CN106310034A - Pharmaceutical composition for increasing bone density and preparation method thereof - Google Patents
Pharmaceutical composition for increasing bone density and preparation method thereof Download PDFInfo
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- CN106310034A CN106310034A CN201610906187.0A CN201610906187A CN106310034A CN 106310034 A CN106310034 A CN 106310034A CN 201610906187 A CN201610906187 A CN 201610906187A CN 106310034 A CN106310034 A CN 106310034A
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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
- A61K35/56—Materials from animals other than mammals
- A61K35/618—Molluscs, e.g. fresh-water molluscs, oysters, clams, squids, octopus, cuttlefish, snails or slugs
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- 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
- A61K31/191—Carboxylic acids, e.g. valproic acid having two or more hydroxy groups, e.g. gluconic acid
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- 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
- A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
- A61K31/592—9,10-Secoergostane derivatives, e.g. ergocalciferol, i.e. vitamin D2
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- 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
- A61K31/66—Phosphorus compounds
- A61K31/661—Phosphorus acids or esters thereof not having P—C bonds, e.g. fosfosal, dichlorvos, malathion or mevinphos
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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
- A61K35/56—Materials from animals other than mammals
- A61K35/57—Birds; Materials from birds, e.g. eggs, feathers, egg white, egg yolk or endothelium corneum gigeriae galli
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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
- A61K36/06—Fungi, e.g. yeasts
- A61K36/07—Basidiomycota, e.g. Cryptococcus
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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
- A61K36/06—Fungi, e.g. yeasts
- A61K36/07—Basidiomycota, e.g. Cryptococcus
- A61K36/076—Poria
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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)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/484—Glycyrrhiza (licorice)
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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)
- A61K36/72—Rhamnaceae (Buckthorn family), e.g. buckthorn, chewstick or umbrella-tree
- A61K36/725—Ziziphus, e.g. jujube
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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)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/894—Dioscoreaceae (Yam family)
- A61K36/8945—Dioscorea, e.g. yam, Chinese yam or water yam
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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)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
- A61K36/8998—Hordeum (barley)
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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
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/06—Tripeptides
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/10—Preparation or pretreatment of starting material
- A61K2236/19—Preparation or pretreatment of starting material involving fermentation using yeast, bacteria or both; enzymatic treatment
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
Abstract
The invention belongs to the field of health products and in particular relates to a pharmaceutical composition for increasing bone density and a preparation method thereof. The pharmaceutical composition provided by the invention is prepared from the following raw materials in parts by weight: 2-6 parts of oysters, 0.5-2 parts of malt, 1-4 parts of Chinese yams, 1-3 parts of poria cocos, 1-4 parts of Chinese dates, 0.5-2 parts of liquorice, 0.5-2 parts of endothelium corneum gigeriae, 0.000001-0.000005 part of vitamin D2, 5-15 parts of calcium gluconate, 2-5 parts of sodium L-ascorbic-acid-2-phosphate, 1-4 parts of glutathione, 1-4 parts of phellinus igniarius fermented powder and 2-75 parts of auxiliary materials. The pharmaceutical composition provided by the invention has a good calcium supplementing effect, is rich in nutritional ingredients, safe and effective, convenient to take and applicable to being taken by children for a long time and can promote sustainable growth of the bone density.
Description
Technical field
The invention belongs to field of health care products, be specifically related to a kind of pharmaceutical composition increasing bone density and preparation method thereof.
Background technology
Osteoporosis is a kind of general bone amount and bone structure change, increases with bone fragility and is easily caused fracture
Disease, it is thinning with bone amount minimizing in unit volume, the micro-architectural deterioration of bone, compact bone, bone trabecula number reduces, medullary cavity
Broadening, bone strength lowers, be prone to fracture is characterized, and has been increasingly becoming the public health problem of world growing interest.
Bone density is the important indicator of diagnosis of osteoporosis, is used for defining osteoporotic diagnosis mark by World Health Organization (WHO)
Accurate.Bone mineral content contained by bone density phalanges unit are.Bone mineral is the most in skeleton deposition, and bone density is the biggest, bone
Bone is the most solid.From preschool period, childhood period to adolescence, osteoblastic osteogenesis more than the bone resorption of osteoclast,
Having two quick bone lengthening phases in the Children and teenager phase: male is 7～8 years old and 15～16 years old, women is 7～8 years old and 13
～14 years old, male's growth rate is faster than women.From 20～40 years old, although the length of bone stops growing, but also a bone amount adds
The strong stage, until 30～40 years old, the densification of bone and hardness just reach peak, referred to as peak bone mount.Skeleton reaches peak
After value density, along with the age increases, function of osteoblast is gradually reduced, and osteoclast, to bone taken in excess, makes bone mineral
Matter is constantly lost, and bone amount gradually decreases.
Owing to osteoporosis causes the minimizing of bone amount to be irreversible, therefore prevent even more important far beyond treatment.There is money
Material display makes bone density peak value at the growth and development stage of bone, is most efficient method to pre-anti-osteoporosis.Prevention
The measure of osteoporosis essence is to improve peak bone mass in early days of growing up, and in child's stage, can bone density obtain sustainable growth
It it is the key factor of the adult peak bone mass of impact.The childhood period of preventing and treating, especially growth promoter speed low bone pre-school age faster is close
Degree is to reduce the important step that rear osteoporosis of growing up occurs.
At present for osteoporotic preventing and treating, it is mainly reflected in two aspects: one is to increase picked-up phase at adolescence
The nutrient substance closed, makes the osseous maturation phase can reach optimal peak bone mass；Two is before and after climacteric, uses adequate measures with as far as possible
Slow down the loss of sclerotin.The health food on market with " increase bone substance density improving function " is many containing mineral element such as calcium, zinc, zinc,
Vitamins such as vitamin D, protein or amino acids such as phosphopeptide caseinate, active ingredient of Chinese herbs such as puerarin, and other
Functional component.These compositions reach to increase bone density by the mode of replenishing the calcium or by the way of adjusting endocrine and promote calcium absorption
Purpose, but still suffer from certain defect, such as safety issue.Research shows, vitamin D is taken in for a long time, and blood drug level is more than
Poisoning easily occurs during 500nmol/L, shows as feeling sick, anorexia, asthenia etc., time serious, even cause renal failure.It addition, it is big
Amount is replenished the calcium and is easily caused hypercalcemia level, can cause the increase of cardiovascular disease risk.Phosphopeptide caseinate at gastric easily by gastrointestinal
Road enzyme destroys, and generally requires the consumption strengthening phosphopeptide caseinate, thus easily causes the side effect such as allergy.As, Publication No.
The patent of CN 101559218 A discloses a kind of compositions having and increasing bone substance density improving function, and said composition is by following components group
Become: calcium carbonate, glucosamine hydrochloride, chondroitin sulfate, phosphopeptide caseinate and soybean isoflavone.Said composition contains plants
Thing estrogen soybean isoflavone, is not suitable for children, anemia of pregnant woman and women breast-feeding their children, gynecologic tumor and has gynecological tumor man
Race medical history person replenishes the calcium use.
