CN101219150A - Rapidly effectual aluminum magnesium carbonate preparation and technique of preparing the same - Google Patents
Rapidly effectual aluminum magnesium carbonate preparation and technique of preparing the same Download PDFInfo
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- CN101219150A CN101219150A CNA2007100931658A CN200710093165A CN101219150A CN 101219150 A CN101219150 A CN 101219150A CN A2007100931658 A CNA2007100931658 A CN A2007100931658A CN 200710093165 A CN200710093165 A CN 200710093165A CN 101219150 A CN101219150 A CN 101219150A
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Abstract
The invention relates to hydrotalcite preparation with rapid efficiency and a preparation process thereof, which belong to the biopharmaceuticals field. Every 1000 hydrotalcite units of the invention comprise the following constituents: 0.45-0.55kg of hydrotalcite, 0.18-0.25kg of mannitol, 12-18g of carboxymethyl starch sodium, 8.0-15.0g of magnesium stearate, 0.5-1.0g of sodium cyclamate, 0.3-0.9ml of peppermint flavor, 0.378kg-0.462kg of pre-gelatinized starch paste (12 percent by mass specific concentration) and 0.504kg-0.616kg of pre-gelatinized starch paste (5 percent by mass specific concentration). The preparation process of the invention comprises the following steps: hydrotalcite and mannitol are prepared into super-fine powder with grain diameter of 5-15um, which are blended with carboxymethyl starch sodium, sodium cyclamate and pre-gelatinized starch paste, wet granulated, sieved by a sieve with 12-16 meshes, totally mixed, packaged or tabletted to prepare finished product of hydrotalcite preparation; the hydrotalcite preparation prepared by adopting the method of the invention has fast effectiveness, good effect with low toxicity, small side-effects, pleasant taste and high suffer compliance, which is an ideal clinical antiacid.
Description
Technical field
The present invention relates to a kind of antiacid medicine that is used for the treatment of gastric disease, relate in particular to hydrotalcite preparation of a kind of quick produce effects and preparation method thereof.
Background technology
Hydrotalcite is a kind of natural mineral matter, and its structural formula is AI
2Mg
6(OH)
16CO
34H
2O; Chemistry carbonic acid ten hexahydroxys two aluminum six magnesium tetrahydrates by name.It is found in nineteen forty-two by people such as Feitknecht the earliest.People are in the process of its structure of research and character, find that hydrotalcite has a lot of good characteristics, as be a kind of efficient, low toxicity, smokeless material as fire retardant, but the most extensive, topmost purposes is as novel antacid, is used for the treatment of gastric ulcer, duodenal ulcer, hyperchlorhydria and gastritis etc.Japan Shionogi company develops first, and listing in 1970 all has production in many countries such as Japan, Britain, Germany, Italy at present, and version in 1998 and version British Pharmacopoeia in 2005 all record.Antacid is the medicine that is used for the treatment of gastric ulcer, duodenal ulcer the earliest, determined curative effect, and toxic and side effects is little, and medical expense is low.Hydrotalcite and traditional antacid such as aluminium hydroxide or magnesium carbonate are compared, and have lattice structure closely, and hydroxyl is piled up and formed the close bilayer of putting in the crystal, and magnesium, aluminium ion are distributed in the octahedral interstices with random fashion, form the basic layer [AI of positively charged
2Mg
6(OH)
16]
2+, the electronegative intermediate layer [CO3 of folder to form between two basic layers by carbanion and hydrone
2-+ 4H
2O]
2-They self can form buffer system in vivo, and have bigger surface area.Therefore, this product effect is rapid, gentle, lasting, the pH value of gastric juice is maintained between 3～5 in a long time, and can fully react with gastric acid, and the acid reaction rate can reach 98%～100%, is called as ideal antacid medicine abroad.Traditional hydrotalcite preparation is taken the side effect that the back exists diarrhoea and constipation, Chinese patent application 20031010504.2 discloses a kind of hydrotalcite preparation that contains the cholinolytic composition, in hydrotalcite, add cholinolytic materials such as similar Semen daturae extractum Ah taking off product, with secretion and the gastrointestinal wriggling that reduces gastric acid, and then the consumption of minimizing hydrotalcite, reduce the side effect that produces when preparation is taken, but the said preparation disintegration time is long, onset is slow, and toxic and side effects is big.The hydrotalcite preparation of present prior art, clinical efficacy is better, but disintegration time is long behind the drug administration, drug effect is after 30 minutes, therefore needing a kind of component and preparation technology of hydrotalcite preparation of optimization, is index with disintegration and dispersing uniformity, the type and the component of screening filler, optimize the technological parameter of preparation, reduce production costs simultaneously.
