CN106692101A - Mecobalamin tablet and preparation method thereof - Google Patents
Mecobalamin tablet and preparation method thereof Download PDFInfo
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- CN106692101A CN106692101A CN201710001902.0A CN201710001902A CN106692101A CN 106692101 A CN106692101 A CN 106692101A CN 201710001902 A CN201710001902 A CN 201710001902A CN 106692101 A CN106692101 A CN 106692101A
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- tablet
- coating
- label
- mecobalamin
- methylcobalamin
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- 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
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- 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
- A61K9/2806—Coating materials
- A61K9/2813—Inorganic compounds
Abstract
The invention provides a mecobalamin tablet and a preparation method thereof. The mecobalamin tablet is composed of a tablet core and a film coating layer. The weight of the film coating layer is 3-5% that of the tablet core. The tablet core comprises, by weight percentage, 0.5-1% of mecobalamin, 87-93.5% of filler, 5-10% of adhesive and 1-2% of lubricant. Raw materials and auxiliary materials of the prescription amount are sieved, premixed and pelletized and undergo dry method tabletting, coating solution preparation, coating and packaging to obtain the mecobalamin tablet. The mecobalamin tablet and the preparation method thereof have the advantages that the mecobalamin tablet is high in active ingredient content, inter-assay reproducibility and good in stability, the bioavailability of the mecobalamin tablet is improved remarkably, a patient's compliance is improved, the medicine stability is improved, the production cost is reduced, and the production efficiency is improved.
Description
Technical field
The present invention relates to pharmaceutical technology field, more particularly to a kind of methylcobalamin tablet and preparation method thereof.
Background technology
With the continuous improvement of the living standard of our people, the incidence of disease of diabetes is gradually rising.According to world health
Tissue statistics, the diabetic of China reached 20,000,000 people from 1998 to 2000, and ascendant trend is extremely bright
It is aobvious, if do not controlled effectively, 60,000,000 people were up to by 2010.Peripheral neuropathy is the most common of diabetes
One of serious complication, the incidence of disease can reach 80% or so.Diabete peripheral herve venereal disease becomes can make patient produce limbs fiber crops
Wood, occurs extremity ulcer, muscular atrophy and violent pain when serious, or even causes the necrosis of limbs to cause maimed person.First cobalt
Amine is the medicine of peripheral neuropathy.It is by promoting the conjunction of nerve cell nucleic acid and protein and neural myelin
Into so that the peripheral nerve of repairing damage, is widely used to clinic at present.
From Spies in 1948 et al. using vitamin B12 as since drug research, the research of vitamin B12 obtains at full speed
Development.Up to the present, mainly have as the vitamin B12 of medicine：Cyanocobalamin, hydroxycobalamin, cobamamide and Mecobalamin.Before
Two kinds of vitamin B12s do not have bioactivity in human body：Cyanocobalamin (vitamin B12) with cobalt amine transporter in vivo through being combined
Form Tcs-VB12 compounds and take in cell, hydroxycobalamin is then gone out by lysosomal protein enzyme r e lease, hydroxycobalamin is in cell liquid
Methylate generation Mecobalamin.Latter two DBC has been carried out artificial synthesized, and this is for peripheral neuropathy patient
Treatment provides powerful mean.In terms of impaired nerve fiber is repaired, cobamamide must first be converted into Mecobalamin could be made
For coenzyme participates in one carbon unit circulation, so as to promote the synthesis of nucleic acid, protein and lecithin.
Mecobalamin is primarily present in blood, the marrow liquid of biology, and compared with cyanocobalamin, it has good biography to nerve fiber
Passing property, nucleic acid, protein, lipid-metabolism, the nerve fiber that reparation is damaged are promoted by methyl conversion reaction.
Clinical test results show that Mecobalamin is a kind of safe and effective medicine for treating diabetic neuropathy；First cobalt
The curative effect that amine and vitamin B12 have good therapeutic action, Mecobalamin to peripheral facial paralysis is better than vitamin B12；Mecobalamin pair
Cubital tunnel syndrome Post operation functional rehabilitation has facilitation, and its curative effect is better than vitamin B12；Mecobalamin also has prevention glaucoma
Property the visual field deteriorate and promote its visual field improve effect.Methylcobalamin tablet uses traditional wet granulation technique, work in the prior art
Skill is cumbersome, and particularly time-consuming for drying.
