CN108324925A - A kind of compound capsule formulation for increasing bone density and having booster action to arthritis - Google Patents
A kind of compound capsule formulation for increasing bone density and having booster action to arthritis Download PDFInfo
- Publication number
- CN108324925A CN108324925A CN201711481185.2A CN201711481185A CN108324925A CN 108324925 A CN108324925 A CN 108324925A CN 201711481185 A CN201711481185 A CN 201711481185A CN 108324925 A CN108324925 A CN 108324925A
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- Prior art keywords
- calcium
- bone density
- booster action
- auxiliary material
- capsule formulation
- Prior art date
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Classifications
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- 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
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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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7008—Compounds having an amino group directly attached to a carbon atom of the saccharide radical, e.g. D-galactosamine, ranimustine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
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- A61K31/728—Hyaluronic acid
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- A—HUMAN NECESSITIES
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/737—Sulfated polysaccharides, e.g. chondroitin sulfate, dermatan sulfate
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- A—HUMAN NECESSITIES
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- 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
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
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- Bioinformatics & Cheminformatics (AREA)
- Food Science & Technology (AREA)
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- Inorganic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
Abstract
The present invention discloses a kind of compound capsule formulation for increasing bone density and having booster action to arthritis comprising following components：Aminoglucose hydrochloride, sodium chondroitin sulfate, calcium, casein phosphopeptide, Sodium Hyaluronate, auxiliary material；It is by weight ratio (10~5):(8~4):(5~2):(2~0.5):(1~0):(2~0.2).Different technical solutions is screened by controlling, the dosage of reduction auxiliary material can be reached can achieve the purpose that energy-saving and environmental protection in process of production under the premise of ensuring dosage form, loading amount, mobility, product quality, consumer can be made to reduce the intake of auxiliary material, the opposite intake for improving raw material again.The present invention is using aminoglucose hydrochloride, sodium chondroitin sulfate, calcium, casein phosphopeptide, Sodium Hyaluronate as health food made of primary raw material, sufficient calcium source is provided for human body, to reach the health-care effect for increasing bone density, also there is booster action to arthritis.
Description
Technical field
The present invention relates to a kind of nutrition and health care agent technical fields；It can increase bone density and to arthritis more particularly to a kind of
There is the research of the compound formulation of booster action.
Background technology
According to incompletely statistics, the senile osteoporosis disease incidence in China 60 years old or more is about 59.89%, and it is close to increase bone
Degree, effectively treatment osteoporosis have become the important topic of people's extensive concern.
Osteoporosis is the disease of a kind of " very quiet ", is thinning, extra large with the reduction of unit volume inner bone tissues amount, cortex of bone
Continuous bone bone trabecula number and the disease that size is reduced, pulp cavity is broadening, bone load miopragia etc. is characterized, will usually wait until bone
Folding occurs just be hardly perceived.Clinically Main Basiss reflect leading indicator, that is, bone density of bone amount to diagnose.Osteoporosis
Signal includes height shortening, circle shoulder, hunchback and examines the bone-loss being diagnosed to be, it is also possible to have the diseases such as neck pain and shoulder pain
Shape.The patient bone of osteoporosis is crisp, risk of bone fracture is caused to increase, and especially hip joint, backbone and wrist are very easy to bone
Folding.
Osteoarthritis is a kind of chronic disease in joint, and the joint of load-bearing, which is particularly susceptible, generates this disease.According to epidemiology
Statistics, at present whole world arthritic have 3.55 hundred million people, be more than 100,000,000 in the patient numbers of China, and also increasing, 50 years old with
On crowd in 70-80% suffer from different degrees of various arthritis.The generation of osteoarthritis is typically gradual, most often
That is involved has hip joint, knee joint, finger and backbone, other joints may also be impacted, and pain is most important symptom,
It aggravates when movement, can be alleviated after rest.With arthritic deterioration, the locomitivity in joint is gradually lost, and goes out
Existing tenderness, it is also possible to feel the prick.The osteoarthritis at backbone position may also result in arm and shouting pain occurs in leg.As
The No.1 disabling condition in the world, serious osteoarthritis can lead to human body whole show Disability.
