A compound composition having the effect of promoting bone health and its preparation method and application

Abstract

The invention discloses a compound composition having the function of promoting bone health, and a preparation method and application thereof. The invention prepares a compound composition having the function of promoting bone health by combining a traditional Chinese medicine extract with chicken cartilage collagen, magnesium, vitamin K2 and vitamin D3. The compound composition overcomes the food safety risk of existing osteoporosis prevention drugs by adding a traditional Chinese medicine extract for improving osteoporosis and promoting bone health. The compound composition disclosed by the invention can be used as a dietary supplement or a health food raw material for preventing or treating osteoporosis. Therefore, it can be seen that the compound composition disclosed by the invention is suitable for promotion and application.

Description

Technical Field

[0001] The present invention belongs to the technical field of natural medicines, specifically to a compound composition formula and its application, and in particular to a compound composition with the function of promoting bone health and its application, which is a Chinese medicine compound composition with the function of nourishing bones, assisting bone reconstruction, and promoting bone health. Background Art

[0002] Osteoporosis (OP) is a systemic bone disease characterized by decreased bone mass, bone microstructure damage, increased bone brittleness, and susceptibility to fractures. As the world's population ages, the prevalence of osteoporosis is rising year by year. Currently, more than 200 million people in the world suffer from osteoporosis, and its incidence has jumped to the sixth place among common and frequently occurring diseases. The number of people suffering from osteoporosis in my country exceeds 90 million, ranking first in the world. The latest epidemiological survey results show that the prevalence of osteoporosis in people aged 50 and over 65 in my country has reached 19.2% and 32% respectively, and has become one of the common causes of death among the elderly. In addition, osteoporosis is considered an "invisible disease" with no obvious clinical symptoms in the early stage. It will only attract the attention of patients when irreversible serious consequences such as fractures occur. Therefore, we should pay more attention to the early prevention of osteoporosis.

[0003] At present, the treatment of osteoporosis mainly regulates bone metabolism by promoting bone formation and inhibiting bone resorption, but the large side effects often limit its wide application. For example, long-term use of estrogen can increase the risk of women suffering from endometrial cancer, breast cancer, etc. And the commonly used osteoporosis prevention method is to supplement calcium and vitamin D, but for some people, only moderate supplementation is not effective, and excessive supplementation may increase the risk of kidney stones and cardiovascular diseases, so there is an urgent need to find safer and more effective osteoporosis prevention measures.

[0004] Therefore, how to develop a safe and effective compound composition for treating or preventing osteoporosis and promoting bone health is an urgent problem to be solved by those skilled in the art. Summary of the invention

[0005] In view of this, the purpose of the present invention is to provide a compound composition having the function of promoting bone health and its application in the preparation of health care products in view of the problems existing in the prior art.

[0006] In order to achieve the above object, the present invention adopts the following technical solution:

[0007] A compound composition having the function of promoting bone health, the compound composition is composed of the following raw materials, calculated by mass percentage:

[0008] Chicken cartilage collagen: 0.8-1.5g (30.768%-68.179%);

[0009] Magnesium 200-300 mg (6.249%-18.750%);

[0010] Vitamin K2: 80-100 μg (0.002%-0.0067%);

[0011] Vitamin D3: 2-15 μg (0.00006%-0.00099%)

[0012] Chinese herbal medicine extract: 0.5-1.5g (21.738%-59.998%).

[0013] The invention discloses a compound composition having the function of promoting bone health, which is obtained by combining a traditional Chinese medicine extract with chicken cartilage collagen, magnesium, vitamin K2 and vitamin D3. The compound composition overcomes the food safety risks of existing osteoporosis prevention drugs by adding the traditional Chinese medicine extract that improves osteoporosis and promotes bone health.

[0014] Preferably, the compound composition is composed of the following raw materials, calculated by mass percentage:

[0015] Chicken cartilage collagen (1g) 45.4525%;

[0016] Magnesium (200 mg) 9.0905%;

[0017] Vitamin K2 (90 μg) 0.004%;

[0018] Vitamin D3 (10 μg) 0.0005%;

[0019] Chinese herbal medicine extract (1g) 45.4525%.

[0020] Further preferably, the Chinese herbal medicine extract is obtained by extracting Chinese medicinal materials, and the Chinese herbal medicine extract is a mixture of Eucommia ulmoides extract, Drynaria fortunei extract and Cuscuta australis extract.

[0021] The Chinese medicinal materials for extracting the eucommia extract are eucommia bark and eucommia leaves, and the mass ratio of the eucommia bark to the eucommia leaves is 2:1.

[0022] Furthermore, the composition of the Chinese medicinal materials, by weight, includes 1 to 300 parts of Eucommia bark, 1 to 150 parts of Eucommia leaves, 1 to 100 parts of Drynariae Rhizoma, and 1 to 50 parts of Cuscuta australis.

[0023] It is worth noting that the Chinese medicinal materials used in the Chinese medicinal extract disclosed in the present invention are screened based on scientific evidence (from prescriptions related to bone health), organically combined, and compatible according to the theory of traditional Chinese medicine, rather than simply superimposed based on the efficacy of a single Chinese medicinal material. The specific efficacy of various Chinese medicinal materials is as follows:

[0024] Eucommia leaf: [Function and indications] Nourishes the liver and kidneys, strengthens the tendons and bones. Used for liver and kidney deficiency, dizziness, back and knee pain, and weakness of tendons and bones.

[0025] Eucommia bark: [Functions and indications] Nourishes the liver and kidneys, strengthens the tendons and bones, and stabilizes the fetus. Used to treat back pain, weak feet and knees, residual urine, itchy genitals, miscarriage, restless fetuses, and high blood pressure.

