CN102600458A - Compound preparation of glucosamine chondroitin and production method of compound preparation - Google Patents
Compound preparation of glucosamine chondroitin and production method of compound preparation Download PDFInfo
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- CN102600458A CN102600458A CN2011103382714A CN201110338271A CN102600458A CN 102600458 A CN102600458 A CN 102600458A CN 2011103382714 A CN2011103382714 A CN 2011103382714A CN 201110338271 A CN201110338271 A CN 201110338271A CN 102600458 A CN102600458 A CN 102600458A
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Abstract
The invention discloses a compound preparation of glucosamine chondroitin. The compound preparation comprises the following main components of: glucosamine salts and chondroitin sulfate as main active components, one or several of dimethyl sulfone and collagen as auxiliary components and an accessory. Mixed granules produced by the compound preparation disclosed by the invention have better compressibility and stability; the consumption of the accessory is reduced, so that the production cost is reduced; the quality of products is reduced; and the compound preparation is especially suitable for middle-aged groups suffering from rheumatic arthritis and groups whose moving joints are injured.
Description
Technical field
:
The present invention relates to field of health care food, be specifically related to compound preparation of a kind of D-glucosamine chrondroitin and preparation method thereof.
Background technology:
Osteoarthritis is common a kind of chronic arthritis, and people are always at the medicine of seeking and explore PD for many years.Rheumatic arthritis, rheumatoid arthritis etc. are brought handicapped to the patient, pain when morning or weather conversion (especially).For a long time, people use aspirin always, and non-steroidal analgesic etc. is helped the patient and palliated the agonizing sufferings.These medicine life-time service, the effect that has reduces gradually, the generation flatulence that has, side effect such as stomachache.
Arthritis mainly is the degeneration and the Secondary cases hyperosteogeny of articular cartilage.Because the mucosa of junction, joint is formed by containing sulfoprotein and glucamine etc.The Protocollagen of sulfur-bearing and glucamine etc. have the generation that promotes collagen protein, increase the combination of water, help to repair the function of damage cartilage.Can make injured cartilage recover normal, periosteum liquid is denseer, toughness more, thus strengthen the defencive function of periosteum, alleviate osteoarticular friction, reduce painful.
Glucosamine is a kind of natural amino monosaccharide; Most important monosaccharide for poly-glucosamine (GS) and proteoglycan in the formation articular cartilage substrate; The normal person can synthesize GS through the amination of glucose, but in osteoarthritis chondrocyte all GS biosynthesis block or deficiency, cause cartilage matrix softening and follow the string; Collagen fiber structural deterioration, cartilage surface lacuna increase makes skeleton wearing and tearing and destruction.The pathogenesis of glucosamine osteoarthritis capable of blocking; Impel the synthetic proteoglycan of chondrocyte with normal configuration; And the generation of the enzyme (like collagenase, phospholipase A2) of inhibition damaged tissue and cartilage, reduce the damage of chondrocyte, improve joint motion; Alleviate arthralgia, delay the osteoarthrosis inflammation course of disease.Simultaneously, it does not suppress the biosynthesis of prostaglandin, and therefore, glucosamine can be blocked the pathological process of osteoarthritis, and the progress that wards off disease is improved joint motion, alleviating pain, and do not have significant side effects.
The effect of chondroitin sulfate comprises: 1, the effect of skeletonization.The formation of animal bone is on the fiber that Organic substances such as collagen protein form, and inorganic salts such as deposition calcium, phosphorus form.Chondroitin sulfate plays a part positive in the deposition process of calcium.Calcium in the bone often is that stripping limit, limit is sedimentary: promptly the calcium one side is dissolved out from bone; Calcium in absorbing blood and deposition and form new bone are in a kind of homeostasis process bone all the time.If the chondroitin sulfate rope is not enough, the deposition of the calcium in the blood on bone will receive certain influence.If can absorb calcium and chondroitin sulfate together, can make sclerotin solid and suppress the generation of osteopathia effectively to a certain extent; 2, the effect of protection cartilage.Be positioned at the joint of the connecting portion of bone and bone, promptly the top of bone is made up of cartilage, and cartilage then mainly is to be made up of II collagen type and a large amount of proteoglycans.In the gap in joint, filled up by joint fluid, when pressurizeing for the joint repeatedly or when moving back and forth, joint fluid plays a part lubricated joint and protection joint, undertaking what suck cartilage to joint fluid is exactly chondroitin sulfate.It is generally acknowledged that cartilage is in case destruction just is difficult to regeneration.
