CN116712515B - 一种治疗发热的中药组合物及其制备方法和用途 - Google Patents
一种治疗发热的中药组合物及其制备方法和用途 Download PDFInfo
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- CN116712515B CN116712515B CN202310999621.4A CN202310999621A CN116712515B CN 116712515 B CN116712515 B CN 116712515B CN 202310999621 A CN202310999621 A CN 202310999621A CN 116712515 B CN116712515 B CN 116712515B
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Abstract
本发明属于中药制剂领域，具体公开了一种治疗发热的中药组合物及其制备方法和用途，其中组合物是含有如下重量配比的原料制备而成：茯苓5~8份、金银花8~15份、连翘5~8份、黄芩5~6份、黄连2~3份、石膏8~15份、厚朴3~5份、枳实3~5份、蝉蜕3~5份、僵蚕3~5份、木蝴蝶5~6份、麦芽8~10份、草果3~6份、槟榔3~5份、马勃3~6份、甘草2~5份。本发明中药组合物具有健脾消食、化湿和胃、疏风解表，清热解毒的功效，在治疗小儿外感、伤食、积食所致的发热持续不退，或伴咽喉红肿疼痛，夜卧不安，消化不良等方面效果显著。
Description
技术领域
本发明属于中药制剂领域，具体涉及一种治疗发热的中药组合物及其制备方法和用途。
背景技术
发热是小儿门诊十分常见的症状之一，作为身体对抗入侵病原体的一种保护性反应，也被认为是机体发动免疫系统抵抗感染的一个过程。但高热或持续发热会影响机体各种调节功能，进而影响到小儿的身体健康。中医认为，小儿外感发热疾病，病在肌表，一年四季均可发生，以冬春季易发，为小儿常见病，严重影响工作、学习和生活，甚者可出现神昏谵语，抽搐惊厥，甚至危及生命。因此，对持续发热或高热小儿，应积极查明原因，针对病因进行相应治疗。
目前用于小儿发热的药物主要为布洛芬，但其存在明显的副作用，如消化不良，皮疹或荨麻疹，此外还有头痛和转氨酶升高等。也有较多的中药复方用于小儿发热的治疗，如小儿柴桂退热颗粒、小儿豉翘清热颗粒等，但许多小儿感染性发热使用后，依然发热难退，或者反反复复，缠绵不愈，仍需运用快速退热药物布洛芬。因此，有必要开发一种退热效果更好，副作用更少的中药方剂。
发明内容
为解决上述问题，本发明提供了一种治疗发热的中药组合物，它是含有如下重量配比的原料制备而成：
茯苓5~8份、金银花8~15份、连翘5~8份、黄芩5~6份、黄连2~3份、石膏8~15份、厚朴3~5份、枳实3~5份、蝉蜕3~5份、僵蚕3~5份、木蝴蝶5~6份、麦芽8~10份、草果3~6份、槟榔3~5份、马勃3~6份、甘草2~5份。
进一步地，它是含有如下重量配比的原料药制备而成：
茯苓5份、金银花12份、连翘8份、黄芩5份、黄连3份、石膏12份、厚朴5份、枳实5份、蝉蜕5份、僵蚕5份、木蝴蝶5份、麦芽10份、草果5份、槟榔5份、马勃5份、甘草3份。
进一步地，它是由原料药的药粉、或原料药的水或有机溶剂提取物为活性成分，加上药品上可接受的辅料制备而成的制剂。
进一步地，所述制剂为口服制剂。
更进一步地，所述口服制剂为溶液剂、颗粒剂、膏剂、片剂、丸剂或胶囊剂。
本发明还提供了一种前述中药组合物的制备方法，其特征在于：它包括以下步骤：
（1）按照前述配比称取原料；
（2）原料药研为粉末，或原料药的水或有机溶剂提取液，加入药品上常用的辅料或辅助性成分，即得。
