CN111686229A - 治疗小儿寒热夹杂咳嗽的水凝胶药贴 - Google Patents
治疗小儿寒热夹杂咳嗽的水凝胶药贴 Download PDFInfo
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Abstract
本申请提供了一种治疗小儿寒热夹杂咳嗽的水凝胶药贴,其有效成分为小青龙汤、桑杏汤中的有效成分以及咳特灵胶囊。
Description
一技术领域
本申请属于中药透皮贴剂和止咳药剂领域,具体地说,本申请提供了一种治疗小儿寒热夹杂咳嗽的水凝胶药贴,其有效成分为小青龙汤、桑杏汤中的有效成分以及咳特灵胶囊。
二背景技术
儿童咳嗽属于多发常见疾病,病因可能是零食过多或饮食不注意发生食积、进而积而化火;夏天空调及风扇使用时感风寒;或者春秋气候多变时因小儿寒暖不知自调,忽于增减衣服,不能适应外界气候的变化,易为风寒热等外邪侵袭而发生咳嗽。在使用抗生素由于耐药性问题使用受限的大背景下,如何快速、安全的治疗小儿咳嗽属于中西医临床上面临的常见问题。
小青龙汤,为解表剂,具有辛温解表,解表散寒,温肺化饮之功效;主治外寒里饮证。恶寒发热,头身疼痛,无汗,喘咳,痰涎清稀而量多,胸痞,或干呕,或痰饮喘咳,不得平卧,或身体疼重,头面四肢浮肿,舌苔白滑,脉浮;临床用于治疗慢性阻塞性肺气肿、支气管哮喘、急性支气管炎、肺炎、百日咳、过敏性鼻炎、卡他性眼炎、卡他性中耳炎等属于外寒里饮证者;方中麻黄、桂枝相须为君,发汗散寒以解表邪,且麻黄又能宣发肺气而平喘咳,桂枝化气行水以利里饮之化。干姜、细辛为臣,温肺化饮,兼助麻、桂解表祛邪。然而素有痰饮,脾肺本虚,若纯用辛温发散,恐耗伤肺气,故佐以五味子敛肺止咳、芍药和养营血;半夏燥湿化痰,和胃降逆,亦为佐药。炙甘草兼为佐使之药,既可益气和中,又能调和辛散酸收之品。再加葛根解肌发表,使外邪从肌表解,苍耳、辛夷宣通鼻窍。桑杏汤,轻宣温燥,凉润止咳;临床多用于呼吸道感染,急慢性支气管炎,百日咳等;方中桑叶清宣燥热,透邪外出;杏仁宣利肺气,润燥止咳,共为君药。豆豉辛凉透散,助桑叶轻宣透热;贝母清化热痰,助杏仁止咳化痰;沙参养阴生津,润肺止咳,共为臣药。栀子皮质轻而入上焦,清泄肺热,为佐药。咳特灵胶囊为成熟的临床常用中西药结合止咳药物,有多家药厂产品在售,成分为小叶榕干浸膏和马来酸氯苯那敏,具有镇咳、平喘、消炎作用,主要用于咳喘和慢性支气管炎。
上述小青龙汤和桑杏汤在治疗小儿/成人支气管炎、感冒等引起的咳嗽中效果稳定,辅以咳特灵胶囊后效果更为显著,但汤药和胶囊剂在使用便利性上存在明显不足,特别是儿童每日多次服用苦味汤药和胶囊剂接受程度低,服用困难往往导致服用次数和量达不到要求,造成治疗效果不佳。中医治疗咳嗽实践中存在改良汤药剂型,提高接受度和使用便利性的需求。
透皮贴剂在皮肤表面给药,通过毛孔扩张,使药物以恒定速度通过皮肤各层,进入体循环产生全身或局部治疗作用,是无创伤性给药的新途径,其优点表现为:药物吸不受消化道内pH、食物和药物在肠道移动时间等复杂因素影响;避免药物在肠胃、肝、肾等器官的不必要的代谢;可持续控制给药速度;用药部位在体表,中断给药方便,是安全、有效的治疗方法。
三发明内容