Glucosamine salt and chondroitin sulfate share has good synergism to osteoarthrosis protection, and action effect was best when both proportionings were 5:4.
Have organic sulfur in the dimethyl sulfone, some basic functions of organic sulfur comprise the formation of keeping the human body internal protein, and the anti-inflammatory property of sulfur comprises that to some diseases arthritis, muscle and arthralgia etc. produce effect very much.The arthritic is studied; Discovery patient cartilage sulfur content has only 1/3 of normal person's cartilage sulfur content; To suffering from the hand rheumatic arthritis, patients such as knee joint degenerative arthritis, omarthritis, neck arthritis carry out obeying day 2250mg dimethyl sulfone and blank test.Through six weeks, take the dimethyl sulfone patient suffering and alleviate 80% than blank control group patient's misery.
Collagen protein is the main constituent of articular cartilage, and equally with age, the collagen protein synthesis ability also decreases, and cartilage elasticity reduces, fragility increases, the wearing and tearing aggravation, and various joint disease have just taken place thereupon.Articular cartilage mainly is made up of collagen protein (59%), proteoglycan (D-glucosamine) and chondrocyte etc.The collagen protein RF is the framework of articular cartilage, and proteoglycan (D-glucosamine) waits other compositions to exist wherein as implant, increases the intensity of articular cartilage, and collagen protein runs off and aggravates.RF relaxes even ruptures, and makes proteoglycan ingredients from lossing such as (oxygen sugar) quicken.The articular cartilage degeneration takes place thereupon, causes the friction of asking of bone and bone, causes arthralgia.This shows that collagen protein is the healthy key of articular cartilage.Have only the human body of letting to obtain sufficient collagen protein and proteoglycan (D-glucosamine), could more effectively quicken the joint rehabilitation.Therefore, the ailing basic method in control joint is to want effective replenishing collagen.
State such as the U.S., Canada market has the dietary supplement of dimethyl sulfone, chitosamine sulfate and chondroitin sulfate, collagen protein composition.Though do not indicate its purposes, introduce the composition that chrondroitin is a cartilage by physical data.Glucosamine cooperates with components such as dimethyl sulfone, chondroitin sulfate, collagen protein, have mutual potentiation, and each component all can be used as the arthritis treatment supplementary food.Therefore, four components are the active drug and the health food of treatment of arthritis.
Summary of the invention:
The purpose of this invention is to provide compound preparation of a kind of D-glucosamine chrondroitin and preparation method thereof; Can make activity component concentration can be up to 99.9% glucosamine salt and chondroitin sulfate compressibility hybrid particles; On the component compatibility, has greater flexibility; The gained hybrid particles has better compressibility and stability, more is prone to absorb.
The objective of the invention is to realize like this; A kind of compound preparation of D-glucosamine chrondroitin; It is characterized in that: comprise following main component: main active component glucosamine salt and chondroitin sulfate, other active component are a kind of in dimethyl sulfone, the collagen protein or several, and adjuvant; Described glucosamine salt is glucosamine sulphate or hydrochlorate or phosphate or its mixture; Described adjuvant comprises excipient, disintegrating agent, lubricant, binding agent, wetting agent, coating pre-mixing agent; Said excipient is one or more the combination in starch, microcrystalline Cellulose, sucrose, lactose, dextrin, maltodextrin, sorbitol, the mannitol; Said disintegrating agent is one or more the combination in crospolyvinylpyrrolidone, hydroxypropyl cellulose, carboxymethyl starch sodium, the cross-linking sodium carboxymethyl cellulose; Said lubricant is one or both the combination in magnesium stearate, stearic acid, the micropowder silica gel; Said binding agent is a kind of or combination more than 2 kinds in polyvinylpyrrolidone, sodium carboxymethyl cellulose, starch, the hydroxypropyl emthylcellulose; Said wetting agent is water or methanol or ethanol, and stabilizing agent is a tartaric acid; The constituent of described coating pre-mixing agent is a kind of or mixing more than 2 kinds in titanium dioxide, polyoxyethylene, Pulvis Talci, Polyethylene Glycol, carboxylic propyl methocel, the lecithin.
