CN101496795B - Technique for preparing biodegradable composite controlled release membrane of medicament - Google Patents
Technique for preparing biodegradable composite controlled release membrane of medicament Download PDFInfo
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- CN101496795B CN101496795B CN2009100105394A CN200910010539A CN101496795B CN 101496795 B CN101496795 B CN 101496795B CN 2009100105394 A CN2009100105394 A CN 2009100105394A CN 200910010539 A CN200910010539 A CN 200910010539A CN 101496795 B CN101496795 B CN 101496795B
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- 239000003814 drug Substances 0.000 title claims abstract description 45
- 238000013270 controlled release Methods 0.000 title claims abstract description 21
- 239000002131 composite material Substances 0.000 title claims abstract description 15
- 239000012528 membrane Substances 0.000 title claims description 17
- 238000000034 method Methods 0.000 title 1
- 229920001661 Chitosan Polymers 0.000 claims abstract description 25
- 238000002360 preparation method Methods 0.000 claims abstract description 23
- DTQVDTLACAAQTR-UHFFFAOYSA-N Trifluoroacetic acid Chemical compound OC(=O)C(F)(F)F DTQVDTLACAAQTR-UHFFFAOYSA-N 0.000 claims abstract description 22
- 229920001606 poly(lactic acid-co-glycolic acid) Polymers 0.000 claims abstract description 20
- 229940079593 drug Drugs 0.000 claims abstract description 15
- 230000003110 anti-inflammatory effect Effects 0.000 claims abstract description 7
- 229920000747 poly(lactic acid) Polymers 0.000 claims abstract description 6
- 239000006184 cosolvent Substances 0.000 claims abstract description 4
- 239000004615 ingredient Substances 0.000 claims abstract description 4
- 230000000922 anti-bactericidal effect Effects 0.000 claims abstract 3
- 239000002260 anti-inflammatory agent Substances 0.000 claims description 13
- SEEPANYCNGTZFQ-UHFFFAOYSA-N sulfadiazine Chemical compound C1=CC(N)=CC=C1S(=O)(=O)NC1=NC=CC=N1 SEEPANYCNGTZFQ-UHFFFAOYSA-N 0.000 claims description 9
- 230000000844 anti-bacterial effect Effects 0.000 claims description 6
- 229960004306 sulfadiazine Drugs 0.000 claims description 6
- 229960003600 silver sulfadiazine Drugs 0.000 claims description 3
- 230000001741 anti-phlogistic effect Effects 0.000 claims 4
- 239000003899 bactericide agent Substances 0.000 claims 2
- OGJPXUAPXNRGGI-UHFFFAOYSA-N norfloxacin Chemical compound C1=C2N(CC)C=C(C(O)=O)C(=O)C2=CC(F)=C1N1CCNCC1 OGJPXUAPXNRGGI-UHFFFAOYSA-N 0.000 claims 1
- 229960001180 norfloxacin Drugs 0.000 claims 1
- 206010052428 Wound Diseases 0.000 abstract description 24
- 208000027418 Wounds and injury Diseases 0.000 abstract description 24
- 230000002980 postoperative effect Effects 0.000 abstract description 3
- 230000015556 catabolic process Effects 0.000 abstract description 2
- 238000006731 degradation reaction Methods 0.000 abstract description 2
- 230000002439 hemostatic effect Effects 0.000 abstract 1
- 238000011084 recovery Methods 0.000 abstract 1
- 230000001225 therapeutic effect Effects 0.000 abstract 1
- 229920002101 Chitin Polymers 0.000 description 9
- 238000005266 casting Methods 0.000 description 9
- 239000006185 dispersion Substances 0.000 description 9
- 230000010355 oscillation Effects 0.000 description 9
- 229940124599 anti-inflammatory drug Drugs 0.000 description 7
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 6
- 206010061218 Inflammation Diseases 0.000 description 6
- 230000001954 sterilising effect Effects 0.000 description 6
- 238000004659 sterilization and disinfection Methods 0.000 description 6
- 230000000694 effects Effects 0.000 description 5
- 239000000203 mixture Substances 0.000 description 4
- 230000003287 optical effect Effects 0.000 description 4
- 230000029663 wound healing Effects 0.000 description 4
- 108010010803 Gelatin Proteins 0.000 description 3
- 229920000159 gelatin Polymers 0.000 description 3
- 239000008273 gelatin Substances 0.000 description 3
- 235000019322 gelatine Nutrition 0.000 description 3
