Medicinal and edible nutritional composition with bone tonifying and strengthening effects as well as preparation method and application of medicinal and edible nutritional composition

Abstract

The invention provides a medicinal and edible nutritional composition for reinforcing and strengthening bones and application of the medicinal and edible nutritional composition in preparation of a bone nutrition preparation, the composition is composed of deer blood powder, peach gum, cucumber seeds, turmeric and epigallocatechin gallate, can improve serum osteocalcin, promote fracture healing and improve osteoporosis, and has nutritional effects of reinforcing and strengthening bones.

Description

Technical Field

[0001] The present invention relates to the field of medical care, and in particular to a medicinal and edible nutritional composition for replenishing and strengthening bones and an application thereof in preparing a bone nutrition preparation. Background Art

[0002] 1. Current status of bone health problems and treatment difficulties

[0003] With the aging of the population and changes in modern lifestyles, the incidence of skeletal diseases such as osteoporosis, decreased bone density, and fractures has shown a significant upward trend worldwide. According to statistics from the World Health Organization, the prevalence of osteoporosis in people over 50 years old has exceeded 30%, and the incidence of fractures caused by osteoporosis has also increased accordingly. Existing clinical treatments mainly rely on basic nutrient supplements such as calcium and vitamin D3 and intervention with bisphosphonates, but there are problems such as low bioavailability (the absorption rate of ordinary calcium carbonate is less than 30%), obvious side effects of drugs (long-term use of bisphosphonates may cause complications such as jaw necrosis), and poor compliance (must be taken on an empty stomach).

[0004] 2. Analysis of existing technical solutions

[0005] (1) Traditional chemical synthetic preparations: Although anti-resorptive drugs, such as alendronate sodium, can increase bone density in the short term, they cannot achieve dynamic balance regulation of bone metabolism and are associated with adverse reactions such as gastrointestinal irritation and cardiovascular risks. Clinical studies have shown that over 40% of patients discontinue treatment due to intolerance to side effects.

[0006] (2) Single nutrient supplementation: Conventional calcium and vitamin D compound preparations, in the absence of synergistic nutritional factors, are unlikely to overcome the intestinal absorption barrier and cell mineralization efficiency limitations. Experimental data show that calcium supplementation alone increases lumbar spine bone density in postmenopausal women by less than 2% per year.

[0007] (3) Chinese herbal compound preparations: These are used under the guidance of traditional Chinese medicine theory and have certain therapeutic effects, but their ingredients are complex and highly professional, so they must be used under the guidance of a traditional Chinese medicine practitioner.

[0008] 3. The unique value of medicine and food in bone health prevention

[0009] Medicinal and edible substances have both food safety and drug regulation functions, are easy to use, and show significant advantages in the prevention of skeletal system diseases compared to traditional treatment methods.

[0010] The deer blood powder in the nutritional composition of the present invention has a tonic effect; cucumber seed has tendon-healing and bone-setting effects, and has been reported to be used in fracture treatment; turmeric has a blood-activating and blood-stasis-removing effect; epigallocatechin gallate has anti-thrombotic and anti-inflammatory effects; and peach gum has a blood-regulating effect. These two ingredients are rarely used in the treatment of osteoporosis and fractures. The combined use of these five ingredients synergistically promotes bone growth by regulating the microenvironment through tonic effects, blood-activating effects, and anti-inflammatory effects. Summary of the Invention

[0011] The purpose of the present invention is to apply the theory of traditional Chinese medicine and dietetic nutrition theory to provide a "medicine and food of the same origin" nutritional product to regulate nutrition for people with bone malnutrition and bone damage, thereby playing a role in replenishing and strengthening bones.

[0012] The purpose of the present invention is achieved through the following technical methods:

[0013] On the one hand, the present invention provides a nutritious composition of medicinal and edible origin for nourishing and strengthening bones, wherein the composition is prepared from the following raw materials: deer blood powder, peach gum, cucumber seeds, turmeric, and epigallocatechin gallate.

