CN105168137A - Lactose celecoxib pharmaceutical composition - Google Patents
Lactose celecoxib pharmaceutical composition Download PDFInfo
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- CN105168137A CN105168137A CN201410282957.XA CN201410282957A CN105168137A CN 105168137 A CN105168137 A CN 105168137A CN 201410282957 A CN201410282957 A CN 201410282957A CN 105168137 A CN105168137 A CN 105168137A
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- celecoxib
- lactose
- solid dispersion
- lauryl sulphate
- sodium lauryl
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Abstract
Belonging to the field of pharmacy, the invention relates to a lactose celecoxib pharmaceutical composition and a preparation method. The composition is characterized in that lactose and celecoxib form solid dispersions by means of coprecipitation.
Description
Technical field
The invention belongs to pharmaceutical field, relate to a kind of pharmaceutical composition and preparation method of lactose celecoxib, it is characterized in that lactose celecoxib forms solid dispersion by coprecipitation.
Background technology
Celecoxib (Celecoxib) is a kind of II type cyclooxygenase (COX-2) inhibitor, and alternative acts on II type cyclooxygenase, is widely used in the treatment of osteoarthritis and rheumatoid arthritis clinically.
Patent CN99802185.7 discloses this compound and dissolves hardly in water, this material also has some other obvious character feature, be needle-like as tied its crystallization, bring the characteristics such as its caking property, low bulk density and low compressibility thus, these all determine that the poor fluidity of such celecoxib, compressibility are poor, and not easily pulverize as less granule.
In order to solve the indissoluble of medicine, the problems such as crystal formation, research worker can go to attempt solving by preparations etc. such as solid dispersion, but because solid dispersion medicine is highly dispersed in a kind of disperse system existed in solid form formed in solid carrier, be similar to crystallization, its internal structure, larger uncertainty can be there is in physicochemical property, same drug and different auxiliary material, same drug is with adjuvant but ratio is different, preparation method kind difference (fusion method, solvent method, solvent-spraying (freezing) seasoning, solvent-antisolvent method) the identical same drug of ratio and adjuvant, all may produce larger impact to the structure of solid dispersion, thus draw the diverse product of physicochemical property.
Fusion method refers to medicine and carrier material mixing melting, then is cooled to rapidly solid and get final product.
Solvent method first medicine and carrier material is dissolved in altogether in organic solvent, boil off solvent again makes medicine and carrier material separate out simultaneously, finally by being drying to obtain, owing to being finally the solid dispersion that employing intermediate processing obtains containing medicine and carrier material usually, so also can coprecipitation be called.
Solvent-spraying (freezing) seasoning first medicine and carrier material is dissolved in altogether in solvent, and then spraying or lyophilization, eliminate solvent and get final product.
Solvent-antisolvent method first medicine and carrier material is dissolved in altogether in solvent, then passes into solvent resistant (antisolvent generally selects supercritical fluid) and make medicine and carrier material separate out simultaneously and get final product.
Patent application CN102000018A discloses a kind of Celecoxib solid dispersion and preparation method thereof, be prepared into preparation according to a conventional method again after Polyethylene Glycol celecoxib crude drug and molecular weight being greater than 4000 adopts fusion method to be prepared into solid dispersion, overcome the deficiency that celecoxib crude drug difficulty is pulverized.But the method preparation temperature is high, the Polyethylene Glycol viscosity of melting is comparatively large, and celecoxib material dissolution is slow, and not easily uniform dissolution, operation easier is large.
Patent application CN102988296 discloses the solid dispersion containing celecoxib and carrier material, described carrier material is selected from one or more in polyvinylpyrrolidone, copolyvidone, polyvinylpolypyrrolidone, and in solid dispersion, the weight ratio of carrier material and celecoxib can be low to moderate 0.2: 1.Its preparation method is jointly dissolved in organic solvent carrier material and celecoxib, or carrier material suspendible is dispersed in the organic solvent of celecoxib, adopt drying under reduced pressure or spray-dired mode to remove organic solvent and namely obtain solid dispersion, this solid dispersion can be prepared into various solid preparation after pulverizing.But the elasticity of this solid dispersion is comparatively large, not easily pulverize as microgranule.
