CN103055319A - Medical slow-release film coating powder - Google Patents
Medical slow-release film coating powder Download PDFInfo
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- CN103055319A CN103055319A CN2013100401695A CN201310040169A CN103055319A CN 103055319 A CN103055319 A CN 103055319A CN 2013100401695 A CN2013100401695 A CN 2013100401695A CN 201310040169 A CN201310040169 A CN 201310040169A CN 103055319 A CN103055319 A CN 103055319A
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- release film
- sustained release
- film coat
- coat powder
- ferric oxide
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Abstract
The invention provides a slow-release film coating powder, which has high safety and fully adopts silk fibroin. The slow-release film coating powder is technically characterized by comprising the following components in percentage by weight: 10-60% of silk fibroin, 20-50% of reference complex, 5-20% of a pore-foaming agent, 0-15% of a coloring agent, 0-30% of an opacifying agent and 15-30% of an antisticking agent. The slow-release film coating powder belongs to the technical field of medicine coating design.
Description
Technical field
The present invention discloses a kind of coating powder, specifically, is a kind of medicinal sustained release film coat powder, belongs to medical coating design field.
Background technology
Slow releasing preparation is in the release medium of regulation, non-constant release medicine lentamente on request, it compares with corresponding ordinary preparation, and administration frequency and ordinary preparation reduce half or administration frequency and ordinary preparation and reduce to some extent, and can significantly increase the preparation of patient's compliance.Compare with ordinary preparation, have following characteristics: 1. delivery time is long, reduces administration number of times; 2. blood drug level is mild in the body, reduces the fluctuation of blood drug level; 3. toxic and side effects is less, increases medicine body internal stability; 4. drug release is slow, and utilization rate is high.
The film controlling type slow releasing preparation is a kind of common oral administration solid slow releasing preparation, be made into coating solution with suitable coating prescription, adopt certain technique to prepare coating membrane continuous, homogeneous, reach the purpose of medicament slow release, common are microporous membrane coated tablet (or piller), microcapsule, coating microsphere, enteric coated capsule etc.
As biodegradable material, fibroin albumen good biocompatibility, stable in properties, safety non-toxic, cheap.In the silk textile industry, all can discharge a large amount of waste water and waste silk every day, and this not only can cause environmental disruption, also is a kind of serious wasting of resources.Fibroin can be prepared into variform after treatment, and such as cellular, membranaceous and tubulose etc., the fibroin fiber that obtains, silk fibroin powder, crosslinked porous fibroin hydrogel, fibroin membrane can be used as good biomaterial.Has widely new purposes at aspects such as biomedicine, food, fermentation industry, environmental conservation, utilization of energy, cosmetics.Biomedical aspect, fibroin albumen are applied to reparation, medical bio bressing, stitching thread, artificial blood vessel anticoagulant material and the biosensor etc. of bone tissue restoration, artificial blood vessel, artificial skin, Urethral defect.What the application in Thermosensitive Material Used for Controlled Releasing of Medicine field was comparatively outstanding is fibroin microsphere/microcapsule medicament slow-released system.
Fibroin albumen contains 18 seed amino acids as the natural polymer protein material, has the charged property of both sexes.Fibroin albumen itself has good mechanical performance and physicochemical property, is insoluble in water, and certain pliability and tensile strength are arranged after the film forming.Through blend, grafting, the method such as crosslinked, can improve the mechanical property of film, increase film strength and elasticity.Based on development and the trend of Thermosensitive Material Used for Controlled Releasing of Medicine, the natural synthetic material take fibroin albumen as representative is just becoming the focus of drug release carrier investigation of materials.Fibroin albumen is paid attention to by people just day by day as good biomaterial.So with Bombyx-mori Bave as a kind of biological raw material, extract preparation fibroin albumen (Silk Fibroin, SF), and it being applied on the medicament slow release preparation, is that its theoretical research and technology are used and all had great academic significance and social economic value.
Summary of the invention
For the problems referred to above, the object of the present invention is to provide a kind of fibroin albumen that effectively utilizes, the safe sustained release film coat powder of gained.
