CN103655505B - A kind of pain relieving class two-layer release-controlled tablet and preparation method thereof - Google Patents
A kind of pain relieving class two-layer release-controlled tablet and preparation method thereof Download PDFInfo
- Publication number
- CN103655505B CN103655505B CN201310716482.6A CN201310716482A CN103655505B CN 103655505 B CN103655505 B CN 103655505B CN 201310716482 A CN201310716482 A CN 201310716482A CN 103655505 B CN103655505 B CN 103655505B
- Authority
- CN
- China
- Prior art keywords
- release
- layer
- slow
- tablet
- release layer
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention provides a kind of pain relieving class two-layer release-controlled tablet, including release layer and slow release layer, described slow release layer is porose, described hole is filled with immediate-release granules, described release layer and immediate-release granules are made up of with pharmaceutic adjuvant analgesic type drug, and described slow release layer is made up of analgesic type drug, slow-release material and pharmaceutic adjuvant.The present invention has the following technical effect that 1) the double-layer tablet physical stability of the present invention is better than common double synusia, is more beneficial for storage and transport.2) this two-layer release-controlled tablet is 10 ~ 30 seconds through dissolution test detection release layer disintegration, and slow release layer is zero-order release profile, greatly improves effectiveness and safety that patient takes medicine.In double-layer tablet preparation process, hole is filled with immediate-release granules.The drug release mode that rapid release combines with slow release ensure that after taking medicine, release layer fater disintegration, makes blood drug level can be rapidly achieved treatment window scope, and slow release layer continues maintaining treatment effect in being slowly released in long period of time, and effectively controls toxic and side effects.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, be specifically related to a kind of pain relieving class two-layer release-controlled tablet and preparation method thereof.
Background technology
Oral solid formulation with tablet as representative is most convenient, safest administering mode, medicine clinical practice,
Always in occupation of main body and leading position in market sale and research and development.Preparation method by changing tablet is protected at present
Card medicine keeps the rock-steady structure of double-layer tablet and regulation and control release to realize the efficacy enhancing and toxicity reducing of medicine and become pharmaceuticals industry at shelf life
Most demand and practical new agent technology.Double-layer tablet be a kind of grow up on the basis of osmotic pump controlled release tablet containing bilayer
The novel two-phase medicine-releasing system of structure, its structure is different with the difference of purpose of design.Comparing with common single-layer sheet, double-layer tablet is being faced
Having many advantages in bed application, it is possible not only to combine two kinds of medicines or same medicine with different release modes reach
To preferable pharmacokinetics behavior, and can improve and have the stability of compatibility reaction medicine, moreover it is possible to give the function that tablet is special.
Double-layer tablet is generally divided into single medicine double-layer tablet and compound double-layer tablet, and single medicine double-layer tablet includes single medicine rapid release double-layer tablet, list
Medicine sustained-release double-layer tablet and single medicine speed/sustained-release double-layer tablet, wherein single medicine speed/sustained-release double-layer tablet is the double-layer tablet that a class is relatively common,
Predominantly reach optimal internal drug-time curve behavior and design, typically formed by rapid release and two kinds of granule compactings of slow release, rapid release
Layer contributes to quick relief, and slow release layer is then used for maintaining effective dose, it is achieved quick-acting and long-acting combination.
Pain not only affects quality of life, has people also can produce psychology disease owing to long pain can not get effectively treating
Sick.A lot of pain-suffered patients are owing to treating not in time, and the prevailing pain making local long-term is converted into the Regional Pain Syndrome of complexity
Or central pain, become the painful diseases of refractory.So, it should pain relieving in time.Ibuprofen ibuprofen modified release capsule in
1991 in Discussion on Chinese Listed, during one of the most safest nonsteroidal anti-inflammatory drug (NSAIDS) ibuprofen is introduced
State, its 12 hours exclusive slow release methods, make ibuprofen can not only persistently effectively pain relieving, and safe secondary effect is low, simultaneously
Use more convenient, successfully filled up China's blank in slow releasing capsule processing technology.
