CN101829135A - Injection preparation with citicoline sodium and inosine as active ingredients, and application thereof - Google Patents
Injection preparation with citicoline sodium and inosine as active ingredients, and application thereof Download PDFInfo
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- CN101829135A CN101829135A CN201010004838A CN201010004838A CN101829135A CN 101829135 A CN101829135 A CN 101829135A CN 201010004838 A CN201010004838 A CN 201010004838A CN 201010004838 A CN201010004838 A CN 201010004838A CN 101829135 A CN101829135 A CN 101829135A
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Abstract
The invention relates to an injection preparation with citicoline sodium and inosine as active ingredients, and application thereof. The injection preparation is prepared from citicoline sodium and inosine as pharmaceutical active ingredients, and pharmaceutically acceptable auxiliary materials. The preparation comprises powder injections, large-volume injections (more than 50ml) and small-volume injections (less than 20ml). The citicoline sodium and the inosine are used as raw materials, a certain type and proportion of the auxiliary materials are added, and then the oral preparation is prepared by the technical method. The preparation can be used for treating diseases of cerebrovascular hysfunction, craniocerebral injury, dementia, Parkinson's syndromes, heart diseases and the like.
Description
Technical field
The present invention relates to a kind of is the injection preparation of active component with C14H25N4NaO11P2 and inosine, comprises injectable powder, bulk capacity injection (more than the 50ml), small-volume injection (20ml is following).Belong to medical technical field.
Background technology
C14H25N4NaO11P2 is the sodium salt of nucleoside derivates citicoline, chemical name is a Cytidine Diphosphate Choline sodium, it is a necessary coenzyme during lecithin synthesizes, can strengthen reticular formation of brain stem especially with consciousness closely-related reticular formation of brain stem function, impel the damaged cell functional rehabilitation, can also strengthen cerebral blood flow in addition, activate and improve metabolism, be mainly used in function and disturbance of consciousness that central nervous system injury causes clinically.
Inosine can directly see through cell and enter somatic cell, activation pyruvate oxidation enzyme, thereby make outer cell under the mental retardation anaerobic condition continue to carry out smoothly metabolism, and participate in human energy metabolism with proteinic synthetic, the present clinical illness such as cardiac disorder, central serous chorioretinopathy, optic atrophy such as leukocyte or thrombocytopenia, various acute and chronic liver disease, pulmonary heart disease that are used for.
Summary of the invention
The patent of the preparation application that inosine and C14H25N4NaO11P2 are made has 95104482.6,95105972.6, and also added procaine in 95105972.6 preparations, but the preparation in these two patents all is used for the treatment of the disease of optic nerve, administering mode is the retrobulbar injection administration, be very different with clinical application range of the present invention, the specification of administering mode and medicine more has a great difference.
The purpose of this invention is to provide a kind of injection preparation, it is to be active component with C14H25N4NaO11P2 and inosine.It is characterized in that, it is to be the injection preparation of active component with C14H25N4NaO11P2 and inosine, and preparation stability is still good under bigger specification, and this ejection preparation can be used for cerebrovascular function obstacle, craniocerebral injury, treatment of diseases such as dementia, parkinson's syndrome, cardiac disorder.
Described injection preparation, its dosage form comprise injectable powder, bulk capacity injection (more than the 50ml), small-volume injection (20ml is following).
Described is the injection preparation of active component with C14H25N4NaO11P2 and inosine, and wherein the C14H25N4NaO11P2 specification is 100-800mg in the injectable powder, and the inosine specification is 50-1000mg; Bulk capacity injection (more than the 50ml) C14H25N4NaO11P2 specification is 0.1%-2%, and the inosine specification is 0.01%-2%; Small-volume injection (20ml is following) specification is 0.5%-40%, and the inosine specification is 0.25%-50%.Described injectable powder, bulk capacity injection (more than the 50ml), small-volume injection (20ml is following) is characterized in that the described pharmaceutic adjuvant that pharmaceutically also can add an amount of acceptance 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 C14H25N4NaO11P2 and inosine, 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 C14H25N4NaO11P2 and inosine, 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 C14H25N4NaO11P2 and inosine, 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 C14H25N4NaO11P2 and inosine, 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 C14H25N4NaO11P2 and inosine, it is characterized in that, the preparation technology of lyophilized powder is for getting part water for injection in the injectable powder, add C14H25N4NaO11P2 and inosine 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 C14H25N4NaO11P2 and inosine, it is characterized in that, its preparation technology is for getting part water for injection, add C14H25N4NaO11P2 and inosine 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 C14H25N4NaO11P2 and inosine freeze-dried powder
Prescription:
Amounts of components
C14H25N4NaO11P2 250g
Inosine 200g
Mannitol 200g
0.5% hydrochloric acid solution is an amount of
0.5% sodium hydroxide solution is an amount of
Water for injection adds to 1500ml
Make 1000 bottles altogether
Preparation method:
Get water for injection 1000ml, the C14H25N4NaO11P2 and the inosine stirring and dissolving that add recipe quantity, the mannitol that adds recipe quantity, with hydrochloric acid solution and sodium hydroxide solution adjust pH 5.5-7.5, add an amount of needle-use activated carbon by amount of preparation, medicinal liquid is heated to about 50 ℃-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: C14H25N4NaO11P2 and inosine aseptic powder injection
Prescription:
Amounts of components
C14H25N4NaO11P2 (aseptic powder) 300g
Inosine (aseptic powder) 300g
Make 1000 bottles altogether
Preparation method:
Take by weighing two kinds of aseptic powder by recipe quantity, mixed 20 minutes at hundred grades of clean areas V-type blender with degerming, mix homogeneously, in the hundred grade clean area packing of relative humidity below 40%, every bottle of citicoline and inosine are respectively 300mg.The control moisture content of finished products is below 2.5%.Get final product.
