CN103054872B - Meloxicam pharmaceutical composition and preparation method thereof - Google Patents
Meloxicam pharmaceutical composition and preparation method thereof Download PDFInfo
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- CN103054872B CN103054872B CN201310025821.6A CN201310025821A CN103054872B CN 103054872 B CN103054872 B CN 103054872B CN 201310025821 A CN201310025821 A CN 201310025821A CN 103054872 B CN103054872 B CN 103054872B
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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 feature of meloxicam maximum is 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 compared with strong and lasting.
But the stability of the existing medicine taking meloxicam as main effective ingredient is all bad at present, this has just affected the application of the medicine taking meloxicam as main effective ingredient, and stability how to improve the medicine taking meloxicam as main effective ingredient has become an important research topic.
Summary of the invention
The object 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, 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 appropriate solvent.
Preferably, in aforementioned pharmaceutical compositions, optional filler includes but not limited to one or more in microcrystalline Cellulose, pregelatinized Starch, lactose; 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, polyvidone; Optional solubilizing agent includes but not limited to one or more the compositions in poloxamer, Tween-80, sodium lauryl sulphate; Optional lubricant includes but not limited to as a kind of, two or more compositions in Pulvis Talci, silicon dioxide, magnesium stearate or 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 appropriate ethanol.
In another aspect of the present invention, also provide a kind of preparation method of aforementioned pharmaceutical compositions: it comprises the steps: 1) solubilizing agent, binding agent are mixed and add appropriate solvent, form mixed solution A; 2) meloxicam and filler are mixed with part disintegrating agent after 60～200 mesh sieves respectively excessively, form mixture B; ) described mixed solution A is joined in described mixture B to granulation C after stirring; 4) by adding remaining disintegrating agent and lubricant after described granule C oven dry, after mix homogeneously, strike out sheet.
Preferably, step 1 in the preparation method of aforementioned pharmaceutical compositions) further comprise: 1.1) described solubilizing agent is dissolved in the ethanol of 4～8 times, forms solubilizing agent solution; 1.2) described binding agent is dissolved in purified water, is mixed with mass concentration and is 8%～15% binder solution; 1.3) described binder solution is joined in 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 to 100 mesh sieves, filler is crossed to 80 mesh sieves; 2.2) filler and the part disintegrating agent by the meloxicam after sieving and after sieving is mixed to form mixture B.
Preferably, step 3 in the preparation method of aforementioned pharmaceutical compositions) in the granularity of prepared granule C be 24-28 order.
Preferably, step 4 in the preparation method of aforementioned pharmaceutical compositions) in the temperature of baking step be 60～80 DEG C, the time is 10～20min; In punching press step in blocks, pressure is 8-10KN, 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, painful osteoarthritis medicine.Wherein 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, make the prepared meloxicam tablet of the present invention in vitro in stripping tool be significantly improved.Meanwhile, 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; By the optimization to prescription and technique, ensure medicine stability in process of production, improve product quality.
Brief description of the drawings
Fig. 1 is the stripping curve figure of embodiment and comparative example.
Specific embodiment
Below in conjunction with specific embodiment 1-6, the present invention is described in detail, and embodiment provided by the present invention is only in order to help understanding technical scheme provided by the present invention, 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 mono-
Composition of raw materials:
Preparation method:
1) poloxamer is dissolved in 5 times of ethanol, makes poloxamer solution; Add purified water to make the pregelatinized Starch solution of concentration 8% pregelatinized Starch; Pregelatinized Starch solution is joined in poloxamer solution, and adding purified water, to make mass concentration be 10% mixed solution A.
2) meloxicam is crossed to 100 mesh sieves, lactose is crossed 80 mesh sieves, mixes meloxicam and lactose after sieving, adds hyprolose to be mixed to form mixture B;
3) described mixed solution A is joined in mixture B, after stirring, making granularity is 24 object granule C;
4) be to dry 15min at 80 DEG C by described granule C in temperature, after drying, additional carboxymethylstach sodium and magnesium stearate are mixed, and are that under 10KN, punching press 1h forms tablet at pressure.
