Bioactive collagen peptides and vitamin C preparations

Abstract

This disclosure provides a formulation containing a bioactive collagen peptide and vitamin C. The formulation may further contain calcium, vitamin D, and / or vitamin K. This disclosure also provides the use of the formulation to treat, suppress, and / or prevent 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 weakens and makes bones brittle. They become so fragile that they can fracture from falls or even minor stress such as bending over or coughing. Osteoporosis-related fractures most commonly occur in the hips, wrists, and spine." The National Institute of Arthritis, Musculoskeletal and Dermatological Diseases states that "osteoporosis is a bone disease caused by a decrease in bone density or bone mass, or by changes in bone structure or strength. This can lead to decreased bone strength and an increased risk of fracture (bone damage)." The institute also calls osteoporosis a "silent disease" because it often has no symptoms, and patients may not be aware of it until a fracture occurs, for example, most commonly in the hip, vertebrae, or carpal bones. Osteoporosis can develop at any age, but the risk increases with age. Currently available treatments for osteoporosis include alendronate drugs. Furthermore, supplements containing vitamins and collagen peptides are used to promote bone health and reduce calcium loss. According to WebMD, "Collagen peptides are used for skin aging and osteoarthritis. They are also used for many other purposes, including osteoporosis, brittle nails, and muscle strengthening, but there is no solid scientific evidence to support most of these uses." Alendronate has side effects, including an increased risk of femoral fracture. While supplements may offer some benefit, they cannot treat, suppress, or prevent osteoporosis. More effective treatments for osteoporosis are needed. [Overview of the project]

[0003] This disclosure relates to formulations containing bioactive collagen peptides and vitamin C, and to the use of these formulations for the treatment, suppression, and / or prevention of osteoporosis. This disclosure is based on the discovery that the combination of bioactive collagen peptides and vitamin C acts synergistically in the treatment of osteoporosis. This disclosure is also based on the discovery that the combination of bioactive collagen peptides and vitamin C has an effect substantially equivalent to that of alendronate in the treatment of osteoporosis.

[0004] One embodiment of the present disclosure is a formulation containing a bioactive collagen peptide and vitamin C. In a particular embodiment of the formulation, the bioactive collagen peptide and vitamin C are present in amounts effective for treating, inhibiting, and / or preventing osteoporosis. In an alternative embodiment, the formulation contains about 1 to about 10 g of bioactive collagen peptide and about 20 to about 200 mg of vitamin C. In another embodiment, the formulation contains amounts of bioactive collagen peptide and vitamin C that produce a synergistic effect. Various bioactive collagen peptides can be used in the formulation. In certain embodiments, the average molecular weight of the bioactive collagen peptide is 500 to 20,000 daltons. In other embodiments, the bioactive collagen peptide is derived from bone, such as bovine bone. In certain embodiments of this disclosure, vitamin C is of natural origin. In one embodiment, vitamin C is extracted from fruit. In certain embodiments, vitamin C is extracted from cherries. The formulations of this disclosure may also contain additional vitamins and / or minerals. For example, in one embodiment, the formulation also contains calcium, magnesium, vitamin D, and / or vitamin K (e.g., vitamin K2). In a particular embodiment, the formulation contains about 10 to about 600 mg of calcium, about 10 to about 400 mg of magnesium, about 5 to about 600 IU of vitamin D, and / or about 10 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 to about 600 mg of calcium and about 5 to about 600 IU of vitamin D. In a further embodiment, the formulation contains probiotics (e.g., 10 6 ~10 11 It contains CFU probiotics and herbal medicines. In some embodiments, the formulation contains about 1 to about 20 g of herbal medicine, for example, Rhizoma drynariae. Furthermore, the formulations of this disclosure may include acidity modifiers (e.g., citric acid), natural flavorings, and / or sweeteners. The formulation may be gluten-free and / or sugar-free. In certain embodiments, the formulation is a liquid. Alternatively, the formulation is a solid dosage form. The formulation may contain bioactive collagen peptide and vitamin C in a ratio of 50:1 or higher. In certain embodiments, the formulation contains about 1 to about 10 g of bioactive collagen peptide and about 20 to about 200 mg of vitamin C.

