CN114533847A - 一种用于辅助治疗肺病的中药穴位敷贴剂 - Google Patents
一种用于辅助治疗肺病的中药穴位敷贴剂 Download PDFInfo
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Abstract
本发明涉及一种用于辅助治疗肺病的中药穴位敷贴剂，及其中药穴位敷贴产品，以及它们在制备辅助治疗慢性肺病药物方面的应用；本发明的中药穴位敷贴剂采用特定的中药组分，可以辅助治疗慢性肺系疾病；特别是，本发明的中药穴位敷贴剂在“邵氏阳虚哮喘贴”穴位敷贴的药物配方进行了改进，增加了特定份数的白芥子、延胡索和干姜，意外发现，能够在原有治疗以“阳虚寒喘”为特点的虚寒型肺系疾病及其它肺系疾病的基础上，对于发生的胸背部疼痛、胸闷气短、痰多气喘有明显的改善效果，还缓解了中药敷贴剂的发泡作用所带来的疼痛感，降低了皮肤发红、起泡、皮炎、瘙痒等副反应的发生，提高了病人对敷贴制剂的耐受度。
Description
技术领域
本发明涉及一种用于辅助治疗肺病的中药穴位敷贴剂，及其中药穴位敷贴产品，以及它们在制备辅助治疗慢性肺病药物方面的应用，属于中药技术领域。
背景技术
贴敷/敷贴疗法是以中医基本理论为指导，应用中草药制剂，施于皮肤、孔窍、俞穴及病变局部等部位的治病方法，属于中药外治法。贴敷疗法简便易学，作用迅速，容易推广，使用安全，副作用极小，乐为患者接受，是中医治疗学的重要组成部分，并较内治法更为简便、实用。
慢性肺系疾病的特点是反复发作，缠绵难愈，其显著特点是多于春秋冬寒冷之际发作或加重，如哮喘、慢阻肺等。目前相关治疗方法有长期糖皮质激素、支气管舒张剂等药物吸入或口服解痉平喘药，但无法解决复发的问题，且药物毒副作用和长期用药困难使得收效甚微。
中医研究人员选用中药穴位敷贴，其适用于老幼虚弱之体罹患慢性肺系疾病，攻补难施之时或不肯服药、不能服药之症，可缓解临床症状，降低复发可能，更有内服法所不具有的诸多优点。
现有的一些治疗肺病的中药剂，一般局限于治疗轻度肺脾气虚者，对于脾肾阳虚的患者改善不佳。
发明内容
为了解决上述技术问题，本发明第一方面提供了一种用于辅助治疗肺病的中药穴位敷贴剂，其中，
所述中药穴位敷贴剂包括基础药物组分；
所述基础药物组分，按重量份，其包括8～12份熟附子、8～12份巴戟肉、8～12份盐补骨脂、8～12份淫羊藿、8～12份槲寄生、8～12份白芥子、8～12份延胡索、2.2～3.8份丁香、2.2～3.8份吴茱萸、2.2～3.8份肉桂、4～6份麻黄和6.5～9.5份干姜。
优选的，所述基础药物组分，按重量份，其包括10份熟附子、10份巴戟肉、10份盐补骨脂、10份淫羊藿、10份槲寄生、10份白芥子、10份延胡索、3份丁香、3份吴茱萸、3份肉桂、5份麻黄和8份干姜。
优选的，所述中药穴位敷贴剂还包括辅料组分。
本发明第二方面提供了一种用于辅助治疗肺病的中药穴位敷贴产品，其中，所述中药穴位敷贴产品采用如上述的中药穴位敷贴剂制成。
优选的，所述中药穴位敷贴产品包括穴位敷贴的药丸或药饼；将所述中药穴位敷贴剂的各组分研磨成粒径小于120目的粉末，将生姜汁或者蜂蜜与所述粉末调和，形成所述药丸或药饼。
优选的，所述的药丸或药饼的直径为1～5cm。
优选的，所述中药穴位敷贴产品还包括医用敷料；所述药丸或药饼被固定在所述医用敷料的粘合面上。
本发明第三方面提供了如上述的中药穴位敷贴剂、如上述的中药穴位敷贴产品，在制备辅助治疗慢性肺病药物方面的应用。
