CN1321080A - 快速溶解口腔消耗膜 - Google Patents
快速溶解口腔消耗膜Info
- Publication number
- CN1321080A CN1321080A CN99811215A CN99811215A CN1321080A CN 1321080 A CN1321080 A CN 1321080A CN 99811215 A CN99811215 A CN 99811215A CN 99811215 A CN99811215 A CN 99811215A CN 1321080 A CN1321080 A CN 1321080A
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- A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
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Abstract
本发明公开了生理可接受薄膜,包括可食用薄膜。所述薄膜含有水溶性成膜聚合物,例如支链淀粉。公开的可食用薄膜含有支链淀粉和抗微生物有效量的精油百里酚、水杨酸甲酯、桉树脑和薄荷醇。所述可食用薄膜有效杀死引起牙斑、齿龈炎和口臭的产斑菌。薄膜还可以含有药学活性剂。本发明还公开了薄膜的制备方法。
Description
发明领域
本发明涉及快速溶解口腔消耗膜。这种膜用于向口腔释放口腔除臭剂、抗菌剂和唾液刺激剂。所述薄膜也可以用于释放药学活性剂。
发明背景
在更理想的社会中,人们将把每次用餐后的口腔清洁作为他们例行口腔卫生行为的一部分。不幸的是,若干因素妨碍着这种良好口腔清洁生活制度基本要求的普及。
口腔清洁有时可能困难或不便,取决于清洁的性质和须进行清洁时的情况。使用多种适合个人隐私的装置和组合物来刷拭、擦洗、清洁你的舌头和口腔是最常见的口腔保健习惯。然而,口腔清洁实践中所用的装置和组合物不适于在家居以外的地方使用,因为那些地方浴室设施缺乏、难以得到或不卫生。
即使不是所有文化,但在多数情况中在公众场合刷拭、擦洗、清洁舌部和口腔被看作是社交上无法接受的行为举止,迄今开发了多种减少唐突性的口腔清洁产品。其中包括口腔清净口香糖和锭剂。虽然配制的口香糖和锭剂能够获得不同的良好作用,但它们在社交上不是总能被接受。例如,在某些机构如学校和某些国家如新加坡中明令禁止口香糖。口香糖和薄荷已在很长时期内为人们使用,它们要求使用者进行一定量的吸吮或咀嚼活动,这可能使人分散注意力、乏味并且不受欢迎。
另一种便携式口腔清洁产品口腔喷雾剂。如同漱口剂一样,口腔喷雾剂可以为使用者提供快速的强口腔清净作用,它们可能胜过长时间消耗产品如口香糖或锭剂。另一方面,口腔喷雾剂也是令人讨厌的。喷雾口腔喷雾剂一般会发出响声,致使使用者引起公众不受欢迎的注意。此外,口腔喷雾剂通常包装在较昂贵且复杂的金属罐中,其在使用中可能堵塞并且对环境不宜。而且,四散的喷雾不但浪费产品,而且可能导致刺痛眼睛、粘着颜面和/或玷污衣物。
据提议,利用可食用薄膜作为赋形剂来雅观地释放口腔清净剂。参见JP 5-236885。然而,日本专利申请中没有教导在薄膜中含有抗菌剂,利用这种薄膜减少口腔中有害细菌的量,或刺激唾液。此外,该专利申请没有公开其薄膜适用于除清净口腔以外的目的或除口腔以外的腔体。
Ozaki等人的美国专利号5518902(Hayashibara)公开了高级支链淀粉内容物产品,例如可食用薄膜、洁齿剂和药物(3栏,44-56行和实施例B-8)。该产品除支链淀粉以外可以含有多种成分,例如其他多糖类化合物、多元醇、防腐剂和矫味剂(4栏,58行至5栏,11行)。其中没有提及精油如百里酚、桉油精、冬青油或薄荷醇可作为适当组分。
Ozaki等人的美国专利号5411945(Hayashibara)公开了支链淀粉粘合剂和由其制备的产品,包括可食用薄膜(实施例B-2)。产品中除支链淀粉以外可以含有多种组分,例如其他多糖类化合物、抗菌剂、矫味剂和药学活性物质(4栏5-15行)。其中没有提及用精油作为适当组分。
Kubodera的美国专利号4851394公开了葡甘露聚糖/多元醇可食用薄膜,该薄膜可含有支链淀粉(3栏59行至4栏21行)。所述薄膜与已有含支链淀粉薄膜形成对照,已有薄膜对水缺乏抵抗力(1栏40-44行)。其中没有提及用精油作为适当组分。
Hijiya等人的美国专利号3784390公开了支链淀粉薄膜及其在食品、药物和其他对氧敏感材料的涂层和包装材料中的应用。该专利所有实施例都教导在热水中混合支链淀粉。
Nakamura等人的美国专利号4623394公开了一种徐缓崩解模制物品,它可以是用支链淀粉制备的薄膜。该物品含有特定的杂聚糖(Heteromannan),其可以是槐树豆胶。
Hijiya等人的美国专利号4562020公开了一种制备自支持的葡聚糖薄膜的方法,其可以是支链淀粉。
日本专利文献JP 5-1198公开了由聚乙烯醇和至少一种角叉菜胶、水溶性纤维素α-淀粉和水溶性多糖制成的薄膜。
WO 99/17753公开了一种释放药物使其在消化道内吸收的快速溶解薄膜。
WO 98/26780公开了用于活性物质施用和释放在颊腔内的扁平、箔、纸或糯米纸类形式的产品。WO 98/26780中公开的具体活性成分是丁丙诺啡。
WO 98/20862公开了一种口腔用薄膜,其可以含有化妆或药物活性成分。
WO 98/26763公开了将活性物质释放在颊腔中的类似扁平、箔、纸或糯米纸形式的产品。其中公开的具体化学物质是阿朴吗啡。
虽然现有技术中存在快速溶解口腔消耗薄膜,但对此类薄膜及其制备方法的改进仍留有余地。
所有此处引用的参考文献在此全文引入作为参考。
发明概述
本发明提供一种生理可接受薄膜,其特别适于粘着并且快速溶解在使用者的口腔中。在本发明的第一种实施方案中,薄膜释放出至少一种口腔保健剂,例如抗菌剂和唾液刺激剂。抗菌剂有效对抗引起口臭、牙斑和齿龈炎的微生物。唾液刺激剂有效防止口腔干燥或口干。此外,口腔保健薄膜是有效防止口腔恶臭的口腔清净剂。用来制备本发明薄膜的成膜剂将口腔保健剂截留在口腔内,产生长效作用。
在本发明的第二种实施例中,快速溶解薄膜起着经口腔、经粘膜或经患者开放性创口释放药学活性剂的赋形剂的作用。
本发明还涉及一种制备特别适合口腔给药的柔软的、非自粘着性薄膜的方法。该方法包括将成膜剂和至少一种稳定剂混合得到成膜混合物;将水溶性组分溶解在水中得到水溶液;将成膜混合物和水溶液混合得到水合聚合物凝胶;混合油类形成油混合物;将该油混合物加入水合聚合物凝胶中并且混合,得到均匀乳化凝胶;将该均匀凝胶浇铸在衬底上;和,干燥该浇铸凝胶得到薄膜。
附图简述
图1是用变异链球菌ATCC 25175涂布的琼脂平板的相片,该平板暴露于本发明的含有0.391mg精油的薄膜。
图2是用变异链球菌ATCC 25175涂布的琼脂平板的相片,该平板暴露于数滴含有0.391mg精油/滴的精油混合物。
优选实施方案详述口腔保健薄膜组合物的描述
本发明的第一种实施方案是特别适宜粘着和溶解在使用者口腔中、释放出可杀死引起口臭、牙斑和齿龈炎的微生物的抗菌剂的生理可接受薄膜。因此,所述薄膜是预防和治疗口臭、牙斑积聚、牙石蓄积和齿龈炎的有效工具。这种薄膜适宜含有支链淀粉、百里酚、水杨酸甲酯、桉油脑和薄荷。
LISTERINE_牌漱口剂也许是最熟知的抗菌口腔用组合物实例,已证实它能够有效杀死口腔中导致牙斑、齿龈炎和口臭的微生物。LISTERINE_牌漱口剂利用精油混合物穿透并且杀死微生物来获得其抗菌作用。这些精油在水醇溶液中含有精确平衡量的百里酚、水杨酸甲酯、薄荷和桉油脑(下文称作“精油”)。许多致口臭菌存活在舌表面的凹陷和裂隙中。LISTERINE_抗菌漱口剂可减小口臭,因为液体介质中存在高浓度抗菌剂,它们易于穿透到这些凹陷和裂隙中。这是含有少量抗菌成分的固体剂型所不能实现的。然而,本发明的优选消耗薄膜以更便利和雅观的耗用形式具有LISTERINE_牌漱口剂的大部分卫生效果和对消费者的吸引力。