针对上述问题,发明人将小青龙汤、桑杏汤中的有效成分辅以咳特灵胶囊透皮水凝胶贴剂剂型,贴于肺俞穴、膻中穴(肺俞是肺之募穴,有宣肺止咳作用,乃治咳嗽之要穴。膻中为气之会穴,有降气调逆、宣肺利气之功。使咳嗽得止)实现疏风散寒,滋阴润肺,止咳化痰平喘的功效;其中调节小青龙汤和桑杏汤有效成分的比例,使祛寒而不助热,清热而不伤正。可用于治疗急慢性支气管炎、支气管哮喘、感冒咳嗽、百日咳及各种咳嗽病症。相比传统中药剂型使用便利性上有很大地提升,同时透皮贴剂在穴位上的持续释放效果也能保持止咳药物药效的充分发挥实现良好的疗效。
一方面,本申请提供了一种治疗小儿寒热夹杂咳嗽的水凝胶药贴,其特征在于,其有效成分为小青龙汤、桑杏汤中的有效成分以及咳特灵胶囊。
进一步地,小青龙汤中有效成为:麻黄、炙甘草、桂枝、干姜、白芍、法半夏、五味子、苍耳子、辛夷、葛根;桑杏汤中的有效成分为:桑叶、杏仁、沙参、浙贝、黑桅子、淡豆豉、荆芥、薄荷。
进一步地,小青龙汤中有效成为:按重量份计,麻黄6、炙甘草10、桂枝10、干姜10、白芍10、法半夏10、五味子6、苍耳子15、辛夷10、葛根30;桑杏汤中的有效成分为:按重量份计,桑叶10、杏仁10、沙参10、浙贝10、黑桅子10、淡豆豉10、荆芥10、薄荷8。进一步地,水凝胶药贴中小青龙汤和桑杏汤中的有效成分干重比例为2:2、2:1.5、2:0.5或1.5:2.5。
进一步地,咳特灵胶囊加入量为小青龙汤和桑杏汤中有效成分干重每100g加入3粒。
进一步地,水凝胶药贴由粘贴层、背衬层、药物贮库层、复膜层、保护层构成,规格为5.5cm×7.5cm。
进一步地,水凝胶药贴的药物贮库层成分为去离子水52.4%、甘油20%、药粉15%、聚丙烯酸钠10%、月桂氮卓酮1%、稳定剂1%、酒石酸0.25%、DMDMH 0.20%、甘羟铝0.15%。
另一方面,本申请提供了所述水凝胶药贴的制备方法,包括将小青龙汤和桑杏汤中有效成分分别烘干后粉碎、研磨、过80-120目筛;按照所需比例混合小青龙汤和桑杏汤中有效成分的干药粉;加入所需重量的咳特灵胶囊;充分搅拌均匀,加入水凝胶药贴的药物贮库层中制作成水凝胶贴。
另一方面,本申请提供了小青龙汤、桑杏汤中的有效成分以及咳特灵胶囊在制备治疗小儿寒热夹杂咳嗽的水凝胶药贴中的用途。
进一步地,小青龙汤中有效成为:按重量份计,麻黄6、炙甘草10、桂枝10、干姜10、白芍10、法半夏10、五味子6、苍耳子15、辛夷10、葛根30;桑杏汤中的有效成分为:按重量份计,桑叶10、杏仁10、沙参10、浙贝10、黑桅子10、淡豆豉10、荆芥10、薄荷8;小青龙汤和桑杏汤中的有效成分干重比例为2:2、2:1.5、2:0.5或1.5:2.5;咳特灵胶囊加入量为小青龙汤和桑杏汤中有效成分干重每100g加入3粒;水凝胶药贴药物贮库层中药粉含量为15%重量。
本申请水凝胶药贴中的小青龙汤、桑杏汤配方不局限于权利要求中所述的,各种成品和中医师提供的成分、功能类似的小青龙汤、桑杏汤配方均可以使用。
可以使用各药厂的咳特灵胶囊产品,具体用量可以根据有效成分含量调整(实施例中使用的白云山制药制造咳特灵胶囊,说明书标每胶囊含小叶榕干浸膏360mg和马来酸氯苯那敏1.4mg,市面上常见的通化东宝、万通药业等生产的咳特灵胶囊规格和有效成分含量类似)。
本申请水凝胶药贴除药物之外的贴膏部分,如粘贴层、背衬层、药物贮库层、复膜层、保护层等可以使用现有各种透皮贴剂材料和配方,由符合资质的生产企业依照常规方法制造,只要其中的成分与本申请所用药物无明显相互作用即可。
四附图说明
图1为本申请止咳贴1号和2号样品外包装图(上有施用穴位和诊所用药指导二维码);
图2为本申请止咳贴1号的内包装图;
