CN102067997B - High-density calcium carbonate particles - Google Patents
High-density calcium carbonate particles Download PDFInfo
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Abstract
The invention discloses high-density calcium carbonate particles, which comprise calcium carbonate powder and a binder, wherein the binder is pregelatinized starch, and the median particle diameter of the calcium carbonate powder is 14 to 15 mu m. The provided high-density calcium carbonate particles have uniform granularity distribution, relatively concentrated granularity, and high product liquidity, and facilitate uniform tablet weight and high compressibility in the tabletting stage; meanwhile, the machine wear can be reduced and the service life can be prolonged.
Description
Technical field
The invention belongs to the inorganic chemicals industry technical field, relate to a kind of calcium carbonate granule, relate in particular to a kind of high density carbonic acid calcium particle.
Background technology
Calcium is the maximum metallic element of people's in-vivo content, and 1200 grams are arranged approximately, also is one of element of the easiest shortage.Wherein 99% be formed at bone, 1% is present in the blood soft tissue.Whether calcium deficiency is relevant with two aspect reasons for human body: the one, and the peak bone amount, namely when one's mid-30s, the calcium content when human body bone amount reaches in life high bone mass is mainly determined by inherent cause, the factor of replenishing the calcium and exercise factors; The 2nd, the calcium loss situation is determined by the replenishing of calcium, number of dropouts and habits and customs, as it is too high to have a liking for tobacco and wine, coffee, tea, cola, salt intake, eats meat less or eats the loss that too many meat all can cause calcium.
The general calcium carbonate that adopts from natural origin of edible calcium tonic comprises lime stone and oyster shell.Recommend according to Chinese Soclety of Nutrition, the magnitude of recruitment of one day calcium of adult is at 600mg.Therefore, the instructions of taking that replenishes the calcium agent is taken the calcium tablet that a slice contains 600mg calcium general every day.Even but like this, most of calcium tablets are still very big, dysphagia or make us uncomfortable.Therefore, some occur and reduced the method for tablet sizes.But the method for existing reduction tablet sizes does not also make the density of calcium carbonate granule reach satisfactory value, and the present invention is improved.
Summary of the invention
Technical problem to be solved by this invention is: a kind of high density carbonic acid calcium particle is provided, and distribution of particle sizes is even, and granularity is relatively concentrated.
For solving the problems of the technologies described above, the present invention adopts following technical scheme:
A kind of high density carbonic acid calcium particle, this calcium carbonate granule comprises calcium carbonate powder, binding agent; Described binding agent is pregelatinized starch.
As a preferred embodiment of the present invention, the median particle diameter of described calcium carbonate powder is 14-15 μ m.
As a preferred embodiment of the present invention, described calcium carbonate powder distribution of particle sizes is:
D0.5：14-15μm；
D0.1：5.2-6.5μm；
D0.9：29-30.5μm；
D[4，3]：15.5-17.2μm。
As a preferred embodiment of the present invention, described calcium carbonate powder is evenly to be mixed by a certain percentage by the winnofil PCC that fine natural magnesium calcium powder FGCC and high-purity chemical reaction method generate; Fine natural magnesium calcium powder FGCC is processed through crushing and classification by food-class high-purity natural whiting GCC; The mixed weight ratio of FGCC and PCC is X: Y, wherein, and 20＜X＜100,0＜Y＜80.
As a preferred embodiment of the present invention, in the described calcium carbonate powder, contain percetage by weight≤0.01% of manganese; The percetage by weight 0.0002% that contains arsenic salt; Mercurous percetage by weight 0.00003%; Leaded percetage by weight 0.0003% contains the percetage by weight 0.002% of heavy metal.The average grain diameter of described calcium carbonate powder is 4 μ m-30 μ m, and bulk density is 0.4g/ml-1.7g/ml.
As a preferred embodiment of the present invention, described high density carbonic acid calcium particle bulk density exists: 0.80g/ml-1.40g/ml, tight ness rating exists: 0.95g/ml-1.60g/ml.
As a preferred embodiment of the present invention, when preparing this calcium carbonate granule, earlier calcium carbonate powder is joined in the mixer-granulator; Then binding agent and water are sized mixing, temperature control is in setting value, the binding agent after sizing mixing and water sprayed in the mixer-granulator granulate.Further, described temperature control is at 65 ± 2 ℃.