It is below the technology of existing double-layer tablet:
CN101073563B discloses a kind of hand-type compositions containing (S)-ibuprofen and LEVO CITRAZINE and slow
Release double-layer tablet, propose a kind of release layer containing (S)-ibuprofen and LEVO CITRAZINE and contain only the slow release of (S)-ibuprofen
The double-layer tablet of layer.Can reach and alleviate rapidly cold symptoms, the effect of long-acting performance antipyretic-antalgic.
CN102188423B discloses spectinomycin hydrochloride and felodipine sustained-release double-layer tablet and preparation method thereof, proposes
Double-layer tablet is respectively spectinomycin hydrochloride slow release layer and felodipine sustained-release layer.
CN102283829B antimalarial pharmaceutical composition and preparation method and purposes, pharmaceutical composition of the present invention will
After Artemether and benflumetol are pelletized respectively, it is prepared as double-layer tablet, it is to avoid the mixed process of Artemether and benflumetol, it is ensured that multiple
Safety in side's preparation process；Further, gained double-layer tablet disintegrate is rapid, compared with existing compound tablet, and effective ingredient dissolution
Degree significantly improves.
CN101084904B discloses cefixime sustained-release double-layer tablet, proposes a kind of release layer and that slow release layer combines is double
Synusia, the slow release layer release in vitro time is more than 12 hours.
CN102188425B double-layer tablet comprising hydrochloric acid and simvastatin and preparation method thereof, proposes at simvastatin
Release layer adds nicotinic acid, and the composition making two kinds of lamellas is close, and elastic deformation is also closer to, and will not occur in process of production point
From, the phenomenon of sliver.
In above-mentioned technology, due to double-layer tablet typically by I layer and II layer by several times compacting, therefore, medicine can be caused in transport and
The unfavorable results such as storage process Chinese medicine tablet splits.
Summary of the invention
In place of it is an object of the invention to overcome the deficiencies in the prior art, it is provided that a kind of pain relieving class two-layer release-controlled tablet and preparation thereof
Method.The drug release model that the rapid release/slow release of the present invention combines, can reach quickly alleviating pain long-time inhibition of pain, improve
Patients ' life quality.
The pain relieving class two-layer release-controlled tablet of the present invention, including release layer and slow release layer, described slow release layer is porose, described hole
In be filled with immediate-release granules, described release layer and immediate-release granules and formed by analgesic type drug and pharmaceutic adjuvant, described is slow
Release layer to be made up of analgesic type drug, slow-release material and pharmaceutic adjuvant.
A diameter of the 1 of the hole of described slow release layer～10mm.
A diameter of the 3 of the hole of described slow release layer～6mm.
Described analgesic type drug selected from aspirin, magnesium salicylate, sodium salicylate, choline magnesium trisalicylate, diflunisal,
Salsalate, ibuprofen, indomethacin, flurbiprofen, fenoprofen, naproxen, nabumetone, piroxicam, guarantor
Safe pine, diclofenac, venlofen, ketone ibuprofen, ketorolac, four clofenamic acides, sulindac, tolmetin or Anisodamine, or
One in the derivant of person's above-claimed cpd；Described slow-release material is selected from hydroxypropyl methylcellulose, ethyl cellulose, hydroxypropyl
One or more of base cellulose；Described pharmaceutic adjuvant is in filler, disintegrating agent, lubricant, binding agent, fluidizer
One or more.
Described two-layer release-controlled tablet, described filler is selected from lactose monohydrate, lactose, pregelatinized Starch and microcrystalline Cellulose
One or more；Described disintegrating agent is in cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium and polyvinylpolypyrrolidone
One or more；Described lubricant selected from stearic acid, magnesium stearate and talcous one or more；Described binding agent choosing
From one or more of polyvidone, hydroxypropyl cellulose and hydroxypropyl methylcellulose；Described fluidizer is silicon dioxide.
