CN102327349A - 一种婴幼儿速效退热散 - Google Patents
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Abstract
本发明涉及一种婴幼儿速效退热散及其制备，具体地说是由杏仁、桃仁、栀仁、枣仁和柴胡组成，按一定分量配比研成粉末，治疗时取治疗时取15～30g药末(依病情增减)，取新鲜鸭蛋蛋清调和药末成糊状，做成小药丸，置于纱布中间，贴敷双脚涌泉穴(男孩左脚，女孩右脚)和大椎穴，外用透气胶布固定，24小时换药一次。本发明通过外用贴敷，尤其对婴幼儿外感寒邪发热及外感热邪发热引起的肺热、胃热等热病操作方面，不吃药、不打针、不输液，疗效确切，治愈率高，无毒副作用，无任何不适及伤痛。
Description
技术领域
本发明涉及一种药物组合，具体地说是以中药为原料，结合中医穴位施治的理论制备的婴幼儿速效退热散中药贴剂，属于中药领域。
背景技术
发热是体温高出正常标准，或自有身热不适的感觉，亦是机体对抗病原菌的一种抵御反应，是儿科临床常见急诊之一。发热过高或过久会使人体各个系统和器官的功能受到损伤，尤其是婴幼儿，因其脏腑娇嫩，形气未充，发病容易，传变迅速，如果高烧超过41℃，使机体各种调节机能紊乱，极易造成脑神经组织损伤。严重者出现神昏、惊厥甚至死亡。据统计，小儿外感发热在幼儿期发病最多，平均为6-7次/年，约有10-15的幼儿发病率大于12次每年。如不及时治疗，感染可经鼻咽部蔓延到附件器官，病原可通过血液循环散播到全身，诱发机体变态反应，引起众多并发症。
目前，市场上的退热药种类繁多，内服、外涂、注射、滴鼻液、口服液等等，用于抗病毒类的常用病毒灵、板蓝根冲剂等，解热止痛的常用扑热息痛、阿司匹林等，以及抗菌消炎类的青霉素注射液等，同时也有一些中医推拿、穴位疗法等物理降温方法，多因婴幼儿不能积极配合，操作比较麻烦，无法正常使用。外敷贴剂是一种便捷的退热方式，且比较实用。
检索近年关于退热类发明专利，已公开的有60余项，例如中国专利CN1049144B，于2000年2月9日审定公告的退热口服液，以柴胡、黄连、黄芩、栀子、石膏、甘草、党参、桂枝为主要原料；中国专利申请CN 1358525A，于2002年7月17日公开的退热消炎中药口服液，由大青叶、重楼、银花、连翘、柴胡、黄芩、白蔻、麻黄、杏仁、竺黄、地龙、榔片、水牛角构成；中国专利申请CN 1509456A，于2005年1月5日公开的一种治疗感冒持续发热的中药制剂“退热胶囊”及其制备方法，由薏仁、滑石、厚朴、通草、竹叶、杏仁组成；中国专利申请CN1615953A，于2005年5月18日公开的小儿柴桂退热泡腾颗粒及其制法，由柴胡、桂枝、葛根、浮萍、黄芩、白芍、蝉蜕为原料药及辅药制成；中国专利公开号CN101279056A，于2008年10月8日公开的小儿退热颗粒，由大青叶、板蓝根、金银花、连翘、栀子、牡丹皮、黄芩、淡竹叶、地龙、重楼、柴胡、白薇等制成的中药颗粒剂。中国专利CN100515442C，于2009年7月22日审定公告的退热外敷散，是由石膏1.5-2.5份、白矾1.5-2.5份、青蒿0.5-1.5份、栀子1.5-2.8份、大黄1.5-2.8份、玄明粉0.5-1.5份的中药经粉碎，磨细，过筛，混合均匀，分剂量包装而成的。中国专利公开号CN101584784A，于2009年11月25日公开的一种小儿退热中药，由黄连、栀子、滑石各、甘草、板蓝根、半夏研磨制成。