[0026] Drynaria: [Functions and indications] Healing wounds and relieving pain, nourishing the kidney and strengthening bones; externally used to eliminate wind and remove spots. Used for falls, sprains, fractures of tendons and bones, kidney deficiency and low back pain, weakness of tendons and bones, tinnitus, deafness, loose teeth; externally used to treat alopecia areata and vitiligo.

[0027] Cuscuta: [Functions and indications] Tonifies the liver and kidneys, consolidates the essence and reduces urine, stabilizes the fetus, improves eyesight, and stops diarrhea; used externally to eliminate wind and remove spots. Used for liver and kidney deficiency, soreness of the waist and knees, impotence and spermatorrhea, enuresis and frequent urination, kidney deficiency and fetal leakage, restless fetal movement, blurred vision and tinnitus, spleen and kidney deficiency and diarrhea; external treatment of vitiligo.

[0028] Through the analysis of the effects of the above-mentioned Chinese medicinal plants, it can be seen that although Eucommia bark, Eucommia leaves and Cuscuta seeds all have the functions of nourishing the liver and kidney and strengthening the tendons and bones, they have different focuses. Eucommia bark strengthens the nourishment of the liver and kidney on this basis and has the effects of treating sore waist and spine, weak feet and knees, etc.; Cuscuta seeds nourish the liver and kidney and have the effects of removing rheumatism, spleen and kidney deficiency and diarrhea. It is not simply superimposed with Eucommia bark and Eucommia leaves but complements each other. In addition, Drynaria has the effects of healing wounds and relieving pain, and tendon and bone fractures. The three are compatible with each other.

[0029] In addition, in the prior art, although the commonly used dosage of each Chinese medicine is known, a prescription is an organic whole after combining multiple medicines for a disease, and its efficacy is not equivalent to the simple addition of its various medicinal ingredients on the basis of the commonly used dosage. The dosage of each Chinese medicine in the prescription cannot usually be determined based on its commonly used dosage. The dosage ratio of the medicinal materials is determined by various considerations such as the characteristics of the medicinal materials, the combination of the monarch, minister, adjuvant and envoy, and cannot be simply optimized through experimental means such as comparison method and orthogonal method.

[0030] In addition, a technical purpose of the present invention is to provide a method for preparing the above-mentioned composite composition having the effect of promoting bone health, which specifically comprises the following steps:

[0031] 1) Mix the bark and leaf of Eucommia ulmoides in a mass ratio of 2:1, add 8 times the amount of 70-85% ethanol, heat and reflux to extract for 2 hours, filter, add 6 times the amount of deionized water to the residue, heat and reflux to extract twice, each time for 1 hour, combine the extracts, purify, concentrate, add 5-10% maltodextrin, spray dry at 150-200° C., and pass through an 80-mesh sieve to obtain the Eucommia ulmoides extract;

[0032] 2) Add 8 times the amount of 70-85% ethanol to the drynaria root medicinal material, heat and reflux to extract for 2 hours, filter, add 6 times the amount of 70-85% ethanol to the medicinal residue, heat and reflux to extract twice, each time for 2 hours, combine the extracts, purify, concentrate, add 5-10% maltodextrin, spray dry at 150-200° C., and pass through an 80-mesh sieve to obtain the drynaria root extract;

[0033] 3) Add 8 times the amount of 40-80% ethanol to the dodder seed medicinal material, soak for 0.5 h, heat and reflux to extract for 2 h, filter, add 6 times the amount of 40-80% ethanol to the medicinal residue, heat and reflux to extract twice, each time for 1 h, combine the extracts, purify, concentrate, spray dry at 150-200° C., and pass through an 80-mesh sieve to obtain the dodder seed extract;

[0034] 4) mixing the Eucommia ulmoides extract, Drynaria fortunei extract and Cuscuta australis extract to obtain a Chinese medicine extract;

[0035] 5) adding chicken cartilage collagen, magnesium, vitamin K2 and vitamin D3 to the traditional Chinese medicine extract and mixing them to prepare the compound composition.

[0036] Preferably, the Chinese medicine extract is prepared by mixing Eucommia ulmoides extract, Drynaria fortunei extract and Cuscuta australis extract, and the weight percentage is:

[0037] Eucommia extract 60-80%,

[0038] Drynaria extract 10-40%,

[0039] Cuscuta extract 5-10%.

[0040] And, the mixed ratio of the above-mentioned Chinese herbal extract, chicken cartilage collagen, magnesium, vitamin K2 and vitamin D3, calculated by mass percentage:

[0041]

[0042]

[0043] Another object of the present invention is to provide a composite composition having the function of promoting bone health and its use in the preparation of health care products.

[0044] The compound composition disclosed in the invention can be used as a dietary supplement or a health food raw material for preventing or treating mild or moderate osteoporosis.

[0045] It can be seen from the above technical scheme that, compared with the prior art, the present invention provides a compound composition having the function of promoting bone health and a preparation method and application thereof, which has the following excellent effects:

[0046] 1. Chinese medicine scholars believe that the main pathogenesis of osteoporosis lies in "kidney deficiency", and Eucommia ulmoides, Drynaria fortunei, and Cuscuta chinensis have the effects of nourishing the liver and kidney and strengthening the tendons and bones. They are used as medicinal materials for nourishing the kidney and strengthening bones in clinical practice, with good therapeutic effects. Among them, Eucommia ulmoides, Drynaria fortunei, and Cuscuta chinensis are used in combination, and their effects on treating osteoporosis and promoting bone health have been verified before. On this basis, the present invention follows the theory of traditional Chinese medicine compatibility, and innovates Eucommia ulmoides, Drynaria fortunei, and Cuscuta chinensis to design an optimal ratio composition that improves osteoporosis and promotes bone health. And by synergizing collagen, magnesium, vitamin K, and vitamin D, it is combined with a traditional Chinese medicine composition, so that the prepared composite composition can finally nourish bones, help bone reconstruction, introduce calcium into bones, and make bones dense and tough.

