CN103054872A - Meloxicam pharmaceutical composition and preparation method thereof - Google Patents
Meloxicam pharmaceutical composition and preparation method thereof Download PDFInfo
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- CN103054872A CN103054872A CN2013100258216A CN201310025821A CN103054872A CN 103054872 A CN103054872 A CN 103054872A CN 2013100258216 A CN2013100258216 A CN 2013100258216A CN 201310025821 A CN201310025821 A CN 201310025821A CN 103054872 A CN103054872 A CN 103054872A
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Abstract
The invention discloses a meloxicam pharmaceutical composition and a preparation method thereof. The meloxicam pharmaceutical composition comprises the following ingredients in percentage by weight: 2-10% of effective component, namely, meloxicam, 70-80% of filling agent, 7-11% of disintegrating agent, 2-5% of adhesive, 0.2-0.8% of solubilizer, 0.2-5% of lubricant and a moderate amount of solvent. Due to the reasonable auxiliary material selection and ratio distribution of the meloxicam pharmaceutical composition disclosed by the invention, the in-vitro dissolution of a meloxicam tablet prepared from the meloxicam pharmaceutical composition is significantly improved; and meanwhile, by using a preparation method of wet granulation, the tablet prepared from the meloxicam pharmaceutical composition disclosed by the invention is attractive in appearance, good in granule flowability, strong in abrasion resistance and good in compression shaping ability; due to the optimization of the preparation method and the process, the stability of the medicine in the production process is ensured, and the product quality is improved.
Description
Technical field
The present invention relates to field of medicaments, particularly relate to a kind of meloxicam pharmaceutical composition and preparation method thereof.
Background technology
Meloxicam is the non-steroid antiinflammatory drug of new generation by the exploitation of German BOEDIRINGER INGELHEIM company, 1996 successively in South Africa, Britain's listing, its dosage form has tablet and suppository.The characteristics of meloxicam maximum are that selectivity suppresses II type cyclooxygenase (COX-2) inhibitor.These product have remarkable and lasting antiinflammatory action and certain antipyretic effect.Meloxicam still has good pharmacokinetics character, as absorb fast, blood drug level is high, bioavailability is high, plasma protein binding rate is also very high, particularly alternative enters inflamed sites, thereby antiinflammatory action is strong and lasting.
But the stability of existing medicine take meloxicam as main effective ingredient is all bad at present, this has just affected the application of the medicine take meloxicam as main effective ingredient, and stability how to improve the medicine take meloxicam as main effective ingredient has become an important research topic.
Summary of the invention
The objective of the invention is to overcome the deficiencies in the prior art, a kind of meloxicam pharmaceutical composition and preparation method thereof is provided, to improve the stability of meloxicam medicine.
For this reason, in one aspect of the invention, a kind of meloxicam pharmaceutical composition is provided, the percentage composition meter comprises following component by weight: 2%～10% effective ingredient meloxicam, 70%～80% filler, 7%～11% disintegrating agent, 2%～5% binding agent, 0.2%～0.8% solubilizing agent, 0.2%～5% lubricant, and an amount of solvent.
Preferably, optional filler includes but not limited in microcrystalline Cellulose, pregelatinized Starch, the lactose one or more in the aforementioned pharmaceutical compositions; Optional disintegrating agent includes but not limited to polyvinylpolypyrrolidone, hyprolose, carboxymethylstach sodium, cross-linked carboxymethyl cellulose a kind of, two or more the compositions in receiving; Optional binding agent includes but not limited to a kind of, two or more the compositions in starch, pregelatinized Starch, the polyvidone; Optional solubilizing agent includes but not limited to one or more the compositions in poloxamer, Tween-80, the sodium lauryl sulphate; Optional lubricant includes but not limited to be a kind of, two or more compositions in Pulvis Talci, silicon dioxide, magnesium stearate or the hard alcohol fumaric acid sodium.
