CN106619557A - Perampanel gastric-soluble micro pellets and preparation method thereof - Google Patents
Perampanel gastric-soluble micro pellets and preparation method thereof Download PDFInfo
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- CN106619557A CN106619557A CN201710094208.8A CN201710094208A CN106619557A CN 106619557 A CN106619557 A CN 106619557A CN 201710094208 A CN201710094208 A CN 201710094208A CN 106619557 A CN106619557 A CN 106619557A
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- lun panai
- pyrrole lun
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/444—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring heteroatom, e.g. amrinone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
- A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses perampanel gastric-soluble micro pellets and a preparation method thereof. The preparation method comprises the following steps: preparing gastric-soluble coated pellets from perampanel serving as a main drug through a fluidized bed coating process, and then mixing the coated pellets with a filler, a disintegrating agent, an adhesive, a plasticizer and a lubricating agent to prepare the gastric-soluble pellets through a dry flaking technology. The pellets can be either directly swallowed or quickly disintegrated into the micro pellets in water, so that the perampanel gastric-soluble micro pellets are convenient for patients having trouble in swallowing, particularly children. The perampanel gastric-soluble micro pellets belong to a dosage form which can guarantee the accuracy of dosage and is safe and convenient to take.
Description
Technical field
The invention belongs to pharmaceutical field, is related to a kind of pellet tablet, and in particular to a kind of pyrrole Lun Panai stomach dissolution types pellet tablet and
Its preparation method.
Background technology
Pyrrole Lun Panai is a kind of methyl -4- isoxazole propionic acid (AMPA) receptor antagonists of alpha-amido -3- hydroxyls -5, and it is by suppression
Postsynaptic AMPA receptors glutamate activity processed, reduces neuron and is overexcited.On October 22nd, 2012 obtains FDA approval listings, this
It is the first antiepileptic with the mechanism of action of FDA approvals.Pyrrole Lun Panai is a kind of very popular antiepileptic,
Because by other treatment method, having many partial seizures patients to be effectively controlled.A current line anti-epileptic
Medicine is played a role by suppressing postsynaptic Glutamate AMPA Receptor, and it is now recognized that postsynaptic Glutamate AMPA Receptor take part in
Epileptic attack.3 clinical test results show, compared with the patient for taking placebo, the patient for taking pyrrole Lun Panai can be more preferable
Ground control epileptic attack.This is the first antiepileptic with the mechanism of action of FDA approvals.
For the patient of dysphagia, particularly children and old man, a kind of both safe and effective, taking conveniences, and energy are developed
Ensure that the accurate product of dosage is very important.
The content of the invention
The invention provides a kind of steady quality, evident in efficacy, the pyrrole Lun Panai stomaches used particular for child patient are molten
Type pellet tablet.
It is micropill that the pellet tablet of the present invention can rapidly be disintegrated in water, and the child patient for facilitating dysphagia is taken, and is improved
Security, it is ensured that medication dose is accurate.
The pellet tablet of the present invention, is prepared into stomach dissolution type coating micro- with fluidized bed coating technique by main ingredient pyrrole Lun Panai first
Ball, with compressing dry granulation technology system after then mixing coating micro-pill and filler, disintegrant, adhesive, plasticizer, lubricant etc.
For into stomach dissolution type pellet tablet.