[0047] 2. The present invention adopts a preparation process in which the medicinal materials are extracted separately and then compounded to determine the main active substances. Compared with the traditional Chinese medicine extraction method, the quality of the extract is more stable and the controllability is higher.

[0048] 3. The compound composition disclosed in the present invention has been confirmed through efficacy experiments to have good effects in nourishing bones, assisting bone reconstruction, improving osteoporosis, and promoting bone health.

[0049] 4. The compound composition disclosed in the present invention has no side effects and is easily absorbed. The Chinese medicinal extract used to treat osteoporosis and promote bone health can not only improve the bone health problems of middle-aged and elderly people, but also effectively avoid other complications caused by osteoporosis. BRIEF DESCRIPTION OF THE DRAWINGS

[0050] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the provided drawings without paying creative work.

[0051] Figure 1 The dynamic test results of body weight of rats in each group (n=8);

[0052] Figure 2 The dynamic detection results of body temperature of rats in each group (n=8).

[0053] Figure 3 The figures are the final blood index test results of rats in each group (n=8).

[0054] Figure 4 The figures are the terminal biochemical index test results of rats in each group (n=8).

[0055] Figure 5 The biomechanical test results of the terminal femur of rats in each group (n=8).

[0056] Figure 6 The micro-CT scan results of the terminal femur of rats in each group (n=8).

[0057] Figure 7 3D-mirco CT scans of the terminal femur of rats in each group. DETAILED DESCRIPTION

[0058] The technical solutions disclosed in the present invention will be described clearly and completely below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0059] The embodiment of the present invention discloses a safe and effective compound composition, which can treat or prevent osteoporosis and has the effect of promoting bone health. The compound composition can be used as a dietary supplement or a health food raw material for preventing or treating mild to moderate osteoporosis.

[0060] In order to better understand the present invention, the present invention is further specifically described below through the following examples, but it should not be understood as a limitation of the present invention. Some non-essential improvements and adjustments made by technicians in this field based on the above invention content are also considered to fall within the protection scope of the present invention.

[0061] The technical solution disclosed in the present invention will be further described below in conjunction with specific embodiments.

[0062] Embodiment 1:

[0063] A compound composition having the function of promoting bone health, the compound composition is composed of the following raw materials, calculated by mass percentage:

[0064]

[0065] Embodiment 2:

[0066] A compound composition having the function of promoting bone health, the compound composition is composed of the following raw materials, calculated by mass percentage:

[0067]

[0068] Embodiment 3:

[0069] A compound composition having the function of promoting bone health, the compound composition is composed of the following raw materials, calculated by mass percentage:

[0070]

[0071] Embodiment 4:

[0072] A compound composition having the function of promoting bone health, the compound composition is composed of the following raw materials, calculated by mass percentage:

[0073]

[0074] Embodiment 5:

[0075] A compound composition having the function of promoting bone health, the compound composition is composed of the following raw materials, calculated by mass percentage:

[0076]

[0077] Embodiment 6:

[0078] The composition of the Chinese medicinal materials used in the Chinese medicinal extract in the composite composition having the function of promoting bone health disclosed in any one of the above Examples 1 to 5 is calculated by weight:

[0079] 100 parts of Eucommia bark, 50 parts of Eucommia leaf, 25 parts of Drynaria fortunei, 8 parts of Cuscuta australis;

[0080] The preparation method of the Chinese medicine extract is as follows:

[0081] Each of the above medicinal materials is extracted by an alcohol extraction process, purified by a macroporous resin, concentrated, and spray-dried to finally obtain a Chinese medicine extract.

[0082] Specifically, the preparation method of the above-mentioned composite composition having the effect of promoting bone health comprises the following steps:

[0083] (1) Each medicinal material is extracted by alcohol extraction process, purified by macroporous resin, concentrated and spray-dried to obtain the Chinese medicine extract;

[0084] (2) The prepared Chinese herbal extract is mixed with chicken cartilage collagen, magnesium, vitamin K2 and vitamin D3 to obtain a composite composition.

[0085] Embodiment 7:

[0086] The composition of the Chinese medicinal materials used in the Chinese medicinal extract in the composite composition having the function of promoting bone health disclosed in any one of the above Examples 1 to 5 is calculated by weight:

[0087] 60 parts of Eucommia bark, 30 parts of Eucommia leaf, 20 parts of Drynaria fortunei, 5 parts of Cuscuta australis;

[0088] The preparation method of the Chinese medicine extract is as follows:

[0089] Each of the above medicinal materials is extracted by an alcohol extraction process, purified by a macroporous resin, concentrated, and spray-dried to finally obtain a Chinese medicine extract.

[0090] Specifically, the preparation method of the above-mentioned composite composition having the effect of promoting bone health comprises the following steps:

[0091] (3) Each medicinal material is extracted by alcohol extraction process, purified by macroporous resin, concentrated and spray-dried to obtain the Chinese medicine extract;

[0092] (4) The prepared Chinese herbal extract is mixed with chicken cartilage collagen, magnesium, vitamin K2 and vitamin D3 to obtain a composite composition.