[0005] This disclosure also includes kits containing formulations. The kit may also include instructions for use. In one embodiment, the kit includes the liquid formulation of this disclosure filled in a bottle, and optionally instructions for use. Furthermore, this disclosure includes the use of formulations in the manufacture of pharmaceuticals for the treatment of osteoporosis. This disclosure further includes the use of formulations for the treatment of osteoporosis. The disclosure also includes methods for treating, preventing, or suppressing osteoporosis. The methods include administering the formulations of the disclosure to subjects such as adults. In certain embodiments, the formulations are administered daily. In other embodiments, the formulations contain at least an amount effective to treat, prevent, or suppress osteoporosis, including bioactive collagen peptides and vitamin C. A further aspect of this disclosure is a method for preventing osteoporotic bone formation by administering the formulation of this disclosure to an adult subject. The subject may be an adult, and the administration may include daily administration of the formulation. Other features and advantages of the present invention will become apparent from the following detailed description and examples. The above summary and the embodiments for carrying out the invention described below will be better understood when read in conjunction with the attached drawings. For the purpose of illustrating the invention, embodiments of the present invention are shown in the drawings. However, it should be understood that the invention is not limited to the exact configuration, embodiments, and means presented. [Brief explanation of the drawing]

[0006] [Figure 1A] This figure shows the efficacy (based on fluorescence) of various treatments for dexamethasone-induced osteoporosis (OP) in zebrafish. Specifically, it shows the effects of treatment with various amounts of vitamin C ("VC"), bioactive collagen peptide (BCP), or a combination of vitamin C and bioactive collagen peptide (BCP+VC). Compared to the model, *p<0.05, **p<0.01, ***p<0.001. Compared to BCP+VC 52.0 μg / mL, ###p<0.001. Compared to BCP+VC 104 μg / mL, $$$p<0.001. Compared to BCP+VC 208 μg / mL, Δp<0.05, ΔΔΔp<0.001. [Figure 1B] These are photographs of alizarin red stained zebrafish with dexamethasone-induced osteoporosis (OP), treated with various amounts of vitamin C ("VC"), bioactive collagen peptide (BCP), or a combination of vitamin C and bioactive collagen peptide (BCP+VC). [Figure 2A] This figure shows the efficacy (based on fluorescence) of various treatments for dexamethasone-induced osteoporosis (OP) in zebrafish. Specifically, it shows the effects of treating zebrafish with alendronate sodium (5 μg / mL), bioactive collagen peptide (BCP) (208 μg / mL), or a combination of bioactive collagen peptide (208 μg / mL) and vitamin C (13.8 μg / mL) (BCP+VC) for 12, 24, 36, and 48 hours. Compared to the dexamethasone-treated group, **p<0.01, ***p<0.001. Compared to BCP, 12 hours, ##p<0.01, ###p<0.001. Compared to BCP+VC, 12 hours, $p<0.05, $$$p<0.001. Compared to BCP+VC over 24 hours, ΔΔp<0.01 and ΔΔΔp<0.001. Compared to BCP+VC over 36 hours, ★p<0.05 and ★★★p<0.001. Compared to BCP+VC over 48 hours, □p<0.05 and □p<0.001. [Figure 2B] These are photographs of alizarin red-stained zebrafish with dexamethasone-induced osteoporosis (OP), treated for 12, 24, 36, and 48 hours with either sodium alendronate (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). [Figure 3A]This figure shows the efficacy (based on fluorescence) of various pretreatments before dexamethasone-induced osteoporosis (OP) in zebrafish. Specifically, it shows the effects of pretreatment 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 before dexamethasone-induced osteoporosis (OP) in zebrafish. Compared to BCP+VC, 48 hours of pretreatment, **p<0.01, ***p<0.001. Compared to BCP+VC, 24 hours of pretreatment, #p<0.05, ###p<0.001. Compared to BCP+VC, 0 hours of pretreatment, $p<0.05, $$$p<0.001. [Figure 3B] These are photographs of alizarin red-stained zebrafish specimens with dexamethasone-induced osteoporosis (OP), pre-treated for 0, 24, and 48 hours with either sodium alendronate (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) before dexamethasone-induced osteoporosis. [Modes for carrying out the invention]

[0007] The general description and the following detailed description are illustrative and descriptive only and do not limit the invention as defined in the attached claims. This disclosure is based on the discovery that a combination of bioactive collagen peptide and vitamin C (ascorbic acid) has a synergistic effect in the treatment of osteoporosis. Specifically, it has been found that the combination of bioactive collagen peptide and vitamin C is effective in the recovery from osteoporosis and / or the prevention of osteoporotic bone formation. In particular (as shown in Example 1 below), the combination of collagen peptide and vitamin C may produce a better effect than collagen peptide alone or vitamin C alone. Specifically, this combination showed an effect equivalent to that of a drug (alendronate sodium), but in the form of a food solution. Accordingly, this disclosure provides formulations containing bioactive collagen peptides and vitamin C. These formulations promote bone growth, reverse osteoporosis, and prevent osteoporotic bone formation. These formulations can treat osteoporosis and have shown effects equivalent to those of the drug (alendronate sodium), but are in the form of food supplements, such as solutions. Other aspects of the present invention will become apparent to those skilled in the art from the modes for carrying out the invention described herein. For clarity in the disclosure and without the intention of limitation, the modes for carrying out the invention are divided into subcategories that describe or explain specific features, embodiments, or applications of the invention.

