Composition and health-care product for promoting bone health and preparation method of health-care product

Abstract

The invention discloses a composition for promoting bone health, a health-care product and a preparation method of the health-care product. The composition for promoting bone health is prepared from 25 to 200 parts of casein phosphopeptides and 25 to 4000 parts of calcium carbonate. Preferably, the composition for promoting bone health further comprises the following components in parts by weight: 60 to 250 parts of magnesium oxide, 0.0005 to 0.0020 part of vitamin D and 0.0020 to 0.010 part of vitamin K. The composition disclosed by the invention is simple in raw material composition, has the effects of increasing the bone calcium content and the constant weight of thighbone, can improve osteoporosis and has a good application prospect. The invention also provides a health-care product prepared from the composition for promoting bone health, and the preparation method of the health-care product is simple, easy to operate and suitable for large-scale production.

Description

Technical Field

[0001] The invention belongs to the technical field of health care products, and in particular relates to a composition for promoting bone health, a health care product and a preparation method thereof. Background Art

[0002] Osteoporosis is a systemic bone metabolic disease, which is mainly characterized by decreased bone mass and changes in bone microstructure. The most common symptom of osteoporosis is low back pain, which accounts for 70% to 80% of patients with pain. The pain spreads to both sides along the spine, and is relieved when lying on your back or sitting. It is aggravated when standing upright or stretching back or standing or sitting for a long time. The pain is mild during the day and worsens at night and when waking up in the early morning, and worsens when bending over or doing muscle exercise. Osteoporosis is usually caused by a decrease in bone calcium content, reduced bone formation, and an imbalance in bone mineral metabolism, leading to a decrease in bone mass. Therefore, improving osteoporosis requires increasing bone calcium content.

[0003] Osteoporosis is a degenerative bone disease, and the risk of disease increases with age. At the same time, osteoporosis is also a common and frequently-occurring disease that threatens menopausal women. Osteoporosis seriously endangers people's physical health and normal life, and patients suffer both physically and mentally. It has now become an important health problem for all mankind. At present, the prevention and treatment of osteoporosis mainly rely on hormone drugs, and long-term use of hormone drugs can cause many side effects. Therefore, it is of great significance to develop a safe and effective health product that can improve osteoporosis. Casein Phosphopeptides (CPPs) are a group of bioactive peptides involved in multiple functional effects. They are used as nutritional supplements worldwide, but the role of CPPs and calcium compound health products in increasing bone calcium content and femoral constant weight has not been reported. Summary of the invention

[0004] In view of this, the present invention provides a composition for promoting bone health, a health product and a preparation method thereof. The composition of the present invention has the effect of improving osteoporosis, has simple ingredients, stable quality, and has a significant effect of increasing bone calcium content and femoral constant weight, and has good market application prospects.

[0005] To achieve the above object, the present invention adopts the following technical solutions:

[0006] In a first aspect, the present invention provides a composition for promoting bone health, comprising, by weight: 25-200 parts of casein phosphopeptide and 25-4000 parts of calcium carbonate.

[0007] Among them, the number of casesin phosphopeptide parts can be 40 parts, 55 parts, 70 parts, 85 parts, 100 parts, 115 parts, 130 parts, 145 parts, 160 parts, 175 parts, 190 parts, etc., the number of calcium carbonate parts can be 100 parts, 500 parts, 1000 parts, 1500 parts, 2000 parts, 2500 parts, 3000 parts, 3500 parts, 3900 parts, etc., and other specific point values ​​within the above numerical ranges can be selected, which will not be repeated here.

[0008] Preferably, the composition comprises, by weight: 50-100 parts of casein phosphopeptide and 250-2000 parts of calcium carbonate.

[0009] Preferably, the composition further comprises magnesium oxide, vitamin D and vitamin K.

[0010] Preferably, the composition further comprises, by weight, 60-250 parts of magnesium oxide, 0.0005-0.0020 parts of vitamin D, and 0.0020-0.010 parts of vitamin K.