As a preferred embodiment of the present invention, described calcium carbonate granule process redrying: before whole grain, carry out predrying step, then whole grain; Whole grain back is dry the processing further.
As a preferred embodiment of the present invention, the percentage by weight of calcium carbonate powder is 90%-91%, and the percentage by weight of binding agent is 9%-10%.Preferably, the percentage by weight of calcium carbonate powder is 90.98%, and the percentage by weight of binding agent is 9.02%.
Beneficial effect of the present invention is: the high density carbonic acid calcium particle that the present invention proposes, and distribution of particle sizes is even, and granularity is relatively concentrated, and product mobile fine was conducive in the compressing tablet stage, and the sheet weight average is spared, and compressibility is good.Simultaneously can reduce machine loss, increase the service life.
Description of drawings
Fig. 1 is the flow chart of high density carbonic acid calcium method for making granules.
Fig. 2 is the Ma Erwen granularity graph of the Paris white powder stock of embodiment one employing.
Fig. 3 is ordinary calcium carbonate Ma Erwen granularity graph.
The specific embodiment
Describe the preferred embodiments of the present invention in detail below in conjunction with accompanying drawing.
Embodiment one
High density carbonic acid calcium particle also can be described as Direct Compress Calcium Carbonate (vertical compression type calcium carbonate granule), is a kind of raw material of directly can compressing tablet making calcium tablet; Now products such as commercially available " calcium magnesium sheet ", " B B-complex calcium tablet ", chewable tablets all available this high density carbonic acid calcium particle as raw material.The present invention is after using calcium carbonate classified, wet granulation, whole grain, dry, sieve, mix.
The present invention discloses a kind of high density carbonic acid calcium particle, and this calcium carbonate granule comprises calcium carbonate powder, binding agent.Wherein, described binding agent is pregelatinized starch; The median particle diameter of described calcium carbonate powder is 14-15 μ m, and as a kind of preferred version, described calcium carbonate powder distribution of particle sizes is:
D0.5：14-15μm；
D0.1：5.2-6.5μm；
D0.9：29-30.5μm；
D[4，3]：15.5-17.2μm。
In the present embodiment, described calcium carbonate powder is evenly to be mixed by a certain percentage by the winnofil PCC that fine natural magnesium calcium powder FGCC and high-purity chemical reaction method generate; Fine natural magnesium calcium powder FGCC is processed through crushing and classification by food-class high-purity natural whiting GCC; The mixed weight ratio of FGCC and PCC is X: Y, wherein, and 20＜X＜100,0＜Y＜80.In the described calcium carbonate powder, contain percetage by weight≤0.01% of manganese; The percetage by weight 0.0002% that contains arsenic salt; Mercurous percetage by weight 0.00003%; Leaded percetage by weight 0.0003% contains the percetage by weight 0.002% of heavy metal.The average grain diameter of described calcium carbonate powder is 4 μ m-30 μ m, and bulk density is 0.4g/ml-1.7g/ml.
See also Fig. 1, the present invention has disclosed a kind of manufacture method of high density carbonic acid calcium particle, and this method comprises the steps:
[steps A] chooses the calcium carbonate powder granularity, and calcium carbonate powder is joined in the mixer-granulator.
In the present embodiment, the raw material of calcium carbonate powder is high purity medical calcium carbonate, and this calcium carbonate is based on natural whiting, has the calcium carbonate content height, that impurity is few, poisonous and harmful element is low is special, is beneficial to absorption by human body, reduces the damage to human body.This raw material meets YBH0581 (2004) standard (as shown in table 1) that obtains the approval of national Bureau of Drugs Supervision.
Table 1
Make high density carbonic acid calcium particle, the size distribution of high purity medical calcium carbonate is very important.Find through test of many times: to calcium carbonate scope as shown in Figure 2 just very suitable the present invention as the calcium raw material; The Ma Erwen particle size distribution figure of above-mentioned raw materials is seen Fig. 2, and ordinary calcium carbonate Ma Erwen granularity graph is seen Fig. 3.