Preferably, aforementioned pharmaceutical compositions by weight percentage composition meter comprises following component: 7.5% meloxicam, 70～80% lactose, 2～5% pregelatinized Starch, 6.5～9% hyprolose, 0.5～2% carboxymethylstach sodium, 0.2～0.8% poloxamer, 0.2～1% magnesium stearate, and an amount of ethanol.
In another aspect of the present invention, a kind of preparation method of aforementioned pharmaceutical compositions also is provided: it comprises the steps: 1) solubilizing agent, binding agent are mixed an amount of solvent of adding, form mixed solution A; 2) meloxicam and filler are mixed with the part disintegrating agent behind 60～200 mesh sieves respectively excessively, form mixture B; ) described mixed solution A is joined among the described mixture B, rear granulation C stirs; 4) with adding remaining disintegrating agent and lubricant after the described granule C oven dry, strike out sheet behind the mix homogeneously.
Preferably, step 1 in the preparation method of aforementioned pharmaceutical compositions) further comprises: 1.1) described solubilizing agent is dissolved in 4～8 times the ethanol, forms solubilizing agent solution; 1.2) described binding agent is dissolved in the purified water, be mixed with mass concentration and be 8%～15% binder solution; 1.3) described binder solution is joined in the described solubilizing agent solution, adding purified water, to make mass concentration be 10～12% described mixed solution A.
Preferably, step 2 in the preparation method of aforementioned pharmaceutical compositions) further comprise: 2.1) meloxicam is crossed 100 mesh sieves, filler is crossed 80 mesh sieves; 2.2) meloxicam after will sieving with sieve after filler and part disintegrating agent mixed-shaped resulting mixture B.
Preferably, the granularity of prepared granule C is the 24-28 order step 3 in the preparation method of aforementioned pharmaceutical compositions).
Preferably, step 4 in the preparation method of aforementioned pharmaceutical compositions) temperature of baking step is 60～80 ℃ in, and the time is 10～20min; Pressure is 8-10KN in the punching press step in blocks, and the time is 0.5～2h.
In another aspect of the present invention, also provide a kind of above-mentioned meloxicam pharmaceutical composition at non-steroidal anti-inflammatory, the application in rheumatoid arthritis, the painful osteoarthritis medicine.Wherein the painful osteoarthritis is preferably arthrosis or degenerative osteoarthritis.
The drug regimen of meloxicam provided by the present invention is chosen and pro rate through rational adjuvant, makes the prepared meloxicam tablet of the present invention have obvious raising at In Vitro Dissolution.Simultaneously, meloxicam compositions provided by the present invention is by the preparation method of wet granulation, and the tablet facial contour that makes is attractive in appearance, wearability is strong, compressibility is good; Optimization by to prescription and technique has ensured medicine stability in process of production, has improved product quality.
Description of drawings
Fig. 1 is the stripping curve figure of embodiment and Comparative Examples.
Specific embodiment
The present invention is described in detail below in conjunction with specific embodiment 1-6, and embodiment provided by the present invention understands technical scheme provided by the present invention in order to help, and can not limit protection scope of the present invention; The multitude of different ways that the present invention can be defined by the claims and cover is implemented.
Embodiment one
Composition of raw materials:
Preparation method:
1) poloxamer is dissolved in 5 times of ethanol, makes poloxamer solution; Pregelatinized Starch is added the pregelatinized Starch solution that purified water is made concentration 8%; Pregelatinized Starch solution is joined in the poloxamer solution, and adding purified water, to make mass concentration be 10% mixed solution A.
2) meloxicam is crossed 100 mesh sieves, lactose is crossed 80 mesh sieves, mixes meloxicam and lactose after sieving, adds hyprolose mixed-shaped resulting mixture B;
3) described mixed solution A is joined among the mixture B, making granularity after stirring is 24 purpose granule C;
4) being 80 ℃ of lower oven dry 15min with described granule C in temperature, adding carboxymethylstach sodium and magnesium stearate after the oven dry and mix, is that punching press 1h forms tablet under the 10KN at pressure.