Phellinus igniarius (L. ex Fr.) Quel. is medical edible fungus, is a kind of famous and precious Chinese medicine, fine containing abundant aminoacid, polysaccharide and meals
Dimension, has anticancer, hepatoprotective, blood sugar lowering, blood fat reducing, antianaphylactic effect, and treatment gout is had good effect.
Sodium ascorbyl phosphate is ascorbic derivant, for novel food additive, in vivo through phosphate
Enzymolysis can dissociate vitamin C, plays the distinctive physiological function of vitamin C, can be used for preventing and treating vitamin C deficiency, alleviating white vitiligo etc.
Disease, sodium ascorbyl phosphate has the effect increasing bone density not to have correlational study to show at present.
Summary of the invention
For solving the problem that prior art exists, it is an object of the invention to provide a kind of drug regimen increasing bone density
Thing and preparation method thereof, this pharmaceutical composition advantages of good calcium supplying effect, rich in nutrition content, and safely and effectively, taking convenience, suitable youngster
Virgin long-term taking, can promote bone density sustainable growth.
The present invention provides a kind of pharmaceutical composition increasing bone density, and it includes the raw material of preparing of following weight portion: Concha Ostreae 2
～6 parts, Fructus Hordei Germinatus 0.5～2 parts, Rhizoma Dioscoreae 1～4 parts, Poria 1～3 parts, Fructus Jujubae 1～4 parts, Radix Glycyrrhizae 0.5～2 parts, Endothelium Corneum Gigeriae Galli 0.5～2
Part, vitamin D20.000001～0.000005 part, calcium gluconate 5～15 parts and adjuvant 2～75 parts.
Preferably, described pharmaceutical composition includes the raw material of preparing of following weight portion: Concha Ostreae 3 parts, 1 part of Fructus Hordei Germinatus, Rhizoma Dioscoreae 2
Part, 1 part of Poria, 2 parts of Fructus Jujubae, 1 part of Radix Glycyrrhizae, Endothelium Corneum Gigeriae Galli 1 part, vitamin D20.0000025 part, calcium gluconate 12 parts and auxiliary
Expect 70 parts.
Further, described adjuvant is at least one in sweeting agent, correctives and filler,
Wherein, described sweeting agent is at least one in white sugar, glucose, oligomeric isomaltose, crystal sugar, lactose；
Described correctives is citric acid；
Described filler is at least one in cyclodextrin, starch, microcrystalline Cellulose, mannitol.
Further, the preparation method of described pharmaceutical composition comprises the following steps:
(1) take Fructus Hordei Germinatus, Rhizoma Dioscoreae, Poria, Fructus Jujubae, Endothelium Corneum Gigeriae Galli and Radix Glycyrrhizae, crushed after being dried, cross 80 mesh sieves, add medical material total
The water soaking 1～2h of weight 8～10 times amount, reflux, extract, 2～3 times, each 3～4 hours, filter and retain filtering residue, merge filter
Liquid, obtains Aqueous extracts；
(2) add, in the filtering residue of step (1), the ethanol that medical material gross weight 8～10 times amount volume fraction is 60～70%,
Reflux, extract, 2～3 times, each 3～4 hours, filter, merging filtrate, obtain alcohol extract；
(3) Aqueous extracts and alcohol extract are merged, drying under reduced pressure, pulverize, cross 100 mesh sieves, obtain powder；
(4) being pulverized by Concha Ostreae, cross 100 mesh sieves, then the powder with step (3) gained mixes, and adds vitamin D2, Fructus Vitis viniferae
Calciofon and adjuvant stir and get final product.
Further, described pharmaceutical composition also includes the raw material of preparing of following weight portion: sodium ascorbyl phosphate 2
～5 parts and glutathion 1～4 parts.
Further, described pharmaceutical composition also includes the raw material of preparing of following weight portion: Phellinus igniarius (L. ex Fr.) Quel. zymophyte powder 1～4
Part.
Preferably, described pharmaceutical composition also includes the raw material of preparing of following weight portion: sodium ascorbyl phosphate 2～5
Part, glutathion 1～4 parts and Phellinus igniarius (L. ex Fr.) Quel. zymophyte powder 1～4 parts.
It is highly preferred that described pharmaceutical composition includes the raw material of preparing of following weight portion: Concha Ostreae 3 parts, 1 part of Fructus Hordei Germinatus, mountain
Medicine 2 parts, 1 part of Poria, 2 parts of Fructus Jujubae, 1 part of Radix Glycyrrhizae, Endothelium Corneum Gigeriae Galli 1 part, vitamin D20.0000025 part, calcium gluconate 12 parts,
Sodium ascorbyl phosphate 4 parts, glutathion 3 parts and adjuvant 70 parts.
Most preferably, Concha Ostreae 3 parts, 1 part of Fructus Hordei Germinatus, Rhizoma Dioscoreae 2 parts, 1 part of Poria, 2 parts of Fructus Jujubae, 1 part of Radix Glycyrrhizae, Endothelium Corneum Gigeriae Galli 1 part, dimension
Raw element D20.0000025 part, calcium gluconate 12 parts, sodium ascorbyl phosphate 4 parts, glutathion 3 parts, Phellinus igniarius (L. ex Fr.) Quel. zymophyte powder
4 parts and adjuvant 70 parts.
Further, the preparation method of described Phellinus igniarius (L. ex Fr.) Quel. zymophyte powder comprises the following steps:
(1) Phellinus igniarius (L. ex Fr.) Quel. seed liquor cultivate: by Phellinus igniarius (L. ex Fr.) Quel. mother plant be inoculated in liquid seed culture medium, at 28～32 DEG C, 135～
Cultivating 6～7d on the shaking table of 150r/min, the mycelium of gained is liquid seeds, and described liquid seed culture medium is by following matter
The component composition of amount concentration: 0.6% peptone, 3.0% glucose, 0.3% potassium dihydrogen phosphate, 0.06% thiamine and 0.04%
Magnesium sulfate, solvent is purified water, and pH value is 5.5～6.5；
(2) fermentation: take step (1) Phellinus igniarius (L. ex Fr.) Quel. seed liquor and access in fermentation medium by the inoculum concentration of 10%, at 28～32 DEG C,
135～150r/min, under the conditions of ventilation is 1:0.6～0.8 cultivate 4d, until solution turns orange transparent time terminate ferment, use yarn
Cloth filters, and filtrate is retained standby, and described fermentation medium is made up of the component of following mass concentration: 1.5% yeast extract,
3% maltose, 0.3% potassium dihydrogen phosphate, 0.06% thiamine and 0.04% magnesium sulfate, solvent is purified water, pH value be 5.5～
6.5；
(3) prepared by mycopowder: step (2) is obtained filtrate and carries out lyophilization and pulverize, obtain Phellinus igniarius (L. ex Fr.) Quel. zymophyte powder.