Pyrrole Lun Panai stomach dissolution type pellet tablets of the present invention, it is composed of the following components：
| Pyrrole Lun Panai | 5-30 parts |
| Filler | 100-500 parts |
| Disintegrant | 15-50 parts |
| Adhesive | 15-50 parts |
| Lubricant | 1-10 parts |
| Macromolecule coating material | 2-6 parts |
| Plasticizer | 1-4 parts |
| Antitackiness agent | 1-4 parts |
| Pigment | 2-5 parts |
Wherein, pyrrole Lun Panai micropills, composed of the following components：
| Pyrrole Lun Panai | 5-30 parts |
| Fine pellet core | 100-200 parts |
| Adhesive | 15-30 parts |
| Antitackiness agent | 1-3 parts |
| Stomach dissolution type coating powder | 10-20 parts |
Wherein, the fine pellet core is the one kind or several in starch ball, sugar-pill, microcrystalline cellulose ball, lactose, dicalcium phosphate
Kind；
Wherein, the filler is starch, sucrose, dextrin, lactose, pregelatinized starch, microcrystalline cellulose, mannitol, inorganic calcium
One or more in salt, xylitol, sorbierite, glucose, erythrite；
Wherein, the disintegrant is dried starch, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, crosslinked polyethylene pyrrolidines
One or more in ketone, Ac-Di-Sol；
Wherein, described adhesive be water, ethanol, starch slurry, sodium carboxymethylcellulose, Hydroxypropyl methylcellulose, methylcellulose and
One or more in ethyl cellulose, Ac-Di-Sol；
Wherein, the lubricant is one or more in magnesium stearate, talcum powder, polyethylene glycols, differential silica gel；
Wherein, the plain edition macromolecule coating material is Hydroxypropyl methylcellulose, hydroxypropylcellulose, methylcellulose, ethoxy
One or more in cellulose；
Wherein, the plasticizer is the one kind or several in glycerine, polyethylene glycol, propane diols, corn oil, castor oil, liquid paraffin
Kind；
Wherein, the antitackiness agent is one or more in talcum powder, magnesium stearate, differential silica gel；
Wherein, the pigment is one or more in yellow ferric oxide, red ferric oxide.
In composition described above, part is weight portion, if in grams, composition described above can be made into 1000 composition lists of composition
Position, the composition unit refers to, made by final product composition, such as make tablet for 1000, such as make capsule for 1000,
Make granule 1000.
Preferably, pyrrole Lun Panai stomach dissolution type pellet tablets of the present invention, (percentage by weight) composed of the following components：
| Pyrrole Lun Panai | 5-30 parts |
| Microcrystalline cellulose | 100-300 parts |
| Low-substituted hydroxypropyl cellulose | 15-50 parts |
| Magnesium stearate | 1-5 parts |
| Hydroxypropyl methylcellulose | 2-10 parts |
| Iron oxide | 2-6 parts |
| Talcum powder | 1-4 parts |
| Macrogol 6000 | 1-4 parts |
Wherein, pyrrole Lun Panai micropills, (percentage by weight) composed of the following components：
| Pyrrole Lun Panai | 5-30 parts |
| Fine pellet core | 100-200 parts |
| Hydroxypropyl methylcellulose | 6-20 parts |
| Talcum powder | 1-3 parts |
| Stomach dissolution type coating powder | 10-20 parts |
Further object is that providing the preparation method of pyrrole Lun Panai stomach dissolution type pellet tablets, comprise the following steps：
1) adhesive is added to the water, heating is completely dissolved it, is cooled down, add pyrrole Lun Panai, after it is completely dissolved, will be anti-
Glutinous agent is dispersed in the solution；
2) fine pellet core is placed in fluid bed, then by step 1) in solution fluidized bed plant be uniformly sprayed at fine pellet core table
Face, makes pyrrole Lun Panai micropills；
3) stomach dissolution type film coating powder is dissolved in ethanol so as to dispersed；
4) pyrrole Lun Panai micropills are placed in fluid bed, then stomach dissolution type film coating solution is coated with fluidized bed plant；
5) it is pyrrole Lun Panai coating micro-pills, filler, disintegrant, mix lubricant is uniform；
6) piece of 0.1～0.5g weights is pressed into, slice, thin piece shape can be polygon, capsule shape, circle, annular and all rational shapes
Shape；
7) plain edition macromolecule coating material, plasticizer, antitackiness agent, pigment are added in ethanol so as to dispersed；
8) piece for weighing up is put into coating pan, by step 7) in solution be uniformly sprayed on pyrrole Lun Panai pellet tablets, you can.
The relatively conventional tablet of pyrrole Lun Panai stomach dissolution type pellet tablets of the present invention has the characteristics that：
The stomach dissolution type pellet tablet not only can be swallowed directly, and for the patient of dysphagia, can be dissolved in water first
Row disintegration takes again for micropill, is difficult to adhere on chamber wall, it is ensured that dosage accurately, improves patient's medication and complies with
Property.
