CN102525997A - Moisture-proof coating citicoline sodium capsule and preparation method thereof - Google Patents
Moisture-proof coating citicoline sodium capsule and preparation method thereof Download PDFInfo
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- CN102525997A CN102525997A CN2012100770267A CN201210077026A CN102525997A CN 102525997 A CN102525997 A CN 102525997A CN 2012100770267 A CN2012100770267 A CN 2012100770267A CN 201210077026 A CN201210077026 A CN 201210077026A CN 102525997 A CN102525997 A CN 102525997A
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- citicoline sodium
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- citicoline
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- 229960004774 citicoline sodium Drugs 0.000 title claims abstract description 81
- YWAFNFGRBBBSPD-OCMLZEEQSA-M sodium;[[(2r,3s,4r,5r)-5-(4-amino-2-oxopyrimidin-1-yl)-3,4-dihydroxyoxolan-2-yl]methoxy-oxidophosphoryl] 2-(trimethylazaniumyl)ethyl phosphate Chemical compound [Na+].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 YWAFNFGRBBBSPD-OCMLZEEQSA-M 0.000 title claims abstract description 81
- 239000002775 capsule Substances 0.000 title claims abstract description 55
- 238000000576 coating method Methods 0.000 title claims abstract description 35
- 239000011248 coating agent Substances 0.000 title claims abstract description 31
- 238000002360 preparation method Methods 0.000 title abstract description 16
- 239000008187 granular material Substances 0.000 claims abstract description 32
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims abstract description 18
- 229920000881 Modified starch Polymers 0.000 claims abstract description 18
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims abstract description 18
- 239000008108 microcrystalline cellulose Substances 0.000 claims abstract description 18
- 229940016286 microcrystalline cellulose Drugs 0.000 claims abstract description 18
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 12
- 239000008188 pellet Substances 0.000 claims description 23
- 238000000034 method Methods 0.000 claims description 15
- 238000001125 extrusion Methods 0.000 claims description 14
- 239000000463 material Substances 0.000 claims description 12
- 238000005563 spheronization Methods 0.000 claims description 12
- 238000001035 drying Methods 0.000 claims description 9
- 238000007873 sieving Methods 0.000 claims description 8
- 239000004925 Acrylic resin Substances 0.000 claims description 6
- 229920000178 Acrylic resin Polymers 0.000 claims description 6
- 238000011049 filling Methods 0.000 claims description 6
- 239000007788 liquid Substances 0.000 claims description 6
- 238000005507 spraying Methods 0.000 claims description 6
- 230000008569 process Effects 0.000 claims description 5
- 239000007787 solid Substances 0.000 claims description 5
- 238000005469 granulation Methods 0.000 claims description 4
- 230000003179 granulation Effects 0.000 claims description 4
- 238000002156 mixing Methods 0.000 claims description 4
- 238000003825 pressing Methods 0.000 claims description 4
- 239000007779 soft material Substances 0.000 claims description 4
- 239000000080 wetting agent Substances 0.000 claims description 4
- 239000004148 curcumin Substances 0.000 claims description 3
- 238000010298 pulverizing process Methods 0.000 claims description 3
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims description 2
- 238000000889 atomisation Methods 0.000 claims description 2
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims description 2
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims description 2
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 2
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 2
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 2
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims description 2
- 229920006397 acrylic thermoplastic Polymers 0.000 claims 1
- 229920003229 poly(methyl methacrylate) Polymers 0.000 claims 1
- ISXSCDLOGDJUNJ-UHFFFAOYSA-N tert-butyl prop-2-enoate Chemical compound CC(C)(C)OC(=O)C=C ISXSCDLOGDJUNJ-UHFFFAOYSA-N 0.000 claims 1
- 239000006187 pill Substances 0.000 abstract 3
- 238000010521 absorption reaction Methods 0.000 abstract 1
- RZZPDXZPRHQOCG-OJAKKHQRSA-O 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-O 0.000 description 5
- 230000007774 longterm Effects 0.000 description 5
- 239000000203 mixture Substances 0.000 description 4
- 210000004556 brain Anatomy 0.000 description 3
