CN102813638A - Preparation method of dexketoprofen trometamol double-layer sustained-release tablets - Google Patents
Preparation method of dexketoprofen trometamol double-layer sustained-release tablets Download PDFInfo
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- CN102813638A CN102813638A CN2011101500523A CN201110150052A CN102813638A CN 102813638 A CN102813638 A CN 102813638A CN 2011101500523 A CN2011101500523 A CN 2011101500523A CN 201110150052 A CN201110150052 A CN 201110150052A CN 102813638 A CN102813638 A CN 102813638A
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Abstract
The invention relates to dexketoprofen trometamol double-layer sustained-release tablets and a preparation method thereof. The tablets are characterized in that the tablets are double-layer tablets obtained by compacting a fast-release layer and a sustained-release layer. The fast-release layer is mainly composed of dexketoprofen trometamol, a disintegrating agent, a diluent agent, an adhesive, and a lubricant. The sustained-release layer is mainly composed of dexketoprofen trometamol, a sustained-release material, a diluent agent, an adhesive, and a lubricant. An effective dosage of dexketoprofen trometamol is 10mg-120mg. A main medicine content ratio of the fast-release layer to the sustained-release layer is 1:(1-5). The invention also provides a preparation method of the dexketoprofen trometamol double-layer sustained-release tablets, and a release-degree testing method of the tablets. With the release of the fast-release part of the dexketoprofen trometamol double-layer sustained-release tablets provided by the invention, an effective blood concentration of the medicine can be reached fast. The sustained-release part is released slowly for maintaining a stable and uniform effective blood concentration. Therefore, medication times can be reduced, patient compliance can be improved, the treatment effect is stable, and toxic and side effects are low.
Description
Technical field
The present invention relates to a kind of new drug formulation preparation of nonsteroidal anti-inflammatory drug preparation category; Be particularly related to a kind of method for preparing of dexketoprofen trometamol double-layer sustained release tablets; It is characterized in that it being the double-layer tablet that is pressed into jointly by release layer and slow release layer, belong to field of medicaments.
Background technology
Double-layer sustained release tablets is that one or both medicines are processed the Tabules of being made up of jointly release layer and slow release layer two parts.Release layer and slow release layer can be medicine of the same race, also can have synergistic medicine for two kinds.Release layer can play one to disease at short notice to be alleviated or therapeutical effect fast, reduces the harm that seizure of disease brings patient, and slow release layer is used to keep intravital blood drug level, and symptoms plays an effect that continues to keep curative effect.This preparation not only can reduce medicining times, can also let patient can not produce bigger dependence effect to some drugs, and can reduce the peak valley difference of medicine, and rapid release and slow release effect are perfectly combined
Ketoprofen belongs to NSAID, is applicable to analgesicly, alleviates moderate pain such as arthritis, neuralgia, myalgia, headache, migraine, toothache, flu and flu-like symptom; Often use its raceme to treat all types of arthritis, postoperative pain, cancer pain and acute gout etc. clinically; But existing research proof, left-handed ketoprofen is the nonactive laevoisomer of ketoprofen, no analgesic, analgesia and antiinflammatory action are the main causes of raceme KPF generation gastrointestinal reaction; And d-isomer is the main component of performance therapeutical effect, and its activity is 2 times of racemic modification; But, its water soluble drug, i.e. dexketoprofen trometamol have been prepared because dexketoprofen is an insoluble drug at present; It can absorb rapidly and distribute in vivo, and the specific activity free acid is high, and its Cmax specific ionization acid is high; The acid of Tmax specific ionization is little, is beneficial to the treatment of acute sharp pain, and it is little to the acid of gastrointestinal toxicity specific ionization in addition; The patient there is better toleration, has broad clinical application prospect.
But the existing clinically dexketoprofen trometamol preparation half-life is short, and general formulation needs day clothes three to four times, and blood concentration fluctuation is bigger, and its slow releasing preparation release is slow, can not discharge active constituents of medicine rapidly, makes maximum plasma concentration lower; And the quick stripping of dexketoprofen trometamol in the release layer and relief of symptoms rapidly behind the double-layer sustained release preparation oral of our development; Slow release layer then slowly discharges, and the easing pain and diminishing inflammation effect was kept 12 hours, reduces medicining times; Improve patient's compliance, and alleviated untoward reaction.