在薄膜中要保持LISTERINE_牌漱口剂的精油相互作用和较高的油含量极具挑战性。然而,本发明人克服了这样的困难,提供了本发明的薄膜。
本发明的另一方面是,虽然LISTERINE_中精油的含量相对高于薄膜中混入的精油量,本发明薄膜每单位剂量释放的精油总量比LISTERINE_漱口剂的还少。然而,该薄膜在口腔中令人惊奇地产生抗菌效能。本发明人推断,适宜的成膜成分支链淀粉在口腔薄膜形成薄层,该薄层捕获少量能够穿透到口腔凹陷和裂隙中的精油从而产生持续的抗菌功效。
虽然本发明人目前不了解任何其它提供抗菌功效的口腔清净消耗薄膜,但本发明的发明人了解到JP 5-236885中公开了一种可消耗薄膜,它据说具有口腔清净作用,但没有公开含有任何具有显著抗菌活性的成分。此外,JP 5-236885教导,其薄膜含有含量为5-7%的矫味剂和提取物,加入的矫味剂为油(没有公开精油),而本发明的薄膜优选含有至少约10重量%,更优选约15重量%至30重量%,最优选约15重量%至约25重量%的油内容物。除实施例中另有说明以外,薄膜中油和其它组分的含量是膜制剂被干燥后制成的薄膜的重量百分比。
薄膜组合物中特定精油的用量可以改变,条件是它们的含量足以提供抗菌功效。通常,百里酚、水杨酸甲酯和桉油脑的含量是薄膜组合物的约0.01至约4重量%,优选约0.50至约3.0重量%,并且更优选是薄膜的约0.70至约2.0重量%。薄荷的加入量可以是组合物的约0.01至约15重量%,优选约2.0至约10重量%,并且更优选是薄膜的约3至约9重量%。所属领域技术人员很容易确定该用量,并且可以超出这些用量,只要总的油含量不致产生粘附或其它加工问题。在一些实施方案中,精油以有效杀死引起牙斑、齿龈炎和口臭的产斑微生物的协同量混合。
在这种具有较高油含量的薄膜的配制中,一个主要困难是直接提高薄膜中的油量,而不确定出许多其它组分的精确比例,一般会导致薄膜过湿并且难以处理或加工。本发明人发现如何提供一种高油含量薄膜,其足够湿润,因此无脆性,但这种湿润不会令人感觉薄膜有另人不快的粘滑或与相邻薄膜严重粘附。因此,本发明的非自粘着薄膜可以相互接触地保存(例如成堆叠),或可以自身卷绕(例如绕轴缠绕),而不需要在薄膜的相邻部分放置去粘着剂(例如塑料膜、纸或其它支撑物)。
本发明薄膜中所用的成膜剂可以选自:支链淀粉、羟丙基甲基纤维素、羟乙基纤维素、羟丙基纤维素、聚乙烯吡咯烷酮、羧甲基纤维素、聚乙烯醇、藻酸钠、聚乙二醇、黄原胶、黄蓍胶、瓜耳胶、阿拉伯胶、金合欢胶、聚丙烯酸、甲基丙烯酸甲酯共聚物、羧乙烯基聚合物、直链淀粉、高级直链淀粉、羟丙基化高级直链淀粉、糊精、果胶、壳多糖、壳聚糖、果聚糖、痂囊腔菌聚糖、胶原、明胶、玉米醇溶蛋白、面筋、大豆蛋白分离物、乳清蛋白分离物、酪蛋白和它们的混合物。优选的成膜剂是支链淀粉,用量范围是该薄膜的约0.01至约99重量%,优选约30至约80重量%,更优选约45至约70重量%,甚至更优选约60至约65重量%。
本发明的薄膜适宜含有作为成膜剂的支链淀粉和作为杀菌剂/矫味剂的精油,并且可以进一步含有水、其它的抗菌剂、其它的成膜剂、塑化剂、其它的矫味剂、硫沉淀剂、唾液刺激剂、清凉剂(cooling agent)、表面活性剂、稳定剂、乳化剂、增稠剂、粘合剂、着色剂、甜味剂、香料等。
由于口腔保健薄膜中油含量较高,薄膜中适宜避免使用大量保湿剂(并且更优选膜中不含有保温剂),由此防止生成过度湿润的自粘着薄膜。特别是,适宜用除甘油之外的塑化剂和除山梨糖醇之外的甜味剂来配制该薄膜,因为甘油也是保温剂,山梨糖醇是中度保湿剂。
本发明的口腔保健薄膜中还可以加入减轻口臭的硫沉淀剂。这些试剂结合并且灭活引起大部分口臭的挥发性硫化合物。适用于本发明的硫沉淀剂包括金属盐,例如铜盐和锌盐。优选的盐包括葡萄糖酸铜、柠檬酸锌和葡萄糖酸锌。硫沉淀剂的含量是该薄膜的约0.01至约2重量%,优选约0.15重量%至约1.5重量%,更优选约0.25重量%至约1.0重量%。
唾液刺激剂也可以加入本发明的口腔保健薄膜中。适用的唾液刺激剂是公开在美国专利号4820506中的那些,该文献在此全文引入作为参考。唾液刺激剂包括食用酸,例如柠檬酸、乳酸、苹果酸、琥珀酸、抗坏血酸、己二酸、富马酸和酒石酸。优选的食用酸是柠檬酸、苹果酸和抗坏血酸。唾液刺激剂在薄膜中的含量是约0.01至约12重量%,优选约1重量%至约10重量%,更优选约2.5重量%至约6重量%。
优选的塑化剂包括甘油三乙酸酯,用量约0至约20重量%,优选约0至约2重量%。其它适当塑化剂包括甘油一乙酸酯和甘油二乙酸酯。
优选的清凉剂(Cooling agent)包括琥珀酸一薄荷酯,其用量为约0.001至约2.0重量%,优选约0.2至约0.4重量%。含琥珀酸一薄荷酯的清凉剂可由Mane,Inc获得。其它适用的清凉剂包括WS3、WS23、UltracoolⅡ等。
优选的表面活性剂包括脂肪酸的单酸甘油酯和二酸甘油酯类化合物以及聚氧化乙烯山梨糖醇酯,例如Atmos 300(甘油的一酸和二酸酯和抗氧剂)和聚山梨酸酯80。表面活性剂的加入量可以是该薄膜的约0.5至约15重量%,优选约1至约5重量%。其它适当表面活性剂包括普卢诺尼克酸、十二烷基硫酸钠等。
优选的稳定剂包括黄原胶、槐树豆胶和角叉菜胶,用量是该薄膜的约0至约10重量%,优选约0.1至约2重量%。其它适用的稳定剂包括瓜耳胶等。
优选的乳化剂包括硬脂酸三乙醇胺、季铵化合物、阿拉伯胶、明胶、卵磷脂、膨润土、胶体镁铝硅酸盐等,用量是该薄膜的约0至约5重量%,优选约0.01至约0.7重量%。
优选的增稠剂包括甲基纤维素、羧甲基纤维素等,用量是约0至约20重量%,优选约0.01至约5重量%。
优选的粘合剂包括淀粉,用量是约0至约10重量%,优选约0.01至约2重量%。
可以含有的适当甜味剂是所属领域技术人员熟知的那些,包括天然和人工甜味剂。适用的甜味剂包括,例如:
A.水溶性甜味剂,例如单糖、二糖和多糖,如木糖、核糖、葡萄糖(右旋糖)、甘露糖、半乳糖、果糖(左旋糖)、蔗糖(糖)、麦芽糖、转化糖(衍生自蔗糖的果糖和葡萄糖的混合物)、部分水解淀粉、玉米糖浆固体、二氢查耳酮、莫尼林(monellin)、蛇菊苷和甘草甜素;
B.水溶性人工甜味剂,例如可溶性糖精盐,即糖精钠或钙盐;环己基氨基磺酸盐;3,4-二氢-6-甲基-1,2,3-噁噻嗪-4-酮-2,2-二氧化物的钠、铵或钙盐;3,4-二氢-6-甲基-1,2,3-噁噻嗪-4-酮-2,2-二氧化物的钾盐(丁磺氨-K),糖精的游离酸形式等;
C.基于二肽的甜味剂,例如L-天门冬氨酸衍生甜味剂,例如L-天门冬氨酰基-L-苯基丙氨酸甲酯(天冬甜素)和美国专利3492131所述的原料,L-α-天门冬氨酰基-N-(2,2,4,4-四甲基-3-硫杂环丁烷基)-D-丙氨酰胺水合物,L-天门冬氨酰基-L-苯基甘油和L-天门冬氨酰基-L-2,5-二氢苯基-甘氨酸的甲酯,L-天门冬氨酰基-2,5-二氢-L-苯基丙氨酸,L-天门冬氨酰基-L-(1-环己烯基)-丙氨酸等;
D.衍生自天然水溶性甜味剂的水溶性甜味剂,例如普通糖(蔗糖)的氯化衍生物,例如三氯半乳蔗糖产品说明书中所述;和
E.基于蛋白的甜味剂,例如非洲竹芋甜素(thaumatoccousdanielli)(沙马汀(thaumatin)Ⅰ和Ⅱ)。