For solving the problems of the technologies described above, technical scheme provided by the invention is such: a kind of medicinal sustained release film coat powder, by weight percentage, comprise fibroin albumen 10 ~ 60%, benchmark coordination compound 20 ~ 50%, porogen 5 ~ 20%, coloring agent 0 ~ 15%, opacifier 0 ~ 30%, antiplastering aid 15 ~ 30%, each component sum is 100%.
Above-mentioned medicinal sustained release film coat powder by weight percentage, comprises fibroin albumen 15 ~ 35%, benchmark coordination compound 25 ~ 35%, porogen 10 ~ 15%, coloring agent 5 ~ 10%, opacifier 5 ~ 25%, antiplastering aid 20 ~ 25%, and each component sum is 100%.
Further, above-mentioned medicinal sustained release film coat powder, described benchmark coordination compound is microcrystalline Cellulose, methacrylic acid/ethyl acrylate copolymer, ethyl cellulose, methacrylic acid/methylmethacrylate copolymer, polyvinyl acetate, cellulose acetate, ethylene/vinyl acetate copolymer, one of them of castor oil hydrogenated or any several mixture.
Further, above-mentioned medicinal sustained release film coat powder, described porogen is hydroxypropyl cellulose, PEG400, Stepanol MG, hydroxypropyl methylcellulose, sodium chloride, potassium chloride, sucrose, sodium laurate, alkyl sulfate, sodium lauryl sulphate, sodium lauryl sulfate, triethyl citrate, cetyl sulfonic acid, alginate, dioctyl sodium sulphosuccinate, dodecyl chloride, cetyl trimethyl ammonium bromide, Polyethylene Glycol, one of them of polyvinylpyrrolidone or any several mixture.
Further, above-mentioned medicinal sustained release film coat powder, described coloring agent is sunset yellow, lemon yellow, light blue, tartrazines, yellow ferric oxide, Brown Ferric Oxide, red ferric oxide, Black Rouge, carmine, erythrosine, Pulvis Talci, red yeast rice, Gardenia Yellow, one of them of radish red or sodium copper chlorophllin or any several mixture.
Further, above-mentioned medicinal sustained release film coat powder, described opacifier is yellow ferric oxide, Brown Ferric Oxide, red ferric oxide, Black Rouge, one of them of titanium dioxide or any several mixture.
Further, above-mentioned medicinal sustained release film coat powder, described antiplastering aid is Pulvis Talci, silicon dioxide, kaolinic one of them or any several mixture.
Compared with prior art, technical scheme provided by the invention has following advantage: this product reduces the filature industrial pollution, effectively utilizes fibroin albumen, turns waste into wealth; 2, component provided by the invention is carried out coating and is made the product good film-forming property; Have good antibiotic, non-oxidizability, pharmacy security is high; 3, this product coated tablet smooth surface of gained, difficult drop-off.
The specific embodiment
Below in conjunction with the specific embodiment; claim to invention is described in further detail; but become not any limitation of the invention, the modification of the limited number of time that anyone makes in claim scope of the present invention is still in claim protection domain of the present invention.
Embodiment 1
A kind of sustained release film coat powder of the present invention is made of fibroin albumen 160g following component; EUDRAGIT L100-55 (1:1) 230g; Microcrystalline Cellulose 270g; Hydroxypropyl methylcellulose 50g; Yellow ferric oxide 30g; Titanium dioxide 10g; Pulvis Talci 150g; Silica 1 00g.
Embodiment 2
Sustained release film coat powder of the present invention also can be made of following component: fibroin albumen 600g; Castor oil hydrogenated 200g; Hydroxypropyl methylcellulose 50g; Pulvis Talci 130g; Kaolin 20g.
Embodiment 3
Sustained release film coat powder of the present invention also can be made of following component: fibroin albumen 500g; Polyvinyl acetate 200g; Triethyl citrate 50g; Polyethylene Glycol 100g; Pulvis Talci 150g.
Embodiment 4
Sustained release film coat powder of the present invention also can be made of following component: fibroin albumen 150g; Ethyl cellulose 400g; Stepanol MG 70g; PVPK30 g; Red ferric oxide 20g; Red yeast rice 10g; Black Rouge 20g; Pulvis Talci 300g.
