Bioactive collagen and vitamin c formulation

Abstract

The present disclosure provides formulations containing bioactive collagen peptides and vitamin C. These formulations can further contain calcium, vitamin D, and / or vitamin K. The present disclosure also provides uses of the formulations for treating, reducing, and / or preventing osteoporosis.

Description

Technical Field

[0001] This disclosure relates to formulations containing bioactive collagen peptides and vitamin C, and their use in the treatment of osteoporosis. Background Technology

[0002] According to the Mayo Clinic, "Osteoporosis makes bones brittle and fragile—so fragile that a fall or even minor stress, such as bending over or coughing, can cause a fracture. Osteoporosis-related fractures most commonly occur in the hip, wrist, or spine." The National Institute of Arthritis, Musculoskeletal and Dermatology states, "Osteoporosis is a bone disease that occurs when bone mineral density and bone mass decrease, or when the structure and strength of the bones change. This can lead to reduced bone strength, thus increasing the risk of fractures (bone breaks)." The National Institute of Arthritis, Musculoskeletal and Dermatology also refers to osteoporosis as a silent disease, as it has no symptoms, and patients may not even realize they have it until a fracture occurs, most commonly in the hip, vertebrae of the spine, and wrist. While osteoporosis can occur at any age, the risk increases with age.

[0003] Currently available treatments for osteoporosis include the drug alendronate. In addition, supplements, including vitamins and collagen peptides, are used to promote bone health and reduce calcium loss. According to WebMD, "[c]collagen peptides are used for aging skin and osteoarthritis. They are also used for osteoporosis, brittle nails, muscle strength, and many other purposes, but there is not good scientific evidence to support most of these uses." Alendronate sodium has side effects, including an increased risk of femur fractures. While supplements may offer some benefits, they cannot treat, reduce, and / or prevent osteoporosis. What is needed is a more effective treatment for osteoporosis. Summary of the Invention

[0004] This invention provides formulations containing bioactive collagen peptides and vitamin C, and the use of these formulations in treating, reducing, and / or preventing osteoporosis. The invention is based on the discovery that the combination of bioactive collagen peptides and vitamin C has a synergistic effect in the treatment of osteoporosis. This disclosure is also based on the finding that the combination of bioactive collagen peptides and vitamin C is almost as effective as alendronate in the treatment of osteoporosis.

[0005] One embodiment of the present invention is a formulation containing bioactive collagen peptides and vitamin C. In some embodiments of the formulation, the bioactive collagen peptides and vitamin C are present in amounts that are effective in treating, reducing, and / or preventing osteoporosis. In alternative embodiments, the formulation comprises about 1 g to about 10 g of bioactive collagen peptides and about 20 mg to about 200 mg of vitamin C. In other embodiments, the formulation comprises synergistically effective amounts of bioactive collagen peptides and vitamin C.

[0006] A variety of bioactive collagen peptides may be used in the formulation. In some embodiments, the average molecular weight of the bioactive collagen peptides is 500 to 20,000 Daltons. In other embodiments, the bioactive collagen peptides are derived from bone, such as bovine bone.

[0007] In some embodiments of this disclosure, vitamin C is of a natural source. In one embodiment, vitamin C is extracted from some fruits. In a particular embodiment, vitamin C is extracted from cherries.

[0008] The formulation disclosed herein may also contain additional vitamins and / or minerals. For example, in one embodiment, the formulation further contains calcium, magnesium, vitamin D, and / or vitamin K (e.g., vitamin K2). In some embodiments, the formulation contains about 10 mg to about 600 mg of calcium, about 10 mg to about 400 mg of magnesium, about 5 IU to about 600 IU of vitamin D, and / or about 10 mcg to about 200 mcg of vitamin K (e.g., vitamin K2). In another embodiment, the formulation contains calcium and vitamin D. For example, the formulation may contain about 10 mg to about 600 mg of calcium and about 5 IU to about 600 IU of vitamin D. In a further embodiment, the formulation contains probiotics (e.g., 10...). 6 ~ 10 11 CFU (probiotics) and herbal therapeutic agents. In some embodiments, the preparation contains about 1g to about 20g of herbal therapeutic agents, such as Drynaria fortunei.

[0009] In addition, the formulations disclosed herein may include acidity regulators (e.g., citric acid), natural flavoring agents, and / or sweeteners.

[0010] The formulation can be gluten-free and / or sugar-free.

[0011] In some implementations, the formulation is a liquid formulation. Alternatively, the formulation is a solid formulation.

[0012] The formulation may contain a ratio of 50:1 or higher of bioactive collagen peptides to vitamin C. In some embodiments, the formulation contains about 1 g to about 10 g of bioactive collagen peptides and about 20 mg to about 200 mg of vitamin C.

[0013] This disclosure also includes a kit containing the formulation. The kit may also include instructions for use. In one embodiment, the kit includes the liquid formulation of the invention filled in a bottle and optional instructions for use.

[0014] Furthermore, the present invention also includes the use of the formulation in the preparation of a medicament for treating osteoporosis. This disclosure also includes the use of said formulation in the treatment of osteoporosis.

[0015] Furthermore, this disclosure includes methods for treating, preventing, or reducing osteoporosis. The methods include administering the disclosed formulation to a subject (e.g., an adult). In some embodiments, the formulation is administered daily. In other embodiments, the formulation contains at least an amount of bioactive collagen peptides and vitamin C effective in treating, preventing, or reducing osteoporosis.

