CN104027304A - Citicoline sodium glucose injection - Google Patents
Citicoline sodium glucose injection Download PDFInfo
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- CN104027304A CN104027304A CN201410244261.8A CN201410244261A CN104027304A CN 104027304 A CN104027304 A CN 104027304A CN 201410244261 A CN201410244261 A CN 201410244261A CN 104027304 A CN104027304 A CN 104027304A
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- glucose
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- citicoline sodium
- glucose injection
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Abstract
The invention relates to citicoline sodium glucose injection, belonging to the field of pharmaceutical preparations. The citicoline sodium glucose injection provided by the invention is composed of 3 g of citicoline sodium, 40 g of glucose, 1.8 g of glycine, and 1.3 g of citric acid; the pH value is adjusted to 5.5-5.6 by using sodium hydroxide; and water for injection is added till the citicoline sodium glucose injection is 1000 ml.
Description
Technical field
The present invention relates to a kind of citicoline sodium glucose injection, belong to field of pharmaceutical preparations.
Background technology
The chemical name of C14H25N4NaO11P2 is single sodium salt of choline cytidine diphosphate ester, and its chemical structural formula is:
Molecular formula is C14H25N4NaO11P2, and molecular weight is 510.31.
C14H25N4NaO11P2 is nucleoside derivate, has the effect that strengthens the up network structure activating system of brain stem and pyramidal system's activity, the level of strengthening the awareness and motion function; Reduce in addition cerebral blood vessel resistance, increase cerebral blood flow, especially increase the blood flow of brain stem portion, thereby improve cerebral circulation, to promoting that brain function recovers and revive to have certain effect.Be mainly used in Acute Brain Injury and the rear disturbance of consciousness of brain operation.
C14H25N4NaO11P2 is white crystals or crystalline powder; Odorless.Easily molten in water, insoluble in ethanol, acetone, chloroform.But there is the problem of poor heat stability in the citicoline sodium glucose injection of having sold, its related substances is higher in production and storage process, can not meet the demand of producing and using.Be badly in need of now a kind of new citicoline sodium glucose injection of invention, the deficiency existing to overcome existing citicoline sodium glucose injection.
Summary of the invention
Present inventor is by groping and test of many times, find to add one of glycine, citric acid or the compositions of the two in the aqueous solution of C14H25N4NaO11P2 and glucose, and use the main ingredient of specified quantitative, the stability that can significantly strengthen the citicoline sodium glucose injection making, significantly reduces the generation of related substance.
Technical solution of the present invention comprises:
1. a citicoline sodium glucose injection, comprising C14H25N4NaO11P2, glucose.
2. a citicoline sodium glucose injection, comprising C14H25N4NaO11P2, glucose, glycine.
3. a citicoline sodium glucose injection, comprising C14H25N4NaO11P2, glucose, citric acid.
4. a citicoline sodium glucose injection, comprising C14H25N4NaO11P2, glucose, glycine, citric acid.
5. a citicoline sodium glucose injection, it is made up of C14H25N4NaO11P2, glucose, glycine, citric acid, its
Middle C14H25N4NaO11P2 is 3g, and glucose is 40g, and glycine is 1.8g, and citric acid is 1.3g, uses sodium hydroxide to regulate
PH value is 5.5-5.6, injects water to 1000ml.
Citicoline sodium glucose injection tool of the present invention has the following advantages:
(1) glycine adding in injection and citric acid have the effect of cosolvent and stabilizing agent for C14H25N4NaO11P2, can strengthen product stability, reduce the generation of related substance.Make product remain high-quality, high stability in production and storage process, be conducive to clinical use.
(2) citicoline sodium glucose injection production technology of the present invention is simple, main ingredient is cheap, can reduce production costs, and brings benefit to the people.
Detailed description of the invention
Further illustrate by the following examples the present invention, but these embodiment do not limit the present invention in any way.
Embodiment 1 citicoline sodium glucose injection
Using 0.1N sodium hydroxide to regulate pH value is 5.5-5.6, injects water to 1000ml.
Preparation technology:
Glucose is soluble in water 1., filter after then adding activated carbon adsorption, filtrate water is diluted to isotonic concentration, thereby obtains the isotonic aqueous solution of glucose; Preferably, described water is water for injection;
2. in the isotonic aqueous solution obtaining through step 1, add C14H25N4NaO11P2, glycine and citric acid, stir it is dissolved, filter after then adding activated carbon adsorption, using 0.1N sodium hydroxide to regulate pH value is 5.5-5.6, filtering with microporous membrane.
Embodiment 2
C14H25N4NaO11P2 3000mg
Glucose 40000mg
Citric acid 1300mg
Using 0.1N sodium hydroxide to regulate pH value is 5.5-5.6, injects water to 1000ml.
Preparation technology: with embodiment 1.
Embodiment 3
C14H25N4NaO11P2 3000mg
Glucose 40000mg
Glycine 1800mg
Using 0.1N sodium hydroxide to regulate pH value is 5.5-5.6, injects water to 1000ml.
Preparation technology: with embodiment 1.
Citicoline sodium glucose injection indices prepared by above-described embodiment meets two pertinent regulations of 2010 editions Chinese Pharmacopoeias.
Character: colourless clear liquid.
PH value: 5.5-5.6
Visible foreign matters: qualified
Sterility test: qualified
Particulate matter: qualified
Content: qualified
Related substance: single impurity is no more than 0.3%, other impurity are no more than 0.5%.
Citicoline sodium glucose injection stability test:
Comparative example 1
C14H25N4NaO11P2 2500mg
Glucose 50000mg
Using 0.1N sodium hydroxide to regulate pH value is 5.5-5.6, injects water to 1000ml.
Preparation technology: with embodiment 1.
