CN111317787A - 中药组合物及其制剂在制备治疗支气管哮喘的药物中的用途 - Google Patents
中药组合物及其制剂在制备治疗支气管哮喘的药物中的用途 Download PDFInfo
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Abstract
本发明属于中药领域,具体涉及一种中药组合物在制备治疗支气管哮喘的药物中的用途,中药组合包括如下原料药:重楼,黄芩,浙贝母,鸭跖草,知母,石膏,陈皮,枳壳,苍耳子,苦杏仁,桔梗,广藿香,紫苏叶,炙甘草。研究结果显示,上述的中药组合物能够改善支气管哮喘模型大鼠的哮喘模型表征,阻断哮喘病理进程,改善气道高反应性,改善肺组织损伤,降低细胞炎症因子水平,对支气管哮喘具有明显的治疗效果,适于临床推广应用。
Description
技术领域
本发明属于中药领域,具体涉及一种中药组合物及其制剂在制备治疗支气管哮喘的药物中的用途。
背景技术
支气管哮喘(Bronchial Asthma,简称哮喘)是一种临床常见的呼吸系统慢性气道疾病,是由多种细胞和细胞组分参与的气道慢性炎性反应性异质性疾病,其发病率高。目前全世界有哮喘患者约1.5-2亿,在我国,14岁以上人群支气管哮喘总体患病率为1.24%,大约有2000万的哮喘患者,且患病率呈明显上升趋势。哮喘不仅严重影响患者生活质量,且因其所产生的直接和间接成本均带来了沉重的经济和社会负担。
支气管哮喘发病原因和机制复杂,目前临床尚未有统一的理论标准。支气管哮喘是由多种细胞因子参与调节的,以嗜酸粒细胞、淋巴细胞和肥大细胞浸润为主,多种细胞参与的慢性气道炎症;以多种炎性细胞在气道内浸润、气道上皮脱落及气道高反应性为主要特征主要以气道慢性炎症、气道高反应性和气道重塑为特征。目前,临床治疗支气管哮喘主要通过抗炎、扩张支气管等方式来控制病情,糖皮质激素、β2受体激动剂、抗M胆碱药、茶碱类药物等都是临床常用的药物。β2受体激动剂通过与β2肾上腺素能受体活化位点相结合来舒张气道平滑肌、增加气道上皮纤毛的摆动以及降低微血管的通透性,从而缓解哮喘症状的。适合于哮喘反复发作以及哮喘夜间或清晨发作或加剧的患者,对嗜酸粒细胞释放的炎症介质也有调节作用,目前临床应用较多的是吸入型制剂,以发挥局部作用功效。但是速效吸入型β2受体激动剂在哮喘的慢性治疗中对哮喘症状及气道高反应性的控制疗效欠佳,且长时间使用β2受体激动剂,可明显降低患者肺部功能,使得支气管气道反复性痉挛或不可逆性缩窄。抗胆碱药可通过阻断或减少乙酰胆碱的释放,抑制支气管反射性收缩,使得气道黏液分泌减少,从而产生支气管扩张功效。但是其对气道炎症及哮喘的速发、迟发相反应无明显作用,且由于其起效缓慢且支气管扩张作用功效低于吸入性β2受体激动剂,因此临床多以联合用药以提高疗效。茶碱类药物可降低支气管平滑肌张力而舒张支气管,可以缓解哮喘患者症状。但是此类药物安全有效治疗指数较窄,药动学个体差异较大,需对患者进行个体化给药方案,因此使得其应用得到限制。
中医中药重视整体调节,在改善患者症状的同时其毒副作用相对较小,对于治疗支气管哮喘具有优势。因此,研究治疗支气管哮喘的中药组合物具有重要意义。
发明内容
因此,本发明要解决的技术问题在于提供一种中药组合物在制备治疗支气管哮喘的药物中的新用途。
为此,本发明提供如下技术方案:
一种中药组合物在制备治疗支气管哮喘的药物中的用途,所述中药组合包括如下原料药:重楼,黄芩,浙贝母,鸭跖草,知母,石膏,陈皮,枳壳,苍耳子,苦杏仁,桔梗,广藿香,紫苏叶,炙甘草。
优选地,上述的中药组合物在制备治疗支气管哮喘的药物中的用途,包括如下重量份的原料药:
