阅读说明：本技术 一种治疗骨质疏松的组合物及其制备方法 (Composition for treating osteoporosis and preparation method thereof ) 是由 骆园 于 2021-06-24 设计创作，主要内容包括：本发明涉及药物或保健品领域,具体公开了一种治疗骨质疏松的组合物及其制备方法。该组合物由以下原料配制而成：鸡蛋壳10-30,食醋或醋酸或冰醋酸100-300,鹌鹑蛋0-10,茯苓0-25,山楂0-20,枸杞子0-25,大叶骨碎补0-80,杜仲0-60,广山药0-80,蜂王浆0-8,蜂蜜10-50,枸橼酸0-0.9,山梨酸0-1.2,甜菊素0-1.0,焦糖色素0-8,延胡索0-90,黄芪0-100,扶方藤0-100,夜交藤0-100,灵芝0-100,常春藤0-100,翠云草0-100。本发明的治疗骨质疏松的组合物具备调节骨细胞活性,促进骨形成,减少钙流失的功效,与中草药配伍使用,具有益肝肾、壮骨止痛、活血消肿,治疗骨质疏松症和风湿关节痛的效果。(The invention relates to the field of medicines or health-care products, and particularly discloses a composition for treating osteoporosis and a preparation method thereof. The composition is prepared from the following raw materials: 10-30 parts of egg shells, 100 parts of vinegar or acetic acid or glacial acetic acid, 0-10 parts of quail eggs, 0-25 parts of poria cocos, 0-20 parts of hawthorn, 0-25 parts of wolfberry fruits, 0-80 parts of rhizoma drynariae macrocephalae, 0-60 parts of eucommia ulmoides, 0-80 parts of rhizoma dioscoreae hypoglauca, 0-8 parts of royal jelly, 10-50 parts of honey, 0-0.9 part of citric acid, 0-1.2 parts of sorbic acid, 0-1.0 part of steviosin, 0-8 parts of caramel pigment, 0-90 parts of rhizoma corydalis, 0-100 parts of astragalus membranaceus, 0-100 parts of euonymus fortunei, 0-100 parts of tuber fleeceflower stems, 0-100 parts of lucid ganoderma, 0-100 parts of ivy stems and 0-100 parts of uncinata spikemoss herbs. The composition for treating osteoporosis has the effects of regulating bone cell activity, promoting bone formation and reducing calcium loss, is compatible with Chinese herbal medicines, and has the effects of benefiting liver and kidney, strengthening bones, relieving pain, promoting blood circulation, relieving swelling and treating osteoporosis and rheumatic arthralgia.)

1. The composition for treating osteoporosis is characterized by being prepared from the following raw materials in parts by weight: 10-30 parts of egg shells, 100-300 parts of vinegar or acetic acid or glacial acetic acid, 0-10 parts of quail eggs, 0-25 parts of poria cocos, 0-20 parts of hawthorn, 0-25 parts of wolfberry fruits, 0-80 parts of Dayegu rhizoma drynariae, 0-60 parts of eucommia ulmoides, 0-80 parts of Guangdong yam, 0-8 parts of royal jelly, 10-50 parts of honey, 0-0.9 part of citric acid, 0-1.2 parts of sorbic acid, 0-1.0 part of steviosin, 0-8 parts of caramel pigment, 0-90 parts of corydalis tuber, 0-100 parts of astragalus membranaceus, 0-100 parts of oriental vine, 0-100 parts of tuber fleeceflower stems, 0-100 parts of lucid ganoderma, 0-100 parts of ivy stems and 0-100 parts of uncinata spikemoss herbs.

2. The composition for treating osteoporosis of claim 1, wherein the composition further comprises a functional additive, and the weight ratio of the functional additive to the eggshells is (0.5-1.0): (10-30), wherein the functional additive consists of the syringomycins and indocalamus leaf polysaccharide in a mass ratio of 2: 3-6.

3. The composition for treating osteoporosis of claim 1, wherein the composition is prepared from the following raw materials in parts by weight: 10-30 parts of egg shells, 5-10 parts of quail eggs, 40-80 parts of Dayegu drynaria rhizome, 30-60 parts of eucommia ulmoides, 40-80 parts of Guang yam rhizome, 1-8 parts of royal jelly, 10-50 parts of honey, 100-300 parts of vinegar or acetic acid or glacial acetic acid, 0.5-1.0 part of functional additives, 50-100 parts of ivy and 50-100 parts of uncinata spikemoss herb.

