CN111068044A - Pharmaceutical composition with bone mineral density increasing effect and preparation thereof - Google Patents
Pharmaceutical composition with bone mineral density increasing effect and preparation thereof Download PDFInfo
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- CN111068044A CN111068044A CN202010008141.3A CN202010008141A CN111068044A CN 111068044 A CN111068044 A CN 111068044A CN 202010008141 A CN202010008141 A CN 202010008141A CN 111068044 A CN111068044 A CN 111068044A
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- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 33
- 230000001965 increasing effect Effects 0.000 title claims abstract description 18
- 210000000988 bone and bone Anatomy 0.000 title abstract description 55
- 229910052500 inorganic mineral Inorganic materials 0.000 title abstract description 44
- 239000011707 mineral Substances 0.000 title abstract description 44
- 238000002360 preparation method Methods 0.000 title abstract description 8
- 239000002994 raw material Substances 0.000 claims abstract description 25
- 241000893536 Epimedium Species 0.000 claims abstract description 15
- 108010010803 Gelatin Proteins 0.000 claims abstract description 15
- 108010001441 Phosphopeptides Proteins 0.000 claims abstract description 15
- 235000018905 epimedium Nutrition 0.000 claims abstract description 15
- 239000008273 gelatin Substances 0.000 claims abstract description 15
- 229920000159 gelatin Polymers 0.000 claims abstract description 15
- 235000019322 gelatine Nutrition 0.000 claims abstract description 15
- 235000011852 gelatine desserts Nutrition 0.000 claims abstract description 15
- 241000096284 Gynochthodes officinalis Species 0.000 claims abstract description 14
- 229960004494 calcium gluconate Drugs 0.000 claims abstract description 14
- 239000004227 calcium gluconate Substances 0.000 claims abstract description 14
- 235000013927 calcium gluconate Nutrition 0.000 claims abstract description 14
- MKJXYGKVIBWPFZ-UHFFFAOYSA-L calcium lactate Chemical compound [Ca+2].CC(O)C([O-])=O.CC(O)C([O-])=O MKJXYGKVIBWPFZ-UHFFFAOYSA-L 0.000 claims abstract description 14
- 229960002401 calcium lactate Drugs 0.000 claims abstract description 14
- 239000001527 calcium lactate Substances 0.000 claims abstract description 14
- 235000011086 calcium lactate Nutrition 0.000 claims abstract description 14
- NEEHYRZPVYRGPP-UHFFFAOYSA-L calcium;2,3,4,5,6-pentahydroxyhexanoate Chemical compound [Ca+2].OCC(O)C(O)C(O)C(O)C([O-])=O.OCC(O)C(O)C(O)C(O)C([O-])=O NEEHYRZPVYRGPP-UHFFFAOYSA-L 0.000 claims abstract description 14
- 239000005018 casein Substances 0.000 claims abstract description 12
- BECPQYXYKAMYBN-UHFFFAOYSA-N casein, tech. Chemical compound NCCCCC(C(O)=O)N=C(O)C(CC(O)=O)N=C(O)C(CCC(O)=N)N=C(O)C(CC(C)C)N=C(O)C(CCC(O)=O)N=C(O)C(CC(O)=O)N=C(O)C(CCC(O)=O)N=C(O)C(C(C)O)N=C(O)C(CCC(O)=N)N=C(O)C(CCC(O)=N)N=C(O)C(CCC(O)=N)N=C(O)C(CCC(O)=O)N=C(O)C(CCC(O)=O)N=C(O)C(COP(O)(O)=O)N=C(O)C(CCC(O)=N)N=C(O)C(N)CC1=CC=CC=C1 BECPQYXYKAMYBN-UHFFFAOYSA-N 0.000 claims abstract description 12
- 235000021240 caseins Nutrition 0.000 claims abstract description 12
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- 239000003814 drug Substances 0.000 claims description 8
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- 235000013305 food Nutrition 0.000 claims description 3
- 235000010755 mineral Nutrition 0.000 abstract description 43
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- 230000000144 pharmacologic effect Effects 0.000 abstract description 2
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- 239000000243 solution Substances 0.000 description 12
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- 230000000052 comparative effect Effects 0.000 description 7
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- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 6
- 241000699670 Mus sp. Species 0.000 description 6
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- 241001465754 Metazoa Species 0.000 description 1
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- WEXRUCMBJFQVBZ-UHFFFAOYSA-N pentobarbital Chemical compound CCCC(C)C1(CC)C(=O)NC(=O)NC1=O WEXRUCMBJFQVBZ-UHFFFAOYSA-N 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
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Classifications
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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
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
-
- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/191—Carboxylic acids, e.g. valproic acid having two or more hydroxy groups, e.g. gluconic acid
-
- 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
-
- 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
- A61K35/36—Skin; Hair; Nails; Sebaceous glands; Cerumen; Epidermis; Epithelial cells; Keratinocytes; Langerhans cells; Ectodermal cells
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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
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/29—Berberidaceae (Barberry family), e.g. barberry, cohosh or mayapple
- A61K36/296—Epimedium
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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
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/74—Rubiaceae (Madder family)
- A61K36/746—Morinda
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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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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
- A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
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- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
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Abstract
The invention relates to the technical field of functional food or biomedicine, in particular to a pharmaceutical composition with the function of increasing bone mineral density and a preparation thereof; the raw materials of the pharmaceutical composition are as follows: drynaria rhizome, morinda officinalis, epimedium herb, donkey-hide gelatin, calcium lactate, calcium gluconate and casein phosphopeptide. Pharmacological tests show that the pharmaceutical composition has good effect of increasing the bone mineral density.
