citicoline sodium
cytidine 5'-diphosphocholine sodium salt dihydrate
CAS: 33818-15-4
Molecular Formula: C14H27N4NaO11P2
citicoline sodium - Names and Identifiers
| Name | cytidine 5'-diphosphocholine sodium salt dihydrate |
| Synonyms | citicoline sodium CITICOLINE SODIUM SALT CYTIDINE-5'-DIPHOSPHOCHOLINE, NA CYTIDINE-5'-DIPHOSPHOCHOLINE, SODIUM CYTIDINE 5'-DIPHOSPHOCHOLINE SODIUM SALT CYTIDINE-5'-DIPHOSPHOCHOLINE MONOSODIUM SALT CYTIDINE 5'-DIPHOSPHOCHOLINE SODIUM SALT DIHYDRATE cytidine 5'-diphosphocholine sodium salt dihydrate sodium 5'-O-[({[2-(trimethylammonio)ethoxy]phosphinato}oxy)phosphinato]cytidine P'-[2-(TRIMETHYLAMMONIO)ETHYL]ESTER CYTIDINE 5'-(TRIHYDROGEN DIPHOSPHATE) INNER SALT MONOSODIUM cytidine 5'-(trihydrogen diphosphate) p'-[2-(trimethylammonio)ethyl] ester inner salt monosodium salt cytidine 5'-(trihydrogen diphosphate) p'-(2-(trimethylammonio)ethyl) ester inner salt monosodium salt |
| CAS | 33818-15-4 |
| EINECS | 251-689-1 |
| InChI | InChI=1/C14H26N4O11P2.Na/c1-18(2,3)6-7-26-30(22,23)29-31(24,25)27-8-9-11(19)12(20)13(28-9)17-5-4-10(15)16-14(17)21;/h4-5,9,11-13,19-20H,6-8H2,1-3H3,(H3-,15,16,21,22,23,24,25);/q;+1/p-1/t9-,11-,12-,13-;/m1./s1 |
| InChIKey | YWAFNFGRBBBSPD-OCMLZEEQSA-M |
citicoline sodium - Physico-chemical Properties
| Molecular Formula | C14H27N4NaO11P2 |
| Molar Mass | 512.32 |
| Melting Point | 259-268°C (dec.) |
| Specific Rotation(α) | D20 +12.5° (c = 1.0 in H2O) |
| Water Solubility | Soluble in water (100 mg/ml). |
| Solubility | H2O: 100mg/mL |
| Appearance | solid |
| Color | white |
| Maximum wavelength(λmax) | ['280nm(HCl aq.)(lit.)'] |
| Merck | 13,2343 |
| BRN | 4110040 |
| Storage Condition | -20°C |
| Sensitive | Easily absorbing moisture |
| MDL | MFCD00150508 |
| Use | Central nervous system medications |
| In vitro study | Citicoline is a complex organic molecule composed of ribose, pyrophosphate, cytosine and choline, the main component of phospholipids in cell membranes. Citicoline is water soluble and its oral bioavailability is greater than 90%. Citicoline has no mitogenic and chemotactic effects on hCMEC/D3. However, it significantly enhanced wound healing, spheroid sprouting, and strongly induced the formation of endothelial tubular structures in the basement membrane matrix. Citicoline was able to induce the expression of phosphorylated ERK1/2. It protects hCMEC/D3 from cell damage/apoptosis. Citicoline induces angiogenesis and improves the survival of human brain microvascular endothelial cells through p-ERK1/2 and IRS-1-related pathways. |
| In vivo study | In the transient ischemia model of reperfusion in rats, Citicoline can increase the nerve cell membrane phospholipids, and reduce the accumulation of free fatty acids, and reverse the neurological deficit. The compound can be rapidly metabolized and the metabolites can participate in various biosynthetic pathways and finally be excreted in the form of carbon dioxide. In rodents and dogs, citicoline has no acute and chronic toxic effects. Citicoline may protect ischemic neurons, it has the effect of protecting blood vessels and promoting angiogenesis. |
citicoline sodium - Risk and Safety
| Safety Description | 24/25 - Avoid contact with skin and eyes. |
| WGK Germany | 3 |
| FLUKA BRAND F CODES | 3-10-21 |
| HS Code | 29349990 |
citicoline sodium - Standard
Authoritative Data Verified Data
This product is choline cytidine diphosphate monosodium salt, calculated as dry product, containing citicoline sodium (C14H25N4NaO11P2) not less than 98.0%.