Additionally, the present invention also provides for the preparation method of a kind of described pharmaceutical composition, it comprises the following steps:
(1) preparation of Phellinus igniarius (L. ex Fr.) Quel. zymophyte powder:
1. Phellinus igniarius (L. ex Fr.) Quel. seed liquor cultivate: by Phellinus igniarius (L. ex Fr.) Quel. mother plant be inoculated in liquid seed culture medium, at 28～32 DEG C, 135～
Cultivating 6～7d on the shaking table of 150r/min, the mycelium of gained is liquid seeds, and described liquid seed culture medium is by following matter
The component composition of amount concentration: 0.6% peptone, 3.0% glucose, 0.3% potassium dihydrogen phosphate, 0.06% thiamine and 0.04%
Magnesium sulfate, solvent is purified water, and pH value is 5.5～6.5；
2. fermentation: take step 1. Phellinus igniarius (L. ex Fr.) Quel. seed liquor and access in fermentation medium by the inoculum concentration of 10%, at 28～32 DEG C,
135～150r/min, under the conditions of ventilation is 1:0.6～0.8 cultivate 4d, until solution turns orange transparent time terminate ferment, use yarn
Cloth filters, and filtrate is retained standby, and described fermentation medium is made up of the component of following mass concentration: 1.5% yeast extract,
3% maltose, 0.3% potassium dihydrogen phosphate, 0.06% thiamine and 0.04% magnesium sulfate, solvent is purified water, pH value be 5.5～
6.5；
3. prepared by mycopowder: 2. step obtains filtrate and carries out lyophilization and pulverize, obtain Phellinus igniarius (L. ex Fr.) Quel. zymophyte powder；
(2) preparation of pharmaceutical composition:
1. take Fructus Hordei Germinatus, Rhizoma Dioscoreae, Poria, Fructus Jujubae, Endothelium Corneum Gigeriae Galli and Radix Glycyrrhizae, crushed after being dried, cross 80 mesh sieves, add medical material gross weight
The water soaking 1～2h of amount 8～10 times amount, reflux, extract, 2～3 times, each 3～4 hours, filter and retain filtering residue, merging filtrate,
Obtain Aqueous extracts；
2. add, in step filtering residue 1., the ethanol that medical material gross weight 8～10 times amount volume fraction is 60～70%, return
Stream extracts 2～3 times, each 3～4 hours, filters, merging filtrate, obtains alcohol extract；
3. merge Aqueous extracts and alcohol extract, drying under reduced pressure, pulverize, cross 100 mesh sieves, obtain powder；
4. being pulverized by Concha Ostreae, cross 100 mesh sieves, then the powder with step 3. gained mixes, and adds Phellinus igniarius (L. ex Fr.) Quel. zymophyte powder, dimension
Raw element D2, calcium gluconate, sodium ascorbyl phosphate, glutathion and adjuvant stir and get final product.
Further, described pharmaceutical composition can make granule, capsule, oral liquid or solid beverage further.
Further, due to vitamin D2Belong to fatsoluble vitamin, when pharmaceutical composition makes oral liquid or solid beverage
Time, vitamin D2Add after micronizing.
The pharmaceutical composition that the present invention provides can provide abundant calcium constituent, P elements, aminoacid etc. can promote ossein
The nutritional labeling that synthesis and bone matrix are formed, and be prone to digestion and absorb, calcium deposition in skeleton can be effectively improved, increase
Bone density.Zoopery shows, adds sodium ascorbyl phosphate and can improve femoral bmd and the calcium content of bone of rat, and with
It is better that glutathion share；Phellinus igniarius (L. ex Fr.) Quel. zymophyte powder can more effectively increase femoral bmd and the calcium content of bone of rat.
Additionally, the inventors discovered that, sodium ascorbyl phosphate and glutathion are in volunteer patients's serum of primary osteoporosis
Alkali phosphatase and the level impact of the phosphatase of resistance to tartaic acid little, but by Phellinus igniarius (L. ex Fr.) Quel. zymophyte powder and described medicine group
Compound share, and is remarkably improved alkaline phosphatase activities, and reduces the phosphatase activity of resistance to tartaic acid, and then suppression bone is inhaled
Receive, can more effectively increase primary osteoporosis volunteer patients's bone density.
Compared with prior art, present invention have an advantage that the present invention passes through substantial amounts of test and proves, vitamin C phosphoric acid
Ester sodium can increase bone density and calcium content of bone, when it share with glutathion, better；Additionally, inventors have surprisingly discovered that,
When Phellinus igniarius (L. ex Fr.) Quel. zymophyte powder share with described pharmaceutical composition, alkaline phosphatase activities can be improved, reduce the phosphorus of resistance to tartaic acid
Phytase activity, and then suppression bone resorption；The each component of pharmaceutical composition that the present invention provides is the most collaborative, mutual gain, effect of replenishing the calcium
The best, rich in nutrition content, it is easy to digest and absorb, good in taste, suitable child on long-term is taken, and can promote that bone density persistently increases
Long, and safely and effectively, taking convenience.
Detailed description of the invention
Further describe the present invention below by way of detailed description of the invention, but the present invention is not limited only to following example.
Embodiment 1 increases the pharmaceutical composition of bone density and the preparation of granule thereof
The embodiment of the present invention 1 increases the pharmaceutical composition of bone density, including the raw material of preparing of following weight portion: Concha Ostreae 3 parts,
1 part of Fructus Hordei Germinatus, Rhizoma Dioscoreae 2 parts, 1 part of Poria, 2 parts of Fructus Jujubae, 1 part of Radix Glycyrrhizae, Endothelium Corneum Gigeriae Galli 1 part, vitamin D20.0000025 part, glucose
Acid calcium 12 parts, oligomeric isomaltose 20 parts, citric acid 5 parts, cyclodextrin 45 parts.
The preparation of pharmaceutical composition:
(1) take Fructus Hordei Germinatus, Rhizoma Dioscoreae, Poria, Fructus Jujubae, Endothelium Corneum Gigeriae Galli and Radix Glycyrrhizae, crushed after being dried, cross 80 mesh sieves, add medical material total
The water soaking 1h of weight 8 times amount, reflux, extract, 2 times, each 4 hours, filters and retains filtering residue, merging filtrate, obtain Aqueous extracts；
(2) it is the ethanol of 60% toward the filtering residue of step (1) adds medical material gross weight 8 times amount volume fraction, reflux, extract, 2
Secondary, each 4 hours, filter, merging filtrate, obtain alcohol extract；
(3) Aqueous extracts and alcohol extract are merged, drying under reduced pressure, pulverize, cross 100 mesh sieves, obtain powder；
(4) being pulverized by Concha Ostreae, cross 100 mesh sieves, then the powder with step (3) gained mixes, and adds vitamin D2, Fructus Vitis viniferae
Calciofon, oligomeric isomaltose, citric acid and cyclodextrin stir, and obtain pharmaceutical composition.
