CN102151286B - Hydrotalcite tablet and preparation method thereof - Google Patents
Hydrotalcite tablet and preparation method thereof Download PDFInfo
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- CN102151286B CN102151286B CN201010584531A CN201010584531A CN102151286B CN 102151286 B CN102151286 B CN 102151286B CN 201010584531 A CN201010584531 A CN 201010584531A CN 201010584531 A CN201010584531 A CN 201010584531A CN 102151286 B CN102151286 B CN 102151286B
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- hydrotalcite
- xylitol
- granularity
- magnesium stearate
- microcrystalline cellulose
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Abstract
The invention discloses a hydrotalcite tablet which comprises the components in every 1000 preparation units: 500-1000g of hydrotalcite, 100-130g of microcrystalline cellulose, 260-350g of xylitol, 30-40g of crosslinking carboxy methyl starch sodium, 0.3-1g of menthol crystal, 3-15g of stevioside, 1-15g of magnesium stearate and 5-45g of silicon dioxide. The hydrotalcite tablet is good in stability and dispersion uniformity, rapid in disintegration and effect and good in mouth feeling. The invention also discloses a preparation method of the hydrotalcite tablet, which adopts the technique of directly compressing powder into the tablet and is simple in technique and low in energy consumption, thus reducing the production cost.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, relate to a kind of antacid and gastric mucosal protection medicine, be specifically related to a kind of hydrotalcite sheet and preparation method thereof.
Background technology
Hydrotalcite is the chemical compound of aluminium hydroxide, magnesium hydroxide, carbonate and water, is the New-type long-acting antacid, and its active component is arranged by layer-lattice structure, and the RF for uniqueness has dual function.Make gastric juice reach the righttest scope of pH 3-5 fast on the one hand, stop pepsic mistake active by force, promote ulcer healing.Combine with cholic acid, pepsin reversibility again simultaneously; Eliminate the infringement of bile acid, be used for hyperchlorhydria, acute or chronic gastritis gastric mucosa; Bile reflux gastritis; Reflux esophagitis, duodenal bulbar ulcer, gastric ulcer, a variety of causes is like excessive use coffee, ethanol, strong tea, nicotine etc. and to take non-ucler dyspepsia and digestive tract that the nonsteroidal anti inflammatory guiding drug rises uncomfortable.
One Chinese patent application CN200310100504.2 discloses a kind of compound recipe stomach medicine; The stomach medicine that particularly comprises hydrotalcite in the component; Added material in this stomach medicine, reduced the secretion and the gastrointestinal wriggling of gastric acid, so can be through reducing the consumption of hydrotalcite with the effect of anti-M choline; Alleviate that hydrotalcite brings just secrete, the side effect of loose stool, strengthen the therapeutical effect of medicine.But the said preparation disintegration time is long, and onset is slow, fast the misery of reduction of patient.
One Chinese patent application CN200710016126.8 discloses compound medicinal formulation of a kind of proton pump inhibitor and hydrotalcite and preparation method thereof.The concrete prescription of this compound medicinal formulation is formed (g/g): proton pump inhibitor 0.2%～2%, and hydrotalcite 10%～95%, diluent 0～85%, correctives 0～60%, binding agent 0～20%, lubricant is an amount of.Method for preparing: with behind the supplementary material mixing by direct compression of full-powder, encapsulated or the pack form; Or supplementary material processed behind the granule and tabletting, the encapsulated or pack again of lubricant mixing; Method of granulating comprises dry method, wet method etc.In this application, embodiment all adopts wet granulation, does not adopt direct compression technology; We once attempted to utilize prescription among this application embodiment to adopt the explained hereafter hydrotalcite sheet of compressing dry granulation or direct compression in research hydrotalcite sheet project, and the result finds; The mixed powder flowability that this prescription obtains is too poor; Surpass 43 degree angle of repose, be not fit to suitability for industrialized production, and the sheet disintegration time that extrudes is all more than 10min.
One Chinese patent application CN200910306413.1 discloses a kind of pharmaceutical composition of treating stomach, dudenal disease, forms with hydrotalcite powder 75-85%, procaine powder 15-25%.Said composition is combined hydrotalcite and two kinds of crude drug of procaine, forms a kind of new medicine, both can reach rapid antacid and suppress pepsic activity, can remove the symptom of disease of stomach patient pain simultaneously again rapidly; And two kinds of crude drug share, and also can produce certain synergistic function, more help bringing into play curative effect of medication.Mentioning 1g hydrotalcite raw material in this application can make the artificial gastric acid pH value of 150ml (about pH1.5) rise to pH3 in 14 seconds; We are in research hydrotalcite sheet project; Find the hydrotalcite raw material in being prepared into the process of preparation, particularly in the process of tablet, because the effect of adjuvant in pressure and the sheet; Make the disintegration time significant prolongation of hydrotalcite raw material, basically all more than 10min.
