CN110604309A - Nutritional supplement for assisting in preventing osteoporosis - Google Patents

Nutritional supplement for assisting in preventing osteoporosis Download PDF

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Publication number
CN110604309A
CN110604309A CN201810611435.8A CN201810611435A CN110604309A CN 110604309 A CN110604309 A CN 110604309A CN 201810611435 A CN201810611435 A CN 201810611435A CN 110604309 A CN110604309 A CN 110604309A
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CN
China
Prior art keywords
vitamin
nutritional supplement
essence
osteoporosis
folic acid
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN201810611435.8A
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Chinese (zh)
Inventor
于多
张磊
徐希平
邢厚恂
王玉
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
AUSA PHARMED Ltd
BEIJING AOSA MEDICINE RESEARCH CENTRE Co Ltd
Shenzhen Flight Nutrition And Health Co Ltd
Original Assignee
AUSA PHARMED Ltd
BEIJING AOSA MEDICINE RESEARCH CENTRE Co Ltd
Shenzhen Flight Nutrition And Health Co Ltd
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Application filed by AUSA PHARMED Ltd, BEIJING AOSA MEDICINE RESEARCH CENTRE Co Ltd, Shenzhen Flight Nutrition And Health Co Ltd filed Critical AUSA PHARMED Ltd
Priority to CN201810611435.8A priority Critical patent/CN110604309A/en
Publication of CN110604309A publication Critical patent/CN110604309A/en
Pending legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/15—Vitamins
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/15—Vitamins
    • A23L33/155—Vitamins A or D
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

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  • Life Sciences & Earth Sciences (AREA)
  • Mycology (AREA)
  • Health & Medical Sciences (AREA)
  • Nutrition Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Food Science & Technology (AREA)
  • Polymers & Plastics (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The invention relates to a nutritional supplement prepared from 100-800ug vitamin A, 1.5-10ug vitamin D, 5-150mg vitamin E and 200-800ug folic acid and a preparation method thereof, wherein the nutritional supplement has the function of preventing osteoporosis and is particularly suitable for pregnant patients. The composition provided by the invention is not limited to be prepared into nutriments or health-care foods, and can also be used for preparing medicines.