[0093] Embodiment 8:

[0094] The composition of the Chinese medicinal materials used in the Chinese medicinal extract in the composite composition having the function of promoting bone health disclosed in any one of the above Examples 1 to 5 is calculated by weight:

[0095] 80 parts of Eucommia bark, 40 parts of Eucommia leaf, 10 parts of Drynaria fortunei, 3 parts of Cuscuta australis;

[0096] The preparation method of the Chinese medicine extract is as follows:

[0097] Each of the above medicinal materials is extracted by an alcohol extraction process, purified by a macroporous resin, concentrated, and spray-dried to finally obtain a Chinese medicine extract.

[0098] Specifically, the preparation method of the above-mentioned composite composition having the effect of promoting bone health comprises the following steps:

[0099] (5) Each medicinal material is extracted by alcohol extraction process, purified by macroporous resin, concentrated and spray-dried to obtain the Chinese medicine extract;

[0100] (6) The prepared Chinese herbal extract is mixed with chicken cartilage collagen, magnesium, vitamin K2 and vitamin D3 to obtain a composite composition.

[0101] For example, the preparation method of the above disclosed composite composition having the effect of promoting bone health and the preparation method of the Chinese herbal extract therein are specifically described in the following examples.

[0102] Embodiment 9:

[0103] A Chinese medicine extract raw material composition of a compound composition having the function of promoting bone health comprises: bark of eucommia bark, drynaria rhizome, and dodder seed;

[0104] And, the preparation method of the above-mentioned Chinese medicine extract comprises the following steps:

[0105] (1) Eucommia bark was extracted once with 6 times the amount of 80% ethanol for 2 hours, filtered, and the residue was extracted twice with 6 times the amount of deionized water, each time for 1.5 hours. The combined extracts were concentrated to a small volume, 5% maltodextrin was added, and the concentration was continued to reach a density of 1.15-1.2. The dried product was spray-dried at 200°C, crushed and passed through an 80-mesh sieve, and then mixed to obtain Eucommia extract.

[0106] (2) After the drynaria herbs are roughly chopped, 75% ethanol is added, and the amount is 6 times, 5 times, and 5 times for extraction 3 times, and each time the amount is refluxed for 2 hours. The extract is filtered and concentrated to a small volume, and 10% maltodextrin of the raw material is added. The concentration is continued to reach a density of 1.2, and the dried material is spray-dried at 200°C. The dried material is crushed and passed through an 80-mesh sieve, and then mixed to obtain the drynaria extract.

[0107] (3) Add 75% ethanol to the dodder seed material, extract it 3 times with 6 times, 5 times, and 5 times the amount, reflux for 2 hours each time, filter the extract to concentrate it to a density of 1.12-1.15, spray dry it at 180°C, and grind the dried material through an 80-mesh sieve and mix it to obtain the dodder seed extract.

[0108] (4) The extracts prepared above are mixed in a ratio of 60%, 30% and 10% to obtain a Chinese medicine extract.

[0109] Example 10

[0110] A Chinese medicine extract raw material composition for promoting bone health comprises: eucommia bark, eucommia leaf, drynariae rhizome, and dodder seed;

[0111] And, the preparation method of the above-mentioned Chinese medicine extract comprises the following steps:

[0112] (1) Eucommia bark and Eucommia leaf are mixed in a ratio of 2:1, and 6 times the amount of 75% ethanol is added for extraction once, for 2 hours, filtered, and the residue is extracted twice with 6 times the amount of deionized water, each time for 1.5 hours. The combined extracts are concentrated to a small volume, and 5% maltodextrin is added to continue to concentrate to a density of 1.15-1.2, and spray-dried at 200°C. The dried product is crushed and passed through an 80-mesh sieve and then mixed to obtain an Eucommia extract.

[0113] (2) After the drynaria herbs are roughly chopped, 75% ethanol is added and extracted three times in 6 times, 5 times and 5 times the amount, each time with 2 hours of reflux. The extract is filtered and concentrated to a small volume, and 10% maltodextrin is added to continue to concentrate to a density of 1.2. The dried product is spray-dried at 200°C, and the dried product is crushed and passed through an 80-mesh sieve and then mixed to obtain the drynaria extract.

[0114] (3) Add 50% ethanol to the dodder seed, extract it 3 times with 6 times, 5 times, and 5 times the amount, reflux for 2 hours each time, filter the extract to a density of 1.12-1.15, spray dry at 180°C, and grind the dried product through an 80-mesh sieve and mix them to obtain the dodder seed extract.

[0115] (4) The extracts prepared above are mixed in a ratio of 60%, 30%, and 10% to obtain a Chinese medicine extract.

[0116] Embodiment 11

[0117] A Chinese medicine extract with bone health promoting effect comprises: eucommia bark, eucommia leaf, drynaria root and dodder seed;

[0118] And, the preparation method of the above-mentioned Chinese medicine extract comprises the following steps:

[0119] (1) Eucommia bark and Eucommia leaf are mixed in a ratio of 2:1, and 6 times the amount of 70% ethanol is added for extraction once, for 2 hours, filtered, and the residue is extracted twice with 6 times the amount of deionized water, each time for 1.5 hours. The combined extracts are concentrated to a small volume, and 5% maltodextrin is added to continue to concentrate to a density of 1.15-1.2, and spray-dried at 180°C. The dried product is crushed and passed through an 80-mesh sieve and then mixed to obtain an Eucommia extract.