The content of the invention
A kind of preparation method it is an object of the invention to disclose methylcobalamin tablet and its methylcobalamin tablet, is used to be to realize improving
The content of active ingredient in methylcobalamin tablet, improves bioavilability and stability, and reduce production cost.
To realize above-mentioned first goal of the invention, the invention provides a kind of methylcobalamin tablet, by label and film-coating layer group
Into；
Wherein, film-coating layer weight is the 3~5% of label weight, and label is prepared from the following ingredients in percentage by weight：First
Cobalt amine 0.5~1%, filler 87~93.5%, adhesive 5~10%, lubricant 1~2%.
As a further improvement on the present invention, the label is made up of the component of following weight portion：0.75 part of Mecobalamin, fill out
Fill 90.25 parts of agent, 7.5 parts of adhesive, 1.5 parts of lubricant；
The based calcium is made up of the component of following weight portion：4.07 parts of film-coating material, 0.93 part of opacifier, second
100 parts of alcohol；Film-coating layer weight is the 4% of label weight.
As a further improvement on the present invention, the filler is selected from starch, lactose, dextrin, amylum pregelatinisatum, crystallite fibre
The mixture of one or more arbitrary proportions in dimension element and Icing Sugar.
As a further improvement on the present invention, described adhesive is selected from starch, pregelatinized starch, hydroxypropylcellulose, hydroxypropyl
The mixture of one or more arbitrary proportions in methylcellulose and PVP.
As a further improvement on the present invention, the film-coating material is selected from Hydroxypropyl methylcellulose, hydroxypropyl cellulose, gathers
The mixture of one or more arbitrary proportions in acrylic resin, polyethylene glycol, talcum powder.
As a further improvement on the present invention, the opacifier is titanium dioxide.
To realize above-mentioned second goal of the invention, present invention further teaches a kind of described Mecobalamin of any of the above-described invention
The preparation method of piece, comprises the following steps：
Step (1), the supplementary material for weighing recipe quantity, cross 80~100 mesh sieves standby respectively；
Step (2), premix：During supplementary material after sieving put into wet granulator, premix 10~15 minutes, form mixed
Powder；
Step (3), granulation：Mixed powder is transferred in dry granulating machine and is granulated, setup parameter is in the dry granulating machine：
30~50kg/cm of oil pressure2, 5~10Hz of feeding, 15~20Hz of compressing tablet, pelletize 8~12Hz, and dry particl is obtained carries out whole grain simultaneously；
Step (4), compressing tablet：By in the material addition mixer after whole grain, lubricant is added, be well mixed, compressing tablet obtains piece
Core, compressing tablet hardness is controlled in 40~80N；
It is prepared by step (5), coating solution：Recipe quantity coating material is weighed, is added in ethanol, stirring is added to dissolving
Opacifier, talcum powder obtain coating solution；
Step (6), coating：Take step (4) gained label to put in coating pan, preheating starts to coating pan after 15~30 minutes
Coating solution obtained by interior spray step (5), while blowing hot-air, when weightening 3~5%, stops being coated, dries, and obtains the Mecobalamin
Piece.
Step (7), packaging：The double aluminium packagings of cold forming.
As a further improvement on the present invention, pre- the doing time in the step (2) is 10~15 minutes；Whole grain is to use Φ
1.0mm nylon screen whole grains.
As a further improvement on the present invention, the coating pan rotating speed in the step (6) is 10~15rpm, EAT
It it is 55~65 DEG C, drying temperature is 60~70 DEG C.
As a further improvement on the present invention, in the step (7) the double aluminium packagings of cold forming are specially cold stamping shaped
Double aluminium packaging.
Compared with prior art, the beneficial effects of the invention are as follows：A kind of disclosed methylcobalamin tablet and its preparation
Method, have the advantages that active constituent content is high, bioavilability is high, batch between favorable reproducibility, good stability, increase patient's compliance
Property, improve the stability of medicine, moreover it is possible to reduce production cost, improve production efficiency.
Specific embodiment
With reference to each implementation method, the present invention is described in detail, but it should explanation, these implementation methods are simultaneously
Non- limitation of the present invention, those of ordinary skill in the art are according in these implementation method institutes works energy, method or structure
Equivalent transformation or replacement, belong within protection scope of the present invention.
Embodiment 1：
The recipe quantity of every 1000 methylcobalamin tablets is as follows.
Label is made up of following component：Mecobalamin 0.5g, lactose 82g, hydroxypropyl cellulose 5.5g, starch 10.95g, firmly
Fatty acid magnesium 1.05g.
