CN116115689A - 七窍通鼻炎喷剂及其制备方法 - Google Patents
七窍通鼻炎喷剂及其制备方法 Download PDFInfo
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- CN116115689A CN116115689A CN202310203071.0A CN202310203071A CN116115689A CN 116115689 A CN116115689 A CN 116115689A CN 202310203071 A CN202310203071 A CN 202310203071A CN 116115689 A CN116115689 A CN 116115689A
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Abstract
本发明涉及医药领域,具体涉及一种七窍通鼻炎喷剂的应用;所述七窍通鼻炎喷剂原料为:苍耳子、黄芩、云防风、辛夷、通关散、鬼针草、诃子、君母札、藏红花、熊胆粉、冰片、薄荷提取物;本发明七窍通鼻炎喷剂以生物免疫疗法为核心,利用靶向定位的治疗优势将熊胆粉及其它药物有效地直达病灶,快速地渗透鼻腔病变组织,修复病变组织细胞,激活自体细胞免疫活性,改善呼吸免疫系统功能,达到快速长效、标本兼治、保健呼吸系统的目的。本发明七窍通鼻炎喷剂充分考虑中药材的性味、归经、配伍禁忌等中医理论,对鼻腔疾病有广谱抗菌消炎的对症作用。可用于治疗通窍消肿,散风清热。用于急、慢性鼻炎、鼻窦炎及鼻塞头痛,浊涕臭气,嗅觉失灵。
Description
本申请是申请日为2018年07月12日、申请号为201810763594.X、发明名称为《七窍通鼻炎喷剂及其制备方法》的分案申请。
技术领域
本发明涉及医药领域,具体涉及七窍通鼻炎喷剂及其制备方法。
背景技术
敏性鼻炎是全球最常见的慢性疾病之一,传统上的过敏性鼻炎为季节性与常年性变应性鼻炎。前者与花粉有关,包括风媒授粉的牧草、树、杂草及真菌芽孢,后者则常由尘螨、动物皮屑等引起。近年来,全球过敏性疾病的发病率呈上升趋势,其造成的医疗支出相当惊人,引起社会越来越多的重视。
长期以来,鼻炎威胁着成千上万人的健康,鼻炎发作时,鼻塞、多涕、嗅觉下降、头痛头昏、食欲不振、易疲倦、记忆力减退及失眠等症状严重困扰这人们的日常生活。在鼻腔内敷药是人们治疗鼻炎时最常用且有效的方法,现有技术中人们常用的治疗方法是将医用棉花(或纱布)涂上药物塞入鼻孔,这种方法非常简单,但如果棉球过大会将整个鼻孔堵住不透气,过小有容易在鼻孔内松动,另外,用手取拿极不方便又不卫生。
发明内容
本发明的目的在于提供七窍通鼻炎喷剂及其制备方法,对鼻腔疾病有广谱抗菌消炎的对症作用;用于治疗通窍消肿,散风清热。
为解决上述的技术问题,本发明采用以下技术方案:
七窍通鼻炎喷剂,包括以下原料:苍耳子、黄芩、云防风、辛夷、通关散、鬼针草、诃子、君母札、藏红花、熊胆粉、冰片、薄荷提取物。
