CN108272766A - A kind of Mecobalamin dispersion slowbreak piece and preparation method thereof - Google Patents
A kind of Mecobalamin dispersion slowbreak piece and preparation method thereof Download PDFInfo
- Publication number
- CN108272766A CN108272766A CN201810235894.0A CN201810235894A CN108272766A CN 108272766 A CN108272766 A CN 108272766A CN 201810235894 A CN201810235894 A CN 201810235894A CN 108272766 A CN108272766 A CN 108272766A
- Authority
- CN
- China
- Prior art keywords
- mecobalamin
- disperse particles
- dispersible tablet
- added
- slowbreak
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7135—Compounds containing heavy metals
- A61K31/714—Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
Abstract
This application provides a kind of Mecobalamins to disperse slowbreak piece and preparation method thereof, including prepares disperse particles and prepare two steps of dispersible tablet；The disperse particles that prepare refer to that Mecobalamin and gas-phase silica, coating material are mixed with coated granule under the conditions of being protected from light；The dispersible tablet for preparing refers to being uniformly mixed auxiliary material with disperse particles according to equivalent principle of progressively increasing, and is then added in dry granulating machine and particle, tabletting is made.That the present invention overcomes techniques in the prior art is cumbersome, efficiency is low, unstable product quality and be easy to cause the shortcomings of product rejection, production cost are high, and improves photophobism, reduces packing cost.
Description
Technical field
The present invention relates to pharmaceutical technology fields, disperse slowbreak piece and preparation method more particularly, to a kind of Mecobalamin.
Background technology
Dispersible tablet refers to that can be disintegrated evenly dispersed tablet rapidly in water.Relative to solids such as conventional tablet, capsules
Preparation, dispersible tablet have the characteristics that convenient to take, disintegration is rapid, it is high to absorb fast and bioavilability.Dispersible tablet be suitable for child,
Old men etc. have the crowd of dysphagia, are a kind of essential dosage forms.
Mecobalamin (Mecobalamin) is endogenous vitamin B12, is present in blood, marrow liquid, with vitamin B12 phase
Than, there is good improvement result to the conduction of neuron, nucleic acid-protein-fat metabolism can be promoted by methyl conversion reaction,
Its coenzyme as methionine synthetase can make homocysteine be converted into methionine, participate in deoxyribonucleoside and synthesize thymus gland
Pyrimidine process promotes nucleic acid, albumen synthesis, promotes the formation of conveying and axonal regeneration and myelin in axon, prevent axonal degeneration,
Repair damaged nerve fiber.Reach within 3 hours after oral medication peak plasma concentrations, it is in dose dependent to absorb.
Illumination decomposition can occur for Mecobalamin in a natural environment, this is because cobalt carbon key is unstable, be easily broken off.This point
The product that solution generates is hydroxycobalamin.The photolysis of Mecobalamin most easily carries out in aqueous solution, and when solid-state, this reaction carried out
It is very slow.Mecobalamin can also decompose at high temperature, decompose about 5% within 4 hours at 100 DEG C, major cleavage is at amide substance and mother
Body.230 DEG C or more direct carbonizations.Mecobalamin aqueous solution is hydrolyzed into carboxylic acid and amine substance under strong acid and highly basic.
Due to the unstability of Mecobalamin, most of Mecobalamin pharmaceutical dosage forms are all coating tablet or capsule, and are needed
Use foil sealing.In terms of dispersible tablet this one dosage type low temperature, CN200510105797.2 provides a kind of mecobalamin dispersible tables and its system
Preparation Method, but the auxiliary material performance that this method is selected is bad, is susceptible to shapeless, sliver of tabletting etc. in the actual production process
Situation；The production technology dried again using wet granulation in the preparation method, since the characteristic of Mecobalamin itself is in illumination and wet
It is very unstable in thermal environment, easily cause related substance in final products exceeded；And the product that this method prepares also needs
It avoids high temperature and is strictly protected from light, closed preservation, the term of validity is 2 years.
In conclusion in the prior art, technique is cumbersome, efficiency is low, unstable product quality, and be easy to cause product report
It is useless, cause production cost high.
