CN107970236A - 抗过敏性炎症滴剂 - Google Patents
抗过敏性炎症滴剂 Download PDFInfo
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- CN107970236A CN107970236A CN201711311178.8A CN201711311178A CN107970236A CN 107970236 A CN107970236 A CN 107970236A CN 201711311178 A CN201711311178 A CN 201711311178A CN 107970236 A CN107970236 A CN 107970236A
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Abstract
一种抗过敏性炎症滴剂,包括色甘酸钠、双氯芬酸钠、盐酸消旋山莨菪碱、***、曲安奈德、甘草酸苷、B族维生素,是多种药物组合发挥协同作用,多环节发挥治疗作用,药效显著,控制疾病迅速有效;内集多种药物不同功效于一体,使单个药量减少,整体药效提高,副作用明显降低,达到事半功倍的效果,疗效十分满意;本方案整体是为过敏性疾病量身打造,具备综合治理、标本兼治、质量求胜、精准定位之特征,是一种对疾病理论全新认识基础上的创新疗法。
Description
技术领域
本发明涉及医药卫生领域,尤其涉及一种抗过敏性炎症滴剂。
背景技术
目前的治疗抗过敏性炎症的药物,多是从病理机理的某一个环节考虑治疗问题,针对过敏反应的某个主要环节用药,单一用药物,这样的弊端一是不足以完全有效的控制疾病。二是使用不方便,大多数情况下,需要同时两种以上抗过敏制剂联合使用,才能见效,但是这种配伍不论是使用还是携带都不是很方便。三是毒副作用大,单一药物通常使用时间长,药效降低,副作用明显,即便是联合用药,时间久了增加了感染的机会,易患细菌性结膜炎。四是治疗效果不稳定因人而异,还受到各种因素干扰,易出现复发和反弹。
发明内容
针对现有技术的不足,本发明提供一种抗过敏性炎症滴剂,由多种有效成分组合而成,针对过敏性病理反应的全过程,着眼关键点和病理变化的不同阶段,发挥不同药物的协同作用,从而达到快速、高效、稳定的治疗效果。
本发明解决其技术问题所采用的技术方案是:
一种抗过敏性炎症滴剂,包括色甘酸钠、双氯芬酸钠、盐酸消旋山莨菪碱、***、曲安奈德、甘草酸苷、B族维生素。
最优的,包括60~80质量份的色甘酸钠、25质量份的双氯芬酸钠、5质量份的盐酸消旋山莨菪碱、1质量份的***、10质量份的曲安奈德、1~2质量份的甘草酸苷、40质量份的B族维生素。
最优的,所述色甘酸钠为色甘酸钠滴眼液,所述双氯芬酸钠为复方双氯芬酸钠注射液,所述盐酸消旋山莨菪碱为盐酸山莨菪碱注射液,所述***为***磷酸钠注射液,所述曲安奈德为曲安奈德注射液,所述甘草酸苷为复方甘草酸苷注射液,所述B族维生素包括维生素B1注射液、维生素B2注射液、维生素B6注射液。
最优的,包括3.0~4.0体积份的色甘酸钠滴眼液、1.0体积份的复方双氯芬酸钠注射液、0.5体积份的盐酸山莨菪碱注射液、0.2体积份的***磷酸钠注射液、1.0体积份的曲安奈德注射液、0.5~1.0体积份的复方甘草酸苷注射液、0.5体积份的维生素B1注射液、0.5体积份的维生素B2注射液、0.5体积份的维生素B6注射液。
最优的,所述色甘酸钠滴眼液中色甘酸钠浓度为20mg/ml,复方双氯芬酸钠注射液中双氯芬酸钠浓度为25mg/ml,盐酸山莨菪碱注射液中盐酸山莨菪碱浓度为10mg/ml,***磷酸钠注射液中***磷酸钠浓度为5mg/ml,曲安奈德注射液中曲安奈德浓度为10mg/ml,复方甘草酸苷注射液中含有2.0415mg/ml 的甘草酸单铵盐、1mg/ml的盐酸半胱氨酸、20mg/ml的甘氨酸,维生素B1注射液中维生素B1浓度为25mg/ml,维生素B2注射液中维生素B2浓度为5mg/ml,维生素B6注射液中维生素B6浓度为50mg/ml。
