CN102697802A - Composite calcium preparation and preparation method thereof - Google Patents
Composite calcium preparation and preparation method thereof Download PDFInfo
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- CN102697802A CN102697802A CN2012102199449A CN201210219944A CN102697802A CN 102697802 A CN102697802 A CN 102697802A CN 2012102199449 A CN2012102199449 A CN 2012102199449A CN 201210219944 A CN201210219944 A CN 201210219944A CN 102697802 A CN102697802 A CN 102697802A
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Abstract
A composite calcium preparation in dosage form of soft capsule comprises (by weight) 51-70 parts of calcium carbonate, 1-10 parts of calcium citrate and 0.0001-0.5 parts of calcium absorption promoter as materials; and 1-5 parts of beeswax and 20-40 parts of vegetable oil as adjuvants. Another composite calcium preparation in dosage form of chewing tablet comprises (by weight) 15-35 parts of calcium carbonate, 3-15 parts of calcium citrate and 20-55 parts of calcium absorption promoter as materials; and 10-40 parts of mannitol, 2-10 parts of milk powder, 0.05-10 parts of hydroxypropyl methylcellulose, 0.01-0.05 parts of trichlorosucrose, 0.01-0.8 parts of malic acid, 0.1-2 parts of silicon dioxide and 0.1-2 parts of magnesium stearate as adjuvants. The composite calcium preparation reduces side effect risk of single calcium source, and improves calcium absorption rate.
Description
Technical field
The present invention relates to a kind of calcium replenishing and use calcium preparation, be meant that especially a kind of calcium that utilizes the Different Calcium Sources cooperation to reach collaborative calcium supplementing effect and effect adds calcium preparation and preparation method thereof.
Background technology
Calcium Ca is a human body the abundantest necessary mineral element, accounts for the 1.5-2.0% of human body body weight, in human body, is bearing important physiological function.Calcium is the key component that constitutes skeleton and tooth, rises and supports and protective effect.The enzyme that many participation cellular metabolisms and macromole synthesize and change all receives the adjusting of calcium ion like adenyl cyclase, guanylate cyclase, phosphodiesterase etc.; Calcium plays charge carrier: its optimum level radius can combine with the inferior position of the various aniones of surface of cell membrane, regulates receptors bind and ion permeability, plays the charge carrier effect; Calcium is participated in nervimuscular activity.The solidifying of the conduction of the release of neurotransmitter, nervimuscular excitement, neural impulse, the secretion of hormone, blood, cell adhesion, muscle contraction etc. all need calcium.
In China, calcium deficiency is more common nutritional disease.Mainly show as the pathological changes of skeleton.The Childhood growth promoter is vigorous, and is more to calcium requirement, as taking the photograph hypocalcia for a long time, and often follows protein and vitamin deficiency, can cause growth retardation, new abnormal bone structure, and bone calcification is bad, and rickets takes place in textured bone.The people was mainly the growth stage of bone in the past at 20 years old, thereafter 10 surplus year sclerotin still continue to increase, about about 35-40 year, the sclerotin in the unit volume reaches the peak, is called peak bone density.After this sclerotin is lost gradually.After the postmenopausal women, because estrogen secretion reduces, bone loss speeds up, and when bone density is reduced to a certain degree, just can not guarantee the complete of skeletal structure, even compression, and under very little external force, can fracture, and is osteoporosis.The bone loss that continues, inevitable development is an osteoporosis, remedial measure also is only limited to slows down bone loss, and can not reach the recovery of sclerotin.Therefore, basic problem is prevention, will note especially the women before and after adolescence to 40 year old is promptly formed the women of bone density peak period, take in enough calcium.
According to the development of calcium preparation, generally calcium preparation is divided into three types or three generations, the first kind is the inorganic calcium preparation; Second type is the organic calcium preparation; The 3rd type is the new calcium preparation.When estimating the effect of multi-form calcium preparation, also to pay special attention to its effect price ratio.Take the photograph the people according to each normal man's calcium every day as a result of l992 national nutrition survey and measure about 400 milligrams, as replenishing 400 milligrams of calculating, best with the effect price ratio of Maalox Antacid by reaching RDA.Calcium carbonate is still the best source of replenishing the calcium at present.
At present; Not enough point below the calcium preparation product mainly exists on the market: the first, less consideration Different Calcium Sources cooperates and reaches better collaborative effect of supplemented calcium; For example calcium carbonate is for the achlorhydria person; The problem that existence is big to GI irritation, the too much absorption of calcium citrate possibly cause small intestinal aluminum to absorb to be increased; The second, the replenish the calcium calcium absorption of product is poor, influences effect of supplemented calcium; Three, replenish the calcium the not good problem of mouthfeel of product, special youngsters and children is difficult to accept.
Summary of the invention
The purpose of this invention is to provide a kind of calcium and add calcium preparation and preparation method thereof; The present invention can reduce the side effect risk that folk prescription calcium source causes; And utilize the Different Calcium Sources cooperation to reach collaborative effect of replenishing the calcium, mainly be presented as and improve calcium absorptivity and improve the relatively poor situation of calcium class preparation ubiquity mouthfeel.
In order to achieve the above object, the technical scheme that the present invention adopts is, a kind of calcium adds calcium preparation, and the batching that described calcium adds calcium preparation does,
Calcium carbonate, calcium citrate, short calcium enhancer and adjuvant, short calcium enhancer is the combination of phosphopeptide caseinate and vitamin D;
Described adjuvant is Cera Flava, vegetable oil;
The mass fraction of said each component of preparation does,
Calcium carbonate: 51-70 part;
Calcium citrate: 1-10 part;
Phosphopeptide caseinate: 0.05-0.5 part;
Vitamin D: 0.0001-0.0002 part;
Cera Flava: 1-5 part;
Vegetable oil: 20-40 part.
Further, described vegetable oil is any one or two or more the mixing in soybean oil, Semen Maydis oil, Oleum Helianthi, olive oil, camellia seed oil, Semen Lini oil, Semen Cucurbitae oil, Oleum Arachidis hypogaeae semen or the Testa oryzae oil.