One Chinese patent application CN200710093165.8 discloses a kind of hydrotalcite sheet and preparation technology; In per 1000 hydrotalcite preparation units of this patent, be grouped into: hydrotalcite 0.45～0.55kg, mannitol 0.18～0.25kg, carboxymethylstach sodium 12～18g, magnesium stearate 8.0～15.0g, cyclamate 0.5～1.0g, Herba Menthae essence 0.3～0.9ml, count 12% pregelatinized Starch slurry 0.378kg-0.462kg than concentration by quality by following one-tenth; By the pregelatinized Starch slurry 0.504kg-0.616kg of quality than densitometer 5%; Preparation technology of the present invention comprises hydrotalcite and mannitol is processed the ultramicronising powder that particle diameter is 5-15 μ m; Again the ultramicronising powder is sneaked in carboxymethylstach sodium, cyclamate and the pregelatinized Starch serosity; Cross 12～16 mesh sieves behind the wet granulation, always mix, encapsulation or tabletting promptly process finished product hydrotalcite preparation.Supplementary material adopts the ultra micro efflorescence in this application, and high to equipment requirements, loss amount is big in the preparation process; Pelletization adopts wet granulation and two steps of spray granulation, and complex process is not suitable for suitability for industrialized production; The time is also long partially about 10min onset time in the clinical application.
The hydrotalcite sheet specification of list marketing at present all is 0.5g, and the amount of every middle hydrotalcite raw material is too big, is guaranteeing under the heavy situation that can not be excessive of sheet; Select proper supplementary material particularly important concerning producing the hydrotalcite sheet, should produce qualified slice, thin piece, have good mouthfeel and disintegration time short again; Rapid-action, stablizing is a difficult problem, and the applicant is in the process of research and development hydrotalcite sheet; Through screening a large amount of prescriptions and technology, finally solved this difficult problem.
Summary of the invention
The present invention provides a kind of hydrotalcite sheet, in per 1000 preparation units, is grouped into by following one-tenth: hydrotalcite 500～1000g; Microcrystalline Cellulose 100～130g, xylitol 260～350g, crosslinked carboxymethyl fecula sodium 30～40g; Mentholum 0.3～1g; Steviol glycosides 3～15g, magnesium stearate 1～15g, silicon dioxide 5～45g.
This hydrotalcite sheet mouthfeel is good, and disintegration time is short, and rapid-action, stability and dispersing uniformity are good.
Said hydrotalcite, Mentholum, magnesium stearate, silicon dioxide granularity are preferably less than 180 microns; Said microcrystalline Cellulose, xylitol, crosslinked carboxymethyl fecula sodium, steviol glycosides granularity are preferably less than 250 microns.
Control supplementary material particle diameter can significantly increase the mixed flowability of supplementary material, is fit to industrialized great production.
The present invention further provides a kind of method for preparing of hydrotalcite sheet, may further comprise the steps:
(1) supplementary material granularity requirements: hydrotalcite, Mentholum, magnesium stearate, silicon dioxide granularity are less than 180 microns; Microcrystalline Cellulose, xylitol, crosslinked carboxymethyl fecula sodium, steviol glycosides granularity are less than 250 microns;
(2) hydrotalcite, microcrystalline Cellulose, xylitol, crosslinked carboxymethyl fecula sodium, Mentholum, steviol glycosides, magnesium stearate, silicon dioxide that take by weighing recipe quantity add in the two-dimensional mixing machine, incorporation time 15～45 minutes, always mix thing;
(3) always mix the thing direct compression.
This technology is simple, and energy consumption is low, has reduced production cost.
The specific embodiment
Below in conjunction with specific embodiment the present invention is further described, but should this be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following embodiment.All technology that realizes based on foregoing of the present invention all belong to scope of the present invention.Adjuvant in following examples can be used pharmaceutically acceptable similar adjuvant replacement, perhaps reduces, increases.
Embodiment 1
1, prescription:
Hydrotalcite 1000g
Microcrystalline Cellulose 130g
Xylitol 260g
Crosslinked carboxymethyl fecula sodium 30g
Mentholum 1g
Steviol glycosides 15g
Magnesium stearate 15g
Silicon dioxide 45g
Process 1000
2, processing step:
(1) supplementary material granularity requirements: hydrotalcite, Mentholum, magnesium stearate, silicon dioxide granularity are less than 180 microns; Microcrystalline Cellulose, xylitol, crosslinked carboxymethyl fecula sodium, steviol glycosides granularity are less than 250 microns;
(2) hydrotalcite, microcrystalline Cellulose, xylitol, crosslinked carboxymethyl fecula sodium, Mentholum, steviol glycosides, magnesium stearate, silicon dioxide that take by weighing recipe quantity add in the two-dimensional mixing machine, incorporation time 15～45 minutes, always mix thing; Total thing that mixes is surveyed flowability, and be 34.2 ° angle of repose (θ).
