CN104540512A - 包含与胶质和/或明胶联合的产生胞外多糖细菌菌株的医疗装置用组合物 - Google Patents
包含与胶质和/或明胶联合的产生胞外多糖细菌菌株的医疗装置用组合物 Download PDFInfo
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- CN104540512A CN104540512A CN201380040172.5A CN201380040172A CN104540512A CN 104540512 A CN104540512 A CN 104540512A CN 201380040172 A CN201380040172 A CN 201380040172A CN 104540512 A CN104540512 A CN 104540512A
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- Materials For Medical Uses (AREA)
Abstract
本发明涉及一种医疗装置用组合物,所述组合物包含特定的粘膜粘附胶凝复合物,其由与植物胶和/或动物和/或植物明胶联合的细菌来源的EPS(胞外多糖)构成,所述细菌来源的EPS由特别选定的细菌菌株在胃肠道中原位产生。所述复合物能够确立遍布整个胃肠道的完整的机械式屏障作用,并能够用作用于预防和治疗与由粘液产生低导致的胃肠区屏障作用缺陷相关的所有病变的药物,例如,作为非限制性实例,所述病变为肠通透性和细菌移位。
Description
本发明涉及一种医疗装置用组合物,所述组合物包含特定的粘膜粘附胶凝复合物,其由与植物胶质(gum)和/或动物和/或植物明胶联合的细菌来源的EPS(exopolysaccharides,胞外多糖)构成,所述细菌来源的EPS由特别选定的菌株在胃肠道中原位产生。所述复合物能够确立遍布整个胃肠道的完整的机械式屏障作用,并能够用作用于预防和治疗与由粘液产生低导致的胃肠区屏障作用缺陷相关的所有病变的药物,例如,作为非限制性实例,所述病变为肠通透性(intestinal permeability)和细菌移位。
已经知道,细菌通常(例如,属于嗜热链球菌(Streptococcus thermophilus)物种的细菌)对胃液敏感,并且其到达胃肠道中的浓度减少且几乎没有活力。
此外,已经知道,当肠粘膜发炎或当肠壁上存在极少粘液时,致病性细菌更容易袭击并穿透肠粘膜。
因此,仍存在能够以充分数量和良好的活力状态保存菌株的需求,所述菌株例如为属于嗜热链球菌种的细菌,所述菌种已存在于肠道的菌群中并在肠道中携带。此外,仍存在以消除、降低或至少抵抗致病性细菌作用的方式保护肠粘膜的需求。
本发明的主题涉及一种医疗装置用组合物,所述组合物具有如所附独立权利要求中所限定的特征。
本发明的优选实施方式由下面的详细描述将变得更加清楚,并在所附权利要求中要求被保护。
本申请人已经发现,开发下述组合物或医疗装置(医疗装置用组合物)是有用的,所述组合物或医疗装置包含与植物胶质和/或动物和/或植物明胶联合的细菌来源的胶质(具体而言,是胞外多糖(EPS))或者由其构成,所述细菌来源的胶质系在所述植物胶质和/或动物和/或植物明胶存在下由胃肠道中的所述细菌原位产生。所述由本发明的益生菌菌株与植物胶质和/或动物和/或植物明胶一起直接产生的细菌胶,能够以消除、降低或至少抵抗对粘膜本身有害的致病性细菌作用的方式保存和保护肠粘膜。
具体而言,本发明涉及一种组合物或医疗装置(医疗装置用组合物),所述组合物或医疗装置(医疗装置用组合物)包含与植物胶质和/或动物和/或植物明胶联合的细菌来源的胶质或者由其构成,所述细菌来源的胶质具体而言是胞外多糖,由胃肠道中的所述细菌原位产生。
