CN103860497A - Meloxicam dispersible tablet and preparation method thereof - Google Patents
Meloxicam dispersible tablet and preparation method thereof Download PDFInfo
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- CN103860497A CN103860497A CN201410094096.2A CN201410094096A CN103860497A CN 103860497 A CN103860497 A CN 103860497A CN 201410094096 A CN201410094096 A CN 201410094096A CN 103860497 A CN103860497 A CN 103860497A
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Abstract
The invention discloses a meloxicam dispersible tablet and a preparation method and application of the meloxicam dispersible tablet. The meloxicam dispersible tablet consists of the following components in percentage by weight: 0.5-15% of meloxicam, 10-50% of filler, 10-50% of disintegrating agent, 10-60% of acidifying agent, 0.1-20% of binding agent, and 0.1-30% of lubricant and flow aid. The meloxicam dispersible tablet disclosed by the invention, compared with normal tablets, is free of a surfactant, good in solubility, dispersibility and disintegration, and capable of being completely disintegrated within 1min. The meloxicam dispersible tablet prepared by the method is high in dissolution rate, good in bioavailability, rapid to in vivo distribution, stable in quality and good in taste; the preparation method is simple and easy, an is applicable to industrial production.
Description
Invention field
The present invention relates to chemical pharmacy field, be specifically related to a kind of Meloxicam Dispersive Tablet and preparation method thereof.
Background of invention
Meloxicam (meloxicam) is a kind of novel tendentiousness cyclooxygenase-2 (COX-2) inhibitor, has stronger analgesia, antiinflammatory action.Be mainly used in clinically treating rheumatoid arthritis and osteoarthritis, there is good effect, take number of times few (every day 1 time), the advantage such as dosage is little, gastrointestinal side effect is little.
Chemistry 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H_l by name of meloxicam; 2-benzothiazine-3-carboxamide-1; 1-dioxide, this compound is insoluble in water, and dissolubility when 5 ℃ and 25 ℃ in distilled water is respectively 3.5 μ g/mL and 4.5 μ g/ml; Dissolubility is relevant with pH value, its dissolubility pH value be 4 o'clock minimum, along with pH value rise hear and rise hear.
CN103054872A discloses a kind of meloxicam pharmaceutical composition, and percentage composition meter comprises following component by weight:
effective ingredient meloxicam,
filler,
disintegrating agent,
binding agent,
solubilizing agent,
lubricant, and appropriate solvent.The meloxicam tablet that this technology makes obviously improves in stripping in vitro, but in technique, has added solubilizing agent as surfactants such as poloxamer, Tween-80, sodium lauryl sulphates.CN101618026B discloses a kind of meloxicam tablet and production technology and purposes, and said preparation is made up of with pregelatinized Starch, micropowder silica gel, magnesium stearate, ethanol, stomach dissolved film coating pre-mix dose meloxicam, lactose, pregelatinized Starch, low-substituted hydroxypropyl cellulose, Polysorbate _ 80,12% concentration punching slurry.Production method comprises steps such as making label, coating.CN103099791A discloses a kind of meloxicam oral formulations that increases dissolution and preparation method thereof, and this technology has added solubilizing agent as surfactants such as Labraso, sodium lauryl sulphate, tween 80, sorbester p17s equally.In above-mentioned patent, all add surfactant, not only increased the insecurity of medication, and easily caused drug effect difference between different medication crowds.
CN102869343A discloses a kind of solid chewable tablet by powder direct pressing, and it comprises the meloxicam and one or more excipient that are dispersed in this sheet, has added the PH regulator that is selected from tartaric acid, maleic acid and Trisodium citrate dihydrate.But chewable tablet is while taking, even sheet is chewed, is also difficult to guarantee the stripping of insoluble drug, and in this invention, have no the beneficial effect that dissolution improves.CN102438627A uses dry grinding legal system for the method for meloxicam granule and the compositions that comprises meloxicam, the meloxicam that uses particle form and/or medicine prepared by compositions.But dry grinding easily makes medium because friction enters in medicine, pollutes.And prior art is the Meloxicam Dispersive Tablet of unexposed pharmaceutical preparation formula of the present invention all.
