CN106214652A - A kind of pharmaceutical composition containing istradefylline - Google Patents
A kind of pharmaceutical composition containing istradefylline Download PDFInfo
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- CN106214652A CN106214652A CN201610794463.9A CN201610794463A CN106214652A CN 106214652 A CN106214652 A CN 106214652A CN 201610794463 A CN201610794463 A CN 201610794463A CN 106214652 A CN106214652 A CN 106214652A
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- istradefylline
- pharmaceutical composition
- puerarin
- composition containing
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Classifications
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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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
- A61K31/52—Purines, e.g. adenine
- A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
-
- 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
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
Abstract
The invention discloses a kind of pharmaceutical composition containing istradefylline, the raw material of following parts by weight be prepared from: istradefylline: 20 50 parts, puerarin: 10 20 parts, starch: 5 12 parts, low-substituted hydroxypropyl cellulose: 19 parts, magnesium stearate: 26 parts, antioxidant: 28 parts, mannitol: 35 parts, micropowder silica gel: 2 10 parts, chitin: 2 10 parts, sodium alginate: 28 parts, lactose: 3 10 parts；Its preparation technology is to weigh the istradefylline of recipe quantity, puerarin, starch, low-substituted hydroxypropyl cellulose, magnesium stearate, antioxidant, mannitol, micropowder silica gel, chitin, sodium alginate, lactose mix homogeneously, separately take 60% ethanol of Sq, it is incorporated in mixed-powder, soft material processed after mix homogeneously, being pelletized by 16 mesh sieves, less than 60 DEG C are dried.Granulate after completing after drying, is mixed evenly with dry granule, tabletting the most again, to obtain final product.The present invention has the parkinsonian advantage for the treatment of.
Description
Technical field
The present invention relates to pharmaceutical technology field, be specifically related to a kind of pharmaceutical composition containing istradefylline.
Background technology
Parkinson, also known as Parkinsonism, is the modal central nervous system degenerative disease of middle-aged and elderly people.Tremble and be
Finger and extremity vibration, shaking, paralysis refer to part or all of limbs of limbs can not autonomic movement, including the dyskinesia,
Tremble and muscular rigidity.Along with China progresses into aged tendency of population society, its sickness rate is the most also to raise year by year, morbidity
Rate increases with the age and is gradually increased.Its age of onset typically starts 50～65 years old, within 60 years old, sickness rate is about 1 ‰, 70 morbidities
Rate reaches 3 ‰～5 ‰, and China the most probably has more than 170 ten thousand people to suffer from this disease.Data shows, parkinson morbidity crowd
The a little higher than women of middle male, there is no radical cure method the most clinically and the neurocyte of degeneration can be made to recover, to primary disease
Treatment is symptomatic treatment.
Istradefylline is the new A2A receptor antagonist that a kind of current effect is the strongest, can be by changing the activity of neuron
And improve the motion function of PD patient, can substantially shorten the pass phase, extend open the phase, and toleration and safety good.Clinical trial
Result shows the agent end phenomenon that can significantly reduce levodopa treatment, for treating PD and improving the dyskinesia at PD initial stage.?
In primate Parkinson disease model, it can improve its akinesia shape.Give the parkinson disease marmoset mouth induced by MPTP
Take it, can dose dependent reverse its motion incapability, its integrated motion ability has been improved, and motion without exception.Identical
Parkinson disease model in, levodopa or selective d 1 and D2 receptor stimulating agent are combined by it, can strengthen these and intend dopamine
The anti-parkinson effect of medicine, is especially combined with levodopa and quinpirole, and in macaque Parkinson disease model, it is with left
Rotation DOPA and the combination of silk hydrazine, can strengthen levodopa and improve the drug effect of motion, and not aggravate movement disorder symptoms.More than transport
Showing by the result of study of animal model for parkinsonism, its use can reduce the consumption of levodopa, such that it is able to prevent
Or the generation of lag motion obstacle.Istradefylline and levodopa and other anti-Parkinson's drug thing in 2 phases with 3 clinical trial phases
Being combined and can not get, in those symptoms, the patient that controls very well, the safety that this medicine shows and effectiveness have all reached to declare to be needed
Ask.It addition, alone its can carry out early treatment to this disease.It can be provided purely for treatment PD symptom in early days, it is possible to treatment PD suffers from
The mental symptom of person, such as anxiety, depression etc., moreover it is possible to it is numb that reverse antipsychotic drug causes.Puerarin is from leguminous plant
The one single composition flavonoid glycoside extracted in Radix Puerariae, has blood circulation promoting and blood stasis dispelling, improves microcirculation, coronary artery dilator and brain blood
The effects such as pipe, reduction myocardial oxygen consumption, its preparation puerarin injection is clinically used for treating cardiovascular and cerebrovascular disease and retinal blood
Pipe disease, retinopathy and sudden deafness etc..