Description
Technical Field
The invention relates to the technical field of functional foods or biomedicines, in particular to a pharmaceutical composition with an effect of increasing bone mineral density and a preparation thereof.
Background
Bone density, which is known as bone mineral density, is an important indicator of bone strength, expressed in grams per cubic centimeter, as an absolute value. When the bone density value is clinically used, the T value is usually used to judge whether the bone density is normal or not because the absolute values of different bone density detectors are different.
The human bone mineral content is closely related to the strength of bones and the homeostasis, and thus is an important index for evaluating the health condition of human beings. In physiological conditions, bone mineral content varies with age in human bones, and in pathological conditions, certain drugs can cause changes in bone mineral content. Therefore, quantitative determination of human bone mineral content has become an important issue in modern medicine. The conventional detection of bone mineral is mainly to measure the content of bone mineral in human body to obtain the accurate content of bone mineral (mainly calcium), which plays an important role in judging and researching bone physiology, pathology and human aging degree and diagnosing various diseases of the whole body. The bone mineral content of normal human is closely related to sex and age. Different sexes of the same age group are different, and women are lower than men. The same sex changes correspondingly with the age, and after the age of 35-40, the bone mineral content gradually declines, and the female is particularly obvious. The physiological change data also provides important diagnosis basis for the diagnosis of diseases and the change of bone mineral content caused by different reasons.
Age and sex are among the factors that affect the bone mineral content of humans. The bone mineral content increases with age from infancy to puberty with no apparent gender differences. After puberty, the increase in bone mineral content is more pronounced in men than in women, with the peak reaching the highest after 30-40 years of age. Later, the bone mineral content gradually decreases with age, and women have a larger decline than men. The data records that when the bone mineral content of the far radius of a woman 50-65 years old is measured, the annual bone mineral content reduction rate is 0.0118g/cm/year, and the bone mineral content of the far radius of an old is reduced by about 39% compared with the bone peak value.
Weight, height and bone transverse diameter are also one of the factors affecting the bone mineral content of a human. The bone mineral content of men and women before menopause is positively correlated with height, and the bone mineral content of women before menopause and women after menopause is positively correlated with weight. Due to individual difference of the transverse diameter of the bone, the content of the bone ore of the same age group is greatly changed. If the Bone Mineral Content (BMC) is corrected by using the bone mineral content/bone transverse diameter (BMC/BW.g/cm 2), so that the normal curve variation coefficient of a person of the same age is reduced to 9% from 12%, the variation coefficient is reduced to 6% by using a multiple regression method, and the height, the weight and the bone transverse diameter are taken into consideration, the variation coefficient of the old is reduced to 10% from 20%, and the variation coefficient of the child is reduced to 8%.
The effects of exercise and diet on the bone mineral content of the human body are considerable. Actual observation proves that the bone mineral content of radius and spine of athletes is obviously higher than that of a control group. With the same calcium intake, people who are engaged in physical labor can maintain a higher bone health than those who are not active. Research by bone experts shows that women on a high calcium diet have a higher average radial mineral content than women on a low calcium diet, and women on a high activity diet can maintain a better skeletal index. Therefore, attention is paid to diet adjustment, more food containing more calcium is eaten, and the risk of bone loss and fracture can be reduced by moderate physical labor or exercise.
The bone mineral content of normal people in different age groups is detected to know the change rule of the bone mineral content in the processes of bone development, growth and aging of human bodies. If the bone mineral content of the young people does not reach the high peak value, diet and medicines are adopted to supplement calcium and strengthen exercise, so that the bone mineral content reaches the high peak level. The bone mineral content of the old can be increased or not reduced by properly activating and sunning except calcium supplement of medicine diet. The detection technology of the single photon bone mineral analyzer provides a simple and non-traumatic bone measurement for clinic, and because of higher accuracy and precision, the single photon bone mineral analyzer is used for observing the change of normal bone mineral content in a life of a human, the influence of various diseases on bones and the curative effect of medicines, and provides a favorable measurement means for clinical research of bone metabolic diseases.