Invention content
For present situation combination China resident to the nutritional need present situation of osteoporosis prevention and health care, with aminoguanidine hydrochloride grape
Sugar, sodium chondroitin sulfate, calcium, casein phosphopeptide, Sodium Hyaluronate are health food made of primary raw material, are provided for human body
Sufficient calcium source also has booster action to reach the health-care effect for increasing bone density to arthritis.Its technical solution is as follows：
Increase bone density and have the compound capsule formulation of booster action to arthritis, said preparation includes aminoguanidine hydrochloride Portugal
Grape sugar, sodium chondroitin sulfate, calcium, casein phosphopeptide, Sodium Hyaluronate, auxiliary material.
One selected raw material of technical solution and its proportioning are as follows：Aminoglucose hydrochloride, sodium chondroitin sulfate, calcium, junket
Protein phosphatase polypeptide, Sodium Hyaluronate, auxiliary material mass ratio be (10~5):(8~4):(5~2):(2~0.5):(1~0):(2
~0.2).
In preferred technical solution, selected raw material and its proportioning are as follows：Aminoglucose hydrochloride, chondroitin sulfate
Sodium, calcium, casein phosphopeptide, Sodium Hyaluronate, auxiliary material mass ratio be (10~5):(8~4):(5~2):(2~0.5):(1
~0.5):(0.5~0.2).
In preferred technical solution, selected raw material and its proportioning are as follows：Aminoglucose hydrochloride, chondroitin sulfate
Sodium, calcium, casein phosphopeptide, Sodium Hyaluronate, auxiliary material mass ratio be 7.5:6.5:3.34:1.2:1.45.When in embodiment 1
Parts by weight unit when preparing capsule is 20g/ parts；
In preferred technical solution, selected raw material and its proportioning are as follows：Aminoglucose hydrochloride, chondroitin sulfate
Sodium, calcium, casein phosphopeptide, auxiliary material mass ratio be (10~5):(8~4):(5~2):(2~0.5):(2~1).
In preferred technical solution, selected raw material and its proportioning are as follows：Aminoglucose hydrochloride, chondroitin sulfate
Sodium, calcium, casein phosphopeptide, auxiliary material mass ratio be 6.3:4.8:3.2:1.13:0.66:0.4.When preparing glue in embodiment 2
Parts by weight unit when wafer is 15g/ parts；
In preferred technical solution, preparation compares mould to three distal end bone density, calcium content of bone indexs in middle dose group
Type group has significant difference.
Preparation is to three distal end bone density, center bone density, calcium content of bone index contrast model group tools in high dose group
There were significant differences.
Preparation has significant difference to three distal end bone density, calcium content of bone index contrast model groups in high dose group.
Parts by weight unit when preparing capsule in scheme one is 20g/ parts, after conversion, aminoglucose hydrochloride and sulfuric acid
The ratio of chondroitin sodium and auxiliary material is 280：29；Parts by weight unit when preparing capsule in scheme two is 15g/ parts, after conversion,
The ratio of aminoglucose hydrochloride and sodium chondroitin sulfate and auxiliary material is 167：6.
In preferred technical solution, calcium carbonate is selected in the calcium agent.
In preferred technical solution, the auxiliary material selects starch, or selects the colloidal state two of following 10 parts by weight of composition
The starch of silica, the magnesium stearate of 1.5 parts by weight, 17.5 parts by weight.
The correlative factors such as different calcium agent and raw material character itself, mesh number, density, moisture, mobility are screened by controlling,
The dosage that reduction auxiliary material can be reached can be in production process under the premise of ensuring dosage form, loading amount, mobility, product quality
In achieve the purpose that energy-saving and environmental protection, and consumer can be made to reduce the intake of auxiliary material, the opposite intake for improving raw material.
The present invention character of innovation be：
Glucosamine is almost distributed in human body institute in a organized way, participates in construction tissue and cell membrane, is proteoglycan
Macromolecular synthesis intermediate material, it can synthesize glutinous polysaccharide, glycoprotein and proteoglycans, especially synthesize those articular cartilages with
And the intermediary of synovia molecule, it is the natural component of glycoprotein in human body and animal body intrinsic articulation tissue, in animal and human body
It is synthesized by Glucoamino endogenous biological.In vitro study is also it has been shown that Glucosamine can intensify the synthesis of proteoglycan
And increase the absorption of sulfate by articular cartilage.
Sodium chondroitin sulfate is the sodium salt of chondroitin sulfate, and chondroitin sulfate (CS) is the glycosaminoglycan of a kind of sulphation
(GAG), it is present in humans and animals connective tissue, is distributed mainly in cartilage, bone, tendon, sarolemma and vascular wall.It is American-European,
Japan and other countries, CS is mainly as health food or drug, for prevention and treatment of coronary heart disease, angina pectoris, myocardial infarction, arthritis, angle
It is relatively low to take toxic side effect for a long time for the diseases such as film inflammation, deafness and tinnitus, neuralgia.