重楼100~160份,黄芩60~100份,浙贝母100~160份,鸭跖草250~300份,知母60~100份,石膏150~200份,陈皮70~100份,枳壳60~100份,苍耳子100~150份,苦杏仁60~100份,桔梗60~100份,广藿香60~100份,紫苏叶60~100份,炙甘草60~100份。
优选地,上述的中药组合物在制备治疗支气管哮喘的药物中的用途,包括如下重量份的原料药:
重楼138.9份,黄芩83.3份,浙贝母138.9份,鸭跖草277.8份,知母83.3份,石膏185.2份,陈皮83.3份,枳壳83.3份,苍耳子138.9份,苦杏仁83.3份,桔梗83.3份,广藿香83.3份,紫苏叶83.3份,炙甘草83.3份。
优选地,上述的中药组合物在制备治疗支气管哮喘的药物中的用途,所述中药组合物按照常规工艺,加入常规辅料,制成临床上可接受的制剂。
进一步优选地,上述的中药组合物在制备治疗支气管哮喘的药物中的用途,所述临床上可接受的制剂选自片剂、胶囊剂、散剂、合剂、丸剂、颗粒剂、糖浆剂、贴膏剂、栓剂、气雾剂、软膏剂或注射剂;
所述常规辅料为:填充剂、崩解剂、润滑剂、助悬剂、粘合剂、甜味剂、矫味剂、防腐剂、基质等。填充剂包括:淀粉、预胶化淀粉、乳糖、甘露醇、甲壳素、微晶纤维素、蔗糖等;崩解剂包括:淀粉、预胶化淀粉、微晶纤维素、羧甲基淀粉钠、交联聚乙烯吡咯烷酮、低取代羟丙纤维素、交联羧甲基纤维素纳等;润滑剂包括:硬脂酸镁、十二烷基硫酸钠、滑石粉、二氧化硅等;助悬剂包括:聚乙烯吡咯烷酮、微晶纤维素、蔗糖、琼脂、羟丙基甲基纤维素等;粘合剂包括,淀粉浆、聚乙烯吡咯烷酮、羟丙基甲基纤维素等;甜味剂包括:糖精钠、阿斯帕坦、蔗糖、甜蜜素、甘草次酸等;矫味剂包括:甜味剂及各种香精;防腐剂包括:尼泊金类、苯甲酸、苯甲酸钠、山梨酸及其盐类、苯扎溴铵、醋酸氯乙定、桉叶油等;基质包括:PEG6000、PEG4000、虫蜡等。
所述临床上可接受的剂型,包括液体剂型、固体剂型、半固体剂型和气体剂型。液体剂型包括:芳香水剂、溶液剂、注射剂、合剂、洗剂、涂剂等。固体剂型包括散剂、丸剂、片剂、膜剂、胶囊剂、颗粒剂等。半固体剂型包括:软膏剂、糊剂、凝胶剂等。气体剂型包括:气雾剂、喷雾剂等。
优选地,所述临床上可接受的制剂为颗粒剂。
优选地,上述的中药组合物在制备治疗支气管哮喘的药物中的用途,所述中药组合物的制备方法包括如下步骤:
取选定重量份的黄芩,加水煎煮,滤过,得第一药渣和第一滤液;第一滤液放置滤过,取滤渣为黄芩甙粗品备用;
取选定重量份的陈皮、枳壳、苦杏仁、广藿香和柴苏叶,加水蒸馏,得馏出液和第二药渣,收集馏出液,分取挥发油备用;
取所述第一药渣、第二药渣与选定重量份的浙贝母、重楼、鸭跖草、知母、石膏、苍耳子、桔梗和甘草,加水煎煮,滤过,得第二滤液;
将所述第二滤液浓缩后加乙醇沉淀,滤取上清液,回收乙醇,继续浓缩至稠状浸膏,取浸膏加入所述黄芩甙粗品,混匀,制成颗粒,干燥,喷入所述挥发油,整粒即得。
进一步优选地,上述的中药组合物在制备治疗支气管哮喘的药物中的用途,所述第一滤液放置滤过的步骤包括:在80℃的温度下调节所述第一滤液的pH为1-2,然后放置滤过。
优选地,上述的中药组合物在制备治疗支气管哮喘的药物中的用途,所述石膏为生石膏,所述苍耳子为炒苍耳子,所述黄芩为炒黄芩,所述枳壳是麸炒枳壳。
优选地,上述的中药组合物在制备治疗支气管哮喘的药物中的用途,所述支气管哮喘为过敏性支气管哮喘。
本发明技术方案,具有如下优点:
本发明通过研究发现,包含如下原料药的中药组合物:重楼、黄芩、浙贝母、鸭跖草、知母、石膏、陈皮、枳壳、苍耳子、苦杏仁、桔梗、广藿香、紫苏叶、炙甘草,可通过改善过敏性支气管哮喘模型大鼠的、气道反应性、降低血清中IgE、IgG、IL-1β、IL-4、IL-5、IL-6、IL-17、IFN-γ和INF-α含量含量,降低肺泡灌洗液(broncholveolr lavage fluid,BALF)中IL-4、IL-17含量,改善过敏性支气管哮喘大鼠的肺组织病理改变。说明以上述原料药制成的中药组合物对由OVA致敏和激发的支气管哮喘具有明显的治疗效果,且效果优于止咳定喘丸,具有良好的临床应用前景。
进一步地,本发明提供了中药组合物中各原料药的重量份,该中药组合物中的各原料药在特定的配比下相互配合、共同作用,从而发挥对支气管哮喘的治疗作用。
进一步地,本发明提供了中药组合物的制备方法,能够充分提取各原料中药的药物有效成分,使制得的药物颗粒保持有高的药物活性,充分发挥对支气管哮喘的治疗作用。
附图说明
为了更清楚地说明本发明具体实施方式或现有技术中的技术方案,下面将对具体实施方式或现有技术描述中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图是本发明的一些实施方式,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图获得其他的附图。
图1是本发明实验例1中实验期间各组大鼠体重的变化趋势;
图2是本发明实验例1中各组大鼠的气道反应性测定结果;
图3是本发明实验例1中各组大鼠肺组织HE染色的病理学观测结果;
图4是本发明实验例1中各组大鼠肺组织Masson染色的病理学观测结果。
具体实施方式
下面将对本发明的技术方案进行清楚、完整地描述,显然,所描述的实施例是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。此外,下面所描述的本发明不同实施方式中所涉及的技术特征只要彼此之间未构成冲突就可以相互结合。
实施例1
本实施例提供一种中药组合物,其原料药组成为:重楼138.9g,黄芩83.3g,浙贝母138.9g,鸭跖草277.8g,知母83.3g,石膏185.2g,陈皮83.3g,枳壳83.3g,苍耳子138.9g,苦杏仁83.3g,桔梗83.3g,广藿香83.3g,紫苏叶83.3g,炙甘草83.3g。
该药物组合物的制备方法包括:
取选定重量的黄芩,加10倍重量的水煎煮1.5小时,滤过,得第一药渣和第一滤液,第一滤液浓缩至5倍量,在80℃调pH值至1-2,放置24小时,滤过,滤渣为黄芩甙粗品,备用;
取选定重量的陈皮、枳壳、苦杏仁、广藿香和紫苏叶5味药材用水湿润后,通水蒸汽蒸馏3小时,得馏出液和第二药渣,收集馏出液,分取挥发油,备用;
将第一药渣、第二药渣与浙贝母、重楼、鸭跖草、知母、石膏、苍耳子、桔梗和甘草8味药材加10倍量水煎煮2次(每次1.5小时),滤过,合并滤液作为第二滤液;
将第二滤液浓缩(d=1.15-1.20,热测),加入乙醇使含醇量达60%,沉淀10-12小时后,滤取上清液,减压回收乙醇,继续浓缩至稠状浸膏(d=1.20-1.25,热测),取浸膏加入1.5倍量的糊精和3.5倍量蔗糖,加入上述黄芩甙粗品,混匀,制成颗粒,干燥,喷入挥发油,密封过夜,整粒,分装,即得。
实施例2
本实施例提供一种中药组合物,其原料药组成为:重楼160g,黄芩100g,浙贝母160g,鸭跖草300g,知母60g,石膏150g,陈皮100g,枳壳100g,苍耳子150g,苦杏仁60g,桔梗60g,广藿香60g,紫苏叶60g,炙甘草60g。
该药物组合物的制备方法包括:
取选定重量的黄芩,加10倍重量的水煎煮1.5小时,滤过,得第一药渣和第一滤液,第一滤液浓缩至5倍量,在80℃调pH值至1-2,放置24小时,滤过,滤渣为黄芩甙粗品,备用;
