CN107049969A - A kind of prednisolone piece and preparation method thereof - Google Patents
A kind of prednisolone piece and preparation method thereof Download PDFInfo
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- CN107049969A CN107049969A CN201710118025.5A CN201710118025A CN107049969A CN 107049969 A CN107049969 A CN 107049969A CN 201710118025 A CN201710118025 A CN 201710118025A CN 107049969 A CN107049969 A CN 107049969A
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- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
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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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic compounds
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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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
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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
- A61K9/2004—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
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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
- A61K9/2004—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
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- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Inorganic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The present invention discloses a kind of prednisolone piece and preparation method thereof, belongs to technical field of medicine, prednisolone piece is made up of following components in parts by weight：1~5 part of prednisolone, 1.5~2.5 parts of magnesium stearate, 0.7~0.9 part of superfine silica gel powder, 70~90 parts of cornstarch, 50~70 parts of lactose, 10~15 parts of PVP K30,10~15 parts of mannitol, 5~15 parts of carboxyrnethyl starch sodium.Cortan of the present invention and preparation method thereof has the following advantages that and marked improvement：Drug-eluting is rapid, steady quality；Preparation method is simple, it is not necessary to complicated preparation equipment, it is easy to industrialized production.
Description
Technical field
The present invention relates to technical field of medicine, more particularly to a kind of prednisolone piece and preparation method thereof.
Background technology
Prednisolone English name：Prednisolone, is middle effect adrenal cortex hormones drug.With anti-inflammatory, resist
Allergy and suppress the multiple pharmacological effect such as immune, be mainly used in serious bacterium infection and serious anaphylactia, various blood
Platelet reduces property purpura, agranulocytosis, severe skin disease, the immunological rejection of organ transplant, oncotherapy and to sugar
Sensitive inflammation of eye section of cortin etc..
Prednisolone as medicine active component, when it is prepared into oral formulations, only prednisolone can it is quick and
Efficiently soluble in water that good absorption could be obtained in stomach and intestine, otherwise its absorption and biological utilisation have very big barrier
Hinder.Therefore, by being optimized to prescription and technique, obtain the faster prednisolone oral solid formulation of dissolution and seem very heavy
Will.
The content of the invention
The invention provides a kind of prednisolone piece and preparation method thereof, it is by being ground to preparation prescription and technique
Medicine Fast Stripping requirement can be met there is provided one kind by studying carefully, and prednisolone tablet and its preparation side of industrialized production are adapted to again
Method.
In order to solve the above technical problems, the technical scheme is that：
A kind of prednisolone piece, is made up of following components in parts by weight：1~5 part of prednisolone, magnesium stearate 1.5~
2.5 parts, it is 0.7~0.9 part of superfine silica gel powder, 70~90 parts of cornstarch, 50~70 parts of lactose, 10~15 parts of PVP K30, sweet
Reveal 10~15 parts of alcohol, 5~15 parts of carboxyrnethyl starch sodium.
Wherein it is preferred to, a kind of prednisolone piece is made up of following components in parts by weight：It is 1~5 part of prednisolone, hard
1.8~2.2 parts of fatty acid magnesium, 0.75~0.85 part of superfine silica gel powder, 75~85 parts of cornstarch, 55~65 parts of lactose, PVP K30
12~14 parts, 12~14 parts of mannitol, 8~12 parts of carboxyrnethyl starch sodium.
The present invention simultaneously provides a kind of preparation method of prednisolone piece, comprises the following steps：
(1) take the half and prednisolone of magnesium stearate total amount to be well mixed, obtain mixed material one；
(2) take superfine silica gel powder, cornstarch and lactose to crush well mixed, obtain mixed material two；
(3) mannitol and PVP K30 are taken, suitable quantity of water is added, binder solution is made；
(4) mixture one and mixed material two are placed in efficient mixer-granulator, mixed, add binder solution, it is wet
Method is pelletized, and is dried, and is crossed 30 mesh sieves, is obtained prednisolone particles；
(5) after being well mixed prednisolone particles, carboxyrnethyl starch sodium and remaining magnesium stearate, it is placed in tablet press machine,
Tabletting, is produced.
