CN102028664A - Citicoline sodium tablets and preparation method thereof - Google Patents
Citicoline sodium tablets and preparation method thereof Download PDFInfo
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- CN102028664A CN102028664A CN 201010600362 CN201010600362A CN102028664A CN 102028664 A CN102028664 A CN 102028664A CN 201010600362 CN201010600362 CN 201010600362 CN 201010600362 A CN201010600362 A CN 201010600362A CN 102028664 A CN102028664 A CN 102028664A
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Abstract
The invention provides citicoline sodium tablets which are medicinal preparations for treating sequela of a nervous system caused by a craniocerebral injury or a cerebrovascular accident, and a preparation method thereof. Every 1,000 tablets comprise 100.0 to 300.0g of citicoline sodium, 20.0 to 70.0g of starch, 50.0 to 160.0g of microcrystalline cellulose, 0.6 to 3g of hydroxypropyl methyl cellulose, 1.7 to 5.5g of magnesium stearate, 0 to 10g of sodium starch glycolate and 0 to 6.0g of pregelatinized starch. The preparation method of the citicoline sodium tablets mainly comprises the steps of sieving, weighing, proportioning, premixing, preparing a soft material, preparing wet granules, drying, granulating, mixing, tabletting, performing aluminum-plastic-aluminum packaging and outer packaging and the like. The tablets prepared by the method have the advantages of high yield, low cost, accurate divided dose, relatively stable medicinal physicochemical property and longer storage period and are convenient to carry and use.
Description
Technical field
The present invention relates to a kind of medicine and preparation method thereof, be specifically related to C14H25N4NaO11P2 sheet and preparation method thereof.
Background technology
C14H25N4NaO11P2 (Citicoline Sodium), its molecular formula is C
14H
25N
4NaO
11P
2, for single sodium salt of choline cytidine diphosphate ester, be nucleoside derivates, C14H25N4NaO11P2 is no less than 98% in the dry product.C14H25N4NaO11P2 can be by reducing cerebral vascular resistance, and cerebral blood flow increasing promotes metabolism of brain, improves cerebral circulation.Also can strengthen the function of brain stem ARAS (ascending reticular activating system), strengthen the function of pyramidal system, improve paralysis motorica, certain effect be arranged so the recovery of promotion brain function and promotion revived.Can enter blood rapidly after injecting the citicoline sodium injection, have part to enter cerebral tissue by blood brain barrier, the choline part becomes the good donor that methylates in vivo, can have transmethylase to turn usefulness into to multiple chemical compound, and about 1% choline is discharged from urine.C14H25N4NaO11P2 is mainly used in acute craniocerebral trauma and brain operation back disturbance of consciousness, can recover the function of extremity gradually to the hemiplegia due to the apoplexy, also can be used for function and disturbance of consciousness that other central nervous system's acute injuries cause, also be used for ischemic cerebrovascular and vascular dementia.
According to present disclosed patent documentation, as can be seen, at present the research of C14H25N4NaO11P2 is mainly concentrated on the preparation method of C14H25N4NaO11P2, and the preparation method of citicoline sodium dispersible tablets, injection etc.As the Chinese patent publication number is the preparation method that the patent of invention of CN1944661 discloses a kind of C14H25N4NaO11P2, mainly be to be biocatalyzer with the yeast, with 5 '-cytidylic acid, phosphocholine, potassium hydroxide, glucose are that the mode of production that raw material carries out biotransformation is produced preparation.The Chinese patent publication number is that the patent of invention of CN1395935 discloses a kind of citicoline sodium injection for intravenous injection and preparation method thereof, its disclosed citicoline sodium injection for intravenous injection, comprise following component (in weight portion): C14H25N4NaO11P2 0.25 to 1.0, sodium chloride 0.45 to 4.5, water for injection 50 to 500.The Chinese patent publication number is that the patent of invention of CN101204396 discloses a kind of citicoline sodium dispersible tablets and preparation method thereof, and its dispersible tablet comprises C14H25N4NaO11P2 and medicine acceptable carrier such as lactose, starch, cellulose or the like.But as injection, its production cost height portably uses and is not easily, and physical and chemical properties of drugs is not very stable.
