CN106880839B - Deer bone tablet and preparation method thereof - Google Patents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/2873—Proteins, e.g. gelatin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
- A61K33/10—Carbonates; Bicarbonates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/32—Bones; Osteocytes; Osteoblasts; Tendons; Tenocytes; Teeth; Odontoblasts; Cartilage; Chondrocytes; Synovial membrane
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/11—Pteridophyta or Filicophyta (ferns)
- A61K36/12—Filicopsida or Pteridopsida
- A61K36/126—Drynaria
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/1703—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
- A61K38/1709—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/39—Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/282—Organic compounds, e.g. fats
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
Abstract
The invention discloses a deer bone tablet, which comprises the following components in parts by weight: 120-180 parts of deer bone meal, 120-180 parts of collagen, 120-180 parts of calcium carbonate, 50-100 parts of drynaria extract, 8-25 parts of casein phosphopeptide and 70-160 parts of pharmaceutic adjuvant. The invention also provides a preparation method and application thereof. The deer bone slices have the obvious effect of increasing bone density, are particularly suitable for middle-aged and elderly people, can be eaten as health-care products and are eaten orally, and the eating suggestion is that 2 times a day and 3 slices each time. The preparation method of the deer bone tablet is simple, and the obtained deer bone tablet has good performance and good stability.
Description
Technical Field
The invention belongs to the field of health care products, and particularly relates to a deer bone tablet and a preparation method thereof.
Background
Osteoporosis is a common and frequently occurring disease that seriously threatens the health of the elderly, especially postmenopausal women. The complications such as fracture caused by osteoporosis cause great pain to patients, and also bring heavy economic and life burden to society and families. Women who have osteoporosis after age 50 have reported a probability of hip, spine, forearm or proximal humerus fractures as high as 45% within 10 years; when the old aged over 65 falls unconsciously, 87 percent of the old aged will cause osteoporotic fracture. The absolute number of the elderly people in China is the first in the world, and the elderly population is rapidly increasing along with the improvement of living standard and the increase of population life, so that the diagnosis and the prevention of osteoporosis are very important.
Osteoporosis can be classified into three major groups, one is primary osteoporosis, and is a physiological degenerative disease that inevitably occurs with the increase of age. The second type is secondary osteoporosis, which is osteoporosis induced by other diseases or drugs. The third category is idiopathic osteoporosis, which is mostly seen in adolescents or adults aged 8-14 years, mostly with family genetic history, and more women than men. Osteoporosis occurring in pregnant and lactating women may also be classified as idiopathic osteoporosis to attract attention.
The main clinical manifestations and signs of osteoporosis are: pain, shortened height, humpback, brittle fracture, respiratory system disorder, etc.
1) Pain (due to cold or dampness)
Pain is a common symptom of osteoporosis, mainly due to high bone turnover and increased bone resorption. In the process of bone resorption, the destruction and disappearance of bone trabeculae, the destruction of the subcortical bone and the like all cause systemic bone pain, with the most common pain in the back and the waist. Another important cause of pain is bone fracture.
2) Height shortening and humpback
The height is shortened or humpback in silent rest is one of important clinical signs which appear after low back pain, and the height is shortened by 5-20 cm in some cases.
3) Brittle fracture
In osteoporosis, the bone fracture threshold is significantly lowered, so that fracture is liable to occur by a slight external force.
4) Disorders of the respiratory system
Compression fracture of thoracic and lumbar vertebrae caused by severe osteoporosis often causes kyphosis and thoracic deformity, the volume of the thoracic cavity is obviously reduced, and sometimes the function changes of a plurality of visceral organs can be caused, wherein the respiratory system has particularly prominent performance.
The final aim of preventing and treating osteoporosis is to reduce the occurrence of fracture. Clinically, the aim is achieved by delaying and reducing bone mass loss, striving for bone mass regaining and increasing bone strength. However, the effects of many current bone density enhancers are not ideal.
Disclosure of Invention
In order to solve the defects in the prior art, the invention aims to provide the deer bone tablet and the preparation method and application thereof.