Summary of the invention
For the deficiencies in the prior art, the invention provides a kind of pharmaceutical composition containing istradefylline, there is treatment
Parkinsonian advantage.
For realizing object above, the present invention is achieved by the following technical programs:
The invention provides a kind of pharmaceutical composition containing istradefylline, by the raw material preparation of following parts by weight
Become: istradefylline: 20-50 part, puerarin: 10-20 part, starch: 5-12 part, low-substituted hydroxypropyl cellulose: 1-9 part, tristearin
Acid magnesium: 2-6 part, antioxidant: 2-8 part, mannitol: 3-5 part, micropowder silica gel: 2-10 part, chitin: 2-10 part, sodium alginate:
2-8 part, lactose: 3-10 part；
Preferably, the raw material of following parts by weight it is prepared from: istradefylline: 25-45 part, puerarin: 12-18 part,
Starch: 6-11 part, low-substituted hydroxypropyl cellulose: 2-8 part, magnesium stearate: 4-5 part, antioxidant: 3-6 part, mannitol: 3-5
Part, micropowder silica gel: 3-9 part, chitin: 4-8 part, sodium alginate: 3-5 part, lactose: 6-8 part.
Preferably, the raw material of following parts by weight it is prepared from: istradefylline: 25 parts, puerarin: 14 parts, starch: 6
Part, low-substituted hydroxypropyl cellulose: 3 parts, magnesium stearate: 4 parts, antioxidant: 3 parts, mannitol: 3 parts, micropowder silica gel: 3 parts, first
Shell element: 4 parts, sodium alginate: 4 parts, lactose: 6 parts.
Preferably, the raw material of following parts by weight it is prepared from: istradefylline: 30 parts, puerarin: 12 parts, starch: 10
Part, low-substituted hydroxypropyl cellulose: 5 parts, magnesium stearate: 4 parts, antioxidant: 3 parts, mannitol: 3 parts, micropowder silica gel: 4 parts, first
Shell element: 6 parts, sodium alginate: 3 parts, lactose: 6 parts.
Preferably, described pharmaceutical composition is oral formulations.
Preferably, described oral formulations is its tablet, slow-release tablet agent, capsule, granule.
The method have the benefit that
The invention provides and a kind of treat the most Parkinsonian new medicine of neurodegenerative diseases and treatment
Method, it has broken neurodegenerative diseases particularly parkinson disease clinical treatment must use the gold rule of levodopa, can
Think that the most Parkinsonian treatment provides a kind of new medication to select.
Detailed description of the invention
For making the purpose of the embodiment of the present invention, technical scheme and advantage clearer, below in conjunction with the enforcement of the present invention
Example, is clearly and completely described the technical scheme in the embodiment of the present invention.Based on the embodiment in the present invention, this area
The every other embodiment that those of ordinary skill is obtained under not making creative work premise, broadly falls into present invention protection
Scope.
Embodiment 1:
A kind of pharmaceutical composition containing istradefylline, is prepared from by the raw material of following parts by weight: istradefylline: 20
Part, puerarin: 10 parts, starch: 5 parts, low-substituted hydroxypropyl cellulose: 1 part, magnesium stearate: 2 parts, antioxidant: 2 parts, manna
Alcohol: 3 parts, micropowder silica gel: 2 parts, chitin: 2 parts, sodium alginate: 2 parts, lactose: 3 parts；
Preparation technology: weigh the istradefylline of recipe quantity, puerarin, starch, low-substituted hydroxypropyl cellulose, stearic acid
Magnesium, antioxidant, mannitol, micropowder silica gel, chitin, sodium alginate, lactose mix homogeneously.Separately take 60% ethanol of Sq,
Being incorporated in mixed-powder, soft material processed after mix homogeneously, pelletized by 16 mesh sieves, less than 60 DEG C are dried.Use after completing after drying
18 mesh sieves carry out granulate, sift out the fine powder in dry granular, the magnesium stearate mixing with sieving, and are mixed evenly with dry granule the most again,
Tabletting, to obtain final product.
Embodiment 2:
A kind of pharmaceutical composition containing istradefylline, is prepared from by the raw material of following parts by weight: istradefylline: 50
Part, puerarin: 20 parts, starch: 12 parts, low-substituted hydroxypropyl cellulose: 9 parts, magnesium stearate: 6 parts, antioxidant: 8 parts, manna
Alcohol: 5 parts, micropowder silica gel: 10 parts, chitin: 10 parts, sodium alginate: 8 parts, lactose: 10 parts；
Preparation technology: weigh the istradefylline of recipe quantity, puerarin, starch, low-substituted hydroxypropyl cellulose, stearic acid
Magnesium, antioxidant, mannitol, micropowder silica gel, chitin, sodium alginate, lactose mix homogeneously.Separately take 60% ethanol of Sq,
Being incorporated in mixed-powder, soft material processed after mix homogeneously, pelletized by 16 mesh sieves, less than 60 DEG C are dried.Use after completing after drying
18 mesh sieves carry out granulate, sift out the fine powder in dry granular, the magnesium stearate mixing with sieving, and are mixed evenly with dry granule the most again,
Tabletting, to obtain final product.