The preparation method of the methylcobalamin tablet is comprised the following steps：
Step (1), the supplementary material for weighing above-mentioned recipe quantity, cross 80 mesh sieves standby respectively.
Step (2), premix：During supplementary material after sieving put into wet granulator, premix 15 minutes, form mixed powder.
Step (3), granulation：Mixed powder is transferred in dry granulating machine and is granulated, setup parameter is in the dry granulating machine：
30~50kg/cm of oil pressure2, 5~10Hz of feeding, 15~20Hz of compressing tablet, pelletize 8~12Hz, and dry particl is obtained carries out whole grain simultaneously.
Step (4), compressing tablet：By in the material addition mixer after whole grain, lubricant is added, be well mixed, compressing tablet is obtained
Label.Compressing tablet hardness is controlled in 40N.
It is prepared by step (5), coating solution：Weigh recipe quantity coating material and be added to concentration in 95wt% ethanol, stirring is extremely
Dissolving, and add opacifier, talcum powder to obtain coating solution.The based calcium is made up of the component of following weight portion：Film-coating
4.07 parts of material, 0.93 part of opacifier, 100 parts of ethanol；Film-coating layer weight is the 4% of label weight.Specifically, in this example
In, the film-coating material is selected from Hydroxypropyl methylcellulose, and opacifier is selected from titanium dioxide.
Step (6), coating：Take step (4) gained label to put in coating pan, preheating starts to coating pan after 15~30 minutes
Coating solution obtained by interior spray step (5), while blowing hot-air, when increase weight 4% when, stop being coated, dry, obtain the methylcobalamin tablet.
Step (7), packaging：The double aluminium packagings of cold forming, specially cold stamping shaped double aluminium packaging.
Embodiment 2：
The recipe quantity of every 1000 methylcobalamin tablets is as follows.
Label is made up of following component：Mecobalamin 0.5g, lactose 82g, PVP 5.5g, starch 10.95g, magnesium stearate
1.05g。
The preparation method of the methylcobalamin tablet is comprised the following steps：
Step (1), the supplementary material for weighing above-mentioned recipe quantity, cross 80 mesh sieves standby respectively.
Step (2), premix：During supplementary material after sieving put into wet granulator, premix 15 minutes, form mixed powder.
Step (3), granulation：Mixed powder is transferred in dry granulating machine and is granulated, setup parameter is in the dry granulating machine：
30~50kg/cm of oil pressure2, 5~10Hz of feeding, 15~20Hz of compressing tablet, pelletize 8~12Hz, and dry particl is obtained carries out whole grain simultaneously.
Step (4), compressing tablet：By in the material addition mixer after whole grain, lubricant is added, be well mixed, compressing tablet is obtained
Label.Compressing tablet hardness is controlled in 80N.
It is prepared by step (5), coating solution：Weigh recipe quantity coating material and be added to concentration in 95wt% ethanol, stirring is extremely
Dissolving, and add opacifier, talcum powder to obtain coating solution.The based calcium is made up of the component of following weight portion：Film-coating
4.07 parts of material, 0.93 part of opacifier, 100 parts of ethanol；Film-coating layer weight is the 3% of label weight.Specifically, in this example
In, the film-coating material is selected from hydroxypropyl cellulose, and opacifier is selected from titanium dioxide.
Step (6), coating：Take step (4) gained label to put in coating pan, preheating starts to coating pan after 15~30 minutes
Coating solution obtained by interior spray step (5), while blowing hot-air, when increase weight 4% when, stop being coated, dry, obtain the methylcobalamin tablet.
Step (7), packaging：The double aluminium packagings of cold forming, specially cold stamping shaped double aluminium packaging.
Embodiment 3：
The recipe quantity of every 1000 methylcobalamin tablets is as follows.
Label is made up of following component：Mecobalamin 0.5g, lactose 82g, PVP 5.5g, starch 10.95g, talcum powder
1.05g。
The preparation method of the methylcobalamin tablet is comprised the following steps：
Step (1), the supplementary material for weighing above-mentioned recipe quantity, cross 100 mesh sieves standby respectively.
Step (2), premix：During supplementary material after sieving put into wet granulator, premix 15 minutes, form mixed powder.