Chinese Pharmacopoeia is defined as dispersible tablet: also homodisperse of the rapid disintegrate of energy in water.Except requiring the quick disintegrate of sheet, also need the uniform particles after disintegrate to disperse.Disintegrate rapidly can be simply can realize by the consumption that increases disintegrating agent, but requires uniform particles to disperse, and needs to add suspending agent, but suspending agent conventional used can have influence on medicine disintegrate as sodium carboxymethyl cellulose etc.; Micropowder silica gels etc., as suspending agent, must be added again extra basic matterial, have increased the kind of adjuvant.
Find by a large amount of retrievals, in order to improve the dissolution of Meloxicam Dispersive Tablet, prior art generally adopts interpolation surfactant, or the technological means of interpolation basic matterial meets the requirement of drug-eluting.
Existing market sell is meloxicam conventional tablet or dispersible tablet, but unexposed drug component ratio of the present invention, do not adopt acidulant yet, Meloxicam Dispersive Tablet provided by the invention adopts acidulant by its parcel or wraps up mutually, thereby reach the effect of embedding, disintegration rate is fast, has also improved its bioavailability simultaneously.
Summary of the invention
The invention provides a kind of Meloxicam Dispersive Tablet, is according to existing meloxicam pharmaceutical dosage forms or adding surfactant has the problems such as stimulation and bioavailability are not high to body, or does not adopt acidulant.The invention provides a kind of Meloxicam Dispersive Tablet, adopt acidulant by its parcel or parcel mutually, thereby reach the effect of embedding, and through repetition test by each component screening to weight ratio of the present invention, be surprised to find that the dispersible tablet steady quality obtaining, stripping is fast, in body, distributes rapidly, and bioavailability is high, dispersibility, disintegrative are good, can disintegrate in 1 minute complete, and this product is containing surfactant, and can reduce stimulates body.
On the one hand, the invention provides a kind of Meloxicam Dispersive Tablet, it comprises as follows according to the component of percetage by weight meter: meloxicam
filler
disintegrating agent
acidulant
60%, binding agent 0.1～20%, lubricant and fluidizer
Some embodiments therein, Meloxicam Dispersive Tablet of the present invention, it comprises as follows according to the component of percetage by weight meter: meloxicam 7.5%, filler 40%, disintegrating agent 37.5%, acidulant 10%, binding agent 2%, lubricant and fluidizer 3%.
In other embodiments, Meloxicam Dispersive Tablet of the present invention, it comprises the component by following percetage by weight:
Meloxicam 7.5g
Lactose 300g
Crospolyvinylpyrrolidone 67.5g
Carboxymethylstach sodium 200g
Hydroxypropyl methylcellulose 3.5g
Citric acid 100g
Micropowder silica gel 25g
Magnesium stearate 7.5g
Water 175
95% ethanol 114g
Make 1000.
Some embodiments therein, Meloxicam Dispersive Tablet of the present invention, wherein, described filler is a kind of in starch, Icing Sugar, dextrin, lactose, microcrystalline Cellulose, mannitol, sorbitol or xylitol or their mixture.
Some embodiments therein, Meloxicam Dispersive Tablet of the present invention, wherein, described disintegrating agent is a kind of in microcrystalline Cellulose, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, cross-linked carboxymethyl cellulose sodium, crospolyvinylpyrrolidone, crosslinked carboxymethyl fecula sodium, dried starch or their mixture.
Some embodiments therein, Meloxicam Dispersive Tablet of the present invention, wherein, described acidulant is a kind of in citric acid, lactic acid, acetic acid, ethanedioic acid, malonic acid, succinic acid, tartaric acid, adipic acid, malic acid, nicotinic acid, pectic acid, ascorbic acid, caffeic acid, fumaric acid, maleic acid, phosphoric acid solution or their mixture.
Some embodiments therein, Meloxicam Dispersive Tablet of the present invention, wherein, described binding agent is a kind of in hypromellose, sodium carboxymethyl cellulose, starch, pregelatinized Starch, polyvidone, gelatin, Polyethylene Glycol, ethanol, water or their mixture.
Some embodiments therein, Meloxicam Dispersive Tablet of the present invention, wherein, described lubricant and fluidizer are a kind of of micropowder silica gel, magnesium stearate, silicon dioxide, Pulvis Talci, Polyethylene Glycol apoplexy due to endogenous wind or their mixture.
