CN101732725B - Composition for speeding up disintegration of tablet and application thereof - Google Patents
Composition for speeding up disintegration of tablet and application thereof Download PDFInfo
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Abstract
The invention discloses a composition for speeding up the disintegration of a tablet and application thereof. The composition comprises the following components in part by weight: 10 to 35 parts of microcrystalline cellulose, 10 to 20 parts of polyvinylpolypyrrolidone, 2 to 10 parts of low-substituted hydroxypropyl cellulose and 0 to 5 parts of insoluble calcium salt or magnesium salt. The auxiliary formulation can facilitate the quick disintegration of the tablet prepared from insoluble medicinal materials or soluble medicinal materials; and when the composition is applied to a medicinal tablet preparation process, the composition can be internally added, externally added or internally and externally added. On such a basis, the composition can be used as the auxiliary formulation of all medicinal tablets, such as dispersible tablets, coating tablets, general tablets, double-layer tablets and the like, has no toxic side effect and is safe to use.
Description
Technical field
The invention belongs to the premix recipe design field of medicinal adjuvant in the field of medicaments.Relate generally to a kind of for promoting the quickly disintegrated compositions of Chinese medicinal tablet and application thereof.
Background technology
All the time, tablet becomes one of dosage form that pharmaceutical industry output is maximum, purposes is the widest, kind is maximum because of advantages such as its technique is simple, easy to use, the easy acceptance of patient.But Chinese medicinal tablet is because ingredient is complicated, and material viscosity is large, and inferior to take the extractum amount large, cause tabletting after disintegrate slow, stripping is poor, bioavailability is lower, uses to be subject to certain limitation.
Good adjuvant can accelerate the disintegrate of Chinese medicinal tablet, regulating medicine rate of release in vivo and in vitro; Can change medicine absorption in vivo, increase bioavailability.Common pharmaceutic adjuvant mostly is single chemical compound, and performance and characteristics are fixed, and the effect of playing also is relatively-stationary.Premixing auxiliary material then is the set of several functions, has specific prescription, and preparation technology is simple, saves production time and cost, and the construction cycle is short, is one of important directions of following adjuvant development.
Summary of the invention
The objective of the invention is to provide a kind of compositions and application thereof of accelerating the Chinese medicinal tablet disintegrate.
Technical scheme provided by the invention is:
A kind of compositions of speeding up disintegration of tablet comprises microcrystalline Cellulose 10～35 weight portions, polyvinylpolypyrrolidone 10～20 weight portions, low-substituted hydroxypropyl cellulose 2～10 weight portions, slightly solubility calcium salt or magnesium salt 0～5 weight portion.
As one embodiment of the present invention, described compositions is by microcrystalline Cellulose 10～35 weight portions, and polyvinylpolypyrrolidone 10～20 weight portions and low-substituted hydroxypropyl cellulose 2～10 weight portions form.
Compositions of the present invention a kind of, preferably microcrystalline cellulose, the weight ratio of polyvinylpolypyrrolidone and low-substituted hydroxypropyl cellulose is 6: 3: 1.
Slightly solubility calcium salt of the present invention or magnesium salt are selected from calcium sulfate, any in calcium carbonate or the magnesium sulfate, and the weight portion in described compositions is 0.1-5.
The another kind of compositions of the present invention is preferred, microcrystalline Cellulose, and polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose form and the weight ratio of slightly solubility calcium salt or magnesium salt is 6: 3: 1: 0.6.
The present invention also provides the application of above-mentioned composition in the Chinese medicinal tablet preparation, and described compositions and water-insoluble Chinese medicine material or water solublity Chinese medicine mixing of materials are pressed into tablet according to the conventional formulation method.
Compositions of the present invention by interior add, add or in add and described water-insoluble Chinese medicine material or water solublity Chinese medicine mixing of materials.
Described tablet refers to dispersible tablet, coated tablet, common plain sheet or double-layer tablet.
Below be to be introduced inventing selected pharmaceutic adjuvant:
Polyvinylpolypyrrolidone: chemical name is cross-linking polyethylene pyrrolidone, is called for short PVPP.This product is the synthesizing cross-linked water-fast homopolymer of N-ethylene-2-Pyrrolidone.Molecular formula is (C
6H
9NO)
n, wherein n represents the average of l-vinyl-2-pyrrolidone chain link.This product is white or off-white powder, and odorless almost has and draws moistly, all insoluble in water and various solvent, but rapid swelling, and volume increases by 150% to 200%.PVPP has very high capillary activity and hydratability, can rapidly water be absorbed in the tablet, and when internal pressure is the intensity that swelling power surpasses tablet, disintegrate just occurs tablet.This product is disintegrating agent, the filler that pharmaceutically is widely used in tablet, granule and capsule.