Summary of the invention
In view of this, purpose of the present invention is exactly the hydrotalcite preparation that a kind of quick produce effects of energy will be provided.For realizing purpose of the present invention, a kind of quickly disintegrated hydrotalcite preparation of the present invention, in per 1000 preparation units, 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%.
Further, described dosage form is a tablet.
Another object of the present invention is to provide a kind of preparation technology who prepares above-mentioned preparation may further comprise the steps:
A. the superfine powder for preparing hydrotalcite and mannitol
Hydrotalcite and mannitol are made the superfine powder that particle diameter is 0.5～15 μ m, stand-by, process conditions: air consumption 40M
3/ min, operating pressure 0.75～0.85Mpa, feed size 60～300 orders
B. wet granulation
By 1000 preparation units, take by weighing hydrotalcite powder 0.45～0.55kg, mannitol 0.18～0.25kg and carboxymethyl starch sodium 12～18g and be added in the wet granulator, start wet granulator stirring at low speed (1000r/min) and made it mix homogeneously in 3～5 minutes; Cyclamate 0.5～1.0g is dissolved in about 0.5Kg purified water, open wet granulator with the 1000r/min stirring at low speed and with 1500r/min slow cutting 1 minute, the solution that makes cyclamate is at the wet granulator mixing, then slow cutting is become the high-speed cutting of 3000r/min, add quality again and be 12% pregelatinized Starch binding agent 0.378kg-0.462kg than concentration, add the back in stirring at low speed under the 1000r/min condition and high-speed cutting 2～3 minutes under the 3000r/min condition, make suitable wet granular;
C. spray granulation
It is 5% pregelatinized Starch slurry 0.504kg-0.616kg than concentration that the wet granular that step b is made is inserted the quality that fills spray in the one-step-granulating method, and control whitewashing speed is 4.0～6.0kg/min, 130～150 ℃ of inlet temperature, 37～43 ℃ of leaving air temps,, for making suitable particles, again with particle drying, 1.5～2.0 hours drying times, moisture is 3-6%, is cooled to the room temperature discharging, granulate, 12～16 orders that sieve promptly get qualified dried granule;
D. total mixing and tabletting
The qualified dried granule that makes among the step c is put in the batch mixer, the magnesium stearate that directly adds 8.0～15.0g, with the Herba Menthae essence of miniaturised nebuliser hand spraying adding 0.3～0.9ml, to open batch mixer and mix about 8～10 minutes to even, encapsulation or tabletting are made 1000 preparation units.
The invention has the beneficial effects as follows that the hydrotalcite preparation of invention reaches 78% at the clinical research cure rate, effective percentage reaches 93%, almost non-toxic side effect and untoward reaction, and clinical use is safer; Adopt the hydrotalcite preparation of process preparation of the present invention, wherein the particle diameter of active component hydrotalcite microgranule has reached 0.5～15 μ m, thereby after user takes, be easy to collapse and connect, shortened the onset time of medicine greatly, the misery of reduction of patient, and low cost of manufacture fast, the process conditions gentleness.
Other advantage of the present invention, target and feature will be set forth to a certain extent in the following description, and to a certain extent, based on being conspicuous to those skilled in the art, perhaps can obtain instruction from the practice of the present invention to investigating hereinafter.
Description of drawings
The present invention is described in further detail below in conjunction with accompanying drawing.
Accompanying drawing is the process chart of the inventive method.