Summary of the invention
The object of the present invention is to provide a kind of dexketoprofen trometamol double-layer sustained release tablets, wherein the release of immediate release section can make medicine reach effective blood drug concentration quickly, and slow-released part slowly discharges, and performance is kept steadily, uniform effective blood drug concentration.Thereby reach the minimizing medicining times, increase patient's compliance and stable curative effect, the effect that toxic and side effects is little.
For solving the problems of the technologies described above, technical scheme provided by the invention is:
The double-layer sustained release tablets of dexketoprofen trometamol provided by the invention comprises slow release layer and release layer; It is characterized in that: said slow release layer mainly is made up of dexketoprofen trometamol, disintegrating agent, diluent; Binding agent; Lubricant is formed, and said slow release layer mainly is made up of dexketoprofen trometamol, slow-release material, diluent, binding agent, lubricant.
Described double-layer sustained release tablets, the effective dose of dexketoprofen trometamol are 10mg～120mg.
The ratio that described double-layer sustained release tablets, its release layer and slow release layer contain the principal agent amount is 1: (1～5).
Described double-layer sustained release tablets; It is characterized in that said slow-release material can select one or more in hydroxypropyl methylcellulose, ethyl cellulose, methylcellulose, phthalic acid hydroxypropyl methylcellulose, cellulose acetate-phthalate, hydroxypropyl cellulose, carboxymethyl cellulose, sodium carboxymethyl cellulose, hydroxyethyl-cellulose, cellulose acetate, cellulose diacetate, Triafol T, hexadecanol, glyceryl monostearate, Brazil wax, the hydroxy methocel for use, preferred hydroxypropyl methylcellulose and ethyl cellulose.
Described double-layer sustained release tablets, one or more that it is characterized in that described disintegrating agent can select that cross linked polyvinyl pyrrolidone, carboxymethyl starch are received for use, low-substituted hydroxypropyl cellulose, cross-linked carboxymethyl cellulose are received, preferred cross-linked carboxymethyl cellulose is received.
Described double-layer sustained release tablets; It is characterized in that described diluent can select lactose, pregelatinized Starch, microcrystalline Cellulose, mannitol, low-substituted hydroxypropyl cellulose, polyvinyl alcohol for use, gather in O-phthalic acid ethyl acetate, Polyethylene Glycol, the ethanol one or more, preferred lactose, microcrystalline Cellulose.
Described double-layer sustained release tablets; It is characterized in that in the optional water of described binding agent, ethanol, dehydrated alcohol, starch slurry, polyvidone, cross linked polyvinyl pyrrolidone, hydroxypropyl methylcellulose and/or other cellulose families one or more, preferred cross linked polyvinyl pyrrolidone.
Described double-layer sustained release tablets is characterized in that described lubricant can select one or more in magnesium stearate, micropowder silica gel, Pulvis Talci, hydrogenated vegetable oil, polyethylene glycols, the sodium laurylsulfate for use, preferred magnesium stearate.
Described double-layer sustained release tablets is characterized in that counting by weight percentage, and it consists of:
Release layer:
Slow release layer:
The present invention also provides the method for preparing of dexketoprofen trometamol double-layer sustained release tablets, it is characterized in that: this method may further comprise the steps:
1, immediate-release granules preparation
Each component that takes by weighing recipe quantity is crossed 100 mesh sieves respectively, then with crude drug, diluent, disintegrating agent mix homogeneously, and with binding agent system soft material, 20 mesh sieve system wet granulars, 60 ℃ of forced air dryings, 20 mesh sieve granulate add the lubricant mixing, get the release layer granule.
2, slow-releasing granules preparation
Each component that takes by weighing recipe quantity is crossed 100 mesh sieves respectively, then with crude drug, slow-release material, diluent, mix homogeneously, and with binding agent system soft material, 20 mesh sieve system wet granulars, 60 ℃ of forced air dryings, 20 mesh sieve granulate add the lubricant mixing, get the slow release layer granule.
3, tabletting
Light earlier pressure release layer granule becomes loose, adds the extrusion forming of slow release layer granule again, promptly gets double-layer tablet.
Described double-layer sustained release tablets is characterized in that, said double-layer sustained release tablets is according to the device of dissolution method (2010 editions two appendix XC second methods of Chinese Pharmacopoeia), and 900mL is a solvent with distilled water (pH7); Rotating speed is that per minute 100 changes, and temperature is 37 ℃, in accordance with the law operation;, respectively at 0.5,1.0,2.0,4.0,6.0,8.0, the 12.0h sampling, each 5mL;,, and in time in process container, replenish above-mentioned solvent with volume with the filtering with microporous membrane of aperture 0.45 μ m; And be mixed with finite concentration, as need testing solution; It is an amount of that precision takes by weighing the dexketoprofen trometamol reference substance in addition, with above-mentioned solvent preparation suitable concentration solution, as reference substance solution, according to spectrophotography, measures trap respectively in the wavelength of 260nm, calculates every respectively in the burst size of not watching the time.The slow releasing tablet of the present invention's preparation discharges 15%～30% in 30min accumulative total, 6h cumulative release 60%～75%, and the 12h cumulative release is more than 90%.
