CN102370639A - Compound preparation of naproxen and sumatriptan - Google Patents
Compound preparation of naproxen and sumatriptan Download PDFInfo
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- CN102370639A CN102370639A CN2010102580304A CN201010258030A CN102370639A CN 102370639 A CN102370639 A CN 102370639A CN 2010102580304 A CN2010102580304 A CN 2010102580304A CN 201010258030 A CN201010258030 A CN 201010258030A CN 102370639 A CN102370639 A CN 102370639A
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- naproxen
- sumatriptan
- compound preparation
- sodium
- cellulose
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Abstract
The invention provides a compound preparation of naproxen and sumatriptan. The compound preparation comprises active components of naproxen and sumatriptan and pharmaceutic adjuvants. A single dose preparation comprises 200-800mg of naproxen and 20-200 mg of sumatriptan. The compound preparation of the invention combines two effect mechanisms of inflammatory resistance and blood vessel diastole into a whole, can be used for treating acute attack of adult tendency or non-tendency migraine and has curative effect better than individual usage of naproxen or sumatriptan and good clinic application value.
Description
Technical field
The present invention relates to pharmaceutical preparation, be specifically related to a kind ofly be used to treat the adult naproxen of tendency or the migrainous acute attack of absence of aura and the compound preparation of sumatriptan arranged.
Background technology
Migraine (Migraine) is meant the one or both sides pulsatile headache of outbreak repeatedly, for clinical common spy sends out headache.It is that a kind of constitutional intracranial vessel motion and function of nervous system regulate not normal caused recurrent disease, has characteristics such as the course of disease is long, intermittence is shown effect repeatedly, touching difficulty heals.Migrainous sickness rate men and women's ratio is 1: 4.Its pathogeny is not clear fully as yet, maybe be relevant with factors such as heredity, endocrine, metabolism, diet and spirit.At present, migrainous sickness rate is 10%-15% in American-European countries, and China is 0.06%.Scholarly forecast, to 2010, migraine will become one of the highest disease of China's sickness rate, and it has had a strong impact on people's quality of life.
Naproxen (Naproxen) is the antipyretic analgesic that U.S. Xin Disi drugmaker succeeds in developing, and belongs to NSAID, because its good medical effect and lower toxic reaction and receive patient's welcome deeply.The same naproxen of the curative effect of naproxen sodium, but after it gets into stomach is scattered in the gastric juice immediately and is precipitated as the granule naproxen, so more be prone to absorb than naproxen, it is fast to prove effective, effect by force and toxic and side effects low.Dosage form in the market has tablet, capsule, suppository and injection.
Sumatriptan (Sumatriptan) is a kind of migrainous medicine that is used to treat, and its chemical name is 3-[2-(dimethylamino) ethyl]-N-methylindole-5-NSC-249992.Sumatriptan is a kind of 5-HT
1Receptor stimulating agent can the exciting blood vessel 5-HT of high selectivity
1Receptor shrinks entocranial artery, and the blood redistribution is improved the cerebral blood flow supply, so can alleviate neurogenic inflammation in the cerebral dura mater, also helps to improve migraine.The listing dosage form mainly contains injection, tablet at present.
Because the treatment mechanism of above-mentioned single preparations of ephedrine is single, clinical effectiveness is also undesirable, also need seek more effective treatment migraine remedy.
Summary of the invention
Problem to be solved by this invention is to overcome above-mentioned weak point, treats migraine from multiple mechanism of action, seeks the best combination of naproxen and sumatriptan, and the research design clinical effectiveness is good, the compound preparation that toxic and side effects is little.
The invention provides the compound preparation of a kind of naproxen and sumatriptan.
Compound preparation of the present invention is by forming as the naproxen of active component and sumatriptan and pharmaceutic adjuvant.
Naproxen in the said active component is naproxen or its pharmaceutically acceptable salt, like naproxen sodium, naproxen zinc, is preferably naproxen sodium.
Sumatriptan in the said active component is a Sumatriptan Succinate.
The weight that contains naproxen in the single-dose preparations of compound preparation of the present invention is 200～800mg, is preferably 250mg, and 500mg is more preferably 500mg.
The weight that contains sumatriptan in the single-dose preparations of compound preparation of the present invention is 20～200mg, is preferably 25mg, 50mg, 85mg or 170mg, more preferably 85mg.