The preparation of granule:
Get it filled compositions, pulverize, cross 150 mesh sieves, obtain coarse powder, add the polyvidone that appropriate mass fraction is 20%
K30 solution, soft material processed, soft material to be crossed 16 mesh sieves and pelletizes, the thermostatic drying chamber being placed in 60 DEG C is dried, by dried granule
Cross 16 mesh sieves and carry out granulate, obtain granule.
Embodiment 2 increases the pharmaceutical composition of bone density and the preparation of granule thereof
The embodiment of the present invention 2 increases the pharmaceutical composition of bone density, including the raw material of preparing of following weight portion: Concha Ostreae 6 parts,
0.5 part of Fructus Hordei Germinatus, Rhizoma Dioscoreae 4 parts, 1 part of Poria, 1 part of Fructus Jujubae, 0.5 part of Radix Glycyrrhizae, Endothelium Corneum Gigeriae Galli 2 parts, vitamin D20.000001 part, Portugal
Grape Calciofon 15 parts, glucose 15 parts, citric acid 5 parts, starch 40 parts.
The preparation reference example 1 of pharmaceutical composition.
The preparation reference example 1 of granule.
Embodiment 3 increases the pharmaceutical composition of bone density and the preparation of granule thereof
The embodiment of the present invention 3 increases the pharmaceutical composition of bone density, including the raw material of preparing of following weight portion: Concha Ostreae 2 parts,
2 parts of Fructus Hordei Germinatus, Rhizoma Dioscoreae 1 part, 3 parts of Poria, 4 parts of Fructus Jujubae, 2 parts of Radix Glycyrrhizae, Endothelium Corneum Gigeriae Galli 0.5 part, vitamin D20.000005 part, Fructus Vitis viniferae
Calciofon 5 parts, white sugar 10 parts, citric acid 5 parts, 50 parts of mannitol.
The preparation reference example 1 of pharmaceutical composition.
The preparation reference example 1 of granule.
Embodiment 4 increases the pharmaceutical composition of bone density and the preparation of granule thereof
The embodiment of the present invention 4 increases the pharmaceutical composition of bone density, including the raw material of preparing of following weight portion: Concha Ostreae 3 parts,
1 part of Fructus Hordei Germinatus, Rhizoma Dioscoreae 2 parts, 1 part of Poria, 2 parts of Fructus Jujubae, 1 part of Radix Glycyrrhizae, Endothelium Corneum Gigeriae Galli 1 part, vitamin D20.0000025 part, glucose
Acid calcium 12 parts, oligomeric isomaltose 20 parts, citric acid 5 parts, cyclodextrin 45 parts, sodium ascorbyl phosphate 4 parts and glutathion 3
Part.
The preparation of pharmaceutical composition:
(1) take Fructus Hordei Germinatus, Rhizoma Dioscoreae, Poria, Fructus Jujubae, Endothelium Corneum Gigeriae Galli and Radix Glycyrrhizae, crushed after being dried, cross 80 mesh sieves, add medical material total
The water soaking 1h of weight 8 times amount, reflux, extract, 2 times, each 4 hours, filters and retains filtering residue, merging filtrate, obtain Aqueous extracts；
(2) it is the ethanol of 60% toward the filtering residue of step (1) adds medical material gross weight 8 times amount volume fraction, reflux, extract, 2
Secondary, each 4 hours, filter, merging filtrate, obtain alcohol extract；
(3) Aqueous extracts and alcohol extract are merged, drying under reduced pressure, pulverize, cross 100 mesh sieves, obtain powder；
(4) being pulverized by Concha Ostreae, cross 100 mesh sieves, then the powder with step (3) gained mixes, and adds vitamin D2, Fructus Vitis viniferae
Calciofon, oligomeric isomaltose, citric acid, cyclodextrin, sodium ascorbyl phosphate and glutathion stir, and obtain medicine
Compositions.
The preparation reference example 1 of granule.
Embodiment 5 increases the pharmaceutical composition of bone density and the preparation of granule thereof
The embodiment of the present invention 5 increases the pharmaceutical composition of bone density, including the raw material of preparing of following weight portion: Concha Ostreae 3 parts,
1 part of Fructus Hordei Germinatus, Rhizoma Dioscoreae 2 parts, 1 part of Poria, 2 parts of Fructus Jujubae, 1 part of Radix Glycyrrhizae, Endothelium Corneum Gigeriae Galli 1 part, vitamin D20.0000025 part, glucose
Acid calcium 12 parts, oligomeric isomaltose 20 parts, citric acid 5 parts, cyclodextrin 45 parts, sodium ascorbyl phosphate 4 parts, glutathion 3 parts
With Phellinus igniarius (L. ex Fr.) Quel. zymophyte powder 4 parts.
The preparation of pharmaceutical composition:
(1) prepared by Phellinus igniarius (L. ex Fr.) Quel. zymophyte powder:
1. Phellinus igniarius (L. ex Fr.) Quel. seed liquor is cultivated: Phellinus igniarius (L. ex Fr.) Quel. mother being planted and be inoculated in liquid seed culture medium, at 30 DEG C, 140r/min shakes
Cultivating 7d on Chuan, the mycelium of gained is liquid seeds, and described liquid seed culture medium is by the component group of following mass concentration
Become: 0.6% peptone, 3.0% glucose, 0.3% potassium dihydrogen phosphate, 0.06% thiamine and 0.04% magnesium sulfate, solvent is
Purified water, pH value is 6.0；
2. fermentation: take step 1. Phellinus igniarius (L. ex Fr.) Quel. seed liquor and access in fermentation medium by the inoculum concentration of 10%, at 30 DEG C, 140r/
Min, ventilation are to cultivate 4d under the conditions of 1:0.6, until solution turns orange transparent time terminate fermenting, by filtered through gauze, and by filtrate
Retaining standby, described fermentation medium is made up of the component of following mass concentration: 1.5% yeast extract, 3% maltose, 0.3%
Potassium dihydrogen phosphate, 0.06% thiamine and 0.04% magnesium sulfate, solvent is purified water, and pH value is 6.0；
3. prepared by mycopowder: 2. step obtains filtrate and carries out lyophilization and pulverize, obtain Phellinus igniarius (L. ex Fr.) Quel. zymophyte powder；
(2) prepared by compositions
1. take Fructus Hordei Germinatus, Rhizoma Dioscoreae, Poria, Fructus Jujubae, Endothelium Corneum Gigeriae Galli and Radix Glycyrrhizae, crushed after being dried, cross 80 mesh sieves, add medical material gross weight
Measure the water soaking 1h of 8 times amount, reflux, extract, 2 times, each 4 hours, filter and retain filtering residue, merging filtrate, obtain Aqueous extracts；
2. it is the ethanol of 60% toward step filtering residue 1. adds medical material gross weight 8 times amount volume fraction, reflux, extract, 2
Secondary, each 4 hours, filter, merging filtrate, obtain alcohol extract；
3. merge Aqueous extracts and alcohol extract, drying under reduced pressure, pulverize, cross 100 mesh sieves, obtain powder；
4. being pulverized by Concha Ostreae, cross 100 mesh sieves, then the powder with step 3. gained mixes, and adds vitamin D2, glucose
Acid calcium, oligomeric isomaltose, citric acid, cyclodextrin, sodium ascorbyl phosphate, glutathion and the stirring of Phellinus igniarius (L. ex Fr.) Quel. zymophyte powder are all
Even, obtain pharmaceutical composition.
