CN117482146A - 一种中药组合物在制备防治急性肺损伤或急性呼吸窘迫综合征药物中的用途 - Google Patents
一种中药组合物在制备防治急性肺损伤或急性呼吸窘迫综合征药物中的用途 Download PDFInfo
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Abstract
本发明提供了一种中药组合物在制备预防或治疗急性肺损伤或急性呼吸窘迫综合征药物中的用途,属于医药技术领域。所述中药组合物由苍耳子、辛夷、麻黄、白芷、薄荷、藁本、黄芩、连翘、野菊花、天花粉、地黄、丹参、茯苓、甘草组成。本发明中药组合物可显著降低急性肺损伤或急性呼吸窘迫综合征小鼠的肺指数,减轻肺泡出血、肺水肿程度,缓解肺损伤,疗效确切,效果显著,与地塞米松磷酸钠相当。且本发明中药组合物副作用小,临床安全性高,可长期使用。
Description
技术领域
本发明属于医药技术领域,涉及一种中药组合物在制备防治急性肺损伤或急性呼吸窘迫综合征药物中的用途。
背景技术
急性肺损伤(acute lung injury,ALI)是指由创伤、感染、有害气体吸入、休克等多种直接或间接因素所导致的以肺弥散功能障碍为特征的疾病。临床表现为顽固难治的低氧血症、肺泡及肺实质内高度水肿和逐渐加重的呼吸窘迫,进一步发展为急性呼吸窘迫综合征(acute respiratory distress syndrome,ARDS),进而发展至多脏器衰竭,死亡率高达30%-50%,严重威胁人们生命健康。即使患者幸存,肺功能被严重损害,生活质量亦被严重影响,给患者、家庭及社会造成巨大的精神负担和经济负担。
急性肺损伤和急性呼吸窘迫综合征发病机制复杂,病理过程主要包括3个阶段:①渗出期,肺毛细血管内皮细胞、Ⅰ型肺泡上皮细胞受损,肺间质和肺泡腔内有富含蛋白质的水肿液及炎症细胞浸润,肺内炎症因子过度释放,促炎抗炎系统和氧化/抗氧化系统平衡失调,进而诱发炎症“瀑布”样级联反应,肺损伤加剧,微血管通透性增加,肺泡发生水肿、出血,肺功能发生障碍,通气血流比例失调;②增殖期,Ⅱ型肺泡上皮细胞开始增殖分化,同时,肺间质成纤维细胞增殖;③纤维化期,成纤维细胞分泌上皮生长因子和胶原蛋白,当胶原蛋白沉积过多时,即导致纤维化。
ALI的治疗目前尚无特效药,常规治疗方法主要包括机械通气疗法、药物治疗、干细胞治疗、基因治疗。治疗所用药物临床上主要糖皮质激素、抗炎药物、抗氧化应激药物、血管扩张剂等,可通过改善氧合、抗炎、抗氧化、改善内皮细胞功能、改善肺纤维化、调节机体免疫等途径改善受损肺组织,取得了较大进展,同时这些药物也有较大的不良的反应,如糖皮质激素,是目前治疗急性肺损伤的重要方式之一,主要采取大量糖皮质激素冲击疗法,且疗效与其受体水平、功能状态以及病因有关,治疗作用存在争议。大量的临床研究证实,糖皮质激素治疗效果并不好,且存在着治标不治本的问题,长期大量使用副作用大,无法从根本上治疗ALI。
发明内容
本发明的第一个目的在于提供一种中药组合物,以解决上述现有技术中存在的技术问题,提供上述中药组合物在制备预防或治疗急性肺损伤药物中的用途。
本发明的第二个目的在于提供上述中药组合物在制备预防或治疗急性呼吸窘迫综合征药物中的用途。
进一步地,所述中药组合物在制备降低急性肺损伤或急性呼吸窘迫综合征肺指数药物中的用途。
本发明提供了一种中药组合物,所述中药组合物是由下述原料药制成的:
优选的,所述中药组合物是由下述原料药制成的:
进一步优选的,所述中药组合物是由下述原料药制成的:
进一步的,所述中药组合物中的苍耳子为炒苍耳子。
