CN112402500A - 一种中药制剂在预防和消杀冠状病毒中的应用 - Google Patents
一种中药制剂在预防和消杀冠状病毒中的应用 Download PDFInfo
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Abstract
本发明涉及一种中药制剂在预防和消杀新型冠状病毒在消毒剂中应用，经过体外细胞筛选试验证明，本发明中药制剂能够对新型冠状病毒(SARS‑COV‑2)有较强的杀灭作用，因此本发明中药制剂可以作为外用消毒制剂广泛应用于环境消杀和，公共卫生空间消毒中使用，还可以制成外用凝胶剂、洗手液、喷雾剂等，并用于手部消毒。本发明外用制剂具有非常广阔的市场应用前景和价值。
Description
技术领域
本发明属于中医药领域，具体涉及一种中药制剂在预防和消杀冠状病毒中的应用。
背景技术
冠状病毒科(Coronaviridae)病毒是自然界广泛存在的一大类病毒，感染脊椎动物，如人、鼠、猪、猫、犬、狼、鸡、牛、禽类。该疾病能引起的人类疾病主要是呼吸系统感染(包括严重急性呼吸综合征，SARS)。该病毒对温度很敏感，在33℃时生长良好，但35℃就使之受到抑制。由于这个特性，冬季和早春是该病毒疾病的流行季节。冠状病毒是成人普通感冒的主要病原之一，儿童感染率较高，主要是上呼吸道感染，主要症状是水样大便、发热、呕吐，严重者甚至出现血水样便，极少数情况下也引起神经系统综合征。2019年，出现新型冠状病毒感染肺炎，该病原体是一种此前未在人类中发现的新型冠状病毒，即新型冠状病毒。基于目前的流行病学调查和研究结果，潜伏期为1-14天，多为3-7天；传染源主要是新型冠状病毒感染的患者，无症状感染者也可能成为传染源；主要传播途径为经呼吸道飞沫和接触传播，在相对封闭的环境中长时间暴露于高浓度气溶胶情况下存在经气溶胶传播的可能，其他传播途径尚待明确；人群普遍易感，目前已成为全球性公共卫生事件，严重影响了各国的经济发展和人民生活，已成为2020年的全球头号难题。中国的抗疫经验得到世界卫生组织的高度赞扬以及世界大多数国家和人民的认可，其中预防和消杀新型冠状病毒、保持社交距离、佩戴口罩、保持良好的个人卫生习惯等功不可没。目前国内的疫情防控重点是严防外输，加强环境和物品等的清洁消毒，但对于出院患者和无症状感染者的随身物品和所接触环境的消毒存在一定的困难，未消毒物品流入社会后易成为新的传染源。因此，市场上急需开发一种对冠状病毒能有效杀灭的消毒或外用药物制剂，对新冠病毒感染起到预防作用，并做好重点疫情高风险地区周围环境的全面消毒灭菌及个人日常防护措施显得尤为关键。
本发明涉及的中药制剂均是指山东步长神州制药有限公司生产的红核妇洁洗液，该药的国药准字号为Z10980131，它是由山楂核干馏油及干馏液等多种成分组成。根据国务院应对新冠肺炎疫情联防联控机制发布的《公共场所新型冠状病毒感染的肺炎卫生防护指南》(肺炎机制发〔2020〕15号)文件中规定对物体表面消毒使用的消毒剂有效氯含量为250～500mg/L”。《新型冠状病毒感染的肺炎诊疗方案(试行第七版)》中指出病毒对热敏感，在热力56℃90 min或75℃30min即可将其灭活；紫外线照射的有效时间为30min。常见的消毒剂，例如，体积分数为75％的乙醇、碘伏、中效季铵盐，含氯类、过氧化物和其他化学消毒剂，可以在指定的时间内有效地将其杀死。此外，过氧化氢气溶胶喷雾、过氧乙酸加热熏蒸、脉冲紫外线杀菌技术、可见光杀菌技术等作为新型消毒剂和消毒技术，对新型冠状病毒灭活效果较好，适用于物品表面消毒。市场上常用的氯消毒剂。漂白粉、次氯酸钠、二氧化氯、二氯异氰脲酸钠、三氯异氰脲酸钠等消毒剂，由于在消毒过程中会产生刺鼻的氯气，有一定的腐蚀性，对人体的危害较大，且该类消毒剂的残留物对环境也产生一定的破坏。鉴于上述消毒制剂使用过程中存在的缺陷，以及对于疫情防控的长期需要，因此开发一种，低毒，高效的对新型冠状病毒起到消杀作用外用产品显得尤为迫切。
