CN1134308C - 静电喷雾装置 - Google Patents
静电喷雾装置 Download PDFInfo
- Publication number
- CN1134308C CN1134308C CNB998045780A CN99804578A CN1134308C CN 1134308 C CN1134308 C CN 1134308C CN B998045780 A CNB998045780 A CN B998045780A CN 99804578 A CN99804578 A CN 99804578A CN 1134308 C CN1134308 C CN 1134308C
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- Prior art keywords
- liquid
- valve
- sprayer unit
- slit
- spraying
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- B—PERFORMING OPERATIONS; TRANSPORTING
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Abstract
本发明涉及一种喷雾装置,它能提供多次单位剂量的液体,每个剂量具有从1至100μl范围内的容量,该装置包括一弹性自密封阀,它具有一液体侧和一输送侧,当给液体侧的液体提供压力时,阀打开以允许液体通过,但压力消失时,阀关闭。该阀能获得在低液体容量时完全的停止-启动流动。该装置特别适用于施加低容量药剂,诸如鼻内喷雾。
Description
本发明的技术领域
本发明涉及一种喷雾装置,它能提供多次单位剂量的液体,该装置包括一弹性的自密封阀,该阀可在低液体容量时获得液体的完全的停止—启动流动。更具体地说,本发明涉及一种装置,它能在从约1至约100μl的范围内传输单位容量。
本发明的技术背景
诸如花粉热或由于着凉引起的充血之类的影响鼻子部位的疾病治疗通常采用鼻内喷雾装置。现在人们发现,鼻腔的粘膜可用作瞄准身体其它部位的药物的方便的输送站。例如,见国际专利申请第WO 92/11049号,它公开了一种笔形装置,以便实施胰岛素的鼻内给药。喷雾形式对于这种治疗是非常方便的。利用喷雾装置还可方便地进行眼睛治疗。对于这种用途的较佳容量的剂量通常是低的,甚至小于10μl。一般来说,需要重复给药,以便使治疗充分有效。然而,要使输送这种低容量的喷雾装置获得完全的停止—启动流动是困难的。所遇到的主要问题包括阀使用后的剩余物的滴落、潜在的后污染、以及阀阻塞。
现在已经发现,弹性阀、特别是狭缝阀能提供完全的停止—启动液体而不会有阻塞,即使喷射的液体包括很细小的微粒。
因此,本发明的一个目的是提供一种喷雾装置,它能有效地在低单位容量下多次输送单位剂量。
本发明的还有一个目的是提供一种喷雾截止装置,它能提供完全截止的喷雾,并不会产生阻塞。
本发明的简要说明
按照本发明,提供一种喷雾装置,它能提供一个或几个单位剂量的液体,各剂量具有从1至100μl范围内的容量,该装置包括一弹性的自密封阀,该阀具有一液体侧和一输送侧,当给液体侧的液体提供压力时,阀打开以让液体通过,当压力消失,阀关闭。
较佳的是,该喷雾装置是一种静电喷雾装置,它能在喷雾进入鼻内前对喷雾充电。
本发明的详细介绍
液体
本发明的喷雾装置优选地包括含药学上可接受液体的液体盒,液体包括选自药物、调味剂、盐、表面活性剂及其混合物的药学上可接受的治疗剂。液体任选地包括溶于其中或分散于其中的其它辅剂。液体可为含水的或不含水的。合适的含水液体包括水,以及水和水可混溶的溶剂,如甘油、丙二醇或诸如乙醇或异丙醇的醇类的混合物。也可使用油包水型或水包油型的含水乳剂。优选的液体是含水溶液、分散液或水包油型乳剂。合适的不含水的液体包括聚乙二醇、甘油、丙二醇、二甲基异山梨醇、硅油、酮类、醚类和它们的混合物。