Further, it is the soft capsule prepn content that described calcium adds calcium preparation, and the batching of said capsule rubber does,
Gelatin, plasticizer, purified water and titanium dioxide;
The mass fraction of said each component does,
Gelatin: 15-30 part;
Plasticizer: 4-20 part;
Purified water: 10-30 part;
Titanium dioxide: 0.1-5 part;
Described plasticizer is the mixing of any one or two kinds in glycerol, the sorbitol.
A kind of described calcium adds the method for preparing of calcium preparation, and its step is following:
Step 1, glue: get the titanium dioxide of formula ratio and the plasticizer of equivalent earlier and mix, stir, cross colloid mill and grind, get titanium dioxide suspension; Take by weighing plasticizer, purified water and gelatin, be heated to 65-85 ℃, stirring is dissolved gelatin entirely, stirs, and being evacuated to glue does not have bubble, adds titanium dioxide suspension, stirs, and then glue is placed 55-75 ℃ of glue bucket insulation, stand for standby use;
Step 2, take a morsel vegetable oil and vitamin D is heated to 70 ℃ of dissolvings and processes vitamin D solution earlier; To remain vegetable oil and formula ratio Cera Flava is heated to 70-75 ℃ and dissolves after-filtration fully in mixer to Cera Flava; It is even to add phosphopeptide caseinate, calcium citrate, calcium carbonate and vitamin D solution stirring, gets soft capsule content;
Step 3, pelleting: the glue box with the soft capsule pellet press is incubated 60-75 ℃ earlier; The glue that then step 1 is made is delivered in the glue box through flexible pipe; In hopper, add the content that step 2 has prepared simultaneously; Operation soft capsule equipment, adjustment rubber thickness are that the loading amount of 0.5-1.0 millimeter, content is that 0.5-2.5g/ grain and sprinkler body temperature are 35-55 ℃, through encapsulating machine content and capsule shell are pressed into soft capsule;
Step 4, drying: the soft capsule that suppresses changes in the tray after the rotating cage typing, is dried to capsule shell moisture≤10%, receives ball and promptly obtains soft capsule prepn.
A kind of calcium adds calcium preparation, and the batching that described calcium adds calcium preparation does,
Calcium carbonate, calcium citrate, short calcium enhancer and adjuvant,
Described adjuvant is mannitol, milk powder, hydroxypropyl emthylcellulose, sucralose, malic acid, silicon dioxide and magnesium stearate, and the mass fraction of said each component does,
Calcium carbonate: 15-35 part;
Calcium citrate: 3-15 part;
Short calcium enhancer: 20-55 part;
Mannitol: 10-40 part;
Milk powder: 2-10 part;
Hydroxypropyl emthylcellulose: 0.05-10 part;
Sucralose: 0.01-0.05 part;
Malic acid: 0.01-0.8 part;
Silicon dioxide: 0.1-2 part;
Magnesium stearate: 0.1-2 part;
Described short calcium enhancer is any one or two or more mixing such as lactose, phosphopeptide caseinate, collagen protein and dietary cellulose class.
Further, to add calcium preparation be the masticatory pattern tablet formulation to described calcium.
A kind of described calcium adds the method for preparing of calcium preparation, and its step is following:
The weighing of sieving of step 1, raw material and adjuvant: calcium citrate, calcium carbonate, silicon dioxide, short calcium enhancer, mannitol, milk powder, sucralose, malic acid are crossed weighing behind the 20-80 mesh sieve respectively, and be subsequent use;
Step 2, granulation: take by weighing the hypromellose powder of ormal weight, add 1/3 hot purified water, temperature is 80-100 ℃, after dispersed with stirring is even; Add the surplus purified water again, be stirred to clear solution, get the hypromellose solution of 2-10%, subsequent use; Calcium carbonate, calcium citrate, short calcium enhancer, the mannitol of getting ormal weight add granulator and mix, and add binding agent hypromellose solution, stir and granulate;
Step 3, drying: the wet granular that makes is transferred in the drying machine, be dried to moisture≤3%;
Step 4, granulate: dried granule is used the pelletizing machine granulate;
Step 5, mix: after sucralose, malic acid, silicon dioxide, the milk powder of getting formula ratio mixed, granule mixed in mixer behind granulate, adds magnesium stearate again and mixes, and promptly get always mixed material;
Step 6, tabletting: will always mix material and put in the hopper of tablet machine, the start pressure testing regulates loading, pressure, and sheet weight, hardness, friability are met the requirements; Pressure limit is adjusted to 25-40KN, and the Hardness Control scope is at 60-120N; Friability＜1%, every heavy 0.5-2.5g, regulating the speed of production scope is 108-160KT/h, the formal tabletting of starting shooting; The plain sheet that extrudes is put in the bucket that is lined with clean turnover bag, and tying is subsequent use, promptly gets calcium and adds calcium masticatory pattern tablet formulation.
Compared with prior art, the invention has the beneficial effects as follows:
The first, calcium carbonate and the calcium citrate collocation advantage of replenishing the calcium: adopt calcium citrate and calcium carbonate to mutually combine and replenish the calcium, calcium citrate remedies calcium carbonate for the achlorhydria person, has the problem big to GI irritation; Calcium carbonate remedies the calcium citrate Excessive Intake and possibly cause small intestinal aluminum to absorb the increase problem;
The second, lactose, calcium citrate and calcium carbonate are united the advantage of collocation: the chewable tablet prescription adds material component such as the lactose that promotes calcium absorption especially, through the dissolving of promotion calcium salt, thus the absorption of increase calcium;
Three, casein phosphoric acid, vitamin D, calcium citrate and calcium carbonate are united the advantage of collocation: add phosphopeptide caseinate (CPP) and be with the bovine casein be raw material through enzyme hydrolysis, separate, purification makes contains phosphoric acid seryl natural physiological active peptide; Be neutral in the alkalescence animal intestinal at pH; Phosphopeptide caseinate can stop the generation of calcium phosphate precipitation, makes dissolving calcium remain on high level; Add the vitamin D3 prevention of osteoporosis, unite phosphopeptide caseinate simultaneously and can significantly promote the absorption of human gastrointestinal tract, thereby the absorption and the utilization of promotion calcium reach better synergism edible calcium;
Four, soft capsule dosage form has quantitatively accurately, and smooth surface is easy to swallow; Chewable tablet selects for use mannitol as filler, and cooling feeling and pleasantly sweet is arranged when orally-dissolvable, and no grittiness is a correctives best in the chewable tablet, also can take into account filler simultaneously and use.