In conclusion, the research on a product for increasing the bone mineral density is of great significance.
Disclosure of Invention
The invention provides a novel pharmaceutical composition for increasing bone mineral density, which comprises the following raw materials: drynaria rhizome, morinda officinalis, epimedium herb, donkey-hide gelatin, calcium lactate, calcium gluconate and casein phosphopeptide; pharmacological tests show that the pharmaceutical composition has good effect of increasing the bone mineral density.
The invention is realized by the following technical scheme.
A pharmaceutical composition is characterized by comprising the following raw materials: drynaria rhizome, morinda officinalis, epimedium herb, donkey-hide gelatin, calcium lactate, calcium gluconate and casein phosphopeptide.
The raw materials of the pharmaceutical composition are as follows: 40-60 parts of rhizoma drynariae, 40-60 parts of morinda officinalis, 70-80 parts of epimedium herb, 40-60 parts of donkey-hide gelatin, 45-55 parts of calcium lactate, 50-60 parts of calcium gluconate and 1-3 parts of casein phosphopeptide.
The raw materials of the pharmaceutical composition are as follows: 50 parts of rhizoma drynariae, 50 parts of morinda officinalis, 75 parts of epimedium, 50 parts of donkey-hide gelatin, 48 parts of calcium lactate, 55.5 parts of calcium gluconate and 2 parts of casein phosphopeptide.
The application of the pharmaceutical composition in the medicines for increasing the bone density.
The pharmaceutical composition is used in food for increasing bone density.
Wherein the pharmaceutical composition is prepared into a pharmaceutical preparation.
Wherein the pharmaceutical composition is prepared into oral liquid.
Detailed Description
In order to make the technical means, the original characteristics, the achieved purposes and the effects of the invention easily understood, the invention is further explained with the following embodiments, but the following embodiments are only the preferred embodiments of the invention, and not all embodiments. Based on the embodiments in the implementation, other embodiments obtained by those skilled in the art without any creative efforts belong to the protection scope of the present invention.
The experimental methods in the following examples are conventional methods unless otherwise specified, and materials, reagents and the like used in the following examples are commercially available unless otherwise specified.
Preparation examples
EXAMPLE 1
A pharmaceutical composition for increasing bone density: 40g of rhizoma drynariae, 40g of morinda officinalis, 70g of epimedium herb, 40g of donkey-hide gelatin, 45g of calcium lactate, 50g of calcium gluconate and 1g of casein phosphopeptide.
The preparation method comprises the following steps: taking drynaria rhizome, morinda officinalis, epimedium herb and donkey-hide gelatin as raw materials, adding deionized water with the weight being 12 times of that of the raw materials, extracting for 5 hours under reflux, and keeping an extracting solution; adding deionized water 10 times the weight of the raw materials into the residue, extracting for 4 hours under reflux, and reserving the extracting solution; adding deionized water 8 times the weight of the raw materials into the residue, extracting for 3 hours under reflux, and reserving the extracting solution; mixing the extractive solutions for 3 times, standing for 12 hr, filtering, adding ethanol into the filtrate until the ethanol concentration is 50%, standing, filtering, recovering ethanol from the filtrate, concentrating, drying, adding calcium lactate, calcium gluconate, and complexing protein phosphopeptide, adding adjuvants, and making into oral liquid.
EXAMPLE 2
A pharmaceutical composition for increasing bone density: 50g of rhizoma drynariae, 50g of morinda officinalis, 75g of epimedium herb, 50g of donkey-hide gelatin, 48g of calcium lactate, 55.5g of calcium gluconate and 2g of casein phosphopeptide.
The preparation method comprises the following steps: taking drynaria rhizome, morinda officinalis, epimedium herb and donkey-hide gelatin as raw materials, adding deionized water with the weight being 12 times of that of the raw materials, extracting for 5 hours under reflux, and keeping an extracting solution; adding deionized water 10 times the weight of the raw materials into the residue, extracting for 4 hours under reflux, and reserving the extracting solution; adding deionized water 8 times the weight of the raw materials into the residue, extracting for 3 hours under reflux, and reserving the extracting solution; mixing the extractive solutions for 3 times, standing for 12 hr, filtering, adding ethanol into the filtrate until the ethanol concentration is 50%, standing, filtering, recovering ethanol from the filtrate, concentrating, drying, adding calcium lactate, calcium gluconate, and complexing protein phosphopeptide, adding adjuvants, and making into oral liquid.
EXAMPLE 3
A pharmaceutical composition for increasing bone density: 60g of rhizoma drynariae, 60g of morinda officinalis, 80g of epimedium herb, 60g of donkey-hide gelatin, 55g of calcium lactate, 60g of calcium gluconate and 3g of casein phosphopeptide.