Specific embodiment
Data below in conjunction with embodiment and prescription study, verify are further set forth technical scheme of the present invention:
Embodiment 1
Prescription (by 1000)
Release layer:
Slow release layer:
Preparation technology
1.1 the particulate preparation of release layer
Each component is crossed 100 mesh sieves respectively in will writing out a prescription; With the abundant mixing of lactose, microcrystalline Cellulose, carboxymethyl starch sodium of recipe quantity,, and be binding agent system soft material with an amount of 10%PVP K30 solution again with the abundant mixing of dexketoprofen trometamol; 20 mesh sieves are granulated; 60 ℃ of forced air dryings, 20 mesh sieve granulate add the magnesium stearate mixing again;
1.2 the particulate preparation of slow release layer
Each component is crossed 100 mesh sieves respectively in will writing out a prescription; Then with the abundant mixing of HPMC K100M, ethyl cellulose, lactose, microcrystalline Cellulose of recipe quantity,, and be binding agent system soft material with an amount of 10%PVP K30 solution again with the abundant mixing of dexketoprofen trometamol; 20 mesh sieves are granulated; 60 ℃ of forced air dryings, 20 mesh sieve granulate add the magnesium stearate mixing again;
1.3 tabletting
Light earlier pressure release layer granule becomes loose, adds the extrusion forming of slow release layer granule again.
Embodiment 2
Prescription (by 1000)
Release layer:
Slow release layer:
Preparation technology
1.1 the particulate preparation of release layer
Each component is crossed 100 mesh sieves respectively in will writing out a prescription; With the abundant mixing of lactose, microcrystalline Cellulose, carboxymethyl starch sodium of recipe quantity,, and be binding agent system soft material with an amount of 10%PVP K30 solution again with the abundant mixing of dexketoprofen trometamol; 20 mesh sieves are granulated; 60 ℃ of forced air dryings, 20 mesh sieve granulate add the magnesium stearate mixing again;
1.2 the particulate preparation of slow release layer
Each component is crossed 100 mesh sieves respectively in will writing out a prescription; Then with the abundant mixing of HPMC K100M, ethyl cellulose, lactose, microcrystalline Cellulose of recipe quantity,, and be binding agent system soft material with an amount of 10%PVP K30 solution again with the abundant mixing of dexketoprofen trometamol; 20 mesh sieves are granulated; 60 ℃ of forced air dryings, 20 mesh sieve granulate add the magnesium stearate mixing again;
1.3 tabletting
Light earlier pressure release layer granule becomes loose, adds the extrusion forming of slow release layer granule again.
Embodiment 3
Prescription (by 1000)
Release layer:
Slow release layer:
Preparation technology
1.1 the particulate preparation of release layer
Each component is crossed 100 mesh sieves respectively in will writing out a prescription; With the abundant mixing of lactose, microcrystalline Cellulose, carboxymethyl starch sodium of recipe quantity,, and be binding agent system soft material with an amount of 10%PVP K30 solution again with the abundant mixing of dexketoprofen trometamol; 20 mesh sieves are granulated; 60 ℃ of forced air dryings, 20 mesh sieve granulate add the magnesium stearate mixing again;
1.2 the particulate preparation of slow release layer
Each component is crossed 100 mesh sieves respectively in will writing out a prescription; Then with the abundant mixing of HPMC K100M, ethyl cellulose, lactose, microcrystalline Cellulose of recipe quantity,, and be binding agent system soft material with an amount of 10%PVP K30 solution again with the abundant mixing of dexketoprofen trometamol; 20 mesh sieves are granulated; 60 ℃ of forced air dryings, 20 mesh sieve granulate add the magnesium stearate mixing again;
1.3 tabletting
Light earlier pressure release layer granule becomes loose, adds the extrusion forming of slow release layer granule again.
The double-layer sustained release tablets of a kind of dexketoprofen trometamol of three embodiment preparations, release characteristic is:
Three concrete release profiles of embodiment are seen Fig. 1.