A deer bone tablet comprises the following components in parts by weight: 120-180 parts of deer bone meal, 120-180 parts of collagen, 120-180 parts of calcium carbonate, 50-100 parts of drynaria extract, 8-25 parts of casein phosphopeptide and 70-160 parts of pharmaceutic adjuvant.
The pharmaceutical excipients are selected from one or more of microcrystalline cellulose, magnesium stearate and film coating agent.
Preferably, the deer bone slices comprise the following components in parts by weight: 120-180 parts of deer bone meal, 120-180 parts of collagen, 120-180 parts of calcium carbonate, 50-100 parts of drynaria extract, 8-25 parts of casein phosphopeptide, 60-120 parts of microcrystalline cellulose, 2-10 parts of magnesium stearate and 8-30 parts of film coating agent.
Further preferably, the deer bone slices comprise the following components in parts by weight: 167 parts of deer bone meal, 167 parts of collagen, 167 parts of calcium carbonate, 84 parts of drynaria extract, 17 parts of casein phosphopeptide, 82.4 parts of microcrystalline cellulose, 5.6 parts of magnesium stearate and 20 parts of film coating agent.
Wherein the film coating tablet is selected from one or more of hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose, glyceryl triacetate and zein; preferably, the film-coated tablet consists of the following components in parts by weight: 10-30 parts of hydroxypropyl methyl cellulose phthalate, 10-30 parts of hydroxypropyl methyl cellulose, 10-30 parts of glyceryl triacetate and 10-30 parts of zein.
In the present invention, in the case of the present invention,
deer bone powder can be purchased directly and should meet the requirements of 'list of articles available for health food' in appendix 2 of No. 51 text;
the collagen can be purchased directly and meets the requirements of QB 2732 hydrolyzed collagen;
calcium carbonate, which should meet the requirements of pharmacopoeia of the people's republic of China;
the casein phosphopeptide is required to meet the requirements of GB31617 national standard food safety food nutrition enhancer casein phosphopeptide;
rhizoma drynariae, namely rhizoma drynariae: rhizoma Drynariae, rhizoma Coptidis, rhizoma Drynariae, radix seu caulis Kadsurae Heteroclitae, Nippon Feilong, caulis et folium Gaultheriae Yunnanensis, and herba Gei Falcati. The name of English: drynaria fortunei. Pteridophyllales order, drynaria family pteridophyceae. The drynaria extract is an extract of dried rhizome thereof, can be obtained by preparation or purchase, and can be extracted from 5-25 parts by weight per 100 parts by weight of drynaria extract, and the obtained drynaria extract needs to meet the quality standard shown in table 1:
TABLE 1 quality standards of drynaria extract
The invention also provides a preparation method of the deer bone tablet, which comprises the following steps:
(1) sieving: sieving Os Cervi powder, collagen, calcium carbonate, rhizoma Drynariae extract, casein phosphopeptide, microcrystalline cellulose, and magnesium stearate respectively;
(2) mixing: taking deer bone powder, collagen, calcium carbonate, drynaria extract, casein phosphopeptide and microcrystalline cellulose according to the formula ratio, and uniformly mixing in a mixer to obtain mixed powder;
(3) and (3) granulating: preparing soft materials from the mixed powder, granulating, drying, and grading to obtain dry granules;
(4) total mixing: adding magnesium stearate with the formula ratio into the dry granules, and uniformly mixing in a mixer to obtain a total mixture;
(5) tabletting: tabletting the total mixture to obtain plain tablets;
(6) coating: taking the film coating agent according to the formula proportion, adding ethanol to prepare coating liquid, and putting the plain tablets and the coating liquid into a coating machine for coating.