Embodiment 5
Sustained release film coat powder of the present invention also can be made of following component: fibroin albumen 100g; Methacrylic acid/methylmethacrylate copolymer (1:1) 150g; Methacrylic acid/methylmethacrylate copolymer (1:2) 150g; Microcrystalline Cellulose 100g; PEG400 30g; Sodium lauryl sulfate 20g; Red ferric oxide 170g; Titanium dioxide 130g; Pulvis Talci 150g.
Embodiment 6
Sustained release film coat powder of the present invention also can be made of following component: fibroin albumen 200g; Microcrystalline Cellulose 300g; Hydroxypropyl cellulose 150g; Polyethylene Glycol 50g; Sunset yellow 70g; Pulvis Talci 80g; Silica 1 50g.
Embodiment 7
Sustained release film coat powder of the present invention also can be made of following component: fibroin albumen 250g; Methacrylic acid/ethyl acrylate copolymer 250g; Hydroxypropyl cellulose 100g; Sunset yellow 70g; Brown Ferric Oxide 100g; Pulvis Talci 230g.
Embodiment 8
Sustained release film coat powder of the present invention also can be made of following component: fibroin albumen 300g; Microcrystalline Cellulose 200g; Hydroxypropyl cellulose 150g; Potassium chloride 50g; Sunset yellow 70g; Pulvis Talci 80g; Silica 1 50g.
Embodiment 9
Sustained release film coat powder of the present invention also can be made of following component: fibroin albumen 250g; Microcrystalline Cellulose 200g; Cellulose acetate 100g; Sodium laurate 50g; Sucrose 50g; Yellow ferric oxide 70g; Pulvis Talci 80g; Silica 1 00g; Pulvis Talci 100g.
During concrete the use, its preparation method:
Preparation process: fibroin albumen is ground to form fine powder, add the abundant mixing of other raw materials, pulverize, cross 100 mesh sieves, get film coating powder a;
Check
1) character---range estimation.
The result: film coating powder a is the uniform powder of color and luster.
2) the outward appearance uniformity---it is an amount of to get film coating powder a, puts on the glossy paper to tile about 5 square centimeters, and its surface is flattened, and observes range estimation at bright place.
Result: present uniform color and luster, without decorative pattern, mottle.
3) loss on drying---precision takes by weighing film coating powder a1.0g, 105 ℃ of dryings 4 hours, calculates and subtracts weight loss.
The result: subtracting weight loss is 3.85%.
4) residue on ignition---get film coating powder a1.0g, check (" two appendix VIII of Chinese pharmacopoeia version in 2010 N, 700 ℃ ~ 800 ℃ of temperature). in accordance with the law
Result: up to specification.
5) heavy metal---get film coating powder a1.0g, slowly blazing to fully carbonization, let cool, add sulphuric acid 0.5 ~ 1.0ml, make just moisteningly, after eliminating with low-temperature heat to sulphuric acid, add nitric acid 0.5ml, evaporate to dryness, after eliminating to the nitrogen oxide steam, let cool, blazingly make complete ashing at 500 ℃ ~ 600 ℃, let cool, add 7mol/L hydrochloric acid solution 10ml dissolving, filter, get filtrate, add 30% hydrogenperoxide steam generator 2ml, put and be evaporated to about 5ml in the water-bath, let cool, in the dislocation separatory funnel, with 7mol/L hydrochloric acid solution 10ml gradation washing container, washing liquid is incorporated in the separatory funnel, extracts 3 times each 20ml with the jolting of hexone solution, heating is 20 minutes in the water-bath of water intaking stratification, let cool, drip ammonia solution regulator solution pH to 3 ~ 5, filter, get filtrate and add acetate buffer (pH3.5) 2ml and make in right amount 25ml with water, check (" two appendix VIII of Chinese pharmacopoeia version in 2010 H the second method). in accordance with the law
Result: up to specification.
6) microbial limit---get film coating powder a10g, add the aseptic sodium chloride peptone buffer agent of pH7.0 100ml, shake well is even, makes the test liquid of 1:10.Draw the test liquid of 20ml and put into respectively two centrifuge tubes, left standstill 20 minutes, get supernatant liquid, as need testing solution, check (" two appendix XI of Chinese pharmacopoeia version in 2010 J). in accordance with the law
Result: up to specification.
