CN101766597A - Injection preparation with levo-oxiracetam as active component - Google Patents
Injection preparation with levo-oxiracetam as active component Download PDFInfo
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- CN101766597A CN101766597A CN200910131292A CN200910131292A CN101766597A CN 101766597 A CN101766597 A CN 101766597A CN 200910131292 A CN200910131292 A CN 200910131292A CN 200910131292 A CN200910131292 A CN 200910131292A CN 101766597 A CN101766597 A CN 101766597A
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Abstract
The invention relates to an injection 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 an injection combination. The form of the preparation includes powder injection, high-capacity injection (more than 50ml) and low-capacity injection (less than 20ml). 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 preparation for intravenous injection according to the technical method shown in the patent.
Description
Technical field
The present invention relates to a kind of is the injection preparation 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 (nootropic oxiracetam) claims that again brain activin (cereboactive drug) oxiracetam 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 injection preparation of active component with the left-handed oxiracetam of higher bioactive nootropics 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, but the pharmaceutical formulation of the stable injection made from acceptable accessories.Advance one and say, the active component of this preparation is left-handed oxiracetam but not its racemic modification.This dosage form can be injectable powder, bulk capacity injection (more than the 50ml), small-volume injection (20ml is following).
Described is the injection preparation of active component with left-handed oxiracetam, and wherein the injectable powder specification is 0.5g-8.0g, is preferably 1.0-4.0g; Bulk capacity injection (more than the 50ml) specification is 0.5%-20%, is preferably 2%-10%; Small-volume injection (20ml is following) specification is 5%-30%, is preferably 10%-20%.
Described injectable powder, bulk capacity injection (more than the 50ml), small-volume injection (20ml is following) is characterized in that described pharmaceutically acceptable pharmaceutic adjuvant comprises one or more in pharmaceutical carrier, isoosmotic adjusting agent, pH regulator agent, antioxidant, the intercalating agent.
Above-mentioned a kind of be the injectable powder of active component with left-handed oxiracetam, it is characterized in that described pharmaceutical carrier can be one or more in mannitol, glucose, sorbitol, sodium chloride, dextran, sucrose, lactose, gelatin hydrolysate, trehalose, nicotiamide, citric acid, citrate, pantothenic acid and salt thereof, agedoite, aminoacid and amino acid salts, cholate, cyclodextrin and the derivant thereof.
Above-mentioned a kind of be the injection preparation of active component with left-handed oxiracetam, it is characterized in that, described pH regulator agent is the water solublity regulator, can be in hydrochloric acid, phosphoric acid, hydrobromic acid, formic acid, acetic acid, potassium acetate, sodium acetate, boric acid, Borax, 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, biatrate, aminoacid and the salt thereof one or more.
Above-mentioned a kind of be the injection preparation of active component with left-handed oxiracetam, it is characterized in that, described isoosmotic adjusting agent can be a sodium chloride, one or more in glucose, glycerol, propylene glycol, mannitol, glucose, sorbitol, dextran, nicotiamide, citric acid, citrate, pantothenic acid and salt thereof, agedoite, aminoacid and the amino acid salts.
Above-mentioned a kind of be the injection preparation of active component with left-handed oxiracetam, it is characterized in that described antioxidant can be one or more in sulfurous acid, sulphite, bisulfites, pyrosulfite, thiosulfate, thioglycerin, gallic acid and salt cysteine, ascorbic acid and the salt thereof.
Above-mentioned a kind of be the injectable powder of active component with left-handed oxiracetam, it is characterized in that, preparation technology is for getting part water for injection, add left-handed oxiracetam stirring and dissolving, add pharmaceutical carrier, if necessary, can add an amount of antioxidant and chelating agen, with pH regulator agent adjust pH, add an amount of needle-use activated carbon, medicinal liquid is heated to 50 ℃-70 ℃, stir, behind the filtering decarbonization, add the injection water to total amount, adopt 0.22 μ m microporous filter membrane fine straining again, fill is in cillin bottle, cillin bottle is placed in the freezer dryer lyophilization.