[0016] Another aspect of the invention is a method for preventing osteoporotic bone formation by administering the formulation of the invention to a subject. The subject may be an adult, and the administration may include daily administration of the formulation. The subject may be an adult.

[0017] Other features and advantages of the present invention will become apparent from the following detailed description and embodiments. Attached Figure Description

[0018] The above-described invention and the following detailed description of the invention will be better understood when read in conjunction with the accompanying drawings. The drawings illustrate embodiments of the invention for illustrative purposes. However, it should be understood that the invention is not limited to the precise arrangements, embodiments, and tools shown.

[0019] Figure 1A A graph shows the effectiveness of various treatments (fluorescence-based) in measuring dexamethasone-induced osteoporosis (OP) in zebrafish. Specifically, Figure 1A The therapeutic effects of different amounts of vitamin C (“VC”), bioactive collagen peptides (BCP), or a combination of vitamin C and bioactive collagen peptides (BCP+VC) were demonstrated. Compared with the model, p<0.05, p<0.01, p < 0.001. Compared with BCP+VC 52.0 μg / mL, ###p < 0.001. Compared with BCP+VC 104 μg / mL, $$$p < 0.001. Compared with BCP+VC 208 μg / mL, Δp < 0.05, ΔΔΔp < 0.001.

[0020] Figure 1B Photographs of zebrafish with dexamethasone-induced osteoporosis (OP) stained with alizarin red, shown after treatment with varying amounts of vitamin C (“VC”), bioactive collagen peptides (BCP) or a combination of vitamin C and bioactive collagen peptides (BCP+VC).

[0021] Figure 2A A graph shows the effectiveness of various treatments (fluorescence-based) in measuring dexamethasone-induced osteoporosis (OP) in zebrafish. Specifically, Figure 2A The study demonstrated the effects of alendronate sodium (5 μg / mL), bioactive collagen peptides (BCP) (208 μg / mL), or a combination of bioactive collagen peptides (208 μg / mL) and vitamin C (13.8 μg / mL) (BCP+VC) on dexamethasone-induced osteoporosis (OP) in zebrafish at 12, 24, 36, and 48 hours. Compared with the dexamethasone treatment group, p<0.01, p < 0.001. Compared with BCP, at 12 hours, ##p < 0.01, ###p < 0.001. Compared with BCP+VC, at 12 hours, $p < 0.05, $$$p < 0.001. Compared with BCP+VC, at 24 hours, ΔΔp < 0.01, ΔΔΔp < 0.001. Compared with BCP+VC, at 36 hours, ★p < 0.05, ★★★p < 0.001. Compared with BCP+VC, at 48 hours, □p < 0.05, □p < 0.001.

[0022] Figure 2B Photographs of alizarin red-stained zebrafish samples with dexamethasone-induced osteoporosis (OP) treated with alendronate sodium (5 μg / mL), bioactive collagen peptides (BCP) (208 μg / mL) or a combination of bioactive collagen peptides (208 μg / mL) and vitamin C (13.8 μg / mL) (BCP+VC) for 12, 24, 36, and 48 hours.

[0023] Figure 3A A graph shows the effectiveness of various pretreatments (fluorescence-based) measured before dexamethasone-induced osteoporosis (OP) in zebrafish. Specifically, Figure 3AThis study demonstrates the effects of pretreatment (OP) of zebrafish with alendronate sodium (5 μg / mL), bioactive collagen peptides (BCP) (208 μg / mL), or a combination of bioactive collagen peptides (208 μg / mL) and vitamin C (13.8 μg / mL) (BCP+VC) at 0, 24, and 48 hours prior to dexamethasone-induced osteoporosis. Compared to BCP+VC, pretreatment at 48 hours significantly reduced... p<0.01, p < 0.001. Compared with BCP+VC, after 24 hours of pretreatment, #p < 0.05, ###p < 0.001. Compared with BCP+VC, after 0 hours of pretreatment, $p < 0.05, $$$p < 0.001.

[0024] Figure 3B Photographs of zebrafish with dexamethasone-induced osteoporosis (OP) stained with Alizarin Red before dexamethasone-induced osteoporosis are shown. The zebrafish were pretreated with alendronate sodium (5 μg / mL), bioactive collagen peptide (BCP) (208 μg / mL), or a combination of bioactive collagen peptide (208 μg / mL) and vitamin C (13.8 μg / mL) (BCP+VC) for 0, 24, and 48 hours. Detailed Implementation

[0025] The general description and the following detailed description are merely illustrative and explanatory, and do not limit the invention as defined in the appended claims.

[0026] This disclosure is based on the finding that the combination of bioactive collagen peptides and vitamin C (ascorbic acid) has a synergistic effect in the treatment of osteoporosis. Specifically, the combination of bioactive collagen peptides and vitamin C has been found to be effective in restoring osteoporotic bone and / or preventing osteoporotic bone formation. In particular (as shown in Example 1 below), the combination of collagen peptides and vitamin C can provide better efficacy than collagen peptides and vitamin C alone. Specifically, this combination, when used as a dietary supplement, has shown efficacy comparable to that of a drug (alendronate sodium).