本发明还提供了一种前述的中药组合物在制备治疗发热的药物中的用途。
进一步地，所述药物是治疗小儿发热的药物。
进一步地，所述药物是治疗小儿外感、伤食或积食所致的发热持续不退的药物。
进一步地，所述药物是治疗小儿咽喉红肿疼痛，咳嗽咳痰，夜卧不安，消化不良，呕吐的药物。
中医通常认为外感热病的原因有风、寒、暑、湿、燥、火六淫，还有疫疠之气（杂气、戾气、异气）等多种，外邪入侵人体的途径，多因人体一时性抵抗力不足或素体虚弱，而外邪由皮毛或口鼻而入，激发相应的病理反应，其一般发展规律是由表入里、由寒变热、由实转虚。与成年人不同之处在于，小儿为稚阴稚阳之体，感邪之后，变化复杂。通过长期临床工作实践，将小儿四季外感归属于三型诊治模式，分为下面三型：
1、消化症状型：因多喜贪食冷饮瓜果，易患外感夹饮食停滞而发热，多发于盛夏，孟秋湿热交蒸；而孟春时节，气候寒冷、人体腠理致密，易患外感风寒，寒郁化热，同时可能出现胃满腹泻等症状。
2、肺系症状型：春季、夏季易感受风热、暑湿等病邪；秋季，易感时令温燥之邪；冬季为外感寒邪之多发季。
3、神经型：小儿元气未充，神气怯弱，不耐外界刺激，此类患儿每因闻大声喧叫，或咋见怪异之物，而罹患发热疾病。
本发明的有益效果为：
依据上述中医辨证，本发明确定小儿外感的内因主要是小儿形气未充，卫外不固，易为外邪所侵；加上喂养不当、寒温失调，进而造成脾胃虚弱，正气亏虚，更易感邪，故本发明方剂中重用茯苓为君，以健脾利湿、宁心安神；以金银花、连翘、马勃、木蝴蝶、黄芩、黄连、石膏、蝉蜕八药共为臣，共奏清热解毒，疏风解表散热之功，其中连翘能消肿散结，与金银花配伍既能透热达表，又能清里热而解毒；马勃能利咽消肿、止血，主要用于咽喉肿痛，木蝴蝶能清肺利咽、疏肝和胃，主要用于肺热咳嗽、咽喉肿痛不适、喑哑等证，蝉蜕具疏风清热、利咽开音、息风止痉之功，在方中还能预防高热导致的抽搐、惊厥症的发生，黄芩、黄连、石膏均为清热泻火之品，三药合用，以泻中、上二焦之邪热为见长，石膏还能生津、除烦、止渴；佐以厚朴、槟榔、麦芽、枳实、草果等行气消食，健脾化痰除湿，以主治脾胃虚弱、食积气滞、痰滞、湿滞，胸腹胀满，气粗喘急等不适，同时防黄芩、黄连及石膏之苦寒太过。甘草为使以和中，调和诸药。诸药合用，共奏健脾消食、化湿和胃、疏风解表，清热解毒之功。从而达到热退身凉、胃和儿安之效果。经临床实验证明：本发明在治疗小儿发热持续不退方面，效果与目前普遍使用的布洛芬相当，优于现临床使用的需要与西药联合使用的退热中药制剂，具备实际推广应用价值。
显然，根据本发明的上述内容，按照本领域的普通技术知识和惯用手段，在不脱离本发明上述基本技术思想前提下，还可以做出其它多种形式的修改、替换或变更。
以下通过实施例形式的具体实施方式，对本发明的上述内容再作进一步的详细说明。但不应将此理解为本发明上述主题的范围仅限于以下的实例。凡基于本发明上述内容所实现的技术均属于本发明的范围。
具体实施方式
本发明具体实施方式中使用的原料、设备均为已知产品，通过购买市售产品获得，其中，由本发明中药组合物制成的现代中药制剂的制备工艺成熟，参照现有技术常规方法即可制成。
实施例1、本发明药物的制备
配方：茯苓5g、金银花8g、连翘5g、黄芩5g、黄连2g、石膏8g、厚朴3g、枳实3g、蝉蜕3g、僵蚕3g、木蝴蝶5g、麦芽8g、草果3g、槟榔3g、马勃3g、甘草2g。
制备方法：按配比称取上述原料，加10倍量水煎煮2次，每次20~30分钟，滤过，合并滤液，滤液减压浓缩成稠膏，加入药品上常用的辅料制成一日剂量的片剂。
实施例2、本发明药物的制备
配方： 茯苓5g、金银花12g、连翘8g、黄芩5g、黄连3g、石膏12g、厚朴5g、枳实5g、蝉蜕5g、僵蚕5g、木蝴蝶5g、麦芽10g、草果5g、槟榔5g、马勃5g、甘草3g。