Summary of the invention
The invention provides a kind of pharmaceutical composition and the preparation method that contain lactose celecoxib, feature is celecoxib, lactose forms solid dispersion by coprecipitation, this solid dispersion has larger fragility relative to celecoxib crude drug below 0 DEG C, be easy to be ground into microgranule, with solid orally ingestible prepared by this kind of microgranule, there is more good dispersive property and dissolution, thus can human bioavailability be improved.
The present invention also provides the preparation method of the solid dispersion containing celecoxib, lactose, simple to operate, comparatively rapid by coprecipitation lactose, celecoxib material dissolution, be easy to be uniformly dispersed, avoid the yellowing problems that lactose coking that fusion method high temperature causes brings simultaneously, be very applicable to suitability for industrialized production.
A kind of pharmaceutical composition, it is characterized in that active component is celecoxib, excipient substance is one or more in lactose and sodium lauryl sulphate, polyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose, magnesium stearate, and wherein celecoxib and lactose form solid dispersion.Above-mentioned compositions, is characterized in that celecoxib and lactose are formed solid dispersion and prepared by coprecipitation.Coprecipitation is dissolved in completely in ethanol water lactose, celecoxib, after rotary evaporation remove portion alcohol solvent, freezing, filters, and solid to be put in vacuum drying oven drying under reduced pressure and be get final product.Wherein in ethanol water, ethanol accounts for 55% of volume ratio, and in distilling under reduced pressure to ethanol water, ethanol content is at 30-35%, and cryogenic temperature is-10 to-5 DEG C.
Above-mentioned compositions, is characterized in that celecoxib, lactose and sodium lauryl sulphate form solid dispersion.Above-mentioned compositions, is characterized in that celecoxib, lactose, sodium lauryl sulphate are formed solid dispersion and prepared by coprecipitation.Coprecipitation is dissolved in completely in ethanol water lactose, sodium lauryl sulphate, celecoxib, after rotary evaporation remove portion alcohol solvent, freezing, filters, and solid to be put in vacuum drying oven drying under reduced pressure and be get final product.Wherein in ethanol water, ethanol accounts for 55% of volume ratio, and in distilling under reduced pressure to ethanol water, ethanol content is at 30-35%, and cryogenic temperature is-10 to-5 DEG C.
Above-mentioned compositions, its feature is lactose, sodium lauryl sulphate, polyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose and magnesium stearate at excipient substance.Above-mentioned compositions, is characterized in that the weight ratio of celecoxib and sodium lauryl sulphate in solid dispersion is 1:0.01-0.15.Above-mentioned compositions, is characterized in that the weight ratio of celecoxib and sodium lauryl sulphate in solid dispersion is 1:0.01-0.1.Above-mentioned compositions, is characterized in that the weight ratio of celecoxib and sodium lauryl sulphate in solid dispersion is 1:0.01-0.05.
Above-mentioned compositions, is characterized in that the weight ratio of celecoxib and lactose in solid dispersion is 1:0.2-1.0.
Above-mentioned compositions, is characterized in that the weight ratio of celecoxib and lactose in solid dispersion is 1:0.3-0.8.
Above-mentioned compositions, is characterized in that the weight ratio of celecoxib and lactose in solid dispersion is 1:0.3-0.6.
Above-mentioned compositions, is characterized in that the content of polyvinylpyrrolidone is 0.5-6wt%, and the content of cross-linking sodium carboxymethyl cellulose is 0.75-15wt%, and the content of sodium lauryl sulphate is 0-5wt%, and the content of magnesium stearate is 0.1-5wt%.
Above-mentioned compositions, is characterized in that forming solid dispersion weight ratio in the composition by celecoxib and lactose is not less than 50%.
Above-mentioned compositions, is characterized in that forming solid dispersion weight ratio in the composition by celecoxib and lactose is not less than 80%.
Above-mentioned compositions, is characterized in that forming solid dispersion weight ratio in the composition by celecoxib and lactose is not less than 90%.
Above-mentioned compositions, is characterized in that preparation type is solid orally ingestible.Above-mentioned compositions, is characterized in that solid orally ingestible is the one in capsule, tablet, granule, powder.
Above-mentioned compositions, is characterized in that lactose is a water alpha-lactose lactose.
A kind of solid dispersion be made up of celecoxib and lactose.
A kind of solid dispersion be made up of celecoxib, lactose, sodium lauryl sulphate.
