CN101766565A - Oral liquid preparation with levo-oxiracetam as active component - Google Patents
Oral liquid preparation with levo-oxiracetam as active component Download PDFInfo
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- CN101766565A CN101766565A CN200810246821A CN200810246821A CN101766565A CN 101766565 A CN101766565 A CN 101766565A CN 200810246821 A CN200810246821 A CN 200810246821A CN 200810246821 A CN200810246821 A CN 200810246821A CN 101766565 A CN101766565 A CN 101766565A
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Abstract
The invention relates to an oral liquid preparation with levo-oxiracetam as an active component. The levo-oxiracetam or salt or a purified hydrate thereof is adopted as the medicinal active component, and accessories that can be accepted in terms of pharmacy are added, so as to prepare the oral liquid preparation. The form of the preparation includes oral solution and syrup. The levo-oxiracetam or the salt or the purified hydrate thereof is adopted as raw materials and some accessories of specific categories and in specific proportion are added, so as to prepare and develop the oral liquid preparation according to the technical method shown in the patent.
Description
Technical field
The present invention relates to a kind of is the oral liquid of active component with left-handed oxiracetam or its salt or its purified hydrate, comprises injectable powder, bulk capacity injection (more than the 50ml), small-volume injection (20ml is following), oral solution and syrup.Belong to medical technical field.
Background technology
Nootropics (the left-handed oxiracetam of nootropic) claims that again the left-handed oxiracetam of brain activin (cereboactive drug) is a kind of promotion study, the novel medicine for central nervous system of memory reinforcing.Nootropics requires selection in cerebral cortex, has to select to activate, protect and promote the feature that the injured nerve cell function recovers.Their above-mentioned effect that different with other neurologic agents a bit is is by reticular system or olfactory bulb, but directly acts on cortex.Neither influence behavior, also do not have calm excitation, so such medicine caused people's extensive concern and interest, the demand of such medicine has also been grown with each passing day.
Oxiracetam (oxiracetam) is a kind of synthetic hydroxy-amino-butyric acid (BABOB) cyclic derivatives; only act on the central nervous system; mainly be distributed in cerebral cortex, Hippocampus; the functional rehabilitation that activation, protection or promotion neurocyte are arranged; improve disturbance of intelligence patient's memory and learning functionality; and medicine itself does not have direct vasoactive, does not have the central excitation effect yet, is a kind of persistent facilitation to the influence of ability of learning and memory.The mechanism result of study shows, oxiracetam can promote the synthetic of phosphatidylcholine and PHOSPHATIDYL ETHANOLAMINE, promotes the brain metabolism, improves the stimulation of blood brain barrier to special nervus centralis road, improve the ratio of ATP/ADP in the brain, make the synthetic increase of protein and nucleic acid in the brain.
This medicine went on the market in Italy in 1987, and the dosage form of listing is a tablet, 800mg; Capsule, 800mg; Injection, 1g/5ml.At present domestic have only oxiracetam capsule and injection listing, and used main active is racemic modification.And we find after deliberation, and left-handed oxiracetam and racemic modification relatively have better therapeutic and malicious attached effect still less.Left-handed its molecular formula of oxiracetam configuration and molecular weight are:
Molecular formula: C6H10N2O3 molecular weight: 158.16
Structural formula:
The pharmacodynamics activity of the left-handed oxiracetam preparation of the present invention is better than the oxiracetam racemic modification, and pharmacology's toxicity is then low than oxiracetam racemic modification, and steady quality, controlled, and is safe and effective.
Summary of the invention
Having the purpose of this invention is to provide a kind of is the oral liquid of active component with left-handed oxiracetam or its salt or its hydrate.It is characterized in that it is to be active component with left-handed oxiracetam or its salt or its hydrate, the pharmaceutical formulation that forms with acceptable accessories.Its dosage form comprises oral solution and syrup.
Above-mentioned oral liquid is characterized in that, oral solution and syrup specification are 3%-30%, are preferably 5%-20%.
Above-mentioned oral liquid is characterized in that, described pharmaceutically acceptable pharmaceutic adjuvant comprises one or more in pH regulator agent, antioxidant, correctives, antiseptic, coloring agent, the intercalating agent.
