TWI819245B - Medical dressing and manufacturing method thereof - Google Patents
Medical dressing and manufacturing method thereof Download PDFInfo
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- TWI819245B TWI819245B TW109136266A TW109136266A TWI819245B TW I819245 B TWI819245 B TW I819245B TW 109136266 A TW109136266 A TW 109136266A TW 109136266 A TW109136266 A TW 109136266A TW I819245 B TWI819245 B TW I819245B
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- composite
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- medical dressing
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- 238000004519 manufacturing process Methods 0.000 title claims description 10
- 239000002131 composite material Substances 0.000 claims abstract description 211
- 229920006254 polymer film Polymers 0.000 claims abstract description 100
- 239000003999 initiator Substances 0.000 claims abstract description 71
- 210000004400 mucous membrane Anatomy 0.000 claims abstract description 10
- 239000011248 coating agent Substances 0.000 claims description 13
- 238000000576 coating method Methods 0.000 claims description 13
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 11
- -1 hydroxypropyl ethyl Chemical group 0.000 claims description 11
- 239000002904 solvent Substances 0.000 claims description 11
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- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 3
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims description 3
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- UHVMMEOXYDMDKI-JKYCWFKZSA-L zinc;1-(5-cyanopyridin-2-yl)-3-[(1s,2s)-2-(6-fluoro-2-hydroxy-3-propanoylphenyl)cyclopropyl]urea;diacetate Chemical compound [Zn+2].CC([O-])=O.CC([O-])=O.CCC(=O)C1=CC=C(F)C([C@H]2[C@H](C2)NC(=O)NC=2N=CC(=CC=2)C#N)=C1O UHVMMEOXYDMDKI-JKYCWFKZSA-L 0.000 claims description 3
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Landscapes
- Materials For Medical Uses (AREA)
Abstract
Description
本揭露係涉及一種具有複合結構之醫用敷料，更具體地，涉及用於皮膚及黏膜組織的醫用敷料，其藉由此複合結構，使各層之間的接著力大幅提升。 The present disclosure relates to a medical dressing with a composite structure, and more specifically, to a medical dressing for skin and mucous membrane tissues. The composite structure greatly improves the adhesion between the layers.
常見的雙層或多層黏附貼片因製程便利性之故，通常分別製備黏附層及墊覆層等層，再將各層疊合，並施以正向壓力進行雙層複合。這樣的製程雖可製得複合結構，但若將該雙層/多層黏附貼片施用於使用者患部，一旦接觸到患部滲出的體液後各層間的接著性降低、使用者的肢體活動對貼片產生拉伸壓縮、扭轉或摩擦，常使複合結構受影響而導致脫離、分層和翹曲，耐用度不持久、更換次數多、且使用者也容易產生異物感，整體使用體驗不佳。 For common double-layer or multi-layer adhesive patches, due to the convenience of the manufacturing process, the adhesive layer and cushioning layer are usually prepared separately, and then the layers are laminated and positive pressure is applied for double-layer compounding. Although such a process can produce a composite structure, if the double/multi-layer adhesive patch is applied to the user's affected area, once it comes into contact with the body fluid exuded from the affected area, the adhesion between the layers will decrease, and the user's body activities will affect the patch. The occurrence of tension, compression, torsion or friction often affects the composite structure, resulting in detachment, delamination and warping. The durability is not long-lasting, the number of replacements is high, and the user is prone to foreign body sensation, resulting in a poor overall user experience.
鑒於上述問題，本揭露提供一種醫用敷料，係包括第一高分子薄膜及第二高分子薄膜，以及佈設於該第一高分子薄膜及該第二高分子薄膜之間並與該第一高分子薄膜及該第二高分子薄膜形成非共價鍵結的複合促進劑及 複合引發劑，其中，該複合促進劑係具有帶負電基團之分子或聚合物，且該複合引發劑係二價或三價離子化合物、幾丁聚醣、陽離子型聚丙烯醯胺(cationic polyacrylamide，CPAM)、聚乙烯亞胺、聚賴胺酸或其組合。 In view of the above problems, the present disclosure provides a medical dressing, which includes a first polymer film and a second polymer film, and is arranged between the first polymer film and the second polymer film and connected with the first polymer film. The molecular film and the second polymer film form a non-covalently bonded composite accelerator and A composite initiator, wherein the composite accelerator is a molecule or polymer with a negatively charged group, and the composite initiator is a divalent or trivalent ionic compound, chitosan, or cationic polyacrylamide , CPAM), polyethylenimine, polylysine acid or combinations thereof.
於一具體實施例中，每平方公分該醫用敷料中該複合促進劑之含量介於0.015公克至0.05公克，以及每平方公分該醫用敷料中該複合引發劑之含量介於0.01公克至0.1公克。 In a specific embodiment, the content of the composite accelerator in the medical dressing is between 0.015 and 0.05 grams per square centimeter, and the content of the composite initiator in the medical dressing is between 0.01 and 0.1 grams per square centimeter. Gram.
於一具體實施例中，該第一高分子薄膜及該第二高分子薄膜係相同或不同。於另一具體實施例中，該第一高分子薄膜及第二高分子薄膜具有黏附能力或不具黏附能力之高分子薄膜，例如，該第一高分子薄膜及第二高分子薄膜可獨立地為具高黏附能力、低黏附能力、或不具黏附能力之高分子薄膜。 In a specific embodiment, the first polymer film and the second polymer film are the same or different. In another specific embodiment, the first polymer film and the second polymer film are polymer films with or without adhesion ability. For example, the first polymer film and the second polymer film can be independently Polymer films with high adhesion ability, low adhesion ability, or no adhesion ability.