The preparation reference example 1 of granule.
Embodiment 6 increases the pharmaceutical composition of bone density and the preparation of capsule thereof
The embodiment of the present invention 6 increases the pharmaceutical composition of bone density, including the raw material of preparing of following weight portion: Concha Ostreae 3 parts,
1 part of Fructus Hordei Germinatus, Rhizoma Dioscoreae 2 parts, 1 part of Poria, 2 parts of Fructus Jujubae, 1 part of Radix Glycyrrhizae, Endothelium Corneum Gigeriae Galli 1 part, vitamin D20.0000025 part, glucose
Acid calcium 12 parts, glucose 15 parts, citric acid 5 parts, starch 40 parts, sodium ascorbyl phosphate 2 parts, glutathion 5 parts and Phellinus igniarius (L. ex Fr.) Quel. are sent out
4 parts of yeast-like fungi powder.
The preparation reference example 5 of pharmaceutical composition.
The preparation of capsule: compositions of getting it filled, pulverizes, and crosses 150 mesh sieves, obtains coarse powder, coarse powder is filled in No. 1 capsule shells
In, obtain capsule.
Embodiment 7 increases the preparation of the drug composition oral liquid of bone density
The embodiment of the present invention 7 increases the pharmaceutical composition of bone density, including the raw material of preparing of following weight portion: Concha Ostreae 3 parts,
1 part of Fructus Hordei Germinatus, Rhizoma Dioscoreae 2 parts, 1 part of Poria, 2 parts of Fructus Jujubae, 1 part of Radix Glycyrrhizae, Endothelium Corneum Gigeriae Galli 1 part, vitamin D20.0000025 part, glucose
Acid calcium 12 parts, white sugar 20 parts, citric acid 5 parts, sodium ascorbyl phosphate 4 parts, glutathion 3 parts and Phellinus igniarius (L. ex Fr.) Quel. zymophyte powder 2
Part.
Preparation method:
(1) prepared by Phellinus igniarius (L. ex Fr.) Quel. zymophyte powder:
1. Phellinus igniarius (L. ex Fr.) Quel. seed liquor is cultivated: Phellinus igniarius (L. ex Fr.) Quel. mother being planted and be inoculated in liquid seed culture medium, at 30 DEG C, 140r/min shakes
Cultivating 7d on Chuan, the mycelium of gained is liquid seeds, and described liquid seed culture medium is by the component group of following mass concentration
Become: 0.6% peptone, 3.0% glucose, 0.3% potassium dihydrogen phosphate, 0.06% thiamine and 0.04% magnesium sulfate, solvent is
Purified water, pH value is 6.0；
2. fermentation: take step 1. Phellinus igniarius (L. ex Fr.) Quel. seed liquor and access in fermentation medium by the inoculum concentration of 10%, at 30 DEG C, 140r/
Min, ventilation are to cultivate 4d under the conditions of 1:0.6, until solution turns orange transparent time terminate fermenting, by filtered through gauze, and by filtrate
Retaining standby, described fermentation medium is made up of the component of following mass concentration: 1.5% yeast extract, 3% maltose, 0.3%
Potassium dihydrogen phosphate, 0.06% thiamine and 0.04% magnesium sulfate, solvent is purified water, and pH value is 6.0；
3. prepared by mycopowder: 2. step obtains filtrate and carries out lyophilization and pulverize, obtain Phellinus igniarius (L. ex Fr.) Quel. zymophyte powder；
(2) preparation of oral liquid:
1. take Fructus Hordei Germinatus, Rhizoma Dioscoreae, Poria, Fructus Jujubae, Endothelium Corneum Gigeriae Galli and Radix Glycyrrhizae, crushed after being dried, cross 80 mesh sieves, add medical material gross weight
Measure the water soaking 1h of 8 times amount, reflux, extract, 2 times, each 4 hours, filter and retain filtering residue, merging filtrate, obtain Aqueous extracts；
2. it is the ethanol of 60% toward step filtering residue 1. adds medical material gross weight 8 times amount volume fraction, reflux, extract, 2
Secondary, each 4 hours, filter, merging filtrate, obtain alcohol extract；
3. merge Aqueous extracts and alcohol extract, drying under reduced pressure, pulverize, cross 100 mesh sieves, obtain powder；
4. vitamin D is taken2, carry out micronizing, obtain superfine powder；
5. being pulverized by Concha Ostreae, cross 100 mesh sieves, then the powder with step 3. gained mixes, and adds purified water, is heated to 70
DEG C, after stirring and dissolving, add calcium gluconate, white sugar, citric acid, sodium ascorbyl phosphate, glutathion and Phellinus igniarius (L. ex Fr.) Quel. fermentation
Mycopowder stirs, and is subsequently adding vitamin D2Superfine powder, continues to stir to room temperature, adds appropriate preservative, sterilizing, fills
Dress, obtains oral liquid.
Comparative example 1 increases the pharmaceutical composition of bone density and the preparation of granule thereof
Comparative example 1 of the present invention increases the pharmaceutical composition of bone density, including the raw material of preparing of following weight portion: Concha Ostreae 3 parts,
1 part of Fructus Hordei Germinatus, Rhizoma Dioscoreae 2 parts, 1 part of Poria, 2 parts of Fructus Jujubae, 1 part of Radix Glycyrrhizae, Endothelium Corneum Gigeriae Galli 1 part, vitamin D20.0000025 part, glucose
Acid calcium 12 parts, oligomeric isomaltose 20 parts, citric acid 5 parts, cyclodextrin 45 parts, glutathion 3 parts and Phellinus igniarius (L. ex Fr.) Quel. zymophyte powder 4 parts.
The preparation method reference example 5 of pharmaceutical composition, this comparative example is without dimension raw with the difference of embodiment 5
Element C sodium phosphate.
The preparation reference example 5 of granule.
Comparative example 2 increases the pharmaceutical composition of bone density and the preparation of granule thereof
Comparative example 2 of the present invention increases the pharmaceutical composition of bone density, including the raw material of preparing of following weight portion: Concha Ostreae 3 parts,
1 part of Fructus Hordei Germinatus, Rhizoma Dioscoreae 2 parts, 1 part of Poria, 2 parts of Fructus Jujubae, 1 part of Radix Glycyrrhizae, Endothelium Corneum Gigeriae Galli 1 part, vitamin D20.0000025 part, glucose
Acid calcium 12 parts, oligomeric isomaltose 20 parts, citric acid 5 parts, cyclodextrin 45 parts, sodium ascorbyl phosphate 4 parts and Phellinus igniarius (L. ex Fr.) Quel. zymocyte
4 parts of powder.