Glucosamine is matched with chondroitin sulfate, research shows that can more preferably inhibit synthesis and the epoxy of prostaglandin E2
The activity of enzyme -2, effectively releive bone, arthritis；Also while to absorb chondroitin sulfate be very heavy when taking Glucosamine
It wants, because chondroitin sulfate can promote the process in Glucosamine infiltration joint.The research of New England Journal of Medicine points out,
It can more effectively be protected in conjunction with intake Glucosamine and chondroitin, reverse damage and promote repairing articular cartilage and membrane bone.
Calcium agent is broadly divided into inorganic calcium, organic calcium, biological calcium preparation.Calcium is to constitute the important micro member of human body mineral matter
Element can supplement bone mineral, promote bone mineralising, to be conducive to the formation of bone while keep the intensity of bone, moreover it is possible to improve
Bone amount.
Casein phosphopeptide (CPP) is using bovine casein as raw material, by enzyme hydrolysis, a kind of life isolated and purified
Object active peptide, special cluster phosphoserine structure have chelated calcium ability.CPP is in neutrality weak in the small enteral pH of animal
In the environment of alkalinity, it can prevent the generation of calcium phosphate precipitation with the calcium salt of calcium chela synthesizing soluble, make containing for enteral solubility calcium
Amount is maintained at higher level, promotes human body that calcium is absorbed and utilized.
Hyaluronic acid and its salt are the physiological activators being widely present in human body, are by glucuronic acid and acetylamino
A kind of macromolecule that the dissacharide units of glucose composition are formed by connecting sticks polysaccharide.Wherein Sodium Hyaluronate clinical application is more.Largely
Clinical applications result show：Sodium Hyaluronate is to treatment Osteoarthritis, the joint diseases such as rheumatoid arthritis are with obvious effects,
Safety.
Specific implementation mode
Following non-limiting embodiments can make those skilled in the art be more fully understood the present invention, but not with
Any mode limits the present invention.
Embodiment 1
Aminoglucose hydrochloride in preparation, sodium chondroitin sulfate, calcium, casein phosphopeptide, auxiliary material mass ratio be 7.5:
6.5:3.34:1.2:1.45；Wherein, the auxiliary material is that following compositions is selected to be mixed to prepare according to weight：10 weight
The starch of the colloidal silicon dioxide of part, the magnesium stearate of 1.5 parts by weight, 17.5 parts by weight.
(1) safety toxicology is tested
1. acute toxicity test
1.1 method foundations：《Health food is examined and assessment technique specification》
1.2 result：
1 male and female chmice acute Oral toxicity test result of table
1.3 conclusion：Preparation is all higher than 20g/kg to the maximum tolerated dose MTD that male and female chmice acute is orally tested.Belong to nothing
Toxicity.
2. Micronucleus test
2.1 test basis：《Health food is examined and assessment technique specification》
2.2 result：
2 marrow polychromatic erythrocyte microkernel incidence of table
Note：* is compared with negative control group (through Chi-square Test), p ＜ 0.01
2.3 conclusion：Preparation is feminine gender to Micronucleus test result.
3. mouse inbred strain
3.1 test basis：《Health food is examined and assessment technique specification》
3.2 result：
3 animal sperm birth prevalence of table
Note：* (is verified) compared with negative control group through card side, P ＜ 0.01
3.3 conclusion：Preparation is feminine gender to mouse inbred strain result.
4.Ames is tested
4.1 test basis：《Health food is examined and assessment technique specification》
4.2 result：
Table 4 first time experimental test result
Second of the experimental test result of table 5
4.3 conclusion：The Salmonella reversion test result of preparation is feminine gender.
5.30 its feeding trial
5.1 test basis：《Health food is examined and assessment technique specification》
The detection data of 5.2 results such as following table：
6 male rat weight of table, weightening, food ration, food utilization result (N=10)
7 female rats weight of table, weightening, food ration, food utilization result (N=10)
8 each dosage group animal viscera absolute weight of table (N=10)
The 9 dirty body ratio of each dosage group rat of table (N=10)
10 blood routine measurement result of table (N=10)
10 blood routine measurement result of table (N=10) (Continued)
11 biochemistry detection result of table (N=10)
11 biochemistry detection result of table (N=10) (Continued)
Note：* it indicates compared with the control group, P ＜ 0.05.