Invention content
In view of the above-mentioned problems existing in the prior art, this application provides a kind of Mecobalamin dispersion slowbreak piece and its preparation sides
Method.That the present invention overcomes techniques in the prior art is cumbersome, efficiency is low, unstable product quality and be easy to cause product rejection, life
The shortcomings of cost is high is produced, and improves photophobism, reduces packing cost.Technical scheme is as follows：
A kind of preparation method of Mecobalamin dispersion slowbreak piece, including prepare disperse particles and prepare two steps of dispersible tablet；
The disperse particles that prepare refer to being proceeded as follows under the conditions of being protected from light：
(1) it is dispersed in 20~35 parts of gas-phase silicas are sonicated in 100 parts of solvents, the solvent is anhydrous
The volume ratio of the mixed liquor of ethanol/acetone, wherein absolute ethyl alcohol and acetone is 1:0.1~0.2；
(2) 2~5 parts of cellulose acetate phthalate CAP is added in the mixture that step (1) obtains, adds 3~5
The polyethylene acetal diethylamine acetate AEA of part；It is uniformly mixed under supersound process；
(3) Mecobalamin raw material is crossed into 300~400 mesh sieve, takes 20~30 parts to be added in the mixture that step (2) obtains and mixes
Uniformly；1~3 part of ethyl cellulose EC is added, is uniformly mixed；Number described above is mass fraction；
(4) mist projection granulating is carried out to the mixture that step (3) obtains；60~70 DEG C of the inlet air temperature of the mist projection granulating,
40~50 DEG C of leaving air temp, it is 120~150 microns to be granulated grain size, obtains disperse particles；
The dispersible tablet for preparing includes the following steps：
Dispersible tablet auxiliary material is respectively weighed into recipe quantity, is uniformly mixed；Auxiliary material and disperse particles are mixed according to equivalent principle of progressively increasing
It closes uniformly, is then added in dry granulating machine and particle, pinch roller 2~5MPa of pressure, pinch roller 14~30rpm of rotating speed, whole grain is made；So
The silica being sieved is added afterwards, total mixed, particle is uniformly mixed, tabletting；Each raw material in described the step of preparing dispersible tablet
Dosage is：
The disperse particles of corrresponding quality are taken according to every 1000 whole grain 0.5g containing Mecobalamin after whole grain；Lactose：56~60g；
Copolyvidone：1~3g；Pregelatinized starch：18~21g；Cross-linked carboxymethyl cellulose sodium：5~9g；Crospovidone：6~10g；Sweet tea
Sweet element：0.1~2g；Silica：2~4g.
The grain size of the gas-phase silica is 100~150nm；Whole grain speed in the dry granulating machine is 1450rpm,
Granulation mesh size is 0.6mm.
The present invention is beneficial to be had technical effect that：
1, the present invention is the dispersible tablet of double-layer coatings, while having the performance of dispersible tablet and slowbreak agent.It is dissolved in first after water
The rapid disintegration of layer coating, Mecobalamin and the second layer are coated the disperse particles to be formed dispersion and suspend in water.This dosage form is not only just
In taking, and Mecobalamin can also be kept being protected from light by second layer coatings so that even if at two hours after dispersible tablet dissolving
Within do not take, can still keep drug effect, the child that being very suitable for crying and screaming be unwilling to take medicine uses, and reduces waste.
This double-layer coatings for hectic fever environment also more resistant to；Even if ambient humidity is big, outer layer coating is slightly peeled off,
Still internal layer coating protects Mecobalamin active ingredient；And the requirement being kept in dark place is also reduced.In common dark-brown
3 years terms of validity can be maintained in plastics package；5 years terms of validity can be maintained in full foil sealing packaging.
2, present invention improves over the auxiliary materials of dispersible tablet, and fully optimized preparation process, simplified processing step reduce technique
Risk solves the problems, such as that production cost is high.