Description

Nutritional supplement for assisting in preventing osteoporosis
Technical Field
The invention relates to a nutritional supplement with an auxiliary prevention effect on osteoporosis, which contains vitamin A, vitamin D, vitamin E and folic acid, and the supplement is also suitable for being prepared into health-care food.
Background
Osteoporosis is a systemic bone disease caused by multiple factors and is characterized by decreased bone density and bone quality, destruction of bone microstructure, increased bone fragility and susceptibility to fracture. Osteoporosis is divided into primary and secondary categories. Primary osteoporosis is classified into postmenopausal osteoporosis (type i), senile osteoporosis (type ii) and idiopathic osteoporosis (including juvenile type). The literature reports that the incidence rate of osteoporosis of women in the age range of 40-50 years is 6.37% + -2.39%, and the incidence rate of osteoporosis of men is 4.11% + -1.70%; in the age range of 50-60 years, the female osteoporosis incidence rate is 21.75% + -5.96%, and the male osteoporosis incidence rate is 12.90% + -6.35%; in the age range of 60-70 years, 46.38% + -12.03% of women and 19.90% + -8.31% of men (Zhang Chihai et al, osteoporosis incidence rate literature retrospective study in the mainland area of China, J.Oesophagostomatosis, No. 21 vol.1 in 2015, No. 1-7).
Vitamin D is considered to be a hormone precursor acting on calcium and phosphorus metabolism, and at least 10 of the currently known vitamin D are known, but most importantly vitamin D2 (ergocalciferol) and vitamin D3 (cholecalciferol). The vitamin D can improve the absorption of the body (intestinal canal wall) to calcium and phosphorus, increase the reabsorption of renal tubule to phosphorus, and promote old bone to release calcium phosphate in cooperation with parathyroid hormone and calcitonin, thereby regulating the concentration of calcium and phosphorus in blood plasma and leading the calcium and phosphorus in blood to reach saturation; through the above multiple pathways, vitamin D promotes calcium deposition at the site of new bone formation, promoting maturation of bone-like tissue, bone growth and calcification.
Vitamin A, also known as retinol, is one of the essential nutrients for human body and is only present in animal food. The vitamin A biological activity is mainly reflected in maintaining normal vision, maintaining the growth of organisms, the integrity of epidermis, the development of embryos and bones, the hematopoiesis and the like, and also has various biological activity functions of enhancing the immunity of the organisms, resisting infection, resisting lipid peroxidation, regulating fat storage and the like. Vitamin a deficiency can lead to decreased dark adaptation, atrophy of glands such as lacrimal glands, and dry corneal epithelium and conjunctiva, which can lead to dry eye. Vitamin A, vitamin D, calcium and the like are used together to maintain the growth and development of bones and teeth, so that the deficiency of vitamin A also has a certain influence on osteoporosis and is easy to ignore.
Vitamin E, also known as tocopherol, is one of the most important antioxidants and is widely used as a nutritional supplement and antioxidant in the pharmaceutical, cosmetic and food industries. Vitamin E plays a role in a defense system for resisting free radical damage, can protect cell membranes, and prevents free radicals or oxidants from damaging polyunsaturated fatty acids, protein components rich in sulfydryl and cytoskeleton in the cell membranes; the tocopherol mercapto radical generated after the vitamin E reacts with the free radical can be reduced into tocopherol again by vitamin C, glutathione and coenzyme Q. Vitamin E can promote sex hormone secretion and increase the concentration of female hormone, so the vitamin E is beneficial to preventing the frequent osteoporosis of climacteric women.
Folic acid belongs to B vitamins, is absorbed by intestinal tracts, is excreted out of the body by urine, has short retention time in a human body and is rarely accumulated, so that the folic acid must be frequently taken in the body to meet the requirements of nutrition and metabolism. When folic acid is deficient in human body, the metabolism of homocysteine is influenced, hyperhomocysteinemia is easily caused, and research shows that the hyperhomocysteinemia is one of risk factors of osteoporosis.
The four vitamins all play a role in assisting in preventing osteoporosis from different aspects, which is equivalent to a multi-target synergistic effect, the health food consisting of the four vitamins provides accurate nutrient supplement, the formula is original, the efficacy is superior to that of similar products in the market, and the health food is a significant improvement on the prior art.
Disclosure of Invention
The technical problem to be solved by the invention is to provide a nutritional supplement for preventing osteoporosis, which is more effective than vitamin D, and consists of the following components:
1) 100-;
2)1.5-10ug vitamin D;
3)5-150mg vitamin E;
4) 200-;
5) and (5) auxiliary materials.
Further, in the nutritional supplement provided by the present invention, the preferred content of vitamin A is 800ug 160-.
In the present invention, said vitamin D is preferably vitamin D2 (ergocalciferol) and vitamin D3.
In the present invention, the folic acid includes folic acid, 5-methyltetrahydrofolic acid (calcium), leucovorin, folinic acid, calcium levofolinate, etc., i.e., various folic acid forms including artificial synthesis and plant extract sources, and folic acid and 5-methyltetrahydrofolic acid (calcium) are preferred.
The nutritional supplement provided by the invention can be prepared into oral dosage forms such as common tablets, chewable tablets, soft capsules, hard capsules, powder, granules and the like.
In the invention, the auxiliary materials are selected from one or more of a filling agent, a wetting agent, an adhesive, a disintegrating agent, a lubricant, a flavoring agent, a stabilizing agent, an embedding substance, a coating premixing agent and an edible pigment.
