CN110123776A - A kind of calcium hydrophenyl sulfonate capsule that efficient microcirculation improves - Google Patents
A kind of calcium hydrophenyl sulfonate capsule that efficient microcirculation improves Download PDFInfo
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- CN110123776A CN110123776A CN201910413944.4A CN201910413944A CN110123776A CN 110123776 A CN110123776 A CN 110123776A CN 201910413944 A CN201910413944 A CN 201910413944A CN 110123776 A CN110123776 A CN 110123776A
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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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
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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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
-
- 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
- A61P9/14—Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers
Abstract
The invention discloses a kind of calcium hydrophenyl sulfonate capsules that efficient microcirculation improves, including following raw material: 50~60 parts of Calcium Dobesilate, 5~10 parts of pregelatinized starch, 5~10 parts of magnesium stearate, 10~15 parts of carboxycellulose sodium, 15~20 parts of ethanol water, 10~15 parts of sugar alcohol；The raw material specifically: 50 parts of Calcium Dobesilate, 5 parts of pregelatinized starch, 5 parts of magnesium stearate, 10 parts of carboxycellulose sodium, 20 parts of ethanol water, 10 parts of sugar alcohol.In the present invention, this simple formula composition such as more existing Calcium Dobesilate, sodium carboxymethyl starch and magnesium stearate, it joined the carboxy starch sodium and pregelatinized starch for being conducive to medicine disintegration and dissolution, pregelatinized starch is also used as adhesive that will be bonded together between raw material in the preparation simultaneously, to improve granulation efficiency, compared with traditional formula, takes the disintegration rate of rear drug in vivo and get a promotion with dissolution rate, more conducively absorption of drugs.
Description
Technical field
The invention belongs to pharmaceutical technology field, specially a kind of calcium hydrophenyl sulfonate capsule that efficient microcirculation improves.
Background technique
Calcium Dobesilate is a kind of chemically synthesized capillary protection medicine, is developed by Di La Rand Corporation, Switzerland.
The medicine is introduced to the market in June, 2001 at home in loading " European Pharmacopoeia " in 1997, loading " British Pharmacopoeia " in 1998.In state
Just it is used to treat diabetes and the varication due to caused by microcirculation disorder, hemorrhoid from 1970s Calcium Dobesilate outside
Sore, myocardial infarction and pruritic dermatitis.In the higher area of living standard, aged people are to improve microcirculation and take for a long time
With, be acknowledged as prevent and treat microcirculation dysfunction, especially diabetic retinopathy unique matured product.
Research shows that Calcium Dobesilate can reduce wall of micrangium permeability, build up one's resistance to disease；Improve lymph reflux, reduces
Oedema；Blood viscosity is reduced, albumins/globulins ratio is corrected, the high aggregation of blood platelet is reduced, thus anti-tampon shape
At, and red blood cell flexibility is improved, it may also suppress vaso-active substance and high penetration caused by capilary acted on, reduce intravascular
Membrane damage improves the biosynthesis of basilar memebrane collagen.In addition, Calcium Dobesilate has apparent improvement to microcirculation disorder function
Effect, can enhance the activity of big blood vessel and microvascular endothelial cells nitric oxide synthetase, the capillary of antagonistic activity oxygen cluster
Permeability changes, to protect blood vessel；Can inhibit macrophage activating factor (MAF), hence it is evident that reduce macrophage adhesion thus have
Anti-inflammatory effect.
The current market orientation of Calcium Dobesilate is mainly based on diabetic retinopathy, but it is as a kind of novel blood
Protection of pipe agent, can also prevent and treat a variety of diseases as caused by microcirculation obstacle as: (1) caused by microcirculation disorder
The heart, brain, kidney diaseases (myocardial infarction, angina pectoris, thrombus sequela, atherosclerosis of renal glomerulus etc.)；(2) blood viscosity is reduced；
(3) prevent microvascular corrosion cast；(4) numb limb, trick be ice-cold, pain, the diseases such as pruitus；(5) varication syndrome
Deng.With deepening continuously to diabetes and its chronic complicating diseases and ischemic Cardial or cerebral vascular diseases study on prevention, which has
Wide application prospect.