Described two-layer release-controlled tablet, in described slow release layer, includes following components according to percentage by weight:
In described release layer and immediate-release granules, include following components according to percentage by weight:
Described two-layer release-controlled tablet also includes coatings, and described coatings includes following components according to percentage by weight:
The preparation method of the pain relieving class two-layer release-controlled tablet of the present invention, it is characterised in that comprise the following steps:
1) analgesic type drug is mixed and made into slow-releasing granules with slow-release material and pharmaceutic adjuvant；By analgesic type drug with medicinal
Adjuvant is mixed and made into immediate-release granules；
2) slow-releasing granules is pressed into porose slow release layer, then slow release layer is reentered in the punch die of tablet machine, filling
Immediate-release granules, carries out second time and suppresses, and forms the double-layer tablet being made up of release layer and slow release layer, wherein fills in the hole of slow release layer
There is immediate-release granules.
The preparation method of described pain relieving class two-layer release-controlled tablet, also includes the step of coating.
Additionally include the step of coating.
The present invention has the following technical effect that
1) the double-layer tablet physical stability that prepared by the present invention is better than common double synusia, is more beneficial for storage and transport.Due to
The slow release layer of two-layer release-controlled tablet is porose, and immediate-release granules in natural ostium, makes double-layer tablet be tightly combined in pressing process,
Storing and transportation is being not readily separated.
2) this two-layer release-controlled tablet is 10～30 seconds through dissolution test detection release layer disintegration, and slow release layer is Zero order release
Pattern, greatly improves effectiveness and safety that patient takes medicine.In double-layer tablet preparation process, hole is filled with rapid release
Grain.The drug release mode that rapid release combines with slow release ensure that after taking medicine, release layer fater disintegration, makes blood drug level quickly to reach
To treatment window scope, slow release layer continues maintaining treatment effect in being slowly released in long period of time, and it is secondary effectively to control poison
Effect.
Accompanying drawing explanation
Fig. 1 is the structure chart of single hole double-layer tablet prepared by the present invention；
Fig. 2 is the structure chart of diplopore double-layer tablet prepared by the present invention；
Fig. 3 is the structure chart of three hole double-layer tablet prepared by the present invention；
Fig. 4 is the impact on dissolution of the slow release layer different pore size；
Fig. 5 is embodiment 1 two-layer release-controlled tablet In-vitro release curves；
Fig. 6 is embodiment 2 two-layer release-controlled tablet sheet In-vitro release curves；
Fig. 7 is embodiment 3 two-layer release-controlled tablet sheet In-vitro release curves；
Fig. 8 is the embodiment 4 external stripping curve of two-layer release-controlled tablet sheet.
Wherein, 1 is slow release layer；2 is release layer；3 is hole.
Detailed description of the invention.
The prescription of the two-layer release-controlled tablet of embodiment 1-5 such as following table:
The prescription of the two-layer release-controlled tablet of each embodiment (1000, g)
Above-mentioned double-layer tablet can use coating, and coatings is containing following component:
Embodiment 1
The prescription of the two-layer release-controlled tablet of the present embodiment is as shown in table 1.Its preparation method is as follows:
1, slow-releasing granules is prepared:
(1) Zolpidemtar Trate crossing 60 mesh sieves and hydroxypropyl methylcellulose K100LV, K4M, the breast of recipe quantity are weighed
Sugar is sufficiently mixed, and adds silicon dioxide and the magnesium stearate of recipe quantity 1/2nd afterwards.The material mixed is transferred to wet
In method granulator；
(2) compound concentration be 70% ethanol solution the mixture in step 1 is carried out soft material processed；
(3) soft material made is carried out granulate with 24 mesh sieves；
(4) it is dried and sieves granule
(5) obtain slow-releasing granules, be used for forming slow release layer.
2, immediate-release granules is prepared:
(1) by the Zolpidemtar Trate of recipe quantity, lactose, microcrystalline Cellulose, polyvidone mixed 60 mesh sieves, added prescription
The silicon dioxide of amount half and magnesium stearate, mix homogeneously in batch mixer；
(2) compound concentration be 80% ethanol solution the mixture in step 1 is carried out soft material processed；
(3) soft material made is carried out granulate with 24 mesh sieves；
(4) it is dried and sieves powder particles；
(5) add cross-linking sodium carboxymethyl cellulose according to outer addition to mix homogeneously with dry granule；
(6) immediate-release granules is obtained, for forming release layer and for filling the hole of slow release layer.
