CN106822029A - A kind of pyrrole Lun Panai soft capsules and preparation method thereof - Google Patents
A kind of pyrrole Lun Panai soft capsules and preparation method thereof Download PDFInfo
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- CN106822029A CN106822029A CN201710094110.2A CN201710094110A CN106822029A CN 106822029 A CN106822029 A CN 106822029A CN 201710094110 A CN201710094110 A CN 201710094110A CN 106822029 A CN106822029 A CN 106822029A
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- lun panai
- soft capsules
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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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
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- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
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- Pharmacology & Pharmacy (AREA)
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- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Preparation (AREA)
Abstract
The present invention relates to a kind of preparation method of pyrrole Lun Panai soft capsules.The everolimus soft capsule for preparing has good stability, the advantage of proterties stabilization.The drug regimen for the treatment of epilepsy of the invention, reasonable mixture ratio can produce good curative effect with rapid delivery of pharmaceuticals to the illness.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, it is related to a kind of soft capsule containing pyrrole Lun Panai and preparation method thereof.
Background technology
Pyrrole Lun Panai is a kind of alpha-amido -3- hydroxyls -5 methyl -4- isoxazoles propionic acid (AMPA) receptor antagonist, 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
Thing, because by other treatment method, thering are many partial seizures patients to be effectively controlled.A current line resists insane
Epilepsy agent is played a role by suppressing postsynaptic Glutamate AMPA Receptor, and it is now recognized that postsynaptic Glutamate AMPA Receptor is participated 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
Control epileptic attack well.This is the first antiepileptic with the mechanism of action of FDA approvals.
The content of the invention
The present invention provides a kind of pyrrole Lun Panai soft capsules.Specifically, soft capsule of the present invention includes softgel shell and content
Thing, by weight, its raw material includes following component：
Softgel shell：10 parts of gelatin, glycerine 3.5-4.5 parts, 10 parts, preservative 1.0-3.5 parts of water；
Content：0.1-10 parts of pyrrole Lun Panai, diluent 50-70 parts, suspending agent 1-5 parts, antioxidant 0-3 parts, preservative 0-3
Part；
The weight ratio of the softgel shell and content is 2:5.
In the present invention, the diluent includes one or two of polyethylene glycols or vegetable oil, wherein polyethylene glycols
Selected from PEG400, polyethylene glycol 2000, vegetable oil is selected from corn oil, soybean oil, peanut oil, sesame oil, olive oil, sunflower
Seed oil, salad oil, cottonseed oil or rapeseed oil.The diluent is preferably PEG400, polyethylene glycol 2000.It is dilute using this
Release agent and advantageously ensure that accurate and preparation the stability of content, so that it is guaranteed that the safety and effectiveness of medicine.
In the present invention, the suspending agent includes ethyl-hydroxyethyl fiber, chitose, methylcellulose, ethyl cellulose, fine jade
Fat, HEMC, hydroxyethyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl cellulose, benzoic acid, poly- second two
In alcohol etc. one or more, the suspending agent is preferably ethyl cellulose, hydroxypropyl methyl cellulose, favourable using the suspending agent
In increase decentralized medium viscosity with reduce particulate sinking speed or increase particulate hydrophily.
In the present invention, the antioxidant include sodium hydrogensulfite, sodium pyrosulfite, potassium metabisulfite, ethylenediamine tetra-acetic acid,
One or more in citric acid, malic acid, ascorbic acid, inositol etc., preferably ascorbic acid, ethylenediamine tetra-acetic acid, use
The antioxidant is conducive to preventing the problems such as oxidation of drug is rotten, cyst wall is aging causes medicine disintegration to extend, and may also operate as gold
Belong to the effect of ion chelating agent.
In the present invention, the preservative include sorbic acid, methyl p-hydroxybenzoate, ethyl-para-hydroxybenzoate, to hydroxyl
In yl benzoic acid propyl ester etc. one or more, the preferred methyl p-hydroxybenzoate of preservative, sorbic acid.Both preservatives
Broad spectrum type preservative, with toxicity stable in properties it is low the characteristics of.
In the present invention, cosolvent can be also added in content, the cosolvent is selected from ethanol, glycerine or propane diols.
Further, the present invention preferably soft capsule, by weight, raw material includes following component：
Softgel shell：10 parts of gelatin, glycerine 3.5-4.5 parts, 10 parts, methyl p-hydroxybenzoate 1.0-3.5 parts of water；
Content：0.1-5 parts of pyrrole Lun Panai, diluent PEG400,50-60 parts, 1-4 parts of suspending agent chitose, hydroxypropyl
Methylcellulose 1-4 parts, antioxidants Ascorbic acid 1-2 parts, 1-2 parts of preservative methyl p-hydroxybenzoate；
The weight ratio of the softgel shell and content is 2:5.