Calcium Dobesilate is clinically widely used at present, a large amount of clinical practices show Calcium Dobesilate be it is long-acting,
Safe and effective drug clinically has special pharmacological action and therapeutic effect, but the existing Calcium Dobesilate of existing market
Capsule is unfavorable for the storage and use of product, simultaneously since its process variations, capsule long-time stability cannot get larger improvement
After taking, the disintegration rate of drug in vivo and dissolution rate have greatly improved space.
Summary of the invention
It is an object of the invention to: storage and medicine disintegration dissolution rate in order to further enhance capsule provide one kind
The calcium hydrophenyl sulfonate capsule that efficient microcirculation improves.
The technical solution adopted by the invention is as follows:
A kind of calcium hydrophenyl sulfonate capsule that efficient microcirculation improves, including following raw material: Calcium Dobesilate 50~
60 parts, 5~10 parts of pregelatinized starch, 5~10 parts of magnesium stearate, 10~15 parts of carboxycellulose sodium, ethanol water 15~20
Part, 10~15 parts of sugar alcohol；
Wherein, the raw material specifically: 50 parts of Calcium Dobesilate, 5 parts of pregelatinized starch, 5 parts of magnesium stearate, carboxyl is fine
Plain 10 parts of the sodium of dimension, 20 parts of ethanol water, 10 parts of sugar alcohol.
Wherein, it comprises the following steps that:
Step 1: Calcium Dobesilate being crossed into 80 meshes, carboxycellulose sodium sieves with 100 mesh sieve, and it is water-soluble to be then mixed into one third ethyl alcohol
In liquid, stir spare；
Step 2: pregelatinized starch and magnesium stearate being added in another one third ethanol water, stirred spare；
Step 3: sugar alcohol being added in another one third ethanol water, is stirred spare；
Step 4: raw material made from step 1 to 3 is stood into 20~30min；
Step 5: step 4 gains are subjected to whole grain by wobbler；
Step 6: particle is finally dried by drying machine；
Step 7: the particle filling after drying is packed into Capsules；
Step 8: sterilizing being carried out using ionising radiation, then carries out packaging finished product.
Wherein, the Capsules use 00# capsule.
Wherein, sterilization is added after step 7, sterilization is irradiated by ultraviolet radiator.
Wherein, preliminarily dried is added after step 4, the raw material after step 4 is stood is put into preliminarily dried in drying machine, does
45~50 DEG C of dry temperature, 20~25min of drying time.
Wherein, the carboxycellulose sodium is sodium carboxymethylcellulose.
Wherein, the sugar alcohol be D-sorbite, maltitol, xylitol, hydroxyl isomaltulose, mannitol, lactitol and
One or more of antierythrite.
Wherein, the sugar alcohol is xylitol.
In conclusion by adopting the above-described technical solution, the beneficial effects of the present invention are:
1, in the present invention, this simple formula composition such as more existing Calcium Dobesilate, sodium carboxymethyl starch and magnesium stearate,
It joined the carboxy starch sodium and pregelatinized starch for being conducive to medicine disintegration and dissolution, while pregelatinized starch is also used as adhesive
It will be bonded together between raw material in the preparation, to improve granulation efficiency, compared with traditional formula, take rear drug in body
Interior disintegration rate gets a promotion with dissolution rate, and more conducively absorption of drugs plays drug more effective, to micro-
Vascular treatment is more efficient.
2, in the present invention, by being mixed and being stood in batches each raw material with ethanol water, guarantee mutual energy
Enough sufficiently fusions ensure that the consistency of every particle drug content avoids to ensure the pharmacological property of capsule in granulation
The case where raw material mixing unevenness causes the influence of capsule pharmacological property amount unevenness to use.
3, in the present invention, the drying to raw material is carried out by preliminarily dried and final dry two step method, after preliminarily dried,
Raw material also has certain structural stability while with humidity, facilitates granulation, while the humidity in particle is by first one
Step is dried, then by finally drying, the humidity of particle can be made maximumlly to be dried, primary drying process is avoided
It is difficult to dry problem inside particle to occur, improves capsule storage capability.
Specific embodiment
In order to make the objectives, technical solutions, and advantages of the present invention clearer, the present invention is carried out below further
It is described in detail.It should be appreciated that described herein, specific examples are only used to explain the present invention, is not intended to limit the present invention.