Last Update：2024-01-02 23:10:35
citicoline sodium - Trait
Authoritative Data Verified Data
- This product is white crystal or crystalline powder; Odorless.
- This product is soluble in water, insoluble in ethanol and acetone.
Last Update：2022-01-01 14:18:44
citicoline sodium - Differential diagnosis
Authoritative Data Verified Data
- take about 1 mg of this product, add 3ml of dilute hydrochloric acid and 1ml of bromine test solution, heat it in a water bath for 30 minutes, put it in a ventilated place, and add 3 after bromine is removed, 5-dihydroxytoluene ethanol solution (1-10 ) 0.2ml, and then human ferrous ammonium sulfate hydrochloric acid solution (l-l000 )3ml, water bath heating 20 minutes, the solution is green.
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 1096).
- the product of the aqueous solution of sodium salt identification (1) of the reaction (General 0301).
Last Update：2022-01-01 14:18:45
citicoline sodium - Exam
Authoritative Data Verified Data
pH
take 0.5g of this product, Add 10ml of water to dissolve, and measure according to law (General rule 0631). The pH value should be 6.0~7.5.
clarity and color of solution
take l.Og of this product, add water to dissolve 8ml, and check according to law (General rule 0901 first method and general rule 0902 first method), the solution should be clear and colorless.
chloride
take 0.10g of this product and check it according to law (General rule 0801). Compared with the reference solution made of 0.05% of standard gasification sodium solution, it should not be more concentrated ().
ammonium salt
take 0.20g of this product and check it according to law (General rule 0808). Compared with the reference solution made of 0.05% of standard ammonium chloride solution, it should not be more concentrated ().
Iron Salt
take 0.20g of this product and check it according to law (General rule 0807). Compared with the control solution made of 2.0 ml of standard iron solution, it should not be deeper (0.01%).
phosphate
take 0.10g of this product, Add 10ml of water to dissolve, add 1 ml of ammonium molybdate solution (take lg of ammonium molybdate and dissolve 40ml of 0.5mol/L sulfuric acid solution), l-amino -2-naphthol -4-sulfonic acid test solution 0.5, placed for 5 minutes; With standard phosphorus solution (precision weighing 105g of potassium dihydrogen phosphate dried to constant weight at 0.286°C, put it in a 1000ml measuring flask, add water to dissolve and dilute to scale, shake well, take 10ml immediately before use, put it in a 100ml measuring flask, dilute it to scale with water, shake well. Each 1 ml is equivalent to 20ug of PO4) 0.1% compared with the control solution prepared by the same method, the color should not be darker ().
Related substances
take this product, precision weighing, adding water to dissolve and quantitatively dilute to make a solution containing 2.5mg per lml as a test solution; Take lml for precision measurement and put it in a 500ml measuring flask, dilute to the scale with water, shake well, as a control solution; Take an appropriate amount of the 5 '-cytidine acid reference substance, add water to dissolve and quantitatively dilute to make a solution containing about 7.5ug per 1 ml, as the chromatographic conditions under the content determination item of the reference solution, 10ul of each of the test solution, the control solution and the 5-cytidine acid reference solution are accurately measured and injected into the liquid chromatograph respectively, the chromatogram was recorded to 2.5 times the retention time of the main peak. If there are impurity peaks in the chromatogram of the test solution, the peak area shall be calculated according to the external standard method, and the content of 5-cytidine acid shall not exceed 0.3%; The peak area of other individual impurities shall not be greater than the main peak area of the control solution (0.2% ) , the sum of the peak areas of other impurities shall not be greater than 3.5 times (0.7%) of the main peak area of the control solution.