通常,利用有效量的辅助甜味剂为特定组合物提供所需水平的甜味,并且该用量随所选甜味剂而改变。当采用易提取甜味剂时,该用量一般是该组合物的0.01%至约10重量%。上述A类所述的水溶性甜味剂一般的用量是约0.01至约10重量%,优选约2至约5重量%。A类中的一些甜味剂(例如甘草甜素)可以根据甜味剂已知的增甜能力以B-E类甜味剂所设定的量使用。相反,B-E类中所述的甜味剂的用量一般是约0.01至约10%(重量),优选约2%至约8重量%和最优选约3%至约6重量%。可使用这些用量以获得预期的甜度而不取决于由任何任选的矫味油所获得的矫味水平。当然,当薄膜是非口腔施用时无需加入甜味剂。
可用的矫味剂包括所属领域技术人员已知的那些,例如天然或人工矫味剂。这些矫味剂可以选自矫味油和矫味芳香剂,和/或油,油树脂和衍生自植物、叶子、花、果实等的提取物,和它们的混合物。代表性矫味油包括:留兰香油、肉桂油、薄荷油、丁子香油、月桂油、百里香油、雪松叶油、肉豆蔻油、鼠尾草油和苦杏仁油。适用的还有人工、天然或合成水果矫味剂,例如香草、巧克力、咖啡、可可;和柑橘叶油,包括柠檬、柑橘、葡萄、酸柠檬和柚子;和水果香精,包括苹果、梨、桃、草莓、覆盆子、樱桃、李子、凤梨、杏等。这些矫味剂可以单用或混合使用。常用的矫味剂包括薄荷属如薄荷,人工香子兰,肉桂衍生物,和多种水果矫味剂,它们可单用或混合使用。也可以使用例如醛类和酯类的矫味剂,其中包括乙酸肉桂醇酯,肉桂醛,柠檬醛,二乙基乙缩醛,乙酸二氢香芹酯,甲酸丁子香酚酯,对-甲基苯甲醚等。通常,可以采用矫味剂或食品添加剂,例如在《食品加工中使用的化学品》(由国家科学院出版,publication 1274,第63-258页)中描述的那些。其他醛类矫味剂的实例包括但不限于:乙醛(苹果);苯甲醛(樱桃,杏仁);肉桂醛(肉桂);柠檬醛,即α柠檬醛(柠檬,酸柠檬);橙花醛,即β-柠檬醛(柠檬,酸柠檬);癸醛(橙,柠檬);乙基香兰素(香兰,乳脂);天芥菜精,即胡椒醛(香兰,乳脂);香兰(香兰,乳脂);α-戊基肉桂醛(辛辣水果矫味剂);丁醛(奶油,干酪);戊醛(奶油,干酪);香茅醛(许多种类的改性剂);癸醛(柑橘属果);C-8醛(柑橘属果);C-9醛(柑橘属果);C-12醛(柑橘属果);2-乙基丁醛(浆果类);己烯醛,即反-2(浆果类);甲苯醛(樱桃,杏仁);藜芦醛(香草);2,6-二甲基-5-庚烯醛,即甜瓜醛(甜瓜);2,6-二甲基辛醛(绿果);和2-十二烯醛(柑橘属,桔子);樱桃;葡萄;它们的混合物;等等。
矫味剂的用量一般与这样的因素如矫味剂类型、矫味剂本身和预期强度有关。所以,可以为了在最终产物中获得预期的结果而改变该用量。这种改变是所属领域技术人员无需过多实验就能够作出的。通常,用量为约0.1至约30重量%,优选约2至约25重量%,并且更优选约8至约10重量%。
本发明的组合物还可以含有着色剂或色料。着色剂的用量可有效产生预期的色泽。本发明所用的着色剂,包括颜料,例如二氧化钛,其混合量至多约5重量%,并且优选小于约1重量%。色料也可以包括天然食物色素和适用于食品、药物和化妆品的染料。这些色料被称作FD&C染料和色淀。能够被上述应用范围接受的物质优选是水溶性的,并且包括FD&C2号蓝,它是5,5-靛蓝二磺酸的二钠盐。同样地,称作3号蓝的染料含有三苯基甲烷染料并且是4-[4-N-乙基-对-磺基苄基氨基]二苯基-亚甲基]-[1-N-乙基-N-对-锍苄基]-2,5-环-己二烯亚胺]的一钠盐。在Kirk-Othmer化工百科全书(Encyclopedia of ChemicalTechnology),5卷,857-884页中可以找到对所有FD&C和D§C染料及其相应化学结构的全面评述,该著作在此引入作为参考。口腔保健薄膜的抗菌功效
本发明的口腔保健薄膜组合物的优选实施方案含有Listerine_漱口剂所用精油以便提供抗菌功效。使薄膜成形并且具有一定大小,可以置于口腔内。薄膜粘着在口腔表面,通常是口腔或舌的上部,并且迅速溶解。精油在一个大小适宜放置在口腔内的单个薄膜中的含量明显小于在Listerine_漱口剂中的推荐量,20ml。
在本发明的优选配方中,百里酚和桉树脑在薄膜中的含量比上述漱口剂中的少约70倍。水杨酸甲酯在薄膜中的含量比上述漱口剂少约46倍。薄荷醇在薄膜中的含量比上述漱口剂少约2.8倍。这些数据是基于20ml剂量的漱口液与0.0358克薄膜的比较。
本发明人意外地发现如此低含量的油可以提供持续抗菌功效。本发明人确信,由于在口腔内形成的支链淀粉薄层能够保持精油,从而增强了精油的功效。这令人感到意外,因为支链淀粉是水溶性的并且薄膜溶解非常迅速。
抗菌活性的延长可在下列实施例中看出。
这些实施例的目的是测定在施用口腔清净薄膜30、60或90分钟后对舌部异味微生物的杀菌功效。30分钟的研究还试验了使用两种薄膜的功效。通过将由舌用棉签收集的微生物接种在选择性琼脂培养基中可以测定出受试者基线口腔异味微生物的可收集数量。分配该试验产物并且令受试者将一种或两种口腔膜溶解在其舌部。受试者留在现场并且在舌部放置试验产物后30、60或90分钟后再使用第二舌用棉签擦试。48小时漱口后,受试者返回接受无处理对照。
使用单一口腔薄膜30分钟组显示出与对照组相比,异味微生物数量的平均对数减小。数据接近于统计学显著性(p=0.052)。在异味微生物菌落数量上,单一薄膜使用组和无处理对照组的差异是降低了42.7%。
在两个薄膜使用组中也观察到统计学显著性的异味微生物减少。得到异味微生物菌落数量的减少率为79.6%。
使用一个口腔薄膜后60分钟观察到统计学显著性的异味微生物减少。得到异味微生物菌落数量的减少率为69.8%(p=0.002)。
使用一个口腔薄膜后90分钟观察到统计学显著性的异味微生物减少。得到异味微生物菌落数量的减少率为69.1%(p=0.006)。
由这些试验获得的数据支持下列结论:(1)基于支链淀粉聚合物的含精油口腔薄膜是抵抗细菌引起的口腔异味的有效抗菌组合物和(2)试验后30、60和90分钟后体内细菌明显减少。试验方法
这些抗菌研究中所用的方法如下所述。要求试验对象在研究前子夜开始避免所有口腔卫生行为(例如刷牙,漱口),食用或饮用任何食物、饮料或甜食品,直至在各个试验日完成研究为止。在异味评估之前的清晨禁止对象吸烟。体内杀菌试验
1.原料
食管含有10ml的灭菌0.01%蛋白胨。
灭菌棉签
OOPS Ⅲ琼脂(B.-F,Turng,G.E.Minah,和W.A.Falkler.《用于测定口腔产H2S生物的琼脂培养基的进展》。牙科研究杂志(JDent Res)76 IADR摘要1997):
哥伦比亚琼脂基质(商品目录号#DF 0792-17-3) 44克
蒸馏水 1L
醋酸铅a(Sigma L3396) 0.2克
氯高铁血红素溶液b(Sigma H-1625) 2ml
谷胱甘肽c(Sigma G4251) 1.2克
44克哥伦比亚血液琼脂基质悬浮在1L蒸馏水中并且沸腾直至完全溶解。在121-124℃下将培养基灭菌15分钟。a将0.2g醋酸铅溶解在1ml蒸馏水中并且过滤灭菌。在将基质培养基高压灭菌后加入。b将50mg氯高铁血红素溶解在1ml的1N NaOH中;用蒸馏水加至100ml。过滤灭菌。基质培养基高压灭菌后每1L的OOPS Ⅲ中加入2ml。c将1.2g谷胱甘肽溶解在10ml的蒸馏水中。灭菌过滤。基质培养基高压灭菌后加入。
2.方法
a.将所有培养基在无氧箱室中过夜预还原。用塑料袋松散包裹平板以防止过分干燥。
b.自试验之前子夜开始,测试人员禁止进行口腔清洁,禁止饮食直至试验结束。利用12名测试人员进行60和90分钟试验。利用18名测试人员进行30分钟试验。
c.通过将棉签置于舌部中点并且向舌尖方向刮擦来擦拭各测试人员的舌部右侧。将棉签置于蛋白胨的试管中。
d.测试人员接受一个或两个薄膜的处理。测试人员将口腔薄膜置于其舌部左侧,由中点覆盖到舌尖并且令薄膜溶解在口腔中,口腔略微张开30分钟以防止薄膜粘着在上腭上。