最优的,pH为6.4~7.7。
最优的,应用于由IgE介导的I型***反应所引起的免疫反应,包括速发型或迟发型过敏性结膜炎、过敏性鼻炎、过敏性耳道炎、过敏性咽炎、过敏性哮喘。
一种抗过敏性炎症滴剂制备方法,包括以下步骤:
首先将色甘酸钠、双氯芬酸钠、盐酸消旋山莨菪碱、***、曲安奈德、甘草酸苷、B族维生素,按照药典分别配置成对应的色甘酸钠滴眼液,复方双氯芬酸钠注射液,盐酸山莨菪碱注射液,***磷酸钠注射液,曲安奈德注射液,复方甘草酸苷注射液,维生素B1注射液、维生素B2注射液、维生素B6注射液;
接着分别取3.0~4.0体积份的色甘酸钠滴眼液,1.0体积份的复方双氯芬酸钠注射液,0.5体积份的盐酸山莨菪碱注射液,0.2体积份的***磷酸钠注射液,1.0体积份的曲安奈德注射液,0.5~1.0体积份的复方甘草酸苷注射液,0.5体积份的维生素B1注射液,0.5体积份的维生素B2注射液,0.5体积份的维生素B6注射液,混合均匀,得到混合液;
调节混合液的pH至6.4~7.7,得到抗过敏性炎症滴剂。
最优的,所述色甘酸钠滴眼液中色甘酸钠浓度为20mg/ml,复方双氯芬酸钠注射液中双氯芬酸钠浓度为25mg/ml,盐酸山莨菪碱注射液中盐酸山莨菪碱浓度为10mg/ml,***磷酸钠注射液中***磷酸钠浓度为5mg/ml,曲安奈德注射液中曲安奈德浓度为10mg/ml,复方甘草酸苷注射液中含有2.0415mg/ml 的甘草酸单铵盐、1mg/ml的盐酸半胱氨酸、20mg/ml的甘氨酸,维生素B1注射液中维生素B1浓度为25mg/ml,维生素B2注射液中维生素B2浓度为5mg/ml,维生素B6注射液中维生素B6浓度为50mg/ml。
最优的,将得到抗过敏性炎症滴剂分装后遮光密封保存。
由上述技术方案可知,本发明提供的抗过敏性炎症滴剂,是多种药物组合发挥协同作用,多环节发挥治疗作用,多点位发力药效显著,控制疾病迅速有效;内集多种药物不同功效于一体,使单个药量减少,整体药效提高,副作用明显降低,达到事半功倍的效果,疗效十分满意;本方案整体是为过敏性疾病量身打造,具备综合治理、标本兼治、质量求胜、精准定位之特征,是一种在对疾病理论全新认识基础上的创新疗法。
具体实施方式
对发明实施例的技术方案做进一步的详细阐述。
实施例1:
抗过敏性炎症滴剂,包括60~80质量份的色甘酸钠、25质量份的双氯芬酸钠、5质量份的盐酸消旋山莨菪碱、1质量份的***、10质量份的曲安奈德、 1~2质量份的甘草酸苷、40质量份的B族维生素,pH为6.4~7.7。
实施例2:
抗过敏性炎症滴剂,包括60mg的色甘酸钠、25mg的双氯芬酸钠、5mg的盐酸消旋山莨菪碱、1mg的***、10mg的曲安奈德、2mg的甘草酸苷、40mg 的B族维生素,pH为6.4~7.7。
实施例3:
抗过敏性炎症滴剂,包括80mg的色甘酸钠、25mg的双氯芬酸钠、5mg的盐酸消旋山莨菪碱、1mg的***、10mg的曲安奈德、1mg的甘草酸苷、40mg 的B族维生素,pH为6.4~7.7。
实施例4:
抗过敏性炎症滴剂,包括3.0~4.0体积份的色甘酸钠滴眼液、1.0体积份的复方双氯芬酸钠注射液、0.5体积份的盐酸山莨菪碱注射液、0.2体积份的***磷酸钠注射液、1.0体积份的曲安奈德注射液、0.5~1.0体积份的复方甘草酸苷注射液、0.5体积份的维生素B1注射液、0.5体积份的维生素B2注射液、0.5体积份的维生素B6注射液,pH为6.4~7.7。
色甘酸钠滴眼液中色甘酸钠浓度为20mg/ml,复方双氯芬酸钠注射液中双氯芬酸钠浓度为25mg/ml,盐酸山莨菪碱注射液中盐酸山莨菪碱浓度为10mg/ml,***磷酸钠注射液中***磷酸钠浓度为5mg/ml,曲安奈德注射液中曲安奈德浓度为10mg/ml,复方甘草酸苷注射液中含有2.0415mg/ml的甘草酸单铵盐、1mg/ml的盐酸半胱氨酸、20mg/ml的甘氨酸,维生素B1注射液中维生素 B1浓度为25mg/ml,维生素B2注射液中维生素B2浓度为5mg/ml,维生素B6 注射液中维生素B6浓度为50mg/ml。
