CN101390840A - Production method of high-assay calcium ascorbate granules capable of directly being compressed - Google Patents
Production method of high-assay calcium ascorbate granules capable of directly being compressed Download PDFInfo
- Publication number
- CN101390840A CN101390840A CNA2008101806293A CN200810180629A CN101390840A CN 101390840 A CN101390840 A CN 101390840A CN A2008101806293 A CNA2008101806293 A CN A2008101806293A CN 200810180629 A CN200810180629 A CN 200810180629A CN 101390840 A CN101390840 A CN 101390840A
- Authority
- CN
- China
- Prior art keywords
- calcium ascorbate
- production method
- granule
- direct compression
- load
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Abstract
The invention discloses a direct-compression production method of high content calcium ascorbate particles. The production method includes: the calcium ascorbate crystalloid raw material is crushed; powder adhesive is added and is mixed evenly with the calcium ascorbate crystalloid raw material; then the mixture is placed in a dry granulator for granules preparation; the granules are placed in a fluidized bed hopper while paste adhesive is sprayed; the granules coated with paste adhesive is dried by the continuously fed wind; direct-compression high content calcium ascorbate particles are obtained after discharging. When the method is adopted, the tablet hardness of prepared particles can reach more than 15 kg; the friability is less than 1%; the compression performance is improved; meanwhile, because the dosage of adhesive is reduced in the production method, the drying time is reduced, so as to avoid the yellow-changing phenomenon of the material; the stability is good.
Description
Technical field
The present invention relates to technical field of medicine, specifically a kind of particulate production method of high-load calcium ascorbate that can direct compression.
Background technology
In field of pharmaceutical preparations, a lot of active component are made into tablet form, but because the compressibility of a variety of active component itself or flowability, dispersibility are very poor, can not be directly used in tabletting, in order to overcome this inadaptability, give enough plasticity, comparatively common way is in advance active substance to be made the granule that is fit to tabletting.Generally speaking, comminution granulation is a technology that can increase the powder particle size, and purpose is that powder solid is converted into different sizes, different porous aggregations, and this is considered to granule.After being made into granule, make to have Practical Performance, as reducing dust, better mobile, good dispersibility, stronger mixing ability and better compressibility.The pelletize approach mainly is wet method and dry method, also has to use fusion method.
Calcium ascorbate is used in medicine, food, food additive, the feed additive widely, a kind of state that wherein is used is a lamellar, high-load calcium ascorbate granule can be added into more other active component before tabletting, and can influence to Min. size, the weight of tablet simultaneously.The ascorbic acid calcium content is from 90%～99% in the high-load calcium ascorbate granule, and wherein comparatively ideal high-load is 97%.This also means can only use 1%～10% adjuvant when making the calcium ascorbate granule.And so few adjuvant is unfavorable for making calcium ascorbate direct compression granule, can not get gratifying tabletting performance and stability.
Summary of the invention
The purpose of this invention is to provide a kind of particulate production method of high-load calcium ascorbate that can direct compression, can solve under situation only tabletting performance and the not good problem of stability behind the calcium ascorbate granule tabletting made from a small amount of adjuvant.
Technical solution of the present invention is that described production method is as follows: the calcium ascorbate crystal raw material is pulverized; add powdery adhesive; mix homogeneously; place dry granulation machine system granule; this granule is put into the fluid bed hopper again; spray into paste binder, paste binder has sprayed back continuation air intake makes drying, and discharging promptly gets the high-load calcium ascorbate granule of direct compression.
Pass through 80 mesh standard sieves after the calcium ascorbate raw material pulverizing of the present invention more than 95%.
Powdery adhesive of the present invention is polyvinylpyrrolidone, cellulose or cellulose derivative, and paste binder is 1%～10% the solution that polyvinylpyrrolidone, cellulose or cellulose derivative and water or aqueous solvent are made.
Cellulose derivative of the present invention is hydroxypropyl emthylcellulose, hydroxypropyl cellulose, natural gum.
Powdery adhesive consumption of the present invention is 1%～10% of a granule gross weight, and the described paste binder amount of giving money as a gift is 0.1%～2% of a granule gross weight.
Ascorbic acid calcium content of the present invention is 90%～99% of a granule gross weight, and water content is 0～1% of a granule gross weight.
Fluid bed inlet temperature of the present invention is at 60 ℃～100 ℃, and the material temperature is at 35 ℃～60 ℃.