4. The composition for treating osteoporosis of claim 1, wherein the composition is prepared from the following raw materials in parts by weight: 10-30 parts of egg shells, 5-10 parts of quail eggs, 40-80 parts of Dayeye drynaria rhizome, 30-60 parts of eucommia ulmoides, 40-80 parts of Guang yam, 1-8 parts of royal jelly, 10-50 parts of honey, 100-300 parts of vinegar or acetic acid or glacial acetic acid, 0.5-1.0 part of functional additives, 50-100 parts of ivy, 50-100 parts of uncinata spikemoss herb, 0.3-0.9 part of citric acid, 0.3-1.2 parts of sorbic acid, 0.2-1.0 part of steviosin and 1-8 parts of caramel pigment.

5. A method for preparing the composition for treating osteoporosis as claimed in claim 1, wherein the egg shell and quail egg are soaked in vinegar or acetic acid or glacial acetic acid for 24-72 hours, then enzymolysis and filtration are carried out to obtain egg shell and quail egg vinegar liquid, the egg shell and quail egg vinegar liquid is uniformly mixed with functional additives and honey, water is added to adjust the volume to a specified volume, and the finished product is obtained through stirring, filtering, filling and sterilization; or adding water and biological enzyme into the traditional Chinese medicines in the formula for enzymolysis, decocting, mixing decoctions, filtering, concentrating, precipitating with gelatin, precipitating with ethanol, filtering, concentrating into fluid extract, mixing the fluid extract with ovum Coturnicis Japonicae vinegar solution of ovum gallus Domesticus crusta, Lac Regis Apis, Mel or adding sorbic acid, caramel pigment, and steviosin, adding water, adjusting to a specified volume, stirring, filtering, bottling, and sterilizing to obtain the final product.

6. A method for preparing the composition for treating osteoporosis of claim 1, wherein the egg shell and quail egg are soaked in vinegar or acetic acid or glacial acetic acid for 24-72 hours, then the mixture is subjected to enzymolysis and filtration to obtain egg shell and quail egg vinegar liquid, the egg shell and quail egg vinegar liquid is uniformly mixed with functional additives and honey, and the mixture is dried in vacuum to obtain the finished product; or adding water and biological enzyme into the Chinese medicinal materials, performing enzymolysis, decocting, mixing decoctions, filtering, concentrating, precipitating with gelatin, precipitating with ethanol, filtering, concentrating to obtain fluid extract, mixing the fluid extract with ovum Coturnicis Japonicae vinegar solution, Lac Regis Apis, Mel or sorbic acid, caramel pigment, and steviosin, and vacuum drying.

7. The method according to claim 5, wherein the biological enzyme is a mixture of cellulase and xylanase.

8. The method according to claim 7, wherein the cellulase activity is 7000U/g, the xylanase activity is 30000U/g, and the cellulase and xylanase are mixed at a ratio of 3: 2 to 5.

9. The method according to claim 6, wherein the cellulase and xylanase are added in an amount of 1-2 wt%.

10. The preparation method of claim 5, wherein the enzymolysis time is 12-15 hours at 35-45 ℃.

Technical Field

The invention belongs to the field of medicines or health-care products, and particularly relates to a composition for treating osteoporosis and a preparation method thereof.

Background

Osteoporosis is a common disease in the elderly, and is mainly characterized in that cortical bone is porous and has a disordered structure, cancellous bone trabeculae are broken and thinned, and the osteoporosis has the characteristics of high morbidity, high disability rate, high medical expense and the like. With the aging of China becoming more and more serious, the problems of osteoporosis and fracture and the like caused by osteoporosis form great challenges for social public health. Therefore, the development of the medicine with remarkable effect of treating the osteoporosis has wide market prospect and can bring good social benefit and economic benefit.