The preparation method reference example 5 of pharmaceutical composition, this comparative example is without paddy Guang with the difference of embodiment 5
Sweet peptide.
The preparation reference example 5 of granule.
Comparative example 3 increases the pharmaceutical composition of bone density and the preparation of granule thereof
Comparative example 3 of the present invention increases the pharmaceutical composition of bone density, including the raw material of preparing of following weight portion: Concha Ostreae 3 parts,
1 part of Fructus Hordei Germinatus, Rhizoma Dioscoreae 2 parts, 1 part of Poria, 2 parts of Fructus Jujubae, 1 part of Radix Glycyrrhizae, Endothelium Corneum Gigeriae Galli 1 part, vitamin D20.0000025 part, glucose
Acid calcium 12 parts, oligomeric isomaltose 20 parts, citric acid 5 parts, cyclodextrin 45 parts, vitamin C 4 parts, glutathion 3 parts and Phellinus igniarius (L. ex Fr.) Quel.
Zymophyte powder 4 parts.
The preparation method reference example 5 of pharmaceutical composition, this comparative example is with the difference of embodiment 5 with vitamin C
Replace sodium ascorbyl phosphate.
The preparation reference example 5 of granule.
Comparative example 4 increases the pharmaceutical composition of bone density and the preparation of granule thereof
Comparative example 4 of the present invention increases the pharmaceutical composition of bone density, including the raw material of preparing of following weight portion: Concha Ostreae 3 parts,
1 part of Fructus Hordei Germinatus, Rhizoma Dioscoreae 2 parts, 1 part of Poria, 2 parts of Fructus Jujubae, 1 part of Radix Glycyrrhizae, Endothelium Corneum Gigeriae Galli 1 part, vitamin D20.0000025 part, glucose
Acid calcium 12 parts, oligomeric isomaltose 20 parts, citric acid 5 parts, cyclodextrin 45 parts, Phellinus igniarius (L. ex Fr.) Quel. zymophyte powder 4 parts.
The preparation method reference example 5 of pharmaceutical composition, this comparative example is without dimension raw with the difference of embodiment 5
Element C sodium phosphate and glutathion.
The preparation reference example 5 of granule.
Test example one, safety testing
The pharmaceutical composition of increase bone density embodiment 1-7 prepared carries out acute toxicity test respectively, within 30 days, feeds
Test and feeding test for 90 days, result shows, the pharmaceutical composition safety non-toxic of the increase bone density that the present invention provides, through feeding
Growth of animal all right, hematological examination, biochemical analysis, main dirty body and histological examination are the most no abnormal, and
The phenomenon of constipation does not occurs.Therefore, the pharmaceutical composition safety non-toxic of the increase bone density that the present invention provides, suitable long-term clothes
With.
The pharmaceutical composition that test example two, the present invention the provide effect to rat bone density
Choose 100 SPF level SD female rats, body weight 250～320g.Take 90 and carry out ovarian resection, remain 10
Only carry out sham-operation.Rat ovary excises latter 5 days, carries out vagina picture inspection, confirms that rat ovary excises completely.Ovum will be carried out
90 rats of nest excision are randomly divided into 9 groups, often group 10, respectively embodiment 1 group, embodiment 4 groups, embodiment 5 groups, contrast
Example 1-4 group, model group and matched group.10 rats carrying out sham-operation are set to sham operated rats.Wherein, sham operated rats and model group
All gavages prepare to embodiment 1,4,5 and comparative example 1-4 to distilled water, embodiment 1,4,5 groups and comparative example 1-4 group gavage respectively
Pharmaceutical composition, given low is 2g/kg, every day gavage 2 times.Matched group gavage increases bone density glue to commercially available dimension Gu Kang
Capsule, given low is 2g/kg, every day gavage 2 times.Each group continuous gavage of rat 90 days.Use DPX-L Dual-energy X-rays absorptionmetry
Measure femoral bmd, and use atomic absorption spectroscopy determination bone calcium content of femur.Result see table 1.
Table 1 pharmaceutical composition of the present invention is on rat femur bone density and the impact of calcium content of bone
| Group | Femoral bmd (g/cm2) | Calcium content of bone (g/g) |
| Sham operated rats | 0.287±0.013 | 0.234±0.011 |
| Model group | 0.242±0.010** | 0.194±0.009** |
| Matched group | 0.252±0.012 | 0.205±0.012 |
| Embodiment 1 group | 0.250±0.013 | 0.203±0.013 |
| Embodiment 4 groups | 0.277±0.007##△◆ | 0.226±0.014##△◆ |
| Embodiment 5 groups | 0.285±0.011##△△◆◆ | 0.232±0.015##△△◆◆ |
| Comparative example 1 group | 0.260±0.009# | 0.210±0.011# |
| Comparative example 2 groups | 0.263±0.010# | 0.211±0.010# |
| Comparative example 3 groups | 0.265±0.013# | 0.214±0.012# |
| Comparative example 4 groups | 0.258±0.007# | 0.208±0.008# |
Note: compare with sham operated rats,**P<0.01；Compare with model group,#P<0.05；##P<0.01；Compare with matched group,△
P<0.05；△△P < 0.01, compares with embodiment 1 group,◆P < 0.05,◆◆P<0.01；Compare with embodiment 5 groups,P<0.05。
Result shows, the pharmaceutical composition that the embodiment of the present invention 1 prepares can improve the femoral bmd of rat and bone calcium contains
Amount, its effect is suitable with the effect of commercially available increase bone density capsule (Wei Gukang).The pharmaceutical composition that embodiment 5 prepares increases big
The femoral bmd of Mus and the best results of calcium content of bone, be secondly the prepared pharmaceutical composition of embodiment 4, and embodiment 4 and 5 is made
The effect of pharmaceutical composition be all significantly better than commercially available dimension Gu Kang increase bone density capsule therapeutic effect (P < 0.05 or P <
0.01).The pharmaceutical composition that comparative example 1,2 prepares is deficient in vitamin C sodium phosphate and glutathion respectively, and it increases rat
The effect of femoral bmd and calcium content of bone relatively embodiment 4 and 5 weakens, but still good compared with the effect of embodiment 1 and matched group.Contrast
Example 4 is deficient in vitamin C sodium phosphate and glutathion simultaneously, and its effect weakens further, but still relatively embodiment 1 and matched group
Effect is good.Comparative example 3 replaces sodium ascorbyl phosphate with vitamin C, and its effect relatively embodiment 4 and 5 weakens, but still relatively implements
The effect of example 1 and matched group is good.Result above shows, sodium ascorbyl phosphate can improve femoral bmd and the bone calcium of rat
Content, and better with what glutathion share；Phellinus igniarius (L. ex Fr.) Quel. zymophyte powder can more effectively increase rat femoral bmd and
Calcium content of bone.
The pharmaceutical composition that test example three, the present invention the provide therapeutic effect to primary osteoporosis
Screen 400 examples through being diagnosed as the volunteer patients of primary osteoporosis, wherein male 150 example, women 250 example,
It is randomly divided into 8 groups, often organizes 50 examples, respectively embodiment 1 group, embodiment 4 groups, embodiment 5 groups, comparative example 1-4 group and matched group.