图3为本申请止咳贴1号的实物图(保护膜半揭开状态)。
五具体实施方式
主要药材、试剂以及病例来源
实施例中所用中药材麻黄、炙甘草、桂枝、干姜、白芍、法半夏、五味子、苍耳子、辛夷、葛根、桑叶、杏仁、沙参、浙贝、黑桅子、淡豆豉、荆芥、薄荷均购自广东正规中药材供应商处,经有经验的中医师和药师鉴定品种、质量无问题。
实施例中所用的咳特灵胶囊由白云山制药制造,说明书标每胶囊含小叶榕干浸膏360mg和马来酸氯苯那敏1.4mg。
本申请中的水凝胶透皮贴剂提供药物后委托山东优杰生物科技有限公司代加工,其中药物贮库层配方由制造商帮助优化提供。
实施例中的病例为急慢性支气管炎、支气管哮喘、感冒咳嗽患者(年龄1-12周岁),患者来源为2016-2018年申请人诊所(汕头仁馨堂)以及另一家合作诊所(按其要求不公开其名称)的病例,病例的诊断、寒热轻重辩证由诊所内有资质的中医医师判定。
实施例1本申请水凝胶药贴的制备
将小青龙汤的有效成分(麻黄6、炙甘草10、桂枝10、干姜10、白芍10、法半夏10、五味子6、苍耳子15、辛夷10、葛根30)和桑杏汤的有效成分(桑叶10、杏仁10、沙参10、浙贝10、黑桅子10、淡豆豉10、荆芥10、薄荷8)分别烘干后粉碎、研磨、过80-120目筛;
混合小青龙汤和桑杏汤中有效成分的干药粉,其中小青龙汤和桑杏汤中的有效成分干重比例:
止咳1号 2:2
止咳2号 2:1.5
止咳3号 2:0.5
肺热方 1.5:2.5
小青龙汤和桑杏汤中有效成分干重每100g加入3粒咳特灵胶囊;充分搅拌均匀,加入水凝胶药贴的药物贮库层(药物贮库层配方为贴剂生产企业针对本申请药物优化:去离子水52.4%、甘油20%、药粉15%、聚丙烯酸钠10%、月桂氮卓酮1%、稳定剂1%、酒石酸0.25%、DMDMH 0.20%、甘羟铝0.15%,5.5cm×7.5cm药贴中每贴药粉加入量约1.5g,加粘贴层、背衬层、复膜层、保护层制作成水凝胶贴。
实施例2本申请水凝胶贴的使用方法
止咳1号用于寒热相当之咳嗽咳喘诸症;
止咳2号用于寒重热轻之咳嗽咳喘诸症;
止咳3号用于体虚标有少许虚热之咳嗽咳喘诸症;
肺热方用于体内积热明显,而外感风寒之邪之咳嗽咳喘诸症。
临床通过辩证,以寒热夹杂,寒热轻重,分别对应不同比例进行穴位贴敷,以肺俞与膻中交替使用,一天两次,每8小时一次,连用4天。
实施例3本申请水凝胶贴的使用效果
疗效判断基本遵循《中华人民共和国中医药行业标准中医病证诊断疗效标准》(国家中医药管理局南京大学出版社2002年出版):
治愈:症状消失或低于轻度标准;
显效:咳嗽由+++转为+,或者由++转为-;
有效:咳嗽由+++转为++,或者由++转为+;
无效:症状无变化或加重。
根据诊所诊疗记录统计
2016-2017年间诊所共使用内服小青龙汤和/或桑杏汤治疗小儿急慢性支气管炎、支气管哮喘、感冒中轻度咳嗽患者92例(统计的病例均为在本诊所完成治疗/有复诊的病例,具体汤剂选择和用量遵循医师的判断),3-5日后,治愈21例、显效22例、有效38例、无效11例。回访到的病例平均咳嗽消失时间11.2日。
2016-2017年间诊所共使用内服小青龙汤和/或桑杏汤以及内服咳特灵胶囊治疗小儿急慢性支气管炎、支气管哮喘、感冒中轻度咳嗽患者42例(统计的病例均为在本诊所完成治疗/有复诊的病例,具体汤剂选择和用量遵循医师的判断),3-5日后,治愈例19、显效例12、有效例9、无效2例。回访到的病例平均咳嗽消失时间7.8日。