Low-substituted hydroxypropyl cellulose: be called for short L-HPC, white or off-white powder, odorless, tasteless.L-HPC is a kind of more novel adjuvant, for a kind of porous white irregular particle or powder, has larger surface area, and it can make the tablet easy-formation, granule dispersion after accelerating again its disintegrate and increasing disintegrate.In addition, between the crude structure of L-HPC and medicated powder and other granule larger tessellation is arranged, tablet adhesive strength and hardness are increased, can produce bonding and disintegrate dual function.This product is mainly made tablet disintegrant and binding agent.
Microcrystalline Cellulose: be called for short MCC.For white or off-white color odorless, tasteless porous crystallite shape granule or powder, be the most widely used a kind of adjuvant of rapidly disintegrating formulation, the pipe that it has spongiform porous splits structure, and is fine with the tablet hardness of MCC compacting, and very easily disintegrate; MCC is plastic deformation in pressure process, in addition capillarity, and moisture very easily infiltrates the hydrogen bond that destroys in the sheet between the crystallite, impels disintegration of tablet.Useful as drug excipient and tablet disintegrant on medical industry are used very extensive.
Calcium sulfate: white powder.Density 2.964g/cm
31450 ℃ of fusing points.Easily the moisture absorption is water insoluble, is dissolved in acid.Usually use with two water things and half water thing form.Two water things are commonly called as Gypsum Fibrosum and Gypsum Fibrosum, are the monoclinic system white powders, are dissolved in acid, ammonium salt, glycerol, are slightly soluble in water, are insoluble to ethanol.Density 2.32g/cm
31350～1375 ℃ of fusing points.128 ℃ lose 1.5 molecular waters, are heated to 163 ℃ and lose 2 molecular waters.Half water thing is white powder, has water absorption, mixes with water to form the slurry that plasticity is easily watered block, namely solidify every certain hour, and with volumetric expansion and the heat release of trace.Half water thing has again two kinds on α type and β type.The α type is commonly called as high-strength building gypsum, and the β type is commonly called as Gypsum Fibrosum preparata and bassanite.
Calcium carbonate: be the main component of Calx rock (abbreviation limestone), its molecular formula is CaCO
3, relative molecular mass is 100.09.Wherein calcium oxide accounts for 56.03%, and carbon dioxide accounts for 43.97%.Calcium carbonate mainly contains three kinds of precipitated calcium carbonates, ground calcium carbonate, activated Calcium carbonate.
Magnesium sulfate: be a kind of chemical compound that contains magnesium, molecular formula is MgSO
4(or MgSO
47H
2O).Crystal or the white powder of colourless or white easy-weathering.Odorless.Bitter saline taste is arranged.Density 1.68.Lose six molecular crystalline water at 150 ℃, lose whole water of crystallization at 200 ℃.The density 2.66 of anhydride, 1124 ℃ of fusing points decompose simultaneously.Water-soluble, glycerol and ethanol.
During referring to produce, " percentage by weight " of the present invention take gram or kilogram as unit adjuvant is carried out proportioning by weight.In view of the needs of Chinese medicinal tablet production and application, its application in Chinese medicinal tablet technique preparation add, add in can being or in add (can add briefly introduce in add, add).
Chinese medicinal tablet can be on the basis of above-mentioned prescription reasonable pharmaceutic adjuvants such as absorb fillers, excipient correctives, fluidizer, to satisfy drug manufacture and use.
The present invention obtains shortly collapses premixing auxiliary material and has that the method preparation is simple, good stability, characteristics that quality is high, easy to use.Concrete research process is as follows:
Because medicine disintegrate, maximum leading factor are speed and the water absorption of adjuvant suction, the adjuvant prescription that absorption speed is faster, water absorption is larger, its disintegration must be stronger, based on this principle, this experimental design following experiment be to seek the optimum prescription that promotes disintegrate.
Get adjuvant total amount 100g, MCC, PVPP, LHPC three mix by following mixture experiment design experimental group prescription, adding certain adhesive granulates, after the drying, add micropowder silica gel 1g, magnesium stearate 1g mixing, the sheet of tablet heavily is the 1.0g/ sheet in accordance with regulations on single punch tablet machine, and the Hardness Control of tablet is measured the tablet water absorption at (3.5 ± 0.5) kg.cm-2 tabletting.(annotate PVPP except specializing, all use ISP PVPP-XL)
Mixture experiment design:
Table 1 factor level table (actual value)
If MCC+PVPP+L-HPC=1
With above factor level, through the design of SAS statistical software, select MCC*PVPP*L-HPC exchange interaction saturation experiments group, provide altogether the experiment of 7 assembly material, by tabletting behind the batching experimental formula, detect water absorption.