进一步,包括以下重量组分原料,以1000ml为计,苍耳子50-70g、黄芩50-70g、云防风30-50g、辛夷30-50g、通关散10-30g、鬼针草10-30g、诃子10-30g、君母札8-12g、藏红花8-12g、熊胆粉4-8g、冰片2-5g、薄荷提取物2-5g。
进一步,包括以下重量组分原料,以1000ml为计,苍耳子60g、黄芩60g、云防风40g、辛夷40g、通关散20g、鬼针草20g、诃子20g、君母札10g、藏红花10g、熊胆粉6g、冰片3g、薄荷提取物3g。
进一步,熊胆粉中活性成分熊去氧胆酸含量为47%-53%。
七窍通鼻炎喷剂的制备方法,包括如下步骤:
S1、取苍耳子炒至焦黄色,将苍耳子、黄芩、云防风、辛夷、通关散、鬼针草、诃子、君母札、藏红花以上九味加入后第一次加水5倍量,煎煮4小时,第二次加水2倍量,煎煮3小时,合并煎液,滤过备用;
S2、取熊胆粉加水500ml,加热煮沸10分钟使溶解,放冷,备用;
S3、另取冰片、薄荷提取物加乙醇使其充分溶解,再加入等量的水,待微晶析出后,滤过,采用水飞工艺,用水多次冲洗微晶至无醇味;将微晶与以上药液混匀,加水至1000ml,滤过,分装,即得。
本发明提供了一种上述技术方案所述七窍通鼻炎组合物在制备鼻腔疾病喷剂中的应用,所述七窍通鼻炎组合物的组分为:苍耳子、黄芩、云防风、辛夷、通关散、鬼针草、诃子、君母札、藏红花、熊胆粉、冰片和薄荷提取物。
进一步,所述鼻腔疾病包括:急性鼻炎、慢性鼻炎、鼻窦炎、鼻塞头痛、浊涕臭气和嗅觉失灵中的一种或两种以上。
与现有技术相比,本发明至少具有以下有益效果之一:
1.本发明其以生物免疫疗法为核心,利用靶向定位的治疗优势将熊胆粉及其它药物有效地直达病灶,快速地渗透鼻腔病变组织,修复病变组织细胞,激活自体细胞免疫活性,改善呼吸免疫系统功能,达到快速长效、标本兼治、保健呼吸系统的目的。
2.对于生产工艺而言,将原料分开处理,并按一定的顺序添加也正是充分考虑并运用冰片与薄荷提取物混合后形成低共熔混合物,可发生液化的现象,大大降低其混合物的熔点和沸点,大大提高其混合物均匀度的特点。
3.本发明由1味动物药(熊胆粉)和11味主产于云南、大理地产药材(苍耳子、黄芩、云防风、辛夷、通关散、鬼针草、诃子、君母札(鸡爪大黄)、藏红花、冰片、薄荷提取物)配伍而成。组方充分考虑了中药材的性味、归经、配伍禁忌等中医理论,是动物药与植物药结合的典范,对鼻腔疾病有广谱抗菌消炎的对症作用。可用于治疗通窍消肿,散风清热。用于急、慢性鼻炎、鼻窦炎及鼻塞头痛,浊涕臭气,嗅觉失灵。本发明所述七窍通鼻炎喷剂组方充分考虑了中药材的性味、归经、配伍禁忌等中医理论,是动物药与植物药结合的典范,对鼻腔疾病有广谱抗菌消炎的对症作用。可用于治疗通窍消肿,散风清热。用于急、慢性鼻炎、鼻窦炎及鼻塞头痛,浊涕臭气,嗅觉失灵。
苍耳子:菊科植物苍耳的干燥成熟带总苞的果实。其味为苦、甘、辛,性温。归肺、肝经。有发散风寒,通鼻窍,祛风湿,止痛的功效。用于治疗风寒感冒,鼻渊,风湿痹痛等症。大理白族少数民族地区有参照《济生方》的民间验方运用取苍耳子、辛夷、白芷,煎服,治疗鼻渊面有外感风寒的民间用药习惯。