residual solvent
accurately weigh an appropriate amount of N-propanol and dilute it with water to make a solution containing 500ug per 1 ml as an internal standard solution; Accurately weigh an appropriate amount of methanol, ethanol and acetone and place it in the same measuring flask, prepare solutions containing 450UG, 750ug and 750ug in each lml by quantitative dilution with water as the reference stock solution; Take 5ml of the reference stock solution and 5ml of the internal standard solution in the same 50ml measuring flask, dilute to scale with water, shake, as a reference solution; Weigh 0.75g of this product accurately, put it in a 50ml measuring flask, add 5ml of internal standard solution to dissolve and dilute to scale with water, shake, as a test solution. Take 5.0ml of each of the reference solution and the test solution respectively, place them in the top empty bottle respectively, seal them, and measure them according to the method of residual solvent determination (General rule 0861 first method). The capillary column used as the stationary liquid was a chromatographic column; The column temperature was 60 ° C.; The injection port temperature was 200 ° C.; The detector temperature was 250 ° C.; The headspace bottle equilibrium temperature was 80 ° C., and the equilibrium time was 45 minutes. Take the reference solution into the headspace, the separation degree between the peaks of each component shall meet the requirements. The test solution and the reference solution were respectively injected in headspace, Record the chromatogram, according to the internal standard method to calculate the peak area, methanol, ethanol and acetone residues should be in accordance with the provisions.
loss on drying
take this product, with phosphorus pentoxide as desiccant, drying at 100°C under reduced pressure for 5 hours, loss of weight shall not exceed 6.0% (General rule 0831).
Heavy metals
take this product 2.0g, inspection according to law (General Principles 0821 The first law), containing heavy metals shall not exceed 5 parts per million.
arsenic salt
take this product 2.0g, inspection according to law (General Principles 0822 The first law), should comply with the provisions (0.0001%).
bacterial endotoxin
take this product, check according to law (General rule 1143), each 1 mg citicoline sodium containing endotoxin amount should be less than 0.30EU.
sterile
take this product, dissolve it with appropriate solvent, and treat it by membrane filtration method. Check it according to law (General rule 1101). (For aseptic dispensing)
Last Update：2022-01-01 14:18:46
citicoline sodium - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with eighteen alkyl silane as filler; Phosphate buffer [0.1 mol/L potassium dihydrogen phosphate solution and tetrabutylammonium solution (O.Olmol/L tetrabutylammonium hydroxide solution was adjusted to pH 4.5 with phosphoric acid. The mobile phase consisted of equal mixing]-methanol (95:5). The detection wavelength was 276nm. Take an appropriate amount of the 5 '-cytidine acid reference, add water to dissolve and dilute to make a solution containing about 0.25mg per 1 ml. Take the appropriate amount, mix it with the citicoline sodium reference solution in the same amount, shake well, and inject 20ul into the liquid chromatograph, adjust the chromatographic system, citicoline peak and cytidine acid peak separation should meet the requirements.
assay
take an appropriate amount of this product, weigh it accurately, add water to dissolve and dilute it to prepare a solution containing about 0.25mg per 1 ml as a test solution, A 10ul injection liquid chromatograph was used for precise measurement, and the chromatogram was recorded. An appropriate amount of citicoline sodium reference substance was taken and determined by the same method, and the peak area was calculated according to the external standard method.
Last Update：2022-01-01 14:18:47
citicoline sodium - Category
Authoritative Data Verified Data
cell metabolism improving drugs.