3, two-layer release-controlled tablet is prepared:
(1) slow release layer granule is added remaining silicon dioxide and magnesium stearate is pressed into middle porose slow releasing tablet, aperture
It is respectively 3mm, 4mm, 6mm；The most also suppress the slow releasing tablet not having hole；
(2) slow releasing tablet is reentered in the punch die of tablet machine, loads release layer granule, rush in row second time pressure by scrobicula
System, forms double-layer tablet；
(3) the hydroxypropyl methyl cellulose E 5 of recipe quantity being dispersed in concentration is in 80% ethanol, the poly-mountain of swelling rear addition
Pears alcohol ester 80, stirring and dissolving is complete, adds titanium dioxide and Pulvis Talci, stirs, as coating solution after filtration；
(4) by double-layer tablet coating, every weightening finish 5%, then dry solidification are made.
In order to investigate the impact on dissolution of the slow release layer aperture, slow release layer is first suppressed into the most with holes, band 3mm by the present embodiment
Hole, band 4mm hole, the slow releasing tablet in band 6mm aperture, carry out dissolution experiment, and slow release layer aperture is the biggest, and dissolution rate is the fastest.Result is shown in
Fig. 4.
The double-layer tablet prepared is carried out dissolution experiment, the effect of slow release after investigation tablet elder generation rapid release, 0.5h samples detection,
Release layer dissolution completely, result is shown in Fig. 5.
Embodiment 2
The prescription of the two-layer release-controlled tablet of the present embodiment is as shown in table 1.Its preparation method is as follows:
1, slow-releasing granules is prepared:
(1) Zolpidemtar Trate crossing 60 mesh sieves and hydroxypropyl methylcellulose K100LV, K4M, the breast of recipe quantity are weighed
Sugar is sufficiently mixed, and adds silicon dioxide and the magnesium stearate of recipe quantity 1/2nd afterwards.The material mixed is transferred to wet
In method granulator；
(2) compound concentration be 75% ethanol solution the mixture in step 1 is carried out soft material processed；
(3) soft material made is carried out granulate with 24 mesh sieves；
(4) it is dried and sieves granule
(5) obtain slow-releasing granules, be used for forming slow release layer.
2, immediate-release granules is prepared:
(1) by the Zolpidemtar Trate of recipe quantity, lactose, microcrystalline Cellulose and hydroxypropyl cellulose-HF, carboxymethyl cellulose
Element sodium mixed 60 mesh sieves, added silicon dioxide and magnesium stearate, the mix homogeneously in batch mixer of recipe quantity half；
(2) compound concentration be 90% ethanol solution the mixture in step 1 is carried out soft material processed；
(3) soft material made is carried out granulate with 24 mesh sieves；
(4) it is dried and sieves powder particles
(5) immediate-release granules is obtained, for forming release layer and for filling the hole of slow release layer.
3, two-layer release-controlled tablet is prepared:
(1) slow release layer granule is added remaining silicon dioxide and magnesium stearate is pressed into middle porose slow releasing tablet, aperture
It is respectively 4mm, 6mm；
(2) slow releasing tablet is reentered in the punch die of tablet machine, loads release layer granule, rush in row second time pressure by scrobicula
System, forms double-layer tablet；
(3) the hydroxypropyl methyl cellulose E 5 of recipe quantity being dispersed in concentration is in 80% ethanol, the poly-mountain of swelling rear addition
Pears alcohol ester 80, stirring and dissolving is complete, adds titanium dioxide and Pulvis Talci, stirs, as coating solution after filtration；
(4) by double-layer tablet coating, every weightening finish 5%, then dry solidification are made.
The effect of slow release after investigation double-layer tablet release layer disintegration rate, and double-layer tablet elder generation rapid release, 0.25h samples detection, speed
Releasing layer dissolution more than 85%, result is shown in Fig. 6.