- 229960001284 citicoline Drugs 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 239000012528 membrane Substances 0.000 description 3
- 239000007921 spray Substances 0.000 description 3
- 238000013112 stability test Methods 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- 102000004190 Enzymes Human genes 0.000 description 2
- 108090000790 Enzymes Proteins 0.000 description 2
- 210000004958 brain cell Anatomy 0.000 description 2
- 230000008859 change 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
- 238000004806 packaging method and process Methods 0.000 description 2
- 239000002245 particle Substances 0.000 description 2
- 150000003904 phospholipids Chemical class 0.000 description 2
- 239000000243 solution Substances 0.000 description 2
- 238000003860 storage Methods 0.000 description 2
- SFLSHLFXELFNJZ-QMMMGPOBSA-N (-)-norepinephrine Chemical compound NC[C@H](O)C1=CC=C(O)C(O)=C1 SFLSHLFXELFNJZ-QMMMGPOBSA-N 0.000 description 1
- ZIIUUSVHCHPIQD-UHFFFAOYSA-N 2,4,6-trimethyl-N-[3-(trifluoromethyl)phenyl]benzenesulfonamide Chemical compound CC1=CC(C)=CC(C)=C1S(=O)(=O)NC1=CC=CC(C(F)(F)F)=C1 ZIIUUSVHCHPIQD-UHFFFAOYSA-N 0.000 description 1
- 208000024827 Alzheimer disease Diseases 0.000 description 1
- 206010008190 Cerebrovascular accident Diseases 0.000 description 1
- 206010019196 Head injury Diseases 0.000 description 1
- 102000015439 Phospholipases Human genes 0.000 description 1
- 108010064785 Phospholipases Proteins 0.000 description 1
- 206010039966 Senile dementia Diseases 0.000 description 1
- 208000006011 Stroke Diseases 0.000 description 1
- 208000030886 Traumatic Brain injury Diseases 0.000 description 1
- 239000012190 activator Substances 0.000 description 1
- 230000032683 aging Effects 0.000 description 1
- 230000033228 biological regulation Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 230000008499 blood brain barrier function Effects 0.000 description 1
- 210000001218 blood-brain barrier Anatomy 0.000 description 1
- 210000000170 cell membrane Anatomy 0.000 description 1
- 208000026106 cerebrovascular disease Diseases 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 239000007884 disintegrant Substances 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 229960003638 dopamine Drugs 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 238000005429 filling process Methods 0.000 description 1
- 235000021588 free fatty acids Nutrition 0.000 description 1
- 230000006870 function Effects 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
- 238000011835 investigation Methods 0.000 description 1
- 238000011031 large-scale manufacturing process Methods 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 230000004060 metabolic process Effects 0.000 description 1
- 230000002438 mitochondrial effect Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 210000005036 nerve Anatomy 0.000 description 1
- 210000000653 nervous system Anatomy 0.000 description 1
- 229960002748 norepinephrine Drugs 0.000 description 1
- SFLSHLFXELFNJZ-UHFFFAOYSA-N norepinephrine Natural products NCC(O)C1=CC=C(O)C(O)=C1 SFLSHLFXELFNJZ-UHFFFAOYSA-N 0.000 description 1
- 230000001151 other effect Effects 0.000 description 1
- 239000001301 oxygen Substances 0.000 description 1
- 229910052760 oxygen Inorganic materials 0.000 description 1
- -1 oxygen free radical Chemical class 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 238000005096 rolling process Methods 0.000 description 1
- 230000000087 stabilizing effect Effects 0.000 description 1
- 238000003786 synthesis reaction Methods 0.000 description 1
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- Medicinal Preparation (AREA)
Abstract
The invention provides a moisture-proof coating citicoline sodium capsule and a preparation method thereof. The citicoline sodium capsule is composed of a capsule casing and quick-release moisture-proof micro pills or granules. All components in each capsule containing citicoline sodium quick-release moisture-proof micro pills or granules by percentage are 40% to 70% of citicoline sodium, 10% to 30% of microcrystalline cellulose, 10% to 30% of pregelatinized starch and 2% to 10% of moisture-proof coatings. The moisture-proof micro pills or granules are obtained by being extruded and rounded or pressed and granulated to be coated with moisture-proof coatings. The citicoline sodium capsule is good in moisture-proof function and resolves the problems that the capsule is prone to absorb water due to the fact that citicoline sodium is strong in moisture absorption, the capsule casing is prone to be fragile, and the like.