The inventor researches a composition for treating osteoporosis for years ago and realizes the industrialized production of results, and the preparation method of the composition in the original technical scheme mainly comprises the steps of soaking egg shells in table vinegar or acetic acid or glacial acetic acid for 24-72 hours to dissolve the egg shells, filtering to obtain egg shell vinegar liquid, uniformly mixing the egg shell vinegar liquid with royal jelly and honey, adding water to adjust the volume to a specified volume, stirring, filtering, filling and sterilizing to obtain the finished product. When the traditional Chinese medicines are required to be matched, the traditional Chinese medicines are decocted with water, the decoction is combined, filtered and concentrated, the gelatin is firstly used for precipitation, then the ethanol is used for precipitation, the filtration and the concentration are carried out to obtain clear paste, the clear paste is uniformly mixed with egg shell vinegar liquid, queen bee powder and honey or added with sorbic acid, caramel pigment and steviosin, the water is added to adjust the volume to the specified volume, and the finished product is obtained after stirring, filtration, filling and sterilization. The inventor further improves the composition for treating the osteoporosis based on the original technical scheme and combines the physiological processes of bone formation, bone metabolism, calcium loss and the like.

Disclosure of Invention

The invention aims to provide a composition for treating osteoporosis and a preparation method thereof, the composition not only can easily absorb calcium, but also has the effects of regulating bone cell activity, promoting bone formation and reducing calcium loss, and has the effects of benefiting liver and kidney, strengthening bones, relieving pain, promoting blood circulation, diminishing swelling and treating osteoporosis and rheumatic arthralgia when being used together with Chinese herbal medicines.

In order to achieve the aim, the invention provides a composition for treating osteoporosis, which is prepared from the following raw materials in parts by weight: 10-30 parts of egg shells, 100-300 parts of vinegar or acetic acid or glacial acetic acid, 0-10 parts of quail eggs, 0-25 parts of poria cocos, 0-20 parts of hawthorn, 0-25 parts of wolfberry fruits, 0-80 parts of Dayegu rhizoma drynariae, 0-60 parts of eucommia ulmoides, 0-80 parts of Guangdong yam, 0-8 parts of royal jelly, 10-50 parts of honey, 0-0.9 part of citric acid, 0-1.2 parts of sorbic acid, 0-1.0 part of steviosin, 0-8 parts of caramel pigment, 0-90 parts of corydalis tuber, 0-100 parts of astragalus membranaceus, 0-100 parts of oriental vine, 0-100 parts of tuber fleeceflower stems, 0-100 parts of lucid ganoderma, 0-100 parts of ivy stems and 0-100 parts of uncinata spikemoss herbs.

Preferably, in the above technical scheme, the composition further comprises a functional additive, and the weight ratio of the functional additive to the eggshell is (0.5-1.0): (10-30), wherein the functional additive consists of the syringomycins and indocalamus leaf polysaccharide in a mass ratio of 2: 3-6. The addition of the additive not only improves the stability of the prepared product and promotes the absorption of calcium, but also is beneficial to regulating the activity of bone cells, and can effectively improve bone metabolism, promote bone formation, reduce the loss of calcium and reverse unbalanced bone metabolism to the positive balance direction by matching with egg shell quail egg vinegar and honey.

Preferably, in the above technical scheme, the composition is prepared from the following raw materials in parts by weight: 10-30 parts of egg shells, 5-10 parts of quail eggs, 40-80 parts of Dayegu drynaria rhizome, 30-60 parts of eucommia ulmoides, 40-80 parts of Guang yam rhizome, 1-8 parts of royal jelly, 10-50 parts of honey, 100-300 parts of vinegar or acetic acid or glacial acetic acid, 0.5-1.0 part of functional additives, 50-100 parts of ivy and 50-100 parts of uncinata spikemoss herb. The ivy has the efficacy of invigorating blood circulation, and is matched with egg shell quail egg vinegar, queen bee, honey and functional additives for use to promote blood to rapidly and efficiently transmit absorbed nutrients such as calcium, phosphorus and the like to required parts for absorption and utilization, improve the cure efficiency of osteoporosis, shorten the cure period and have good treatment auxiliary effect; the rhizoma Drynariae can be added to achieve effects of invigorating kidney, strengthening bone, promoting blood circulation, and relieving pain; strengthening the middle warmer is added, so that the effects of nourishing liver and kidney and strengthening bones and muscles are achieved; the uncinata spikemoss herb has the effects of clearing heat and promoting diuresis and treating rheumatic arthralgia; guang shan Yao can tonify spleen and stomach, and strengthen the effect of tonifying kidney and strengthening bone.