虽然对电阻率的范围没有限定,但本发明特别应用于低电阻率的液体,特别是体积电阻率低于1×108ohm.cm,较佳的是电阻率低于1×104ohm.cm,更佳的是低于1×103ohm.cm。需要时,液体可包含电阻率修饰剂,如药学上可接受的盐,以使体积电阻率处于所需的范围里。
液体优选的是药学上可接受的鼻内用载体。较佳的是,鼻用组合物是等渗的,即它与血液和泪液的渗透压相同。本发明组合物所需的等渗性可使用已经存在的氯化钠,或其它药学上可接受的试剂,如右旋糖、硼酸、柠檬酸、酒石酸钠、柠檬酸钠、磷酸钠、磷酸钾、丙二醇或其它无机或有机溶质来达到。氯化钠对于含钠离子的缓冲液尤为优选。Remington′s Pharmaceutical Sciences(Alfonso Gennaro第18版,1990)1491-1497页揭示了氯化钠等价物的例子,在此并入供参考。
药物
液体可包括各种药物。“药物”表示对机体有治疗作用的药物或其它物质。药物的合适水平是0.001-20%,较佳的是0.01-5%,更佳的是0.1-5%。应当明白,特定药物的水平根据包括药物的效力、安全曲线、溶解度/分散的容易性和迅速的作用等许多因素而定。药物可为,在使用时对施加部位有作用的物质,如减充血剂、抗组胺或抗炎药物,或供全身吸收的药物,如抗病毒药、抗抑郁药、抗呕吐药、解热药或激素或类似的药物。药物可溶于液体或不溶于液体,或是分散在液体里的细分散颗粒液体或固体。
合适的减充血剂包括去甲唑啉、曲马唑啉、赛洛唑啉、萘甲唑林、四氢唑啉(tetrahydrazoline)、假麻黄碱、麻黄碱、苯福林,它们的药学上可接受的盐,如盐酸盐,和它们的混合物。优选的减充血剂选自去甲唑啉、赛洛唑啉,它们的药学上可接受的盐,和它们的混合物。本发明使用的特别优选的是盐酸去甲唑啉,它溶于水。当用于本发明组合物时,去充血剂优选的存在浓度为约0.01%-3.0%,更优选的是约0.01-1%。
用于本发明的抗组胺包括,但不限于,速效的组胺H-1受体拮抗剂。这类H-1受体抗组胺药选自下列抗组胺类:烷基烷、乙醇胺、亚乙基二胺、哌嗪、吩噻嗪、哌啶。有用的速效抗组胺例子包括阿伐斯汀、卡比沙明、苯海拉明、氯苯那敏、溴苯那敏、右氯苯那敏、多西那敏、氯马斯汀、异丙嗪、阿利马嗪、甲地嗪、羟嗪、美吡拉敏、曲吡那敏、美克洛嗪、曲普利啶、阿扎他定、赛庚啶、罗卡斯汀(rocastine)、苯茚胺或其药学上可接受的盐,和它们的混合物。其它有用的抗组胺类包括特非那定、氮斯汀、西替利嗪、阿司咪唑、依巴斯汀、酮替芬、洛草氨酸、氯雷他定、左旋卡巴斯汀、美喹他嗪、奥沙米特、司他斯汀、他齐茶碱、替美斯汀或其药学上可接受的盐,和它们的混合物。当组合物用于本发明时,抗组胺组分优选的浓度为约0.01-3.0%,更优选的是约0.01-1%。
也可使用抗炎药物,如皮质类固醇。该类中特别优选的是糖皮质激素,选自倍他米松、9-去氟肤轻松、氟替米松、莫米松(memetasone)、布地奈德,其药学上可接受的盐,和它们的混合物。用于本发明组合物时,抗炎药优选的浓度为约0.001%-0.1%,更优选的是约0.01%-0.1%。
在此还有用的是黄嘌呤衍生物,如咖啡因和甲基黄嘌呤等;抗变态反应药;溶粘蛋白剂;抗胆碱药;非鸦片类止痛剂,如扑热息痛、乙酰水杨酸、布洛芬、依托度酸、芬布洛芬(fenbuprofen)、非诺洛芬、酮咯酸、氟比洛芬、吲哚美辛、酮洛芬、萘普生,其药学上可接受的盐,和它们的混合物;诸如布托啡诺的鸦片类止痛剂;白三烯受体拮抗剂;肥大细胞(mast cell)稳定剂,如色甘酸钠、奈多罗米和洛草氨酸;和脂肪氧合酶抑制化合物。
在WO97/46243、EP-A-780127、US-A-5,656,255和US-A-5,705,490中可发现合适药物的其它例子。
调味剂
各种调味和/或芳香组分(如,醛和酯)可用于本发明的液体。这些包括,如甲醇、樟脑、桉脑、苯甲醛(樱桃、杏仁);柠檬醛(柠檬、酸橙);橙花醛;癸醛(橙、柠檬);C-8醛、C-9醛和C-12醛(柑橘类水果);甲苯醛(樱桃、杏仁);2,6-二甲基辛醛(绿色水果);2-十二碳烯醛(柑橘、中国柑桔);和草本植物组分,如麝草香、迷迭香和鼠尾草油。适用于本发明的另外的芳香组分包括美国专利4,136,163(授予Watson等)、美国专利4,459,425(授予Amano等)和美国专利4,230,688(授予Rowsell等)中所揭示的芳香组分,所有这些专利文献并入本文供参考。也可使用这些芳香物的混合物。