Invention also provides the preparation method of above-mentioned pyrrole Lun Panai soft capsules, the preparation method includes following step
Suddenly：
1) preparation of capsule shell fluid：Gelatin, G ＆ W are mixed in proportion, 80-90 DEG C of heating water bath dissolving is added appropriate
Preservative, stirring, after vacuumizing degassing, 50-70 DEG C of insulation is standby；
2) preparation of content：The solid dispersions and diluent, suspending agent, antioxidant, preservative are sufficiently mixed uniformly；
3) content and capsule shell fluid are made soft capsule.The step 2) in can also add cosolvent.
Specific embodiment
Following examples are used to illustrate the present invention, but are not limited to the scope of the present invention.
The pyrrole Lun Panai soft capsules of embodiment 1
Softgel shell：Gelatin 1.25g, glycerine 0.45g, water .12g, methyl p-hydroxybenzoate 0.15g.
Content：Pyrrole Lun Panai 5mg, PEG400 3g, chitose 0.25g, hydroxypropyl methyl cellulose 0.13g,
Ascorbic acid 0.1g, methyl p-hydroxybenzoate 0.05g.
The pyrrole Lun Panai soft capsules of embodiment 2
Softgel shell：Gelatin 1.35g, glycerine 0.50g, water 1.21g, methyl p-hydroxybenzoate 0.23g.
Content：Weigh pyrrole Lun Panai 5mg, PEG400 4g, glycerine 0.25g, hydroxypropyl methyl cellulose 0.1g,
Ascorbic acid 0.12g, methyl p-hydroxybenzoate 0.03g.
The pyrrole Lun Panai soft capsules of embodiment 3
Softgel shell：Gelatin 1.45g, glycerine 0.60g, water 1.3g, methyl p-hydroxybenzoate 0.15g.
Content：Weigh pyrrole Lun Panai 5mg, PEG400 4.3g, chitose 0.2g, hydroxypropyl methyl cellulose
0.1g, ascorbic acid 0.10g, methyl p-hydroxybenzoate 0.02g.
The pyrrole Lun Panai soft capsules of embodiment 4
Softgel shell：Gelatin 1.26g, glycerine 0.58g, water 1.13g, methyl p-hydroxybenzoate 0.45g.
Content：Weigh pyrrole Lun Panai 5mg, polyethylene glycol 2000 4g, ethyl cellulose 0.22g, hydroxypropyl methyl fiber
Plain 0.1g, ascorbic acid 0.13g, methyl p-hydroxybenzoate 0.04g.
The pyrrole Lun Panai soft capsules of embodiment 5
Softgel shell：Gelatin 1.22g, glycerine 0.51g, water 1.1g, methyl p-hydroxybenzoate 0.4g.
Content：Weigh pyrrole Lun Panai 5mg, polyethylene glycol 2000 6g, ethyl cellulose 0.5g, hydroxypropyl methyl fiber
Plain 0.1g.
The pyrrole Lun Panai soft capsules of embodiment 6
Softgel shell：Gelatin 1.2g, glycerine 0.55g, water 1.1g, methyl p-hydroxybenzoate 0.42g.
Content：Weigh pyrrole Lun Panai 5mg, polyethylene glycol 2000 3g, ethyl cellulose 0.21g, hydroxypropyl methyl fiber
Plain 0.2g, ascorbic acid 0.2g, methyl p-hydroxybenzoate 0.2g.
The preparation of the pyrrole Lun Panai soft capsules of embodiment 7
Pyrrole Lun Panai soft capsules are prepared according to the prescription of embodiment 1, its step is as follows：
1) preparation of capsule shell fluid：Gelatin, G ＆ W are well mixed, 80 DEG C of heating water bath dissolvings add P-hydroxybenzoic acid
Methyl esters, agitated, after vacuumizing degassing, 70 DEG C of insulations are standby；
2) preparation of softgel shell content：Weigh pyrrole Lun Panai solid dispersions, PEG400, chitose, hydroxypropyl methyl fine
Dimension element, ascorbic acid, methyl p-hydroxybenzoate are well mixed, standby；
3) above-mentioned softgel shell content and capsule shell fluid are fitted into automatic rotation rolling capsule machine, temperature control is prepared at 40-50 DEG C
Pyrrole Lun Panai soft capsules.
The preparation of the pyrrole Lun Panai soft capsules of embodiment 8
Pyrrole Lun Panai soft capsules are prepared according to the formula of embodiment 2, its step is as follows：
1) preparation of capsule shell fluid：Gelatin is weighed, glycerine, water is well mixed, 80 DEG C of heating water bath dissolvings add para hydroxybenzene first
Sour methyl esters is agitated, and after vacuumizing degassing, 70 DEG C of insulations are standby；
2) preparation of softgel shell content：Weigh pyrrole Lun Panai solid dispersions 4g, polyethylene glycol, glycerine, hydroxypropyl methyl fiber
Element, ascorbic acid, methyl p-hydroxybenzoate, are well mixed, standby；
3) above-mentioned softgel shell content and softgel shell are fitted into automatic rotation rolling capsule machine, temperature control is prepared into pyrrole at 40-50 DEG C
Lun Panai soft capsules.