Last Update：2022-01-01 14:18:47
citicoline sodium - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 14:18:47
citicoline sodium - Citicoline Sodium Tablets
Authoritative Data Verified Data
This product contains citicoline sodium (C14H25N4NaO11P2) should be labeled the amount of 90.0% to 110.0%.
trait
This product is a white tablet or film-coated tablet, white or white after removing the coating.
identification
take an appropriate amount of fine powder of this product (about 1 mg of citicoline sodium), and show the same results according to the identification (1) and (2) tests under the item of citicoline sodium.
examination
- appropriate amount of fine powder under the content determination item of related substances is accurately weighed, dissolved with water and quantitatively diluted to make a solution containing about 2.5mg of citicoline sodium per 1 ml, and filtered, take the continued filtrate as the test solution; Take 1 ml with precision, put it in a 500ml measuring flask, dilute it with water to the scale, shake it well, and use it as the control solution; in addition, an appropriate amount of 5-cytidine acid control was accurately weighed, dissolved with water and quantitatively diluted to prepare a solution containing about 7.5ug per 1 ml as a 5 '-cytidine acid control solution. Test according to the chromatographic conditions under the item of citicoline sodium content determination. If there are impurity peaks in the chromatogram of the test solution, the peak area shall be calculated according to the external standard method, and the content of 5 '-cytidine acid shall not exceed 0.3% of the labeled amount of citicoline sodium; the Peak area of other individual impurities shall not be greater than the main peak area of the control solution (0.2%), and the sum of the peak areas of other impurities shall not be greater than 3.5 times (0.7%) of the main peak area of the control solution.
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 second method), water 900ml as the dissolution medium, the speed of 50 rpm, according to the law, after 25 minutes, take the appropriate amount of solution, filter, take the filtrate as the test solution (0.lg specification or precision take the appropriate amount of filtrate, with the dissolution medium quantitative dilution made per 1 ml containing about citicoline sodium 0.llmg solution, as a test solution (0.2g specification); Another appropriate amount of citicoline sodium control, precision weighing, dissolved and quantitatively diluted with water to make about 0 per 1 ml. llmg solution, as a control solution. According to the method under the content determination item, the dissolution amount of each tablet was calculated by the peak area according to the external standard method. The limit is 80% of the labeled amount and shall be in accordance with the provisions.
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
Content determination
Take 20 tablets of this product, precision weighing, fine grinding, precision weighing fine powder (about 125mg equivalent to citicoline sodium), put 100ml flask, add appropriate amount of water, shake, dissolve citicoline sodium, dilute to the scale with water, shake well, filter, take 10ml of continuous filtrate precisely, put it in a 50ml measuring flask, dilute to the scale with water, shake well, as a test solution, determination according to the method under the item citicoline sodium.
category
Same as citicoline sodium.
specification
(1 ) 0.lg ( 2 ) 0.2g
storage
light shielding, sealed storage.
Last Update：2022-01-01 14:18:48
citicoline sodium - Citicoline Sodium Injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of citicoline sodium. Citicoline-containing sodium (C14H25N4Na011P2) shall be between 90.0% and 110.0% of the indicated amount.
trait
This product is colorless and clear liquid.
identification
take this product, according to citicoline sodium under the identification of (1), (2) and (4) test, showed the same results.
examination
- the pH value should be 6.0 to 8.0 (General 0631).
- precise measurement of related substances: take an appropriate amount of this product and quantitatively dilute it with water to make a solution containing 2.5mg of citicoline sodium per 1ml as a test solution; Take 1ml of the precise measurement and put it in a 200ml measuring flask, dilute to the scale with water, shake well, as a control solution; Accurately weigh an appropriate amount of 5-cytidine acid control, add water to dissolve and quantitatively dilute to make a solution containing 7.5ug per 1ml, as a 5-cytidine acid control solution. Determination of related substances according to the method of citicoline sodium. If there are impurity peaks in the chromatogram of the test solution, the peak area shall be calculated according to the external standard method, and the content of 5 '-cytidine acid shall not exceed 0.3% of the labeled amount of citicoline sodium; other single impurity peak area shall not be greater than the main peak area of the control solution (0.5% ), and the sum of other impurity peak surface g shall not be greater than 1.4 times (0.7%) of the main peak area of the control solution.
