CN105395503B - A kind of Compound Chlorzoxazone dispersible tablet - Google Patents
A kind of Compound Chlorzoxazone dispersible tablet Download PDFInfo
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- CN105395503B CN105395503B CN201510996045.3A CN201510996045A CN105395503B CN 105395503 B CN105395503 B CN 105395503B CN 201510996045 A CN201510996045 A CN 201510996045A CN 105395503 B CN105395503 B CN 105395503B
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- chlorzoxazone
- dispersible tablet
- compound
- crospovidone
- added
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- TZFWDZFKRBELIQ-UHFFFAOYSA-N chlorzoxazone Chemical compound ClC1=CC=C2OC(O)=NC2=C1 TZFWDZFKRBELIQ-UHFFFAOYSA-N 0.000 title claims abstract description 40
- 229960003633 chlorzoxazone Drugs 0.000 title claims abstract description 39
- 150000001875 compounds Chemical class 0.000 title claims abstract description 26
- 239000007919 dispersible tablet Substances 0.000 title claims abstract description 26
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims abstract description 18
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims abstract description 16
- 229960000913 crospovidone Drugs 0.000 claims abstract description 16
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims abstract description 16
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims abstract description 16
- 238000002360 preparation method Methods 0.000 claims abstract description 14
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 claims abstract description 13
- 229960005489 paracetamol Drugs 0.000 claims abstract description 13
- 239000000853 adhesive Substances 0.000 claims abstract description 9
- 230000001070 adhesive effect Effects 0.000 claims abstract description 9
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 9
- 229940075614 colloidal silicon dioxide Drugs 0.000 claims abstract description 9
- 239000000314 lubricant Substances 0.000 claims abstract description 8
- 238000002156 mixing Methods 0.000 claims abstract description 7
- 239000006185 dispersion Substances 0.000 claims abstract description 6
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 25
- 239000007962 solid dispersion Substances 0.000 claims description 15
- 239000000463 material Substances 0.000 claims description 8
- 239000012876 carrier material Substances 0.000 claims description 6
- 229920002472 Starch Polymers 0.000 claims description 5
- 230000002829 reductive effect Effects 0.000 claims description 5
- 238000007873 sieving Methods 0.000 claims description 5
- 239000008107 starch Substances 0.000 claims description 5
- 235000019698 starch Nutrition 0.000 claims description 5
- 238000005550 wet granulation Methods 0.000 claims description 5
- 235000020985 whole grains Nutrition 0.000 claims description 5
- 230000036961 partial effect Effects 0.000 claims description 4
- 229920003081 Povidone K 30 Polymers 0.000 claims description 2
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 claims description 2
- 235000013539 calcium stearate Nutrition 0.000 claims description 2
- 239000008116 calcium stearate Substances 0.000 claims description 2
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 claims description 2
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 2
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 2
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 2
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims description 2
- 229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 claims description 2
- 239000000203 mixture Substances 0.000 claims description 2
- 239000002002 slurry Substances 0.000 claims description 2
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 claims 1
- 235000021355 Stearic acid Nutrition 0.000 claims 1
- 239000008119 colloidal silica Substances 0.000 claims 1
- 229910052749 magnesium Inorganic materials 0.000 claims 1
- 239000011777 magnesium Substances 0.000 claims 1
- 235000001055 magnesium Nutrition 0.000 claims 1
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical group CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims 1
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims 1
- 229910052710 silicon Inorganic materials 0.000 claims 1
- 239000010703 silicon Substances 0.000 claims 1
- 239000008117 stearic acid Substances 0.000 claims 1
- 238000000034 method Methods 0.000 abstract description 8
- 239000000047 product Substances 0.000 abstract description 7
- 238000004519 manufacturing process Methods 0.000 abstract description 2
- 239000002245 particle Substances 0.000 abstract description 2
- 239000012467 final product Substances 0.000 abstract 1
- 239000000243 solution Substances 0.000 description 14
- 238000004090 dissolution Methods 0.000 description 12
- 235000019441 ethanol Nutrition 0.000 description 9
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 8
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 6
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 description 5