Step (3), granulation：Mixed powder is transferred in dry granulating machine and is granulated, setup parameter is in the dry granulating machine：
30~50kg/cm of oil pressure2, 5~10Hz of feeding, 15~20Hz of compressing tablet, pelletize 8~12Hz, and dry particl is obtained carries out whole grain simultaneously.
Step (4), compressing tablet：By in the material addition mixer after whole grain, lubricant is added, be well mixed, compressing tablet is obtained
Label.Compressing tablet hardness is controlled in 50N.
It is prepared by step (5), coating solution：Weigh recipe quantity coating material and be added to concentration in 95wt% ethanol, stirring is extremely
Dissolving, and add opacifier, talcum powder to obtain coating solution.The based calcium is made up of the component of following weight portion：Film-coating
4.07 parts of material, 0.93 part of opacifier, 100 parts of ethanol；Film-coating layer weight is the 5% of label weight.Specifically, in this example
In, the film-coating material is selected from acrylic resin, and opacifier is selected from titanium dioxide.
Step (6), coating：Take step (4) gained label to put in coating pan, preheating starts to coating pan after 15~30 minutes
Coating solution obtained by interior spray step (5), while blowing hot-air, when increase weight 4% when, stop being coated, dry, obtain the methylcobalamin tablet.
Step (7), packaging：The double aluminium packagings of cold forming, specially cold stamping shaped double aluminium packaging.
Embodiment 4：
The recipe quantity of every 1000 methylcobalamin tablets is as follows.
Label is made up of following component：Mecobalamin 0.5g, microcrystalline cellulose 82g, PVP 5.5g, starch 10.95g are sliding
Stone flour 1.05g.
The preparation method of the methylcobalamin tablet is comprised the following steps：
Step (1), the supplementary material for weighing above-mentioned recipe quantity, cross 90 mesh sieves standby respectively.
Step (2), premix：During supplementary material after sieving put into wet granulator, premix 15 minutes, form mixed powder.
Step (3), granulation：Mixed powder is transferred in dry granulating machine and is granulated, setup parameter is in the dry granulating machine：
30~50kg/cm of oil pressure2, 5~10Hz of feeding, 15~20Hz of compressing tablet, pelletize 8~12Hz, and dry particl is obtained carries out whole grain simultaneously.
Step (4), compressing tablet：By in the material addition mixer after whole grain, lubricant is added, be well mixed, compressing tablet is obtained
Label.Compressing tablet hardness is controlled in 60N.
It is prepared by step (5), coating solution：Weigh recipe quantity coating material and be added to concentration in 95wt% ethanol, stirring is extremely
Dissolving, and add opacifier, talcum powder to obtain coating solution.The based calcium is made up of the component of following weight portion：Film-coating
4.07 parts of material, 0.93 part of opacifier, 100 parts of ethanol；Film-coating layer weight is the 3.5% of label weight.Specifically, in this reality
In example, the film-coating material is selected from the mixture of polyethylene glycol and talcum powder, and both ratios are 1：1, opacifier is selected from dioxy
Change titanium.
Step (6), coating：Take step (4) gained label to put in coating pan, preheating starts to coating pan after 15~30 minutes
Coating solution obtained by interior spray step (5), while blowing hot-air, when increase weight 4% when, stop being coated, dry, obtain the methylcobalamin tablet.
Step (7), packaging：The double aluminium packagings of cold forming, specially cold stamping shaped double aluminium packaging.
Influence factor is tested：
1) strong illumination experiment：Methylcobalamin tablet sample obtained in Example 4, is placed in closed clean container,
Placed under 4500Lx ± 500Lx illumination, sampled respectively at 0,5,10 days, detected according to content is investigated.
2) hot test：Methylcobalamin tablet sample obtained in Example 4, places, respectively at 0,5,10 under the conditions of 60 DEG C
Its sampling, is detected according to content is investigated.
3) high humility experiment：Methylcobalamin tablet sample obtained in Example 4, opening is placed in the clean container of closed constant humidity
In, in RH90.0% ± 5% (saturation KNO3Solution, RH92.5%) and the decentralization of RH75% ± 5% (saturation NaCl solution) condition
Put, sampled respectively at 0,5,10 days, detected according to content is investigated.
The illumination effect result of the test (4500lx) of table 1
The high temperature of table 2 influences result of the test (60 DEG C)
The high humidity of table 3 influences result of the test (RH92.5%)
The high humidity of table 4 influences result of the test (RH75%)
Accelerated test：
Methylcobalamin tablet sample obtained in Example 1 to embodiment 3, simulation listing packaging, in 40 DEG C ± 2 DEG C of temperature, RH
Placed 6 months under conditions of 75 ± 5%；Sampled once at 0,1,2,3,6 the end of month investigated respectively, according to the content investigated
Carry out item detection.