- bacterial endotoxin take this product, according to the method under the item of citicoline sodium inspection, should comply with the provisions.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
an appropriate amount of this product was quantitatively diluted with water to prepare a solution containing 0.25mg of citicoline sodium per 1 ml, which was used as a test solution and measured according to the method under the item of citicoline sodium.
category
Same as citicoline sodium.
specification
(l)2ml:0.1g (2)2ml:0.25g (3)2ml:0.5g
storage
light shielding, closed storage.
Last Update：2022-01-01 14:18:49
citicoline sodium - Citicoline sodium and glucose injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of citicoline sodium and glucose. Citicoline-containing sodium (C14H25N4NaO11P2) shall be between 90.0% and 110.0% of the indicated amount. The glucose content (C6H1206 • H20) shall be between 95.0% and 105.0% of the labeled amount.
trait
This product is colorless or almost colorless clear liquid.
identification
- taking this product, according to the identification (2) and (4) test under the item of citicoline sodium, the same results were shown.
- take 1ml of this product and slowly drop 5ml of slightly warm alkaline copper tartrate solution to generate red precipitate of cuprous oxide.
examination
- the pH value should be 4.5 to 6.5 (General 0631).
- precise measurement of related substances: take an appropriate amount of this product and dilute it with water to make a solution containing 2.5mg of sodium Chole-Chole per 1 ml as a test solution; Take lml for precise measurement, put it in a 200ml measuring flask, dilute it to the scale with water, shake it well, and use it as a control solution. Take an appropriate amount of 5-cytidine acid reference substance by precision weighing, water was added to dissolve and quantitatively diluted to a solution containing 7.5ug per 1 ml, and the solution was determined as a 5-cytidine acid control solution according to the method under the item of citicoline sodium related substances. If there are impurity peaks in the chromatogram of the test solution, calculated by the peak area according to the external standard method, the content of 5 '-cytidine acid shall not exceed 0.3% of the labeled amount of citicoline sodium; Except for the peak of 5-hydroxymethylfurfural, the Peak area of other individual impurities shall not be greater than the main peak area of the control solution (0.5% ) , and the sum of the peak areas of other impurities shall not be greater than 1.4 times (0.7%) of the main peak area of the control solution.
- S-hydroxymethyl furfural precise quantity take an appropriate amount of this product (about 0.25g equivalent to glucose), put it in a 25ml measuring flask, dilute it with water to the scale, shake it well, and use it as a test solution; an appropriate amount of 5-hydroxymethylfurfural reference substance was accurately weighed, dissolved with water and quantitatively diluted to prepare a solution containing 2.4ug per 1 ml as a reference solution. According to the chromatographic condition test under the item of citicoline sodium content determination, the detection wavelength was 284nm. Take 10ul of each of the reference solution and the test solution, respectively inject the human liquid chromatograph, and record the chromatogram. If there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of the main peak of the reference solution, the amount of 5-hydroxymethylfurfural shall not exceed 0.024% of the labeled amount of glucose calculated by the peak area according to the external standard method.
- take an appropriate amount of heavy metal (equivalent to about 3g of glucose), evaporate to about 20ml, let it cool, and add acetate buffer solution (pH 3.5)2.Oml and water are appropriately adjusted to 25mu for inspection according to law (General rules 0821, Law 1), and heavy metals shall not exceed three million of the labeled amount of glucose.
- The osmolality should be 260 to 0632 mosmol/kg (general).
- bacterial endotoxin this product, according to the inspection (General 1143), the amount of endotoxin per lm l should be less than 0.50EU.
- sterile take this product, by membrane filtration method, with Staphylococcus aureus as positive control bacteria, according to law inspection (General Principles 1101), should comply with the provisions.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
- citicoline sodium an appropriate amount of this product was quantitatively diluted with water to prepare a solution containing 0.25mg of citicoline sodium per 1 ml, which was used as a test solution and measured according to the method under the item of citicoline sodium.