- 235000011852 gelatine desserts Nutrition 0.000 description 3
- 102000008186 Collagen Human genes 0.000 description 2
- 108010035532 Collagen Proteins 0.000 description 2
- YCKRFDGAMUMZLT-UHFFFAOYSA-N Fluorine atom Chemical compound [F] YCKRFDGAMUMZLT-UHFFFAOYSA-N 0.000 description 2
- 239000004372 Polyvinyl alcohol Substances 0.000 description 2
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 description 2
- 230000036592 analgesia Effects 0.000 description 2
- 229940088710 antibiotic agent Drugs 0.000 description 2
- 230000006196 deacetylation Effects 0.000 description 2
- 238000003381 deacetylation reaction Methods 0.000 description 2
- 210000000416 exudates and transudate Anatomy 0.000 description 2
- 229910052731 fluorine Inorganic materials 0.000 description 2
- 239000011737 fluorine Substances 0.000 description 2
- 230000000025 haemostatic effect Effects 0.000 description 2
- 230000023597 hemostasis Effects 0.000 description 2
- 239000012456 homogeneous solution Substances 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 239000008363 phosphate buffer Substances 0.000 description 2
- 229920002451 polyvinyl alcohol Polymers 0.000 description 2
- 230000036560 skin regeneration Effects 0.000 description 2
- 238000013268 sustained release Methods 0.000 description 2
- 239000012730 sustained-release form Substances 0.000 description 2
- IXPNQXFRVYWDDI-UHFFFAOYSA-N 1-methyl-2,4-dioxo-1,3-diazinane-5-carboximidamide Chemical compound CN1CC(C(N)=N)C(=O)NC1=O IXPNQXFRVYWDDI-UHFFFAOYSA-N 0.000 description 1
- 208000035143 Bacterial infection Diseases 0.000 description 1
- 102000012422 Collagen Type I Human genes 0.000 description 1
- 108010022452 Collagen Type I Proteins 0.000 description 1
- 102000009123 Fibrin Human genes 0.000 description 1
- 108010073385 Fibrin Proteins 0.000 description 1
- BWGVNKXGVNDBDI-UHFFFAOYSA-N Fibrin monomer Chemical compound CNC(=O)CNC(=O)CN BWGVNKXGVNDBDI-UHFFFAOYSA-N 0.000 description 1
- 206010020880 Hypertrophy Diseases 0.000 description 1
- 239000002671 adjuvant Substances 0.000 description 1
- 208000022362 bacterial infectious disease Diseases 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 229920002988 biodegradable polymer Polymers 0.000 description 1
- 239000004621 biodegradable polymer Substances 0.000 description 1
- 239000013060 biological fluid Substances 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 229920001436 collagen Polymers 0.000 description 1
- 210000001608 connective tissue cell Anatomy 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- 229950003499 fibrin Drugs 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 150000004676 glycans Chemical class 0.000 description 1
- 208000026278 immune system disease Diseases 0.000 description 1
- 230000002503 metabolic effect Effects 0.000 description 1
- 230000004060 metabolic process Effects 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 230000036407 pain Effects 0.000 description 1
- 229920001282 polysaccharide Polymers 0.000 description 1
- 239000005017 polysaccharide Substances 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 230000008591 skin barrier function Effects 0.000 description 1
- 235000010413 sodium alginate Nutrition 0.000 description 1
- 239000000661 sodium alginate Substances 0.000 description 1
- 229940005550 sodium alginate Drugs 0.000 description 1
- 229910000030 sodium bicarbonate Inorganic materials 0.000 description 1
- 235000017557 sodium bicarbonate Nutrition 0.000 description 1
- 230000002194 synthesizing effect Effects 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
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- Medicinal Preparation (AREA)
Abstract
可生物降解复合药物控制释放膜的制备工艺，为了解决现有敷料膜不同程度的存在机械强度较差，不易于保持创面湿润，对创面治疗作用不明显以及价格较为昂贵，且具有一定的抗原性，不利于大范围应用等技术问题而设计的，释放膜是按下述重量百分比配制的：壳聚糖0％-35％、PLA或PLGA 50％-100％及消炎杀菌药物0.1％-25％。其制备工艺是通过下述步骤实现的：先将壳聚糖和PLA或PLGA溶解于共溶剂三氟乙酸中，制备成均匀溶液，然后加入药物成分，经超声振荡，使药物充分溶解分散，再流延成膜。特点：具有成膜性好、机械强度适中、止血效果好、降解速度适中及能保持创面湿润、有明显的消炎杀菌作用，且制备工艺简单，成本低，可广泛用于烧、创伤创面的治疗及术后伤口的恢复治疗。
