CN102614519A - Preparation method of premixed auxiliary material for dispersible tablet - Google Patents
Preparation method of premixed auxiliary material for dispersible tablet Download PDFInfo
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- CN102614519A CN102614519A CN2012100978227A CN201210097822A CN102614519A CN 102614519 A CN102614519 A CN 102614519A CN 2012100978227 A CN2012100978227 A CN 2012100978227A CN 201210097822 A CN201210097822 A CN 201210097822A CN 102614519 A CN102614519 A CN 102614519A
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- auxiliary material
- microcrystalline cellulose
- dispersible tablet
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Abstract
The invention discloses a preparation method of a premixed auxiliary material for a dispersible tablet. The method comprises the following steps of: dispersing cross-linked polyvidone and silicon dioxide into 75 percent ethanol by taking microcrystalline cellulose as a mother nucleus, and spraying onto the microcrystalline cellulose; and spraying and drying simultaneously to obtain the premixed auxiliary material suitable for the dispersible tablet. The method has the technical effects that: the premixed auxiliary material for the dispersible tablet is spherulite-shaped, and the angle of repose is smaller than 30 degrees, so that the premixed auxiliary material is extremely easy to mix uniformly with a raw material of the dispersible table, the mixing time is reduced, and dust in a production process is greatly reduced; and moreover, the cross-linked polyvidone is embedded into microcrystalline cellulose, and the hygroscopic property of the cross-linked polyvidone is lowered according to the water-retaining property of the microcrystalline cellulose, so that the humidity requirement of a production environment is greatly lowered, and the preparation of a dispersible table with superior quality is facilitated.
Description
Technical field
The present invention relates to a kind of method for preparing of premixing auxiliary material, relate in particular to the method for preparing of a kind of dispersible tablet with premixing auxiliary material.
Background technology
Dispersible tablet means in water disintegrate and homodisperse tablet rapidly, and conventional tablet has that speed collapses, quick-acting, taking convenience relatively, the bioavailability advantages of higher.Its production process is with blend such as raw material and diluents microcrystalline cellulose, disintegrating agent polyvinylpolypyrrolidone, fluidizer silicon dioxide, carries out direct powder compression behind the mix homogeneously and promptly gets.
Because the disintegrating agent polyvinylpolypyrrolidone hygroscopicity that dispersible tablet is commonly used is strong and mobile poor; Therefore control requires very high (requiring humidity less than 40%) to production environment humidity in the powder mixes process; The polyvinylpolypyrrolidone moisture absorption occurs through regular meeting in the production process and cause that the tablet tabletting is glutinous to be dashed; Cause tablet appearance fiber crops sheet, the defective that tablet hardness is not enough, thus influence the product quality of dispersible tablet.And adjuvant used in the dispersible tablet production is more, requires incorporation time even than long ability and raw materials mix, and production efficiency is low on the one hand, and dust is unfavorable to medicine cleaning production greatly on the other hand.
In sum, with the used adjuvant of dispersible tablet can with raw materials mix before carry out premix and handle, help solving the above-mentioned difficult problem that dispersible tablet is produced.
Summary of the invention
The object of the present invention is to provide the method for preparing of a kind of dispersible tablet with premixing auxiliary material; The present invention is directed to the defective that dispersible tablet production process raw material exists when mixing with multiple adjuvant and the adjuvant that dispersible tablet is used carried out pretreatment, aim to provide the premixing auxiliary material that a kind of suitable dispersible tablet is used.
The present invention realizes that like this method is:, polyvinylpolypyrrolidone and silicon dioxide is scattered in mass fraction 75% ethanol sparges microcrystalline Cellulose as parent nucleus with microcrystalline Cellulose, drying makes the premixing auxiliary material that a kind of suitable dispersible tablet is used while spraying; Polyvinylpolypyrrolidone, silicon dioxide, microcrystalline Cellulose three mass ratio relation are 5:1:50; Be that polyvinylpolypyrrolidone accounts for 8.93% in premixing auxiliary material; Silicon dioxide accounts for 1.79% in premixing auxiliary material; Microcrystalline Cellulose accounts for 89.29% in premixing auxiliary material, require spray velocity to be set at hydrojet speed 10 r/min, atomizing pressure 1.5bar.
Through the premixing auxiliary material for preparing is to carry out physical mixed by polyvinylpolypyrrolidone, silicon dioxide and microcrystalline Cellulose to get, and its mixed process chemical reaction does not take place produces new material.
Technique effect of the present invention is: make dispersible tablet with the present invention and be pelletiod with premixing auxiliary material, angle of repose is less than 30 degree, and therefore as easy as rolling off a log and dispersible tablet raw material mix homogeneously have not only reduced incorporation time and the production process dust significantly reduces; And polyvinylpolypyrrolidone is embedded on the microcrystalline Cellulose, and the water-retaining property of microcrystalline Cellulose has reduced the hygroscopicity of polyvinylpolypyrrolidone, and the humidity requirement to production environment relaxes greatly like this, thereby helps making superior in quality dispersible tablet.
The specific embodiment
Non-limiting examples is narrated as follows:
Get 5kg polyvinylpolypyrrolidone (200 mesh sieves excessively) and 1kg silicon dioxide (crossing 200 mesh sieves) and place 26kg75% ethanol (solid content is 20%), disperse to be uniformly dispersed subsequent use in one hour with homogenizer.