Detailed description of the invention
Below will the invention will be further described by embodiment, these descriptions are not be further limited content of the present invention.One skilled in the art will understand that the equivalent replacement that technical characteristic of the present invention is done, or improve accordingly, still belong within protection scope of the present invention.
Particle diameter corresponding when D90 particle diameter refers to that the cumulative particle sizes distribution number of a sample reaches 90%.Its physical significance be particle diameter be less than it granule account for 90%.
Alpha-lactose in embodiment is a water alpha-lactose.
Embodiment 1
Solid one water alpha-lactose, celecoxib 60 DEG C are dissolved in 55% ethanol water (ethanol accounts for 55% of volume ratio) completely, in distilling under reduced pressure to ethanol water, ethanol content is at 30-35%,-10 to-5 DEG C freezing, and after filtration, solid to be put in vacuum drying oven drying under reduced pressure and be get final product.The ratio of alpha-lactose, celecoxib sees the following form.Alpha-lactose, Celecoxib solid dispersion cross No. two sieves after simple pulverizing, D90 particle diameter is measured with laser particle analyzer, undertaken 2 times by jet mill again to pulverize, grinding time is 10 minutes/time, the D90 particle diameter of powder is measured afterwards again with laser particle analyzer, both subtract each other and show that D90 particle diameter is poor, and during pulverizing, temperature is respectively room temperature (25 ± 2 DEG C), low temperature (-2 ± 2 DEG C).
The fusing point of embodiment 1-1 to 1-5 is between 166-173 DEG C.
Embodiment 2
Solid one water alpha-lactose, celecoxib 60 DEG C are dissolved in 55% ethanol water (ethanol accounts for 55% of volume ratio) completely, in distilling under reduced pressure to ethanol water, ethanol content is at 30-35%,-10 to-5 DEG C freezing, and after filtration, solid to be put in vacuum drying oven drying under reduced pressure and be get final product.The ratio of alpha-lactose, celecoxib sees the following form.The solid dispersion of sodium lauryl sulphate, alpha-lactose, celecoxib crosses No. two sieves after simple pulverizing, D90 particle diameter is measured with laser particle analyzer, undertaken 2 times by jet mill again to pulverize, grinding time is 10 minutes/time, the D90 particle diameter of powder is measured afterwards again with laser particle analyzer, both subtract each other and show that D90 particle diameter is poor, and during pulverizing, temperature is respectively room temperature (25 ± 2 DEG C), low temperature (-2 ± 2 DEG C).
The fusing point of embodiment 2-1 to 2-5 is between 161-170 DEG C.
Embodiment 3
Solid one water alpha-lactose, celecoxib 60 DEG C are dissolved in 55% ethanol water (ethanol accounts for 55% of volume ratio) completely, in distilling under reduced pressure to ethanol water, ethanol content is at 30-35%,-10 to-5 DEG C freezing, and after filtration, solid to be put in vacuum drying oven drying under reduced pressure and be get final product.The ratio of alpha-lactose, celecoxib sees the following form.Alpha-lactose, Celecoxib solid dispersion cross No. two sieves after simple pulverizing, measure D90 particle diameter with laser particle analyzer, then carry out 2 pulverizing by jet mill, grinding time is 10 minutes/time, measure the D90 particle diameter of powder with laser particle analyzer more afterwards, both subtract each other and show that D90 particle diameter is poor.
The fusing point of embodiment 3-1 to 3-5 is between 170-178 DEG C.
Comparative examples 1
According to the method corresponding preparation comparative examples 2-1 to 2-3 of embodiment 1-3 in invention CN102000018B.
The particle diameter measured before and after solid dispersion comminution by gas stream according to the method for embodiment 1 is poor.
Comparative examples 2
Corresponding comparative examples 2-1 to 2-5 is prepared according to solid dispersion Example formulations 2,6,10,14,19 in invention CN102988296A.The particle diameter measured before and after solid dispersion comminution by gas stream according to the method for embodiment 1 is poor.