e.30或60分钟后,测试人员擦拭其舌左侧,这是通过将棉签置于舌的中点并且向舌尖刮擦。将棉签置于蛋白胨的试管中。
f.将蛋白胨的管子剧烈涡旋10秒,并且将其连续稀释。用SpiralBiotech自动平板4000(Bethesda,MD)将10-4稀释液一式双份接种在OOPS Ⅲ琼脂上。将所有平板标明受试人员的姓名首字母、试验日期、取样时间段和重复号。
g.将平板在无氧腔室中在35-37℃下培养7天,使菌落生长完全但不过度生长。
h.48小时洗漱期后,测试人员返回进行无处理对照试验。不施用薄膜,并且进行上述步骤(e)至(g)。
i.48小时洗漱期后,60分钟测试人员返回进行另一单个薄膜施用试验。除了在步骤e中测试人员是在90分钟后返回以外,进行步骤(a)至(h)。
j.通过在适当放大率下手动或利用Spiral Biotech计数模板通过区域计数计算出整个平板的变黑菌落(产H2S生物)数。将适当编码加入数据表以表示计数。通过除以表A中所列的适当指数体积常数(exponential volume constant)并且乘以1000将CFU的数量转换为CFU/ml。随后该数值乘以平板稀释因子(104)。
表A.区域对的指数体积常数
最后计数区域 | 指数体积常数 |
8 | 1.214 |
9 | 2.968 |
10 | 5.500 |
11 | 9.157 |
12 | 14.482 |
13 | 25.015 |
总平板 | 50.030 |
体内杀菌试验中所用的薄膜如表2所述的实施例19。该研究中所用的薄膜约为22mm×32mm,厚度约0.0013和0.0015英寸厚并且重量约35至约37mg。
在附图1和2也显示出含精油支链淀粉薄膜的高活性。图1是用变异链球菌ATCC#25175涂布的琼脂平板的照片,平板中加入本发明的精油支链淀粉薄膜片。利用下文的实施例15薄膜片释放约0.391mg精油。
图2是用变异链球菌ATCC#25175涂布的琼脂平板的照片,平板中加入数滴精油。液滴的体积为148μl并且含有0.391mg的精油。液滴中各精油在水醇溶液中的百分比是2.200%薄荷醇、0.186%桉树脑、0.186%水杨酸甲酯和0.1300%百里酚。
附图1中环绕在薄膜四周的抑制区或抑制带明显大于薄膜的大小。这归因于支链淀粉的存在,因为支链淀粉薄膜中的油通过支链淀粉展着开,向外扩散并且经反复漂洗后也不会被冲掉。相反,图2中的精油不会扩散到液滴以外,始终保持为环状并且很容易在漂洗1-2次后被冲洗掉。这表明,精油的抗菌功效由于支链淀粉的存在而得到提高。含精油薄膜的制备方法
本发明薄膜的制备方法能够将油成分包封在成膜基质内并且维持薄膜的完整性,甚至当薄膜的含油量为10重量%或更多时亦如此。
在某些制备本发明薄膜的方法中,将成膜成分和水溶性成分分别与水混合并水合,它们与有机成分和表面活性剂分别混合在水溶液中。在这些方法中,适宜通过将成膜相与水相混合,随后混合在有机相中来制备最终的制剂,所述有机相中含有表面活性剂,例如聚山梨酸酯80和Atmos 300。混合此物料直至乳化。在其他实施方案中,通过将水溶性成分溶解在水中并且随后将胶加入水合物中使水相和成膜相混合为单一相。随后将有机相加入该单一水相中。
将所得制剂铸塑在适当衬底上并且干燥形成薄膜。该薄膜适宜风干或在热空气下干燥,并且切割为预定大小,包装并且保藏。该薄膜可以含有约0.1%至约10重量%水分,优选约3%至约8重量%的水分,更优选约4至约7重量%的水分。
成膜相可以含有支链淀粉和稳定剂,例如黄原胶、槐树豆胶和角叉菜胶。将这些成分混合并且随后水合在水中约30分钟至48小时,形成凝胶。优选将水加热至约25至约45℃的温度以促进水合。水含量是凝胶的约40-80重量%。此后将所得水合凝胶冷却至约20至约30℃约1小时至约48小时,优选的水是去离子水。
水相可以含有成分,例如着色剂、葡萄糖酸铜和甜味剂。优选将水去离子并且水的用量是最终凝胶混合物的约5至约80重量%。
如果糖精钠和葡萄糖铜同时成为制剂的组分,优选分别将它们溶解在溶液中以避免沉淀。
在本发明的含精油薄膜的优选制备方法中,可以水合成膜成分并且无需加热即可将所有成分混合。制备薄膜的优选方法包括,将水溶性成分溶解在水中形成含水混合物;将粉末形式的成膜成分混合成粉末混合物;将该粉末混合物加入到所述含水混合物中形成水合聚合物凝胶;室温下搅拌该水合聚合物约30分钟至约48小时;将清凉剂,百里酚和薄荷醇在矫味油中混合形成油混合物;向油混合物中加入水杨酸甲酯,桉树脑和表面活性剂;将油混合物加入水合聚合物凝胶中并且混合直至均匀;使薄膜脱气直至除去气泡,将均匀混合物浇铸在适当衬底上;并且干燥该浇铸混合物,形成薄膜。
含精油薄膜的优选制备方法是水合成膜成分而无需加热水。加热成分会增高制备过程中的能耗。此外,加热可导致挥发性成分蒸发损失,这也影响组合物的杀菌活性,因为损失了精油。而且,在两个步骤中混合油可以减少矫味剂的损失量。
虽然不希望受到任何理论的约束,但可以相信成膜成分可以水合并且混合而无需加热,因为称作唐南平衡的离子效应的存在。在电解质存在下成膜成分在溶液中水合可有效降低形成的聚合物凝胶的粘度,由此提高水合过程的效率。制剂的水溶性成分提供电解质,它们在加入成膜成分之前已经溶解在水合溶液中。高剪切混合也可以加速水合,高剪切打碎粉末,为水接触提供了更大的表面积。此外,在剪切区域中产生的局部热效应为水合提供了能量,而基本上不会提高物料的温度。
适宜避免同时将葡萄糖酸铜和糖精加入水溶液中,由于同时加入将生成沉淀。所以,适宜将除糖精以外的甜味剂与葡萄糖酸铜混合。释放药剂的薄膜组合物说明
本发明的第二实施方案是一种快速溶解薄膜,其中含有至少一种生理可接受的药学活性剂。此处所用术语“生理可接受”包括在对患者给药时足以被耐受而不会引起不适当副作用的化合物。该术语包括可食用化合物。
在此所用的术语“药学活性剂”包括除食品以外的在施用时于机体中和/或在机体上产生结构和/或机能改变的试剂。这些试剂无特别限定;然而,它们应是生理可接受且与薄膜相容的。适用的药学活性剂包括但不限于:
A.抗菌剂,例如三氯生、氯化十六烷基吡啶鎓、溴化度米芬、季铵盐、锌类化合物、血根碱、氟化物类、阿来西定、奥克尼定(octonidine)、EDTA等;
B.非甾类抗炎药,例如阿斯匹林、对乙酰氨基酚、布洛芬、酮洛芬、二氟尼柳、非诺洛芬钙、萘普生、托美丁、吲哚美辛等;
C.镇咳药,例如苯佐那酯、乙二磺酸咳美芬、薄荷醇、氢溴酸右美沙芬、氯苯达诺盐酸盐等;
D.减充血剂,例如盐酸伪麻黄碱、去氧肾上腺素、苯丙醇胺、硫酸伪麻黄碱等;
E.抗组胺剂,例如马来酸溴苯那敏、马来酸氯苯那敏、卡比沙明马来酸盐、富马酸氯马斯汀、马来酸右氯苯那敏、盐酸苯海拉明、盐酸二苯拉林、阿扎他定马来酸盐、柠檬酸苯海拉明、琥珀酸多西拉明、盐酸异丙嗪、马来酸美吡拉明、柠檬酸曲吡那敏、盐酸曲普利啶、阿伐斯丁、氯雷他定、溴苯那敏、右溴苯那敏等;
F.祛痰药,例如愈创甘油醚、吐根、碘化钾、萜品醇等;
G.止泻剂,例如洛派丁胺等;
H.H2-拮抗剂,例如法莫替丁、雷尼替丁等;和
I.质子泵抑制剂,例如奥美拉唑、兰索拉唑等;
J.全身性非选择性CNS抑制剂,例如脂族醇类化合物,巴比妥类药物等;
K.全身性非选择性CNS兴奋剂,例如咖啡因、烟碱、马钱子碱、印防己毒素、戊四氮等;
L.选择性调节CNS机能的药物,例如苯乙内酰脲(phenyhydantoin)、苯巴比妥、扑米酮、卡马西平、乙琥胺、甲琥胺、苯琥胺、三甲双酮、地西泮、苯并二氮卓类、苯乙酰脲、苯丁酰脲、乙酰唑胺、舒噻嗪、溴化物等;
M.帕金森氏综合征治疗药,例如左旋多巴、金刚烷胺等;
N.麻醉镇痛剂,例如吗啡、海洛因、氢吗啡酮、美托酮、羟吗啡酮、左吗啡、可待因、氢可酮、纳洛芬、纳洛酮、纳曲酮等;
O.镇痛解热剂,例如水杨酸盐、保泰松、消炎痛、非那西汀等;