According to the double-layer sustained release tablets that embodiment 1 adopts the HPMC of different size to prepare, its release characteristic is:
And the release profiles of the slow releasing tablet of these three kinds of different size HPMC is seen Fig. 2.
Three kinds of double-layer sustained release tablets according to embodiment 1 preparation carry out drug release determination respectively in three kinds of different media, be respectively phosphate buffer and the 0.1mol/L hydrochloric acid solution of distilled water, pH6.8, and its release characteristic is:
Release profiles in three kinds of different release medium is seen Fig. 3.
Claims (10)
1. dexketoprofen trometamol double-layer sustained release tablets; Comprise slow release layer and release layer; It is characterized in that: said slow release layer mainly is made up of dexketoprofen trometamol, disintegrating agent, diluent; Binding agent, lubricant is formed, and said slow release layer mainly is made up of dexketoprofen trometamol, slow-release material, diluent, binding agent, lubricant.
2. dexketoprofen trometamol double-layer sustained release tablets as claimed in claim 1 is characterized in that: the effective dose of dexketoprofen trometamol is 10mg～120mg, and the ratio that release layer and slow release layer contain the principal agent amount is 1: (1～5).
3. dexketoprofen trometamol double-layer sustained release tablets as claimed in claim 1; It is characterized in that said slow-release material can select one or more in hydroxypropyl methylcellulose, ethyl cellulose, methylcellulose, phthalic acid hydroxypropyl methylcellulose, cellulose acetate-phthalate, hydroxypropyl cellulose, carboxymethyl cellulose, sodium carboxymethyl cellulose, hydroxyethyl-cellulose, cellulose acetate, cellulose diacetate, Triafol T, hexadecanol, glyceryl monostearate, Brazil wax, the hydroxy methocel for use, preferred hydroxypropyl methylcellulose and ethyl cellulose.
4. dexketoprofen trometamol double-layer sustained release tablets as claimed in claim 1; One or more that it is characterized in that described disintegrating agent can select that cross linked polyvinyl pyrrolidone, carboxymethyl starch are received for use, low-substituted hydroxypropyl cellulose, cross-linked carboxymethyl cellulose are received, preferred cross-linked carboxymethyl cellulose is received.
5. dexketoprofen trometamol double-layer sustained release tablets as claimed in claim 1; It is characterized in that described diluent can select lactose, pregelatinized Starch, microcrystalline Cellulose, mannitol, low-substituted hydroxypropyl cellulose, polyvinyl alcohol for use, gather in O-phthalic acid ethyl acetate, Polyethylene Glycol, the ethanol one or more, preferred lactose, microcrystalline Cellulose.
6. dexketoprofen trometamol double-layer sustained release tablets as claimed in claim 1; It is characterized in that in the optional water of described binding agent, ethanol, dehydrated alcohol, starch slurry, polyvidone, cross linked polyvinyl pyrrolidone, hydroxypropyl methylcellulose and/or other cellulose families one or more, preferred cross linked polyvinyl pyrrolidone.
7. dexketoprofen trometamol double-layer sustained release tablets as claimed in claim 1; Described double-layer sustained release tablets; It is characterized in that described lubricant can select one or more in magnesium stearate, micropowder silica gel, Pulvis Talci, hydrogenated vegetable oil, polyethylene glycols, the sodium laurylsulfate for use, preferred magnesium stearate.
8. like the described dexketoprofen trometamol double-layer sustained release tablets of the arbitrary claim of claim 1～8, it is characterized in that counting by weight percentage, it consists of:
Release layer:
Slow release layer:
9. like the described dexketoprofen trometamol double-layer sustained release tablets of the arbitrary claim of claim 1～8, it is characterized in that comprising and be prepared as follows step:
The immediate-release granules preparation: each component that takes by weighing recipe quantity is crossed 100 mesh sieves respectively, then with crude drug, diluent, disintegrating agent mix homogeneously, with binding agent system soft material; 20 mesh sieve system wet granulars, 60 ℃ of forced air dryings, 20 mesh sieve granulate; Add the lubricant mixing, get the release layer granule.
The slow-releasing granules preparation: each component that takes by weighing recipe quantity is crossed 100 mesh sieves respectively, then with crude drug, slow-release material, diluent, mix homogeneously, with binding agent system soft material; 20 mesh sieve system wet granulars, 60 ℃ of forced air dryings, 20 mesh sieve granulate; Add the lubricant mixing, get the slow release layer granule.