表面活件剂
液体也可包含一种或多种药学上可接受的表面活性剂。这类表面活性剂可用于分散或乳化药物或调味剂,以增加穿越鼻膜的吸收,或凭本身的性能作为治疗剂,如供软化耳垢。表面活性剂可为阴离子、非离子、阳离子或两性离子型的,优选的是非离子型的。用于本发明的典型的非离子表面活性剂包括:山梨醇酸酐的脂肪酸偏酯的聚氧乙烯衍生物,如吐温80;脂肪酸的聚氧乙烯衍生物,如聚氧乙烯50硬脂酸酯,以及氧乙烯化的叔辛基苯酚甲醛聚合物(SterlingOrganics出售,商品名Tyloxapol)或它们的混合物。通常的浓度为0.1-3重量%。
盐
液体也可包含一种或多种药学上可接受的盐。该盐可为无机盐,如氯化钠,或有机盐,如柠檬酸钠。
其它辅剂
液体可进一步包含其它组分,如增稠剂、湿润剂、悬浮助剂、形成胶囊助剂、螯合剂和保存剂。
用药学上可接受的增稠剂使组合物的粘度保持在选定的水平。合适的增稠剂包括,如黄蓍胶、甲基纤维素、微晶纤维素、羧甲基纤维素、脱乙酰壳多糖、羟丙基纤维素、羟丙基甲基纤维素、羟甲基纤维素、羟乙基纤维素、羧基乙烯基聚合物、卡波姆(carbomer)等或其药学上可接受的盐。也可使用这类增稠剂的混合物。增稠剂优选的浓度取决于所选的试剂。重要的是使用能达到选定粘度的用量。通常通过加入这类粘稠剂而从溶液中制备粘稠的组合物。
用于本发明的液体也可包含约0.01%-5%湿润剂,以抑制粘膜干燥,并防止刺激。也可使用各种药学上可接受的湿润剂,包括,如山梨醇、丙二醇、聚乙二醇、甘油或它们的混合物。增稠剂的粘度可随选定的试剂而变,但这些试剂的存在与否,或它们的浓度不是本发明的必要特征。
通常使用药学上可接受的保存剂以增加本发明组合物的贮存期限。可使用各种保存剂,包括,如苄基醇、对羟苯甲酸酯类、苯乙基醇、硫柳汞、氯丁醇、葡萄糖洗必太或氯苄烷铵。用于本发明的最优选的保存剂系统是氯苄烷铵、葡萄糖酸洗必太和作为螯合剂的乙二胺四乙酸(EDTA)二钠的组合。虽然根据所选定的试剂有所改变,但保存剂合适的浓度,基于总总量,为0.001%-2%。
喷雾装置和喷雾性能
喷雾装置通常包括一控制喷射液体剂量的设备。它可能是如一双位开关那样简单,允许使用者根据需要控制剂量。该喷雾装置能提供一个或几个单位液体剂量,较佳的是,多次液体剂量。各剂量具有从约1至约100μl、较佳的是从约1至约20μl、更佳的是从约5至约15μl的容量。该剂量的容量较佳的是预先设定,但也可由使用者按照所需的容量进行调节。该装置较适当的是包括一储存液体的盒子,及有选择地从盒子里输送一单位剂量给喷雾发生器的给药设备。该给药设备例如可是一计量阀或一注射泵。
该装置较佳的是能产生具有液体直线部分的喷雾,该直线部分从鼻甲处延伸,并具有一鼻甲端部和一发送端,该喷雾还包括一喷雾锥形部分,它自直线部分的发送端散开。所谓的“鼻甲端部”是一点,在该点处画一垂直于直线部分的轴线的平面(下面叫做“鼻甲平面”),该平面正好与鼻甲的外部接触,且与直线部分的中心相交。该直线部分从鼻甲端部到发送端较佳的是具有从约1至约20mm、更佳的是从约1至约10mm、最佳的是从约2至约8mm、特别是从约3至约6mm的长度。
在较佳的实施例里,喷雾锥形部分具有从约10至约90°、较佳的是从约20至约50°、更佳的是从约30至约40°的锥形角。在静电装置里,直线部分的长度和喷雾锥形角可通过以下方式进行调节,即改变液体的粘性或表面张力,改变液体流速或输出速率,或通过施加电压、电位梯度或使用强化电场电极改变电场强度。
直线部分的总长度可大于、较佳的是大于从鼻甲端部至发送端的长度,因为直线部分较佳的是从在鼻甲平面的装置一侧的一点处、诸如从这里所述的弹性的自密封阀处发生、并通过在该鼻甲里的一通道。从直线部分的发生点至鼻甲平面的距离在从约2至约15mm、较佳的是在从约3至约10mm、更佳的是在从约5至约9mm的范围内。这样,鼻甲可作为强化电场,从而有助于控制直线部分的长度。为此,鼻甲较佳的是非导电材料、诸如聚丙烯之类的塑料,但较佳的是柔软的热塑性弹性体,当抵着鼻子时它能提供最大的舒适性。这里所述的用于自密封阀的弹性体也适用于鼻甲。
