CN105412039A - Frovatriptan succinate controlled-release tablet and preparation method thereof - Google Patents
Frovatriptan succinate controlled-release tablet and preparation method thereof Download PDFInfo
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- CN105412039A CN105412039A CN201510886953.7A CN201510886953A CN105412039A CN 105412039 A CN105412039 A CN 105412039A CN 201510886953 A CN201510886953 A CN 201510886953A CN 105412039 A CN105412039 A CN 105412039A
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- China
- Prior art keywords
- controlled
- succinic acid
- controlled release
- release
- acid furan
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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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
-
- 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
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
-
- 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
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
-
- 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
Abstract
The invention discloses a frovatriptan succinate controlled-release tablet and a preparation method thereof. The frovatriptan succinate controlled-release tablet consists of a medicine-containing tablet core and a coating film covering outside the tablet core, wherein the medicine-containing tablet core contains frovatriptan succinate, a filling agent and sodium chloride; the coating film contains a controlled-release material, a plasticizer and a pore-forming agent; and during preparing, the coating film covers the medicine-containing tablet core, so that the controlled-release tablet is obtained. The controlled-release tablet disclosed by the invention has the characteristics that the controlled-release tablet includes a quick-release part and a controlled-release part, and as the controlled-release tablet enters a human body, the quick-release part rapidly releases so as to achieve a certain blood concentration while the controlled-release part slowly releases to keep the certain blood concentration; therefore, a good efficacy is achieved, and meanwhile, the side effects of drugs are effectively avoided. The controlled-release tablet disclosed by the invention has the advantages of rapid dissolution, quick absorption, high bioavailability, good stability, convenient mediation and the like, so that side effects on patients caused by medication are relieved; and the preparation process is simple, the quality of the prepared product is stable and the preparation method is applicable to large-scale production.
Description
Technical field
The present invention relates to a kind of technical field of chemical medicine controlled release tablet, particularly relate to the smooth controlled release tablet of a kind of succinic acid furan Luo Qu, the invention still further relates to the preparation method of this controlled release tablet.
Background technology
Migraine is clinical modal primary headache type; clinical with ictal middle severe, sample of beating headache for main manifestations; headache mostly is inclined side; general lasting 4-72 hour; can with Nausea and vomiting; light, Sound stimulat or daily routines all can increase the weight of headache, and quiet environment, rest can alleviate headache.Migraine is a kind of common chronic forms vascular illness, and a lot of disease is in child and adolescence, and the young and middle-aged phase reaches onset peak, and women is common, and in crowd, prevalence is 5%-10%, often has genetic background.
Migraine is primary in central nervous system function disorder, and Vascular change is secondary, disorderly with neurotransmitter numerous in blood and cerebrospinal fluid during migraine.Someone also proposes neurogenic inflammation and causes migraine, thinks that cause the neurogenic inflammation of cerebral dura mater and institute's Supply Organization thereof, its main manifestations is plasma protein extravasation and vasodilation by stimulating nervi trigeminus peripheral vessels fiber to discharge vasoactive peptide.Recent research finds that the NO be present in central nervous system plays an important role to the transmission of pain stimulation at maincenter.But what receive much attention in recent years is trigemino-vascular reflex theory, nerve, blood vessel and neurotransmitter triplicity is got up, and is unified in trigeminal vascular system.This hypothesis is thought by stimulating some specific region in brain, causes the outer vasodilation of cranium and internal carotid artery vasodilation, produce headache through series reaction.In the process, the 5-HT of intra platelet free calcium enhances the sensitivity of vascular receptor, plays an important role to the generation of pain.Some the migrainous clinical manifestations of this hypothesis well explain, were used for the treatment of migraine provided rational explanation for some have both acted on medicine that nervus centralis nervous system also acts on peripheral nervous system.
Succinic acid furan sieve Qu Tan is the in vitro cerebral vasoconstriction agent of multiple species (comprising people).Arterial Rings In Vitro blood vessel observes the activity of succinic acid furan sieve Qu Tan as vasoconstrictor, and compares with sumatriptan.On people's middle cerebral artery, succinic acid furan sieve Qu Tan is a kind of partial agonist (relative to 5-HT), and effect is at least 5 times of sumatriptan.Succinic acid furan sieve Qu Tan is a kind of full agonists to people's basilar artery, and its effect is about 8.3 times of sumatriptan.The effect of succinic acid furan sieve Qu Tan to rabbit basilar artery and cat brain medium-sized artery is 23 and 3 times of sumatriptan respectively.Rabbit, compared with 5-HT, succinic acid furan sieve Qu Tan is a kind of partial agonist, and sumatriptan is a kind of full agonist.Cat, relative to 5-HT, succinic acid furan sieve Qu Tan and sumatriptan are all partial agonists.