优选的，所述慢性肺病为阳虚哮喘。
本发明的用于辅助治疗肺病的中药穴位敷贴剂，采用特定的中药组分，可以辅助治疗慢性肺系疾病，例如可以与诸如喘可治、黄芪注射液或核酪注射液等配合治疗寒证、虚证(肺虚、脾虚、肾虚)为主的支气管哮喘、慢阻肺、反复呼吸道感染、慢性咳嗽等慢性肺病，能显著降低患者的中医证候积分，改善患者的肺功能和免疫功能，减少3个月内急性发作次数，提高患者的生活质量，充分体现了“治未病”的思想；特别是，本发明的中药穴位敷贴剂在“邵氏阳虚哮喘贴”穴位敷贴的药物配方进行了改进，增加了特定份数的白芥子、延胡索和干姜，意外发现，能够在原有治疗以“阳虚寒喘”为特点的虚寒型肺系疾病及其它肺系疾病的基础上，对于发生的胸背部疼痛、胸闷气短、痰多气喘有明显的改善效果，还缓解了中药敷贴剂的发泡作用所带来的疼痛感，降低了皮肤发红、起泡、皮炎、瘙痒等副反应的发生，提高了病人对敷贴制剂的耐受度。
具体实施方式
在本发明的一个具体实施方案中，提供了一种用于辅助治疗肺病的中药穴位敷贴剂，其中，所述中药穴位敷贴剂包括基础药物组分；
所述基础药物组分，按重量份，其包括8～12份熟附子、8～12份巴戟肉、8～12份盐补骨脂、8～12份淫羊藿、8～12份槲寄生、8～12份白芥子、8～12份延胡索、2.2～3.8份丁香、2.2～3.8份吴茱萸、2.2～3.8份肉桂、4～6份麻黄和6.5～9.5份干姜。
其中，关于“熟附子”，其来源于乌头，是乌头的根部经过严谨的炮制工艺之后就可以做成，也是在中医上很重要的一种天然药物；按照目前医学理论，熟附子具有强心、抗心肌缺血、抗休克、抑制凝血功能和抗血栓形成、抗炎、镇痛、局部麻醉、增强体液免疫、兴奋肠管自发性收缩、抑制胃排空、平喘、松弛气管，以及对抗平滑肌痉挛等作用。
关于“巴戟肉”，其为植物巴戟天的干燥根；按照目前医学理论，巴戟肉有增强抗疲劳能力、抗炎、升高血中白细胞等作用。
关于“盐补骨脂”，其是通过补骨脂用盐水拌匀，微润，置锅内用文火炒至微鼓起而制得的；按照目前医学理论，盐补骨脂能扩张冠状动脉、兴奋心脏、提高心脏功率；能收缩子宫及缩短出血时间，减少出血量；抗早孕和有雌激素样作用；有致光敏作用，内服或外涂皮肤，经日光或紫外线照射，可使局部皮肤色素沉着。
关于“淫羊藿”：植物“淫羊藿”为多年生草本植物，全草可入药；按照目前医学理论，作为中药的“淫羊藿”具有以下作用：对下丘脑-垂体-性腺轴功能具有调节作用；调节机体免疫功能；对阳虚动物模型具有“助阳”的作用，可增加冠脉血流量，降低血压等；延缓衰老，有较强的抗HSVⅡ作用。动物实验表明，有广泛的激素样作用，有促进性腺功能；水提液可抗衰老与促进物质代谢；淫羊藿多糖和总黄酮有免疫调节功能；煎剂有强心、降压和增加冠脉流量的作用。
关于“槲寄生”：植物“槲寄生”为桑寄生科槲寄生属灌木植物，带叶的茎枝可入药。按照目前医学理论，作为中药的“槲寄生”具有降压作用，对冠脉呈舒张作用，显著增加冠脉血流量，减慢心率，对心肌收缩力呈先抑制后增强作用；具有抗血小板凝聚作用等，能显著增加豚鼠离体心脏和颤动状态离体心脏的冠脉流量，并能对抗神经垂体素对冠脉收缩的作用；其醇提物静脉注射或腹腔注射可使犬和兔血压明显下降；槲寄生总苷在体内、体外均有抗血小板聚集作用。
关于“白芥子”：植物“白芥子”为十字花科一年或二年生植物，白芥的干燥成熟种子，可入药。按照目前医学理论，作为中药的“白芥子”具有利气豁痰、温中散寒、通络止痛的功效，并有抑制前列腺增生、抗炎镇痛、镇咳祛痰平喘和透皮吸收促进作用；可外压治疗近视、外敷治疗肺炎和支气管哮喘，也可内服治疗各种炎症，缓解各种疼痛。