发明内容
本发明目的在于提供一种中药制剂的新用途，具体涉及一种中药制剂在预防和消杀冠状病毒中的应用。本申请人在使用过程中意外的发现，本发明中药洗液对新型冠状病毒的有显著消杀作用，经过体外细胞筛选试验证明，本发明中药制剂能够对新型冠状病毒(SARS-COV-2)有较强的杀灭作用，因此本发明中药制剂可以作为外用消毒制剂广泛应用于环境消杀和个人消毒中使用，还可以制成其他的各种外用剂型使用，如凝胶剂、洗手液、喷雾剂等，可用于身体裸露部位的消毒。
本发明提供一种中药制剂在制备预防和消杀病毒中的应用，所述中药制剂的原料药组成及其重量比为：山楂核干馏油3-7份、山楂核干馏液18-22份、药用辅料适量。
所述中药制剂的原料药组成及其重量比为：山楂核干馏油5份、山楂核干馏液20份、吐温-80，25份、去离子水50份。
所述中药制剂的制备方法为：
取山楂核干馏油，山楂核干馏液，再加入药用辅料，混合均匀后，再常温搅拌20-40分钟，得混合药液，静置，过滤，即得。
所述中药制剂的制备方法为：
⑴、将山楂核干馏油置于配料缸中，加入过120目的筛网吐温-80，在常温下搅拌30分钟；
⑵、将山楂核干馏液加入上述⑴步骤的药液中，在常温下搅拌30分钟，得混合药液；
⑶、将纯化水加入上述步骤⑵的药液中，在常温下搅拌30分钟，得混合液；
⑷、将上述⑶步骤所得的混合液，静置4小时后，过滤，即得。
所述中药制剂的剂型为外用制剂。
所述中药制剂的剂型为清洗液、凝胶剂、洗手液、喷雾剂等。
所述中药制剂在制备用于预防和消杀冠状病毒的消毒剂中的应用。
所述中药制剂在制备用于预防和消杀SARS-COV-2新型冠状病毒的消毒剂中的应用。
本发明体外细胞实验以新型冠状病毒(SARS-COV-2)为代表，进行实验，本发明预防和消杀的疾病不限于新型冠状病毒，也可以所指为新型冠状病毒相类似的冠状病毒。
本发明中药制剂的活性组分为山楂核提取物，其所有效成分物质为山楂核干馏液和山楂核干馏油。其有效物质成分的提取工艺方法为：取山楂核，将山楂核置于干馏釜中，投料量为设备容积率的55％，采用以氮气为驱动力的动态干馏工艺，加热升温速率为40℃/小时，控制干馏液的反应过程，保持干馏釜内压力0.04-0.12MPa，在加热温度达到160～190℃，加热保温时间为1小时，收集160℃以上的干馏产物，并在加热温度达到250～280℃，保持温度为3小时，进行馏分收集，可得本发明的山楂核干馏液和干馏油。对上述物质进行成分研究表明其主要含有有机酸、熊果酸、糠醛类、酚类等多种有效成分。
本发明中药制剂外用剂型可以利用山楂核提取物，再加入药剂学上常用的辅料制成清洗液剂、凝胶剂、洗手液、喷雾剂、消毒剂等。
清洗液剂：将山楂核提取物，与适量药用辅料制成清洗液剂。所选的溶剂为：水、甘油、乙醇、丙二醇、脂肪油等。增溶剂为：硬脂酸钠、月桂酸、三乙醇胺有机皂、碱金属皂、硫酸化蓖麻油、十二烷基硫酸钠、卵磷脂、豆磷脂、聚山梨脂(吐温80)。助溶剂：苯甲酸、碘化钾等。潜溶剂：甘油、乙醇、丙二醇等。所选的防腐剂为：苯甲酸钠、山梨酸、苯扎溴铵、对羟基苯甲酸脂等。