制备方法：按配比称取上述原料，加8倍量水煎煮2次，每次20~30分钟，滤过，合并滤液，即得一日剂量的药液。
实施例3、本发明药物的制备
配方：茯苓8g、金银花15g、连翘8g、黄芩6g、黄连3g、石膏15g、厚朴5g、枳实5g、蝉蜕5g、僵蚕5g、木蝴蝶6g、麦芽10g、草果6g、槟榔5g、马勃6g、甘草5g。
制备方法：按配比称取上述原料，加10倍量水煎煮2次，每次20~30分钟，滤过，合并滤液，滤液减压浓缩成稠膏, 加入药品上常用的辅料制成一日剂量颗粒剂。
以下通过试验例进一步说明本发明的有益效果
试验例1 本发明中药组合物治疗小儿发热的临床研究
1、临床资料
以2016年8月24日至2022年12月31日在贵州省大方县中医院及大方县人民医院主诉为发热的儿童患者为对象，将其分为治疗组和对照组，以3d内发热症状消失率、发热症状首次消失时间、发热最高峰及持续时间等作为主要疗效指标，评价该中药组合物退热的有效性。
其中，发热儿童的病因涉及外感、伤食、积食，部分患者中症状除发热外还伴有咽喉红肿疼痛、咳嗽咳痰，夜卧不安，消化不良，呕吐等。
2、治疗方法
治疗组：纳入病例117例，使用实施例2制备的药液，每日一剂，一天三次。
对照组：纳入病例112例，使用布洛芬混悬液口服。规格：100毫升：2 克。每毫升含主药成分布洛芬20毫克。辅料为：预胶化淀粉、黄原胶、甘油、蔗糖、无水枸椽酸、苯甲酸钠、吐温80、食用色素、食用香精、纯水。服药方法：2-3岁（12-14公斤），1次3毫升，若发热或疼痛不缓解，可每隔4-6小时重复用药一次，24小时不超过4次；4--6岁（16-20公斤），1次5毫升，若发热或疼痛不缓解,可每隔4-6小时重复用药一次，24小时不超过4次；7--9岁（22-26公斤），1次8毫升，若发热或疼痛不缓解，可每隔4-6小时重复用药一次，24小时不超过4次；10-12岁（28-32公斤），1次10毫升，若发热或疼痛不缓解，可每隔4-6小时重复用药一次，24小时不超过4次。
3、疗效观察
3.1体温变化疗效评定标准依据《中药新药临床研究指导原则》(2002年)拟定：
痊愈:体温下降至37℃或37℃以下，证候、体征恢复正常；
显效:体温下降至37℃或37℃以下，证候、体征尚未恢复正常；
有效:体温下降>0.5℃，体温>37℃，证候、体征尚未恢复正常；
无效:体温下降<0.5℃，证候、体征尚未恢复正常。
总有效率计算方法：总有效率%= (痊愈+显效)/患者例数×100%。
3.2 证候疗效判定标准依据《中药新药临床研究指导原则》(2002年)执行临床：
痊愈:症状、体征消失或基本消失，证候积分减少>95%。
显效:症状、体征明显改善，证候积分减少>70%。
有效:症状、体征均有好转，证候积分减少>30%。
无效:症状、体征无明显改善，甚或加重，证候积分减少不足30%。
总有效率计算方法：总有效率%= (显效+痊愈+有效)/患者例数×100%。
4、结果
两组治疗后观察时间为3天，主要终点指标是发热症状消失率，即按照体温变化疗效评定标准依据《中药新药临床研究指导原则》(2002年)，服药后每半小时测量体温一次，以连续48小时及以上体温等于或低于37℃为发热症状消失的判定标准。在体温首次等于或低于37℃时，记录发热首次消失时间，在72h后按照“发热症状消失率=发热症状消失人数/患者例数×100%”计算发热症状消失率。次要终点指标为临床证候总有效率（症状、体征）。
对所有纳入研究的人群体温变化情况进行统计分析，具体结果见表1。对证候进行分类统计分析，具体结果见表2。
表1 临床体温变化疗效比较
表2临床证候疗效比较