[0014] Preferably, the weight ratio of the raw materials is: 5-10 parts of deer blood powder, 3-8 parts of peach gum, 3-8 parts of cucumber seeds, 2-5 parts of turmeric, and 1-3 parts of epigallocatechin gallate.

[0015] More preferably, the weight ratio of the raw materials is: 9 parts of deer blood powder, 6 parts of peach gum, 6 parts of cucumber seeds, 3 parts of turmeric, and 1 part of epigallocatechin gallate.

[0016] In addition, the nutritional composition is characterized in that the oral preparation is a tablet, powder, oral liquid, emulsion, syrup, capsule, or pill; preferably a tablet.

[0017] On the other hand, the present invention also provides a method for preparing the above-mentioned composition, which comprises:

[0018] (1) Grind peach gum, cucumber seeds and turmeric into powder respectively.

[0019] (2) The powder obtained in step (1) is stirred and mixed with deer blood powder and epigallocatechin gallate until uniform.

[0020] In another aspect, the present invention provides use of the above composition in preparing a bone nutrition preparation.

[0021] The composition of the present invention can promote the healing of injured bones, effectively improve osteoporosis, and play a role in replenishing and strengthening bones. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1This is the X-ray image of the model group in the fracture experiment 3 weeks after fracture, and the fracture gap is obvious.

[0023] Figure 2 This is the X-ray image of the fracture experiment after 3 weeks of oral administration of composition 1. The fracture gap has been significantly reduced and some parts have begun to heal.

[0024] Figure 3 This is the X-ray image of the fracture experiment after three weeks of oral administration of composition 2. The fracture gap is more obvious, slightly better than that of the model group.

[0025] Figure 4 This is the X-ray image of the fracture experiment after three weeks of oral administration of composition 3. The fracture gap has disappeared and the fracture has healed.

[0026] Figure 5 This is an X-ray image of the femur in the sham operation group in the osteoporosis experiment. White represents high bone density and gray represents low bone density.

[0027] Figure 6 This is an X-ray image of the femur of the model group in the osteoporosis experiment. White represents high bone density and gray represents low bone density.

[0028] Figure 7 These are X-ray images of the femurs of three groups of composite materials in an osteoporosis experiment. White represents high bone density and gray represents low bone density.

[0029] Figure 8 This is the X-ray image of the femur of the positive drug group in the osteoporosis experiment. White represents high bone density and gray represents low bone density. DETAILED DESCRIPTION

[0030] The present invention will be further described in detail below in conjunction with specific embodiments. The examples given are only for illustrating the present invention, not for limiting the scope of the present invention.

[0031] Example 1: Preparation of nutritional composition raw material powder

[0032] (1) Grind enough peach gum, pass it through an 80-mesh sieve, and take 500g of dry powder.

[0033] (2) Crush enough cucumber seeds, pass through an 80-mesh sieve, and take 500 g of dry powder.

[0034] (3) Grind enough turmeric, pass through an 80-mesh sieve, and take 500 g of dry powder.

[0035] Example 2: Preparation of Nutritional Composition (Ratio 1) Tablets

[0036] 100 g of deer blood powder, 80 g of peach gum powder, 80 g of cucumber seed powder, and 20 g of turmeric prepared according to the method of Example 1 were weighed respectively, mixed with 10 g of epigallocatechin gallate, 200 g of microcrystalline cellulose, and 50 g of magnesium stearate, granulated, and tableted.

[0037] The tablets are packaged and sterilized.

[0038] Example 3: Preparation of Nutritional Composition (Ratio 2) Tablets

[0039] 50 g of deer blood powder, 30 g of peach gum powder, 30 g of cucumber seed powder, and 50 g of turmeric prepared according to the method of Example 1 were weighed respectively, mixed with 30 g of epigallocatechin gallate, 150 g of microcrystalline cellulose, and 30 g of magnesium stearate, granulated, and tableted.

[0040] The tablets are packaged and sterilized.

[0041] Example 4: Preparation of Nutritional Composition (Ratio 3) Tablets

[0042] 90 g of deer blood powder, 60 g of peach gum powder, 60 g of cucumber seed powder, and 30 g of turmeric prepared according to the method of Example 1 were weighed respectively, mixed with 10 g of epigallocatechin gallate, 180 g of microcrystalline cellulose, and 40 g of magnesium stearate, granulated, and tableted.