凝胶剂：将山楂核提取物，与适量药用辅料制成凝胶剂。其所选的水性凝胶基质，如：西黄蓍胶、明胶、聚乙二醇、聚维酮、聚醋酸乙烯酯、纤维素衍生物、丙二醇、海藻酸钠、卡波姆等。油性凝胶基质，如：液体石蜡、聚氧乙烯、脂肪油、胶体硅、铝皂或锌皂等。防腐剂，如：尼泊金甲酯、苯扎溴铵等。保湿剂，如：聚乙二醇、甘油、丙二醇、山梨醇、吡咯烷酮羧酸钠、PDS-3高效保湿剂等。油质，如：乙氧基化酯类、杏仁油等。pH调节剂，如三乙醇胺、氢氧化钠等。增溶剂，如：PEG-40氢化蓖麻油或吐温80等。
洗手液：将山楂核提取物，与适量药用辅料制成洗手液剂或搽剂。其所选为分散介质，高浓度的乙醇。阳离子杀菌剂：季铵盐类如：苯扎氯铵、苯甲基烷基氯化铵、西吡氯铵、卤化二烷基二甲基铵、卤化单烷基苯甲基烷基氯化铵；双胍类如葡糖酸洗必泰、乙酸洗必泰、盐酸洗必泰、聚六亚甲基胍等。增稠剂：包括烷醇酰胺类如椰油二乙醇酰胺、椰油单乙醇酰胺、椰油单异丙醇酰胺、椰油酰胺、月桂酰-亚油酰二乙醇酰胺、月桂酰-豆蔻酰二乙醇酰胺、异硬脂二乙醇酰胺、亚油二乙醇酰胺等。表面活性剂为：茶皂素、皂树酸、胆固醇、磷脂、阿拉伯胶、西黄芪胶、海藻酸、壳聚糖等。非离子表面活性剂：烷基糖苷、椰子油二乙醇酰胺、月桂酰胺丙基氧化胺、蔗糖酯、烷基酚聚氧乙烯醚等。两性离子表面活性剂：椰油酰胺丙基甜菜碱或十二烷基二甲基甜菜碱。阴离子表面活性剂：脂肪醇聚氧乙烯醚硫酸钠、仲烷基磺酸钠、脂肪酸甲酯磺酸钠、a-烯基磺酸盐、十二烷基硫酸钠、月桂酰肌氨酸钠、烷基磷酸钾、烷基磷酸钠、烷基硫酸铵等。pH调节剂：柠檬酸。保湿剂：丙三醇，乙二醇，山梨糖醇等。香精：桂花香精、苹果香精、薰衣草香精等。
喷雾剂：将山楂核提取物，与适量药用辅料制成喷雾剂。其所选的药用辅料增溶剂为：无水乙醇、蒸馏水等。保湿剂：丙二醇，甘油，聚乙二醇等。表面活性剂：如，聚乙二醇，吐温80，十二烷基硫酸钠等。防腐剂：对羟基苯甲酸甲酯，对羟基苯甲酸乙酯，苯扎氯铵，苯扎溴铵，醋酸氯己定等。pH调节剂：枸橼酸二钠、枸橼酸三钠、枸橼酸钠、一水柠檬酸、枸椽酸钾、碳酸钠、碳酸氢钠、碳酸氢钾、氢氧化钠、氢氧化钾、磷酸盐、磷酸二氢盐、磷酸氢盐、酒石酸、酒石酸盐、酒石酸氢盐、氨基酸及其盐中的一种或几种。抗氧剂：亚硫酸、亚硫酸盐、亚硫酸氢盐、焦亚硫酸盐、硫代硫酸盐、抗坏血酸等。芳香剂：天然或合成香精香料，包括玫瑰香精、丁香油、桉油等。
本发明中药制剂的有益效果为：
通过体外药效试验证明，本发明中药制剂能够对新型冠状病毒(SARS-COV-2)有较强的杀灭作用，本发明所选的活性组分为山楂核提取物中所含酚类、醛类、酮类、有机酸类等多种有效活性成份，具有较强的体外杀菌，杀灭和抑制病毒复制作用。本发明中药活性成分的山楂核提取物可以制成外用制剂，作为预防和消杀新冠病毒的外用清洗液剂、凝胶剂、洗手液、喷雾剂、消毒剂提供了一种新的疫情防控消毒用药。
本发明中药制剂还具有质量稳定，生产成本较低，可产业化的优势明显，具有非常广阔的市场应用前景和价值。
为了更加充分理解本发明的实施，下面通过典型的实施例对本发明做进一步的说明。以下及通过体外抗病毒试验，证明本发明中药制剂的有益的治疗效果。
1.新型冠状病毒(SARS-COV-2)体外筛选实验报告
1.1、实验目的
并在疫情应急期间，在细胞水平评价药物红核的抗新型冠状病毒(SARS-COV-2)效果。
1.2、实验材料：
1.2.1受试药物：采用本发明中药制剂不同药物浓度进行试验，药物名称及浓度见表1。
1.2.2测试细胞：VeroE6细胞，由广州呼吸健康研究院呼吸疾病国家重点实验室病毒室保存。
1.2.3测试的病毒柱来源：SARS-CoV-2,滴度为TCID50＝10-6/100μL，由广州海关技术中心BSL-3实验室(呼吸疾病国家重点实验室高致病病原微生物研究室)-80℃保存。使用病毒滴度为100TCID50。
1.3、实验方法：
1.3.1样品准备