[0008] definition Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those skilled in the art to which the present invention pertains. Any methods and materials similar or equivalent to those described herein may also be used in carrying out or testing the present invention, but representative exemplary methods and materials are described below. All publications and patents referenced herein are incorporated herein by reference as if specifically and individually indicated that each publication or patent is being referred to by reference, and are incorporated herein by reference to disclose and explain methods and / or materials relating to the cited publications. Any reference to a publication is intended to indicate that the disclosure occurred prior to the filing date of this application and should not be construed as acknowledging that the application does not have prior rights to such publication by prior invention. Furthermore, the publication dates stated may differ from the actual publication dates and may require further verification.

[0009] It should be noted that the singular forms "a," "an," and "the" used herein and in the appended claims include the plural form unless otherwise clearly indicated by the context. Furthermore, it should be noted that claims may be written to exclude any element. For this reason, this statement is intended to serve as an antecedent for the use of exclusive terms such as "exclusively" and "only," or for the use of "negative" limitation, in relation to the description of elements of a claim. Each embodiment described and illustrated herein has its own distinct components and features, which can be readily separated or combined with features of any of the other embodiments without departing from the scope or spirit of the invention. The methods described may be carried out in the order described herein or in any other logically possible order. The term “about” as used herein, when referring to a measurable value such as quantity or time, means to include a difference of ±20% or ±10%, more preferably ±5%, even more preferably ±1%, and even more preferably ±0.1% from a specified value, such a difference being appropriate for carrying out the disclosed method. It should also be understood that the terms used herein are for the purpose of describing specific embodiments and are not intended to be limiting. As used herein, the terms "comprising," "including," "containing," and "characterized by" are interchangeable, inclusive, and non-limiting, and do not exclude additional elements or method steps not recited. In particular, in the description of the components of a composition and the elements of an apparatus, the term "comprising" as used herein should be understood to encompass compositions and methods consisting essentially of or consisting of the recited components or elements. As used herein, the term "consisting of" excludes any element, step, or component not specified in the claim element. As used in the specification, the term "about" when referring to a measurable value such as an amount, time, etc. means including a difference of ±20% or ±10%, more preferably ±5%, still more preferably ±1%, and even more preferably ±0.1% from the specified value, and such differences are appropriate for carrying out the disclosed method.

[0010] Before describing specific embodiments in detail, it should be understood that the present invention is not limited to the specific embodiments described, and of course there may be differences. Since the scope of the present invention is limited only by the appended claims, it should also be understood that the terms used herein are for the purpose of describing specific embodiments and are not intended to be limiting. When providing a range of values, unless clearly indicated otherwise in the context, each intermediate value between the upper and lower limits of the range is to the tenth of the unit of the lower limit and, as well as any other recited value or intermediate value within the recited range, is understood to be included in the present invention. The upper and lower limits of these narrower ranges may independently be included in a narrower range and are also included in the present invention, except where there are limits specifically excluded within the recited range. When the recited range includes one or both of the limits, ranges excluding either or both of the included limits are also included in the present invention. It should also be understood that the terms used herein are for the purpose of describing specific embodiments and are not intended to be limiting. As used herein, the terms "comprising," "including," "containing," and "characterized by" are interchangeable, inclusive, and open-ended, and do not exclude additional elements or method steps not recited. In particular, in the description of the components of a composition and the elements of an apparatus, the term "comprising" as used herein should be understood to encompass compositions and methods consisting essentially of, or consisting of, the recited components or elements.

[0011] As used herein, the terms "patient" or "subject" are interchangeable and refer to a mammal. In some embodiments, the patient or subject is a human. In other embodiments, the patient or subject is a farm animal or work animal, a breeding animal 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 pediatric, i.e., less than 18 years of age. Ranges: Throughout this disclosure, various aspects of the invention may be presented in a range format. The description in range format is for convenience and brevity only and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to specifically disclose all the possible sub-ranges within that range, as well as the individual numerical values. For example, a description of the range 1-6 should be considered to specifically disclose sub-ranges such as 1-3, 1-4, 1-5, 2-4, 2-6, 3-6, etc., as well as the individual numerical values within that range, such as 1, 2, 2.7, 3, 4, 5, 5.3, and 6. This applies regardless of the width of the range. As used herein, and as is well known to those of skill in the art, "treatment" is an approach for obtaining a beneficial or desirable result, including clinical results. For the purposes of the present invention, beneficial or desirable clinical results include, but are not limited to, alleviation or improvement of one or more symptoms, reduction in the degree of a disease, stabilization of a disease state (i.e., not worsening), prevention of disease spread, delay or deceleration of disease progression, improvement or alleviation of a disease state, and (partial or complete) remission, whether detectable or not. "Treatment" can also mean an extension of survival as compared to the expected survival period without treatment.

