CN1628690A - Citicoline slow controlled release preparation and preparing method thereof - Google Patents
Citicoline slow controlled release preparation and preparing method thereof Download PDFInfo
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- CN1628690A CN1628690A CN 200310119094 CN200310119094A CN1628690A CN 1628690 A CN1628690 A CN 1628690A CN 200310119094 CN200310119094 CN 200310119094 CN 200310119094 A CN200310119094 A CN 200310119094A CN 1628690 A CN1628690 A CN 1628690A
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- Prior art keywords
- citicoline
- preparation
- controlled release
- release
- slow release
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- RZZPDXZPRHQOCG-OJAKKHQRSA-M CDP-choline(1-) Chemical compound O[C@@H]1[C@H](O)[C@@H](COP([O-])(=O)OP([O-])(=O)OCC[N+](C)(C)C)O[C@H]1N1C(=O)N=C(N)C=C1 RZZPDXZPRHQOCG-OJAKKHQRSA-M 0.000 title claims abstract description 35
- 229960001284 citicoline Drugs 0.000 title claims abstract description 35
- 239000003405 delayed action preparation Substances 0.000 title claims abstract description 17
- 238000000034 method Methods 0.000 title abstract description 6
- 238000002360 preparation method Methods 0.000 claims abstract description 16
- 239000002671 adjuvant Substances 0.000 claims abstract description 6
- 238000013270 controlled release Methods 0.000 claims abstract description 6
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 17
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 12
- -1 hydroxypropyl Chemical group 0.000 claims description 6
- 235000019359 magnesium stearate Nutrition 0.000 claims description 6
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 5
- 239000008101 lactose Substances 0.000 claims description 5
- 235000021355 Stearic acid Nutrition 0.000 claims description 4
- GLDOVTGHNKAZLK-UHFFFAOYSA-N octadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCCCO GLDOVTGHNKAZLK-UHFFFAOYSA-N 0.000 claims description 4
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims description 4
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims description 4
- 239000008117 stearic acid Substances 0.000 claims description 4
- LNAZSHAWQACDHT-XIYTZBAFSA-N (2r,3r,4s,5r,6s)-4,5-dimethoxy-2-(methoxymethyl)-3-[(2s,3r,4s,5r,6r)-3,4,5-trimethoxy-6-(methoxymethyl)oxan-2-yl]oxy-6-[(2r,3r,4s,5r,6r)-4,5,6-trimethoxy-2-(methoxymethyl)oxan-3-yl]oxyoxane Chemical compound CO[C@@H]1[C@@H](OC)[C@H](OC)[C@@H](COC)O[C@H]1O[C@H]1[C@H](OC)[C@@H](OC)[C@H](O[C@H]2[C@@H]([C@@H](OC)[C@H](OC)O[C@@H]2COC)OC)O[C@@H]1COC LNAZSHAWQACDHT-XIYTZBAFSA-N 0.000 claims description 2
- NIXOWILDQLNWCW-UHFFFAOYSA-N Acrylic acid Chemical compound OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims description 2
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 2
- 239000004375 Dextrin Substances 0.000 claims description 2
- 229920001353 Dextrin Polymers 0.000 claims description 2
- 239000001856 Ethyl cellulose Substances 0.000 claims description 2
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 claims description 2
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 2
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims description 2
- 229930195725 Mannitol Natural products 0.000 claims description 2
- 229920003091 Methocel™ Polymers 0.000 claims description 2
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 2
- 229920000881 Modified starch Polymers 0.000 claims description 2
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 2
- 229920002125 Sokalan® Polymers 0.000 claims description 2
- 229920002472 Starch Polymers 0.000 claims description 2
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 2
- 229930006000 Sucrose Natural products 0.000 claims description 2
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 2
- 239000002253 acid Substances 0.000 claims description 2
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims description 2
- 229960001631 carbomer Drugs 0.000 claims description 2
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 2
- 235000019425 dextrin Nutrition 0.000 claims description 2
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 claims description 2
- 239000002552 dosage form Substances 0.000 claims description 2
- 229920001249 ethyl cellulose Polymers 0.000 claims description 2
- 235000019325 ethyl cellulose Nutrition 0.000 claims description 2
- 239000008103 glucose Substances 0.000 claims description 2
- 125000002887 hydroxy group Chemical group [H]O* 0.000 claims description 2
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims description 2
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims description 2
- 239000000594 mannitol Substances 0.000 claims description 2
- 235000010355 mannitol Nutrition 0.000 claims description 2
- 239000011159 matrix material Substances 0.000 claims description 2
- 229920000609 methyl cellulose Polymers 0.000 claims description 2
- 239000001923 methylcellulose Substances 0.000 claims description 2
- 235000010981 methylcellulose Nutrition 0.000 claims description 2
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 2
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 2
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 2