[0027] Therefore, this disclosure provides formulations containing bioactive collagen peptides and vitamin C. These formulations support bone growth, repair osteoporosis, and prevent osteoporotic bone formation. These formulations can treat osteoporosis with efficacy comparable to drugs (alendronate sodium), but in the form of dietary supplements, such as solutions.

[0028] Other aspects of the invention will be apparent to those skilled in the art from the detailed description of the invention provided herein.

[0029] For clarity and not limitation, the detailed description of the invention is divided into subsections that describe or illustrate certain features, embodiments, or applications of the invention.

[0030] Definitions Unless otherwise defined, 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 invention pertains. Although any methods and materials similar to or equivalent to those described herein may also be used in the practice or testing of this invention, representative illustrative methods and materials are described hereafter.

[0031] All publications and patents referenced in this specification are incorporated herein by reference, just as each individual publication or patent is specifically and individually indicated to be incorporated herein by reference, and is incorporated herein by reference for the purpose of disclosing and describing the methods and / or materials of those publications. References to any publication are based on its disclosure prior to the filing date and should not be construed as an admission that the invention is not entitled to a prior invention. Furthermore, the publication dates provided may differ from the actual publication dates, which may require independent verification.

[0032] It should be noted that, unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “the” used herein and in the appended claims all have plural meanings. It should also be noted that claims may be drafted to exclude any optional elements. Therefore, this statement is intended as a prerequisite for using exclusive terms such as “only,” “unique,” ​​and the restrictive term “negative” when describing the elements of the claims.

[0033] The various embodiments described and illustrated herein include independent components and features that can be easily separated from or combined with features in other embodiments without departing from the scope or spirit of the invention. Any of the described methods may be performed in the order of the events or in any other logically possible order. The term “about” as used herein, when referring to measurable values ​​(such as quantity, duration of time, etc.), means including a deviation from the specified value of ±0.20% or ±10%, more preferably ±5%, even more preferably ±1%, and most preferably ±0.1%, because such deviation is appropriate for performing the disclosed methods.

[0034] It should also be clarified that the terminology used herein is for describing particular embodiments only and is not intended to be limiting.

[0035] As used herein, the terms “comprising,” “including,” “containing,” and “characterized in” are interchangeable, inclusive, and open-ended, and do not exclude other unlisted elements or method steps. Whenever the word “comprising” is used herein, particularly when describing components of a composition or elements of an apparatus, it should be understood to include compositions and methods consisting primarily of the listed components or elements.

[0036] As used herein, the term "composed of" does not include any element, step, or component not expressly listed in the elements of the claims.

[0037] As used herein, when the word “about” is used to refer to a measurable value (such as quantity, duration of time, etc.), it means including a deviation of ±0.20% or ±10% from the specified value, more preferably ±5%, even more preferably ±1%, and still more preferably ±0.1%, because such deviations are appropriate for performing the disclosed method.

[0038] Before describing certain embodiments in more detail, it should be understood that the invention is not limited to the described embodiments, as these embodiments may, of course, vary. It should also be understood that the terminology used herein is for describing certain embodiments only and is not intended to be limiting, as the scope of the invention is defined only by the appended claims.

[0039] Where a numerical range is provided, unless the context explicitly states otherwise, it should be understood that every intermediate value (accurate to one-tenth of the lower limit unit) between the upper and lower limits of the range, as well as any other specified value or intermediate value within the specified range, is included within the scope of this invention. The upper and lower limits of these smaller ranges may be independently included within the smaller range and also within the scope of this invention, but are subject to any explicitly excluded limits within the specified range. Where a specified range includes one or two endpoint values, the range excluding either or both ends of that endpoint is also included in this invention.

[0040] It should also be clarified that the terminology used herein is for describing particular embodiments only and is not intended to be limiting.

[0041] As used herein, the terms “comprising,” “including,” “containing,” and “characterized in” are interchangeable, inclusive, and open-ended, and do not exclude other unlisted elements or method steps. Any reference to the word “comprising” in this document, particularly when describing components of a composition or elements of an apparatus, should be understood to include compositions and methods consisting primarily of the listed components or elements.

[0042] As used herein, the terms “patient” or “subject” are used interchangeably and both refer to mammals. In some embodiments, the patient or subject is a human. In other embodiments, the patient or subject is a veterinary or farm animal, livestock or pet, or an animal commonly used in clinical research. In some embodiments, the patient is an adult, i.e., 18 years of age or older. In other embodiments, the patient is a child, i.e., under 18 years of age.

[0043] Scope: In this disclosure, various aspects of the invention may be presented in the form of scope. It should be understood that the description in the form of scope is for convenience and brevity only and should not be regarded as constituting an inflexible limitation on the scope of the invention. Therefore, the description of scope should be regarded as specifically disclosing all possible sub-ranges within that range as well as individual numerical values. For example, the description of a range such as 1 to 6 should be regarded as specifically disclosing sub-ranges such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, etc., as well as individual numbers within that range, such as 1, 2, 2.7, 3, 4, 5, 5.3, and 6. This principle applies regardless of how wide the scope may be.