Compound preparation of the present invention, the weight ratio of naproxen and sumatriptan meter is 40: 1～1: 1 in the single-dose preparations, preferred weight ratio is (20: 1), (10: 1), (5.88: 1), (2.94: 1), and (1.47: 1), preferred weight ratio is (5.88: 1).
Compound preparation of the present invention can be processed following dosage form: preparations such as tablet, capsule, granule, powder.
Contain buffer agent in the compound preparation of the present invention, buffer agent is one or more the combination in sodium bicarbonate, sodium carbonate, sodium phosphate, sodium hydrogen phosphate or the sodium citrate, is preferably sodium bicarbonate, and its weight ratio is 5～15%.
Pharmaceutic adjuvant described in the compound preparation of the present invention be can be compatible pharmaceutical carrier, this pharmaceutical carrier is one or more the combination in filler or diluent, binding agent, disintegrating agent, lubricant, correctives, coloring agent, antioxidant, opacifier and the coating material.
Contain active component naproxen 200～800mg, sumatriptan 20～200mg in the preparations such as the tablet of every single dose, capsule, granule, powder.The weight percent proportioning of forming medicinal supplementary material is: naproxen 10-80%, sumatriptan 1-20%, filler or diluent 10～90%; Disintegrating agent 0～10%, lubricant 0.1～1%, binding agent 1～15%; Correctives 0.01～5%, coloring agent 0～0.2%, antioxidant 0.1～0.5%; Buffer agent 5～15%, opacifier 0～0.2%, coating material 2-5%.
Described filler or diluent are one or more the combination in lactose, glucose, sucrose, mannitol, sorbitol, xylitol, maltose alcohol, erythrose, microcrystalline Cellulose, starch, soluble starch, calcium hydrogen phosphate or the calcium sulfate.
Described binding agent is one or more the combination in hydroxypropyl cellulose, hydroxyethyl-cellulose, hypromellose, ethyl cellulose, polyvinylpyrrolidone, lake essence, starch, pregelatinized Starch, water or the ethanol.
Described disintegrating agent is one or more the combination in starch, carboxymethyl starch, modified starch, carboxymethyl starch sodium, carboxymethylcellulose calcium, crospolyvinylpyrrolidone, the cross-linking sodium carboxymethyl cellulose.
Said lubricant or fluidizer are one or more the combinations in magnesium stearate, stearic acid, calcium stearate, hard paraffin, silicon dioxide, sodium stearyl fumarate, the Pulvis Talci.
Said correctives is sucrose and simple syrup thereof, the combination of one or more in saccharin sodium, aspartame, starch, the arabic gum.
Said antioxidant comprises one or more combinations in sulphite, ascorbic acid, thio-compounds or the organic acid; Buffer agent is one or more the combination in sodium bicarbonate, sodium carbonate, sodium phosphate, sodium hydrogen phosphate or the sodium citrate; Opacifier is a titanium dioxide.
Described coating material is one or more the combination in hydroxypropyl emthylcellulose, methylcellulose, hydroxyethyl-cellulose, hydroxypropyl cellulose, methacrylate copolymer, ethyl cellulose, polyethylene glycols, cellulose acetate phthalate ester, polyvinyl alcohol phthalate ester, EUDRAGIT S100 or the hydroxypropyl methyl cellulose phthalate.
In order to confirm to add in this compound preparation the effect of buffer agent, we have carried out contrast test, and correlation test is following:
Prescription 1:
Naproxen sodium 500g (in naproxen)
Sumatriptan Succinate 25g (in sumatriptan)
Cross-linking sodium carboxymethyl cellulose 50g
Calcium hydrogen phosphate 80g
Microcrystalline Cellulose 400g
Sodium bicarbonate 25g
Magnesium stearate 5g
5% polyvinylpyrrolidonesolution solution 700ml
Opadry coating powder 40g
The preparation process is following: with Sumatriptan Succinate, naproxen sodium, cross-linking sodium carboxymethyl cellulose, calcium hydrogen phosphate, microcrystalline Cellulose, sodium bicarbonate mix homogeneously, granulate with 5% polyvinylpyrrolidonesolution solution, put 60 ℃ of oven for drying; Granulate sieves; Add the magnesium stearate mix homogeneously, direct compression is processed 1000; Use Opadry coating powder coating at last, promptly get.Every contains naproxen 500mg, sumatriptan 25mg.