Embodiment bis-
Composition of raw materials:
Preparation method:
1) poloxamer is dissolved in 8 times of ethanol, makes poloxamer solution; Add purified water to make the pregelatinized Starch solution of concentration 15% pregelatinized Starch; Pregelatinized Starch solution is joined in poloxamer solution, and adding purified water, to make mass concentration be 12% mixed solution A.
2) meloxicam is crossed to 100 mesh sieves, lactose is crossed 80 mesh sieves, mixes meloxicam and lactose after sieving, adds hyprolose to be mixed to form mixture B;
3) described mixed solution A is joined in described mixture B, after stirring, making granularity is 24 object granule C;
4) be to dry 15min at 80 DEG C by described granule C in temperature, after drying, additional carboxymethylstach sodium and magnesium stearate are mixed, and are that under 10KN, 1h punching press forms tablet at pressure.
Embodiment tri-
Composition of raw materials:
Preparation method: with embodiment mono-.
Embodiment tetra-
Composition of raw materials: with embodiment mono-.
Preparation method:
1) poloxamer and pregelatinized Starch are mixed to add purified water to make mass concentration be 10% mixed solution A.
2) meloxicam is crossed to 150 mesh sieves, lactose is crossed 150 mesh sieves, mixes meloxicam and lactose after sieving, adds hyprolose to be mixed to form mixture B;
3) described mixture B is joined in described mixed solution A, after stirring, making granularity is 28 object granule C;
4) be to dry 20min at 60 DEG C by described granule C in temperature, after drying, additional carboxymethylstach sodium and magnesium stearate are mixed, and are that under 8KN, punching press 2h forms tablet at pressure.
Embodiment five
Preparation method: with embodiment mono-.
Embodiment six
Composition of raw materials:
Preparation method: with embodiment mono-.
Embodiment seven
Composition of raw materials:
Preparation method: with embodiment tetra-.
Comparative example one
Composition of raw materials:
Preparation method: with embodiment 1
Comparative example two
Composition of raw materials:
Preparation method:
1) poloxamer is dissolved in 5 times of ethanol, makes poloxamer solution; Add purified water to make the pregelatinized Starch solution of concentration 5% pregelatinized Starch; Pregelatinized Starch solution is joined in poloxamer solution, and adding purified water, to make mass concentration be 20% mixed solution A.
2) meloxicam is crossed to 40 mesh sieves, lactose is crossed 40 mesh sieves, mixes meloxicam and lactose after sieving, adds hyprolose to be mixed to form mixture B;
3) described mixed solution A is joined in described mixture B, after stirring, making granularity is 26 object granule C;
4) be to dry 20min at 60 DEG C by described granule C in temperature, after drying, additional carboxymethylstach sodium and magnesium stearate are mixed, and are that 10KN undershoot swaging becomes tablet at pressure.
Test one:
Get the prepared sample of the prepared sample of embodiment mono-～embodiment seven and comparative example one～comparative example two and carry out stability test and dissolution investigation, test method is as follows:
(1) by each sample respectively at placing under 60 DEG C of high temperature, 40 DEG C, RH75%, RH92.5% and intensity of illumination 4500Lx ± 500Lx condition, respectively at sampling in 5 days, 10 days, detect, and compared with 0 day, result of the test is in Table 1-table 9.
(2) each sample is carried out to dissolution investigation according to Chinese Pharmacopoeia version Meloxicam sheet in 2010, sample 5ml respectively at 5min, 10min, 20min, 30min, 45min, 60min, supplement the dissolution medium of synthermal same volume simultaneously, filter, get subsequent filtrate as need testing solution, measure dissolution, result of the test is in table 10.Stripping curve figure is shown in Figure of description.