Table 2 experimental program and table as a result
Date processing and interpretation of result
Draw regression equation, section prediction collection of illustrative plates and equal pitch contour optimization through the analysis of SAS software statistics, collapse condition take water absorption 2.5 to 3.5 as short, draw, the short prescription scope that collapses
MCC?10％～35％ PVPP?10％～20％ LHPC?2％～10％
(MCC+PVPP+LHPC＝100％)
And MCC: PVPP: LHPC ≈ 6: 3: 1 o'clock, water absorption is maximum, is 3.50ml
Confirmatory experiment:
With above prescription, repeated authentication three times, and with the independent tabletting of MCC, PVPP, LHPC three relatively, the result is as follows:
Table 3 confirmatory experiment table (n=3)
| Prescription | Water absorption (ml) |
| MCC∶PVPP∶LHPC6∶3∶1 | 3.45 |
| PVPP | 3.14 |
| MCC | 1.5 |
| LHPC | 2.2 |
Draw MCC from the result: PVPP: LHPC (6: 3: 1) prescription water absorption is maximum, and it is all relatively poor that MCC and LHPC use separately water absorption.Therefore, MCC: PVPP: LHPC (6: 3: 1) disintegrate effect is preferably the highest as disintegrate prescription cost performance.
In infantile heat-clearing and antitussive dispersing tablets, antiviral dispersant tablet and the research of WUJI BAIFENG WAN dispersible tablet formulation and technology; we find; three prescription application urge to collapse prescription one, and still disintegrate is slow; possible reason is; this three prescription is the water extracted immersing paste, and viscosity is large, meets water and forms protecting film; water is difficult for infiltrating the sheet heart, causes the disintegrate difficulty.For this reason, we have added 3% inorganic salt in prescription, and as a result disintegrate is effect improved very obvious.
For the checking inorganic salt can improve the water extracted immersing paste dispersible tablet moisture processed permeating speed, this problem has been carried out following experiment:
Prescription one: infantile heat-clearing and antitussive medicated powder 40g, microcrystalline Cellulose 33g, crospolyvinylpyrrolidone 18g, low-substituted hydroxypropyl cellulose sodium 6g, micropowder silica gel 1g, magnesium stearate 1g,
Prescription two: infantile heat-clearing and antitussive medicated powder 40g, microcrystalline Cellulose 32g, crospolyvinylpyrrolidone 17g, low-substituted hydroxypropyl cellulose sodium 5g, micropowder silica gel 1g, magnesium stearate 1g, calcium sulfate 3g
Be pressed into 0.8 specification tablet at single punch tablet machine respectively, the Hardness Control of tablet is at (3.5 ± 0.5) kg.cm-2 tabletting.The same method detects absorbtivity, and the result is as follows:
Table 4 prescription one and prescription two absorption speed tables
From upper table analysis as can be known, add calcium sulfate salt obviously than the salt adding rate of water absorption is not fast; And the short prescription two that collapses:
MCC∶PVPP∶LHPC∶GaSO4＝6∶3∶1∶0.6
Be conducive to the dispersible tablet disintegrate processed of the water extracted immersing paste material.
The specific embodiment:
The invention will be further described below in conjunction with the specific embodiment, but the present invention is not limited to following embodiment.
Embodiment 1 short Orally disintegrating composition one:
2 parts of 10 parts of low-substituted hydroxypropyl celluloses of 35 parts of polyvinylpolypyrrolidone of microcrystalline Cellulose
Embodiment 2 short Orally disintegrating compositions two:
5 parts of 15 parts of low-substituted hydroxypropyl celluloses of 25 parts of polyvinylpolypyrrolidone of microcrystalline Cellulose
Embodiment 3 short Orally disintegrating compositions three:
10 parts of 20 parts of low-substituted hydroxypropyl celluloses of 10 parts of polyvinylpolypyrrolidone of microcrystalline Cellulose
Embodiment 4 short Orally disintegrating compositions four:
5 parts of 20 parts of low-substituted hydroxypropyl celluloses of 20 parts of polyvinylpolypyrrolidone of microcrystalline Cellulose
Embodiment 5 short Orally disintegrating compositions five:
1 part of 9 parts of low-substituted hydroxypropyl cellulose of 18 parts of polyvinylpolypyrrolidone of microcrystalline Cellulose
Embodiment 6 short Orally disintegrating compositions six:
5 parts of 15 parts of low-substituted hydroxypropyl celluloses of 25 parts of polyvinylpolypyrrolidone of microcrystalline Cellulose
2.5 parts in calcium sulfate
Embodiment 7 short Orally disintegrating compositions seven:
5 parts of 15 parts of low-substituted hydroxypropyl celluloses of 30 parts of polyvinylpolypyrrolidone of microcrystalline Cellulose
3 parts in calcium sulfate
Embodiment 8 short Orally disintegrating compositions eight:
5 parts of 15 parts of low-substituted hydroxypropyl celluloses of 30 parts of polyvinylpolypyrrolidone of microcrystalline Cellulose
3 parts of calcium carbonate
Embodiment 9 short Orally disintegrating compositions nine:
5 parts of 15 parts of low-substituted hydroxypropyl celluloses of 30 parts of polyvinylpolypyrrolidone of microcrystalline Cellulose
3 parts in magnesium sulfate
The short premixing auxiliary material that collapses of the present invention through disintegration of tablet experiment and water absorption experimentation, all can significantly promote the Chinese medicinal tablet disintegrate, the results are shown in hereinafter embodiment.