- 229940079593 drug Drugs 0.000 description 5
- 239000003814 drug Substances 0.000 description 5
- RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical compound CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 description 4
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 4
- 230000000052 comparative effect Effects 0.000 description 4
- 210000003205 muscle Anatomy 0.000 description 4
- 238000010521 absorption reaction Methods 0.000 description 3
- 239000013558 reference substance Substances 0.000 description 3
- 230000001133 acceleration Effects 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 2
- 239000002075 main ingredient Substances 0.000 description 2
- 239000000843 powder Substances 0.000 description 2
- 239000000377 silicon dioxide Substances 0.000 description 2
- 239000012085 test solution Substances 0.000 description 2
- 230000010148 water-pollination Effects 0.000 description 2
- CDAWCLOXVUBKRW-UHFFFAOYSA-N 2-aminophenol Chemical class NC1=CC=CC=C1O CDAWCLOXVUBKRW-UHFFFAOYSA-N 0.000 description 1
- 206010067484 Adverse reaction Diseases 0.000 description 1
- 241000167880 Hirundinidae Species 0.000 description 1
- 206010024453 Ligament sprain Diseases 0.000 description 1
- 206010054949 Metaplasia Diseases 0.000 description 1
- QSMTUAJDOTXEDZ-UHFFFAOYSA-N N1C=CC=C1.[Cl] Chemical class N1C=CC=C1.[Cl] QSMTUAJDOTXEDZ-UHFFFAOYSA-N 0.000 description 1
- 208000010040 Sprains and Strains Diseases 0.000 description 1
- 125000000218 acetic acid group Chemical group C(C)(=O)* 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 230000006838 adverse reaction Effects 0.000 description 1
- 235000011114 ammonium hydroxide Nutrition 0.000 description 1
- 230000000202 analgesic effect Effects 0.000 description 1
- 230000001760 anti-analgesic effect Effects 0.000 description 1
- 230000003110 anti-inflammatory effect Effects 0.000 description 1
- 239000002221 antipyretic Substances 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000033228 biological regulation Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 210000000988 bone and bone Anatomy 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 210000003710 cerebral cortex Anatomy 0.000 description 1
- 230000001684 chronic effect Effects 0.000 description 1
- 238000002425 crystallisation Methods 0.000 description 1
- 230000008025 crystallization Effects 0.000 description 1
- 238000011978 dissolution method Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000010812 external standard method Methods 0.000 description 1
- 210000003195 fascia Anatomy 0.000 description 1
- 239000000706 filtrate Substances 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 230000003760 hair shine Effects 0.000 description 1
- 238000005213 imbibition Methods 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 230000003902 lesion Effects 0.000 description 1
- 210000003041 ligament Anatomy 0.000 description 1
- 230000000670 limiting effect Effects 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 238000005461 lubrication Methods 0.000 description 1
- 235000019359 magnesium stearate Nutrition 0.000 description 1
- 235000013372 meat Nutrition 0.000 description 1
- 230000015689 metaplastic ossification Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 239000003158 myorelaxant agent Substances 0.000 description 1
- 230000001537 neural effect Effects 0.000 description 1
- 239000000842 neuromuscular blocking agent Substances 0.000 description 1
- 230000009965 odorless effect Effects 0.000 description 1
- 150000003180 prostaglandins Chemical class 0.000 description 1
- 230000011514 reflex Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 239000004576 sand Substances 0.000 description 1
- 210000004872 soft tissue Anatomy 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 210000000278 spinal cord Anatomy 0.000 description 1
- 230000001629 suppression Effects 0.000 description 1
- 230000008961 swelling Effects 0.000 description 1
- 230000000946 synaptic effect Effects 0.000 description 1
- 230000002195 synergetic effect Effects 0.000 description 1
- 238000003786 synthesis reaction Methods 0.000 description 1
- 239000003826 tablet Substances 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/42—Oxazoles
- A61K31/423—Oxazoles condensed with carbocyclic rings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses a kind of Compound Chlorzoxazone dispersible tablets, said preparation adsorbs the Chlorzoxazone and paracetamol of recipe quantity by crospovidone and colloidal silicon dioxide, is dried to obtain dispersion, adds adhesive, disintegrating agent and lubricant, mixing, tabletting to obtain the final product.Compared with prior art, rapidly, the particle after disintegration can pass through No. 2 sieves for the product disintegration that the present invention obtains, and simple process is suitble to industrialized production.
Description
Technical field
The invention belongs to pharmaceutical technology fields, and in particular to a kind of Compound Chlorzoxazone dispersible tablet.