P.精神药理学药物,例如氯丙嗪、左美丙嗪、氟哌啶醇、氯氮平、利血平、丙咪嗪、反苯环丙胺、苯乙肼、锂等;
可在本发明快速溶解薄膜中使用的药物的量取决于提供药物有效量所需的剂量。由每条快速溶解口腔薄膜释放出的具体药物的剂量实例如表1所述。
表1
药物 | 剂量 |
马来酸氯苯那敏 | 4mg |
马来酸溴苯那敏 | 4mg |
右氯苯那敏 | 2mg |
右溴苯那敏 | 2mg |
盐酸曲普利啶 | 2.5mg |
阿伐斯丁 | 8mg |
马来酸阿扎他定 | 1mg |
氯雷他定 | 10mg |
盐酸去氧肾上腺素 | 10mg |
盐酸右美沙芬 | 10-20mg |
酮洛芬 | 12.5mg |
琥珀酸舒马普坦 | 35-70mg |
佐利普坦(zolmitriptan) | 2.5mg |
洛派丁胺 | 2mg |
法莫替丁 | 10mg |
尼古丁 | 2mg |
盐酸苯海拉明 | 25mg |
盐酸伪麻黄碱 | 30mg |
用于制备含药物薄膜的成分与那些制备口腔保健薄膜的那些成分类似。具体而言,在本发明的所有薄膜中还可以采用塑化剂、清凉剂、表面活性剂、稳定剂、乳化剂、增稠剂、粘合剂、成膜剂、甜味剂、矫味剂和着色剂。
释放药剂的薄膜也可以包括甘油三酯。甘油三酯的实例包括:植物油,例如玉米油、向日葵油、花生油、橄榄油、低芥酸菜子油、大豆油和它们的混合物。优选的甘油三酯是橄榄油。加入薄膜中的甘油三酯量是该薄膜的约0.1重量%至约12重量%,优选约0.5重量%至约9重量%。
含有药剂的薄膜也可以含有防腐剂。加入薄膜中的防腐剂量是该薄膜的约0.001重量%至约5重量%,优选约0.01%至约1重量%。优选的防腐剂包括苯甲酸钠和山梨酸钾。
含药剂薄膜还可以含有聚氧化乙烯化合物。聚氧化乙烯化合物的分子量范围是约50000至约6000000。优选的聚氧化乙烯化合物是可购自Union Carbide公司的N-10。聚氧化乙烯化合物的加入量是该薄膜的约0.1重量%至约5重量%,优选约0.2重量%至约4.0重量%。
含药剂薄膜也可以含有丙二醇。丙二醇的加入量是该薄膜的约1重量%至约20重量%,优选约5重量%至约15重量%。
可以将薄膜所用活性成分包衣以掩蔽活性成分的味道或防止活性成分使舌部或口腔中的其它表面麻木。可采用的包衣层是所属领域技术人员已知的那些。这些这些包括聚合物,例如Eudragit_E,纤维素类,例如乙基纤维素等。
另一种掩蔽活性成分味道的途径是通过使用离子交换树脂,例如可购自Rohm和Haas的Amberlite RP-69,以及可购自Dow Chemcial公司的Dow XYS-40010.00。实施例
本发明将参考下列实施例更详细的说明,但应理解,本发明不仅仅局限于这些实施例。制备方法Ⅰ
下列方法用于制备实施例1-13的薄膜。
A.将除了聚山梨酸酯80和Atmos 300以外的成膜成分(例如黄原胶、槐树豆胶、角叉菜胶和支链淀粉)混合并且水合在热的纯水中形成凝胶并且在约4℃的冰箱中保存过夜,形成制备物A。
B.加入着色剂、葡萄糖酸铜和甜味剂并且溶解在纯水中形成制备物B。
C.将制备物B加入制备物A中并且充分混合形成制备物C。
D.将矫味剂和油(例如清凉剂、百里酚、水杨酸甲酯、桉树脑和薄荷醇)混合形成制备物D。
E.将聚山梨酸酯80和Atmos 300加入制备物D中并且充分混合形成制备物E。
F.将制备物E加入制备物C并且充分混合形成制备物F。
室温下将制备物F倾入模子中并且浇铸形成预定厚度的薄膜。在热空气下干燥该薄膜并且切割成预定的尺寸,包装并且储藏。
制备方法Ⅱ
实施例14-18利用优选的方法进行制备,其中包括下列步骤:
A.将葡萄糖酸铜、丁磺氨K、天冬甜素、甘油、山梨糖醇和染料溶解在纯水中形成含水混合物;
B.将粉末形式的支链淀粉、黄原胶、槐树豆胶和角叉菜胶混合在一起形成粉末混合物;
C.将步骤B的粉末混合物加入步骤A制得的含水混合物中形成水合聚合物凝胶;
D.室温下,低速(约50-100RPM)搅拌步骤C制得的水合聚合物过夜;
E.将清凉剂、百里酚和薄荷醇混合并且溶解在矫味油中;
F.向步骤E制得的油混合物中加入水杨酸甲酯、桉树脑、聚山梨酸酯80和Atmos 300;
G.将步骤F的油混合物加入步骤D制得的水合聚合物凝胶中并且混合直至均匀为止;
H.将步骤G制得的均匀混合物浇铸在适当衬底(backing)上,和
I.干燥该浇铸混合物形成薄膜。实施例1
实施例制备了本发明的薄膜,该薄膜具有蓝绿色、薄荷气味和清新的薄荷味道。实施例2-4
实施例2-4含有山梨糖醇、甘油或两者同时存在。这些实施例制成的产品易于破碎为碎片,或过度湿润和/或自身粘附在一起。然而,它们也制得了具有清新薄荷味道的可在口腔中快速溶解的薄膜。实施例5-6
实施例5和6不含有甘油和山梨糖醇。所得薄膜在加工和包装过程中不再粘附在一起,并且在长时间内对湿气稳定。实施例7-9
制备实施例7-9是为了测定Avicel_对杀菌活性的影响。虽然实施例7-9制备了从加工和操作方面看更可接受的薄膜,但它们与无Avicel_的薄膜(例如实施例8)相比降低了抗菌活性。实施例10-15
实施例10-15改变天冬甜素和薄荷醇的含量,从而改变了薄膜的甜度和清凉程度。实施例16
通过用麦芽糖醇代替山梨糖醇来制备实施例16的产品,麦芽糖醇的保湿性更差。所得薄膜在加工和长时间保存期间粘附性更低。实施例17
制备实施例17,其中用另一种成膜剂聚乙烯吡咯烷酮代替支链淀粉,从而制得本发明的薄膜。实施例18
制备实施例18,其中支链淀粉部分被另一种成膜剂魔芋胶(konjcagum),制成本发明的薄膜。实施例19
实施例19代表含有唾液刺激剂柠檬酸的薄膜。实施例20
实施例20是在上述抗菌功效研究中使用的薄膜组合物。
实施例1-20的配方概括在表2中。这些实施例中的量表示为实际重量(g)或w/w%。这些配方产生溶液/凝胶,将它们浇铸并且干燥形成薄膜。在最终干燥薄膜中各成分的实际量取决于干燥期间除去的相对水分量。
表2
成分 | Ex.1w/w% | 2wt(g) | 3wt(g) | 4wt(g) | 5wt(g) | 6wt(g) | 7wt(g) | 8wt(g) | 9wt(g) |
黄原胶,食品级 | 0.1070 | 11.60 | 12.60 | 11.60 | |||||
黄原胶,(1%溶液) | 3.85 | 3.85 | 3.85 | 3.85 | 3.85 | ||||
槐树豆胶,澄清 | 0.2150 | 23.40 | 25.40 | 23.40 | |||||
槐树豆胶(1%溶液) | 7.70 | 7.70 | 7.70 | 7.70 | 7.70 | ||||
聚乙烯吡咯烷酮 | |||||||||
魔芋胶 | |||||||||
角叉菜胶 | 1.0730 | 116.60 | 126.10 | 116.60 | |||||
角叉菜胶(5%溶液) | 7.70 | 7.70 | 7.70 | 7.70 | 7.70 | ||||
Avicel | 500.00 | 500.00 | |||||||
支链淀粉 | 51.5780 | 5604.00 | 6513.00 | 5949.00 | |||||
支链淀粉(25%溶液) | 74 | 74 | 74 | 74 | 74 | ||||
百里酚NF | 0.4070 | 0.146 | 0.146 | 0.146 | 40.70 | 40.70 | 40.70 | ||
水杨酸甲酯NF | 0.4210 | 0.151 | 0.151 | 0.151 | 58.50 | 58.50 | 58.50 | ||
桉树脑 | 0.5850 | 0.21 | 0.21 | 0.21 | 42.10 | 42.10 | 42.10 | ||
