CN113456710A - 一种中草药抗过敏性哮喘冲剂 - Google Patents
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Abstract
本发明公开了一种中草药抗过敏性哮喘冲剂,该冲剂主要包括活性提取物和辅料;所属活性提取物主要包括90%的枳实提取物;所述辅料包括矫味剂和赋形剂,矫味剂为5%的阿巴斯甜,赋形剂为5%的糊精。本发明冲剂对OVA诱导的过敏性哮喘具有良好的缓解作用。本发明便于携带,易于保存,将其用开水冲泡后,口服使用,可达到温肺散寒,化痰平喘的效果。
Description
技术领域
本发明属于中药提取物制剂,具体涉及含枳实提取物的中草药抗过敏性哮喘冲剂。
背景技术
随着现代社会工业化水平的提高,人们生活节奏的加快,过敏性哮喘的患病率大幅增加,给家庭和社会带来了巨大的经济负担,并且严重降低了患者的生活质量。过敏性哮喘被公认是一种慢性炎症疾病,但还没有完全清楚其病理及生理变化,临床患者对各种药物具有不同程度的反应性,即使按照全球哮喘防治创议(GINA)进行规范化治疗,仍然大约有10%的哮喘患者未能得到有效控制。根据中医中药的哮病辨证论治指出,温肺散寒,化痰平喘为其主要的缓解方法。
现有技术公开了一种抗过敏性哮喘冲剂的制备方法,冲剂需要在水中溶解后服用。相对于其他缓解过敏性哮喘药物,冲剂使用方便易于吸收,广受欢迎。
发明内容
本发明的目的是提供含枳实提取物的抗过敏性哮喘冲剂的制备方法。该冲剂对过敏性哮喘具有良好的抑制效果,可达到治疗过敏性哮喘的目的。
本发明提供的含枳实提取物的抗过敏性哮喘冲剂,主要包括活性成分和辅料。
所述活性成分包括90%的枳实提取物。
所述辅料包括矫味剂和赋形剂。进一步的矫味剂采用阿巴斯甜;药物赋形剂糊精。
本发明提供的含枳实提取物的抗过敏性哮喘冲剂的制备方法,包括:
(1)枳实提取物浓缩液的制备
将枳实粉碎得到小于75微米的枳实粉末,准确称量一定质量的枳实粉末,加入10倍量的水进行超声提取,时间为45min,重复提取两次,合并滤液,滤纸过滤,获得初步提取产物,过大孔吸附树脂,乙醇洗脱,减压抽滤得到枳实提取物浓缩液。
(2)枳实提取物抗过敏性哮喘活性
采用OVA诱导过敏性哮喘小鼠动物模型,评价枳实提取物抗过敏性哮喘活性。
(3)抗过敏性哮喘冲剂的制备
按照质量比提取物浓缩液:矫味剂:赋形剂=2:0.1:0.1搅拌均匀配置成基本配方,混合均匀,获得冲剂初始样品,通过电热恒温鼓风干燥,制粒。
以下将结合实施例进一步说明本发明。以下实施例为本发明较佳的实施方式,并不对本发明保护范围作任何形式的限定。实施例分为三部分:第一部分具有枳实提取物的制备;第二部分提取物的抗过敏活性的评价;第三部分抗过敏活性冲剂的制备。
附图说明
为了更清楚地说明本发明的实施例的技术方案,下面将对实施例中所需使用的附图进行简单介绍,以下附图仅示出了本发明的某些实施例,因此不应被看作对范围的限定。
图1枳实提取物对小鼠体重的影响
图2枳实提取物对小鼠体温的影响
图3枳实提取物对小鼠脾脏系数的影响(Mean±SE,N=6)(#P<0.05,##P<0.01,表示和对照组有显著性差异.*P<0.05**P<0.01,表示和模型组有显著性差异)
图4枳实提取物对小鼠胸腺系数的影响(Mean±SE,N=6)(#P<0.05,##P<0.01,表示和对照组有显著性差异.*P<0.05**P<0.01,表示和模型组有显著性差异)
图5枳实提取物对小鼠血清中总IgE水平的影响(Mean±SE,N=6)(#P<0.05,##P<0.01,表示和对照组有显著性差异.*P<0.05**P<0.01,表示和模型组有显著性差异)
图6枳实提取物对小鼠肺泡灌洗液中IL-4水平的影响(Mean±SE,N=6)(#P<0.05,##P<0.01,表示和对照组有显著性差异.*P<0.05**P<0.01,表示和模型组有显著性差异)
图7枳实提取物对小鼠肺泡灌洗液中IL-13水平的影响(Mean±SE,N=6)(#P<0.05,##P<0.01,表示和对照组有显著性差异.*P<0.05**P<0.01,表示和模型组有显著性差异)
图8枳实提取物对小鼠肺泡灌洗液中IFN-gama水平的影响(Mean±SE,N=6)(#P<0.05,##P<0.01,表示和对照组有显著性差异.*P<0.05**P<0.01,表示和模型组有显著性差异)
具体实施方式
实施例1枳实提取物的制备
参阅权利要求1,本实施例抗过敏性哮喘冲剂由以下成分制备而成,90%的枳实提取物,5%的矫味剂以及5%的赋形剂。该冲剂制备方法包括以下步骤:
称量:准确称量原料药材500g于烧杯中备用
制备枳实提取物:加入10倍量纯净水进行超声提取45min,过滤后保留滤液;残渣再用10倍量纯净水超声提取45min,过滤后保留滤液;合并两次提取滤液并用量筒量体积,加入适量无水乙醇用旋转蒸发仪进行减压浓缩,在浓缩过程中适当加入无水乙醇降低溶液沸点浓缩至5ml,放入冰箱备用。