以上专利公开的各种退热药物与本发明的婴幼儿速效退热散的组成和分量完全不同，其效果也不同。
发明内容
发明人总结40余年临床工作经验，针对婴幼儿反复发热，临床药物使用不便的情况，发明了一种婴幼儿速效退热散，本发明由杏仁、桃仁、栀仁、枣仁和柴胡组成，其各组份用量为1∶1∶1∶1∶1。
本发明的制备方法为：
(1)称取等量杏仁、桃仁、栀仁、枣仁和柴胡，以放射元素钴照射消毒，分别清洗去杂干燥后研成细末，混合备用；
(2)将混合后的药末过100～120目筛装瓶密封备用；
(3)治疗时取15～30g药末(依病情增减)，取新鲜鸭蛋蛋清调和药末成糊状，做成小药丸，置于纱布中间，贴敷双脚涌泉穴(男孩左脚，女孩右脚)和大椎穴，外用透气胶布固定，24小时换药一次。
下面结合药性具体说明本发明的优点：
本发明中的杏仁味苦性温，归肺、脾、大肠经，有毒。具有宣肺止咳，降气平喘，润肠通便，杀虫解毒功效；主治咳嗽，喘促胸满，喉痹咽痛，肠燥便秘，虫毒疮疡。
桃仁味苦、甘，性平，归心、肝、大肠经，有活血祛瘀，润肠通便，止咳平喘。用于经闭，痛经，癓瘕痞块，跌扑损伤，肠燥便秘。其含有的苦杏仁甙，有镇咳作用，桃仁有增加药物吸收作用。
栀仁性寒味苦，入心、肝、肺、胃经，有清热，泻火，凉血功效，主治热病虚烦不眠、黄疸、淋病、消渴，目赤，咽痛，吐血，衄血，血痢，尿血，热毒疮疡，扭伤肿痛。
枣仁性平味甘，入心、脾、肝、胆经，有养肝、宁心、安神、敛汗、降温之效。主治虚烦不眠、惊悸怔忡、烦渴、虚汗。
柴胡味苦性微寒，归肝经、胆经，有疏散退热，升阳舒肝功能，主治感冒发热、寒热往来、疟疾，肝郁气滞，胸肋胀痛，脱肛，子宫脱落，月经不调。
本发明将上述中药进行配伍，使得各药物产生协同作用，从而能够有效治疗外感寒邪发热及外感热邪发热引起的肺热、胃热等热病，选用鸭蛋清调和，可促进药物吸收，鸭蛋清富含的溶菌酶是一种天然的抗感染物质，能起到抗过敏等功效，鸭蛋清微寒，有很好的清热解毒功效，加之其所含蛋白质、氨基酸及多种有益菌，利于药物的吸收。同时选用大椎穴和涌泉穴施药，大椎穴乃手足三阳及督脉之会，主治热病，疟疾，咳嗽，喘逆，骨蒸潮热，项强，肩背痛，腰脊强，角弓反张，小儿惊风，癫狂痫证，五劳虚损，七伤乏力，中暑，霍乱，呕吐，黄疸，风疹；涌泉穴乃是肾经的首穴，有散热生气之功效，其沟通着脚底大多穴位，是防病、保健的重要穴位。本发明通过外用贴敷，尤其对婴幼儿热病操作方面，不吃药、不打针、不输液，疗效确切，治愈率高，无毒副作用，无任何不适及伤痛。
附图说明
附图1：扑热息痛组与速效退热散组用药后不同时间体温变化。
具体实施方式
下面结合实施例来进一步说明本发明的制备。
实施例一
(1)称取杏仁、桃仁、栀仁、枣仁和柴胡各3g，以放射元素钴照射消毒，分别清洗去杂干燥后研成细末，混合备用；
(2)将混合后的药末过100～120目筛装瓶密封备用；
(3)治疗时取15g药末(依病情增减)，取新鲜鸭蛋蛋清调和药末成糊状，做成小药丸，置于纱布中间，贴敷双脚涌泉穴(男孩左脚，女孩右脚)和大椎穴，外用透气胶布固定，24小时换药一次。
实施例二
(1)称取杏仁、桃仁、栀仁、枣仁和柴胡各6g，以放射元素钴照射消毒，分别清洗去杂干燥后研成细末，混合备用；
(2)将混合后的药末过100～120目筛装瓶密封备用；