[0044] As used herein and as is widely understood in the art, "treatment" is a method of achieving a beneficial or anticipated outcome (including clinical outcomes). For the purposes of this invention, beneficial or anticipated clinical outcomes include, but are not limited to, relief or improvement of one or more symptoms, reduction of disease severity, stabilization (i.e., cessation of worsening) of a disease state, prevention of disease spread, delay or slowing of disease progression, improvement or relief of a disease state, and remission (whether partial or complete), regardless of whether these outcomes are detectable. "Treatment" may also refer to extended survival compared to expected survival without treatment.

[0045] It should be understood that, for clarity, certain features of the invention are described herein in the form of individual embodiments, but these features may also be combined in a single embodiment. That is, unless obviously incompatible or excluded, each individual embodiment is considered to be combinable with any other embodiment(s), and such combination is considered another embodiment. Conversely, for brevity, various features of the invention are described in the context of a single embodiment, but these features may also be provided individually or in any sub-combination. It should also be noted that the claims may be drafted to exclude any optional elements. Therefore, this statement is intended as a premise for the use of exclusive terms such as “only,” “unique,” ​​or the use of “negative” limitations in the statement of the claim elements.

[0046] While embodiments may be described as part of a series of steps or a more general structure, each step may also be considered an independent embodiment. Before describing certain embodiments in more detail, it is important to understand that the invention is not limited to the described embodiments and therefore variations are permissible. It is also important to understand that the terminology used herein is for describing certain embodiments only and is not intended to be limiting, as the scope of the invention is defined only by the appended claims.

[0047] Formulations This invention provides formulations containing bioactive collagen peptides and vitamin C. These formulations may be liquid, solid, or gel formulations. In other embodiments, these formulations may be chewable tablets. One embodiment of the invention is a liquid formulation containing bioactive collagen peptides and vitamin C. Another embodiment of the invention is a solid formulation containing bioactive collagen peptides and vitamin C.

[0048] In further embodiments, the present invention provides formulations containing active ingredients capable of treating, alleviating, and / or preventing osteoporosis. In some embodiments of these formulations, the active ingredients capable of treating, alleviating, and / or preventing osteoporosis are bioactive collagen peptides and vitamin C. In further embodiments, the active ingredients capable of treating, alleviating, and / or preventing osteoporosis are bioactive collagen peptides and vitamin C, and the formulation does not contain any other active ingredients capable of treating, alleviating, and / or preventing osteoporosis.

[0049] In some embodiments, the average molecular weight of the bioactive collagen peptides is from about 500 Daltons to about 20,000 Daltons, or from about 1,000 Daltons to about 10,000 Daltons, or from about 500 Daltons to about 15,000 Daltons, or from about 1,000 Daltons to about 8,000 Daltons, or from about 5,000 Daltons, or from about 3,000 Daltons to about 6,000 Daltons, or from about 4,500 Daltons to 5,500 Daltons. In some embodiments, the bioactive collagen peptides are fragments of animal collagen. In some embodiments, the bioactive collagen peptides are derived from bone. In one embodiment, the bioactive collagen peptides are bioactive collagen peptides derived from bovine bone.

[0050] In some embodiments, vitamin C is provided in the form of a fruit powder containing vitamin C. In other embodiments, vitamin C is extracted from fruits such as cherries. In some embodiments, vitamin C is extracted from acerola cherries. In other embodiments, vitamin C is obtained through chemical synthesis.

[0051] In some embodiments, the content of bioactive collagen peptides and vitamin C is sufficient to effectively treat, alleviate, and / or prevent osteoporosis. In one embodiment, the content of bioactive collagen peptides and vitamin C is sufficient to effectively treat osteoporosis. In another embodiment, the content of bioactive collagen peptides and vitamin C is sufficient to alleviate osteoporosis. In another alternative embodiment, the content of bioactive collagen peptides and vitamin C is sufficient to prevent osteoporosis. In yet another embodiment, the content of bioactive collagen peptides and vitamin C is sufficient to prevent the formation of osteoporotic bone.

[0052] In some embodiments, the formulation contains synergistically effective amounts of bioactive collagen peptides and vitamin C for treating, alleviating, and / or preventing osteoporosis. In one embodiment, the formulation contains synergistically effective amounts of bioactive collagen peptides and vitamin C for treating osteoporosis. In another embodiment, the formulation contains synergistically effective amounts of bioactive collagen peptides and vitamin C for alleviating osteoporosis. In yet another embodiment, the amount of bioactive collagen peptides and vitamin C is sufficient to prevent osteoporosis.

[0053] The formulations disclosed herein may contain additional vitamins and / or minerals. In some embodiments, the formulation also contains calcium, magnesium, vitamin D, and / or vitamin K. In some embodiments, vitamin K is vitamin K2. In alternative embodiments, the formulation also contains calcium and vitamin D. In some embodiments, the formulation also contains probiotics and herbal therapeutic agents. In some embodiments, the formulation contains 10 6 ~10 11 CFU, or 10 7 ~10 10 CFU, or 10 8 ~10 10 CFU probiotics. In some embodiments, the formulation contains about 1g to about 20g, or about 1g to about 15g, or about 2g to about 10g of a herbal therapeutic agent, such as Drynaria fortunei.

[0054] Furthermore, the formulations disclosed herein may contain additives commonly used in the preparation of formulations. In some embodiments, the formulations also contain sweeteners, colorants, natural flavoring agents, acidity regulators, and combinations thereof. In one embodiment, the acidity regulator is citric acid.

