CN106806356A - 一种伊曲康唑药膜 - Google Patents
一种伊曲康唑药膜 Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K9/00—Medicinal preparations characterised by special physical form
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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Abstract
本发明涉及用于治疗细菌引起的溃疡的药物,具体涉及一种伊曲康唑药膜。包含A膜和B膜,A膜是由聚合度为2000的聚乙烯醇100~150份,水400~600份,蔗糖脂肪酸酯10‑20份,伊曲康唑1‑2份,环糊精或其衍生物50‑80份,卵磷脂10‑20份,预糊化淀粉100‑150份,海藻酸钠15‑25份所制备;B膜是由聚合度为2000的聚乙烯醇100~150份,水400~600份,pH为5‑5.5的磷酸缓释液15‑35份,环糊精或其衍生物50‑80份,壳聚糖5‑10份,预糊化淀粉100‑180份,海藻酸钠15‑25份,卵磷脂5‑10份所制备。通过A、B两层膜体粘合,并将含有伊曲康唑成分的A膜黏贴在细菌感染的溃疡部位,A膜中的伊曲康唑成分与B膜中的酸性成分反应,提高药物的被吸收的效率。
Description
技术领域
本发明涉及用于治疗细菌引起的溃疡的药物,具体涉及一种伊曲康唑药膜。
背景技术
人体的内环境并非无菌的,在人体的组织受到擦伤、割伤等,皮肤或者粘膜表面组织破损,会更容易被细菌感染,而产生溃疡。
对于皮肤表层的组织破损,我们能通过用杀菌液清洗、涂抹药膏、贴合杀菌胶布等方式处理伤口,防止伤口的细菌感染;但对于人体内环境的细菌性组织溃疡,如真菌性角膜炎、口腔念珠菌病、外阴阴道念珠菌病等细菌性溃疡症状,由于部分药物刺激性较大、或不适于口服,或无法较长时间的与伤口贴合接触,导致体内溃疡较难被治愈。
伊曲康唑是一种合成的广谱抗真菌药,为三氮唑衍生物,对皮肤癣菌(毛癣菌属、小孢子菌属、絮状表皮癣菌)、酵母菌[新生隐球菌、糠秕孢子菌属、念珠菌属(包括白色念珠菌、光滑念珠菌和克柔念珠菌)]、曲霉菌属、组织胞浆菌属、巴西副球孢子菌、申克孢子丝菌、着色真菌属、枝孢霉属、皮炎芽生菌以及各种其它的酵母菌和真菌感染有效。体外研究已证实该品可抑制真菌细胞膜的主要成份之一麦角甾醇的合成,从而发挥抗真菌效应。
目前伊曲康唑常被用于制作成胶囊,通过口服的方式给药,在胃内酸性环境下被吸收,而吸收后的伊曲康唑需要在通过血液循环到达伤口部位才能起到抑菌效果,需要加大药剂量才能获得良好效果;由于伊曲康唑在水性介质中溶解性极低,要制备成口服液类的制剂较为困难,且对于在口腔、咽喉中的溃疡组织的给药,难以使药物有效的附着在伤口上,使伤口持续获得药物有效的治疗。
发明内容
本发明的目的在于提供一种伊曲康唑药膜,通过A、B两层膜体粘合,并将含有伊曲康唑成分的A膜黏贴在细菌感染的溃疡部位,A膜中的伊曲康唑成分与B膜中的酸性成分反应,提高药物的被吸收的效率。
为实现上述目的,本发明通过以下技术手段加以实施:
一种伊曲康唑药膜,包含A膜和B膜,所述的A膜是由以下原料制备的:
聚合度为2000的聚乙烯醇100~150份,水400~600份,蔗糖脂肪酸酯10-20份,伊曲康唑1-2份,环糊精或其衍生物50-80份,卵磷脂10-20份,预糊化淀粉100-150份,海藻酸钠15-25份;