The specific embodiment
Be elaborated below in conjunction with embodiment, so that technical characterictic of the present invention and advantage are carried out more deep annotation.
Embodiment 1
A kind of calcium adds calcium preparation, and the batching that described calcium adds calcium preparation does,
Calcium carbonate, calcium citrate, short calcium enhancer and adjuvant, short calcium enhancer is the combination of phosphopeptide caseinate and vitamin D; Described adjuvant is Cera Flava, vegetable oil;
The mass fraction of said each component of preparation does,
Calcium carbonate: 51 parts;
Calcium citrate: 1 part;
Phosphopeptide caseinate: 0.05 part;
Vitamin D: 0.0001 part;
Cera Flava: 1 part;
Vegetable oil: 20 parts.
Further, described vegetable oil is any one or two or more the mixing in soybean oil, Semen Maydis oil, Oleum Helianthi, olive oil, camellia seed oil, Semen Lini oil, Semen Cucurbitae oil, Oleum Arachidis hypogaeae semen or the Testa oryzae oil.
Further, it is the soft capsule prepn content that described calcium adds calcium preparation, and the batching of said capsule rubber does,
Gelatin, plasticizer, purified water and titanium dioxide;
The mass fraction of said each component does,
Gelatin: 15 parts;
Plasticizer: 4 parts;
Purified water: 10 parts;
Titanium dioxide: 0.1 part;
Described plasticizer is the mixing of any one or two kinds in glycerol, the sorbitol.
A kind of described calcium adds the method for preparing of calcium preparation, and its step is following:
Step 1, glue: get the titanium dioxide of formula ratio and the plasticizer of equivalent earlier and mix, stir, cross colloid mill and grind, get titanium dioxide suspension; Take by weighing plasticizer, purified water and gelatin, be heated to 65-85 ℃, stirring is dissolved gelatin entirely, stirs, and being evacuated to glue does not have bubble, adds titanium dioxide suspension, stirs, and then glue is placed 55-75 ℃ of glue bucket insulation, stand for standby use;
Step 2, take a morsel vegetable oil and vitamin D is heated to 70 ℃ of dissolvings and processes vitamin D solution earlier; To remain vegetable oil and formula ratio Cera Flava is heated to 70-75 ℃ and dissolves after-filtration fully in mixer to Cera Flava; It is even to add phosphopeptide caseinate, calcium citrate, calcium carbonate and vitamin D solution stirring, gets soft capsule content;
Step 3, pelleting: the glue box with the soft capsule pellet press is incubated 60-75 ℃ earlier; The glue that then step 1 is made is delivered in the glue box through flexible pipe; In hopper, add the content that step 2 has prepared simultaneously; Operation soft capsule equipment, adjustment rubber thickness are that the loading amount of 0.5-1.0 millimeter, content is that 0.5-2.5g/ grain and sprinkler body temperature are 35-55 ℃, through encapsulating machine content and capsule shell are pressed into soft capsule;
Step 4, drying: the soft capsule that suppresses changes in the tray after the rotating cage typing, is dried to capsule shell moisture≤10%, receives ball and promptly obtains soft capsule prepn.
A kind of calcium adds calcium preparation, and the batching that described calcium adds calcium preparation does,
Calcium carbonate, calcium citrate, short calcium enhancer and adjuvant,
Described adjuvant is mannitol, milk powder, hydroxypropyl emthylcellulose, sucralose, malic acid, silicon dioxide and magnesium stearate, and short calcium enhancer is a phosphopeptide caseinate, and the mass fraction of said each component does,
Calcium carbonate: 15 parts;
Calcium citrate: 3 parts;
Phosphopeptide caseinate: 20 parts;
Mannitol: 10 parts;
Milk powder: 2 parts;
Hydroxypropyl emthylcellulose: 0.05 part;
Sucralose: 0.01 part;
Malic acid: 0.01 part;
Silicon dioxide: 0.1 part;
Magnesium stearate: 0.1 part;
Further, to add calcium preparation be the masticatory pattern tablet formulation to described calcium.
A kind of described calcium adds the method for preparing of calcium preparation, and its step is following:
The weighing of sieving of step 1, raw material and adjuvant: calcium citrate, calcium carbonate, silicon dioxide, phosphopeptide caseinate, mannitol, milk powder, sucralose, malic acid are crossed weighing behind the 20-80 mesh sieve respectively, and be subsequent use;
Step 2, granulation: take by weighing the hypromellose powder of ormal weight, add 1/3 hot purified water, temperature is 80-100 ℃, after dispersed with stirring is even; Add the surplus purified water again, be stirred to clear solution, get the hypromellose solution of 2-10%, subsequent use; Calcium carbonate, calcium citrate, phosphopeptide caseinate, the mannitol of getting ormal weight add granulator and mix, and add binding agent hypromellose solution, stir and granulate;
Step 3, drying: the wet granular that makes is transferred in the drying machine, be dried to moisture≤3%;
Step 4, granulate: dried granule is used the pelletizing machine granulate;
Step 5, mix: after sucralose, malic acid, silicon dioxide, the milk powder of getting formula ratio mixed, granule mixed in mixer behind granulate, adds magnesium stearate again and mixes, and promptly get always mixed material;
Step 6, tabletting: will always mix material and put in the hopper of tablet machine, the start pressure testing regulates loading, pressure, and sheet weight, hardness, friability are met the requirements; Pressure is adjusted to 25-40KN, and hardness is at 60-120N; Friability＜1%, every heavy 0.5-2.5g, the adjusting speed of production is 108-160KT/h, the formal tabletting of starting shooting; The plain sheet that extrudes is put in the bucket that is lined with clean turnover bag, and tying is subsequent use, promptly gets calcium and adds calcium masticatory pattern tablet formulation.