Description
Technical Field
The invention relates to a moisture-proof coated citicoline sodium capsule and a preparation method thereof, belonging to the technical field of pharmaceutical preparations.
Background
Citicoline sodium can be used for treating nervous system sequelae caused by craniocerebral injury and cerebrovascular accident, and for treating Parkinson's syndromeAlso has certain curative effect on senile dementia; other effects such as delaying aging and improving memory. The citicoline sodium enters the brain through the blood brain barrier after entering the organism, is combined with the membrane phospholipid of brain cells to promote the synthesis of the membrane phospholipid, promote the metabolism of the brain, and increase mitochondrial ATP enzyme and membrane Na+/K+2ATP enzyme activity, inhibition of phospholipase A2The composition can increase the level of noradrenaline and dopamine in brain, and has the effects of stabilizing cell membrane, protecting brain cell, and reducing free fatty acid and oxygen free radical release. Citicoline has been clinically proven for many years as one of the most clinically used nerve activators, and its efficacy and safety have been improved.
Citicoline sodium was developed by the pharmaceutical company martial arts in japan, and was marketed under the trade name "Nicholin" (nicolin) in 1967 and imported into china in 1988. The preparation on the market at home is an injection preparation, a common tablet or a capsule.
Citicoline sodium is easy to absorb moisture, and is easy to absorb moisture when being excessively exposed to air in the filling process of citicoline sodium capsules, so that sticking is caused or filling is influenced; in addition, in the process of placing the capsule, water in the capsule shell is easily absorbed by citicoline particles in the capsule shell, so that the capsule shell becomes brittle; after packaging, if aluminum-plastic packaging is adopted, the particles are easy to absorb moisture, and the moisture is increased.
Chinese patent document CN102028664 discloses citicoline sodium tablets and a preparation method thereof, but does not relate to the problem that citicoline sodium is easy to absorb moisture. Chinese patent document CN1260177(CN98122857.7) discloses a citicoline oral preparation and a preparation method thereof, but specific components of pharmaceutic adjuvants are not specified, and the practicability is not strong.
Disclosure of Invention
Aiming at the defects of the prior art, the invention provides a moisture-proof coated citicoline sodium capsule suitable for mass production and a preparation method thereof. Not only can avoid the change of the water content of the capsule in the preparation process and the placement process, but also can ensure that the water content in the capsule shell is not absorbed and becomes crisp.
The technical scheme of the invention is as follows:
each capsule contains citicoline sodium quick-release moisture-proof pellets or granules, the citicoline sodium quick-release moisture-proof pellets or granules are prepared by spraying moisture-proof coatings on quick-release pellets or granules prepared from citicoline sodium, microcrystalline cellulose and pregelatinized starch, and the citicoline sodium capsules comprise the following components in percentage by mass:
40-70% of citicoline sodium, 10-30% of microcrystalline cellulose, 10-30% of pregelatinized starch and 2-10% of moisture-proof coating, wherein the sum of the addition amount of each component is 100%.
According to the invention, the moisture-proof coating material is selected from opadry, hydroxypropyl cellulose, hydroxypropyl methylcellulose or acrylic resins. Among them, Opadry is preferably moisture-proof Opadry AMB, and acrylic resin is preferably acrylic resin E100.
According to the present invention, preferably, the citicoline sodium capsule is formulated as follows:
according to the present invention, preferably, the citicoline sodium capsule is formulated as follows:
the main and auxiliary raw materials used by the citicoline sodium capsule can be purchased in the market.