统计结果表明，使用本发明治疗发热患者117例，其中年龄中位数为3岁，男性占58.32%、女性占41.68%；使用布洛芬混悬液口服治疗的发热患者112例，其中年龄中位数为8.32岁，男性占57.1%、女性占42.9%。治疗组3日内体温变化总有效率为97.4%，明显高于对照组。发热症状消失人群（即经治疗72h后不再发热的人群）中，治疗组的平均发热症状首次消失(体温等于或低于37℃)时间明显短于对照组。
证候分析发现，患者中最常见的证型是：风热犯肺。通过治疗观察到，治疗组证候改善总有效率为94.02%，远远高于对照组。整个治疗过程中，所有患者均未报告严重不良反应。
Claims (9)
1.一种治疗小儿发热的中药组合物，其特征在于：由如下重量配比的原料制备而成：
茯苓5份、金银花12份、连翘8份、黄芩5份、黄连3份、石膏12份、厚朴5份、枳实5份、蝉蜕5份、僵蚕5份、木蝴蝶5份、麦芽10份、草果5份、槟榔5份、马勃5份、甘草3份。
2.根据权利要求1所述的中药组合物，其特征在于：由原料药的药粉、或原料药的水或有机溶剂提取物为活性成分，加上药品上可接受的辅料制备而成的制剂。
3.根据权利要求2所述的中药组合物，其特征在于：所述制剂为口服制剂。
4.根据权利要求3所述的中药组合物，其特征在于：所述口服制剂为溶液剂、颗粒剂、膏剂、片剂、丸剂或胶囊剂。
5.权利要求1~4任一项所述中药组合物的制备方法，其特征在于：它包括以下步骤：
（1）按照所述配比称取原料；
（2）原料药研为粉末，或原料药的水或有机溶剂提取液，加入药品上常用的辅料或辅助性成分，即得。
6.权利要求1~4任一项所述的中药组合物在制备治疗发热的药物中的用途。
7.根据权利要求6所述的用途，其特征在于：所述药物是治疗小儿发热的药物。
8.根据权利要求7所述的用途，其特征在于：所述药物是治疗小儿外感、伤食或积食所致的发热持续不退的药物。
9.根据权利要求7所述的用途，其特征在于：所述药物是治疗小儿咽喉红肿疼痛，咳嗽咳痰，夜卧不安，消化不良，呕吐的药物。
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| CN1537609A (zh) * | 2003-06-23 | 2004-10-20 | 内蒙古宇航人高技术产业有限责任公司 | 一种治疗外感热病的内服药剂及其制备方法 |
| CN104127832A (zh) * | 2014-08-25 | 2014-11-05 | 李纯苓 | 一种治疗小儿疱疹性咽峡炎发热的中药 |
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2023
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|---|---|---|---|---|
| CN1537609A (zh) * | 2003-06-23 | 2004-10-20 | 内蒙古宇航人高技术产业有限责任公司 | 一种治疗外感热病的内服药剂及其制备方法 |
| CN104127832A (zh) * | 2014-08-25 | 2014-11-05 | 李纯苓 | 一种治疗小儿疱疹性咽峡炎发热的中药 |
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| 自拟银蚕汤治疗小儿外感发热体会;田晓翔;《http://www.chinaqking.com/yc/2020/2651547.html》;正文"4、典型病例"项下病例1以及正文"5、讨论"项下第1段 * |
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