黄芩:唇形科黄芩属多年生草本植物,以根入药。其性味苦,寒,无毒。归肺、大肠经。有清热燥湿、泻火解毒、止血的功效,用于治疗上呼吸道感染、肺热咳嗽、湿热黄疸、痈肿疖疮等症。大理白族少数民族地区习用黄芩、大理绿茶、通关散冲泡饮用的习俗,用于肺热咳嗽、清肺抑火、调心降火,效果尤佳。
云防风:主产于云南省西北部,为伞形科植物竹叶西风芹、松叶西风芹和多毛西风芹的根。其味辛,微甘,性微温。归肺、肝、脾经。有祛风胜湿,止痛止痉的功效,用于治疗感冒、头痛、风湿痹痛、耳鸣鼻塞等症状。大理洱源地区白族民间习用云防风泡酒内服或适量煎汤外洗患处,用于祛风胜湿,止痛止痉,追风除湿。
辛夷:主产云南,为木兰科植物望春花、玉兰和武当玉兰的干燥花蕾。其味辛,性温。归肺、胃经。有发散风寒,通鼻窍的功效。主治风寒感冒,鼻渊,鼻塞。云南少数民族地区习用“治脑漏鼻渊,祛风,新瓦烘焙为末,热酒送服。用于治面寒痛,胃气痛,”(《滇南本草》)。大理州盛产玉兰,取其干燥花蕾,在初春时节与茶叶同时冲泡饮用,用来发散风寒,通鼻窍,提高身体免疫力。
通关散:收载于《全国中草药汇编》,其来源于萝藦科牛奶菜属植物通关散,以藤茎入药。别名“通关散”、“黄木香”。其味苦,性微寒。归肺、肝经。有清热解毒,止渴平喘的功效。用于治疗肺炎、支气管炎、咽喉炎、鼻炎等症。大理白族少数民族地区有直接切片泡水服用的用药习惯,用于治疗喉头炎,口腔溃疡等上呼吸道疾病,效果显著。
鬼针草:菊科一年生草本植物,为我国民间常用草药。云南地区俗称“粘连子”、“粘人草”。其味苦,性平,无毒。归肺、肝、大肠经。有清热解毒,散瘀消肿的功效。用于治疗上呼吸道感染,扁桃体炎,喉炎,鼻炎和皮肤感染等症。大理云龙县部分地区习用酒精浸泡鬼针草,取浸泡液用来擦拭创口和皮肤表面感染,抗菌消炎,对体外革兰氏阳性细菌和金黄色葡萄球菌有很强的抑菌作用。
诃子:主产于云南,为使君子科植物诃子或绒毛诃子的干燥成熟果实,又名诃黎勒、随风子。在藏药学经典著作《晶珠本草》里,诃子被称为“藏药之王”。其味苦、酸、涩,性平。归肺经;大肠经;胃经。有涩肠止泻,敛肺止咳,降火利咽的功效。用于久泻久痢,便血脱肛,肺虚喘咳,久嗽不止,咽痛音哑等症。诃子为传统“药食同源”的品种,云南临沧少数名族地区习用食用白酒浸泡诃子或榨汁泡水,作为日常保健饮品服用,以防治肺虚喘咳,久嗽不止,咽痛音哑等症。
君母札(鸡爪大黄):为蓼科大黄属多年生高大草本植物。其味苦,性寒。归肺、胃经、大肠经、肝经、脾经。有攻积滞;清湿热;泻火;凉血;祛瘀;解毒的功效。用于实热便秘,黄疸;淋病;小便不利;目赤;咽喉肿痛;口舌生疮等症。
藏红花:鸢尾科番红花属的多年生花卉,也是一种常见的香料,多年生草本。其气香特异,微有刺激味,味微苦。甘,性平。归肺经、心经、肝经。有活血祛瘀;散瘀开结;凉血解毒的功效。用于腹中包块疼痛;跌扑损伤;忧郁痞闷;惊悸;温病发斑;麻疹等症。大理白族少数民族地区视藏红花为珍贵之物,常与每年三月民族节购买后,泡水或泡酒服用,用于居家常备活血祛瘀,散瘀开结,凉血解毒之用。
冰片:由菊科艾纳香茎叶或樟科植物龙脑樟枝叶经水蒸汽蒸馏并重结晶而得,为五官科常用中药材。外用研末撒或调敷患处。其性味苦辛,微寒。归肝、心、肺经。有清热散毒,明目退翳的功效,“疗喉痹、脑痛、鼻痹、齿痛。通诸窍,散郁火。”(《本草纲目》)。用于治疗目赤肿痛,翳膜遮睛,口疮齿肿等症。