Summary of the invention
The object of the present invention is to provide a kind of tablet output height, cost low; Divided dose accurately, carry with easy to use; The C14H25N4NaO11P2 sheet that physical and chemical properties of drugs is more stable, storage period is long.
The present invention is achieved in that
A kind of C14H25N4NaO11P2 sheet is characterized in that per 1000 comprise following component:
C14H25N4NaO11P2 100.0 is to 300g
Starch 20.0 is to 70.0g
Microcrystalline Cellulose 50.0 is to 160.0g
Hydroxypropyl emthylcellulose 0.6 is to 4.5g
Pregelatinized Starch 0 is to 6.0g
Magnesium stearate 1.7 is to 5.5g.
Carboxymethylstach sodium 0 is to 10.0g
Further scheme is that the pregelatinized Starch consumption is 1 to 5g, and the carboxymethylstach sodium consumption is 2 to 8g.
The invention also discloses the preparation method of described C14H25N4NaO11P2 sheet, comprise the steps:
1) gets the raw materials ready: C14H25N4NaO11P2 was pulverized 100 mesh sieves, hydroxypropyl emthylcellulose is mixed with 1.0 to 4.0% aqueous solution as binding agent, with starch, microcrystalline Cellulose, pregelatinized Starch, magnesium stearate, carboxymethylstach sodium mesh sieve;
2) take by weighing C14H25N4NaO11P2, starch, microcrystalline Cellulose, pregelatinized Starch, magnesium stearate, carboxymethylstach sodium, binding agent;
3) with starch, microcrystalline Cellulose and C14H25N4NaO11P2 mix homogeneously, add binding agent, stir, make soft material, cross 20 order nylon sieve series granules;
4) granule is placed drying baker, heat drying under 50 ℃ of conditions;
5) dried granule is with 18 order stainless steel sift granulate, adds magnesium stearate etc. and adds the adjuvant mix homogeneously;
6) semi-finished product chemical examination is measured the content of C14H25N4NaO11P2 in the granule and is determined that sheet is heavy;
7) punch die tabletting adopts plastic-aluminum aluminum packing after the assay was approved, promptly makes the C14H25N4NaO11P2 sheet.
The present invention pulverized 100 mesh sieves with C14H25N4NaO11P2, starch, microcrystalline Cellulose etc., pulverized carefullyyer, more helped the performance of effective ingredient, instant effect; Adopt the hydroxypropyl emthylcellulose aqueous solution as binding agent, it is bonded together various composition moistenings easilier, forms the film type granule, strengthen and make particulate flowability and uniformity, for accurate controlling agent amount provides assurance, and increased the dissolution of this medicine; Adopt 50 ℃ oven drying at low temperature, can either reach the effect of oven dry, avoided the too high variation that causes the product chemical constituent of temperature again, adopt plastic-aluminum aluminum packing at last, promptly play protection against the tide and play the light blocking effect again, the tablet stable in properties of preparation, storage period is grown (effect duration is 36 months); Add magnesium stearate behind the granulate, the consumption that will control magnesium stearate on the one hand is minimum, reach the effect of fluidizer, allow the starch in itself and the tablet interact on the other hand, impel tabletting smooth, and starch can improve the hydrophobicity of magnesium stearate and reduce influence to disintegration of tablet and functional component stripping, and unilateral bright and clean attractive in appearance behind the tabletting.Determine that by citicoline sodium content in the always mixed granule of mensuration intermediate sheet is heavy, the tablet divided dose that the present invention is prepared is more accurate, the stability and the suitability that improve product.In prescription, add pregelatinized Starch through the test of many times proof and can significantly improve particulate uniformity, increased the fineness of particulate relaxed and comfortable degree and label outward appearance, thereby improved the presentation quality and the tablet weight variation quality of C14H25N4NaO11P2 sheet.In addition, carboxymethylstach sodium adds in this prescription as disintegrating agent, and the rapid disintegrate of quickening this product improves the dissolution rate of this product, improves the inherent quality of this product.