(1) excipient is improved to lactose by microcrystalline cellulose, and compressibility is more preferable when tabletting, is easily formed, it is not easy to sliver；
(2) adhesive is improved to copolyvidone by povidone, it is possible to reduce the dosage of povidone half is effectively relieved because poly-
The moisture absorption caused by ketone is tieed up, finished product hygroscopicity is reduced, ensures that product possesses better stability；
(3) disintegrant is improved to cross-linked carboxymethyl cellulose sodium by carboxyrnethyl starch sodium, low substitution-hydroxypropylcellulose, crosslinking gathers
Ketone is tieed up, compared with carboxyrnethyl starch sodium, low substitution-hydroxypropylcellulose, cross-linked carboxymethyl cellulose sodium, crospovidone meet water can be rapid
It expands, there is preferably disintegration effect, drug can be made more rapidly to be disintegrated and dissolve out, be the super-disintegrants in tablet, be used as medicine
The rate of release of effective ingredient during piece is disintegrated and improves；
(4) glidant eliminates magnesium stearate, can be disintegrated and disperse more rapidly；
(5) antiplastering aid talcum powder is eliminated, the Probability of adverse reaction is reduced.
3, prior art preparation dispersible tablet is through wet granulation, drying, tabletting, and the present invention directly uses dry granulation pressure
Piece eliminates wet granulation and drying course, and due to the characteristic of Mecobalamin itself, it is various that generation is extremely easy in decomposition in hygrothermal environment
Related substance will greatly reduce the generation in relation to substance using the present invention, ensure that product quality is stablized.
Specific implementation mode
Embodiment 1
The preparation method of Mecobalamin dispersion slowbreak piece provided in this embodiment is including preparing disperse particles and preparing dispersible tablet
Two steps；
The disperse particles that prepare refer to being proceeded as follows under the conditions of being protected from light：
(1) by grain size be 100~120nm 20g gas-phase silicas it is sonicated be dispersed in 100g solvents, institute
The mixed liquor that solvent is absolute ethyl alcohol/acetone is stated, the wherein volume ratio of absolute ethyl alcohol and acetone is 1:0.1；
(2) the cellulose acetate phthalate CAP of 2g is added in the mixture that step (1) obtains, adds the poly- second of 3g
Alkene acetal diethylamine acetate AEA；It is uniformly mixed under supersound process；
(3) Mecobalamin raw material is crossed into 400 mesh sieve, takes 20g to be added in the mixture that step (2) obtains and is uniformly mixed；Again plus
Enter the ethyl cellulose EC of a concentration of 1g, is uniformly mixed；
(4) mist projection granulating is carried out to the mixture that step (3) obtains；60~70 DEG C of the inlet air temperature of the mist projection granulating,
40~50 DEG C of leaving air temp, it is 120~150 microns to be granulated grain size, obtains disperse particles；After testing, Mecobalamin in disperse particles
Mass fraction be 43%.
The dispersible tablet for preparing includes the following steps：
Dispersible tablet auxiliary material is respectively weighed into recipe quantity, is uniformly mixed；Auxiliary material and disperse particles are mixed according to equivalent principle of progressively increasing
It closes uniformly, is then added in dry granulating machine and particle, pinch roller pressure 2MPa, pinch roller rotating speed 30rpm, whole grain, wherein whole grain is made
Speed is 1450rpm, and granulation mesh size is 0.6mm；Then the silica being sieved is added, total mixed, particle is uniformly mixed,
Tabletting；
The dosage of each raw material is in described the step of preparing dispersible tablet：
The disperse particles 1.17g of corrresponding quality is taken according to every 1000 whole grain 0.5g containing Mecobalamin after whole grain；Lactose：56g；
Copolyvidone：1g；Pregelatinized starch：18g；Cross-linked carboxymethyl cellulose sodium：5g；Crospovidone：6g；Honey element：0.1g；Dioxy
SiClx：2g.
