CN102085337B - 一种用于治疗小儿哮喘的贴剂 - Google Patents
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Abstract
本发明公开了一种用于治疗小儿哮喘的贴剂，包括药用组合物，其特征在于所述药用组合物采用以下主要组分和重量份用量：麻黄10-30份、白芥子10-30份、丁香1-15份、矮地茶15-45份、细辛5-20份、生姜10-30份。经临床试验，本发明的贴剂无任何不良反应，疗效显著，还发现病人经治疗后，其体质有明显增强，提示本品具有增强机体的免疫功能。说明用香麻寒喘贴贴敷穴位具有显著的治喘及增强哮喘患儿体质，预防哮喘病复发的作用。
Description
技术领域
本发明属于中药贴剂，具体涉及一种用于治疗小儿哮喘的贴剂。
背景技术
小儿哮喘、支气管炎是儿科临床常见多发病，不仅危害小儿健康，而且给家庭和社会造成巨大的经济负担。据资料报导，我国儿童哮喘患病率为0.5％～2％，个别地方高达5％，全国约有2～4千万患儿。现代医学认为支气管哮喘是一种由超敏反应引起的呼吸道高反应性疾病。在药物治疗方面强调根据病情需要，除使用解痉平喘药物外(对症治疗)，还应该结合使用抗气道过敏性炎症的药物(病因治疗)，糖皮质激素(GCS)是目前治疗哮喘的最有效药物，主要采用喷喉或雾化吸入。通过平喘和抗过敏炎症药物双管齐下的办法，以便达到迅速和持久的疗效，但GCS吸入的副作用是全身性，特别是对哮喘儿童，Nicolaizik研究认为哮喘儿童即使是短期吸入小剂量的GCS亦可引起肾上腺抑制，长期服用GCS可使哮喘儿童骨密度降低，使生长速率降低，由此GCS用于小儿哮喘的临床治疗受到了较大限制。
近年来，采用“冬病夏治”，敷贴疗法防治小儿哮喘，在全国各地广泛地开展。处方的组成，各地根据当地的情况，各有不同，贴药的方法及穴位选择，则异中有同，大都是将处方药材碾成粉末，用生姜汁调和成糊状，制成药饼，敷贴在百劳、膏肓、肺俞穴位，于炎热的三伏天敷贴。有一种叫敷贴发泡法，药物制作将生姜汁改为蜜调和成药饼，放在火上烘热，先用生姜擦穴位皮肤使之发热，病人感到刺痛为止，再将烘热药饼贴上，皮肤会发生水泡，局部感到热辣刺痛表示有效。这种方法，容易引起皮肤发炎感染，另外，发生水泡的皮肤对药物的吸收，将会受到影响。哮喘外治还有很多方法，如穴位埋藏疗法，用肠线埋藏穴位，这种方法疗效并不确切。针灸疗法治疗哮喘，小儿不易接受，难以配合。有人用挑四缝穴治小儿哮喘，痛苦难当。还有人制出中药背心和中药枕头防治哮喘，将传统的穴位敷贴疗法和香袋佩带疗法融合为一体，药物芳香温通，可由皮肤吸收和呼吸吸收，确有好处，但由于空气潮湿，或出汗，容易受潮，结块霉变，影响疗效。
发明内容
本发明的目的是提供一种使用方便、无副作用、疗效好，可增强机体的免疫功能的用于治疗小儿哮喘的贴剂。
实现上述发明目的采用的技术方案是：用于治疗小儿哮喘的贴剂，其药用组合物采用以下主要组分和用量(按重量份)：
麻黄10-30份、白芥子10-30份、丁香1-15份、矮地茶15～45份、细辛5～20份、生姜10-30份。
优选用量为：麻黄20份、白芥子20份、丁香3.3份、矮地茶33.3份、细辛10份、生姜20份。
本发明的贴剂中，麻黄具有发汗、利尿、镇咳、平喘、抗过敏、升高血压、兴奋中枢神经系统、解热、抗病毒及影响神经肌肉传递等作用。白芥子功效主治化痰逐饮、散结消肿、咳喘痰多、胸满胁痛、肢体麻木、关节肿痛、湿痰流注、阴疽肿毒、治喘咳宜敷贴背部肺俞、心俞、膈痰饮等。丁香，功效有暖胃、温肾，主治胃寒痛胀、呃逆、吐泻、痹痛、疝痛、口臭、牙痛。矮地茶，功效有止咳平喘，清利湿热，活血化瘀。细辛，功效有解表散寒，祛风止痛，通窍，温肺化饮。生姜的主要功效有散寒解表；降逆止呕；化痰止咳，主治风寒感冒、恶寒发热、头痛鼻塞、呕吐、痰饮喘咳、胀满、泄泻等。