Background technique
Chlorzoxazone is colourless crystallization or white to off-white color crystalline powder, and odorless bitter is slightly soluble in water, is dissolved in 20 parts
Ethyl alcohol, 250 parts of chloroforms, 60 parts of ether, are dissolved in dilute ammoniacal liquor and highly basic.Molecular formula: C7H4ClNO2, molecular weight: 169.57, CAS:
95-25-0。
This product is a novel neuromuscular blocking agent.The external U.S., Japan's production, and recorded respectively in United States Pharmacopeia 21 editions
With Pharmacopeia of Japan the 10th edition.This product is a central muscle relaxant, mainly acts on maincenter under spinal cord and cerebral cortex.Suppression
System more synaptic neural reflex arcs related with muscle spasmus is generated, are reached by alleviation muscle spasmus and eliminate pain and increase lesion flesh
The effect of meat mobility.
Paracetamol is nonsteroidal analgesic-antipyretic, by inhibiting the synthesis of prostaglandin to play analgesic effect.With
Chlorzoxazone has synergistic effect, and more remarkable treatment effect in ease pain, and adverse reaction is smaller.
So Chlorzoxazone and paracetamol match the compound preparation formed with 5:6, there is central relaxation bone
Flesh and anti-inflammatory and analgesic effect, be clinically mainly used for various acute and chronic soft tissues (muscle ligament, fascia) sprain, dampen and
The caused pain of muscle after exercise strain.
The currently marketed dosage form of the compound preparation mainly has COMPOUND CHLORZOXAZONE TABLETS, Compound Chlorzoxazone capsule, compound chlorine
Azoles sand ancestor's dispersible tablet, wherein for dispersible tablet with good dispersing state, disintegration time is short, and drug-eluting is rapid, absorbs fast, bioavilability
Height, it is convenient to take the features such as favor by patient.Especially it is suitble to old or swallows difficult patient, dispersible tablet is added
In suitable quantity of water, take after mixing evenly.Chlorzoxazone dissolves in methanol, ethyl alcohol or acetone, slightly molten in ether, several in water
It is insoluble；Paracetamol this product is readily soluble in hot water or ethyl alcohol, dissolves in acetone, slightly molten in water.So the compound
The dissolution rate of preparation is not very high and problem to be solved！
Summary of the invention
It is an object of the invention in view of the above drawbacks of the prior art, provide a kind of Compound Chlorzoxazone dispersible tablet.Hair
Bright people carries out in research process for the not high problem of two kinds of main ingredient dissolution rates of existing Compound Chlorzoxazone dispersible tablet, unexpected to send out
It is existing, it is dry after being adsorbed with ethanol solution of the crospovidone to two kinds of main ingredients, cured load medicinal powder end can be obtained, and
Rapid expansible drug dissolution is rapid in water, but discovery dissolution is declined after tabletting, and then, inventor is in absorption medical fluid mistake
Certain colloidal silicon dioxide is added in journey, increases water imbibition, drug-eluting is rapid.
Specifically, the present invention is achieved through the following technical solutions:
A kind of Compound Chlorzoxazone dispersible tablet, the dispersible tablet by Chlorzoxazone, paracetamol, carrier material and other
Pharmaceutically acceptable auxiliary material composition, the carrier material are made of crospovidone and colloidal silicon dioxide.
The Compound Chlorzoxazone dispersible tablet, the partial size of crospovidone are 10~30 μm.
The Compound Chlorzoxazone dispersible tablet, the weight ratio of Chlorzoxazone and carrier material are as follows: 1:1-8；It is preferred that 1:4.
The Compound Chlorzoxazone dispersible tablet, the weight ratio of colloidal silicon dioxide and crospovidone are as follows: 1:1-5；It is excellent
Select 1:3.
The Compound Chlorzoxazone dispersible tablet, the pharmaceutically acceptable auxiliary material include disintegrating agent, adhesive and profit
Lubrication prescription.
The Compound Chlorzoxazone dispersible tablet, the disintegrating agent are dried starch, low-substituted hydroxypropyl cellulose, carboxylic first
One of starch is a variety of.
The Compound Chlorzoxazone dispersible tablet, the adhesive are starch slurry, hydroxypropyl methylcellulose, PVP K30
One of or it is a variety of.
The Compound Chlorzoxazone dispersible tablet, the lubricant are magnesium stearate, calcium stearate, one in talcum powder
Kind is a variety of.