Embodiment 2
A kind of calcium adds calcium preparation, and the batching that described calcium adds calcium preparation does,
Calcium carbonate, calcium citrate, short calcium enhancer and adjuvant, short calcium enhancer is the combination of phosphopeptide caseinate and vitamin D;
Described adjuvant is Cera Flava, vegetable oil;
The mass fraction of said each component of preparation does,
Calcium carbonate: 60 parts;
Calcium citrate: 5 parts;
Phosphopeptide caseinate: 0.25 part;
Vitamin D: 0.00015 part;
Cera Flava: 3 parts;
Vegetable oil: 30 parts.
Further, described vegetable oil is any one or two or more the mixing in soybean oil, Semen Maydis oil, Oleum Helianthi, olive oil, camellia seed oil, Semen Lini oil, Semen Cucurbitae oil, Oleum Arachidis hypogaeae semen or the Testa oryzae oil.
Further, it is the soft capsule prepn content that described calcium adds calcium preparation, and the batching of said capsule rubber does,
Gelatin, plasticizer, purified water and titanium dioxide;
The mass fraction of said each component does,
Gelatin: 22.5 parts;
Plasticizer: 12 parts;
Purified water: 20 parts;
Titanium dioxide: 3 parts;
Described plasticizer is the mixing of any one or two kinds in glycerol, the sorbitol.
A kind of described calcium adds the method for preparing of calcium preparation, and its step is following:
Step 1, glue: get the titanium dioxide of formula ratio and the plasticizer of equivalent earlier and mix, stir, cross colloid mill and grind, get titanium dioxide suspension; Take by weighing plasticizer, purified water and gelatin, be heated to 65-85 ℃, stirring is dissolved gelatin entirely, stirs, and being evacuated to glue does not have bubble, adds titanium dioxide suspension, stirs, and then glue is placed 55-75 ℃ of glue bucket insulation, stand for standby use;
Step 2, take a morsel vegetable oil and vitamin D is heated to 70 ℃ of dissolvings and processes vitamin D solution earlier; To remain vegetable oil and formula ratio Cera Flava is heated to 70-75 ℃ and dissolves after-filtration fully in mixer to Cera Flava; It is even to add phosphopeptide caseinate, calcium citrate, calcium carbonate and vitamin D solution stirring, gets soft capsule content;
Step 3, pelleting: the glue box with the soft capsule pellet press is incubated 60-75 ℃ earlier; The glue that then step 1 is made is delivered in the glue box through flexible pipe; In hopper, add the content that step 2 has prepared simultaneously; Operation soft capsule equipment, adjustment rubber thickness are that the loading amount of 0.5-1.0 millimeter, content is that 0.5-2.5g/ grain and sprinkler body temperature are 35-55 ℃, through encapsulating machine content and capsule shell are pressed into soft capsule;
Step 4, drying: the soft capsule that suppresses changes in the tray after the rotating cage typing, is dried to capsule shell moisture≤10%, receives ball and promptly obtains soft capsule prepn.
A kind of calcium adds calcium preparation, and the batching that described calcium adds calcium preparation does,
Calcium carbonate, calcium citrate, short calcium enhancer and adjuvant,
Described adjuvant is mannitol, milk powder, hydroxypropyl emthylcellulose, sucralose, malic acid, silicon dioxide and magnesium stearate, and short calcium enhancer is a lactose and the mixing of phosphopeptide caseinate, and the mass fraction of said each component does,
Calcium carbonate: 25 parts;
Calcium citrate: 9 parts;
Lactose mixes with phosphopeptide caseinate: 37.5 parts;
Mannitol: 25 parts;
Milk powder: 6 parts;
Hydroxypropyl emthylcellulose: 5 parts;
Sucralose: 0.03 part;
Malic acid: 0.4 part;
Silicon dioxide: 1 part;
Magnesium stearate: 1 part;
Further, to add calcium preparation be the masticatory pattern tablet formulation to described calcium.
A kind of described calcium adds the method for preparing of calcium preparation, and its step is following:
The weighing of sieving of step 1, raw material and adjuvant: calcium citrate, calcium carbonate, silicon dioxide, lactose and phosphopeptide caseinate, mannitol, milk powder, sucralose, malic acid are crossed weighing behind the 20-80 mesh sieve respectively, and be subsequent use;
Step 2, granulation: take by weighing the hypromellose powder of ormal weight, add 1/3 hot purified water, temperature is 80-100 ℃, after dispersed with stirring is even; Add the surplus purified water again, be stirred to clear solution, get the hypromellose solution of 2-10%, subsequent use; Calcium carbonate, calcium citrate, lactose and phosphopeptide caseinate, the mannitol of getting ormal weight add granulator and mix, and add binding agent hypromellose solution, stir and granulate;
Step 3, drying: the wet granular that makes is transferred in the drying machine, be dried to moisture≤3%;
Step 4, granulate: dried granule is used the pelletizing machine granulate;
Step 5, mix: after sucralose, malic acid, silicon dioxide, the milk powder of getting formula ratio mixed, granule mixed in mixer behind granulate, adds magnesium stearate again and mixes, and promptly get always mixed material;
Step 6, tabletting: will always mix material and put in the hopper of tablet machine, the start pressure testing regulates loading, pressure, and sheet weight, hardness, friability are met the requirements; Pressure limit is adjusted to 25-40KN, and hardness is 60-120N; Friability＜1%, every heavy 0.5-2.5g, the adjusting speed of production is 108-160KT/h, the formal tabletting of starting shooting; The plain sheet that extrudes is put in the bucket that is lined with clean turnover bag, and tying is subsequent use, promptly gets calcium and adds calcium masticatory pattern tablet formulation.
Embodiment 3
A kind of calcium adds calcium preparation, and the batching that described calcium adds calcium preparation does,
Calcium carbonate, calcium citrate, short calcium enhancer and adjuvant, short calcium enhancer is the combination of phosphopeptide caseinate and vitamin D;
Described adjuvant is Cera Flava, vegetable oil;
The mass fraction of said each component of preparation does,
Calcium carbonate: 70 parts;
Calcium citrate: 10 parts;
Phosphopeptide caseinate: 0.5 part;
Vitamin D: 0.0002 part;
Cera Flava: 5 parts;
Vegetable oil: 40 parts.
Further, described vegetable oil is any one or two or more the mixing in soybean oil, Semen Maydis oil, Oleum Helianthi, olive oil, camellia seed oil, Semen Lini oil, Semen Cucurbitae oil, Oleum Arachidis hypogaeae semen or the Testa oryzae oil.