实施例5:
抗过敏性炎症滴剂,包括3.0ml的色甘酸钠滴眼液、1.0ml的复方双氯芬酸钠注射液、0.5ml的盐酸山莨菪碱注射液、0.2ml的***磷酸钠注射液、1.0ml 的曲安奈德注射液、1.0ml的复方甘草酸苷注射液、0.5ml的维生素B1注射液、 0.5ml的维生素B2注射液、0.5ml的维生素B6注射液,pH为6.4~7.7。
色甘酸钠滴眼液中色甘酸钠浓度为20mg/ml,复方双氯芬酸钠注射液中双氯芬酸钠浓度为25mg/ml,盐酸山莨菪碱注射液中盐酸山莨菪碱浓度为10mg/ml,***磷酸钠注射液中***磷酸钠浓度为5mg/ml,曲安奈德注射液中曲安奈德浓度为10mg/ml,复方甘草酸苷注射液中含有2.0415mg/ml的甘草酸单铵盐、1mg/ml的盐酸半胱氨酸、20mg/ml的甘氨酸,维生素B1注射液中维生素 B1浓度为25mg/ml,维生素B2注射液中维生素B2浓度为5mg/ml,维生素B6 注射液中维生素B6浓度为50mg/ml。
实施例6:
抗过敏性炎症滴剂,包括4.0ml的色甘酸钠滴眼液、1.0ml的复方双氯芬酸钠注射液、0.5ml的盐酸山莨菪碱注射液、0.2ml的***磷酸钠注射液、1.0ml 的曲安奈德注射液、0.5ml的复方甘草酸苷注射液、0.5ml的维生素B1注射液、 0.5ml的维生素B2注射液、0.5ml的维生素B6注射液,pH为6.4~7.7。
色甘酸钠滴眼液中色甘酸钠浓度为20mg/ml,复方双氯芬酸钠注射液中双氯芬酸钠浓度为25mg/ml,盐酸山莨菪碱注射液中盐酸山莨菪碱浓度为10mg/ml,***磷酸钠注射液中***磷酸钠浓度为5mg/ml,曲安奈德注射液中曲安奈德浓度为10mg/ml,复方甘草酸苷注射液中含有2.0415mg/ml的甘草酸单铵盐、1mg/ml的盐酸半胱氨酸、20mg/ml的甘氨酸,维生素B1注射液中维生素 B1浓度为25mg/ml,维生素B2注射液中维生素B2浓度为5mg/ml,维生素B6 注射液中维生素B6浓度为50mg/ml。
主要应用于由IgE介导的I型***反应所引起的免疫反应,包括速发型或迟发型过敏性结膜炎、过敏性鼻炎、过敏性耳道炎、过敏性咽炎、过敏性哮喘。
实施例7:
本发明方案还包括一种抗过敏性炎症滴剂制备方法,包括以下步骤:
首先将色甘酸钠、双氯芬酸钠、盐酸消旋山莨菪碱、***、曲安奈德、甘草酸苷、B族维生素,按照药典分别配置成对应的色甘酸钠滴眼液,复方双氯芬酸钠注射液,盐酸山莨菪碱注射液,***磷酸钠注射液,曲安奈德注射液,复方甘草酸苷注射液,维生素B1注射液、维生素B2注射液、维生素B6 注射液。
接着分别取3.0~4.0体积份的色甘酸钠滴眼液,1.0体积份的复方双氯芬酸钠注射液,0.5体积份的盐酸山莨菪碱注射液,0.2体积份的***磷酸钠注射液,1.0体积份的曲安奈德注射液,0.5~1.0体积份的复方甘草酸苷注射液, 0.5体积份的维生素B1注射液,0.5体积份的维生素B2注射液,0.5体积份的维生素B6注射液,混合均匀,得到混合液。
调节混合液的pH至6.4~7.7,得到抗过敏性炎症滴剂,将得到抗过敏性炎症滴剂分装后遮光密封保存。
其中色甘酸钠滴眼液中色甘酸钠浓度为20mg/ml,复方双氯芬酸钠注射液中双氯芬酸钠浓度为25mg/ml,盐酸山莨菪碱注射液中盐酸山莨菪碱浓度为10mg/ml,***磷酸钠注射液中***磷酸钠浓度为5mg/ml,曲安奈德注射液中曲安奈德浓度为10mg/ml,复方甘草酸苷注射液中含有2.0415mg/ml的甘草酸单铵盐、1mg/ml的盐酸半胱氨酸、20mg/ml的甘氨酸,维生素B1注射液中维生素B1浓度为25mg/ml,维生素B2注射液中维生素B2浓度为5mg/ml,维生素B6注射液中维生素B6浓度为50mg/ml。
实施例8:
本发明方案还包括一种抗过敏性炎症滴剂制备方法,包括以下步骤:
首先将色甘酸钠、双氯芬酸钠、盐酸消旋山莨菪碱、***、曲安奈德、甘草酸苷、B族维生素,按照药典分别配置成对应的色甘酸钠滴眼液,复方双氯芬酸钠注射液,盐酸山莨菪碱注射液,***磷酸钠注射液,曲安奈德注射液,复方甘草酸苷注射液,维生素B1注射液、维生素B2注射液、维生素B6 注射液。
接着分别取3.0ml的色甘酸钠滴眼液,1.0ml的复方双氯芬酸钠注射液,0.5ml 的盐酸山莨菪碱注射液,0.2ml的***磷酸钠注射液,1.0ml的曲安奈德注射液,1.0ml的复方甘草酸苷注射液,0.5ml的维生素B1注射液,0.5ml的维生素B2注射液,0.5ml的维生素B6注射液,混合均匀,得到混合液。
调节混合液的pH至6.4~7.7,得到抗过敏性炎症滴剂,将得到抗过敏性炎症滴剂遮光密封保存。
其中色甘酸钠滴眼液中色甘酸钠浓度为20mg/ml,复方双氯芬酸钠注射液中双氯芬酸钠浓度为25mg/ml,盐酸山莨菪碱注射液中盐酸山莨菪碱浓度为 10mg/ml,***磷酸钠注射液中***磷酸钠浓度为5mg/ml,曲安奈德注射液中曲安奈德浓度为10mg/ml,复方甘草酸苷注射液中含有2.0415mg/ml的甘草酸单铵盐、1mg/ml的盐酸半胱氨酸、20mg/ml的甘氨酸,维生素B1注射液中维生素B1浓度为25mg/ml,维生素B2注射液中维生素B2浓度为5mg/ml,维生素B6注射液中维生素B6浓度为50mg/ml。
实施例8:
本发明方案还包括一种抗过敏性炎症滴剂制备方法,包括以下步骤:
首先将色甘酸钠、双氯芬酸钠、盐酸消旋山莨菪碱、***、曲安奈德、甘草酸苷、B族维生素,按照药典分别配置成对应的色甘酸钠滴眼液,复方双氯芬酸钠注射液,盐酸山莨菪碱注射液,***磷酸钠注射液,曲安奈德注射液,复方甘草酸苷注射液,维生素B1注射液、维生素B2注射液、维生素B6 注射液。
接着分别取4.0ml的色甘酸钠滴眼液,1.0ml的复方双氯芬酸钠注射液,0.5ml 的盐酸山莨菪碱注射液,0.2ml的***磷酸钠注射液,1.0ml的曲安奈德注射液,0.5ml的复方甘草酸苷注射液,0.5ml的维生素B1注射液,0.5ml的维生素B2注射液,0.5ml的维生素B6注射液,混合均匀,得到混合液。
调节混合液的pH至6.4~7.7,得到抗过敏性炎症滴剂,将得到抗过敏性炎症滴剂遮光密封保存。
其中色甘酸钠滴眼液中色甘酸钠浓度为20mg/ml,复方双氯芬酸钠注射液中双氯芬酸钠浓度为25mg/ml,盐酸山莨菪碱注射液中盐酸山莨菪碱浓度为 10mg/ml,***磷酸钠注射液中***磷酸钠浓度为5mg/ml,曲安奈德注射液中曲安奈德浓度为10mg/ml,复方甘草酸苷注射液中含有2.0415mg/ml的甘草酸单铵盐、1mg/ml的盐酸半胱氨酸、20mg/ml的甘氨酸,维生素B1注射液中维生素B1浓度为25mg/ml,维生素B2注射液中维生素B2浓度为5mg/ml,维生素B6注射液中维生素B6浓度为50mg/ml。
本发明方案治疗原理如下所述。
根据医学界普遍认知的原理,即急则治其标、缓则治其本。本发明是基于过敏性疾病首先应当是一个急性发作的疾病。其急性特征集中反映在如下三个方面:一是速度快(当接触到过敏原后几分钟即可发病)!二是病像凶险(局部立即奇痒无比、严重鼻塞、咳嗽不止、无法控制的清鼻水溢流、伴随着球结膜高度水肿)!三是患者感觉非常痛苦(神经压迫症状)!这才是本病初发期的主要矛盾。但是,仅仅把治疗盯在此处是片面的,治疗的目的是为了使已经受到伤害的病损组织控制起来并尽快恢复正常,这就需要及时判断和顺势推动各阶段主要矛盾的及时转化。如果不及时将矛盾转化到病损组织的有效恢复阶段,切断“入侵者”来源,必然使疾病迁延不愈,且最初的治疗效果也消耗殆尽,病情处于“好坏交替”阶段而使疗效大打折扣。这也是本方案显著区别于临床常用的治疗方法。
正常过敏反应分四个阶段:
第一阶段:抗原侵入。外源物质进入体内,刺激正常组织,发生两个变化:一是刺激CD4T细胞增殖分化;二是产生抗体IgE。