Comparative examples 3
According to the crystallization that the preparation method of celecoxib in invention CN1141630A obtains, the particle diameter measured before and after solid dispersion comminution by gas stream according to the method for embodiment 1 is poor.
| Comparative examples number | Celecoxib (g) | Room temperature D90 particle diameter difference (μm) | Low temperature D90 particle diameter difference (μm) |
| 3 | 100 | 326 | 361 |
By the data of embodiment 1,2,3 comparative examples 1,2,3, can illustrate under cryogenic with the effect pulverized under normal temperature condition compared with other solid dispersion, solid dispersion containing lactose, celecoxib composition is more the microgranule that particle diameter is less with pulverizing, and add the lactose of sodium lauryl sulphate, celecoxib composition the crushing effect that do not add of solid dispersion better, and the crushing effect of the solid dispersion made when being equal to or less than active component celecoxib with the weight of standard empirical adjuvant lactose is by contrast better.
Example of formulations 1
Prescription (unit be gram):
The solid dispersion that embodiment obtained is pulverized as D90 is the microgranule of 20 ± 2 μm, mix with microcrystalline Cellulose, lactose, cross-linking sodium carboxymethyl cellulose, sodium lauryl sulphate, starch with polyvinylpyrrolidone, wet granulation, dry, add magnesium stearate, be distributed into capsule, obtain the capsule containing celecoxib 100mg.
Example of formulations 2
Prescription (unit be gram):
The solid dispersion that embodiment obtained is pulverized as D90 is the microgranule of 20 ± 2 μm, measure crosslinked carboxymethyl fecula sodium with lactose, microcrystalline Cellulose, half, sodium lauryl sulphate mixes, starch with polyvinylpyrrolidone, granulate, dry, add magnesium stearate and another half amount crosslinked carboxymethyl fecula sodium mixing, tabletted is heavily the fusiformis element sheet of 500mg, with Opadry white coating material coating, must containing the coated tablet of celecoxib 100mg.
Example of formulations 3
Prescription (unit be gram):
The solid dispersion that embodiment obtained is pulverized as D90 is the microgranule of 20 ± 2 μm, mix with microcrystalline Cellulose, lactose, cross-linking sodium carboxymethyl cellulose, sodium lauryl sulphate, starch with polyvinylpyrrolidone, wet granulation, dry, add magnesium stearate, be distributed into capsule, obtain the capsule containing celecoxib 100mg.
Example of formulations 4
Prescription (unit be gram):
The solid dispersion that comparative examples obtained is pulverized as D90 is the microgranule of 20 ± 2 μm, measure crosslinked carboxymethyl fecula sodium with lactose, microcrystalline Cellulose, half, sodium lauryl sulphate mixes, starch with polyvinylpyrrolidone, granulate, dry, add magnesium stearate and another half amount crosslinked carboxymethyl fecula sodium mixing, tabletted is heavily the fusiformis element sheet of 500mg, with Opadry white coating material coating, must containing the coated tablet of celecoxib 100mg.Control formulation embodiment 1
Prescription (unit be gram):
The solid dispersion that embodiment obtained is pulverized as D90 is the microgranule of 20 ± 2 μm, mix with microcrystalline Cellulose, lactose, cross-linking sodium carboxymethyl cellulose, sodium lauryl sulphate, starch with polyvinylpyrrolidone, wet granulation, dry, add magnesium stearate, be distributed into capsule, obtain the capsule containing celecoxib 100mg.Control formulation embodiment 2
Prescription (unit be gram):
The solid dispersion that comparative examples obtained is pulverized as D90 is the microgranule of 20 ± 2 μm, measure crosslinked carboxymethyl fecula sodium with lactose, microcrystalline Cellulose, half, sodium lauryl sulphate mixes, starch with polyvinylpyrrolidone, granulate, dry, add magnesium stearate and another half amount crosslinked carboxymethyl fecula sodium mixing, tabletted is heavily the fusiformis element sheet of 500mg, with Opadry white coating material coating, must containing the coated tablet of celecoxib 100mg.
Control formulation embodiment 3
Celecoxib, lactose are pulverized as D90 is the microgranule of 20 ± 2 μm, mix with microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, sodium lauryl sulphate, starch with polyvinylpyrrolidone, wet granulation, dry, add magnesium stearate, be distributed into capsule, obtain the capsule containing celecoxib 100mg.