2017-2018年间诊所使用本申请的透皮水凝胶贴治疗(统计的病例均为在本诊所完成治疗/有复诊的病例,按照实施例2中的使用方法)小儿急慢性支气管炎、支气管哮喘、感冒中轻度咳嗽患者108例,使用4日后,治愈例53、显效例29、有效例21、无效5例。回访到的病例平均咳嗽消失时间8日。
根据上述统计结果可见,本申请的水凝胶药贴实现了不亚于“内服小青龙汤和/或桑杏汤以及内服咳特灵胶囊”的效果,明显优于单纯内服小青龙汤和/或桑杏汤。
相比汤药和胶囊剂联合使用,本申请的贴剂使用方便,不影响正常生活学习,儿童接受程度明显优于药汤和胶囊剂;外用时西药成分马来酸氯苯那敏不良反应发生的可能性和危险性也明显较小;透皮贴剂与其他治疗气管炎、哮喘、感冒的中西药制剂潜在的相互干扰也较少。本发明的水凝胶药贴是治疗儿童急慢性支气管炎、支气管哮喘、感冒咳嗽、百日咳及各种咳嗽病症的良好选择。
Claims (10)
1.一种治疗小儿寒热夹杂咳嗽的水凝胶药贴,其特征在于,其有效成分为小青龙汤、桑杏汤中的有效成分以及咳特灵胶囊。
2.根据权利要求1的水凝胶药贴,其中小青龙汤中有效成为:麻黄、炙甘草、桂枝、干姜、白芍、法半夏、五味子、苍耳子、辛夷、葛根;桑杏汤中的有效成分为:桑叶、杏仁、沙参、浙贝、黑桅子、淡豆豉、荆芥、薄荷。
3.根据权利要求2的水凝胶药贴,其中小青龙汤中有效成为:按重量份计,麻黄6、炙甘草10、桂枝10、干姜10、白芍10、法半夏10、五味子6、苍耳子15、辛夷10、葛根30;桑杏汤中的有效成分为:按重量份计,桑叶10、杏仁10、沙参10、浙贝10、黑桅子10、淡豆豉10、荆芥10、薄荷8。
4.根据权利要求3的水凝胶药贴,其中小青龙汤和桑杏汤中的有效成分干重比例为2:2、2:1.5、2:0.5或1.5:2.5。
5.根据权利要求4的水凝胶药贴,其中咳特灵胶囊加入量为小青龙汤和桑杏汤中有效成分干重每100g加入3粒。
6.根据权利要求3-5任一项的水凝胶药贴,其中水凝胶药贴由粘贴层、背衬层、药物贮库层、复膜层、保护层构成,规格为5.5cm×7.5cm。
7.根据权利要求6的水凝胶药贴,其中水凝胶药贴的药物贮库层成分为去离子水52.4%、甘油20%、药粉15%、聚丙烯酸钠10%、月桂氮卓酮1%、稳定剂1%、酒石酸0.25%、DMDMH 0.20%、甘羟铝0.15%。
8.根据权利要求1-7任一项的水凝胶药贴的制备方法,包括将小青龙汤和桑杏汤中有效成分分别烘干后粉碎、研磨、过80-120目筛;按照所需比例混合小青龙汤和桑杏汤中有效成分的干药粉;加入所需重量的咳特灵胶囊;充分搅拌均匀,加入水凝胶药贴的药物贮库层中制作成水凝胶贴。
9.小青龙汤、桑杏汤中的有效成分以及咳特灵胶囊在制备治疗小儿寒热夹杂咳嗽的水凝胶药贴中的用途。
10.根据权利要求9的用途,其中小青龙汤中有效成为:按重量份计,麻黄6、炙甘草10、桂枝10、干姜10、白芍10、法半夏10、五味子6、苍耳子15、辛夷10、葛根30;桑杏汤中的有效成分为:按重量份计,桑叶10、杏仁10、沙参10、浙贝10、黑桅子10、淡豆豉10、荆芥10、薄荷8;小青龙汤和桑杏汤中的有效成分干重比例为2:2、2:1.5、2:0.5或1.5:2.5;咳特灵胶囊加入量为小青龙汤和桑杏汤中有效成分干重每100g加入3粒;水凝胶药贴药物贮库层中药粉含量为15%重量。
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