Claims (7)
1. a medicinal sustained release film coat powder is characterized in that, by weight percentage, comprises fibroin albumen 10 ~ 60%, benchmark coordination compound 20 ~ 50%, porogen 5 ~ 20%, and coloring agent 0 ~ 15%, opacifier 0 ~ 30%, antiplastering aid 15 ~ 30%, each component sum is 100%.
2. medicinal sustained release film coat powder according to claim 1 is characterized in that, by weight percentage, comprises fibroin albumen 15 ~ 35%, benchmark coordination compound 25 ~ 35%, porogen 10 ~ 15%, coloring agent 5 ~ 10%, opacifier 5 ~ 25%, antiplastering aid 20 ~ 25%, each component sum is 100%.
3. medicinal sustained release film coat powder according to claim 1 and 2, it is characterized in that, described benchmark coordination compound is microcrystalline Cellulose, methacrylic acid/ethyl acrylate copolymer, ethyl cellulose, methacrylic acid/methylmethacrylate copolymer, polyvinyl acetate, cellulose acetate, ethylene/vinyl acetate copolymer, one of them of castor oil hydrogenated or any several mixture.
4. medicinal sustained release film coat powder according to claim 1 and 2 is characterized in that, described porogen is hydroxypropyl cellulose, PEG400, Stepanol MG, hydroxypropyl methylcellulose, sodium chloride, potassium chloride, sucrose, sodium laurate, alkyl sulfate, sodium lauryl sulphate, sodium lauryl sulfate, triethyl citrate, cetyl sulfonic acid, alginate, dioctyl sodium sulphosuccinate, dodecyl chloride, cetyl trimethyl ammonium bromide, Polyethylene Glycol, one of them of polyvinylpyrrolidone or any several mixture.
5. medicinal sustained release film coat powder according to claim 1 and 2 is characterized in that, described coloring agent is sunset yellow, lemon yellow, light blue, tartrazines, yellow ferric oxide, Brown Ferric Oxide, red ferric oxide, Black Rouge, carmine, erythrosine, Pulvis Talci, red yeast rice, Gardenia Yellow, one of them of radish red or sodium copper chlorophllin or any several mixture.
6. medicinal sustained release film coat powder according to claim 1 and 2 is characterized in that, described opacifier is yellow ferric oxide, Brown Ferric Oxide, red ferric oxide, Black Rouge, one of them of titanium dioxide or any several mixture.
7. medicinal sustained release film coat powder according to claim 1 and 2 is characterized in that, described antiplastering aid is Pulvis Talci, silicon dioxide, kaolinic one of them or any several mixture.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2013100401695A CN103055319A (en) | 2013-02-01 | 2013-02-01 | Medical slow-release film coating powder |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2013100401695A CN103055319A (en) | 2013-02-01 | 2013-02-01 | Medical slow-release film coating powder |
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| CN103055319A true CN103055319A (en) | 2013-04-24 |
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| CN2013100401695A Pending CN103055319A (en) | 2013-02-01 | 2013-02-01 | Medical slow-release film coating powder |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112245495A (en) * | 2020-11-21 | 2021-01-22 | 陕西远志医药生物工程有限公司 | Slow-release antibacterial gel and preparation method thereof |
-
2013
- 2013-02-01 CN CN2013100401695A patent/CN103055319A/en active Pending
Non-Patent Citations (3)
| Title |
|---|
| OGUZ BAYRAKTAR ET AL.: "Silk fibroin as a novel coating material for controlled release of theophylline", 《EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS》 * |
| 曹阳 等: "基于丝素蛋白的药物缓释材料", 《中国组织工程研究与临床康复》 * |
| 杨立群 等: "丝素蛋白作为药物缓释载体的研究进展", 《中国医药生物技术》 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112245495A (en) * | 2020-11-21 | 2021-01-22 | 陕西远志医药生物工程有限公司 | Slow-release antibacterial gel and preparation method thereof |
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Application publication date: 20130424 |