As can be seen from Figure 2, the size distribution of the employed purity calcium carbonate raw material of this patent is different with other common products, and granularity concentrates on about 14.51 microns mostly, and the span scope of particle diameter is little, and concrete data see Table 2:
| Project | Numerical value (micron) |
| d 05 | 14-15 |
| d 0.1 | 5.2-6.5 |
| d 0.9 | 29-30.5 |
| D[4，3] | 15.5-17.2 |
Table 2
[step B] sizes mixing binding agent and water, and temperature control sprays into the binding agent after sizing mixing and water in the mixer-granulator and to granulate under setting value.In the present embodiment, binding agent is pregelatinized starch.The percentage by weight of calcium carbonate powder is 90%-91%, and the percentage by weight of binding agent is 9%-10%.Preferably, the percentage by weight of calcium carbonate powder is 90.98%, and the percentage by weight of binding agent is 9.02%.
The general conventional binding agent that uses has CMC, PVPk30, maltodextrin, and the effect of these binding agents is pretty good, but expense is very expensive.The price of PVPK30 is 280 yuan/kg, and the price of CMC is 50 yuan/kg, and the price of maltodextrin is 25 yuan/kg.And the present invention uses pregelatinized starch as binding agent, and the price of pregelatinized starch has only 8 yuan/kg well below the above two.And the granular mass of pregelatinized starch manufacturing is higher than the product that the above two binding agents are made, and therefore can reduce cost greatly.
Existing method of granulating is that one-step method is granulated, and is a kind of wet granulation.So-called one-step method directly adds calcium carbonate and binding agent in the granulator earlier exactly, after water filling is granulated again, and drying, screening, mixed processes.
And the present invention joins calcium carbonate in the mixer-granulator earlier; binding agent and water are sized mixing back control under uniform temperature; spray in the mixer-granulator and granulate, the uniform particles of working it out like this is good, and quality is better than the particle of external one-step method granulation gained greatly.
[step C] carries out predrying step before whole grain, then whole grain.
The conventional drying operation of wet granulation adopts a step dry.Find through test of many times, will be far superior to the one-step method drying through the dried granular mass of two step method.Product of the present invention improves the uniformity of particle earlier by the whole grain in predrying back, reduces fine powder, good fluidity.And during external one-step method granulates, use also be a step seasoning, on the uniformity of particle, flowability far away not as good as the calcium carbonate granule that utilizes manufacture method of the present invention to produce.
[step D] carries out drying to the particle after handling through step C and handles;
[step e] is divided into particle the particle section that varies in size by screening;
[step F] blend step.
The present invention compares with other like products, and following advantage is arranged:
High density carbonic acid calcium particle of the present invention is as the primary raw material of calcium tablet, and its superiority not only is embodied on its chemistry and the physical index, makes the advantage behind the calcium tablet in addition: the density that 1) improves tablet; 2) improve production output; 3) reduce machine loss, increase the service life.
The present invention is with regard to particle, and its distribution of particle sizes is even, and granularity is relatively concentrated, and the mobile fine of product was beneficial to like this in the compressing tablet stage, and the sheet weight average is even, and compressibility is good.
1, formulation selection
The prescription of high density carbonic acid calcium particle of the present invention, through test of many times, test sees Table 3.
| The auxiliary material percentage by weight | 5％ | 9.08％ | 12％ |
| 20 screen residues (%) | 6.5 | 3.5 | 0 |
| 200 screen residues (%) | 75 | 90 | 100％ |
| Conclusion | Fine powder is too much | Moderate | Thick partially and particle is harder |
Table 3
According to the sample that above-mentioned 3 proportionings are produced, carry out the compressing tablet test, find:
1) particle of auxiliary material percentage by weight 5%, because fine powder is too many, slice, thin piece becomes type hardness tester undesirable ,≤200kn during compressing tablet.
2) the auxiliary material percentage by weight 9.08%, uniform granularity, and the slice, thin piece moulding, hardness is about 250kn, and slice, thin piece fineness is good; Compressing tablet pressure is little, about the about 3kn of pressure, reduces the drift wearing and tearing.
3) the auxiliary material percentage by weight 12%, and particle increases because of the binding agent adding proportion, and particle is harder.In the whole grain stage, particle is really up to the mark, and when compressing tablet, compressing tablet pressure is substantially at 6-7kn, the drift serious wear.
According to above-mentioned experiment, select weight of calcium carbonate percentage 90.98%, the proportioning superiority of auxiliary material (pregelatinized starch) percentage by weight 9.08% is obvious.
2, mobile contrast
The flowability of high density carbonic acid calcium particle of the present invention is better than general particle, and the result who tests comparison with other particles is as follows.
Test specific as follows:
1) testing equipment: Powerer Flowability Index Test Instrument (powder flowbility index test instrument)
2) subjects: product of the present invention, conventional granulates
3) test procedure:
A, a certain amount of particle of first weighing.