国际专利申请第WO 96/40441号、欧洲专利第EP-A-501,725号和待批申请第PCT/GB97/02746号介绍了能以直线方式喷雾的静电装置。本装置较佳的是一种按照欧洲专利第EP-A-501,725号和待批申请第PCT/GB97/02746号中的实施例的装置,其中,通过机械设备产生喷射,而提供的高电压将使喷射或直线部分散开成喷雾锥形部分。该喷射可由(例如)一喷雾泵进行。适当的喷射速度从约0.5至约0.8、较佳的是从约1至约3ms-1。
适当的高电压在从约1kV至约15kV、较佳的是从约2kV至约10kV、更佳的是从约2kV至约5kV范围内。该电压可较容易地由一低电压(1.5V就足够了)电池加上一升压变压器提供,即使是在小型手持式装置里。该电池较佳的是耐用型的,并且可重复充电。如果使用金属注射泵,电压可施加在通过该泵的液体上,而该泵较佳的是由绝缘的塑料壳体包裹。此外,该液体也可由插入液体的电极充电。发生器可由使用者通过外部开关启动,而该开关还可以使泵起动。该开关较佳的是包括一金属部分,使用者可利用该金属部分实现至高电压线路的接地回路。PCT/GB97/02746介绍了一种整个装置结构的适当布局。这样,使用者不会得到净电荷。也可使用交流设备来提供交流电压,从而防止产生电荷。
启动该装置将产生喷雾。喷雾的直线部分在散开形成喷雾锥形部分前延伸通过鼻孔开口,进入前庭,较佳的是鼻阀开口的一短距离内。该装置可制成能同时喷射两支喷雾,以便直接进入两个鼻孔。两支喷雾可由两个单独的定量给药设备产生,也可通过使用一Y型阀将一单独的喷射分成两部分来提供。
为了在低单位容量时提供完全的停止—启动,该装置包括一弹性的自密封输出阀,该阀具有一液体侧和一输送侧,当对液体侧的液体施加压力时,该阀打开以允许液体通过,当压力消失时,阀关闭。这里所述的“输出阀”是指该弹性阀是最后一个分配阀,该装置没有其它的元件来机械地约束或改变在该阀的下游侧的液体流动。在较佳的实施例里,该阀是一狭缝阀。该阀可包括一条狭缝或两条以上的相交的狭缝,以便形成交叉的形状。然而,较佳的是,该阀包括一条狭缝。虽然该阀可以是扁平的,但较佳的是一圆拱形的,这意味着它是一个具有凹槽的非扁平的阀,诸如具有半球形的或截头圆锥形的圆拱。在较佳的实施例里,该阀基本上是半球形的圆拱,具有沿着其周边的凸缘,这样,可用一套环将该阀固定在该装置上。阀的直径(包括凸缘)一般从约2至6mm,而圆拱部分具有从约1至约4mm、通常约2.5mm的直径,并具有从内向外约0.5至约1.5mm、较佳的是约1mm的厚度。该阀不需要均匀的厚度。在较佳的实施例里,该阀的圆拱形的外表面是半球形的,但内表面在圆拱形顶部处、即形成狭缝的地方可略平坦。适当的狭缝宽度从约50至约400μm、较佳的是从约150至约250μm。应该明白,狭缝的宽度涉及狭缝第一次形成时的最大尺寸。这里所使用的术语“弹性体”涉及一种材料,它既可弹性压缩,又可弹性伸长。可使用的弹性体的范围包括(但不限于)聚氨酯、氯丁二烯、丁基合成橡胶、丁二烯和苯乙烯-丁二烯橡胶,以及硅弹性体,诸如2份室温硫化(RTV)硅树脂。这里较佳的是使用2份硅树脂RTVs。适当的硅树脂RTVs的商标是Nusil,它具有从约30至约80的肖氏A硬度、较佳的是从约40至70肖氏A硬度。该弹性体可有选择地与适当的可塑剂或发泡剂混合,以使它们具有更好的压缩性。该弹性体也可有其它的分布在其中的材料,以便改变它的性能,诸如它的导电性。如果使用低撕裂强度的弹性体,在狭缝保持打开一较长时间时狭缝的宽度可能会增加。该狭缝阀可通过使用一具有尖锐末端的针刺穿一注塑成形的、具有与所需阀相同尺寸和形状的弹性密封件而形成。狭缝的宽度大致与针的宽度成比例。该针可以是一扁平的刀片,也可以具有多边形或圆形的横截面。该针较佳的是具有多边形、特别是圆形的横截面。已经发现,尖锐边缘的针产生的切口使用时更象是一条扁平缝,而不是一个孔。这可能导致喷射不是笔直的、或者甚至产生两个以上的喷射,从而可能导致不可靠的和不可预知的喷射。针的适当直径从约100至约350、较佳的是从150至250μm。当使用硅树脂弹性体时,较佳的是刺穿针在形成狭缝后迅速退出,以避免狭缝不必要地扩大。还发现,弹性密封件的几何形状和刺穿的方法对狭缝形成的效率和重复性具有显著的影响。如果密封件的刺穿是从圆拱的内侧而不是从外侧进行,可更可靠地形成狭缝。