[0120] (2) After the drynaria herbs are roughly chopped, 80% ethanol is added, and the amount is 6 times, 5 times, and 5 times for extraction 3 times, and each time the amount is refluxed for 2 hours. The extract is filtered and concentrated to a small volume, and 10% maltodextrin of the raw material is added. The concentration is continued to reach a density of 1.2, and the dried material is spray-dried at 180°C. The dried material is crushed and passed through an 80-mesh sieve and then mixed to obtain the drynaria extract.

[0121] (3) 80% ethanol was added to the dodder seed medicinal material, and the amount was 6 times, 5 times, and 5 times for extraction 3 times, and each time refluxed for 2 hours. The extract was filtered and concentrated to a density of 1.12-1.15, and spray-dried at 180°C. The dried material was crushed and passed through an 80-mesh sieve and then mixed to obtain the dodder seed extract.

[0122] (4) The extracts prepared above are mixed in a ratio of 75%, 15% and 10% to obtain a Chinese medicine extract.

[0123] Example 12

[0124] A compound composition with the function of promoting bone health, the raw materials of which are: eucommia bark, eucommia leaf, drynaria, dodder seed, chicken cartilage collagen, magnesium, vitamin K2 and vitamin D3.

[0125] And, the preparation method of the above-mentioned compound composition comprises the following steps:

[0126] (1) Eucommia bark and Eucommia leaf are mixed in a ratio of 2:1, and 6 times the amount of 75% ethanol is added for extraction once, for 2 hours, filtered, and the residue is extracted twice with 6 times the amount of deionized water, each time for 1.5 hours. The combined extracts are concentrated to a small volume, and 5% maltodextrin is added to continue to concentrate to a density of 1.15-1.2, and spray-dried at 200°C. The dried product is crushed and passed through an 80-mesh sieve and then mixed to obtain an Eucommia extract.

[0127] (2) After the drynaria herbs are roughly chopped, 75% ethanol is added and extracted three times in 6 times, 5 times and 5 times the amount, each time with 2 hours of reflux. The extract is filtered and concentrated to a small volume, and 10% maltodextrin is added to continue to concentrate to a density of 1.2. The dried product is spray-dried at 200°C, and the dried product is crushed and passed through an 80-mesh sieve and then mixed to obtain the drynaria extract.

[0128] (3) Add 50% ethanol to the dodder seed, extract it 3 times with 6 times, 5 times, and 5 times the amount, reflux for 2 hours each time, filter the extract to a density of 1.12-1.15, spray dry at 180°C, and grind the dried product through an 80-mesh sieve and mix them to obtain the dodder seed extract.

[0129] (4) The extracts prepared above were mixed in a ratio of 60%, 30%, and 10% to obtain a Chinese medicine extract.

[0130] (5) The prepared Chinese herbal extract is added to chicken cartilage collagen, magnesium, vitamin K2 and vitamin D3 to obtain the composite composition; wherein the Chinese herbal extract accounts for 45.4525%, chicken cartilage collagen accounts for 45.4525%, magnesium accounts for 9.0905%, vitamin K2 accounts for 0.004% and vitamin D3 accounts for 0.0005%.

[0131] Example 13

[0132] A composite material for promoting bone health comprises raw materials of eucommia bark, eucommia leaf, drynaria, dodder seed, chicken cartilage collagen, magnesium, vitamin K2 and vitamin D3.

[0133] And, the preparation method of the above-mentioned compound composition comprises the following steps:

[0134] (1) Eucommia bark and Eucommia leaf are mixed in a ratio of 2:1, and 6 times the amount of 70% ethanol is added for extraction once, for 2 hours, filtered, and the residue is extracted twice with 6 times the amount of deionized water, each time for 1.5 hours, and the combined extracts are concentrated to a small volume, and 5% maltodextrin is added to continue to concentrate to a density of 1.15-1.2, and spray dried at 200°C. The dried matter is crushed and passed through an 80-mesh sieve and then mixed to obtain an Eucommia extract.

[0135] (2) After the drynaria herbs are roughly chopped, 80% ethanol is added, and the amount is 6 times, 5 times, and 5 times for extraction 3 times, and each time the amount is refluxed for 2 hours. The extract is filtered and concentrated to a small volume, and maltodextrin of 10% of the raw material is added. The extract is further concentrated to a density of 1.2, and spray-dried at 200°C. The dried product is crushed and passed through an 80-mesh sieve and then mixed to obtain the drynaria extract.

[0136] (3) 80% ethanol was added to the dodder seed medicinal material, and the amount was 6 times, 5 times, and 5 times for extraction 3 times, and each time refluxed for 2 hours. The extract was filtered and concentrated to a density of 1.12-1.15, and spray-dried at 180°C. The dried material was crushed and passed through an 80-mesh sieve and then mixed to obtain the dodder seed extract.

[0137] (4) The extracts prepared above were mixed in a ratio of 75%, 15%, and 10% to obtain a Chinese medicine extract.

[0138] (5) The prepared Chinese herbal extract is added to chicken cartilage collagen, magnesium, vitamin K2 and vitamin D3 to obtain the composite composition; wherein the Chinese herbal extract accounts for 45.4525%, chicken cartilage collagen accounts for 45.4525%, magnesium accounts for 9.0905%, vitamin K2 accounts for 0.004% and vitamin D3 accounts for 0.0005%.

[0139] Embodiment 14

[0140] Capsule preparation:

[0141] A composite composition for promoting bone health comprises raw materials of eucommia bark, eucommia leaf, drynaria, dodder seed, chicken cartilage collagen, magnesium, vitamin K2 and vitamin D3.