取选定重量的陈皮、枳壳、苦杏仁、广藿香和紫苏叶5味药材用水湿润后,通水蒸汽蒸馏3小时,得馏出液和第二药渣,收集馏出液,分取挥发油,备用;
将第一药渣、第二药渣与浙贝母、重楼、鸭跖草、知母、石膏、苍耳子、桔梗和甘草8味药材加10倍量水煎煮2次(每次1.5小时),滤过,合并滤液作为第二滤液;
将第二滤液浓缩(d=1.15-1.20,热测),加入乙醇使含醇量达60%,沉淀10-12小时后,滤取上清液,减压回收乙醇,继续浓缩至稠状浸膏(d=1.20-1.25,热测),取浸膏加入1.5倍量的糊精和3.5倍量蔗糖,加入上述黄芩甙粗品,混匀,制成颗粒,干燥,喷入挥发油,密封过夜,整粒,分装,即得。
实施例3
本实施例提供一种中药组合物,其原料药组成为:重楼100g,黄芩60g,浙贝母100g,鸭跖草250g,知母100g,石膏200g,陈皮70g,枳壳60g,苍耳子100g,苦杏仁100g,桔梗100g,广藿香100g,紫苏叶100g,炙甘草100g。
该药物组合物的制备方法包括:
取选定重量的黄芩,加10倍重量的水煎煮1.5小时,滤过,得第一药渣和第一滤液,第一滤液浓缩至5倍量,在80℃调pH值至1-2,放置24小时,滤过,滤渣为黄芩甙粗品,备用;
取选定重量的陈皮、枳壳、苦杏仁、广藿香和紫苏叶5味药材用水湿润后,通水蒸汽蒸馏3小时,得馏出液和第二药渣,收集馏出液,分取挥发油,备用;
将第一药渣、第二药渣与浙贝母、重楼、鸭跖草、知母、石膏、苍耳子、桔梗和甘草8味药材加10倍量水煎煮2次(每次1.5小时),滤过,合并滤液作为第二滤液;
将第二滤液浓缩(d=1.15-1.20,热测),加入乙醇使含醇量达60%,沉淀10-12小时后,滤取上清液,减压回收乙醇,继续浓缩至稠状浸膏(d=1.20-1.25,热测),取浸膏加入1.5倍量的糊精和3.5倍量蔗糖,加入上述黄芩甙粗品,混匀,制成颗粒,干燥,喷入挥发油,密封过夜,整粒,分装,即得。
实验例1
1、实验目的:研究中药组合物对支气管哮喘的治疗效果,中药组合物为实施例1中制备的药物颗粒。
2、实验方法:
2.1给药剂量选取的依据
依据《中药药理实验方法学》所述方法进行人和动物之间的等效剂量的换算,计算公式:动物等效剂量(g/kg)=人日服总量(g)/60kg×(人转换因子/动物转换因子)。据药物颗粒临床剂量,计算大鼠的等效剂量,将等效剂量设为中剂量,等效剂量×1/2倍为低剂量,等效剂量×2倍为高剂量。
2.2给药时间确立的依据
依据据文献报道及预试验结果确立正式试验的给药时间。
2.3分组
将大鼠(SPF级SD大鼠雄性,共72只)分为6组,分别为:正常组(A组)、哮喘模型组(B组)、止咳定喘丸(C组)、药物颗粒低剂量组(D组)、药物颗粒中剂量组(E组)、药物颗粒高剂量组(F组),每组12只。
2.4造模与给药
除正常组外,其余各组均采用卵蛋白(OVA)致敏和激发建立大鼠的哮喘模型。造模第1天、第8天腹腔注射1ml OVA致敏液致敏,正常对照组大鼠使用生理盐水代替OVA致敏液在相同时间、相同剂量腹腔注射。从第15天开始,除正常对照组外,将大鼠置于雾化箱内,使用1%的OVA雾化液雾化激发,每天20min,共7天。正常对照组大鼠则使用生理盐水替代OVA雾化液进行雾化,其时间、方式均与哮喘模型组大鼠相同。
止咳定喘片、药物颗粒三个剂量组除正常致敏激发外,每次于激发前30分钟分别给予阳性药、药物颗粒灌胃给药,空白对照组给予生理盐水。阳性对照组止咳定喘丸混悬液2.7g/kg,药物颗粒高、中、低剂量组分别灌服药物颗粒混悬液7.2、3.6、1.8g/kg,正常对照组和模型组灌服等量生理盐水。1次/天,连续7天。
2.5动物一般情况观察