Above-mentioned oral liquid, it is characterized in that, described pH regulator agent is the water solublity regulator, can be in hydrochloric acid, phosphoric acid, acetic acid, sodium acetate, citric acid, disodium citrate, citric acid trisodium, sodium citrate, citric acid monohydrate, Monopotassium citrate, sodium carbonate, sodium bicarbonate, potassium bicarbonate, sodium hydroxide, potassium hydroxide, phosphate, dihydric phosphate, hydrophosphate, tartaric acid, tartrate, biatrate, aminoacid and the salt thereof one or more.
Above-mentioned oral liquid is characterized in that, described antioxidant can be one or more in sulfurous acid, sulphite, bisulfites, pyrosulfite, thiosulfate, gallic acid and salt cysteine, ascorbic acid and the salt thereof.
Above-mentioned oral liquid, it is characterized in that described correctives includes but are not limited to steviosin, sorbitol, mannitol, maltose alcohol, glycyrrhizin, stem tea element, Sodium Cyclamate, flavoring banana essence, grape essence, cacao essence, flavoring pineapple essence, orange flavor, honey peach essence, apple essence, Herba Menthae essence, strawberry essence, Fructus Foeniculi, vanillin, Fructus Citri Limoniae essence, cherry essence or rose essence.
Above-mentioned oral liquid is characterized in that, described antiseptic comprises but is not limited only to parabens, benzoic acid and salt thereof, sorbic acid and salt thereof, benzalkonium bromide, benzalkonium chloride, chlorhexidine acetate, Oleum Eucalypti, Oleum Cinnamomi, Oleum menthae.
Above-mentioned oral solution, it is characterized in that described oral solution preparation technology is as follows: get partial purification water, add the principal agent dissolving, add antioxidant, correctives, antiseptic, coloring agent (necessary words), intercalating agent (necessary words) again, regulate pH at last to prescribed limit.
Above-mentioned syrup, it is characterized in that, described syrup preparation technology is as follows: get partial purification water, add the principal agent dissolving, add antioxidant, correctives (necessary words), antiseptic, coloring agent (necessary words), intercalating agent (necessary words) again, regulate pH at last to prescribed limit, add simple syrup to full dose and get final product.
Described a kind of be the oral liquid of active component with left-handed oxiracetam, it is characterized in that described intercalating agent can be one or more in sodium ethylene diamine tetracetate, calcium disodium edathamil, Ca-EDTA, citric acid and salt thereof, glycine and the salt thereof.
The specific embodiment
Come the present invention done further specifying by following example, comprise but be not restricted to following example.
Embodiment 1: left-handed oxiracetam oral administration solution
Prescription:
Preparation method:
Get purified water 3500ml, add the left-handed oxiracetam of recipe quantity, stirring and dissolving, add aspartame, essence and the sodium benzoate of recipe quantity, make dissolving, regulating pH value with citric acid soln and liquor sodii citratis is 3-6, add purified water to total amount, intermediate detects.After the intermediate detection was qualified, microporous filter membrane filtered, and is sub-packed in the oral liquid bottle, and specification is 4%, seals, and gets final product.
Embodiment 2: left-handed oxiracetam oral administration solution
Prescription:
Preparation method:
Get purified water 3500ml, the left-handed oxiracetam that adds recipe quantity, stirring and dissolving is got ethanol, adds the oxybenzene formic acid and the propyl ester of recipe quantity, make dissolving, add in the medicinal liquid, add the sucralose and the essence of recipe quantity, regulating pH value with citric acid soln and liquor sodii citratis is 3-6, add purified water to total amount, intermediate detects.After the intermediate detection was qualified, the microporous filter membrane fine straining was sub-packed in the oral liquid bottle, and specification is 8%, seals, and gets final product.
Embodiment 3: left-handed oxiracetam oral administration solution
Prescription:
Preparation method:
Get purified water 3500ml, add the vitamin C stirring and dissolving, add the left-handed oxiracetam of recipe quantity, stirring and dissolving adds sucralose, essence and propyl hydroxybenzoate, makes dissolving, regulating pH value with sodium hydroxide solution is 3-6, adds purified water to total amount, and intermediate detects.After the intermediate detection was qualified, the microporous filter membrane fine straining was sub-packed in the oral liquid bottle, and specification is 8%, seals, and gets final product.
Embodiment 4: left-handed oxiracetam oral administration solution
Prescription:
Preparation method:
Get purified water 3500ml, add the left-handed oxiracetam of recipe quantity, stirring and dissolving, add essence, potassium sorbate and the aspartame of recipe quantity, make dissolving, regulating pH value with potassium dihydrogen phosphate and disodium phosphate soln is 3-6, add purified water to total amount, intermediate detects.After the intermediate detection was qualified, the microporous filter membrane fine straining was sub-packed in the oral liquid bottle, and specification is 8%, seals, and gets final product.