[0055] In some embodiments, the formulation disclosed herein is gluten-free (i.e., contains no gluten). In other embodiments, the formulation is sugar-free (i.e., contains no added sugar). In still other embodiments, the formulation is neither gluten-free nor sugar-free.

[0056] In some embodiments, the formulation contains about 1g to about 10g, or about 2g to about 11g, or about 2g to about 8g, or about 1g to about 5g, or about 1.25g to about 5g, or about 1g to about 6g, or about 1g to about 7g of bioactive collagen peptides. In other embodiments, the formulation contains about 20mg to about 200mg, or about 10mg to about 150mg, or about 50mg to about 150mg, or about 10mg to about 90mg, or about 20mg to about 85mg, or about 20mg to about 120mg of vitamin C. In a further embodiment, the formulation contains about 10mg to about 600mg, or about 10mg to about 400mg, or about 10mg to about 150mg, or about 50mg to 400mg, or about 100mg to about 600mg of calcium. In alternative embodiments, the formulation contains about 10 mg to about 400 mg, or about 10 mg to about 200 mg, or about 10 mg to about 150 mg, or about 50 mg to about 400 mg, or about 100 mg to about 400 mg of magnesium. In further embodiments, the formulation contains about 5 IU to about 600 IU of vitamin D, or about 10 IU to about 600 IU of vitamin D, or about 10 IU to about 500 IU of vitamin D, or about 50 IU to about 450 IU of vitamin D. In a further embodiment, the formulation contains about 10 mcg to about 200 mcg of vitamin K, or about 20 mcg to about 180 mcg of vitamin K, or about 30 mcg to about 150 mcg of vitamin K, or about 50 mcg to about 125 mcg of vitamin K. In some embodiments, the formulation contains a bioactive peptide, vitamin C, and one or more of calcium, magnesium, vitamin D, and vitamin K, each in an amount specified above. In some embodiments, the formulation is prepared in a solid or liquid form to deliver the above dose as a single daily dose. Alternatively, the above dose may be provided in the form of multiple daily doses.

[0057] In some embodiments, the formulation contains at least the components of formulation AG as shown in the table below, and the amounts of each component are shown in the table below. In some embodiments, the formulation contains at least the components of formulation AG as shown in the table below, and the formulation is prepared to provide the daily dose shown in the table below. Formulation AG may also contain 10 6 ~10 11 CFU containing probiotics and / or approximately 1g to approximately 20g of herbal therapeutic agents, such as Drynaria fortunei.

[0058]

[0059] In some embodiments, the formulation is a liquid. This liquid formulation is prepared to provide the aforementioned amounts of bioactive collagen peptides, vitamin C, and other ingredients in the formulation.

[0060] In some embodiments, the formulation contains bioactive collagen peptides and vitamin C, and the ratio of bioactive collagen peptides to vitamin C is at least about 50:1, or at least 60:1, or 40-65:1, or 45-65:1, or 15:1, or 14-15:1, or about 14-50:1, or about 13-52:1, or at least 14-15:1, or 10-1:0.2-0.02, or about 500:1.

[0061] In some embodiments, the formulation contains bioactive collagen peptides and vitamin C, and the formulation contains about 1g to about 10g, or about 0.5g to about 11g, or about 2g to about 8g, or about 3g to about 7g, or about 1g to about 5g of bioactive collagen peptides, and about 20mg to about 200mg, or about 10mg to about 100mg, or about 50mg to 150mg, or about 20mg to about 125mg of vitamin C. The formulation may be solid or liquid.

[0062] In other embodiments, the formulation is a dietary supplement.

[0063] In another embodiment, the formulation comprises an active ingredient capable of treating, reducing, and / or preventing osteoporosis, calcium, and / or vitamin D. In one embodiment, the active ingredient capable of treating, reducing, and / or preventing osteoporosis is a bioactive collagen peptide and vitamin C, and the formulation does not contain any other active ingredient capable of treating, reducing, and / or preventing osteoporosis. In another embodiment, the formulation comprises: an active ingredient capable of treating, reducing, and / or preventing osteoporosis, wherein the active ingredient is a bioactive collagen peptide and vitamin C; calcium; and vitamin D. In yet another embodiment, the formulation comprises: an active ingredient capable of treating, reducing, and / or preventing osteoporosis, wherein the active ingredient consists of a bioactive collagen peptide and vitamin C; calcium; and vitamin D.

[0064] Use of formulations The formulations containing bioactive collagen peptides and vitamin C disclosed herein can promote bone growth, repair osteoporosis, and prevent osteoporotic bone formation. Tests in Example 1 below demonstrate that these formulations can treat, alleviate, and / or prevent osteoporotic bone formation. Furthermore, the formulations of this disclosure exhibit better efficacy compared to using bioactive collagen peptides or vitamin C alone.

[0065] Therefore, another aspect of this disclosure is the use of preparations containing bioactive collagen peptides and vitamin C in preventing osteoporotic bone formation, treating, alleviating and / or preventing osteoporosis.