薄荷提取物:本品为唇形科植物薄荷的新鲜叶和茎经水蒸气蒸馏、冷冻、重结晶得到的一种饱和的环状醇白色晶体。有薄荷的特殊香气,味初灼热后清凉。在本方剂中用于皮肤或粘膜,清凉止痒、消炎、止痛、促进血液循环、减轻浮肿等作用。内服可作为驱风药,用于头痛及鼻、咽、喉炎症。
冰片为无色透明或白色半透明的片状松脆结晶;气清香,味辛、凉;具挥发性,易升华;易溶于乙醇、氯仿、汽油或乙醚中,几乎不溶与水。其熔点为208℃,沸点为212℃。
薄荷提取物为无色针或棱柱状结晶或白色结晶性粉末;有薄荷的特殊香气,味初灼热后清凉;易溶于乙醇等有机溶媒,在水中极微溶解。其熔点为41-43℃,沸点为212℃。
冰片与薄荷提取物混合后形成低共熔混合物,可发生液化。(使两种或两种以上药物混合后,出现润湿或液化现象的混合物,称之为“低共熔混合物”。“低共熔混合物”可使各组成药物的熔点和沸点大幅度降低)。冰片与薄荷提取物混合时产生的液化丝毫不影响药物的疗效,但能大大降低其混合物的熔点(8-10℃)和沸点(90℃),大大提高其混合物均匀度。
冰片与薄荷提取物均是中药制剂中透皮吸收促进剂,先将两者混合,使其发生液化现象,降低其混合物的熔点(8-10℃)和沸点,提高其混合物均匀度,增加冰片和薄荷提取物混合物的靶向增强作用,再配合熊胆粉及其它中药材的使用,利用靶向定位的治疗优势将熊胆粉及其它药物有效地直达病灶,快速地渗透口腔病变组织,修复病变组织细胞,激活自体细胞免疫活性,改善呼吸免疫系统功能,达到快速长效、标本兼治、保健呼吸系统的目的。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白,以下结合实施例,对本发明进行进一步详细说明。应当理解,此处所描述的具体实施例仅仅用以解释本发明,并不用于限定本发明。
实施例1
七窍通鼻炎喷剂,包括以下原料:苍耳子、黄芩、云防风、辛夷、通关散、鬼针草、诃子、君母札、藏红花、熊胆粉、冰片、薄荷提取物,本发明其以生物免疫疗法为核心,利用靶向定位的治疗优势将熊胆粉及其它药物有效地直达病灶,快速地渗透鼻腔病变组织,修复病变组织细胞,激活自体细胞免疫活性,改善呼吸免疫系统功能,达到快速长效、标本兼治、保健呼吸系统的目的。
实施例2
七窍通鼻炎喷剂,包括以下重量组分原料,以1000ml为计,苍耳子50g、黄芩50g、云防风30g、辛夷30g、通关散10g、鬼针草10g、诃子10g、君母札8g、藏红花8g、熊胆粉4g、冰片2g、薄荷提取物2g,本发明其以生物免疫疗法为核心,利用靶向定位的治疗优势将熊胆粉及其它药物有效地直达病灶,快速地渗透鼻腔病变组织,修复病变组织细胞,激活自体细胞免疫活性,改善呼吸免疫系统功能,达到快速长效、标本兼治、保健呼吸系统的目的。
实施例3
七窍通鼻炎喷剂,包括以下重量组分原料,以1000ml为计,苍耳子70g、黄芩70g、云防风50g、辛夷50g、通关散30g、鬼针草30g、诃子30g、君母札12g、藏红花12g、熊胆粉8g、冰片5g、薄荷提取物5g,本发明其以生物免疫疗法为核心,利用靶向定位的治疗优势将熊胆粉及其它药物有效地直达病灶,快速地渗透鼻腔病变组织,修复病变组织细胞,激活自体细胞免疫活性,改善呼吸免疫系统功能,达到快速长效、标本兼治、保健呼吸系统的目的。