Preferably, in the above technical scheme, the composition is prepared from the following raw materials in parts by weight: 10-30 parts of egg shells, 5-10 parts of quail eggs, 40-80 parts of Davallia mariesii, 30-60 parts of eucommia ulmoides, 40-80 parts of Guangdong Chinese yams, 1-8 parts of royal jelly, 10-50 parts of honey, 100-300 parts of vinegar or acetic acid or glacial acetic acid, 0.5-1.0 part of functional additives, 50-100 parts of ivy, 50-100 parts of uncinata spikemoss herb, 0.3-0.9 part of citric acid, 0.3-1.2 parts of sorbic acid, 0.2-1.0 part of steviosin and 1-8 parts of caramel pigments.

According to the technical scheme, the invention also provides a preparation method of the composition for treating osteoporosis, which comprises the following steps: soaking ovum gallus domesticus crusta and ovum Coturnicis japonicae in vinegar or acetic acid or glacial acetic acid for 24-72 hr, performing enzymolysis and filtration to obtain ovum Coturnicis japonicae vinegar liquid, mixing the vinegar liquid with functional additive and Mel, adding water to a predetermined volume, stirring, filtering, bottling, and sterilizing to obtain the final product; or adding water and biological enzyme into the traditional Chinese medicines in the formula for enzymolysis, decocting, mixing decoctions, filtering, concentrating, precipitating with gelatin, precipitating with ethanol, filtering, concentrating into fluid extract, mixing the fluid extract with ovum Coturnicis Japonicae vinegar solution of ovum gallus Domesticus crusta, Lac Regis Apis, Mel or adding sorbic acid, caramel pigment, and steviosin, adding water, adjusting to a specified volume, stirring, filtering, bottling, and sterilizing to obtain the final product.

According to the technical scheme, the invention also provides another preparation method of the composition for treating osteoporosis, which comprises the following steps: soaking ovum gallus Domesticus crusta and ovum Coturnicis japonicae in edible vinegar or acetic acid or glacial acetic acid for 24-72 hr, performing enzymolysis and filtration to obtain ovum Coturnicis japonicae vinegar solution, mixing with functional additive and Mel, and vacuum drying to obtain the final product; or adding water and biological enzyme into the Chinese medicinal materials, performing enzymolysis, decocting, mixing decoctions, filtering, concentrating, precipitating with gelatin, precipitating with ethanol, filtering, concentrating to obtain fluid extract, mixing the fluid extract with ovum Coturnicis Japonicae vinegar solution, Lac Regis Apis, Mel or sorbic acid, caramel pigment, and steviosin, and vacuum drying.

Further, in the technical scheme, the biological enzyme is formed by mixing cellulase and xylanase.

Further, in the above technical scheme, the cellulase activity is 7000U/g, the xylanase activity is 30000U/g, and the mixing ratio of the cellulase and the xylanase is 3: 2 to 5.

Further, in the technical scheme, the addition amount of the cellulase and the xylanase is 1-2 wt%.

Further, in the technical scheme, the enzymolysis time is 12-15 hours at 35-45 ℃.

Compared with the prior art, the invention has the following beneficial effects:

1. the medicine of the invention is added with the ivy, which has the efficacy of invigorating blood circulation and also has the treatment effect on rheumatoid arthritis, and the ivy, the eggshell quail egg vinegar, the royal jelly, the honey and the functional additive are matched to use the blood to quickly and efficiently transmit the absorbed nutrient substances such as calcium, phosphorus and the like to the required part for absorption and utilization, thereby improving the cure efficiency of osteoporosis, shortening the cure period and having good treatment auxiliary effect; the uncinata spikemoss herb is added, so that the medicine has the effects of clearing heat and promoting diuresis and treating rheumatic arthralgia; the rhizoma drynariae with the big leaves is added to have the effects of tonifying the kidney, strengthening the bone, activating blood and relieving pain, so that muscles and bones channels can be nourished, and symptoms such as waist soreness and pain can be relieved; strengthening the middle warmer is added, so that the effects of nourishing liver and kidney and strengthening bones and muscles are achieved; the yam rhizome added has the functions of tonifying spleen and stomach and benefiting liver and kidney, and the yam rhizome has the functions of tonifying spleen and stomach and strengthening kidney and bone.

