Nutritional composition for joint protection

Abstract

The invention provides a composition. The composition is prepared from spirulina, haematococcus pluvialis, vitamin D and health-care food or food acceptable auxiliary materials. The composition has the advantages that the composition has a synergistic effect, can effectively improve the swelling degree of inflammatory joints, reduce the inflammatory factor level, increase the bone density and maintain the bone mass, so that the composition can be used for joint protection and can also be used for nutritional supplement of specific people. In addition, the multi-component compound form of the product can obviously improve the taking compliance of users, and the total use cost is saved.

Description

Technical Field

[0001] The invention relates to a composition containing spirulina, Haematococcus pluvialis, vitamin D and supplementary materials acceptable to health products or foods and application thereof, belonging to the field of health foods. Background Art

[0002] Osteoarthritis is a joint disease that is mainly characterized by articular cartilage damage and involves the entire joint tissue, and eventually articular cartilage degeneration, fibrosis, fracture, ulceration and damage to the entire joint surface occur. The clinical manifestations of osteoarthritis are joint pain, stiffness, hypertrophy and limited mobility, which is common in middle-aged and elderly people and is also one of the main causes of disability in the elderly. Although there are many types of products for bone and joint health care in the market, the efficacy of the products is single, the rationality of the formula is insufficient, the absorption and utilization rate is low, and the actual health care effect is limited. In addition, middle-aged and elderly people are also susceptible to osteoporosis, especially women (related to the decline in estrogen levels). Therefore, for the comprehensive health problems of the above bones and joints, it is necessary to develop health care products with both efficacy and efficacy to meet market demand.

[0003] Spirulina is a prokaryotic organism that is spiral or filamentous. It is a photosynthetic multicellular blue-green algae with the characteristics of high protein, low cholesterol and low sugar. It contains 60-70% high-quality protein, essential amino acids, vitamins, essential fatty acids, provitamin A (β-carotene) and other nutrients. It has a wide range of biological activities and health functions and is an ideal pure natural biologically active food. Haematococcus pluvialis is a unicellular green algae that mainly grows in fresh water. It is rarely distributed in the ocean, but the salinity in seawater is conducive to the accumulation of astaxanthin in the algae. Haematococcus pluvialis is recognized as the most ideal source of natural astaxanthin in nature. Astaxanthin, as one of the most efficient pure natural antioxidants discovered, shows good biological activity in scavenging free radicals, anti-aging, anti-tumor and immune regulation. Vitamin D is a fat-soluble vitamin, a general term for a group of steroid derivatives with similar structures, mainly including vitamin D3 (cholecalciferol, cholecalciferol) and vitamin D2 (calciferol). It is well known that vitamin D can promote calcium and phosphorus absorption and prevent rickets in children.

[0004] In the experiment, we explored the combined application of the above nutrients in various forms and different proportions. The results showed that the combined use of a certain proportion of Spirulina, Haematococcus pluvialis and vitamin D can effectively reduce the swelling of the bilateral feet of experimental animals, reduce the expression of inflammatory factors, and increase femoral bone density, regulate bone metabolism balance, promote bone formation and protect bone tissue. Based on this, the present invention provides a multi-component nutritional composition with synergistic effects through optimization, which is used to assist in protecting bone joints, preventing or treating osteoporosis, and improving the symptoms and signs of osteoarthritis. Summary of the invention

[0005] In view of the health care needs of middle-aged and elderly people for dual protection of bones and joints, the present invention provides a safe and effective nutritional composition.

[0006] To achieve the above object, the present invention adopts the following technical solutions:

[0007] A composition comprising:

[0008] a) Spirulina; b) Haematococcus pluvialis; c) vitamin D; d) health food or acceptable excipients for foods, wherein the mass ratio of spirulina, astaxanthin and vitamin C is 50-10000:10-1000:0.002-0.02.

[0009] In the present invention, as a preferred embodiment, the mass ratio of Spirulina, Haematococcus pluvialis and vitamin D is 200-5000:20-500:0.005-0.01.

[0010] In the present invention, the amount of spirulina is 50 to 10,000 parts, the amount of Haematococcus pluvialis is 10 to 1,000 parts, and the amount of vitamin D is 0.002 to 0.02 parts.

[0011] In the present invention, the spirulina is 2000-5000 parts, the Haematococcus pluvialis is 200-500 parts, and the vitamin D is 0.005-0.01 parts.

[0012] In the present invention, as a preferred embodiment, the composition comprises 500 parts of Spirulina, 100 parts of Haematococcus pluvialis and 0.002 parts of vitamin D.