Above-mentioned a kind of be bulk capacity injection (more than the 50ml), the small-volume injection (20ml is following) of active component with left-handed oxiracetam, it is characterized in that, its preparation technology is for getting part water for injection, add left-handed oxiracetam stirring and dissolving, if necessary, can add an amount of antioxidant and chelating agen, with pH regulator agent adjust pH, add an amount of needle-use activated carbon, medicinal liquid is heated to 50 ℃-70 ℃, stir, behind the filtering decarbonization, add the injection water, adopt 0.22 μ m microporous filter membrane fine straining again to total amount, fill is in ampoule bottle, and sterilization gets final product.
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 freeze-dried powder
Prescription:
Preparation method:
Get water for injection 3000ml, the left-handed oxiracetam stirring and dissolving that adds recipe quantity, the mannitol that adds recipe quantity, with hydrochloric acid solution and sodium hydroxide solution adjust pH 3.0-6.0, add 0.1% needle-use activated carbon by amount of preparation, medicinal liquid is heated to about 60 ℃, stir 20min, behind the filtering decarbonization, add the injection water to total amount, intermediate detects.After the intermediate detection is qualified, adopt 0.22 μ m microporous filter membrane fine straining again, fill places cillin bottle in the freezer dryer lyophilization in cillin bottle.
The lyophilization condition is :-40 ℃ of pre-freezes 4 hours, and the phase I is warming up to-10 ℃, 3 hours time, vacuum drying 22 hours, second stage heats up in 1 hour from-10 ℃～30 ℃, and is incubated 4 hours.
After the lyophilization, press rubber stopper, roll aluminium-plastic cap.
The lyophilization curve is seen accompanying drawing 1
Embodiment 2: left-handed oxiracetam freeze-dried powder
Prescription:
Preparation method:
Get water for injection 3000ml, the left-handed oxiracetam stirring and dissolving that adds recipe quantity, with glycine solution and sodium hydroxide solution adjust pH 3.0-6.0, add 0.1% needle-use activated carbon by amount of preparation, medicinal liquid is heated to about 60 ℃, stir 20min, behind the filtering decarbonization, add the aseptic injection lactose, stirring and dissolving, add the injection water to total amount, intermediate detects.After the intermediate detection is qualified, adopt 0.22 μ m microporous filter membrane fine straining again, fill places cillin bottle in the freezer dryer lyophilization in cillin bottle.
The lyophilization condition is 1 consistent with prescription, is-40 ℃ of pre-freezes 4 hours, and the phase I is warming up to-10 ℃, 3 hours time, and vacuum drying 22 hours, second stage heats up in 1 hour from-10 ℃～30 ℃, and is incubated 4 hours.
After the lyophilization, press rubber stopper, roll aluminium-plastic cap.
The lyophilization curve is seen accompanying drawing 1
Embodiment 3: left-handed oxiracetam freeze-dried powder
Prescription:
Preparation method:
Get water for injection 1250ml, the left-handed oxiracetam stirring and dissolving that adds recipe quantity, the dextran that adds recipe quantity, with citric acid soln and liquor sodii citratis adjust pH 3.0-6.0, add 0.1% needle-use activated carbon by amount of preparation, medicinal liquid is heated to about 60 ℃, stir 20min, behind the filtering decarbonization, add the injection water to total amount, intermediate detects.After the intermediate detection is qualified, adopt 0.22 μ m microporous filter membrane fine straining again, fill places cillin bottle in the freezer dryer lyophilization in cillin bottle.
The lyophilization condition :-40 ℃ of pre-freezes 4 hours, the phase I is warming up to-10 ℃, 2 hours time, vacuum drying 20 hours, second stage heats up in 1 hour from-10 ℃～30 ℃, and is incubated 4 hours.
After the lyophilization, press rubber stopper, roll aluminium-plastic cap.