[0012] For clarity, it should be understood that certain features of the invention described herein in the context of separate embodiments may also be provided in combination in a single embodiment. That is, unless clearly incompatible or excluded, each individual embodiment is considered combinable with any other one or more embodiments, and such combination is considered a separate embodiment. Conversely, for brevity, various features of the invention described in the context of a single embodiment may also be provided individually or in any partial combination. Furthermore, it should be noted that claims may be written to exclude any element. For this reason, this statement is intended to serve as an antecedent for the use of exclusive terms such as “exclusively,” “only,” or “negative” limitation in relation to the description of elements of a claim. Embodiments may be described as part of a series of steps or as part of a more general structure, but each of the steps may also be considered an independent embodiment in itself. Before describing specific embodiments in detail, it should be understood that the present invention is not limited to the specific embodiments described and may, of course, differ. Since the scope of the present invention is limited only by the appended claims, it should also be understood that the terms used herein are merely for describing specific embodiments and are not intended to limit them.

[0013] formulation This disclosure provides formulations containing bioactive collagen peptides and vitamin C. The formulations may be liquids, solids, or gels. In other embodiments, the formulations may be chewable. One embodiment of this disclosure is a liquid formulation containing bioactive collagen peptides and vitamin C. Another embodiment of this disclosure is a solid formulation containing bioactive collagen peptides and vitamin C. In further embodiments, the Disclosure provides formulations containing active ingredients capable of treating, inhibiting, and / or preventing osteoporosis. In certain embodiments of these formulations, the active ingredients capable of treating, inhibiting, and / or preventing osteoporosis are bioactive collagen peptides and vitamin C. In further embodiments, the active ingredients capable of treating, inhibiting, and / or preventing osteoporosis are bioactive collagen peptides and vitamin C, and the formulation does not contain any additional active ingredients capable of treating, inhibiting, and / or preventing osteoporosis.

[0014] In certain embodiments, the average molecular weight of the bioactive collagen peptide is approximately 500 to 20,000 daltons, or approximately 1,000 to 10,000 daltons, or approximately 500 to 15,000 daltons, or approximately 1,000 to 8,000 daltons, or approximately 5,000 daltons, or approximately 3,000 to 6,000 daltons, or approximately 4,500 to 5,500 daltons. In certain embodiments, the bioactive collagen peptide is a fragment of animal collagen. In certain embodiments, the bioactive collagen peptide is bone-derived. In one embodiment, the bioactive collagen peptide is a bioactive collagen peptide derived from bovine bone. In certain embodiments, vitamin C is provided in the form of a fruit powder containing vitamin C. In other embodiments, vitamin C is extracted from a fruit such as a cherry. In certain embodiments, vitamin C is extracted from acerola cherries. In other embodiments, vitamin C is obtained by chemical synthesis. In certain embodiments, the bioactive collagen peptide and vitamin C are present in amounts effective for treating, inhibiting, and / or preventing osteoporosis. In one embodiment, the bioactive collagen peptide and vitamin C are present in amounts effective for treating osteoporosis. In another embodiment, the bioactive collagen peptide and vitamin C are present in amounts that inhibit osteoporosis. In an alternative embodiment, the bioactive collagen peptide and vitamin C are present in amounts that prevent osteoporosis. In yet another embodiment, the bioactive collagen peptide and vitamin C are present in amounts that prevent osteoporotic bone formation. In some embodiments, the formulation contains a synergistic amount of bioactive collagen peptide and vitamin C to treat, suppress, and / or prevent osteoporosis. In one embodiment, the formulation contains a synergistic amount of bioactive collagen peptide and vitamin C to treat osteoporosis. In another embodiment, the formulation contains a synergistic amount of bioactive collagen peptide and vitamin C to suppress osteoporosis. In an alternate embodiment, the bioactive collagen peptide and vitamin C are present in amounts sufficient to prevent osteoporosis.