取本发明中药制剂(红核妇洁洗液)分别用纯化水稀释800、1000、1600、3200倍并作为样品的测定样品溶液。
1.3.2受试药物：
表1：药物名称、实验浓度和分组
1.3.3受试药物抗病毒实验
(1)、无菌96孔培养板，每孔加入100μL浓度为2×105cells/mL VeroE6细胞，37℃5％ CO2培养24小时；
(2)、培养板实验组和病毒对照组加入100TCID50病毒液100μL/孔，37℃，5％CO2培养箱吸附2h；
(3)、2h后，弃去96孔培养板中细胞培养液；受试药物稀释成表1中的各个浓度，每个浓度3个复孔，100μl/孔加入上述药液；
(4)、同时设立细胞对照、空白对照(溶剂对照)和病毒对照(阴性对照)；
(5)、细胞37℃，5％C02孵箱孵育3-4天；
(6)、光学显微镜下观察细胞病变(CPE),细胞出现病变程度按以下6级标准记录：“-”无病变出现；“±”为细胞病变少于10％；“+”为细胞病变约25％；“++”为细胞病变约50％；“+ ++”为约75％的细胞出现病变：“++++”为75％以上病变。采用Reed-Muench法或GraphPad Prism5.0计算半数有效浓度(IC50)。判断药效标准：具有50％的抑制病毒CPE的浓度视为有效浓度。
1.3.4实验条件：以上实验操作均在BSL-3实验室内完成。
1.4、实验结果
表1 红核(批号180802)抗新型冠状病毒药效结果
实验结果表明，本发明试验药物红核妇洁洗液(批号180802)对新型冠状病毒(SARS-COV-2)感染Vero E6细胞致细胞病变的IC50值为稀释743.2倍。
附图说明
此处所说明的附图用来提供对本发明的进一步理解，构成本发明的一部分，本发明的示意性实施例及其说明用于解释本发明，并不构成对本发明的不当限定，其中本发明药物为红核妇洁洗液。
图1-红核(批号180802)抗新型冠状病毒药效结果。
具体实施方式
以下是本发明内容的具体实施例，用于阐述本申请文件中所要解决技术问题的技术方案，有助于本领域技术人员理解本发明内容，但本发明技术方案的实现并不限于这些实施例。
实施例1本发明中药洗液剂的制备方法
⑴、将山楂核干馏油5g置于配料缸中，加入过120目的筛网，吐温-80，25g，在常温下搅拌30分钟；
⑵、将山楂核干馏液20g、加入上述药液中，在常温下搅拌30分钟；
⑶、将纯化水50g加入上述药液中，在常温下搅拌30分钟；
⑷、将上述混合液静置4小时后，过滤，制成清洗液。
作为外用消毒剂使用方法：取本发明实施例1的清洗液：水的配制比例(1:40-200)比例进行稀释，并对周围环境的物品进行清洗和消杀，并可杀灭新型冠状病毒。
实施例2本发明中药凝胶剂的制备方法
⑴、称量8g卡波姆940、加适量纯化水浸泡6小时，待其完全溶胀，制成卡波姆溶液，备用；
⑵、称取山楂核干馏油5g、山楂核干馏液20g、聚山梨酯80，12ml、甘油20g、苯甲酸钠1.5g，混合均匀，加入步骤⑴卡波姆溶液中，搅拌均匀；
⑶、再补加纯化水到1000ml，搅拌混匀，滴入三乙醇胺8g，溶液搅拌，均匀后，制成凝胶。
实施例3本发明中药凝胶剂的制备方法
⑴、称量10g卡波姆940、加适量纯化水浸泡5小时，待其完全溶胀，制成卡波姆溶液，备用；
⑵、称取山楂核干馏油3g、山楂核干馏液18g、聚山梨酯80，20ml、甘油20g、苯甲酸钠1.0g，混合均匀，加入步骤⑴卡波姆溶液中，搅拌均匀；
⑶、再补加纯化水到1000ml，搅拌混匀，滴入三乙醇胺6g，溶液搅拌，均匀后，制成凝胶。
实施例4本发明中药凝胶剂的制备方法
⑴、称量12g卡波姆940、加适量纯化水浸泡6小时，待其完全溶胀，制成卡波姆溶液，备用；