Embodiment 3
The prescription of the two-layer release-controlled tablet of the present embodiment is as shown in table 1.Its preparation method is as follows:
1, slow-releasing granules is prepared:
(1) weighing the zopiclone crossing 60 mesh sieves and hydroxypropyl methylcellulose K100LV, the K4M of recipe quantity, lactose fills
Divide mixing, add silicon dioxide and the magnesium stearate of recipe quantity 1/2nd afterwards.The material mixed is transferred to wet method system
In grain machine；
(2) compound concentration be 80% ethanol solution the mixture in step 1 is carried out soft material processed；
(3) soft material made is carried out granulate with 24 mesh sieves；
(4) it is dried and sieves granule
(5) obtain slow-releasing granules, be used for forming slow release layer.
2, immediate-release granules is prepared:
(1) by the zopiclone of recipe quantity, lactose, microcrystalline Cellulose and hydroxypropyl cellulose-HF, sodium carboxymethyl cellulose
Mix 60 mesh sieves, add silicon dioxide and magnesium stearate, the mix homogeneously in batch mixer of recipe quantity half；
(2) compound concentration be 90% ethanol solution the mixture in step 1 is carried out soft material processed；
(3) soft material made is carried out granulate with 24 mesh sieves；
(4) it is dried and sieves powder particles
(5) immediate-release granules is obtained, for forming release layer and for filling the hole of slow release layer.
3, two-layer release-controlled tablet is prepared:
(1) slow release layer granule is added remaining silicon dioxide and magnesium stearate is pressed into middle porose slow releasing tablet, aperture
It is respectively 4mm, 6mm；
(2) slow releasing tablet is reentered in the punch die of tablet machine, loads release layer granule, rush in row second time pressure by scrobicula
System, forms double-layer tablet；
(3) the hydroxypropyl methyl cellulose E 5 of recipe quantity being dispersed in concentration is in 80% ethanol, the poly-mountain of swelling rear addition
Pears alcohol ester 80, stirring and dissolving is complete, adds titanium dioxide and Pulvis Talci, stirs, as coating solution after filtration；
(4) by double-layer tablet coating, every weightening finish 5%, then dry solidification are made.
The double-layer tablet prepared is carried out dissolution experiment, the effect of slow release after investigation tablet elder generation rapid release, 0.5h samples detection,
Release layer dissolution completely, result is shown in Fig. 7.
Embodiment 4
The prescription of the two-layer release-controlled tablet of the present embodiment is as shown in table 1.Its preparation method is as follows:
1, slow-releasing granules is prepared:
(1) weighing the Zaleplon crossing 60 mesh sieves and hydroxypropyl methylcellulose K100LV, the K4M of recipe quantity, lactose fills
Divide mixing, add silicon dioxide and the magnesium stearate of recipe quantity 1/2nd afterwards.The material mixed is transferred to wet method system
In grain machine；
(2) compound concentration be 80% ethanol solution the mixture in step 1 is carried out soft material processed；
(3) soft material made is carried out granulate with 24 mesh sieves；
(4) it is dried and sieves granule
(5) obtain slow-releasing granules, be used for forming slow release layer.
2, immediate-release granules is prepared:
(1) by the Zaleplon of recipe quantity, lactose, microcrystalline Cellulose and hydroxypropyl cellulose-HF, sodium carboxymethyl cellulose
Mix 60 mesh sieves, add silicon dioxide and magnesium stearate, the mix homogeneously in batch mixer of recipe quantity half；
(2) compound concentration be 90% ethanol solution the mixture in step 1 is carried out soft material processed；
(3) soft material made is carried out granulate with 24 mesh sieves；
(4) it is dried and sieves powder particles
(5) immediate-release granules is obtained, for forming release layer and for filling the hole of slow release layer.
3, two-layer release-controlled tablet is prepared:
(1) slow release layer granule is added remaining silicon dioxide and magnesium stearate is pressed into middle porose slow releasing tablet, aperture
It is respectively 4mm, 6mm；
(2) slow releasing tablet is reentered in the punch die of tablet machine, loads release layer granule, rush in row second time pressure by scrobicula
System, forms double-layer tablet；
(3) the hydroxypropyl methyl cellulose E 5 of recipe quantity being dispersed in concentration is in 80% ethanol, the poly-mountain of swelling rear addition
Pears alcohol ester 80, stirring and dissolving is complete, adds titanium dioxide and Pulvis Talci, stirs, as coating solution after filtration；
(4) by double-layer tablet coating, every weightening finish 5%, then dry solidification are made.