The preparation of the pyrrole Lun Panai soft capsules of embodiment 9
Formula according to embodiment 3 prepares pyrrole Lun Panai soft capsules, and its step is as follows：
1）The preparation of capsule shell fluid：Gelatin is weighed, glycerine, water is well mixed, 80 DEG C of heating water bath dissolvings add para hydroxybenzene first
Sour methyl esters is agitated, and after vacuumizing degassing, 70 DEG C of insulations are standby；
2）The preparation of softgel shell content：Weigh pyrrole Lun Panai solid dispersions 4g, polyethylene glycol, glycerine, hydroxypropyl methyl fiber
Element, ascorbic acid, methyl p-hydroxybenzoate, are well mixed, standby；
3）Above-mentioned softgel shell content and softgel shell are fitted into automatic rotation rolling capsule machine, temperature control is prepared into pyrrole at 40-50 DEG C
Lun Panai soft capsules.
The preparation of the pyrrole Lun Panai soft capsules of embodiment 10
Formula according to embodiment 4 prepares pyrrole Lun Panai soft capsules, and its step is as follows：
1）The preparation of capsule shell fluid：Gelatin is weighed, glycerine, water is well mixed, 80 DEG C of heating water bath dissolvings add para hydroxybenzene first
Sour methyl esters is agitated, and after vacuumizing degassing, 70 DEG C of insulations are standby；
2）The preparation of softgel shell content：Weigh pyrrole Lun Panai solid dispersions 4g, polyethylene glycol, glycerine, hydroxypropyl methyl fiber
Element, ascorbic acid, methyl p-hydroxybenzoate, are well mixed, standby；
3）Above-mentioned softgel shell content and softgel shell are fitted into automatic rotation rolling capsule machine, temperature control is prepared into pyrrole at 40-50 DEG C
Lun Panai soft capsules.
The preparation of the pyrrole Lun Panai soft capsules of embodiment 11
Formula according to embodiment 5 prepares pyrrole Lun Panai soft capsules, and its step is as follows：
1）The preparation of capsule shell fluid：Gelatin is weighed, glycerine, water is well mixed, 80 DEG C of heating water bath dissolvings add para hydroxybenzene first
Sour methyl esters is agitated, and after vacuumizing degassing, 70 DEG C of insulations are standby；
2）The preparation of softgel shell content：Weigh pyrrole Lun Panai solid dispersions 4g, polyethylene glycol, glycerine, hydroxypropyl methyl fiber
Element, ascorbic acid, methyl p-hydroxybenzoate, are well mixed, standby；
3）Above-mentioned softgel shell content and softgel shell are fitted into automatic rotation rolling capsule machine, temperature control is prepared into pyrrole at 40-50 DEG C
Lun Panai soft capsules.
The preparation of the pyrrole Lun Panai soft capsules of embodiment 12
Formula according to embodiment 6 prepares pyrrole Lun Panai soft capsules, and its step is as follows：
1）The preparation of capsule shell fluid：Gelatin is weighed, glycerine, water is well mixed, 80 DEG C of heating water bath dissolvings add para hydroxybenzene first
Sour methyl esters is agitated, and after vacuumizing degassing, 70 DEG C of insulations are standby；
2）The preparation of softgel shell content：Weigh pyrrole Lun Panai solid dispersions 4g, polyethylene glycol, glycerine, hydroxypropyl methyl fiber
Element, ascorbic acid, methyl p-hydroxybenzoate, are well mixed, standby；
3）Above-mentioned softgel shell content and softgel shell are fitted into automatic rotation rolling capsule machine, temperature control is prepared into pyrrole at 40-50 DEG C
Lun Panai soft capsules.
The pyrrole Lun Panai soft capsules that the method provided with the present invention is made with formula, dissolution rate is high, absorbs effect
It is good.
These modifications or improvements, belong to claimed without departing from theon the basis of the spirit of the present invention
Scope.
Claims (9)
1. a kind of pyrrole Lun Panai soft capsules, the soft capsule includes softgel shell and content, and by weight, its raw material includes such as the following group
Point：
Softgel shell：10 parts of gelatin, glycerine 3.5-4.5 parts, 10 parts, preservative 1.0-3.5 parts of water；
Content：0.1-10 parts of pyrrole Lun Panai, diluent 50-80 parts, suspending agent 1-5 parts, antioxidant 0-3 parts, preservative 0-3
Part；
The weight ratio of the softgel shell and content is 2：5.