Quality standard test method of the present invention:
(1) the related substance precision takes by weighing this product fine powder an amount of (being equivalent to C14H25N4NaO11P2 50mg approximately), adds the mobile phase dissolving, filters, and gets subsequent filtrate and makes the solution that every 1ml contains C14H25N4NaO11P2 0.5mg approximately, as need testing solution; It is an amount of that precision is measured need testing solution, makes the solution that every 1ml contains C14H25N4NaO11P2 5 μ g approximately, solution in contrast with mobile phase.According to the test of the chromatographic condition under the assay item, measure contrast solution 20 μ l and inject chromatograph of liquid, regulate detection sensitivity, make the peak height of main constituent chromatographic peak be about 20%～25% of monitor full scale.Measure each 20 μ l of above-mentioned two kinds of solution again and inject chromatograph of liquid, the record chromatogram is to 3 times of main constituent peak retention time.As showing impurity peaks, measure each impurity peak area sum in the chromatogram of need testing solution, must not be greater than the peak area (1.0%) at contrast solution main constituent peak.
(2) dissolution is got this product, and according to dissolution method (two appendix XC second methods of Chinese Pharmacopoeia version in 2005), 900ml is a solvent with hydrochloric acid solution (9 → 1000), and rotating speed is that per minute 75 changes, operation in accordance with the law.In the time of 30 minutes, it is an amount of to get solution, filters, and precision is measured subsequent filtrate 1ml, adds hydrochloric acid solution (9 → 1000) and is diluted to 10ml as need testing solution; Other gets the C14H25N4NaO11P2 reference substance and adds hydrochloric acid solution (9 → 1000) in right amount and make the solution that every 1ml contains 20 μ g, in contrast product solution.Get above-mentioned two kinds of solution,, measure trap respectively, calculate every stripping quantity at the wavelength place of 280nm according to spectrophotography (two appendix IVA of Chinese Pharmacopoeia version in 2005).Limit is 80% of a labelled amount, should be up to specification.
(3) assay: according to high effective liquid chromatography for measuring (two appendix V of Chinese Pharmacopoeia version in 2005 D).
The test of chromatographic condition and system suitability is a filler with the octadecylsilane chemically bonded silica, with potassium dihydrogen phosphate (get the 2.72g potassium dihydrogen phosphate, be dissolved in water and be diluted to 1000ml, add the 5ml triethylamine after, regulate pH value to 5.5 with phosphoric acid) be mobile phase; The detection wavelength is 274nm.Theoretical cam curve is calculated by the C14H25N4NaO11P2 peak should be not less than 1500.
Algoscopy is got 10 of this product, and accurate the title decided porphyrize, mix homogeneously, precision take by weighing in right amount (being equivalent to C14H25N4NaO11P2 50mg approximately), put in the 100ml measuring bottle, add the mobile phase dissolving, and be diluted to scale, and shake up, filter, precision is measured subsequent filtrate 5ml, put in the 50ml measuring bottle, be diluted to scale, as need testing solution with mobile phase; Other learns from else's experience with the phosphorus pentoxide is desiccant, and 100 ℃ of drying under reduced pressure are an amount of to the C14H25N4NaO11P2 reference substance of constant weight, make the solution that contains C14H25N4NaO11P2 50 μ g among every 1ml approximately with mobile phase, in contrast product solution.Get each 20 μ l of above-mentioned solution and inject chromatograph of liquid, the record chromatogram.By external standard method promptly with calculated by peak area.