於一具體實施例中，該第一高分子薄膜及該第二高分子薄膜之高分子化合物係獨立地選自幾丁質、殼聚糖、甲基纖維素、乙基纖維素、丙基纖維素、醋酸鄰苯二甲酸纖維素、羥甲基纖維素、羥乙基纖維素、羥丙基纖維素、羥丙基甲基纖維素、羥丙基乙基纖維素、羧甲基纖維素、羧乙基纖維素、羧丙基纖維素、聚乙二醇、聚乙烯醇、泊咯沙姆(Poloxamer)、聚乙烯吡咯烷酮、聚乙酸乙烯酯、聚乙烯吡咯烷酮-乙酸乙烯酯共聚物、聚乙烯、聚氯乙烯、聚氨酯、丙烯酸聚合物及甲基丙烯酸聚合物所組成群組中之至少一者。 In a specific embodiment, the polymer compounds of the first polymer film and the second polymer film are independently selected from the group consisting of chitin, chitosan, methyl cellulose, ethyl cellulose, and propyl fiber. Cellulose acetate phthalate, hydroxymethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, hydroxypropylethylcellulose, carboxymethylcellulose, Carboxyethylcellulose, carboxypropylcellulose, polyethylene glycol, polyvinyl alcohol, Poloxamer, polyvinylpyrrolidone, polyvinyl acetate, polyvinylpyrrolidone-vinyl acetate copolymer, polyethylene , at least one of the group consisting of polyvinyl chloride, polyurethane, acrylic polymer and methacrylic polymer.
於一具體實施例中，該帶負電基團係包括-OH基團、-CONH基團、-CONH2基團及-COOH基團中之至少一者。 In a specific embodiment, the negatively charged group includes at least one of -OH group, -CONH group, -CONH 2 group and -COOH group.
於一具體實施例中，該複合促進劑包括多醣類、多肽類、或其組合。 In a specific embodiment, the composite accelerator includes polysaccharides, polypeptides, or combinations thereof.
於一具體實施例中，該複合促進劑係選自果膠、褐藻膠、瓊脂(agar)、明膠(gelatin)、結蘭膠(gellan gum)、黃原膠(xanthan gum)、 瓜爾膠(guar gum)、卡拉膠(carrageenan)、阿拉伯膠(gum arabic)、刺梧桐樹膠(gum karayan)、包含乙烯基或胺基之聚丙烯酸或聚甲基丙烯酸、陰離子型聚丙烯醯胺(anionic polyacrylamide，APAM)、透明質酸、肝素、硫酸軟骨素、纖維素或其衍生物(例如羧甲基纖維素)及其鹽類所組成群組中之至少一者。 In a specific embodiment, the composite accelerator is selected from pectin, algin, agar, gelatin, gellan gum, xanthan gum, Guar gum, carrageenan, gum arabic, gum karayan, polyacrylic acid or polymethacrylic acid containing vinyl or amine groups, anionic polyacrylamide At least one of the group consisting of (anionic polyacrylamide, APAM), hyaluronic acid, heparin, chondroitin sulfate, cellulose or its derivatives (such as carboxymethylcellulose) and its salts.
於一具體實施例中，適用於本揭露之複合引發劑之實例包括，但不限於，氯化鈣、氫氧化鈣、碳酸鈣、氯化鎂及氫氧化鎂。 In a specific embodiment, examples of composite initiators suitable for the present disclosure include, but are not limited to, calcium chloride, calcium hydroxide, calcium carbonate, magnesium chloride and magnesium hydroxide.
於一具體實施例中，本揭露之醫用敷料係用於皮膚或黏膜組織之敷料，例如，傷口敷料、皮膚貼片等。於另一具體實施例中，該黏膜組織包括口腔黏膜、食道黏膜、胃黏膜以及腸黏膜。 In a specific embodiment, the medical dressing of the present disclosure is a dressing for skin or mucosal tissue, such as a wound dressing, a skin patch, etc. In another specific embodiment, the mucosal tissue includes oral mucosa, esophageal mucosa, gastric mucosa and intestinal mucosa.
本揭露還提供一種醫用敷料之製造方法，係包括：於第一高分子薄膜及/或第二高分子薄膜之表面上均勻塗佈複合促進劑；將該第一高分子薄膜及該第二高分子薄膜以該表面貼合，以使該複合促進劑佈設於該第一高分子薄膜及該第二高分子薄膜之間；將貼合之該第一高分子薄膜及該第二高分子薄膜浸入含有複合引發劑的溶液中並施加壓力進行雙層複合；以及乾燥經複合之該第一高分子薄膜及該第二高分子薄膜而形成該醫用敷料。 The disclosure also provides a method for manufacturing a medical dressing, which includes: uniformly coating a composite accelerator on the surface of the first polymer film and/or the second polymer film; and combining the first polymer film and the second polymer film. The polymer film is bonded to the surface so that the composite accelerator is disposed between the first polymer film and the second polymer film; the bonded first polymer film and the second polymer film are Dip into a solution containing a composite initiator and apply pressure to perform double-layer composite; and dry the composite first polymer film and the second polymer film to form the medical dressing.
於一具體實施例中，進一步在塗佈該複合促進劑於該第一高分子薄膜及/或該第二高分子薄膜之表面上之前，包括將該複合促進劑溶於溶劑中而形成含有複合促進劑的溶液。 In a specific embodiment, before coating the composite accelerator on the surface of the first polymer film and/or the second polymer film, the method further includes dissolving the composite accelerator in a solvent to form a composite accelerator containing accelerator solution.
於一具體實施例中，該含有複合促進劑的溶液之濃度介於15g/L至50g/L。於另一具體實施例中，該含有複合引發劑的溶液之濃度介於5g/L至100g/L。於又一具體實施例中，該含有複合引發劑的溶液每公升所含公克數之濃度與該含有複合促進劑的溶液每公升所含公克數之濃度之乘積值不超過 1500。舉例而言，若含有複合引發劑的溶液之濃度為X(單位為g/L)，含有複合促進劑的溶液之濃度為Y(單位為g/L)，則X與Y之乘積值不超過1500(XY≦1500)。 In a specific embodiment, the concentration of the solution containing the complex accelerator is between 15g/L and 50g/L. In another specific embodiment, the concentration of the solution containing the composite initiator is between 5g/L and 100g/L. In another specific embodiment, the product value of the concentration of the solution containing the composite initiator in grams per liter and the concentration of the solution containing the composite accelerator in grams per liter does not exceed 1500. For example, if the concentration of the solution containing the composite initiator is X (unit is g/L) and the concentration of the solution containing the composite accelerator is Y (unit is g/L), then the product value of 1500(XY≦1500).