Summary of the invention
Current China market mainly contains oral tablet, the tablet of succinic acid furan sieve Qu Tan, and injection, although oral tablet and tablet taking convenience, but be subject to the impact of the factor such as disintegrate, drug release, assimilation effect is undesirable, although and injection curative effect is fast, carries, uses all inconveniences, and succinic acid furan sieve Qu Tan is also unstable in aqueous.
In recent years, the research and development of controlled release tablet come into one's own gradually, and controlled release tablet is that release by time effects constant release, can not obtain more stable blood drug level by the release of zero-order rule, and " peak valley " fluctuation is less, until basic absorption is complete.Controlled release tablet can make patient reduce medicining times, administration frequency reduces half than ordinary preparation, facilitate patient's Long-term taking medicine, significantly improve the compliance of patient consumes, by the control of drug release rate, medicine slowly absorbs with suitable speed, make blood drug level steady, avoid or reduce peak valley phenomenon, contribute to the toxic and side effects and the raising curative effect that reduce medicine, reduce medicine at gastrointestinal local concentration, reduce zest.
In order to overcome the deficiencies in the prior art, the present invention to adjuvant screening and process optimization, provides the smooth controlled release tablet of a kind of succinic acid furan Luo Qu, this controlled release tablet steady quality by lot of experiments, and drug release is even, and preparation technology is simple.
for achieving the above object, the technical scheme taked of the present invention:
(1) the smooth controlled release tablet of a kind of succinic acid furan Luo Qu, by pastille label be wrapped in its outer coatings rete and form, described pastille label comprises succinic acid furan sieve Qu Tan, filler and osmotic pressure active substance, and described coating rete comprises controlled-release material, plasticizer and porogen.
(2) according to the controlled release tablet of succinic acid furan sieve Qu Tan according to claim 1, it is characterized in that controlled release portion is made up of rapid release and controlled release two parts, wherein immediate release section is containing the smooth 0.5 ~ 2mg of succinic acid furan Luo Qu, and controlled release portion is containing the smooth 1.5 ~ 5mg of succinic acid furan Luo Qu.
(3) according to the controlled release tablet of claim 2, wherein immediate release section is containing the smooth 1.0mg of succinic acid furan Luo Qu, and controlled release portion is containing the smooth 2.91mg of succinic acid furan Luo Qu.
(4) according to the smooth controlled release tablet of succinic acid furan Luo Qu according to claim 1, it is characterized in that: described filler is lactose; Described osmotic pressure active substance is sodium chloride; Described controlled-release material is at least one in cellulose acetate, methylcellulose and polyvinyl alcohol; Described plasticizer is triethyl citrate; Described porogen is dextrin.
(5) according to the smooth controlled release tablet of succinic acid furan Luo Qu according to claim 4, it is characterized in that: described controlled-release material is cellulose acetate and methylcellulose.
(6) according to the smooth controlled release tablet of succinic acid furan Luo Qu according to claim 4, it is characterized in that: the weight ratio of described cellulose acetate and described methylcellulose is 2:1.
the smooth controlled release tablet of succinic acid furan Luo Qu of the present invention can be prepared as follows:
(1) get succinic acid furan sieve Qu Tan, filler mixs homogeneously with osmotic pressure active substance, with 85% ethanol for binding agent, make soft material, 18 ~ 24 mesh sieves are granulated, and tabletting after dry, obtains pastille label;
(2) with 80% dissolve with ethanol controlled-release material, plasticizer and porogen, make controlled release coat liquid;
(3) the controlled release coat liquid prepared evenly is sprayed at the pastille wicking surface that step (1) prepares, after drying, obtains the smooth controlled release tablet of succinic acid furan Luo Qu.
the smooth controlled release tablet of succinic acid furan Luo Qu of the present invention has following beneficial effect:
(1) after controlled release tablet of the present invention enters human body, immediate release section discharges rapidly, reaches certain blood drug level, and controlled release portion slow releasing maintains certain blood drug level, not only can play good drug effect and effectively can avoid drug side effect again.
(2) the present invention has the advantages such as stripping is rapid, absorption is fast, bioavailability is high, good stability, taking convenience, thus the side effect that minimizing drug administration brings to patient, and preparation technology is simple, products obtained therefrom steady quality, applicable large-scale production.
Detailed description of the invention
Be further described the specific embodiment of the present invention below in conjunction with embodiment, advantage and disadvantage of the present invention will be more clear along with description.But these embodiments are only exemplary, do not form any restriction to scope of the present invention.It will be understood by those skilled in the art that and can modify to the details of technical solution of the present invention and form or replace down without departing from the spirit and scope of the present invention, but these amendments and replacement all fall within the scope of protection of the present invention.