Preferably, the preparation method comprises the following steps:
(1) sieving: sieving Os Cervi powder, collagen, calcium carbonate, rhizoma Drynariae extract, casein phosphopeptide, microcrystalline cellulose, and magnesium stearate with 80 mesh sieve respectively;
(2) mixing: taking deer bone powder, collagen, calcium carbonate, drynaria extract, casein phosphopeptide and microcrystalline cellulose according to the formula ratio, mixing in a mixer for 30 minutes, and uniformly mixing to obtain mixed powder;
(3) and (3) granulating: preparing the mixed powder into a soft material by using 90% of ethanol by mass fraction, granulating by using a 18-mesh sieve, drying at 50 ℃ until the moisture content is below 5%, and granulating by using a 18-mesh sieve to obtain dry granules;
(4) total mixing: adding magnesium stearate with the formula ratio into the dry granules, mixing for 15 minutes in a mixer, and uniformly mixing to obtain a total mixture;
(5) tabletting: tabletting the total mixture to obtain plain tablets;
(6) coating: taking the film coating agent according to the formula proportion, adding ethanol with the mass fraction of 70% to prepare coating liquid with the mass fraction of 10% of the film coating agent, and putting the plain tablets and the coating liquid into a coating machine for coating.
Wherein the content of the first and second substances,
the weight of the plain tablets in the step (5) is 0.65-0.72 g/tablet, and preferably 0.69 g/tablet.
The weight of the coating in the step (6) is 1.5-2.5% of the weight of the plain tablets, and the coating is preferably 2%.
The invention also provides the application of the deer bone tablet in preparing medicines and health products for enhancing bone density.
The invention has the beneficial effects that:
the deer bone slices have the obvious effect of increasing bone density, are particularly suitable for middle-aged and elderly people, can be eaten as health-care products and are eaten orally, and the eating suggestion is that 2 times a day and 3 slices each time. The preparation method of the deer bone tablet is simple, and the obtained deer bone tablet has good performance and good stability.
Detailed Description
The present invention is described in detail below by way of examples, and it should be noted that the following examples are only for illustrating the present invention and should not be construed as limiting the scope of the present invention. The invention is susceptible to numerous insubstantial modifications and adaptations by those skilled in the art in view of the foregoing disclosure.
In the examples and the comparative examples,
deer bone powder is purchased from the company Limited in the million peak deer industry of Changchun city, and meets the requirements of 'list of articles available for health food' in appendix 2 of No. 51;
the collagen is purchased from Wuhan medicated leaven biochemical engineering Co., Ltd, has the model of XEM-02, and meets the requirements of QB 2732 'hydrolyzed collagen';
the casein phosphopeptide is purchased from Baiwei biological science and technology limited company in Hebei and meets the requirement of GB31617 Casein phosphopeptide which is a food nutrition enhancer in national standard of food safety;
the drynaria extract is purchased from biotechnology limited of Nanjing Zelangang, and has a specification of 10:1 (namely 10 weight parts of drynaria extract is extracted from 100 weight parts of drynaria, which meets the quality standard in Table 1).
EXAMPLE 1 preparation of deer bone tablet
The formula of each 1000 tablets is as follows: 167g of deer bone meal, 167g of collagen, 167g of calcium carbonate, 84g of rhizoma drynariae extract, 17g of casein phosphopeptide, 82.4g of microcrystalline cellulose, 5.6g of magnesium stearate and 20g of film coating agent.
Wherein the film coating tablet consists of hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose, glyceryl triacetate and zein according to the weight ratio of 1:1:1: 1.
The preparation method comprises the following steps:
(1) sieving: sieving Os Cervi powder, collagen, calcium carbonate, rhizoma Drynariae extract, casein phosphopeptide, microcrystalline cellulose, and magnesium stearate with 80 mesh sieve respectively;
(2) mixing: taking deer bone powder, collagen, calcium carbonate, drynaria extract, casein phosphopeptide and microcrystalline cellulose according to the formula ratio, mixing in a mixer for 30 minutes, and uniformly mixing to obtain mixed powder;
(3) and (3) granulating: preparing the mixed powder into a soft material by using 90% of ethanol by mass fraction, granulating by using a 18-mesh sieve, drying at 50 ℃ until the moisture content is below 5%, and granulating by using a 18-mesh sieve to obtain dry granules;
(4) total mixing: adding magnesium stearate with the formula ratio into the dry granules, mixing for 15 minutes in a mixer, and uniformly mixing to obtain a total mixture;
(5) tabletting: tabletting the total mixture to obtain plain tablets with the weight of 0.69 g/tablet;
(6) coating: taking the film coating agent according to the formula proportion, adding ethanol with the mass fraction of 70% to prepare coating liquid with the mass fraction of 10% of the film coating agent, and putting the plain tablets and the coating liquid into a coating machine for coating, wherein the weight of the deer bone tablets obtained by coating is 0.7 g/tablet.