於一具體實施例中，用於複合促進劑溶液及複合引發劑溶液之溶劑為水或包含水之混合溶劑，例如包含選自甲醇、乙醇、異丙醇、丙酮、乙酸乙酯所組成群組中之至少一者。 In a specific embodiment, the solvent used for the composite accelerator solution and the composite initiator solution is water or a mixed solvent containing water, for example, a solvent selected from the group consisting of methanol, ethanol, isopropyl alcohol, acetone, and ethyl acetate. At least one of them.
於一具體實施例中，該複合促進劑可經由刮刀逗號式塗佈、刮刀非逗號式塗佈、三輥塗佈、T-DIE塗佈、線棒式塗佈、D-bar塗佈、凹版塗佈或噴塗塗佈施加於該第一高分子薄膜及該第二高分子薄膜之複合面上。 In a specific embodiment, the composite accelerator can be coated by scraper comma coating, scraper non-comma coating, three-roller coating, T-DIE coating, wire bar coating, D-bar coating, gravure coating Coating or spray coating is applied on the composite surface of the first polymer film and the second polymer film.
本揭露的複合結構中，複合促進劑與複合引發劑之間彼此配合，形成非共價鍵結物理性交聯，且透過調控複合促進劑與複合引發劑之含量，可使複合結構各層之間的接著力大幅提升，加強各層的複合作用。因此，具有此複合結構的本揭露的醫用敷料可長時間施用於局部，例如作為傷口敷料附著於黏著標的(如生物黏膜組織)，而不會有因吸收體液而降低揭著力進而發生層狀結構脫離、分層和翹曲等的問題，可長時間附著於黏著標的，減少醫用敷料的更換次數，避免更換過程中對黏著標的的拉扯而產生的二次傷害，同時，亦提供較佳的防護及阻隔。本揭露的複合結構適用於任何高分子材質之薄膜，應用極為廣泛且效果優異。 In the composite structure disclosed in the present disclosure, the composite accelerator and the composite initiator cooperate with each other to form non-covalent bonding physical cross-links, and by regulating the contents of the composite accelerator and the composite initiator, the cross-linking between the layers of the composite structure can be achieved. The subsequent force is greatly increased, strengthening the composite effect of each layer. Therefore, the medical dressing of the present disclosure with this composite structure can be applied locally for a long time, for example, as a wound dressing attached to an adhesive target (such as biological mucosal tissue), without reducing the adhesion force due to absorption of body fluids and causing lamination. Problems such as structural detachment, delamination and warping can be solved by adhering to the adhesive target for a long time, reducing the number of replacements of medical dressings and avoiding secondary damage caused by pulling on the adhesive target during the replacement process. At the same time, it also provides better protection and isolation. The disclosed composite structure is suitable for films made of any polymer material, and has extremely wide applications and excellent effects.
本說明書中所使用如「第一」、「第二」、「上」等之用語，僅為便於敘述之明瞭，而非用以限定本揭露可實施之範圍，其相對關係之改變或調整，在無實質變更本揭露技術內容下，當視為本揭露可實施之範圍。 Terms such as "first", "second", "top", etc. used in this specification are only for convenience of description and are not used to limit the scope of the present disclosure. Changes or adjustments in their relative relationships. As long as there are no substantial changes to the technical content of this disclosure, it shall be regarded as the scope of implementation of this disclosure.
本揭露第一實施態樣係關於一種具有複合結構之醫用敷料，該複合結構包括第一高分子薄膜、第二高分子薄膜、以及佈設於該第一高分子薄膜及該第二高分子薄膜之間的複合促進劑與複合引發劑。 The first embodiment of the present disclosure relates to a medical dressing with a composite structure. The composite structure includes a first polymer film, a second polymer film, and is arranged on the first polymer film and the second polymer film. between composite accelerator and composite initiator.
於本揭露中，第一高分子薄膜與第二高分子薄膜只要能施加後述之複合促進劑於其表面上者，皆為本揭露適用的材質。於本揭露的一個實施例中，高分子薄膜本身具有黏附能力；然須注意的是，於本揭露中只要能夠藉由後述之複合促進劑及複合引發劑增加複合結構各層間的接著力，即便高分子薄膜僅具低黏附能力，甚至是不具黏附能力，仍將適用於本揭露的其他實施態樣中。 In this disclosure, the first polymer film and the second polymer film are all suitable materials for this disclosure as long as the composite accelerator described below can be applied to their surfaces. In one embodiment of the present disclosure, the polymer film itself has the ability to adhere; however, it should be noted that in the present disclosure, as long as the adhesion between the layers of the composite structure can be increased through the composite accelerator and composite initiator described later, even if The polymer film only has low adhesion ability, or even has no adhesion ability, and will still be applicable to other implementation aspects of the present disclosure.
以下僅例示性列出本揭露可能使用作為高分子薄膜之成分，並不以此為限。舉例而言，該高分子薄膜之材質包括，但不限於，幾丁質、殼聚糖、甲基纖維素、乙基纖維素、丙基纖維素、醋酸鄰苯二甲酸纖維素、羥甲基纖維素、羥乙基纖維素、羥丙基纖維素、羥丙基甲基纖維素、羥丙基乙基纖維素、羧甲基纖維素、羧乙基纖維素、羧丙基纖維素、聚乙二醇、聚乙烯醇、泊咯沙姆(Poloxamer)、聚乙烯吡咯烷酮、聚乙酸乙烯酯、聚乙烯吡咯烷酮-乙酸乙烯酯共聚物、聚乙烯、聚氯乙烯、聚氨酯、丙烯酸聚合物、甲基丙烯酸聚合物、或上述之任意組合等。此外，第一高分子薄膜與第二高分子薄膜可選自相同或不同之材質。 The following is only an illustrative list of the components that may be used as polymer films in the present disclosure, and is not limited thereto. For example, the materials of the polymer film include, but are not limited to, chitin, chitosan, methyl cellulose, ethyl cellulose, propyl cellulose, cellulose acetate phthalate, hydroxymethyl cellulose Cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl ethyl cellulose, carboxymethyl cellulose, carboxyethyl cellulose, carboxypropyl cellulose, poly Ethylene glycol, polyvinyl alcohol, Poloxamer, polyvinylpyrrolidone, polyvinyl acetate, polyvinylpyrrolidone-vinyl acetate copolymer, polyethylene, polyvinyl chloride, polyurethane, acrylic polymer, methyl Acrylic polymer, or any combination of the above, etc. In addition, the first polymer film and the second polymer film can be made of the same or different materials.