Table 1 embodiment mono-is from film-making influence factor result of the test
Table 2 embodiment bis-is from film-making influence factor result of the test
Table 3 embodiment tri-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 example one is from film-making influence factor result of the test
Table 9 comparative example two is from film-making influence factor result of the test
Table 10 embodiment and comparative example are from film-making stripping curve result of the test
Contrast and be not difficult to find out by influence factor's result of comparative example in embodiment in table 1-7 and table 8-9, by the stability of cooperation provided by the present invention and the prepared embodiment sample of method significantly better than comparative example.Therefore the present invention can significantly improve the stability of medicine.
Test two
Get the prepared sample of the prepared sample of embodiment mono-～embodiment seven and comparative example one～comparative example two and carry out as test in 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 ° of <
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
From data in table 11, 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; By the optimization to prescription and technique, ensure medicine stability in process of production, improve product quality.
The foregoing is only the preferred embodiments of the present invention, be not limited to the present invention, 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 amendment of doing, be equal to replacement, improvement etc., within all should being included in protection scope of the present invention.
Claims (5)
1. a meloxicam pharmaceutical composition, it is characterized in that, it is percentage composition meter by weight, the tablet of being made by following component: 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 appropriate ethanol.
2. according to the meloxicam pharmaceutical composition of claim 1, it is characterized in that, make the raw material composition of 1000, be by weight:
Meloxicam 7.5g
Lactose 80g
Pregelatinized Starch 2.5g
Hyprolose 8g
Carboxymethylstach sodium 1g
Poloxamer 0.5g
Magnesium stearate 0.5g
Appropriate amount of ethanol.
3. according to the meloxicam pharmaceutical composition of claim 1, it is characterized in that, make the raw material composition of 1000, be by weight:
Meloxicam 7.5g
Lactose 75g
Pregelatinized Starch 5g
Hyprolose 9g
Carboxymethylstach sodium 2g
Poloxamer 0.5g
Magnesium stearate 1g
Appropriate amount of ethanol.
4. preparation, according to the method for the meloxicam pharmaceutical composition of claim 2, is characterized in that, comprises the following steps:
1) poloxamer is dissolved in 5 times of ethanol, makes poloxamer solution; Add purified water to make the pregelatinized Starch solution of concentration 8% pregelatinized Starch; Pregelatinized Starch solution is joined in poloxamer solution, and adding purified water, to make mass concentration be 10% mixed solution A;
2) meloxicam is crossed to 100 mesh sieves, lactose is crossed 80 mesh sieves, mixes meloxicam and lactose after sieving, adds hyprolose to be mixed to form mixture B;
3) described mixed solution A is joined in mixture B, after stirring, making granularity is 24 object granule C;
4) be to dry 15min at 80 DEG C by described granule C in temperature, after drying, additional carboxymethylstach sodium and magnesium stearate are mixed, and are that under 10KN, punching press 1h forms tablet at pressure.
5. preparation, according to the method for the meloxicam pharmaceutical composition of claim 3, is characterized in that, comprises the following steps:
1) poloxamer is dissolved in 8 times of ethanol, makes poloxamer solution; Add purified water to make the pregelatinized Starch solution of concentration 15% pregelatinized Starch; Pregelatinized Starch solution is joined in poloxamer solution, and adding purified water, to make mass concentration be 12% mixed solution A;
2) meloxicam is crossed to 100 mesh sieves, lactose is crossed 80 mesh sieves, mixes meloxicam and lactose after sieving, adds hyprolose to be mixed to form mixture B;
3) described mixed solution A is joined in described mixture B, after stirring, making granularity is 24 object granule C;
4) be to dry 15min at 80 DEG C by described granule C in temperature, after drying, additional carboxymethylstach sodium and magnesium stearate are mixed, and are that under 10KN, 1h punching press forms tablet at pressure.
?
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Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103772378B (en) * | 2014-01-26 | 2016-02-24 | 悦康药业集团有限公司 | Meloxicam compound and tablet thereof |
| CN103860497A (en) * | 2014-03-14 | 2014-06-18 | *** | Meloxicam dispersible tablet and preparation method thereof |
| 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 |
| CN105434388B (en) * | 2014-08-29 | 2018-06-19 | 武汉光谷人福生物医药有限公司 | Mei Suoshuli Film coated tablets |
| 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 |