[0043] The tablets are packaged and sterilized.

[0044] Example 5: Comparative study of different compositions

[0045] 1. Experimental Materials

[0046] 1.1 Nutritional combination group

[0047] Composition 1: 90g of deer blood powder, 60g of cucumber seed powder, and 30g of turmeric were prepared into a 16mg / mL suspension with 0.5% sodium carboxymethylcellulose before use and administered orally to rats.

[0048] Composition 2: Peach gum powder 60g, epigallocatechin gallate 10g, mix well. Immediately before use, prepare a 16mg / mL suspension with 0.5% sodium carboxymethylcellulose and administer to rats by gavage.

[0049] Composition 3: Mix 90g of deer blood powder, 60g of peach gum powder, 60g of cucumber seed powder, 30g of turmeric, and 10g of epigallocatechin gallate. Immediately before use, dilute with 0.5% sodium carboxymethylcellulose to a 16mg / mL suspension for oral administration to rats.

[0050] 1.2 Reagents

[0051] Rat bone morphogenetic protein (BMPs) enzyme-linked immunosorbent assay kit, a product of Shanghai Shuangying Biotechnology Co., Ltd.

[0052] 1.3 Animals

[0053] SD rats, female, SPF grade, were provided by Sibeifu (Beijing) Biotechnology Co., Ltd., animal qualification certificate number SCXK (Beijing) 2024-0001.

[0054] 1.4 Instruments

[0055] Multifunctional microplate reader (M5), Berthold, Germany.

[0056] High-frequency digital veterinary X-ray machine (DR), Kangpai (Jiangsu) Medical Technology Co., Ltd.

[0057] 2. Experimental Methods

[0058] Model Preparation: Rats were anesthetized by intraperitoneal injection and fixed in the supine position on an operating table. The right lower leg was flexed and abducted. Hair was removed, and the skin was disinfected with iodine. A longitudinal incision was made along the subtibial tuberosity, with the muscles separated and the blood vessels and nerves avoided. The tibia was exposed, and a hacksaw was used to create a fracture approximately 2 mm x 1 mm below the tibial tuberosity. The wound was sutured layer by layer and fixed with a plaster bandage. Penicillin was injected to prevent infection.

[0059] Grouping and Oral Gavage: Rats with fractures were randomly divided into four groups, 10 rats in each group, for a total of 40 rats. The model group was orally gavaged with 0.5% sodium carboxymethylcellulose. The Composition 1 group was orally gavaged with 160 mg / kg body weight of the Composition 1 suspension, the Composition 2 group was orally gavaged with 160 mg / kg body weight of the Composition 2 suspension, and the Composition 3 group was orally gavaged with 160 mg / kg body weight of the Composition 3 suspension. The gavage volume was 10 mL / kg body weight. The rats were orally gavaged once daily for 3 consecutive weeks (21 days).

[0060] Index measurement: After the rats were anesthetized, X-rays were taken and the degree of tibial fracture was scored. The scoring criteria were:

[0061] 0 points: The fracture ends are clear, with no periosteal reaction and no callus formation;

[0062] 1 point: The edges of the fracture ends tend to be blurred, the periosteal reaction is mild, and no callus can be recorded;

[0063] 2 points: The edges of the fracture ends are blurred, the periosteal reaction is light, the amount of callus is small, the density is poor, and the edges are irregular;

[0064] 3 points: The edge of the fracture end is still visible but almost disappeared, the periosteal reaction is deep, the callus is large but has not yet filled the defect, the density is deepened, and the edge is clear;

[0065] 4 points: The edges of the fracture ends completely disappear, the density of the periosteal reaction is close to that of the bone shadow, the callus defect is filled, has the same density as the cortical bone, and is connected to each other.

[0066] After X-ray filming, blood was collected from the abdominal aorta of the rats and centrifuged at 3000 rpm for 10 min. The upper serum was collected and the serum bone morphogenetic protein (BMPs) level of rats was determined by enzyme-linked immunosorbent assay.