Embodiment 5: left-handed oxiracetam syrup
Prescription:
Preparation method:
Get purified water 2000ml, add the left-handed oxiracetam of recipe quantity, stirring and dissolving, the essence and the sodium benzoate of adding recipe quantity, make dissolving, regulating pH value with citric acid soln and liquor sodii citratis is 3-6, adds purified water to 2500ml, filter, add simple syrup to full dose, intermediate detects.After the intermediate detection is qualified, be sub-packed in the oral liquid bottle, specification is 4%, seals, and gets final product.
Embodiment 6: left-handed oxiracetam syrup
Prescription:
Preparation method:
Get purified water 2000ml, the left-handed oxiracetam that adds recipe quantity, stirring and dissolving, the oxybenzene formic acid and the propyl ester of adding recipe quantity make dissolving, add in the medicinal liquid, the essence that adds recipe quantity, regulating pH value with citric acid soln and liquor sodii citratis is 3-6, adds purified water to 2500ml, filter, add simple syrup to full dose.After the intermediate detection is qualified, be sub-packed in the oral liquid bottle, specification is 8%, seals, and gets final product.
Embodiment 7: left-handed oxiracetam syrup
Prescription:
Preparation method:
Get purified water 2000ml, add the vitamin C stirring and dissolving, the left-handed oxiracetam that adds recipe quantity, stirring and dissolving adds essence and propyl hydroxybenzoate, make dissolving, regulating pH value with sodium hydroxide solution is 3-6, adds purified water to 2500ml, the microporous filter membrane fine straining, add simple syrup to full dose, intermediate detects.After the intermediate detection is qualified, be sub-packed in the oral liquid bottle, specification is 8%, seals, and gets final product.
Embodiment 8: left-handed oxiracetam syrup
Prescription:
Preparation method:
Get purified water 2000ml, the left-handed oxiracetam that adds recipe quantity, stirring and dissolving, add essence, the potassium sorbate of recipe quantity, make dissolving, regulating pH value with potassium dihydrogen phosphate and disodium phosphate soln is 3-6, add purified water to 2500ml, the microporous filter membrane fine straining adds simple syrup to full dose, and intermediate detects.After the intermediate detection is qualified, be sub-packed in the oral liquid bottle, specification is 10%, seals, and gets final product.
Embodiment 9: left-handed oxiracetam syrup
Prescription:
Preparation method:
Get purified water 1500ml, the propylene glycol that adds recipe quantity makes mix homogeneously, adds the left-handed oxiracetam of recipe quantity, stirring and dissolving adds the recipe quantity Fructus Citri Limoniae essence, stirring and dissolving, get the ethanol of recipe quantity, add methyl hydroxybenzoate and propyl ester, stirring and dissolving, join in the drug solution, regulating pH value with sodium hydrogen phosphate and potassium dihydrogen phosphate is 3-6, adds purified water to 2500ml, filters, add simple syrup again to 5000ml, intermediate detects.Intermediate detect qualified after, fill in the syrup bottle, every bottle of 100ml, specification is 20%, seals, and gets final product.
Claims (10)
1. one kind is the oral liquid of active component with left-handed oxiracetam, it is characterized in that containing the left-handed oxiracetam of active component or its salt or its purified hydrate and pharmaceutically acceptable pharmaceutic adjuvant.
2. oral liquid according to claim 1 is characterized in that, oral solution and syrup specification are 3%-30%, are preferably 5%-20%.
3. according to the described oral liquid of claim 1, its dosage form comprises oral solution and syrup.
4. according to the described oral liquid of claim 1, it is characterized in that described pharmaceutically acceptable pharmaceutic adjuvant comprises one or more in pH regulator agent, antioxidant, correctives, antiseptic, coloring agent, the intercalating agent.
5. preparation according to claim 4, it is characterized in that, described pH regulator agent is the water solublity regulator, can be in hydrochloric acid, phosphoric acid, acetic acid, sodium acetate, citric acid, disodium citrate, citric acid trisodium, sodium citrate, citric acid monohydrate, Monopotassium citrate, sodium carbonate, sodium bicarbonate, potassium bicarbonate, sodium hydroxide, potassium hydroxide, phosphate, dihydric phosphate, hydrophosphate, tartaric acid, tartrate, biatrate, aminoacid and the salt thereof one or more.