本申请人已经发现一种形成特定粘膜粘附胶凝复合物的方法,所述复合物由与植物胶质和/或动物和/或植物明胶联合的细菌来源的EPS(胞外多糖)构成,所述细菌来源的EPS由特别选定的细菌菌株在胃肠道中原位产生。
本发明的主题涉及一种特定的粘膜粘附胶凝复合物,所述复合物由与植物胶质和/或动物和/或植物明胶联合的细菌来源的EPS(胞外多糖)构成,所述细菌来源的EPS由特别选定的细菌菌株在胃肠道中原位产生,如所附权利要求所要求保护的,所述复合物用于优选在肠道渗透性和细菌移位的情况下,用作预防和治疗与由粘液产生低导致的胃肠区屏障作用缺陷相关的所有病变的药物。
简洁起见,在本发明的上下文中,组合物或医疗装置(医疗装置用组合物)将在本说明书其余部分中统称为“本发明的组合物”。
本发明的组合物包含与植物胶质和/或动物和/或植物明胶联合的至少一种益生菌菌株或者由其构成,所述益生菌菌株为胞外多糖(简写为EPS)的产生者。
所述产EPS菌株中的至少一种菌株选自包括属于链球菌属(Streptococcus)、乳杆菌属(Lactobacillus)和双歧杆菌属(Bifidobacteria)的菌株的组。优选的是,所述至少一种菌株选自下述组,所述组包括属于嗜热链球菌(Streptococcus thermophilus)、植物乳杆菌(Lactobacillus plantarum)、鼠李糖乳杆菌(Lactobacillus rhamnosus)、戊糖乳杆菌(Lactobacillus pentosus)、嗜酸乳杆菌(Lactobacillus acidophilus)、短乳杆菌(Lactobacillus brevis)、罗伊氏乳杆菌(Lactobacillus reuteri)、短双歧杆菌(Bifidobacterium breve)、两歧双歧杆菌(Bifidobacterium bifidum)、乳双歧杆菌(Bidifobacterium lactis)、发酵乳杆菌(Lactobacillus fermentum)和德氏乳杆菌(Lactobacillus delbrueeckii)物种的益生菌菌株,或者由其组成。
所述至少一种细菌菌株选自下组,所述组包括属于嗜热链球菌、植物乳杆菌或鼠李糖乳杆菌物种的益生菌菌株,或者由其组成。所述益生菌菌株必须是胃肠道中的原位EPS产生者。
有利的是,所述产EPS菌株属于嗜热链球菌物种。
本发明的组合物包含与植物胶质植物胶和/或动物和/或植物明胶联合的一种或两种或三种或四种选自所述菌株中的产EPS益生菌菌株,或者由其构成。
本发明的组合物包含与植物胶质和/或动物和/或植物明胶联合的一种或两种或三种或四种产EPS益生菌菌株或者由其构成,所述产EPS益生菌菌株选自下述组,所述组包括属于嗜热链球菌、植物乳杆菌或鼠李糖乳杆菌种的益生菌菌株或者由其组成。
有利的是,所述一种或两种或三种或四种产EPS细菌菌株属于嗜热链球菌物种。
包含与植物胶质和/或动物和/或植物明胶联合的两种或三种或四种细菌菌株的混合物的实施方式也是本发明的一部分,所述菌株选自属于嗜热链球菌和/或植物乳杆菌和/或鼠李糖乳杆菌种的益生菌菌种。
胶质是粉末或薄片形式的脱水或冻干或干燥的材料,其一旦与水接触则产生在水中的胶质凝胶(含水凝胶)或胶质明胶。,可以有效使用已经准备的凝胶或明胶。
所使用的胶质均是允许用在食品补充剂和医疗装置中的口服用胶质。
在一个实施方式中,植物胶质和/或动物和/或植物明胶选自下述组,所述组包括芦荟、库拉索芦荟(库拉索芦荟——Aloe barbadensis Miller,是芦荟科家族的一种植物)、木立芦荟、藻酸盐/酯、木葡聚糖(或木糖凝胶(xylogels))、鞣酸盐/酯、明胶鞣酸盐/酯、角叉菜胶、果胶、琼脂和塔拉胶,或者由其组成。