On the other hand, the present invention relates to a kind of preparation method of Meloxicam Dispersive Tablet, it comprises the steps: that (1) sieve meloxicam and pharmaceutic adjuvant respectively; Binding agent be dissolved in concentration be 85% or following alcoholic solution or aqueous solution in after, then the acidulant of recipe quantity is dissolved in the solution containing binding agent, obtain acid solution; (2) meloxicam is mixed homogeneously with filler, disintegrating agent, fluidizer after adopting the made acid solution embedding of step (1), adds binding agent, mixes, and makes soft material; (3) by soft material mistake
mesh sieve, 40～60 ℃ are dry,
order granulate; (4) add lubricant, mix homogeneously; (5) tabletting, makes Meloxicam Dispersive Tablet.
Some embodiments therein, the preparation method of Meloxicam Dispersive Tablet of the present invention wherein, is that meloxicam and acid solution are passed through to fluid bed embedding with acid solution embedding described in step (2), or meloxicam is put into together with acid solution to colloid mill and sheared, drier.
The prescription ratio of Meloxicam Dispersive Tablet of the present invention is not by teaching material or other reference material gained, but by the testing program gained conforming with the regulations in a large number, made dispersible tablet has carried out quality research, meets " Chinese Pharmacopoeia " 2010 editions two and make by oneself about dispersible tablet and other requirement of quality standard.In research, find the obvious existing conventional tablet of dissolution of technical solution of the present invention.
Compared with prior art, the present invention has following beneficial effect:
(1) meloxicam is made tablet formulation by the present invention, and each drug component ratio is to be screened and obtained by repetition test, can significantly improve its bioavailability;
(2) the present invention granulates after adopting acidulant to process in Meloxicam Dispersive Tablet preparation, greatly improves its bioavailability;
(3) tablet formulation that the present invention makes, compared with ordinary tablet, stripping is rapid, and disintegrative is good, and disintegrate completely in 1 minute absorbs soon, and bioavailability is high, stable in properties;
(4) tablet formulation that the present invention makes, does not use surface active agent solubilization in manufacturing process, reduce body is stimulated, and has reduced the untoward reaction of medicine, has increased patient's compliance.
Excipient of the present invention comprises, but be not limited to, ion-exchanger, aluminum, aluminium stearate, lecithin, serum albumin, as human albumin, buffer substance is as phosphate, glycine, sorbic acid, potassium sorbate, the partial glycerol ester admixture of saturated vegetable fatty acid, water, salt or electrolyte, as protamine sulfate, sodium hydrogen phosphate, potassium hydrogen phosphate, sodium chloride, zinc salt, colloid silicon, magnesium trisilicate, polyvinylpyrrolidone, polyacrylate, wax, polyethylene-polyoxypropylene-blocking-up polymer, lanoline, sugar, as lactose, dextrose plus saccharose, starch is as corn starch and potato starch, the derivant of cellulose and it is as sodium carboxymethyl cellulose, ethyl cellulose and cellulose acetate, natural gum powder, Fructus Hordei Germinatus, gelatin, Pulvis Talci, adjuvant is as cocoa butter and suppository wax, oily as Oleum Arachidis hypogaeae semen, Oleum Gossypii semen, safflower oil, Oleum Sesami, olive oil, Semen Maydis oil and Oleum Glycines, glycols compound, as propylene glycol and Polyethylene Glycol, esters is as ethyl oleate and ethyl laurate, agar, buffer agent is as magnesium hydroxide and aluminium hydroxide, alginic acid, pyrogen-free water, Deng oozing salt, Lin Ge (family name) solution, ethanol, phosphate buffer solution, and other nontoxic proper lubrication agent are as sodium laurylsulfate and magnesium stearate, coloring agent, releasing agent, coating dress material, sweeting agent, flavoring agent and spice, antiseptic and antioxidant.
Pharmaceutical composition of the present invention can also optionally contain one or more diluent.The example of diluent comprises mannitol, sorbitol, biphosphate calcium dihydrate, microcrystalline Cellulose and efflorescence cellulose.Preferred diluent is microcrystalline Cellulose.Microcrystalline Cellulose can be obtained from several suppliers, comprises Avicel PH101, Avicel PH102, Avicel PH103, Avicel PH105 and Avicel PH200 that FMC Corporation manufactures.