Further, it is the soft capsule prepn content that described calcium adds calcium preparation, and the batching of said capsule rubber does,
Gelatin, plasticizer, purified water and titanium dioxide;
The mass fraction of said each component does,
Gelatin: 30 parts;
Plasticizer: 20 parts;
Purified water: 30 parts;
Titanium dioxide: 5 parts;
Described plasticizer is the mixing of any one or two kinds in glycerol, the sorbitol.
A kind of described calcium adds the method for preparing of calcium preparation, and its step is following:
Step 1, glue: get the titanium dioxide of formula ratio and the plasticizer of equivalent earlier and mix, stir, cross colloid mill and grind, get titanium dioxide suspension; Take by weighing plasticizer, purified water and gelatin, be heated to 65-85 ℃, stirring is dissolved gelatin entirely, stirs, and being evacuated to glue does not have bubble, adds titanium dioxide suspension, stirs, and then glue is placed 55-75 ℃ of glue bucket insulation, stand for standby use;
Step 2, take a morsel vegetable oil and vitamin D is heated to 70 ℃ of dissolvings and processes vitamin D solution earlier; To remain vegetable oil and formula ratio Cera Flava is heated to 70-75 ℃ and dissolves after-filtration fully in mixer to Cera Flava; It is even to add phosphopeptide caseinate, calcium citrate, calcium carbonate and vitamin D solution stirring, gets soft capsule content;
Step 3, pelleting: the glue box with the soft capsule pellet press is incubated 60-75 ℃ earlier; The glue that then step 1 is made is delivered in the glue box through flexible pipe; In hopper, add the content that step 2 has prepared simultaneously; Operation soft capsule equipment, adjustment rubber thickness are that the loading amount of 0.5-1.0 millimeter, content is that 0.5-2.5g/ grain and sprinkler body temperature are 35-55 ℃, through encapsulating machine content and capsule shell are pressed into soft capsule;
Step 4, drying: the soft capsule that suppresses changes in the tray after the rotating cage typing, and < 10%, the receipts ball promptly obtains soft capsule prepn to be dried to capsule shell moisture.
A kind of calcium adds calcium preparation, and the batching that described calcium adds calcium preparation does,
Calcium carbonate, calcium citrate, short calcium enhancer and adjuvant,
Described adjuvant is mannitol, milk powder, hydroxypropyl emthylcellulose, sucralose, malic acid, silicon dioxide and magnesium stearate,
Short calcium enhancer is that lactose, phosphopeptide caseinate mix with collagen protein,
The mass fraction of said each component does,
Calcium carbonate: 35 parts;
Calcium citrate: 15 parts;
Lactose, phosphopeptide caseinate mix with collagen protein: 55 parts;
Mannitol: 40 parts;
Milk powder: 10 parts;
Hydroxypropyl emthylcellulose: 10 parts;
Sucralose: 0.05 part;
Malic acid: 0.8 part;
Silicon dioxide: 2 parts;
Magnesium stearate: 2 parts;
Further, to add calcium preparation be the masticatory pattern tablet formulation to described calcium.
A kind of described calcium adds the method for preparing of calcium preparation, and its step is following:
The weighing of sieving of step 1, raw material and adjuvant: calcium citrate, calcium carbonate, silicon dioxide, short calcium enhancer, mannitol, milk powder, sucralose, malic acid are crossed weighing behind the 20-80 mesh sieve respectively, and be subsequent use;
Step 2, granulation: take by weighing the hypromellose powder of ormal weight, add 1/3 hot purified water, temperature is 80-100 ℃, after dispersed with stirring is even; Add the surplus purified water again, be stirred to clear solution, get the hypromellose solution of 2-10%, subsequent use; Calcium carbonate, calcium citrate, lactose, phosphopeptide caseinate and collagen protein, the mannitol of getting ormal weight add granulator and mix, and add binding agent hypromellose solution, stir and granulate;
Step 3, drying: the wet granular that makes is transferred in the drying machine, be dried to moisture≤3%;
Step 4, granulate: dried granule is used the pelletizing machine granulate;
Step 5, mix: after sucralose, malic acid, silicon dioxide, the milk powder of getting formula ratio mixed, granule mixed in mixer behind granulate, adds magnesium stearate again and mixes, and promptly get always mixed material;
Step 6, tabletting: will always mix material and put in the hopper of tablet machine, the start pressure testing regulates loading, pressure, and sheet weight, hardness, friability are met the requirements; Pressure is adjusted to 25-40KN, and Hardness Control is at 60-120N; Friability＜1%, every heavy 0.5-2.5g, the adjusting speed of production is 108-160KT/h, the formal tabletting of starting shooting; The plain sheet that extrudes is put in the bucket that is lined with clean turnover bag, and tying is subsequent use, promptly gets calcium and adds calcium masticatory pattern tablet formulation.
Embodiment 4
A kind of calcium adds calcium preparation, and the batching that described calcium adds calcium preparation does,
Calcium carbonate, calcium citrate, short calcium enhancer and adjuvant, short calcium enhancer is the combination of phosphopeptide caseinate and vitamin D;
Described adjuvant is Cera Flava, vegetable oil;
The mass fraction of said each component does,
Calcium carbonate: 60 parts;
Calcium citrate: 4.75 parts;
Vitamin D: 0.000125 part;
Phosphopeptide caseinate: 0.3 part;
Cera Flava: 1.5 parts;
Vegetable oil: 33.45 parts;
Further, described vegetable oil is any one or two or more the mixing in soybean oil, Semen Maydis oil, Oleum Helianthi, olive oil, camellia seed oil, Semen Lini oil, Semen Cucurbitae oil, Oleum Arachidis hypogaeae semen or the Testa oryzae wet goods edible oil.
Further, it is soft capsule prepn that described calcium adds calcium preparation, and the batching of said capsule rubber does,
Gelatin, plasticizer, purified water and titanium dioxide;
The mass fraction of said each component does,
Gelatin: 17.92 parts;
Plasticizer: 7.17 parts;
Purified water: 14.34 parts;
Titanium dioxide: 0.81 part;
Described plasticizer is the mixing of any one or two kinds such as glycerol, sorbitol.