Get 50kg microcrystalline Cellulose (crossing 200 mesh sieves) and place Fluidbedgranulatingdrier; Setting EAT is 70 ℃; After the equipment EAT of treating reaches design temperature; Adopt end spray mode that the finely dispersed material in front is sprayed, spray velocity is set at hydrojet speed 10 r/min, atomizing pressure 1.5bar, and the spray process spray liquid should be sprayed under stirring.After material spray finishes, cool to 40 ℃ with bottom discharge.
Material is carried out weighing, and packing promptly gets.
Test effect
Dispersible tablet prescription 1: azithromycin 1000g
Microcrystalline Cellulose 500g
Polyvinylpolypyrrolidone 50g
Silica 1 0g
Magnesium stearate 5g
Dispersible tablet prescription 2: azithromycin 1000g
Premixing auxiliary material 560g
Magnesium stearate 5g
Method for making: above prescription is put into the V-arrangement mixer respectively mix, measure respectively after the mixing and mix back material angle of repose, moisture, tabletting carries out the detection of tablet weight variation and dispersing uniformity respectively behind the tabletting then.
The test comparing result:
| ? | Incorporation time (min) | Mix back material angle of repose (°) | Mix back material moisture (%) | Tablet weight variation (RSD) | Jitter time (S) |
| Dispersible tablet prescription 1 | 10 | 38 | 6.3 | 5.6 | 60 |
| Dispersible tablet prescription 2 | 6 | 33 | 4.2 | 4.7 | 32 |
Can find out that from above-mentioned logarithmic data the dispersible tablet prescription incorporation time behind the employing premixing auxiliary material shortens, mixed material little thereby good fluidity angle of repose, thus the tablet weight variation fluctuation is little.Adopt the more former prescription jitter time of prescription of premixing auxiliary material to shorten greatly simultaneously, thereby improved bioavailability.
Claims (1)
1. a dispersible tablet is with the method for preparing of premixing auxiliary material; It is characterized in that method is: with microcrystalline Cellulose as parent nucleus; Polyvinylpolypyrrolidone and silicon dioxide is scattered in mass fraction 75% ethanol sparges microcrystalline Cellulose, drying makes the premixing auxiliary material that a kind of suitable dispersible tablet is used while spraying; Polyvinylpolypyrrolidone, silicon dioxide, microcrystalline Cellulose three mass ratio relation are 5:1:50; Be that polyvinylpolypyrrolidone accounts for 8.93% in premixing auxiliary material; Silicon dioxide accounts for 1.79% in premixing auxiliary material; Microcrystalline Cellulose accounts for 89.29% in premixing auxiliary material, require spray velocity to be set at hydrojet speed 10 r/min, atomizing pressure 1.5bar.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012100978227A CN102614519A (en) | 2012-04-06 | 2012-04-06 | Preparation method of premixed auxiliary material for dispersible tablet |
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| Application Number | Priority Date | Filing Date | Title |
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| CN2012100978227A CN102614519A (en) | 2012-04-06 | 2012-04-06 | Preparation method of premixed auxiliary material for dispersible tablet |
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| CN102614519A true CN102614519A (en) | 2012-08-01 |
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| CN2012100978227A Pending CN102614519A (en) | 2012-04-06 | 2012-04-06 | Preparation method of premixed auxiliary material for dispersible tablet |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104548112A (en) * | 2013-10-31 | 2015-04-29 | 安徽山河药用辅料股份有限公司 | Direct compression composite accessory and preparation method thereof |
| CN114522147A (en) * | 2020-11-23 | 2022-05-24 | 武汉武药科技有限公司 | Carglutamic acid solid preparation and preparation method thereof |
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| CN101708336A (en) * | 2009-10-23 | 2010-05-19 | 湖南湘药制药有限公司 | Novel medicinal premixing auxiliary material |
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| US20110151014A1 (en) * | 2009-12-22 | 2011-06-23 | Fmc Corporation | Microcrystalline cellulose and calcium carbonate compositions useful as recompactible pharmaceutical excipients |
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- 2012-04-06 CN CN2012100978227A patent/CN102614519A/en active Pending
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| WO2010132431A1 (en) * | 2009-05-11 | 2010-11-18 | Jrs Pharma Gmbh+Co.Kg | Orally disintegrating excipient |
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| CN101664556A (en) * | 2009-10-09 | 2010-03-10 | 山东聊城阿华制药有限公司 | Lactose-polyvidone-crospolyvidone premixed agent and preparation method thereof |
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| US20110151014A1 (en) * | 2009-12-22 | 2011-06-23 | Fmc Corporation | Microcrystalline cellulose and calcium carbonate compositions useful as recompactible pharmaceutical excipients |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104548112A (en) * | 2013-10-31 | 2015-04-29 | 安徽山河药用辅料股份有限公司 | Direct compression composite accessory and preparation method thereof |
| CN104548112B (en) * | 2013-10-31 | 2017-10-24 | 安徽山河药用辅料股份有限公司 | A kind of direct tablet compressing composite auxiliary material and preparation method thereof |
| CN114522147A (en) * | 2020-11-23 | 2022-05-24 | 武汉武药科技有限公司 | Carglutamic acid solid preparation and preparation method thereof |
| CN114522147B (en) * | 2020-11-23 | 2023-08-04 | 武汉武药科技有限公司 | Solid preparation of carboglutamic acid and preparation method thereof |
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Application publication date: 20120801 |