本揭露之高分子薄膜可藉由本領域中任何習知的方式製得，例如可經由高分子與溶劑混合、成形和乾燥而製備。 The polymer film of the present disclosure can be prepared by any conventional method in the art, for example, it can be prepared by mixing the polymer and a solvent, shaping and drying.
於本揭露中，複合促進劑係指含有帶負電基團之分子或聚合物，而複合引發劑則係指可與該複合促進劑產生非共價鍵結之物理性交聯者。當複合促進劑施加於第一高分子薄膜與第二高分子薄膜之表面(複合面)後， 經由複合引發劑之作用，可使第一高分子薄膜與第二高分子薄膜之間產生穩固的物理性交聯。 In this disclosure, a composite accelerator refers to a molecule or polymer containing a negatively charged group, and a composite initiator refers to a physical cross-linker that can produce non-covalent bonds with the composite accelerator. When the composite accelerator is applied to the surfaces (composite surface) of the first polymer film and the second polymer film, Through the action of the composite initiator, firm physical cross-linking can be generated between the first polymer film and the second polymer film.
本揭露的複合促進劑中適合的帶負電基團例如為-OH基團、-CONH基團、-CONH2基團、-COOH基團之至少其中一者，但不限於此。舉例而言，適合的複合促進劑包括多醣類、多肽類、或其組合，例如：果膠、褐藻膠、瓊脂(agar)、明膠(gelatin)、結蘭膠(gellan gum)、黃原膠(xanthan gum)、瓜爾膠(guar gum)、卡拉膠(carrageenan)、阿拉伯膠(gum arabic)、刺梧桐樹膠(gum karayan)、包含乙烯基或胺基之聚丙烯酸或聚甲基丙烯酸、陰離子型聚丙烯醯胺(anionic polyacrylamide，APAM)、透明質酸、肝素、硫酸軟骨素、纖維素或其衍生物(例如羧甲基纖維素)及其鹽類，或可將上述成分任意組合而合併使用。 Suitable negatively charged groups in the composite accelerator of the present disclosure are, for example, at least one of -OH group, -CONH group, -CONH 2 group, and -COOH group, but are not limited thereto. For example, suitable compound accelerators include polysaccharides, polypeptides, or combinations thereof, such as: pectin, algin, agar, gelatin, gellan gum, xanthan gum (xanthan gum), guar gum, carrageenan, gum arabic, gum karayan, polyacrylic acid or polymethacrylic acid containing vinyl or amine groups, anionic Polyacrylamide (anionic polyacrylamide, APAM), hyaluronic acid, heparin, chondroitin sulfate, cellulose or its derivatives (such as carboxymethylcellulose) and its salts, or any combination of the above ingredients use.
本揭露適合的複合引發劑為任何能與複合促進劑產生非共價鍵結者，包括小分子化合物、高分子化合物、或其組合。在本揭露的一個實施態樣中，複合引發劑為於水中可解離出離子之化合物，如二價或三價離子化合物。在本揭露的其他實施態樣中，複合引發劑可為氯化鈣、氫氧化鈣、碳酸鈣、氯化鎂、氫氧化鎂或其任意組合。在本揭露的另一實施態樣中，複合引發劑可為選自幾丁聚醣、陽離子型聚丙烯醯胺(CPAM)、聚乙烯亞胺及聚賴胺酸所組成群組中之至少一種高分子化合物。上述所列舉的各種適用作為複合引發劑的成分可以任意組合而合併使用。複合引發劑經解離成為帶負電之陰離子及帶正電之陽離子，其中帶正電之陽離子可與帶負電基團的複合促進劑藉由正負電荷吸引形成非共價鍵結物理性交聯的複合介面，此複合介面的形成較不易受到外在環境的影響而失效。 Suitable composite initiators for the present disclosure are any that can produce non-covalent bonds with the composite accelerator, including small molecule compounds, polymer compounds, or combinations thereof. In one embodiment of the present disclosure, the composite initiator is a compound that can dissociate into ions in water, such as a divalent or trivalent ionic compound. In other embodiments of the present disclosure, the composite initiator may be calcium chloride, calcium hydroxide, calcium carbonate, magnesium chloride, magnesium hydroxide or any combination thereof. In another embodiment of the present disclosure, the composite initiator may be at least one selected from the group consisting of chitosan, cationic polyacrylamide (CPAM), polyethylenimine and polylysine acid. polymer compounds. The various components listed above that are suitable as composite initiators can be used in any combination. The composite initiator is dissociated into negatively charged anions and positively charged cations. The positively charged cations can form a non-covalently bonded, physically cross-linked composite interface with the negatively charged composite accelerator through positive and negative charge attraction. , the formation of this composite interface is less susceptible to failure due to the influence of the external environment.