[0142] The preparation method of the above-mentioned compound composition comprises the following steps:

[0143] (1) Eucommia bark and Eucommia leaf are mixed in a ratio of 2:1, and 6 times the amount of 75% ethanol is added for extraction once, for 2 hours, filtered, and the residue is extracted twice with 6 times the amount of deionized water, each time for 1.5 hours. The combined extracts are concentrated to a small volume, and 5% maltodextrin is added to continue to concentrate to a density of 1.15-1.2, and spray-dried at 200°C. The dried product is crushed and passed through an 80-mesh sieve and then mixed to obtain an Eucommia extract.

[0144] (2) After the drynaria herbs are roughly chopped, 80% ethanol is added, and the amount is 6 times, 5 times, and 5 times for extraction 3 times, and each time the amount is refluxed for 2 hours. The extract is filtered and concentrated to a small volume, and maltodextrin of 10% of the raw material is added. The extract is further concentrated to a density of 1.2, and spray-dried at 200°C. The dried product is crushed and passed through an 80-mesh sieve and then mixed to obtain the drynaria extract.

[0145] (3) Add 50% ethanol to the dodder seed, extract it 3 times with 6 times, 5 times, and 5 times the amount, reflux for 2 hours each time, filter the extract to a density of 1.12-1.15, spray dry at 180°C, and grind the dried product through an 80-mesh sieve and mix them to obtain the dodder seed extract.

[0146] The extracts prepared above are evenly mixed in a ratio of 60%, 30% and 10% to obtain a Chinese medicine extract.

[0147] (4) The prepared Chinese herbal extract is added to chicken cartilage collagen, magnesium, vitamin K2 and vitamin D3, wherein the Chinese herbal extract accounts for 45.4525%, chicken cartilage collagen accounts for 45.4525%, magnesium accounts for 9.0905%, vitamin K2 accounts for 0.004% and vitamin D3 accounts for 0.0005%.

[0148] (5) The extracts prepared above are mixed evenly and passed through an 80-mesh sieve to obtain a Chinese medicine extract, pregelatinized starch, talc and magnesium stearate are added, mixed evenly, and filled into capsules to prepare capsules.

[0149] Embodiment 15

[0150] Tablet preparation:

[0151] A composite composition having the function of promoting bone health, comprising raw materials of: eucommia bark, eucommia leaf, drynaria, dodder seed, chicken cartilage collagen, magnesium, vitamin K2, and vitamin D3;

[0152] And, the preparation method of the above-mentioned compound composition comprises the following steps:

[0153] (1) Eucommia bark and Eucommia leaf are mixed in a ratio of 2:1, and 6 times the amount of 75% ethanol is added for extraction once, for 2 hours, filtered, and the residue is extracted twice with 6 times the amount of deionized water, each time for 1.5 hours. The combined extracts are concentrated to a small volume, and 5% maltodextrin is added to continue to concentrate to a density of 1.15-1.2, and spray-dried at 200°C. The dried product is crushed and passed through an 80-mesh sieve and then mixed to obtain an Eucommia extract.

[0154] (2) After the drynaria herbs are roughly chopped, 80% ethanol is added, and the amount is 6 times, 5 times, and 5 times for extraction 3 times, and each time the amount is refluxed for 2 hours. The extract is filtered and concentrated to a small volume, and maltodextrin of 10% of the raw material is added. The extract is further concentrated to a density of 1.2, and spray-dried at 200°C. The dried product is crushed and passed through an 80-mesh sieve and then mixed to obtain the drynaria extract.

[0155] (3) Add 50% ethanol to the dodder seed, extract it 3 times with 6 times, 5 times, and 5 times the amount, reflux for 2 hours each time, filter the extract to a density of 1.12-1.15, spray dry at 180°C, and grind the dried product through an 80-mesh sieve and mix them to obtain the dodder seed extract.

[0156] (4) The extracts prepared above were mixed in a ratio of 60%, 30%, and 10% to obtain a Chinese medicine extract.

[0157] (5) The prepared Chinese herbal extract is added to chicken cartilage collagen, magnesium, vitamin K2 and vitamin D3, wherein the Chinese herbal extract accounts for 45.4525%, chicken cartilage collagen accounts for 45.4525%, magnesium accounts for 9.0905%, vitamin K2 accounts for 0.004% and vitamin D3 accounts for 0.0005%.

[0158] (6) The composite composition prepared above is mixed evenly and passed through an 80-mesh sieve, and then starch and magnesium stearate are added and mixed evenly, pressed into tablets, and film-coated to prepare tablets.

[0159] Example 16

[0160] Granule preparation:

[0161] A composite material for promoting bone health, comprising the following raw materials: eucommia bark, eucommia leaf, drynaria, dodder seed, chicken cartilage collagen, magnesium, vitamin K2 and vitamin D3.

[0162] And, the preparation method of the above-mentioned compound composition comprises the following steps:

[0163] (1) Eucommia bark and Eucommia leaf are mixed in a ratio of 2:1, and 6 times the amount of 75% ethanol is added for extraction once, for 2 hours, filtered, and the residue is extracted twice with 6 times the amount of deionized water, each time for 1.5 hours. The combined extracts are concentrated to a small volume, and 5% maltodextrin is added to the raw material. The concentration is continued to reach a density of 1.15-1.2 to obtain the Eucommia extract.

[0164] (2) After the drynaria herbs are roughly chopped, 80% ethanol is added, and the amount is extracted three times in 6 times, 5 times, and 5 times. Each time, the extract is refluxed for 2 hours. The extract is filtered and concentrated to a small volume. Maltodextrin of 10% of the raw material is added, and the extract is further concentrated to a density of 1.2 to obtain the drynaria extract.