(3) always mix the thing direct compression, the every heavy 1.5g of sheet.
This prescription and technology are that the applicant screens through lot of test, select for use microcrystalline Cellulose and the coupling of crosslinked carboxymethyl fecula sodium as disintegrating agent, can significantly shorten the disintegration time of tablet; Xylitol, Mentholum and stevioside coupling are as correctives, and this hydrotalcite sheet mouthfeel is fragrant, and is tasty and refreshing, chews several no grains of sand senses, are easy to pediatric patient and use; The granularity of control supplementary material can significantly be improved the mixed flowability of supplementary material, is fit to industrialized great production, and granularity control can be adopted method such as sieve.
Investigation project and method
Dispersing uniformity is got 2 of these article, puts jolting in the 100ml water respectively, and in 20 ℃ ± 1 ℃ water, jolting 3 minutes is observed and the record phenomenon.
Assay is got 20 of these article, and accurate the title decides, porphyrize, and precision takes by weighing in right amount (being equivalent to hydrotalcite 0.3g approximately); Add 7mol/L hydrochloric acid solution 2ml, heating in water bath 15 minutes is put coldly, adds water 150ml; Accurate Calcium Disodium Versenate volumetric solution (0.05mol/L) 50ml that adds, 2 of the red indicator solutions of methylate are neutralized to the solution displaing yellow with the 1mol/L sodium hydroxide solution; Heating in water bath 30 minutes is put coldly, adds hexamethylenamine 3g and xylenol orange indicator solution 1ml; Transfer to the solution displaing yellow with the 1mol/L hydrochloric acid solution, become aubergine with zinc volumetric solution (0.05mol/L) titration to solution by yellow, and titrating result is proofreaied and correct with blank assay.The Calcium Disodium Versenate volumetric solution (0.05mol/L) of every 1ml is equivalent to the Al of 15.09mg
2Mg
6(OH)
16CO
34H
2O.
Antacid power is got the fine powder an amount of (being equivalent to hydrotalcite 0.5g approximately) under the assay item, and accurate the title decides, and adds mixes with small amount of water and makes into uniform pulpous state; Add water again and make into 100ml; Accurate hydrochloric acid volumetric solution (0.1mol/L) 160ml that adds stirred 1 hour at 37 ℃ of rotating speeds that change with per minute 200, put cold after; Add 8 of bromophenol blue indicator solutions, with sodium hydroxide volumetric solution (0.1mol/L) titration.Every 1g hydrotalcite consumes hydrochloric acid volumetric solution (0.1mol/L) must not be less than 260ml.
Other indexs are according to " (Chinese pharmacopoeia version in 2005 two the appendix XI XC stability test guideline and the hydrotalcite sheet national drug standards [WS1-(X-317)-2003Z] are confirmed.
Embodiment 1 sample quality check result
Embodiment 2
1, prescription:
Hydrotalcite 500g
Microcrystalline Cellulose 100g
Xylitol 350g
Crosslinked carboxymethyl fecula sodium 40g
Mentholum 0.3g
Steviol glycosides 3g
Magnesium stearate 1g
Silicon dioxide 5g
Process 1000
2, processing step:
(1) supplementary material granularity requirements: hydrotalcite, Mentholum, magnesium stearate, silicon dioxide granularity are less than 180 microns; Microcrystalline Cellulose, xylitol, crosslinked carboxymethyl fecula sodium, steviol glycosides granularity are less than 250 microns;
(2) hydrotalcite, microcrystalline Cellulose, xylitol, crosslinked carboxymethyl fecula sodium, Mentholum, steviol glycosides, magnesium stearate, silicon dioxide that take by weighing recipe quantity add in the two-dimensional mixing machine, incorporation time 15～45 minutes, always mix thing; Total thing that mixes is surveyed flowability, and be 33.8 ° angle of repose (θ).
(3) always mix the thing direct compression, the every heavy 1.0g of sheet.
Investigation project and method reference implementation example 1
Embodiment 2 sample quality check results
Embodiment 3
Stability test
Investigate sample (embodiment 1, embodiment 2) through long-term (condition: 25 ℃ ± 2 ℃, RH60% ± 10%) investigation of 60 months, it is following to investigate the result:
The result shows: 60 months long-term investigation of result, each item index does not have significant change.