Embodiment 2
The preparation method of Mecobalamin dispersion slowbreak piece provided in this embodiment is including preparing disperse particles and preparing dispersible tablet
Two steps；
The disperse particles that prepare refer to being proceeded as follows under the conditions of being protected from light：
(1) by grain size be 120~130nm 30g gas-phase silicas it is sonicated be dispersed in 100g solvents, institute
The mixed liquor that solvent is absolute ethyl alcohol/acetone is stated, the wherein volume ratio of absolute ethyl alcohol and acetone is 1:0.1~0.2；
(2) the cellulose acetate phthalate CAP of 3g is added in the mixture that step (1) obtains, adds the poly- second of 4g
Alkene acetal diethylamine acetate AEA；It is uniformly mixed under supersound process；
(3) Mecobalamin raw material is crossed into 325 mesh sieve, takes 25g to be added in the mixture that step (2) obtains and is uniformly mixed；Again plus
Enter the ethyl cellulose EC of a concentration of 2g, is uniformly mixed；G numbers described above are quality g numbers；
(4) mist projection granulating is carried out to the mixture that step (3) obtains；60~70 DEG C of the inlet air temperature of the mist projection granulating,
40~50 DEG C of leaving air temp, it is 120~150 microns to be granulated grain size, obtains disperse particles；After testing, Mecobalamin in disperse particles
Mass fraction be 39%.
The dispersible tablet for preparing includes the following steps：
Dispersible tablet auxiliary material is respectively weighed into recipe quantity, is uniformly mixed；Auxiliary material and disperse particles are mixed according to equivalent principle of progressively increasing
It closes uniformly, is then added in dry granulating machine and particle, pinch roller pressure 3MPa, pinch roller rotating speed 20rpm, whole grain, wherein whole grain is made
Speed is 1450rpm, and granulation mesh size is 0.6mm；Then the silica being sieved is added, total mixed, particle is uniformly mixed,
Tabletting；
The dosage of each raw material is in described the step of preparing dispersible tablet：
The disperse particles 1.28g of corrresponding quality is taken according to every 1000 whole grain 0.5g containing Mecobalamin after whole grain；Lactose：
58.5g；Copolyvidone：3g；Pregelatinized starch：20g；Cross-linked carboxymethyl cellulose sodium：7g；Crospovidone：8g；Honey element：
0.5g；Silica：3g.
Embodiment 3
The preparation method of Mecobalamin dispersion slowbreak piece provided in this embodiment is including preparing disperse particles and preparing dispersible tablet
Two steps；
The disperse particles that prepare refer to being proceeded as follows under the conditions of being protected from light：
(1) by grain size be 130~150nm 35g gas-phase silicas it is sonicated be dispersed in 100g solvents, institute
The mixed liquor that solvent is absolute ethyl alcohol/acetone is stated, the wherein volume ratio of absolute ethyl alcohol and acetone is 1:0.1~0.2；
(2) the cellulose acetate phthalate CAP of 5g is added in the mixture that step (1) obtains, adds the poly- second of 5g
Alkene acetal diethylamine acetate AEA；It is uniformly mixed under supersound process；
(3) Mecobalamin raw material is crossed into 300 mesh sieve, takes 30g to be added in the mixture that step (2) obtains and is uniformly mixed；Again plus
Enter the ethyl cellulose EC of a concentration of 3g, is uniformly mixed；G numbers described above are quality g numbers；
(4) mist projection granulating is carried out to the mixture that step (3) obtains；60~70 DEG C of the inlet air temperature of the mist projection granulating,
40~50 DEG C of leaving air temp, it is 120~150 microns to be granulated grain size, obtains disperse particles；After testing, Mecobalamin in disperse particles
Mass fraction be 38%.
The dispersible tablet for preparing includes the following steps：
Dispersible tablet auxiliary material is respectively weighed into recipe quantity, is uniformly mixed；Auxiliary material and disperse particles are mixed according to equivalent principle of progressively increasing
It closes uniformly, is then added in dry granulating machine and particle, pinch roller pressure 5MPa, pinch roller rotating speed 14rpm, whole grain, wherein whole grain is made
Speed is 1450rpm, and granulation mesh size is 0.6mm；Then the silica being sieved is added, total mixed, particle is uniformly mixed,
Tabletting；
The dosage of each raw material is in described the step of preparing dispersible tablet：
The disperse particles 1.32g of corrresponding quality is taken according to every 1000 whole grain 0.5g containing Mecobalamin after whole grain；Lactose：60g；
Copolyvidone：3g；Pregelatinized starch：21g；Cross-linked carboxymethyl cellulose sodium：9g；Crospovidone：10g；Honey element：2g；Dioxy
SiClx：4g.
Test case 1
By CN200510105797.2 as a comparison case 1, according to the detection method provided in comparative example 1 to Examples 1 to 3
The product being prepared is sampled detection, and calculates the sampling average result of each embodiment.