Tuckahoe, poria cocos: induce diuresis and drain dampness, invigorate spleen and calm heart. Can be used for treating edema, oliguria, phlegm and fluid retention, dizziness, palpitation, spleen deficiency, anorexia, loose stool, diarrhea, uneasiness, palpitation, and insomnia.

Hawthorn fruit: promote digestion, invigorate stomach, promote qi circulation and dissipate blood stasis.

Wolfberry fruit: the medlar contains a large amount of vitamins and iron, zinc, phosphorus, calcium, amino acid and protein which are needed by human body, and is beneficial to promoting the absorption and growth of bone calcium.

Astragalus root: tonify qi, strengthen superficies, induce diuresis, expel pus, heal wound and promote tissue regeneration. Can be used for treating deficiency of vital energy, asthenia, anorexia, loose stool, collapse of middle-warmer energy, chronic diarrhea, rectocele, hematochezia, metrorrhagia, superficial deficiency, spontaneous perspiration, qi deficiency, edema, carbuncle, cellulitis, intractable ulcer, blood deficiency, debility with yellowish complexion, internal heat, and diabetes; proteinuria due to chronic nephritis and diabetes.

B, Chinese hibiscus stems: relaxing muscles and tendons, activating collateral flow, stopping bleeding, and removing blood stasis. Treating lumbar muscle strain, rheumatalgia, hemoptysis, metrorrhagia, menoxenia, traumatic injury, fracture and traumatic hemorrhage

Caulis Polygoni Multiflori: nourish heart and induce tranquilization, dispel wind and dredge collaterals. Can be used for treating insomnia, dreaminess, blood deficiency, body pain, skin numbness, rheumatalgia, and rubella pruritus.

Ganoderma lucidum: it is used to treat consumptive disease, cough, asthma, insomnia and indigestion.

Therefore, after the traditional Chinese medicine components are added, the medicine has the effects of treating rheumatic arthralgia, tonifying spleen and activating blood, tonifying liver and kidney, strengthening bone and relieving pain and the like while supplementing calcium.

2. The functional additive is added into the composition for treating osteoporosis, the additive consists of the syringyl lipin and the indocalamus leaf polysaccharide according to a certain mass ratio, the addition of the additive not only improves the stability of the prepared product, promotes the absorption of calcium and improves the bioavailability of the medicine, but also has the effect of regulating the activity of bone cells, and the additive is mutually coordinated with egg white quail egg vinegar liquid, royal jelly and honey to effectively improve bone metabolism, promote bone formation, reduce the loss of calcium and reverse unbalanced bone metabolism to the positive balance direction, thereby achieving good effect of treating osteoporosis.

3. In the process of preparing the composition for treating osteoporosis, the traditional Chinese medicine components are subjected to enzymolysis by biological enzyme and then decocted, filtered and concentrated, so that the components such as cellulose and the like of the traditional Chinese medicine components are partially decomposed, the plant cell wall composition is broken, the effective active ingredients are fully released, and the extraction rate of the active ingredients of the traditional Chinese medicine is improved.

Detailed Description

The following detailed description is presented in conjunction with specific embodiments of the invention, but it should be understood that the scope of the invention is not limited by the specific embodiments.

Example 1

(1) Preparation of composition for treating osteoporosis

The composition is prepared from the following raw materials in parts by weight: 30 parts of egg shells, 10 parts of quail eggs, 300 parts of vinegar or acetic acid or glacial acetic acid, 1.0 part of functional additives and 50 parts of honey;

the functional additive consists of syringaresinol and indocalamus leaf polysaccharide in a mass ratio of 1: 3.

(2) Preparation method of composition for treating osteoporosis

Soaking ovum gallus Domesticus crusta and ovum Coturnicis Japonicae in vinegar or acetic acid or glacial acetic acid for 72 hr, performing enzymolysis, filtering to obtain ovum Coturnicis Japonicae vinegar solution, mixing with functional additive and Mel, adding water, adjusting to a predetermined volume, stirring, filtering, bottling, and sterilizing to obtain the final product. The product is orally administered 30 ml each time, 3 times a day, and 3 months for 1 course of treatment, and has good effects of treating and preventing osteoporosis

Example 2

(1) Preparation of composition for treating osteoporosis

The composition is prepared from the following raw materials in parts by weight: 20 parts of egg shells, 10 parts of quail eggs, 200 parts of vinegar or acetic acid or glacial acetic acid, 0.8 part of functional additives, 80 parts of rhizoma drynariae macrophyllae, 60 parts of eucommia ulmoides, 80 parts of rhizoma dioscoreae hypoglaucae, 5 parts of royal jelly, 40 parts of honey, 100 parts of ivy and 100 parts of uncinata spikemoss herb;

the functional additive consists of syringaresinol and indocalamus leaf polysaccharide in a mass ratio of 2: 3.