A kind of described calcium adds the method for preparing of calcium preparation, and its step is following:
Step 1, glue: get the titanium dioxide of formula ratio and the plasticizer of equivalent earlier and mix, stir, cross colloid mill and grind, get titanium dioxide suspension; Take by weighing plasticizer, purified water and gelatin, be heated to 65-85 ℃, stirring is dissolved gelatin entirely, stirs, and being evacuated to glue does not then have bubble, adds titanium dioxide suspension, and glue is placed 55-75 ℃ of glue bucket insulation, stand for standby use;
Step 2, preparation content: take a morsel vegetable oil and vitamin D are heated to 70 ℃ of dissolvings and process vitamin D solution; To remain vegetable oil and formula ratio Cera Flava is heated to 70-75 ℃ and dissolves after-filtration fully in mixer to Cera Flava; It is even to add phosphopeptide caseinate, calcium citrate, calcium carbonate and vitamin D solution stirring, gets soft capsule content;
Step 3, pelleting: the glue box with the soft capsule pellet press is incubated 60-75 ℃ earlier; The glue that then step 1 is made is delivered in the glue box through flexible pipe; In hopper, add the content that step 2 has prepared simultaneously; Operation soft capsule equipment is adjusted 35-55 ℃ of the tolerant loading amount 0.5-2.5g of rubber thickness 0.5-1.0mm, every intragranular and sprinkler body temperature according to products characteristics and needs, through encapsulating machine content and capsule shell is pressed into soft capsule;
Step 4, drying: the soft capsule that suppresses changes in the tray after the rotating cage typing, is dried to capsule shell moisture≤10%, receives ball and promptly obtains soft capsule prepn.
Further, described vegetable oil is any one or two or more the mixing in soybean oil, Semen Maydis oil, Oleum Helianthi, olive oil, camellia seed oil, Semen Lini oil, Semen Cucurbitae oil, Oleum Arachidis hypogaeae semen or the Testa oryzae wet goods edible oil.
A kind of calcium adds calcium preparation, and the batching that described calcium adds calcium preparation does,
Calcium carbonate, calcium citrate, short calcium enhancer and adjuvant,
Described adjuvant is mannitol, milk powder, hydroxypropyl emthylcellulose, sucralose, malic acid, silicon dioxide and magnesium stearate,
Short calcium enhancer is a lactose
The mass fraction of said each component does,
Calcium carbonate: 21 parts;
Calcium citrate: 7.62 parts;
Lactose: 38.45 parts;
Mannitol: 28 parts;
Milk powder: 2 parts;
Hydroxypropyl emthylcellulose: 0.5 part;
Sucralose: 0.03 part;
Malic acid: 0.04 part;
Silicon dioxide: 1 part;
Magnesium stearate: 1 part.
Described short calcium enhancer or be any one or two or more mixing such as phosphopeptide caseinate, collagen protein and dietary cellulose class; The short calcium enhancer of masticatory pattern tablet is preferably lactose.
Further, to add calcium preparation be tablet formulation to described calcium.
A kind of described calcium adds the method for preparing of calcium preparation, and its step is following:
The weighing of sieving of step 1, raw material and adjuvant: calcium citrate, calcium carbonate, silicon dioxide, lactose, mannitol, milk powder, sucralose, malic acid are crossed weighing behind the 20-80 mesh sieve respectively, and be subsequent use;
Step 2, granulation: take by weighing the hypromellose powder of ormal weight, add 1/3 hot purified water (80-100 ℃), after dispersed with stirring is even; Add the surplus purified water again, be stirred to clear solution, get the hypromellose solution of 2-10%, subsequent use; Calcium carbonate, calcium citrate, lactose, the mannitol of getting ormal weight add granulator and mix, and add binding agent hypromellose solution, stir and granulate;
Step 3, drying: the wet granular that makes is transferred in the drying machine, be dried to moisture≤3%;
Step 4, granulate: dried granule is used the pelletizing machine granulate;
Step 5, mix: after sucralose, malic acid, silicon dioxide, the milk powder of getting formula ratio mixed, granule mixed in mixer behind granulate, adds magnesium stearate again and mixes, and promptly get always mixed material;
Step 6, tabletting: will always mix material and put in the hopper of tablet machine, the start pressure testing regulates loading, pressure, and sheet weight, hardness, friability are met the requirements; Pressure limit is adjusted to 25-40KN Hardness Control scope at 60-120N; Friability＜1%, every heavy 0.5-2.5g regulate suitable speed of production, and velocity interval is 108-160KT/h, the formal tabletting of starting shooting; The plain sheet that extrudes is put in the bucket that is lined with clean turnover bag, and tying is subsequent use, promptly gets calcium and adds the calcium tablet preparation.
Experimental result of the present invention is following:
Experiment one: product of the present invention to 11-18 year teenager and the adult to the therapeutical effect of calcium deficiency:
1 object: 11-18 year teenager and adult, healthy, renal function is healthy;
2 divide into groups: 70 people altogether are divided into 7 groups, every group 10 people;
3 methods: the matched group prescription is calcic not, and other 7 groups to take 500mg calcium every day, takes 30 days, and each is organized respectively and chemically examines behind the vein haemospasia: blood calcium, blood aluminum concentration, and twenty-four-hour urine aluminum output, group does
| Group | Matched group | 1 group | 2 groups | 3 groups |
| Prescription calcium source | Calcic blank sample not | Calcium carbonate | Calcium citrate | Calcium carbonate: calcium citrate=2:1 |
| Group | 4 groups | 5 groups | 6 groups | 7 groups |
| Prescription calcium source | Calcium carbonate: calcium citrate=12:1 | Calcium carbonate: calcium citrate (12:1)+vitamin D | Calcium carbonate: calcium citrate (12:1)+vitamin D+phosphopeptide caseinate (CPP) | Calcium carbonate: calcium citrate (2:1)+lactose |
4. observation index: matched group and test crowd detect the index of blood calcium, urine aluminum output, blood aluminum concentration, before and after test, respectively detect 1 time;
5. result:
5.1 the result of blood calcium: as shown in table 1; 6 groups of preparations except that matched group with take before relatively all in various degree risings of blood calcium, the 1st group 14.4%, the 2nd group 15.1%, the 3rd group 15.1%, the 4th group 14.7%, the 5th group 16.3%, the 6th group 22.8%, the 7th group 19.9%;
Experiment shows: the 6th group of effect of supplemented calcium obviously is superior to other group, promptly adds vitamin D and CPP in the prescription, can effectively promote calcium absorption; In addition, the 7th group is added the blood calcium height of lactose than the 4th group, and the absorbance of calcium citrate and calcium carbonate collocation that hence one can see that is better than folk prescription calcium carbonate or calcium citrate, can better promote calcium absorption.
