CN102335327B - 一种治疗哮喘的药物组合物 - Google Patents
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Abstract
本发明公开了一种治疗哮喘的药物组合物，其由如下重量份的活性成分制备而成：元胡10-15份、桔梗8-12份、白果仁8-12份、厚朴4-8份、五味子4-8份、川贝4-8份、黄芩8-12份、甘草4-8份、麻黄4-8份。该药物对治疗哮喘具有疗效好、安全高的优点。
Description
技术领域
本发明涉及一种治疗哮喘的药物组合物，属于中药技术领域。
背景技术
哮喘是一种常见的呼吸系统疾病，发病率有逐年升高的趋势。哮喘的发病机制非常复杂，至今尚未完全明确。20世纪50年代曾认为是一种气道平滑肌功能异常性疾病，80年代初提出了哮喘的本质是气道高反应性。目前认为哮喘是多种细胞和细胞成分参与的气道慢性炎症性疾病，以肺部可逆性气流阻塞、气道黏膜炎症和气道高反应性为特征。
最近的研究又表明，哮喘患者长期的慢性炎症可导致气道重构，造成患者肺通气功能下降，极易诱发严重的哮喘发作。β-受体激动剂和皮质激素类药物是目前临床上治疗哮喘、慢性阻塞性肺病等呼吸系统疾病最为有效的药物，但从根本上讲，并不能使哮喘患者痊愈，患者仍然需要终生服药。另外，β-受体激动剂对于有心脏疾病的患者来说，使用过程中存在着较大的风险，易于诱发心律失常，而且，对于很多的长期哮喘患者，都存在着不同程度的心脏疾患，这更增加了用药的风险。另外，β-受体激动剂在使用过程中掩盖了哮喘患者已经十分严重的气道炎症症状，易于诱发致命的哮喘发作，而皮质激素类药物具有强大的抗炎活性，但若全身使用，不良反应十分严重，呼吸道局部使用对很多的婴幼儿或高龄老年患者十分不便，且局部使用在药物的制备上造价升高，这在很大程度上加大了患者的医疗费用。
因而寻求开发一种成本低，疗效好，安全性高，能够抑制哮喘患者气道重构的药物，从根本上治愈哮喘，减轻患者的痛苦和巨额的医疗费用，这符合广大患者的利益，对于建设我们的和谐社会具有重要意义。
发明内容
鉴于现有技术的不足，本发明的目的在于通过大量动物实验研究，提供一种治疗哮喘的药物组合物。该药物能够抑制哮喘患者气道重构，对哮喘有显著疗效，并且成本低，安全性高。
本发明的目的是这样实现的：
一种治疗哮喘的药物组合物，由如下重量份的活性成分制备而成：
| 元胡10-15份 | 桔梗8-12份 | 白果仁8-12份 |
| 厚朴4-8份 | 五味子4-8份 | 川贝4-8份 |
| 黄芩8-12份 | 甘草4-8份 | 麻黄4-8份。 |
优选地，所述的治疗哮喘的药物组合物，由如下重量份的活性成分制备而成：
| 元胡10份 | 桔梗9份 | 白果仁10份 |
| 厚朴6份 | 五味子6份 | 川贝5份 |
| 黄芩8份 | 甘草6份 | 麻黄6份。 |
进一步优选地，所述的治疗哮喘的药物组合物是口服液。
通过动物试验研究发现，由上述活性成分组成的药物组合物在治疗哮喘模型大鼠方面具有显著的疗效。因此，本发明的第二个目的在于提供一种医药新用途，即上述的中药组合物在制备治疗哮喘的药物中的应用。
根据中医药史料记载，上述9味中药具有如下药理活性和功能主治：
元胡：活血化瘀、行气止痛，用于全身各部气滞血瘀之痛，痛经，经闭，症瘕，产后瘀阻，跌扑损伤，疝气作痛。选用罂粟科(Papaveraceae)植物延胡索或齿瓣延胡索的块茎。
桔梗：开宣肺气，祛痰排脓。治外感咳嗽，咽喉肿痛，适用于外感风寒，咽喉肿痛，肺脓疡，咳吐脓血，痢痰腹痛等症。选用双子叶植物桔梗科Campanulaceae 桔梗Platycodon grandiflorum ( Jacq.) A. DC.的根。
