proton pump inhibitors after using this herbal combination. He has been off the medication for over a year without any side effects.

[0113] The above herbal combination was also tested on a refractory 51-year-old male who had undergone sleeve gastrectomy and was unresponsive to twice-daily proton pump inhibitors and nighttime epcid. This patient successfully discontinued his prescription medication within a week following the same dosing regimen.

[0114] The above description is intended to instruct those skilled in the art on how to implement this application, and is not intended to detail all obvious modifications and variations that become apparent to those skilled in the art upon reading this specification. However, it is intended that all such obvious modifications and variations be included within the scope of this application as defined by the appended claims. The claims are intended to cover the claimed components and steps, and these components and steps may be performed in any order that effectively achieves the intended purpose, unless the context clearly indicates otherwise.

[0115] Example 2: The herbal supplement of this application was effective in relieving GERD symptoms in an extended study. In an extended observational study, 31 participants aged 24 to 67 years (median age 47.5 years) took two capsules twice daily for 30 days. Each capsule contained 225 mg of Atractylodes macrocephala extract (extraction ratio 10:1), 125 mg of Taraxacum mongolicum extract (extraction ratio 10:1), 200 mg of Noni fruit extract (extraction ratio 5:1), and 50 mg of hesperidin extract (90% HPLC). The study cohort included 22 women and 9 men. Of these, 14 participants presented with typical GERD heartburn, 7 presented with only upper mid-abdominal pain, and 10 presented with a combination of GERD heartburn and upper abdominal pain. Notably, 21 participants took a proton pump inhibitor (PPI) daily, while 10 did not. In this cohort, 9 had gastrointestinal comorbidities such as inflammatory bowel disease (IBD), small intestinal bacterial overgrowth (SIBO), and morbid obesity, and 7 had hiatal hernias ranging from 2 cm to 4 cm. All participants underwent endoscopy, and 17 cases showed visible esophagitis, while 31 cases showed pathological records of esophagitis, including one case diagnosed with Barrett's esophagus.

[0116] After a 30-day treatment course, among patients taking daily PPIs, 17 participants successfully discontinued all medications, 2 participants reduced their PPI usage by 75%, 1 participant switched to taking only an H2 blocker daily, and 1 participant continued taking PPIs due to Barrett's esophagus. Additionally, all 31 participants who reported bloating and pain experienced relief.

[0117] The product presented in this application demonstrated a high level of patient satisfaction, as evidenced by 14 proactive requests for additional doses, with four participants consistently returning monthly to purchase more than two bottles. No reports of side effects were received. These findings suggest that the natural GERD product presented in this application can provide significant therapeutic benefits, particularly in reducing reliance on traditional GERD medications while alleviating symptoms and improving overall gastrointestinal health.

Claims

1. A herbal supplement comprising two or more herbal ingredients selected from the group consisting of Atractylodes lancea extract, dandelion root extract, noni extract, hesperidin extract, and aralia extract, wherein, This supplement is formulated for oral administration to relieve symptoms of gastroesophageal reflux disease.

2. The herbal supplement according to claim 1, comprising three or more ingredients selected from the group consisting of Atractylodes lancea extract, dandelion root extract, noni extract, hesperidin extract and aralia extract.

3. The herbal supplement according to claim 2, comprising four or more ingredients selected from the group consisting of Atractylodes lancea extract, dandelion root extract, noni extract, hesperidin extract and aralia extract.

4. The herbal supplement according to claim 3, comprising Atractylodes lancea extract, dandelion root extract, noni extract and hesperidin extract.

5. The herbal supplement according to claim 3, comprising Atractylodes lancea extract, dandelion root extract, noni extract, hesperidin extract and aralia extract.

6. The herbal supplement according to claim 2, wherein, This herbal supplement is formulated in unit doses, and in which, Each unit dose contains at least three components selected from the following groups: Atractylodes lancea extract in the range of 45~1125mg, Dandelion root extract in the range of 25-625 mg, Noni fruit extract in the range of 40-1000 mg, and Hesperidin extract in the range of 10-250 mg.

7. The herbal supplement according to claim 6, wherein, The Atractylodes lancea extract is an Atractylodes macrocephala extract with an extraction ratio of 10:

1. The dandelion root extract has an extraction ratio of 10:1, the noni fruit extract has an extraction ratio of 5:1, and the hesperidin extract has a purity of 90% by HPLC.

8. The herbal supplement according to claim 7, wherein, Each unit dose contains: Atractylodes lancea extract in the range of 100-450 mg, Dandelion root extract in the range of 50-250 mg, Noni fruit extract in the range of 80-400mg, and Hesperidin extract in the range of 20-100 mg.

9. The herbal supplement according to claim 5, wherein, This herbal supplement is formulated in unit doses, and in which, Each unit dose contains: Red pine extract in the range of 50-1250 mg, Atractylodes lancea extract in the range of 50-1250 mg, Dandelion root extract in the range of 300~7500mg, Noni extract in the range of 100-2500 mg, and Hesperidin in the range of 20-500 mg.

10. The herbal supplement according to any one of claims 1 to 9, further comprising one or more extracts selected from Satsuma mandarin orange peel extract, ginseng extract, jujube extract, deglycyrrhizic acid glycyrrhizin (DGL), and carob (… Ceratonia siliqua Herbal ingredients composed of extracts.

11. A method for relieving symptoms of gastroesophageal reflux disease (GRED) in human patients, comprising: Orally administer an effective amount of the herbal supplement according to any one of claims 1 to 10 to human patients in urgent need.

12. The method according to claim 11, wherein, This herbal supplement is given daily for a week or longer.

13. The method according to claim 11, wherein, This herbal supplement is given twice daily for a week or longer.

14. The method according to claim 11, wherein, This herbal supplement is taken twice daily, and among other things, Each dose contains 450 mg of Atractylodes macrocephala extract (extraction ratio 10:1), 250 mg of Taraxacum mongolicum root extract (extraction ratio 10:1), 400 mg of Noni fruit extract (extraction ratio 5:1), and 100 mg of hesperidin extract (90% HPLC).

15. The method according to any one of claims 11 to 14, wherein, The GRED symptoms were selected from a group consisting of heartburn, upper abdominal pain, reflux, chest pain, difficulty swallowing, sour / bitter taste in the mouth, vomiting, bloating, dry cough and throat clearing, sore throat, hoarseness, laryngitis, shortness of breath, excessive salivation, and halitosis.

16. The method according to any one of claims 11 to 15, wherein, The patient was diagnosed with GRED.

17. The method according to any one of claims 11 to 15, wherein, The patient has been treated with proton pump inhibitors and / or H2 blockers.

18. A method for preparing the herbal supplement according to any one of claims 1 to 10, comprising: The herbal ingredients are mixed to form a mixture; as well as The mixture is formulated into a unit dose suitable for oral administration.

19. The method according to claim 18, wherein, The unit dose is in capsule form.

20. The method according to claim 18, wherein, This unit dose is in tablet form.