The accelerated test of table 5 (40 DEG C ± 2 DEG C, RH 75% ± 5%)
Long term test：
Example 1 is to implementing methylcobalamin tablet sample obtained in 3, simulation listing packaging, in 25 DEG C ± 2 DEG C of temperature, RH
Placed under conditions of 60% ± 10% 12 months, respectively with 0,3,6,9,12,18,24, the 36 the end of month sampling investigated once, pressed
Item detection is carried out according to the content investigated.
The long term test of table 6 (25 DEG C ± 2 DEG C, RH 60% ± 10%)
Evaluation of test result：
1) exposure experiments to light：After illumination 5,10 days, relevant material in methylcobalamin tablet rises to 2.04% from 1.06%,
2.57%, there is certain change, content drops to 98.65 from 99.70 after illumination 10 days, varies slightly, and other indexs are without significant change.
2) hot test：After 60 DEG C of hot conditions are placed 10 days, the relevant material of methylcobalamin tablet rises to from 1.06%
2.19%, content is varied slightly, and 98.68% is down to from 99.70%, and other indexs are without significant change.
3) high humility experiment：After RH92.5% super-humid conditions are placed 10 days, weight increases by 37.66%, and other indexs are basic
It is unchanged.After being placed 10 days under RH75% high humidities, weight increases by 6.65%, and other indexs are substantially unchanged.
4) accelerated test：After being placed 6 months under the conditions of accelerated test, the relevant material point in three batches of samples in methylcobalamin tablet
1.27%, 1.34%, 1.33% is not risen to from 1.01%, 1.06%, 1.09%, is had increased slightly, other indexs such as content are without bright
Aobvious change.
5) long term test：Long term test has been carried out 36 months.Under conditions of this experiment, after placing 36 months, three lot samples
The relevant material of methylcobalamin tablet increases in product, rise to 1.22% from 1.01%, 1.06%, 1.09% respectively, 1.25%,
1.23%；Other indexs such as content are without significant change.
Conclusion：
Influence factor result of the test shows that illumination condition can produce certain influence to the relevant material of methylcobalamin tablet, high
Warm condition slightly influences on the relevant material of methylcobalamin tablet, content, and super-humid conditions piece increases more substantially again, but does not influence other matter
Figureofmerit；After accelerated test 6 months and long-term placement are tested 36 months, the quality of this product is not changed significantly, indices
Still in the claimed range of quality standard.Therefore, it is suggested that this product lucifuge, keeping away high temperature, closed preservation.As can be seen here, it is of the invention
Pharmaceutical composition reasonable mixture ratio, feasible process, package materials selection is reasonable.Product quality stabilization, favorable reproducibility between batch.
Those listed above is a series of to be described in detail only for feasibility implementation method of the invention specifically
Bright, they simultaneously are not used to limit the scope of the invention, all equivalent implementations made without departing from skill spirit of the present invention
Or change should be included within the scope of the present invention.
It is obvious to a person skilled in the art that the invention is not restricted to the details of above-mentioned one exemplary embodiment, Er Qie
In the case of without departing substantially from spirit or essential attributes of the invention, the present invention can be in other specific forms realized.Therefore, no matter
From the point of view of which point, embodiment all should be regarded as exemplary, and be nonrestrictive, the scope of the present invention is by appended power
Profit requires to be limited rather than described above, it is intended that all in the implication and scope of the equivalency of claim by falling
Change is included in the present invention.
Moreover, it will be appreciated that although the present specification is described in terms of embodiments, not each implementation method is only wrapped
Containing an independent technical scheme, this narrating mode of specification is only that for clarity, those skilled in the art should
Specification an as entirety, the technical scheme in each embodiment can also be formed into those skilled in the art through appropriately combined
May be appreciated other embodiment.
Claims (10)
1. a kind of methylcobalamin tablet, it is characterised in that be made up of label and film-coating layer；
Wherein, film-coating layer weight is the 3~5% of label weight, and label is prepared from the following ingredients in percentage by weight：Mecobalamin
0.5~1%, filler 87~93.5%, adhesive 5~10%, lubricant 1~2%.