- glucose the optical rotation was measured at 25 ° C. According to the law (General rule 0621), and multiplied by 2.0852 to obtain a Weight (g) containing C6H1206 · H20 in the Test amount.
category
Same as citicoline sodium.
specification
- 100ml: citicoline sodium 0.25g and glucose 5.0g
- 200ml: citicoline sodium 0.5g and glucose lOg
- 250ml: citicoline sodium 0.5g and glucose 10G
- 500ml: citicoline sodium 0.25g and glucose 25g
storage
light shielding, closed storage.
Last Update：2022-01-01 14:18:50
citicoline sodium - Citicoline sodium chloride injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of citicoline sodium and sodium chloride. Citicoline-containing sodium (C14H25N4NaO11p2) shall be between 90.0% and 110.0% of the indicated amount. The content of sodium chloride (NaCl) shall be between 95.0% and 105.0% of the labeled amount.
trait
This product is colorless and clear liquid.
identification
- take an appropriate amount of this product, add 2ml of 1% ferric chloride hydrochloric acid solution and 2ml of 0.01mol/L hydrochloric acid solution of 6% 3, 5-dihydroxytoluene, and heat it in a water bath to make it green.
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
- This product sodium salt identification (1) and gasification identification (1) reaction (General 0301).
examination
- the pH value should be 5.5 to 7.5 (General 0631).
- Related substances precise quantity take proper amount of this product and dilute it with water to make citicoline sodium l per lml. 0 mg of solution, as the test solution; Precision take 1 ml, 200ml flask, diluted with water to the scale, shake, as a control solution; in addition, an appropriate amount of cytidine acid control was accurately weighed, dissolved with water and quantitatively diluted to prepare a solution containing 3.0ug per 1 ml as a 5 '-cytidine acid control solution. Determination of related substances according to the method of citicoline sodium. If there are impurity peaks in the chromatogram of the test solution, the peak area shall be calculated according to the external standard method, and the content of 5 '-cytidine acid shall not exceed 0.3% of the labeled amount of citicoline sodium; other single impurity peak area shall not be greater than the main peak area of the control solution (0. 5), the sum of the peak areas of other impurities shall not be greater than 1.4 times (0.7%) of the main peak area of the control solution.
- take 50ml of heavy metal, evaporate to about 20ml, let it cool, add 2.0ml of acetate buffer solution (pH 3.5) and appropriate amount of water to make 25ml, inspection according to law (General Principles 0821, Law 1), containing heavy metals must not exceed three million.
- The osmolality should be 260 to 320 mosmol/kg (General 0632).
- bacterial endotoxin this product, according to the law to check (General 1143), the amount of endotoxin per lml should be less than 0.50EU.
- sterile take this product, by membrane filtration method, with Staphylococcus aureus as positive control bacteria, according to law inspection (General Principles 1101), should comply with the provisions.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
- citicoline sodium an appropriate amount of this product was quantitatively diluted with water to prepare a solution containing 0.25mg of citicoline sodium per 1 ml, which was used as a test solution and measured according to the method under the item of citicoline sodium.
- sodium chloride precision take 10ml of this product, put it in an Erlenmeyer flask, add 5 drops of potassium chromate indicator solution, and titrate with silver nitrate titration solution (O.lmol/L). Each 1 ml of silver nitrate titration solution (0.1 mol/L) corresponds to 5.844mg of NaCl.
category
Same as citicoline sodium.
specification
- 50ml: citicoline sodium 0.5g and sodium chloride 0.45g
- 100ml: citicoline sodium 0.25g and sodium chloride 0.9g
- 100ml: citicoline sodium 0.5g and sodium chloride 0.9g
- 250ml: citicoline sodium 0.25g and sodium chloride 2.25g
storage
light shielding, closed storage.