药物拮抗:复方甘草酸苷、***、曲安奈德。其中***、曲安奈德是本方案中的“杀毒剂和消肿剂”,其特征:一是能够迅速控制各个环节的炎症反应程度,并大大减缓或消弱炎症反应的峰值。二是早期即开始促进炎症水肿吸收,控制炎症发生规模。***体现在快上,而曲安奈德则体现在持续全程发力,复方甘草酸苷体现在平和缓冲上。三是对本病的程度和时间有控制作用,属于治标。
第二阶段:细胞致敏。机体合成的IgE吸附在满布组织间的肥大细胞和嗜酸性粒细胞表面,使细胞处于致敏状态。
药物拮抗:色甘酸钠、复方甘草酸苷、***、曲安奈德。色甘酸钠的作用使致敏细胞脱敏,防止其再次与过敏原接触;复方甘草酸苷、***、曲安奈德的作用是对已经接触致敏的细胞采取包围态势,长短结合,中西结合,减低发作程度,控制病程和时间。相当于控制战争规模和程度的“司令部”。
第三阶段:释放介质。抗原再次进入机体,抗体迎击抗原,相互作用产生复合物,使致敏的肥大细胞和嗜酸性粒细胞释放炎性介质、脱颗粒和趋化因子,例如组胺、激肽、白三烯、***素、五羟色胺、嗜酸细胞趋化因子、血小板活化因子等。
药物拮抗:双氯芬酸钠、色甘酸钠、复方甘草酸苷、***、曲安奈德。其中色甘酸钠、双氯芬酸钠、复方甘草酸苷相当于解决本案问题的“特种部队”,针对的是过敏炎症反应的重要环节和过程,即通过稳定肥大细胞膜和干扰花生四烯酸的转化作用,从而影响了炎性介质、组胺等作用的发挥。除此以外,复方甘草酸苷还有加强激素的作用,增强局部病变的免疫平衡,属于治本。
第四阶段:组织损害。上述各种炎性物质作用于周围血管、微血管、腺体、平滑肌、末梢神经等,局部产生炎性渗出、小血管扩张、血管通透性增加、腺体大量分泌、支气管痉挛、组织水肿、微血管痉挛、微循环障碍等一系列病损现象。
药物拮抗:山莨菪碱、B组维生素、双氯芬酸钠、复方甘草酸苷、***、曲安奈德。其中山莨菪碱、B组维生素组合在一起,相当于“专业组”,专门针对病变局部区域的血管、神经异常发挥稳定或纠正其异常的作用。属于综合治理。
本发明方案的特点分析:
1、组合药液针对四个阶段的关键环节,使用的越早,医疗效果就越突出,病程越短,副作用就越小,从而机体的炎症反应也很轻微。
2、本病发展有一个特征,即呈“阶梯样扩散”的现象。治病的关键在于遏制第三环节,即稳住肥大细胞和嗜酸性粒细胞膜。从根本上堵住问题的总阀门。
3、过敏第四阶段是组织病损的重灾区,凡是在区域内的所有血管、神经、腺体、平滑肌都不同程度的受到炎症累及,使局部代谢紊乱、血运不畅、电解质和酸碱失平衡,组织缺氧,水肿。
4、过敏四个阶段相互联系,而又各有特点。有些药全程参与控制疾病发生发展的全过程,有些药是在不同阶段的关键环节发挥独特作用。
5、药物的组合突出了重点环节的针对性,同时兼顾了病变的发生发展,各阶段既相互协调,又相互加强,且主打的药物主题明确,你中有我,我中有你,使得整个病变过程在治疗期间平稳、高效、彻底和不留死角。
本发明使用了七种药物配伍,不同药物的协同作用,从而达到快速控制病情,高效、稳定的治疗疾病。每一种药物的药效如下:
(1)色甘酸钠(cromolynsodium):属于肥大细胞稳定剂。结膜组织中有丰富的肥大细胞,约5000个/mm2,活化肥大细胞脱颗粒后释放大量组胺和炎性介质,引起一系列过敏的症状与体征。肥大细胞膜稳定剂通过抑制钙离子内流稳定肥大细胞,阻止组胺和其他介质的释放而发挥作用。但是,肥大细胞稳定剂只能阻止肥大细胞释放炎性介质,但对已释放的炎性介质无作用,临床起效比较慢。有预防和维持治疗的作用,较安全,2-4岁患儿可应用。
使用色甘酸钠的主要目的:一是在疾病治疗早期和病损及连接毗邻区,划定一个治疗隔离区,用于稳定肥大细胞,使其在治疗的早期发挥隔离作用。二是在隔离区阻止组胺和其他介质的释放从而有效的减轻炎症反应过程,并使疾病的病程有了明显的时间限定。三是病损区肥大细胞不在释放炎性介质,炎症呈现出逐步衰减的趋势,具有快速结束炎症反应的效果。