基本制备方法：以上六味药经预处理后，加6倍量水蒸馏4小时，挥发油另置，药液及药渣备用；余药加水煎煮二次，第一次加8倍量水，煎煮2小时，滤过，药液备用；药渣再与提油后的药渣合并煎煮第二次，加6倍水量煎煮1小时，滤过。合并上述煎液及提挥发油后的药液，浓缩至相对密度约为1.20(80℃)的清膏，加乙醇使含醇量达50％，搅匀，静置24小时。取上清液，减压回收乙醇，浓缩至相对密度约为1.28(80℃)的稠膏，备用。将生橡胶100g切成条状，用压胶机压成网状胶片，去静电、放冷，浸入汽油中约24小时，使其充分溶胀，再移入配料锅内搅拌约3小时，依次加入松香80g、氧化锌80g、羊毛脂15g、凡士林15g、液体石蜡10g，混匀，加入上述清膏及挥发油，搅匀，经80目铜丝筛网滤过，进行涂膏，切段，盖衬，切块，即得。
用药方法和疗效
将本发明贴剂(香麻寒喘贴)分别贴主穴双侧肺俞(第3胸椎棘突下旁开1.5寸)和配穴双侧定喘(大椎穴旁开0.5寸)、双侧膏肓(第4胸椎棘突下旁开3寸)，一日贴1次，一次4～6小时。疗程为4天。
香麻寒喘贴可以缓解哮喘症状和寒饮停肺证候，其单项症状的疗效：香麻寒喘贴对喉中哮鸣，咳嗽，恶寒怕冷，鼻流清涕，痰液清稀等症状均有疗效，香麻寒喘贴对哮鸣症状有显著疗效，总有效率为94.68％。
本发明的主要特点：①是《内经》“冬病夏治”、“内病外治”理论的具体体现；②是在《张氏医通》“白芥子涂法”基础上改进而来；③属于采用现代工艺制成的一种橡胶膏类外用药；④应用中医脏腑与腧穴相关理论，选择与儿童支气管哮喘病(寒哮型)密切相关的重要穴位，进行贴药治疗，使药性效能通过皮毛腠理由表入里，循穴位经络的感传载运直达病所，发挥治疗作用；⑤剂型选择与儿童用药特点相结合，制剂由过去外敷散剂改为橡胶膏剂，利用现代透皮吸收技术，既保证了药效，又方便使用，勿需打针服药，患儿容易接受，充分考虑了儿童用药的特点。经临床试验，本发明的贴剂无任何不良反应，疗效显著，还发现病人经治疗后，其体质有明显增强，提示本品具有增强机体的免疫功能。说明用香麻寒喘贴贴敷穴位具有显著的治喘及增强哮喘患儿体质，预防哮喘病复发的作用。
具体实施方式
本发明贴剂(药品名称为香麻寒喘贴)可通过试验例来说明其有益效果，包括毒理试验和主要药效学试验。
毒理试验
(1)急性毒性试验：将香麻寒喘贴每次以小儿外贴量的6倍量贴家兔完整和破损皮肤，多次给药均无刺激，对豚鼠皮肤无过敏反应，且未见任何毒副反应。
(2)长期毒性试验：将香麻寒喘贴每次以小儿外贴量的2倍、5倍、10倍量，分别贴于脱去毛的家兔背部(双肺投影背部)，每次贴4小时，每日贴1次，连续2周。对其血象、肺、肝、肾功能观察，未发现有毒性作用；经病理切片未发现心、肝、脾、肺、肾等器官有毒性损害。故提示临床推荐用药剂量使用安全。
主要药效学试验
一、动物试验
(1)对氨水引咳小鼠和枸橡酸引咳豚鼠均可明显延长发生咳嗽的潜伏期，减少咳嗽次数，提示本品具有止咳作用。
(2)能显著促进小鼠气管排泌酚红，增加大鼠气管的排痰量，提示本品具有明显的祛痰作用。
(3)对乙酰胆碱和组胺混合引喘豚鼠可明显延长哮喘发生的时间，提示本品具有平喘作用。
(4)对巴豆油致小鼠耳肿胀具有明显的抑制作用，对2.4-二硝基氯苯所致小鼠迟发型皮肤超敏反应具有明显的抑制作用，对环磷酰胺所致免疫功能低下小鼠具有促进血清溶血抗体形成，提高巨噬细胞吞噬功能的作用，提示本品具有抗炎、提高免疫功能的作用。