於本揭露的醫用敷料中，每平方公分的醫用敷料含有介於0.015公克至0.05公克含量的複合促進劑，且每平方公分的醫用敷料含有介於0.01公 克至0.1公克含量的複合引發劑。若複合促進劑及/或複合引發劑之含量過低時，將使得交聯不完全；相反地，若複合促進劑及/或複合引發劑之含量過高時，複合作用中正負電荷的吸引現象將過於強烈，使得複合結構邊緣先接觸到複合引發劑之部分迅速形成緻密的物理性交聯，進而屏蔽複合引發劑滲入至複合結構的內部，導致交聯不均勻或不充分。 In the medical dressing disclosed in the present disclosure, each square centimeter of the medical dressing contains between 0.015 grams and 0.05 grams of the compound accelerator, and each square centimeter of the medical dressing contains between 0.01 grams. Gram to 0.1 gram content of composite initiator. If the content of the composite accelerator and/or composite initiator is too low, the cross-linking will be incomplete; conversely, if the content of the composite accelerator and/or the composite initiator is too high, the attraction of positive and negative charges in the composite reaction will occur. If it is too strong, the edge of the composite structure that first contacts the composite initiator will quickly form dense physical cross-links, thereby blocking the penetration of the composite initiator into the interior of the composite structure, resulting in uneven or insufficient cross-linking.
本揭露之複合結構可用於皮膚及黏膜組織，其中黏膜組織包括口腔黏膜、食道黏膜、胃黏膜以及腸黏膜等。更具體地，黏膜組織之環境可為口腔黏膜炎、口腔潰瘍、牙周病、口腔手術、拔牙、齒槽骨炎(alveolar osteitis)、鵝口瘡(oral thrush)、口腔潰瘍(aphthous ulcer)等，且不以此為限。本揭露之醫用敷料不易受到皮膚及黏膜環境的影響而產生翹曲、脫離和分層等現象。 The composite structure disclosed in the present disclosure can be used in skin and mucosal tissues, where mucosal tissues include oral mucosa, esophageal mucosa, gastric mucosa, intestinal mucosa, etc. More specifically, the environment of the mucosal tissue may be oral mucositis, oral ulcers, periodontal disease, oral surgery, tooth extraction, alveolar osteitis, oral thrush, aphthous ulcer, etc., And it is not limited to this. The medical dressing disclosed in the present disclosure is not easily affected by the skin and mucous membrane environment to cause warping, detachment, delamination and other phenomena.
本揭露的第二實施態樣係具有複合結構之醫用敷料之製造方法，該製造方法係包括：於第一高分子薄膜及/或第二高分子薄膜之表面(複合面)上均勻塗佈複合促進劑；將該第一高分子薄膜及該第二高分子薄膜以該表面(複合面)貼合，以使該複合促進劑佈設於該第一高分子薄膜及該第二高分子薄膜之間；將貼合之該第一高分子薄膜及該第二高分子薄膜浸入含有複合引發劑的溶液中；施加壓力進行雙層複合；以及乾燥經複合之該第一高分子薄膜及該第二高分子薄膜，而形成該醫用敷料。 The second embodiment of the present disclosure is a method for manufacturing a medical dressing with a composite structure. The manufacturing method includes: uniformly coating on the surface (composite surface) of the first polymer film and/or the second polymer film. Composite accelerator; laminate the first polymer film and the second polymer film on the surface (composite surface) so that the composite accelerator is disposed between the first polymer film and the second polymer film time; immerse the bonded first polymer film and the second polymer film into a solution containing a composite initiator; apply pressure to perform double-layer composite; and dry the composite first polymer film and the second polymer film polymer film to form the medical dressing.
於本揭露中，使用複合促進劑時，可將複合促進劑溶於溶劑中，以形成含有複合促進劑的溶液。合適的溶劑包括水、甲醇、乙醇、異丙醇、丙酮、乙酸乙酯等，亦可選擇上述的溶劑適當地混合使用。 In the present disclosure, when using a composite accelerator, the composite accelerator can be dissolved in a solvent to form a solution containing the composite accelerator. Suitable solvents include water, methanol, ethanol, isopropyl alcohol, acetone, ethyl acetate, etc. You can also choose to mix the above solvents appropriately.
於本揭露含有複合引發劑的溶液中，適合的溶劑包括水、甲醇、乙醇、異丙醇、丙酮、乙酸乙酯等，亦可選擇上述的溶劑適當地混合使用。 In the solution containing the composite initiator disclosed in the present disclosure, suitable solvents include water, methanol, ethanol, isopropyl alcohol, acetone, ethyl acetate, etc. The above solvents can also be selected and mixed appropriately.
於本揭露中，含有複合促進劑的溶液之濃度可介於15g/L至50g/L之間，含有複合引發劑的溶液之濃度可介於5g/L至100g/L。在上揭濃度範圍內，可大幅增加複合結構各層之間的接著力。當濃度過低，施加於複合面之複合促進劑含量可能不足，致使交聯不充分；當濃度過高，複合作用時正負電荷吸引的現象則過於強烈，使得複合結構邊緣先接觸到複合引發劑之部分迅速形成緻密的物理性交聯，因而屏蔽複合引發劑滲入至內部，導致交聯不均勻或不充分。 In the present disclosure, the concentration of the solution containing the complex accelerator can be between 15g/L and 50g/L, and the concentration of the solution containing the complex initiator can be between 5g/L and 100g/L. Within the upper concentration range, the adhesion between the layers of the composite structure can be greatly increased. When the concentration is too low, the content of the composite accelerator applied to the composite surface may be insufficient, resulting in insufficient cross-linking; when the concentration is too high, the attraction of positive and negative charges during composite interaction is too strong, causing the edges of the composite structure to contact the composite initiator first. The parts quickly form dense physical cross-links, thus blocking the penetration of the composite initiator into the interior, resulting in uneven or insufficient cross-linking.