Embodiment two
Composition of raw materials:
Preparation method:
1) poloxamer is dissolved in 8 times of ethanol, makes poloxamer solution; Pregelatinized Starch is added the pregelatinized Starch solution that purified water is made concentration 15%; Pregelatinized Starch solution is joined in the poloxamer solution, and adding purified water, to make mass concentration be 12% mixed solution A.
2) meloxicam is crossed 100 mesh sieves, lactose is crossed 80 mesh sieves, mixes meloxicam and lactose after sieving, adds hyprolose mixed-shaped resulting mixture B;
3) described mixed solution A is joined among the described mixture B, making granularity after stirring is 24 purpose granule C;
4) being 80 ℃ of lower oven dry 15min with described granule C in temperature, adding carboxymethylstach sodium and magnesium stearate after the oven dry and mix, is that the 1h punching press forms tablet under the 10KN at pressure.
Embodiment three
Composition of raw materials:
Preparation method: with embodiment one.
Embodiment four
Composition of raw materials: with embodiment one.
Preparation method:
1) poloxamer and pregelatinized Starch are mixed adds purified water to make mass concentration be 10% mixed solution A.
2) meloxicam is crossed 150 mesh sieves, lactose is crossed 150 mesh sieves, mixes meloxicam and lactose after sieving, adds hyprolose mixed-shaped resulting mixture B;
3) described mixture B is joined in the described mixed solution A, making granularity after stirring is 28 purpose granule C;
4) being 60 ℃ of lower oven dry 20min with described granule C in temperature, adding carboxymethylstach sodium and magnesium stearate after the oven dry and mix, is that punching press 2h forms tablet under the 8KN at pressure.
Embodiment five
Preparation method: with embodiment one.
Embodiment six
Composition of raw materials:
Preparation method: with embodiment one.
Embodiment seven
Composition of raw materials:
Preparation method: with embodiment four.
Comparative Examples one
Composition of raw materials:
Preparation method: with embodiment 1
Comparative Examples two
Composition of raw materials:
Preparation method:
1) poloxamer is dissolved in 5 times of ethanol, makes poloxamer solution; Pregelatinized Starch is added the pregelatinized Starch solution that purified water is made concentration 5%; Pregelatinized Starch solution is joined in the poloxamer solution, and adding purified water, to make mass concentration be 20% mixed solution A.
2) meloxicam is crossed 40 mesh sieves, lactose is crossed 40 mesh sieves, mixes meloxicam and lactose after sieving, adds hyprolose mixed-shaped resulting mixture B;
3) described mixed solution A is joined among the described mixture B, making granularity after stirring is 26 purpose granule C;
4) being 60 ℃ of lower oven dry 20min with described granule C in temperature, adding carboxymethylstach sodium and magnesium stearate after the oven dry and mix, is that 10KN undershoot swaging becomes tablet at pressure.
Test one:
Get embodiment one～embodiment seven prepared sample and Comparative Examples one～Comparative Examples two prepared samples and carry out stability test and dissolution investigation, test method is as follows:
(1) with each sample respectively at placing under 60 ℃ of high temperature, 40 ℃, RH75%, RH92.5% and the intensity of illumination 4500Lx ± 500Lx condition, respectively at sampling in 5 days, 10 days, detect, and compared with 0 day, result of the test sees Table 1-table 9.
(2) each sample being carried out dissolution according to Chinese Pharmacopoeia version Meloxicam in 2010 sheet investigates, respectively at 5min, 10min, 20min, 30min, 45min, the 60min 5ml that takes a sample, replenish simultaneously synthermal dissolution medium with volume, filter, get subsequent filtrate as need testing solution, measure dissolution, result of the test sees Table 10.Stripping curve figure sees Figure of description.