Pyrrole Lun Panai stomach dissolution type pellet tablets of the present invention, also have the advantages that：
(1) dosage is easy to carry mainly for children, taking convenience；
(2) pyrrole Lun Panai has bitter taste, and coating can cover bitter taste, and drug compliance is good；
(3) tablet can rapidly be disintegrated into micropill in water, and convenient for children is swallowed, and rapidly discharge main ingredient in gastric juice, biological profit
Expenditure is high；
(4) main ingredient micropill improves medicine stability Jing after stomach dissolution type film coating liquid coating, is easy to storage.
Specific embodiment
By specific examples below, the present invention is further illustrated, but not as the restriction of the present invention.
It is prepared by the pyrrole Lun Panai stomach dissolution types pellet tablet of embodiment 1
1.1 prescriptions
A, pyrrole Lun Panai stomach dissolution type micropills
| Pyrrole Lun Panai | 12g |
| Starch capsule core | 150g |
| Hydroxypropyl methylcellulose | 10g |
| Talcum powder | 3g |
| Stomach dissolution type coating powder | 10g |
| Purified water | 300g |
| Ethanol | 100g |
B, pyrrole Lun Panai stomach dissolution type pellet tablets
1.2 methods for preparing above-mentioned prescription pyrrole Lun Panai stomach dissolution type pellet tablets, follow the steps below：
1) Hydroxypropyl methylcellulose is added to the water, heating is completely dissolved it, is cooled down, add pyrrole Lun Panai, treat that it is completely dissolved
Afterwards, talcum powder is dispersed in the solution；
2) starch capsule core is placed in fluid bed, then solution fluidized bed plant is uniformly sprayed at starch capsule core table in inciting somebody to action " 1) "
Face, makes pyrrole Lun Panai micropills；
3) stomach dissolution type film coating powder is dissolved in ethanol so as to dispersed；
4) pyrrole Lun Panai micropills are placed in fluid bed, then stomach dissolution type film coating solution is coated with fluidized bed plant；
5) pyrrole Lun Panai coating micro-pills, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate are well mixed；
6) it is pressed into the piece of 0.1～0.8g weights.Slice, thin piece shape can be polygon, capsule shape, circle, annular and all rational shapes
Shape；
7) Hydroxypropyl methylcellulose, Macrogol 6000, talcum powder, yellow ferric oxide are added in ethanol so as to be uniformly dispersed；
8) piece for weighing up is put into coating pan, will " 7) " and in solution be uniformly sprayed on pyrrole Lun Panai pellet tablets so as to surface
Smooth, color is uniform.
It is prepared by the pyrrole Lun Panai stomach dissolution types pellet tablet of embodiment 2
2.1 prescriptions
A, pyrrole Lun Panai stomach dissolution type micropills
| Pyrrole Lun Panai | 6g |
| Starch capsule core | 100g |
| Hydroxypropyl methylcellulose | 8g |
| Talcum powder | 3g |
| Stomach dissolution type coating powder | 10g |
| Purified water | 250g |
| Ethanol | 100g |
B, pyrrole Lun Panai stomach dissolution type pellet tablets
2.2 methods for preparing above-mentioned prescription pyrrole Lun Panai stomach dissolution type pellet tablets, follow the steps below：
1) Hydroxypropyl methylcellulose is added to the water, heating is completely dissolved it, is cooled down, add pyrrole Lun Panai, treat that it is completely dissolved
Afterwards, talcum powder is dispersed in the solution；
2) starch capsule core is placed in fluid bed, then solution fluidized bed plant is uniformly sprayed at starch capsule core table in inciting somebody to action " 1) "
Face, makes pyrrole Lun Panai micropills；
3) stomach dissolution type film coating powder is dissolved in ethanol so as to dispersed；
4) pyrrole Lun Panai micropills are placed in fluid bed, then stomach dissolution type film coating solution is coated with fluidized bed plant；
5) pyrrole Lun Panai coating micro-pills, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate are well mixed；
6) it is pressed into the piece of 0.1～0.8g weights.Slice, thin piece shape can be polygon, capsule shape, circle, annular and all rational shapes
Shape；
7) Hydroxypropyl methylcellulose, Macrogol 6000, talcum powder, yellow ferric oxide are added in ethanol so as to be uniformly dispersed；
8) piece for weighing up is put into coating pan, will " 7) " and in solution be uniformly sprayed on pyrrole Lun Panai pellet tablets so as to surface
Smooth, color is uniform.