本揭露的發明人意外地發現，含有複合引發劑的溶液之濃度具有特定的上限值，其對應複合促進劑的含量(或含有複合促進劑的溶液之濃度)而變化。更具體地，若含有複合引發劑的溶液之濃度具有上限值X(單位為g/L)，而含有複合促進劑的溶液之濃度為Y(單位為g/L)時，則X與Y之乘積值應不超過1500。當複合促進劑的含量(或含有複合促進劑的溶液之濃度)提升，則複合引發劑之含量(或含有複合引發劑的溶液之濃度)應相對下降，以避免反應過快，致使複合結構邊緣先形成緻密的物理性交聯，進而影響複合結構內側的複合作用；另一方面，當複合促進劑的含量(或含有複合促進劑的溶液之濃度)提升，則可提供的鍵結量將隨之提升，故參與反應的複合引發劑的含量應跟著增加。因此，複合促進劑與複合引發劑之間的關係構成了複合引發劑的上限值。 The inventor of the present disclosure unexpectedly discovered that the concentration of the solution containing the complex initiator has a specific upper limit, which changes corresponding to the content of the complex accelerator (or the concentration of the solution containing the complex accelerator). More specifically, if the concentration of the solution containing the composite initiator has an upper limit value X (unit is g/L), and the concentration of the solution containing the composite accelerator is Y (unit is g/L), then X and Y The product value should not exceed 1500. When the content of the composite accelerator (or the concentration of the solution containing the composite accelerator) increases, the content of the composite initiator (or the concentration of the solution containing the composite initiator) should be relatively reduced to avoid reacting too fast, resulting in the edge of the composite structure First, dense physical cross-links are formed, which then affects the composite effect inside the composite structure. On the other hand, when the content of the composite accelerator (or the concentration of the solution containing the composite accelerator) increases, the amount of bonding that can be provided will increase accordingly. Increase, so the content of the composite initiator participating in the reaction should increase accordingly. Therefore, the relationship between the composite accelerator and the composite initiator constitutes the upper limit of the composite initiator.
於本揭露中，於高分子薄膜之複合面上塗佈複合促進劑的方式不受限制，只要能使複合促進劑均勻分布在複合面上即可，例如，該複合促進劑可與溶劑先混合，再藉由刮刀以逗號式塗佈、藉由刮刀以非逗號式塗佈、三 輥塗佈、T-DIE塗佈、線棒式塗佈、D-bar塗佈、凹版塗佈或噴塗塗佈等方式施加於高分子薄膜之複合面上。 In this disclosure, the method of coating the composite accelerator on the composite surface of the polymer film is not limited, as long as the composite accelerator can be evenly distributed on the composite surface. For example, the composite accelerator can be mixed with a solvent first. , and then use the scraper to coat in comma style, and then use the scraper to coat in non-comma style, three Roller coating, T-DIE coating, wire bar coating, D-bar coating, gravure coating or spray coating are applied to the composite surface of the polymer film.
由上可知，本揭露的複合結構經由複合面上之複合促進劑與複合引發劑之間所產生的正負電荷吸引而形成非共價鍵結的物理性交聯。由於複合促進劑與複合引發劑彼此配合，藉由調控複合促進劑與複合引發劑之含量使複合結構各層之間的接著力得以大幅提升，並可適用於任何高分子材質之薄膜，效果極為優異。相較於習知作為黏附劑之材料僅利用高分子滲入(diffusion)或空間相互糾纏的機制來進行黏合，本揭露的方法更為有效，且可經調控，並更加穩固。此外，本揭露還可使兩低黏附能力或不具黏附能力之高分子薄膜彼此複合，不須額外設置黏附層或使用黏著劑，適用性因而更廣，且製程亦更加簡便。 It can be seen from the above that the composite structure of the present disclosure forms non-covalent physical cross-links through the attraction of positive and negative charges generated between the composite accelerator and the composite initiator on the composite surface. Since the composite accelerator and the composite initiator cooperate with each other, the adhesion between the layers of the composite structure can be greatly improved by adjusting the contents of the composite accelerator and the composite initiator. It can be applied to films of any polymer material, and the effect is extremely excellent. . Compared with conventional adhesive materials that only use polymer diffusion or spatial entanglement mechanisms for adhesion, the method disclosed in the present disclosure is more effective, controllable, and more stable. In addition, the present disclosure can also make two polymer films with low or no adhesion ability compounded with each other without the need to provide an additional adhesion layer or use an adhesive. The applicability is therefore wider, and the manufacturing process is simpler.
以下藉由特定的具體實施例說明本揭露之實施方式，熟悉此技藝之人士可由本說明書所揭示之內容輕易地瞭解本揭露之其他優點及功效。 The following describes the implementation of the present disclosure through specific embodiments. Those familiar with the art can easily understand other advantages and effects of the present disclosure from the content disclosed in this specification.
製備例1：高分子薄膜 Preparation Example 1: Polymer film
將3公克之幾丁質溶於100毫升之0.5%乙酸水溶液中，攪拌使其溶解，再加入0.2公克之甘油，繼續攪拌2小時。於真空狀態下高速均質10分鐘以得到幾丁質溶液，接著將該幾丁質溶液注入底面積為10平方公分之鋁皿中，放置於45℃烘箱中乾燥1小時，以得到高分子薄膜A。 Dissolve 3 grams of chitin in 100 ml of 0.5% acetic acid aqueous solution, stir to dissolve, then add 0.2 grams of glycerin, and continue stirring for 2 hours. Homogenize at high speed for 10 minutes under vacuum to obtain a chitin solution. Then pour the chitin solution into an aluminum dish with a bottom area of 10 square centimeters and place it in a 45°C oven to dry for 1 hour to obtain polymer film A. .
將10公克之甲基纖維素溶於100毫升之純水中，攪拌使其溶解，再加入0.1公克之甘油，繼續攪拌2小時。於真空狀態下高速均質10分鐘以得到 甲基纖維素溶液，接著將該甲基纖維素溶液注入底面積為10平方公分之鋁皿中，放置於45℃烘箱中乾燥1小時，以得到高分子薄膜B。 Dissolve 10 grams of methylcellulose in 100 ml of pure water, stir to dissolve, then add 0.1 grams of glycerin, and continue stirring for 2 hours. Homogenize at high speed for 10 minutes under vacuum to obtain methylcellulose solution, and then pour the methylcellulose solution into an aluminum dish with a bottom area of 10 square centimeters, and place it in a 45°C oven to dry for 1 hour to obtain polymer film B.
高分子薄膜C係同上述高分子薄膜B的製備過程，惟將10公克之甲基纖維素替換為5公克之乙基纖維素。 The preparation process of polymer film C is the same as that of polymer film B above, except that 10 grams of methyl cellulose is replaced by 5 grams of ethyl cellulose.