Example 2 preparation of deer bone tablet
The preparation was carried out as in example 1.
Replacing the film coating agent with a mixture of hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose and glyceryl triacetate in a mass ratio of 1:1: 1.
EXAMPLE 3 preparation of deer bone tablet
The preparation was carried out as in example 1.
The film coating agent is replaced by a mixture of hydroxypropyl methyl cellulose phthalate, zein and glyceryl triacetate in a mass ratio of 1:1: 1.
Example 4 preparation of deer bone tablet
The preparation was carried out as in example 1.
Replacing the film coating agent with a mixture of hydroxypropyl methylcellulose phthalate, zein and hydroxypropyl methylcellulose in a mass ratio of 1:1: 1.
EXAMPLE 5 preparation of deer bone tablet
The preparation was carried out as in example 1.
Replacing the film coating agent with a mixture of glyceryl triacetate, zein and hydroxypropyl methylcellulose in a mass ratio of 1:1: 1.
Comparative example 1 preparation of tablet for increasing bone Density
The formula of each 1000 tablets is as follows: 195g of deer bone meal, 195g of collagen, 195g of calcium carbonate, 17g of casein phosphopeptide, 82.4g of microcrystalline cellulose, 5.6g of magnesium stearate and 20g of film coating agent.
Wherein the film coating tablet consists of hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose, glyceryl triacetate and zein according to the weight ratio of 1:1:1: 1.
The preparation method comprises the following steps:
(1) sieving: sieving Os Cervi powder, collagen, calcium carbonate, casein phosphopeptide, microcrystalline cellulose, and magnesium stearate with 80 mesh sieve respectively;
(2) mixing: taking deer bone powder, collagen, calcium carbonate, casein phosphopeptide and microcrystalline cellulose according to the formula ratio, mixing in a mixer for 30 minutes, and uniformly mixing to obtain mixed powder;
(3) and (3) granulating: preparing the mixed powder into a soft material by using 90% of ethanol by mass fraction, granulating by using a 18-mesh sieve, drying at 50 ℃ until the moisture content is below 5%, and granulating by using a 18-mesh sieve to obtain dry granules;
(4) total mixing: adding magnesium stearate with the formula ratio into the dry granules, mixing for 15 minutes in a mixer, and uniformly mixing to obtain a total mixture;
(5) tabletting: tabletting the total mixture to obtain plain tablets with the weight of 0.69 g/tablet;
(6) coating: taking the film coating agent according to the formula proportion, adding ethanol with the mass fraction of 70% to prepare coating liquid with the mass fraction of 10% of the film coating agent, and putting the plain tablets and the coating liquid into a coating machine for coating, wherein the weight of the deer bone tablets obtained by coating is 0.7 g/tablet.
Comparative example 2 preparation of tablet for increasing bone Density
The formula of each 1000 tablets is as follows: 250.5g of deer bone meal, 250.5g of collagen, 84g of drynaria extract, 17g of casein phosphopeptide, 82.4g of microcrystalline cellulose, 5.6g of magnesium stearate and 20g of film coating agent.
Wherein the film coating tablet consists of hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose, glyceryl triacetate and zein according to the weight ratio of 1:1:1: 1.
The preparation method comprises the following steps:
(1) sieving: sieving Os Cervi powder, collagen, casein phosphopeptide, microcrystalline cellulose, and magnesium stearate with 80 mesh sieve respectively;
(2) mixing: taking deer bone powder, collagen, drynaria extract, casein phosphopeptide and microcrystalline cellulose according to the formula ratio, mixing in a mixer for 30 minutes, and uniformly mixing to obtain mixed powder;
(3) and (3) granulating: preparing the mixed powder into a soft material by using 90% of ethanol by mass fraction, granulating by using a 18-mesh sieve, drying at 50 ℃ until the moisture content is below 5%, and granulating by using a 18-mesh sieve to obtain dry granules;
(4) total mixing: adding magnesium stearate with the formula ratio into the dry granules, mixing for 15 minutes in a mixer, and uniformly mixing to obtain a total mixture;
(5) tabletting: tabletting the total mixture to obtain plain tablets with the weight of 0.69 g/tablet;
(6) coating: taking the film coating agent according to the formula proportion, adding ethanol with the mass fraction of 70% to prepare coating liquid with the mass fraction of 10% of the film coating agent, and putting the plain tablets and the coating liquid into a coating machine for coating, wherein the weight of the deer bone tablets obtained by coating is 0.7 g/tablet.