Embodiment one, a kind of calcium hydrophenyl sulfonate capsule that efficient microcirculation improves, including following raw material: hydroxyl
50~60 parts of benzene sulfonic acid calcium, 5~10 parts of pregelatinized starch, 5~10 parts of magnesium stearate, 10~15 parts of carboxycellulose sodium, ethyl alcohol
15~20 parts of aqueous solution, 10~15 parts of sugar alcohol；
The raw material specifically: 50 parts of Calcium Dobesilate, 5 parts of pregelatinized starch, 5 parts of magnesium stearate, carboxycellulose
10 parts of sodium, 20 parts of ethanol water, 10 parts of sugar alcohol；
A kind of calcium hydrophenyl sulfonate capsule that efficient microcirculation improves, comprises the following steps that:
Step 1: Calcium Dobesilate being crossed into 85 meshes, magnesium stearate and carboxycellulose sodium cross 90 meshes, spare；
Step 2: the raw material that step 1 is sieved is mixed with ethanol water, and pregelatinized starch is added while stirring, is made wet
Material；
Step 3: wet feed is stood into 10~15min；
Step 4: sugar alcohol being added in the wet feed after standing, is stirred evenly；
Step 5: step 4 gains are subjected to whole grain by wobbler；
Step 6: particle is dried by drying machine；
Step 7: the particle filling after drying is packed into Capsules；
Step 8: sterilizing being carried out using ionising radiation, then carries out packaging finished product.
Embodiment two, a kind of calcium hydrophenyl sulfonate capsule that efficient microcirculation improves, including following raw material: hydroxyl
50~60 parts of benzene sulfonic acid calcium, 5~10 parts of pregelatinized starch, 5~10 parts of magnesium stearate, 10~15 parts of carboxycellulose sodium, ethyl alcohol
15~20 parts of aqueous solution, 10~15 parts of sugar alcohol；
The raw material specifically: 50 parts of Calcium Dobesilate, 5 parts of pregelatinized starch, 5 parts of magnesium stearate, carboxycellulose
10 parts of sodium, 20 parts of ethanol water, 10 parts of sugar alcohol；
A kind of calcium hydrophenyl sulfonate capsule that efficient microcirculation improves, comprises the following steps that:
Step 1: Calcium Dobesilate being crossed into 85 meshes, magnesium stearate and carboxycellulose sodium cross 90 meshes, spare；
Step 2: step 1 sieve raw material is mixed into the ethanol water of general component, uniform stirring；
Step: 3: the raw material of step 2 being mixed with the ethanol water of the other half component, pregelatinated is added while stirring and forms sediment
Wet feed is made in powder；
Step 4: wet feed being put into wobbler while sugar alcohol progress whole grain is added；
Step 5: particle is dried by drying machine；
Step 6: the particle filling after drying is packed into Capsules；
Step 8: sterilizing being carried out using ionising radiation, then carries out packaging finished product.
Embodiment three, a kind of calcium hydrophenyl sulfonate capsule that efficient microcirculation improves, including following raw material: hydroxyl
50~60 parts of benzene sulfonic acid calcium, 5~10 parts of pregelatinized starch, 5~10 parts of magnesium stearate, 10~15 parts of carboxycellulose sodium, ethyl alcohol
15~20 parts of aqueous solution, 10~15 parts of sugar alcohol；
The raw material specifically: 50 parts of Calcium Dobesilate, 5 parts of pregelatinized starch, 5 parts of magnesium stearate, carboxycellulose
10 parts of sodium, 20 parts of ethanol water, 10 parts of sugar alcohol；
A kind of calcium hydrophenyl sulfonate capsule that efficient microcirculation improves, comprises the following steps that:
Step 1: Calcium Dobesilate being crossed into 80 meshes, magnesium stearate and carboxycellulose sodium cross 90 meshes, spare；
Step 2: the raw material that step 1 is sieved being mixed with the ethanol water of half component, pregelatinated is added while stirring and forms sediment
Wet feed is made in powder；
Step 3: wet feed is stood into 10~15min；
Step 4: the ethanol water of sugar alcohol and the other half component being added in the wet feed after standing, is stirred evenly；
Step 5: step 4 gains are subjected to whole grain by wobbler；
Step 6: particle is dried by drying machine；
Step 7: the particle filling after drying is packed into Capsules；
Step 8: sterilizing being carried out using ionising radiation, then carries out packaging finished product.