实施例4
七窍通鼻炎喷剂,包括以下重量组分原料,以1000ml为计,苍耳子60g、黄芩60g、云防风40g、辛夷40g、通关散20g、鬼针草20g、诃子20g、君母札10g、藏红花10g、熊胆粉6g、冰片3g、薄荷提取物3g,本发明其以生物免疫疗法为核心,利用靶向定位的治疗优势将熊胆粉及其它药物有效地直达病灶,快速地渗透鼻腔病变组织,修复病变组织细胞,激活自体细胞免疫活性,改善呼吸免疫系统功能,达到快速长效、标本兼治、保健呼吸系统的目的。
实施例5
在实施例1-4的基础上,熊胆粉中活性成分熊去氧胆酸含量为47%,本发明由1味动物药(熊胆粉)和11味主产于云南、大理地产药材(苍耳子、黄芩、云防风、辛夷、通关散、鬼针草、诃子、君母札(鸡爪大黄)、藏红花、冰片、薄荷提取物)配伍而成。组方充分考虑了中药材的性味、归经、配伍禁忌等中医理论,是动物药与植物药结合的典范,对鼻腔疾病有广谱抗菌消炎的对症作用。可用于治疗通窍消肿,散风清热。用于急、慢性鼻炎、鼻窦炎及鼻塞头痛,浊涕臭气,嗅觉失灵。
实施例6
在实施例1-4的基础上,熊胆粉中活性成分熊去氧胆酸含量为50%,本发明由1味动物药(熊胆粉)和11味主产于云南、大理地产药材(苍耳子、黄芩、云防风、辛夷、通关散、鬼针草、诃子、君母札(鸡爪大黄)、藏红花、冰片、薄荷提取物)配伍而成。组方充分考虑了中药材的性味、归经、配伍禁忌等中医理论,是动物药与植物药结合的典范,对鼻腔疾病有广谱抗菌消炎的对症作用。可用于治疗通窍消肿,散风清热。用于急、慢性鼻炎、鼻窦炎及鼻塞头痛,浊涕臭气,嗅觉失灵。
实施例7
在实施例1-4的基础上,熊胆粉中活性成分熊去氧胆酸含量为53%,本发明由1味动物药(熊胆粉)和11味主产于云南、大理地产药材(苍耳子、黄芩、云防风、辛夷、通关散、鬼针草、诃子、君母札(鸡爪大黄)、藏红花、冰片、薄荷提取物)配伍而成。组方充分考虑了中药材的性味、归经、配伍禁忌等中医理论,是动物药与植物药结合的典范,对鼻腔疾病有广谱抗菌消炎的对症作用。可用于治疗通窍消肿,散风清热。用于急、慢性鼻炎、鼻窦炎及鼻塞头痛,浊涕臭气,嗅觉失灵。
实施例8
七窍通鼻炎喷剂,组分原料为,以1000ml为计,苍耳子50g、黄芩50g、云防风30g、辛夷30g、通关散10g、鬼针草10g、诃子10g、君母札8g、藏红花8g、熊胆粉4g、冰片2g、薄荷提取物2g。
以上所述七窍通鼻炎喷剂的制备方法,步骤如下:
S1、取苍耳子炒至焦黄色,将苍耳子、黄芩、云防风、辛夷、通关散、鬼针草、诃子、君母札、藏红花以上九味加入后第一次加水5倍量,煎煮4小时,第二次加水2倍量,煎煮3小时,合并煎液,滤过备用;
S2、取熊胆粉加水500ml,加热煮沸10分钟使溶解,放冷,备用;
S3、另取冰片、薄荷提取物加乙醇使其充分溶解,再加入等量的水,待微晶析出后,滤过,采用水飞工艺,用水多次冲洗微晶至无醇味;将微晶与以上药液混匀,加水至1000ml,滤过,分装,即得。