The weight proportion of each main auxiliary material of the present invention is following:
500 parts of glucosamine salts
400 parts of chondroitin sulfate
10～200 parts of collagen protein
10～200 parts of dimethyl sulfones
1～200 part of excipient
0.1～0.9 part of binding agent
1～100 part of disintegrating agent
1～50 part of lubricant
1～100 part of fluidizer
0.1～1 part of stabilizing agent
1～100 part of coating pre-mixing agent
Wetting agent is an amount of
The present invention processes according to the following steps:
(1) glucosamine and chondroitin sulfate wet granulation step:
1, the binding agent of material gross mass 0.05～0.1% and stabilizing agent are mixed, using the mixed solvent of suitable quantity of water or methanol and water to be configured to concentration is 0.1～5% binder solution, fully is dissolved to clear;
2,, cross 60～120 mesh sieves with raw material pulverizing;
3,, drop in the wet granulator and stirred mixing 1～10 minute with glucosamine and 3%～10% chondroitin sulfate;
4, evenly, slowly add the solution of the binding agent of configuration, liquid feeding is granulated while stirring, behind the corning, and strict control EAT, drying is crossed 12～20 mesh sieves, makes glucosamine sulfur acid chrondroitin granule;
(2) high-concentration sulfuric acid chrondroitin dry granulation step:
1, chondroitin sulfate is pulverized, crossed 60～120 mesh sieves;
2, with good each parameter of dry granulation machine debugging, the granularity screen sizes is controlled to be 20 orders;
3, raw material is added the dry granulation machine, carry out dry granulation, make the chondroitin sulfate crude granule;
(3) granule that above two kinds of methods is made mixes, and directly processes the compressibility hybrid particles;
(4) in hybrid particles, adding excipient, disintegrating agent, lubricant fully mixes; By tabletting behind the conventional method mensuration intermediate content; Preparation coating pre-mixing agent solution; Compound concentration is 1～25%, and EAT, sheet bed tempertaure, leaving air temp during the control coating carry out coating to prepared tablet.
The optimum synergistic quality proportioning of glucosamine salt of the present invention and chondroitin sulfate is 5:4.
The present invention makes activity component concentration can be up to 99.9% glucosamine salt and chondroitin sulfate compressibility hybrid particles, and glucosamine and chondroitin sulfate can carry out the compound compatibility preparation with arbitrary proportion, comprises that the two mass ratio of synergy is 5:4; On the component compatibility, has greater flexibility; The gained hybrid particles has better compressibility and stability, more is prone to absorb, and has reduced supplementary product consumption; Reduce production cost, improved product quality.
The specific embodiment:
The compound preparation of the D-glucosamine chrondroitin that the preparation activity component concentration is high, main component is: every contains glucosamine 40-1500mg, chondroitin sulfate 40-1200mg; Collagen protein 50-300mg, dimethyl sulfone 50-300mg, microcrystalline Cellulose 50-200mg; Carboxymethyl starch sodium 10-50mg, binding agent 0.2-10mg, stabilizing agent 0.1-10 mg; Magnesium stearate 1-20mg, coating pre-mixing agent 10-100mg.
Below in conjunction with specific embodiment the present invention is further specified:
Embodiment 1: the compound preparation preparation of glucosamine salt and chondroitin sulfate (5:4)
Glucosamine hydrochloride 1500g
Chondroitin sulfate 1200g
Microcrystalline Cellulose 120g
Carboxymethyl starch sodium 45g
Sodium carboxymethyl cellulose 1.5g
Tartaric acid 0.5g
Magnesium stearate 15g
Water is an amount of
Coating pre-mixing agent 40g
Prepare according to following step:
1. binding agent and stabilizing agent are mixed, using suitable quantity of water to be configured to concentration is 0.1～5% binder solution, fully is dissolved to clear; With raw material pulverizing, cross 60～120 mesh sieves, glucosamine is dropped in the wet granulator with an amount of chondroitin sulfate (accounting for 3～10%) stirred 1～10 minute; Mixing, even, the slow solution that adds the binding agent of configuration, liquid feeding is granulated while stirring; Behind the corning, strict control EAT, drying; Cross 12～20 mesh sieves, make glucosamine (sulfur acid chrondroitin) granule;
2. chondroitin sulfate is dropped in the dry granulation machine, regulate operating parameter, carry out dry granulation, granulate or mistake 12～20 mesh sieves make the chondroitin sulfate crude granule;
3. the granule that step 1 and step 2 is made mixes by a certain percentage, and processing glucosamine and chondroitin sulfate ratio is the high concentration compressibility hybrid particles of 5:4;
4. in step 3 gained hybrid particles, adding excipient, disintegrating agent, lubricant fully mixes; By tabletting behind the conventional method mensuration intermediate content; Preparation coating pre-mixing agent solution; Compound concentration is 1～25%, and EAT, sheet bed tempertaure, leaving air temp during the control coating carry out coating to prepared tablet.