当在液体侧对液体施加压力时,阀打开,当压力消失时,阀关闭。如前面所述的,可由诸如注射泵之类的定量设备对液体施加压力。所施加的压力适合于在从约200至约5000mbar(20至500kPa)的范围内,较佳的是从约500至约3000mbar(50至300kPa)的范围内。通过阀的流动速率一般与所施加的压力成比例,适合于从约5至约50、较佳的是从约5至约30μl的范围内。在该压力下,并具有所述的阀类型及狭缝尺寸时,可获得输出速度在从约0.5至约8、较佳的是从约1至约3ms-1范围内的笔直的液体直线部分。
所喷出的直线部分的直径部分地是由流动速率决定的,且一般小于狭缝的宽度。按照所述的流动速率,即使在阀的狭缝宽度是200μm,也可获得小于50μm的直线部分直径。直线部分的直径显著地影响喷雾在散开成锥形部分后的喷雾的微粒大小,微粒尺寸大部分类似于直线部分的直径。这里所述的直线方式的静电喷雾的特点是,可获得紧密分布的、几乎单独分散的喷雾。这样,有可能获得从约20至约80的、较佳的是从约30至约70、更佳的是从约40至约60μm的中间小滴尺寸,微粒尺寸分布通常具有小于5、一般小于2μm、较佳的是小于1μm的标准偏差。一般的共识是,对于鼻内喷雾来说,10μm或更小的微粒尺寸是理想的,这样,微粒不会被携带入肺里。然而,应该相信,喷雾微粒所具有的静电荷将使它们不大可能被携带至鼻子后面,因为带电微粒趋向于相当快地发现接地表面。
末端阀的完全停止动作可通过导入阀工作后期的压力释放特征得到进一步的改善。这将采用在液体盒上形成旁路的方式,以便使由于弹性体的松弛而加压的任何剩余的液体返回到一盒里,而不是从阀出口处滴落。
如果需要,可一前一后地使用几个自密封阀,以便获得较高容量的喷射量,同时仍较佳地维持较小的喷雾微粒尺寸。用来制成阀的密封件可通过传统的注塑模制工艺方便地制造出来。
方法
这里所述的喷雾装置适合于向体腔、特别是人的鼻子、嘴巴或耳朵喷雾。低容量和温和的喷雾也使它适合于(例如)眼药喷雾。较佳的是,该装置是一鼻内喷雾装置。实施从喷雾装置向鼻腔提供液体的较佳方法包括,将液体喷入鼻腔,而基本上不需要该装置进入鼻孔。这里所谓的“基本上不需要进入鼻孔”是指,没有一个喷嘴或类似东西插入鼻子前庭。使用时,该装置的鼻甲较佳的是与鼻孔开口接触,从而获得这里所述的、与鼻甲有关的强化电场效果的全部好处。如果由使用者提供压力,为确保接触或有助于其取向,可使鼻孔略微张开或与隔膜软骨重叠,但不管怎样,鼻甲将不会完全被鼻孔包围。
现在仅通过例子并参考附图来介绍本发明,其中:
图1是人的鼻子的剖视图;
图2是按照本发明的喷雾装置的立体图;
图3是图2中的喷雾装置的简化的剖视图,它显示了鼻甲上的弹性喷嘴与定量给药设备的关系;
图4是一示意的零件剖视图,它显示了由按照本发明的装置实施的喷雾;
图5是按照本发明的弹性输出阀的放大的剖视图。
参看图1,鼻子包括鼻腔1,鼻甲骨2位于其中,盘旋的指状结构上覆盖着上皮,而鼻腔容易发炎。鼻腔通过两个鼻孔3向外开放。由于鼻甲骨位于鼻腔的较后部位上,因此如不将喷雾装置插入鼻孔里将难以对它们进行有效的喷雾。
参看图2和3,它们显示了喷雾装置4具有柔软的弹性鼻甲5,它将紧抵使用者的鼻孔开口而不插入鼻孔里。该鼻甲上设有一与喷雾泵7连接的通道6(其内部细节未画出),该喷雾泵被用来产生通过弹性输出阀8的带状雾。该装置的绝缘壳体9还包括(未画出)可更换的液体盒、电池、变压器和电子线路,以便由变压器提供高压给液体。该装置还设置一启动机构10,它通过机械启动泵,并使其释放以输出预定单位剂量的液体。该启动机构包括金属部分,以便提供自使用者至高电压线路的接地回路。