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims description 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 2
- 239000011347 resin Substances 0.000 claims description 2
- 229920005989 resin Polymers 0.000 claims description 2
- 150000003839 salts Chemical class 0.000 claims description 2
- 239000000741 silica gel Substances 0.000 claims description 2
- 229910002027 silica gel Inorganic materials 0.000 claims description 2
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims description 2
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims description 2
- 239000008107 starch Substances 0.000 claims description 2
- 235000019698 starch Nutrition 0.000 claims description 2
- 239000005720 sucrose Substances 0.000 claims description 2
- DMBUODUULYCPAK-UHFFFAOYSA-N 1,3-bis(docosanoyloxy)propan-2-yl docosanoate Chemical compound CCCCCCCCCCCCCCCCCCCCCC(=O)OCC(OC(=O)CCCCCCCCCCCCCCCCCCCCC)COC(=O)CCCCCCCCCCCCCCCCCCCCC DMBUODUULYCPAK-UHFFFAOYSA-N 0.000 claims 1
- 239000004615 ingredient Substances 0.000 claims 1
- 239000000463 material Substances 0.000 claims 1
- 239000003814 drug Substances 0.000 abstract description 10
- 230000000694 effects Effects 0.000 abstract description 3
- 239000000203 mixture Substances 0.000 abstract description 3
- 238000001647 drug administration Methods 0.000 abstract 2
- 238000009472 formulation Methods 0.000 abstract 1
- 230000007721 medicinal effect Effects 0.000 abstract 1
- 239000003826 tablet Substances 0.000 description 7
- 229940079593 drug Drugs 0.000 description 6
- 230000006870 function Effects 0.000 description 5
- 210000000170 cell membrane Anatomy 0.000 description 4
- 239000011248 coating agent Substances 0.000 description 4
- 238000000576 coating method Methods 0.000 description 4
- 206010013786 Dry skin Diseases 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 230000002490 cerebral effect Effects 0.000 description 2
- VYFYYTLLBUKUHU-UHFFFAOYSA-N dopamine Chemical compound NCCC1=CC=C(O)C(O)=C1 VYFYYTLLBUKUHU-UHFFFAOYSA-N 0.000 description 2
- 238000001035 drying Methods 0.000 description 2
- 239000008187 granular material Substances 0.000 description 2
- 239000012528 membrane Substances 0.000 description 2
- 238000002156 mixing Methods 0.000 description 2
- 210000002569 neuron Anatomy 0.000 description 2
- 150000003904 phospholipids Chemical class 0.000 description 2
- 230000035790 physiological processes and functions Effects 0.000 description 2
- 239000007779 soft material Substances 0.000 description 2
- 239000000243 solution Substances 0.000 description 2
- 206010048962 Brain oedema Diseases 0.000 description 1
- 208000032843 Hemorrhage Diseases 0.000 description 1
- 102100037611 Lysophospholipase Human genes 0.000 description 1
- 108010058864 Phospholipases A2 Proteins 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 230000001133 acceleration Effects 0.000 description 1
- OIPILFWXSMYKGL-UHFFFAOYSA-N acetylcholine Chemical compound CC(=O)OCC[N+](C)(C)C OIPILFWXSMYKGL-UHFFFAOYSA-N 0.000 description 1
- 229960004373 acetylcholine Drugs 0.000 description 1
- 230000004913 activation Effects 0.000 description 1
- 230000033228 biological regulation Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 210000004556 brain Anatomy 0.000 description 1
- 210000004958 brain cell Anatomy 0.000 description 1
- 208000006752 brain edema Diseases 0.000 description 1
- 230000003925 brain function Effects 0.000 description 1
- 210000000133 brain stem Anatomy 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- 230000005779 cell damage Effects 0.000 description 1
- 208000037887 cell injury Diseases 0.000 description 1
- 230000003727 cerebral blood flow Effects 0.000 description 1
- 230000004087 circulation Effects 0.000 description 1
- 230000007850 degeneration Effects 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 208000035475 disorder Diseases 0.000 description 1
- 229960003638 dopamine Drugs 0.000 description 1
- 230000003291 dopaminomimetic effect Effects 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 230000005764 inhibitory process Effects 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 208000028867 ischemia Diseases 0.000 description 1
- 229940041476 lactose 100 mg Drugs 0.000 description 1
- 239000013563 matrix tablet Substances 0.000 description 1
- 230000004060 metabolic process Effects 0.000 description 1
- 230000007830 nerve conduction Effects 0.000 description 1
- 239000002777 nucleoside Substances 0.000 description 1
- 150000003833 nucleoside derivatives Chemical class 0.000 description 1
- 230000003204 osmotic effect Effects 0.000 description 1
- 210000004189 reticular formation Anatomy 0.000 description 1
- 230000028327 secretion Effects 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses a citicoline slow controlled release preparation and preparing method by using prescription amount of citicoline and conventional adjuvant, preparing slow release, controlled release formulation by employing preparation making processes. The advantages of the preparation include reduced frequency of drug administration, stable blood-medicine concentration in human body, long duration of medicinal effect and less side effects, thus is suitable for long-period drug administration.