Embodiment 2: the compound preparation preparation of glucosamine salt and chondroitin sulfate (5:4)
Glucosamine Sulfate Potassium salt 750g
Chondroitin sulfate 600g
Collagen protein 150g
Microcrystalline Cellulose 120g
Carboxymethyl starch sodium 45g
Hydroxypropyl emthylcellulose 0.5g
Sodium carboxymethyl cellulose 0.5g
Tartaric acid 0.5g
Magnesium stearate 15g
Water is an amount of
Coating pre-mixing agent 40g
Prepare according to following step:
1. binding agent and stabilizing agent are mixed, using suitable quantity of water to be configured to concentration is 0.1～5% binder solution, fully is dissolved to clear; With raw material pulverizing, cross 60～120 mesh sieves, glucosamine is dropped in the wet granulator with an amount of chondroitin sulfate (3～10%) stirred 1～10 minute; Mixing, even, the slow solution that adds the binding agent of configuration, liquid feeding is granulated while stirring; Behind the corning, strict control EAT, drying; Cross 12～20 mesh sieves, make glucosamine (chondroitin sulfate) granule;
2. chondroitin sulfate is dropped in the dry granulation machine, regulate operating parameter, carry out dry granulation, granulate or mistake 12～20 mesh sieves make the chondroitin sulfate crude granule;
3. the granule that step 1 and step 2 is made mixes by a certain percentage, and processing glucosamine and chondroitin sulfate ratio is the high concentration compressibility hybrid particles of 5:4;
4. in step 3 gained hybrid particles, adding excipient, disintegrating agent, lubricant fully mixes; By tabletting behind the conventional method mensuration intermediate content; Preparation coating pre-mixing agent solution; Compound concentration is 1～25%, and EAT, sheet bed tempertaure, leaving air temp during the control coating carry out coating to prepared tablet.
Embodiment 3: the compound preparation preparation of glucosamine salt and chondroitin sulfate (5:4)
Glucosamine hydrochloride 500g
Chondroitin sulfate 400g
Collagen protein 150g
Dimethyl sulfone 150g
Microcrystalline Cellulose 120g
Carboxymethyl starch sodium 45g
Sodium carboxymethyl cellulose 0.8g
Tartaric acid 0.5g
Magnesium stearate 15g
Water is an amount of
Coating pre-mixing agent 40g
Prepare according to following step:
1. binding agent and stabilizing agent are mixed, using suitable quantity of water to be configured to concentration is 0.1～5% binder solution, fully is dissolved to clear; With raw material pulverizing, cross 60～120 mesh sieves, glucosamine is dropped in the wet granulator with an amount of chondroitin sulfate (3～10%) stirred 1～10 minute; Mixing, even, the slow solution that adds the binding agent of configuration, liquid feeding is granulated while stirring; Behind the corning, strict control EAT, drying; Cross 12～20 mesh sieves, make glucosamine (chondroitin sulfate) granule;
2. chondroitin sulfate is dropped in the dry granulation machine, regulate operating parameter, carry out dry granulation, granulate or mistake 12～20 mesh sieves make the chondroitin sulfate crude granule;
3. the granule that step 1 and step 2 is made mixes by a certain percentage, and processing glucosamine and chondroitin sulfate ratio is the high concentration compressibility hybrid particles of 5:4;
4. in step 3 gained hybrid particles, adding excipient, disintegrating agent, lubricant fully mixes; By tabletting behind the conventional method mensuration intermediate content; Preparation coating pre-mixing agent solution; Compound concentration is 1～25%, and EAT, sheet bed tempertaure, leaving air temp during the control coating carry out coating to prepared tablet.