(5)以小儿外贴量的2倍、5倍、10倍量，分别贴于脱去毛的家兔背部(双肺投影背部)，每次贴4小时，每日贴1次，连续2周。对其血象、肺、肝、肾功能观察，未发现有毒性作用；经病理切片未发现心、肝、脾、肺、肾等器官有毒性损害。故提示临床推荐用药剂量使用安全。
二、临床试验
经用香麻寒喘贴治疗小儿哮喘120例疗效观察，
1、试验目的：验证香麻寒喘贴辅助治疗儿童支气管哮喘寒饮停肺证的有效性，初步评价香麻寒喘贴临床应用的安全性。
2、观测指标：(1)人口学资料：①性别；②年龄；③身高；④体重。(2)主要疗效性指标：①中医证候：主症(喘息、喉中哮鸣、咳嗽)；次症(恶寒怕冷、鼻流清涕、咯痰清稀、四肢欠温、面色淡白)；异常舌脉。②肺功能：PEFR。(3)次要疗效指标：①周围血嗜酸粒细胞计数。②血清IgE。(4)安全性指标：①可能出现的不良反应症状。②一般体检项目：体温、安静时心率、呼吸、血压等。③血常规、尿常规、便常规、心电图和肝功能GPT、肾功能BUN和Cr。
3、试验总体设计
本项试验采用平行组设计、分层区组随机、双盲加载试验、多中心临床研究的方法。所选病证为儿童支气管哮喘发作期寒饮停肺证，按1∶1为试验组和对照组两组，受试者分别为120例，共240例。
4、试验人群
符合儿童支气管哮喘寒饮停肺证中西医诊断、辨证标准、年龄在3岁～14岁之间、发病本次在48小时以内、病情属于轻中度者。
5、给药方案
氨茶碱：两组均用。每次4～6mg/Kg，q.8.h口服。最大剂量不超过200mg/次。香麻寒喘贴及其模拟药：两组均外用。使用方法：分别贴主穴双侧肺俞和配穴双侧定喘、双侧膏肓，每日贴1次，每次4～6个小时。疗程：4天。合并用药规定：对于合并各种病原微生物感染者，可分别加用病毒唑、红霉素类治疗，必要时应补充液体入量。但不能加用止咳化痰、抗组胺、糖皮质激素类西药以及同类中药。
6、评价标准
(1)疾病疗效评定标准：①临床控制：哮喘症状完全缓解，即使偶有轻度发作不需用药即可缓解。PEFR增加量＞35％，或治疗后PEFR＞＝80％预计值。PEFR昼夜波动＜20％。②显效：哮喘发作较治疗前明显减轻，PEFR增加量范围25％～35％，或治疗后PEFR达到预计值的60％～＜80％，PEFR昼夜波动＜20％。③好转：哮喘症状有所减轻，PEFR增加量范围15％～＜25％。④无效：临床症状和PEFR测定值无改善或反而加重。
(2)中医证候疗效评定标准：①临床痊愈：证候计分值减少率＞95％。②显效：证候计分值减少率＞70％～95％。③进步：证候计分值减少率30％～70％。④无效：证候计分值减少率＜30％。
(3)安全性评价标准：①一级：安全，无任何不良反应。②二级：比较安全，如有不良反应，不需做任何处理可继续给药。③三级：有安全性问题，有中等程度的不良反应，做处理后可继续给药。④四级：因不良反应中止试验。
7、统计方法
(1)、对计量数据，采用t检验、t’检验、秩和检验、方差分析、协方差分析等方法。
(2)、对计数数据，采用四格表X2检验、Yates连续校正X2检验、Fisher精确概率法、多表格X2检验等方法。
(3)、对等级数据，采用符号秩和检验、秩和检验。
8、受试者入组情况及各组人口学资料
按试验计划，五家参试单位共入选240例病例。其中，脱落4例，剔除2例。两组病例来源情况门诊208例，病房32例；两组在基线点，其性别、年龄、身高、体重、病程、病情、生命体征、中医证候等资料比较，差异均无显著性意义，具有可比性。
9、各组疗效结果
试验结果表明，两组疾病疗效比较，ITT分析试验组疾病控显率为78.81％，总有效率为92.37％，对照组疾病控显率为39.17％，总有效率为66.67％；PP分析试验组疾病控显率为80.17％，总有效率为93.97％，对照组疾病控显率为39.83％，总有效率为67.8％，两组比较均有显著性差异。