The filler comprises one or more of starch, soluble starch, dextrin, maltodextrin, potato starch, corn starch, wheat starch, D-mannitol, calcium hydrogen phosphate, anhydrous calcium hydrogen phosphate, maltose, xylitol, sorbitol, microcrystalline cellulose, isomaltulose, milk powder, low-substituted hydroxypropyl cellulose, sucrose, glucose, lactose, pregelatinized starch, maltodextrin and the like.
The wetting agent comprises purified water and ethanol, and the adhesive comprises one or more of hydroxypropyl methyl cellulose, povidone, hydroxypropyl cellulose, sodium carboxymethyl cellulose, starch, methyl cellulose, ethyl cellulose, gelatin, polyethylene glycol, pregelatinized starch, sucrose, glucose and the like.
The disintegrating agent comprises one or more of starch, carboxymethyl starch sodium, crospovidone, croscarmellose sodium, low-substituted hydroxypropyl cellulose, sodium bicarbonate, citric acid and the like, and the lubricant comprises one or more of magnesium stearate, stearic acid, talcum powder, silicon dioxide, hydrogenated vegetable oil, polyethylene glycol, sodium dodecyl sulfate, glyceryl behenate, sodium stearyl fumarate and the like.
The flavoring agent comprises one or more of fruit powder, edible essence, high-intensity sweetener, sour agent and the like, wherein the fruit powder comprises one or more of orange powder, lemon powder, cherry powder, apple powder, strawberry powder, kiwi fruit powder, orange powder, seabuckthorn fruit powder, green plum fruit powder, mango fruit powder, mulberry fruit powder, hawthorn fruit powder, watermelon fruit powder, pineapple fruit powder, blueberry fruit powder, honey peach fruit powder, hami melon fruit powder, grape fruit powder, vanilla fruit powder, pomegranate fruit powder, rose fruit powder and the like.
The edible essence comprises one or more of vanilla essence, sweet orange essence, milk essence, apple essence, grape essence, strawberry essence, pineapple essence, honey peach essence, hami melon essence, lemon essence, cherry essence, sweet corn essence, banana essence, grape essence, rose essence, blackcurrant essence, green apple essence, mango essence, green mango essence, orange essence, fragrant orange essence, snow pear essence, strawberry essence, green plum essence, blueberry essence, waxberry essence, grapefruit essence, pineapple essence, guava essence, passion fruit essence, kiwi fruit essence, cherry essence, kiwi fruit essence, watermelon essence, papaya essence, hami melon essence, durian essence, lychee essence, hawthorn essence, olive essence, mulberry essence and the like.
The high-power sweetener comprises sucralose, aspartame, mogroside, neotame and stevioside, the sour agent comprises citric acid, malic acid, lactic acid, tartaric acid and fumaric acid, the edible pigment comprises caramel color, gardenia yellow, curcumin, chlorophyll, capsicum orange, capsanthin, grape skin red, carmine and aluminum lake thereof, sunset yellow and aluminum lake thereof, brilliant blue and aluminum lake thereof, indigo blue and aluminum lake thereof, beet red, natural amaranth, gardenia blue, plant carbon black, iron oxide red, black bean red, quinoline yellow, lycopene, monascus red, yellow iron oxide, cocoa shell color, safflower yellow, monascus yellow and the like.
The stabilizer comprises vitamin E, dibutyl hydroxy toluene (BHT), Butyl Hydroxy Anisol (BHA) and vitamin C, and the embedding substance comprises one or more of beta-cyclodextrin, alpha-cyclodextrin, gamma-cyclodextrin, dextrin, starch, edible modified starch, sucrose, maltodextrin, gum arabic and the like.
The vitamin with synergistic screening function of the nutritional supplement provided by the invention is scientifically formulated to ensure the efficacy of the product, and has a remarkable auxiliary prevention effect on osteoporosis by supplementing optimal doses of vitamin A, vitamin D, vitamin E and folic acid, and the effect of the nutritional supplement is remarkably stronger than the effect of single application of the components. The nutritional supplement provided by the invention is also suitable for being used as a health food, and because the nutritional supplement contains a proper amount of folic acid and vitamin E, the composition preparation provided by the invention is especially suitable for pregnant and climacteric women, and is an ideal treatment adjuvant drug for osteoporosis of the two women.
The present invention is further described with reference to the following detailed description, which is not intended to be limiting, but rather is intended to cover by the appended claims any and all equivalent variations of the invention that fall within the true scope of the invention.
Detailed Description
Example 1: vitamin A vitamin D vitamin E folic acid tablet
The components are as follows:
160ug of vitamin A, 5ug of vitamin D, 50mg of vitamin E, 400ug of folic acid and 76mg of microcrystalline cellulose were mixed, and 16mg of croscarmellose sodium was added to the resulting mixture to obtain a mixed powder. Adding 24mg of mixed solution of polyvidone K30 and wetting agent (water or ethanol) into the mixed powder, adding 25ml of mixed solution per 100mg of mixed powder, uniformly binding, and sieving with 18 mesh sieve to obtain granule. Drying the wet granules at 60 ℃ for 4 hours, and controlling the mentioned moisture content to be less than or equal to 7%. The dried granules were sieved through a 18 mesh sieve to obtain dried granules. Magnesium stearate was added and mixed for 10 minutes to obtain total mixed granules. Tabletting the total mixed granules to obtain tablets containing vitamin A, vitamin D, vitamin E and folic acid.
Example 2: vitamin A, vitamin D, vitamin E and folic acid soft capsule
The components are as follows:
the preparation method comprises the following steps: adding Cera flava into soybean oil, heating at 50 deg.C to dissolve Cera flava, standing to room temperature, adding vitamin A, vitamin D, vitamin E and folic acid into soybean oil to obtain suspension. Preparing gelatin solution from gelatin, purified water, caramel color and p-hydroxybenzoate, making into soft capsule, shaping, washing, and drying.