[0066] One embodiment of the present invention is a method for treating, alleviating, and / or preventing osteoporosis in a subject. The method includes administering a formulation of the present invention. In some embodiments, the method includes administering the formulation in an amount effective in treating, alleviating, and / or preventing osteoporosis in the subject. In one embodiment, the method treats osteoporosis. In another embodiment, the method alleviates osteoporosis. In yet another embodiment, the method prevents osteoporosis. As used herein, “preventing osteoporosis” includes prophylactic administration of the formulation. In some embodiments of the present invention, the method includes screening for osteoporosis. In other embodiments, administration includes providing the liquid formulation of the present invention, which is then taken by the subject. In some embodiments, the subject is an adult, such as thirty years of age or older. In a further embodiment, the method includes daily administration of the formulation.

[0067] Another embodiment of this disclosure is a method for preventing osteoporotic bone formation. The method includes administering a formulation of this disclosure, for example, in an amount effective in preventing osteoporotic bone formation. In some embodiments of these methods, administration includes a liquid formulation comprising providing this disclosure, which is then taken by a subject. The subject may be an adult. In one embodiment, the subject is thirty years of age or older.

[0068] Another embodiment is the use of the formulation of this disclosure in the preparation of a medicament for treating osteoporosis. Yet another embodiment is the use of the formulation of this disclosure for treating osteoporosis.

[0069] In some embodiments, the methods of use and applications of the formulations disclosed herein are as effective as alendronate sodium. In other embodiments, the combination of the bioactive peptide and vitamin C works synergistically to treat, reduce, and / or prevent osteoporosis and / or prevent osteoporotic bone formation.

[0070] Kits In another embodiment, the present invention relates to a kit comprising the formulations disclosed herein. The kit may optionally include instructions for use.

[0071] In some embodiments of this disclosure, the kit comprises the liquid formulation disclosed herein contained in a bottle and may optionally include instructions for use. In other embodiments, the formulation of this disclosure is in the form of pills, tablets, or capsules, and the kit includes a bottle containing the pills, tablets, or capsules. In still other embodiments, the formulation of this disclosure is in the form of pills, tablets, or capsules, and the kit includes a blister pack containing the pills, tablets, or capsules.

[0072] Without further description, it is believed that those skilled in the art will be able to make and use the present invention and practice the claimed methods using the foregoing description and the following exemplary embodiments. Therefore, the following working examples specifically point to preferred embodiments of the present invention and should not be considered as limiting the remainder of this disclosure in any way.

[0073] Examples Example 1: Effects of bioactive collagen peptides and vitamin C on osteoporosis Existing dietary components (vitamin C and collagen peptides) are believed to have certain health benefits for collagen formation in our bodies, which may be closely related to bone health. However, the direct health benefits of this combination of components for osteoporosis are unclear. Therefore, this study investigated the protective effect of bovine bone-derived bioactive collagen peptides (BCP) in combination with vitamin C (VC) against dexamethasone-induced osteoporosis (OP) in zebrafish.

[0074] Methods Anti-osteoporosis: Dexamethasone-induced osteoporotic zebrafish (wild-type, AB strain, 72 hours post-fertilization) were treated with different concentrations of BCP and / or vitamin C for 48 hours. BCP was derived from bovine bone and processed using a specific hydrolysis technique, exhibiting a characteristic peptide pattern with an average molecular weight of 5 kDa. Vitamin C was extracted from acerola cherry. Alizarin red staining was performed at different time points within 48 hours. The fluorescence intensity of the vertebrae was analyzed.

[0075] Prevention of osteoporosis: Zebrafish (wild-type, AB strain) were pretreated with bisphosphonates (BCP) and / or vitamin C for 48 hours or 24 hours post-fertilization, respectively, followed by co-treatment with dexamethasone. Alizarin red staining was performed 48 hours after co-treatment. The fluorescence intensity of the vertebrae was analyzed. Both experiments included a control group (wild-type, AB strain, no treatment), a model group (wild-type, AB strain, treated with dexamethasone), and an alendronate sodium positive control group (5 μg / mL).

[0076] Results Dexamethasone treatment significantly reduced the fluorescence intensity of zebrafish vertebrae, while alendronate sodium effectively repaired dexamethasone-induced bone loss.

[0077] Anti-osteoporosis Compared with the control group, both BCP and vitamin C treatments significantly increased the fluorescence intensity of vertebrae (p<0.05). The protective effect was observed to be dose-dependent, and the effect was enhanced when BCP was used in combination with vitamin C, indicating a synergistic effect between BCP and vitamin C.

[0078] Prevention of osteoporosis Compared with the untreated group, the fluorescence intensity of the middle vertebrae of zebrafish treated with dexamethasone showed a recovery trend after pretreatment with BCP and vitamin C (p=0.16).

[0079] Specifically, a synergistic effect between BCP and vitamin C was observed to improve dexamethasone-induced osteoporosis in zebrafish (see [link to study]). Figure 1A and Figure 1B Compared with the control group, both BCP and vitamin C treatments significantly increased the fluorescence intensity of the vertebrae (p<0.05). Furthermore, the protective effect was dose-dependent, and the effect was better when BCP was used in combination with vitamin C, indicating a synergistic effect between BCP and vitamin C.

