CN111110756A - 一种治疗小儿热性哮喘的中药组合物及其制备方法 - Google Patents
一种治疗小儿热性哮喘的中药组合物及其制备方法 Download PDFInfo
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- CN111110756A CN111110756A CN202010138977.5A CN202010138977A CN111110756A CN 111110756 A CN111110756 A CN 111110756A CN 202010138977 A CN202010138977 A CN 202010138977A CN 111110756 A CN111110756 A CN 111110756A
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Abstract
本发明公开了一种治疗小儿热性哮喘的中药组合物及其制备方法，其由麻黄、苦杏仁、黄芩、地骨皮、地龙、葶苈子、紫苏子、丹参、赤芍、仙鹤草十味中药按照一定重量比制备而成，可以制备成中药口服制剂，例如颗粒剂、胶囊剂、片剂、糖浆剂、合剂等。本发明所涉及中药组合物具有宣肺涤痰，化瘀定喘的功效，临床用于治疗外感风热，痰瘀内蕴所致的小儿热性哮喘，疗效显著。针对小儿支气管哮喘急性发作治疗，在缓解患儿咳嗽喘憋症状，减少复发次数方面获得了满意的效果，同时，具有口感好，无副作用，依从性好等优点，是治疗小儿热性哮喘药物上的创新。
Description
技术领域
本发明涉及中药技术领域，具体地说是一种治疗小儿热性哮喘的中药组合物及其制备方法。
背景技术
支气管哮喘(简称哮喘)是一种比较常见的过敏性疾病，由内源性和外源性两种因素诱导，多种细胞如(嗜酸性粒细胞、T淋巴细胞、中性粒细胞及肥大细胞以及气道上皮细胞等)共同参与的慢性气道过敏性疾病。其常于夜间或者清晨发作，以气道高反应为主要特征并常伴有喘息加快、气促、胸闷、咳嗽等一系列呼吸困难症状。目前，临床上对于支气管哮喘治疗尚无有效的根治手段，仍停留在控制阶段，已成为当今医学的“四大顽固性”疾病之一。目前国内约有2000万哮喘患者，年龄分布广泛，不受性别限制，尤其在14岁以内群体中较为严重，调查研究表明0～14岁儿童哮喘患病人数已从2000年的1.54％上升到2010年3.02％，并且学龄前儿童的发病率最高，5％-10％的哮喘儿童可发展为成人严重哮喘。
西医治疗儿童支气管哮喘，主要的药物类型包括有支气管舒张剂、消除非特异炎症药物、抑制过敏介质释放药物、免疫抑制药物等，能起到部分缓解哮喘患儿咳喘症状的作用，但不能改变病程，难以达到根治的目的。同时由于服药时间长、费用高、副作用大，家长依从性差，导致坚持持续、规范使用长期控制药物治疗的比例不高，给治疗带来困难。
中医认为儿童哮喘发作时肺气郁滞，清肃失常，气机紊乱，使津液凝而为痰，痰郁气滞影响血液运行形成瘀血，痰可酿瘀，瘀亦能生痰，形成痰瘀互生的因果循环，痰瘀胶着互结，阻于肺络，风邪诱动，痰、瘀交阻于气道，造成哮喘发作。风有内风、外风之分，外风与感染有关，内风则与过敏有关，痰瘀闭阻肺络则是哮喘的病理基础，哮喘的发作就是风痰瘀相互作用的结果。哮喘发作是“风、痰、瘀”相互作用的结果，发作期以“祛风、豁痰、化瘀”为治疗大法，由于小儿“阳常有余”，诸邪极易化热，临床以阳证、热证多见，故常辅以清热之法。本发明所述中药组合物正是在此理论和多年临床应用的基础上创制而成，用于治疗急性发作期的小儿支气管哮喘。
发明内容
本发明的目的是针对现有技术中的不足，提供一种治疗小儿哮喘的中药组合物，显著提高临床相关症状的改善。
为实现上述目的，本发明采取的技术方案是：