[0013] In the present invention, as a preferred embodiment, the composition comprises 5000 parts of Spirulina, 500 parts of Haematococcus pluvialis and 0.01 parts of vitamin D.

[0014] In the present invention, the mass ratio of Spirulina, Haematococcus pluvialis and vitamin D is 500-5000:100-500:0.002-0.01.

[0015] In the present invention, as a preferred embodiment, the mass ratio of Spirulina, Haematococcus pluvialis and vitamin D is 500:100:0.002.

[0016] In the present invention, as a preferred embodiment, the mass ratio of Spirulina, Haematococcus pluvialis and vitamin D is 5000:500:0.01.

[0017] In the present invention, based on the extraction rate of effective components of microalgae being 10%, the mass ratio of effective extract of Spirulina: effective extract of Haematococcus pluvialis: vitamin D is 50-1000:10-100:0.002-0.02.

[0018] In the present invention, based on the extraction rate of effective components of microalgae being 10%, the mass ratio of effective extract of Spirulina: effective extract of Haematococcus pluvialis: vitamin D is 50-500:10-50:0.002-0.01.

[0019] In the present invention, as a preferred embodiment, based on the extraction rate of effective components of microalgae being 10%, the mass ratio of the effective extract of Spirulina, the effective extract of Haematococcus pluvialis and vitamin D is 50:10:0.002.

[0020] In the present invention, as a preferred embodiment, based on the extraction rate of effective components of microalgae being 10%, the mass ratio of the effective extract of Spirulina, the effective extract of Haematococcus pluvialis and vitamin D is 500:50:0.01.

[0021] In the present invention, a portion may be micrograms, milligrams, grams, microliters, milliliters, deciliters, etc.

[0022] In the present invention, the spirulina is selected from one or more of Spirulina platensis, Spirulina maxima and Spirulina salizawa.

[0023] In the present invention, the spirulina includes spirulina powder and effective spirulina extract, wherein the effective spirulina extract is selected from one or more of spirulina polysaccharide extract, β-carotene extract, superoxide dismutase extract and phycocyanin extract.

[0024] In the present invention, the Haematococcus pluvialis includes Haematococcus pluvialis powder and effective extracts of Haematococcus pluvialis, wherein the effective extracts of Haematococcus pluvialis are selected from a combination of one or more of astaxanthin extracts, algae polysaccharide extracts and algae protein extracts.

[0025] In the present invention, the effective extract of Spirulina can be formulated into the form of liquid and powder.

[0026] In the present invention, vitamin D is selected from one or more of vitamin D1, vitamin D2 and vitamin D3.

[0027] In the present invention, the health food or food-acceptable auxiliary materials include one or more of food sugars or functional sweeteners, fillers, wetting agents, adhesives and lubricants.

[0028] In the present invention, the dosage form of the composition is a health food or a food acceptable dosage form, including but not limited to ordinary tablets, double-layer tablets, multi-layer tablets, granules, capsules, pills, oral liquids, compressed candies, solid beverages, syrups, liquid preparations, powders and the like.

[0029] In the present invention, the composition can be further made into fluid dairy products, dairy products, fermented beverages, milk powder, soy milk, juice, sports drinks, desserts, jelly, candy, milk, soft drinks, yogurt, cheese, bread, biscuits, soda crackers, energy bars, pizza crust, formulated milk powder, liquid food, food for specific diets, food for patients, nutritional food, frozen food, processed food, other commercially available foods and the like, baby food, health food, animal feed, Chinese herbal medicine composition or dietary supplement.

[0030] In the present invention, the composition can be used in combination with conventionally known medical products or foods having bone and joint protection effects.

[0031] In the present invention, the composition is in an administrable form selected from nutritional formulations, tube feeding formulations, dietary supplements, functional foods and beverage products.

[0032] In the present invention, the composition is used in preparing a product for assisting in preventing and treating osteoporosis.

[0033] In the present invention, the composition is used in preparing a product for auxiliary treatment of osteoarthritis.

[0034] In the present invention, the composition can be in the form of health food, functional food or food for special medical purposes.