Prescription 2:
Naproxen sodium 500g (in naproxen)
Sumatriptan Succinate 25g (in sumatriptan)
Cross-linking sodium carboxymethyl cellulose 50g
Calcium hydrogen phosphate 80g
Microcrystalline Cellulose 400g
Magnesium stearate 5g
5% polyvinylpyrrolidonesolution solution 700ml
Opadry coating powder 40g
The preparation process is following: with Sumatriptan Succinate, naproxen sodium, cross-linking sodium carboxymethyl cellulose, calcium hydrogen phosphate, microcrystalline Cellulose mix homogeneously, granulate with 5% polyvinylpyrrolidonesolution solution, put 60 ℃ of oven for drying; Granulate sieves; Add the magnesium stearate mix homogeneously, direct compression is processed 1000; Use Opadry coating powder coating at last, promptly get.Every contains naproxen 500mg, sumatriptan 25mg.
The compound recipe naproxen sumatriptan sheet that we obtain test has carried out 6 months stability test, and the result is as shown in the table:
This shows; After adding the buffer agent sodium bicarbonate; Quicken after 6 months, significant change does not all appear in the content of naproxen and sumatriptan and dissolution, and does not add the buffer agent sodium bicarbonate; Its dissolution and content all are obvious downward trend, explain that buffer agent plays a very good protection in this compound preparation.
The present invention is a kind of compound preparation, collection antiinflammatory and two mechanism of action of vasodilator, and treating the adult has tendency or the migrainous acute attack of absence of aura, and curative effect is superior to using separately any one medicine in naproxen and the sumatriptan.
The specific embodiment
Following instance will be done further elaboration to the present invention, but not limit content involved in the present invention in any form.The weight that contains naproxen is 200～800mg, is preferably 250mg, and 500mg is more preferably 500mg.
The weight that contains sumatriptan in the single-dose preparations of compound preparation of the present invention is 20～200mg, is preferably 25mg, 50mg, 85mg or 170mg, more preferably 85mg.
Compound preparation of the present invention, the weight ratio of naproxen and sumatriptan meter is 40: 1～1: 1 in the single-dose preparations, preferred weight ratio is (20: 1), (10: 1), (5.88: 1), (2.94: 1), and (1.47: 1), preferred weight ratio is (5.88: 1).
Embodiment 1 naproxen sodium sumatriptan sheet
Prescription:
Naproxen sodium 500g (in naproxen)
Sumatriptan Succinate 50g (in sumatriptan)
Cross-linking sodium carboxymethyl cellulose 50g
Calcium hydrogen phosphate 100g
Microcrystalline Cellulose 450g
Sodium bicarbonate 25g
Magnesium stearate 5g
5% polyvinylpyrrolidonesolution solution 700ml
Opadry coating powder 40g
The preparation process is following: with Sumatriptan Succinate, naproxen sodium, cross-linking sodium carboxymethyl cellulose, calcium hydrogen phosphate, microcrystalline Cellulose, sodium bicarbonate mix homogeneously, granulate with 5% polyvinylpyrrolidonesolution solution, put 60 ℃ of oven for drying; Granulate sieves; Add the magnesium stearate mix homogeneously, direct compression is processed 1000; Use Opadry coating powder coating at last, promptly get.Every contains naproxen 500mg, sumatriptan 85mg.
Embodiment 2 naproxen sodium sumatriptan capsules
Prescription:
Naproxen sodium 500g (in naproxen)
Sumatriptan Succinate 85g (in sumatriptan)
Microcrystalline Cellulose 200g
The smart 100g in Fructus Hordei Germinatus lake
Sodium bicarbonate 50g
Pulvis Talci 5g
2% Gonak 500ml
The preparation process is following: with Sumatriptan Succinate, naproxen sodium, Fructus Hordei Germinatus lake essence, microcrystalline Cellulose, sodium bicarbonate mix homogeneously, granulate with 2% Gonak, put 60 ℃ of oven for drying; Granulate sieves; Add the Pulvis Talci mix homogeneously,, process 1000 again with the mixture filled capsules; Every capsules contains naproxen 500mg, sumatriptan 85mg.