Comparative example 3 preparation of tablet for increasing bone Density
The formula of each 1000 tablets is as follows: 250.5g of deer bone meal, 250.5g of calcium carbonate, 84g of rhizoma drynariae extract, 17g of casein phosphopeptide, 82.4g of microcrystalline cellulose, 5.6g of magnesium stearate and 20g of film coating agent.
Wherein the film coating tablet consists of hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose, glyceryl triacetate and zein according to the weight ratio of 1:1:1: 1.
The preparation method comprises the following steps:
(1) sieving: sieving Os Cervi powder, calcium carbonate, casein phosphopeptide, microcrystalline cellulose, and magnesium stearate with 80 mesh sieve respectively;
(2) mixing: taking deer bone powder, calcium carbonate, rhizoma drynariae extract, casein phosphopeptide and microcrystalline cellulose according to the formula ratio, mixing in a mixer for 30 minutes, and uniformly mixing to obtain mixed powder;
(3) and (3) granulating: preparing the mixed powder into a soft material by using 90% of ethanol by mass fraction, granulating by using a 18-mesh sieve, drying at 50 ℃ until the moisture content is below 5%, and granulating by using a 18-mesh sieve to obtain dry granules;
(4) total mixing: adding magnesium stearate with the formula ratio into the dry granules, mixing for 15 minutes in a mixer, and uniformly mixing to obtain a total mixture;
(5) tabletting: tabletting the total mixture to obtain plain tablets with the weight of 0.69 g/tablet;
(6) coating: taking the film coating agent according to the formula proportion, adding ethanol with the mass fraction of 70% to prepare coating liquid with the mass fraction of 10% of the film coating agent, and putting the plain tablets and the coating liquid into a coating machine for coating, wherein the weight of the deer bone tablets obtained by coating is 0.7 g/tablet.
Comparative example 4 preparation of tablet for increasing bone Density
The formula of each 1000 tablets is as follows: 250.5g of collagen, 250.5g of calcium carbonate, 84g of rhizoma drynariae extract, 17g of casein phosphopeptide, 82.4g of microcrystalline cellulose, 5.6g of magnesium stearate and 20g of film coating agent.
Wherein the film coating tablet consists of hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose, glyceryl triacetate and zein according to the weight ratio of 1:1:1: 1.
The preparation method comprises the following steps:
(1) sieving: respectively sieving collagen, calcium carbonate, casein phosphopeptide, microcrystalline cellulose and magnesium stearate with 80 mesh sieve;
(2) mixing: taking collagen, calcium carbonate, rhizoma drynariae extract, casein phosphopeptide and microcrystalline cellulose according to the formula ratio, mixing in a mixer for 30 minutes, and uniformly mixing to obtain mixed powder;
(3) and (3) granulating: preparing the mixed powder into a soft material by using 90% of ethanol by mass fraction, granulating by using a 18-mesh sieve, drying at 50 ℃ until the moisture content is below 5%, and granulating by using a 18-mesh sieve to obtain dry granules;
(4) total mixing: adding magnesium stearate with the formula ratio into the dry granules, mixing for 15 minutes in a mixer, and uniformly mixing to obtain a total mixture;
(5) tabletting: tabletting the total mixture to obtain plain tablets with the weight of 0.69 g/tablet;
(6) coating: taking the film coating agent according to the formula proportion, adding ethanol with the mass fraction of 70% to prepare coating liquid with the mass fraction of 10% of the film coating agent, and putting the plain tablets and the coating liquid into a coating machine for coating, wherein the weight of the deer bone tablets obtained by coating is 0.7 g/tablet.