Beneficial effect of the present invention：
Compared with prior art, Cortan of the present invention and preparation method thereof has the following advantages that and significantly entered
Step property：(1) drug-eluting is rapid, steady quality；(2) preparation method is simple, it is not necessary to complicated preparation equipment, it is easy to industrialize
Big production.
The present invention first adds fine grain magnesium stearate in prednisolone, can effectively improve metacortandracin in preparation method
The mobility of dragon, good basis is provided for wet granulation technology below.In addition, making glidant superfine silica gel powder and filler beautiful
Rice starch, lactose are sufficiently mixed, and can have this tablet filler and preferably help stream to act on and lubrication, be below
Wet granulation technology provides good basis.
Embodiment
Below in conjunction with the specific embodiment of the invention, the technical scheme to the present invention carries out clear, complete description, institute
The example of description is only the section Example of the present invention, rather than whole embodiments.Based on the embodiment in the present invention, sheet
Field those of ordinary skill, the every other embodiment obtained under the premise of creative work is not made, belongs to this hair
Bright protection domain.
Embodiment 1
The present embodiment provides a kind of prednisolone piece, is made up of following components in parts by weight：It is prednisolone 0.01kg, hard
Fatty acid magnesium 0.016kg, superfine silica gel powder 0.008kg, cornstarch 0.8kg, lactose 0.6kg, PVP K30 0.12kg, mannitol
0.12kg, carboxyrnethyl starch sodium 0.13kg.
The preparation method of above-mentioned prednisolone piece, comprises the following steps：
(1) take magnesium stearate 0.008kg and prednisolone well mixed, obtain mixed material one；
(2) take superfine silica gel powder, cornstarch and lactose to crush well mixed, obtain mixed material two；
(3) mannitol and PVP K30 are taken, suitable quantity of water is added, binder solution is made；
(4) mixture one and mixed material two are placed in efficient mixer-granulator, mixed, add binder solution, it is wet
Method is pelletized, and is dried, and is crossed 30 mesh sieves, is obtained prednisolone particles；
(5) after being well mixed prednisolone particles, carboxyrnethyl starch sodium and remaining magnesium stearate, it is placed in tablet press machine,
Tabletting, is in batches 100,000, and specification is 1mg/ pieces.
Embodiment 2
The present embodiment provides a kind of prednisolone piece, is made up of following components in parts by weight：It is prednisolone 0.01Kg, hard
Fatty acid magnesium 0.015Kg, superfine silica gel powder 0.009Kg, cornstarch 0.7Kg, lactose 0.7Kg, PVP K30 0.1Kg, mannitol
0.15Kg, carboxyrnethyl starch sodium 0.05Kg.
The present invention simultaneously provides a kind of preparation method of prednisolone piece, comprises the following steps：
(1) take magnesium stearate 0.075kg and prednisolone well mixed, obtain mixed material one；
(2) take superfine silica gel powder, cornstarch and lactose to crush well mixed, obtain mixed material two；
(3) mannitol and PVP K30 are taken, suitable quantity of water is added, binder solution is made；
(4) mixture one and mixed material two are placed in efficient mixer-granulator, mixed, add binder solution, it is wet
Method is pelletized, and is dried, and is crossed 30 mesh sieves, is obtained prednisolone particles；
(5) after being well mixed prednisolone particles, carboxyrnethyl starch sodium and remaining magnesium stearate, it is placed in tablet press machine,
Tabletting, is in batches 10, and specification is 1mg/ pieces.
Embodiment 3
The present embodiment provides a kind of prednisolone piece, is made up of following components in parts by weight：It is prednisolone 0.01kg, hard
Fatty acid magnesium 0.025kg, superfine silica gel powder 0.007kg, cornstarch 0.9kg, lactose 0.5kg, PVP K30 0.15kg, mannitol
0.1kg, carboxyrnethyl starch sodium 0.15kg.
The present invention simultaneously provides a kind of preparation method of prednisolone piece, comprises the following steps：
(1) take magnesium stearate 0.0125kg and prednisolone well mixed, obtain mixed material one；
(2) take superfine silica gel powder, cornstarch and lactose to crush well mixed, obtain mixed material two；
(3) mannitol and PVP K30 are taken, suitable quantity of water is added, binder solution is made；
(4) mixture one and mixed material two are placed in efficient mixer-granulator, mixed, add binder solution, it is wet
Method is pelletized, and is dried, and is crossed 30 mesh sieves, is obtained prednisolone particles；
(5) after being well mixed prednisolone particles, carboxyrnethyl starch sodium and remaining magnesium stearate, it is placed in tablet press machine,
Tabletting, is in batches 100,000, specification 1mg/ pieces,.