製備例2：含有複合促進劑的溶液 Preparation Example 2: Solution containing composite accelerator
以海藻酸鈉作為複合促進劑A，將1.0公克、1.5公克、3.0公克及5公克之海藻酸鈉分別溶於100毫升之純水中攪拌1小時，接著於真空狀態下高速均質10分鐘，以得到含有複合促進劑A的溶液。 Using sodium alginate as the composite accelerator A, dissolve 1.0 g, 1.5 g, 3.0 g and 5 g of sodium alginate respectively in 100 ml of pure water and stir for 1 hour, then homogenize at high speed for 10 minutes under vacuum. A solution containing composite accelerator A was obtained.
以果膠作為複合促進劑B，將1.5公克之果膠溶於100毫升之純水中攪拌1小時，接著於真空狀態下高速均質10分鐘，以得到含有複合促進劑B的溶液。 Using pectin as composite accelerator B, dissolve 1.5 grams of pectin in 100 ml of pure water and stir for 1 hour, then homogenize at high speed under vacuum for 10 minutes to obtain a solution containing composite accelerator B.
製備例3：含有複合引發劑的溶液 Preparation Example 3: Solution containing composite initiator
以氯化鈣作為複合引發劑A，將0.1公克、0.5公克、5公克、10公克及20公克之氯化鈣溶於100毫升之純水中攪拌1小時，以得到含有複合引發劑A的溶液。 Using calcium chloride as composite initiator A, dissolve 0.1 g, 0.5 g, 5 g, 10 g and 20 g of calcium chloride in 100 ml of pure water and stir for 1 hour to obtain a solution containing composite initiator A. .
以氫氧化鎂作為複合引發劑B，將0.5公克之氫氧化鎂溶於100毫升之純水中攪拌1小時，以得到含有複合引發劑B的溶液。 Using magnesium hydroxide as composite initiator B, dissolve 0.5 grams of magnesium hydroxide in 100 ml of pure water and stir for 1 hour to obtain a solution containing composite initiator B.
製備例4：複合結構 Preparation Example 4: Composite Structure
於乾燥的第一高分子薄膜及第二高分子薄膜之複合面上以噴塗塗佈之方式均勻塗佈約10毫升之複合促進劑溶液，再以兩高分子薄膜之複合面彼此貼合形成雙層結構，接著將雙層結構浸入複合引發劑溶液中，並對雙層結構施以正向壓力進行雙層複合，隨後於40℃下烘乾，最終得到雙層複合結構。 Apply about 10 ml of the composite accelerator solution evenly on the composite surface of the dried first polymer film and the second polymer film by spray coating, and then the composite surfaces of the two polymer films are bonded to each other to form a double layer. The double-layer structure is then immersed in the composite initiator solution, and forward pressure is applied to the double-layer structure to perform double-layer composite, and then dried at 40°C to finally obtain a double-layer composite structure.
使用製備例1至3中所得之高分子薄膜、複合促進劑、複合引發劑之種類及濃度製備各複合結構之實施例及比較例，所使用之詳細組分如下表1及表2所示： Examples and comparative examples of each composite structure were prepared using the types and concentrations of polymer films, composite accelerators, and composite initiators obtained in Preparation Examples 1 to 3. The detailed components used are shown in Table 1 and Table 2 below:
表1：比較例
表2：實施例
測試例1：翹曲測試 Test Example 1: Warpage Test
將上述實施例及比較例之複合結構裁切為1公分×1公分尺寸之正方形式樣，並平貼於燒杯底部，再加入純水直至淹沒複合結構之表面。接著放入超音波振盪器開始振盪，記錄複合結構自振盪開始至發生翹曲或脫離現象為止所歷經之時間。因超音波振盪將導致水溫上升，為避免水溫過高而影響測試結果，故翹曲測試最長觀察30分鐘。各實施例及比較例之測試結果如下表3所示： The composite structures of the above examples and comparative examples were cut into square shapes of 1 cm x 1 cm, and placed flat on the bottom of the beaker. Pure water was then added until the surface of the composite structure was submerged. Then, an ultrasonic oscillator was put in to start oscillation, and the time elapsed from the start of oscillation to the occurrence of warping or detachment of the composite structure was recorded. Since ultrasonic oscillation will cause the water temperature to rise, in order to prevent the water temperature from being too high and affecting the test results, the maximum observation time for the warpage test is 30 minutes. The test results of each embodiment and comparative example are shown in Table 3 below:
表3
表3之測試結果顯示，藉由使用複合促進劑及複合引發劑(實施例1至18)可有效提升複合結構各層之間的接著力，優於僅使用複合促進劑而未使用複合引發劑之比較例1、7、10、13。 The test results in Table 3 show that the use of composite accelerators and composite initiators (Examples 1 to 18) can effectively improve the adhesion between the layers of the composite structure, which is better than using only composite accelerators without using composite initiators. Comparative Examples 1, 7, 10, and 13.