Description
Technical field
The invention belongs to medical technical field, be specifically related to slow release, controlled release preparation of a kind of citicoline and preparation method thereof.
Background technology
Citicoline (Citicoline) is the endogenous nucleoside of natural generation in a kind of body, is the intermedium of cell membrane phospholipid biosynthesis main path.The reparation of neuron membrane needs a large amount of citicolines.The citicoline of supplemented with exogenous can promote the synthetic of neurocyte membrane phospholipid.Citicoline plays a part extremely important in keeping the various kinds of cell physiological process.In multiple because ischemia, hemorrhage caused cell membrane function disorder, in the degeneration, citicoline has tangible clinical therapeutic efficacy.
1, this product can be recovered the structure of brain cell damage back cell membrane, strengthens function of plasma membrane, improves function of neurons; 2, can reduce cerebral vascular resistance, the cerebral blood flow increasing amount promotes the brain metabolism, improves cerebral circulation, improves brain function; 3, the secretion that increases the nerve conduction medium that comprises acetylcholine and dopamine is arranged, strengthen the reticular formation of brain stem function relevant, improve the state of consciousness of body, improve the speed of reviving with consciousness; But 4, the also activation of inhibition of phospholipase A 2, thereby the heavily absorption of acceleration cerebral edema.5, can promote the dopaminergic activity, the physiological function of regulation and control extrapyramidal system.6, proved to have and improved one's memory, promoted the function of study.
The citicoline preparation now mostly is injection, clinical use inconvenience.Ordinary preparation is short because of its biological half-life, thus eliminate in vivo after oral fast, the effective blood drug concentration weak point of holding time, it is more day to take number of times, therefore brings many inconvenience to the patient, and take often cause often the interior blood drug level of body than great fluctuation process.After making slow release, controlled release preparation, can reduce administration number of times, improve patient's compliance, make better efficacy, side effect is littler.
Summary of the invention
The purpose of this invention is to provide a kind of medicine of can controlling and steadily discharge for a long time, duration of efficacy is long, and administration number of times is few, the slow release that contains citicoline, controlled release preparation that side effect is little.
Another object of the present invention provides the preparation method of citicoline slow release, controlled release preparation.
The present invention is slow release, the controlled release preparation that contains citicoline, is made by medicine and adjuvant.Said medicine is citicoline or its officinal salt, particularly C14H25N4NaO11P2.Said adjuvant is the combination of one or more components in the following adjuvant: hydroxypropyl emthylcellulose, carbomer, hydroxy methocel, ethyl cellulose, stearic acid, octadecanol, Rikemal B 200 and crylic acid resin; Starch, pregelatinized Starch, lactose, dextrin, microcrystalline Cellulose, polyvinylpyrrolidone, sodium carboxymethyl cellulose, hydroxypropyl cellulose, methylcellulose, sucrose, glucose and mannitol; Magnesium stearate, Pulvis Talci, micropowder silica gel, stearic acid and 10-100% ethanol.
The present invention is slow release, the controlled release preparation that contains citicoline, and wherein the per unit dosage form contains citicoline 50-500mg, preferred 100mg, 200mg, 300mg.
Citicoline slow release of the present invention, controlled release preparation, said preparation can be slow release, controlled release tablet, by making matrix tablet, film controlled release tablet, osmotic pump tablet, and reach the purpose of slow release, control-release long-acting.Said preparation also can be slow release, Extencap, by piller, film controlled release small pieces, the film controlled release piller of making matrix type, in incapsulating, and reaches the purpose of slow release, control-release long-acting.
The specific embodiment
Below in conjunction with embodiment this explanation is further elaborated.
The following example only is used to illustrate the present invention, rather than an any way limits the present invention.
Embodiment 1:
Prescription: citicoline 100mg
Hydroxypropyl emthylcellulose 150mg
Lactose 100mg
Magnesium stearate 10mg
80% ethanol is an amount of
Coating solution is an amount of
Preparation: citicoline, hydroxypropyl emthylcellulose, the lactose of recipe quantity are pressed equivalent incremental method mixing, and with an amount of 80% ethanol preparation soft material, 20 mesh sieves are granulated, 50 ℃ of dryings, granulate.Add magnesium stearate, mix homogeneously, tabletting, coating promptly gets the citicoline slow releasing tablet.