对于生产工艺而言,将原料分开处理,并按一定的顺序添加也正是充分考虑并运用冰片与薄荷提取物混合后形成低共熔混合物,可发生液化的现象,大大降低其混合物的熔点和沸点,大大提高其混合物均匀度的特点。
实施例9
七窍通鼻炎喷剂,组分原料为,以1000ml为计,苍耳子70g、黄芩70g、云防风50g、辛夷50g、通关散30g、鬼针草30g、诃子30g、君母札12g、藏红花12g、熊胆粉8g、冰片5g、薄荷提取物5g。
以上所述七窍通鼻炎喷剂的制备方法,步骤如下:
S1、取苍耳子炒至焦黄色,将苍耳子、黄芩、云防风、辛夷、通关散、鬼针草、诃子、君母札、藏红花以上九味加入后第一次加水5倍量,煎煮4小时,第二次加水2倍量,煎煮3小时,合并煎液,滤过备用;
S2、取熊胆粉加水500ml,加热煮沸10分钟使溶解,放冷,备用;
S3、另取冰片、薄荷提取物加乙醇使其充分溶解,再加入等量的水,待微晶析出后,滤过,采用水飞工艺,用水多次冲洗微晶至无醇味;将微晶与以上药液混匀,加水至1000ml,滤过,分装,即得。
对于生产工艺而言,将原料分开处理,并按一定的顺序添加也正是充分考虑并运用冰片与薄荷提取物混合后形成低共熔混合物,可发生液化的现象,大大降低其混合物的熔点和沸点,大大提高其混合物均匀度的特点。
实施例10
七窍通鼻炎喷剂,组分原料为,以1000ml为计,苍耳子60g、黄芩60g、云防风40g、辛夷40g、通关散20g、鬼针草20g、诃子20g、君母札10g、藏红花10g、熊胆粉6g、冰片3g、薄荷提取物3g。
以上所述七窍通鼻炎喷剂的制备方法,步骤如下:
S1、取苍耳子炒至焦黄色,将苍耳子、黄芩、云防风、辛夷、通关散、鬼针草、诃子、君母札、藏红花以上九味加入后第一次加水5倍量,煎煮4小时,第二次加水2倍量,煎煮3小时,合并煎液,滤过备用;
S2、取熊胆粉加水500ml,加热煮沸10分钟使溶解,放冷,备用;
S3、另取冰片、薄荷提取物加乙醇使其充分溶解,再加入等量的水,待微晶析出后,滤过,采用水飞工艺,用水多次冲洗微晶至无醇味;将微晶与以上药液混匀,加水至1000ml,滤过,分装,即得。
对于生产工艺而言,将原料分开处理,并按一定的顺序添加也正是充分考虑并运用冰片与薄荷提取物混合后形成低共熔混合物,可发生液化的现象,大大降低其混合物的熔点和沸点,大大提高其混合物均匀度的特点。
通过多年实践经验证明同时使用能起到阴阳协调、相辅相成、共同促进药效和治疗鼻腔疾病的良好效果,其相互之间配伍无禁忌、药物毒理学等反应,其药物安全性和有效性有很大保障,临床试验多年均无药物不良反应(ADR)情况发生,药物安全性较高。本发明所述七窍通鼻炎喷剂组方充分考虑了中药材的性味、归经、配伍禁忌等中医理论,是动物药与植物药结合的典范,对鼻腔疾病有广谱抗菌消炎的对症作用。可用于治疗通窍消肿,散风清热。用于急、慢性鼻炎、鼻窦炎及鼻塞头痛,浊涕臭气,嗅觉失灵。使用所述七窍通鼻炎喷剂是治疗儿童慢性鼻窦炎的一种有效方法。
应用例
使用鼻腔压缩雾化吸入本发明实施例10制备的七窍通鼻炎喷剂治疗儿童慢性鼻窦炎临床观察,具体实验步骤和实验结果如下:
1.资料与方法
1.1一般资料:选择2016-06至2018-06在大理州人民医院门诊确诊的210例慢性鼻窦炎患儿,男134例,女76例,年龄3~12岁,平均6.8岁,71%为4~8岁儿童,病程4周。临床表现为不同程度的鼻塞、流涕,部分患儿岀现头痛、夜间打鼾。鼻窦平片或鼻窦CT显示鼻窦内高密度影。所有患儿鼻腔内均有大量粘脓性分泌物,明显鼻甲肿大107例(51%),腺样体中度肥大63例(30%)渗出性中耳炎24例(11%)。
1.2治疗210例患儿随机分为A、B、C三组,每组70例。
常规治疗组(A):所有患儿均采用口服鼻窦炎口服液;对鼻腔分泌物较多的患儿进行鼻腔负压吸引治疗,每日1次;对患有渗出性中耳炎的患儿,在鼻腔负压吸引基础上,根据病情选择咽鼓管吹张治疗,1次/d,治疗2周。
辅舒良治疗组(B):在A组基础上加用辅舒良喷鼻,2次/d,每次2喷,连用2周。
七窍通鼻炎喷剂治疗组(C):在A组的基础上,加用七窍通鼻炎喷剂喷鼻治疗,每次1mL,由压缩泵(PARI SINUS,德国百瑞公司)从鼻腔喷入,2次/d,每次喷入时间5min,连续治疗2周。
1.3疗效评定标准
1.3.1门诊复查:根据患儿自觉症状及鼻内镜检查、鼻窦CT或X线摄片结果进行疗效评定。
治愈:患儿无自觉症状,鼻内镜检查黏膜正常,鼻窦CT成X线摄片未见异常;
有效:有轻度可以耐受的自觉症状,鼻内镜检查鼻黏膜轻度充血、水肿,鼻腔内有少许分泌物,鼻窦CT或X线摄片显示轻度的炎性反应;
无效:有种重度的自觉症状,鼻内镜检查鼻黏膜明显异常,鼻腔内大量分泌物,鼻窦CT或X线摄片显示鼻窦炎症
1.3.2电话随访:通过家长了解患儿病情,以鼻塞、流涕、头痛、打鼾4组症状为指标,I级:无症状;II级轻微症状;III级:症状明显。4组症状均为I级时为治愈:有II级症状存在时为好转;有一项III级症状时为无效。
1.4统计学处理:采用SPSS 13.0统计学软件包进行统计学分析表。
表1A,B,C组治疗1个月后复查疗效比较(%)
注:与C组比较,*P<0.01。
2.结果
2.1门诊复查
A、B、C组治疗1个月后复查疗效比较见表1,3组治愈率的差异有统计学意义(P<0.01)。
2.2电证随访
全部患儿3个月后均进行了电话随访。根据对患儿父母进行问卷调查来判断结果。3组患儿的治愈率及总有效率均有所下降,A组分别为9%和44%,B组分别为24%和56%,C组分别为40%和77%,3组治愈率的差异有统计学意义(P<005)A组与C组及B组与C组总有效率比较差异有统计学意义(P<0.01),A组和B组总有效率比较差异无统计学意义(P>0.05)。
3.讨论
目前较为一致的观点是:儿童鼻窦炎应选保守治疗,只有在系统药物治疗无效时才考虑内镜手术治疗。即便选择手术治疗,术中尽可能保留窦内黏膜,尽可能控制手术范围。感染与变态反应造成的黏膜水肿是鼻窦炎的主要原因,黏膜水肿可以导致狭窄的窦口和引流通道迅速受阻,局部组织缺氧,纤毛活动减弱,为病原体定居提供了良好的基础环境,促进了黏膜炎症的恶性循环。因此抗炎抗水肿已成为治疗儿童鼻窦炎的关键环节。