Embodiment 4: the compound preparation preparation of glucosamine salt and chondroitin sulfate (5:4)
Glucosamine Sulfate Potassium salt 250g
Chondroitin sulfate 200g
Collagen protein 150g
Dimethyl sulfone 150g
Microcrystalline Cellulose 120g
Carboxymethyl starch sodium 45g
Sodium carboxymethyl cellulose 0.4g
Tartaric acid 0.5g
Magnesium stearate 15g
Water is an amount of
Coating pre-mixing agent 40g
Prepare according to following step:
1. binding agent and stabilizing agent are mixed, using suitable quantity of water to be configured to concentration is 0.1～5% binder solution, fully is dissolved to clear; With raw material pulverizing, cross 60～120 mesh sieves, glucosamine is dropped in the wet granulator with an amount of chondroitin sulfate (3～10%) stirred 1～10 minute; Mixing, even, the slow solution that adds the binding agent of configuration, liquid feeding is granulated while stirring; Behind the corning, strict control EAT, drying; Cross 12～20 mesh sieves, make glucosamine (chondroitin sulfate) granule;
2. chondroitin sulfate is dropped in the dry granulation machine, regulate operating parameter, carry out dry granulation, granulate or mistake 12～20 mesh sieves make the chondroitin sulfate crude granule;
3. the granule that step 1 and step 2 is made mixes by a certain percentage, and processing glucosamine and chondroitin sulfate ratio is the high concentration compressibility hybrid particles of 5:4;
4. in step 3 gained hybrid particles, adding excipient, disintegrating agent, lubricant fully mixes; By tabletting behind the conventional method mensuration intermediate content; Preparation coating pre-mixing agent solution; Compound concentration is 1～25%, and EAT, sheet bed tempertaure, leaving air temp during the control coating carry out coating to prepared tablet.
Embodiment 5: the compound preparation preparation of glucosamine salt and chondroitin sulfate
Glucosamine hydrochloride 750g
Chondroitin sulfate 40g
Collagen protein 150g
Dimethyl sulfone 150g
Microcrystalline Cellulose 120g
Carboxymethyl starch sodium 45g
Sodium carboxymethyl cellulose 0.6g
Tartaric acid 0.5g
Magnesium stearate 15g
Water is an amount of
Coating pre-mixing agent 40g
Prepare according to following step:
1. binding agent and stabilizing agent are mixed, using suitable quantity of water to be configured to concentration is 0.1～5% binder solution, fully is dissolved to clear; With raw material pulverizing, cross 60～120 mesh sieves, glucosamine is dropped in the wet granulator with an amount of chondroitin sulfate (3～10%) stirred 1～10 minute; Mixing, even, the slow solution that adds the binding agent of configuration, liquid feeding is granulated while stirring; Behind the corning, strict control EAT, drying.Cross 12～20 mesh sieves, make glucosamine (chondroitin sulfate) granule;
2. chondroitin sulfate is dropped in the dry granulation machine, regulate operating parameter, carry out dry granulation.Cross 12～20 mesh sieves, make the chondroitin sulfate crude granule;
3. the granule that step 1 and step 2 is made mixes by a certain percentage, processes the glucosamine and the chondroitin sulfate high concentration compressibility hybrid particles that meet formula proportion;
4. in step 3 gained hybrid particles, adding excipient, disintegrating agent, lubricant fully mixes; By tabletting behind the conventional method mensuration intermediate content; Preparation coating pre-mixing agent solution; Compound concentration is 1～25%, and EAT, sheet bed tempertaure, leaving air temp during the control coating carry out coating to prepared tablet.
Embodiment 6: the compound preparation preparation of glucosamine salt and chondroitin sulfate
Glucosamine Sulfate Potassium salt 750g
Chondroitin sulfate 750g
Collagen protein 150g
Dimethyl sulfone 150g
Microcrystalline Cellulose 120g
Carboxymethyl starch sodium 45g
Sodium carboxymethyl cellulose 1.0g
Tartaric acid 0.5g
Magnesium stearate 15g
Water is an amount of
Coating pre-mixing agent 40g
Prepare according to following step:
1. binding agent and stabilizing agent are mixed, using suitable quantity of water to be configured to concentration is 0.1～5% binder solution, fully is dissolved to clear, with raw material pulverizing, crosses 60～120 mesh sieves.With stirring mixing, the solution of the binding agent of even, slow adding configuration 1～10 minute in glucosamine and an amount of chondroitin sulfate (3～10%) the input wet granulator; Liquid feeding is granulated while stirring; Behind the corning, strict control EAT, drying; Cross 12～20 mesh sieves, make glucosamine (chondroitin sulfate) granule;
2. chondroitin sulfate is dropped in the dry granulation machine, regulate operating parameter, carry out dry granulation.Cross 12～20 mesh sieves, make the chondroitin sulfate crude granule;
3. the granule that step 1 and step 2 is made mixes by a certain percentage, processes the glucosamine and the chondroitin sulfate high concentration compressibility hybrid particles that meet formula proportion;
4. in step 3 gained hybrid particles, adding excipient, disintegrating agent, lubricant fully mixes; By tabletting behind the conventional method mensuration intermediate content; Preparation coating pre-mixing agent solution; Compound concentration is 1～25%, and EAT, sheet bed tempertaure, leaving air temp during the control coating carry out coating to prepared tablet.