(2) Preparation method of composition for treating osteoporosis

Soaking ovum Coturnicis Japonicae in vinegar or acetic acid or glacial acetic acid for 72 hr, performing enzymolysis, and filtering to obtain vinegar solution; adding 1 wt% of water and biological enzyme (the biological enzyme is formed by mixing cellulase and xylanase, the activity of the cellulase is 7000U/g, the activity of the xylanase is 30000U/g, and the mixing ratio of the cellulase and the xylanase is 3: 5) into the traditional Chinese medicine in the formula, stirring and mixing for 12h at 45 ℃, decocting, merging decoction, filtering and concentrating, firstly using gelatin for precipitation, then using ethanol for precipitation, filtering and concentrating into clear paste, uniformly mixing the clear paste with the egg shell quail egg vinegar liquid, royal jelly and honey, adding water for adjusting to a specified volume, stirring, filtering, filling and sterilizing to obtain the finished product. The finished product is orally taken, 30 milliliters of the product is taken every time, 3 times a day, 3 months are taken as 1 course of treatment, the product not only has good effects of treating and preventing osteoporosis, but also has the effects of strengthening spleen and tonifying kidney, strengthening bones and activating blood circulation and treating rheumatic arthralgia.

Example 3

(1) Preparation of composition for treating osteoporosis

The composition is prepared from the following raw materials in parts by weight: 10 parts of egg shells, 100 parts of vinegar or acetic acid or glacial acetic acid, 0.5 part of functional additives, 10 parts of quail eggs, 25 parts of poria cocos, 20 parts of hawthorn, 25 parts of wolfberry fruits, 80 parts of rhizoma drynariae, 60 parts of eucommia ulmoides, 80 parts of dioscorea panthaica, 8 parts of royal jelly, 50 parts of honey, 0.9 part of citric acid, 1.2 parts of sorbic acid, 1.0 part of steviosin, 8 parts of caramel pigment, 100 parts of ivy and 100 parts of uncinata spikemoss;

the functional additive consists of syringaresinol and indocalamus leaf polysaccharide in a mass ratio of 2: 5.

(2) Preparation method of composition for treating osteoporosis

Soaking eggshell and quail egg in vinegar or acetic acid or glacial acetic acid for 72 hours, performing enzymolysis and filtration to obtain eggshell quail egg vinegar, adding water and biological enzyme (the biological enzyme is formed by mixing cellulase and xylanase, the cellulase activity is 7000U/g, the xylanase activity is 30000U/g, and the mixing ratio of the cellulase and xylanase is 3: 2)2 wt% into the formula traditional Chinese medicine, stirring and mixing for 15 hours at 35 ℃, decocting, combining decoction, filtering and concentrating, precipitating with gelatin, precipitating with ethanol, filtering and concentrating into clear paste, mixing the clear paste with the eggshell quail egg vinegar, royal jelly and honey uniformly, adding sorbic acid, caramel pigment and steviosin, mixing uniformly, adding water to a specified volume, stirring, filtering, filling and sterilizing to obtain the finished product. The product has good effects of treating and preventing osteoporosis, invigorating spleen and kidney, strengthening bone and promoting blood circulation, treating rheumatic arthralgia, tranquilizing mind and promoting urination.

Example 4

(1) Preparation of composition for treating osteoporosis

The composition is prepared from the following raw materials in parts by weight: 15 parts of egg shells, 150 parts of vinegar or acetic acid or glacial acetic acid, 0.8 part of functional additives, 7 parts of quail eggs, 20 parts of poria cocos, 10 parts of hawthorn fruits, 20 parts of wolfberry fruits, 50 parts of rhizoma drynariae, 30 parts of eucommia ulmoides, 40 parts of Chinese yam, 5 parts of royal jelly, 30 parts of honey, 0.6 part of citric acid, 1.0 part of sorbic acid, 6.0 parts of steviosin, 5 parts of caramel pigment, 60 parts of corydalis tuber, 100 parts of astragalus mongholicus, 100 parts of euonymus fortunei, 100 parts of tuber fleeceflower stems, 100 parts of lucid ganoderma, 50 parts of ivy stems and 50 parts of uncinata spikemoss herb;

the functional additive consists of syringaresinol and indocalamus leaf polysaccharide in a mass ratio of 2: 5.