2. pyrrole Lun Panai soft capsules according to claim 1, it is characterised in that the diluent include polyethylene glycols or
Vegetable oil one or two, the polyethylene glycols be selected from PEG400, polyethylene glycol 2000, vegetable oil be selected from corn
Oil, soybean oil, peanut oil, sesame oil, olive oil, sunflower oil, salad oil, cottonseed oil or rapeseed oil；The diluent is preferably
PEG400, polyethylene glycol 2000.
3. pyrrole Lun Panai soft capsules according to claim 1, it is characterised in that the suspending agent includes that ethyl-hydroxyethyl is fine
Dimension element, chitose, methylcellulose, ethyl cellulose, agar, HEMC, hydroxyethyl cellulose, hydroxypropyl first
In base cellulose, hydroxypropyl cellulose, benzoic acid, polyethylene glycol one or more, the suspending agent be preferably ethyl cellulose,
Hydroxypropyl methyl cellulose.
4. pyrrole Lun Panai soft capsules according to claim 1, it is characterised in that the antioxidant include sodium hydrogensulfite,
One or more in sodium pyrosulfite, potassium metabisulfite, ethylenediamine tetra-acetic acid, citric acid, malic acid, ascorbic acid, inositol,
The antioxidant is preferably ascorbic acid, ethylenediamine tetra-acetic acid.
5. pyrrole Lun Panai soft capsules according to claim 1, it is characterised in that the preservative A includes sorbic acid, to hydroxyl
In yl benzoic acid methyl esters, ethyl-para-hydroxybenzoate, propylparaben one or more, the preservative preferred pair hydroxyl
Yl benzoic acid methyl esters, sorbic acid.
6. pyrrole Lun Panai soft capsules according to claim 1, it is characterised in that be also added into the content latent molten
Agent, described latent molten selected from ethanol, glycerine or propane diols, the addition of the cosolvent is 1-5 parts by weight.
7. pyrrole Lun Panai soft capsules according to claim 1, it is characterised in that the solid dispersion carrier includes poly- second
Glycol 6000, acrylic resin.
8. pyrrole Lun Panai soft capsules according to claim any one of 1-7, it is characterised in that by weight, its raw material bag
Include following component：
Softgel shell：10 parts of gelatin, glycerine 3.5-4.5 parts, 10 parts, methyl p-hydroxybenzoate 1.0-3.5 parts of water；
Content：0.1-10 parts of pyrrole Lun Panai, 50-70 parts of diluent PEG400,1-4 parts of suspending agent chitose, hydroxypropyl
1-4 parts of ylmethyl cellulose, antioxidants Ascorbic acid 1-2 parts, 1-2 parts of preservative methyl p-hydroxybenzoate；
The weight ratio of the softgel shell and content is 2:5.
9. the preparation method of pyrrole Lun Panai soft capsules described in any one of claim 1-8, comprises the following steps：
The preparation of capsule shell fluid：Gelatin is weighed, glycerine, water is well mixed, 80 DEG C of heating water bath dissolvings add P-hydroxybenzoic acid
Methyl esters is agitated, and after vacuumizing degassing, 70 DEG C of insulations are standby；
The preparation of softgel shell content：Weigh pyrrole Lun Panai solid dispersions 4g, polyethylene glycol, glycerine, hydroxypropyl methyl cellulose,
Ascorbic acid, methyl p-hydroxybenzoate, are well mixed, standby；
Above-mentioned softgel shell content and softgel shell are fitted into automatic rotation rolling capsule machine, temperature control is prepared into pyrrole logical sequence at 40-50 DEG C
Handkerchief how soft capsule.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710094110.2A CN106822029A (en) | 2017-02-21 | 2017-02-21 | A kind of pyrrole Lun Panai soft capsules and preparation method thereof |
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| CN201710094110.2A CN106822029A (en) | 2017-02-21 | 2017-02-21 | A kind of pyrrole Lun Panai soft capsules and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112494433A (en) * | 2020-12-11 | 2021-03-16 | 南京海纳医药科技股份有限公司 | Dosage form for improving Perampanel static electricity and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN105748432A (en) * | 2014-12-15 | 2016-07-13 | 蚌埠丰原涂山制药有限公司 | Fenofibrate soft capsule and preparation method thereof |
-
2017
- 2017-02-21 CN CN201710094110.2A patent/CN106822029A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN105748432A (en) * | 2014-12-15 | 2016-07-13 | 蚌埠丰原涂山制药有限公司 | Fenofibrate soft capsule and preparation method thereof |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112494433A (en) * | 2020-12-11 | 2021-03-16 | 南京海纳医药科技股份有限公司 | Dosage form for improving Perampanel static electricity and preparation method thereof |
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