有利的是,植物胶质和/或动物和/或植物明胶选自下述组,所述组包括木立芦荟、明胶鞣酸盐/酯和塔拉胶,或者由其组成。
在一个实施方式中,对明胶鞣酸盐/酯(明胶与鞣酸的复合物)进行了使用,其通过机械手段起到保护发炎肠粘膜的作用。明胶鞣酸盐/酯形成蛋白来源的粘膜粘附保护膜,其保护肠粘膜。但是,从其摄入时间至其到达其肠中目的地的时间,植物胶质和/或动物或植物明胶在其由胃送至肠的同时进行了缓慢但不可避免的降解。胶质降解并失去其恢复肠壁生理功能的功效。
该降解是多种因素造成的,例如pH、酶、内源性菌群的攻击、胃十二指肠屏障的作用和稀释作用。实际上来说,存在随着明胶鞣酸盐/酯通过胃肠道而渐进地发生的功效损失,这也是酸、胆汁盐、胰液和酶攻击的结果。当明胶鞣酸盐/酯到达结肠时,其部分降解,由此保护肠壁免受能够借助其鞭毛透过肠壁的致病性细菌的作用较低。
本申请人已经发现,一方面由本发明的菌株(选自下述组,所述组包括属于嗜热链球菌、植物乳杆菌或鼠李糖乳杆菌物种的益生菌菌株,或者由其组成)原位产生的细菌来源的胶质,和另一方面的植物胶质和/或动物和/或植物明胶,各自具有其所拥有的作用并且它们彼此互补。
第一作用是植物胶质和/或动物和/或植物明胶所起的胶凝作用,其在胃中最大(最大保护)并在结肠中达到最小,原因在于降解和随之而来的保护发炎肠粘膜的作用的损失。
第二作用是细菌来源的胶质特别是由本发明的菌株原位产生的胞外多糖(EPS)所起的保护作用,所述菌株选自下述组,所述组包括属于嗜热链球菌、植物乳杆菌或鼠李糖乳杆菌物种的益生菌菌株,或者由其组成。该第二作用在胃中最小并在结肠中最大,其中活着并有活力并以高浓度到达的本发明的细菌原位产生EPS。
加在一起,这两种互补作用确保了对于胃(由于植物胶和/或动物和/或植物明胶)和胃肠道(由于细菌来源的胶质)中细菌感染的完全覆盖。
本发明的主题涉及一种组合物或医疗装置(医疗装置用组合物),其用作用于预防和治疗与由粘液产生低导致的胃肠区屏障作用缺陷相关的所有病变的药物。
本发明的组合物能够恢复由于胃肠道中粘膜保护不充分而丧失的的屏障作用。
本发明的组合物能够预防和治疗胃肠道感染、发炎和紊乱、致病性细菌、念珠菌病和肠通透性。
本发明的组合物能够形成特定的粘膜粘附胶凝复合物,所述复合物由细菌来源的EPS(胞外多糖)(由以下指定的选定菌株产生,具体属于嗜热链球菌物种,例如嗜热链球菌ST10-DSM 25246、嗜热链球菌(YO4)DSM 16592,或其重量比为1:2~2:1、优选1:1的混合物)和塔拉胶(一种植物来源的多糖)构成。所述胶凝复合物能够确立遍布整个胃肠道的机械式屏障作用。
由于胶凝剂塔拉胶的存在,本发明的组合物能够凭借其触变特性在摄入后数分钟内形成水凝胶,并且能够由此在胃肠道的第一部分中形成抵抗致病性细菌及具有促炎作用的代谢产物的机械式屏障作用。该屏障作用因胞外多糖(EPS)的存在而实现并遍布整个长度的胃肠道,所述胞外多糖由属于以下所指定的嗜热链球菌物种的益生菌菌株原位产生,所述嗜热链球菌物种例如为嗜热链球菌ST10、嗜热链球菌YO04或其混合物,其起到通过独有的机械的自我调整机制提高周围环境粘性的作用。上述细菌的摄入向人体肠道传送了具有胶凝活性的分子源,因而起到与塔拉胶完全互补的作用。上述粘膜粘附胶凝复合物具有需要考虑的革新的性质:在其肠道转运过程中,塔拉胶(如植物来源的所有胶质)由常驻微生物群逐渐降解,使得其机械地抵抗胶凝的能力被渐进地减小。植物胶质作用的逐渐降低被例如由菌株ST10和/或YO04产生的胞外多糖(EPS)在肠腔中释放的逐渐增加而有效补偿,这体现了其首要的在回肠中和在结肠中的特定特性。结果,塔拉胶与胞外多糖(EPS)的协同组合确保了胶凝分子存在于胃肠道的整个长度中,由此最大化并优化了产物的机械屏障作用。亲水性凝胶在器官内腔中的存在、产生和停留可以因此而首次被认为真正实现,具有其中植物胶质的作用最大化的第一区和其中胞外多糖(EPS)的作用最大化的第二区。