According to the invention, the preparation method of the citicoline sodium capsule comprises the following steps:
(1) pulverizing citicoline sodium, sieving with 100 mesh sieve, and sieving pregelatinized starch and microcrystalline cellulose with 40 mesh sieve respectively;
(2) mixing the sieved citicoline sodium, pregelatinized starch and microcrystalline cellulose according to the proportion, and preparing a soft material by using water as a wetting agent; preparing pellets or granules by an extrusion spheronization method; then drying at 30-50 ℃ to obtain the citicoline sodium quick-release pellets or granules;
or,
mixing the sieved citicoline sodium, pregelatinized starch and microcrystalline cellulose according to the proportion, and performing dry-pressing granulation to obtain citicoline sodium quick-release granules;
(3) preparing a coating solution with the solid content of 3-10 wt% by taking the moisture-proof coating material according to the proportion;
(4) putting the citicoline sodium quick-release pellets or granules obtained in the step (2) into a fluidized bed, and spraying the coating liquid obtained in the step (3); keeping fluidized state after coating, and continuously drying for 5-15min to obtain citicoline sodium moisture-proof quick-release pellet or granule;
(5) and filling the citicoline sodium moisture-proof quick-release pellets or granules into a capsule shell to obtain the capsule.
According to the method of the present invention, preferably, in the step (2), an extrusion spheronizer is used to prepare pellets or granules, the extrusion rate is set to be 20-30HZ, the spheronization rotation speed is set to be 300-500rpm, and the spheronization time is set to be 30s-1 min.
According to the method of the present invention, preferably, the process conditions in step (4) are: the air inlet temperature is 40-60 ℃, and the air inlet volume is 600-800m3The atomization pressure is 1.0-1.5bar, the material temperature is 30-40 ℃, and the spraying speed of the coating liquid is 60-120 g/min.
The extrusion spheronizer, the fluidized bed, etc. used in the process of the present invention described above are all conventional equipment in the art.
The citicoline sodium capsule product has low hygroscopicity, stable and controllable quality, controllable key technological parameter range and long effective period, and the preparation process is suitable for large-scale production. Compared with the prior art, the citicoline sodium capsule has the following advantages:
1. auxiliary materials with low hygroscopicity such as pregelatinized starch and microcrystalline cellulose with good compressibility are adopted as the filling agent and the disintegrant, and the moisture-proof coating is coated after dry-pressing granulation, so that the granules with good granularity and easy disintegration are obtained.
2. The quick-release pellets or granules are prepared by an extrusion rolling method and then coated with the moisture-proof coating, so that under the condition of lower coating weight increment, good moisture-proof function and disintegration time limit can be ensured, in long-term 36-month stability investigation, the water content is not obviously increased, the capsule shell is not embrittled, and the product is stable and has long storage time.
Detailed Description
It is to be understood that other embodiments and modifications which are obvious to those skilled in the art in the practice of the invention and which do not depart from the scope and spirit of the invention as described above are deemed to be within the scope and spirit of the invention. Therefore, it should not be understood that the scope of the claims is limited to the following examples.
Example 1: the prescription composition is as follows:
the preparation process comprises the following steps:
crushing the prescription amount of citicoline sodium, and sieving the crushed citicoline sodium with a 100-mesh sieve, wherein the prescription amount of pregelatinized starch and microcrystalline cellulose are respectively sieved with a 40-mesh sieve for later use; preparing soft materials from the screened citicoline sodium, the pregelatinized starch and the microcrystalline cellulose by using water as a wetting agent, setting the extrusion speed of an extrusion spheronizer to be 20-30HZ, the spheronization rotating speed to be 300rpm and the spheronization time to be 30s, preparing granules by using an extrusion spheronization method, and drying at 30-50 ℃ to obtain the citicoline sodium quick-release granules.
A coating solution with the solid content of 5 wt% is prepared by taking the prescription amount of the moisture-proof coating material acrylic resin E100. Placing the citicoline sodium quick-release granules in a fluidized bed for coating: the air inlet temperature is 40-60 ℃, and the air inlet volume is 600-800m3H, atomizing at 1.0-1.5bar, material temperature at 30-40 deg.C, spray speed at 60-120g/min, keeping fluidized state after coating, and continuously drying for 5-15min to obtain citicoline sodium moisture-proof quick-release granule; filling into capsule to obtain capsule.