[0165] (3) Add 50% ethanol to the dodder seed, extract three times with 6 times, 5 times, and 5 times the amount, reflux for 2 hours each time, filter the extract and concentrate it to a density of 1.12-1.15 to obtain the dodder seed extract.

[0166] (4) mixing the extracts prepared above evenly and continuing to boil until the temperature reaches 1 g / mL to obtain an extract;

[0167] (5) The above-prepared extract is placed in a beaker, and weighed chicken cartilage collagen, magnesium, vitamin K2, vitamin D3, sucrose, starch and dextrin are added, and mixed evenly. When the extract is kneaded into a ball and falls apart when touched, the particles that cannot pass through a 20-mesh sieve and an 80-mesh sieve but can pass through a 10-mesh sieve are screened, and the particles are placed in an oven to dry in time, and collected for later use.

[0168] (6) The prepared granules are placed in a vacuum dryer for drying so that the water content of the granules is controlled at 4%, thereby preparing a composite granule for promoting bone health.

[0169] The content of the present invention is not limited to the content of the above embodiments. The combination of one or more embodiments can also achieve the purpose of the present invention.

[0170] In order to further verify the excellent effect of the present invention, the inventors also conducted the following efficacy experiments:

[0171] Among them, the drugs to be tested include: Example 9 group, Example 10 group, Example 12 group, and competitor drug administration group.

[0172] 1. Test method:

[0173] 64 Wistar rats were divided into 7 groups, normal group, negative group, competitor drug group, low dose group of Example 9, high dose group of Example 9, Example 12 group, and Example 10 group. They were raised in separate cages, with 4 rats in each cage and 2 cages in each group. After 7 days of adaptive growth without abnormality, they were used for osteoporosis model construction and preventive drug administration evaluation.

[0174] 2. Modeling:

[0175] The model was constructed according to the methods described in the preparation and application of medical experimental animal models and the standard operating procedures for the construction of osteoporosis models in the Model Animal Center. The method is as follows:

[0176] (1) Fix the rats in each model construction group and draw prednisone injection with a sterile syringe;

[0177] (2) 4.5 mg / kg prednisolone, intramuscular injection, twice a week for 8 weeks;

[0178] (7) Rats in the normal control group received the same treatment and were injected with 0.2 ml of saline;

[0179] (8) After the injection, the rats were fed normally and their condition was observed daily.

[0180] 3. Drug administration:

[0181] The intragastric concentrations of each group of rats are shown in the table below. Each rat was given the drug by intragastric gavage from the day of model establishment, once a day. The negative group was given an equal volume of drug solution (normal saline) by intragastric gavage every day for 8 consecutive weeks, i.e., 56 days.

[0182] Group Group Mark Dosage Drug concentration Normal group Normal / / Negative group Placebo / Volume of drug solution Competitor drug group FJ-1 90 30mg / ml Example 9 Low dose FJ-2 90 30mg / ml Example 9 High Dose FJ-3 180 60mg / ml Example 12 Group FJ-4 214 70mg / ml Example 10 Group FJ-5 135 45mg / ml

[0183] 4. Experimental results

[0184] 4.1 Dynamic test results of body weight and temperature

[0185] During the dynamic detection of body weight and body temperature, there was no significant difference in the changes of body temperature among the groups. There was a very significant difference in weight gain among the groups. The weight gain of rats in the model group was slow, and the weight of each drug-treated group was significantly lower than that of the normal control group. There was no significant difference between FJ-1 and FJ-2 in the drug-treated group and the model group, and the weight gain of FJ-3, FJ-4, and FJ-5 was significantly improved compared with the model group.

[0186] Table 1 Dynamic body weight test results of rats in each group (n=8)

[0187]

[0188] Table 2 Dynamic body temperature test results of rats in each group (n=8)

[0189]

[0190]

[0191] 4.2 Serum ELISA index test results

[0192] The final ELISA results of each group showed (Table 3 and Figure 3 ), OPG indexes in each model construction group decreased significantly compared with the normal control group (p<0.01), among which, FJ-1 and FJ-2 had no significant difference compared with the model group (p>0.05). FJ-3 and FJ-4 had extremely significant differences compared with the model group (p<0.01), and FJ-5 had significant differences compared with the model group (p<0.05).

[0193] The RANKL index in each model construction group was significantly higher than that in the normal control group (p<0.01), among which, FJ-1 and FJ-2 had no significant difference compared with the model group (p>0.05). FJ-3, FJ-4 and FJ-5 had extremely significant difference compared with the model group (p<0.01).

[0194] The BGP indexes in each model construction group were significantly higher than those in the normal control group (p<0.01), among which FJ-1, FJ-2, FJ-3 and FJ-5 had no significant difference compared with the model group (p>0.05). FJ-4 had a significant difference compared with the model group (p<0.05).

[0195] The NTx indexes in each model construction group were significantly higher than those in the normal control group (p<0.01), among which FJ-1, FJ-2 and FJ-5 had no significant difference compared with the model group (p>0.05). FJ-3 had a significant difference compared with the model group (p<0.05), and FJ-4 had an extremely significant difference compared with the model group (p<0.01).

[0196] Table 3 Results of blood index test at the end of each group of rats (n=8)

[0197]

[0198]

[0199] 4.3 Blood and urine calcium and phosphorus determination

[0200] Judging from the final results of blood calcium, blood phosphorus, and 24-hour urine calcium and urine phosphorus concentrations in each group, drug FJ-4 had the best efficacy and could significantly inhibit the loss of calcium and phosphorus in the body compared with the model group, followed by FJ-3 and FJ-5 groups.