The volunteer patients of embodiment 1,4,5 and comparative example 1-4 group takes the granule that embodiment 1,4,5 and comparative example 1-4 prepare respectively,
Take after mixing it with water 1 bag (5g/ bag), three times a day every time.Matched group volunteer patients takes commercially available GUSHUKANG KELI, and (Liaoning Kang Chen Pharmaceutical is limited
Company), each 10g, every day 2 times.After each group volunteer patients takes 6 months continuously, carry out therapeutic evaluation.Wherein, osteoporosis
The standard of curative effect evaluation of disease is: 1) effective: pain is wholly absent, and bone density inspection display bone density increases；Effective: pain is bright
Show and alleviate, or bone density inspection has no that bone density declines；Invalid: and compare before treatment, each side is all without improving.Use XR-
36 type Study of bone mineral density instrument (NORLAND company of the U.S.) carry out Bone mineral density, and to alkali in the serum of volunteer patients
Acid phosphatase and the phosphatase level of resistance to tartaic acid are measured.Result see table 2-4.
The table 2 pharmaceutical composition of the present invention therapeutic effect to primary osteoporosis volunteer patients
| Group | Effective | Effectively | Invalid | Total effective rate (%) |
| Matched group | 26 | 16 | 8 | 84 |
| Embodiment 1 group | 28 | 13 | 9 | 82 |
| Embodiment 4 groups | 36 | 10 | 4 | 92 |
| Embodiment 5 groups | 41 | 8 | 1 | 98 |
| Comparative example 1 group | 31 | 13 | 6 | 88 |
| Comparative example 2 groups | 33 | 11 | 6 | 88 |
| Comparative example 3 groups | 34 | 11 | 5 | 90 |
| Comparative example 4 groups | 30 | 13 | 7 | 86 |
The impact on primary osteoporosis volunteer patients's bone density of table 3 pharmaceutical composition of the present invention
Note: compare with before treatment,*P < 0.05,**P<0.01；Compare with matched group,#P<0.05；Compare with embodiment 1 group
,△P<0.05；Compare with embodiment 5 groups,P<0.05。
Table 4 pharmaceutical composition of the present invention is to primary osteoporosis volunteer patients's alkali phosphatase and the phosphorus of resistance to tartaic acid
The impact of acid enzyme level
Note: compare with before treatment,*P<0.05。
From table 2 and 3, primary osteoporosis is had certain by the pharmaceutical composition that the embodiment of the present invention 1 prepares
Therapeutic effect, can increase volunteer patients's bone density.The treatment of primary osteoporosis is imitated by the pharmaceutical composition that embodiment 5 prepares
Fruit is optimal, and total effective rate reaches 98%, and it is the most notable to increase bone density effect, and next is the pharmaceutical composition that embodiment 4 prepares,
Total effective rate reaches 92%, and the effect of the pharmaceutical composition that embodiment 4 and 5 prepares all is significantly better than the treatment of commercially available GUSHUKANG KELI
Effect (P < 0.05 or P < 0.01).The pharmaceutical composition that comparative example 1,2 prepares is deficient in vitamin C sodium phosphate and gluathione respectively
Peptide, its therapeutic effect relatively embodiment 4 and 5 weakens, but still good compared with the effect of embodiment 1.Comparative example 4 is deficient in vitamin C phosphorus simultaneously
Acid esters sodium and glutathion, its therapeutic effect weakens further, but still good compared with the effect of embodiment 1.Comparative example 3 is with vitamin C
Replacing sodium ascorbyl phosphate, its therapeutic effect relatively embodiment 4 and 5 weakens, but still good compared with the effect of embodiment 1.Can by table 4
Knowing, Phellinus igniarius (L. ex Fr.) Quel. zymophyte powder share with aforementioned pharmaceutical compositions, is remarkably improved alkaline phosphatase activities, and reduces the acid of resistance to tartaric acid
Acid phosphatase activity, and then suppression bone resorption.
Result above shows, sodium ascorbyl phosphate can increase primary osteoporosis volunteer patients's bone density, when its with
Glutathion share, better；Phellinus igniarius (L. ex Fr.) Quel. zymophyte powder can more effectively increase primary osteoporosis volunteer patients's bone density.
Below it is only the preferred embodiment of the present invention, it is noted that it is right that above-mentioned preferred implementation is not construed as
The restriction of the present invention, protection scope of the present invention should be as the criterion with claim limited range.For the art
For those of ordinary skill, without departing from the spirit and scope of the present invention, it is also possible to make some improvements and modifications, these change
Enter and retouch and also should be regarded as protection scope of the present invention.
Claims (10)
1. the pharmaceutical composition increasing bone density, it is characterised in that described pharmaceutical composition includes following weight portion
Prepare raw material: Concha Ostreae 2～6 parts, Fructus Hordei Germinatus 0.5～2 parts, Rhizoma Dioscoreae 1～4 parts, Poria 1～3 parts, Fructus Jujubae 1～4 parts, Radix Glycyrrhizae 0.5～2
Part, Endothelium Corneum Gigeriae Galli 0.5～2 parts, vitamin D20.000001～0.000005 part, calcium gluconate 5～15 parts and adjuvant 2～75
Part.
The pharmaceutical composition of increase bone density the most according to claim 1, it is characterised in that described pharmaceutical composition bag
Include the raw material of preparing of following weight portion: Concha Ostreae 3 parts, 1 part of Fructus Hordei Germinatus, Rhizoma Dioscoreae 2 parts, 1 part of Poria, 2 parts of Fructus Jujubae, 1 part of Radix Glycyrrhizae, Endothelium Corneum Gigeriae Galli
1 part, vitamin D20.0000025 part, calcium gluconate 12 parts and adjuvant 70 parts.
The pharmaceutical composition of increase bone density the most according to claim 1 and 2, it is characterised in that described drug regimen
Thing also includes the raw material of preparing of following weight portion: sodium ascorbyl phosphate 2～5 parts and glutathion 1～4 parts.
The pharmaceutical composition of increase bone density the most according to claim 3, it is characterised in that described pharmaceutical composition is also
Raw material of preparing including following weight portion: Phellinus igniarius (L. ex Fr.) Quel. zymophyte powder 1～4 parts.
The pharmaceutical composition of increase bone density the most according to claim 3, it is characterised in that described pharmaceutical composition bag
Include the raw material of preparing of following weight portion: Concha Ostreae 3 parts, 1 part of Fructus Hordei Germinatus, Rhizoma Dioscoreae 2 parts, 1 part of Poria, 2 parts of Fructus Jujubae, 1 part of Radix Glycyrrhizae, Endothelium Corneum Gigeriae Galli
1 part, vitamin D20.0000025 part, calcium gluconate 12 parts, sodium ascorbyl phosphate 4 parts, glutathion 3 parts and adjuvant
70 parts.