由表3可見，比較例2至6中含有複合促進劑的溶液之濃度僅為10g/L，未達15g/L，施加於複合面上的複合促進劑含量不足，無法提供足夠的接著力。比較例8、11、14中含有複合引發劑的溶液之濃度則過低，僅1g/L，複合引發劑含量不足，無法提供足夠的正電荷與複合促進劑之負電荷交聯。比較例9中含有複合引發劑的溶液之濃度則過高(200g/L)，而比較例12及15中含有複合引發劑的溶液之濃度超過上限(與複合促進劑之濃度的乘積值分別為3000及2500，均超過1500)，此顯示正負電荷吸引力過強，於複合結構浸入複合引發劑溶液時，複合結構之邊緣將瞬間形成緻密的物理性交聯，此緻密的物理性交聯形成物理性屏障，導致複合引發劑溶液無法有效滲入複合結構之複合面中間及內側的部分，使得複合作用因而不充分或不均勻，從而使複合結構各層之間的接著力較弱。 As can be seen from Table 3, the concentration of the solutions containing the composite accelerator in Comparative Examples 2 to 6 is only 10g/L, not reaching 15g/L. The content of the composite accelerator applied to the composite surface is insufficient and cannot provide sufficient adhesion. The concentration of the solutions containing the composite initiator in Comparative Examples 8, 11, and 14 was too low, only 1g/L. The content of the composite initiator was insufficient to provide sufficient positive charges for cross-linking with the negative charges of the composite accelerator. The concentration of the solution containing the composite initiator in Comparative Example 9 is too high (200g/L), and the concentration of the solution containing the composite initiator in Comparative Examples 12 and 15 exceeds the upper limit (the product value with the concentration of the composite accelerator is respectively 3000 and 2500, both exceeding 1500), which shows that the attraction between positive and negative charges is too strong. When the composite structure is immersed in the composite initiator solution, dense physical cross-links will be instantly formed at the edges of the composite structure. This dense physical cross-link forms a physical The barrier prevents the composite initiator solution from effectively penetrating into the middle and inner parts of the composite surface of the composite structure, making the composite effect incomplete or uneven, resulting in weak adhesion between the layers of the composite structure.
測試例2：不同酸鹼值環境下之翹曲測試 Test Example 2: Warpage test under different pH environments
將上述實施例1至3之複合結構裁切為1公分×1公分尺寸之正方形式樣，並平貼於燒杯底部，再加入鹽酸水溶液(pH=2)或氫氧化鈉水溶液(pH=11)，直至淹沒複合結構之表面。接著放入超音波振盪器開始振盪，記錄複合結構自振盪開始至發生翹曲或脫離現象為止所歷經之時間。因超音波振盪將導 致水溫上升，為避免水溫過高而影響測試結果，故翹曲測試最長觀察30分鐘。各實施例及比較例之測試結果如下表4所示： Cut the composite structures of the above-mentioned Examples 1 to 3 into square shapes of 1 cm × 1 cm, and place them flatly on the bottom of the beaker, then add hydrochloric acid aqueous solution (pH=2) or sodium hydroxide aqueous solution (pH=11). Until the surface of the composite structure is submerged. Then, an ultrasonic oscillator was put in to start oscillation, and the time elapsed from the start of oscillation to the occurrence of warping or detachment of the composite structure was recorded. Due to ultrasonic oscillation will lead to This will cause the water temperature to rise. In order to prevent the water temperature from being too high and affecting the test results, the maximum observation time for the warpage test is 30 minutes. The test results of each embodiment and comparative example are shown in Table 4 below:
表4
表4之測試結果顯示，即便於不同的酸鹼值環境下，本揭露之複合結構皆仍具有優異的穩定性，且複合結構各層之間的接著力極佳，可有效降低翹曲、脫離、分層等現象的發生。 The test results in Table 4 show that even under different pH environments, the composite structure of the present disclosure still has excellent stability, and the adhesion between the layers of the composite structure is excellent, which can effectively reduce warpage, detachment, The occurrence of phenomena such as delamination.
測試例3：複合結構中之複合引發劑的含量 Test Example 3: Content of composite initiator in composite structure
從含有複合引發劑的溶液中取出上述實施例1至12之複合結構後，取10毫升之含有複合引發劑的溶液並裝至錐形瓶內，再加入5毫升之氫氧化鈉水溶液(8莫耳/公升)攪拌5分鐘，隨後滴入0.1公克之Patton-Reeder指示劑形成粉紅色待測液。以EDTA水溶液(0.025莫耳/公升)滴定待測液，直至待測液之顏色由粉紅色轉變為藍色的瞬間。計算滴定所消耗掉之EDTA莫耳數，並以EDTA：鈣離子=1：1之比例關係計算出複合結構中之複合引發劑含量(即參與複合反應之複合引發劑含量)，結果如下表5所示： After taking out the composite structures of the above embodiments 1 to 12 from the solution containing the composite initiator, take 10 ml of the solution containing the composite initiator and put it into an Erlenmeyer flask, and then add 5 ml of sodium hydroxide aqueous solution (8 Mo ears/liter) and stir for 5 minutes, then drop 0.1 g of Patton-Reeder indicator to form a pink liquid to be tested. Titrate the liquid to be tested with EDTA aqueous solution (0.025 mol/L) until the color of the liquid to be tested changes from pink to blue. Calculate the number of moles of EDTA consumed in the titration, and calculate the composite initiator content in the composite structure (that is, the composite initiator content participating in the composite reaction) based on the ratio of EDTA: calcium ions = 1:1. The results are as follows in Table 5 Shown:
表5
上述實施例係用以例示性說明本揭露之原理及其功效，而非用於限制本揭露的內容。任何熟習此項技藝之人士均可在不違背本揭露之精神及範圍下，對上述實施例進行修改。應當理解地，在本揭露所示之技術內容得涵蓋之範圍內，各技術特徵(例如具體實施例所揭示者)可以自由地相互組合以形成新的或更佳的技術方案，為簡潔起見，在此不再贅述。此外，本揭露所示由端值所構成之數值範圍中，只要數值落於上、下兩端值之間，即應包含在本揭露所示的範圍內，且其與端點或其他數值所形成之次範圍亦應理所當然地包含在本揭露所示的範圍內。因此，本揭露之權利保護範圍，應如後述之申請專利範圍所列。 The above embodiments are used to illustrate the principles and effects of the present disclosure, but are not used to limit the content of the present disclosure. Anyone skilled in the art can make modifications to the above embodiments without departing from the spirit and scope of the present disclosure. It should be understood that within the scope of the technical content shown in this disclosure, various technical features (such as those disclosed in the specific embodiments) can be freely combined with each other to form new or better technical solutions. For the sake of brevity, , which will not be described in detail here. In addition, in the numerical range shown in this disclosure consisting of end values, as long as the value falls between the upper and lower end values, it shall be included in the range shown in this disclosure, and it shall be consistent with the end points or other numerical values. The resulting sub-range should naturally be included in the scope shown in this disclosure. Therefore, the scope of rights protection of this disclosure should be as listed in the patent application scope described below.
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