The preparation method of the Compound Chlorzoxazone dispersible tablet the following steps are included:
(1) take Chlorzoxazone, the paracetamol of recipe quantity, ethanol in proper amount be added, be vigorously stirred be allowed to be dissolved as it is clear
Crospovidone after sieving is added in clear solution, is slowly stirred, is uniformly dispersed, add colloidal state two by clear solution
Silica is sufficiently stirred, and keeps material dispersion uniform；Solid dispersions are prepared using being dried under reduced pressure, by solid dispersions
It carries out crushing and crossing 80 meshes, it is spare；
(2) solid dispersions that step (1) obtains are subjected to wet granulation with suitable adhesive, dry whole grain is added
The disintegrating agent and lubricant of recipe quantity, mixing, tabletting to get.
Compared with prior art, the present invention drug-eluting speed is fast, simple process does not need micronization processes.Accelerate examination
Verify bright, rapidly, the particle after disintegration can pass through No. 2 sieves, simple process, suitable work to the disintegration of product that the present invention obtains
Industry metaplasia produces.
Specific embodiment
Beneficial effects of the present invention are now further described by following embodiment, these embodiments are only used for the mesh of illustration
, it should not be construed as limiting the invention, the obvious improvement and modification that those skilled in the art are the present invention
Also within that scope of the present invention.
Embodiment 1
Preparation process:
(1) take Chlorzoxazone, the paracetamol of recipe quantity, ethanol in proper amount be added, be vigorously stirred be allowed to be dissolved as it is clear
Crospovidone after sieving is added in clear solution, is slowly stirred, is uniformly dispersed, add colloidal state two by clear solution
Silica is sufficiently stirred, and keeps material dispersion uniform；Solid dispersions are prepared using being dried under reduced pressure, by solid dispersions
It carries out crushing and crossing 80 meshes, it is spare；
(2) solid dispersions that step (1) obtains are subjected to wet granulation with suitable adhesive, dry whole grain is added
The disintegrating agent and lubricant of recipe quantity, mixing, tabletting to get.
Embodiment 2
Preparation process: with embodiment 1.
Embodiment 3
Embodiment 4
Preparation process: with embodiment 1.
Embodiment 5
Preparation process: with embodiment 1.
Embodiment 6
Preparation process: with embodiment 1.
Comparative example 1
Preparation process:
(1) take Chlorzoxazone, the paracetamol of recipe quantity, ethanol in proper amount be added, be vigorously stirred be allowed to be dissolved as it is clear
Crospovidone after sieving is added in clear solution, is slowly stirred, keeps material dispersion uniform by clear solution；Using
It is dried under reduced pressure and solid dispersions is prepared, solid dispersions are carried out to crush and cross 80 meshes, it is spare；
(2) solid dispersions that step (1) obtains are subjected to wet granulation with suitable adhesive, dry whole grain is added
The disintegrating agent and lubricant of recipe quantity, mixing, tabletting to get.
Comparative example 2
Preparation process:
(1) colloidal silicon dioxide of recipe quantity crosses 80 meshes, spare；
(2) take Chlorzoxazone, the paracetamol of recipe quantity, ethanol in proper amount be added, be vigorously stirred be allowed to be dissolved as it is clear
Colloidal silicon dioxide after step (1) sieving is sufficiently stirred, keeps material dispersion uniform by clear solution；Using being dried under reduced pressure
Solid dispersions are prepared, solid dispersions are carried out to crush and cross 80 meshes, it is spare；
(3) solid dispersions that step (2) obtains are subjected to wet granulation with suitable adhesive, dry whole grain is added
The disintegrating agent and lubricant of recipe quantity, mixing, tabletting to get.
Comparative example 3
Preparation process: with embodiment 1.
Verify embodiment
The dissolution rate and dispersing uniformity of Compound Chlorzoxazone dispersible tablet measure
1. dissolution determination: it shines dissolution method (two the second methods of annex XC of Chinese Pharmacopoeia version in 2010), with
0.1mol/L hydrochloric acid solution 900ml is solvent, and revolving speed is 100 turns per minute, operates according to methods, when through 5min, takes solution appropriate, filters
It crosses, subsequent filtrate is as test solution.Chlorzoxazone reference substance 15mg and paracetamol reference substance 18mg separately are taken, is set
In 100ml measuring bottle, a small amount of methanol is added to make to dissolve, scale is diluted to 0.1mol/L hydrochloric acid solution, as reference substance solution.According to containing
The chromatographic condition determined under item is measured, precision measures each 20 μ l of test solution and control solution and injects liquid chromatograph, record
Chromatogram is gone out with calculated by peak area every the amount of dissolution by external standard method.The limit of Chlorzoxazone is the 75% of labelled amount, to acetyl
The limit of amino phenols is the 80% of labelled amount, should all meet regulation.