关于“延胡索”：植物“延胡索”为罂粟科，紫堇属多年生草本植物，干燥块茎可入药；按照目前医学理论，作为中药的“延胡索”具有活血、行气、止痛的功效；并有镇痛、镇静催眠、抗心肌缺血、抗脑缺血、抗溃疡、抗肿瘤、抗抑郁等药理作用；改善多种药物所致成瘾的戒断症状；作用于内分泌系统，具有提升甲状腺-性腺轴功能，从而加强内分泌系统功能。
关于“丁香”：植物“丁香”为木犀科，属落叶灌木或小乔木。按照目前医学理论，作为中药的“丁香”具有抗胃溃疡，止泻，利胆，镇痛，抗缺氧，抗凝血，抗突变，抑菌杀虫，健胃(浸出液具有明显的刺激胃液分泌作用，并能缓解腹胀、恶心、呕吐等)，以及对多种致病性真菌、球菌、链球菌及肺炎、痢疾、大肠、伤寒等杆菌以及流感病毒有抑制作用。
关于“吴茱萸”，植物“吴茱萸”的嫩果经泡制凉干后即是传统中药吴茱萸，按照目前医学理论，作为中药的“吴茱萸”具有芳香健胃作用，能祛除肠内积气及抑制肠内异常发酵，增加消化液分泌，抑制胃肠蠕动而解痉、止吐，并有镇痛、抗胃溃疡、降血压、兴奋子宫、抗血栓形成、杀虫、抗菌、升高体温、保肝利胆、抑制中枢神经系统、改善心血管系统功能、抗血栓、抗缺氧等药理作用。
关于“肉桂”：植物“肉桂”的树皮可入药。按照目前医学理论，作为中药的“肉桂”，对肠胃有缓和的刺激作用，并能解除胃肠平滑肌痉挛，具有很强的抗溃疡作用；可拮抗血小板聚集，具有改善心血管系统的作用，调节机体免疫功能；对中枢神经系统，具有镇静、镇痛、解热、抗惊厥等作用；对阳虚、阴虚模型有预防和保护作用；具有一定的抗炎作用；具有很强的杀真菌作用；抗肿瘤等。
关于“麻黄”：植物草麻黄、中麻黄或木贼麻黄的干燥草质茎即为传统中药“麻黄”；按照目前医学理论，作为中药的“麻黄”对心血管系统，具有拟肾上腺能神经作用，升血压作用可产生快速的耐受性；对呼吸系统有平喘、镇咳、祛痰作用；可使汗腺分泌增加；具有明显的利尿作用；具有抗变态反应作用及一定的抗炎作用；具有解热作用及不同程度的抗病原微生物作用；可兴奋中枢，影响神经肌肉的传递。有利胆作用，可降低血尿素氮和升高血清胆固醇。可兴奋虹膜辐射肌而使瞳孔扩大；还可以兴奋离体子宫，而对正常妇女则可减少子宫的活动。麻黄碱对胃肠道分泌通常表现抑制。可引起血糖升高，但作用弱而不恒定。能抗过敏，对流感病毒有抑制作用。
关于“干姜”：姜科多年生草本植物姜的干燥根茎即为传统中药“干姜”；按照目前医学理论，“干姜”的水煎液及浸膏有中枢兴奋、健胃、止呕、抗菌作用；挥发油有抗炎及解热止痛作用。具有镇静、镇痛、抗炎、升血压、抗凝血作用；对消化系统具有止吐、增强离体肠收缩等作用；灭螺，抗血吸虫，促进肾上腺皮质激素的合成与释放等。
本申请的发明人在本单位多年临床实践的基础上，对“邵氏阳虚哮喘贴”穴位敷贴的药物配方进行了改进，增加了特定份数的白芥子、延胡索和干姜，意外发现，能够在原有治疗以“阳虚寒喘”为特点的虚寒型肺系疾病及其它肺系疾病的基础上，对于发生的胸背部疼痛、胸闷气短、痰多气喘有明显的改善效果，还缓解了中药敷贴剂的发泡作用所带来的疼痛感，降低了皮肤发红、起泡、皮炎、瘙痒等副反应的发生，提高了病人对敷贴制剂的耐受度。
以下通过实施例对本发明作进一步的说明，但本发明并不限于这些具体实施方式。
附注：具体实施方式中出现的百分比(％)，如无特别表示，均为重量百分比(％wt)。
实施例1
实施例1的用于辅助治疗肺病的中药穴位敷贴剂及其敷贴产品
