CN104398827A - 一种治疗支气管哮喘的药剂 - Google Patents

一种治疗支气管哮喘的药剂 Download PDF

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CN104398827A
CN104398827A CN201410740895.2A CN201410740895A CN104398827A CN 104398827 A CN104398827 A CN 104398827A CN 201410740895 A CN201410740895 A CN 201410740895A CN 104398827 A CN104398827 A CN 104398827A
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庄宿龙
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Abstract

本发明涉及一种治疗支气管哮喘的药剂，它包含下列重量份的物质：小果排草10-20份、石壁莲10-30份、云苔草1-20份、牛尾泡1-20份、雉子筵1-20份、毛排钱草10-30份、芦荟10-30份、六棱麻1-20份、枸杞子10-30份、白冷草1-20份、酸枣仁10-30份、肉桂10-20份、川层草10-20份、人参1-20份、水藿香10-20份、大青叶1-10份、白头翁1-20份、玉龙鞭10-20份、茯苓20-50份、菊花20-30份、紫苏子10-20份、青黛1-20份、龙舌草10-30份、白及10-20份和甘草10-30份。本发明所述的药剂互相影响，协同作用，辛温走窜，散寒化饮，利气止痛，调动经脉功能，发挥行气血、调阴阳作用，治疗支气管哮喘效果显著，值得临床推广。