Embodiment 7: the compound preparation preparation of glucosamine salt and chondroitin sulfate
Glucosamine Sulfate Potassium salt 500g
Chondroitin sulfate 750g
Collagen protein 150g
Dimethyl sulfone 150g
Microcrystalline Cellulose 120g
Carboxymethyl starch sodium 45g
Sodium carboxymethyl cellulose 1.0g
Tartaric acid 0.5g
Magnesium stearate 15g
Water is an amount of
Coating pre-mixing agent 40g
Prepare according to following step:
1. binding agent and stabilizing agent are mixed, using suitable quantity of water to be configured to concentration is 0.1～5% binder solution, fully is dissolved to clear; With raw material pulverizing, cross 60～120 mesh sieves, glucosamine is dropped in the wet granulator with an amount of chondroitin sulfate (3～10%) stirred 1～10 minute; Mixing, even, the slow solution that adds the binding agent of configuration, liquid feeding is granulated while stirring; Behind the corning, strict control EAT, drying; Cross 12～20 mesh sieves, make glucosamine (chondroitin sulfate) granule;
2. chondroitin sulfate is dropped in the dry granulation machine, regulate operating parameter, carry out dry granulation, cross 12～20 mesh sieves, make the chondroitin sulfate crude granule;
3. the granule that step 1 and step 2 is made mixes by a certain percentage, processes the glucosamine and the chondroitin sulfate high concentration compressibility hybrid particles that meet formula proportion;
4. in step 3 gained hybrid particles, adding excipient, disintegrating agent, lubricant fully mixes; By tabletting behind the conventional method mensuration intermediate content; Preparation coating pre-mixing agent solution; Compound concentration is 1～25%, and EAT, sheet bed tempertaure, leaving air temp during the control coating carry out coating to prepared tablet.
Embodiment 8: the compound preparation preparation of glucosamine salt and chondroitin sulfate
Glucosamine hydrochloride 40g
Chondroitin sulfate 750g
Collagen protein 150g
Dimethyl sulfone 150g
Microcrystalline Cellulose 120g
Carboxymethyl starch sodium 45g
Sodium carboxymethyl cellulose 0.2g
Tartaric acid 0.5g
Magnesium stearate 15g
Water is an amount of
Coating pre-mixing agent 40g
Prepare according to following step:
1. binding agent and stabilizing agent are mixed, using suitable quantity of water to be configured to concentration is 0.1～5% binder solution, fully is dissolved to clear; With raw material pulverizing, cross 60～120 mesh sieves, glucosamine is dropped in the wet granulator with an amount of chondroitin sulfate (3～10%) stirred 1～10 minute; Mixing, even, the slow solution that adds the binding agent of configuration, liquid feeding is granulated while stirring; Behind the corning, strict control EAT, drying; Cross 12～20 mesh sieves, make glucosamine (chondroitin sulfate) granule;
2. chondroitin sulfate is dropped in the dry granulation machine, regulate operating parameter, carry out dry granulation, cross 12～20 mesh sieves, make the chondroitin sulfate crude granule;
3. the granule that step 1 and step 2 is made mixes by a certain percentage, processes the glucosamine and the chondroitin sulfate high concentration compressibility hybrid particles that meet formula proportion;
4. in step 3 gained hybrid particles, adding excipient, disintegrating agent, lubricant fully mixes; By tabletting behind the conventional method mensuration intermediate content; Preparation coating pre-mixing agent solution; Compound concentration is 1～25%, and EAT, sheet bed tempertaure, leaving air temp during the control coating carry out coating to prepared tablet.