Table feeds hepatic pathology microscopic examination result in 12 30 days
Table feeds Pathological microscopic examination result in 13 30 days
Table feeds spleen pathology microscopic examination result in 14 30 days
Table feeds gastroenteric pathology microscopic examination result in 15 30 days
Table feeds orchiopathology microscopic examination result in 16 30 days
Table feeds ovary pathology microscopic examination result in 17 30 days
5.3 conclusion：Each group animal substantially examine it is without exception, liver,kidney,spleen, stomach and intestine, sexual organ histological indications
Do not find that Histopathology related with tested material changes.
(2) function assessment zoopery
1. test basis：《Health food is examined and assessment technique specification》
2. conclusion：
Influence of 2.1 preparations to rat body weight
Influence of 18 sample of table to rat body weight
* it notes:Indicate that difference is significant (P ＜ 0.05) between each group in same row and model control group relatively foot.
Influence of 2.2 preparations to the weight, bone calcium and bone density of rat femur
Influence of 19 sample of table to the weight, bone calcium and bone density of rat femur
* it notes:Indicate that difference is significant (P ＜ 0.05) between each group in same row and model control group relatively foot.
Preparation has significant difference to three distal end bone density, calcium content of bone index contrast model groups in middle dose group.
Preparation is to three distal end bone density, center bone density, calcium content of bone index contrast model group tools in high dose group
There were significant differences.Influence of 2.3 preparations to rat calcium uptake
Influence of 20 sample of table to calcium uptake in rat experiment periods
3 conclusions：Preparation has the function of rat to increase bone density
Embodiment 2
The mass ratio of aminoglucose hydrochloride, sodium chondroitin sulfate, calcium, casein phosphopeptide, Sodium Hyaluronate in preparation
It is 10~5:8~4:5~2:2~0.5:1~0.5.
(1) safety toxicology is tested
3. acute toxicity test
1.1 method foundations：《Health food is examined and assessment technique specification》
1.2 result：
21 male and female chmice acute Oral toxicity test result of table
1.3 conclusion：Preparation is all higher than 20g/kg to the maximum tolerated dose MTD that male and female chmice acute is orally tested.Belong to nothing
Toxicity.
4. Micronucleus test
2.1 test basis：《Health food is examined and assessment technique specification》
Note：* is compared with negative control group (through Chi-square Test), p ＜ 0.01
2.3 conclusion：Preparation is feminine gender to Micronucleus test result.
3. mouse inbred strain
3.1 test basis：《Health food is examined and assessment technique specification》
3.2 result：
23 animal sperm birth prevalence of table
Note：* (is verified) compared with negative control group through card side, P ＜ 0.01
3.3 conclusion：Preparation is feminine gender to mouse inbred strain result.
4.Ames is tested
4.1 test basis：《Health food is examined and assessment technique specification》
4.2 result：
Table 24 first time experimental test result
Second of the experimental test result of table 25
4.3 conclusion：The Salmonella reversion test result of preparation is feminine gender.
5.30 its feeding trial
5.1 test basis：《Health food is examined and assessment technique specification》
5.2 result
26 male rat weight of table, weightening, food ration, food utilization result (N=10)
27 female rats weight of table, weightening, food ration, food utilization result (N=10)
28 each dosage group animal viscera absolute weight of table (N=10)
The 29 dirty body ratio of each dosage group rat of table (N=10)
30 blood routine measurement result of table (N=10)
30 blood routine measurement result of table (N=10) (Continued)
31 biochemistry detection result of table (N=10)
31 biochemistry detection result of table (N=10) (Continued)
Note：* it indicates compared with the control group, P ＜ 0.05.
Table feeds hepatic pathology microscopic examination result in 32 30 days
Table feeds Pathological microscopic examination result in 33 30 days
Table feeds spleen pathology microscopic examination result in 34 30 days
Table feeds gastroenteric pathology microscopic examination result in 35 30 days
Table feeds orchiopathology microscopic examination result in 36 30 days
Table feeds ovary pathology microscopic examination result in 37 30 days
5.3 conclusion：Each group animal substantially examine it is without exception, liver,kidney,spleen, stomach and intestine, sexual organ histological indications
Do not find that Histopathology related with tested material changes.