Description

一种治疗支气管哮喘的药剂
技术领域
本发明涉及医药领域，具体来说涉及一种治疗支气管哮喘的药剂。
背景技术
支气管哮喘作为一种慢性呼吸系统疾病，严重影响患者的身心健康，冬季好发及受寒易发，是最常见的慢性气道炎症性疾病，气道的高反应性为哮喘的特征，且在缓解期依然存在，该病易复发，临床治疗颇为棘手。
发明内容
本发明的目的是提供一种治疗支气管哮喘的药剂。
为了实现本发明的目的，本发明提供一种治疗支气管哮喘的药剂，它包含下列重量份的物质：小果排草10-20份、石壁莲10-30份、云苔草1-20份、牛尾泡1-20份、雉子筵1-20份、毛排钱草10-30份、芦荟10-30份、六棱麻1-20份、枸杞子10-30份、白冷草1-20份、酸枣仁10-30份、肉桂10-20份、川层草10-20份、人参1-20份、水藿香10-20份、大青叶1-10份、白头翁1-20份、玉龙鞭10-20份、茯苓20-50份、菊花20-30份、紫苏子10-20份、青黛1-20份、龙舌草10-30份、白及10-20份和甘草10-30份。
优选地，本发明所述的治疗支气管哮喘的药剂包含下列重量份的物质：小果排草12份、石壁莲20份、云苔草10份、牛尾泡10份、雉子筵10份、毛排钱草20份、芦荟20份、六棱麻10份、枸杞子20份、白冷草10份、酸枣仁20份、肉桂15份、川层草15份、人参10份、水藿香12份、大青叶5份、白头翁10份、玉龙鞭15份、茯苓30份、菊花25份、紫苏子15份、青黛10份、龙舌草20份、白及15份和甘草20份。
优选地，所述药剂可以是片剂、分散片、胶囊剂、软胶囊剂或汤剂。
本发明还提供组合物在制备治疗支气管哮喘的药物中的用途，所述组合物包含下列重量份的物质：小果排草10-20份、石壁莲10-30份、云苔草1-20份、牛尾泡1-20份、雉子筵1-20份、毛排钱草10-30份、芦荟10-30份、六棱麻1-20份、枸杞子10-30份、白冷草1-20份、酸枣仁10-30份、肉桂10-20份、川层草10-20份、人参1-20份、水藿香10-20份、大青叶1-10份、白头翁1-20份、玉龙鞭10-20份、茯苓20-50份、菊花20-30份、紫苏子10-20份、青黛1-20份、龙舌草10-30份、白及10-20份和甘草10-30份。
优选地，所述组合物包含下列重量份的物质：小果排草12份、石壁莲20份、云苔草10份、牛尾泡10份、雉子筵10份、毛排钱草20份、芦荟20份、六棱麻10份、枸杞子20份、白冷草10份、酸枣仁20份、肉桂15份、川层草15份、人参10份、水藿香12份、大青叶5份、白头翁10份、玉龙鞭15份、茯苓30份、菊花25份、紫苏子15份、青黛10份、龙舌草20份、白及15份和甘草20份。
优选地，所述药物可以是片剂、分散片、胶囊剂、软胶囊剂或汤剂。
在本发明的组合物中，小果排草、石壁莲、云苔草性温入肺经，以温化伏肺之寒饮而止咳平喘，为君药；牛尾泡、雉子筵、毛排钱草、芦荟、六棱麻、枸杞子、白冷草逐痰平喘、利气止痛，辛温解表，温肺止咳，为臣药；酸枣仁、肉桂、川层草、人参、水藿香、大青叶、白头翁、玉龙鞭、茯苓、菊花、紫苏子、青黛、龙舌草、白及辛温走窜，散寒化饮，行气血、调阴阳，为佐药；甘草调和诸药，为使药。
本发明所述的药剂互相影响，协同作用，相辅相成，共奏君臣佐使之功，辛温走窜，散寒化饮，利气止痛，调动经脉功能，发挥行气血、调阴阳作用，治疗支气管哮喘效果显著，值得临床推广。
具体实施方式
下面通过实施例进一步说明本发明。应该理解的是，本发明的实施例是用于说明本发明而不是对本发明的限制。根据本发明的实质对本发明进行的简单改进都属于本发明要求保护的范围。除非另有说明，否则本发明中的百分数是重量百分数。
实施例本发明的汤剂
称取小果排草12克、石壁莲20克、云苔草10克、牛尾泡10克、雉子筵10克、毛排钱草20克、芦荟20克、六棱麻10克、枸杞子20克、白冷草10克、酸枣仁20克、肉桂15克、川层草15克、人参10克、水藿香12克、大青叶5克、白头翁10克、玉龙鞭15克、茯苓30克、菊花25克、紫苏子15克、青黛10克、龙舌草20克、白及15克和甘草20克，粉碎，加入3000毫升水，在装有冷凝管的烧瓶中加热回流3小时，然后过滤，得到滤液1和滤渣1；2)向滤渣1中加入2000毫升水，在装有冷凝管的烧瓶中加热3小时，过滤，得到滤液2和滤渣2；3)向滤渣2中加入1000毫升水，在装有冷凝管的烧瓶中加热1小时，过滤，得到滤液3和滤渣3；4)合并所述滤液1、滤液2和滤液3，冷却至室温，即得。
毒性试验
急性毒性试验：应用NIH小鼠60只，SPF级，雌雄各半，体重17～24g，进行急性毒性试验。小鼠随机分为两组，每组30只，即对照组和给药组，实验前禁食12小时；调整实施例中制备的汤剂，使得浓度为6.68g生药/ml，灌胃，灌胃容积为5ml/kg(即单次给予药剂量为33.4g生药/kg)，对照组给予等量生理盐水，一天给药2次，给药间隔时间6小时，给药后连续观察14天，并记录小鼠的毒性反应及死亡数。实验结果表明：与对照组比较，给药后小鼠未见明显差异，实验连续观察14天，小鼠全身状况、饮食、饮水、体重增长均正常。选择处死给药组小鼠，显微镜下检查：心、肝、肺、胃内及胸腺等重要脏器，未见异常改变。小鼠口服灌胃本发明的汤剂LD50>33.4g生药/kg，每日最大给药量为66.8g生药/kg/日。本发明的药物临床用药量为5.12g生药/日/人，成人体重以60kg计，平均用药剂量为0.085g生药/kg/日。按体重计：小鼠(平均体重以21g计)口服灌胃本发明的中药的耐受量为临床用量的786倍。因此本发明内服的药剂急性毒性低，临床用药安全。
长期毒性试验：应用SD大鼠，体重200g±10g，雌雄各半。使用实施例中制备的汤剂来进行测试。配制高、中、低三个剂量组，分别为临床用药量的300、150、75倍，用含2重量％阿拉伯树胶的生理盐水1:1混合。采用灌胃给药方式，连续用药16周(1.0ml/100g体重，每天2次)及停药4周后，结果表明：本发明药物对大鼠的毛发、行为、大小便、体重、脏器重量、血象、肝肾功能、血糖、血脂等指标均无明显影响，脏器肉眼没有发现异样变化和组织学检查结果表明，用药16周及停药4周后，大鼠各个脏器均无明显改变。说明本发明内服的药剂对大鼠长期用药后毒性小，停药后也没有异样反应，应用安全。
实验例
诊断和辨证标准参照《支气管哮喘防治指南》(中华医学会呼吸病学分学会哮喘学组.支气管哮喘防治指南[J]-中华结核和呼吸杂志，2003,26(3):132-138.)中的诊断标准。选取我院收治的支气管哮喘患者100例，其中男50例，女50例；年龄18-71岁，平均年龄39.5岁；病程1-6年，平均2.5年。
口服实施例中制备的汤剂来进行治疗，每日2次，本发明的药物临床用药量为5.12g生药/日/人。连续治疗30天。
观察指标及方法
①根据自拟评分标准对患者哮喘症状包括喘息和哮鸣音进行评分，并记录患者缓解期时间、发作次数和发作持续时间。②参照《成人哮喘生命质量评分表》(李明华，殷凯生，蔡映云.哮喘病学[M].2版.北京:人民卫生出版社，2006:758-760.)对患者治疗前后生命质量评估。全表共37个问题，分6个部分，包括活动受限(1-7题)，回避刺激物(8-12题)，哮喘症状(13-22题)，心理情绪(23-28题)，对刺激物反应(29-33题)，对疾病担心(34-37题)。按5分制评分，1分为最好，5分为最差。③对贴敷后疗效进行评价，并分析贴敷时间与疗效的关系。
疗效评价标准
临床控制:不需任何平喘药物，保持无症状1年以上者。显效:偶用平喘药物而缓解喘息者。有效:喘息症状有所减轻，但时常仍需药物治疗者，或缓解期延长，发作次数减少，发作时间缩短者。无效:症状无改善。
统计学方法
采用SPSS 18.0软件包进行统计分析，计量资料自身对照用t检验，计数资料用χ2检验，组间比较采用方差分析。
结果
经过治疗，在100例患者中，临床控制54例，显效23例，有效16例，无效7例，总有效率为93％。
治疗前后患者哮喘症状、缓解期时间、发作次数和发作持续时间比较见下表
注：与治疗前比较，＊P＜0.05，＊＊P＜0.01
治疗前后患者生命质量评分比较见下表
注：与治疗前比较，＊P＜0.05，＊＊P＜0.01
由上面两表可见，治疗后各项指标都有显著性改善。