白果仁：敛肺定喘，止带浊，缩小便，用于痰多喘咳、带下白浊、遗尿尿频。选用银杏科落叶乔木银杏GinkgobilobaL.的成熟种子。
厚朴：主温中，益气，消痰下气，治霍乱及腹痛，胀满，胃中冷逆，胸中呕逆不止，泄痢，淋露，除惊，去留热，止烦满，厚肠胃。选用木兰科植物厚朴Magnolia officinalis Rehd. et Wils.或凹叶厚朴Magnolia officinalis Rehd. et Wils. var. biloba Rehd. et Wils.的干燥干皮、根皮及枝皮。
五味子：收敛固涩，益气生津，补肾宁心。用于久嗽虚喘，梦遗滑精，遗尿尿频，久泻不止，自汗，盗汗，津伤口渴，短气脉虚，内热消渴，心悸失眠。
川贝：润肺止咳，化痰平喘，清热化痰。治虚劳咳嗽，吐痰咯血，心胸郁结，肺痿，肺痈，喉痹。选用百合科植物川贝母、暗紫贝母、甘肃贝母、梭砂贝母的干燥鳞茎。
黄芩：清热燥湿，泻火解毒，止血，安胎，降血压。用于湿温、暑温胸闷呕恶，湿热痞满，泻痢，黄疸，肺热咳嗽，高热烦渴，血热吐衄，痈肿疮毒，胎动不安。选用唇形科植物黄芩 Scutellaria baicalensis Georgi 的干燥根。
甘草：补脾益气，清热解毒，祛痰止咳，缓急止痛，调和诸药。用于脾胃虚弱，倦怠乏力，心悸气短，咳嗽痰多，脘腹、四肢挛急疼痛，痈肿疮毒，缓解药物毒性、烈性。选用为双子叶植物豆科 Leguminosae甘草 Glycyrrhiza uralensis Fisch. ，胀果甘草 G. inflata Bat.， 或光果甘草 G. glabra L. 的根及根茎。
麻黄：发汗散寒，宣肺平喘，利水消肿。多用于风寒表实证，胸闷喘咳，风水浮肿，风湿痹痛，阴疽，痰核。选用为麻黄科植物草麻黄 Ephedra sinica Stapf，中麻黄Ephedra intermedia Schrenk et C. A. Mey. 或木贼麻黄Ephedra equisetina Bge. 的草质茎。
将上述各中药材制备成本发明的中药复方制剂的制备方法，包括如下步骤：
（1）取处方量的上述9味中药材，洗净去杂，晾干，粉碎成颗粒；
（2）再将上述颗粒状药材加水漫过药面2cm，浸泡1-1.2h，捞出药材置多功能提取灌中加水煎煮二次，第一次加总药材8-10倍量的水，煎煮2h，取煎液，滤过，第二次加总药材6-8倍量的水，煎煮1h，取两次煎液合并，滤过，浓缩至90℃时相对密度为1.05的浓缩液；
（3）将浓缩液置0-5℃低温冷藏24h，将冷藏液加0.3%的助滤剂硅藻土，滤过，滤液再浓缩至每ml含2-3g生药量，再加入0.2%的山梨酸钾，搅拌均匀，置0-5℃低温冷藏24h，将冷藏液滤过，灌封，包装即得口服液。
用法用量：患者每次服10-20ml，每天早晚各一次。
与现有技术相比，本发明涉及的药物组合物具有如下优点和显著的进步：（1）疗效好。根据本试验表2的结果显示，本发明的中药口服液对大鼠的哮喘症状有显著的协同抑制作用，大大延长了支气管哮喘发病的潜伏期，与阳性对照药地塞米松的治疗效果相当。（2）安全性高。由于本发明的药物由采用传统中药材制备而成，毒性低，患者用药更安全。
具体实施方式
下面通过实施例进一步说明本发明。本发明的实施例仅仅是用于说明本发明，而不是对本发明的限制，在本发明的构思前提下对本发明制备方法的简单改进都属于本发明要求保护的范围。
实施例1中药口服液的制备
生药处方：
| 元胡100g | 桔梗90g | 白果仁100g |
| 厚朴60g | 五味子60g | 川贝50g |
| 黄芩80g | 甘草60g | 麻黄60g |
制备方法：
（1）取处方量的上述9味中药材，洗净去杂，晾干，粉碎成颗粒；