[0015] The formulations of this disclosure may also contain additional vitamins and / or minerals. In certain embodiments, the formulation also contains calcium, magnesium, vitamin D, and / or vitamin K. In certain 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 medicines. In certain embodiments, the formulation contains 10 6 ~10 11 cfu, or 10 7 ~10 10 cfu, or 10 8 ~10 10 It contains CFU probiotics. In certain embodiments, the formulation contains about 1 to about 20 g, or about 1 to about 15 g, or about 2 to about 10 g of herbal medicine, such as Rhizoma drynariae. Furthermore, the formulations of this disclosure may contain additives commonly used in the manufacture of formulations. In certain embodiments, the formulations may also contain sweeteners, colorants, natural flavorings, acidity modifiers, and combinations thereof. In embodiments, the acidity modifier is citric acid. In certain embodiments, the formulations of this disclosure are gluten-free (i.e., do not contain gluten). In other embodiments, the formulations are sugar-free (i.e., no sugar is added). In additional embodiments, the formulations are gluten-free and sugar-free.

[0016] In certain embodiments, the formulation contains about 1 to about 10 g, or about 2 to about 11 g, or about 2 to about 8 g, or about 1 to about 5 g, or about 1.25 to about 5 g, or about 1 to about 6 g, or about 1 to about 7 g of bioactive collagen peptides. In other embodiments, the formulation contains about 20 to about 200 mg, or about 10 to about 150 mg, or about 50 to about 150 mg, or about 10 to about 90 mg, or about 2 to about 85 mg, or about 2 to about 120 mg of vitamin C. In further embodiments, the formulation contains about 10 to about 600 mg, or about 10 to about 400 mg, or about 10 to about 150 mg, or about 50 to 400 mg, or about 100 to about 600 mg of calcium. In alternative embodiments, the formulation contains about 10 to about 400 mg, or about 10 to about 200 mg, or about 10 to about 150 mg, or about 50 to 400 mg, or about 100 to about  400 mg of magnesium. In additional embodiments, the formulation contains about 5 to about 600 IU, or about 10 to about 600 IU, or about 10 to about 500 IU, or about 50 to about 450 IU of vitamin D. In further embodiments, the formulation contains about 10 to about 200 mcg, or about 2 to about 180 mcg, or about 3 to about 150 mcg, or about 50 to about 125 mcg of vitamin K. In certain embodiments, the formulation contains one or more of bioactive peptides, vitamin C, and calcium, magnesium, vitamin D, and vitamin K in one of the appropriate amounts described respectively. In certain embodiments, the formulation is formulated to provide the above dosages once daily, either as a solid or as a liquid. Alternatively, the above dosages may be provided in a multiple-dosage form per day.

[0017] In certain embodiments, the formulation contains at least the components of Formulations A - G shown in the following table in the amounts described in the table. In certain embodiments, the formulation contains at least the components of Formulations A - G shown in the following table and is formulated to provide a daily dosage in the amounts described in the table. Formulations A - G contain 10 6 ~10 11 cfu of probiotics and / or about 1 to about 20 g of crude drugs, such as Rhizoma drynariae, may be included. [Table 1]

[0018] In some embodiments, the formulation is a liquid. The liquid formulation is formulated to provide the amounts of the bioactive collagen peptide, vitamin C, and other components of the formulation as described above. In certain embodiments, the formulation contains a bioactive collagen peptide and vitamin C, wherein the ratio of the bioactive collagen peptide 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. In certain embodiments, the formulation contains bioactive collagen peptide and vitamin C, wherein the formulation contains about 1 to about 10 g, or about 0.5 to about 11 g, or about 2 to about 8 g, or about 3 to about 7 g, or about 1 to about 5 g of bioactive collagen peptide, and about 20 to about 200 mg, or about 10 to about 100 mg, or about 50 to about 150 mg, or about 20 to about 125 mg of vitamin C. The formulation may be solid or liquid. In other embodiments, the formulation is a food supplement. In additional embodiments, the formulation comprises an active ingredient capable of treating, inhibiting, and / or preventing osteoporosis, calcium, and / or vitamin D. In one embodiment, the active ingredient capable of treating, inhibiting, and / or preventing osteoporosis is a bioactive collagen peptide and vitamin C, and the formulation does not contain any additional active ingredient capable of treating, inhibiting, and / or preventing osteoporosis. In a further embodiment, the formulation comprises: an active ingredient capable of treating, inhibiting, and / or preventing osteoporosis, wherein the active ingredients are a bioactive collagen peptide and vitamin C; calcium; and vitamin D. In a further embodiment, the formulation comprises: an active ingredient capable of treating, inhibiting, and / or preventing osteoporosis, wherein the active ingredients consist of a bioactive collagen peptide and vitamin C; calcium; and vitamin D.