所述的B膜是由以下原料制备的:
聚合度为2000的聚乙烯醇100~150份,水400~600份,pH为5-5.5的磷酸缓释液15-35份,环糊精或其衍生物50-80份,壳聚糖5-10份,预糊化淀粉100-180份,海藻酸钠15-25份,卵磷脂5-10份。
作为优选,所述的A膜由以下原料制备的:
聚合度为2000的聚乙烯醇100~150份,水400~600份,蔗糖脂肪酸酯12-15份,伊曲康唑1.5-1.8份,环糊精或其衍生物50-80份,卵磷脂13-16份,预糊化淀粉120-150份,海藻酸钠16-28份;
所述的B膜是由以下原料制备的:
聚合度为2000的聚乙烯醇100~150份,水400~600份,pH为5-5.5的磷酸缓释液25-28份,环糊精或其衍生物50-80份,壳聚糖5-10份,预糊化淀粉100-150份,海藻酸钠17-23份,卵磷脂6-8份。
进一步的,所述的预糊化淀粉为木薯、玉米、马铃薯混合制成以预糊化淀粉。
所述的环糊精及其衍生物为α-环糊精或其衍生物、β-环糊精或其衍生物、γ-环糊精或其衍生物;作为进一步的优选方案,所述β-环糊精的衍生物为甲基-β-环糊精、2,6-二甲基-β-环糊精中的一种或两种混合。
为了提升适口性,所述的A膜和B膜还包括风味矫正剂,所述的风味矫正剂可选择蜜桃香精、黄瓜香精、巧克力香精、薄荷香精。
该伊曲康唑药膜的制作方法如下:
A膜:将除伊曲康唑外所述的A膜的原料充分混合,并加热到70-80℃,并使所有物质完全溶解后,冷却至50-60℃,之后加入伊曲康唑充分混合得到A混合液后,用涂膜机将上述A混合液涂覆在基材聚酯薄膜上,并在70-80℃左右干燥,制成A膜。
B膜:将所述的B膜的原料充分混合,并加热到80-90℃,使所有物质完全溶解后得到B混合液后,将所述的B混合液冷却至50-60℃并涂覆在基材聚酯薄膜上,并在70-80℃左右干燥,制成B膜。
在使用时,将所述的A膜和B膜两者贴合,并将A膜面贴合于伤口的表面,使用药膜贴合在伤口的方式,能够为伤口提供持续、直接、有效的治疗效果,且能减少有效成分伊曲康唑的使用量;使用中B膜中的磷酸缓释液能够为伊曲康唑提供弱酸性,使伊曲康唑能够缓慢对伤口释放药力,减少药物刺激,杀灭溃疡部位滋生的细菌。
具体实施方式
上述说明仅是本发明技术方案的概述,为了能够更清楚了解本发明的技术手段,并可依照说明书的内容予以实施,以下以本发明的较佳实施例对本专利进行详细说明。
实施例1
一种伊曲康唑药膜,包含A膜和B膜,所述的A膜是由以下原料制备的:
聚合度为2000的聚乙烯醇100份,水400份,蔗糖脂肪酸酯15份,伊曲康唑0.5份,环糊精或其衍生物50份,卵磷脂10份,预糊化淀粉100份,海藻酸钠15份;
所述的B膜是由以下原料制备的:
聚合度为2000的聚乙烯醇100份,水400份,pH为5的磷酸缓释液15份,甲基-β-环糊精25份、2,6-二甲基-β-环糊精25份,壳聚糖5份,预糊化淀粉100份,海藻酸钠15份,卵磷脂5份。
将上述原料按以下方法制备伊曲康唑药膜:
A膜:将聚合度为2000的聚乙烯醇、水、蔗糖脂肪酸酯、环糊精或其衍生物、卵磷脂、预糊化淀粉、海藻酸钠充分混合,并加热到70℃,并使所有物质完全溶解后,冷却至50℃,之后加入伊曲康唑充分混合得到A混合液后,用涂膜机将上述A混合液涂覆在基材聚酯薄膜上,并在70℃左右干燥,制成A膜。