进一步的,所述中药组合物可经过常规工艺直接或加入药学上可接受的辅料后制备成临床上可接受的剂型。
进一步的,所述临床上可接受的剂型为颗粒剂、口服液、丸剂、片剂、糖浆剂、胶囊剂。
优选的,所述临床上可接受的剂型为颗粒剂。
进一步的,所述中药组合物人用剂量为0.1g/kg/d-20g/kg/d。
优选的,所述中药组合物人用剂量为0.2g/kg/d-10g/kg/d。
鼻渊通窍颗粒是根据宋代严用和《济生方》所载“苍耳子散”的基础上加味而成。由苍耳子、辛夷、麻黄、白芷、薄荷、藁本、黄芩、连翘、野菊花、天花粉、地黄、丹参、茯苓、甘草14味中药所组成。方中苍耳子、辛夷为君。苍耳子散风通窍,除湿止痛;辛夷散风解表,宣肺通窍;二药合用,能起到疏散外邪、宣通鼻窍、祛湿止痛之功效。辅以麻黄辛散宣肺,以助其通窍之力;白芷散寒解表,祛风止痛;薄荷轻清扬散,助辛夷、苍耳子疏风解热、清利头目;上述三味药作为臣药,助君药宣通肺气,疏散外邪。黄芩、连翘、野菊花清热解毒,使风热之邪得以从表解;藁本上入巅顶,燥湿祛风,治疗头痛;天花粉、生地滋阴润燥、凉血生津,以制方中辛温药之燥性;茯苓健脾渗湿;丹参活血化瘀;诸药配合,加强通窍排脓之功效,以上共为佐药。甘草调和诸药作为使药。上述药物大都入肺经,肺开窍于鼻。综观全方,配伍严谨,组方合理,散外寒兼清里热,散外寒以开窍利鼻,清里热以透脑止嚏。诸药配伍,标本同治,共奏疏风清热,宣肺通窍之功效。
与现有技术相比,本发明的有益效果是:
1.本发明中药组合物可显著降低急性肺损伤或急性呼吸窘迫综合征小鼠的肺指数,减轻肺泡出血、肺水肿程度,缓解肺损伤,疗效确切,效果显著,与地塞米松磷酸钠相当。
2.本发明中药组合物副作用小,临床安全性高,可长期使用。
附图说明
图1急性肺损伤或急性呼吸窘迫综合征模型各组小鼠肺组织病理切片,放大倍数:40.0X。
A:正常组;B:模型组;C:阳性药物组;D:低剂量组;
E:中剂量组;F:高剂量组。
具有实施方式
下面将对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅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。
实施例1颗粒剂的制备
其中,苍耳子以炒苍耳子为佳。
以上14味药,辛夷、薄荷、藁本、野菊花四味药中加入450ml提取挥发油,蒸馏后的水溶液及药渣分别另器收集;其余原料药加水2100ml煎煮3小时,趁热过滤,滤液备用,过滤后的药渣与上述药渣合并,再加2100ml水煎煮3次,每次1.5小时,过滤,合并所有滤液和上述辛夷等蒸馏后的水溶液,浓缩成清膏;与辅料混合制粒,喷挥发油,密闭24小时,即得颗粒剂。
实施例2颗粒剂的制备
其中,苍耳子以炒苍耳子为佳。
以上14味药,辛夷、薄荷、藁本、野菊花四味药中加入750ml提取挥发油,蒸馏后的水溶液及药渣分别另器收集;其余原料药加水5500ml煎煮3小时,趁热过滤,滤液备用,过滤后的药渣与上述药渣合并,再加5500ml水煎煮3次,每次1.5小时,过滤,合并所有滤液和上述辛夷等蒸馏后的水溶液,浓缩成清膏;与辅料混合制粒,喷挥发油,密闭24小时,即得颗粒剂。
实施例3颗粒剂的制备
其中,苍耳子以炒苍耳子为佳。
以上14味药,辛夷、薄荷、藁本、野菊花四味药中加入75ml提取挥发油,蒸馏后的水溶液及药渣分别另器收集;其余原料药加水705ml煎煮1小时,趁热过滤,滤液备用,过滤后的药渣与上述药渣合并,再加705ml水煎煮1次,每次0.5小时,过滤,合并所有滤液和上述辛夷等蒸馏后的水溶液,浓缩成清膏;与辅料混合制粒,喷挥发油,密闭24小时,即得颗粒剂。
实施例4丸剂的制备