Embodiment 1
Prescription 1(is by 1000)
The smooth 3.91g of succinic acid furan Luo Qu
Lactose 627g
Sodium chloride 50g
Cellulose acetate 80g
Triethyl citrate 30g
Dextrin 30g
Method for making:
(1) get succinic acid furan sieve Qu Tan, filler mixs homogeneously with osmotic pressure active substance, with 85% ethanol for binding agent, make soft material, 18 ~ 24 mesh sieves are granulated, and tabletting after dry, obtains pastille label;
(2) with 80% dissolve with ethanol controlled-release material, plasticizer and porogen, make controlled release coat liquid;
(3) the controlled release coat liquid prepared evenly is sprayed at the pastille wicking surface that step (1) prepares, after drying, obtains the smooth controlled release tablet of succinic acid furan Luo Qu.
Embodiment 2
Prescription 2(is by 1000)
The smooth 3.91g of succinic acid furan Luo Qu
Lactose 627g
Sodium chloride 50g
Methylcellulose 80g
Triethyl citrate 30g
Dextrin 30g
Method for making is with embodiment 1.
Embodiment 3
Prescription 3(is by 1000)
The smooth 3.91g of succinic acid furan Luo Qu
Lactose 627g
Sodium chloride 50g
Polyvinyl alcohol 80g
Triethyl citrate 30g
Dextrin 30g
Method for making is with embodiment 1.
Embodiment 4
Prescription 4(is by 1000)
The smooth 3.91g of succinic acid furan Luo Qu
Lactose 627g
Sodium chloride 50g
Cellulose acetate 80g
Methylcellulose 40g
Triethyl citrate 30g
Dextrin 30g
Method for making is with embodiment 1.
Embodiment 5
Prescription 5(is by 1000)
The smooth 3.91g of succinic acid furan Luo Qu
Lactose 627g
Sodium chloride 50g
Cellulose acetate 40g
Polyvinyl alcohol 40g
Triethyl citrate 30g
Dextrin 30g
Method for making is with embodiment 1.
test example 1the preparation of the smooth controlled release tablet of succinic acid furan Luo Qu
The supplementary material of according to the form below, by above-mentioned preparation method, the smooth controlled release tablet of succinic acid furan Luo Qu that each embodiment obtains respectively.Wherein, "/" representative does not use.
test example 2vitro release is tested
Measure according to dissolution and drug release determination method (" Chinese Pharmacopoeia " 2015 editions four general rule 0931 first methods), analogue body digested road condition, temperature controls at 37 DEG C ± 0.5 DEG C, with degassed fresh purified water for release medium, dilute hydrochloric acid (0.001 ~ 0.1mol/L) is used to carry out drug release rate test to the smooth controlled release tablet of succinic acid furan Luo Qu, respectively 1,2,4,6,8,12h sampling, according to ultraviolet visible spectrophotometry (" Chinese Pharmacopoeia " 2015 editions four general rules 0401), measure absorbance, calculate accumulative releasing degree according to standard curve.
Can find out, the smooth controlled release tablet of succinic acid furan Luo Qu obtained by the present invention can constant speed, evenly discharge, the medicine effective blood drug concentration of long period can be maintained, reduce medicining times; Wherein the smooth controlled release tablet of succinic acid furan Luo Qu of embodiment 4 discharged evenly in 12 hours, higher release can be reached at the 12nd hour, illustrate and use cellulose acetate and the succinic acid furan Luo Qu smooth controlled release tablet best results of ethyl cellulose (weight ratio is 2:1) made by controlled-release material, this formula preparation technique is simple, steady quality is reliable, can meet the requirement of industrialized great production.
Claims (7)
1. the smooth controlled release tablet of succinic acid furan Luo Qu, by pastille label be wrapped in its outer coatings rete and form, described pastille label comprises succinic acid furan sieve Qu Tan, filler and osmotic pressure active substance, and described coating rete comprises controlled-release material, plasticizer and porogen.
2. according to the controlled release tablet of succinic acid furan sieve Qu Tan according to claim 1, it is characterized in that controlled release portion is made up of rapid release and controlled release two parts, wherein immediate release section is containing the smooth 0.5 ~ 2mg of succinic acid furan Luo Qu, and controlled release portion is containing the smooth 1.5 ~ 5mg of succinic acid furan Luo Qu.
3. according to the controlled release tablet of claim 2, wherein immediate release section is containing the smooth 1.0mg of succinic acid furan Luo Qu, and controlled release portion is containing the smooth 2.91mg of succinic acid furan Luo Qu.