6. preparation according to claim 4 is characterized in that, described antioxidant can be one or more in sulfurous acid, sulphite, bisulfites, pyrosulfite, thiosulfate, gallic acid and salt cysteine, ascorbic acid and the salt thereof.
7. preparation according to claim 4, it is characterized in that described correctives includes but are not limited to steviosin, sorbitol, mannitol, maltose alcohol, glycyrrhizin, stem tea element, Sodium Cyclamate, flavoring banana essence, grape essence, cacao essence, flavoring pineapple essence, orange flavor, honey peach essence, apple essence, Herba Menthae essence, strawberry essence, Fructus Foeniculi, vanillin, Fructus Citri Limoniae essence, cherry essence or rose essence.
8. preparation according to claim 4, it is characterized in that described antiseptic comprises but is not limited only to parabens, benzoic acid and salt thereof, sorbic acid and salt thereof, benzalkonium bromide, benzalkonium chloride, chlorhexidine acetate, Oleum Eucalypti, Oleum Cinnamomi, Oleum menthae.
9. oral solution according to claim 3, it is characterized in that, described oral solution preparation technology is as follows: get partial purification water, add the principal agent dissolving, add antioxidant, correctives, antiseptic, coloring agent (necessary words), intercalating agent (necessary words) again, regulate pH at last to prescribed limit.
10. syrup according to claim 3, it is characterized in that, described syrup preparation technology is as follows: get partial purification water, add the principal agent dissolving, add antioxidant, correctives (necessary words), antiseptic, coloring agent (necessary words), intercalating agent (necessary words) again, regulate pH at last to prescribed limit, add simple syrup to full dose and get final product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200810246821A CN101766565A (en) | 2008-12-31 | 2008-12-31 | Oral liquid preparation with levo-oxiracetam as active component |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200810246821A CN101766565A (en) | 2008-12-31 | 2008-12-31 | Oral liquid preparation with levo-oxiracetam as active component |
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| CN101766565A true CN101766565A (en) | 2010-07-07 |
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| CN200810246821A Pending CN101766565A (en) | 2008-12-31 | 2008-12-31 | Oral liquid preparation with levo-oxiracetam as active component |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102871959A (en) * | 2012-05-31 | 2013-01-16 | 北京阜康仁生物制药科技有限公司 | Stable (S)-4-hydroxy-2-oxo-1-pyrrolidine acetamide pharmaceutical composition |
| CN104370792A (en) * | 2013-08-13 | 2015-02-25 | 天津汉瑞药业有限公司 | Oxiracetam compound |
| CN104800151A (en) * | 2014-01-24 | 2015-07-29 | 重庆东泽医药科技发展有限公司 | Oxiracetam oral liquid and preparation method thereof |
| CN106236697A (en) * | 2016-08-08 | 2016-12-21 | 王春艳 | Flavoured syrups of discomfort mouthfeel and preparation method thereof when improving oral drug preparation |
| CN107303266A (en) * | 2016-04-18 | 2017-10-31 | 重庆润泽医药有限公司 | Levo-oxiracetam parenteral solution and preparation method thereof |
-
2008
- 2008-12-31 CN CN200810246821A patent/CN101766565A/en active Pending
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102871959A (en) * | 2012-05-31 | 2013-01-16 | 北京阜康仁生物制药科技有限公司 | Stable (S)-4-hydroxy-2-oxo-1-pyrrolidine acetamide pharmaceutical composition |
| CN104370792A (en) * | 2013-08-13 | 2015-02-25 | 天津汉瑞药业有限公司 | Oxiracetam compound |
| CN104370792B (en) * | 2013-08-13 | 2016-09-07 | 天津汉瑞药业有限公司 | Oxiracetam compound |
| CN104800151A (en) * | 2014-01-24 | 2015-07-29 | 重庆东泽医药科技发展有限公司 | Oxiracetam oral liquid and preparation method thereof |
| CN107303266A (en) * | 2016-04-18 | 2017-10-31 | 重庆润泽医药有限公司 | Levo-oxiracetam parenteral solution and preparation method thereof |
| CN107303266B (en) * | 2016-04-18 | 2020-09-08 | 重庆润泽医药有限公司 | Levo-oxiracetam injection and preparation method thereof |
| CN106236697A (en) * | 2016-08-08 | 2016-12-21 | 王春艳 | Flavoured syrups of discomfort mouthfeel and preparation method thereof when improving oral drug preparation |
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Open date: 20100707 |