(2) function assessment zoopery
1. test basis：《Health food is examined and assessment technique specification》
2. conclusion：
Influence of 2.1 preparations to rat body weight
Influence of 38 sample of table to rat body weight
* it notes:Indicate that difference is significant (P ＜ 0.05) between each group in same row and model control group relatively foot.
Influence of 2.2 preparations to the weight, bone calcium and bone density of rat femur
Influence of 39 sample of table to the weight, bone calcium and bone density of rat femur
* it notes:Indicate that difference is significant (P ＜ 0.05) between each group in same row and model control group relatively foot.
Preparation has significant difference to three distal end bone density, calcium content of bone index contrast model groups in high dose group.
Influence of 2.3 preparations to rat calcium uptake
Influence of 40 sample of table to calcium uptake in rat experiment periods
3 conclusions：Preparation has the function of rat to increase bone density
Embodiment 3
Technical solution one：The matter of aminoglucose hydrochloride, sodium chondroitin sulfate, calcium, casein phosphopeptide, auxiliary material in preparation
Amount is than being 10~5:8~4:5~2:2~0.5：2~1 (7.5:6.5:3.34:1.2:1.45).
Technical solution two：Aminoglucose hydrochloride, sodium chondroitin sulfate, calcium, casein phosphopeptide, hyaluronic acid in preparation
Sodium, auxiliary material mass ratio be 10~5:8~4:5~2:2~0.5:1~0.5:0.5~0.2 (6.3:4.8:3.2:1.13:
0.66:0.4)
The ratio of aminoglucose hydrochloride and sodium chondroitin sulfate and auxiliary material is 280 in scheme one：29；Hydrochloric acid in scheme two
The ratio of Glucosamine and sodium chondroitin sulfate and auxiliary material is 167：6.
The correlative factors such as different calcium agent and raw material character itself, mesh number, density, moisture, mobility are screened by controlling,
The dosage that reduction auxiliary material can be reached can be in production process under the premise of ensuring dosage form, loading amount, mobility, product quality
In achieve the purpose that energy-saving and environmental protection, and consumer can be made to reduce the intake of auxiliary material, the opposite intake for improving raw material.
One technical study of scheme
Since this product is using originals such as aminoglucose hydrochloride, sodium chondroitin sulfate, calcium agent (calcium carbonate), casein phosphopeptide
Material, wherein raw material aminoglucose hydrochloride, sodium chondroitin sulfate hygroscopicity are stronger, therefore this product selects capsule formulation, both neatly
It is beautiful, convenient for taking, and the protection to damp and hot unstable raw material can be effectively improved, make up the deficiency of other dosage forms.
(1) supplementary product consumption is studied
41 supplementary product consumption of table investigates result
Experimental result shows that the 9th group of formula scheme mixed powder mobility is best, analyzes its result colloidal silicon dioxide to this
Product mobility influences maximum.Supplementary product consumption is in compound：Colloidal silicon dioxide 10g, magnesium stearate 1.5g, starch 17.5g.
(2) Process Route Planning
Compound capsule production technology is intended directly carrying out capsule filling, the whether uniform direct shadow of material mixing after using mixing
Ring the quality of finished product.Since colloidal silica Silicon forms are fluffy, heap density is smaller, consider hybrid technique using first by colloidal state two
Silica, magnesium stearate, starch and casein phosphopeptide are premixed, and premixing flour 1 is obtained；Calcium agent, sodium chondroitin sulfate, hydrochloric acid
Glucosamine is premixed, and premixing flour 2 is obtained；By 2 premixing flours, always mixed 3 steps are completed again.According to the skill generally produced
Art requires and previous knowhow setting premix, progress cross-over experiment of always doing time, and samples and surveys in total mixture material different level
Determine calcium content uniformity, investigates best hybrid technique parameter.It the results are shown in Table 2.
The investigation result of 42 incorporation time of table
The result shows that when doing time in advance more than 20min or always doing time more than 40min, calcium content homogeneity is good, and RSD is equal
Less than 4%.It is another to consider to shorten life cycle of the product, reduce production cost, energy-saving and environmental protection, determine that scheme 14 is one capsule of scheme
Hybrid technique optimal parameter：It premixes 20min, premix 20min, always mix 40min.
(3) processing quality is studied
Product Validation processing quality result of study：
43 process results of table
Two technical study of scheme
Due to this product using aminoglucose hydrochloride, sodium chondroitin sulfate, calcium agent (newborn mineral salt), casein phosphopeptide,
The raw materials such as Sodium Hyaluronate, wherein raw material aminoglucose hydrochloride, sodium chondroitin sulfate hygroscopicity are stronger, therefore this product selects glue
Cap dosage, it is not only neat and artistic, convenient for taking, but also the protection to damp and hot unstable raw material can be effectively improved, make up other dosage forms
Deficiency.