The present invention combines fluidized bed prilling and non-slurry pelletizing, and the tablet hardness behind the granule direct compression of making reaches more than the 15kg, and friability has improved the tabletting performance less than 1%; Because the pulp amount of binder that the inventive method adds significantly reduces, can reduce drying time simultaneously, thereby reduce material flavescence color phenomenon, good stability.
The specific embodiment
Production method of the present invention is that the calcium ascorbate raw material is pulverized, and the raw material granularity after the pulverizing must be by 80 mesh standard sieves more than 95%, and the raw material that particle diameter is too big will be unfavorable for making the hardness of granule tabletting.Get the powdery adhesive of granule gross weight 1%～10%, powdery adhesive is polyvinylpyrrolidone, cellulose or cellulose derivative, and cellulose derivative is hydroxypropyl emthylcellulose, hydroxypropyl cellulose, natural gum.With above-mentioned calcium ascorbate place mix 5～30 minutes in the blender after; place the dry granulation machine to granulate; should control the pressure of dry granulation machine running roller and the rotating speed of running roller during granulation, and the aperture of pelletizing machine and pelletizing machine rotating speed, to obtain better distribution of particle sizes.
To put into fluidised bed granulator from the granule that dry granulation mechanism is come out.Other gets polyvinylpyrrolidone, cellulose or the cellulose derivative of granule gross weight 0.1%～2%, make and be dissolved in fully in aqueous solution or the aqueous solvent, paste binder concentration after the dissolving fully is 1%～10%, the binding agent that is used to pull an oar should be few more good more, Jiang concentration also is the bigger the better simultaneously, so more helps making particulate stability.Paste binder is slowly sprayed in the fluid bed, and the inlet temperature of control fluid bed is at 60 ℃～100 ℃ during whitewashing, and the material temperature is at 35 ℃～60 ℃.Paste binder spray into flow velocity, and the inlet temperature of fluid bed, material temperature have all determined to make particulate granularity, particulate bulk density and binding agent and have been scattered in the uniformity in the granule.
Paste binder has sprayed the back and has continued air intake, keeps certain temperature and makes drying, and the moisture content of expecting in the control hopper is 0.5% ± 0.5%, and discharging then promptly gets the high-load calcium ascorbate granule of direct compression.After the granule that obtains is pressed into tablet, to the desirable properties of tablet be: friability≤1%; Tablet hardness 〉=15kg; Disintegration≤15 minute; 30 minutes dissolution 〉=80%.
Embodiment 1:
In blender, add the calcium ascorbate 1940g and the Powdered hydroxypropyl emthylcellulose 50g of crushing screening, fully mix 5 minutes after, put experiment with dry granulation mechanism grain, and use 24 eye mesh screen granulate simultaneously.The material that granulate comes out is all put into fluid bed.Other gets 10g hydroxypropyl emthylcellulose binding agent, makes to be dissolved in aqueous solution fully, and this moment, concentration was 10%.Binding agent is slowly sprayed in the fluid bed, and the inlet temperature of control fluid bed is 80 ℃ during whitewashing, and the material temperature is 48 ℃.Binding agent has sprayed back continuation air intake made drying, discharging in 5 minutes.
Get granule 995 gram and add 5 gram stearic acid and mixed 2 minutes, with 35000 speed tabletting per hour, measure the tablet data and be: friability 0.49%; Tablet hardness 19.25kg; Disintegration and dissolution meet the pharmacopeia regulation.Product quality meets the requirements fully.
Embodiment 2:
In blender, add the calcium ascorbate 97Kg and the Powdered hydroxypropyl emthylcellulose 2.5Kg of crushing screening, fully mix 12 minutes after, put dry granulation mechanism grain, and use 20 eye mesh screen granulate simultaneously.The material that granulate comes out is all put into fluid bed.Other gets 0.5Kg hydroxypropyl emthylcellulose binding agent, makes to be dissolved in aqueous solution fully, and this moment, concentration was 10%.Binding agent is slowly sprayed in the fluid bed, and the inlet temperature of control fluid bed is 70 ℃ during whitewashing, and the material temperature is 45 ℃.Binding agent has sprayed back continuation air intake made drying, discharging in 10 minutes.
Get granule 995 gram and add 5 gram stearic acid and mixed 2 minutes, with 35000 speed tabletting per hour, measure the tablet data and be: friability 0.58%; Tablet hardness 17.95kg; Disintegration and dissolution meet the pharmacopeia regulation.Product quality meets the requirements fully.