Pharmaceutical composition of the present invention can also optionally contain disintegrating agent.Disintegrating agent can be the one in several modified starches, modified cellulose polymer or polycarboxylic acids, such as crosslinked Carboxymethyl cellulose sodium, Explotab, polacrilin potassium and calcium carboxymethylcellulose (CMCCalcium).In one embodiment, disintegrating agent is croscarmellose sodium.Croscarmellose sodium NF type A obtains with trade name " Ac-di-sol " on market.
Pharmaceutical composition of the present invention can also optionally contain one or more surfactants or wetting agent.Surfactant can be anion, cation or neutral surface active agent.Anion surfactant comprises sodium lauryl sulfate, dodecyl sodium sulfate, oleyl sodium sulfate and the sodium laurate mixing with stearate and Talcum.Cationic surfactant comprises benzalkonium chloride and alkyl trimethyl ammonium bromide.Neutral surface active agent comprises glycerol list olein, polyoxyethylene sorbitan fatty acid ester, polyvinyl alcohol and anhydro sorbitol fat.The embodiment of wetting agent comprises poloxamer, polyoxyethylene alkyl ether, castor oil derivatives and polyoxyethylene 8 stearate fat.
The present invention can also optionally join antioxidant in preparation, thereby gives its chemical stability.Antioxidant is selected from the extract of a-tocopherol, Y-tocopherol, S-tocopherol, tocopherol enrichment natural origin, sodium or calcium salt, the Vitamin C acyl cetylate of L-AA and it, amass wealth by heavy taxation propyl propionate, amass wealth by heavy taxation misery ester, amass wealth by heavy taxation sour dodecyl ester, Yoshinox BHT (BHT) and butylated hydroxyanisol (BHA).In one embodiment, antioxidant is BHT or BHA.
The preferred dosage form of drug composition of the present invention is the tablet of preparing by compression method.Described tablet can carry out film with the mixture such as hydroxypropyl cellulose and hydroxypropyl emthylcellulose, contains titanium dioxide and/or other coloring agent, such as ferrum oxide, dyestuff and Se Dian in this mixture; The mixture of polyvinyl alcohol (PVA) and Polyethylene Glycol (PEG), contains titanium dioxide and/or other coloring agent, such as ferrum oxide, dyestuff and Se Dian; Or any other suitable instant-free coating agent.Coating provides taste masked and other stability to final tablet.What commercially available film provided for Colorcon is preparation mixture of powders
The present invention can also add sweeting agent and/or fumet.
The specific embodiment
Further explain the present invention below in conjunction with embodiment, but embodiment does not limit in any form to the present invention.
Embodiment 1
Meloxicam 7.5g
Lactose 300g
Crospolyvinylpyrrolidone 200g
Carboxymethylstach sodium 200g
Hydroxypropyl methylcellulose 7.5g
Micropowder silica gel 30g
Magnesium stearate 15g
Water 140g
95% ethanol 100g
Make 1000.
Preparation method:
Step 1: the meloxicam of having pulverized and pharmaceutic adjuvant are crossed respectively to 120 mesh sieves, and hydroxypropyl methylcellulose first uses hot water swelling, is stirred to dissolving, then adds ethanol, makes concentration of alcohol reach 80%.
Step 2: press recipe quantity by meloxicam, lactose, polyvinylpolypyrrolidone, micropowder silica gel mix homogeneously, add the solution of hypromellose described in step 1 to make soft material.
Step 3: made soft material in step 2 is crossed to 18 mesh sieves and granulate, 50 ℃ dry, and moisture is 2.6%, 18 mesh sieve granulate.
Step 4: mix homogeneously with magnesium stearate making granule in step 3.
Step 5: semi-finished product detect, and determine sheet weight, and tabletting, obtains Meloxicam Dispersive Tablet.
Embodiment 1 dispersible tablet smooth in appearance, dispersibility meets relevant regulations, but dissolution is not good.
Embodiment 2
Meloxicam 7.5g
Lactose 300g
Crospolyvinylpyrrolidone 67.5g
Carboxymethylstach sodium 200g
Hydroxypropyl methylcellulose 3.5g
Citric acid 100g
Micropowder silica gel 25g
Magnesium stearate 7.5g
Water 175
95% ethanol 114g
Make 1000.