薄荷醇USP | 5.8830 | 2.23 | 2.11 | 2.11 | 588.00 | 588.00 | 588.00 | ||
薄荷矫味 | 8.3640 | 2 | 3.0 | 3.0 | 836.00 | 836.00 | 836.00 | ||
柠檬酸 | |||||||||
葡萄糖酸铜 | 1.1150 | 0.275 | 0.41 | 0.14 | 112.00 | 112.00 | 112.00 | ||
纯水,USP/EP | 22.32 | 2 | 10.22 | 12.22 | 8.0 | 8.0 | 2230.00 | 2230.00 | 2230.00 |
糖精钠USP颗粒 | 6.6910 | 1.8 | 1.4 | 1.4 | 2.0 | 2.4 | |||
糖精钠 | 609.00 | 609.00 | 609.00 | ||||||
丁磺氨-K | |||||||||
天冬甜素 | |||||||||
清凉剂 | 0.05 | 0.05 | 0.05 | 13.90 | 13.90 | 13.90 | |||
麦芽糖醇 | |||||||||
山梨糖醇(结晶) | 64.30 | 64.30 | 64.30 | ||||||
山梨糖醇70%溶液 | 4 | 4.0 | |||||||
甘油 | 2 | 2.0 | 136.00 | 136.00 | 136.00 | ||||
聚山梨酸酯80NF/EP | 0.5580 | 0.3 | 0.2 | 0.2 | 0.2 | 0.2 | 112.00 | 112.00 | 112.00 |
Atmos300 | 0.5580 | 112.00 | 112.00 | 112.00 | |||||
Atlas3000 | 0.3 | 0.2 | 0.2 | 0.2 | 0.2 | ||||
HiSel C淀粉 | 77.0 | ||||||||
FD&C绿#3 | 0.0084 | 0.3 | 0.3 | 0.3 | 0.3 | 0.3 | 0.84 | 0.84 | 0.84 |
D&C黄#10 |
表2(续)
成分 | 10wt(g) | 11wt(g) | 12wt(g) | 13wt(g) | 14w/w% | 15w/w% | 16w/w% | 17w/w% | 18w/w% | 19w/w% | 20w/w% |
黄原胶,食品级 | 0.0385 | 0.0385 | 0.0385 | 0.0385 | 0.342 | 0.342 | 0.342 | 0.04 | 0.04 | 0.34 | 0.342 |
黄原胶(1%溶液) | |||||||||||
槐树豆胶,澄清 | 0.077 | 0.077 | 0.077 | 0.077 | 0.0684 | 0.0684 | 0.0684 | 0.07 | 0.07 | 0.68 | 0.0684 |
槐树豆胶(1%溶液) | |||||||||||
聚乙烯吡咯烷酮 | 16.5 | ||||||||||
魔芋胶 | 5.0 | ||||||||||
角叉菜胶 | 0.385 | 0.385 | 0.385 | 0.385 | 0.342 | 0.342 | 0.342 | 0.34 | 0.34 | .34 | 0.342 |
角叉菜胶(5%溶液) | |||||||||||
Avicel | |||||||||||
支链淀粉 | 18.5 | 18.5 | 18.5 | 18.5 | 16.43 | 16.43 | 16.43 | 11.0 | 16.34 | 16.43 | |
支链淀粉(25%溶液) | |||||||||||
百里酚NF | 0.146 | 0.146 | 0.146 | 0.146 | 0.130 | 0.13 | 0.13 | 0.13 | 0.13 | 0.129 | 0.13 |
水杨酸甲酯NF | 0.21 | 0.21 | 0.21 | 0.21 | 0.186 | 0.186 | 0.186 | 0.186 | 0.186 | 0.185 | 0.18 |
桉树脑 | 0.21 | 0.21 | 0.21 | 0.21 | 0.186 | 0.186 | 0.186 | 0.186 | 0.186 | 0.185 | 0.18 |
薄荷醇USP | 2.11 | 1.95 | 2.36 | 2.36 | 2.096 | 2.520 | 2.096 | 2.096 | 2.096 | 2.084 | 2.096 |
薄荷矫味 | 3.0 | 3.0 | 3.0 | 3.0 | 2.664 | 2.344 | 2.664 | 2.664 | 2.664 | 2.649 | 2.0 |
柠檬酸 | 2.5 | ||||||||||
葡萄糖酸酮 | 0.4 | 0.4 | 0.4 | 0.4 | 0.355 | 0.355 | 0.355 | 0.35 | 0.35 | 0.353 | 0.355 |
纯水,USP/EP | 84.25 | 84.25 | 84.25 | 84.25 | 74.81 | 74.63 | 74.81 | 75 | 75 | 74.39 | 72.2168 |
糖精钠USP颗粒 | |||||||||||
糖精钠 | |||||||||||
丁磺氨-K | 0.5 | 0.5 | 0.5 | 0.5 | 0.444 | 0.444 | 0.444 | 0.45 | 0.45 | .4420 | 0.444 |
天冬甜素 | 1.30 | 1.60 | 1.30 | 1.60 | 1.421 | 1.421 | 1.4 | 1.4 | 1.431 | 1.421 | |
清凉剂 | 0.10 | 0.10 | 0.10 | 0.10 | 0.089 | 0.089 | 0.089 | 0.089 | 0.089 | 0.088 | 0.89 |
麦芽糖醇 | 2.80 | ||||||||||
山梨糖醇(结晶) | |||||||||||
山梨糖醇70%溶液 | 0.199 | ||||||||||
甘油 | 0.418 | ||||||||||
聚山梨酸酯80NF/EP | 0.4 | 0.4 | 0.4 | 0.4 | 0.355 | 0.355 | 0.355 | 0.355 | 0.355 | 0.353 | 0.355 |
Atmos300 | 0.355 | 0.355 | 0.355 | 0.355 | 0.355 | 0.353 | 0.355 | ||||
Atlas3000 | 0.4 | 0.4 | 0.4 | 0.4 | |||||||
HiSet C淀粉 | |||||||||||
FD&C绿#3 | 0.003 | 0.003 | 0.003 | 0.003 | 0.0026 | 0.0026 | 0.0026 | 0.0026 | 0.0026 | ||
D&C黄#10 |
下列实施例是本发明第二实施方案的薄膜,其中快速溶解薄膜含有药剂。实施例21A-21E(列于表3中)是含药物快速溶解口腔薄膜配方。表3中的量以毫克表示。
表3
实施例序号 | 21A | 21B | 21C | 21D | 21E |
氢溴酸右美沙芬 | 7.500 | ||||
盐酸去氧肾上腺素 | 10.0000 | 10.0000 | |||
马来酸氯苯那敏 | 4.0000 | ||||
洛派丁胺HCl | 2.0000 | ||||
居古丁 | 2.0000 | ||||
黄原胶 | 0.0818 | 0.0818 | 0.0818 | 0.0818 | 0.0818 |