The granulation prescription of glucosamine salt, chondroitin sulfate prior art and granulation prescription of the present invention and relevant the comparison:
Prior art granulation formula examples:
Glucosamine salt (prescription 1):
Glucosamine hydrochloride 935g
Polyvinylpyrrolidone-K30 (in add) 60 g
Sodium carboxymethyl cellulose (water slurrying adds) 5g
Glucosamine salt (prescription 2):
Glucosamine hydrochloride 920g
Carboxylic propyl methocel (in add) 75 g
Sodium carboxymethyl cellulose (water slurrying adds) 5g
Glucosamine salt (prescription 3):
Glucosamine hydrochloride 910g
Ethyl cellulose (in add) 85g
Sodium carboxymethyl cellulose (water slurrying adds) 5g
Chondroitin sulfate (prescription 4):
Chondroitin sulfate 800g
Microcrystalline Cellulose 140g
Polyvinylpyrrolidone-K30 (water slurrying adds) 60g
Chondroitin sulfate (prescription 5):
Chondroitin sulfate 700g
Glucosamine hydrochloride 240g
Polyvinylpyrrolidone-K30 (water slurrying adds) 60 g
Chondroitin sulfate (prescription 6):
Chondroitin sulfate 650g
Glucosamine hydrochloride 250g
Polyvinylpyrrolidone-K30 (water slurrying adds) 100 g
The present invention's technology granulation formula examples:
Glucosamine salt (prescription 7):
Glucosamine hydrochloride 969.5g
Chondroitin sulfate (in add) 30 g
Sodium carboxymethyl cellulose (water slurrying adds) 0.5g
Glucosamine salt (prescription 8):
Glucosamine hydrochloride 939.5g
Chondroitin sulfate (in add) 60 g
Sodium carboxymethyl cellulose (water slurrying adds) 0.5g
Glucosamine salt (prescription 9):
Glucosamine hydrochloride 899.5g
Chondroitin sulfate (in add) 100 g
Sodium carboxymethyl cellulose (water slurrying adds) 0.5g
Chondroitin sulfate dry granulation (prescription 10):
Chondroitin sulfate 1000g (directly non-slurry pelletizing)
The comparative test of granule compressibility: with the granule compatibility that above-mentioned prescription makes, be made into the compressibility hybrid particles of certain active component ratio respectively, again by following prescription tabletting, to be that 12 millimeters circles are flat dash the sheet type, and the sheet weight average is 0.8 gram.
The tabletting prescription:
Hybrid particles: 986 g
Silicon dioxide: 8 g
Magnesium stearate: 6 g
Result of the test:
1, carries out compatibility with prior art gained granule (prescription 1-6); Gained granule of the present invention (prescription 7-10) carries out compatibility, and making glucosamine hydrochloride and chondroitin sulfate mass ratio is the hybrid particles of 7:3, the pressing tablet formula test; The test highest hardness, the result is following:
| The formula combination mode | Highest hardness (newton) |
| Prescription 1 and prescription 4 | 45 |
| Prescription 1 and prescription 5 | 42 |
| Prescription 1 and prescription 6 | 58 |
| Prescription 2 and prescription 4 | 62 |
| Prescription 2 and prescription 5 | 54 |
| Prescription 2 and prescription 6 | 55 |
| Prescription 3 and prescription 4 | 63 |
| Prescription 3 and prescription 5 | 59 |
| Prescription 3 and prescription 6 | 65 |
| Prescription 7 and prescription 10 | 112 |
| Prescription 8 and prescription 10 | 115 |
| Prescription 9 and prescription 10 | 110 |
2, carry out compatibility with prior art gained granule (prescription 1-6), gained granule of the present invention (prescription 7-10) carries out compatibility, and making glucosamine hydrochloride and chondroitin sulfate mass ratio is the hybrid particles of 5:5, the pressing tablet formula test, and the result is following:
| The formula combination mode | Highest hardness (newton) |
| Prescription 1 and prescription 4 | 62 |
| Prescription 1 and prescription 5 | 59 |
| Prescription 1 and prescription 6 | 78 |
| Prescription 2 and prescription 4 | 66 |
| Prescription 2 and prescription 5 | 62 |
| Prescription 2 and prescription 6 | 72 |
| Prescription 3 and prescription 4 | 68 |
| Prescription 3 and prescription 5 | 74 |
| Prescription 3 and prescription 6 | 67 |
| Prescription 7 and prescription 10 | 130 |
| Prescription 8 and prescription 10 | 142 |
| Prescription 9 and prescription 10 | 138 |
3, carry out compatibility with prior art gained granule (prescription 1-6), gained granule of the present invention (prescription 7-10) carries out compatibility, and making glucosamine hydrochloride and chondroitin sulfate mass ratio is the hybrid particles of 3:7, the pressing tablet formula test, and the result is following:
| The formula combination mode | Highest hardness (newton) |
| Prescription 1 and prescription 4 | 81 |
| Prescription 1 and prescription 5 | 79 |
| Prescription 1 and prescription 6 | 88 |
| Prescription 2 and prescription 4 | 84 |
| Prescription 2 and prescription 5 | 77 |
| Prescription 2 and prescription 6 | 85 |
| Prescription 3 and prescription 4 | 86 |
| Prescription 3 and prescription 5 | 91 |
| Prescription 3 and prescription 6 | 86 |
| Prescription 7 and prescription 10 | 151 |
| Prescription 8 and prescription 10 | 158 |
| Prescription 9 and prescription 10 | 149 |
Result: under two kinds of any proportioning situation of active component, adopt the compressibility of technology gained hybrid particles of the present invention all obviously to be superior to the hybrid particles that prior art makes.Simultaneously, gained hybrid particles activity component concentration of the present invention obviously is superior to prior art up to 99.9%.