（2）再将上述颗粒状药材加水漫过药面2cm，浸泡1h，捞出药材置多功能提取灌中加水煎煮二次，第一次加总药材10倍量的水，煎煮2h，取煎液，滤过，第二次加总药材8倍量的水，煎煮1h，取两次煎液合并，滤过，浓缩至90℃时相对密度为1.05的浓缩液；
（3）将浓缩液置0℃低温冷藏24h，将冷藏液加0.3%的助滤剂硅藻土，滤过，滤液再浓缩至每ml含2g生药量，再加入0.2%的山梨酸钾，搅拌均匀，置0℃低温冷藏24h，将冷藏液滤过，灌封，包装即得口服液。
实施例2中药口服液的制备
生药处方：
| 元胡150g | 桔梗80g | 白果仁80g |
| 厚朴80g | 五味子80g | 川贝40g |
| 黄芩100g | 甘草40g | 麻黄80g |
制备方法：
（1）取处方量的上述9味中药材，洗净去杂，晾干，粉碎成颗粒；
（2）再将上述颗粒状药材加水漫过药面2cm，浸泡1.2h，捞出药材置多功能提取灌中加水煎煮二次，第一次加总药材8倍量的水，煎煮2h，取煎液，滤过，第二次加总药材8倍量的水，煎煮1h，取两次煎液合并，滤过，浓缩至90℃时相对密度为1.05的浓缩液；
（3）将浓缩液置5℃低温冷藏24h，将冷藏液加0.3%的助滤剂硅藻土，滤过，滤液再浓缩至每ml含2g生药量，再加入0.2%的山梨酸钾，搅拌均匀，置5℃低温冷藏24h，将冷藏液滤过，灌封，包装即得口服液。
实施例3中药口服液的制备
生药处方：
| 元胡120g | 桔梗120g | 白果仁120g |
| 厚朴40g | 五味子40g | 川贝80g |
| 黄芩120g | 甘草80g | 麻黄40g |
制备方法：
（1）取处方量的上述9味中药材，洗净去杂，晾干，粉碎成颗粒；
（2）再将上述颗粒状药材加水漫过药面2cm，浸泡1h，捞出药材置多功能提取灌中加水煎煮二次，第一次加总药材8倍量的水，煎煮2h，取煎液，滤过，第二次加总药材6倍量的水，煎煮1h，取两次煎液合并，滤过，浓缩至90℃时相对密度为1.05的浓缩液；
（3）将浓缩液置0℃低温冷藏24h，将冷藏液加0.3%的助滤剂硅藻土，滤过，滤液再浓缩至每ml含3g生药量，再加入0.2%的山梨酸钾，搅拌均匀，置0℃低温冷藏24h，将冷藏液滤过，灌封，包装即得口服液。
实施例4 本发明中药口服液对哮喘大鼠模型的影响
1、动物分组
SD大鼠按体重随机分为3组，每组14只，雌雄各半。造模成功后，各组大鼠按照如表1给药。
表1实验动物分组及给药 
2、造模与给药
SD大鼠适应5天后，体重为260~360g，按体重随机分为3组，每组14只。分别灌胃给予不同的药物，模型组灌胃给予纯水作为对照。各组分别腹腔注射新鲜制备的5%卵白蛋白(1ml/只)和白百破疫苗(0.1ml/只)，5天后强化一次。10天后雾化吸入1%卵白蛋白溶液，每天一次，15min/次，连续35天。同时各组分别灌胃给予表1所示受试物，连续灌胃45天。
大鼠速发相哮喘的诱发：用1%卵白蛋白和2%乙酰胆碱雾化攻击，诱发哮喘，观察各组的潜伏期和哮喘症状。
在试验组的大鼠中，本发明的中药口服液对大鼠的哮喘症状有显著的协同抑制作用，大大延长了支气管哮喘发病的潜伏期，与阳性对照药地塞米松的治疗效果相当。具体实验结果见表1。
与模型组比较，*P<0.05
Claims (3)
1.一种治疗哮喘的药物组合物，由如下重量份的活性成分制备而成：元胡10份，桔梗9份，白果仁10份，厚朴6份，五味子6份，川贝5份，黄芩8份，甘草6份，麻黄6份。
2.根据权利要求1所述的治疗哮喘的药物组合物，其特征在于：所述药物组合物为口服液。
3.权利要求1所述的药物组合物在制备治疗哮喘的药物中的应用。
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