B, with product of the present invention and conventional granulates successively by the aperture, see flowability.
C, particle pass through fully, see the aperture of screen cloth.
According to this test procedure, test data such as table 4:
| Product | Conventional granulates | Product of the present invention |
| Mobile | 6mm | 4mm |
Table 4
The liquidity scale comes the mobile quality of constant product with the size in aperture.The aperture is more little, and flowability is more good; Otherwise flowability is then more poor.
3, volume contrast
The scope of the degree of tightness density control of high density carbonic acid calcium particle of the present invention is very tight:
Bulk density exists: 0.80g/ml-1.40g/ml, tight ness rating exists: 0.95g/ml-1.60g/ml.Such standard is very crucial for later stage result of use of the present invention.
Utilize the calcium tablet of high density carbonic acid calcium particle of the present invention compacting, compare with like product on the market, and with " calcium carbonate D
3Sheet " under the identical situation of prescription in the average sheet about 1.8g, volume is 0.9ml, density is 2g/ml.Its compression performance is good, and " calcium carbonate D3 sheet ", volume reduces 15%; " calcium carbonate chewable tablets ", volume reduces 30%; Concrete data see Table 5.
Wherein, the calcium content of high density calcium tablet of the present invention and " calcium carbonate D
3Sheet " identical, be the 600mg/ sheet, and the calcium content of " calcium carbonate chewable tablets " is the 500mg/ sheet.
| Title | Calcium carbonate D 3Sheet | The calcium carbonate chewable tablets | The present invention |
| The heavy g of sheet | 1.8 | 2.5 | 1.8 |
| Volume ml | 1 | 1.5 | 0.9 |
| Density g/ml | 1.8 | 1.67 | 2 |
| Calcium content mg/ sheet | 600 | 500 | 600 |
Table 5
4, disintegration relatively
For tablet, disintegration is a very important index.Because tablet reaches stomach, need complete disintegration of short time, so disintegration is self-evident for the importance of tablet.
High density carbonic acid calcium particle basis of the present invention and " calcium carbonate D
3Sheet " tablet that makes of same recipe compressing tablet, carry out test disintegration time limited relatively.
Test specific as follows:
1) testing equipment: LB-2D intelligence instrument disintegration time limited (Shanghai Huanghai Sea medicine inspection Instr Ltd.)
2) subjects: product of the present invention, " calcium carbonate D
3Sheet "
3) test procedure:
A, elder generation carry out preheating with instrument, 37 ℃ ± 1 ℃ of water temperature control.
B, with 6 of products of the present invention and " calcium carbonate D
3Sheet " 6 slices, drop into respectively in 2 hanging baskets.
C, press start key, hanging basket moves up and down, and tablet is in disintegration slowly.
After D, 6 tablets of tablets dissolve all fully, writing time.
According to this test procedure, test data is as shown in table 6:
| Product | Calcium carbonate D 3Sheet | Product of the present invention |
| Disintegration time | 3″ | 2″30′ |
Table 6
5, machine loss reduces
The hardness of tablet also is the index of an outbalance.If tablet hardness is not enough, is easy to fracture, and influences attractive in appearance.And on the technology of producing, reaching satisfied hardness as how less compressing tablet pressure is a technical barrier.
For sheeting equipment, used pressure is more little, and is just more little for the loss of equipment, can prolong the service time of equipment like this.
High density carbonic acid calcium particle of the present invention has just in time solved this difficult problem.Because uniform particles, compressibility is good, reaching under the identical hardness, can reduce compressing tablet pressure.
The common calcium carbonate granule of general use carries out compressing tablet, and compressing tablet pressure is in 5-6kn, and the hardness of tablet can reach 200kn; And high-compressibility calcium carbonate granule of the present invention, compressing tablet pressure is about 3kn, and the hardness of tablet can reach 250kn.Pressure has nearly descended 50%.When producing like this, can reduce the damage of mechanical wear and drift, prolong service life of equipment.Directly have influence on the sunk cost of product the service life of drift, and pressure is more little during compressing tablet, and the drift wearing and tearing are more few, and service life is more long, and sunk cost is more low.
In sum, utilize the high density carbonic acid calcium particle of the manufacture method manufacturing that the present invention proposes, its distribution of particle sizes is even, and granularity is relatively concentrated, and product mobile fine was conducive in the compressing tablet stage, and the sheet weight average is even, and compressibility is good; Simultaneously can reduce machine loss, increase the service life.