在一个实施方式中,细菌菌株选自包含下述菌株或者由其组成的组:
-嗜热链球菌DSM 16590(YO2),2004年7月20日由德国保藏机构DSMZ保藏,
-嗜热链球菌DSM 16592(YO4),2004年7月20日由德国保藏机构DSMZ保藏,
-嗜热链球菌DSM 17843(YO8),2005年12月21日由德国保藏机构DSMZ保藏,
-嗜热链球菌DSM 25246(ST10),2011年9月19日由德国保藏机构DSMZ保藏,
-嗜热链球菌DSM 25247(ST11),2011年9月19日由德国保藏机构DSMZ保藏,
-嗜热链球菌DSM 25282(ST12),2011年9月19日由德国保藏机构DSMZ保藏。
这些菌株按照布达佩斯条约保藏,并向公众开放。
在一个实施方式中,本发明的组合物包含与植物胶质和/或动物和/或植物明胶联合的选自下述组的至少一种细菌菌株或者由其构成,所述组包含下述菌株或者由其组成:嗜热链球菌DSM 16590(YO2)、嗜热链球菌DSM 16592(YO4)、嗜热链球菌DSM17843(YO8)和嗜热链球菌DSM 25246(ST10),所述植物胶质和/或动物和/或植物明胶选自包括木立芦荟、明胶鞣酸盐/酯和塔拉胶或者由其组成的组。
在另一实施方式中,本发明的组合物包含下述组分或由其构成:与植物胶质和/或动物和/或植物明胶联合的嗜热链球菌DSM 25246(ST10),所述植物胶质和/或动物和/或植物明胶选自包括木立芦荟、明胶鞣酸盐/酯和塔拉胶或者由其组成的组;有利的是塔拉胶。
在另一实施方式中,本发明的组合物包含下述组分或由其构成:与植物胶质和/或动物和/或植物明胶联合的嗜热链球菌25246(ST10)和选自嗜热链球菌DSM 16590(YO2)、嗜热链球菌DSM 16592(YO4)和嗜热链球菌DSM 17843(YO8)中的至少一种菌株,所述植物胶质和/或动物和/或植物明胶选自包括木立芦荟、明胶鞣酸盐/酯和塔拉胶或者由其组成的组;有利的是塔拉胶。
在另一实施方式中,本发明的组合物包含下述组分或由其构成:与植物胶质和/或动物和/或植物明胶联合的嗜热链球菌DSM 25246(ST10)和嗜热链球菌DSM 16592(YO4),所述植物胶质和/或动物和/或植物明胶选自包括木立芦荟、明胶鞣酸盐/酯和塔拉胶或者由其组成的组;有利的是塔拉胶。
在益生菌属于嗜热链球菌物种的情形中,所述细菌处于受保护的形式(经包被的细菌)。该细菌可以包被有动物或植物来源的一个脂质涂层(单包被)或两个脂质涂层(双包被)(微胶囊化形式)。脂质涂层具有35℃~85℃、优选45℃~75℃、进而更优选55℃~65℃的熔点。
作为另外一种选择,细菌可以被插入胶囊中,所述胶囊优选由软或硬明胶制成。该胶囊可以涂布有能够越过胃屏障的胃保护膜。
上述菌株以下述量存在于本发明的组合物中,所述量相对于组合物或补充物总重为0.1重量%~50重量%,优选0.5重量%~15重量%,进而更优选1重量%~10重量%。但是,所述百分比取决于其所期望生产的药物剂型。例如,在胶囊的情形中,所述细菌的量大于30%,例如大约35%。在一个实施方式中,该组合物包含浓度为1x106CFU/g~1x1011CFU/g、优选1x108CFU/g~1x1010CFU/g的单独细菌菌株或细菌菌株的混合物。