Embodiment 3:
In blender, add the calcium ascorbate 97Kg and the Powdered hydroxypropyl emthylcellulose 2.2Kg of crushing screening, fully mix 15 minutes after, put dry granulation mechanism grain, and use 20 eye mesh screen granulate simultaneously.The material that granulate comes out is all put into fluid bed.Other gets 0.8Kg hydroxypropyl emthylcellulose binding agent, makes to be dissolved in aqueous solution fully, and this moment, concentration was 10%.Binding agent is slowly sprayed in the fluid bed, and the inlet temperature of control fluid bed is 75 ℃ during whitewashing, and the material temperature is 46 ℃.Binding agent has sprayed back continuation air intake made drying, discharging in 10 minutes.
Get granule 995 gram and add 5 gram stearic acid and mixed 2 minutes, with 35000 speed tabletting per hour, measure the tablet data and be: friability 0.39%; Tablet hardness 19.05kg; Disintegration and dissolution meet the pharmacopeia regulation.Product quality meets the requirements fully.
The invention is not restricted to these disclosed embodiment; the present invention is with the described scope of soverlay technique scheme; and the various distortion of claim scope and equivalence variation; under the prerequisite that does not depart from technical solution of the present invention, any modification or improvement that those skilled in the art that the present invention did are realized easily all belong to the present invention's scope required for protection.
Claims (7)
- One kind can direct compression the particulate production method of high-load calcium ascorbate; it is characterized in that described production method is as follows: the calcium ascorbate crystal raw material is pulverized; add powdery adhesive; mix homogeneously; place dry granulation machine system granule, this granule is put into the fluid bed hopper again, spray into paste binder; paste binder has sprayed back continuation air intake makes drying, and discharging promptly gets the high-load calcium ascorbate granule of direct compression.
- 2, a kind of particulate production method of high-load calcium ascorbate that can direct compression according to claim 1 is characterized in that after the calcium ascorbate raw material pulverizing more than 95% by 80 mesh standard sieves.
- 3, a kind of particulate production method of high-load calcium ascorbate that can direct compression according to claim 1, it is characterized in that described powdery adhesive is polyvinylpyrrolidone, cellulose or cellulose derivative, paste binder is 1%～10% the solution that polyvinylpyrrolidone, cellulose or cellulose derivative and water or aqueous solvent are made.
- 4, a kind of particulate production method of high-load calcium ascorbate that can direct compression according to claim 3 is characterized in that described cellulose derivative is hydroxypropyl emthylcellulose, hydroxypropyl cellulose, natural gum.
- 5, a kind of particulate production method of high-load calcium ascorbate that can direct compression according to claim 1, it is characterized in that described powdery adhesive consumption is 1%～10% of a granule gross weight, the described paste binder amount of giving money as a gift is 0.1%～2% of a granule gross weight.
- 6, a kind of particulate production method of high-load calcium ascorbate that can direct compression according to claim 1 is characterized in that the ascorbic acid calcium content is 90%～99% of a granule gross weight, and water content is 0～1% of a granule gross weight.
- 7, a kind of particulate production method of high-load calcium ascorbate that can direct compression according to claim 1 is characterized in that the fluid bed inlet temperature at 60 ℃～100 ℃, and the material temperature is at 35 ℃～60 ℃.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2008101806293A CN101390840B (en) | 2008-11-18 | 2008-11-18 | Production method of high-assay calcium ascorbate granules capable of directly being compressed |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2008101806293A CN101390840B (en) | 2008-11-18 | 2008-11-18 | Production method of high-assay calcium ascorbate granules capable of directly being compressed |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101390840A true CN101390840A (en) | 2009-03-25 |
| CN101390840B CN101390840B (en) | 2012-05-09 |
Family
ID=40491481
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2008101806293A Active CN101390840B (en) | 2008-11-18 | 2008-11-18 | Production method of high-assay calcium ascorbate granules capable of directly being compressed |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN101390840B (en) |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104740640A (en) * | 2015-04-17 | 2015-07-01 | 广东彼迪药业有限公司 | crystallization modifier capable of improving properties of chemical drug raw material powder and preparation method for crystallization modifier |