[0019] Use of preparations The formulations of this disclosure, containing bioactive collagen peptides and vitamin C, can promote bone growth, reverse osteoporosis, and prevent osteoporotic bone formation. The tests shown in Example 1 below demonstrate that the formulations can treat, suppress, and / or prevent osteoporosis and also prevent osteoporotic bone formation. Furthermore, the formulations of this disclosure exhibit superior efficacy compared to the use of bioactive collagen peptides or vitamin C alone. Accordingly, another aspect of the present disclosure is the use of a formulation containing bioactive collagen peptides and vitamin C to prevent osteoporotic bone formation and to treat, suppress, and / or prevent osteoporosis. One embodiment of the present disclosure is a method for treating, suppressing, and / or preventing osteoporosis in a subject. The method comprises administering a formulation of the present disclosure. In certain embodiments, the method comprises administering the formulation in an amount effective to treat, suppress, and / or prevent osteoporosis in a subject. In one embodiment, the method treats osteoporosis. In another embodiment, the method suppresses osteoporosis. In another embodiment, the method prevents osteoporosis. As used herein, “preventing osteoporosis” includes prophylactic administration of the formulation. In certain embodiments of the present disclosure, the method includes screening for osteoporosis. In other embodiments, administration includes providing a liquid formulation of the present disclosure for the subject to be ingested later. In certain embodiments, the subject is an adult, e.g., 30 years of age or older. In further embodiments, the method includes daily administration of the formulation. Another embodiment of the present disclosure is a method for preventing osteoporotic bone formation. The method includes, for example, administering a formulation of the present disclosure in an amount effective to prevent osteoporotic bone formation. Certain embodiments of the method include providing a liquid formulation of the present disclosure for later intake by a subject. The subject may be an adult. In one embodiment, the subject is 30 years of age or older. Another embodiment is the use of the formulation of the present disclosure in the manufacture of a pharmaceutical product for the treatment of osteoporosis. Yet another embodiment is the use of the formulation of the present disclosure for the treatment of osteoporosis. In certain embodiments, the methods and uses of the formulations of this disclosure have effects equivalent to those of alendronate sodium. In other embodiments, the combination of bioactive peptides and vitamin C acts synergistically to treat, suppress and / or prevent osteoporosis, and / or prevent osteoporotic bone formation.

[0020] kit In another embodiment, this disclosure relates to a kit comprising the formulation disclosed herein. The kit may optionally include instructions for use. In certain embodiments of the Disclosure, the kit includes the liquid formulation disclosed herein, filled in a bottle, and optionally, instructions for use. In other embodiments, the formulation of the Disclosure is in the form of a pill, tablet, or capsule, and the kit includes a bottle containing the pill, tablet, or capsule. In other embodiments, the formulation of the Disclosure is in the form of a pill, tablet, or capsule, and the kit includes a blister pack containing the pill, tablet, or capsule. Without further detail, those skilled in the art will likely be able to implement and utilize the present invention and practice the claimed methods using the foregoing description and the following examples. Accordingly, the following examples illustrate preferred embodiments of the present invention and should not be construed as limiting the remainder of this disclosure in any way. [Examples]

[0021] Example 1: Effects of bioactive collagen peptide and vitamin C on osteoporosis Existing food components (vitamin C and collagen peptides) are thought to have some health benefits related to collagen formation in the body, which may be associated with bone health. However, the direct health effects of this combination of components on osteoporosis are unknown. Therefore, in this study, we investigated the protective effect of a combination of bovine bone-derived bioactive collagen peptide (BCP) and vitamin C (VC) against dexamethasone-induced osteoporosis (OP) in zebrafish.

[0022] method Anti-osteoporosis: Zebrafish (wild-type, AB strain, 72 hours post-fertilization) with dexamethasone-induced osteoporosis were treated with various concentrations of BCP and / or vitamin C for 48 hours. BCP was derived from bovine bone subjected to a specific hydrolysis process, possessing a characteristic peptide pattern and an average molecular weight of 5 kDa. Vitamin C was extracted from acerola cherries. Alizarin red staining was performed at various time points within 48 hours. Fluorescence intensity of vertebrae was analyzed. Prevention of osteoporosis: Zebrafish (wild-type, AB strain) 24 or 48 hours post-fertilization were pre-treated with BCP and / or vitamin C for 48 or 24 hours, respectively, followed by co-treatment with dexamethasone. Alizarin red staining was performed 48 hours after co-treatment. Fluorescence intensity of the vertebrae was analyzed. A control group (wild-type, AB strain, untreated), a model group (wild-type, AB strain, dexamethasone-treated), and a group treated with alendronate sodium (5 μg / mL) were established in both groups as a positive control.