槐树豆胶 | 0.0954 | 0.0954 | 0.0954 | 0.0954 | 0.0954 |
角叉菜胶 | 0.4088 | 0.4088 | 0.4088 | 0.4088 | 0.4088 |
支链淀粉 | 21.8036 | 21.8036 | 21.8036 | 21.8036 | 21.8036 |
苯甲酸钠 | 0.0954 | 0.0954 | 0.0954 | 0.0954 | 0.0954 |
丁磺氨钾盐 | 0.6814 | 0.6814 | 0.6814 | 0.6814 | 0.6814 |
天冬甜素 | 1.9078 | 1.9078 | 1.9078 | 1.9078 | 1.9078 |
纯水 | * | * | * | * | * |
清凉剂 | 0.1363 | 0.1363 | 0.1363 | 0.1363 | 0.1363 |
薄荷醇 | 2.7255 | 2.7255 | 2.7255 | 2.7255 | 2.7255 |
聚山梨酸酯80NF | 0.4770 | 0.4770 | 0.4770 | 0.4770 | 0.4770 |
Atmos 300 | 0.4770 | 0.4770 | 0.4770 | 0.4770 | 0.4770 |
丙二醇 | 4.0882 | 4.0882 | 4.0882 | 4.0882 | 4.0882 |
橄榄油 | 0.6814 | 0.6814 | 0.6814 | 0.6814 | 0.6814 |
二氧化钛 | 0.3407 | 0.3407 | 0.3407 | 0.3407 | 0.3407 |
总重量 | 41.5000 | 44.0000 | 48.0000 | 36.0000 | 36.0000 |
*计算是假定干燥后薄膜中的水分完全蒸发。
表4概括了本发明的其它薄膜。表4中的量是干燥之前的百分含量%w/w。
表4
实施例 | 22A | 22B | 22C | 22D | 22E | 22F | 22G | 22H | 22I |
黄原胶 | .03 | .03 | .06 | .03 | .03 | .03 | .06 | .06 | .06 |
槐树豆胶 | .07 | .07 | .07 | .07 | .07 | .07 | .07 | .07 | .07 |
角叉菜胶 | 0.3 | 0.3 | 0.3 | 0.3 | 0.3 | 0.3 | 0.3 | 0.3 | 0.3 |
支链淀粉 | 16.0 | 16.0 | 16.0 | 16.0 | 16.0 | 16.0 | 16.0 | 16.0 | 16.0 |
苯甲酸钠 | 0.1 | 0.1 | 0.1 | .07 | .07 | .07 | .07 | .07 | 0.7 |
丁磺氨钾 | 0.5 | 0.5 | 0.5 | 0.5 | 0.5 | 0.5 | 0.5 | 0.5 | 0.5 |
天冬甜素 | 1.4 | 1.4 | 1.4 | 1.4 | 1.4 | 1.4 | 1.4 | 1.4 | 1.4 |
水 | qs100 | qs100 | qs100 | Qs100 | qs100 | qs100 | qs100 | qs100 | Qs100 |
清凉剂 | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 |
薄荷醇 | 2.0 | 2.0 | 2.0 | 1.3 | 2.0 | 2.0 | 2.0 | 2.0 | 2.0 |
聚山梨酸酯80 | 0.35 | 0.35 | 0.35 | 0.35 | 0.35 | 0.35 | 0.35 | 0.35 | 0.35 |
Atmos 300 | 0.35 | 0.35 | 0.35 | 0.35 | 0.35 | 0.35 | 0.35 | 0.35 | 0.35 |
丙二醇 | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | 3.0 | 3.0 | 3.0 |
Peg 1450 | . | 3.10 | . | . | . | . | . | . | . |
橄榄油 | . | . | . | 1.2 | 2.0 | 2.0 | .5-2 | . | .5 |
polyo×N-10 | . | . | . | . | . | . | . | . | 1.0 |
二氧化钛 | . | 0.25 | 0.25 | 0.25 | 0.25 | . | 0.25 | . | 0.25 |
实施例22A用于制备的薄膜含有a)7.5mg氢溴酸右美沙芬,b)2.5mg曲普利啶(tripolidine),c)4.0mg的马来酸氯苯那敏和d)12.5mg的盐酸苯海拉明。
实施例22B用来制备的薄膜含有10mg氢溴酸右美沙芬。
实施例22C用来制备的薄膜含有10mg氢溴酸右美沙芬。
实施例22D用来制备的薄膜含有a)10mg盐酸去氧肾上腺素,b)10mg盐酸去氧肾上腺素和4mg马来酸氯苯那敏和c)10mg氢溴酸右美沙芬。
实施例22E用来制备的薄膜含有7.5mg氢溴酸右美沙芬。
实施例22F用来制备的薄膜含有20mg的提供7.5mg剂量的包衣氢溴酸右美沙芬。
实施例22G用来制备的薄膜含有a)7.5mg氢溴酸右美沙芬,b)10mg盐酸去氧肾上腺素和c)10mg盐酸去氧肾上腺素和4mg马来酸氯苯那敏。
实施例22H用来制备的薄膜含有15mg的氢溴酸右美沙芬。
实施例22I用来制备的薄膜含有15mg氢溴酸右美沙芬。制备含药物薄膜的方法
实施例22A采用下列方法制备。
1.将苯甲酸钠和甜味剂加入水中。
2.将槐树豆胶、黄原胶和角叉菜胶混合在一起。
3.将胶混合物加入步骤1的混合物中并且混合直至溶解。
4.将活性成分与水或丙二醇混合。如果需要加热。
5.向步骤4的混合物中加入剩余的成分或将剩余成分混合为单独的混合物。
6.将步骤4和步骤5的混合物加入步骤3的混合物中。浇铸并且干燥制得薄膜并且切割以获得所需剂量的大小。
实施例22B-22E利用下列方法制备。
1.将苯甲酸钠加到加热至50℃的水中。混合以溶解。
2.分别将Peg 1450、二氧化钛和活性成分加入步骤1的混合物中,每次加料后混合。
3.将槐树豆胶、黄原胶和角叉菜胶混合在一起。
4.将胶加入步骤2的混合物中并且混合直至溶解。
5.一起加入剩余成分,如果需要可加热。
6.将步骤4和5的混合物加在一起。浇铸并且干燥制成薄膜,切割以获得所需剂量的大小。
实施例22F-22I按照实施例20B-20E相同的方法制备,但是活性成分是在浇铸薄膜之前分散的。
虽然本发明参考具体实施例已作了详细说明,对于所属领域技术人员很显然的是,可以在不脱离本发明的实质和范围下进行不同的改变和改进。
Claims (47)
1.一种适于粘着并且溶解在使用者口腔中的可消耗薄膜,其中该薄膜含有至少一种水溶性聚合物和抗菌有效量的至少一种精油,所述精油选自百里酚、水杨酸甲酯、桉树脑和薄荷醇。
2.根据权利要求1的可消耗薄膜,其中含有至少两种所述精油。
3.根据权利要求1的可消耗薄膜,其中含有至少三种所述精油。
4.根据权利要求1的可消耗薄膜,其中含有百里酚、水杨酸甲酯、桉树脑和薄荷醇。
5.根据权利要求4的可消耗薄膜,进一步含有葡萄糖酸的盐。
6.根据权利要求4的可消耗薄膜,进一步含有葡萄糖酸铜。
7.根据权利要求1的可消耗薄膜,其中所述水溶性聚合物选自:支链淀粉、羟丙基甲基纤维素、羟乙基纤维素、羟丙基纤维素、聚乙烯吡咯烷酮、羧甲基纤维素、聚乙烯醇、藻酸钠、聚乙二醇、黄蓍胶、瓜耳胶、阿拉伯胶、金合欢胶、聚丙烯酸、甲基丙烯酸甲酯共聚物、羧乙烯基聚合物、直链淀粉、高级直链淀粉、羟丙基化高级直链淀粉、糊精、果胶、壳多糖、壳聚糖、果聚糖、痂囊腔菌聚糖、胶原、明胶、玉米醇溶蛋白、面筋、大豆蛋白分离物、乳清蛋白分离物、酪蛋白和它们的混合物。
