CN106344532A - Preparation method of cobamamide tablets - Google Patents
Preparation method of cobamamide tablets Download PDFInfo
- Publication number
- CN106344532A CN106344532A CN201610794348.1A CN201610794348A CN106344532A CN 106344532 A CN106344532 A CN 106344532A CN 201610794348 A CN201610794348 A CN 201610794348A CN 106344532 A CN106344532 A CN 106344532A
- Authority
- CN
- China
- Prior art keywords
- cobamamide
- preparation
- piece
- ethanol solution
- tablets
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Classifications
-
- 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
- A61K9/2059—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
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Molecular Biology (AREA)
- Inorganic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention relates to a preparation method of cobamamide tablets. The preparation method includes: evenly mixing auxiliary materials weighed according to prescription, slowly adding into a 40-50% ethanol solution dissolved with cobamamide to prepare soft materials, pelletizing twice, drying, adding magnesium stearate, tableting and performing sugar-coating to obtain the cobamamide tablets, wherein the 40-50% ethanol solution dissolved with the cobamamide is prepared by dissolving the cobamamide with a small amount of purified water, adding the cobamamide dissolved in the purified water into the 40-50% ethanol solution and stirring until sufficient dissolving is achieved. By the preparation method, the product uniformity and stability of the cobamamide tablets can be increased effectively, and accordingly product quality is increased.
Description
Technical field
The invention belongs to pharmaceutical technology field, more particularly to a kind of preparation method of cobamamide piece.
Background technology
Cobamamide piece is used for vitamin b12Disease caused by lacking, such as anemia in pregnancy, malnutritional anemia.Also may be used
Auxiliary treatment for nutritional disorder and lonizing radiation and drug-induced leukopenia.
Determine that prescription is cobamamide 0.2～0.3g according to test data, starch 25～40g, dextrin 15～25g, sucrose
Powder 15～30g, magnesium stearate 0.1～1g, ethanol (40～50%) is appropriate, is recorded according to " Chinese Pharmacopoeia " version in 2015 two
" cobamamide piece " standard detection, result checks regulation.Its preparation method is: will be by the load weighted starch of recipe quantity, dextrin and pulverizing
Good cane sugar powder is mixed, be slowly added to after mix homogeneously dissolved with cobamamide 40～50% ethanol, stirring while adding,
Make soft material, pelletized with screen cloth, the granule making is carried out second granulation, granule is dried, in dried granule
After adding magnesium stearate to mix, tabletting, sugar coating, obtain final product.There are the following problems for this method: at present, in the life of cobamamide piece
It is primarily present problems with: 1, cobamamide is met light and is extremely easy in decomposition during product.2nd, cobamamide is slightly molten in water, in ethanol
Almost insoluble.3rd, property is unstable, and content is easily degraded.
Content of the invention
The purpose of the present invention is that the defect overcoming above-mentioned prior art, provides one kind to effectively improve cobamamide piece and produces
The product uniformity and stability, thus the preparation method of the cobamamide piece of improve product quality.
The technical scheme taken for achieving the above object is:
A kind of preparation method of cobamamide piece, its process is: will by recipe quantity load weighted adjuvant mix homogeneously,
It is then slowly added to make soft material dissolved with 40～50% ethanol solution of cobamamide, be dried after secondary granulation, plus
Enter magnesium stearate tabletting, sugar coating, obtain final product it is characterised in that described 40～50% ethanol solution dissolved with cobamamide refer to elder generation
By cobamamide first with a small amount of purification water dissolution, then it is then added to be stirred in 40～50% ethanol solution, fully dissolve.
Opacifier titanium dioxide is contained in the coating powder of described sugar coating.
The consumption of described opacifier titanium dioxide is to be the 2～3% of amount of talc.
Adopt 36w redness fluorescent tube in the operation room producing cobamamide piece.
The present invention has a following technical advantage:
1st, pass through to change 36w red light pipe, lucifuge operational issue when solving to produce.
2nd, during preparing tablet, first by cobamamide with, after a small amount of purification water dissolution, being then added to 50% second
It is stirred in alcohol, the abundant dissolving of achievable cobamamide.Solving because cobamamide dissolving is insufficient leads to product to contain
Measure uneven, the underproof problem of the uniformity.
3rd, sugar coating: 2/3 Pulvis Talci of input amount is mixed with opacifier titanium dioxide, after mix homogeneously, crosses 80～100
Mesh sieve.Solve because cobamamide property unstable, content hold problem of easy degradation.
In sum, the preparation method of the present invention can effectively improve the cobamamide flake products uniformity and stability, and then
Improve product quality.
Specific implementation method
It is explained the present invention with example below it should be understood that example is for illustrating rather than to this
The restriction of invention.The scope of the present invention is determined according to claims with core content.
Embodiment 1
Cobamamide piece supplementary material forms: cobamamide 0.25g starch 29.1g dextrin 20g sucrose 25g magnesium stearate
0.5g.
Preparation method:
1st, first operation room fluorescent tube is all replaced by the red fluorescent tube of 36w before manufacture, only opens during production operation
Away from the lamp of dog-house, operated under faint light as far as possible, reduce to greatest extent and decompose.
2nd, by the starch in above-mentioned prescription, dextrin and the cane sugar powder that crushes is mixed.