[0080] Furthermore, vitamin C accelerated the protective effect of BCP against dexamethasone-induced bone loss in zebrafish (see...). Figure 2A and Figure 2B At 48 hours post-dexamethasone treatment, both the BCP and BCP+VC groups showed protective effects against bone loss. At each time point, the BCP+VC group demonstrated superior protection against dexamethasone-induced bone loss compared to the BCP group. During treatment, the BCP+VC group recovered the same amount of bone loss earlier than the BCP group (BCP+VC at 12 hours vs. BCP at 24 hours; BCP+VC at 24 hours vs. BCP at 36 hours).

[0081] Furthermore, BCP + vitamin C pretreatment showed a tendency to prevent bone loss in dexamethasone-treated zebrafish (see [link]). Figure 3A and Figure 3B Pretreatment with BCP and vitamin C showed a trend toward restoring fluorescence intensity in the middle vertebrae of dexamethasone-treated zebrafish (p=0.16). Furthermore, the combined treatment with BCP and vitamin C was almost as effective as alendronate sodium alone.

[0082] The tests in this embodiment demonstrate that bioactive collagen peptides and vitamin C work synergistically to improve dexamethasone-induced osteoporosis in zebrafish. Specifically, the combination of bioactive collagen peptides and vitamin C has been shown to be more effective than either ingredient in treating dexamethasone-induced osteoporosis in zebrafish. The observed effects in repairing osteoporosis and preventing osteoporotic bone formation are comparable to those of alendronate, a drug used to treat osteoporosis.

[0083] Example 2: Converting test doses to human doses In Example 1, we evaluated various combinations of bioactive collagen peptides and vitamin C in a zebrafish model. These doses are equivalent to the following doses in humans.

[0084]

[0085]

[0086] While the invention has been described and illustrated herein by reference to various specific materials, procedures, and embodiments, it should be understood that the invention is not limited to the specific combination of materials and procedures chosen for this purpose. Those skilled in the art will understand that these details can have many variations. This specification and embodiments are illustrative only, and the true scope and spirit of the invention are indicated by the following claims. All references, patents, and patent applications cited in this application are incorporated herein by reference in their entirety.

[0087] Implementation Plan The present invention also provides the following non-limiting embodiments.

[0088] Implementation Scheme 1: A formulation comprising bioactive collagen peptides and vitamin C, wherein the bioactive collagen peptides and vitamin C are present in amounts that effectively treat, alleviate, and / or prevent osteoporosis.

[0089] Implementation Scheme 2: The formulation according to Implementation Scheme 1, wherein the formulation comprises synergistically effective amounts of bioactive collagen peptides and vitamin C.

[0090] Implementation Scheme 3: The formulation according to Implementation Scheme 1 or 2, wherein the average molecular weight of the bioactive collagen peptide is 500 to 20,000 Daltons.

[0091] Implementation Scheme 4: A formulation according to any one of Implementation Schemes 1 to 3, wherein the bioactive collagen peptides are derived from bone.

[0092] Implementation Plan 5: A preparation according to any one of Implementation Plans 1 to 4, wherein vitamin C is extracted from fruit.

[0093] Implementation Scheme 6: The formulation according to Implementation Scheme 5, wherein vitamin C is extracted from cherries.

[0094] Implementation Scheme 7: The formulation according to any one of Implementation Schemes 1 to 6 further comprises calcium, magnesium, vitamin D and / or vitamin K.

[0095] Implementation Scheme 8: The formulation according to Implementation Scheme 7, wherein the formulation comprises about 10 mg to about 600 mg of calcium, about 10 mg to about 400 mg of magnesium, about 5 IU to about 600 IU of vitamin D and / or about 10 mcg to about 200 mcg of vitamin K.

[0096] Implementation Scheme 9: The formulation according to Implementation Scheme 8, wherein the formulation contains calcium and vitamin D.

[0097] Implementation Scheme 10: The formulation according to Implementation Scheme 9, wherein the formulation contains about 10 mg to about 600 mg of calcium and about 5 IU to about 600 IU of vitamin D.

[0098] Implementation Scheme 11: A formulation according to any one of Implementation Schemes 1 to 10, wherein the formulation is gluten-free.

[0099] Implementation Scheme 12: The formulation according to any one of Implementation Schemes 1 to 11 further comprises an acidity regulator.

[0100] Implementation Scheme 13: The formulation according to Implementation Scheme 12, wherein the acidity regulator is citric acid.

[0101] Implementation Scheme 14: The formulation according to any one of Implementation Schemes 1 to 13 further comprises a natural flavoring agent.

[0102] Implementation Scheme 15: The formulation according to any one of Implementation Schemes 1 to 14 further comprises a sweetener.

[0103] Implementation Scheme 16: A formulation according to any one of Implementation Schemes 1 to 15, wherein the formulation is sugar-free.

[0104] Implementation Scheme 17: A formulation according to any one of Implementation Schemes 1 to 16, wherein the formulation comprises bioactive collagen peptides and vitamin C in a ratio of 50:1.

[0105] Implementation Scheme 18: A formulation according to any one of Implementation Schemes 1 to 17, wherein the formulation comprises about 1 g to about 10 g of bioactive collagen peptides and about 20 to about 200 mg of vitamin C.

[0106] Implementation Scheme 19: The formulation according to Implementation Scheme 18, wherein the formulation further comprises 10 6 ~10 11 CFU probiotics and / or approximately 1 to 20g of herbal therapeutic drugs.

[0107] Implementation Scheme 20: The formulation according to Implementation Scheme 19, wherein the formulation contains Drynaria fortunei.