The lyophilization curve is seen accompanying drawing 2
Embodiment 4: left-handed oxiracetam liquid drugs injection
Prescription:
Preparation method:
Get water for injection 3000ml, add sodium ethylene diamine tetracetate calcium stirring and dissolving, add the left-handed oxiracetam of recipe quantity, stirring and dissolving, add the sodium sulfite of recipe quantity, make dissolving, regulating pH value with hydrochloric acid solution and sodium hydroxide solution is 3-6, add 0.1% needle-use activated carbon by amount of preparation, medicinal liquid is heated to about 60 ℃, stirs 20min, behind the filtering decarbonization, add the injection water to total amount, intermediate detects.Intermediate detect qualified after, adopt 0.22 μ m microporous filter membrane fine straining again, fill is in ampoule bottle, every bottle of 5ml or 10ml seal, moist heat sterilization gets final product.
Embodiment 5: left-handed oxiracetam liquid drugs injection
Prescription:
Preparation method:
Get water for injection 3000ml, add sodium ethylene diamine tetracetate calcium stirring and dissolving, the left-handed oxiracetam that adds recipe quantity, stirring and dissolving, regulating pH value with citric acid soln and liquor sodii citratis is 3-6, add 0.1% needle-use activated carbon by amount of preparation, medicinal liquid is heated to about 60 ℃, stirs 20min, behind the filtering decarbonization, add the injection water to total amount, intermediate detects.Intermediate detect qualified after, adopt 0.22 μ m microporous filter membrane fine straining again, fill is in ampoule bottle, every bottle of 5ml or 10ml seal, moist heat sterilization gets final product.
Embodiment 6: left-handed oxiracetam liquid drugs injection
Prescription:
Preparation method:
Get water for injection 3000ml, add the disodiumedetate stirring and dissolving, add the left-handed oxiracetam of recipe quantity, stirring and dissolving, add the sodium sulfite of recipe quantity, make dissolving, regulating pH value with tartaric acid solution and sodium hydroxide solution is 3-6, add needle-use activated carbon, medicinal liquid is heated to about 60 ℃, stirs 20min, behind the filtering decarbonization, add the injection water to total amount, intermediate detects.Intermediate detect qualified after, adopt 0.22 μ m microporous filter membrane fine straining again, fill is in ampoule bottle, every bottle of 5ml or 10ml seal, moist heat sterilization gets final product.
Embodiment 7: left-handed oxiracetam liquid drugs injection
Prescription:
Preparation method:
Get water for injection 3000ml, add the calcio-disodium edetate stirring and dissolving, the left-handed oxiracetam that adds recipe quantity, stirring and dissolving, regulating pH value with glycine solution and sodium hydroxide solution is 3-6, add 0.1% needle-use activated carbon by amount of preparation, medicinal liquid is heated to about 60 ℃, stirs 20min, behind the filtering decarbonization, add the injection water to total amount, intermediate detects.Intermediate detect qualified after, adopt 0.22 μ m microporous filter membrane fine straining again, fill is in ampoule bottle, every bottle of 5ml or 10ml seal, moist heat sterilization gets final product.
Embodiment 8: left-handed oxiracetam primary infusion
Prescription: every bottle of prescription
Preparation method:
Get water for injection 80ml, add sodium ethylene diamine tetracetate calcium stirring and dissolving, add the left-handed oxiracetam of recipe quantity, stirring and dissolving, add the vitamin C and the sodium chloride of recipe quantity, make dissolving, regulating pH value with hydrochloric acid solution and sodium hydroxide solution is 3-6, add 0.1% needle-use activated carbon by amount of preparation, medicinal liquid is heated to about 60 ℃, stirs 20min, behind the filtering decarbonization, add the injection water to total amount, intermediate detects.After the intermediate detection is qualified, adopt 0.22 μ m microporous filter membrane fine straining again, fill is in infusion bottle, and every bottle of 100ml seals, and moist heat sterilization gets final product.