The comparison of urine aluminum output, blood aluminum concentration before and after 5.2 replenish the calcium: like table 2, before taking with after the blood aluminum concentration rising is all arranged: the 1st group 4.6%, the 2nd group 53%, the 3rd group 22.9%, the 4th group 8.3%, the 5th group 8.0%, the 6th group 7.0%, the 7th group 8.1%; Folk prescription is taken calcium citrate can obviously increase aluminum absorption in the diet; So this prescription adopts calcium carbonate and calcium citrate collocation to replenish the calcium together, can better work in coordination with effect of supplemented calcium and reduce the side effect risk that folk prescription calcium source causes.
6. conclusion:
6.1 select for use the collocation of calcium carbonate and calcium citrate to replenish the calcium, teenager and adult that needs are replenished the calcium produce effect;
6.2 shown by the result: the calcium source is selected calcium carbonate and calcium citrate collocation for use, and the calcium level that adds vitamin D, phosphopeptide caseinate is significantly higher than matched group and other group, more produces effect to replenishing the calcium;
6.3 the 7th group of blood calcium that adds lactose is obviously high than the 1st, 2,3,4,5 group, hence one can see that, and lactose has the effect that increases calcium absorption.
Table 1:
| Group | Example number (n) | Blood calcium m mol/L before replenishing the calcium | Back blood calcium m mol/L replenishes the calcium |
| Matched group | 10 | 2.101±0.10 | 2.153±0.11 |
| (1) calcium carbonate | 10 | 2.008±0.11 | 2.298±0.08 |
| (2) calcium citrate | 10 | 2.020±0.12 | 2.325±0.05 |
| (3) calcium carbonate: calcium citrate=2:1 | 10 | 2.050±0.11 | 2.360±0.06 |
| (4) calcium carbonate: calcium citrate=12:1 | 10 | 2.105±0.11 | 2.414±0.05 |
| (5) calcium carbonate: calcium citrate (12:1)+VD | 10 | 2.081±0.12 | 2.420±0.05 |
| (6) calcium carbonate: calcium citrate (12:1)+VD+CPP | 10 | 2.101±0.10 | 2.580±0.05 |
| (7) calcium carbonate: calcium citrate (2:1)+lactose | 10 | 2.102±0.11 | 2.520±0.06 |
Table 2: urine aluminum output, blood aluminum concentration before and after replenishing the calcium
Experiment two: the mouthfeel screening of tablet chewable tablet
The most exquisite mouthfeel of 1 chewable tablet, extremely important to selecting for use of adjuvant, as shown in table 3, whole milk powder has good mouthfeel and abnormal smells from the patient, can give product strong milk fragrance, and the defatted milk powder effect is then relatively poor.Mannitol has cooling feeling and pleasantly sweet when orally-dissolvable, no grittiness is a correctives best in the chewable tablet, also can take into account filler simultaneously and use.
2 place 40 ℃ of temperature with product that makes among the embodiment 1,2,3 and common sample (comparative sample), under the condition of humidity 75%, quicken to investigate 3 months and room temperature condition held 24 months, investigate content, local flavor, mouthfeel index situation of change, compare.Divide evaluation local flavor and mouthfeel with 0-10, grade＜6 explanations are unacceptable products.Analysis of experiments result sees table 1-2.
The contrast of table 3 prescription:
| The material composition title | Comparative sample 1 | Embodiment 1 | Embodiment 2 | Embodiment 3 |
| Calcium carbonate | 25% | 22.5% | 22.5% | 22.5% |
| Calcium citrate | / | 7.8% | 7.8% | 7.8% |
| Lactose | 0.2% | 53.344% | 47.67% | 36.67% |
| Vitamin D | 0.8% | / | / | / |
| Starch | 73.8% | / | / | / |
| Essence | 0.2% | / | / | / |
| Mannitol | / | 5% | 20% | 20% |
| Milk powder | / | 8% | 8% | 10% |
| Hydroxypropyl emthylcellulose | / | 1.326% | 1% | 1% |
| Sucralose | / | 0.03% | 0.03% | 0.03% |
| Malic acid | / | 0.4% | 0.4% | 0.4% |
| Silicon dioxide | / | 0.8% | 0.8% | 0.8% |
| Magnesium stearate | / | 0.8% | 0.8% | 0.8% |
Table 4 is situations of change of investigating 3 months calcium contents according to invention technical scheme sample and comparative sample 40 ℃ of acceleration;
Table 5 is embodiment 1 sample and comparative sample sensory test (comprising local flavor and chewiness) situation;
Table 4
Table 5
Contrast experiment's conclusion:
1) product of present embodiment is very small in the variation of 3 months calcium contents of process acceleration investigation, and comparative sample changes also variation not quite;
2) product of present embodiment local flavor, chewiness after storing in 24 months through room temperature divides number average that attenuating is arranged, but still at acceptability limit; Though and comparative sample changes not quite, after standing time was long, local flavor and chewiness all dropped in the undesirable scope.
Through result's contrast of above-mentioned table 2, embodiment 1 product, embodiment 2 products, embodiment 3 products are under the storage condition of long-term room temperature, and the scoring of local flavor and chewiness all has decline, but can both meet the requirements of the standard.And comparative sample is removed 0 month especially on local flavor and chewiness, and the scoring that room temperature was deposited 12 months, 24 months all is lower than qualified branch 6 minutes, promptly all can't meet the requirements.
Obviously, the above embodiment of the present invention only be for clearly the present invention is described and is done for example, and be not to be qualification to embodiment of the present invention.For the those of ordinary skill in affiliated field, on the basis of above-mentioned explanation, can also make other multi-form variation or change.Here can't give exhaustive to all embodiments.Everyly belong to the row that conspicuous variation that technical scheme of the present invention extends out or change still are in protection scope of the present invention.