[0108] Implementation Scheme 21: A formulation according to any one of Implementation Schemes 1 to 20, wherein the formulation is a liquid formulation.

[0109] Implementation Scheme 22: A formulation according to any one of Implementation Schemes 1 to 20, wherein the formulation is a solid dosage form.

[0110] Implementation Scheme 23: A kit comprising the formulation of any one of Implementation Schemes 1 to 20, and optionally including instructions for use.

[0111] Implementation Scheme 24: A kit comprising the liquid formulation of Implementation Scheme 21 in a bottle, and optionally including instructions for use.

[0112] Implementation Scheme 25: Use of an formulation of any one of Implementation Schemes 1 to 22 in the preparation of a medicament for treating osteoporosis.

[0113] Implementation Scheme 26: Use of an formulation of any one of Implementation Schemes 1 to 22 for the treatment of osteoporosis.

[0114] Implementation Plan 27: A method for treating, preventing or alleviating osteoporosis, comprising administering to a subject a formulation of any one of Implementation Plans 1 to 22.

[0115] Implementation scheme 28: The method of implementation scheme 27, wherein the subjects are adults.

[0116] Implementation Scheme 29: The method according to Implementation Scheme 27 or 28, wherein the method includes daily administration of the formulation.

[0117] Implementation Plan 30: A method for preventing osteoporotic bone formation, comprising administering to a subject a formulation of any one of Implementation Plans 1 to 22.

[0118] Implementation Scheme 31: The method according to Implementation Scheme 30, wherein the subjects are adults.

[0119] Implementation Scheme 32: The method according to Implementation Scheme 30 or 31, wherein the method includes daily administration of the formulation.

Claims

1. A formulation comprising bioactive collagen peptides and vitamin C, wherein the bioactive collagen peptides and vitamin C are present in amounts that effectively treat, alleviate, and / or prevent osteoporosis.

2. The formulation according to claim 1, wherein the formulation comprises synergistically effective amounts of bioactive collagen peptides and the vitamin C.

3. The formulation according to claim 1 or 2, wherein the average molecular weight of the bioactive collagen peptide is 500 to 20,000 Daltons.

4. The formulation according to any one of claims 1 to 3, wherein the bioactive collagen peptide is derived from bone.

5. The preparation according to any one of claims 1 to 4, wherein the vitamin C is extracted from fruit.

6. The formulation according to claim 5, wherein the vitamin C is extracted from cherries.

7. The formulation according to any one of claims 1 to 6 further comprises calcium, magnesium, vitamin D and / or vitamin K.

8. The formulation of claim 7, wherein the formulation comprises about 10 mg to about 600 mg of calcium, about 10 mg to about 400 mg of magnesium, about 5 IU to about 600 IU of said vitamin D and / or about 10 mcg to about 200 mcg of vitamin K.

9. The formulation according to claim 8, wherein the formulation comprises calcium and vitamin D.

10. The formulation of claim 9, wherein the formulation comprises about 10 mg to about 600 mg of calcium and about 5 IU to about 600 IU of vitamin D.

11. The formulation according to any one of claims 1 to 10, wherein the formulation is gluten-free.

12. The formulation according to any one of claims 1 to 11 further comprises an acidity regulator.

13. The formulation according to claim 12, wherein the acidity regulator is citric acid.

14. The formulation according to any one of claims 1 to 13 further comprises a natural flavoring agent.

15. The formulation according to any one of claims 1 to 14, further comprising a sweetener.

16. The formulation according to any one of claims 1 to 15, wherein the formulation is sugar-free.

17. The formulation according to any one of claims 1 to 16, wherein the formulation comprises bioactive collagen peptides and vitamin C in a ratio of 50:

1.

18. The formulation according to any one of claims 1 to 17, wherein the formulation comprises about 1 g to about 10 g of bioactive collagen peptides and about 20 mg to about 200 mg of vitamin C.

19. The formulation of claim 18, wherein the formulation further comprises 10 6 Up to 10 11 CFU probiotics and / or approximately 1g to approximately 20g of herbal therapeutic agents.

20. The formulation of claim 19, wherein the formulation comprises Drynaria fortunei.

21. The formulation according to any one of claims 1 to 20, wherein the formulation is a liquid formulation.

22. The formulation according to any one of claims 1 to 20, wherein the formulation is a solid dosage form.

23. A kit comprising the formulation of any one of claims 1 to 20, and optionally comprising instructions for use.

24. A kit comprising the liquid formulation of claim 21 contained in a bottle, and optionally including instructions for use.

25. Use of the formulation of any one of claims 1 to 22 in the preparation of a medicament for treating osteoporosis.

26. Use of the formulation of any one of claims 1 to 22 for the treatment of osteoporosis.

27. A method of treating, preventing or alleviating osteoporosis, comprising administering to a subject the formulation of any one of claims 1 to 22.

28. The method of claim 27, wherein the subject is an adult.

29. The method of claim 27 or 28, wherein the method comprises administering the formulation daily.

30. A method for preventing osteoporotic bone formation, comprising administering to a subject the formulation of any one of claims 1 to 22.

31. The method of claim 30, wherein the subject is an adult.

32. The method of claim 30 or 31, wherein the method comprises administering the formulation daily.

Images