Last Update：2022-01-01 14:18:51
citicoline sodium - Citicoline Sodium for Injection
Authoritative Data Verified Data
This product is sterile lyophilized or sterile powder of citicoline sodium. The content of citicoline sodium (C14H25N4NaO11P2) shall be between 90.0% and 110.0% of the labeled amount calculated as the average loading.
trait
This product is white or off-white loose blocks or white crystals or crystalline powder.
identification
take this product, according to citicoline sodium under the identification of (1), (2), (4) test, showed the same results.
examination
- clarity and color of solution take this product, add water to dissolve and dilute to make a solution containing about 0902G of citicoline sodium per 1 ml, and check according to law (General rules 0901 1 and 1), the solution should be clear and colorless.
- Ph, loss on drying, related substances and bacterial endotoxin take this product and check it according to the method under the item of citicoline sodium.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
take 5 pieces of this product, weigh the contents accurately respectively, add water to dissolve the contents of each container completely, transfer the whole amount to the same suitable measuring bottle, dilute with water to the scale, shake well, take appropriate children with precision, and make it quantitatively diluted with water to contain about 0 citicoline sodium per 1 ml. 25mg of the solution, as a test solution, was measured according to the method under the item citicoline sodium.
category
Same as citicoline sodium.
specification
(1)0.25g (2)0.5g
storage
light shielding, closed storage.
Last Update：2022-01-01 14:18:52
citicoline sodium - Citicoline Sodium for Injection inosine
Authoritative Data Verified Data
This product is a sterile lyophilized product of citicoline sodium and inosine. Citicoline sodium (C14H25N4NaO11P2) and inosine (C10H12N405) should be between 90.0% and 110.0% of the labeled amount.
trait
This product is white or off-white loose block or powder.
identification
- take 1 piece of this product, add 2ml of water to dissolve, add 3 drops of silver nitrate test solution, which will produce white colloidal precipitate.
- in the chromatogram recorded under the content determination item, the retention time of the two main peaks of the test solution should be consistent with the retention time of the corresponding two main peaks of the control solution.
- take 1 branch of this product, add sodium carbonate lg, burn Ash, add water to dissolve, filter, filtrate phosphate identification reaction (General rule 0301).
examination
- pH value: take this product, add 2ml of water to dissolve and mix well for determination according to law (General rule 0631), and the pH value should be 6.0~7.5.
- light transmittance of the solution take 1 piece of this product, add 5ml of 0.9% sodium chloride solution to dissolve it, and measure the light transmittance at the wavelength of 403nm according to UV-visible spectrophotometry (General rule 0401), not less than 97.0%.
- appropriate amount of related substances should be taken, dissolved with water and diluted to prepare a solution containing 2.5mg of citicoline sodium per 1ml, which should be used as a sample solution; 1ml should be accurately measured and placed in a 100ml measuring flask, dilute to the scale with water, shake well, as a control solution; Take an appropriate amount of the 5 '-cytidine acid reference substance, add water to dissolve and quantitatively dilute to make a solution containing about 7.5ug per 1ml, as a 5'-cytidine acid control solution. According to the chromatographic conditions under the content determination item, the sample solution, the control solution and the 5-cytidine acid reference solution are respectively injected into the liquid chromatograph, the chromatogram was recorded to twice the retention time of the inosine peak. If there are impurity peaks in the chromatogram of the test solution, the peak area shall be calculated according to the external standard method, and the content of 5 '-cytidine acid shall not exceed 0.3% of the labeled amount of citicoline sodium; the sum of other impurity peak areas shall not be greater than 0.7 times (0.7%) of the sum of the two main peak areas of the control solution.
- weight loss on drying this product shall be dried at 105°C to constant weight, and the weight loss shall not exceed 7.0% (General rule 0831).