The specific embodiment
Below in conjunction with accompanying drawing, the preferred embodiments of the present invention are described in detail, rather than restriction the present invention.
1000 hydrotalcite sheets of embodiment 1 preparation
A. the superfine powder for preparing hydrotalcite and mannitol
Hydrotalcite and mannitol are made the superfine powder that particle diameter is 0.5 μ m, stand-by, process conditions: air consumption 40M
3/ min, operating pressure 0.75Mpa, feed size 60 orders
B. wet granulation
By 1000 preparation units, take by weighing hydrotalcite powder 0.45kg, mannitol 0.18kg and carboxymethyl starch sodium 12g and be added in the wet granulator, start wet granulator stirring at low speed (1000r/min) and made it mix homogeneously in 3 minutes; Cyclamate 0.5g is dissolved in about 0.5Kg purified water, open wet granulator with the 1000r/min stirring at low speed and with 1500r/min slow cutting 1 minute, the solution that makes cyclamate is at the wet granulator mixing, then slow cutting is become the high-speed cutting of 3000r/min, add quality again and be 12% pregelatinized Starch binding agent 0.378kg than concentration, add the back in stirring at low speed under the 1000r/min condition and high-speed cutting 2 minutes under the 3000r/min condition, make suitable wet granular;
C. spray granulation
It is 5% pregelatinized Starch slurry 0.504kgkg than concentration that the wet granular that step b is made is inserted the quality that fills spray in the one-step-granulating method, and control whitewashing speed is 4.0kg/min, 130 ℃ of inlet temperature, 37 ℃ of leaving air temps,, for making suitable particles, again with particle drying, 1.5 hours drying times, moisture is 3%, is cooled to the room temperature discharging, granulate, 12 orders that sieve promptly get qualified dried granule;
D. total mixing and tabletting
The qualified dried granule that makes among the step c is put in the batch mixer, directly added the magnesium stearate of 8.0g, with the Herba Menthae essence of miniaturised nebuliser hand spraying adding 0.3ml, open batch mixer and mix about 8 minutes to even, encapsulation or tabletting are made 1000 preparation units.
1000 hydrotalcite sheets of embodiment 2 preparations
A. the superfine powder for preparing hydrotalcite and mannitol
Hydrotalcite and mannitol are made the superfine powder that particle diameter is 3 μ m, stand-by, process conditions: air consumption 40M
3/ min, operating pressure 0.8Mpa, feed size 100 orders
B. wet granulation
By 1000 preparation units, take by weighing hydrotalcite powder 0.5kg, mannitol 0.20kg and carboxymethyl starch sodium 15g and be added in the wet granulator, start wet granulator stirring at low speed (1000r/min) and made it mix homogeneously in 4 minutes; Sweet 0.75g honey element is dissolved in about 0.5Kg purified water, open wet granulator with the 1000r/min stirring at low speed and with 1500r/min slow cutting 1 minute, the solution that makes cyclamate is at the wet granulator mixing, then slow cutting is become the high-speed cutting of 3000r/min, add quality again and be 12% pregelatinized Starch binding agent 0.40kg than concentration, add the back in stirring at low speed under the 1000r/min condition and high-speed cutting 2.5 minutes under the 3000r/min condition, make suitable wet granular;
C. spray granulation
It is 5% pregelatinized Starch slurry 0.55kg than concentration that the wet granular that step b is made is inserted the quality that fills spray in the one-step-granulating method, control whitewashing speed is 5.0kg/min, 140 ℃ of inlet temperature, 40 ℃ of leaving air temps, for making suitable particles, with particle drying, 1.8 hours drying times, moisture is 5% again, be cooled to the room temperature discharging, granulate, 14 orders that sieve promptly get qualified dried granule;