Embodiment 3:
A kind of pharmaceutical composition containing istradefylline, is prepared from by the raw material of following parts by weight: istradefylline: 25
Part, puerarin: 12 parts, starch: 6 parts, low-substituted hydroxypropyl cellulose: 2 parts, magnesium stearate: 4 parts, antioxidant: 3 parts, manna
Alcohol: 3 parts, micropowder silica gel: 3 parts, chitin: 4 parts, sodium alginate: 3 parts, lactose: 6 parts；
Preparation technology: weigh the istradefylline of recipe quantity, puerarin, starch, low-substituted hydroxypropyl cellulose, stearic acid
Magnesium, antioxidant, mannitol, micropowder silica gel, chitin, sodium alginate, lactose mix homogeneously.Separately take 60% ethanol of Sq,
Being incorporated in mixed-powder, soft material processed after mix homogeneously, pelletized by 16 mesh sieves, less than 60 DEG C are dried.Use after completing after drying
18 mesh sieves carry out granulate, sift out the fine powder in dry granular, the magnesium stearate mixing with sieving, and are mixed evenly with dry granule the most again,
Tabletting, to obtain final product.
Embodiment 4:
A kind of pharmaceutical composition containing istradefylline, is prepared from by the raw material of following parts by weight: istradefylline: 45
Part, puerarin: 18 parts, starch: 11 parts, low-substituted hydroxypropyl cellulose: 8 parts, magnesium stearate: 5 parts, antioxidant: 6 parts, manna
Alcohol: 5 parts, micropowder silica gel: 9 parts, chitin: 8 parts, sodium alginate: 5 parts, lactose: 8 parts；
Preparation technology: weigh the istradefylline of recipe quantity, puerarin, starch, low-substituted hydroxypropyl cellulose, stearic acid
Magnesium, antioxidant, mannitol, micropowder silica gel, chitin, sodium alginate, lactose mix homogeneously.Separately take 60% ethanol of Sq,
Being incorporated in mixed-powder, soft material processed after mix homogeneously, pelletized by 16 mesh sieves, less than 60 DEG C are dried.Use after completing after drying
18 mesh sieves carry out granulate, sift out the fine powder in dry granular, the magnesium stearate mixing with sieving, and are mixed evenly with dry granule the most again,
Tabletting, to obtain final product.
Embodiment 5:
A kind of pharmaceutical composition containing istradefylline, is prepared from by the raw material of following parts by weight: istradefylline: 25
Part, puerarin: 14 parts, starch: 6 parts, low-substituted hydroxypropyl cellulose: 3 parts, magnesium stearate: 4 parts, antioxidant: 3 parts, manna
Alcohol: 3 parts, micropowder silica gel: 3 parts, chitin: 4 parts, sodium alginate: 4 parts, lactose: 6 parts；
Preparation technology: weigh the istradefylline of recipe quantity, puerarin, starch, low-substituted hydroxypropyl cellulose, stearic acid
Magnesium, antioxidant, mannitol, micropowder silica gel, chitin, sodium alginate, lactose mix homogeneously.Separately take 60% ethanol of Sq,
Being incorporated in mixed-powder, soft material processed after mix homogeneously, pelletized by 16 mesh sieves, less than 60 DEG C are dried.Use after completing after drying
18 mesh sieves carry out granulate, sift out the fine powder in dry granular, the magnesium stearate mixing with sieving, and are mixed evenly with dry granule the most again,
Tabletting, to obtain final product.
Embodiment 6:
A kind of pharmaceutical composition containing istradefylline, is prepared from by the raw material of following parts by weight: istradefylline: 30
Part, puerarin: 12 parts, starch: 10 parts, low-substituted hydroxypropyl cellulose: 5 parts, magnesium stearate: 4 parts, antioxidant: 3 parts, manna
Alcohol: 3 parts, micropowder silica gel: 4 parts, chitin: 6 parts, sodium alginate: 3 parts, lactose: 6 parts；
Preparation technology: weigh the istradefylline of recipe quantity, puerarin, starch, low-substituted hydroxypropyl cellulose, stearic acid
Magnesium, antioxidant, mannitol, micropowder silica gel, chitin, sodium alginate, lactose mix homogeneously.Separately take 60% ethanol of Sq,
Being incorporated in mixed-powder, soft material processed after mix homogeneously, pelletized by 16 mesh sieves, less than 60 DEG C are dried.Use after completing after drying
18 mesh sieves carry out granulate, sift out the fine powder in dry granular, the magnesium stearate mixing with sieving, and are mixed evenly with dry granule the most again,
Tabletting, to obtain final product.