[0011] The invention compounds casein phosphopeptide and calcium carbonate in a specific ratio, and the composition has the effect of increasing bone calcium content and femur constant weight, thereby improving osteoporosis.

[0012] In a second aspect, the present invention provides a use of the composition according to the first aspect in preparing a health product for promoting bone health.

[0013] Preferably, the promoting bone health is to increase bone calcium content and / or increase femoral constant weight.

[0014] In a third aspect, the present invention provides a health product for promoting bone health, wherein the raw materials for preparing the health product include the composition described in the first aspect.

[0015] Preferably, the health care product further comprises pharmaceutically acceptable excipients.

[0016] Preferably, the auxiliary material comprises any one of fillers, flavoring agents, colorants, wetting agents or lubricants, or a combination of at least two of them.

[0017] Preferably, the filler comprises maltodextrin, sorbitol or mannitol.

[0018] Preferably, the flavoring agent comprises orange flavor or sucralose.

[0019] Preferably, the colorant is sunset yellow.

[0020] Preferably, the wetting agent is ethanol.

[0021] Preferably, the lubricant is magnesium stearate.

[0022] Preferably, the dosage form of the health care product includes tablets, granules, pills or capsules.

[0023] In a fourth aspect, the present invention provides a method for preparing the health product for promoting bone health according to the third aspect, the preparation method comprising the following steps: (1) Sieving: After weighing the raw materials according to their amounts, sieve them for later use; (2) Granulation: the raw materials in step (1) are mixed evenly, a wetting agent is sprayed into the mixture to make a soft material, and the soft material is sieved to obtain wet granules; (3) Drying: Drying the wet granules obtained in step (2) to obtain the health care product.

[0024] Preferably, in step (2), the wetting agent is 65% concentration ethanol, and the amount used is 30%-35% of the weight of the mixed powder.

[0025] Preferably, in step (3), the drying temperature of the drying treatment is 55-60°C, and the particles are dried to a moisture content of 2-5%.

[0026] Compared with the prior art, the present invention has the following beneficial effects: 1. The present invention reasonably compounds casein phosphopeptide and calcium carbonate in a specific ratio to prepare a composition which has the effect of increasing bone calcium content and femoral constant weight, and can be used to improve osteoporosis; 2. The raw material components of the composition of the present invention are simple and easy to control in quality; 3. The preparation method provided by the present invention is simple and easy to operate, and is suitable for large-scale production. DETAILED DESCRIPTION

[0027] To make this application clearer and more complete, the technical solution of the present invention is further described below by specific embodiments. However, the following embodiments are merely examples of the present invention and do not represent or limit the scope of protection of the present invention. The scope of protection of the present invention shall be subject to the claims. It should be noted that, in the absence of conflict, the embodiments in this application and the features in the embodiments may be combined with each other. The present application will be described in detail below with reference to specific embodiments.

[0028] Example 1

[0029] Provided is a composition for promoting bone health, a health product and a preparation method thereof

[0030] A composition for promoting bone health is prepared from the following main raw materials, measured by weight: 100 parts of casein phosphopeptide and 500 parts of calcium carbonate.

[0031] A health product for promoting bone health, wherein the raw materials for preparing the health product include the above-mentioned composition for promoting bone health, and the raw materials for preparing the health product also include 300 parts of mannitol, 100 parts of sorbitol, 0.5 parts of sucralose, 10 parts of orange flavor, and 10 parts of magnesium stearate by weight. The preparation method of the health product comprises the following steps:

[0032] (1) Ingredient sieving: Weigh casein phosphopeptide, calcium carbonate, mannitol, sorbitol, sucralose, and orange flavor according to the formula and sieve for later use;

[0033] (2) Mixing and granulation: the raw materials and auxiliary materials in step (1) are mixed evenly, and a colorant solution of sunset yellow is added, the colorant dosage is 0.02 g / kg; 65% concentration ethanol is used as a wetting agent for granulation, the dosage is 30% of the weight of the mixed powder, and a sieve is used to form wet granules;

[0034] (3) Drying: Drying the wet granules obtained in step (2) at 55° C. until the moisture content of the granules is 2%, and screening the granules with a sieve to obtain granules;

[0035] (4) Tableting: Add magnesium stearate to the granules obtained in step (3), mix well, and tablet.