The preparation process of the biodegradable composite drug controlled release film, in order to solve the existing dressing films in different degrees, has poor mechanical strength, is not easy to keep the wound moist, has no obvious therapeutic effect on the wound, and is relatively expensive, and has certain antigenicity , not conducive to large-scale application and other technical problems, the release film is formulated according to the following weight percentages: chitosan 0%-35%, PLA or PLGA 50%-100%, and anti-inflammatory and bactericidal drugs 0.1%-25% . Its preparation process is realized through the following steps: first, dissolving chitosan and PLA or PLGA in the co-solvent trifluoroacetic acid to prepare a uniform solution, then adding the drug ingredients, and ultrasonically oscillating to fully dissolve and disperse the drug, and then Cast film. Features: good film-forming properties, moderate mechanical strength, good hemostatic effect, moderate degradation speed, ability to keep wounds moist, obvious anti-inflammatory and bactericidal effects, simple preparation process, low cost, and can be widely used in the treatment of burns and wounds and postoperative wound recovery.
Description
Technical field:
The present invention relates to a kind of preparation technology of controlled release membrane of medicament, relate in particular to a kind of preparation technology of Biodegradable composite controlled release membrane of medicament.Can be widely used in burning, the Wound treating of wound and resuming treatment of postoperative wound.
Background technology:
Skin is the organ of human body maximum, if skin is subjected to large tracts of land damage, then can cause many parts even general problem, as metabolism aggravation, moisture and protein excessively scatter and disappear, immune system disorder etc., the serious entail dangers to life of going back.If wound surface covers suitable dressing, can effectively reduce the metabolic order of severity of patient's body superelevation, ease the pain, prevent bacterial infection, quicken wound healing.Therefore, people extensively explore the Wound dressing that can be used as skin barrier in recent years.Chinese patent [CN 1395968] discloses a kind of biological fluid dressing chitosan membrane and preparation method thereof.It is characterized in that through acidolysis, add adjuvants such as gelatin, glycerol, neutralize and filter through sodium bicarbonate again.But this fluid dressing membrane mechanical strength is relatively poor, is not easy to keep wound surface moistening.Chinese patent [CN 1554448] discloses the biological bleeding-stopping dressing of a kind of chitosan gelatin polyvinyl alcohol, is formulated by chitosan, gelatin, polyvinyl alcohol, glycerol.This dressing has hydrophilic, film property, tractive and haemostatic effect preferably, but wound surface is not had the obvious treatment effect.Chinese patent [CN 1380109] discloses a kind of chitosan, collagen and sodium alginate compounded spongy biological dressing and preparation technology thereof.This dressing good biocompatibility, adhesiveness is strong, has the active function and the anastalsis that promote wound healing.But its used type i collagen price is comparatively expensive, and has certain antigenicity, is unfavorable for widespread adoption.
Summary of the invention:
The present invention for solve existing dressing membrane in various degree exist mechanical strength relatively poor, be not easy to keep wound surface moistening, not obvious and price is comparatively expensive to the Wound treating effect, and has certain antigenicity, be unfavorable for technical problems such as widespread adoption, a kind of preparation technology of Biodegradable composite controlled release membrane of medicament is provided, and this release film is prepared by following percentage by weight: chitosan 0%-35%, PLA or PLGA 49.9%-99.9% and anti-inflammation and sterilization medicine 0.1%-25%.