(2) Preparation method of composition for treating osteoporosis

Soaking eggshell and quail egg in vinegar or acetic acid or glacial acetic acid for 72 hours, then filtering after enzymolysis to obtain eggshell quail egg vinegar liquid, adding water and biological enzyme (the biological enzyme is formed by mixing cellulase and xylanase, the cellulase activity is 7000U/g, the xylanase activity is 30000U/g, and the mixing ratio of the cellulase and xylanase is 3: 4)1.5 wt% of the traditional Chinese medicine in the formula, stirring and mixing for 13 hours at 40 ℃, decocting, combining decoction, filtering and concentrating, firstly using gelatin to precipitate, then using ethanol to precipitate, filtering and concentrating into clear paste, uniformly mixing the clear paste with the eggshell quail egg vinegar liquid, royal jelly and honey, then adding sorbic acid, caramel pigment and steviosin to uniformly mix, adding water to regulate the volume, stirring, filtering, filling and sterilizing to obtain the finished product. The product has good effects of treating and preventing osteoporosis, invigorating spleen and kidney, strengthening bone and promoting blood circulation, treating rheumatic arthralgia, tranquilizing mind and promoting urination, and treating asthenia and asthma.

Example 5

(1) Preparation of composition for treating osteoporosis

The composition is prepared from the following raw materials in parts by weight: 15 parts of egg shells, 100 parts of vinegar or acetic acid or glacial acetic acid, 0.8 part of functional additives, 10 parts of quail eggs, 20 parts of poria cocos, 20 parts of hawthorn fruits, 20 parts of wolfberry fruits, 50 parts of rhizoma drynariae, 50 parts of eucommia ulmoides, 60 parts of dioscorea panthaica, 8 parts of royal jelly, 50 parts of honey, 0.9 part of citric acid, 1.2 parts of sorbic acid, 1.0 part of steviosin, 8 parts of caramel pigment, 50 parts of ivy and 50 parts of uncinata spikemoss herb;

the functional additive consists of syringaresinol and indocalamus leaf polysaccharide in a mass ratio of 2: 3.

(2) Preparation method of composition for treating osteoporosis

Soaking egg shells and quail eggs in vinegar or acetic acid or glacial acetic acid for 72 hours, performing enzymolysis and filtration to obtain egg shell and quail egg vinegar liquid, adding 2 wt% of water and biological enzymes (the biological enzymes are formed by mixing cellulase and xylanase, the activity of the cellulase is 7000U/g, the activity of the xylanase is 30000U/g, and the mixing ratio of the cellulase and the xylanase is 3: 2) into the formula traditional Chinese medicines, stirring and mixing for 14 hours at 35 ℃, decocting, combining decoction, filtering and concentrating, precipitating with gelatin, precipitating with ethanol, filtering and concentrating into clear paste, uniformly mixing the clear paste with the egg shell and quail egg vinegar liquid, royal jelly and honey, adding sorbic acid, caramel pigment and steviosin, uniformly mixing, and performing vacuum drying to obtain the finished product. The product has good effects of treating and preventing osteoporosis, invigorating spleen and kidney, strengthening bone and promoting blood circulation, treating rheumatic arthralgia, tranquilizing mind and promoting urination.

Comparative example 2-1

Essentially the same as in example 2, except that the functional additive was replaced by an equal amount of syringaresinol monocomponent;

comparative examples 2 to 2

The method is basically the same as the method in the embodiment 2, but the method is different in that the functional additive is replaced by the single component of indocalamus leaf polysaccharide with the same quantity;

comparative examples 2 to 3

The composition is prepared from the following raw materials in parts by weight: 20 parts of egg shell, 200 parts of vinegar or acetic acid or glacial acetic acid, 80 parts of Dayeye rhizoma drynariae, 60 parts of eucommia bark, 80 parts of Guangdong yam rhizome, 5 parts of royal jelly, 40 parts of honey,