其中,苍耳子以炒苍耳子为佳。
以上14味药,辛夷、薄荷、藁本、野菊花四味药中加入300ml提取挥发油,蒸馏后的水溶液及药渣分别另器收集;其余原料药加水1500ml煎煮2小时,趁热过滤,滤液备用,过滤后的药渣与上述药渣合并,再加1500ml水煎煮2次,每次1小时,过滤,合并所有滤液和上述辛夷等蒸馏后的水溶液,浓缩成清膏;最后经过常规工序加入药学上可接受的辅料制成丸剂。
实施例5片剂的制备
其中,苍耳子以炒苍耳子为佳。
以上14味药,辛夷、薄荷、藁本、野菊花四味药中加入550ml提取挥发油,蒸馏后的水溶液及药渣分别另器收集;其余原料药加水2500ml煎煮2小时,趁热过滤,滤液备用,过滤后的药渣与上述药渣合并,再加2500ml水煎煮2次,每次1小时,过滤,合并所有滤液和上述辛夷等蒸馏后的水溶液,浓缩成清膏;最后经过常规工序加入药学上可接受的辅料制成片剂。
实施例6胶囊剂的制备
其中,苍耳子以炒苍耳子为佳。
以上14味药,辛夷、薄荷、藁本、野菊花四味药中加入900ml提取挥发油,蒸馏后的水溶液及药渣分别另器收集;其余原料药加水2500ml煎煮2小时,趁热过滤,滤液备用,过滤后的药渣与上述药渣合并,再加2500ml水煎煮2次,每次1.5小时,过滤,合并所有滤液和上述辛夷等蒸馏后的水溶液,浓缩成清膏;最后经过常规工序加入药学上可接受的辅料制成胶囊剂。
实施例7口服液的制备
其中,苍耳子以炒苍耳子为佳。
以上14味药,辛夷、薄荷、藁本、野菊花四味药中加入100ml提取挥发油,蒸馏后的水溶液及药渣分别另器收集;其余原料药加水1800ml煎煮2小时,趁热过滤,滤液备用,过滤后的药渣与上述药渣合并,再加1800ml水煎煮2次,每次1小时,过滤,合并所有滤液和上述辛夷等蒸馏后的水溶液,浓缩成清膏;最后经过常规工序加入药学上可接受的辅料制成口服液。
实施例8鼻渊通窍颗粒对气管滴注脂多糖导致的小鼠急性肺损伤或急性呼吸窘迫综合征的影响
1.实验材料
1.1实验动物:SPF级ICR小鼠,3周龄,体重20-22g,雄性,90只。
1.2实验药物:
鼻渊通窍颗粒:山东新时代药业有限公司,批号:0022010017
阳性药物:地塞米松磷酸钠注射液,辰欣药业股份有限公司,批号:2108230612
舒泰50:法国维克有限公司,批号:7XDYA
盐酸赛拉嗪注射液:吉林省华牧动物保健品有效公司,批号:2020118
2.实验方法
2.1分组与给药
实验前适应性喂养7d后,随机分成6组,每组15只,分别为正常组、模型组、鼻渊通窍颗粒低剂量组、中剂量组、高剂量组、阳性药物组。低剂量组、中剂量组、高剂量组给药剂量分别为鼻渊通窍颗粒2.93g/kg、5.86g/kg、11.72g/kg(相当于临床剂量的1/2、1、2倍剂量),给药方式为灌胃给药,给药体积为10ml/kg,阳性药物组腹腔注射地塞米松磷酸钠注射液为5mg/kg,正常组、模型组灌胃给予等体积的纯化水,连续给药13天,每天1次。
2.2造模
各组第12天给药完毕后造模。先用舒泰50腹腔麻醉后,将小鼠固定在手术板上,颈部消毒,纵向切开颈部皮肤,剥离皮下组织,暴露气管,使用微量进样器对正常组小鼠气管滴注纯化水,其余各组气管滴注脂多糖溶液(1.7mg/ml)0.1ml,建立小鼠急性肺损伤或急性呼吸窘迫综合征模型。造模24h后处死小鼠取材。
2.3观察指标
2.3.1肺指数
肺指数=肺重量(mg)/体重(g),可以用来评估肺水肿的严重程度。结果见表1。
2.3.2肺湿重/干重(W/D)
肺干/湿比=(肺干重wet/肺湿重dry ratio),可以用来评估肺水肿的严重程度。结果见表1。
2.3.3肺组织处理
将小鼠肺组织固定于福尔马林溶液中,用于病理观察。结果见图1。