B膜:将所述的B膜的原料充分混合,并加热到80℃,使所有物质完全溶解后得到B混合液后,将所述的B混合液冷却至50-60℃并涂覆在基材聚酯薄膜上,并在70-80℃左右干燥,制成B膜。
实施例2
一种伊曲康唑药膜,包含A膜和B膜,所述的A膜是由以下原料制备的:
聚合度为2000的聚乙烯醇150份,水500份,蔗糖脂肪酸酯12份,伊曲康唑1.5份,环糊精或其衍生物50份,卵磷脂13份,木薯预糊化淀粉120份,海藻酸钠16份;
所述的B膜是由以下原料制备的:
聚合度为2000的聚乙烯醇150份,水500份,pH为5.5的磷酸缓释液28份,环糊精或其衍生物50份,壳聚糖8份,预糊化淀粉150份,海藻酸钠23份,卵磷脂6份,风味矫正剂4份。
将上述原料按以下方法制备伊曲康唑药膜:
A膜:将聚合度为2000的聚乙烯醇、水、蔗糖脂肪酸酯、环糊精或其衍生物、卵磷脂、预糊化淀粉、海藻酸钠充分混合,并加热到80℃,并使所有物质完全溶解后,冷却至60℃,之后加入伊曲康唑充分混合得到A混合液后,用涂膜机将上述A混合液涂覆在基材聚酯薄膜上,并在75℃左右干燥,制成A膜。
B膜:将所述的B膜的原料充分混合,并加热到85℃,使所有物质完全溶解后得到B混合液后,将所述的B混合液冷却至50℃并涂覆在基材聚酯薄膜上,并在70℃左右干燥,制成B膜。
Claims (6)
1.一种伊曲康唑药膜,包含A膜和B膜,其特征在于:
所述的A膜是由以下原料制备的:
聚合度为2000的聚乙烯醇100~150份,水400~600份,蔗糖脂肪酸酯10-20份,伊曲康唑1-2份,环糊精或其衍生物50-80份,卵磷脂10-20份,预糊化淀粉100-150份,海藻酸钠15-25份;
所述的B膜是由以下原料制备的:
聚合度为2000的聚乙烯醇100~150份,水400~600份,pH为5-5.5的磷酸缓释液15-35份,环糊精或其衍生物50-80份,壳聚糖5-10份,预糊化淀粉100-180份,海藻酸钠15-25份,卵磷脂5-10份。
2.如权利要求1所述的一种伊曲康唑药膜,其特征在于:
所述的A膜由以下原料制备的:
聚合度为2000的聚乙烯醇100~150份,水400~600份,蔗糖脂肪酸酯12-15份,伊曲康唑1.5-1.8份,环糊精或其衍生物50-80份,卵磷脂13-16份,预糊化淀粉120-150份,海藻酸钠16-28份;
所述的B膜是由以下原料制备的:
聚合度为2000的聚乙烯醇100~150份,水400~600份,pH为5-5.5的磷酸缓释液25-28份,环糊精或其衍生物50-80份,壳聚糖5-10份,预糊化淀粉100-150份,海藻酸钠17-23份,卵磷脂6-8份。
3.如权利要求1或2所述的一种伊曲康唑药膜,其特征在于,所述的预糊化淀粉为木薯、玉米、马铃薯混合制成以预糊化淀粉。
4.如权利要求1或2所述的一种伊曲康唑药膜,其特征在于,所述的环糊精及其衍生物为α-环糊精或其衍生物、β-环糊精或其衍生物、γ-环糊精或其衍生物。
5.如权利要求4所述的一种伊曲康唑药膜,其特征在于:所述β-环糊精的衍生物为甲基-β-环糊精、2,6-二甲基-β-环糊精中的一种或两种混合。
6.如权利要求1或2所述的一种伊曲康唑药膜,其特征在于,所述的A膜和B膜还包括风味矫正剂,所述的风味矫正剂可选择蜜桃香精、黄瓜香精、巧克力香精、薄荷香精。
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