[0023] result Dexamethasone treatment significantly reduced the fluorescence intensity of zebrafish vertebrae, and alendronate sodium effectively restored dexamethasone-induced bone loss. Anti-osteoporosis: Compared to the control group, treatment with both BCP and vitamin C significantly increased the fluorescence intensity of the vertebrae (p<0.05). The protective effect was dose-dependent, and better results were obtained by combining BCP and vitamin C, suggesting a synergistic effect between BCP and vitamin C. Prevention of osteoporosis: Compared to the untreated group, pretreatment with BCP and vitamin C tended to restore the fluorescence intensity of the vertebrae of dexamethasone-treated zebrafish (p=0.16). Specifically, it was observed that BCP acted synergistically with vitamin C to improve dexamethasone-induced osteoporosis in zebrafish (see Figures 1A and 1B). Compared to the control group, treatment with both BCP and vitamin C significantly increased the fluorescence intensity of the vertebrae (p<0.05). Furthermore, the protective effect was dose-dependent, and better results were obtained by combining BCP and vitamin C, suggesting a synergistic effect between BCP and vitamin C. Furthermore, vitamin C enhanced the protective effect of BCP against dexamethasone-induced bone loss in zebrafish (see Figures 2A and 2B). The protective effect against bone loss was observed as early as 48 hours after dexamethasone treatment in both the BCP and BCP+VC groups. The protective effect against dexamethasone-induced bone loss was superior in the BCP+VC group compared to the BCP group at all measurement time points. During the treatment period (BCP+VC 12 hours vs. BCP 24 hours; BCP+VC 24 hours vs. BCP 36 hours), the BCP+VC group recovered comparable levels of bone loss earlier than the BCP group. Furthermore, pretreatment with BCP + vitamin C tended to prevent bone loss in dexamethasone-treated zebrafish (see Figures 3A and 3B). Pretreatment with BCP and vitamin C tended to restore the fluorescence intensity of the vertebrae in dexamethasone-treated zebrafish (p=0.16). In addition, treatment with the combination of BCP and vitamin C showed an effect almost equivalent to treatment with alendronate sodium. The tests in this embodiment demonstrated that bioactive collagen peptides synergistically act with vitamin C to improve dexamethasone-induced osteoporosis in zebrafish. Specifically, in zebrafish with dexamethasone-induced osteoporosis, the combination of bioactive collagen peptides and vitamin C was found to be more effective than the single component. The observed effects were comparable to those of alendronate, an osteoporosis treatment drug, in terms of recovery from osteoporosis and prevention of osteoporotic bone formation.

[0024] Example 2: Conversion of test dose to human dose In Example 1, various combinations of bioactive collagen peptides and vitamin C were evaluated in a zebrafish model. These dosages correspond to the following human dosages. [Table 2] [Table 3] While the present invention has been described and illustrated herein with reference to various specific materials, procedures, and examples, it is naturally not limited to any particular combination of materials and procedures selected for its purposes. As those skilled in the art will understand, numerous variations can be implied in such details. The specification and examples are illustrative only, and the true scope and spirit of the invention are intended to be shown by the following claims. All references, patents, and patent applications referenced herein are incorporated herein by reference in their entirety.