Embodiment 4
The external antiacid test of rossett rice is with 30ml water and 0.1mol.L
-1Hydrochloric acid solution 70ml adds in the reaction vessel, is in 37 ℃ with magnetic force heating stirrer and contact temperature meter control reactant liquor, and magnetic agitation, mixing speed are 400rmin
-1, with the variation of pH value in the pH meter assaying reaction container of being furnished with glass electrode, calomel electrode, constant flow pump is with (2.0 ± 0.1) mlmin
-1Speed in reaction vessel, pump into 37 ℃ of homothermic 0.1mol.L
-1Hydrochloric acid solution.After adding antacid to be measured, open constant flow pump and magnetic stirring apparatus immediately, simultaneously writing time and pH value.
The test result of several kinds of antacids
The result shows: the time that the sample of embodiment 1 and embodiment 2 reaches pH3 listing article significantly shorten, can meet the demands with 30 seconds, the alleviation that is exceedingly fast patient's misery.
Claims (2)
1. a hydrotalcite sheet is characterized in that: in per 1000 preparation units, be grouped into by following one-tenth: hydrotalcite 500～1000g; Microcrystalline Cellulose 100～130g, xylitol 260～350g, crosslinked carboxymethyl fecula sodium 30～40g; Mentholum 0.3～1g, steviol glycosides 3～15g, magnesium stearate 1～15g; Silicon dioxide 5～45g, said hydrotalcite, Mentholum, magnesium stearate, silicon dioxide granularity are less than 180 microns; Said microcrystalline Cellulose, xylitol, crosslinked carboxymethyl fecula sodium, steviol glycosides granularity are less than 250 microns.
2. the method for preparing of the said hydrotalcite sheet of claim 1 may further comprise the steps:
(1) supplementary material granularity requirements: hydrotalcite, Mentholum, magnesium stearate, silicon dioxide granularity are less than 180 microns; Microcrystalline Cellulose, xylitol, crosslinked carboxymethyl fecula sodium, steviol glycosides granularity are less than 250 microns;
(2) hydrotalcite, microcrystalline Cellulose, xylitol, crosslinked carboxymethyl fecula sodium, Mentholum, steviol glycosides, magnesium stearate, silicon dioxide that take by weighing recipe quantity add in the two-dimensional mixing machine, incorporation time 15～45 minutes, always mix thing;
(3) always mix the thing direct compression.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN201010584531A CN102151286B (en) | 2010-12-13 | 2010-12-13 | Hydrotalcite tablet and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201010584531A CN102151286B (en) | 2010-12-13 | 2010-12-13 | Hydrotalcite tablet and preparation method thereof |
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| CN102151286A CN102151286A (en) | 2011-08-17 |
| CN102151286B true CN102151286B (en) | 2012-09-05 |
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| CN105287625B (en) * | 2015-12-04 | 2019-03-22 | 重庆希尔安药业有限公司 | A kind of Hydrotalcite composition of medicine tablet, preparation method and applications |
| CN108078937B (en) * | 2018-01-10 | 2020-01-21 | 海南皇隆制药股份有限公司 | Hydrotalcite tablet and preparation method thereof |
| CN111481568B (en) * | 2020-04-22 | 2021-04-02 | 一力制药(罗定)有限公司 | Hydrotalcite tablet and preparation process thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101219150A (en) * | 2007-12-19 | 2008-07-16 | 游洪涛 | Rapidly effectual aluminum magnesium carbonate preparation and technique of preparing the same |
| CN101901865A (en) * | 2009-05-28 | 2010-12-01 | 三星电机株式会社 | Metallic laminate and manufacturing method of light emitting diode package using the same |
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2010
- 2010-12-13 CN CN201010584531A patent/CN102151286B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101219150A (en) * | 2007-12-19 | 2008-07-16 | 游洪涛 | Rapidly effectual aluminum magnesium carbonate preparation and technique of preparing the same |
| CN101901865A (en) * | 2009-05-28 | 2010-12-01 | 三星电机株式会社 | Metallic laminate and manufacturing method of light emitting diode package using the same |
Non-Patent Citations (1)
| Title |
|---|
| 王早堂等.铝碳酸镁分散片的处方优化.《科学技术与工程》.2007,第7卷(第17期),4441-4443. * |
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| C14 | Grant of patent or utility model | ||
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| EE01 | Entry into force of recordation of patent licensing contract |
Application publication date: 20110817 Assignee: Chongqing Jewelland Pharmaceutical Development Co., Ltd. Assignor: Sichuan Jewelland Pharmaceutical Co., Ltd. Contract record no.: 2013500000042 Denomination of invention: Hydrotalcite tablet and preparation method thereof Granted publication date: 20120905 License type: Common License Record date: 20130527 |
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| LICC | Enforcement, change and cancellation of record of contracts on the licence for exploitation of a patent or utility model |