CN108926528A - Liquid oral compositions containing Amisulpride resinate - Google Patents
Liquid oral compositions containing Amisulpride resinate Download PDFInfo
- Publication number
- CN108926528A CN108926528A CN201710379941.4A CN201710379941A CN108926528A CN 108926528 A CN108926528 A CN 108926528A CN 201710379941 A CN201710379941 A CN 201710379941A CN 108926528 A CN108926528 A CN 108926528A
- Authority
- CN
- China
- Prior art keywords
- amisulpride
- pharmaceutical composition
- weak
- exchange resin
- amberlite irp
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- 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
-
- 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
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or 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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Inorganic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
Contain Amisulpride-weak-acid cation-exchange resin Amberlite IRP-88 complex taken liquid medicine composition this application involves a kind of.
Description
Technical field
This application involves the liquid oral compositions containing Amisulpride resinate, belong to pharmaceutical technology field.
Background technique
Amisulpride is a kind of atypical psychotolytic drug, for treating class paranoiac's progressive schizophrenia
Disease, can be used for treating schizoid defect state, remaining spiritual disease-process and with blunt holddown.Ammonia
The sulphur willowstone tablet form that often every tablet amounts are 100,200 and 400 milligrams is administered orally（Vidal, edition2003,
Solianmonograph page 1736 and 1738）.However during acute psychotic episode, the oral daily agent of Amisulpride
Amount will often be increased to 1200 mg/days, therefore, must daily several pieces tablets using the patient that Amisulpride is treated.
Due to the special pathological state of patient, and the taste of active constituent Amisulpride is especially bitter, to correctly in accordance with doctor's advice
A large amount of tablets are taken in timing to meet difficulty, and influence the medication compliance of patient, mostly swallow tablet shape currently on the market with oral
Formula sale, therefore the sensory issues of Amisulpride in the urgent need to address and develop a kind of oral solution prescription containing Amisulpride.
Amisulpride slightly soluble in water, but the Fast Stripping of drug is clinically needed, rapid-onset, this requires preparations
The dissolution rate of drug is improved in production using suitable prescription and technique.
Summary of the invention
The object of the present invention is to provide a kind of liquid oral medicines containing Amisulpride-Amberlite IRP-88 complex
Compositions.
Oral liquid medicine combination of the invention can be prepared with traditional method, for example, can by Amisulpride and
Amberlite IRP-88 is mixed together in aqueous medium, and the usage ratio of IRP-88 and Amisulpride is 1:1-2:1 compared with
To be suitable, wherein using 2:The effect of excellent cover bitter taste can be obtained when 1 ratio.
Acceptable excipient on other drugs, such as dispersing agent such as propylene glycol etc., moisturizer such as glycerol etc. can also be added,
Sweetener such as sorbierite and saccharin sodium etc., buffer citric acid and sodium citrate etc., preservative such as sodium benzoate, Metagin
Ester, ethylparaben, propylben etc., colorant such as sunset yellow etc., flavouring agent such as natural orange etc. and defoaming agent such as silicon oxygen
Alkane etc..
The dosage of buffer, which preferably controls, can obtain pH4-6, best pH4.5-6.0.
Amisulpride oral administration solution produced by the present invention, property are stablized, convenient to take, good mouthfeel.Below by way of specific
Embodiment invention is further explained.These embodiments are merely illustrative, and are not construed as to of the invention
Limitation.
Specific embodiment
The ratio of 1 Amberlite IRP-88 of embodiment and Amisulpride is 1:1
。
The ratio of 2 Amberlite IRP-88 of embodiment and Amisulpride is 2:1
。
The above embodiment of the present invention be only to clearly illustrate example of the present invention, and not be to the present invention
The restriction of embodiment can also make on the basis of the above description other to those of ordinary skill in the art
Various forms of variations or variation here can not be exhaustive all embodiments, all to belong to technical side of the invention
The obvious changes or variations that case is extended out are still in the scope of protection of the present invention.