Prepare monolayer fast-release tablet and double-layer tablet carries out dissolution experiment, investigate tablet release layer disintegration rate, and double-layer tablet is first
The effect of slow release after rapid release, 0.5h samples detection, and release layer dissolution is more than 90%, and result is shown in Fig. 8.
Embodiment 5
The prescription of the two-layer release-controlled tablet of the present embodiment is as shown in table 1.Its preparation method is with embodiment 3.
The experiment of embodiment 6 friability and stability experiment
According to the method in embodiment 1, being prepared for slow release layer does not has hole (to be i.e. simply made up of one layer of rapid release of one layer of slow release
Double-layer tablet), slow release layer have a 3mm hole, slow release layer to have a 4mm hole and slow release layer to have the double-layer tablet each 100 in a 6mm hole
Sheet, carries out friability Experimental comparison's research, result such as table 2 in friability detector respectively:
Table 2
From table 2 it can be seen that in the case of supplementary material composition and proportioning are completely the same, 100 double-layer tablet not having hole
The sheet number of layering is occurred to have 8 in upset collision.Separately take with 100 porose, double-layer tablet 6mm aperture, 100,4mm aperture,
100,3mm aperture carries out same experimentation, and result shows the relatively cracky that aperture is big, but all without the phenomenon of lamella separation.
According to the method in embodiment 4, be prepared for slow release layer do not have hole, slow release layer have 3mm hole, slow release layer have 4mm hole and
Slow release layer has each 20 of the double-layer tablet in 6mm hole, is positioned in stability test case, and humidity set is RH95%, and temperature is set to 25
DEG C, observe after placing 24h, result such as table 3 below:
Table 3
Slow release layer does not has what 20 middle levels in hole separated to have 18, and porose not have the appearance being layered.
Containing super-disintegrant in this prescription release layer, the hygroscopicity of disintegrating agent is relatively strong, when ambient humidity is bigger, and rapid release
Layer is bigger than slow release layer degrees of expansion, and the double-layer tablet levels not having hole is easily separated.Rapid release after slow release layer band is porose, in hole
Grain moisture expantion, release layer engages tightr with slow release layer.Historical facts or anecdotes test during with porose double-layer tablet all without segregation phenomenon.
According to the method for embodiment 3, suppressed respectively slow release layer do not have hole, one hole of slow release layer, two holes of slow release layer and
The double-layer tablet in three holes of slow release layer, owing to containing only active component and excipient in release layer, does not contains binding agent, respectively takes 20
Sheet, carries out friability Experimental comparison's research, result such as table 4 in friability detector respectively:
Table 4
It can be seen from the results above that double-layer tablet physical stability prepared by the present invention is better than common double synusia, more favorably
In storage and transport.
Claims (6)
1. a pain relieving class two-layer release-controlled tablet, including release layer and slow release layer, it is characterised in that described slow release layer is porose, institute
The hole stated is filled with immediate-release granules, described release layer and immediate-release granules formed with pharmaceutic adjuvant by analgesic type drug, institute
The slow release layer stated is made up of analgesic type drug, slow-release material and pharmaceutic adjuvant, a diameter of the 3 of the hole of described slow release layer～6mm,
The number in hole is 1-3；
The described two-layer release-controlled piece preparation method of pain relieving class is as follows:
1) analgesic type drug is mixed and made into slow-releasing granules with slow-release material and pharmaceutic adjuvant；By analgesic type drug and pharmaceutic adjuvant
It is mixed and made into immediate-release granules；
2) slow-releasing granules is pressed into porose slow release layer, then slow release layer is reentered in the punch die of tablet machine, load rapid release
Granule, carries out second time and suppresses, form the double-layer tablet being made up of release layer and slow release layer, be wherein filled with speed in the hole of slow release layer
Release granule.