Example 3: vitamin A, vitamin D, vitamin E and 5-methyltetrahydrofolic acid hard capsule
The components are as follows:
the preparation method comprises the following steps: mixing the vitamin AD and 20% of microcrystalline cellulose, sieving, adding the vitamin E and the 5-methyltetrahydrofolic acid, mixing the obtained raw material mixture and the residual microcrystalline cellulose in an equivalent incremental manner, adding the lactose and the magnesium stearate, mixing, filling by using a full-automatic capsule filling machine, and polishing to obtain the hard capsule of the nutritional supplement.
Example 4: vitamin A vitamin D vitamin E folic acid lipid nanoparticle
Preparation: 1. 1.0g of polyethylene glycol-8 caprylocamphetamine, 1.0g of cetearyl glucoside and 92.5g of deionized water were weighed into a beaker and heated in a water bath at 60 ℃.
2. 2.0g of acetylated monoglyceride and 0.5g of caprylic capric glyceride were weighed and heated in a water bath of 60 ℃.
3. After the lipid in the beaker is completely melted, adding the vitamin A, the vitamin D, the vitamin E and the folic acid, and heating and mixing uniformly.
4. Adding the water phase into the system, stirring uniformly, shearing, starting a high-pressure homogenizer, and heating to 60 ℃ by using 70 ℃ deionized water.
5. And injecting the high-temperature emulsion system after being uniformly sheared into a high-pressure homogenizer.
6. Cooling to room temperature to obtain the composite lipid nanoparticles.
Example 5: protective effect of nutritional supplement on osteoporosis rats
40 rats were randomly divided into 4 groups by weight: blank control group, model group, vitamin D group, compound composition group, each group contains 10. Except for the blank control group, the hind limbs of all the groups were alternately injected with dexamethasone 2.5mg/kg, 2 times a week for 10 weeks. From week 2, the placebo group and the model group were administered by gavage with physiological saline 10ml/kg, the vitamin D group was administered with vitamin D0.5 ug/day, and the nutritional supplement (the tablet prepared in example 1 was dissolved in 1ml water, 100ul of the solution was gavage) was administered once a day for 12 weeks.
At the end of 12 weeks, rats were anesthetized with 3% chloral hydrate, blood was taken from the abdominal aorta, centrifuged, and serum was taken, and the blood Ca content and the serum alkaline phosphatase (ALP) content were measured by o-cresolphthalein coppery and p-nitrophenyl phosphate method using a full-automatic biochemical analyzer according to the kit instructions. After the rats were sacrificed, the femurs of both hind limbs were dissociated, the surrounding tissues were removed, the femurs were placed on a small animal platform, placed along the long axis of the platform, and the femoral bone density (BMD) was measured with a dual energy X-ray bone densitometer. The statistical test method adopts t test.
As a result: as shown in table 1, compared with the blank control group, the bone density of femur of rats in the model control group and the vitamin D group is significantly reduced (P < 0.01); the bone density values of the thighbones of rats in the model control group and the vitamin D group are similar; compared with the model control group and the vitamin D group, the bone density of the thighbone of the rats in the nutrition supplement group is obviously increased (P < 0.05). Osteoporosis is a skeletal disease characterized by a reduced femoral strength that increases the risk of fracture in the body. The bone strength is mainly determined by the bone mass, and BMD (bone Mass Detector), namely the amount of bone mineral contained in unit bone area, is a main index reflecting the bone strength and the bone mass and is an important index currently used for osteoporosis diagnosis and fracture risk evaluation. The experimental results in table 1 show that the BMD of the rat femur in the model control group is significantly reduced, which indicates that the method adopted in the experiment results in successful establishment of the rat osteoporosis model; compared with the bone density of the femur of rats in a model control group and a vitamin D group, the bone density of the femur of rats in a nutrition supplement group is obviously increased, which indicates that the nutrition supplement can resist the reduction of BMD caused by glucocorticoid, and the effect is obviously stronger than that of the vitamin D alone.
As shown in Table 2, compared with the blank control group, the Ca content in the serum and the ALP activity of the rat in the model control group are both reduced remarkably (P < 0.01); compared with a model control group, the content of Ca in serum and the activity of ALP of the nutritional supplement group are both obviously increased (P < 0.05); compared with a model control group, the Ca content and ALP activity of the femoral blood serum of the rats in the vitamin D group have rising tendency, but the difference has no statistical significance; compared with the serum ALP activity of femur of rats in the vitamin D group, the serum ALP activity of the nutritional supplement group is remarkably increased (P < 0.05). It is known that an increase in the level of blood calcium contributes to the formation or calcification of new bone, and at the same time, inhibits the migration of femoral calcium into the blood, reduces the loss of bone mass, and treats osteoporosis. Serum ALP is an extracellular enzyme of osteoblasts, and exerts its effect of promoting bone formation in the blood circulation. The data in table 2 show that the nutritional supplement can significantly increase blood calcium and improve ALP activity, and the effect is stronger than that of vitamin D.
TABLE 1 Effect of nutritional supplements on osteoporotic rat femoral bone Densityn＝10)
Note: in comparison with the normal group,*P<0.05，**P<0.01; in comparison to the group of nutritional supplements,##P<0.01。
TABLE 2 Effect of nutritional supplements on Biochemical indicators of serum in osteoporotic rats: (n＝10)
Note: in comparison with the normal group,**P<0.01，*P<0.05; in comparison to the group of nutritional supplements,#P<0.05。