Table 1 embodiment one is from film-making influence factor result of the test
Table 2 embodiment two is from film-making influence factor result of the test
Table 3 embodiment three is from film-making influence factor result of the test
Table 4 embodiment four selfs film-making influence factor result of the test
Table 5 embodiment five is from film-making influence factor result of the test
Table 6 embodiment six is from film-making influence factor result of the test
Table 7 embodiment seven is from film-making influence factor result of the test
Table 8 Comparative Examples one is from film-making influence factor result of the test
Table 9 Comparative Examples two is from film-making influence factor result of the test
Table 10 embodiment and Comparative Examples are from film-making stripping curve result of the test
Compare by the influence factor result of Comparative Examples among embodiment among the table 1-7 and the table 8-9 and to be not difficult to find out, by the stability of the prepared embodiment sample of cooperation provided by the present invention and method significantly better than comparative example.Therefore the present invention can significantly improve the stability of medicine.
Test two
Get embodiment one～embodiment seven prepared sample and Comparative Examples one～Comparative Examples two prepared samples and carry out such as test in the following table 11, test result is as shown in table 11.
The detection index of sheet facial contour is: perusal, and unilateral smooth, without pit.
The detection index of mobility of particle is: angle of repose＜40 °
The detection index of wearability is: less loss weight must not cross 1%, and the sheet that must not detect fracture all the time, chap and pulverize.
The detection index of compression forming performance is: 8-13kg.
Table 11
By data in the table 11 as can be known, meloxicam compositions provided by the present invention is by the preparation method of wet granulation, and the tablet facial contour that makes is attractive in appearance, mobility of particle good, wearability is strong, compressibility is good; Optimization by to prescription and technique has ensured medicine stability in process of production, has improved product quality.
The above is the preferred embodiments of the present invention only, is not limited to the present invention, and for a person skilled in the art, the present invention can have various modifications and variations.Within the spirit and principles in the present invention all, any modification of doing, be equal to replacement, improvement etc., all should be included within protection scope of the present invention.
Claims (10)
1. meloxicam pharmaceutical composition, it is characterized in that, the percentage composition meter comprises following component by weight: 2%～10% effective ingredient meloxicam, 70%～80% filler, 7%～11% disintegrating agent, 2%～5% binding agent, 0.2%～1% solubilizing agent, 0.2%～5% lubricant, and an amount of solvent.
2. pharmaceutical composition according to claim 1 is characterized in that,
Described filler is one or more in microcrystalline Cellulose, pregelatinized Starch, the lactose;
Described disintegrating agent is a kind of, two or more the compositions during polyvinylpolypyrrolidone, hyprolose, carboxymethylstach sodium, cross-linked carboxymethyl cellulose are received;
Described binding agent is a kind of, two or more the compositions in starch, pregelatinized Starch, the polyvidone;
Described solubilizing agent is one or more the compositions in poloxamer, Tween-80, the sodium lauryl sulphate;
Described lubricant is a kind of, two or more the compositions in Pulvis Talci, silicon dioxide, magnesium stearate or the hard alcohol fumaric acid sodium.
3. pharmaceutical composition according to claim 1, it is characterized in that, the percentage composition meter comprises following component by weight: 7.5% meloxicam, 75～80% lactose, 2～5% pregelatinized Starch, 6.5～9% hyprolose, 0.5～2% carboxymethylstach sodium, 0.2～0.8% poloxamer, 0.2～1% magnesium stearate, and an amount of ethanol.
4. a method for preparing the described pharmaceutical composition of claim 1 is characterized in that, comprises the steps:
1) solubilizing agent, binding agent are mixed an amount of solvent of adding, form mixed solution A;
2) meloxicam and filler are mixed with the part disintegrating agent behind 60～200 mesh sieves respectively excessively, form mixture B;
3) described mixed solution A is joined among the described mixture B, rear granulation C stirs;
4) with adding remaining disintegrating agent and lubricant after the described granule C oven dry, strike out sheet behind the mix homogeneously.
5. pharmaceutical composition according to claim 1 is characterized in that, described step 1) further comprise:
1.1) described solubilizing agent is dissolved in 3～5 times the ethanol, form solubilizing agent solution;
1.2) described binding agent is dissolved in the purified water, be mixed with mass concentration and be 8%～15% binder solution;
1.3) described binder solution is joined in the described solubilizing agent solution, adding purified water, to make mass concentration be 10～12% described mixed solution A.