1, the specification for the Mecobalamin dispersion slowbreak piece that embodiment is prepared is 0.5mg Mecobalamins/piece.Related substance contains
Amount is respectively 1.29%, 1.23%, 1.38%.The maximum single impurity peaks peak area of standard regulation is not greater than contrast solution main peak
1/4 (0.5%) of peak area, each impurity peaks peak area and be not greater than contrast solution main peak peak area (2.0%), the application
The methylcobalamin tablet being prepared is met the requirements of the standard.
Dissolution determination requires to carry out according to controlled release drug dissolution rate test, and dissolution determination average value is respectively
100.12%, 100.03%, 100.09%.
2, disintegration time mensuration：Using lift disintegration tester, tablet is placed in 37 ± 1 DEG C of water, and shaking is to being completely dispersed
Required time is respectively 45 seconds, 38 seconds, 47 seconds.
3, dispersing uniformity：According to disintegration time limited inspection technique, using lift disintegration tester, the sieve pore internal diameter of stainless steel cloth is
710 μm, water temperature is 15-25 DEG C, takes for reagent product 6, is all disintegrated 60 seconds, 55 seconds, 68 seconds and passes through sieve.
4, strong illumination：4500 ± 500lx irradiates 4 hours, the catabolite of Mecobalamin increases separately 0.59%,
0.36%, 0.43%.
5, it is copied according to the method that comparative example 1 provides, finds its waste paper rate 10% or more, the embodiment of the present application 1
Waste paper rate can control within 3% in~3 preparation process.
Test case 2：The dissolubility of disperse particles is tested
Comparative example 2~6 is prepared according to the preparation method of the discrete particles of embodiment 2, only makes auxiliary material into other situations,
Specific auxiliary material is as shown in table 1.
Table 1
| Comparative example is numbered | Auxiliary material and dosage |
| Comparative example 2 | Gas-phase silica 30g, starch 9g |
| Comparative example 3 | Gas-phase silica 30g, Opadry 9g |
| Comparative example 4 | Gas-phase silica 30g, CAP 9g |
| Comparative example 5 | Gas-phase silica 30g, AEA 9g |
| Comparative example 6 | Gas-phase silica 30g, CAP 4.5g, AEA 4.5g |
| Embodiment 2 | Gas-phase silica 30g, CAP 3g, AEA 4g, EC 2g |
The disperse particles that comparative example 2~6 and embodiment 2 are prepared are subjected to strong 4500 ± 500lx of light and irradiate 5 respectively
It and 10 days, it is as shown in table 2 to measure the data in relation to substance and Mecobalamin content.Auxiliary material, which is commonly used, using other prepares disperse particles
Photophobism it is similar to comparative example 2~5, therefore repeat no more.
2 (unit of table：%)
Note 1：The content of Mecobalamin raw material used is 99.93% before experiment.
Note 2：When preparing comparative example, if being added without gas-phase silica, Mecobalamin raw material and coating material is only used to mix
Granulation, what is obtained is viscous group not of uniform size, can not obtain one one particle dress product；So the design of comparative example is necessary
Gas-phase silica is added.
As can be seen from Table 2, the Mecobalamin palliating degradation degree of the disperse particles of comparative example 6 and the disperse particles of embodiment 2 is most
It is small, therefore the disperse particles that comparative example 6 and embodiment 2 are prepared carry out slowbreak disintegration experiment.As a result it is point of comparative example 6
It is 50~55 minutes to dissipate the time that particle is disintegrated completely in simulated gastric fluid+simulated intestinal fluid, and the disperse particles of embodiment 2 are in people
The time being disintegrated completely in work gastric juice+simulated intestinal fluid is 25~30 minutes.