[0035] The beneficial effects of the present invention are as follows: the present invention provides a composition for dual protection of bones and joints. On the basis of selecting specific types and amounts of Spirulina and Haematococcus pluvialis, vitamin D is creatively added. The combination produces an unexpected synergistic effect, has the effects of protecting bones (reducing bone turnover rate and maintaining bone mass), relieving joint inflammation (reducing joint swelling, reducing the expression of inflammatory factors and relieving joint pain), so it can be used for middle-aged and elderly people, has joint protection effect, and can prevent or treat osteoporosis, promote disease improvement and physical recovery. The raw materials of the product of the present invention are all medicinal and edible or general food-grade raw materials, and can be used as a daily safe and healthy nutritional supplement. DETAILED DESCRIPTION

[0036] The present invention is further described below in conjunction with specific implementation modes, which is not intended to limit the present invention. Any equivalent replacements in the art made according to the contents of the present invention shall fall within the protection scope of the present invention.

[0037] In order to verify the scientific nature of the pharmaceutical composition provided by the present invention, and to illustrate that the three components of the pharmaceutical composition are reasonably matched and can play a synergistic role in combination, rather than simply superimposing pharmacological effects, the Jin Zhengjun Q value method is introduced for analysis. The Jin Zhengjun Q value method is also known as the probability addition method. According to the pharmacological effects of the combination of two drugs and the pharmacological effects of the two drugs alone in the dose-effect curve area, the following calculation formula is used to calculate: Q = E A+B / (E A +E B -E A *E B ), where the numerator represents the "measured combined effect" and the denominator represents the "expected combined effect". (In order to analyze the pharmacological effects of components and combinations, their pharmacological effects are converted into effects that can intuitively reflect the strength of the pharmacological effects. The calculation formula is: E i =1-P i / P 模型组 , P i is the pharmacological index of each component, P 模型组 is the pharmacological index of the model group), Q is the ratio of the two: when Q is less than 0.85, the combination of the two drugs is considered to be antagonistic; when it is less than 1.15 and greater than 0.85, it is considered to be additive; when it is greater than or equal to 1.15, it is considered to be synergistic.

[0038] Example 1: Effect of the composition of the present invention on bone density in ovariectomized rats

[0039] 1. Methods

[0040] Experimental animals and groups: SD rats, female, 12-13 weeks old, were purchased from Guangdong Medical Experimental Animal Center. They were raised in an environment with a room temperature of 18-28°C and a relative humidity of 40%-70%, with free access to water. They were adaptively fed with ordinary feed for 1 week.

[0041] Construction of menopausal rat model: rats were anesthetized with 40 mg / kg sodium pentobarbital (0.1 g / kg) intraperitoneally, their hair was trimmed, 1.5 cm incisions were made in the back muscles on both sides of the spine, and the ovaries of the rats were removed. The blank control group rats only had the fat tissue around the ovaries removed. The wound was sutured with autologous catgut, and 80×10 4 U / kg penicillin sodium, once a day, for 5 consecutive days to prevent postoperative infection.

[0042] Drug administration: 4 weeks after surgery, the doses listed in Table 1 were administered. The blank control group and the model control group were given an equal volume of normal saline. The drug was administered once a day for 3 consecutive months.

[0043] Detection indicators: (1) Alkaline phosphatase (ALP): Blood was collected from the abdominal cavity and allowed to stand at room temperature for 1 hour. The blood was then centrifuged at 3000 r / min for 10 minutes to separate the serum. The ALP content in the serum was detected using a fully automatic biochemical analyzer. (2) Femur weight, bone density, and bone calcium content: The rats were killed, the right femur was peeled off, and the femur was baked to constant weight and then weighed. The bone density at the center of the femur was measured. The bone calcium content was determined by atomic absorption spectrophotometry (flame method).

[0044] Explanation of indicators: (1) Serum ALP activity is a commonly used indicator for evaluating bone formation and bone turnover. 50% of ALP in serum comes from osteoblast secretion. It is generally believed that the increase in ALP is caused by the increase in compensatory bone formation accompanied by hyperabsorption of bone. (2) Bone density, that is, bone mineral density, is an important indicator of bone strength and is used to determine osteoporosis and evaluate bone health. (3) Femoral weight and bone calcium content are important indicators for evaluating bone formation and osteoporosis.

[0045] 2. Results

[0046] As shown in Table 1 and Table 2, compared with the blank control group, the serum ALP of the rats in the model control group was significantly increased (P < 0.01), and the bone density, femur weight and bone calcium content were significantly reduced (P < 0.05 or P < 0.01), indicating that the osteoporosis model was successfully established. Compared with the model control group, the serum ALP of the rats in the VD group and the Spirulina powder + Haematococcus pluvialis powder + VD group was significantly decreased (P < 0.05 or P < 0.01), and the bone density, femur weight and bone calcium content were significantly increased (P < 0.05 or P < 0.01), indicating that the above-mentioned composition has a significant effect on improving femoral bone density, regulating bone metabolism balance, promoting bone formation and protecting bone tissue in ovariectomized rats.