Test example 1 Effect of deer bone fragments on bone Density in rats
90 male SD rats were divided into 9 groups according to the weight balance principle: blank control group, examples 1-5 group, comparative examples 1-4 group, except control group, each group was administered at a dose of 3.22g/kg body weight, administered by gavage after dosing with deionized water, continuously administered for 12 weeks, fed with low calcium feed (calcium content 150mg/100g feed) during administration period, sacrificed 24 hours after the last administration, left femur was separated, skin was removed, and bone density of left femur was measured.
TABLE 2 rhizoma Drynariae extract quality criteria
| Examples | Femoral mid-point bone density (g/cm)2) |
| Blank control group | 0.106±0.007 |
| Example 1 | 0.121±0.009 |
| Example 2 | 0.119±0.010 |
| Example 3 | 0.121±0.008 |
| Example 4 | 0.120±0.008 |
| Example 5 | 0.119±0.009 |
| Comparative example 1 | 0.112±0.009 |
| Comparative example 2 | 0.114±0.011 |
| Comparative example 3 | 0.112±0.006 |
| Comparative example 4 | 0.111±0.008 |
The results show that in the bone density experiment, compared with a blank control group, the point bone density in the thighbone of the groups 1 to 4 of the invention is obviously increased, which indicates that the invention has the inhibiting effect on osteoporosis. Example 1 compared to comparative example 1, the addition of drynaria extract was more effective than the absence of addition at the same total dose administered. Example 1 compared with comparative examples 2-4, example 1 uses the combination of deer bone powder, collagen and calcium carbonate to achieve better effect than any two of the combination.
Test example 2 physical and chemical Properties of deer bone fragments
Test example 2 the deer bone fragments of examples 1-4 were tested for their physicochemical properties, and the test results are shown in table 3.
TABLE 3 test of physicochemical Properties of deer bone fragments
| Item | Example 1 | Example 2 | Example 3 | Example 4 | Example 5 |
| Disintegration time limit, min | 43 | 50 | 55 | 52 | 57 |
| Ash content% | 19.6 | 21.8 | 26.3 | 24.5 | 22.6 |
The results show that in the deer bone tablets of examples 1-5, the disintegration time and ash content both meet the relevant regulations of health products. In particular, in example 1, compared with examples 2 to 5, the film coating agent prepared by compounding four components of hydroxypropyl methylcellulose phthalate, zein, hydroxypropyl methylcellulose and glyceryl triacetate in proportion is used in example 1, so that the disintegration time is minimum, the ash content is minimum, the effect is better, and the technical effect of synergy is achieved.
Test example 3 hygroscopicity test of deer bone tablet
The deer bone slices prepared in examples 1-5 were placed at 37 ℃ under a relative humidity of 75% and tested for hygroscopicity after 10 days, and the test results are shown in Table 4.
Table 4 results of moisture absorption test
| Examples | Degree of moisture absorption (%) |
| Example 1 | 1.8 |
| Example 2 | 2.8 |
| Example 3 | 2.6 |
| Example 4 | 3.3 |
| Example 5 | 2.9 |
The results show that the deer bone slices of examples 1-5 have low hygroscopicity and good moisture resistance.
In particular, in example 1, compared with examples 2 to 5, the film coating agent prepared by compounding hydroxypropyl methylcellulose phthalate, zein, hydroxypropyl methylcellulose and triacetin in proportion is used in example 1, and compared with the film coating agent prepared by compounding any three of the components, the film coating agent prepared by compounding hydroxypropyl methylcellulose phthalate, zein, hydroxypropyl methylcellulose and triacetin, has lower hygroscopicity, better moisture resistance and easy storage.
Claims (6)
1. A deer bone tablet is characterized in that: the deer bone tablet is prepared from the following components in parts by weight: 167 parts of deer bone meal, 167 parts of collagen, 167 parts of calcium carbonate, 84 parts of drynaria extract, 17 parts of casein phosphopeptide, 82.4 parts of microcrystalline cellulose, 5.6 parts of magnesium stearate and 20 parts of film coating agent; the film coating agent comprises the following components in parts by weight according to the following ratio of 1:1:1:1, composition: hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose, glyceryl triacetate, and zein.