实验过程当中记录大鼠的一般情况,如出现烦躁,易激惹,唇耳发绀、咳嗽,呼吸加深、加快,腹式呼吸,点头呼吸,甚至出现大小便失禁等类似人类哮喘症状。同时每隔2天称量体重,并记录。
2.6气道反应性测定
采用无创性全身体积描记系统对各组大鼠的气道反应性进行测定。将大鼠密封于体描箱内适应5min后,使用乙酰甲胆碱(Mch)溶液进行支气管激发,观察Mch激发下其气道阻力参数值的变化情况。以气道反应性升高为基值2倍时的Mch激发浓度即PC100作为评价指标。
2.7样本的采集
气道反应性测定完毕后麻醉大鼠,经腹主动脉采集血液,在离心机中以3000r/min离心10min,吸取上清液分装,置于-20℃冰箱内保存、待测。
取血后切开大鼠颈部皮肤,钝性分离出气管,T形切口插入平头针并固定结扎右主支气管,用注射器取4mL生理盐水反复抽注灌洗左肺3次,收集全部支气管肺泡灌洗液(BALF),进行离心(3000r/min)10分钟,吸取上清液分装,置于-20℃冰箱内保存、待测。
迅速切开大鼠胸腔(观察整个肺外观、支气管、支气管和肺泡腔内黏液分泌等情况),用眼科剪取下右肺肺叶,将其放入4%多聚甲醛固定液中固定、保存、备用。
2.8免疫球蛋白的测定
于96孔细胞培养板每孔加入卵清蛋白4℃过夜,用PBS缓冲液冲洗,然后加入1%BSA,每孔150μL,在37℃培养1h,用PBS缓冲液冲洗。把已经取好的血清用缓冲液稀释后,每孔加入200μL在37℃培养3h,用PBS缓冲液冲洗。将IgE和IgG抗体用缓冲液稀释后,每孔加入100μL 37℃培养2h,再用PBS缓冲液冲洗,最后取底物用碳酸盐缓冲液配成1g/L,每孔加入100μL,分别培养15min(IgG)和12h(IgE),于波长405nm和492nm下测定吸光度(A)。
2.9细胞炎症因子的测定
采用ELISA法,按照试剂盒说明书,分别检测BALF、血清中IL-lβ、IL-4、IL-5、IL-6、IL-10、IL-17、IFN-γ和TNF-α等表达水平的变化。
2.10BALF中炎性细胞总数和嗜酸性粒细胞计数
取2mL BALF常温下1500rpm离心10min,弃上清,使用细胞计数仪计数炎性细胞总数。
使细胞悬液和2%伊红-丙酮嗜酸性粒细胞稀释液按1:5的体积比混匀,染色,使用计数板计数嗜酸性粒细胞,方法同前。
2.11肺组织病理变化观察
将固定好的肺组织取出,经乙醇脱水、二甲苯透明,石蜡包埋切片后,HE、Masson染色后观察肺组织病理组织学改变。
2.12统计学分析
试验数据以平均数±标准差(x±S)表示,采用SPSS 20.0统计软件进行单因素方差分析,组间比较符合正态分布且方差齐时,采用LSD检验;方差不齐时,采用Games-Howell检验。若不符合正态分布时,则采用非参数检验(Kruskal-Wallis test)。以P<0.05为差异有统计学意义。
3、实验结果:
3.1一般情况
腹腔注射OVA后,各组大鼠均无明显变化。使用OVA致敏激发的哮喘模型组大鼠雾化吸入后,出现搔抓头、鼻及躯干,唇发绀、咳嗽,呼吸加深、加快,腹式呼吸等症状;使用生理盐水处理的正常组大鼠行为活动如常,未出现上述症状;给药后大鼠上述表现程度均有不同程度的改善。
实验期间各组大鼠体重如图1所示。正常组(A组)、哮喘模型组(B组)、止咳定喘丸(C组)、药物颗粒低剂量组(D组)、药物颗粒中剂量组(E组)及药物颗粒高剂量组(F组)体重随着时间的增加而增长。
3.2气道反应性测定
气道反应性升高为基值2倍时的Mch激发浓度即PC100值越小,气道敏感性越高。与正常组(A组)相比,模型组(B组)PC100显著降低(P<0.01);与模型组(B组)相比,各给药组PC100均增大,其中药物颗粒高剂量组(F组)显著性增大(P<0.01),见图2。