Claims (7)

1. a nutritional supplement comprises
1) 100-;
2)1.5-10ug vitamin D;
3)5-150mg vitamin E;
4)200-800ug folic acid;
5) and (5) auxiliary materials.
2. The nutritional supplement according to claim 1, wherein the folic acid comprises folic acid, 5-methyltetrahydrofolic acid, leucovorin, folinic acid, calcium levofolinate.
3. The nutritional supplement according to claim 1, wherein the vitamin D comprises vitamin D2 and vitamin D3.
4. The nutritional supplement according to claim 1, characterized in that the vitamin A content is 800ug 160-.
5. The nutritional supplement according to claim 1, wherein the excipients are selected from one or more of a filler, a wetting agent, a binder, a disintegrant, a lubricant, a flavoring agent, a food color, a stabilizer, an embedding material, a coating premix and the like.
6. The nutritional supplement according to claims 1-4, characterized in that: the health food is prepared into common tablets, chewable tablets, soft capsules, hard capsules, lipid nanoparticles, powder and granules.
7. Use of the nutritional supplement according to claims 1-5 for the preparation of a product for the prevention, treatment of osteoporosis.
CN201810611435.8A 2018-06-14 2018-06-14 Nutritional supplement for assisting in preventing osteoporosis Pending CN110604309A (en)

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Application Number Priority Date Filing Date Title
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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107028191A (en) * 2017-05-24 2017-08-11 深圳泰乐德营养与健康有限公司 A kind of vitamin combination of the accurate nutrition of suitable mid-aged population
CN107232611A (en) * 2017-05-22 2017-10-10 深圳泰乐德营养与健康有限公司 A kind of nutrient composition being made up of vitamin D, K and folic acid
CN110584120A (en) * 2019-09-25 2019-12-20 东莞自然衡健康科技有限公司 Bone health composition

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107232611A (en) * 2017-05-22 2017-10-10 深圳泰乐德营养与健康有限公司 A kind of nutrient composition being made up of vitamin D, K and folic acid
CN107028191A (en) * 2017-05-24 2017-08-11 深圳泰乐德营养与健康有限公司 A kind of vitamin combination of the accurate nutrition of suitable mid-aged population
CN110584120A (en) * 2019-09-25 2019-12-20 东莞自然衡健康科技有限公司 Bone health composition

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
王小敏等: "枸杞多糖对糖皮质激素性骨质疏松大鼠钙吸收及生化指标的影响", 《中国预防医学杂志》 *
雷泽等: "重要维生素的摄入与中老年骨健康", 《中国骨质疏松杂志》 *

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Application publication date: 20191224