Tabletting: light earlier pressure release layer granule becomes loose, adds the extrusion forming of slow release layer granule again, promptly gets double-layer tablet.
10. like the described dexketoprofen trometamol double-layer sustained release tablets of the arbitrary claim of claim 1～8, it is characterized in that said double-layer sustained release tablets is according to the device of dissolution method (2010 editions two appendix XC second methods of Chinese Pharmacopoeia); 900mL is a solvent with distilled water (pH7), and rotating speed is that per minute 100 changes, and temperature is 37 ℃; Operation in accordance with the law,, respectively at 0.5,1.0,2.0,4.0,6.0,8.0, the 12.0h sampling; Each 5mL;,, and in time in process container, replenish above-mentioned solvent with volume with the filtering with microporous membrane of aperture 0.45 μ m; And be mixed with finite concentration, as need testing solution; It is an amount of that precision takes by weighing the dexketoprofen trometamol reference substance in addition, with above-mentioned solvent preparation suitable concentration solution, as reference substance solution, according to spectrophotography, measures trap respectively in the wavelength of 260nm, calculates every burst size at different time respectively.The slow releasing tablet of the present invention's preparation discharges 15%～30% in 30min accumulative total, 6h cumulative release 60%～75%, and the 12h cumulative release is more than 90%.
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| CN2011101500523A CN102813638A (en) | 2011-06-07 | 2011-06-07 | Preparation method of dexketoprofen trometamol double-layer sustained-release tablets |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106137997A (en) * | 2015-04-19 | 2016-11-23 | 浙江九洲药物科技有限公司 | A kind of dexketoprofen trometamol slow releasing tablet and preparation method thereof |
| WO2019212426A3 (en) * | 2017-12-29 | 2019-11-28 | Neutec Ar-Ge Sanayi Ve Ticaret Anonim Şirketi | Delayed release dexketoprofen composition |
Citations (5)
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|---|---|---|---|---|
| JPS60132915A (en) * | 1983-12-21 | 1985-07-16 | ロ−ン−プ−ラン・サント | Release controlled tablet for oral administration of ketoprofen and manufacture |
| EP0403383A1 (en) * | 1989-06-16 | 1990-12-19 | Rhone-Poulenc Sante | Sustained release pharmaceutical formulations |
| CN1260172A (en) * | 1998-12-18 | 2000-07-19 | 国家医药管理局上海医药工业研究院 | Dextro-betoprofen preparation |
| US20050118247A1 (en) * | 2000-07-05 | 2005-06-02 | Gunter Cordes | Method of making ketoprofen patch delivery system |
| CN101784262A (en) * | 2007-08-15 | 2010-07-21 | 麦克内尔-Ppc股份有限公司 | Immediate release and sustained release ibuprofen dosing regiment |
-
2011
- 2011-06-07 CN CN2011101500523A patent/CN102813638A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS60132915A (en) * | 1983-12-21 | 1985-07-16 | ロ−ン−プ−ラン・サント | Release controlled tablet for oral administration of ketoprofen and manufacture |
| EP0403383A1 (en) * | 1989-06-16 | 1990-12-19 | Rhone-Poulenc Sante | Sustained release pharmaceutical formulations |
| CN1260172A (en) * | 1998-12-18 | 2000-07-19 | 国家医药管理局上海医药工业研究院 | Dextro-betoprofen preparation |
| US20050118247A1 (en) * | 2000-07-05 | 2005-06-02 | Gunter Cordes | Method of making ketoprofen patch delivery system |
| CN101784262A (en) * | 2007-08-15 | 2010-07-21 | 麦克内尔-Ppc股份有限公司 | Immediate release and sustained release ibuprofen dosing regiment |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106137997A (en) * | 2015-04-19 | 2016-11-23 | 浙江九洲药物科技有限公司 | A kind of dexketoprofen trometamol slow releasing tablet and preparation method thereof |
| CN106137997B (en) * | 2015-04-19 | 2020-06-05 | 瑞博(杭州)医药科技有限公司 | Dexketoprofen trometamol sustained release tablet and preparation method thereof |
| WO2019212426A3 (en) * | 2017-12-29 | 2019-11-28 | Neutec Ar-Ge Sanayi Ve Ticaret Anonim Şirketi | Delayed release dexketoprofen composition |
| WO2020022976A3 (en) * | 2017-12-29 | 2020-03-12 | NEUTEC AR-GE SANAYİ VE TĺCARET ANONİM ŞİRKETİ | A formulation comprising dexketoprofen |
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