the preparation method of the composition for treating osteoporosis comprises the following steps:

soaking ovum gallus Domesticus crusta in edible vinegar or acetic acid or glacial acetic acid for 72 hr to dissolve completely, and filtering to obtain ovum gallus Domesticus crusta vinegar solution; decocting the Chinese medicinal materials in water, mixing decoctions, filtering, concentrating, precipitating with gelatin, precipitating with ethanol, filtering, concentrating to obtain fluid extract, mixing with ovum gallus Domesticus crusta vinegar solution, Lac Regis Apis, and Mel, adding water, adjusting to a predetermined volume, stirring, filtering, bottling, and sterilizing to obtain the final product. The finished product is orally taken 30 ml each time, 3 times a day, and 3 months is 1 course of treatment.

The results of toxicity tests, pharmacodynamic tests and clinical tests of the medicament of the invention are as follows:

(ii) toxicity test

1. The sample prepared in example 2 is used as a test substance, and the test is carried out by gastric lavage administration of mice after fasting for 16h, wherein the median lethal dose of the gastric lavage administration is 127.3ml/kg & BW, and the 95% confidence limit is 123.6-131.2 ml/kg. Through a gastric lavage administration experiment on rats after fasting for 16h, the one-time gastric lavage dosage is 120ml/kg & BW, the appearance, the behavior, the spirit and the appetite of the rats are not abnormal after the test objects are continuously observed for 14 days, and the main organs in the autopsy are not abnormal.

2. Long-term toxicity test: the composition is administered orally to rats at a dose of 80, 40 or 20ml/kg by gavage for 180 days, and the rats have normal behavior, diet and appearance, no obvious toxic reaction, and no obvious abnormality in hematology, blood biochemistry and organ and tissue examination. This demonstrates that the composition of the present invention for treating osteoporotic fractures is non-toxic.

(II) pharmacodynamic test:

comparative example 2 the effect of treating osteoporosis in ovariectomized rats of the samples prepared in example 2 and the comparative samples (comparative 2-1, comparative 2-2 and comparative 2-3) were compared by animal experiments, and the sham-operated group and the model control group were gavaged with physiological saline daily at an amount of 1.5ml/kg per time for 12 weeks at 1 time per day, and the difference in the values of the comparative bone density was analyzed, and the results are shown in table 1. The table shows that the product and the comparative sample both obviously improve the bone mineral density of rats, and the effect of the product is more prominent than that of the comparative sample.

TABLE 1 bone Density values of rats of different experimental group samples

Group of	Bone density value (g/cm)
		False operation	0.273±0.009
Model comparison	0.217±0.008
		Example 2	0.275±0.009
Comparative example 2-1	0.257±0.008
		Comparative example 2 to 2	0.243±0.007
Comparative examples 2 to 3	0.241±0.007

(III) clinical Studies

Clinical trials show that the symptoms and signs related to bone density, X-ray bone change and osteoporosis are observed. The product has obvious efficiency, the effective rates are respectively 32.1 percent and 63.7 percent, the total effective rate is 95.8 percent, and the total effective rate is obviously improved compared with comparative examples 2-3 without functional additives. The traditional Chinese medicine composition has the advantages that the traditional Chinese medicine composition does not have obvious adverse reaction and toxic or side effect when the patient is subjected to routine examination of blood, urine and excrement, and no obvious adverse reaction and toxic or side effect are found in the examination of heart, liver and kidney functions, and the indication that the traditional Chinese medicine composition has a good clinical curative effect on osteoporosis and is safe and reliable to use.

TABLE 2 clinical test results of samples from different experimental groups

The composition for treating osteoporosis has the effects of regulating the activity of bone cells and promoting bone formation, is compatible with Chinese herbal medicines, and has the effects of benefiting liver and kidney, strengthening bones, relieving pain, activating blood circulation, reducing swelling and treating osteoporosis and rheumatic arthralgia.

The foregoing descriptions of specific exemplary embodiments of the present invention have been presented for purposes of illustration and description. It is not intended to limit the invention to the precise form disclosed, and obviously many modifications and variations are possible in light of the above teaching. The exemplary embodiments were chosen and described in order to explain certain principles of the invention and its practical application to enable one skilled in the art to make and use various exemplary embodiments of the invention and various alternatives and modifications as are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the claims and their equivalents.