Pharmacological Examples:
Dissolution test: according to the dissolution of the pharmaceutical preparation that first method (basket method) the method mensuration example of formulations in 2010 editions Chinese Pharmacopoeia annex XC dissolution methods, control formulation embodiment obtain, with simulated gastric fluid 1000ml for dissolution medium, rotating speed is 50 turns of rain, operate in accordance with the law, get solution during 45min appropriate, filter, to measure subsequent filtrate appropriate for precision respectively, the solution about containing 0.1mg celecoxib in every 1ml is become, as need testing solution with mobile phase dissolved dilution; Separately get celecoxib reference substance appropriate, add mobile phase dissolved dilution and make the solution of every 1ml containing 0.1mg, solution in contrast, measure in accordance with the law, the stripping quantity of celecoxib in calculating every, calculate the dissolution of average dissolution as embodiment, limit all should be 75% of labelled amount.
Claims (10)
1. a pharmaceutical composition, it is characterized in that active component is celecoxib, excipient substance is one or more in lactose and sodium lauryl sulphate, polyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose, magnesium stearate, and wherein celecoxib and lactose form solid dispersion.
2. compositions as claimed in claim 1, is characterized in that solid dispersion also containing sodium lauryl sulphate.
3. compositions as claimed in claim 1, its feature is lactose, sodium lauryl sulphate, polyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose and magnesium stearate at excipient substance.
4. compositions as claimed in claim 1, is characterized in that the weight ratio of celecoxib and lactose in solid dispersion is 1:0.2-1.0.
5. compositions as claimed in claim 2, is characterized in that the weight ratio of celecoxib and sodium lauryl sulphate in solid dispersion is 1:0.01-0.15.
6. compositions as claimed in claim 1, it is characterized in that the content of polyvinylpyrrolidone is 0.5-6wt%, the content of cross-linking sodium carboxymethyl cellulose is 0.75-15wt%, and the content of sodium lauryl sulphate is 0-5wt%, and the content of magnesium stearate is 0.1-5wt%.
7. the compositions as described in claim 1,2, is characterized in that forming solid dispersion weight ratio in the composition by celecoxib and lactose is not less than 50%.
8. the compositions as described in claim 1,2, is characterized in that preparation type is solid orally ingestible.
9. the solid dispersion formed by celecoxib and lactose.
10. the solid dispersion be made up of celecoxib, lactose, sodium lauryl sulphate.
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|---|---|---|---|
| CN201410282957.XA CN105168137A (en) | 2014-06-23 | 2014-06-23 | Lactose celecoxib pharmaceutical composition |
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| CN201410282957.XA CN105168137A (en) | 2014-06-23 | 2014-06-23 | Lactose celecoxib pharmaceutical composition |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105878191A (en) * | 2016-04-26 | 2016-08-24 | 广州帝奇医药技术有限公司 | Sustained-release microgranules, method for preparing same and application of sustained-release microgranules |
| CN105878190A (en) * | 2016-04-26 | 2016-08-24 | 广州帝奇医药技术有限公司 | Preparation method of slow-released microgranules, prepared slow-released microgranules and application thereof |
| CN105963257A (en) * | 2016-04-26 | 2016-09-28 | 广州帝奇医药技术有限公司 | Preparation method of sustained-release microparticles |
| CN105963258A (en) * | 2016-04-26 | 2016-09-28 | 广州帝奇医药技术有限公司 | Preparation method of sustained-release microparticles |
| CN110604722A (en) * | 2019-09-19 | 2019-12-24 | 山东创新药物研发有限公司 | Solid dispersion method of celecoxib and preparation method of celecoxib capsules |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105878191A (en) * | 2016-04-26 | 2016-08-24 | 广州帝奇医药技术有限公司 | Sustained-release microgranules, method for preparing same and application of sustained-release microgranules |
| CN105878190A (en) * | 2016-04-26 | 2016-08-24 | 广州帝奇医药技术有限公司 | Preparation method of slow-released microgranules, prepared slow-released microgranules and application thereof |
| CN105963257A (en) * | 2016-04-26 | 2016-09-28 | 广州帝奇医药技术有限公司 | Preparation method of sustained-release microparticles |
| CN105963258A (en) * | 2016-04-26 | 2016-09-28 | 广州帝奇医药技术有限公司 | Preparation method of sustained-release microparticles |
| CN110604722A (en) * | 2019-09-19 | 2019-12-24 | 山东创新药物研发有限公司 | Solid dispersion method of celecoxib and preparation method of celecoxib capsules |
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Application publication date: 20151223 |