Embodiment 3 naproxen sodium sumatriptan powders
Prescription:
Naproxen sodium 500g (in naproxen)
Sumatriptan Succinate 170g (in sumatriptan)
Microcrystalline Cellulose 250g
Sodium bicarbonate 50g
Calcium hydrogen phosphate 75g
Magnesium stearate 8g
The preparation process is following: with Sumatriptan Succinate, naproxen sodium, microcrystalline Cellulose, sodium bicarbonate, calcium hydrogen phosphate, magnesium stearate mix homogeneously, again mixture is distributed into 1000 pouches, every bag contains naproxen 500mg, sumatriptan 85mg.
Embodiment 4 naproxen zinc sumatriptan granules
Prescription:
Naproxen zinc 500g (in naproxen)
Sumatriptan Succinate 85g (in sumatriptan)
Sucrose 1500g
Sodium carboxymethyl cellulose 15g
Sodium bicarbonate 75g
Pulvis Talci 5g
20% Diluted Alcohol 1000ml
The preparation process is following: supplementary material is placed drying for standby under 60 ℃ of conditions.With naproxen sodium, Sumatriptan Succinate, sucrose mix homogeneously, cross 60 mesh sieves.Add sodium carboxymethyl cellulose, add 20% Diluted Alcohol solution again and make soft material in right amount, cross 20 mesh sieve system wet granulars.60 ℃ dry 3-4 hour, the granulate that sieves is distributed into 1000 parcel granules with mixture again, whenever comprises naproxen 500mg, sumatriptan 85mg.
Embodiment 5 naproxen sodium sumatriptan sheets
Prescription:
Naproxen sodium 500g (in naproxen)
Sumatriptan Succinate 25g (in sumatriptan)
Cross-linking sodium carboxymethyl cellulose 50g
Calcium hydrogen phosphate 80g
Microcrystalline Cellulose 400g
Sodium bicarbonate 25g
Magnesium stearate 5g
5% polyvinylpyrrolidonesolution solution 700ml
Opadry coating powder 40g
The preparation process is following: with Sumatriptan Succinate, naproxen sodium, cross-linking sodium carboxymethyl cellulose, calcium hydrogen phosphate, microcrystalline Cellulose, sodium bicarbonate mix homogeneously, granulate with 5% polyvinylpyrrolidonesolution solution, put 60 ℃ of oven for drying; Granulate sieves; Add the magnesium stearate mix homogeneously, direct compression is processed 1000; Use Opadry coating powder coating at last, promptly get.Every contains naproxen 500mg, sumatriptan 25mg.
Claims (10)
1. the compound preparation of naproxen and sumatriptan is characterized in that said compound preparation is by forming as the naproxen of active component and sumatriptan and pharmaceutic adjuvant.
2. compound preparation according to claim 1 is characterized in that, the naproxen of the composition active component of said compound preparation and the weight percent proportioning of sumatriptan and pharmaceutic adjuvant are: naproxen 10-80%; Sumatriptan 1-20%, filler or diluent 10～90%, disintegrating agent 0～10%; Lubricant 0.1～1%, binding agent 1～15%, correctives 0.01～5%; Coloring agent 0～0.2%, antioxidant 0.1～0.5%, buffer agent 5～15%; Opacifier 0～0.2%, coating material 2-5%.
3. compound preparation according to claim 2; It is characterized in that; Described filler or diluent are one or more the combination in lactose, glucose, sucrose, mannitol, sorbitol, xylitol, maltose alcohol, erythrose, microcrystalline Cellulose, starch, soluble starch, calcium hydrogen phosphate or the calcium sulfate, are preferably sodium bicarbonate;
Described binding agent is one or more the combination in hydroxypropyl cellulose, hydroxyethyl-cellulose, hypromellose, ethyl cellulose, polyvinylpyrrolidone, lake essence, starch, pregelatinized Starch, water or the ethanol;
Described disintegrating agent is one or more the combination in starch, carboxymethyl starch, modified starch, carboxymethyl starch sodium, carboxymethylcellulose calcium, crospolyvinylpyrrolidone, the cross-linking sodium carboxymethyl cellulose;
Said lubricant or fluidizer are one or more the combinations in magnesium stearate, stearic acid, calcium stearate, hard paraffin, silicon dioxide, sodium stearyl fumarate, the Pulvis Talci;
Said correctives is sucrose and simple syrup thereof, the combination of one or more in saccharin sodium, aspartame, starch, the arabic gum;
Said antioxidant comprises one or more combinations in sulphite, ascorbic acid, thio-compounds or the organic acid; Buffer agent is one or more the combination in sodium bicarbonate, sodium carbonate, sodium phosphate, sodium hydrogen phosphate or the sodium citrate; Opacifier is a titanium dioxide;
Described coating material is one or more the combination in hydroxypropyl emthylcellulose, methylcellulose, hydroxyethyl-cellulose, hydroxypropyl cellulose, methacrylate copolymer, ethyl cellulose, polyethylene glycols, cellulose acetate phthalate ester, polyvinyl alcohol phthalate ester, EUDRAGIT S100 or the hydroxypropyl methyl cellulose phthalate.