(2)***(DEXAMETHASONEACETATEINJECTION)又名氟美松,是糖皮质类激素。其药理作用主要是抗炎、抗毒、抗过敏、抗风湿,临床使用较广泛。抗炎、抗过敏和抗毒作用较***更强,水钠潴留和促进排钾作用很轻。在眼部的常见不良反应有长期使用可引起医源性青光眼、白内障。
使用***的主要目的:一是抗炎作用,可减轻和防止组织对炎症的反应,从而减轻炎症的表现。激素抑制炎症细胞,包括巨噬细胞和白细胞在炎症部位的集聚,并抑制吞噬作用、溶酶体酶的释放以及炎症化学中介物的合成和释放。二是免疫抑制作用,包括防止或抑制细胞介导的免疫反应,延迟性的过敏反应,减少T淋巴细胞、单核细胞、嗜酸性细胞的数目,降低免疫球蛋白与细胞表面受体的结合能力,并抑制白介素的合成与释放,从而降低T淋巴细胞向淋巴母细胞转化,并减轻原发免疫反应的扩展。可降低免疫复合物通过基底膜,并能减少补体成份及免疫球蛋白的浓度。
(3)盐酸消旋山莨菪碱(Anisodamine)具有外周抗M胆碱受体作用,能解除乙酰胆碱所致平滑肌痉挛,也能解除微血管痉挛,改善微循环。其抑制消化道腺体分泌作用为阿托品1/10。抑制唾液腺分泌及扩瞳作用较弱,为阿托品的 1/20~1/10。青光眼者慎用。
使用盐酸消旋山莨菪碱的主要目的:一是抗M胆碱药,主要用于解除病损区的微血管平滑肌痉挛,改善微循环,促进局部区域组织代谢环境的改变,从而有利于病变区组织功能的恢复等。二是由于鼻腔各处均由呼吸区粘膜覆盖,该区粘膜属复层或假复层柱状纤毛上皮,其纤毛的运动主要由前向后朝鼻咽部。粘膜内含有丰富的浆液腺、粘液腺和杯状细胞,能产生大量分泌物,使粘膜表面复有一层随纤毛运动不断向后移动的粘液毯(mucousblanket)。病灶区使用山莨菪碱具有明显的抑制腺体分泌作用,故可以快速抑制过敏性鼻炎鼻腔中的腺体分泌。三是又由于鼻腔粘膜内有丰富的静脉丛,构成海绵状组织,具有灵活的舒缩性,能迅速改变其充血状态,为调节空气温度与湿度的主要部分。山莨菪碱具有迅速收缩小血管的作用,故而使鼻粘膜水肿减轻和血管丛收缩,有利于鼻腔通气功能的迅速改善。
(4)曲安奈德注射液为灭菌混悬液。本品为微细颗粒的混悬液,静置后微细颗粒下沉,振摇后成均匀的乳白色混悬液。作用与去炎松相似,其抗炎和抗过敏作用较强且远较持久。
使用曲安奈德的主要目的:一是针对支气管哮喘、过敏性鼻炎和荨麻疹疗效明显。二是本品属于肾上腺皮质激素类药物,为合成的皮质类固醇,具有强力抗炎作用。三是其分子量较大,化学性能稳定,成颗粒状态存在,散布在隔离区具有持续发挥疗效的作用,并可维持数周,有利于疾病后期的恢复和停药以后的疗效平稳。
(5)双氯芬酸钠(DiclofenacSodium)是一种衍生于苯乙酸类的非甾体消炎镇痛药,其作用机理为抑制环氧化酶活性,从而阻断花生四烯酸向***素的转化。同时,它也能促进花生四烯酸与甘油三脂结合,降低细胞内游离的花生四烯酸浓度,而间接抑制白三烯的合成。双氯芬酸钠是非甾体消炎药中作用较强的一种,它对***素合成的抑制作用强于阿司匹林和消炎痛等。
使用双氯芬酸钠的主要目的:***素是引起粘膜过敏性炎症的介质之一,能导致血管扩张、血管通透性增加、白细胞趋化、病变区组织水肿显著,而双氯芬酸钠在整个病变区组织修复过程发挥着堵漏、清淤和改善环境的作用。对因季节花粉等引起的过敏性疾病等,疗效更加显著。
(6)复方甘草酸苷注射液(CompoundGlycyrrhizinInjection)为复方制剂,其组分为:甘草酸苷、盐酸半胱氨酸、甘氨酸。本品为无色澄明液体。主治功效为解毒药,有抗炎、抗过敏作用。
使用复方甘草酸苷注射液的主要目:一是抗过敏作用,甘草酸苷具有抑制兔的局部过敏坏死反应(ArthusPhenomenon)及抑制施瓦茨曼现象(Shwartzman Phenomenon)等抗过敏作用。对皮质激素,有增强激素的抑制应激反应作用,拮抗激素的抗肉芽形成和胸腺萎缩作用。对激素的渗出作用无影响。二是对花生四烯酸代谢酶的阻碍作用,甘草酸苷可以直接与花生四烯酸代谢途径的启动酶--磷脂酶A2(phospholipaseA2)结合以及与作用于花生四烯酸使其产生炎性介质的脂氧合酶(lipoxygenase)结合,选择性地阻碍这些酶的磷酸化而抑制其活化。三是免疫调节作用,甘草酸苷在体外试验具有以下免疫调节作用:对T 细胞活化的调节作用;对γ干扰素的诱导作用;活化NK细胞作用;促进胸腺外 T淋巴细胞分化作用。