Claims (6)

1.一种治疗支气管哮喘的药剂，其特征在于，它包含下列重量份的物质：小果排草10-20份、石壁莲10-30份、云苔草1-20份、牛尾泡1-20份、雉子筵1-20份、毛排钱草10-30份、芦荟10-30份、六棱麻1-20份、枸杞子10-30份、白冷草1-20份、酸枣仁10-30份、肉桂10-20份、川层草10-20份、人参1-20份、水藿香10-20份、大青叶1-10份、白头翁1-20份、玉龙鞭10-20份、茯苓20-50份、菊花20-30份、紫苏子10-20份、青黛1-20份、龙舌草10-30份、白及10-20份和甘草10-30份。
2.根据权利要求1所述的治疗支气管哮喘的药剂，其特征在于，它包含下列重量份的物质：小果排草12份、石壁莲20份、云苔草10份、牛尾泡10份、雉子筵10份、毛排钱草20份、芦荟20份、六棱麻10份、枸杞子20份、白冷草10份、酸枣仁20份、肉桂15份、川层草15份、人参10份、水藿香12份、大青叶5份、白头翁10份、玉龙鞭15份、茯苓30份、菊花25份、紫苏子15份、青黛10份、龙舌草20份、白及15份和甘草20份。
3.根据权利要求1或2所述的治疗支气管哮喘的药剂，其特征在于，所述药剂可以是片剂、分散片、胶囊剂、软胶囊剂或汤剂。
4.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，所述组合物包含下列重量份的物质：小果排草10-20份、石壁莲10-30份、云苔草1-20份、牛尾泡1-20份、雉子筵1-20份、毛排钱草10-30份、芦荟10-30份、六棱麻1-20份、枸杞子10-30份、白冷草1-20份、酸枣仁10-30份、肉桂10-20份、川层草10-20份、人参1-20份、水藿香10-20份、大青叶1-10份、白头翁1-20份、玉龙鞭10-20份、茯苓20-50份、菊花20-30份、紫苏子10-20份、青黛1-20份、龙舌草10-30份、白及10-20份和甘草10-30份。
5.根据权利要求4所述的用途，其特征在于，所述组合物包含下列重量份的物质：小果排草12份、石壁莲20份、云苔草10份、牛尾泡10份、雉子筵10份、毛排钱草20份、芦荟20份、六棱麻10份、枸杞子20份、白冷草10份、酸枣仁20份、肉桂15份、川层草15份、人参10份、水藿香12份、大青叶5份、白头翁10份、玉龙鞭15份、茯苓30份、菊花25份、紫苏子15份、青黛10份、龙舌草20份、白及15份和甘草20份。
6.根据权利要求4或5所述的用途，其特征在于，所述药物可以是片剂、分散片、胶囊剂、软胶囊剂或汤剂。
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