Its preparation technology realizes by following step by said ratio:
Earlier chitosan and PLA or PLGA are dissolved in the cosolvent trifluoroacetic acid, are prepared into homogeneous solution, add ingredient then,, make medicine fully dissolve dispersion, casting film-forming again through sonic oscillation.
Characteristics of the present invention and beneficial effect: medicine sustained release composite membrane of the present invention has good film-forming property, mechanical strength is moderate, haemostatic effect good, degradation speed is moderate and can keep wound surface moistening, tangible anti-inflammation and sterilization effect arranged, and preparation technology is simple, cost is low, can be widely used in the treatment of burning, wound and wound surface and resuming treatment of postoperative wound.
The biodegradable blend film of chitosan and PLA or PLGA has excellent biological compatibility, degradability, toughness and breathability, has the protection wound surface, attracts effects such as wound exudate, anti-inflammation and sterilization, hemostasis, analgesia, promotion wound healing and skin regeneration for large-area burns, wound.Improved its anti-inflammatory and blend film and antibacterials are combined with each other.
Description of drawings:
Fig. 1. contain the optical microscope photograph that 15% ring third kills this controlled release membrane of medicament of star
Fig. 2. contain the release profiles that 15% ring third kills this controlled release membrane of medicament of star
Fig. 3. contain the optical microscope photograph of this controlled release membrane of medicament of 8% sulfadiazine
Fig. 4. contain the release profiles of this controlled release membrane of medicament of 8% sulfadiazine
The specific embodiment:
The preparation technology of Biodegradable composite controlled release membrane of medicament, this release film is prepared by following percentage by weight: chitosan 0%-35%, PLA or PLGA 49.9%-99.9% and anti-inflammation and sterilization medicine 0.1%-25%.
Its preparation technology realizes by following step:
Earlier chitosan and PLA or PLGA are dissolved in the cosolvent trifluoroacetic acid, are prepared into homogeneous solution, add ingredient then,, make medicine fully dissolve dispersion, casting film-forming again through sonic oscillation.
Described chitosan is a medicated chitin, and molecular weight is below 10000, and deacetylation is 75%～95%.
Described PLA or PLGA, molecular weight be 20,000-500,000.
Described anti-inflammation and sterilization medicine is that oil-soluble or water miscible silver sulfadiazine, sulfadiazine, promise fluorine kill star or encircle third and kill the star medicine.
Chitosan is that occurring in nature is only second to cellulosic second largest biological polyoses, also is the alkaline polysaccharide of the unique a large amount of existence of occurring in nature simultaneously.Biologically active of chitosan own and anastalsis can stop formation, the hypertrophy of connective tissue cell and the synthesizing of collagen protein of fibrin element.Poly-'alpha '-hydroxy acids such as PLA or PLGA is the biodegradable polymer of synthetic, have advantages such as good biocompatibility, mechanical strength be good, especially PLA by U.S. food and drug administration regard as can be applicable to clinical, as as operation suture thread and embedded material etc., and can go out good intermingling material with Preparation of Chitosan.Poly-'alpha '-hydroxy acids excellent mechanical intensity such as PLA or PLGA can remedy the defective of chitosan bad mechanical strength just.The biodegradable blend film of chitosan and PLA or PLGA has excellent biological compatibility, degradability, toughness and breathability, has the protection wound surface, attracts effects such as wound exudate, anti-inflammation and sterilization, hemostasis, analgesia, promotion wound healing and skin regeneration for large-area burns, wound.Improved its anti-inflammatory and blend film and antibacterials are combined with each other.
Embodiment 1. is dissolved in medicated chitin 35% (molecular weight is 10,000) and PLA 50% (molecular weight is 100,000) in the trifluoroacetic acid, adds anti-inflammatory drug ring third then and kills star 15%, and sonic oscillation makes medicine fully dissolve dispersion, casting film-forming again.Referring to Fig. 1 is the optical microscope photograph of this film.Referring to Fig. 2 is the sustained release curve of this controlled release membrane of medicament in 37 ℃ of phosphate buffers.