(7)维生素B类。维生素B都是水溶性维生素,它们协同作用,调节新陈代谢,维持皮肤和粘膜的健康,增进免疫***和神经***的功能,促进细胞生长和***。
选取的维生素B有3种,它们是维生素B1(硫胺素)、维生素B2(核黄素)、维生素B6(吡哆素)。
使用B类维生素的主要作用:维持神经肌节头兴奋性,促进细胞代谢,参与重要酶的激活与转化,维持皮肤粘膜正常功能,减轻皮肤粘膜发炎症状。
本方案应用效果很显著,以下是部分案例。
患者1,男性,21岁,宁夏吴忠利通区人,主因季节性双眼异痒,伴鼻塞流涕打喷嚏10余天就诊。病史2年,与去年发病在同一季节(7-8月),症状体征一致。局部检查:眼结膜充血,结膜囊轻度水肿,鼻腔淡白色水肿。诊断为过敏性结膜炎和过敏性鼻炎。治疗:李氏速停1支,第一天使用2次(下午3 点、晚上10点),一次1滴;第二天使用一次,一次1滴;第三天使用一次,一次1滴,完全治愈。效果:第一次用药5分钟后开始发挥药效,20分钟时,全部症状消失,98%的体征消失。以后的治疗时间里,症状体征未再出现,一直到治疗结束。
患者2,男性,51岁,宁夏银川市金凤区人,主因双鼻一年四季遇冷风(空调)、洗澡生水刺鼻、到牛场呼入牛粪便气味等因素,即刻出现眼异痒、鼻塞、打喷嚏、大量流鼻涕等,时间近7年以上。病史:反反复复发作,多种药物,多家治疗单位均诊断为过敏性鼻炎,治疗的效果不尽人意,从国内各种化学制剂,到国外进口的各种专用鼻腔喷剂;从中医中药针灸,到一些“土”办法治疗,均没有得到很好的控制,更谈不上治愈。近期主要使用国外进口喷雾制剂,病情复发后,喷剂起先还能管5小时以上,再反复使用,现在只管1个小时左右,甚至是十几分钟。治疗:李氏速停1支,第一天使用一次(下午5点),一次1滴,第二天两次,一次1滴,第三天使用一次,一次1滴,完全治愈。效果:眼鼻同时用药,5分钟起效,20分钟时,所有的鼻塞、流涕和打喷嚏全部消失,患者立刻感到轻松正常,疾病消失了。第二,使用两次李氏速停,病情无复发,第三天使用一次,无复发,治愈。之后曾到牧场培训讲学,症状出现反复,但程度轻,能够忍受,使用一次李氏速停,立即见效,以后每到牧场之前,提前使用一次,则效果更好,无复发。
患者3,女性,5岁,宁夏吴忠利通区人,主因双眼异痒伴球结膜水肿突出不能闭眼半小时就诊。病史:今年第一次发作,发病月份为7月,以往无过敏史。诊断:过敏性结膜炎伴球结膜高度水肿。治疗:李氏速停1支,第一天用药两次,即上午11时用药,一次1滴。下午5时用药一次,眼部症状全部消失,基本恢复正常。第二天用药1次,第三天用药1次,痊愈。效果:滴用李氏速停后,患者不再有揉眼现象,闭眼10分钟后眼部水肿吸收缩小到来时的1/2大小,20分钟后缩回到眼眶内,伴随着的鼻塞、流涕症状也尽消失,3天后无复发。
本发明提供的抗过敏性炎症滴剂,是将7种以上作用不同的药物,按照不同剂量、浓度混合在一起,并保持其化学性能稳定,使其共处于一种液体状态中,药物的化学性能稳定,各自以较为稳定的形态存在于同一制剂当中,相互间不发生化学反应,也不影响其他药物发挥功效,但彼此之间是一种相互协作、作用相加和互为因果的关系。多种药物组合发挥协同作用,多环节发挥治疗作用,药效显著,控制疾病迅速有效;内集多种药物不同功效于一体,使单个药量减少,整体药效提高,副作用明显降低,达到事半功倍的效果,疗效十分满意;本方案整体是为过敏性疾病量身打造,具备综合治理、标本兼治、质量求胜、精准定位之特征,是一种对疾病理论全新认识基础上的创新疗法。
Claims (10)
1.一种抗过敏性炎症滴剂,其特征在于:包括色甘酸钠、双氯芬酸钠、盐酸消旋山莨菪碱、***、曲安奈德、甘草酸苷、B族维生素。