中药穴位敷贴剂的基础药物组分，按重量份，其包括10份熟附子、10份巴戟肉、10份盐补骨脂、10份淫羊藿、10份槲寄生、10份白芥子、10份延胡索、3份丁香、3份吴茱萸、3份肉桂、5份麻黄和8份干姜。
具体制备过程：称取10g熟附子、10g巴戟肉、10g盐补骨脂、10g淫羊藿、10g槲寄生、10g白芥子、10g延胡索、3g丁香、3g吴茱萸、3g肉桂、5g麻黄和8g干姜；将这些中草药混合后研磨成药粉，药粉过120目筛后，加入适量的生姜汁调和，并揉成直径约1.5cm的药丸；
最后将药丸压成药饼，置于7-10cm的医用敷料中央固定即可。
在本实施例的一个替代实施例中，药粉过80-100目筛后，加入适量的蜂蜜进行调和，揉成大蜜丸；再固定在医用敷料上。
具体应用：先选取穴位(例如大椎穴、天突穴，或颈部夹脊穴等)，中药穴位敷贴剂固定于选取穴位；一般敷贴4-6小时。
对比例1
对比例1的中药穴位敷贴剂及其敷贴产品，与实施例1的区别仅在于：没有添加白芥子、延胡索和干姜。对比例1的其余组分以及制备过程，均与实施例1的相同，具体不再赘述。
效果数据
本实验共收集阳虚寒喘型支气管哮喘病例128例(来自上海中医药大学附属龙华医院内科门诊)，均为2018年7月到2019年7月收治的患者，其中男性42例，女性86例，年龄13～85岁，平均(50±16)岁；病程0～70年，中位病程9年。
上述病例中，70例施用实施例1的敷贴产品，58例施用对比例1的敷贴产品，随机选择。
治疗方法：每次治疗，对患者注射核酪注射液(注入两侧足三里)，同时作为辅助将上述实施例1或对比例1的敷贴产品固定于患者的天突穴(颈部前正中线上胸骨上窝中央)和大椎穴(背部正中线上第7颈椎棘突下凹陷中)，敷贴时间一般4-6小时；治疗时间为夏季7-9月间，冬季12-2月间；每周治疗2次，治疗周期为3个月。
中医证候：分别于治疗前及末次治疗后10天，参照《中药新药临床研究指导原则》中的有关标准，采用积分法评价中医症候(喘促、哮鸣音、咳嗽、畏寒、胸背部疼痛、胸闷气短、痰多气喘、腰膝酸软、二便)的情况；其中，1)临床控制：症状消失或基本消失，证候积分减少≥95％；2)显效：症状明显改善，证候积分减少70％-94％；3)有效：症状有好转，证候积分减少30％～69％；4)无效：症状无明显改善，甚或加重，证候积分减少﹤30％。
免疫学指标：分别于治疗前及治疗后10天，检测嗜酸性粒细胞绝对计数(EOS)、嗜酸性粒细胞阳离子蛋白(ECP)、免疫球蛋白E、免疫球蛋白A、免疫球蛋白M、免疫球蛋白G以及T淋巴细胞亚群(CD3+、CD4+、CD8+)水平。
统计学方法：观察数据采用SPSS 15.0软件包进行统计学分析。采用t检验，以P﹤0.05为差异具有统计学意义。
施用实施例1敷贴产品的患者和施用对比例1产品的患者，在“喘促、哮鸣音、咳嗽、畏寒、腰膝酸软、二便”方面的中医证候积分，纵向来看(治疗后的中医证候积分，相较于治疗前的)，有明显下降(差异具有统计学意义(P<0.05))；此外，部分免疫学指标(例如EOS、ECP和IgE)水平，均较治疗前有明显下降(差异均有统计学意义(P<0.05))。
具体在“胸背部疼痛、胸闷气短、痰多气喘”这三方面的中医证候积分结果，参见下表1和表2。
表1：施用实施例1敷贴产品的中医证候积分结果
| 中医证候指标 | 治疗前 | 治疗后 |
| 胸背部疼痛 | 19.85±3.74 | 8.57±3.91 |
| 胸闷气短 | 22.59±4.12 | 11.27±3.87 |