参看图4,喷雾包括直线部分11和具有锥形角θ的锥形部分12。具体地说,锥形角可通过从一固定距离喷射至显象纸、然后测量喷射图案的直径来测得,或直接使用带背照射的高速视频照相术观察喷雾。直线部分具有发送端13,直线部分在那里分裂成锥形部分,而鼻甲端部14由平面A-A与直线部分11的相交点限定。平面A-A垂直于直线部分的轴线,且正好与鼻甲5的末端接触。
图5显示了按照本发明的一弹性输出阀8。该圆形对称的喷嘴包括一将喷嘴固定在喷雾装置上的凸缘15、一圆拱形头部16、一凹槽17和一狭缝18,狭缝18从凹槽延伸至圆拱形头部的顶部。该喷嘴是通过在基本相同形状的模具里注塑形成的,然后,用尖锐的、具有圆形横截面和200μm直径的针从凹槽的内侧向外刺破圆拱形头部。
例子
下面的例子进一步介绍和论证了在本发明范围内的实施例。这些例子只是为了介绍,而并不是用来限定本发明的范围。
例子1
本发明的液体是通过合成下列成分准备的,它利用了类似于下面所述的、传统的混合技术。
组分 重量%
盐酸羟甲唑啉 0.31
柠檬酸钠二水合物 1.75
柠檬酸 0.35
四丁酚醛 0.70
二葡萄糖酸洗必太 0.054
氯苄烷铵 0.02
樟脑 0.04
桉树脑 0.02
EDTA二钠二水合物 0.01
蒸馏水 加到100毫升
在一适当大小的容器里加入上述成分,每次用水混和,以便在加入后一成分前让其溶解。在所有的成分加入后,使用纯净水使该批料达到适当重量。该溶液具有120ohm.cm的体电阻系数。将该溶液注入一柔软的薄片盒里并安装在图2所示的静电喷雾装置里。该装置还包括图5所示的弹性阀,该阀通过夹住凸缘的螺旋环定位。该装置的鼻甲对着鼻孔,这样方向的装置喷雾的直线部分将进入鼻孔。启动该装置,喷雾泵在阀下面产生约100kPa(1000mbar)的压力,使阀的狭缝打开约50μm的宽度,在约1秒的时间里喷射约8μl的溶液。当喷射液体后,阀完全关闭,以防止进一步输出液体和污染在盒里的液体。这样喷射的液体可减轻鼻充血,且不会在鼻子上或内侧产生显而易见的湿润。这种低剂量和温和的输送使使用者不会觉察到来自喷雾装置的任何可感觉到的机械冲击。
例子2
通过合成下列成分准备另一种液体,它利用了类似于例子1所述的、传统的混合技术。
组分 重量%
9-去氟肤轻松 0.025
氯苯那敏 0.350
左旋卡巴斯汀 0.0125
丙二醇 2.000
聚乙二醇 1.000
亚乙基二胺四乙酸 0.050
氯苄烷铵 0.010
蒸馏水 加到100毫升
用例子1的方式进行鼻内喷雾,使用大约10μl的液体混合物,以便减轻过敏症或类似过敏的症状。
例子3
通过合成下列成分准备本发明的一种液体,它利用了类似于例子1所述的、传统的混合技术。
组分 重量%
二丙酸氯地米松单水合物 0.042
氯苯那敏 0.500
阿维塞尔(Avicel)RC-5911 0.200
右旋糖 5.100
吐温80 0.050
氯苄烷铵 0.020
苯乙基醇 0.025
蒸馏水 加到100毫升
1微晶纤维素和羧甲基纤维素,由FMC公司提供。
用例子1的方式进行鼻内喷雾,使用大约10μl的液体混合物,以便减轻过敏症或类似过敏的症状。
Claims (8)
1.一种静电喷雾装置,它能提供一个或几个单位剂量的、呈具有液体直线部分的喷雾的液体,各剂量具有从1至100μl范围内的容量,该装置包括一弹性的自密封阀,该阀具有一液体侧和一输送侧,当给液体侧的液体提供压力时,阀打开以让液体通过,当压力消失,阀关闭,其特征在于,该装置能给液体提供200至5000mbar(20至500kPa)范围内的压力,以及液体作为笔直的液体直线部分从阀中喷出。
2.如权利要求1所述的喷雾装置,其特征在于,它能提供多次单位剂量的液体。
3.如权利要求1或2所述的喷雾装置,其特征在于,该阀是一狭缝阀,该狭缝具有50至400μm的宽度。
4.如权利要求3所述的喷雾装置,其特征在于,该狭缝具有150至250μm的宽度。
5.如权利要求1所述的喷雾装置,其特征在于,该阀是圆拱形的。
6.如权利要求3至5之一所述的喷雾装置,其特征在于,该狭缝是用尖锐的针刺穿形成的。