Above example only in order to technical scheme to be described, is not intended to limit；Although with reference to previous embodiment
The present invention is described in detail, it will be understood by those within the art that: it still can be to aforementioned each enforcement
Technical scheme described in example is modified, or wherein portion of techniques feature is carried out equivalent；And these amendment or
Replace, do not make the essence of appropriate technical solution depart from the spirit and scope of various embodiments of the present invention technical scheme.
Claims (6)
1. the pharmaceutical composition containing istradefylline, it is characterised in that be prepared from by the raw material of following parts by weight: she
Bent theophylline: 20-50 part, puerarin: 10-20 part, starch: 5-12 part, low-substituted hydroxypropyl cellulose: 1-9 part, magnesium stearate:
2-6 part, antioxidant: 2-8 part, mannitol: 3-5 part, micropowder silica gel: 2-10 part, chitin: 2-10 part, sodium alginate: 2-8 part,
Lactose: 3-10 part.
2. the pharmaceutical composition containing istradefylline as claimed in claim 1, it is characterised in that former by following parts by weight
Material is prepared from: istradefylline: 25-45 part, puerarin: 12-18 part, starch: 6-11 part, low-substituted hydroxypropyl cellulose: 2-8
Part, magnesium stearate: 4-5 part, antioxidant: 3-6 part, mannitol: 3-5 part, micropowder silica gel: 3-9 part, chitin: 4-8 part, Sargassum
Acid sodium: 3-5 part, lactose: 6-8 part.
3. the pharmaceutical composition containing istradefylline as claimed in claim 2, it is characterised in that former by following parts by weight
Material is prepared from: istradefylline: 25 parts, puerarin: 14 parts, starch: 6 parts, low-substituted hydroxypropyl cellulose: 3 parts, stearic acid
Magnesium: 4 parts, antioxidant: 3 parts, mannitol: 3 parts, micropowder silica gel: 3 parts, chitin: 4 parts, sodium alginate: 4 parts, lactose: 6 parts.
4. the pharmaceutical composition containing istradefylline as claimed in claim 2, it is characterised in that former by following parts by weight
Material is prepared from: istradefylline: 30 parts, puerarin: 12 parts, starch: 10 parts, low-substituted hydroxypropyl cellulose: 5 parts, stearic acid
Magnesium: 4 parts, antioxidant: 3 parts, mannitol: 3 parts, micropowder silica gel: 4 parts, chitin: 6 parts, sodium alginate: 3 parts, lactose: 6 parts.
5. the pharmaceutical composition containing istradefylline as claimed in claim 1, it is characterised in that described pharmaceutical composition is
Oral formulations.
6. the pharmaceutical composition containing istradefylline as claimed in claim 1, it is characterised in that described oral formulations is it
Tablet, slow-release tablet agent, capsule, granule.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610794463.9A CN106214652A (en) | 2016-08-31 | 2016-08-31 | A kind of pharmaceutical composition containing istradefylline |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610794463.9A CN106214652A (en) | 2016-08-31 | 2016-08-31 | A kind of pharmaceutical composition containing istradefylline |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN106214652A true CN106214652A (en) | 2016-12-14 |
Family
ID=58075477
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201610794463.9A Pending CN106214652A (en) | 2016-08-31 | 2016-08-31 | A kind of pharmaceutical composition containing istradefylline |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2020186190A (en) * | 2019-05-13 | 2020-11-19 | 東和薬品株式会社 | Istradefylline preparation |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104321057A (en) * | 2012-04-20 | 2015-01-28 | Ucb医药有限公司 | Methods for treating parkinson's disease |
| CN104814963A (en) * | 2015-03-24 | 2015-08-05 | 南京昂谷医药科技有限公司 | Pharmaceutical composition containing istradefylline and application thereof |
-
2016
- 2016-08-31 CN CN201610794463.9A patent/CN106214652A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104321057A (en) * | 2012-04-20 | 2015-01-28 | Ucb医药有限公司 | Methods for treating parkinson's disease |
| CN104814963A (en) * | 2015-03-24 | 2015-08-05 | 南京昂谷医药科技有限公司 | Pharmaceutical composition containing istradefylline and application thereof |
Non-Patent Citations (1)
| Title |
|---|
| 李兴泰等: "伊曲茶碱合成工艺改进", 《药学研究》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2020186190A (en) * | 2019-05-13 | 2020-11-19 | 東和薬品株式会社 | Istradefylline preparation |
| JP7382737B2 (en) | 2019-05-13 | 2023-11-17 | 東和薬品株式会社 | istradefylline preparation |
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Application publication date: 20161214 |