2. A method for preparing the deer bone slices as claimed in claim 1, which comprises the steps of:
(1) sieving: sieving Os Cervi powder, collagen, calcium carbonate, rhizoma Drynariae extract, casein phosphopeptide, microcrystalline cellulose, and magnesium stearate respectively;
(2) mixing: taking deer bone powder, collagen, calcium carbonate, drynaria extract, casein phosphopeptide and microcrystalline cellulose according to the formula ratio, and uniformly mixing in a mixer to obtain mixed powder;
(3) and (3) granulating: preparing soft materials from the mixed powder, granulating, drying, and grading to obtain dry granules;
(4) total mixing: adding magnesium stearate with the formula ratio into the dry granules, and uniformly mixing in a mixer to obtain a total mixture;
(5) tabletting: tabletting the total mixture to obtain plain tablets;
(6) coating: taking the film coating agent according to the formula proportion, adding ethanol to prepare coating liquid, and putting the plain tablets and the coating liquid into a coating machine for coating.
3. The method for preparing deer bone slices according to claim 2, comprising the steps of:
(1) sieving: sieving Os Cervi powder, collagen, calcium carbonate, rhizoma Drynariae extract, casein phosphopeptide, microcrystalline cellulose, and magnesium stearate with 80 mesh sieve respectively;
(2) mixing: taking deer bone powder, collagen, calcium carbonate, drynaria extract, casein phosphopeptide and microcrystalline cellulose according to the formula ratio, mixing in a mixer for 30 minutes, and uniformly mixing to obtain mixed powder;
(3) and (3) granulating: preparing the mixed powder into a soft material by using 90% of ethanol by mass fraction, granulating by using a 18-mesh sieve, drying at 50 ℃ until the moisture content is below 5%, and granulating by using a 18-mesh sieve to obtain dry granules;
(4) total mixing: adding magnesium stearate with the formula ratio into the dry granules, mixing for 15 minutes in a mixer, and uniformly mixing to obtain a total mixture;
(5) tabletting: tabletting the total mixture to obtain plain tablets;
(6) coating: taking the film coating agent according to the formula proportion, adding ethanol with the mass fraction of 70% to prepare coating liquid with the mass fraction of 10% of the film coating agent, and putting the plain tablets and the coating liquid into a coating machine for coating.
4. A method for preparing deer bone slices as claimed in claim 2 or 3, wherein: the weight of the plain tablets in the step (5) is 0.69 g/tablet.
5. A method for preparing deer bone slices as claimed in claim 2 or 3, wherein: the weight of the coating in the step (6) is 2% of that of the plain tablets.
6. The use of the deer bone tablet of claim 1 in the preparation of a medicine or health product for enhancing bone density.
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| CN107581608A (en) * | 2017-09-22 | 2018-01-16 | 张丽艳 | A kind of capsule preparations for increasing bone density and preparation method thereof |
| CN110115385A (en) * | 2018-02-05 | 2019-08-13 | 常州英莱克斯生物工程有限公司 | A kind of strength osteocomma increasing bone density and its production method |
| CN110115380A (en) * | 2018-02-05 | 2019-08-13 | 常州英莱克斯生物工程有限公司 | A kind of strength capsule increasing bone density and its production method |
| CN115804451A (en) * | 2022-11-25 | 2023-03-17 | 广州欣盛通健康管理科技有限公司 | Composition beneficial to increase of bone density and application of composition in food |
| CN117462507B (en) * | 2023-12-28 | 2024-03-15 | 山东齐都药业有限公司 | Vonola fumarate crude drug composition and preparation method thereof |
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| CN101874632A (en) * | 2009-11-05 | 2010-11-03 | 蒋小明 | Collagen deer bone calcium capsules and preparation method thereof |
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| CN101810336B (en) * | 2010-04-30 | 2012-03-21 | 广东仙乐制药有限公司 | Chewable soft capsules and method for preparing same |
| CN103099842A (en) * | 2011-11-14 | 2013-05-15 | 甘肃创兴生物工程有限责任公司 | Soft capsule helpful for increasing bone density and preparation method thereof |
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