D. total mixing and tabletting
The qualified dried granule that makes among the step c is put in the batch mixer, directly added the magnesium stearate of 12.0g, with the Herba Menthae essence of miniaturised nebuliser hand spraying adding 0.6ml, open batch mixer and mix about 9 minutes to even, encapsulation or tabletting are made 1000 preparation units
1000 hydrotalcite sheets of embodiment 3 preparations
A. the superfine powder for preparing hydrotalcite and mannitol
Hydrotalcite and mannitol are made the superfine powder that particle diameter is 15 μ m, stand-by, process conditions: air consumption 40M
3/ min, operating pressure 0.85Mpa, feed size 300 orders
B. wet granulation
By 1000 preparation units, take by weighing hydrotalcite powder 0.55kg, mannitol 0.25kg and carboxymethyl starch sodium 18g and be added in the wet granulator, start wet granulator stirring at low speed (1000r/min) and made it mix homogeneously in 5 minutes; The 1.0g cyclamate is dissolved in about 0.5Kg purified water, open wet granulator with the 1000r/min stirring at low speed and with 1500r/min slow cutting 1 minute, the solution that makes cyclamate is at the wet granulator mixing, then slow cutting is become the high-speed cutting of 3000r/min, add quality again and be 12% pregelatinized Starch binding agent 0.462kg than concentration, add the back in stirring at low speed under the 1000r/min condition and high-speed cutting 3 minutes under the 3000r/min condition, make suitable wet granular;
C. spray granulation
It is 5% pregelatinized Starch slurry 0.616kg than concentration that the wet granular that step b is made is inserted the quality that fills spray in the one-step-granulating method, and control whitewashing speed is 6.0kg/min, 150 ℃ of inlet temperature, 43 ℃ of leaving air temps,, for making suitable particles, again with particle drying, 2.0 hours drying times, moisture is 6%, is cooled to the room temperature discharging, granulate, 16 orders that sieve promptly get qualified dried granule;
D. total mixing and tabletting
The qualified dried granule that makes among the step c is put in the batch mixer, directly added the magnesium stearate of 15.0g, with the Herba Menthae essence of miniaturised nebuliser hand spraying adding 0.9ml, open batch mixer and mix about 10 minutes to even, encapsulation or tabletting are made 1000 preparation units.
Contrast test: the clinical comparison experiment of tablet of the present invention and prior art
Carry out clinical observation according to 100 routine patients are taken hydrotalcite sheet of the present invention, take hydrotalcite sheet of the present invention, after taking 10 minutes, just begin produce effects, shortened 20 minutes than the hydrotalcite sheet effective time of taking prior art.
Above-mentioned experimental result shows, adopts the hydrotalcite sheet of component of the present invention and preparation technology preparation and the hydrotalcite sheet ratio of prior art, and it is fast to have disintegration rate, the advantage that onset time is short, and fabrication process condition gentleness, and cost is low.
Although by reference some preferred embodiment of the present invention, invention has been described, but those of ordinary skill in the art is to be understood that, can make various changes to it in the form and details, and the spirit and scope of the present invention that do not depart from appended claims and limited.
Claims (3)
1. the hydrotalcite preparation of a quick produce effects, it is characterized in that: in per 1000 preparation units, 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%.
2. the hydrotalcite preparation of a kind of quick produce effects according to claim 1, it is characterized in that: described dosage form is a tablet, takes in back 10 minutes and gets final product produce effects.