Claims (7)
1. a calcium adds calcium preparation, and the batching that described calcium adds calcium preparation does,
Calcium carbonate, calcium citrate, short calcium enhancer and adjuvant, short calcium enhancer is the combination of phosphopeptide caseinate and vitamin D;
Described adjuvant is Cera Flava, vegetable oil;
The mass fraction of said each component of preparation does,
Calcium carbonate: 51-70 part;
Calcium citrate: 1-10 part;
Phosphopeptide caseinate: 0.05-0.5 part;
Vitamin D: 0.0001-0.0002 part;
Cera Flava: 1-5 part;
Vegetable oil: 20-40 part.
2. calcium according to claim 1 adds calcium preparation, it is characterized in that: described vegetable oil is any one or two or more the mixing in soybean oil, Semen Maydis oil, Oleum Helianthi, olive oil, camellia seed oil, Semen Lini oil, Semen Cucurbitae oil, Oleum Arachidis hypogaeae semen or the Testa oryzae oil.
3. calcium according to claim 2 adds calcium preparation, it is characterized in that: it is the soft capsule prepn content that described calcium adds calcium preparation, and the batching of said capsule rubber does,
Gelatin, plasticizer, purified water and titanium dioxide;
The mass fraction of said each component does,
Gelatin: 15-30 part;
Plasticizer: 4-20 part;
Purified water: 10-30 part;
Titanium dioxide: 0.1-5 part;
Described plasticizer is the mixing of any one or two kinds in glycerol, the sorbitol.
4. one kind adds the method for preparing of calcium preparation like each described calcium among the claim 1-3, and its step is following:
Step 1, glue: get the titanium dioxide of formula ratio and the plasticizer of equivalent earlier and mix, stir, cross colloid mill and grind, get titanium dioxide suspension; Take by weighing plasticizer, purified water and gelatin, be heated to 65-85 ℃, stirring is dissolved gelatin entirely, stirs, and being evacuated to glue does not have bubble, adds titanium dioxide suspension, stirs, and then glue is placed 55-75 ℃ of glue bucket insulation, stand for standby use;
Step 2, take a morsel vegetable oil and vitamin D is heated to 70 ℃ of dissolvings and processes vitamin D solution earlier; To remain vegetable oil and formula ratio Cera Flava is heated to 70-75 ℃ and dissolves after-filtration fully in mixer to Cera Flava; It is even to add phosphopeptide caseinate, calcium citrate, calcium carbonate and vitamin D solution stirring, gets soft capsule content;
Step 3, pelleting: the glue box with the soft capsule pellet press is incubated 60-75 ℃ earlier; The glue that then step 1 is made is delivered in the glue box through flexible pipe; In hopper, add the content that step 2 has prepared simultaneously; Operation soft capsule equipment, adjustment rubber thickness are that the loading amount of 0.5-1.0 millimeter, content is that 0.5-2.5g/ grain and sprinkler body temperature are 35-55 ℃, through encapsulating machine content and capsule shell are pressed into soft capsule;
Step 4, drying: the soft capsule that suppresses changes in the tray after the rotating cage typing, is dried to capsule shell moisture≤10%, receives ball and promptly obtains soft capsule prepn.
5. a calcium adds calcium preparation, and the batching that described calcium adds calcium preparation does,
Calcium carbonate, calcium citrate, short calcium enhancer and adjuvant,
Described adjuvant is mannitol, milk powder, hydroxypropyl emthylcellulose, sucralose, malic acid, silicon dioxide and magnesium stearate, and the mass fraction of said each component does,
Calcium carbonate: 15-35 part;
Calcium citrate: 3-15 part;
Short calcium enhancer: 20-55 part;
Mannitol: 10-40 part;
Milk powder: 2-10 part;
Hydroxypropyl emthylcellulose: 0.05-10 part;
Sucralose: 0.01-0.05 part;
Malic acid: 0.01-0.8 part;
Silicon dioxide: 0.1-2 part;
Magnesium stearate: 0.1-2 part;
Described short calcium enhancer is any one or two or more mixing such as lactose, phosphopeptide caseinate, collagen protein and dietary cellulose class.
6. calcium according to claim 5 adds calcium preparation, it is characterized in that: it is the masticatory pattern tablet formulation that described calcium adds calcium preparation.
7. a calcium as claimed in claim 6 adds the method for preparing of calcium preparation, and its step is following:
The weighing of sieving of step 1, raw material and adjuvant: calcium citrate, calcium carbonate, silicon dioxide, short calcium enhancer, mannitol, milk powder, sucralose, malic acid are crossed weighing behind the 20-80 mesh sieve respectively, and be subsequent use;
Step 2, granulation: take by weighing the hypromellose powder of ormal weight, add 1/3 hot purified water, temperature is 80-100 ℃, after dispersed with stirring is even; Add the surplus purified water again, be stirred to clear solution, get the hypromellose solution of 2-10%, subsequent use; Calcium carbonate, calcium citrate, short calcium enhancer, the mannitol of getting ormal weight add granulator and mix, and add binding agent hypromellose solution, stir and granulate;
Step 3, drying: the wet granular that makes is transferred in the drying machine, be dried to moisture≤3%;
Step 4, granulate: dried granule is used the pelletizing machine granulate;
Step 5, mix: after sucralose, malic acid, silicon dioxide, the milk powder of getting formula ratio mixed, granule mixed in mixer behind granulate, adds magnesium stearate again and mixes, and promptly get always mixed material;
Step 6, tabletting: will always mix material and put in the hopper of tablet machine, the start pressure testing regulates loading, pressure, and sheet weight, hardness, friability are met the requirements; Pressure limit is adjusted to 25-40KN, and the Hardness Control scope is at 60-120N; Friability＜1%, every heavy 0.5-2.5g, regulating the speed of production scope is 108-160KT/h, the formal tabletting of starting shooting; The plain sheet that extrudes is put in the bucket that is lined with clean turnover bag, and tying is subsequent use, promptly gets calcium and adds calcium masticatory pattern tablet formulation.
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Application publication date: 20121003 |