It is prepared by the pyrrole Lun Panai stomach dissolution types pellet tablet of embodiment 3
3.1 prescriptions
A, pyrrole Lun Panai stomach dissolution type micropills
| Pyrrole Lun Panai | 24g |
| Starch capsule core | 100g |
| Hydroxypropyl methylcellulose | 6g |
| Talcum powder | 3g |
| Stomach dissolution type coating powder | 10g |
| Purified water | 260g |
| Ethanol | 150g |
B, pyrrole Lun Panai stomach dissolution type pellet tablets
3.2 methods for preparing above-mentioned prescription pyrrole Lun Panai stomach dissolution type pellet tablets, follow the steps below：
1) Hydroxypropyl methylcellulose is added to the water, heating is completely dissolved it, is cooled down, add pyrrole Lun Panai, treat that it is completely dissolved
Afterwards, talcum powder is dispersed in the solution；
2) starch capsule core is placed in fluid bed, then solution fluidized bed plant is uniformly sprayed at starch capsule core table in inciting somebody to action " 1) "
Face, makes pyrrole Lun Panai micropills；
3) stomach dissolution type film coating powder is dissolved in ethanol so as to dispersed；
4) pyrrole Lun Panai micropills are placed in fluid bed, then stomach dissolution type film coating solution is coated with fluidized bed plant；
5) pyrrole Lun Panai coating micro-pills, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate are well mixed；
6) it is pressed into the piece of 0.1～0.8g weights.Slice, thin piece shape can be polygon, capsule shape, circle, annular and all rational shapes
Shape；
7) Hydroxypropyl methylcellulose, Macrogol 6000, talcum powder, yellow ferric oxide are added in ethanol so as to be uniformly dispersed；
8) piece for weighing up is put into coating pan, will " 7) " and in solution be uniformly sprayed on pyrrole Lun Panai pellet tablets so as to surface
Smooth, color is uniform.
Claims (3)
1. a kind of pyrrole Lun Panai stomach dissolution type pellet tablets, composed of the following components：
Described pellet tablet in accordance with the above, it is characterised in that pyrrole Lun Panai micropills, it is composed of the following components：
Pellet tablet in accordance with the above, it is characterised in that
Wherein, the fine pellet core is the one kind or several in starch ball, sugar-pill, microcrystalline cellulose ball, lactose, dicalcium phosphate
Kind；
Wherein, the filler is starch, sucrose, dextrin, lactose, pregelatinized starch, microcrystalline cellulose, mannitol, inorganic calcium
One or more in salt, xylitol, sorbierite, glucose, erythrite；
Wherein, the disintegrant is dried starch, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, crosslinked polyethylene pyrrolidines
One or more in ketone, Ac-Di-Sol；
Wherein, described adhesive be water, ethanol, starch slurry, sodium carboxymethylcellulose, Hydroxypropyl methylcellulose, methylcellulose and
One or more in ethyl cellulose, Ac-Di-Sol；
Wherein, the lubricant is one or more in magnesium stearate, talcum powder, polyethylene glycols, differential silica gel；
Wherein, the plain edition macromolecule coating material is Hydroxypropyl methylcellulose, hydroxypropylcellulose, methylcellulose, ethoxy
One or more in cellulose；
Wherein, the plasticizer is the one kind or several in glycerine, polyethylene glycol, propane diols, corn oil, castor oil, liquid paraffin
Kind；
Wherein, the antitackiness agent is one or more in talcum powder, magnesium stearate, differential silica gel；
Wherein, the pigment is one or more in yellow ferric oxide, red ferric oxide.
2. pellet tablet according to claim 1, it is characterised in that composed of the following components：
Pellet tablet according to claim 1, it is characterised in that pyrrole Lun Panai micropills, it is composed of the following components：
Pellet tablet according to claim 1, it is characterised in that be 0.1～0.8g per sheet weight.