3. prepare the preparation technology of the described preparation of claim 1, it is characterized in that may further comprise the steps:
The superfine powder of a, preparation hydrotalcite and mannitol
Hydrotalcite and mannitol are made the superfine powder that particle diameter is 0.5～15 μ m, stand-by, process conditions: air consumption 40M
3/ min, operating pressure 0.75～0.85Mpa, feed size 60～300 orders
B, wet granulation
By 1000 preparation units, take by weighing hydrotalcite powder 0.45～0.55kg, mannitol 0.18～0.25kg and carboxymethyl starch sodium 12～18g and be added in the wet granulator, start wet granulator stirring at low speed (1000r/min) and made it mix homogeneously in 3～5 minutes; Cyclamate 0.5～1.0g is dissolved in about 0.5Kg purified water, open wet granulator with the 1000r/min stirring at low speed and with 1500r/min slow cutting 1 minute, the solution that makes cyclamate is at the wet granulator mixing, then slow cutting is become the high-speed cutting of 3000r/min, add quality again and be 12% pregelatinized Starch binding agent 0.378kg-0.462kg than concentration, add the back in stirring at low speed under the 1000r/min condition and high-speed cutting 2～3 minutes under the 3000r/min condition, make suitable wet granular;
C, spray granulation
It is 5% pregelatinized Starch slurry 0.504kg-0.616kg than concentration that the wet granular that step b is made is inserted the quality that fills spray in the one-step-granulating method, control whitewashing speed is 4.0～6.0kg/min, 130～150 ℃ of inlet temperature, 37～43 ℃ of leaving air temps, make suitable particles, with particle drying, 1.5～2.0 hours drying times, moisture is 3-6% again, be cooled to the room temperature discharging, granulate, 12～16 orders that sieve promptly get qualified dried granule;
D. total mixing and tabletting
The qualified dried granule that makes among the step c is put in the batch mixer, the magnesium stearate that directly adds 8.0～15.0g, with the Herba Menthae essence of miniaturised nebuliser hand spraying adding 0.3～0.9ml, to open batch mixer and mix about 8～10 minutes to even, encapsulation or tabletting are made 1000 preparation units.
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|---|---|---|---|
| CNA2007100931658A CN101219150A (en) | 2007-12-19 | 2007-12-19 | Rapidly effectual aluminum magnesium carbonate preparation and technique of preparing the same |
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|---|---|---|---|
| CNA2007100931658A CN101219150A (en) | 2007-12-19 | 2007-12-19 | Rapidly effectual aluminum magnesium carbonate preparation and technique of preparing the same |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102151286A (en) * | 2010-12-13 | 2011-08-17 | 四川健能制药有限公司 | Hydrotalcite tablet and preparation method thereof |
| CN102813634A (en) * | 2012-01-04 | 2012-12-12 | 重庆华森制药有限公司 | Hydrotalcite tablet and its preparation method |
| CN108078937A (en) * | 2018-01-10 | 2018-05-29 | 海南皇隆制药股份有限公司 | A kind of hydrotalcite tablet and preparation method thereof |
| CN110131965A (en) * | 2019-05-10 | 2019-08-16 | 特一药业集团股份有限公司 | A kind of bangxiaoan preparation facility for granulating and bangxiaoan production technology |
| CN112675192A (en) * | 2021-01-12 | 2021-04-20 | 遂成药业股份有限公司 | Hydrotalcite chewable tablet and preparation method thereof |
| CN114699427A (en) * | 2022-04-12 | 2022-07-05 | 广西南宁百会药业集团有限公司 | Hydrotalcite chewable tablet and preparation method thereof |
-
2007
- 2007-12-19 CN CNA2007100931658A patent/CN101219150A/en active Pending
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102151286A (en) * | 2010-12-13 | 2011-08-17 | 四川健能制药有限公司 | Hydrotalcite tablet and preparation method thereof |
| CN102151286B (en) * | 2010-12-13 | 2012-09-05 | 四川健能制药有限公司 | Hydrotalcite tablet and preparation method thereof |
| CN102813634A (en) * | 2012-01-04 | 2012-12-12 | 重庆华森制药有限公司 | Hydrotalcite tablet and its preparation method |
| CN102813634B (en) * | 2012-01-04 | 2013-06-12 | 重庆华森制药有限公司 | Hydrotalcite tablet and its preparation method |
| CN108078937A (en) * | 2018-01-10 | 2018-05-29 | 海南皇隆制药股份有限公司 | A kind of hydrotalcite tablet and preparation method thereof |
| 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 |
| CN110131965A (en) * | 2019-05-10 | 2019-08-16 | 特一药业集团股份有限公司 | A kind of bangxiaoan preparation facility for granulating and bangxiaoan production technology |
| CN112675192A (en) * | 2021-01-12 | 2021-04-20 | 遂成药业股份有限公司 | Hydrotalcite chewable tablet and preparation method thereof |
| CN114699427A (en) * | 2022-04-12 | 2022-07-05 | 广西南宁百会药业集团有限公司 | Hydrotalcite chewable tablet and preparation method thereof |
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