Embodiment 3: C14H25N4NaO11P2 and inosine liquid drugs injection
Prescription:
Amounts of components
C14H25N4NaO11P2 250g
Inosine 300g
Sodium sulfite 1g
Sodium ethylene diamine tetracetate calcium 1g
1% hydrochloric acid solution is an amount of
1% sodium hydroxide solution is an amount of
Water for injection adds to 5000ml
Make 1000 bottles/500 bottles altogether
Preparation method:
Get water for injection 3000ml, add sodium ethylene diamine tetracetate calcium stirring and dissolving, add the C14H25N4NaO11P2 and the inosine 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 5.5-7.5, add an amount of needle-use activated carbon, medicinal liquid is heated to about 50 ℃-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 4: C14H25N4NaO11P2 and inosine liquid drugs injection
Prescription:
Amounts of components
C14H25N4NaO11P2 500g
Inosine 500g
5% citric acid is an amount of
5% trisodium citrate is an amount of
Water for injection adds to 5000ml
Make 1000 bottles/500 bottles altogether
Preparation method:
Get water for injection 3000ml, the C14H25N4NaO11P2 and the inosine that add recipe quantity, stirring and dissolving, regulating pH value with citric acid soln and liquor sodii citratis is 5.5-7.5, adds an amount of needle-use activated carbon, and medicinal liquid is heated to about 50 ℃-60 ℃, stir 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: C14H25N4NaO11P2 and inosine primary infusion
Prescription: every bottle of prescription
Amounts of components
C14H25N4NaO11P2 0.5g
Inosine 0.5g
Calcio-disodium edetate 0.01g
Sodium chloride 0.75g
0.5% hydrochloric acid solution is an amount of
0.5% sodium hydroxide solution is an amount of
Water for injection adds to 100ml
Preparation method:
Get water for injection 80ml, add sodium ethylene diamine tetracetate calcium stirring and dissolving, add the C14H25N4NaO11P2 and the inosine of recipe quantity, stirring and dissolving, add recipe quantity sodium chloride, make dissolving, regulating pH value with hydrochloric acid solution and sodium hydroxide solution is 5.5-7.5, add an amount of needle-use activated carbon, medicinal liquid is heated to about 50 ℃-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 6: C14H25N4NaO11P2 and inosine primary infusion
Prescription: every bottle of prescription
Amounts of components
C14H25N4NaO11P2 0.25g
Inosine 0.30g
Sodium sulfite 0.005g
Sodium chloride 0.35g
0.5M citric acid soln is an amount of
0.5M liquor sodii citratis is an amount of
Water for injection adds to 50ml
Preparation method:
Get water for injection 40ml, the C14H25N4NaO11P2 and the inosine that add recipe quantity, stirring and dissolving, the sodium sulfite and the sodium chloride of adding recipe quantity, make dissolving, regulating pH value with citric acid soln and liquor sodii citratis is 5.5-7.5, adds needle-use activated carbon, 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 50ml seals, and moist heat sterilization gets final product.
Embodiment 7 C14H25N4NaO11P2s and inosine freeze-dried powder
Prescription:
Amounts of components
C14H25N4NaO11P2 250g
Inosine 100g
0.5% hydrochloric acid solution is an amount of
0.5% sodium hydroxide solution is an amount of
Water for injection adds to 1500ml
Make 1000 bottles altogether
Preparation method:
Get water for injection 1000ml, the C14H25N4NaO11P2 and the inosine stirring and dissolving that add recipe quantity, with hydrochloric acid solution and sodium hydroxide solution adjust pH 5.5-7.5, add an amount of needle-use activated carbon by amount of preparation, medicinal liquid is heated to about 50 ℃-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 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.