The specific embodiment
Embodiment 1:
A kind of C14H25N4NaO11P2 sheet, per 1000 comprise following component:
C14H25N4NaO11P2 200.0g
Starch 50.0g
Microcrystalline Cellulose 100.0g
Hydroxypropyl emthylcellulose 0.125g
Magnesium stearate 3.5g.
The preparation method of above-mentioned C14H25N4NaO11P2 sheet comprises the steps:
1) gets the raw materials ready: C14H25N4NaO11P2 was pulverized 100 mesh sieves, starch, microcrystalline Cellulose and magnesium stearate are crossed 100 mesh sieves, hydroxypropyl emthylcellulose is mixed with 2.5% aqueous solution as binding agent;
2) by accurately taking by weighing each supplementary material;
3) with starch, microcrystalline Cellulose and C14H25N4NaO11P2 mix homogeneously, add binding agent, stir, make soft material, cross 20 order nylon sieve series granules;
4) granule is placed drying baker, heat drying under 50 ℃ of conditions;
5) dried granule adds the magnesium stearate mix homogeneously with 18 order stainless steel sift granulate;
6) semi-finished product chemical examination is measured the content of C14H25N4NaO11P2 in the granule and is determined that sheet is heavy;
7) punch die tabletting adopts plastic-aluminum aluminum packing, promptly makes the C14H25N4NaO11P2 sheet.
Embodiment 2:
A kind of C14H25N4NaO11P2 sheet, per 1000 comprise following component:
C14H25N4NaO11P2 300.0g
Starch 60.0g
Microcrystalline Cellulose 110.0g
Hydroxypropyl emthylcellulose 1.8g
Pregelatinized Starch 5.0g
Magnesium stearate 5g
Carboxymethylstach sodium 8g
The preparation method of above-mentioned C14H25N4NaO11P2 sheet comprises the steps:
1) gets the raw materials ready: C14H25N4NaO11P2 was pulverized 100 mesh sieves, starch, microcrystalline Cellulose, carboxymethylstach sodium and magnesium stearate are crossed 100 mesh sieves, hydroxypropyl emthylcellulose is mixed with 2.5% aqueous solution as binding agent;
2) by accurately taking by weighing each supplementary material;
3) with starch, microcrystalline Cellulose, C14H25N4NaO11P2 mix homogeneously, add binding agent, stir, make soft material, cross 20 order nylon sieve series granules;
4) granule is placed drying baker, heat drying under 50 ℃ of conditions;
5) dried granule adds magnesium stearate, carboxymethylstach sodium mix homogeneously with 18 order stainless steel sift granulate;
6) semi-finished product chemical examination is measured the content of C14H25N4NaO11P2 in the granule and is determined that sheet is heavy;
7) punch die tabletting adopts plastic-aluminum aluminum packing, promptly makes the C14H25N4NaO11P2 sheet.
Embodiment 3:
A kind of C14H25N4NaO11P2 sheet, per 1000 comprise following component:
C14H25N4NaO11P2 100.0g
Starch 40g
Microcrystalline Cellulose 55.0g
Hydroxypropyl emthylcellulose 0.7g
Magnesium stearate 1.5g
Carboxymethylstach sodium 2g
The preparation method of above-mentioned C14H25N4NaO11P2 sheet comprises the steps:
1) gets the raw materials ready: C14H25N4NaO11P2 was pulverized 100 mesh sieves, starch, microcrystalline Cellulose, pregelatinized Starch and magnesium stearate are crossed 100 mesh sieves, hydroxypropyl emthylcellulose is mixed with 2.5% aqueous solution as binding agent;
2) by accurately taking by weighing each supplementary material;
3) with starch, microcrystalline Cellulose, pregelatinized Starch and C14H25N4NaO11P2 mix homogeneously, add binding agent, stir, make soft material, cross 20 order nylon sieve series granules;
4) granule is flat in the drying baker heat drying under 50 ℃ of conditions;
5) dried granule adds magnesium stearate, carboxymethylstach sodium mix homogeneously with 18 order stainless steel sift granulate;
6) semi-finished product chemical examination is measured the content of C14H25N4NaO11P2 in the granule and is determined that sheet is heavy;
7) punch die tabletting adopts plastic-aluminum aluminum packing, promptly makes the C14H25N4NaO11P2 sheet.