Example 2: the prescription composition is as follows:
preparation process
Crushing the prescription amount of citicoline sodium, and sieving the crushed citicoline sodium with a 100-mesh sieve, wherein the prescription amount of pregelatinized starch and microcrystalline cellulose are respectively sieved with a 40-mesh sieve for later use; preparing soft materials from the sieved citicoline sodium, the pregelatinized starch and the microcrystalline cellulose by using water as a wetting agent, setting the extrusion speed of an extrusion spheronizer to be 20-30HZ, the spheronization rotating speed to be 500rpm, the spheronization time to be 1min, preparing pellets by using an extrusion spheronization method, and drying at 30-50 ℃ to obtain the citicoline sodium quick-release pellets.
The prescription amount of the moisture-proof coating material Eupata AMB is taken to prepare coating liquid with the solid content of 10wt percent. Putting the citicoline sodium quick-release pellet into a fluidized bed for coating: the air inlet temperature is 40-60 ℃, and the air inlet volume is 600-800m3H, atomizing at 1.0-1.5bar, material temperature at 30-40 deg.C, spray speed at 60-120g/min, keeping fluidized state after coating, and continuously drying for 5-15min to obtain citicoline sodium dampproof quick-release pellet; filling into capsule shell to obtain capsule.
Example 3: the prescription composition is as follows:
the preparation process comprises the following steps:
pulverizing citicoline sodium, sieving with 100 mesh sieve, and sieving pregelatinized starch and microcrystalline cellulose with 40 mesh sieve respectively; and (3) carrying out dry-pressing granulation on the screened citicoline sodium, the pregelatinized starch and the microcrystalline cellulose to obtain the citicoline sodium quick-release granules.
The moisture-proof coating powder with the prescription amount is taken to prepare coating liquid with the solid content of 3wt percent. Placing the citicoline sodium quick-release granules in a fluidized bed for coating: the air inlet temperature is 50-70 ℃, and the air inlet volume is 600-800m3H, atomizing at 1.0-1.5bar, material temperature at 30-40 deg.C, spray speed at 60-200g/min, keeping fluidized state after coating, and continuously drying for 5-15min to obtain citicoline sodium moisture-proof quick-release granule; filling into capsule to obtain capsule.
Example 4:
3 batches of the citicoline sodium capsules prepared in examples 1, 2 and 3 above, respectively, example 1 batch number: 081201, 081202, 081203; example 2 corresponds to batch number: 090101, 090102, 090103; example 3 corresponds to batch number: 090201, 090202, 090203. Measuring water content, dissolution rate, related substances, content index amount, etc. (detection is based on WS-051(x-047) -2002). After a long-term storage for 36 months, the above-mentioned indices were measured, and the results are shown in tables 1 to 3.
TABLE 1 Long-term stability test results of 36-month citicoline sodium capsules
TABLE 2 Long-term stability test results of 36-month citicoline sodium capsules
TABLE 3 Long-term stability test results of 36-month citicoline sodium capsules
The results show that: the citicoline sodium capsule has small difference among batches and stable and controllable product quality. After being placed for 36 months under the condition of 30 ℃/60 percent RH, compared with 0 day, the water content and related substances are slightly increased, but the water content and the related substances meet the regulations, and other indexes have no obvious change.
Claims (8)
1. A citicoline sodium capsule is characterized in that each capsule contains citicoline sodium quick-release moisture-proof pellets or granules, the citicoline sodium quick-release moisture-proof pellets or granules are prepared by spraying moisture-proof coatings on quick-release pellets or granules prepared from citicoline sodium, microcrystalline cellulose and pregelatinized starch, and the citicoline sodium capsule comprises the following components in percentage by mass:
40-70% of citicoline sodium, 10-30% of microcrystalline cellulose, 10-30% of pregelatinized starch and 2-10% of moisture-proof coating, wherein the sum of the addition amount of each component is 100%.
2. The citicoline sodium capsule of claim 1 wherein said moisture resistant coating material is selected from the group consisting of opadry, hydroxypropyl cellulose, hydroxypropyl methylcellulose, and acrylics.