[0067] 3. Experimental Results

[0068] After 3 weeks of oral administration, the fracture severity of group 3 of the rats was significantly reduced and the healing rate was significantly increased compared with the model group (P < 0.01); the fracture severity of group 1 of the rats was reduced and the healing rate was increased (P < 0.05); the fracture severity of group 2 of the rats showed a trend of reduction, and the healing rate was not significant (P > 0.05). The results showed that group 3 of the rats had the strongest effect in promoting fracture recovery, which was superior to group 1 of the rats and group 2 of the rats, and the difference was significant (P < 0.05, P < 0.01). See Table 1 and Figures 1-4 .

[0069] Compared with the model group, serum BMPs levels in Composition 3 were significantly elevated (P < 0.01); serum BMPs levels in Composition 1 were elevated (P < 0.05); and serum BMPs levels in Composition 2 showed a trend toward elevation, but no significant difference was observed. The results showed that Composition 3 had the strongest effect in promoting the elevation of serum BMPs, outperforming Composition 1 and Composition 2, with significant differences (P < 0.05, P < 0.01). See Table 2.

[0070] Table 1 Scoring results of X-ray films of rat fractures (n=10)

[0071]

[0072] Note: Compared with the model group, * represents P < 0.05, ** represents P < 0.01; compared with the combination 1, △ Represents P < 0.05; compared with composition 2, § represents P < 0.05, §§ Represents P < 0.01.

[0073] Table 2 Effects on serum BMPs levels in rats (n=10)

[0074]

[0075] Note: Compared with the model group, * represents P < 0.05, ** represents P < 0.01; compared with the combination 1, △ Represents P < 0.05; compared with composition 2, § represents P < 0.05, §§ Represents P < 0.01.

[0076] Example 6: Effect of Composition 3 on Osteoporosis Model in Ovariectomized Rats

[0077] 1. Experimental Materials

[0078] 1.1 Experimental samples

[0079] Composition 3: Mix 90g of deer blood powder, 60g of peach gum powder, 60g of cucumber seed powder, 30g of turmeric, and 10g of epigallocatechin gallate. Immediately before use, dilute with 0.5% sodium carboxymethylcellulose to a 16mg / mL suspension for oral administration to rats.

[0080] Calcium Carbonate D3 Chewable Tablets: Product of Wyeth Pharmaceuticals Co., Ltd.

[0081] 1.2 Reagents

[0082] Type I procollagen N-terminal propeptide (PINP) enzyme-linked immunosorbent assay kit, Shanghai Yanqi Biotechnology Co., Ltd.

[0083] 1.3 Instruments

[0084] Electronic balance (BCE223I-1CCN), Sartorius Scientific Instruments (Beijing) Co., Ltd.

[0085] High-frequency digital veterinary X-ray machine (DR), Kangpai (Jiangsu) Medical Technology Co., Ltd.

[0086] 1.4 Animals

[0087] SD rats, female, SPF grade, were provided by Sibeifu (Beijing) Biotechnology Co., Ltd., animal qualification certificate number SCXK (Beijing) 2024-0001.

[0088] 2. Experimental Methods

[0089] Model Preparation: 30 healthy female Sprague-Dawley rats were anesthetized and immobilized in the prone position. Hair was shaved above the top of the iliac crest and on both sides of the lumbar sacrospinal muscles. After disinfection with iodine, a longitudinal incision was made. The retroperitoneum was dissected to reveal the bilateral cauliflower-shaped ovaries. These ovaries were ligated and excised, followed by thorough hemostasis, suture of the incisions, and penicillin injection for infection. A sham-operated group of 10 rats underwent only a lumbar incision without ovariectomy. A normal diet was maintained postoperatively.

[0090] Grouped gavage: Ovariectomized rats were randomly divided into a model group, a Composition 3 group, and a Calcium Carbonate D3 group, with 10 rats in each group. Together with the sham-operated group, a total of 40 rats were administered. The sham-operated and model groups were gavaged with 0.5% sodium carboxymethylcellulose. The Composition 3 group was gavaged with 160 mg / kg body weight of a Composition 3 suspension. The Calcium Carbonate D3 group was gavaged with 160 mg / kg body weight of a Calcium Carbonate D3 suspension (10 mL / kg body weight). This was administered once daily for 8 consecutive weeks (approximately 2 months).