Embodiment 10:
Get the peaceful medicated powder 51g of gallbladder, embodiment 1 described compositions one mixing, add an amount of 4PVPK
30(Chinese?) 20% ethanol, 40 eye mesh screens are granulated, 60 ℃ of dryings 2 hours, and granulate, granule is for subsequent use; Add micropowder silica gel 1g, magnesium stearate 1g mixing in granule, be pressed into the 0.5g/ sheet by dose calculating on single punch tablet machine, the Hardness Control of tablet is at (3.5 ± 0.5) kg.cm-2 tabletting.Observe outward appearance and measure its disintegration time, dissolution, the results are shown in Table 4.
Embodiment 11:
Get the peaceful medicated powder 53g of gallbladder, embodiment 2 described compositions two mixings, add an amount of 4PVPK
30(Chinese?) 20% ethanol, 40 eye mesh screens are granulated, 60 ℃ of dryings 2 hours, and granulate, granule is for subsequent use; Add microcrystalline Cellulose 10g and micropowder silica gel 1g, magnesium stearate 1g mixing in the granule, calculate by dose on single punch tablet machine and be pressed into the 0.5g/ sheet, the Hardness Control of tablet is at (3.5 ± 0.5) kg.cm-2 tabletting.Observe outward appearance and measure its disintegration time, dissolution, the results are shown in Table 4.
Embodiment 12
Get the peaceful medicated powder 58g of gallbladder, embodiment 3 described compositions three mixings, add an amount of 4PVPK
30(Chinese?) 20% ethanol, 40 eye mesh screens are granulated, 60 ℃ of dryings 2 hours, and granulate, granule is for subsequent use; Add polyvinylpolypyrrolidone 10g and micropowder silica gel 1g, magnesium stearate 1g mixing in the granule, calculate by dose on single punch tablet machine and be pressed into the 0.5g/ sheet, the Hardness Control of tablet is at (3.5 ± 0.5) kg.cm-2 tabletting.Observe outward appearance and measure its disintegration time, dissolution, the results are shown in Table 4.
Table 4 embodiment 10-12 measurement result table (n=3)
Embodiment 13:
Cancellation bolt collateral dredging medicated powder 53g, embodiment 4 described compositions mixings add an amount of 4PVPK
3020% ethanol, 40 eye mesh screens are granulated, 60 ℃ of dryings 2 hours, and granulate, granule is for subsequent use; Add micropowder silica gel 1g, magnesium stearate 1g mixing in granule, be pressed into the 1.2g/ sheet by dose calculating on single punch tablet machine, the Hardness Control of tablet is at (3.5 ± 0.5) kg.cm-2 tabletting.Observe outward appearance and measure its disintegration time, dissolution, the results are shown in Table 5.
Embodiment 14:
Cancellation bolt collateral dredging medicated powder 38g, embodiment 5 described compositions mixings add an amount of 4PVPK
3020% ethanol, 40 eye mesh screens are granulated, 60 ℃ of dryings 2 hours, and granulate, granule is for subsequent use; Add microcrystalline Cellulose 10g and micropowder silica gel 1g, magnesium stearate 1g mixing in the granule, calculate by dose on single punch tablet machine and be pressed into the 1.2g/ sheet, the Hardness Control of tablet is at (3.5 ± 0.5) kg.cm-2 tabletting.Observe outward appearance and measure its disintegration time, dissolution, the results are shown in Table 5.