Example IV, a kind of calcium hydrophenyl sulfonate capsule that efficient microcirculation improves, including following raw material: hydroxyl
50~60 parts of benzene sulfonic acid calcium, 5~10 parts of pregelatinized starch, 5~10 parts of magnesium stearate, 10~15 parts of carboxycellulose sodium, ethyl alcohol
15~20 parts of aqueous solution, 10~15 parts of sugar alcohol；
The raw material specifically: 50 parts of Calcium Dobesilate, 5 parts of pregelatinized starch, 5 parts of magnesium stearate, carboxycellulose
10 parts of sodium, 20 parts of ethanol water, 10 parts of sugar alcohol；
A kind of calcium hydrophenyl sulfonate capsule that efficient microcirculation improves, comprises the following steps that:
Step 1: Calcium Dobesilate being crossed into 85 meshes, magnesium stearate and carboxycellulose sodium cross 90 meshes, spare；
Step 2: sugar alcohol being poured into the ethanol water of one third component, stirred spare；
Step 3: by raw material that step 1 is sieved with another three/two-component ethanol water mixes, be added while stirring pre-
Wet feed is made in gelling starch；
Step 3: wet feed is stood into 10~15min；
Step 4: step 2 product and the wet feed after standing being mixed, and uniform stirring；
Step 5: step 4 gains are subjected to whole grain by wobbler；
Step 6: particle is dried by drying machine；
Step 7: the particle filling after drying is packed into Capsules；
Step 8: sterilizing being carried out using ionising radiation, then carries out packaging finished product.
Embodiment five, a kind of calcium hydrophenyl sulfonate capsule that efficient microcirculation improves, including following raw material: hydroxyl
50~60 parts of benzene sulfonic acid calcium, 5~10 parts of pregelatinized starch, 5~10 parts of magnesium stearate, 10~15 parts of carboxycellulose sodium, ethyl alcohol
15~20 parts of aqueous solution, 10~15 parts of sugar alcohol；
The raw material specifically: 50 parts of Calcium Dobesilate, 5 parts of pregelatinized starch, 5 parts of magnesium stearate, carboxycellulose
10 parts of sodium, 20 parts of ethanol water, 10 parts of sugar alcohol；
A kind of calcium hydrophenyl sulfonate capsule that efficient microcirculation improves, comprises the following steps that:
Step 1: Calcium Dobesilate being crossed into 80 meshes, carboxycellulose sodium sieves with 100 mesh sieve, and it is water-soluble to be then mixed into one third ethyl alcohol
In liquid, stir spare；
Step 2: pregelatinized starch and magnesium stearate being added in one third ethanol water, stirred spare；
Step 3: sugar alcohol being added in one third ethanol water, is stirred spare；
Step 4: raw material made from step 1 to 3 is stood into 20~30min；
Step 5: the raw material after step 4 is stood is put into preliminarily dried in drying machine, and 45~50 DEG C of drying temperature, drying time 20
~25min
Step 6: step 5 gains are subjected to whole grain by wobbler；
Step 7: particle is finally dried by drying machine；
Step 8: the particle filling after drying is packed into Capsules；
Step 8: sterilizing being carried out using ionising radiation, then carries out packaging finished product.
The foregoing is merely illustrative of the preferred embodiments of the present invention, is not intended to limit the invention, all in essence of the invention
Made any modifications, equivalent replacements, and improvements etc., should all be included in the protection scope of the present invention within mind and principle.
Claims (9)
1. a kind of calcium hydrophenyl sulfonate capsule that efficient microcirculation improves, which is characterized in that including following raw material: hydroxyl
50~60 parts of benzene sulfonic acid calcium, 5~10 parts of pregelatinized starch, 5~10 parts of magnesium stearate, 10~15 parts of carboxycellulose sodium, ethyl alcohol
15~20 parts of aqueous solution, 10~15 parts of sugar alcohol.
2. the calcium hydrophenyl sulfonate capsule that a kind of efficient microcirculation as described in claim 1 improves, which is characterized in that described
Raw material specifically: 50 parts of Calcium Dobesilate, 5 parts of pregelatinized starch, 5 parts of magnesium stearate, 10 parts of carboxycellulose sodium, second
20 parts of alcohol solution, 10 parts of sugar alcohol.