Embodiment 9: left-handed oxiracetam primary infusion
Prescription: every bottle of prescription
Preparation method:
Get water for injection 80ml, the left-handed oxiracetam that adds recipe quantity, stirring and dissolving, the sodium sulfite and the glucose of adding recipe quantity, make dissolving, regulating pH value with citric acid soln and liquor sodii citratis is 3-6, adds 0.1% needle-use activated carbon by amount of preparation, and medicinal liquid is heated to about 60 ℃, stir 20min, behind the filtering decarbonization, add the injection water to total amount, intermediate detects.After the intermediate detection is qualified, adopt 0.22 μ m microporous filter membrane fine straining again, fill is in infusion bottle, and every bottle of 100ml seals, and moist heat sterilization gets final product.
Claims (10)
1. one kind is the injection preparation 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. according to the described injection preparation of claim 1, its dosage form comprises injectable powder, bulk capacity injection (more than the 50ml), small-volume injection (20ml is following).
3. injectable powder according to claim 2, its specification is 0.5g-8.0g, is preferably 1.0-4.0g; Bulk capacity injection (more than the 50ml) specification is 0.5%-20%, is preferably 2%-10%; Small-volume injection (20ml is following) specification is 5%-30%, is preferably 10%-20%.
4. injectable powder according to claim 2, bulk capacity injection (more than the 50ml), small-volume injection (20ml is following) is characterized in that described pharmaceutically acceptable pharmaceutic adjuvant comprises one or more in pharmaceutical carrier, isoosmotic adjusting agent, pH regulator agent, antioxidant, the intercalating agent.
5. preparation according to claim 4, it is characterized in that described pharmaceutical carrier can be one or more in mannitol, glucose, sorbitol, sodium chloride, dextran, sucrose, lactose, gelatin hydrolysate, trehalose, nicotiamide, citric acid, citrate, pantothenic acid and salt thereof, agedoite, aminoacid and amino acid salts, cholate, cyclodextrin and the derivant thereof.
6. 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, hydrobromic acid, formic acid, acetic acid, potassium acetate, sodium acetate, boric acid, Borax, 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, biatrate, aminoacid and the salt thereof one or more.
7. preparation according to claim 4, it is characterized in that, described isoosmotic adjusting agent can be a sodium chloride, one or more in glucose, glycerol, propylene glycol, mannitol, glucose, sorbitol, dextran, nicotiamide, citric acid, citrate, pantothenic acid and salt thereof, agedoite, aminoacid and the amino acid salts.
8. preparation according to claim 4, it is characterized in that described antioxidant can be one or more in sulfurous acid, sulphite, bisulfites, pyrosulfite, thiosulfate, thioglycerin, gallic acid and salt cysteine, ascorbic acid and the salt thereof.
9. preparation according to claim 2, it is characterized in that, described preparation of injection is for getting part water for injection, add left-handed oxiracetam stirring and dissolving, add pharmaceutical carrier, if necessary, can add an amount of antioxidant and chelating agen, with pH regulator agent adjust pH, add an amount of needle-use activated carbon, medicinal liquid is heated to 50 ℃-70 ℃, stir, behind the filtering decarbonization, add the injection water to total amount, adopt 0.22 μ m microporous filter membrane fine straining again, fill is in cillin bottle, cillin bottle is placed in the freezer dryer lyophilization.
10. preparation according to claim 2, it is characterized in that, described bulk capacity injection (more than the 50ml), small-volume injection (20ml is following) preparation technology are for getting part water for injection, add left-handed oxiracetam stirring and dissolving, if necessary, can add an amount of antioxidant and chelating agen, with pH regulator agent adjust pH, add an amount of needle-use activated carbon, medicinal liquid is heated to 50 ℃-70 ℃, stir, behind the filtering decarbonization, add the injection water, adopt 0.22 μ m microporous filter membrane fine straining again to total amount, fill is in ampoule bottle, and sterilization gets final product.
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| CN200910131292A CN101766597A (en) | 2008-12-31 | 2009-04-14 | Injection preparation with levo-oxiracetam as active component |
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| CN200810246822.2 | 2008-12-31 | ||
| CN200910131292A CN101766597A (en) | 2008-12-31 | 2009-04-14 | Injection preparation with levo-oxiracetam as active component |
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