2.根据权利要求1所述的抗过敏性炎症滴剂,其特征在于:包括60~80质量份的色甘酸钠、25质量份的双氯芬酸钠、5质量份的盐酸消旋山莨菪碱、1质量份的***、10质量份的曲安奈德、1~2质量份的甘草酸苷、40质量份的B族维生素。
3.根据权利要求2所述的抗过敏性炎症滴剂,其特征在于:所述色甘酸钠为色甘酸钠滴眼液,所述双氯芬酸钠为复方双氯芬酸钠注射液,所述盐酸消旋山莨菪碱为盐酸山莨菪碱注射液,所述***为***磷酸钠注射液,所述曲安奈德为曲安奈德注射液,所述甘草酸苷为复方甘草酸苷注射液,所述B族维生素包括维生素B1注射液、维生素B2注射液、维生素B6注射液。
4.根据权利要求3所述的抗过敏性炎症滴剂,其特征在于:包括3.0~4.0体积份的色甘酸钠滴眼液、1.0体积份的复方双氯芬酸钠注射液、0.5体积份的盐酸山莨菪碱注射液、0.2体积份的***磷酸钠注射液、1.0体积份的曲安奈德注射液、0.5~1.0体积份的复方甘草酸苷注射液、0.5体积份的维生素B1注射液、0.5体积份的维生素B2注射液、0.5体积份的维生素B6注射液。
5.根据权利要求4所述的抗过敏性炎症滴剂,其特征在于:所述色甘酸钠滴眼液中色甘酸钠浓度为20mg/ml,复方双氯芬酸钠注射液中双氯芬酸钠浓度为25mg/ml,盐酸山莨菪碱注射液中盐酸山莨菪碱浓度为10mg/ml,***磷酸钠注射液中***磷酸钠浓度为5mg/ml,曲安奈德注射液中曲安奈德浓度为10mg/ml,复方甘草酸苷注射液中含有2.0415mg/ml的甘草酸单铵盐、1mg/ml的盐酸半胱氨酸、20mg/ml的甘氨酸,维生素B1注射液中维生素B1浓度为25mg/ml,维生素B2注射液中维生素B2浓度为5mg/ml,维生素B6注射液中维生素B6浓度为50mg/ml。
6.根据权利要求1~5中任意一项所述的抗过敏性炎症滴剂,其特征在于:pH为6.4~7.7。
7.根据权利要求6所述的抗过敏性炎症滴剂,其特征在于:应用于由IgE介导的I型***反应所引起的免疫反应,包括速发型或迟发型过敏性结膜炎、过敏性鼻炎、过敏性耳道炎、过敏性咽炎、过敏性哮喘。
8.一种抗过敏性炎症滴剂制备方法,其特征在于,包括以下步骤:
首先将色甘酸钠、双氯芬酸钠、盐酸消旋山莨菪碱、***、曲安奈德、甘草酸苷、B族维生素,按照药典分别配置成对应的色甘酸钠滴眼液,复方双氯芬酸钠注射液,盐酸山莨菪碱注射液,***磷酸钠注射液,曲安奈德注射液,复方甘草酸苷注射液,维生素B1注射液、维生素B2注射液、维生素B6注射液;
接着分别取3.0~4.0体积份的色甘酸钠滴眼液,1.0体积份的复方双氯芬酸钠注射液,0.5体积份的盐酸山莨菪碱注射液,0.2体积份的***磷酸钠注射液,1.0体积份的曲安奈德注射液,0.5~1.0体积份的复方甘草酸苷注射液,0.5体积份的维生素B1注射液,0.5体积份的维生素B2注射液,0.5体积份的维生素B6注射液,混合均匀,得到混合液;
调节混合液的pH至6.4~7.7,得到抗过敏性炎症滴剂。
9.根据权利要求8所述的抗过敏性炎症滴剂制备方法,其特征在于:所述色甘酸钠滴眼液中色甘酸钠浓度为20mg/ml,复方双氯芬酸钠注射液中双氯芬酸钠浓度为25mg/ml,盐酸山莨菪碱注射液中盐酸山莨菪碱浓度为10mg/ml,***磷酸钠注射液中***磷酸钠浓度为5mg/ml,曲安奈德注射液中曲安奈德浓度为10mg/ml,复方甘草酸苷注射液中含有2.0415mg/ml的甘草酸单铵盐、1mg/ml的盐酸半胱氨酸、20mg/ml的甘氨酸,维生素B1注射液中维生素B1浓度为25mg/ml,维生素B2注射液中维生素B2浓度为5mg/ml,维生素B6注射液中维生素B6浓度为50mg/ml。
10.根据权利要求8~9中任意一项所述的抗过敏性炎症滴剂制备方法,其特征在于:将得到抗过敏性炎症滴剂分装后遮光密封保存。
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