- pyrogen to take this product, each add sodium chloride injection 2ml to dissolve, according to the law to check (General 1142), the dose of rabbit body weight per lkg injection 1ml, should comply with the provisions.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test with eighteen alkyl silane bonded silica as filler; With phosphate buffer [0.1mol/L potassium dihydrogen phosphate solution and tetrabutylammonium solution (0.01mol/L tetrabutylammonium hydroxide solution was adjusted to pH 4.5 with phosphoric acid) were mixed equally with methanol (95:5) as mobile phase; the detection wavelength was 254nm. Add appropriate amount of 5-cytidine acid reference, add water to dissolve and dilute to make a solution containing about 0.25mg per 1 ml. Take appropriate amount, mix with citicoline sodium reference solution in equal amount, and shake well, 20ul injection liquid chromatograph, adjust the chromatographic system, citicoline peak and 5 '-cytidine acid peak separation should meet the requirements.
- determine the contents under the item of loading difference, mix evenly, weigh an appropriate amount (equivalent to 250mg citicoline sodium) accurately, and put it in a 100ml measuring flask, add water to shake to dissolve and dilute to the scale, shake well, take 2ml accurately, put it in a 100ml measuring flask, dilute it to the scale with water, shake well, filter, the continuous filtrate 10 u1 was accurately measured, and human liquid chromatography was injected, and the chromatogram was recorded. The contents of citicoline sodium and inosine were calculated by peak area according to external standard method.
category
cell metabolism improving drugs.
specification
0.3g (sodium cytosolic choline 250mg with inosine 50mg)
storage
sealed storage.
Last Update：2022-01-01 14:18:53
citicoline sodium - Reference Information
| appearance properties | white crystal or crystalline powder at room temperature, odorless, soluble in water, insoluble in ethanol, acetone and chloroform. |
| overview | citicoline is a nucleic acid derivative. Geiger found in animal experiments in 1956 that citicoline can restore brain injury. Studies Kennedy in 1957 confirmed that it is very important in the synthesis of cephalin. In 1961, Japan's Takeda Pharmaceutical Company developed and produced this product and registered it in China in 1988. It is currently the best sales of drugs used to treat brain diseases in clinical practice. It plays an important role in the synthesis of lecithin and improves brain function by promoting the synthesis of lecithin. Experiments have proved that citicoline can enhance the levels of norepinephrine and dopamine in the central nervous system, thereby treating cerebrovascular disease, brain trauma and cognitive impairment caused by various reasons, and there are no obvious side effects. Citicoline sodium can enhance the brainstem reticular structure, especially the function of the ascending reticular structure that is closely related to consciousness, enhance the role of the pyramidal system, inhibit the role of the extrapyramidal system, and promote awakening. At the same time, it can reduce cerebrovascular resistance, increase cerebral blood perfusion, and promote brain substance metabolism. It is mainly used to treat the sequelae of the nervous system caused by craniocerebral injury and cerebrovascular accident, and can be used for the treatment of Parkinson's syndrome. It has a certain effect on Alzheimer's disease; it is used to treat cerebrovascular and cardiovascular diseases; Others, such as delaying aging, improving learning effect and memory, also have certain effects. |
| biological activity | Citicoline (CDP-choline) is a necessary intermediate product for the synthesis of lecithin, the main phospholipids in cell membranes. It can increase plasma adrenocorticotropic hormone levels and strengthen serum thyrotropin levels. |
| Use | Central nervous system medication Coenzyme. It is used for acute craniocerebral trauma and postoperative consciousness disorder. Acute craniocerebral trauma and consciousness disorder after brain surgery, hemiplegia caused by stroke can gradually restore the function of the limbs, can also be used for other central nervous system acute injury caused by functional and consciousness disorders, but also for ischemic cerebrovascular disease and vascular dementia. cytidine 5 '-bischoline phosphate (CDP-choline), supports the synthesis of lecithin, produced by choline-phosphate cytidine acyltransferase EC 2.7.7.15; used to study its role in neural rehabilitation |
Last Update：2024-04-09 19:05:11
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