在一个实施方式中,组合物包含浓度为1x106CFU/剂~1x1011CFU/剂、优选1x108CFU/剂~1x1010CFU/剂的菌株。剂量可以为0.2g~10g,例如可以为0.25g、1g、3g、5g或7g。细菌菌株可以以固体形式,例如粉末、脱水粉末或冻干粉末的形式存在于组合物中。
实验部分
1.评价用益生菌菌株发酵的血清样品的粘度,所述益生菌菌株属于产生胞外多糖(EPS)的嗜热链球菌种。粘度可以通过粘度计测量,所述粘度计测量适当尺寸的圆盘在所测样品中的旋转:圆盘受到的摩擦越大,则其旋转越慢,设定的转速是相等的。结果以与百分比SP相关的厘泊(CPs)表达,其是数据优度的表达(该方法要求其大于或等于15%)。培养基是在80℃巴氏消毒20分钟的10%的重组血清,向其中接种浓度为3%的以下指定的菌株:嗜热链球菌DSM 16590(YO2)、嗜热链球菌DSM 16592(YO4)、嗜热链球菌DSM 17843(YO8)、嗜热链球菌DSM 25246(ST10)、嗜热链球菌DSM 25247(ST11)和嗜热链球菌DSM 25282(ST12)。
2.以下显示的是关于片剂形式(片剂1~8)的最终产品所发现的分析数据,所述产品基于不同之处仅在于所使用的胶质的相同混合物。塔拉胶被用于片剂1、3、5和7,而瓜尔胶被用于片剂2、4、6和8,其他成分和浓度均相等。
使用相同的成分和以下指定的菌株,以相同的形式制备上述片剂。
片剂1:菌株ST10–DSM 25246、赋形剂和塔拉胶。
片剂2:菌株ST10–DSM 25246、赋形剂和瓜尔胶。
片剂3:菌株ST10–DSM 25246和菌株YO4–DSM 16592、赋形剂和塔拉胶。
片剂4:菌株ST10–DSM 25246和菌株YO4–DSM 16592、赋形剂和瓜尔胶。
片剂5:菌株ST10–DSM 25246和菌株YO2–DSM 16590、赋形剂和塔拉胶。
片剂6:菌株ST10–DSM 25246和菌株YO2–DSM 16590、赋形剂和瓜尔胶。
片剂7:菌株ST10–DSM 25246和菌株YO8–DSM 17843、赋形剂和塔拉胶。
片剂8:菌株ST10–DSM 25246和菌株YO8–DSM 17843、赋形剂和瓜尔胶。
对这些混合物进行挤压测试,之后确定细菌总数,以评价形成片剂时导致的应力(stress)和死亡率。
如可观察到的,在相同的22KN的挤压力下,使用塔拉胶比使用瓜尔胶获得更高的总数;甚至当施加于塔拉胶混合物的挤压力增加至26KN时,所获得的总数仍高于使用瓜尔胶的同一混合物所获得的总数。
Claims (15)
1.一种医疗装置用组合物,所述组合物包含特定的粘膜粘附胶凝复合物,所述复合物由与植物胶质和/或动物和/或植物明胶联合的细菌来源的胞外多糖EPS构成,所述细菌来源的胞外多糖由特别选定的细菌菌株在胃肠道中原位产生,所述组合物用作用于预防和治疗与由粘液产生低导致的胃肠区屏障作用缺陷相关的所有病变的药物。
2.如权利要求1所述的医疗装置用组合物,其中所述由粘液产生低导致的胃肠区屏障作用缺陷发生在肠通透性和细菌移位的情形下。
3.如权利要求1或2所述的医疗装置用组合物,其中产生胞外多糖的所述细菌菌株选自属于植物乳杆菌(Lactobacillus plantarum)物种的细菌的组,并能够在胃肠道中原位产生胞外多糖以保护肠粘膜免受致病性细菌的作用。
4.如权利要求1或2所述的医疗装置用组合物,其中产生胞外多糖的所述细菌菌株选自属于鼠李糖乳杆菌(Lactobacillus rhamnosus)物种的细菌的组,并能够在胃肠道中原位产生胞外多糖以保护肠粘膜免受致病性细菌的作用。
5.如权利要求1或2所述的医疗装置用组合物,其中产生胞外多糖的所述细菌菌株选自属于嗜热链球菌(Streptococcus thermophilus)物种的细菌的组,并能够在胃肠道中原位产生胞外多糖以保护肠粘膜免受致病性细菌的作用。