Claims (9)
1. a kind of oral drugs group containing Amisulpride weak-acid cation-exchange resin Amberlite IRP-88 complex
Close object.
2. the method for preparing the pharmaceutical composition that claim 1 defines, this method includes by Amisulpride and Subacidity cation
Exchanger resin Amberlite IRP-88 is mixed together in water-bearing media.
3. wherein the molar ratio of weak-acid cation-exchange resin and Amisulpride is 1 according to method for claim 2:1-
2:1。
4. according to the pharmaceutical composition of claim 1, wherein following one or more additives are added：Thickener, dispersing agent are protected
Humectant, sweetener, buffer, preservative, synthetic coloring matter, flavouring agent and defoaming agent.
5. wherein the dosage of buffer should control the range in pH4.0-6.0 according to the pharmaceutical composition of claim 4.
6. form is unit dosage according to the pharmaceutical composition of any one of claim 1,4 or 5.
7. according to the pharmaceutical composition of claim 6, wherein the content of the Amisulpride in the unit dosage be 100mg,
200mg or 400mg.
8. according to the pharmaceutical composition of any one of claim 1,4 or 5, wherein the Amisulpride is in half water of hydrochloride
Hydrate form.
9. as what claim 1 defined cooperates containing Amisulpride-weak-acid cation-exchange resin Amberlite IRP-88
The taken liquid medicine composition of object, for treating class paranoiac's process schizophrenia, can be used for treatment essence in manufacture
The defect state of refreshing Split disease, remaining spiritual disease-process and with blunt holddown drug in terms of purposes.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710379941.4A CN108926528A (en) | 2017-05-25 | 2017-05-25 | Liquid oral compositions containing Amisulpride resinate |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710379941.4A CN108926528A (en) | 2017-05-25 | 2017-05-25 | Liquid oral compositions containing Amisulpride resinate |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN108926528A true CN108926528A (en) | 2018-12-04 |
Family
ID=64450036
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201710379941.4A Pending CN108926528A (en) | 2017-05-25 | 2017-05-25 | Liquid oral compositions containing Amisulpride resinate |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN108926528A (en) |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1140411A (en) * | 1994-02-03 | 1997-01-15 | 史密丝克莱恩比彻姆有限公司 | Oral liquid compositions contg. paroxetine resinate |
| WO2012096929A2 (en) * | 2011-01-11 | 2012-07-19 | Sunovion Pharmaceuticals Inc. | Heteroaryl compounds and methods of use thereof |
| CN102600132A (en) * | 2012-03-13 | 2012-07-25 | 齐鲁制药有限公司 | Oral preparation containing amisulpride |
| WO2014104414A1 (en) * | 2012-12-28 | 2014-07-03 | Askat Inc. | Salts and crystal forms |
-
2017
- 2017-05-25 CN CN201710379941.4A patent/CN108926528A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1140411A (en) * | 1994-02-03 | 1997-01-15 | 史密丝克莱恩比彻姆有限公司 | Oral liquid compositions contg. paroxetine resinate |
| WO2012096929A2 (en) * | 2011-01-11 | 2012-07-19 | Sunovion Pharmaceuticals Inc. | Heteroaryl compounds and methods of use thereof |
| CN102600132A (en) * | 2012-03-13 | 2012-07-25 | 齐鲁制药有限公司 | Oral preparation containing amisulpride |
| WO2014104414A1 (en) * | 2012-12-28 | 2014-07-03 | Askat Inc. | Salts and crystal forms |
Non-Patent Citations (2)
| Title |
|---|
| BERGEMANN N等: "Plasma amisulpride levels in schizophrenia or schizoaffective disorder", 《EUROPEAN NEUROPSYCHOPHARMACOLOGY》 * |
| I.A. DAN等: "P-1223 - Schizophrenia: switching from any oral antypsychotics to RLAI, a good solution to avoid relapses", 《EUROPEAN PSYCHIATRY》 * |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| WD01 | Invention patent application deemed withdrawn after publication | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20181204 |