Table 5 embodiment 13-14 measurement result table (n=3)
Implement 15:
Get infantile heat-clearing and antitussive medicated powder 50.5g, embodiment 6 described compositions mixings, add an amount of 4PVPK
3020% ethanol, 40 eye mesh screens are granulated, 60 ℃ of dryings 2 hours, and granulate, granule is for subsequent use; Add micropowder silica gel 1g, magnesium stearate 1g mixing in granule, be pressed into the 0.8g/ sheet by dose calculating on single punch tablet machine, the Hardness Control of tablet is at (3.5 ± 0.5) kg.cm-2 tabletting.Observe outward appearance and measure its disintegration time, dissolution, the results are shown in Table 6.
Embodiment 16:
Get infantile heat-clearing and antitussive medicated powder 45g, embodiment 7 described compositions mixings, add an amount of 4PVPK
3020% ethanol, 40 eye mesh screens are granulated, 60 ℃ of dryings 2 hours, and granulate, granule is for subsequent use; Add polyvinylpolypyrrolidone 5g and micropowder silica gel 1g, magnesium stearate 1g mixing in the granule, calculate by dose on single punch tablet machine and be pressed into the 0.8g/ sheet, the Hardness Control of tablet is at (3.5 ± 0.5) kg.cm-2 tabletting.Observe outward appearance and measure its disintegration time, dissolution, the results are shown in Table 6.
Embodiment 17:
Get infantile heat-clearing and antitussive medicated powder 45g, embodiment 8 described compositions mixings, add an amount of 4PVPK
3020% ethanol, 40 eye mesh screens are granulated, 60 ℃ of dryings 2 hours, and granulate, granule is for subsequent use; Add micropowder silica gel 1g, magnesium stearate 1g mixing in granule, be pressed into the 0.8g/ sheet by dose calculating on single punch tablet machine, the Hardness Control of tablet is at (3.5 ± 0.5) kg.cm-2 tabletting.Observe outward appearance and measure its disintegration time, dissolution, the results are shown in Table 6.
Embodiment 18:
Get infantile heat-clearing and antitussive medicated powder 45g, embodiment 9 described compositions mixings, add an amount of 4PVPK
3020% ethanol, 40 eye mesh screens are granulated, 60 ℃ of dryings 2 hours, and granulate, granule is for subsequent use; Add polyvinylpolypyrrolidone 10g and micropowder silica gel 1g, magnesium stearate 1g mixing in the granule, calculate by dose on single punch tablet machine and be pressed into the 0.8g/ sheet, the Hardness Control of tablet is at (3.5 ± 0.5) kg.cm-2 tabletting.Observe outward appearance and measure its disintegration time, dissolution, the results are shown in Table 6.
Table 6 embodiment 15-18 measurement result table (n=3)
Above embodiment proves, use short collapse the premix prescription after, after gallbladder was peaceful, eliminating thrombus and removing obstruction in channels, infantile heat-clearing and antitussive prescription be prepared into Chinese medicinal tablet, disintegration time was accelerated, the index components dissolution rate improves.The present invention urgees to collapse the disintegrate that compositions helps Chinese medicinal tablet.
Claims (3)
1. the compositions of a speeding up disintegration of tablet, described compositions comprises microcrystalline Cellulose, polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose, slightly solubility calcium salt or magnesium salt is characterized in that: described microcrystalline Cellulose, polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose forms and the weight ratio of slightly solubility calcium salt or magnesium salt is 6: 3: 1: 0.6, and described slightly solubility calcium salt or magnesium salt are selected from any in calcium sulfate, calcium carbonate or the magnesium sulfate.
2. the according to claim 1 application of described compositions in the Chinese medicinal tablet preparation, it is characterized in that: described compositions and water-insoluble Chinese medicine material or water solublity Chinese medicine mixing of materials are pressed into tablet according to the conventional formulation method.
3. application according to claim 2 is characterized in that: described tablet refers to dispersible tablet, coated tablet, common plain sheet or double-layer tablet.
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| CN116370423A (en) * | 2023-02-28 | 2023-07-04 | 天津力生制药股份有限公司 | Ticagrelor orally disintegrating tablet and preparation method thereof |
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| CN1927372A (en) * | 2006-09-05 | 2007-03-14 | 江西本草天工科技有限责任公司 | Antiviral dispersant tablet and method for making same |
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| CN1927372A (en) * | 2006-09-05 | 2007-03-14 | 江西本草天工科技有限责任公司 | Antiviral dispersant tablet and method for making same |
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| Title |
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| 陈燕军等.几种常用填充剂与崩解剂在中药分散片应用中的性能比较.《中国中药杂志》.2002,第27卷(第8期),580-583. * |
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