[0047] At the same time, the effect of Spirulina powder + Haematococcus pluvialis powder group in reducing serum ALP, increasing bone density, femur weight and bone calcium content was calculated to be 1.06, 0.97, 0.99 and 0.92 respectively compared with the Spirulina powder and Haematococcus pluvialis powder groups alone, which was a simple additive effect, and there was no significant effect compared with the model group (P>0.05). The Q values ​​of the four test indicators of serum ALP, bone density, femur weight and bone calcium content in the Spirulina powder + Haematococcus pluvialis powder + VD group and the corresponding Spirulina powder + Haematococcus pluvialis powder group and the VD group alone were calculated to be 1.72, 1.44, 1.29 and 1.58 respectively (Q values ​​were all >1.15), indicating that the triple combination has a synergistic effect in reducing bone turnover rate and maintaining bone mass compared with the double combination and VD group, so it can be used to prevent or treat osteoporosis.

[0048] Table 1 Effect of the composition of the present invention on serum ALP and bone density in ovariectomized rats ( n=8~10) Note: Compared with the blank control group, a P<0.05, aa P<0.01; compared with the model control group, b P<0.05, bb P<0.01.

[0049] Table 2 Effect of the composition of the present invention on femur weight and bone calcium content in ovariectomized rats ( n=8~10)

[0050]

[0051]

[0052] Note: Compared with the blank control group, a P<0.05, aa P<0.01; compared with the model control group, b P<0.05, bb P<0.01.

[0053] Example 2: Study on the therapeutic effect of the composition of the present invention on adjuvant arthritis rats

[0054] 1. Methods

[0055] Experimental animals and groups: SPF SD rats, half male and half female, weighing 220±20g, were purchased from Guangdong Medical Experimental Animal Center. They were raised in an environment with a room temperature of 18-28℃ and a relative humidity of 40%-70%, with free access to water. They were adaptively fed with ordinary feed for 1 week.

[0056] Modeling: 0.1 mL of complete Freund's adjuvant was injected into the right toe of the rats in the modeling group to induce inflammation. On the 7th day after injection, 0.1 mL of complete Freund's adjuvant was injected subcutaneously in the right tail of the rat to boost immunity and replicate the adjuvant arthritis model. Rats in the blank control group were injected with an equal volume of saline in the same way. Two weeks after injection, the inflammatory scores of the bilateral hind foot joints of the rats in the modeling group were scored according to the "0-4 arthritis scoring method": 0 points for no swelling and erythema; 1 point for erythema and mild swelling in the ankle joint; 2 points for erythema and mild swelling from the ankle joint to the metatarsal joint or the palm joint; 3 points for erythema and moderate swelling from the ankle joint to the metatarsophalangeal joint or the palm joint; 4 points for erythema and severe swelling from the ankle joint to the toe joint. When the cumulative score of the bilateral foot joints of the rat (the right side is the primary side and the left side is the secondary side) is greater than 4, it indicates that the modeling is successful.

[0057] Drug administration: rats with unsuccessful modeling were eliminated, and rats with successful modeling were randomly divided into the groups shown in Table 3 below. Rats in each drug administration group were gavaged with corresponding drugs, and the blank control group and the model control group were given an equal volume of normal saline once a day for 2 consecutive months. Among them, the extraction rate of Spirulina extract and Haematococcus pluvialis extract involved in the group was about 10%.

[0058] Index determination: After the last administration, (1) Foot swelling: The thickness of the same site of the hind ankle joints of both sides of the rats (the right side is the primary side, the left side is the secondary side) was measured with a vernier caliper, and the measurement was repeated three times in parallel, and the average value was taken, and the foot swelling was calculated (foot swelling = average ankle thickness of rats after gavage - average ankle thickness of rats before modeling). (2) Arthritis score: The inflammatory score of the hind ankle joints of both sides of the rats after gavage was performed according to the above-mentioned "0-4 grade arthritis scoring method". (3) Serum IL-1β and TNF-α levels: ELISA method was used for detection. The rats were anesthetized with 10% chloral hydrate and blood was collected from the abdominal aorta. After the blood sample was allowed to stand at room temperature for 2 hours, it was centrifuged at 3000r / min for 10 minutes, and the upper serum was aspirated. According to the relevant method in the kit instructions, the serum TNF-α and IL-1β levels were determined using an enzyme marker.