Here description of the invention and application is illustrative, is not to want with scope restriction of the present invention in the above-described embodiments.Here the distortion of disclosed embodiment and change is possible, and the various parts of the replacement of embodiment and equivalence are known for those those of ordinary skill in the art.Those skilled in the art are noted that under the situation that does not break away from spirit of the present invention or substantive characteristics, and the present invention can be with other form, structure, layout, ratio, and realize with other assembly, material and parts.Under the situation that does not break away from the scope of the invention and spirit, can carry out other distortion and change to disclosed embodiment here.
Claims (5)
1. a high density carbonic acid calcium particle is characterized in that this calcium carbonate granule comprises calcium carbonate powder, binding agent; Described binding agent is pregelatinized starch;
Described calcium carbonate powder is evenly to be mixed by a certain percentage by the winnofil PCC that fine natural magnesium calcium powder FGCC and high-purity chemical reaction method generate;
Fine natural magnesium calcium powder FGCC is processed through crushing and classification by food-class high-purity natural whiting GCC;
The mixed weight ratio of FGCC and PCC is X: Y, wherein, and 20＜X＜100,0＜Y＜80;
The percentage by weight of described calcium carbonate powder is 90%-91%, and the percentage by weight of described binding agent is 9%-10%;
The median particle diameter of described calcium carbonate powder is 14-15 μ m;
Described calcium carbonate powder distribution of particle sizes is:
D0.5：14-15μm；
D0.1：5.2-6.5μm；
D0.9：29-30.5μm；
D[4,3]：15.5-17.2μm；
Described high density carbonic acid calcium particle bulk density exists: 0.80g/ml-1.40g/ml, tight ness rating exists: 0.95g/ml-1.60g/ml.
2. high density carbonic acid calcium particle according to claim 1 is characterized in that:
In the described calcium carbonate powder, contain Chong amount Bai Fen Shuo ≦ 0.01% of manganese; Chong amount Bai Fen Shuo ≦ 0.0002% that contains arsenic salt; Mercurous Chong amount Bai Fen Shuo ≦ 0.00003%; Leaded percetage by weight 0.0003% contains the percetage by weight 0.002% of heavy metal; The average grain diameter of described calcium carbonate powder is 4-30 μ m, and bulk density is 0.4-1.7g/ml.
3. high density carbonic acid calcium particle according to claim 1 is characterized in that:
When preparing this calcium carbonate granule, earlier calcium carbonate powder is joined in the mixer-granulator; Then binding agent and water are sized mixing, temperature is controlled at 65 ± 2 ℃, the binding agent after sizing mixing and water is sprayed in the mixer-granulator granulate.
4. high density carbonic acid calcium particle according to claim 1 is characterized in that:
Described calcium carbonate granule process redrying: before whole grain, carry out predrying step, then whole grain; Whole grain back is dry the processing further.
5. high density carbonic acid calcium particle according to claim 1 is characterized in that:
The percentage by weight of calcium carbonate powder is 90.98%, and the percentage by weight of binding agent is 9.02%.
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| CN104622893A (en) * | 2013-11-13 | 2015-05-20 | 上海诺成药业股份有限公司 | Suspension containing calcium carbonate and preparation method as well as usage thereof |
| CN106389344A (en) * | 2016-10-18 | 2017-02-15 | 广州中大南沙科技创新产业园有限公司 | Calcium carbonate particles and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1183902C (en) * | 1998-11-13 | 2005-01-12 | 尼康姆德法尔马公司 | Process for preparing oral calcium compositions |
| CN1587056A (en) * | 2004-07-09 | 2005-03-02 | 胡志彤 | High purity medicinal calcium carboante and its producing method |
| CN100543427C (en) * | 2003-07-31 | 2009-09-23 | 德拉沃有限责任公司 | Calcium carbonate granule |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1183902C (en) * | 1998-11-13 | 2005-01-12 | 尼康姆德法尔马公司 | Process for preparing oral calcium compositions |
| CN100543427C (en) * | 2003-07-31 | 2009-09-23 | 德拉沃有限责任公司 | Calcium carbonate granule |
| CN1587056A (en) * | 2004-07-09 | 2005-03-02 | 胡志彤 | High purity medicinal calcium carboante and its producing method |
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