(3)治疗时取30g药末(依病情增减)，取新鲜鸭蛋蛋清调和药末成糊状，做成小药丸，置于纱布中间，贴敷双脚涌泉穴(男孩左脚，女孩右脚)和大椎穴，外用透气胶布固定，24小时换药一次。
试验例1本发明婴幼儿速效退热散毒性试验
(1)急性毒性试验：选取正常皮肤及人为破损皮肤SD大鼠各10只，分别贴敷5倍(15g/kg体重)婴幼儿速效退热散，多次贴敷，均未出现皮肤过敏及毒副反应。
(2)长期毒性试验：选取SD大鼠80只，体重60～80g，随机分成四组，每组20只，雌雄各半，单笼饲养。设2倍、5倍、10倍三个剂量组分别以汤剂灌胃SD大鼠，每24小时灌胃一次，1周后，对其血象、肝、肾、脾未见毒副作用，实验结束后处死大鼠，对肝、肾、脾等进行病理组织学检查(石蜡切片)，试验结果如表1。
表1各组动物脏体比值结果(％)
从表1可以看出，所有动物肝、肾、脾等均未见明显病理改变，说明平喘止咳贴无毒副作用、安全可靠。
试验例2
一、一般资料
1、病人来源：本试验共观察病例180例，男孩100例，女孩80，随机分成2组，其中扑热息痛组80例(对照组)，本发明婴幼儿速效退热散组100例(试验组)，两组资料的年龄、病程、体温比较差异无统计学意义(P＞0.05)，见表2。
表2两组一般资料比较
二、纳入病例标准
腋下体温＞38.5℃上呼吸道感染患儿，年龄为6月～6岁，平均年龄2.5岁。
三、试验方法
扑热息痛组，口服东北制药总厂生产的扑热息痛10～15mg/kg；婴幼儿速效退热散组，采用本发明散剂药粉(3g/kg体重)，以鸭蛋清调成糊状，做成小药丸，置于纱布中间，贴敷双脚涌泉穴(男孩左脚，女孩右脚)和大椎穴，外用透气胶布固定。分别观察用药后40min，1h，2h，3h，4h，6h，8h，12h，患儿体温变化及不良反应。
四、疗效判定标准患儿出汗，体温下降为起效；体温下降0.5℃以上为有效。
五、结果
1.两组综合疗效，扑热息痛组用药后1h总有效率65％(52/80)，速效退热散组用药后1h为91％(91/100)，差异有非常显著意义(P＜0.01)。
2.两组用药后不同时间体温变化在用药后各时间点速效退热散组平均体温均低于扑热息痛，见表3。
表3两组用药后不同时间体温变化
六、结论
180例临床试验结果显示，此种速效退热散组对治疗外感寒邪发热及外感热邪发热引起的肺热、胃热等热病具有显著疗效，其综合症状疗效总有效率分别为91％。综合对比该中药散剂疗效确切，敷用方便，且在应用过程中未发现明显不良反应和毒副作用。
Claims (4)
1.一种婴幼儿速效退热散，其特征在于它主要是由等重量份的杏仁、桃仁、栀仁、枣仁和柴胡原药研制而成。
2.权利要求1所述药剂的制备方法，它包括下列步骤：
a)称取等量杏仁、桃仁、栀仁、枣仁和柴胡，以放射元素钴照射消毒，分别清洗去杂干燥后研成细末，混合备用；
b)将混合后的药末过100～120目筛装瓶密封备用即得权利要求1所述的速效退热散。
3.根据权利要求1和2中所述药物治疗时取15～30g药末(依病情增减)，取新鲜鸭蛋蛋清调和药末成糊状，做成小药丸，置于纱布中间，贴敷双脚涌泉穴(男孩左脚，女孩右脚)和大椎穴，外用透气胶布固定，24小时换药一次。
4.根据权利要求1或3所述的药物，经过增添辅料，可以制成贴敷，广泛使用。
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