The preparation method comprises the following steps: taking drynaria rhizome, morinda officinalis, epimedium herb and donkey-hide gelatin as raw materials, adding deionized water with the weight being 12 times of that of the raw materials, extracting for 5 hours under reflux, and keeping an extracting solution; adding deionized water 10 times the weight of the raw materials into the residue, extracting for 4 hours under reflux, and reserving the extracting solution; adding deionized water 8 times the weight of the raw materials into the residue, extracting for 3 hours under reflux, and reserving the extracting solution; mixing the extractive solutions for 3 times, standing for 12 hr, filtering, adding ethanol into the filtrate until the ethanol concentration is 50%, standing, filtering, recovering ethanol from the filtrate, concentrating, drying, adding calcium lactate, calcium gluconate, and complexing protein phosphopeptide, adding adjuvants, and making into oral liquid.
Comparative example 1
In comparison with example 2, the raw material rhizoma Drynariae was removed.
Comparative example 2
Compared with example 2, the raw material epimedium is removed.
Comparative example 3
In comparison with example 2, the raw material donkey-hide gelatin was removed.
Example 4
In comparison with example 2, the casein phosphopeptide as a raw material was removed.
Test examples
Test for increasing bone Density
Test animals: .
The test instrument: bone mineral density tester.
The test method comprises the following steps: ICR mice and males are taken, and the mice are randomly grouped according to body weight, and 10 mice are selected in each group except 12 mice in a normal control group. And 2d after grouping, weighing, carrying out intraperitoneal injection of 0.1% sodium pentobarbital (0.1 ml/10g) for anesthesia, removing the testis after conventional disinfection of the operation field, and clamping the hemostatic forceps without sewing. Ciprofloxacin (0.1 ml/10g) was injected intra-abdominally after surgery and administered for 3 days continuously and 7 days after surgery. In each group, except the normal control group, dexamethasone was intramuscularly administered at a rate of 0.1 ml (0.01 mg/10 g) per week for 2 times. Each test drug group was administered to the abdominal cavity at an amount of 5mg/kg 1 time per day for 15 days, and the mice were sacrificed and the bone density was measured from the right femur. The test results are shown in Table 1.
TABLE 1 Effect on bone Density in osteoporosis model mice
| Group of | Bone mineral density |
| Normal control group | 0.107±0.022** |
| Model set | 0.052±0.011 |
| EXAMPLE 1 group | 0.080±0.009* |
| EXAMPLE 2 group | 0.088±0.011* |
| EXAMPLE 3 group | 0.082±0.011* |
| Comparative example 1 group | 0.065±0.007 |
| Comparative example 2 group | 0.060±0.008 |
| Comparative example 3 group | 0.070±0.011 |
| Comparative example 4 group | 0.062±0.009 |
Note: p <0.01, P <0.05 was compared to model groups.
And (4) test conclusion: the tests show that the pharmaceutical composition is an organic whole, any raw material is removed, the effect of increasing the bone density is reduced, the data show that the pharmaceutical composition has no statistical significance with a model group, the embodiment group of the invention can obviously increase the bone density of mice, and has significant difference compared with the model group, thereby fully indicating that the pharmaceutical composition has important significance.
The foregoing is a preferred embodiment of the present invention, and is not intended to limit the invention in any way, so that modifications and equivalents may be made thereto without departing from the spirit and scope of the invention.
Claims (7)
1. A pharmaceutical composition is characterized by comprising the following raw materials: drynaria rhizome, morinda officinalis, epimedium herb, donkey-hide gelatin, calcium lactate, calcium gluconate and casein phosphopeptide.
2. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is prepared from the following raw materials: 40-60 parts of rhizoma drynariae, 40-60 parts of morinda officinalis, 70-80 parts of epimedium herb, 40-60 parts of donkey-hide gelatin, 45-55 parts of calcium lactate, 50-60 parts of calcium gluconate and 1-3 parts of casein phosphopeptide.
3. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is prepared from the following raw materials: 50 parts of rhizoma drynariae, 50 parts of morinda officinalis, 75 parts of epimedium, 50 parts of donkey-hide gelatin, 48 parts of calcium lactate, 55.5 parts of calcium gluconate and 2 parts of casein phosphopeptide.
4. A pharmaceutical composition according to any one of claims 1 to 3, for use in a medicament for increasing bone density.
5. A pharmaceutical composition according to any one of claims 1 to 3, characterized in that it is used in a food for increasing bone density.
6. A pharmaceutical composition according to any one of claims 1-3, wherein the pharmaceutical composition is formulated as a pharmaceutical formulation.
7. A pharmaceutical composition according to any one of claims 1-3, wherein the pharmaceutical composition is formulated as an oral liquid.
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