2. dispersing uniformity: taking this product 6, set in 250ml beaker, add 20 DEG C of water 100ml, shake 3min, should all collapse
It solves and crosses No. 2 sieves.
Verifying embodiment the results are shown in Table 1.
Acceleration environment: 40 DEG C, the 75%RH acceleration time: 6 months.
1 dispersing uniformity of table and dissolution determination
As can be seen from the table, the present invention passes through by swelling in ethyl alcohol but undissolved crospovidone and with absorption
Property, hydrophilic colloidal silicon dioxide absorption Chlorzoxazone and paracetamol, the dispersible tablet disintegration enabled to rapidly,
Dissolution rate obviously increases.Obtained product conforms to quality requirements.Especially the partial size of crospovidone should also have corresponding requirement,
The reason is that the partial size of crospovidone is excessive to lead to the dissolution that is too deep and influencing drug that drug sucks；Such as comparative example 3
Diameter increases dissolution rate and accordingly reduces.The adsorptivity and hydrophily of colloidal silicon dioxide, can adsorb certain drug and
Hydrophily accelerates the speed and drug dissolution of crospovidone water-swellable.
Claims (4)
1. a kind of Compound Chlorzoxazone dispersible tablet, which is characterized in that the dispersible tablet is by Chlorzoxazone, paracetamol, carrier
Material and other pharmaceutically acceptable auxiliary material compositions, the carrier material is by crospovidone and colloidal silicon dioxide group
At；The weight ratio of Chlorzoxazone and carrier material are as follows: 1:1-8；The weight ratio of colloidal silicon dioxide and crospovidone are as follows: 1:1-
5；The partial size of crospovidone is 10~30 μm；Preparation method includes the following steps:
(1) take Chlorzoxazone, the paracetamol of recipe quantity, ethanol in proper amount be added, be vigorously stirred be allowed to be dissolved as it is clear
Crospovidone after sieving is added in clear solution, is slowly stirred, is uniformly dispersed, add colloidal silica by solution
Silicon is sufficiently stirred, and keeps material dispersion uniform；Solid dispersions are prepared using being dried under reduced pressure, solid dispersions are carried out
80 meshes are crushed and cross, it is spare；
(2) solid dispersions that step (1) obtains are subjected to wet granulation with suitable adhesive, prescription is added in dry whole grain
The disintegrating agent and lubricant of amount, mixing, tabletting to get.
2. Compound Chlorzoxazone dispersible tablet according to claim 1, which is characterized in that the disintegrating agent be dried starch,
One of low-substituted hydroxypropyl cellulose, carboxymethylstarch are a variety of.
3. Compound Chlorzoxazone dispersible tablet according to claim 1, which is characterized in that the adhesive be starch slurry,
One of hydroxypropyl methylcellulose, PVP K30 are a variety of.
4. Compound Chlorzoxazone dispersible tablet according to claim 1, which is characterized in that the lubricant is stearic acid
One of magnesium, calcium stearate, talcum powder are a variety of.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510996045.3A CN105395503B (en) | 2015-12-25 | 2015-12-25 | A kind of Compound Chlorzoxazone dispersible tablet |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510996045.3A CN105395503B (en) | 2015-12-25 | 2015-12-25 | A kind of Compound Chlorzoxazone dispersible tablet |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN105395503A CN105395503A (en) | 2016-03-16 |
| CN105395503B true CN105395503B (en) | 2019-02-26 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510996045.3A Active CN105395503B (en) | 2015-12-25 | 2015-12-25 | A kind of Compound Chlorzoxazone dispersible tablet |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN105395503B (en) |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103830184A (en) * | 2014-02-18 | 2014-06-04 | 北京大学 | Solid dispersion system of febuxostat and preparation method of solid dispersion system, and pharmaceutical applications |
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2015
- 2015-12-25 CN CN201510996045.3A patent/CN105395503B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103830184A (en) * | 2014-02-18 | 2014-06-04 | 北京大学 | Solid dispersion system of febuxostat and preparation method of solid dispersion system, and pharmaceutical applications |
Non-Patent Citations (1)
| Title |
|---|
| 复方氯唑沙宗分散片的相对生物利用度研究;孙亚欣等;《中国药学杂志》;20050331;第40卷(第6期);第448-450页 |
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| Publication number | Publication date |
|---|---|
| CN105395503A (en) | 2016-03-16 |
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