Comparative example 2
C14H25N4NaO11P2 3000mg
Glucose 40000mg
Using 0.1N sodium hydroxide to regulate pH value is 5.5-5.6, injects water to 1000ml.
Preparation technology: with embodiment 1.
Comparative example 3
Using 0.1N sodium hydroxide to regulate pH value is 5.7-6.3, injects water to 1000ml.
Preparation technology: referring to CN102144963B
Comparative example 4
Using 0.1N sodium hydroxide to regulate pH value is 5.5-5.6, injects water to 1000ml.
Preparation technology: with embodiment 1.
Stability test 1:
The product that above-mentioned 3 embodiment and 4 comparative examples are made is positioned in 60 DEG C of climatic chambers, in sampling calibrating in the 5th, 10 days, and result and comparison in 0 day:
Related substance, content are by high effective liquid chromatography for measuring (be shown in table 1).
Table 1
Result:
Embodiment 1-3: selecting glycine or citric acid or the compositions of the two is cosolvent and stabilizing agent, regulates pH to 5.5-5.6.
Comparative example 1: do not use cosolvent and stabilizing agent
Comparative example 2: do not use cosolvent and stabilizing agent
Comparative example 3: use malic acid and sodium sulfite as cosolvent and stabilizing agent
Comparative example 4: use glycine and citric acid as cosolvent and stabilizing agent, but consumption is different from embodiment 1-3
Embodiment 1-3 and comparative example 1-4 comparison, pH, related substance, stable content have obvious advantage, select glycine and citric acid as cosolvent and stabilizing agent, regulate pH to 5.5-5.6, can significantly increase the dissolubility of C14H25N4NaO11P2 in water, and significantly improve the stability of Citicoline sodium injection.
Stability test 2: long-term stable experiment
The Citicoline sodium injection of Citicoline sodium injection prepared by embodiment of the present invention 1-3 and comparative example 1-4 carries out long-time stability investigation (25 DEG C ± 2 DEG C, RH60% ± 10%), the results are shown in Table 2:
Table 2
Result:
Embodiment 1-3: selecting glycine or citric acid or the compositions of the two is cosolvent and stabilizing agent, regulates pH to 5.5-5.6.
Comparative example 1: do not use cosolvent and stabilizing agent
Comparative example 2: do not use cosolvent and stabilizing agent
Comparative example 3: use malic acid and sodium sulfite as cosolvent and stabilizing agent
Comparative example 4: use glycine and citric acid as cosolvent and stabilizing agent, but consumption is different from embodiment 1-3
Embodiment 1-3 and comparative example 1-4 comparison, pH, related substance, stable content have obvious advantage, select glycine and citric acid as cosolvent and stabilizing agent, regulate pH to 5.5-5.6, can significantly increase the dissolubility of C14H25N4NaO11P2 in water, and significantly improve the stability of Citicoline sodium injection.
By aforementioned stable contrast test, can find that glycine and citric acid can significantly increase the dissolubility of C14H25N4NaO11P2 in water and the stability of injection.The technical scheme of the application's claim request protection (corresponding to embodiment 1-3, restriction pH value is 5.5-5.6, using glycine and citric acid as cosolvent and stabilizing agent), has better dissolubility and stability with respect to comparative example 1-4.
Claims (2)
1. a citicoline sodium glucose injection, comprising C14H25N4NaO11P2, glucose.
2. a citicoline sodium glucose injection, comprising C14H25N4NaO11P2, glucose, glycine, citric acid.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201410244261.8A CN104027304B (en) | 2014-06-04 | 2014-06-04 | Citicoline sodium glucose injection |
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| CN201410244261.8A CN104027304B (en) | 2014-06-04 | 2014-06-04 | Citicoline sodium glucose injection |
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| CN104027304B CN104027304B (en) | 2015-05-27 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104940133A (en) * | 2015-06-11 | 2015-09-30 | 山东新时代药业有限公司 | Fluconazole injection and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101675925A (en) * | 2008-09-17 | 2010-03-24 | 秦引林 | Dimethylaminoethyl ginkgolide B mesylate injection and preparation method thereof |
| CN102144963A (en) * | 2010-02-05 | 2011-08-10 | 四川科伦药物研究有限公司 | Citicoline sodium glucose injecta and preparation process thereof |
-
2014
- 2014-06-04 CN CN201410244261.8A patent/CN104027304B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101675925A (en) * | 2008-09-17 | 2010-03-24 | 秦引林 | Dimethylaminoethyl ginkgolide B mesylate injection and preparation method thereof |
| CN102144963A (en) * | 2010-02-05 | 2011-08-10 | 四川科伦药物研究有限公司 | Citicoline sodium glucose injecta and preparation process thereof |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104940133A (en) * | 2015-06-11 | 2015-09-30 | 山东新时代药业有限公司 | Fluconazole injection and preparation method thereof |
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Address after: 331800 No. 6, Dongshan Industrial Park, Dongxiang Economic Development Zone, Fuzhou, Jiangxi. Patentee after: HUIYINBI GROUP JIANGXI EAST ASIA PHARMACEUTICAL Co.,Ltd. Address before: 331800 Dongxiang Province Economic Development Zone, Dongshan Industrial Park, Fuzhou, Hui Road, No. 6, No. Patentee before: HUIYINBI GROUP (JIANGXI) EAST ASIA PHARMACEUTICAL CO.,LTD. |
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Denomination of invention: Citicoline sodium glucose injection Effective date of registration: 20230926 Granted publication date: 20150527 Pledgee: Bank of China Limited Dongxiang sub branch Pledgor: HUIYINBI GROUP JIANGXI EAST ASIA PHARMACEUTICAL Co.,Ltd. Registration number: Y2023980059384 |