3.3免疫球蛋白的测定
与正常组(A组)相比,模型组(B组)血清中的IgE和IgG明显增多,差异有统计学意义(P<0.01);与模型组(B组)相比,各给药组IgE和IgG均降低,其中药物颗粒高剂量组(F组)显著性降低(P<0.05),见表1。
表1各组大鼠血清中IgE、IgG含量比较
IgE(μg/L) | IgG(μg/L) | |
A组 | 2.36±0.33 | 130.15±29.69 |
B组 | 7.07±0.91## | 211.73±51.60## |
C组 | 6.07±1.13 | 181.70±29.61 |
D组 | 6.14±0.88 | 185.91±52.20 |
E组 | 6.13±1.00 | 179.81±44.33 |
F组 | 6.36±0.90 | 165.48±28.39* |
注:与正常组(A组)比较,##P<0.01;与模型组(B组)比较,*P<0.05。
3.4细胞炎症因子的测定
各组大鼠BALF中IL-4、IL-5、IL-17及IFN-γ含量见表2。与正常组(A组)相比,模型组(B组)血清中的IL-4、IL-5、IL-17及IFN-γ明显增多,差异有统计学意义(P<0.05或P<0.01);与模型组(B组)相比,各给药组IL-4、IL-5、IL-17及IFN-γ均降低,其中IL-4、IL-17显著降低(P<0.05或P<0.01)。
表2各组大鼠BALF中IL-4、IL-5、IL-17及IFN-γ含量比较
pg/ml | A组 | B组 | C组 | D组 | E组 | F组 |
IL-4 | 36.34±6.60 | 219.60±25.05<sup>##</sup> | 163.95±38.34<sup>*</sup> | 187.69±35.93 | 162.101±44.57<sup>*</sup> | 153.03±51.12<sup>**</sup> |
IL-5 | 39.63±6.23 | 104.74±17.72<sup>##</sup> | 90.12±32.22 | 97.52±26.02 | 94.43±21.75 | 91.14±33.00 |
IL-17 | 113.25±27.5 | 376.19±43.67<sup>##</sup> | 311.75±46.33<sup>**</sup> | 305.08±42.22<sup>**</sup> | 304.58±38.60<sup>**</sup> | 317.54±49.42<sup>**</sup> |
IFN-γ | 50.22±10.3 | 61.01±22.15<sup>#</sup> | 55.78±12.87 | 57.77±17.73 | 56.26±16.99 | 57.00±10.35 |
注:与正常组(A组)比较,#P<0.05,##P<0.01;与模型组(B组)比较,*P<0.05,**P<0.01。
各组大鼠血清中IL-lβ、IL-4、IL-5、IL-6、IL-10、IL-17、IFN-γ和TNF-α含量见表3。与正常组(A组)相比,模型组(B组)血清中的IL-lβ、IL-4、IL-5、IL-6、IL-17、IFN-γ和TNF-α含量明显增多,IL-10含量显著减少,差异有统计学意义(P<0.05或P<0.01);与模型组(B组)相比,各给药组IL-lβ、IL-4、IL-5、IL-6、IL-17、IFN-γ和TNF-α含量均降低,IL-10含量升高。
表3各组大鼠血清中IL-lβ、IL-4、IL-5、IL-6、IL-10、IL-17、IFN-γ和TNF-α水平