Preparation method:
Step 1: the meloxicam of having pulverized and pharmaceutic adjuvant are crossed respectively to 120 mesh sieves, and hydroxypropyl methylcellulose first uses hot water swelling, is stirred to dissolving, then adds ethanol, makes concentration of alcohol reach 80%.Separately get above-mentioned hydroxypropyl methylcellulose solution 3.5g, add 175g water, add citric acid mix homogeneously.
Step 2: recipe quantity meloxicam is mixed homogeneously with recipe quantity lactose, crospolyvinylpyrrolidone, carboxymethylstach sodium, micropowder silica gel after the embedding of fluid bed acid solution with citric acid solution in step 1, adds described in step 1, to remain hypromellose solution and make soft material.
Step 3: made soft material in step 2 is crossed to 16 mesh sieves and granulate, 50 ℃ dry, and moisture is 2.5%, 16 mesh sieve granulate.
Step 4: mix homogeneously with magnesium stearate making granule in step 3.
Step 5: semi-finished product detect, and determine sheet weight, and tabletting, obtains Meloxicam Dispersive Tablet.
Embodiment 2 has added acidulant, has reduced the amount of disintegrating agent, and technique is optimized on the basis of embodiment 1, after first acidification, granulates again, finds dispersible tablet smooth in appearance, and dissolution is better, and dispersion effect is good, substantially again can disintegrate in 1 minute complete.
Embodiment 3
Meloxicam 7.5g
Crospolyvinylpyrrolidone 350g
Carboxymethylstach sodium 250g
Hydroxypropyl methylcellulose 4g
Citric acid 100g
Micropowder silica gel 15g
Magnesium stearate 7.5g
Water 166
95% ethanol 100g
Make 1000.
Preparation method is with embodiment 2.
Implementing 3 increases crospolyvinylpyrrolidone, carboxymethylstarch sodium content, and dispersible tablet dispersibility meets 2010 editions pharmacopeia requirements, and dissolution is better.
Embodiment 4
It is identical that embodiment 4 and embodiment 3 write out a prescription, and selects different acidify embedding modes, and meloxicam and acidulant solution are put into colloid mill and sheared, then spraying is dry.The indices of dispersible tablet and the embodiment 3 made dispersible tablet there was no significant difference of writing out a prescription.
Embodiment 5
Meloxicam 7.5g
Lactose 300g
Crospolyvinylpyrrolidone 150g
Carboxymethylstach sodium 100g
Starch 4g
Citric acid 100g
Acetic acid 100g
Micropowder silica gel 15g
Magnesium stearate 7.5g
Water 216g
Make 1000.
Preparation method:
Step 1: the meloxicam of having pulverized and pharmaceutic adjuvant are crossed respectively to 120 mesh sieves, and starch adds water and makes starch slurry.Get the starch slurry 50g preparing, stir and add 180g water, then add citric acid, mix equal Uniform.Step 2: recipe quantity meloxicam is mixed homogeneously with recipe quantity lactose, crospolyvinylpyrrolidone, carboxymethylstach sodium, micropowder silica gel, acetic acid after the embedding of fluid bed acid solution with part acid solution in step 1, adds remaining starch slurry described in step 1 to make soft material.
Step 3: made soft material in step 2 is crossed to 24 mesh sieves and granulate, 60 ℃ dry, and moisture is 2.4%, 24 mesh sieve granulate.
Step 4: mix homogeneously with magnesium stearate making granule in step 3.
Step 5: semi-finished product detect, and determine sheet weight, and tabletting, obtains Meloxicam Dispersive Tablet.
Embodiment 5 starch in replace hydroxypropyl methylcellulose, all the other are constant, find that made dispersible tablet hardness declines to some extent at equal pressure condition lower sheeting, but also meet 2010 editions pharmacopeia dispersible tablet standards.
Embodiment 6
Meloxicam 7.5g
Starch 300g
Crospolyvinylpyrrolidone 200g
Carboxymethylstach sodium 50g
Hydroxypropyl methylcellulose 3.5g
Malic acid 100g
Micropowder silica gel 15g
Magnesium stearate 7g
Water 217g
95% ethanol 100g
Make 1000.