3rd, by the cobamamide in above-mentioned prescription first with a small amount of purification water dissolution, then it is then added in 45% ethanol solution
It is stirred, after it all dissolves, be slow added into said process 2) in the mixed material of gained, stirring while adding, make
Soft material, is pelletized with 20 eye mesh screens.
For ensureing the uniform of content, the wet granular made is carried out secondary granulation with 20 eye mesh screens again, then 50 DEG C of dryings
7h, dried granule, with 18 eye mesh screen granulate, after finally adding magnesium stearate to mix in dry particl, is pressed after the assay was approved
Piece.
4th, before sugar coating, input amount 2/3 Pulvis Talci and opacifier titanium dioxide is first taken (to measure as being amount of talc
2%) close, after mix homogeneously, cross 100 mesh sieves.By remaining Pulvis Talci and above-mentioned Pulvis Talci and opacifier titanium dioxide mixture and
Syrup, sugar coating obtains final product.
Following table is by the operation of embodiment 1 method, meets two " glands recording of " Chinese Pharmacopoeia " version in 2015 through inspection data
Glycosides cobalt amine piece " examination criteria, assay is all qualified.
Embodiment 2
Cobamamide piece supplementary material forms: cobamamide 0.25g starch 32g dextrin 20g cane sugar powder 22g magnesium stearate
0.6g.
Preparation method:
1st, first operation room fluorescent tube is all replaced by the red fluorescent tube of 36w before manufacture, only opens during production operation
Away from the lamp of dog-house, operated under faint light as far as possible, reduce to greatest extent and decompose.
2nd, by the starch in above-mentioned prescription, dextrin and the cane sugar powder that crushes is mixed.
3rd, by the cobamamide in above-mentioned prescription first with a small amount of purification water dissolution, then it is then added in 48% ethanol solution
It is stirred, after it all dissolves, be slow added into said process 2) in the mixed material of gained, stirring while adding, make
Soft material, is pelletized with 24 eye mesh screens.
For ensureing the uniform of content, the wet granular made is carried out secondary granulation with 24 eye mesh screens again, then 48 DEG C of dryings
8h, dried granule, with 20 eye mesh screen granulate, after finally adding magnesium stearate to mix in dry particl, is pressed after the assay was approved
Piece.
4th, before sugar coating, input amount 2/3 Pulvis Talci and opacifier titanium dioxide is first taken (to measure as being amount of talc
3%) mix, after mix homogeneously, cross 100 mesh sieves.By remaining Pulvis Talci and above-mentioned Pulvis Talci and opacifier titanium dioxide mixture
And syrup, sugar coating obtains final product.
Following table is by the operation of embodiment 2 method, meets two " glands recording of " Chinese Pharmacopoeia " version in 2015 through inspection data
Glycosides cobalt amine piece " examination criteria, assay is all qualified.
Claims (4)
1. a kind of preparation method of cobamamide piece, its process is: will be by recipe quantity load weighted adjuvant mix homogeneously, so
It is slowly added into afterwards and makes soft material dissolved with 40～50% ethanol solution of cobamamide, be dried after secondary granulation, add hard
Fatty acid magnesium tabletting, sugar coating, obtain final product it is characterised in that described 40～50% ethanol solution dissolved with cobamamide refer to first by gland
Glycosides cobalt amine first with a small amount of purification water dissolution, is then then added to be stirred in 40～50% ethanol solution, fully dissolves.
2. according to the cobamamide piece described in claim 1 preparation method it is characterised in that described sugar coating coating powder in
Containing opacifier titanium dioxide.
3. according to cobamamide piece described in claim 2 preparation method it is characterised in that described opacifier titanium dioxide
Consumption is to be the 2～3% of amount of talc.
4. according to the cobamamide piece described in claim 1-3 any one preparation method it is characterised in that produce adenosine
The operation room of cobalt amine piece adopts 36w redness fluorescent tube.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610794348.1A CN106344532A (en) | 2016-08-31 | 2016-08-31 | Preparation method of cobamamide tablets |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610794348.1A CN106344532A (en) | 2016-08-31 | 2016-08-31 | Preparation method of cobamamide tablets |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN106344532A true CN106344532A (en) | 2017-01-25 |
Family
ID=57856487
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201610794348.1A Pending CN106344532A (en) | 2016-08-31 | 2016-08-31 | Preparation method of cobamamide tablets |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN106344532A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108186668A (en) * | 2018-01-23 | 2018-06-22 | 广东伊茗药业有限公司 | A kind of composition containing cobamamide |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104490759A (en) * | 2014-12-05 | 2015-04-08 | 海南卫康制药(潜山)有限公司 | Cobamamide composition freeze-dried tablets and preparation method thereof |
-
2016
- 2016-08-31 CN CN201610794348.1A patent/CN106344532A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104490759A (en) * | 2014-12-05 | 2015-04-08 | 海南卫康制药(潜山)有限公司 | Cobamamide composition freeze-dried tablets and preparation method thereof |
Non-Patent Citations (3)
| Title |
|---|
| 任娟清等: "《实用药物手册》", 31 January 1999 * |
| 未知: "腺苷钴胺主要用于治什么病", 《HTTPS://WWW.JIANKE.COM/A/20140916/935140.HTML》 * |
| 潘卫三等: "《工业药剂学》", 31 August 2015, 中国医药科技出版社 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108186668A (en) * | 2018-01-23 | 2018-06-22 | 广东伊茗药业有限公司 | A kind of composition containing cobamamide |
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Application publication date: 20170125 |