[0036] Example 2

[0037] Provided is a composition for promoting bone health, a health product and a preparation method thereof

[0038] A composition for promoting bone health is prepared from the following main raw materials, measured by weight: 50 parts of casein phosphopeptide and 500 parts of calcium carbonate.

[0039] A health product for promoting bone health, wherein the raw materials for preparing the health product include the above-mentioned composition for promoting bone health, and the raw materials for preparing the health product also include 300 parts of mannitol, 100 parts of sorbitol, 0.5 parts of sucralose, 10 parts of orange flavor, and 10 parts of magnesium stearate by weight. The preparation method of the health product comprises the following steps:

[0040] (1) Ingredient sieving: Weigh casein phosphopeptide, calcium carbonate, mannitol, sorbitol, sucralose, and orange flavor according to the formula and sieve for later use;

[0041] (2) Mixing and granulation: the raw materials and auxiliary materials in step (1) are mixed evenly, and a colorant solution of sunset yellow is added, the colorant dosage is 0.02 g / kg; 65% concentration ethanol is used as a wetting agent for granulation, the dosage is 32% of the weight of the mixed powder, and the wet granules are formed through a sieve;

[0042] (3) Drying: Drying the wet granules obtained in step (2) at 60° C. until the moisture content of the granules is 5%, and screening the granules with a sieve to obtain granules;

[0043] (4) Tableting: Add magnesium stearate to the granules obtained in step (3), mix well, and tablet.

[0044] Example 3

[0045] Provided is a composition for promoting bone health, a health product and a preparation method thereof

[0046] A composition for promoting bone health is prepared from the following main raw materials, measured by weight: 33 parts of casein phosphopeptide, 500 parts of calcium carbonate, 0.0010 parts of vitamin D, 0.0015 parts of vitamin K, and 150 parts of magnesium oxide.

[0047] A health product for promoting bone health, wherein the raw materials for preparing the health product include the above-mentioned composition for promoting bone health, and the raw materials for preparing the health product also include 400 parts of maltodextrin, 5 parts of sucralose, and 10 parts of orange flavor in parts by weight. The preparation method of the health product includes the following steps:

[0048] (1) Ingredient sieving: weigh casein phosphopeptide, calcium carbonate, magnesium oxide, vitamin D, vitamin K, maltodextrin, sucralose, and orange flavor according to the formula and sieve for later use;

[0049] (2) Mixing and granulation: the raw materials and auxiliary materials in step (1) are mixed evenly, and a colorant solution of sunset yellow is added, the colorant dosage is 0.02 g / kg; 65% concentration ethanol is used as a wetting agent for granulation, the dosage is 35% of the weight of the mixed powder, and the wet granules are formed through a sieve;

[0050] (3) Drying: The wet granules obtained in step (2) are dried at 60°C until the moisture content of the granules is 3%, and sieved to obtain granules.

[0051] Example 4

[0052] Provided is a composition for promoting bone health, a health product and a preparation method thereof

[0053] A composition for promoting bone health is prepared from the following main raw materials, measured by weight: 25 parts of casein phosphopeptide, 500 parts of calcium carbonate, 0.0020 parts of vitamin D, 0.010 parts of vitamin K, and 250 parts of magnesium oxide.

[0054] A health product for promoting bone health, wherein the raw materials for preparing the health product include the above-mentioned composition for promoting bone health, and the raw materials for preparing the health product also include 400 parts of maltodextrin, 5 parts of sucralose, and 10 parts of orange flavor in parts by weight. The preparation method of the health product includes the following steps:

[0055] (1) Ingredient sieving: weigh casein phosphopeptide, calcium carbonate, magnesium oxide, vitamin D, vitamin K, maltodextrin, sucralose, and orange flavor according to the formula and sieve for later use;

[0056] (2) Mixing and granulation: the raw materials and auxiliary materials in step (1) are mixed evenly, and a colorant solution of sunset yellow is added, the colorant dosage is 0.02 g / kg; 65% concentration ethanol is used as a wetting agent for granulation, the dosage is 35% of the weight of the mixed powder, and the wet granules are formed through a sieve;

[0057] (3) Drying: Dry the wet granules obtained in step (2) at 58°C until the moisture content of the granules is 4%, and then sieve the granules to obtain granules.