The pharmaceutical composition of increase bone density the most according to claim 4, it is characterised in that described pharmaceutical composition bag
Include the raw material of preparing of following weight portion: Concha Ostreae 3 parts, 1 part of Fructus Hordei Germinatus, Rhizoma Dioscoreae 2 parts, 1 part of Poria, 2 parts of Fructus Jujubae, 1 part of Radix Glycyrrhizae, Endothelium Corneum Gigeriae Galli
1 part, vitamin D20.0000025 part, calcium gluconate 12 parts, sodium ascorbyl phosphate 4 parts, glutathion 3 parts, Phellinus igniarius (L. ex Fr.) Quel. send out
4 parts of yeast-like fungi powder and adjuvant 70 parts.
The pharmaceutical composition of increase bone density the most according to claim 1 and 2, it is characterised in that described adjuvant is sweet
At least one in taste agent, correctives and filler；
Described sweeting agent is at least one in white sugar, glucose, oligomeric isomaltose, crystal sugar, lactose；
Described correctives is citric acid；
Described filler is at least one in cyclodextrin, starch, microcrystalline Cellulose, mannitol.
The pharmaceutical composition of increase bone density the most according to claim 4, it is characterised in that described Phellinus igniarius (L. ex Fr.) Quel. zymophyte powder
Preparation method comprises the following steps:
(1) Phellinus igniarius (L. ex Fr.) Quel. seed liquor is cultivated: Phellinus igniarius (L. ex Fr.) Quel. mother is planted and is inoculated in liquid seed culture medium, at 28～32 DEG C, and 135～150r/
Cultivating 6～7d on the shaking table of min, the mycelium of gained is liquid seeds, and described liquid seed culture medium is dense by following quality
The component composition of degree: 0.6% peptone, 3.0% glucose, 0.3% potassium dihydrogen phosphate, 0.06% thiamine and 0.04% sulphuric acid
Magnesium, solvent is purified water, and pH value is 5.5～6.5；
(2) fermentation: take step (1) Phellinus igniarius (L. ex Fr.) Quel. seed liquor and access in fermentation medium by the inoculum concentration of 10%, at 28～32 DEG C, 135
～150r/min, ventilation are to cultivate 4d under the conditions of 1:0.6～0.8, until solution turns orange transparent time terminate fermenting, use gauze mistake
Filter, and retains standby by filtrate, and described fermentation medium is made up of the component of following mass concentration: 1.5% yeast extract, 3%
Maltose, 0.3% potassium dihydrogen phosphate, 0.06% thiamine and 0.04% magnesium sulfate, solvent is purified water, pH value be 5.5～
6.5；
(3) prepared by mycopowder: step (2) is obtained filtrate and carries out lyophilization and pulverize, obtain Phellinus igniarius (L. ex Fr.) Quel. zymophyte powder.
9. the method preparing the as claimed in claim 6 pharmaceutical composition increasing bone density, it is characterised in that include with
Lower step:
(1) preparation of Phellinus igniarius (L. ex Fr.) Quel. zymophyte powder:
1. Phellinus igniarius (L. ex Fr.) Quel. seed liquor is cultivated: Phellinus igniarius (L. ex Fr.) Quel. mother is planted and is inoculated in liquid seed culture medium, at 28～32 DEG C, and 135～150r/
Cultivating 6～7d on the shaking table of min, the mycelium of gained is liquid seeds, and described liquid seed culture medium is dense by following quality
The component composition of degree: 0.6% peptone, 3.0% glucose, 0.3% potassium dihydrogen phosphate, 0.06% thiamine and 0.04% sulphuric acid
Magnesium, solvent is purified water, and pH value is 5.5～6.5；
2. fermentation: take step 1. Phellinus igniarius (L. ex Fr.) Quel. seed liquor and access in fermentation medium by the inoculum concentration of 10%, at 28～32 DEG C, 135～
150r/min, ventilation are to cultivate 4d under the conditions of 1:0.6～0.8, until solution turns orange transparent time terminate fermenting, use gauze mistake
Filter, and retains standby by filtrate, and described fermentation medium is made up of the component of following mass concentration: 1.5% yeast extract, 3%
Maltose, 0.3% potassium dihydrogen phosphate, 0.06% thiamine and 0.04% magnesium sulfate, solvent is purified water, pH value be 5.5～
6.5；
3. prepared by mycopowder: 2. step obtains filtrate and carries out lyophilization and pulverize, obtain Phellinus igniarius (L. ex Fr.) Quel. zymophyte powder；
(2) preparation of pharmaceutical composition:
1. take Fructus Hordei Germinatus, Rhizoma Dioscoreae, Poria, Fructus Jujubae, Endothelium Corneum Gigeriae Galli and Radix Glycyrrhizae, crushed after being dried, cross 80 mesh sieves, add medical material gross weight 8
～10 water soakings 1～2h of times amount, reflux, extract, 2～3 times, each 3～4 hours, filter and retain filtering residue, merging filtrate,
Aqueous extracts；
2. adding, in step filtering residue 1., the ethanol that medical material gross weight 8～10 times amount volume fraction is 60～70%, backflow carries
Take 2～3 times, each 3～4 hours, filter, merging filtrate, obtain alcohol extract；
3. merge Aqueous extracts and alcohol extract, drying under reduced pressure, pulverize, cross 100 mesh sieves, obtain powder；
4. being pulverized by Concha Ostreae, cross 100 mesh sieves, then the powder with step 3. gained mixes, and adds Phellinus igniarius (L. ex Fr.) Quel. zymophyte powder, vitamin
D2, calcium gluconate, sodium ascorbyl phosphate, glutathion and adjuvant stir and get final product.
10. according to the pharmaceutical composition of the arbitrary described increase bone density of claim 1-8, it is characterised in that described medicine
Compositions can make granule, capsule, oral liquid or solid beverage further.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610906187.0A CN106310034B (en) | 2016-10-18 | 2016-10-18 | A kind of pharmaceutical composition for increasing bone density and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN109511973A (en) * | 2019-01-09 | 2019-03-26 | 湖南大湖生物技术有限公司 | A kind of Chinese medicine and health food and preparation method thereof increasing bone density |
| CN109567170A (en) * | 2019-01-15 | 2019-04-05 | 湖南大湖生物技术有限公司 | A kind of health care product and preparation method thereof of pre- preventing bone rarefaction |
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| CN101327015A (en) * | 2008-07-21 | 2008-12-24 | 范十足 | Bone-tonifying growth-encouraging rice flour and formulating method thereof |
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| CN101327015A (en) * | 2008-07-21 | 2008-12-24 | 范十足 | Bone-tonifying growth-encouraging rice flour and formulating method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109511973A (en) * | 2019-01-09 | 2019-03-26 | 湖南大湖生物技术有限公司 | A kind of Chinese medicine and health food and preparation method thereof increasing bone density |
| CN109567170A (en) * | 2019-01-15 | 2019-04-05 | 湖南大湖生物技术有限公司 | A kind of health care product and preparation method thereof of pre- preventing bone rarefaction |
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