⑵、称取山楂核干馏油3g、山楂核干馏液22g、聚山梨酯80，30ml、甘油15g、苯甲酸钠1.5g，混合均匀，加入步骤⑴卡波姆溶液中，搅拌均匀；
⑶、再补加纯化水到1000ml，搅拌混匀，滴入三乙醇胺8g，溶液搅拌，均匀后，制成凝胶。
适用于人体卫生消毒，如作为外用凝胶剂的使用方法：取本发明实施例2-4的凝胶剂于手心，双手分别均匀涂抹手周围，持续半分钟左右，即可。
实施例5本发明中药喷雾剂的制备方法
⑴、称取山楂核干馏油7g、山楂核干馏液15g、十二烷基硫酸钠80g、甘油160g、苯甲酸钠8g、薄荷油8ml、羧甲基纤维素96g，备用；
⑵、取纯化水适量，加入称量好的羧甲基纤维素96g，浸泡12小时，待其完全溶胀，备用。
⑶、依次将山楂核提取物、薄荷油、十二烷基硫酸钠、甘油、苯甲酸钠、加入步骤2项溶液中，边加边搅拌，搅拌均匀。
⑷、再补加纯化水至8000ml，搅拌混匀，静置，过滤，即得。
适用于各种医疗公共物品表面的清洁和消毒。作为外用凝胶剂的使用方法：取本发明实施例5的喷雾剂并喷雾于物品的表面，进行消杀，即可。
实施例6本发明中药制剂洗手液的制备方法
⑴、按山楂核干馏油4g、山楂核干馏液16g、十二烷基硫酸钠80g、吐温80，20ml、甘油 50g、苯甲酸钠1g、茉莉香精1g，备用。
⑵、取纯化水适量，依次加入称量好的山楂核提取物、十二烷基硫酸钠、聚山梨酯-80、甘油、苯甲酸钠、茉莉香精，边加边搅拌，搅拌均匀。
⑶、再补加纯化水至8000ml，搅拌混匀，静置24小时，过滤，即得。
适用于人体卫生消毒，如作为洗手液的使用方法：取本发明实施例6的洗手液于手心，双手分别均匀涂抹手周围，持续半分钟左右，即可。
显然，上述实施例仅仅是为清楚地说明所作的举例，而并非对实施方式的限定。对于所属领域的普通技术人员来说，在上述说明的基础上还可以做出其它不同形式的变化或变动。这里无需也无法对所有的实施方式予以穷举。而由此所引伸出的显而易见的变化或变动仍处于本发明创造的保护范围之中。
Claims (8)
1.一种中药制剂在制备预防和消杀冠状病毒中的应用，其特征在于，所述中药制剂的原料药组成及其重量比为：山楂核干馏油3-7份、山楂核干馏液18-22份、药用辅料适量。
2.如权利要求1所述的应用，其特征在于，所述中药制剂的原料药组成及其重量比为：山楂核干馏油5份、山楂核干馏液20份、吐温-80，25份、去离子水50份。
3.如权利要求1所述的应用，其特征在于，所述中药制剂的制备方法为：
取山楂核干馏油，山楂核干馏液，再加入药用辅料，混合均匀后，再常温搅拌20-40分钟，得混合药液，静置，过滤，即得。
4.如权利要求2所述的应用，其特征在于，所述中药制剂的制备方法为：
⑴、将山楂核干馏油置于配料缸中，加入过120目的筛网吐温-80，在常温下搅拌30分钟；
⑵、将山楂核干馏液加入上述⑴步骤的药液中，在常温下搅拌30分钟，得混合药液；
⑶、将纯化水加入上述步骤⑵的药液中，在常温下搅拌30分钟，得混合液；
⑷、将上述⑶步骤所得的混合液，静置4小时后，过滤，即得。
5.如权利要求1或2所述的应用，其特征在于，所述中药制剂的剂型为外用制剂。
6.如权利要求5所述的应用，其特征在于，所述中药制剂的剂型为清洗液、凝胶剂、洗手液、喷雾剂。
7.如权利要求1或2所述的应用，其特征在于，所述中药制剂在制备用于预防和消杀冠状病毒中的应用。
8.如权利要求7所述的应用，其特征在于，所述中药制剂在制备用于预防和消杀SARS-COV-2新型冠状病毒中的应用。
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