Preparation method is with embodiment 2.
Embodiment 6 changes filler, and replace lactose with starch, and malic acid is replaced to citric acid, the made dispersible tablet there was no significant difference of dispersible tablet and embodiment 3, dispersibility and dissolution are all better.
Embodiment 7
Meloxicam 7.5g
Icing Sugar 250g
Crospolyvinylpyrrolidone 150g
Carboxymethylstach sodium 150g
Hydroxypropyl methylcellulose 4g
Citric acid 100g
Micropowder silica gel 15g
Magnesium stearate 7.5g
Water 216g
95% ethanol 100g
Make 1000.
Preparation method is with implementing 2.
Embodiment 7 changes filler, replaces lactose with Icing Sugar, all the other with embodiment 3 together, the made dispersible tablet there was no significant difference of dispersible tablet and embodiment 3, dispersibility and dissolution are all better.
Embodiment 8
Meloxicam 7.5g
Starch 300g
Crospolyvinylpyrrolidone 100g
Carboxymethylstach sodium 150g
Hydroxypropyl methylcellulose 4g
Maleic acid 100g
Micropowder silica gel 15g
Magnesium stearate 7.5g
Water 216g
95% ethanol 100g
Make 1000.
Preparation method is with embodiment 7.
The made dispersible tablet smooth in appearance of embodiment 8, dissolution are good, and dispersibility is slightly poorer than adopting the dispersible tablet of citric acid, but adopts the dispersible tablet of oxalic acid to get well.
Biological test
(1) table 1 is the dissolution comparative result of Meloxicam Dispersive Tablet and meloxicam ordinary tablet (embodiment 1 gained dispersible tablet).
With reference to dissolution method (2010 editions two appendix XC bis-methods of Chinese Pharmacopoeia).
The comparison of ordinary tablet cumulative percentage dissolution is sold in table 1 Meloxicam Dispersive Tablet and market
As can be seen from Table 1, the dissolution in vitro of Meloxicam Dispersive Tablet in 10-30min is obviously better than ordinary tablet.
(2) Meloxicam Dispersive Tablet assay
Measure with reference to high-efficient liquid phase technique (two appendix VD of Chinese Pharmacopoeia version in 2010).
Table 2 Meloxicam Dispersive Tablet assay
| Batch | Meloxicam Dispersive Tablet content (%) |
| Batch 1 | 100.34 |
| Batches 2 | 100.39 |
| Batches 3 | 100.40 |
As can be seen from Table 2, the content of the Meloxicam Dispersive Tablet requirement that conforms with the regulations.
(3) the quality stability comparison of Meloxicam Dispersive Tablet
Meloxicam Dispersive Tablet accelerated test: the Meloxicam Dispersive Tablet of blister package is put under the condition of 40 ℃ ± 2 ℃ of temperature, relative humidity 75% ± 5% and place six months, outcome quality is stable, and indices is as shown in table 3.
Six months accelerated test testing results of table 3 Meloxicam Dispersive Tablet
| Inspection batch | Outward appearance | Disintegration | Dispersing uniformity | Dissolution % | Content % |
| Batch 1 | Faint yellow smooth | 38 | Conform with the regulations | 100.41 | 100.25 |
| Batches 2 | Faint yellow smooth | 39 | Conform with the regulations | 100.47 | 100.36 |
| Batches 3 | Faint yellow smooth | 39 | Conform with the regulations | 100.32 | 100.13 |
Claims (10)
1. a Meloxicam Dispersive Tablet, it comprises as follows according to the component of percetage by weight meter: meloxicam
filler
disintegrating agent
acidulant
binding agent 0.1～20%, lubricant and fluidizer
2. Meloxicam Dispersive Tablet according to claim 1, it comprises as follows according to the component of percetage by weight meter: meloxicam 7.5%, filler 40%, disintegrating agent 37.5%, acidulant 10%, binding agent 2%, lubricant and fluidizer 3%.