| 痰多气喘 | 20.63±4.01 | 10.33±3.75 |
表2：施用对比例1敷贴产品的中医证候积分结果
| 中医证候指标 | 治疗前 | 治疗后 |
| 胸背部疼痛 | 19.69±3.86 | 10.85±4.00 |
| 胸闷气短 | 21.90±3.99 | 13.02±3.83 |
| 痰多气喘 | 20.09±4.11 | 12.63±4.04 |
从上面的表1、表2各自的结果可以看出，无论是施用实施例1的敷贴产品还是对比例1的敷贴产品，“胸背部疼痛、胸闷气短、痰多气喘”三方面的中医证候积分，治疗后相比治疗前，均有显著的下降效果(下降幅度均存在统计学差异(P<0.05))。
但从表1与表2两者的对比结果来看：与对比例1的敷贴产品相比，施用实施例1的敷贴产品在“胸背部疼痛、胸闷气短、痰多气喘”三方面的中医证候积分下降幅度更显著(存在统计学差异(P<0.05))；这说明，本发明实施例1的中药穴位敷贴剂产品在“胸背部疼痛、胸闷气短、痰多气喘”方面的缓解效果更为显著。
应当理解，虽然本说明书按照实施方式加以描述，但并非每个实施方式仅包含一个独立的技术方案，说明书的这种叙述方式仅仅是为清楚起见，本领域技术人员应当将说明书作为一个整体，各实施方式中的技术方案也可以经适当组合，形成本领域技术人员可以理解的其他实施方式。
上文所列出的一系列的详细说明仅仅是针对本发明的可行性实施方式的具体说明，它们并非用以限制本发明的保护范围，凡未脱离本发明技艺精神所作的等效实施方式或变更均应包含在本发明的保护范围之内。
Claims (9)
1.一种用于辅助治疗肺病的中药穴位敷贴剂，其特征在于：
所述中药穴位敷贴剂包括基础药物组分；
所述基础药物组分，按重量份，其包括8～12份熟附子、8～12份巴戟肉、8～12份盐补骨脂、8～12份淫羊藿、8～12份槲寄生、8～12份白芥子、8～12份延胡索、2.2～3.8份丁香、2.2～3.8份吴茱萸、2.2～3.8份肉桂、4～6份麻黄和6.5～9.5份干姜。
2.如权利要求1所述的中药穴位敷贴剂，其特征在于：
所述基础药物组分，按重量份，其包括10份熟附子、10份巴戟肉、10份盐补骨脂、10份淫羊藿、10份槲寄生、10份白芥子、10份延胡索、3份丁香、3份吴茱萸、3份肉桂、5份麻黄和8份干姜。
3.如权利要求1或2的中药穴位敷贴剂，其特征在于：
所述中药穴位敷贴剂还包括辅料组分。
4.一种用于辅助治疗肺病的中药穴位敷贴产品，其特征在于：
所述中药穴位敷贴产品采用如权利要求1至3中任意一项所述的中药穴位敷贴剂制成。
5.如权利要求4所述的中药穴位敷贴产品，其特征在于：
所述中药穴位敷贴产品包括穴位敷贴的药丸或药饼；
将所述中药穴位敷贴剂的各组分研磨成粒径小于120目的粉末，将生姜汁或者蜂蜜与所述粉末调和，形成所述药丸或药饼。
6.如权利要求5所述的中药穴位敷贴产品，其特征在于：
所述的药丸或药饼的直径为1～5cm。
7.如权利要求5或6所述的中药穴位敷贴产品，其特征在于：
所述中药穴位敷贴产品还包括医用敷料；所述药丸或药饼被固定在所述医用敷料的粘合面上。
8.如权利要求1至3中任意一项所述的中药穴位敷贴剂、如权利要求4至7中任意一项所述的中药穴位敷贴产品，在制备辅助治疗慢性肺病药物方面的应用。
9.如权利要求6所述应用，其特征在于：所述慢性肺病为阳虚哮喘。
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