Claims (3)
1. a kind of preparation method of Mecobalamin dispersion slowbreak piece, it is characterised in that including preparing disperse particles and preparing dispersible tablet two
A step；
The disperse particles that prepare refer to being proceeded as follows under the conditions of being protected from light：
(1) it is dispersed in 20~35 parts of gas-phase silicas are sonicated in 100 parts of solvents, the solvent is anhydrous second
The volume ratio of the mixed liquor of alcohol/acetone, wherein absolute ethyl alcohol and acetone is 1:0.1~0.2；
(2) 2~5 parts of cellulose acetate phthalate CAP and 3~5 parts of polyethylene are added in the mixture that step (1) obtains
Acetal diethylamine acetate AEA is uniformly mixed under supersound process；
(3) the Mecobalamin raw material for taking 20~30 parts of 300~400 mesh of mistake to sieve is added in the mixture that step (2) obtains and mixes
It is even；1~3 part of ethyl cellulose EC is added, is uniformly mixed；
(4) mist projection granulating is carried out to the mixture that step (3) obtains；60~70 DEG C of the inlet air temperature of the mist projection granulating, outlet air
40~50 DEG C of temperature, it is 120~150 microns to be granulated grain size, obtains disperse particles；Number described in above step is mass parts
Number；
The dispersible tablet for preparing includes the following steps：
Dispersible tablet auxiliary material is weighed into recipe quantity respectively, is uniformly mixed；Auxiliary material is mixed with disperse particles according to equivalent principle of progressively increasing
Uniformly, it is then added in dry granulating machine and particle, pinch roller 2~5MPa of pressure, pinch roller 14~30rpm of rotating speed, whole grain is made；Then
The silica being sieved is added, total mixed, particle is uniformly mixed, tabletting；
The dosage of the raw material each when preparing dispersible tablet is：
The quality of disperse particles is the dosage of every 1000 whole grain 0.5g containing Mecobalamin after whole grain；Lactose：56~60g；Copolymerization dimension
Ketone：1~3g；Pregelatinized starch：18~21g；Cross-linked carboxymethyl cellulose sodium：5~9g；Crospovidone：6~10g；Honey element：
0.1~2g；Silica：2~4g.
2. the preparation method of Mecobalamin dispersion slowbreak piece according to claim 1, it is characterised in that the gas-phase silica
Grain size be 100~150nm.
3. the preparation method of Mecobalamin dispersion slowbreak piece according to claim 1, it is characterised in that the dry granulating machine
Interior whole grain speed is 1450rpm, and granulation mesh size is 0.6mm.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810235894.0A CN108272766B (en) | 2018-03-21 | 2018-03-21 | Mecobalamin dispersion delayed-release tablet and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810235894.0A CN108272766B (en) | 2018-03-21 | 2018-03-21 | Mecobalamin dispersion delayed-release tablet and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN108272766A true CN108272766A (en) | 2018-07-13 |
| CN108272766B CN108272766B (en) | 2020-07-07 |
Family
ID=62810159
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201810235894.0A Active CN108272766B (en) | 2018-03-21 | 2018-03-21 | Mecobalamin dispersion delayed-release tablet and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN108272766B (en) |
Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3101293A (en) * | 1960-05-17 | 1963-08-20 | Strong Cobb Arner Inc | Controlled release compositions and their preparation |
| CN1134108A (en) * | 1994-07-08 | 1996-10-23 | 阿斯特拉公司 | Beads for controlled release and pharmaceutical preparation contg. same |
| CN1388758A (en) * | 2000-08-09 | 2003-01-01 | 灵药生物技术有限公司 | Pharmaceutical compositions of anti-tubercular drugs and process for their preparation |
| WO2006048895A1 (en) * | 2004-11-08 | 2006-05-11 | Rubicon Research Pvt. Ltd. | Aqueous pharmaceutical coating |
| WO2007085888A1 (en) * | 2006-01-27 | 2007-08-02 | Wockhardt Limited | Controlled release formulations of methylcobalamin |
| CN102716102A (en) * | 2012-05-30 | 2012-10-10 | 杭州康恩贝制药有限公司 | Mecobalamin tablet and preparation method thereof |