一种治疗小儿哮喘的中药组合物，所述中药组合物是由如下所述重量份的中药制成：麻黄3-7份、苦杏仁8-12份、黄芩8-12份、地骨皮8-12份、地龙8-12份、葶苈子4-8份、紫苏子4-8份、丹参8-12份、赤芍8-12份、仙鹤草8-12份。
作为本发明的一个优选实施方案，所述中药组合物是由如下所述重量份的中药制成：麻黄4-6份、苦杏仁9-11份、黄芩9-11份、地骨皮9-11份、地龙9-11份、葶苈子5-7份、紫苏子5-7份、丹参9-11份、赤芍9-11份、仙鹤草9-11份。
作为本发明的一个优选实施方案，所述中药组合物是由如下所述重量份的中药制成：麻黄5份、苦杏仁10份、黄芩10份、地骨皮10份、地龙10份、葶苈子6份、紫苏子6份、丹参10份、赤芍10份、仙鹤草10份。
一种治疗小儿热性哮喘的中药组合物的制备方法，其特征在于，包括如下步骤：制备过程如下：
步骤1：中药组合物；
称取原料药：蜜麻黄5份、苦杏仁10份、黄芩10份、地骨皮10份、地龙10份、葶苈子6份、紫苏子6份、丹参10份、赤芍10份、仙鹤草10份；
步骤2：中药提取物一的制备；
中药提取物一：取步骤1所述的中药，加入7-10倍量水，煎煮提取2次，每次1.5-2.5小时，提取液滤过，精制，浓缩至一定密度的流浸膏；
步骤3：中药提取物二的制备；
中药提取物二：取步骤1所述的中药，加入7-10倍量水，加热煎煮提取2次，每次1.5-2.5小时，提取液滤过，精制，浓缩至一定密度的流浸膏，干燥成干浸膏，粉碎，混合；
步骤4：颗粒剂的制备；
取步骤2或3制备的中药提取物，加入适量药用辅料，混合均匀，采用制粒设备，制成颗粒，可选用辅料包括但不限于淀粉、纤维素、糖粉、乳糖、糊精、甘露醇、滑石粉、硬脂酸镁等；
步骤5：胶囊剂的制备；
取步骤2或3制备的中药提取物，加入适量药用辅料，混合均匀，制粒，并采用胶囊填充设备灌装胶囊，制成胶囊剂。可选用辅料包括但不限于蔗糖、乳糖、微晶纤维素、改良性淀粉、二氧化硅、滑石粉、硬脂酸镁等；
步骤6：片剂的制备；
取步骤2或3制备的中药提取物，加入适量药用辅料，混合均匀，制粒，加入润滑剂，采用压片机压制成片剂，可选用辅料包括但不限于淀粉、预胶化淀粉、蔗糖、糊精、乳糖、微晶纤维素、糖醇类、无机盐类、羧甲淀粉钠、低取代羟丙纤维素、交联羧甲基纤维素钠、交联聚维酮、聚维酮、羟丙基纤维素、硬脂酸镁、硬脂酸、滑石粉、微粉硅胶、氢化植物油、聚乙二醇类、蔗糖素、阿司帕坦、安赛蜜、甜叶菊苷、木糖醇等；
步骤7：糖浆剂的制备；
取步骤2或3制备的中药提取物，加入适量单糖浆及其它药用辅料，混合，滤过，分装，制成糖浆剂；可选用辅料包括但不限于甘油、滑石粉、山梨酸、苯甲酸、对羟基苯甲酸脂类等；
步骤8：合剂的制备；
取步骤2制备的中药提取物，加入适量药用辅料，配液，滤过，灭菌，分装，制成合剂；可选用辅料包括但不限于蜂蜜、单糖浆、甘草甜素、甜菊苷、山梨酸、苯甲酸、对羟基苯甲酸脂类等。
本发明选择上述进行组合，将这些药物组合使得各药味功效产生协同作用，从而能有效治疗小儿热性哮喘，显著提高临床相关症状的改善。
方解：本发明处方由麻黄、苦杏仁、黄芩、地骨皮、地龙、葶苈子、紫苏子、丹参、赤芍、仙鹤草等十味中药组成。麻黄、苦杏仁共为君药，疏风宣肺，恢复肺气升降之机；黄芩、地骨皮共为臣药，清泻肺热，余药为佐使，地龙、葶苈子、紫苏子同用，降气化痰，使气顺痰消；丹参、赤芍、仙鹤草同用，活血化瘀，可使痰瘀消散，窠臼得平，肺气宣降清肃功能恢复正常。诸药合用，共奏宣肺涤痰，化瘀定喘之功效。
本发明上述中药可以为不同产地、不同基源的中药材，以及由上述药材所炮制而成的饮片及提取的中间体、中药制剂。