2. methylcobalamin tablet according to claim 1, it is characterised in that the label is made up of the component of following weight portion：
0.75 part of Mecobalamin, 90.25 parts of filler, 7.5 parts of adhesive, 1.5 parts of lubricant；
The based calcium is made up of the component of following weight portion：4.07 parts of film-coating material, 0.93 part of opacifier, ethanol
100 parts；Film-coating layer weight is the 4% of label weight.
3. methylcobalamin tablet according to claim 2, it is characterised in that the filler be selected from starch, lactose, dextrin, can
The mixture of one or more arbitrary proportions in pressure property starch, microcrystalline cellulose and Icing Sugar.
4. methylcobalamin tablet according to claim 2, it is characterised in that described adhesive is selected from starch, pregelatinized starch, hydroxyl
Third cellulose, Hydroxypropyl methylcellulose and in PVP one or more arbitrary proportions mixture.
5. methylcobalamin tablet according to claim 2, it is characterised in that the film-coating material be selected from Hydroxypropyl methylcellulose,
The mixture of one or more arbitrary proportions in hydroxypropyl cellulose, polyacrylic resin, polyethylene glycol, talcum powder.
6. methylcobalamin tablet according to claim 2, it is characterised in that the opacifier is titanium dioxide.
7. the preparation method of a kind of methylcobalamin tablet as any one of claim 1~6, it is characterised in that including as follows
Step：
Step (1), the supplementary material for weighing recipe quantity, cross 80~100 mesh sieves standby respectively；
Step (2), premix：During supplementary material after sieving put into wet granulator, premix 10~15 minutes, form mixed powder；
Step (3), granulation：Mixed powder is transferred in dry granulating machine and is granulated, setup parameter is in the dry granulating machine：Oil pressure
30~50kg/cm2, 5~10Hz of feeding, 15~20Hz of compressing tablet, pelletize 8~12Hz, and dry particl is obtained carries out whole grain simultaneously；
Step (4), compressing tablet：By in the material addition mixer after whole grain, lubricant is added, be well mixed, compressing tablet obtains label, pressure
Piece hardness is controlled in 40~80N；
It is prepared by step (5), coating solution：Recipe quantity coating material is weighed, is added in ethanol, stirring adds shading to dissolving
Agent, talcum powder obtain coating solution；
Step (6), coating：Take step (4) gained label to put in coating pan, preheating starts to be sprayed in coating pan after 15~30 minutes
Coating solution obtained by step (5), while blowing hot-air, when weightening 3~5%, stops being coated, dries, and obtains the methylcobalamin tablet.
Step (7), packaging：The double aluminium packagings of cold forming.
8. preparation method according to claim 7, it is characterised in that pre- the doing time in the step (2) is 10~15
Minute；Whole grain is with Φ 1.0mm nylon screen whole grains.
9. preparation method according to claim 7, it is characterised in that coating pan rotating speed in the step (6) for 10~
15rpm, EAT is 55~65 DEG C, and drying temperature is 60~70 DEG C.
10. preparation method according to claim 7, it is characterised in that the double aluminium packaging tools of cold forming in the step (7)
Body is cold stamping shaped double aluminium packaging.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201710001902.0A CN106692101A (en) | 2017-01-03 | 2017-01-03 | Mecobalamin tablet and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201710001902.0A CN106692101A (en) | 2017-01-03 | 2017-01-03 | Mecobalamin tablet and preparation method thereof |
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ID=58905795
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108403655A (en) * | 2018-04-24 | 2018-08-17 | 江苏四环生物制药有限公司 | A kind of preparation method of methylcobalamin tablet |
| CN110251477A (en) * | 2019-08-07 | 2019-09-20 | 北京斯利安药业有限公司 | A kind of methylcobalamin tablet and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104784049A (en) * | 2014-01-17 | 2015-07-22 | 南京瑞尔医药有限公司 | Preparation method for mecobalamin tablets |
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2017
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108403655A (en) * | 2018-04-24 | 2018-08-17 | 江苏四环生物制药有限公司 | A kind of preparation method of methylcobalamin tablet |
| CN110251477A (en) * | 2019-08-07 | 2019-09-20 | 北京斯利安药业有限公司 | A kind of methylcobalamin tablet and preparation method thereof |
| CN110251477B (en) * | 2019-08-07 | 2021-09-28 | 北京斯利安药业有限公司 | Mecobalamin tablet and preparation method thereof |
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Application publication date: 20170524 |