Claims (4)
1. the compound preparation of a D-glucosamine chrondroitin is characterized in that: comprise following main component: main active component glucosamine salt and chondroitin sulfate, other active component are a kind of in dimethyl sulfone, the collagen protein or several, and adjuvant; Described glucosamine salt is glucosamine sulphate or hydrochlorate or phosphate or its mixture; Described adjuvant comprises excipient, disintegrating agent, lubricant, binding agent, wetting agent, coating pre-mixing agent; Said excipient is one or more the combination in starch, microcrystalline Cellulose, sucrose, lactose, dextrin, maltodextrin, sorbitol, the mannitol; Said disintegrating agent is one or more the combination in crospolyvinylpyrrolidone, hydroxypropyl cellulose, carboxymethyl starch sodium, the cross-linking sodium carboxymethyl cellulose; Said lubricant is one or both the combination in magnesium stearate, stearic acid, the micropowder silica gel; Said binding agent is a kind of or combination more than 2 kinds in polyvinylpyrrolidone, sodium carboxymethyl cellulose, starch, the hydroxypropyl emthylcellulose; Said wetting agent is water or methanol or ethanol, and stabilizing agent is a tartaric acid; The constituent of described coating pre-mixing agent is a kind of or mixing more than 2 kinds in titanium dioxide, polyoxyethylene, Pulvis Talci, Polyethylene Glycol, carboxylic propyl methocel, the lecithin.
2. the compound preparation of a kind of D-glucosamine chrondroitin according to claim 1 is characterized in that: the weight proportion of each main auxiliary material is following:
3. the manufacture method of the compound preparation of a kind of D-glucosamine chrondroitin according to claim 1 and 2 is characterized in that: processing according to the following steps:
(1) glucosamine and chondroitin sulfate wet granulation step:
1), the binding agent of material gross mass 0.05～0.1% and stabilizing agent are mixed, using the mixed solvent of suitable quantity of water or methanol and water to be configured to concentration is 0.1～5% binder solution, fully is dissolved to clear;
2), with raw material pulverizing, cross 60～120 mesh sieves;
3), with glucosamine and 3%～10% chondroitin sulfate, drop in the wet granulator and stirred mixing 1～10 minute;
4), evenly, slowly add the solution of the binding agent of configuration, liquid feeding is granulated while stirring, behind the corning, and strict control EAT, drying is crossed 12～20 mesh sieves, makes glucosamine sulfur acid chrondroitin granule;
(2) high-concentration sulfuric acid chrondroitin dry granulation step:
1), with chondroitin sulfate pulverizing, 60～120 mesh sieve excessively;
2), with good each parameter of dry granulation machine debugging, the granularity screen sizes is controlled to be 20 orders;
3), raw material is added the dry granulation machine, carry out dry granulation, make the chondroitin sulfate crude granule;
(3) granule that above two kinds of methods is made mixes, and directly processes the compressibility hybrid particles;
(4) in hybrid particles, adding excipient, disintegrating agent, lubricant fully mixes; By tabletting behind the conventional method mensuration intermediate content; Preparation coating pre-mixing agent solution; Compound concentration is 1～25%, and EAT, sheet bed tempertaure, leaving air temp during the control coating carry out coating to prepared tablet.
4. the manufacture method of the compound preparation of a kind of D-glucosamine chrondroitin according to claim 3 is characterized in that: the optimum synergistic quality proportioning of glucosamine salt and chondroitin sulfate is 5: 4.
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