CN115040561B - 一种抗肠道病毒71型的中药组合物及其制备方法与应用 - Google Patents
一种抗肠道病毒71型的中药组合物及其制备方法与应用 Download PDFInfo
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Abstract
本发明公开了一种抗肠道病毒71型的中药组合物及其制备方法与应用,所述中药组合物包括以下原料:金银花、连翘、广藿香、薄荷、苍术、甘草;所述中药组合物可通过抑制病毒、调节机体免疫功能等多种作用发挥抗肠道病毒71型作用,对肠道病毒71型的杀灭率达到99%以上,有效的预防和治疗肠道病毒71型的感染,解决了目前缺少有效抗肠道病毒71型产品的问题,同时采用中药复方结合现代制剂技术方法,极大的提高了预防和治疗效果,与化学成分抗肠道病毒71型病毒的方法相比,提高了安全性,降低了毒副作用。
Description
技术领域
本发明属中药领域,具体是一种抗肠道病毒71型的中药组合物及其制备方法与应用。
背景技术
手足口病是以手、足、口出现水疱为特征,病情轻而短暂,儿童多见,潜伏期3~5天,有低热、全身不适、腹痛等前驱症。1~2天内口腔、咽、软腭、颊黏膜、舌、齿龈出现疼痛性粟粒至绿豆大小水疱,周围绕以红晕,破溃成小溃疡,由于疼痛,常流涎和拒食。同时手足亦出现皮疹,在手足的背侧面和手指(趾)背侧缘、甲周围、掌跖部,出现数目不定的水疱,除手足口外,亦可见于臀部及肛门附近,偶可见于躯干及四肢,数天后干涸、消退,皮疹无瘙痒,无疼痛感。个别儿童可出现泛发性丘疹、水疱,伴发无菌性脑膜炎、脑炎、心肌炎等。
手足口病是由肠道病毒引起的传染病,引发手足口病的肠道病毒有20多种(型),其中以柯萨奇病毒A16型(CoxA16)和肠道病毒71型(EV71)最为常见,且后者较凶险,更易导致严重并发症而致死、致残,危害性较大。目前对肠道病毒71型感染尚缺乏有效的药物,市场中消毒产品大多使用化学杀菌成分,安全性、刺激性存在较大问题。利用传统中药复方结合现代制剂技术,提供一种安全、有效的防治方法。
发明内容
本发明的目的在于克服现有技术的不足,提供一种抗肠道病毒71型的中药组合物及其制备方法与应用,有效预防和治疗肠道病毒71型感染,切断传播途径,降低手足口病传染率,且安全性高、毒副作用小。
本发明的目的是通过以下技术方案来实现的:一种抗肠道病毒71型的中药组合物,其特征在于,包括以下原料:金银花、连翘、广藿香、薄荷,苍术,甘草。
金银花味甘,性寒。归肺、心、胃经。清热解毒,疏散风热。用于痈肿疔疮,喉痹,丹毒,热毒血痢,风热感冒,温病发热。
广藿香味辛,性微温。归脾、胃、肺经。芳香化浊,和中止呕,发表解暑。用于湿浊中阻,脘痞呕吐,暑湿表证,湿温初起,发热倦怠,胸闷不舒,寒湿闭暑,腹痛吐泻,鼻渊头痛。
连翘味苦,性微寒。归肺、心、小肠经。清热解毒,消肿散结,疏散风热。用于痈疽,瘰疬,乳痈,丹毒,风热感冒,温病初起,温热入营,高热烦渴,神昏发斑,热淋涩痛。
甘草味甘,性平。归心、肺、脾、胃经。补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药。用于脾胃虚弱,倦怠乏力,心悸气短,咳嗽痰多,脘腹、四肢挛急疼痛,痈肿疮毒,缓解药物毒性、烈性。
苍术味辛、苦,性温。燥湿健脾,祛风散寒,明目。用于湿阻中焦,脘腹胀满,泄泻,水肿,脚气痿躄,风湿痹痛,风寒感冒,夜盲,眼目昏涩。
薄荷味辛,性凉。归肺、肝经。疏散风热,清利头目,利咽,透疹,疏肝行气。用于风热感冒,风温初起,头痛,目赤,喉痹,口疮,风疹,麻疹,胸胁胀闷。