3. pellet tablet according to claim 1, it is characterised in that composed of the following components：
Wherein, pyrrole Lun Panai micropills are consisted of the following composition：
The preparation method of the pellet tablet described in claim 1, it is characterised in that comprise the following steps：
1）Adhesive is added to the water, heating is completely dissolved it, is cooled down, add pyrrole Lun Panai, after it is completely dissolved, will be anti-
Glutinous agent is dispersed in the solution；
2）Fine pellet core is placed in fluid bed, then by step 1) in solution fluidized bed plant be uniformly sprayed at fine pellet core table
Face, makes pyrrole Lun Panai micropills；
3）Stomach dissolution type film coating powder is dissolved in ethanol so as to dispersed；
4）Pyrrole Lun Panai micropills are placed in fluid bed, then stomach dissolution type film coating solution is coated with fluidized bed plant；
5）Pyrrole Lun Panai coating micro-pills, filler, disintegrant, mix lubricant is uniform；
6）The piece of 0.1～0.5g weights is pressed into, slice, thin piece shape can be polygon, capsule shape, circle, annular and all rational shapes
Shape；
7）Plain edition macromolecule coating material, plasticizer, antitackiness agent, pigment are added in ethanol so as to dispersed；
8) piece for weighing up is put into coating pan, by step 7) in solution be uniformly sprayed on pyrrole Lun Panai pellet tablets, you can.
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|---|---|---|---|
| CN201710094208.8A CN106619557A (en) | 2017-02-21 | 2017-02-21 | Perampanel gastric-soluble micro pellets and preparation method thereof |
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Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104644592A (en) * | 2013-11-25 | 2015-05-27 | 天津市汉康医药生物技术有限公司 | Perampanel pharmaceutical composition and preparation method thereof |
| CN104706604A (en) * | 2013-12-12 | 2015-06-17 | 北京星昊医药股份有限公司 | Perampanel freeze-dried oral disintegrating tablet and preparation method thereof |
| WO2015153263A1 (en) * | 2014-04-02 | 2015-10-08 | Yale University | Compositions and methods to treat addiction |
| CN105287411A (en) * | 2015-09-22 | 2016-02-03 | 美吉斯制药（厦门）有限公司 | Perampanel dispersible tablet and preparation method thereof |
| CN105640900A (en) * | 2014-11-11 | 2016-06-08 | 天津市汉康医药生物技术有限公司 | Perampanel medicinal composition |
| CN105663064A (en) * | 2016-03-31 | 2016-06-15 | 河南蓝图制药有限公司 | Imatinib mesylate gastric-soluble pellet tablet and preparation method thereof |
| CN106389367A (en) * | 2016-11-16 | 2017-02-15 | 杭州朱养心药业有限公司 | Perampanel coated tablet pharmaceutical composition |
-
2017
- 2017-02-21 CN CN201710094208.8A patent/CN106619557A/en active Pending
Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104644592A (en) * | 2013-11-25 | 2015-05-27 | 天津市汉康医药生物技术有限公司 | Perampanel pharmaceutical composition and preparation method thereof |
| CN104706604A (en) * | 2013-12-12 | 2015-06-17 | 北京星昊医药股份有限公司 | Perampanel freeze-dried oral disintegrating tablet and preparation method thereof |
| WO2015153263A1 (en) * | 2014-04-02 | 2015-10-08 | Yale University | Compositions and methods to treat addiction |
| CN105640900A (en) * | 2014-11-11 | 2016-06-08 | 天津市汉康医药生物技术有限公司 | Perampanel medicinal composition |
| CN105287411A (en) * | 2015-09-22 | 2016-02-03 | 美吉斯制药（厦门）有限公司 | Perampanel dispersible tablet and preparation method thereof |
| CN105663064A (en) * | 2016-03-31 | 2016-06-15 | 河南蓝图制药有限公司 | Imatinib mesylate gastric-soluble pellet tablet and preparation method thereof |
| CN106389367A (en) * | 2016-11-16 | 2017-02-15 | 杭州朱养心药业有限公司 | Perampanel coated tablet pharmaceutical composition |
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Application publication date: 20170510 |