Embodiment 2. is dissolved in medicated chitin 25% (molecular weight is 3000) and PLGA 65% (molecular weight is 80,000) in the trifluoroacetic acid, adds anti-inflammatory drug ring third then and kills star 10%, and sonic oscillation makes medicine fully dissolve dispersion, casting film-forming again.
Embodiment 3. is dissolved in medicated chitin 20% (molecular weight is 8000) and PLA 72% (molecular weight is 150,000) in the trifluoroacetic acid, adds anti-inflammatory drug sulfadiazine 8% then, and sonic oscillation makes medicine fully dissolve dispersion, casting film-forming again.Referring to Fig. 3 is the optical microscope photograph of this film.Referring to Fig. 4 is the release profiles of this controlled release membrane of medicament in 37 ℃ of phosphate buffers.
Embodiment 4. is dissolved in medicated chitin 10% (molecular weight is 3000) and PLGA 70% (molecular weight is 50,000) in the trifluoroacetic acid, adds anti-inflammatory drug sulfadiazine 20% then, and sonic oscillation makes medicine fully dissolve dispersion, casting film-forming again.
Embodiment 5. is dissolved in medicated chitin 0% (molecular weight is 0) and PLA 99.9% (molecular weight is 40,000) in the trifluoroacetic acid, adds anti-inflammatory drug ring third then and kills star 0.1%, and sonic oscillation makes medicine fully dissolve dispersion, casting film-forming again.
Embodiment 6. is dissolved in medicated chitin 50% (molecular weight is 5000) and PLGA 49.9% (molecular weight is 200,000) in the trifluoroacetic acid, adds anti-inflammatory drug promise fluorine then and kills star 0.1%, and sonic oscillation makes medicine fully dissolve dispersion, casting film-forming again.
Embodiment 7. is dissolved in medicated chitin 30% (molecular weight is 6000) and PLA 45% (molecular weight is 300,000) in the trifluoroacetic acid, adds anti-inflammatory drug silver sulfadiazine 25% then, and sonic oscillation makes medicine fully dissolve dispersion, casting film-forming again.
The deacetylation of the medicated chitin described in the foregoing description 1-7 is 75%～95%.
Claims (8)
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| CN2009100105394A CN101496795B (en) | 2009-03-03 | 2009-03-03 | Technique for preparing biodegradable composite controlled release membrane of medicament |
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| CN2009100105394A CN101496795B (en) | 2009-03-03 | 2009-03-03 | Technique for preparing biodegradable composite controlled release membrane of medicament |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103418023B (en) * | 2013-07-29 | 2014-09-03 | 大连医科大学 | Multilayer composite hemostatic material and preparation method thereof |
| CN103434229B (en) * | 2013-08-22 | 2015-09-16 | 华南理工大学 | A kind of multi-layer oriented controlled release antibiotic film and preparation method thereof and application |
| CN118126370B (en) * | 2024-02-20 | 2025-06-27 | 山东益诺康药业有限公司 | Polymer microsphere-loaded chitosan antibacterial film and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1857236A (en) * | 2006-03-08 | 2006-11-08 | 曾敬 | Compound medicine release controlling film of chitosan, sodium alginate and gelatin and its preparing process |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1857236A (en) * | 2006-03-08 | 2006-11-08 | 曾敬 | Compound medicine release controlling film of chitosan, sodium alginate and gelatin and its preparing process |
Non-Patent Citations (4)
| Title |
|---|
| Manisara Peesan et al.Preparation and characterization of hexanoyl chitosan/polylactide blend films.Carbohydrate Polymers.2005,60343-350. * |
| Nugraha E. Suyatma et al.Mechanical and Barrier Properties of Biodegradable Films Made from Chitosan and Poly (Lactic Acid) Blends.Journal of Polymers and the Environment.2004,12(1),1-6. * |
| P. Perugini et al.Periodontal delivery of ipriflavone: new chitosan/PLGA film delivery system for a lipophilic drug.International Journal of Pharmaceutics.2003,1-9. * |
| Shaobing Zhou et al.In vitro degradation and release profiles for Poly-dl-lactide film containing paracetamol.J Mater Sci: Mater Med.2007,(18),1623-1626. * |
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