8.根据权利要求7的可消耗薄膜,其中所述水溶性聚合物是支链淀粉。
9.根据权利要求8的可消耗薄膜,含有:
约40-约80重量%支链淀粉;
约0.01-约4重量%百里酚;
约0.01-约4重量%水杨酸甲酯;
约0.01-约4重量%桉树脑;和
约0.01-约15重量%薄荷醇。
10.根据权利要求7的可消耗薄膜,进一步含有:
约0.01-约5重量%至少一种稳定剂;
约0.001-约0.1重量%至少一种着色剂;
约0.1-约8重量%水;
约0.1-约15重量%至少一种甜味剂;
约0.1-约15重量%至少一种矫味剂;
约0.1-约4重量%至少一种清凉剂;和
约0.1-约5重量%至少一种表面活性剂。
11.根据权利要求10的可消耗薄膜,其中所述至少一种稳定剂选自黄原胶、槐树豆胶和角叉菜胶,并且所述至少一种甜味剂选自糖精、天冬甜素和丁磺氨K。
12.根据权利要求1的可消耗薄膜,其中所述薄膜基本上不自身粘着在一起。
13.根据权利要求1的可消耗薄膜,其中所述薄膜不含有甘油和山梨糖醇。
14.根据权利要求1的可消耗薄膜,其中所述薄膜不含有保湿剂。
15.根据权利要求1的可消耗薄膜,其中精油是该薄膜的至少约10重量%。
16.根据权利要求15的可消耗薄膜,其中精油是该薄膜的至少约15重量%。
17.根据权利要求1的可消耗薄膜,进一步含有约3重量%至约8重量%的水。
18.一种生理相容薄膜的制备方法,该方法包括:
将至少一种水溶性成膜剂与至少一种稳定剂混合提供成膜混合物;
将水溶性成分溶解在水中得到水溶液;
将该成膜混合物和该水溶液混合得到水合聚合物凝胶;
混合油形成油混合物;
将该油混合物加入所述水合聚合物凝胶并且混合,得到均匀凝胶;
将该均匀凝胶浇铸在衬底上;和
干燥该浇铸凝胶得到所述薄膜。
19.根据权利要求18的方法,其中至少一种表面活性剂被混合在所述油混合物中。
20.根据权利要求18的方法,其中所述油在油混合物中的总量是该方法各组分总量的至少约5重量%。
21.根据权利要求20的方法,其中油的所述总量至少是约15重量%。
22.根据权利要求18的方法,其中进行所述干燥直至该薄膜的水分含量为约3重量%至约8重量%。
23.根据权利要求18的方法,其中在与所述水溶液混合之前,所述成膜混合物在约25℃至约50℃下与水水合并且随后冷却至约4至约30℃的温度约2至48小时。
24.根据权利要求18的方法,其中所述成膜混合物是粉末,其直接与所述水溶液混合。
25.根据权利要求24的方法,其中所述水合聚合物凝胶在无需加热的条件下形成。
26.根据权利要求25的方法,其中所述水合聚合物凝胶在室温下搅拌约2至约48小时。
27.根据权利要求26的方法,其中所述油混合物通过将百里酚和薄荷醇混合在矫味油中,并且随后加入水杨酸甲酯和桉树脑而制备。
28.根据权利要求18所述方法制备的非自粘附的薄膜。
29.根据权利要求18的方法,其中水溶性成膜剂选自:支链淀粉、羟丙基甲基纤维素、羟乙基纤维素、羟丙基纤维素、聚乙烯吡咯烷酮、羧甲基纤维素、聚乙烯醇、藻酸钠、聚乙二醇、黄蓍胶、瓜耳胶、金合欢胶、阿拉伯胶、聚丙烯酸、甲基丙烯酸甲酯共聚物、羧乙烯基聚合物、直链淀粉、高级直链淀粉、羟丙基化高级直链淀粉、糊精、果胶、壳多糖、壳聚糖、果聚糖、痂囊腔菌聚糖、胶原、明胶、玉米醇溶蛋白、面筋、大豆蛋白分离物、乳清蛋白分离物、酪蛋白和它们的混合物。
30.根据权利要求29的方法,其中该水溶性聚合物是支链淀粉。
31.适于溶解在使用者口腔中的可消耗薄膜,其中该薄膜包括含有支链淀粉和至少一种药剂的单层。
32.根据权利要求31的可消耗薄膜,其中该药剂选自:抗菌剂、非甾类抗炎药、镇咳药、减充血剂、抗组胺药、祛痰药、止泻药、H2-拮抗剂、质子泵抑制剂、中枢神经系统药物、止痛药,和它们的混合物。
33.根据权利要求32的可消耗薄膜,其中抗菌剂选自三氯生、氯化十六烷基吡啶鎓、溴化度米芬、季铵盐、锌类化合物、血根碱、氟化物类、阿来西定、奥克尼定、EDTA和它们的混合物。
34.根据权利要求32的可消耗薄膜,其中非甾类抗炎药选自阿斯匹林、对乙酰氨基酚、布洛芬、二氟尼柳、非诺洛芬钙、萘普生、托美丁、吲哚美辛和它们的混合物。
35.根据权利要求32的可消耗薄膜,其中所述镇咳药选自苯佐那酯、乙二磺酸卡拉美芬、氢溴酸右美沙芬、氯苯达诺盐酸盐和它们的混合物。
36.根据权利要求32的可消耗薄膜,其中所述减充血剂选自盐酸伪麻黄碱、去氧肾上腺素、苯丙醇胺和它们的混合物。
37.根据权利要求32的可消耗薄膜,其中所述抗组胺药选自马来酸溴苯那敏、马来酸氯苯那敏、卡比沙明马来酸盐、富马酸氯马斯汀、马来酸右氯苯那敏、盐酸苯海拉明、柠檬酸苯海拉明、盐酸二苯拉林、琥珀酸多西拉明、盐酸异丙嗪、马来酸美吡拉明、柠檬酸曲吡那敏、盐酸曲普利啶和它们的混合物。
38.根据权利要求32的可消耗薄膜,其中所述祛痰药选自愈创甘油醚、吐根、碘化钾、萜品醇和它们的混合物。
39.根据权利要求32的可消耗薄膜,其中所述止泻剂选自洛派丁胺。
40.根据权利要求32的可消耗薄膜,其中H2-拮抗剂选自法莫替丁、雷尼替丁和它们的混合物。
41.根据权利要求32的可消耗薄膜,其中所述质子泵抑制选自奥美拉唑、兰索拉唑和它们的混合物。
42.一种释放和提高有效量抗菌剂在口腔中的保持力的方法,该方法包括在口腔中引入含有支链淀粉和抗菌剂的快速溶解薄膜,该薄膜含有薄荷醇及水杨酸甲酯、桉树脑和百里酚中的至少一种,其中所述支链淀粉提高了抗菌剂在口腔中的保持力。
43.根据权利要求42的方法,其中抗菌剂包括薄荷醇、水杨酸甲酯、桉树脑和百里酚。
44.根据权利要求42的方法,其中支链淀粉在该薄膜中的含量是约40重量%至约80重量%。
45.根据权利要求42的方法,其中抗菌剂在薄膜中的含量是约5重量%至约12重量%。
46.根据权利要求43的方法,其中抗菌剂在薄膜中的含量是约5重量%至约12重量%。
47.一种释放和提高有效量抗菌剂在口腔中的保持力的方法,该方法包括向口腔中引入权利要求9所述的可消耗薄膜。
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- 1999-09-23 KR KR1020017003793A patent/KR20010075347A/ko not_active Application Discontinuation
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CN1750809B (zh) * | 2003-04-25 | 2010-05-26 | 沃尼尔·朗伯有限责任公司 | 含有药学活性剂的快速溶解的口腔可消耗薄膜 |
CN101111150B (zh) * | 2005-02-02 | 2016-03-16 | 诺瓦制药研究(澳大利亚)有限公司 | 生物稳定聚合物制成的制品 |
CN102836144A (zh) * | 2012-09-28 | 2012-12-26 | 天津市聚星康华医药科技有限公司 | 一种去氧肾上腺素口腔速溶膜及其制备方法 |
CN102871984A (zh) * | 2012-11-05 | 2013-01-16 | 天津市聚星康华医药科技有限公司 | 一种盐酸去氧肾上腺素口腔速溶膜及其制备方法 |
CN102871984B (zh) * | 2012-11-05 | 2015-11-11 | 天津市聚星康华医药科技有限公司 | 一种盐酸去氧肾上腺素口腔速溶膜及其制备方法 |
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