[0058] Test Case

[0059] Test on the efficacy of the composition of the present invention in improving bone calcium content and femur constant weight

[0060] 1. Experimental Materials

[0061] (1) Preparation of test samples:

[0062] ① Test samples in the positive control group: Weigh CaCO3 powder, add deionized water, mix well, prepare a 12.65 mg / ml suspension, and shake again before oral administration.

[0063] ② Test samples of Example 1 group: Weigh the composition of Example 1, add deionized water, mix well, prepare a 15.80 mg / ml suspension, and shake well again before oral administration.

[0064] ③ Test samples of group 2 of Example 2: Weigh the composition of Example 2, add deionized water, mix well, prepare a 14.15 mg / ml suspension, and shake well again before oral administration.

[0065] ④ Test samples of group 3 of Example 3: Weigh the composition of Example 3, add deionized water, mix well, prepare a 16.20 mg / ml suspension, and shake well again before oral administration.

[0066] ⑤ Test samples of group 4 of Example: Weigh the composition of Example 4, add deionized water, mix well, and prepare a 21.15 mg / ml suspension. Shake well again before oral administration.

[0067] (2) Experimental animals:

[0068] Female weaned SD rats were obtained from Zhejiang Weitonglihua Experimental Animal Technology Co., Ltd. The experimental animal production license was SCXK (Zhejiang) 2019-0001, issued by the Zhejiang Provincial Department of Science and Technology. The animals were kept in the barrier environment rodent room of China Pharmaceutical University. Four animals were kept in each cage on a daily basis, with free access to water and food. The ambient room temperature was 20-26°C, the relative humidity was 40%-70%, the light was 12 hours, the dark was 12 hours, the ventilation was 12 times / h, and the fresh air was 100%.

[0069] 2. Experimental methods

[0070] (1) Grouping and dosing regimen:

[0071] After a one-week adaptation period, four-week-old female weaned SD rats were randomly divided into 6 groups according to body weight: model control group, positive control group, Example 1 group (administered with the composition corresponding to Example 1), Example 2 group (administered with the composition corresponding to Example 2), Example 3 group (administered with the composition corresponding to Example 3), and Example 4 group (administered with the composition corresponding to Example 4), with 20 rats in each group. All groups were fed with low-calcium feed (the measured calcium content in the feed was 151.8 mg / 100 g), the positive control group was gavaged with 10 ml / kg of the test sample prepared with CaCO3, each example group was gavaged with 10 ml / kg of the test sample prepared with the composition of Examples 1-4, and the model control group was gavaged with an equal volume of deionized water.

[0072] (2) Test method:

[0073] During the experiment, each rat in each group was weighed once a week. After 4 weeks of administration, 10 rats from each group were selected and killed, and the femurs on both sides were stripped out and baked in an oven at 105℃ until constant weight. The dry weight of the femur was weighed, and the constant weight of the femur and the bone calcium content of the rats in each group were tested. Another 10 rats were killed 3 months after administration, and the femurs on both sides were stripped out and baked in an oven at 105℃ until constant weight. The dry weight of the femur was weighed, and the constant weight of the femur and the bone calcium content of the rats in each group were tested.

[0074] 3. Experimental results

[0075] After 4 weeks of administration, the results of femur constant weight and bone calcium content of rats in each group are shown in Table 1:

[0076] Table 1 Effects of samples on femoral constant weight and bone calcium content in rats after 4 weeks of administration ( )

[0077] Note: Compared with the model control group, * P<0.05, ** P<0.01.