实施例2枳实提取物的抗过敏活性评价
6-8周的雌性BALB/c小鼠,体重18-22g,购自辽宁长生生物有限责任公司。小鼠饲养采取常规分笼方式,饮水和采食自由,温度24±2℃,相对湿度40-80%,实验在吉林大学动物中心的指导下完成。小鼠饲养一周适应环境后进行实验。共30只小鼠,分成五组:对照组、模型组、枳实提取物10mg/kg组,枳实提取物30mg/kg组和枳实提取物组100mg/kg采用腹腔的方式在第0、7、14天每只每次注射OVA0.2mL致敏,空白组注射生理盐水。在第16至25天,枳实提取物组经灌胃相应浓度的枳实总黄酮,灌胃量为0.2mL,模型组和空白组灌胃生理盐水。第21至25天药物灌胃1h后,对模型组和枳实总黄酮组的小鼠进行滴鼻激发,激发液为50μL的OVA,空白组使用生理盐水,最后一次滴鼻激发24h后,处死小鼠。
(一)枳实提取物对小鼠体重、脾脏和胸腺的影响
胸腺和脾脏是重要的免疫器官,影响细胞和体液免疫。当过敏性哮喘发生时,免疫细胞的增殖能力受到影响,从而影响体重、体温学以及免疫器官脾脏和胸腺的脏器系数。结果如图1-4所示:体重变化方面,从第14天到24天,枳实提取物作用组小鼠体重减轻明显受到抑制(图1);体温变化方面,高浓度50和100mg/kg组,能够抑制过敏性哮喘的体温降低(图2);在脏器系数方面,相比于对照组,模型组的脾脏系数明显升高,而胸腺系数明显降低。枳实提取物组抑制了脾脏系数上升和胸腺系数降低说明枳实提取物对免疫系统有调节作用。
(二)小鼠血清中IgE检测
最后一次滴鼻激发24h后,进行小鼠眼球取血,获得血液,室温放置60min后,离心制备血清,采用试剂盒检测血清中总IgE水平。
血清中1gE结果显示,相比于对照组,模型组的血清中IgE水平显著升高,相比于模型组,经枳实提取物作用后,枳实提取物作用组中血清IgE的水平显著降低了。
(三)小鼠肺泡灌洗液中细胞因子检测
小鼠牺牲后,用PBS缓冲液对肺组织进行灌洗,收集灌洗液约1mL,离心获得肺泡灌洗上清液,使用ELISA试剂盒检测上清液中IL-4、IL-13和INF-gamma水平。
如图5-8所示,与对照组相比,模型组的肺泡灌洗液中的细胞因子IL-4、1L-13和IFN-gamma都显著升高,与模型组相对比,枳实提取物组中肺泡灌洗液中的细胞因子水平全部下降,尤其是炎性因子IL-13,随着枳实提取物浓度的升高,显著降低。因此,有足够的理由证明,枳实提取物组能够显著缓解过敏性哮喘。
综合体内实验结果,我们从体重变化、体温变化、脏器系数、血清抗体水平以及肺泡灌洗液中细胞因子水平等几个方面对枳实提取物的具有抗过敏性哮喘活性,并取得了显著效果。
实施例3抗过敏活性冲剂的制备
该抗过敏性哮喘冲剂还包括矫味剂和赋形剂,二者比例为1:1,各占冲剂固体质量的5%。
辅料添加:按照如下比例,枳实提取物:矫味剂:赋形剂=2:0.1:0.1混合,混合均匀后,得到冲剂初始样品,进一步进行制备颗粒。
制备冲剂颗粒:采用喷雾干燥方法制备抗过敏性哮喘冲剂的颗粒样品,具体条件如下:进风温度145℃、给气量为87%,进料速度为23mL/min。
Claims (5)
1.一种中草药抗过敏性哮喘冲剂,其特征在于:
主要包括活性成分和辅料;所述成分包括枳实提取物;所述辅料包括矫味剂和药物赋形剂,枳实提取物占10~99%质量分数,制粒得到抗过敏哮喘冲剂。
2.根据权利要求1所述的抗过敏性哮喘冲剂,其特征在于,该冲剂由以下重量份的中药成分制备而成,枳实提取物90%。
3.根据权利要求1或2所述的抗过敏性哮喘冲剂,其特征在于该冲剂的成分还包括矫味剂和药物赋形剂,矫味剂为阿巴斯甜;药物赋形剂为糊精。
4.根据权利要求1所述的抗过敏性哮喘冲剂的制备方法,其特征在于,所述枳实提取物的制备方法包括:将枳实粉碎得到小于75微米的枳实粉末,超声提取,提取物过大孔吸附树脂,乙醇洗脱,减压抽滤得到枳实提取物浓缩液,按照质量比提取物浓缩液:矫味剂:赋形剂=2:0.1:0.1搅拌均匀配置成基本配方,制粒,低温干燥。
5.含枳实提取物的中草药抗过敏性哮喘冲剂在抗过敏性哮喘中的应用。
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CN102233026A (zh) * | 2010-04-28 | 2011-11-09 | 天津药物研究院 | 一种药物组合物及其制备方法和用途 |
CN102935131A (zh) * | 2011-08-15 | 2013-02-20 | 天津药物研究院 | 枳实总黄酮提取物在制备用于治疗哮喘药物中的应用 |
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