通过上述方案,本发明从中医药理论出发,采用传统中药复方思维,形成有效抗肠道病毒71型的中药组合物,对肠道病毒71型的杀灭率达到99%以上,有效的预防和治疗肠道病毒71型的感染。解决了目前缺少有效抗肠道病毒71型的问题,同时采用中药复方结合现代制剂技术方法,极大的提高了预防和治疗效果,与化学成分抗病毒方法相比,提高了安全性,降低了毒副作用。
进一步的,包括以下重量份的原料:金银花5-15份、连翘5-20份、广藿香3-15份、薄荷1-8份,苍术3-12份,甘草1-9份。
进一步的,包括以下重量份的原料:金银花5-12份、连翘5-15份、广藿香3-12份、薄荷1-6份,苍术3-8份,甘草1-6份。
进一步的,包括以下重量份的原料:金银花5-10份、连翘5-10份、广藿香3-8份、薄荷 1-4份,苍术3-7份,甘草1-4份。
进一步的,包括以下重量份的原料:金银花5-8份、连翘5-10份、广藿香3-6份、薄荷2-3份,苍术3-7份,甘草1-3份。
一种抗肠道病毒71型的中药组合物的应用,将所述的中药组合物应用于病毒性肺炎、细菌性肺炎、手足口病、抗肠道病毒71型的药物以及卫生用品、消毒产品、化妆品中,所述相关药品和消毒产品包括但不限于片剂、颗粒剂、胶囊剂和液体制剂等,卫生用品包括但不限于湿纸巾、洗手液,化妆品包括但不限于沐浴露、香皂等。
一种中药洗手液的制备方法,包括以下步骤:
S1、准备原料:以重量份计,准备所述的中药组合物8-20份,表面活性剂5-15份、保湿剂1-5份、氯化钠0.5-1.5份、pH调节剂0.01-0.1份、苯甲酸钠0.01-0.1份、乙二胺四乙酸二钠0.01-0.05份、葡萄糖酸氯己定0.01-0.3份、香精0.01-0.1份、天然色素0.001-0.005份、去离子水55-75份;
S2、制备中药提取液:向所述中药组合物中加入所述中药组合物质量的10倍质量的乙醇浸泡后,进行第一次回流提取,其后过滤,得提取滤液和滤渣,再向所述滤渣中加入中药组合物质量的10倍质量的乙醇进行第二次回流;再次过滤,弃去滤渣,得到滤液,将两次滤液合并后进行减压浓缩,直至浓缩液中无乙醇,再将浓缩液离心10min,取上清液,向所述上清液中加入去离子水,定容至生药重量:药液体积之比为1:2g/mL备用,所述乙醇浓度为65%;
S3、制备混合水溶液:取步骤S1中重量份数60%的去离子水,依次向所述去离子水中加入表面活性剂、保湿剂、氯化钠,每次加入一种物质后均搅拌5min;其后再加入苯甲酸钠和乙二胺四乙酸二钠,其后搅拌10min,备用;
S4、制备中药洗手液:将所述中药提取液与所述混合水溶液混合,并搅拌10min;其后加入pH调节剂、香精、天然色素,并搅拌5min;最后依次加入葡萄糖酸氯己定和剩余的去离子水,并搅拌30min。
进一步的,步骤S2中浸泡时间为30min,一次回流提取时间为1h,二次回流时间为1h,离心时转速为3000r/min。
本发明的有益效果是:本发明组合中药可通过抑制病毒、调节机体免疫功能等多种作用,对肠道病毒71型的杀灭率达到99%以上,有效的预防和治疗肠道病毒71型引起的感染,且毒副作用低,提高了安全性;将其应用于病毒性肺炎、细菌性肺炎、手足口病、抗肠道病毒 71型的药物以及卫生用品、消毒产品、化妆品中的制备中,使用方便,且能有效降低手足口病的传播、感染率。
具体实施方式
下面进一步详细描述本发明的技术方案,但本发明的保护范围不局限于以下所述。
实施例1
一种抗肠道病毒71型的中药组合物,包括以下重量份的原料:金银花5份、连翘5份、广藿香3份、薄荷1份,苍术3份,甘草1份。
实施例2
一种抗肠道病毒71型的中药组合物,包括以下重量份的原料:金银花15份、连翘20份、广藿香15份、薄荷8份,苍术12份,甘草9份。