| CN107772478A (en) * | 2016-08-24 | 2018-03-09 | 南京逐陆医药科技有限公司 | A kind of multivitamin tablet and preparation method thereof |
| CN110934297A (en) * | 2019-11-19 | 2020-03-31 | 杭州民生健康药业有限公司 | Choline particle and preparation method and application thereof |
| CN112956595A (en) * | 2021-04-01 | 2021-06-15 | 南通大学 | Livestock and poultry breeding sterilization nutrition tablet and preparation method thereof |
| CN113367347A (en) * | 2021-06-18 | 2021-09-10 | 仙乐健康科技股份有限公司 | Preparation method of vitamin C sustained-release composition |
-
2008
- 2008-11-18 CN CN2008101806293A patent/CN101390840B/en active Active
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104740640A (en) * | 2015-04-17 | 2015-07-01 | 广东彼迪药业有限公司 | crystallization modifier capable of improving properties of chemical drug raw material powder and preparation method for crystallization modifier |
| CN104740640B (en) * | 2015-04-17 | 2018-03-23 | 广东彼迪药业有限公司 | A kind of crystal modification thing for improving chemical drugs material powder property and preparation method thereof |
| CN107772478A (en) * | 2016-08-24 | 2018-03-09 | 南京逐陆医药科技有限公司 | A kind of multivitamin tablet and preparation method thereof |
| CN110934297A (en) * | 2019-11-19 | 2020-03-31 | 杭州民生健康药业有限公司 | Choline particle and preparation method and application thereof |
| CN112956595A (en) * | 2021-04-01 | 2021-06-15 | 南通大学 | Livestock and poultry breeding sterilization nutrition tablet and preparation method thereof |
| CN113367347A (en) * | 2021-06-18 | 2021-09-10 | 仙乐健康科技股份有限公司 | Preparation method of vitamin C sustained-release composition |
Also Published As
| Publication number | Publication date |
|---|---|
| CN101390840B (en) | 2012-05-09 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN101390840B (en) | Production method of high-assay calcium ascorbate granules capable of directly being compressed | |
| CN102134281A (en) | Method for producing high-flowability pregelatinized starch | |
| CN109531857B (en) | Preparation method of hyaluronic acid or salt particles thereof and obtained product | |
| CN103099789A (en) | Preparation method of vitamin C granules | |
| CN100358843C (en) | Brucite granular fertilizer and its preparation method | |
| CN102599508A (en) | Preparation for preparing chondroitin glucosamine particles by wet method and preparation method | |
| CN102166197B (en) | Racecadotril granules and production process thereof | |
| US7138142B2 (en) | Process for producing granules containing branched amino acids | |
| CN109512789B (en) | High-purity granular xylitol capable of being directly tabletted and preparation method thereof | |
| CN101474158B (en) | Preparation method of vitamin B6 granule for direct tablet forming | |
| CN102885791A (en) | Method for preparing fexofenadine hydrochloride orally disintegrating tablet | |
| CN101366461B (en) | Preparation method for salinomycin sodium fine granular formulation | |
| CN101474162A (en) | Preparation method of naproxen granule for direct tablet forming | |
| CN107468655B (en) | Lentinan particles and preparation method thereof | |
| CN103110588A (en) | Production method of vitamin B6 granules | |
| CN102166361A (en) | Quick-collapsed type pellet core and preparation method thereof | |
| CN103202817B (en) | Preparation method for mannitol grains capable of being directly pressed | |
| CN103110515A (en) | Glucosamine potassium sulfate particle production method | |
| CN106176655A (en) | A kind of penicillin V potassium and preparation technology thereof | |
| CN103110105A (en) | Production method for food additive sugar-free vitamin C sodium salt particles | |
| CN109364037B (en) | Lafutidine tablet and preparation method thereof | |
| CN107669652A (en) | A kind of preparation method for extracting species high-viscosity material particle | |
| CN110507621A (en) | A kind of preparation method of lorazepam tablet | |
| JP3228288B1 (en) | Method for producing pharmaceutical granule preparation containing branched chain amino acids | |
| CN101904918B (en) | Cough-relieving tablets and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| C56 | Change in the name or address of the patentee |
Owner name: ALAND (JIANGSU) NUTRACEUTICAL CO., LTD. Free format text: FORMER NAME: JIANGSHAN PHARMACEUTICAL CO., LTD., JIANGSU PROV. |
|
| CP03 | Change of name, title or address |
Address after: 214500, 61 Jiangshan Road, Taizhou, Jiangsu, Jingjiang Patentee after: DSM (Jiangsu) Co., Ltd. Jiangshan pharmaceutical Address before: 214500, Jiangshan Road, Jiangsu, Jingjiang 20 Patentee before: Jiangshan Pharmaceutical Co., Ltd., Jiangsu Prov. |