Two-layer release-controlled tablet the most according to claim 1, it is characterised in that described analgesic type drug selected from aspirin,
Magnesium salicylate, sodium salicylate, choline magnesium trisalicylate, diflunisal, salsalate, ibuprofen, indomethacin, flurbiprofen,
Fenoprofen, naproxen, nabumetone, piroxicam, Phenylbutazone, diclofenac, venlofen, ketone ibuprofen, ketone are coughed up
Any one in acid, four clofenamic acides, sulindac, tolmetin or Anisodamine；Described slow-release material is selected from hydroxypropyl
Cellulose, ethyl cellulose, hydroxypropyl cellulose one or more；Described pharmaceutic adjuvant is selected from filler, disintegrating agent, profit
One or more in lubrication prescription, binding agent, fluidizer.
Two-layer release-controlled tablet the most according to claim 2, it is characterised in that described filler selected from lactose monohydrate, lactose,
One or more of pregelatinized Starch and microcrystalline Cellulose；Described disintegrating agent is selected from cross-linking sodium carboxymethyl cellulose, carboxymethyl
One or more in Starch Sodium and polyvinylpolypyrrolidone；Described lubricant is selected from stearic acid, magnesium stearate and talcous
Plant or several；Described binding agent is selected from one or more of polyvidone, hydroxypropyl cellulose and hydroxypropyl methylcellulose；Described
Fluidizer be silicon dioxide.
Two-layer release-controlled tablet the most according to claim 1, it is characterised in that
In described slow release layer, include following components according to percentage by weight:
In described release layer and immediate-release granules, include following components according to percentage by weight:
Two-layer release-controlled tablet the most according to claim 1, it is characterised in that also include coatings, described coatings according to
Percentage by weight includes following components:
6. according to the pain relieving class two-layer release-controlled tablet described in claim 1, it is characterised in that described preparation method also includes bag
The step of clothing.
Priority Applications (9)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310716482.6A CN103655505B (en) | 2013-12-23 | 2013-12-23 | A kind of pain relieving class two-layer release-controlled tablet and preparation method thereof |
| DK14874251.3T DK3087980T3 (en) | 2013-12-23 | 2014-12-19 | DOUBLE LAYER TABLE AND METHOD OF PRODUCING THEREOF |
| JP2016543032A JP6296371B2 (en) | 2013-12-23 | 2014-12-19 | Preparation method of bilayer tablet |
| EP14874251.3A EP3087980B1 (en) | 2013-12-23 | 2014-12-19 | Double-layer tablet and preparation method thereof |
| PCT/CN2014/094367 WO2015096668A1 (en) | 2013-12-23 | 2014-12-19 | Double-layer tablet and preparation method thereof |
| ES14874251T ES2712129T3 (en) | 2013-12-23 | 2014-12-19 | Double-layer tablet and method of preparation |
| US15/107,892 US10137092B2 (en) | 2013-12-23 | 2014-12-19 | Double-layer tablet and preparation method thereof |
| US16/178,547 US10925836B2 (en) | 2013-12-23 | 2018-11-01 | Double-layer tablet and painkiller tablet with same structure |
| US16/178,543 US10940114B2 (en) | 2013-12-23 | 2018-11-01 | Hypnotics tablet with double-layer structure |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310716482.6A CN103655505B (en) | 2013-12-23 | 2013-12-23 | A kind of pain relieving class two-layer release-controlled tablet and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN103655505A CN103655505A (en) | 2014-03-26 |
| CN103655505B true CN103655505B (en) | 2016-10-26 |
Family
ID=50295070
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201310716482.6A Active CN103655505B (en) | 2013-12-23 | 2013-12-23 | A kind of pain relieving class two-layer release-controlled tablet and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN103655505B (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10137092B2 (en) | 2013-12-23 | 2018-11-27 | Xiaoguang WEN | Double-layer tablet and preparation method thereof |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103948556A (en) * | 2014-04-08 | 2014-07-30 | 闻晓光 | Novel controlled release tablet |
| CN109316457B (en) * | 2018-11-26 | 2021-07-13 | 正大制药（青岛）有限公司 | Cyclobenzaprine hydrochloride sustained release preparation and preparation method thereof |