[0059] 2. Results

[0060] As shown in Tables 3 and 4, compared with the blank control group, the bilateral foot swelling, arthritis score, TNF-α, and IL-1β of the rats in the model control group were significantly increased (P < 0.01), indicating that the inflammatory response in the model rats was aggravated, the joint structure was severely damaged, and the model was successfully constructed. Compared with the model control group, the secondary foot swelling, primary foot swelling, arthritis score, TNF-α, and IL-1β of the rats in the high-dose Spirulina extract + Haematococcus pluvialis extract group, high-dose VD group, and low (high) Spirulina extract + Haematococcus pluvialis extract + VD group were significantly reduced (P < 0.01). Therefore, it is shown that the drugs in the above groups all have the effect of improving arthritis.

[0061] At the same time, the Q values ​​of the low-dose Spirulina extract + Haematococcus pluvialis extract + VD group in reducing the secondary foot swelling, primary foot swelling, arthritis score, TNF-α, and IL-1β of rats were 1.54, 1.19, 1.35, 1.54, and 1.27, respectively, and the Q values ​​of the high-dose Spirulina extract + Haematococcus pluvialis extract + VD group were 1.86, 1.57, 1.61, 1.37, and 1.52, respectively. The Q values ​​were all >1.15, indicating that the components of the combination have a synergistic effect in reducing bilateral foot swelling, reducing the expression of inflammatory factors, and alleviating cartilage damage.

[0062] Table 3 Effects of the composition on rat foot swelling and arthritis score ( n=8~10)

[0063]

[0064]

[0065] Note: Compared with the blank control group, a P<0.05, aa P<0.01; compared with the model control group, b P<0.05, bb P<0.01.

[0066] Table 4 Effects of the composition on TNF-α and IL-1β in rat serum ( n=8~10)

[0067]

[0068] Note: Compared with the blank control group, a P<0.05, aa P<0.01; compared with the model control group, b P<0.05, bb P<0.01.

Claims

1. A composition comprising: a) Spirulina; b) Haematococcus pluvialis; c) Vitamin D; d) Health food or acceptable excipients for food.

2. The composition according to claim 1, characterized in that The mass ratio of the spirulina: Haematococcus pluvialis: vitamin D is 50-10000: 10-1000: 0.002-0.

02.

3. The composition according to claim 1, characterized in that The spirulina is in an amount of 50 to 10,000 parts, the Haematococcus pluvialis is in an amount of 10 to 1,000 parts, and the vitamin D is in an amount of 0.002 to 0.02 parts.

4. The composition according to claim 3, characterized in that The spirulina is in an amount of 200 to 5000 parts, the Haematococcus pluvialis is in an amount of 20 to 500 parts, and the vitamin D is in an amount of 0.005 to 0.01 parts.

5. The composition according to claim 2, characterized in that The mass ratio of the spirulina, Haematococcus pluvialis and vitamin D is 500-5000:100-500:0.002-0.

01.

6. The composition according to claim 1, characterized in that The spirulina is selected from one or more of Spirulina platensis, Spirulina maxima and Spirulina salizawa, and the vitamin D is selected from one or more of vitamin D1, vitamin D2 and vitamin D3.

7. The composition according to claim 1, characterized in that The spirulina comprises spirulina powder and effective spirulina extract, wherein the effective spirulina extract is selected from a combination of one or more of spirulina polysaccharide extract, beta-carotene extract, superoxide dismutase extract and phycocyanin extract; the Haematococcus pluvialis comprises Haematococcus pluvialis powder and effective Haematococcus pluvialis extract, wherein the effective Haematococcus pluvialis extract is selected from a combination of one or more of astaxanthin extract, algae polysaccharide extract and algae protein extract.

8. The composition according to claim 2, characterized in that Calculated based on the extraction rate of effective components of microalgae being 10%, the mass ratio of the effective extract of Spirulina: the effective extract of Haematococcus pluvialis: vitamin D is 50-1000:10-100:0.002-0.

02.

9. The composition according to claim 8, characterized in that Calculated based on the extraction rate of effective components of microalgae being 10%, the mass ratio of the effective extract of Spirulina: the effective extract of Haematococcus pluvialis: vitamin D is 50-500:10-50:0.002-0.

01.

10. Use of the composition according to any one of claims 1 to 9 in the preparation of a product for assisting in the prevention and treatment of osteoporosis.

11. Use of the composition according to any one of claims 1 to 9 in preparing a product for the auxiliary treatment of osteoarthritis.

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