For essence of the present invention better is described, will illustrate that below its physical and chemical properties of drugs is stable, storage period is long with the long-term stable experiment of the prepared C14H25N4NaO11P2 sheet of the present invention.
Get three batches of the C14H25N4NaO11P2 sheets that embodiment one to three makes, lot number is respectively: 060601,060602,060603.
Reference substance: the C14H25N4NaO11P2 reference substance (lot number: 140675-200401), Nat'l Pharmaceutical ﹠ Biological Products Control Institute.
Instrument: 756 ultraviolet-uisible spectrophotometers (limited company of Shanghai spectral instrument), the intelligent dissolution test instrument of ZRS-8G (Radio Factory of Tianjin Univ.); LC-10AT type high performance liquid chromatograph (day island proper Tianjin), SPD-10AVP type detector, N2000 two pass chromatographic work station; BP211D type electronic balance (German Sai Duolisi)
Reagent: potassium dihydrogen phosphate: Tianjin lucky star chemical reagent factory; Triethylamine: Chongqing, Shen, Chongqing chemical reagent factory; Phosphoric acid: Chengdu chemical reagent factory; Methanol: import; Redistilled water: self-control.
Investigation project: character, dissolution, related substance, sign content, limit test of microbe.
Test basis: " national drug standards " (trying) YBH07132006.
Content of the test and condition
Plastic-aluminum aluminum packing, long-term stable experiment under the normal temperature condition.
Long-term stable experiment the results are shown in Table 1 to 3.
36 months ambient stable result of the tests of table 1 C14H25N4NaO11P2 sheet
Batch number: 060601
36 months ambient stable result of the tests of table 2 C14H25N4NaO11P2 sheet
Batch number: 060602
36 months ambient stable result of the tests of table 3 C14H25N4NaO11P2 sheet
Batch number: 060603
Conclusion: place under the condition of 0 ℃ to 30 ℃ at normal temperatures of C14H25N4NaO11P2 sheet, relative humidity 60% ± 15%, respectively at getting the check that keeps sample 3rd month, 6 months, 9 months, 12 months, 18 months, 24 months, 36 the end of month, result and comparison in 0 month, removing related substance slightly increases, other every indexs have no significant change, and related substance is still in the scope of standard-required, and the long-term stable experiment result shows that the C14H25N4NaO11P2 sheet stores 36 months its steady qualities under normal temperature condition.
Claims (3)
1. C14H25N4NaO11P2 sheet is characterized in that per 1000 comprise following component:
C14H25N4NaO11P2 100.0 is to 300g
Starch 20.0 is to 70.0g
Microcrystalline Cellulose 50.0 is to 160.0g
Hydroxypropyl emthylcellulose 0.6 is to 4.5g
Pregelatinized Starch 0 is to 6.0g
Magnesium stearate 1.7 is to 5.5g
Carboxymethylstach sodium 0 is to 10g.
2. C14H25N4NaO11P2 sheet according to claim 1 is characterized in that: described pregelatinized Starch consumption is 1 to 5g, and the carboxymethylstach sodium consumption is 2 to 8g.