Embodiment 4
The present embodiment provides a kind of prednisolone piece, is made up of following components in parts by weight：It is prednisolone 0.05kg, hard
It is fatty acid magnesium 0.018kg, superfine silica gel powder 0.0085kg, cornstarch 0.75kg, lactose 0.65kg, PVP K30 0.12kg, sweet
Reveal alcohol 0.14kg, carboxyrnethyl starch sodium 0.08kg.
The present invention simultaneously provides a kind of preparation method of prednisolone piece, comprises the following steps：
(1) take magnesium stearate 0.009kg and prednisolone well mixed, obtain mixed material one；
(2) take superfine silica gel powder, cornstarch and lactose to crush well mixed, obtain mixed material two；
(3) mannitol and PVP K30 are taken, suitable quantity of water is added, binder solution is made；
(4) mixture one and mixed material two are placed in efficient mixer-granulator, mixed, add binder solution, it is wet
Method is pelletized, and is dried, and is crossed 30 mesh sieves, is obtained prednisolone particles；
(5) after being well mixed prednisolone particles, carboxyrnethyl starch sodium and remaining magnesium stearate, it is placed in tablet press machine,
Tabletting, is in batches 100,000, and specification is 5mg/ pieces,.
Embodiment 5
The present embodiment provides a kind of prednisolone piece, is made up of following components in parts by weight：It is prednisolone 0.05kg, hard
It is fatty acid magnesium 0.022kg, superfine silica gel powder 0.0075kg, cornstarch 0.85kg, lactose 0.55kg, PVP K30 0.14kg, sweet
Reveal alcohol 0.12kg, carboxyrnethyl starch sodium 0.12kg.
The present invention simultaneously provides a kind of preparation method of prednisolone piece, comprises the following steps：
(1) take magnesium stearate 0.011kg and prednisolone well mixed, obtain mixed material one；
(2) take superfine silica gel powder, cornstarch and lactose to crush well mixed, obtain mixed material two；
(3) mannitol and PVP K30 are taken, suitable quantity of water is added, binder solution is made；
(4) mixture one and mixed material two are placed in efficient mixer-granulator, mixed, add binder solution, it is wet
Method is pelletized, and is dried, and is crossed 30 mesh sieves, is obtained prednisolone particles；
(5) after being well mixed prednisolone particles, carboxyrnethyl starch sodium and remaining magnesium stearate, it is placed in tablet press machine,
Tabletting, is in batches 100,000, and specification is 5mg/ pieces.
Prednisolone piece dissolution rate made from the various embodiments described above is measured
This product is taken, according to dissolution method (Chinese Pharmacopoeia two annex X C of version in 2015, the first method), with pure water solution
1000ml is solvent, and rotating speed is 50 turns per minute, is operated in accordance with the law.During through 5 minutes, take solution to filter, take subsequent filtrate 5ml, with pure
Water is diluted to 20ml as need testing solution.
According to UV-VIS spectrophotometry (general rule 0401), absorbance is determined at 243nm wavelength, by C21H2805's
Absorption coefficientCalculate, produce for 415
Prednisone dissolution prepared by various embodiments of the present invention is rapid, steady quality.And sample made from above-described embodiment
Product 0 day and acceleration are pressed for 6 months《Chinese Pharmacopoeia》The two prednisolone piece standard detections of version in 2015, meet standard regulation.
The foregoing is merely illustrative of the preferred embodiments of the present invention, is not intended to limit the invention, all essences in the present invention
God is with principle, and any modification, equivalent substitution and improvements made etc. should be included in the scope of the protection.
Claims (3)
1. a kind of prednisolone piece, it is characterised in that be made up of following components in parts by weight：1~5 part of prednisolone, stearic acid
1.5~2.5 parts of magnesium, 0.7~0.9 part of superfine silica gel powder, 70~90 parts of cornstarch, 50~70 parts of lactose, PVP K30 10~
15 parts, 10~15 parts of mannitol, 5~15 parts of carboxyrnethyl starch sodium.
2. a kind of prednisolone piece according to claim 1, it is characterised in that be made up of following components in parts by weight：Sprinkle
1~5 part of Ni Songlong, 1.8~2.2 parts of magnesium stearate, 0.75~0.85 part of superfine silica gel powder, 75~85 parts of cornstarch, lactose 55
~65 parts, 12~14 parts of PVP K30,12~14 parts of mannitol, 8~12 parts of carboxyrnethyl starch sodium.
3. the preparation method of the prednisolone piece described in a kind of any one of claim 1 or 2, it is characterised in that including following step
Suddenly：
(1) take the half and prednisolone of magnesium stearate total amount to be well mixed, obtain mixed material one；
(2) take superfine silica gel powder, cornstarch and lactose to crush well mixed, obtain mixed material two；
(3) mannitol and PVP K30 are taken, suitable quantity of water is added, binder solution is made；
(4) mixture one and mixed material two are placed in efficient mixer-granulator, mixed, add binder solution, wet method system
Grain, is dried, and is crossed 30 mesh sieves, is obtained prednisolone particles；
(5) after being well mixed prednisolone particles, carboxyrnethyl starch sodium and remaining magnesium stearate, it is placed in tablet press machine, tabletting,
Produce.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710118025.5A CN107049969A (en) | 2017-03-01 | 2017-03-01 | A kind of prednisolone piece and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710118025.5A CN107049969A (en) | 2017-03-01 | 2017-03-01 | A kind of prednisolone piece and preparation method thereof |
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| Publication Number | Publication Date |
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| CN107049969A true CN107049969A (en) | 2017-08-18 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201710118025.5A Pending CN107049969A (en) | 2017-03-01 | 2017-03-01 | A kind of prednisolone piece and preparation method thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108714144A (en) * | 2018-06-08 | 2018-10-30 | 华益药业科技(安徽)有限公司 | A kind of dosulepin piece and preparation method thereof |
| CN109925288A (en) * | 2017-12-18 | 2019-06-25 | 江苏开元药业有限公司 | A kind of glucocorticoid medicine tablet and preparation method thereof |
| CN110559267A (en) * | 2019-09-11 | 2019-12-13 | 华益药业科技(安徽)有限公司 | prednisolone tablets and preparation method thereof |
Citations (4)
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|---|---|---|---|---|
| RU2187307C1 (en) * | 2001-10-15 | 2002-08-20 | Сыров Кирилл Константинович | Stable solid medicinal forms of prednisolon |
| CN1418634A (en) * | 2002-12-19 | 2003-05-21 | 王登之 | Prednisolone oral disintegrant for treating acute bacterial infection, and its prepn. method |
| CN104721160A (en) * | 2015-03-27 | 2015-06-24 | 贾红瑞 | Prednisone acetate tablet and preparation method thereof |
| EP2082732B1 (en) * | 2008-01-25 | 2016-03-16 | Substipharm Developpement | Orodispersible tablets of prednisolone |
-
2017
- 2017-03-01 CN CN201710118025.5A patent/CN107049969A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RU2187307C1 (en) * | 2001-10-15 | 2002-08-20 | Сыров Кирилл Константинович | Stable solid medicinal forms of prednisolon |
| CN1418634A (en) * | 2002-12-19 | 2003-05-21 | 王登之 | Prednisolone oral disintegrant for treating acute bacterial infection, and its prepn. method |
| EP2082732B1 (en) * | 2008-01-25 | 2016-03-16 | Substipharm Developpement | Orodispersible tablets of prednisolone |
| CN104721160A (en) * | 2015-03-27 | 2015-06-24 | 贾红瑞 | Prednisone acetate tablet and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| WITOLD BRNIAK ET AL.: "Orodispersible films and tablets with prednisolone microparticles", 《EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES》 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109925288A (en) * | 2017-12-18 | 2019-06-25 | 江苏开元药业有限公司 | A kind of glucocorticoid medicine tablet and preparation method thereof |
| CN108714144A (en) * | 2018-06-08 | 2018-10-30 | 华益药业科技(安徽)有限公司 | A kind of dosulepin piece and preparation method thereof |
| CN110559267A (en) * | 2019-09-11 | 2019-12-13 | 华益药业科技(安徽)有限公司 | prednisolone tablets and preparation method thereof |
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Application publication date: 20170818 |
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