The drug release determination result shows that the citicoline slow releasing tablet has tangible slow release characteristic, and drug release can be kept 4-12 hour.
Embodiment 2:
Prescription: citicoline 200mg
Hydroxypropyl emthylcellulose 350mg
Lactose 150mg
Magnesium stearate 15mg
90% ethanol is an amount of
Coating solution is an amount of
Preparation: citicoline, hydroxypropyl emthylcellulose, the lactose of recipe quantity are pressed equivalent incremental method mixing, and with an amount of 90% ethanol preparation soft material, 20 mesh sieves are granulated, 50 ℃ of dryings, granulate.Add magnesium stearate, mix homogeneously, tabletting, coating promptly gets the citicoline slow releasing tablet.
The drug release determination result shows that the citicoline slow releasing tablet has tangible slow release characteristic, and drug release can be kept 8-24 hour.
Claims (7)
1, a kind of slow release, controlled release preparation that contains citicoline, the effective ingredient that it is characterized in that this slow release, control-release long-acting preparation is citicoline or its officinal salt, particularly C14H25N4NaO11P2.
2, citicoline slow release according to claim 1, controlled release preparation is characterized in that skeletal matrix is the combination of one or more components in the following slow-release auxiliary material: hydroxypropyl emthylcellulose, carbomer, hydroxy methocel, ethyl cellulose, stearic acid, octadecanol, Rikemal B 200 (Compritol 888 ATO) and crylic acid resin.
3, citicoline slow release according to claim 1, controlled release preparation is characterized in that adding in the following adjuvant one or more: starch, pregelatinized Starch, lactose, dextrin, microcrystalline Cellulose, polyvinylpyrrolidone, sodium carboxymethyl cellulose, hydroxypropyl cellulose, methylcellulose, sucrose, glucose and mannitol.
4, citicoline slow release according to claim 1, controlled release preparation is characterized in that adding in the following adjuvant one or more: magnesium stearate, Pulvis Talci, micropowder silica gel, stearic acid and 10-100% ethanol.
5, citicoline slow release according to claim 1, controlled release preparation is characterized in that wherein the per unit dosage form contains citicoline 50-500mg.
6, citicoline slow release according to claim 1, controlled release preparation is characterized in that said preparation can be slow release, controlled release tablet.
7, citicoline slow release according to claim 1, controlled release preparation is characterized in that said preparation can be slow release, Extencap.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200310119094 CN1628690A (en) | 2003-12-15 | 2003-12-15 | Citicoline slow controlled release preparation and preparing method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200310119094 CN1628690A (en) | 2003-12-15 | 2003-12-15 | Citicoline slow controlled release preparation and preparing method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1628690A true CN1628690A (en) | 2005-06-22 |
Family
ID=34843852
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200310119094 Pending CN1628690A (en) | 2003-12-15 | 2003-12-15 | Citicoline slow controlled release preparation and preparing method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1628690A (en) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2010026467A2 (en) | 2008-09-04 | 2010-03-11 | Torrent Pharmaceuticals Ltd. | Controlled release dosage form of high solubility active ingredient |
| CN102028664A (en) * | 2010-12-22 | 2011-04-27 | 四川梓橦宫药业有限公司 | Citicoline sodium tablets and preparation method thereof |
| CN102579320A (en) * | 2012-02-29 | 2012-07-18 | 四川梓橦宫药业有限公司 | Citicoline sodium brain-targeting thermosensitive gel and preparation method thereof |
| WO2024098854A1 (en) * | 2022-11-11 | 2024-05-16 | 中国药科大学 | Citicoline pharmaceutical composition and use thereof |
-
2003
- 2003-12-15 CN CN 200310119094 patent/CN1628690A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2010026467A2 (en) | 2008-09-04 | 2010-03-11 | Torrent Pharmaceuticals Ltd. | Controlled release dosage form of high solubility active ingredient |
| CN102028664A (en) * | 2010-12-22 | 2011-04-27 | 四川梓橦宫药业有限公司 | Citicoline sodium tablets and preparation method thereof |
| CN102028664B (en) * | 2010-12-22 | 2013-09-25 | 四川梓橦宫药业有限公司 | Citicoline sodium tablets and preparation method thereof |
| CN102579320A (en) * | 2012-02-29 | 2012-07-18 | 四川梓橦宫药业有限公司 | Citicoline sodium brain-targeting thermosensitive gel and preparation method thereof |
| CN102579320B (en) * | 2012-02-29 | 2013-07-10 | 四川梓橦宫药业有限公司 | Citicoline sodium brain-targeting thermosensitive gel and preparation method thereof |
| WO2024098854A1 (en) * | 2022-11-11 | 2024-05-16 | 中国药科大学 | Citicoline pharmaceutical composition and use thereof |
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