| CN110037994B (en) * | 2019-05-24 | 2022-04-12 | 中国药科大学 | Ibuprofen quick-release and slow-release double-layer tablet and preparation method thereof |
| CN114177155B (en) * | 2020-09-08 | 2023-10-03 | 越洋医药开发(广州)有限公司 | Ibuprofen controlled release tablet and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102085196A (en) * | 2009-12-08 | 2011-06-08 | 北京科信必成医药科技发展有限公司 | Nefopam hydrochloride bilayer slow-release tablet and preparation method thereof |
| WO2012118180A1 (en) * | 2011-03-03 | 2012-09-07 | 武田薬品工業株式会社 | Laminated tablet and manufacturing method therefor |
-
2013
- 2013-12-23 CN CN201310716482.6A patent/CN103655505B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102085196A (en) * | 2009-12-08 | 2011-06-08 | 北京科信必成医药科技发展有限公司 | Nefopam hydrochloride bilayer slow-release tablet and preparation method thereof |
| WO2012118180A1 (en) * | 2011-03-03 | 2012-09-07 | 武田薬品工業株式会社 | Laminated tablet and manufacturing method therefor |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10137092B2 (en) | 2013-12-23 | 2018-11-27 | Xiaoguang WEN | Double-layer tablet and preparation method thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| CN103655505A (en) | 2014-03-26 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN103655505B (en) | A kind of pain relieving class two-layer release-controlled tablet and preparation method thereof | |
| RU2616516C2 (en) | Pharmaceutical composition containing olmesartan medoxomil and rosuvastatin or its salt | |
| CN101257894A (en) | Sustained release pharmaceutical compositions for highly water soluble drugs | |
| US20230321090A1 (en) | Bromocriptine formulations | |
| WO2011071139A1 (en) | Dry-coated orally disintegrating tablet | |
| CN113018273A (en) | Solid preparation and preparation method and application thereof | |
| JP5208729B2 (en) | Method for producing sustained-release tablets | |
| CN103690505B (en) | A kind of sleeping class two-layer release-controlled tablet and preparation method thereof | |
| CN101990427A (en) | Combination of mitiglinide and metformin and process for preparing same | |
| WO2015096668A1 (en) | Double-layer tablet and preparation method thereof | |
| CN111202731B (en) | Combined application, medicinal composition and application thereof | |
| CN111939136A (en) | Compound preparation containing ticagrelor and aspirin and preparation method thereof | |
| CN103690503B (en) | A kind of preparation method of double-layer tablet | |
| EP2696857A1 (en) | Pharmaceutical composition comprising bosentan | |
| CN106580898B (en) | A kind of erigeron breviscapus dispersion tablet and preparation method | |
| CA2735203C (en) | A method for the production of bioadhesive compact matrices that can be used either as such or for the prolonged release of active substances, and compact matrices thus obtained | |
| CN115518066A (en) | Pharmaceutical composition for treating anticoagulation and application | |
| AU2020301401B2 (en) | Novel ibuprofen and acetaminophen composition | |
| WO2017093890A1 (en) | Clobazam tablet formulation and process for its preparation | |
| CN108366969A (en) | The Modified Release Formulation of naproxen sodium | |
| CN115919867B (en) | Aidenafil citrate oral sustained-release preparation and preparation method and application thereof | |
| RU2611339C2 (en) | Pharmaceutical compositions with prolonged release for treating cerebrovascular disorders | |
| Patel et al. | Pulsatile release of ketoprofen from compression coated tablets using Eudragit (r) polymers | |
| CN114533694A (en) | Compound capsule preparation containing ticagrelor and aspirin and preparation method thereof | |
| Rajpurohit et al. | Formulation and Evaluation of bi-layered tablets of Divalproex sodium. |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| TR01 | Transfer of patent right | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20180827 Address after: 510000 self compiled A015 of A Building 5, No. 2, No. 2, No. Patentee after: Yueyang medicine (Guangzhou) Development Co., Ltd. Address before: 225300, 1 new drug development base, No. 1209, Yao Cheng Road, Taizhou, Jiangsu, 2 phase D building, room 1209. Patentee before: Wen Xiaoguang |