ITT分析试验组中医证候控显率为56.78％，总有效率为92.37％，对照组中医证候控显率为18.33％，总有效率为68.33％，PP分析试验组中医证候控显率为57.76％，总有效率为93.97％，对照组中医证候控显率为18.64％，总有效率为69.49％，两组比较均有显著性差异。
主要观察指标的改善情况，两组各中医证候指标治疗前后证候总计分和、主症计分和的变化和改善情况，两组患者PEFR治疗前后差值和增加量组间比较，PP分析和ITT分析差异均有非常显著性意义；单项症状的改善情况自身比较，差异均有非常显著性意义；且除面色淡白、四肢欠温外的全部证候指标的组间比较，差异也均有显著性意义。
10、各组安全性结果
试验中，两组各有1例病例应用香麻寒喘贴后出现局部皮肤红痒、皮疹，此外无其他不良事件发生。实验室检查未发现有与试验药物有关的改变。
11、结论
香麻寒喘贴对儿童支气管哮喘寒饮停肺证具有治疗作用，不良反应的发生率低，安全性好，具有临床使用价值。
以下是本发明提供的贴剂实施例，其用药量为1000贴中的药用组合物。
实施例1
麻黄100克、白芥子101克、丁香10克、矮地茶450克、细辛200克、生姜300克。
实施例2
麻黄200克、白芥子300克、丁香150克、矮地茶150克、细辛50克、生姜100克。
实施例3
麻黄200克、白芥子200克、丁香33克、矮地茶333克、细辛100克、生姜200克。
Claims (2)
1.一种用于治疗小儿哮喘的贴剂，包括药用组合物，其特征在于所述药用组合物采用以下原料药和重量份用量：
麻黄10-30份、白芥子10-30份、丁香1-15份、矮地茶15～45份、细辛5～20份、生姜10-30份；
以上六味药经预处理后，加6倍量水蒸馏4小时，挥发油另置，药液及药渣备用；余药加水煎煮二次，第一次加8倍量水，煎煮2小时，滤过，药液备用；药渣再与提油后的药渣合并煎煮第二次，加6倍水量煎煮1小时，滤过；合并上述煎液及提挥发油后的药液，浓缩至80℃时的相对密度为1.20的清膏，加乙醇使含醇量达50％，搅匀，静置24小时；取上清液，减压回收乙醇，浓缩至80℃时的相对密度为1.28的稠膏，备用；将生橡胶100g切成条状，用压胶机压成网状胶片，去静电、放冷，浸入汽油中约24小时，使其充分溶胀，再移入配料锅内搅拌约3小时，依次加入松香 80g、氧化锌80g、羊毛脂15g、凡士林15g、液体石蜡10g，混匀，加入上述清膏及挥发油，搅匀，经80目铜丝筛网滤过，进行涂膏，切段，盖衬，切块，即得。
2.根据权利要求1所述的用于治疗小儿哮喘的贴剂，其特征在于所述组分的重量份用量为：麻黄20份、白芥子20份、丁香3.3份、矮地茶33.3份、细辛10份、生姜20份。
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| CN105267915A (zh) * | 2015-10-19 | 2016-01-27 | 翔宇药业股份有限公司 | 一种可用于化痰止咳的贴剂及其制备工艺 |
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| CN101332290B (zh) * | 2008-08-05 | 2010-12-08 | 赵桂香 | 一种治疗慢性支气管炎的中药组合物 |
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