[0201] Table 4 Results of terminal biochemical indexes of rats in each group (n=8)

[0202]

[0203] 4.4 Femoral biomechanical analysis

[0204] The rat femur specimens were placed on the biomechanical testing instrument and the parameters were set: span of 15 mm, loading speed of 10 mm / min, horizontal distance of 2-3 mm, vertical distance of 4-5 mm, and biomechanical recording of the maximum load (Fmax) and elastic load (Fp) of the femur specimens, see Table 5. From the statistical results, it can be seen that after 8 weeks of glucocorticoid modeling, the Fmax and F values ​​of the femur of the model group rats were significantly lower than those of the normal control group. After drug intervention, the drug-treated groups FJ-3 and FJ-4 were able to reverse the glucocorticoid-induced femoral biomechanical changes, with the best effect, followed by FJ-5. FJ-4 had the best effect, but the difference was not significant compared with FJ-3. The difference analysis between each group and the model group is shown in Figure 5 and Table 5.

[0205] Table 5 Biomechanical test results of the terminal femur of rats in each group (n=8)

[0206]

[0207] 4.5 Femoral micro-CT scan analysis

[0208] The test indicators are as follows: Bone volume fraction BV / TV (%): the ratio of the total volume of trabeculae in the selected area to the total volume of the sample; Trabecular thickness Tb.Th (mm): the average thickness of trabeculae; Trabecular separation Tb.Sp (mm): the average width of the medullary cavity between trabeculae; Trabecular number Tb.N (1 / mm): the number of trabeculae per millimeter; Structural model index SMI: reflects the plate-like or rod-like structure characteristics of trabeculae. When osteoporosis occurs, trabeculae change from plate-like structure to rod-like structure, and the SMI value increases; Bone density BMD (g / cm 3 ): Cancellous bone density in the selected area.

[0209] The results show that the bone density of the rats in the model construction group was significantly lower than that in the normal control group, and the SMI index of the model construction group was significantly higher than that in the normal control group. After drug intervention, FJ-4 had the best effect, which was significantly improved compared with the model group, followed by FJ-3 group, which were significantly different from the model group (p<0.05).

[0210] Table 6 Micro-CT scan results of the femur of rats in each group (n=8)

[0211]

[0212] The above description of the disclosed embodiments enables one skilled in the art to implement or use the present invention. Various modifications to these embodiments will be apparent to one skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to the embodiments shown herein, but rather to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A compound composition having the effect of promoting bone health, characterized in that: The compound composition is composed of the following raw materials, calculated by mass percentage: Chicken cartilage collagen 30.768%-68.179%; Magnesium 6.249%-18.750%; Vitamin K2 0.002%-0.0067%; Vitamin D3 0.00006%-0.00099%; Chinese herbal medicine extracts 21.738%-59.998%; The Chinese medicine extract is obtained by extracting Chinese medicinal materials, and the Chinese medicine extract is a mixture of Eucommia ulmoides extract, Drynaria fortunei extract and Cuscuta australis extract; The Chinese medicinal materials for extracting the Eucommia ulmoides extract are Eucommia ulmoides bark and Eucommia ulmoides leaves, and the mass ratio of the Eucommia ulmoides bark to the Eucommia ulmoides leaves is 2:1; The Chinese herbal medicine extract is calculated by weight percentage: Eucommia extract 60-80%, Drynaria extract 10-30%, Cuscuta extract 5-10%.

2. The compound composition having the function of promoting bone health according to claim 1, characterized in that: The compound composition is composed of the following raw materials, calculated by mass percentage: Chicken cartilage collagen 45.4525%; Magnesium 9.0905%; Vitamin K2 0.004%; Vitamin D3 0.0005%; Chinese herbal medicine extract 45.4525%.

3. A method for preparing the composite composition having the effect of promoting bone health as claimed in claim 1, characterized in that: The specific steps include: 1) Mix the bark and leaf of Eucommia ulmoides in a mass ratio of 2:1, add 8 times the amount of 70-85% ethanol, heat and reflux to extract for 2 hours, filter, add 6 times the amount of deionized water to the residue, heat and reflux to extract twice, each time for 1 hour, combine the extracts, purify, concentrate, add 5-10% maltodextrin, spray dry at 150-200° C., and pass through an 80-mesh sieve to obtain the Eucommia ulmoides extract; 2) Add 8 times the amount of 70-85% ethanol to the drynaria root medicinal material, heat and reflux to extract for 2 hours, filter, add 6 times the amount of 70-85% ethanol to the medicinal residue, heat and reflux to extract twice, each time for 2 hours, combine the extracts, purify, concentrate, add 5-10% maltodextrin, spray dry at 150-200° C., and pass through an 80-mesh sieve to obtain the drynaria root extract; 3) Add 8 times the amount of 40-80% ethanol to the dodder seed medicinal material, soak for 0.5 h, heat and reflux to extract for 2 h, filter, add 6 times the amount of 40-80% ethanol to the medicinal residue, heat and reflux to extract twice, each time for 1 h, combine the extracts, purify, concentrate, spray dry at 150-200° C., and pass through an 80-mesh sieve to obtain the dodder seed extract; 4) mixing the Eucommia ulmoides extract, Drynaria fortunei extract and Cuscuta australis extract to obtain a Chinese medicine extract; 5) adding chicken cartilage collagen, magnesium, vitamin K2 and vitamin D3 to the traditional Chinese medicine extract and mixing them to prepare the compound composition.

4. Use of the composite composition having the function of promoting bone health as claimed in claim 1 in the preparation of health food.

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