实施例3
一种抗肠道病毒71型的中药组合物包括以下重量份的原料:金银花12份、连翘15份、广藿香12份、薄荷6份,苍术8份,甘草6份。
实施例4
一种抗肠道病毒71型的中药组合物包括以下重量份的原料:金银花10份、连翘10份、广藿香8份、薄荷4份,苍术7份,甘草4份。
实施例5
一种抗肠道病毒71型的中药组合物包括以下重量份的原料:金银花8份、连翘10份、广藿香6份、薄荷3份,苍术7份,甘草3份。
应用例1
将上述中药组合物用于中药洗手液的制备,所中药洗手液的制备方法包括以下步骤:
S1、准备原料:以重量份计,以实施例1至实施例5任意组分准备所述的中药组合物,表面活性剂5份、保湿剂1份、氯化钠0.5份、pH调节剂0.01份、苯甲酸钠0.01份、乙二胺四乙酸二钠0.01份、葡萄糖酸氯己定0.01份、香精0.01份、天然色素0.001份、去离子水 55份;
S2、制备中药提取液:向所述中药组合物中加入所述中药组合物质量的10倍质量的乙醇浸泡30min后,进行1h第一次回流提取,其后过滤,得提取滤液和滤渣,再向所述滤渣中加入中药组合物质量的10倍质量的乙醇进行1h第二次回流;再次过滤,弃去滤渣,得到滤液,将两次滤液合并后进行减压浓缩,直至浓缩液中无乙醇,再将浓缩液在3000r/min下离心 10min,取上清液,向所述上清液中加入去离子水,定容至生药重量:药液体积之比为1g/mL 备用,所述乙醇浓度为65%;
S3、制备混合水溶液:取步骤S1中重量份数60%的去离子水,依次向所述去离子水中加入表面活性剂、保湿剂、氯化钠,每次加入一种物质后均搅拌5min;其后再加入苯甲酸钠和乙二胺四乙酸二钠,其后搅拌10min,备用;
S4、制备中药洗手液:将所述中药提取液与所述混合水溶液混合,并搅拌10min;其后加入pH调节剂、香精、天然色素,并搅拌5min;最后依次加入葡萄糖酸氯己定和剩余的去离子水,并搅拌30min。
应用例2
将上述中药组合物用于中药洗手液的制备,所中药洗手液的制备方法包括以下步骤:
S1、准备原料:以重量份计,以实施例1至实施例5任意组分准备所述的中药组合物,表面活性剂10份、保湿剂3份、氯化钠1.1份、pH调节剂0.05份、苯甲酸钠0.05份、乙二胺四乙酸二钠0.07份、葡萄糖酸氯己定0.2份、香精0.07份、天然色素0.003份、去离子水 63份;
S2、制备中药提取液:制备中药提取液:向所述中药组合物中加入所述中药组合物质量的10倍质量的乙醇浸泡后,进行1h第一次回流提取,其后过滤,得提取滤液和滤渣,再向所述滤渣中加入中药组合物质量的10倍质量的乙醇进行1h第二次回流;再次过滤,弃去滤渣,得到滤液,将两次滤液合并后进行减压浓缩,直至浓缩液中无乙醇,再将浓缩液在3000r/min下离心10min,取上清液,向所述上清液中加入去离子水,定容至生药重量:药液体积之比为2g/mL备用,所述乙醇浓度为65%;
S3、制备混合水溶液:取步骤S1中重量份数60%的去离子水,依次向所述去离子水中加入表面活性剂、保湿剂、氯化钠,每次加入一种物质后均搅拌5min;其后再加入苯甲酸钠和乙二胺四乙酸二钠,其后搅拌10min,备用;
S4、制备中药洗手液:将所述中药提取液与所述混合水溶液混合,并搅拌10min;其后加入pH调节剂、香精、天然色素,并搅拌5min;最后依次加入葡萄糖酸氯己定和剩余的去离子水,并搅拌30min。
应用例3
将上述中药组合物用于中药洗手液的制备,所中药洗手液的制备方法包括以下步骤:
S1、准备原料:以重量份计,以实施例1至实施例5任意组分准备所述的中药组合物,表面活性剂15份、保湿剂5份、氯化钠1.5份、pH调节剂0.1份、苯甲酸钠0.1份、乙二胺四乙酸二钠0.05份、葡萄糖酸氯己定0.3份、香精0.1份、天然色素0.005份、去离子水75 份;
S2、制备中药提取液:向所述中药组合物中加入所述中药组合物质量的10倍质量的乙醇浸泡后,进行1h第一次回流提取,其后过滤,得提取滤液和滤渣,再向所述滤渣中加入中药组合物质量的10倍质量的乙醇进行1h第二次回流;再次过滤,弃去滤渣,得到滤液,将两次滤液合并后进行减压浓缩,直至浓缩液中无乙醇,再将浓缩液在3000r/min下离心10min,取上清液,向所述上清液中加入去离子水,定容至生药重量:药液体积之比为2g/mL备用,所述乙醇浓度为65%;
S3、制备混合水溶液:取步骤S1中重量份数60%的去离子水,依次向所述去离子水中加入表面活性剂、保湿剂、氯化钠,每次加入一种物质后均搅拌5min;其后再加入苯甲酸钠和乙二胺四乙酸二钠,其后搅拌10min,备用;
S4、制备中药洗手液:将所述中药提取液与所述混合水溶液混合,并搅拌10min;其后加入pH调节剂、香精、天然色素,并搅拌5min;最后依次加入葡萄糖酸氯己定和剩余的去离子水,并搅拌30min。
检测:
依据T/FDSA005-2019《消毒剂灭活手足口病病毒效果的测试方法》,将应用例制备的中药洗手液原液进行肠道病毒71型灭活试验,检测结果如表1和表2所示。
表1:中和剂鉴定实验结果
表2:对肠道病毒71型的灭活效果
由表1、表2可知:
(1)经3次重复试验,所用D/E中和肉汤溶液可有效中和中药洗手液原液对肠道病毒 71型的残留作用,且中和剂和中和产物对肠道病毒71型及细胞的生长基本无影响。
(2)经3次重复试验,在20℃恒温试验条件下,应用中药洗手液原液,作用10.0min,对肠道病毒71型的平均灭活对数值为2.17(即灭活率为99.32%)。
依据《消毒技术规范》2002年版,将应用例制备的中药洗手液进行多次完整皮肤刺激试验,检测结果如表3。
表3:中药洗手液对家兔多次完整皮肤刺激反应评分
由表3可知,所述中药洗手液对家兔多次完整皮肤刺激试验结论为无刺激性。
将应用例制备的中药洗手液进行微生物学检验和理化指标检测,检测依据为:《消毒技术规范》(2002年版)、《一次性使用卫生用品卫生标准》GB15979-2002、《化妆品安全技术规范》2015年版,检测结论如下:
1.所述中药洗手液存放前葡萄糖酸氯己定平均含量为0.048%(W/V),54℃存放14d后,葡萄糖酸氯已定平均含量为0.046%(W/V),下降率为4.2%,小于10%。检验前后中药洗手液性状,颜色无变化,无悬浮物产生。根据评价标准《消毒技术规范》(2002年版)要求,该样品有效期均为1年。
2.所述中药洗手液的pH值为4.22。
3.所述中药洗手液铅含量<0.001mg/L、砷含量<0.004mg/L、汞含量为0.10mg/L,铅、砷、汞含量均符合《手消毒剂卫生要求》GB27950-2011的规定。
4.所述中药洗手液的细菌菌落总数、大肠菌群、金黄色葡萄球菌、真菌菌落总数、铜绿假单胞菌(绿脓杆菌)、溶血性链球菌结果均符合《一次性使用卫生用品卫生标准》GB15979-2002 的规定。
5.所述中药洗手液对金黄色葡萄球菌作用2min时的抑菌率为83.8%,有抑菌作用,5min、10min、20min的抑菌率分别为91.6%、94.6%、96.7%,有较强的抑菌作用,符合《一次性使用卫生用品卫生标准》GB15979-2002的规定。
将应用例制备的中药洗手液进行抑菌试验,检验依据:《消毒技术规范》卫生部(2002年版),检验结论如下:
所述中药洗手液对大肠杆菌作用2min、5min、10min、20min的平均抑菌率均>99.9%,有较强抑菌作用,符合《一次性使用卫生用品卫生标准》GB15979-2002的规定。
综上,本发明涉及的中药组合物应用于包括但不限于洗手液的制备中,皆能达到上述对肠道病毒71型的杀灭率达到99%以上的技术效果,对肠道病毒71型的杀灭率达到99%以上,达到抑制手足口病传播的目的。
以上所述仅是本发明的优选实施方式,应当理解本发明并非局限于本文所披露的形式,不应看作是对其他实施例的排除,而可用于各种其他组合、修改和环境,并能够在本文所述构想范围内,通过上述教导或相关领域的技术或知识进行改动。而本领域人员所进行的改动和变化不脱离本发明的精神和范围,则都应在本发明所附权利要求的保护范围内。
Claims (6)
1.一种抗肠道病毒71型的中药组合物,其特征在于,由以下重量份的原料组成:金银花5-15份、连翘5-20份、广藿香3-15份、薄荷1-8份、苍术3-12份、甘草1-9份。
2.根据权利要求1所述的一种抗肠道病毒71型的中药组合物,其特征在于:由以下重量份的原料组成:金银花5-12份、连翘5-15份、广藿香3-12份、薄荷1-6份、苍术3-8份、甘草1-6份。
3.根据权利要求2所述的一种抗肠道病毒71型的中药组合物,其特征在于:由以下重量份的原料组成:金银花5-10份、连翘5-10份、广藿香3-8份、薄荷1-4份、苍术3-7份、甘草1-4份。
4.根据权利要求3所述的一种抗肠道病毒71型的中药组合物,其特征在于:由以下重量份的原料组成:金银花5-8份、连翘5-10份、广藿香3-6份、薄荷2-3份、苍术3-7份、甘草1-3份。
5.一种中药洗手液的制备方法,其特征在于:包括以下步骤:
S1、准备原料:以重量份计,准备权利要求1-权利要求4任意一项所述的中药组合物8-20份,表面活性剂5-15份、保湿剂1-5份、氯化钠0.5-1.5份、pH调节剂0.01-0.1份、苯甲酸钠0.01-0.1份、乙二胺四乙酸二钠0.01-0.05份、葡萄糖酸氯己定0.01-0.3份、香精0.01-0.1份、天然色素0.001-0.005份、去离子水55-75份;
S2、制备中药提取液:向所述中药组合物中加入所述中药组合物质量的10倍质量的乙醇浸泡后,进行第一次回流提取,其后过滤,得提取滤液和滤渣;再向所述滤渣中加入中药组合物质量的10倍质量的乙醇进行第二次回流,再次过滤,弃去滤渣,得到滤液,将两次滤液合并后进行减压浓缩,直至浓缩液中无乙醇,再将浓缩液离心10min,取上清液,向所述上清液中加入去离子水,定容至生药重量:药液体积之比为1:2g/mL备用,所述乙醇浓度为65%;
S3、制备混合水溶液:取步骤S1中重量份数60%的去离子水,依次向所述去离子水中加入表面活性剂、保湿剂、氯化钠,每次加入一种物质后均搅拌5min;其后再加入苯甲酸钠和乙二胺四乙酸二钠,其后搅拌10min,备用;
S4、制备中药洗手液:将所述中药提取液与所述混合水溶液混合,并搅拌10min;其后加入pH调节剂、香精、天然色素,并搅拌5min;最后依次加入葡萄糖酸氯己定和剩余的去离子水,并搅拌30min。
6.根据权利要求5所述的一种中药洗手液的制备方法,其特征在于:步骤S2中浸泡时间为30min,第一次回流提取时间为1h,第二次回流时间为1h,离心时转速为3000r/min。
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手足口病中医治疗经验及预防方药研究概况;张国梁等;中医药临床杂志;22(7);574-582 * |
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