3. the calcium hydrophenyl sulfonate capsule that a kind of efficient microcirculation as described in claim 1 improves, which is characterized in that including
Following making step:
Step 1: Calcium Dobesilate being crossed into 80 meshes, carboxycellulose sodium sieves with 100 mesh sieve, and it is water-soluble to be then mixed into one third ethyl alcohol
In liquid, stir spare；
Step 2: pregelatinized starch and magnesium stearate being added in another one third ethanol water, stirred spare；
Step 3: sugar alcohol being added in another one third ethanol water, is stirred spare；
Step 4: raw material made from step 1 to 3 is stood into 20~30min；
Step 5: step 4 gains are subjected to whole grain by wobbler；
Step 6: particle is finally dried by drying machine；
Step 7: the particle filling after drying is packed into Capsules；
Step 8: sterilizing being carried out using ionising radiation, then carries out packaging finished product.
4. the calcium hydrophenyl sulfonate capsule that a kind of efficient microcirculation as claimed in claim 3 improves, which is characterized in that described
Capsules use 00# capsule.
5. the calcium hydrophenyl sulfonate capsule that a kind of efficient microcirculation as claimed in claim 3 improves, which is characterized in that in step
Sterilization is added after rapid 7, sterilization is irradiated by ultraviolet radiator.
6. the calcium hydrophenyl sulfonate capsule that a kind of efficient microcirculation as claimed in claim 3 improves, which is characterized in that in step
Preliminarily dried is added after rapid 4, the raw material after step 4 is stood is put into preliminarily dried in drying machine, 45~50 DEG C of drying temperature, does
Dry 20~25min of time.
7. the calcium hydrophenyl sulfonate capsule that a kind of efficient microcirculation as described in claim 1 improves, which is characterized in that described
Carboxycellulose sodium is sodium carboxymethylcellulose.
8. the calcium hydrophenyl sulfonate capsule that a kind of efficient microcirculation as described in claim 1 improves, which is characterized in that described
Sugar alcohol be one of D-sorbite, maltitol, xylitol, hydroxyl isomaltulose, mannitol, lactitol and antierythrite or
It is several.
9. the calcium hydrophenyl sulfonate capsule that a kind of efficient microcirculation as claimed in claim 8 improves, which is characterized in that described
Sugar alcohol is xylitol.
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| CN201910413944.4A CN110123776A (en) | 2019-05-17 | 2019-05-17 | A kind of calcium hydrophenyl sulfonate capsule that efficient microcirculation improves |
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Citations (7)
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|---|---|---|---|---|
| US6147112A (en) * | 1996-04-03 | 2000-11-14 | Laboratorios Del Dr. Esteve, S.A. | Use of 2,5-dihydroxybenzenesulfonic derivatives for the normalization of endothelial function |
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| CN102579396A (en) * | 2012-04-01 | 2012-07-18 | 宁夏康亚药业有限公司 | Calcium dobesilate capsule composition |
| US20130172414A1 (en) * | 2010-06-29 | 2013-07-04 | Tianjin Nankai Share Pharmaceutical Science & Technology Co., Ltd. | Pharmaceutical composition comprising levocarnitine and dobesilate |
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2019
- 2019-05-17 CN CN201910413944.4A patent/CN110123776A/en active Pending
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| US6147112A (en) * | 1996-04-03 | 2000-11-14 | Laboratorios Del Dr. Esteve, S.A. | Use of 2,5-dihydroxybenzenesulfonic derivatives for the normalization of endothelial function |
| US20130172414A1 (en) * | 2010-06-29 | 2013-07-04 | Tianjin Nankai Share Pharmaceutical Science & Technology Co., Ltd. | Pharmaceutical composition comprising levocarnitine and dobesilate |
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| CN102579396A (en) * | 2012-04-01 | 2012-07-18 | 宁夏康亚药业有限公司 | Calcium dobesilate capsule composition |
| CN103230383A (en) * | 2013-03-31 | 2013-08-07 | 北京万全阳光医学技术有限公司 | Calcium dobesilate capsule composition and preparation method thereof |
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