pg/ml | A组 | B组 | C组 | D组 | E组 | F组 |
IL-lβ | 63.58±27.23 | 104.74±12.72<sup>#</sup> | 90.12±21.51 | 67.52±20.02<sup>*</sup> | 64.43±21.75<sup>*</sup> | 61.14±16.51<sup>**</sup> |
IL-4 | 32.62±2.76 | 98.50±10.94<sup>##</sup> | 63.95±7.99<sup>**</sup> | 77.83±13.42<sup>*</sup> | 79.75±10.00<sup>*</sup> | 53.85±11.34<sup>**</sup> |
IL-5 | 130.15±29.65 | 211.73±51.63<sup>##</sup> | 175.48±38.93 | 186.87±52.26 | 179.80±44.39 | 165.68±28.25<sup>*</sup> |
IL-6 | 50.22±12.3 | 61.01±12.15 | 52.78±12.87 | 57.77±12.25 | 49.26±11.99 | 49.26±9.99 |
IL-10 | 118.08±14.42 | 50.08±7.20<sup>##</sup> | 52.827±11.23 | 53.38±10.33 | 54.58±12.09 | 55.85±14.24 |
IL-17 | 48.50±7.5 | 407.75±42.86<sup>##</sup> | 330.75±54.20<sup>**</sup> | 402.08±47.34 | 314.58±57.77<sup>**</sup> | 317.54±40.90<sup>**</sup> |
IFN-γ | 44.79±13.67 | 94.62±19.77<sup>##</sup> | 85.16±22.62 | 87.20±29.00 | 84.23±28.08 | 81.43±21.74 |
TNF-α | 125.18±17.88 | 285.45±20.71<sup>##</sup> | 240.72±32.86 | 242.45±20.86 | 234.47±21.14 | 226.16±25.14<sup>*</sup> |
注:与正常组(A组)比较,#P<0.05,##P<0.01;与模型组(B组)比较,*P<0.05,**P<0.01。
3.5BALF中炎性细胞总数和嗜酸性粒细胞计数
与正常组(A组)相比,模型组(B组)BALF中的炎性细胞及嗜酸性细胞数明显增多,差异有统计学意义(P<0.01);与模型组(B组)相比,各给药组炎性细胞及嗜酸性细胞数显著降低(P<0.05或P<0.01),见表4。
表4各组大鼠BALF中炎性细胞及嗜酸性细胞数计数
注:与正常组(A组)比较,##P<0.01;与模型组(B组)比较,*P<0.05,**P<0.01。
3.6肺组织病理变化观察
肺组织大体观察,可见正常组大鼠肺组织表面光滑,色泽红润,无充血、出血;模型组大鼠肺组织表面粗糙,色泽偏黄,有形状不规则的暗红色充血区;药物干预后充血现象有改善。
各组大鼠肺组织经HE染色后,光学显微镜观察结果如下:正常组未见明显炎症反应,肺组织结构完整,无炎症细胞浸润;模型组可见在支气管及其周围充血,肺泡壁增厚、肺泡腔变小,肺泡腔、间隔及血管周围有大量嗜酸粒细胞、淋巴细胞等炎性细胞浸润;与模型组相比,止咳定喘丸组可见充血,肺泡壁、肺泡腔有改善,仍有嗜酸粒细胞、淋巴细胞等炎性细胞浸润;与模型组相比,药物颗粒底剂量组可见充血,肺泡壁、肺泡腔有改善,仍有嗜酸粒细胞、淋巴细胞等炎性细胞浸润,药物颗粒中、高剂量组可见少量充血,肺泡壁、肺泡腔有改善,嗜酸粒细胞、淋巴细胞等炎性细胞浸润减少,见图3。