[0025] Embodiment The present invention also provides the following non-limiting embodiments. Embodiment 1. A formulation comprising a bioactive collagen peptide and vitamin C, wherein the bioactive collagen peptide and vitamin C are present in amounts effective for treating, suppressing, and / or preventing osteoporosis. Embodiment 2. The formulation according to Embodiment 1, wherein the formulation contains a synergistic amount of bioactive collagen peptide and vitamins. Embodiment 3. The formulation according to Embodiment 1 or 2, wherein the average molecular weight of the bioactive collagen peptide is 500 to 20,000 daltons. Embodiment 4. The formulation according to any one of Embodiments 1 to 3, wherein the bioactive collagen peptide is derived from bone. Embodiment 5. The formulation according to any one of Embodiments 1 to 4, wherein vitamin C is extracted from fruit. Embodiment 6. The formulation according to Embodiment 5, wherein vitamin C is extracted from cherries. Embodiment 7. The formulation according to any one of Embodiments 1 to 6, further comprising calcium, magnesium, vitamin D, and / or vitamin K. Embodiment 8. The formulation according to Embodiment 7, wherein the formulation comprises about 10 to about 600 mg of calcium, about 10 to about 400 mg of magnesium, about 5 to about 600 IU of vitamin D, and / or about 10 to about 200 mcg of vitamin K. Embodiment 9. The formulation according to Embodiment 8, wherein the formulation contains calcium and vitamin D. Embodiment 10. The formulation according to Embodiment 9, wherein the formulation contains about 10 to about 600 mg of calcium and about 5 to about 600 IU of vitamin D. Embodiment 11. The formulation according to any one of Embodiments 1 to 10, wherein the formulation is gluten-free. Embodiment 12. The formulation according to any one of Embodiments 1 to 11, further comprising an acidity adjusting agent. Embodiment 13. The formulation according to Embodiment 12, wherein the acidity adjusting agent is citric acid. Embodiment 14. The formulation according to any one of Embodiments 1 to 13, further comprising a natural flavoring agent. Embodiment 15. The formulation according to any one of Embodiments 1 to 14, further comprising a sweetener. Embodiment 16. The formulation according to any one of Embodiments 1 to 15, wherein the formulation is sugar-free. Embodiment 17. The formulation according to any one of Embodiments 1 to 16, wherein the formulation contains bioactive collagen peptide and vitamin C in a ratio of 50:1. Embodiment 18. The formulation according to any one of Embodiments 1 to 17, wherein the formulation contains about 1 to about 10 g of bioactive collagen peptide and about 20 to about 200 mg of vitamin C. Embodiment 19. The formulation is 10 6 ~10 11 The formulation according to Embodiment 18, further comprising a probiotic of cfu and / or about 1 to about 20 g of herbal medicine. Embodiment 20. The formulation according to Embodiment 19, wherein the formulation contains Rhizoma drynariae. Embodiment 21. The formulation according to any one of Embodiments 1 to 20, wherein the formulation is a liquid formulation. Embodiment 22. The formulation according to any one of Embodiments 1 to 20, wherein the formulation is a solid dosage form. Embodiment 23. A kit comprising the formulation described in any one of Embodiments 1 to 20, and optionally an instruction manual. Embodiment 24. A kit comprising the liquid formulation described in Embodiment 21, filled in a bottle, and optionally an instruction manual. Embodiment 25. Use of a formulation according to any one of Embodiments 1 to 22 in the manufacture of a pharmaceutical product for treating osteoporosis. Embodiment 26. Use of the formulation according to any one of Embodiments 1 to 22 for the treatment of osteoporosis. Embodiment 27. A method for treating, preventing, or suppressing osteoporosis, comprising administering a preparation described in any one of Embodiments 1 to 22 to the target. Embodiment 28. The method of Embodiment 27, wherein the subject is an adult. Embodiment 29. The method according to Embodiment 27 or 28, wherein the method includes daily administration of the formulation. Embodiment 30. A method for preventing osteoporotic bone formation, comprising administering the preparation described in any one of Embodiments 1 to 22 to a target. Embodiment 31. The method according to Embodiment 30, wherein the subject is an adult. Embodiment 32. The method according to Embodiment 30 or 31, wherein the method includes daily administration of the formulation.

Claims

1. A formulation comprising a bioactive collagen peptide and vitamin C, wherein the bioactive collagen peptide and vitamin C are present in amounts effective for treating, suppressing, and / or preventing osteoporosis.

2. The formulation according to claim 1, wherein the formulation comprises an amount of the bioactive collagen peptide and vitamins that produces a synergistic effect.

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. A preparation according to any one of claims 1 to 6, further comprising calcium, magnesium, vitamin D, and / or vitamin K.

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

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

10. The preparation according to claim 9, wherein the preparation comprises about 10 to about 600 mg of calcium and about 5 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. A formulation according to any one of claims 1 to 11, further comprising an acidity adjusting agent.

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

14. A formulation according to any one of claims 1 to 13, further comprising a natural flavoring agent.

15. A 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 a bioactive collagen peptide and vitamin C in a ratio of 50:

1.

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

19. The aforementioned formulation is 10 6 ~10 11 The formulation according to claim 18, further comprising a probiotic of CFU and / or about 1 to about 20 g of herbal medicine.

20. The formulation according to claim 19, wherein the formulation comprises Rhizoma drynariae.

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

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

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

24. A kit comprising the liquid preparation described in claim 21, filled in a bottle, and optionally an instruction manual.

25. Use of a preparation according to any one of claims 1 to 22 in the manufacture of a pharmaceutical product for treating osteoporosis.

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

27. A method for treating, preventing, or suppressing osteoporosis, comprising administering a preparation according to any one of claims 1 to 22.

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

29. The method according to claim 27 or 28, wherein the method includes daily administration of the formulation.

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

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

32. The method according to claim 30 or 31, wherein the method includes daily administration of the formulation.

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