6. pharmaceutical composition according to claim 1 is characterized in that, described step 2) further comprise:
2.1) described meloxicam is crossed 100 mesh sieves, described filler is crossed 80 mesh sieves;
2.2) meloxicam after will sieving with sieve after filler mix with hyprolose as disintegrating agent and form described mixture B.
7. pharmaceutical composition according to claim 1 is characterized in that, described step 3) in the granularity of prepared granule C be the 24-28 order.
8. pharmaceutical composition according to claim 1 is characterized in that, described step 4) in the temperature of baking step be 60～80 ℃, the time is 10～20min; Pressure is 8-10KN in the punching press step in blocks, and the time is 0.5～2h.
In the claims 1 to 3 each described meloxicam pharmaceutical composition at non-steroidal anti-inflammatory, the application in rheumatoid arthritis, the painful osteoarthritis medicine.
10. application according to claim 9 is characterized in that, described painful osteoarthritis is arthrosis or degenerative osteoarthritis.
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| CN103772378A (en) * | 2014-01-26 | 2014-05-07 | 悦康药业集团有限公司 | Meloxicam compound and tablet thereof |
| CN103860497A (en) * | 2014-03-14 | 2014-06-18 | 王志刚 | Meloxicam dispersible tablet and preparation method thereof |
| WO2016029495A1 (en) * | 2014-08-29 | 2016-03-03 | 武汉光谷人福生物医药有限公司 | 4-methoxynimesulide thin film coated tablets |
| CN105435239A (en) * | 2014-08-29 | 2016-03-30 | 武汉光谷人福生物医药有限公司 | Use of microcrystalline cellulose in Meisuoshuli preparation, auxiliary material used for Meisuoshuli, Meisuoshuli preparation and preparation method of Meisuoshuli preparation |
| CN106619547A (en) * | 2016-11-18 | 2017-05-10 | 江苏飞马药业有限公司 | Low-specification meloxicam tablet composition and preparation method thereof |
| CN107970219A (en) * | 2017-12-27 | 2018-05-01 | 佛山市南海东方澳龙制药有限公司 | Pet meloxicam tablet and its preparation method and application |
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103772378A (en) * | 2014-01-26 | 2014-05-07 | 悦康药业集团有限公司 | Meloxicam compound and tablet thereof |
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| WO2016029495A1 (en) * | 2014-08-29 | 2016-03-03 | 武汉光谷人福生物医药有限公司 | 4-methoxynimesulide thin film coated tablets |
| CN105435239A (en) * | 2014-08-29 | 2016-03-30 | 武汉光谷人福生物医药有限公司 | Use of microcrystalline cellulose in Meisuoshuli preparation, auxiliary material used for Meisuoshuli, Meisuoshuli preparation and preparation method of Meisuoshuli preparation |
| CN105435239B (en) * | 2014-08-29 | 2019-04-26 | 武汉光谷人福生物医药有限公司 | Mei Suoshuli Film coated tablets and preparation method thereof |
| CN106619547A (en) * | 2016-11-18 | 2017-05-10 | 江苏飞马药业有限公司 | Low-specification meloxicam tablet composition and preparation method thereof |
| CN107970219A (en) * | 2017-12-27 | 2018-05-01 | 佛山市南海东方澳龙制药有限公司 | Pet meloxicam tablet and its preparation method and application |
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Address after: 750002 the Ningxia Hui Autonomous Region street, Jinfeng District, Yinchuan City Fu Ning Lane No. 57 Patentee after: Ningxia Kang Ya pharmaceutical Limited by Share Ltd Address before: 750002 No. 6 road, hi tech Industrial Development Zone, the Ningxia Hui Autonomous Region, Yinchuan Patentee before: Kangya Pharmaceutical Industry Co., Ltd., Ningxia |