4. compound preparation according to claim 1 is characterized in that, the weight ratio of naproxen and sumatriptan is 40: 1～1: 1 in the single-dose preparations of said compound preparation; Preferred weight ratio is 20: 1,10: 1,5.88: 1,2.94: 1 or 1.47: 1; Preferred weight ratio is 5.88: 1.
5. compound preparation according to claim 1 is characterized in that, the weight that contains naproxen in the preparation of single dose is 200～800mg; Be preferably 250mg or 500mg; Be more preferably 500mg.
6. compound preparation according to claim 1 is characterized in that, the weight that contains sumatriptan in the preparation of single dose is 20～200mg; Be preferably 25mg50mg, 85mg or 170mg, more preferably 85mg.
7. compound preparation according to claim 1 is characterized in that, described naproxen is naproxen, naproxen sodium or naproxen zinc; Preferred naproxen sodium.
8. compound preparation according to claim 1 is characterized in that, described sumatriptan is a Sumatriptan Succinate.
9. compound preparation according to claim 1 is characterized in that, contains buffer agent in the described naproxen sumatriptan preparation, and its weight ratio is 5～15%.
10. compound preparation according to claim 1 is characterized in that, described preparation is tablet, capsule, granule or powder.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2010102580304A CN102370639A (en) | 2010-08-20 | 2010-08-20 | Compound preparation of naproxen and sumatriptan |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2010102580304A CN102370639A (en) | 2010-08-20 | 2010-08-20 | Compound preparation of naproxen and sumatriptan |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN102370639A true CN102370639A (en) | 2012-03-14 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2010102580304A Pending CN102370639A (en) | 2010-08-20 | 2010-08-20 | Compound preparation of naproxen and sumatriptan |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107648226A (en) * | 2017-11-08 | 2018-02-02 | 莫玉艳 | A kind of pharmaceutical composition for treating antimigraine and preparation method thereof |
| CN107789343A (en) * | 2017-11-08 | 2018-03-13 | 莫玉艳 | A kind of medicine for treating antimigraine and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20090186086A1 (en) * | 2008-01-17 | 2009-07-23 | Par Pharmaceutical, Inc. | Solid multilayer oral dosage forms |
| US20100008986A1 (en) * | 2008-07-14 | 2010-01-14 | Glenmark Generics, Ltd. | Pharmaceutical compositions comprising sumatriptan and naproxen |
-
2010
- 2010-08-20 CN CN2010102580304A patent/CN102370639A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20090186086A1 (en) * | 2008-01-17 | 2009-07-23 | Par Pharmaceutical, Inc. | Solid multilayer oral dosage forms |
| US20100008986A1 (en) * | 2008-07-14 | 2010-01-14 | Glenmark Generics, Ltd. | Pharmaceutical compositions comprising sumatriptan and naproxen |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107648226A (en) * | 2017-11-08 | 2018-02-02 | 莫玉艳 | A kind of pharmaceutical composition for treating antimigraine and preparation method thereof |
| CN107789343A (en) * | 2017-11-08 | 2018-03-13 | 莫玉艳 | A kind of medicine for treating antimigraine and preparation method thereof |
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Owner name: SHANGHAI XINYA PHARMACEUTICAL INDUSTRY CO. LTD. Free format text: FORMER OWNER: SHANGHAI MEDICINE SCIENCE + TECHNOLOGY DEVELOPING CO., LTD. Effective date: 20130228 |
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Effective date of registration: 20130228 Address after: 201203 No. 978, Chuansha Road, Shanghai, Pudong New Area Applicant after: Shanghai Xinya Pharmaceutical Industry Co., Ltd. Address before: 201203 92 Zhangjiang Road, Shanghai, Pudong Applicant before: Shanghai Medicine Science-Technology Development Co., Ltd. |
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Application publication date: 20120314 |