7.如权利要求1所述的喷雾装置,其特征在于,该装置能给液体提共1kV至10kV范围内的电压。
8.如权利要求1所述的喷雾装置,其特征在于,该装置能给液体提共500至3000mbar(50至300kPa)范围内的压力。
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EP1374883A1 (de) * | 2002-06-21 | 2004-01-02 | Roland. Dr. Lingg | Nasenspray enthaltend ein Pflanzenextrakt zur Behandlung von Krankheiten wie Herpes Zoster, Blutergüssen, Mastitis und Kreislaufschwäche |
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EP0432431B1 (en) | 1989-11-16 | 1993-06-16 | PHIDEA S.p.A. | Liquid pharmaceutical composition for nasal administration containing a polypeptide as active ingredient |
WO1993002729A1 (en) * | 1990-07-12 | 1993-02-18 | Habley Medical Technology Corporation | Super atomizing nonchlorinated fluorocarbon medication inhaler |
US5248672A (en) | 1990-11-01 | 1993-09-28 | The Regents Of The University Of Michigan | Polysubstituted benzimidazole nucleosides as antiviral agents |
DK302890D0 (da) | 1990-12-21 | 1990-12-21 | Novo Nordisk As | Dispenser |
EP1084758B1 (en) * | 1991-03-01 | 2005-11-09 | The Procter & Gamble Company | Spraying of liquids |
GB9200047D0 (en) | 1992-01-03 | 1992-02-26 | Univ Alberta | Nicotine-containing nasal spray |
GB2273872A (en) * | 1992-12-22 | 1994-07-06 | Unilever Plc | A method of treating skin |
EP0780127A1 (en) | 1995-12-19 | 1997-06-25 | The Procter & Gamble Company | A nasal spray containing a steroid and a antihistamine |
US5890655A (en) * | 1997-01-06 | 1999-04-06 | The Procter & Gamble Company | Fan spray nozzles having elastomeric dome-shaped tips |
-
1998
- 1998-03-31 GB GBGB9806937.0A patent/GB9806937D0/en not_active Ceased
-
1999
- 1999-03-22 EP EP99907787A patent/EP1087841A1/en not_active Withdrawn
- 1999-03-22 TR TR2000/02807T patent/TR200002807T2/xx unknown