3. The citicoline sodium capsule of claim 2 wherein the opadry is opadry AMB and the acrylic resin is acrylic resin E100.
4. The citicoline sodium capsule of claim 1 wherein said citicoline sodium capsule is formulated as follows:
5. the citicoline sodium capsule of claim 1 wherein said citicoline sodium capsule is formulated as follows:
6. a method for preparing the citicoline sodium capsule of any one of claims 1 to 5, comprising the steps of:
(1) pulverizing citicoline sodium, sieving with 100 mesh sieve, and sieving pregelatinized starch and microcrystalline cellulose with 40 mesh sieve respectively;
(2) mixing the sieved citicoline sodium, pregelatinized starch and microcrystalline cellulose according to the proportion, and preparing a soft material by using water as a wetting agent; preparing pellets or granules by an extrusion spheronization method; then drying at 30-50 ℃ to obtain citicoline sodium quick-release pellets or granules; or,
mixing the sieved citicoline sodium, pregelatinized starch and microcrystalline cellulose according to the proportion, and performing dry-pressing granulation to obtain citicoline sodium quick-release granules;
(3) preparing a coating solution with the solid content of 3-10 wt% by taking the moisture-proof coating material according to the proportion;
(4) putting the citicoline sodium quick-release pellets or granules obtained in the step (2) into a fluidized bed, and spraying the coating liquid obtained in the step (3); keeping fluidized state after coating, and continuously drying for 5-15min to obtain citicoline sodium moisture-proof quick-release pellet or granule;
(5) and filling the citicoline sodium moisture-proof quick-release pellets or granules into a capsule shell to obtain the capsule.
7. The method for preparing citicoline sodium capsule as claimed in claim 6, wherein in step (2), the pellet or granule is prepared by using an extrusion spheronizer, wherein the extrusion rate is set to 20-30Hz, the spheronization speed is set to 300-500rpm, and the spheronization time is set to 30s-1 min.
8. The method for preparing citicoline sodium capsule according to claim 6, wherein the process conditions in step (4) are as follows: the air inlet temperature is 40-60 ℃, and the air inlet volume is 600-800m3The atomization pressure is 1.0-1.5bar, the material temperature is 30-40 ℃, and the spraying speed of the coating liquid is 60-120 g/min.
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| CN 201210077026 CN102525997B (en) | 2012-03-21 | 2012-03-21 | Moisture-proof coating citicoline sodium capsule and preparation method thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103509073A (en) * | 2013-08-29 | 2014-01-15 | 洪军 | Citicoline sodium compound |
| CN103830200A (en) * | 2012-11-21 | 2014-06-04 | 石药集团中奇制药技术（石家庄）有限公司 | Composition of 3-n-butylphthalide derivative, 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 |
| CN106727415A (en) * | 2016-12-28 | 2017-05-31 | 江苏飞马药业有限公司 | A kind of capsule composition containing C14H25N4NaO11P2 and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101053572A (en) * | 2006-04-11 | 2007-10-17 | 中国医药研究开发中心有限公司 | Citicoline enteric coated preparation and its preparation method |
-
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- 2012-03-21 CN CN 201210077026 patent/CN102525997B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101053572A (en) * | 2006-04-11 | 2007-10-17 | 中国医药研究开发中心有限公司 | Citicoline enteric coated preparation and its preparation method |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103830200A (en) * | 2012-11-21 | 2014-06-04 | 石药集团中奇制药技术（石家庄）有限公司 | Composition of 3-n-butylphthalide derivative, and preparation method thereof |
| CN103509073A (en) * | 2013-08-29 | 2014-01-15 | 洪军 | Citicoline sodium compound |
| CN103509073B (en) * | 2013-08-29 | 2016-01-06 | 洪军 | A kind of Citicoline sodium compound |
| 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 |
| CN106727415A (en) * | 2016-12-28 | 2017-05-31 | 江苏飞马药业有限公司 | A kind of capsule composition containing C14H25N4NaO11P2 and preparation method thereof |
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| CN102525997B (en) | 2013-07-17 |
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