[0091] Determination of Indicators: Rats were fasted and weighed, and body weight was recorded. Anesthetized rats were then anesthetized, and leg X-rays were taken. Grayscale values ​​were compared with standard images and converted to bone density. The animals were exsanguinated, and the left femur was excised, dried to a constant weight, accurately weighed, and the value recorded.

[0092] 3. Experimental Results

[0093] Compared with the sham operation group, the bone density of the rats in the model group was significantly reduced (P<0.01); compared with the model group, the bone density of the composition 3 group was significantly increased (P<0.01), and the bone density of the positive drug group was significantly increased (P<0.05); compared with the positive drug group, the bone density of the composition 3 group was significantly increased (P<0.05). The results show that composition 3 can increase bone density and improve osteoporosis, and its effect is better than that of the positive drug calcium carbonate D3. See Table 3 for details. Figure 5-8 .

[0094] Compared with the sham-operated group, the model group had a significantly lower ratio of femoral dry weight to body weight (P<0.01). Compared with the model group, the ratio of femoral dry weight to body weight in the Combination 3 group was significantly increased (P<0.01), and the ratio of femoral dry weight to body weight in the positive drug group was significantly increased (P<0.01). Compared with the positive drug group, the ratio of femoral dry weight to body weight in the Combination 3 group was significantly increased (P<0.05). These results indicate that Combination 3 can increase femoral weight and improve osteoporosis, and its effect is superior to that of the positive drug calcium carbonate D3. See Table 4 for details.

[0095] Table 3 Effects on bone density in rats (n=10)

[0096]

[0097] Note: Compared with the sham operation group, # represents P < 0.05, ## Represents P < 0.01; compared with the model group, △ represents P < 0.05, △△ Represents P < 0.01; compared with the positive drug group, § Represents P < 0.05.

[0098] Table 4 Effects on femoral dry weight / body weight of rats (n=10)

[0099]

[0100] Note: Compared with the sham operation group, # represents P < 0.05, ## Represents P < 0.01; compared with the model group, △ represents P < 0.05, △△ Represents P < 0.01; compared with the positive drug group, § Represents P < 0.05.

[0101] In summary, the patented full-formula composition of the present invention has the effect of replenishing and strengthening bones, and can promote fracture healing and improve osteoporosis.

Claims

1. A nutritious composition of both medicinal and edible origin with the effect of strengthening and invigorating bones, wherein the composition is prepared from the following raw materials: deer blood powder, peach gum, cucumber seeds, turmeric, and epigallocatechin gallate.

2. The nutritional composition according to claim 1, characterized in that The weight ratio of the raw materials is: 5-10 parts of deer blood powder, 3-8 parts of peach gum, 3-8 parts of cucumber seeds, 2-5 parts of turmeric, and 1-3 parts of epigallocatechin gallate.

3. The nutritional composition according to claim 1-2, characterized in that The weight ratio of the raw materials is more preferably: 9 parts of deer blood powder, 6 parts of peach gum, 6 parts of cucumber seeds, 3 parts of turmeric, and 1 part of epigallocatechin gallate.

4. The nutritional composition according to any one of claims 1 to 3, characterized in that The drug can be prepared into any pharmaceutically acceptable oral dosage form.

5. The nutritional composition according to claim 4, characterized in that The oral preparations are tablets, powders, oral liquids, emulsions, syrups, capsules, and pills; tablets are preferred.

6. A method for preparing the composition according to any one of claims 1 to 3, comprising: (1) Grind peach gum, cucumber seeds and turmeric into powder respectively. (2) The powder obtained in step (1) is stirred and mixed with deer blood powder and epigallocatechin gallate until uniform.

7. Use of the nutritional composition according to any one of claims 1 to 6 in the preparation of a bone nutrition preparation.

Images