3. Meloxicam Dispersive Tablet according to claim 1, the component that it comprises following percetage by weight meter:
Meloxicam 7.5g
Lactose 300g
Crospolyvinylpyrrolidone 67.5g
Carboxymethylstach sodium 200g
Hydroxypropyl methylcellulose 3.5g
Citric acid 100g
Micropowder silica gel 25g
Magnesium stearate 7.5g
Water 175
95% ethanol 114g
Make 1000.
4. Meloxicam Dispersive Tablet according to claim 1, wherein, described filler is a kind of in starch, Icing Sugar, dextrin, lactose, microcrystalline Cellulose, mannitol, sorbitol or xylitol or their mixture.
5. Meloxicam Dispersive Tablet according to claim 1, wherein, described disintegrating agent is a kind of in microcrystalline Cellulose, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, cross-linked carboxymethyl cellulose sodium, crospolyvinylpyrrolidone, crosslinked carboxymethyl fecula sodium, dried starch or their mixture.
6. Meloxicam Dispersive Tablet according to claim 1, wherein, described acidulant is a kind of in citric acid, lactic acid, acetic acid, ethanedioic acid, malonic acid, succinic acid, tartaric acid, adipic acid, malic acid, nicotinic acid, pectic acid, ascorbic acid, caffeic acid, fumaric acid, maleic acid, phosphoric acid solution or their mixture.
7. Meloxicam Dispersive Tablet according to claim 1, wherein, described binding agent is a kind of in hypromellose, sodium carboxymethyl cellulose, starch, pregelatinized Starch, polyvidone, gelatin, Polyethylene Glycol, ethanol, water or their mixture.
8. Meloxicam Dispersive Tablet according to claim 1, wherein, described lubricant and fluidizer are a kind of of micropowder silica gel, magnesium stearate, silicon dioxide, Pulvis Talci, Polyethylene Glycol apoplexy due to endogenous wind or their mixture.
9. a preparation method for Meloxicam Dispersive Tablet described in any one in claim 1-8, it comprises the steps: that (1) sieve meloxicam and pharmaceutic adjuvant respectively; Binding agent be dissolved in concentration be 85% or following alcoholic solution or aqueous solution in after, then the acidulant of recipe quantity is dissolved in the solution containing binding agent, obtain acid solution; (2) meloxicam is mixed homogeneously with filler, disintegrating agent, fluidizer after adopting the made acid solution embedding of step (1), adds binding agent, mixes, and makes soft material; (3) by soft material mistake
mesh sieve, 40～60 ℃ are dry,
order granulate; (4) add lubricant, mix homogeneously; (5) tabletting, makes Meloxicam Dispersive Tablet.
10. the preparation method of Meloxicam Dispersive Tablet according to claim 9, wherein, described in step (2), be that meloxicam and acid solution are passed through to fluid bed embedding with acid solution embedding, or meloxicam put into together with acid solution to colloid mill and sheared, drier.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN111346097A (en) * | 2018-12-22 | 2020-06-30 | 江苏先声药业有限公司 | Composition and preparation method thereof |
| CN111888477A (en) * | 2020-09-15 | 2020-11-06 | 北京福元医药股份有限公司 | Bedaquinoline pharmaceutical preparation |
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| CN102266300A (en) * | 2011-07-14 | 2011-12-07 | 广东药学院 | Gefitinib dispersible tablet and preparation method and application thereof |
| CN103054872A (en) * | 2013-01-24 | 2013-04-24 | 宁夏康亚药业有限公司 | Meloxicam pharmaceutical composition and preparation method thereof |
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- 2014-03-14 CN CN201410094096.2A patent/CN103860497A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102266300A (en) * | 2011-07-14 | 2011-12-07 | 广东药学院 | Gefitinib dispersible tablet and preparation method and application thereof |
| CN103054872A (en) * | 2013-01-24 | 2013-04-24 | 宁夏康亚药业有限公司 | Meloxicam pharmaceutical composition and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN111346097A (en) * | 2018-12-22 | 2020-06-30 | 江苏先声药业有限公司 | Composition and preparation method thereof |
| CN111888477A (en) * | 2020-09-15 | 2020-11-06 | 北京福元医药股份有限公司 | Bedaquinoline pharmaceutical preparation |
| CN111888477B (en) * | 2020-09-15 | 2023-03-07 | 北京福元医药股份有限公司 | Bedaquinoline pharmaceutical preparation |
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Application publication date: 20140618 |