| CN106107055A (en) * | 2016-06-30 | 2016-11-16 | 湖南晶天科技实业有限公司 | A kind of feed additive enteric coating butanoic acid and preparation method and a kind of feedstuff |
| WO2016185413A1 (en) * | 2015-05-20 | 2016-11-24 | Nestec S.A. | Modified release formulations |
-
2018
- 2018-03-21 CN CN201810235894.0A patent/CN108272766B/en active Active
Patent Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3101293A (en) * | 1960-05-17 | 1963-08-20 | Strong Cobb Arner Inc | Controlled release compositions and their preparation |
| CN1134108A (en) * | 1994-07-08 | 1996-10-23 | 阿斯特拉公司 | Beads for controlled release and pharmaceutical preparation contg. same |
| CN1388758A (en) * | 2000-08-09 | 2003-01-01 | 灵药生物技术有限公司 | Pharmaceutical compositions of anti-tubercular drugs and process for their preparation |
| WO2006048895A1 (en) * | 2004-11-08 | 2006-05-11 | Rubicon Research Pvt. Ltd. | Aqueous pharmaceutical coating |
| WO2007085888A1 (en) * | 2006-01-27 | 2007-08-02 | Wockhardt Limited | Controlled release formulations of methylcobalamin |
| CN102716102A (en) * | 2012-05-30 | 2012-10-10 | 杭州康恩贝制药有限公司 | Mecobalamin tablet and preparation method thereof |
| WO2016185413A1 (en) * | 2015-05-20 | 2016-11-24 | Nestec S.A. | Modified release formulations |
| CN106107055A (en) * | 2016-06-30 | 2016-11-16 | 湖南晶天科技实业有限公司 | A kind of feed additive enteric coating butanoic acid and preparation method and a kind of feedstuff |
Non-Patent Citations (3)
| Title |
|---|
| S.SBIJU ET AL.: "Dual coated erodible microcapsules for modified release of diclofenac sodium", 《EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS》 * |
| 李玲: "薄膜包衣技术的应用", 《中国药业》 * |
| 赵振宇: "颗粒剂包衣材料的现状", 《天津药学》 * |
Also Published As
| Publication number | Publication date |
|---|---|
| CN108272766B (en) | 2020-07-07 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US10189957B2 (en) | Formulation process method to produce spray dried products | |
| JPS62174013A (en) | Vitamin granule for direct tableting, production thereof and tablet prepared therefrom | |
| WO1995013794A1 (en) | Process for producing stable medicinal composition, and pharmaceutical preparation | |
| CN105030725B (en) | Vonoprazan fumarate enteric-coated composition and preparation method thereof | |
| RU2713428C1 (en) | Particles containing amorphous empagliflozin, a method for preparing them and a medicinal agent containing them | |
| CN108078944A (en) | Solid composite containing ticagrelor and preparation method thereof | |
| CN112206213A (en) | Sildenafil citrate composition and preparation method thereof | |
| CN109718215A (en) | A kind of Ezetimibe piece | |
| CN105476970B (en) | A kind of Huangyangning dispersion tablets and preparation method thereof | |
| CN108272766A (en) | A kind of Mecobalamin dispersion slowbreak piece and preparation method thereof | |
| CN108836973B (en) | Metformin-glibenclamide capsule and preparation method thereof | |
| CN105919943A (en) | Clonidine hydrochloride controlled-release granule and preparation method thereof | |
| CN104758266B (en) | A kind of felodipine sustained-release tablets and its preparation technology | |
| CN108888603B (en) | Amoxicillin tablet and preparation method thereof | |
| CN106692149A (en) | Cariprazine medical oral preparation and preparation method thereof | |
| CN112245402A (en) | Indapamide tablet and preparation method thereof | |
| CN101991859A (en) | Beta-cyclodextrin inclusion compound of huperzine A, and preparation method and preparation thereof | |
| CN112353784A (en) | Aspirin enteric-coated micro-tablet capsule and preparation method thereof | |
| CN110237097A (en) | A kind of Fufang Anfenwanan capsules pellet and preparation method thereof | |
| CN105560209B (en) | A kind of compound preparation and preparation method thereof for treating cardiovascular disease | |
| CN104490790A (en) | Cefuroxime axetil solid dispersion-coated composition and preparation method thereof | |
| JP2020111532A (en) | Solid preparation comprising vitamin b1 | |
| CA2433962C (en) | Antibacterial clarithromycin compositions and processes for making the same | |
| CN113244197B (en) | Carbamazepine sustained-release capsule and preparation method thereof | |
| CN113599366B (en) | Tenofovir disoproxil fumarate granules and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant |