CN111643465A - Spirolactone tablet and production process thereof - Google Patents
Spirolactone tablet and production process thereof Download PDFInfo
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- CN111643465A CN111643465A CN202010700682.2A CN202010700682A CN111643465A CN 111643465 A CN111643465 A CN 111643465A CN 202010700682 A CN202010700682 A CN 202010700682A CN 111643465 A CN111643465 A CN 111643465A
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- crospovidone
- spironolactone
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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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- 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
- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
- A61K31/585—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin containing lactone rings, e.g. oxandrolone, bufalin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/12—Drugs for disorders of the urinary system of the kidneys
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/10—Antioedematous agents; Diuretics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives
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Abstract
The invention relates to the technical field of spironolactone tablets, and discloses a spironolactone tablet and a production process thereof, wherein the spironolactone tablet comprises the following components in parts by weight: 20-60 parts of spironolactone, 134.64-178.89 parts of calcium sulfate, 48-108 parts of corn starch, 0.320-0.558 part of quinoline yellow aluminum lake, 6.4-9 parts of crospovidone, 4-9 parts of pregelatinized starch, 2.8-3 parts of povidone, 78-147 parts of purified water, 2.2-3.78 parts of mint essence and 1.76-3 parts of magnesium stearate. The spironolactone tablet and the production process thereof provided by the invention have excellent drug effect; the preparation method is excellent.
Description
Technical Field
The invention relates to the field of spironolactone tablets, in particular to a spironolactone tablet and a production process thereof.
Background
With the development of society, people have endless diseases.
For example: the spironolactone tablet is various, and therefore the spironolactone tablet and the production process thereof are provided.
Disclosure of Invention
Objects of the invention
In order to solve the technical problems existing in the background technology, the invention provides a spironolactone tablet and a production process thereof, and the spironolactone tablet has excellent drug effect; the preparation method is excellent.
(II) technical scheme
In order to solve the problems, the invention provides a spirolactone tablet which comprises the following components in parts by weight:
20-60 parts of spironolactone, 134.64-178.89 parts of calcium sulfate, 48-108 parts of corn starch, 0.320-0.558 part of quinoline yellow aluminum lake, 6.4-9 parts of crospovidone, 4-9 parts of pregelatinized starch, 2.8-3 parts of povidone, 78-147 parts of purified water, 2.2-3.78 parts of mint essence and 1.76-3 parts of magnesium stearate.
Preferably, the composition comprises the following components in parts by weight:
20 parts of spironolactone, 134.64 parts of calcium sulfate, 48 parts of corn starch, 0.320 part of quinoline yellow aluminum lake, 6.4 parts of crospovidone, 4 parts of pregelatinized starch, 2.8 parts of povidone, 78 parts of purified water, 2.2 parts of mint essence and 1.76 parts of magnesium stearate.
Preferably, the composition comprises the following components in parts by weight:
60 parts of spironolactone, 178.89 parts of calcium sulfate, 108 parts of corn starch, 0.558 part of quinoline yellow aluminum lake, 9 parts of crospovidone, 9 parts of pregelatinized starch, 3 parts of povidone, 147 parts of purified water, 3.78 parts of mint essence and 3 parts of magnesium stearate.
Preferably, the composition comprises the following components in parts by weight:
40 parts of spironolactone, 156 parts of calcium sulfate, 78 parts of corn starch, 0.42 part of quinoline yellow aluminum lake, 7.7 parts of crospovidone, 6.5 parts of pregelatinized starch, 2.9 parts of povidone, 112.5 parts of purified water, 3 parts of mint essence and 2.4 parts of magnesium stearate.
A spirolactone tablet is prepared by the following production process:
s1, weighing spironolactone, corn starch, calcium sulfate, quinoline yellow aluminum lake and crospovidone according to the weight ratio, and adding into a mixing device for dry mixing;
s2, weighing the crospovidone, the pregelatinized starch and the purified water according to the weight ratio, and granulating the weighed crospovidone, the pregelatinized starch and the purified water with the raw materials in the dry mixing mode in the S1;
s3, drying and loss on drying after granulation;
s4, carrying out granule finishing treatment by a granule finishing machine;
s5, mixing the small batches of granules, weighing the mint essence and the magnesium stearate in the weight ratio, and mixing for 5 min;
s6, tabletting;
and S7, packaging.
Preferably, in S1, the dry mixing time is 15min and the speed of the stirring paddle is 100 rpm.
Preferably, in S3, the drying is stopped after 10 minutes of the initial drying; drying for 20-40min after turning.
Preferably, in S4, the size of the screen of the granulator is 1.5mm, and the rotation speed of the granulator is 200-400 rpm.
The technical scheme of the invention has the following beneficial technical effects:
the corn starch is added, so that the bonding and disintegration effects of the starch in the tablet can be improved, the forming property of the tablet is improved, and meanwhile, the production process is strictly controlled, so that the forming rate is favorably improved; the bioavailability is effectively improved; the preparation method is simple and has high stability.
Drawings
FIG. 1 is a production process flow chart of the spironolactone tablet and the production process thereof.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention will be described in further detail with reference to the accompanying drawings 1 in conjunction with the following detailed description. It should be understood that the description is intended to be exemplary only, and is not intended to limit the scope of the present invention. Moreover, in the following description, descriptions of well-known structures and techniques are omitted so as to not unnecessarily obscure the concepts of the present invention.
Example 1
A spirolactone tablet comprises the following components in parts by weight:
20 parts of spironolactone, 134.64 parts of calcium sulfate, 48 parts of corn starch, 0.320 part of quinoline yellow aluminum lake, 6.4 parts of crospovidone, 4 parts of pregelatinized starch, 2.8 parts of povidone, 78 parts of purified water, 2.2 parts of mint essence and 1.76 parts of magnesium stearate.
A spirolactone tablet is prepared by the following production process:
s1, weighing spironolactone, corn starch, calcium sulfate, quinoline yellow aluminum lake and crospovidone according to the weight ratio, and adding into a mixing device for dry mixing;
s2, weighing the crospovidone, the pregelatinized starch and the purified water according to the weight ratio, and granulating the weighed crospovidone, the pregelatinized starch and the purified water with the raw materials in the dry mixing mode in the S1;
s3, drying and loss on drying after granulation;
s4, carrying out granule finishing treatment by a granule finishing machine;
s5, mixing the small batches of granules, weighing the mint essence and the magnesium stearate in the weight ratio, and mixing for 5 min;
s6, tabletting;
and S7, packaging.
In an alternative embodiment, in S1, the dry mixing time is 15min and the speed of the paddle is 100 rpm.
In an alternative embodiment, in S3, drying is stopped after 10 minutes of initial drying; the drying time after turning over was 30 min.
In an alternative embodiment, at S4, the granulator screen size is 1.5mm and the granulator speed is 300 rpm.
Example 2
A spirolactone tablet comprises the following components in parts by weight:
60 parts of spironolactone, 178.89 parts of calcium sulfate, 108 parts of corn starch, 0.558 part of quinoline yellow aluminum lake, 9 parts of crospovidone, 9 parts of pregelatinized starch, 3 parts of povidone, 147 parts of purified water, 3.78 parts of mint essence and 3 parts of magnesium stearate.
A spirolactone tablet is prepared by the following production process:
s1, weighing spironolactone, corn starch, calcium sulfate, quinoline yellow aluminum lake and crospovidone according to the weight ratio, and adding into a mixing device for dry mixing;
s2, weighing the crospovidone, the pregelatinized starch and the purified water according to the weight ratio, and granulating the weighed crospovidone, the pregelatinized starch and the purified water with the raw materials in the dry mixing mode in the S1;
s3, drying and loss on drying after granulation;
s4, carrying out granule finishing treatment by a granule finishing machine;
s5, mixing the small batches of granules, weighing the mint essence and the magnesium stearate in the weight ratio, and mixing for 5 min;
s6, tabletting;
and S7, packaging.
In an alternative embodiment, in S1, the dry mixing time is 15min and the speed of the paddle is 100 rpm.
In an alternative embodiment, in S3, drying is stopped after 10 minutes of initial drying; the drying time after tumbling was 35 min.
In an alternative embodiment, at S4, the granulator screen size is 1.5mm and the granulator speed is 250 rpm.
Example 3
A spirolactone tablet comprises the following components in parts by weight:
40 parts of spironolactone, 156 parts of calcium sulfate, 78 parts of corn starch, 0.42 part of quinoline yellow aluminum lake, 7.7 parts of crospovidone, 6.5 parts of pregelatinized starch, 2.9 parts of povidone, 112.5 parts of purified water, 3 parts of mint essence and 2.4 parts of magnesium stearate.
A spirolactone tablet is prepared by the following production process:
s1, weighing spironolactone, corn starch, calcium sulfate, quinoline yellow aluminum lake and crospovidone according to the weight ratio, and adding into a mixing device for dry mixing;
s2, weighing the crospovidone, the pregelatinized starch and the purified water according to the weight ratio, and granulating the weighed crospovidone, the pregelatinized starch and the purified water with the raw materials in the dry mixing mode in the S1;
s3, drying and loss on drying after granulation;
s4, carrying out granule finishing treatment by a granule finishing machine;
s5, mixing the small batches of granules, weighing the mint essence and the magnesium stearate in the weight ratio, and mixing for 5 min;
s6, tabletting;
and S7, packaging.
In an alternative embodiment, in S1, the dry mixing time is 15min and the speed of the paddle is 100 rpm.
In an alternative embodiment, in S3, drying is stopped after 10 minutes of initial drying; the drying time after turning over was 30 min.
In an alternative embodiment, at S4, the granulator screen size is 1.5mm and the granulator speed is 260 rpm.
It should be noted that:
QA and QC assays
It is to be understood that the above-described embodiments of the present invention are merely illustrative of or explaining the principles of the invention and are not to be construed as limiting the invention. Therefore, any modification, equivalent replacement, improvement and the like made without departing from the spirit and scope of the present invention should be included in the protection scope of the present invention. Further, it is intended that the appended claims cover all such variations and modifications as fall within the scope and boundaries of the appended claims or the equivalents of such scope and boundaries.
Claims (8)
1. The spirolactone tablet is characterized by comprising the following components in parts by weight:
20-60 parts of spironolactone, 134.64-178.89 parts of calcium sulfate, 48-108 parts of corn starch, 0.320-0.558 part of quinoline yellow aluminum lake, 6.4-9 parts of crospovidone, 4-9 parts of pregelatinized starch, 2.8-3 parts of povidone, 78-147 parts of purified water, 2.2-3.78 parts of mint essence and 1.76-3 parts of magnesium stearate.
2. A spirolactone tablet of claim 1 comprising, in parts by weight:
20 parts of spironolactone, 134.64 parts of calcium sulfate, 48 parts of corn starch, 0.320 part of quinoline yellow aluminum lake, 6.4 parts of crospovidone, 4 parts of pregelatinized starch, 2.8 parts of povidone, 78 parts of purified water, 2.2 parts of mint essence and 1.76 parts of magnesium stearate.
3. A spirolactone tablet of claim 1 comprising, in parts by weight:
60 parts of spironolactone, 178.89 parts of calcium sulfate, 108 parts of corn starch, 0.558 part of quinoline yellow aluminum lake, 9 parts of crospovidone, 9 parts of pregelatinized starch, 3 parts of povidone, 147 parts of purified water, 3.78 parts of mint essence and 3 parts of magnesium stearate.
4. A spirolactone tablet of claim 1 comprising, in parts by weight:
40 parts of spironolactone, 156 parts of calcium sulfate, 78 parts of corn starch, 0.42 part of quinoline yellow aluminum lake, 7.7 parts of crospovidone, 6.5 parts of pregelatinized starch, 2.9 parts of povidone, 112.5 parts of purified water, 3 parts of mint essence and 2.4 parts of magnesium stearate.
5. A spirolactone tablet according to any one of claims 1-4, characterized in that the production process is as follows:
s1, weighing spironolactone, corn starch, calcium sulfate, quinoline yellow aluminum lake and crospovidone according to the weight ratio, and adding into a mixing device for dry mixing;
s2, weighing the crospovidone, the pregelatinized starch and the purified water according to the weight ratio, and granulating the weighed crospovidone, the pregelatinized starch and the purified water with the raw materials in the dry mixing mode in the S1;
s3, drying and loss on drying after granulation;
s4, carrying out granule finishing treatment by a granule finishing machine;
s5, mixing the small batches of granules, weighing the mint essence and the magnesium stearate in the weight ratio, and mixing for 5 min;
s6, tabletting;
and S7, packaging.
6. A process according to claim 5, wherein in S1, the dry mixing time is 15min and the speed of the stirring paddle is 100 rpm.
7. A process for producing spirolactone sheets as claimed in claim 5 wherein in S3, drying is stopped after 10 minutes of initial drying; drying for 20-40min after turning.
8. The process for producing spirolactone sheets as claimed in claim 5, wherein in S4, the size of the screen of the granulator is 1.5mm, and the rotation speed of the granulator is 200-400 rpm.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010700682.2A CN111643465A (en) | 2020-07-20 | 2020-07-20 | Spirolactone tablet and production process thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010700682.2A CN111643465A (en) | 2020-07-20 | 2020-07-20 | Spirolactone tablet and production process thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN111643465A true CN111643465A (en) | 2020-09-11 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN202010700682.2A Pending CN111643465A (en) | 2020-07-20 | 2020-07-20 | Spirolactone tablet and production process thereof |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2815542A1 (en) * | 2010-10-26 | 2012-05-03 | Pontificia Universidad Catolica De Chile | Use of a spironolactone-based composition that exhibits an inhibitory action on t-lymphocyte activation which is useful for preventing and/or treating multiple sclerosis |
| CN104490750A (en) * | 2014-12-05 | 2015-04-08 | 海南卫康制药(潜山)有限公司 | Spirolactone composition freeze-dried tablets and preparation method thereof |
| CN105832680A (en) * | 2016-05-12 | 2016-08-10 | 沈阳药科大学 | Pharmaceutical composition for improving in-vitro dissolution and liquidity of spironolactone |
| CN107519138A (en) * | 2016-06-21 | 2017-12-29 | 北京科信必成医药科技发展有限公司 | A kind of spirolactone microplate and preparation method thereof |
-
2020
- 2020-07-20 CN CN202010700682.2A patent/CN111643465A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2815542A1 (en) * | 2010-10-26 | 2012-05-03 | Pontificia Universidad Catolica De Chile | Use of a spironolactone-based composition that exhibits an inhibitory action on t-lymphocyte activation which is useful for preventing and/or treating multiple sclerosis |
| CN104490750A (en) * | 2014-12-05 | 2015-04-08 | 海南卫康制药(潜山)有限公司 | Spirolactone composition freeze-dried tablets and preparation method thereof |
| CN105832680A (en) * | 2016-05-12 | 2016-08-10 | 沈阳药科大学 | Pharmaceutical composition for improving in-vitro dissolution and liquidity of spironolactone |
| CN107519138A (en) * | 2016-06-21 | 2017-12-29 | 北京科信必成医药科技发展有限公司 | A kind of spirolactone microplate and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 网络证据: "《https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012151s075lbl.pdf》", 31 March 2018 * |
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