[0078] As can be seen from Table 1, compared with the model control group, each test sample group has a tendency to increase the femoral constant weight and bone calcium content, among which Example 1 group (P=0.0110) and Example 2 group (P=0.0149) can significantly increase the femoral constant weight; the positive control group (P<0.01) and Example 2 group (P<0.05) can significantly increase the bone calcium content, and Example 1 group has an increasing trend, and the difference is approximately significant (P=0.0506).

[0079] After 3 months of administration, the results of femur constant weight and bone calcium content of rats in each group are shown in Table 2:

[0080] Table 2 Effects of samples on femoral constant weight and bone calcium content in rats after 3 months of administration ( )

[0081] As can be seen from Table 2, compared with the model control group, each test sample group can significantly increase the femoral constant weight and bone calcium content (P<0.05), among which Example 2 group (P<0.0001) has the best effect in increasing the femoral constant weight and bone calcium content.

[0082] It can be seen from the above experimental data that the composition of the present invention can significantly increase the femur constant weight and bone calcium content of rats on a low-calcium diet, indicating that the composition of the present invention can be used to improve osteoporosis.

[0083] The embodiments described above are part of the embodiments of the present application, rather than all of the embodiments. The detailed description of the embodiments of the present application is not intended to limit the scope of the present application for protection, but merely represents the selected embodiments of the present application. Those skilled in the art should understand that any improvements to the present invention, the equivalent replacement of each raw material of the product of the present invention and the addition of auxiliary components, the selection of specific methods, etc., all fall within the protection scope and disclosure scope of the present invention.

[0084] The preferred embodiments of the present invention are described in detail above. However, the present invention is not limited to the specific details in the above embodiments. Within the technical concept of the present invention, a variety of simple modifications can be made to the technical solution of the present invention, and these simple modifications all belong to the protection scope of the present invention.

Claims

1. A composition for promoting bone health, characterized in that: In parts by weight, the composition comprises: 25-200 parts of casein phosphopeptide and 25-4000 parts of calcium carbonate.

2. The composition according to claim 1, characterized in that In parts by weight, the composition comprises: 50-100 parts of casein phosphopeptide and 250-2000 parts of calcium carbonate.

3. The composition according to claim 1, characterized in that In parts by weight, the composition further comprises: 60-250 parts of magnesium oxide, 0.0005-0.0020 parts of vitamin D and 0.0020-0.010 parts of vitamin K.

4. Use of the composition according to any one of claims 1 to 3 in the preparation of a health product for promoting bone health.

5. The use according to claim 4, characterized in that: The promoting bone health is to increase bone calcium content and / or increase femoral constant weight.

6. A health product for promoting bone health, characterized in that: The raw materials for preparing the health care product include the composition according to any one of claims 1 to 3; Preferably, the health product further comprises a pharmaceutically acceptable excipient; Preferably, the auxiliary material comprises any one of fillers, flavoring agents, colorants, wetting agents or lubricants, or a combination of at least two of them.

7. The health care product according to claim 6, characterized in that: The filler includes maltodextrin, sorbitol or mannitol; Preferably, the flavoring agent includes orange flavor or sucralose; Preferably, the colorant is sunset yellow; Preferably, the wetting agent is ethanol; Preferably, the lubricant is magnesium stearate.

8. The health care product according to claim 6 or 7, characterized in that: The dosage form of the health care product includes tablets, granules, pills or capsules.

9. The method for preparing the health care product according to any one of claims 6 to 8, characterized in that: Includes the following step: (1) Sieving: After weighing the raw materials according to their amounts, sieve them for later use; (2) Granulation: the raw materials in step (1) are mixed evenly, a wetting agent is sprayed into the mixture to make a soft material, and the soft material is sieved to obtain wet granules; (3) Drying: Drying the wet granules obtained in step (2) to obtain the health care product.

10. The preparation method according to claim 9, characterized in that: In step (3), the drying temperature of the drying treatment is 55-60°C, and the particles are dried to a moisture content of 2-5%.

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