Embodiment 8: the drug effect demonstration test
The Wistar rat, body weight 250-300g, male and female half and half.After carrying out the adaptability raising, be divided into 4 groups at random:
1, blank group: inject same dosage water for injection
2, model group: ip ALCl3 50mg/kg
3, lyophilized powder group: ip ALCl3 50mg/kg, frozen powder for injection pin (embodiment 1) simultaneously
4, liquid drugs injection group: ip ALCl3 50mg/kg, inject liquid drugs injection (embodiment 3) simultaneously
Each organizes equal successive administration 30 days, measures the activities in rats ability, and rat is put into the circular open center of being decorated with grid, observes the walking grid number in the rat 2 minutes, respectively organizes difference, and the result is as follows:
As seen, behind injection ALCl3, cranial nerve there is certain damaging action, and injects this product simultaneously, can obviously improve the cranial nerve repair ability of rat.
Description of drawings:
Accompanying drawing 1: compound recipe C14H25N4NaO11P2 inosine freeze-drying curve figure.
Claims (10)
1. one kind is the injection preparation of active component with C14H25N4NaO11P2 and inosine, it is characterized in that containing active component C14H25N4NaO11P2 and inosine 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 C14H25N4NaO11P2 specification is 100-800mg, the inosine specification is 50-1000mg; Bulk capacity injection (more than the 50ml) C14H25N4NaO11P2 specification is 0.1%-2%, and the inosine specification is 0.01%-2%; Small-volume injection (20ml is following) specification is 0.5%-40%, and the inosine specification is 0.25%-50%.
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, sodium chloride, dextran, sucrose, lactose, gelatin hydrolysate, trehalose, nicotiamide, agedoite, aminoacid and amino acid salts, cyclodextrin and the derivant thereof.
6. 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.
7. 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.
8. injectable powder preparation according to claim 2, it is characterized in that, the preparation technology of lyophilized powder is for getting part water for injection in the described injectable powder, add C14H25N4NaO11P2 and inosine stirring and dissolving, if necessary, can add an amount of pharmaceutical carrier, antioxidant and chelating agen,, add an amount of needle-use activated carbon with pH regulator agent adjust pH, 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 places cillin bottle in the freezer dryer lyophilization in cillin bottle.
9. 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 C14H25N4NaO11P2 and inosine 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 bottle, and sterilization gets final product.
10. the described preparation of claim 1 can be used for cerebrovascular function obstacle, craniocerebral injury, treatment of diseases such as dementia, parkinson's syndrome, cardiac disorder.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201010004838A CN101829135A (en) | 2009-03-09 | 2010-01-17 | Injection preparation with citicoline sodium and inosine as active ingredients, and application thereof |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910079741.2 | 2009-03-09 | ||
| CN201010004838A CN101829135A (en) | 2009-03-09 | 2010-01-17 | Injection preparation with citicoline sodium and inosine as active ingredients, and application thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101829135A true CN101829135A (en) | 2010-09-15 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201010004838A Pending CN101829135A (en) | 2009-03-09 | 2010-01-17 | Injection preparation with citicoline sodium and inosine as active ingredients, and application thereof |
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| CN (1) | CN101829135A (en) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102462659A (en) * | 2010-11-17 | 2012-05-23 | 华北制药股份有限公司 | Citicoline sodium injection and preparation method thereof |
| ITMI20121223A1 (en) * | 2012-07-13 | 2014-01-14 | Gregorio Fabio De | NEW PHARMACOLOGICAL COMPOSITION INCLUDING CITICOLINE IN COMBINATION WITH GLYCEROL AND / OR ACETAZOLAMIDE |
| CN104523739A (en) * | 2014-12-30 | 2015-04-22 | 山东新时代药业有限公司 | Citicoline sodium lyophilized preparation for injection and preparation method of cticoline sodium lyophilized preparation |
| CN106727296A (en) * | 2016-12-31 | 2017-05-31 | 辰欣药业股份有限公司 | A kind of Citicoline sodium injection and preparation method thereof |
-
2010
- 2010-01-17 CN CN201010004838A patent/CN101829135A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102462659A (en) * | 2010-11-17 | 2012-05-23 | 华北制药股份有限公司 | Citicoline sodium injection and preparation method thereof |
| CN102462659B (en) * | 2010-11-17 | 2013-04-24 | 华北制药股份有限公司 | Citicoline sodium injection and preparation method thereof |
| ITMI20121223A1 (en) * | 2012-07-13 | 2014-01-14 | Gregorio Fabio De | NEW PHARMACOLOGICAL COMPOSITION INCLUDING CITICOLINE IN COMBINATION WITH GLYCEROL AND / OR ACETAZOLAMIDE |
| CN104523739A (en) * | 2014-12-30 | 2015-04-22 | 山东新时代药业有限公司 | Citicoline sodium lyophilized preparation for injection and preparation method of cticoline sodium lyophilized preparation |
| CN106727296A (en) * | 2016-12-31 | 2017-05-31 | 辰欣药业股份有限公司 | A kind of Citicoline sodium injection and preparation method thereof |
| CN106727296B (en) * | 2016-12-31 | 2020-06-02 | 辰欣药业股份有限公司 | Citicoline sodium injection and preparation method thereof |
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Open date: 20100915 |