4. according to the smooth controlled release tablet of succinic acid furan Luo Qu according to claim 1, it is characterized in that: described filler is lactose; Described osmotic pressure active substance is sodium chloride; Described controlled-release material is at least one in cellulose acetate, methylcellulose and polyvinyl alcohol; Described plasticizer is triethyl citrate; Described porogen is dextrin.
5. according to the smooth controlled release tablet of succinic acid furan Luo Qu according to claim 4, it is characterized in that: described controlled-release material is cellulose acetate and methylcellulose.
6. according to the smooth controlled release tablet of succinic acid furan Luo Qu according to claim 4, it is characterized in that: the weight ratio of described microcrystalline Cellulose and described methylcellulose is 2:1.
7. the smooth controlled release tablet of succinic acid furan Luo Qu of the present invention can be prepared as follows:
(1) get succinic acid furan sieve Qu Tan, filler mixs homogeneously with osmotic pressure active substance, with 85% ethanol for binding agent, make soft material, 18 ~ 24 mesh sieves are granulated, and tabletting after dry, obtains pastille label;
(2) with 80% dissolve with ethanol controlled-release material, plasticizer and porogen, make controlled release coat liquid;
(3) the controlled release coat liquid prepared evenly is sprayed at the pastille wicking surface that step (1) prepares, after drying, obtains the smooth controlled release tablet of succinic acid furan Luo Qu.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510886953.7A CN105412039A (en) | 2015-12-07 | 2015-12-07 | Frovatriptan succinate controlled-release tablet and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510886953.7A CN105412039A (en) | 2015-12-07 | 2015-12-07 | Frovatriptan succinate controlled-release tablet and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN105412039A true CN105412039A (en) | 2016-03-23 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510886953.7A Withdrawn CN105412039A (en) | 2015-12-07 | 2015-12-07 | Frovatriptan succinate controlled-release tablet and preparation method thereof |
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| Country | Link |
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| CN (1) | CN105412039A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107496380A (en) * | 2017-08-24 | 2017-12-22 | 青岛正大海尔制药有限公司 | Smooth sustained-release micro-spheres of a kind of butanedioic acid furan Luo Qu and preparation method thereof |
| CN111544404A (en) * | 2020-04-29 | 2020-08-18 | 正大制药（青岛）有限公司 | Dolichocalcitol controlled-release tablet |
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| CN103142539A (en) * | 2013-03-21 | 2013-06-12 | 青岛正大海尔制药有限公司 | Alginic sodium diester controlled-release tablet and preparation method thereof |
| CN103142540A (en) * | 2013-03-21 | 2013-06-12 | 青岛正大海尔制药有限公司 | PGMS (Propylene Glycol Mannate Sulfate) controlled-release tablet and preparation method thereof |
| CN104800184A (en) * | 2015-04-22 | 2015-07-29 | 青岛正大海尔制药有限公司 | Slow-release tablet comprising succinate frovatriptan |
| EP2939663A1 (en) * | 2012-12-31 | 2015-11-04 | Samyang Biopharmaceuticals Corporation | Melt extruded pharmaceutical composition for controlling release, and medicine for oral administration including same |
-
2015
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Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2939663A1 (en) * | 2012-12-31 | 2015-11-04 | Samyang Biopharmaceuticals Corporation | Melt extruded pharmaceutical composition for controlling release, and medicine for oral administration including same |
| CN103142539A (en) * | 2013-03-21 | 2013-06-12 | 青岛正大海尔制药有限公司 | Alginic sodium diester controlled-release tablet and preparation method thereof |
| CN103142540A (en) * | 2013-03-21 | 2013-06-12 | 青岛正大海尔制药有限公司 | PGMS (Propylene Glycol Mannate Sulfate) controlled-release tablet and preparation method thereof |
| CN104800184A (en) * | 2015-04-22 | 2015-07-29 | 青岛正大海尔制药有限公司 | Slow-release tablet comprising succinate frovatriptan |
Non-Patent Citations (3)
| Title |
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| 张婧等: "微孔型渗透泵控释制剂的研究进展", 《中国医院药学杂志》 * |
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| 王效山等主编: "《制药工艺学》", 31 July 2003 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107496380A (en) * | 2017-08-24 | 2017-12-22 | 青岛正大海尔制药有限公司 | Smooth sustained-release micro-spheres of a kind of butanedioic acid furan Luo Qu and preparation method thereof |
| CN107496380B (en) * | 2017-08-24 | 2019-10-01 | 正大制药（青岛）有限公司 | A kind of succinic acid furan Luo Qutan sustained-release micro-spheres and preparation method thereof |
| CN111544404A (en) * | 2020-04-29 | 2020-08-18 | 正大制药（青岛）有限公司 | Dolichocalcitol controlled-release tablet |
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Application publication date: 20160323 |
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