3. the preparation method of claim 1 or 2 described C14H25N4NaO11P2 sheets is characterized in that comprising the steps:
1) gets the raw materials ready: C14H25N4NaO11P2 was pulverized 100 mesh sieves, hydroxypropyl emthylcellulose is mixed with 1.0 to 4.0% aqueous solution as binding agent, starch, microcrystalline Cellulose, pregelatinized Starch, magnesium stearate, carboxymethylstach sodium are crossed 100 mesh sieves;
2) take by weighing C14H25N4NaO11P2, starch, microcrystalline Cellulose, pregelatinized Starch, magnesium stearate, carboxymethylstach sodium, binding agent;
3) with starch, microcrystalline Cellulose, pregelatinized Starch and C14H25N4NaO11P2 mix homogeneously, add binding agent, stir, make soft material, cross 20 order nylon sieve series granules;
4) granule is placed drying baker dry, heat drying under 50 ℃ of conditions;
5) dried granule adds adjuvant magnesium stearate and carboxymethylstach sodium, mix homogeneously with 18 order stainless steel sift granulate;
6) semi-finished product chemical examination is measured the content of C14H25N4NaO11P2 in the granule and is determined that sheet is heavy;
7) punch die tabletting adopts plastic-aluminum aluminum packing after the assay was approved, promptly makes the C14H25N4NaO11P2 sheet.
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|---|---|---|---|
| CN 201010600362 CN102028664B (en) | 2010-12-22 | 2010-12-22 | Citicoline sodium tablets and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201010600362 CN102028664B (en) | 2010-12-22 | 2010-12-22 | Citicoline sodium tablets and preparation method thereof |
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| CN102028664A true CN102028664A (en) | 2011-04-27 |
| CN102028664B CN102028664B (en) | 2013-09-25 |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103191079A (en) * | 2013-04-01 | 2013-07-10 | 济南利民制药有限责任公司 | Citicoline sodium tablet and preparation method thereof |
| CN106727377A (en) * | 2016-12-28 | 2017-05-31 | 江苏飞马药业有限公司 | A kind of tablet composition containing C14H25N4NaO11P2 main ingredient and preparation method thereof |
| CN110196297A (en) * | 2019-06-24 | 2019-09-03 | 山东玉满坤生物科技有限公司 | Detection method in relation to substance in a kind of citicoline, its sodium salt and its preparation |
| CN114432253A (en) * | 2022-02-21 | 2022-05-06 | 平顶山市第二人民医院 | Citicoline sodium tablet and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1628673A (en) * | 2003-12-15 | 2005-06-22 | 孟繁浩 | Citicoline Dispersible tablet and preparation method thereof |
| CN1628690A (en) * | 2003-12-15 | 2005-06-22 | 孟繁浩 | Citicoline slow controlled release preparation and preparing method thereof |
-
2010
- 2010-12-22 CN CN 201010600362 patent/CN102028664B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1628673A (en) * | 2003-12-15 | 2005-06-22 | 孟繁浩 | Citicoline Dispersible tablet and preparation method thereof |
| CN1628690A (en) * | 2003-12-15 | 2005-06-22 | 孟繁浩 | Citicoline slow controlled release preparation and preparing method thereof |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103191079A (en) * | 2013-04-01 | 2013-07-10 | 济南利民制药有限责任公司 | Citicoline sodium tablet and preparation method thereof |
| CN103191079B (en) * | 2013-04-01 | 2014-03-26 | 济南利民制药有限责任公司 | Citicoline sodium tablet and preparation method thereof |
| CN106727377A (en) * | 2016-12-28 | 2017-05-31 | 江苏飞马药业有限公司 | A kind of tablet composition containing C14H25N4NaO11P2 main ingredient and preparation method thereof |
| CN110196297A (en) * | 2019-06-24 | 2019-09-03 | 山东玉满坤生物科技有限公司 | Detection method in relation to substance in a kind of citicoline, its sodium salt and its preparation |
| CN114432253A (en) * | 2022-02-21 | 2022-05-06 | 平顶山市第二人民医院 | Citicoline sodium tablet and preparation method thereof |
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| CN102028664B (en) | 2013-09-25 |
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Address after: 641000 No. 456, Anji street, Neijiang economic and Technological Development Zone, Sichuan Patentee after: Sichuan zitonggong pharmaceutical Limited by Share Ltd Address before: 641001 Neijiang City, Sichuan Province in central music town Vitex dam Patentee before: Sichuan Zitonggong Pharmaceutical Co., Ltd. |