本研究发现常规治疗儿童鼻窦炎有一定的疗效,A组总有效率为48%,B组总有效率为61%,较A组有所提高,C组总有效率为84%,C组是在A组的基础上,加用七窍通鼻炎喷剂喷鼻治疗。七窍通鼻炎喷雾剂中独含的中药成分熊胆,具有清热解毒,抑菌抗炎,疏风通窍,抗过敏等药理功能,故能减轻鼻炎和鼻窦炎过程中黏膜的炎性反应,充血和水肿。我们选用专用于鼻窦炎治疗的压缩雾化吸入机,利用脉冲震荡压力波,使七窍通鼻炎喷剂的药物微粒更易扩散至鼻腔深部及裂隙,产生广泛的消炎消肿作用。中药喷雾具有热敷湿润、机械震动、细微按摩和药物综合治疗作用,不但能促进局部血液循环,还可以杀菌及有效抑制病毒繁殖。本文结果显示,C组儿童慢性鼻窦炎的治愈率较以往的药物治疗明显提高,其疗效明显优于A、B两组,可见使用七窍通鼻炎喷剂是治疗儿童慢性鼻窦炎的一种有效方法,因此,本发明能够 达到本发明的技术效果和能解决的技术问题。
尽管这里参照本发明的多个解释性实施例对本发明进行了描述,但是,应该理解,本领域技术人员可以设计出很多其他的修改和实施方式,这些修改和实施方式将落在本申请公开的原则范围和精神之内。更具体地说,在本申请公开和权利要求的范围内,可以对主题组合布局的组成部件和/或布局进行多种变型和改进。除了对组成部件和/或布局进行的变形和改进外,对于本领域技术人员来说,其他的用途也将是明显的。
Claims (6)
1.一种七窍通鼻炎组合物在制备鼻腔疾病喷剂中的应用,所述七窍通鼻炎组合物的组分为:苍耳子、黄芩、云防风、辛夷、通关散、鬼针草、诃子、君母札、藏红花、熊胆粉、冰片和薄荷提取物。
2.根据权利要求1所述应用,所述鼻腔疾病包括:急性鼻炎、慢性鼻炎、鼻窦炎、鼻塞头痛、浊涕臭气和嗅觉失灵中的一种或两种以上。
3.根据权利要求1所述的应用,所述喷剂的组分为:以1000ml为计,苍耳子50-70g、黄芩50-70g、云防风30-50g、辛夷30-50g、通关散10-30g、鬼针草10-30g、诃子10-30g、君母札8-12g、藏红花8-12g、熊胆粉4-8g、冰片2-5g、薄荷提取物2-5g。
4.根据权利要求1所述的应用,所述喷剂的组分为:以1000ml为计,苍耳子60g、黄芩60g、云防风40g、辛夷40g、通关散20g、鬼针草20g、诃子20g、君母札10g、藏红花10g、熊胆粉6g、冰片3g、薄荷提取物3g。
5.根据权利要求1所述的应用,所述喷剂中熊胆粉中活性成分熊去氧胆酸含量为47%-53%。
6.根据权利要求1-5任意一项所述的应用,所述喷剂的制备方法,步骤如下:
S1、取苍耳子炒至焦黄色,将苍耳子、黄芩、云防风、辛夷、通关散、鬼针草、诃子、君母札、藏红花以上九味加入后第一次加水5倍量,煎煮4小时,第二次加水2倍量,煎煮3小时,合并煎液,滤过备用;
S2、取熊胆粉加水500ml,加热煮沸10分钟使溶解,放冷,备用;
S3、另取冰片、薄荷提取物加乙醇使其充分溶解,再加入等量的水,待微晶析出后,滤过,采用水飞工艺,用水多次冲洗微晶至无醇味;将微晶与以上药液混匀,加水至1000ml,滤过,分装,即得。
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