(1) supplementary product consumption is studied
There is good mobility (angle of repose is less than 30 °) due to primary raw material mixed powder, add the mesh of auxiliary material
Be to play the role of filling.
(2) Process Route Planning
Compound capsule production technology is intended directly carrying out capsule filling, the whether uniform direct shadow of material mixing after using mixing
Ring the quality of finished product.Consider that hybrid technique using first Sodium Hyaluronate, starch and casein phosphopeptide is premixed, obtains
Premixing flour；Newborn mineral salt, sodium chondroitin sulfate, aminoglucose hydrochloride and premixing flour are always mixed.According to the skill generally produced
Art requires setting premix, progress cross-over experiment of always doing time is examined in total mixture material different level sampling and measuring calcium content uniformity
Examine best hybrid technique parameter.It the results are shown in Table 2.
The investigation result of 44 incorporation time of table
The result shows that being done time in advance more than 15min, when always doing time more than 40min, calcium content homogeneity is good, and RSD is small
In 4%.It is another to consider to shorten life cycle of the product, reduce production cost, determine that scheme 5 is that two hybrid technique of scheme is most preferably joined
Number：It premixes 15min, always mix 40min.
3) processing quality is studied
Product Validation processing quality result of study：
45 process results of table
Production technology includes the flows such as dry, sieving, weighing, premix, total mixed, dress capsule, and production process is to ensure product
Based on quality, the factors such as energy-saving and environmental protection are considered, finally determine corresponding production technology.
Claims (8)
1. a kind of compound capsule formulation for increasing bone density and having booster action to arthritis, it is characterised in that：Including following
Component：Aminoglucose hydrochloride, sodium chondroitin sulfate, calcium, casein phosphopeptide, Sodium Hyaluronate, auxiliary material；By weight ratio
For (10~5):(8~4):(5~2):(2~0.5):(1~0):(2~0.2).
2. a kind of compound capsule formulation for increasing bone density and having booster action to arthritis according to claim 1,
It is characterized in that：The aminoglucose hydrochloride, sodium chondroitin sulfate, calcium, casein phosphopeptide, Sodium Hyaluronate, auxiliary material
Mass ratio is (10~5):(8~4):(5~2):(2~0.5):(1~0.5):(0.5~0.2).
3. a kind of compound capsule formulation for increasing bone density and having booster action to arthritis according to claim 1,
It is characterized in that：The aminoglucose hydrochloride, sodium chondroitin sulfate, calcium, casein phosphopeptide, Sodium Hyaluronate, auxiliary material
Mass ratio is 7.5:6.5:3.34:1.2:1.45.
4. a kind of compound capsule formulation for increasing bone density and having booster action to arthritis according to claim 1,
It is characterized in that：The aminoglucose hydrochloride, sodium chondroitin sulfate, calcium, casein phosphopeptide, auxiliary material mass ratio be (10
~5):(8~4):(5~2):(2~0.5):(2~1).
5. a kind of compound capsule formulation for increasing bone density and having booster action to arthritis according to claim 1,
It is characterized in that：The aminoglucose hydrochloride, sodium chondroitin sulfate, calcium, casein phosphopeptide, auxiliary material mass ratio be 6.3:
4.8:3.2:1.13:0.66:0.4。
6. a kind of compound capsule formulation for increasing bone density and having booster action to arthritis according to claim 1,
It is characterized in that：Calcium carbonate is selected in the calcium agent.
7. a kind of compound capsule formulation for increasing bone density and having booster action to arthritis according to claim 1,
It is characterized in that：The auxiliary material selects starch, or selects following composition compositions：The colloidal silicon dioxide of 10 parts by weight, 1.5
The starch of the magnesium stearate of parts by weight, 17.5 parts by weight.
8. a kind of compound capsule formulation for increasing bone density and having booster action to arthritis according to claim 1,
It is characterized in that：Preparation has three distal end bone density, calcium content of bone index contrast model groups aobvious in the middle dose group
Write difference；Preparation has three distal end bone density, center bone density, calcium content of bone index contrast model groups in high dose group
Significant difference.Preparation has significant difference to three distal end bone density, calcium content of bone index contrast model groups in high dose group.
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