2.3.4统计方法
采用SPSS17.0软件进行统计学处理,实验数据以“均值±标准差”的形式表示,组间比较采用单因素方差分析,两组间比较采用t检验。以P<0.05表示差异具有统计学意义。
3.实验结果
3.1鼻渊通窍颗粒对肺指数及肺湿重/干重(W/D)的影响
表1鼻渊通窍颗粒对肺指数及肺湿重/干重(W/D)的影响
注:与正常组比较**p<0.01;与模型组比较#p<0.05,##p<0.01。
由表1可知,与正常组比较,模型组肺指数、W/D显著的升高,有极显著统计学差异(p<0.01),造模成功。与模型组比较,高剂量组肺指数和W/D显著的降低,有统计学差异(p<0.05);阳性药物组肺指数无统计学差异(p>0.05),W/D显著降低,有统计学差异(p<0.01)。以上结果表明,鼻渊通窍颗粒可显著降低肺指数和W/D,减轻肺水肿程度,缓解肺损伤,疗效确切,与地塞米松磷酸钠相当。
3.2鼻渊通窍颗粒对肺组织的病理影响
由图1可知,与正常组比较,脂多糖导致的小鼠急性肺损伤,模型组小鼠肺组织肺泡出血、水肿,各给药组肺泡出血、肺水肿均有不同程度的改善,中、高剂量组与阳性药物组相当。可见鼻渊通窍颗粒可减轻肺组织受损程度,具有治疗肺损伤的作用,效果显著,与地塞米松磷酸钠相当。
发明人按照实施例8的实验方法,研究了鼻渊通窍颗粒、实施例2颗粒剂对气管滴注脂多糖导致的小鼠急性肺损伤或急性呼吸窘迫综合征的影响,结果表明鼻渊通窍颗粒组、实施例2颗粒剂组对疾病模型的改善效果与地塞米松磷酸钠组相当。此外,鼻渊通窍颗粒组在指标改善上优于实施例2颗粒剂组,与实施例2颗粒剂组相比,鼻渊通窍颗粒组肺指数具有显著性差异。
鼻渊通窍颗粒是一种纯中药制剂,自批准上市以来,不良反应仅是偶见腹泻,一般停药后症状会消失,副作用较小,具有良好的临床安全性。
地塞米松磷酸钠是一种肾上腺皮质激素类药物,长期大量使用副作用大。万姜维等(中医药治疗糖皮质激素副作用研究进展.《河南中医》.2016.36(5):914-917)公开了糖皮质激素在应用过程中存在各种副作用,如肾上腺皮质醇增多症(向心性肥胖、满月脸、水牛背、痤疮、多毛等类库欣综合征表现)、代谢紊乱(激素性血糖、血压升高、水、电解质紊乱等)、诱发或加重感染、溃疡、精神病及抑制儿童生长发育等。
与地塞米松磷酸钠比较,鼻渊通窍颗粒副作用小,临床安全性好,可长期使用。
Claims (10)
1.一种中药组合物在制备预防或治疗急性肺损伤药物中的用途。
2.一种中药组合物在制备预防或治疗急性呼吸窘迫综合征药物中的用途。
3.根据权利要求1-2任一项所述的用途,其特征在于,所述中药组合物在制备降低急性肺损伤或急性呼吸窘迫综合征肺指数药物中的用途。
4.根据权利要求1-3任一项所述的用途,其特征在于,所述中药组合物是由下述原料药制成的:
5.根据权利要求4所述的用途,其特征在于,所述中药组合物是由下述原料药制成的:
6.根据权利要求5所述的用途,其特征在于,所述中药组合物是由下述原料药制成的:
7.根据权利要求4-6任一项中所述的用途,其特征在于,所述中药组合物中苍耳子是炒苍耳子。
8.根据权利要求1-7任一项中所述的用途,其特征在于,所述中药组合物可经过常规工艺直接或加入药学上可接受的辅料后制备成临床上可接受的剂型。
9.根据权利要求8所述的用途,其特征在于,所述临床上可接受的剂型为颗粒剂、口服液、合剂、丸剂、片剂、糖浆剂、胶囊剂。
10.根据权利要求9所述的用途,其特征在于,所述临床上可接受的剂型为颗粒剂。
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