- 1999-03-22 WO PCT/IB1999/000474 patent/WO1999049984A1/en not_active Application Discontinuation
- 1999-03-22 CZ CZ20003511A patent/CZ20003511A3/cs unknown
- 1999-03-22 CN CNB998045780A patent/CN1134308C/zh not_active Expired - Fee Related
- 1999-03-22 BR BR9909269-7A patent/BR9909269A/pt not_active Application Discontinuation
- 1999-03-22 JP JP2000540942A patent/JP2002509797A/ja not_active Abandoned
- 1999-03-22 KR KR10-2000-7010816A patent/KR100463692B1/ko not_active IP Right Cessation
- 1999-03-22 CA CA002325043A patent/CA2325043A1/en not_active Abandoned
- 1999-03-22 HU HU0101096A patent/HUP0101096A3/hu unknown
- 1999-03-22 ID IDW20001935A patent/ID26014A/id unknown
- 1999-03-22 AU AU27414/99A patent/AU751624B2/en not_active Ceased
- 1999-03-30 PE PE1999000250A patent/PE20000575A1/es not_active Application Discontinuation
- 1999-03-31 EG EG32599A patent/EG21747A/xx active
-
2000
- 2000-09-29 NO NO20004901A patent/NO20004901L/no not_active Application Discontinuation
Also Published As
Publication number | Publication date |
---|---|
WO1999049984A1 (en) | 1999-10-07 |
BR9909269A (pt) | 2001-09-04 |
JP2002509797A (ja) | 2002-04-02 |
GB9806937D0 (en) | 1998-05-27 |
EG21747A (en) | 2002-02-27 |
HUP0101096A2 (hu) | 2001-07-30 |
NO20004901D0 (no) | 2000-09-29 |
KR20010042276A (ko) | 2001-05-25 |
AU2741499A (en) | 1999-10-18 |
KR100463692B1 (ko) | 2004-12-29 |
CZ20003511A3 (cs) | 2001-12-12 |
ID26014A (id) | 2000-11-16 |
CA2325043A1 (en) | 1999-10-07 |
NO20004901L (no) | 2000-11-29 |
TR200002807T2 (tr) | 2001-02-21 |
AU751624B2 (en) | 2002-08-22 |
PE20000575A1 (es) | 2000-08-16 |
EP1087841A1 (en) | 2001-04-04 |
HUP0101096A3 (en) | 2001-12-28 |
CN1295502A (zh) | 2001-05-16 |
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