各组大鼠肺组织经Masson染色后,光学显微镜未观察到有气道重塑现象。结果如图4所示。
显然,上述实施例仅仅是为清楚地说明所作的举例,而并非对实施方式的限定。对于所属领域的普通技术人员来说,在上述说明的基础上还可以做出其它不同形式的变化或变动。这里无需也无法对所有的实施方式予以穷举。而由此所引伸出的显而易见的变化或变动仍处于本发明创造的保护范围之中。
Claims (9)
1.一种中药组合物在制备治疗支气管哮喘的药物中的用途,其特征在于,所述中药组合包括如下原料药:重楼,黄芩,浙贝母,鸭跖草,知母,石膏,陈皮,枳壳,苍耳子,苦杏仁,桔梗,广藿香,紫苏叶,炙甘草。
2.根据权利要求1所述的中药组合物在制备治疗支气管哮喘的药物中的用途,其特征在于,包括如下重量份的原料药:
重楼100~160份,黄芩60~100份,浙贝母100~160份,鸭跖草250~300份,知母60~100份,石膏150~200份,陈皮70~100份,枳壳60~100份,苍耳子100~150份,苦杏仁60~100份,桔梗60~100份,广藿香60~100份,紫苏叶60~100份,炙甘草60~100份。
3.根据权利要求1或2所述的中药组合物在制备治疗支气管哮喘的药物中的用途,其特征在于,包括如下重量份的原料药:
重楼138.9份,黄芩83.3份,浙贝母138.9份,鸭跖草277.8份,知母83.3份,石膏185.2份,陈皮83.3份,枳壳83.3份,苍耳子138.9份,苦杏仁83.3份,桔梗83.3份,广藿香83.3份,紫苏叶83.3份,炙甘草83.3份。
4.根据权利要求1-3任一项所述的中药组合物在制备治疗支气管哮喘的药物中的用途,其特征在于,所述中药组合物按照常规工艺,加入常规辅料,制成临床上可接受的制剂。
5.根据权利要求4所述的中药组合物在制备治疗支气管哮喘的药物中的用途,其特征在于,所述临床上可接受的制剂选自片剂、胶囊剂、散剂、合剂、丸剂、颗粒剂、糖浆剂、贴膏剂、栓剂、气雾剂、软膏剂或注射剂;
优选地,所述临床上可接受的制剂为颗粒剂。
6.根据权利要求1-5任一项所述的中药组合物在制备治疗支气管哮喘的药物中的用途,其特征在于,所述中药组合物的制备方法包括如下步骤:
取选定重量份的黄芩,加水煎煮,滤过,得第一药渣和第一滤液;第一滤液放置滤过,取滤渣为黄芩甙粗品备用;
取选定重量份的陈皮、枳壳、苦杏仁、广藿香和柴苏叶,加水蒸馏,得馏出液和第二药渣,收集馏出液,分取挥发油备用;
取所述第一药渣、第二药渣与选定重量份的浙贝母、重楼、鸭跖草、知母、石膏、苍耳子、桔梗和甘草,加水煎煮,滤过,得第二滤液;
将所述第二滤液浓缩后加乙醇沉淀,滤取上清液,回收乙醇,继续浓缩至稠状浸膏,取浸膏加入所述黄芩甙粗品,混匀,制成颗粒,干燥,喷入所述挥发油,整粒即得。
7.根据权利要求6所述的中药组合物在制备治疗支气管哮喘的药物中的用途,其特征在于,所述第一滤液放置滤过的步骤包括:在80℃的温度下调节所述第一滤液的pH为1-2,然后放置滤过。
8.根据权利要求1-7任一项所述的中药组合物在制备治疗支气管哮喘的药物中的用途,其特征在于,所述石膏为生石膏,所述苍耳子为炒苍耳子,所述黄芩为炒黄芩,所述枳壳是麸炒枳壳。
9.根据权利要求1-8任一项所述的中药组合物在制备治疗支气管哮喘的药物中的用途,其特征在于,所述支气管哮喘为过敏性支气管哮喘。
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