6.如权利要求5所述的医疗装置用组合物,其中属于嗜热链球菌物种的所述细菌菌株选自包含下述菌株或者由下述菌株组成的组:
-嗜热链球菌DSM 16590(YO2),2004年7月20日由德国保藏机构DSMZ保藏,
-嗜热链球菌DSM 16592(YO4),2004年7月20日由德国保藏机构DSMZ保藏,
-嗜热链球菌DSM 17843(YO8),2005年12月21日由德国保藏机构DSMZ保藏,
-嗜热链球菌DSM 25246(ST10),2011年9月19日由德国保藏机构DSMZ保藏,
-嗜热链球菌DSM 25247(ST11),2011年9月19日由德国保藏机构DSMZ保藏,
-嗜热链球菌DSM 25282(ST12),2011年9月19日由德国保藏机构DSMZ保藏。
7.如权利要求1~6中任一项所述的医疗装置用组合物,其中产生胞外多糖的所述细菌菌株是选自属于植物乳杆菌和/或鼠李糖乳杆菌和/或嗜热链球菌物种的细菌的组的细菌的混合物,并能够在胃肠道中原位产生胞外多糖以保护肠粘膜免受致病性细菌的作用。
8.如权利要求1~7中任一项所述的医疗装置用组合物,其中所述植物胶质和/或植物明胶为鞣酸盐/酯或明胶鞣酸盐/酯。
9.如权利要求1~7中任一项所述的医疗装置用组合物,其中所述植物胶质和/或植物明胶为芦荟(Aloe)、库拉索芦荟(Aloe vera)或木立芦荟(Aloe arborescens)。
10.如权利要求1~7中任一项所述的医疗装置用组合物,其中所述植物胶质和/或植物明胶为藻酸盐/酯或塔拉胶。
11.如权利要求1~7中任一项所述的医疗装置用组合物,其中所述植物胶质和/或植物明胶为木葡聚糖或木糖凝胶。
12.如前述权利要求1~11中任一项所述的医疗装置用组合物,其中所述组合物包含与植物胶质和/或动物和/或植物明胶联合的至少一种细菌菌株或者由其构成,所述细菌菌株选自包含下述菌株或者由下述菌株组成的组:嗜热链球菌DSM 16590(YO2)、嗜热链球菌DSM 16592(YO4)、嗜热链球菌DSM 17843(YO8)和嗜热链球菌DSM 25246(ST10),所述植物胶质和/或动物和/或植物明胶选自包括以下物质或由以下物质组成的组:木立芦荟、明胶鞣酸盐/酯和塔拉胶。
13.如权利要求12所述的医疗装置用组合物,其中所述组合物包含与植物胶质和/或动物和/或植物明胶联合的嗜热链球菌DSM 25246(ST10)或者由其构成,所述植物胶质和/或动物和/或植物明胶选自包括以下物质或由以下物质组成的组:木立芦荟、明胶鞣酸盐/酯和塔拉胶;优选的是塔拉胶。
14.如权利要求12所述的医疗装置用组合物,其中所述组合物包含下述组分或者由下述组分构成:与植物胶质和/或动物和/或植物明胶联合的嗜热链球菌25246(ST10)和选自嗜热链球菌DSM 16590(YO2)、嗜热链球菌DSM 16592(YO4)和嗜热链球菌DSM 17843(YO8)中的至少一种菌株;所述植物胶质和/或动物和/或植物明胶选自包括以下物质或由以下物质组成的组:木立芦荟、明胶鞣酸盐/酯和塔拉胶;优选的是塔拉胶。
15.如权利要求12所述的医疗装置用组合物,其中所述组合物包含与植物胶质和/或动物和/或植物明胶联合的嗜热链球菌DSM 25246(ST10)和嗜热链球菌DSM16592(YO4)或者由其构成,所述植物胶质和/或动物和/或植物明胶选自包括以下物质或由以下物质组成的组:木立芦荟、明胶鞣酸盐/酯和塔拉胶;优选的是塔拉胶。
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