本发明的中药组合物可以采用中药制剂的常规方法(例如采用煎煮、浸渍、渗漉、回流、生药粉碎等制备方法)制备成任何一种口服制剂。例如可以在一定量、一定组成的中药中，加入一定量的溶媒，加热煎煮提取，提取液浓缩得中间体。中间体浸膏或中间体干燥物中加入一定的辅料，可得不同剂型的中药口服制剂。
本发明中药组合物的用量和疗程可根据剂型、患者的年龄、疾病的轻重程度做适当的调整，以5～7天为一个疗程，可连续使用多个疗程。
作为本发明的一个优选实施方案，所述中药组合物还包括药用载体或辅料，制备成中药口服制剂。
作为本发明的一个优选实施方案，所述药用载体或辅料包括但不限于：淀粉、纤维素、糖粉、蔗糖、乳糖、糊精、微晶纤维素、改良性淀粉、预胶化淀粉、羧甲淀粉钠、低取代羟丙纤维素、交联羧甲基纤维素钠、交联聚维酮、聚维酮、羟丙基纤维素、甘露醇、滑石粉、硬脂酸、硬脂酸镁、二氧化硅、微粉硅胶、氢化植物油、聚乙二醇类、糖醇类、无机盐类、甘油、山梨酸、苯甲酸、对羟基苯甲酸脂类、蜂蜜、单糖浆、甘草甜素、甜菊苷、蔗糖素、阿司帕坦、安赛蜜、甜叶菊苷、木糖醇等。
作为本发明的一个优选实施方案，所述口服制剂具体为颗粒剂、胶囊剂、片剂、糖浆剂、合剂等。
本发明中药组合物通过多年临床应用，证明其对小儿热性哮喘具有显著的疗效。另外，该药物的组分均采用天然的中药原料，其配制简便、药源广、成本低，患者花费少，具有较好的经济效益。
具体实施方式
下面结合具体实施方式，进一步阐述本发明，应理解，这些实施例仅用于说明本发明而不用于限制本发明的范围。此外应理解，在阅读了本发明记载的内容之后，本领域技术人员可以对本发明作各种改动或修改，这些等价形式同样落于本申请所附权利要求书所限定的范围。
以下实施例中采用的仪器设备如下：电子天平，直筒提取罐、提取储液罐、离心机、单效浓缩器、风冷式粉碎机、三维运动混合机，真空干燥箱，多功能流化床，自动硬胶囊填充机，旋转压片机，口服液灌装机，塑料瓶糖浆灌装联动机组。
所述治疗小儿哮喘的中药组合物是由如下所述重量份的中药制成：麻黄5份、苦杏仁10份、黄芩10份、地骨皮10份、地龙10份、葶苈子6份、紫苏子6份、丹参10份、赤芍10份、仙鹤草10份。
制备过程如下：
步骤1：中药组合物
称取原料药：蜜麻黄5份、苦杏仁10份、黄芩10份、地骨皮10份、地龙10份、葶苈子6份、紫苏子6份、丹参10份、赤芍10份、仙鹤草10份。
步骤2：中药提取物一的制备
中药提取物一：取步骤1所述的中药，加入7-10倍量水，煎煮提取2次，每次1.5-2.5小时，提取液滤过，精制，浓缩至一定密度的流浸膏。
步骤3：中药提取物二的制备
中药提取物二：取步骤1所述的中药，加入7-10倍量水，加热煎煮提取2次，每次1.5-2.5小时，提取液滤过，精制，浓缩至一定密度的流浸膏，干燥成干浸膏，粉碎，混合。
步骤4：颗粒剂的制备
取步骤2或3制备的中药提取物，加入适量药用辅料，混合均匀，采用制粒设备，制成颗粒。可选用辅料包括但不限于淀粉、纤维素、糖粉、乳糖、糊精、甘露醇、滑石粉、硬脂酸镁等。
步骤5：胶囊剂的制备
取步骤2或3制备的中药提取物，加入适量药用辅料，混合均匀，制粒，并采用胶囊填充设备灌装胶囊，制成胶囊剂，可选用辅料包括但不限于蔗糖、乳糖、微晶纤维素、改良性淀粉、二氧化硅、滑石粉、硬脂酸镁等。
步骤6：片剂的制备
取步骤2或3制备的中药提取物，加入适量药用辅料，混合均匀，制粒，加入润滑剂，采用压片机压制成片剂，可选用辅料包括但不限于淀粉、预胶化淀粉、蔗糖、糊精、乳糖、微晶纤维素、糖醇类、无机盐类、羧甲淀粉钠、低取代羟丙纤维素、交联羧甲基纤维素钠、交联聚维酮、聚维酮、羟丙基纤维素、硬脂酸镁、硬脂酸、滑石粉、微粉硅胶、氢化植物油、聚乙二醇类、蔗糖素、阿司帕坦、安赛蜜、甜叶菊苷、木糖醇等。
步骤7：糖浆剂的制备
取步骤2或3制备的中药提取物，加入适量单糖浆及其它药用辅料，混合，滤过，分装，制成糖浆剂。可选用辅料包括但不限于甘油、滑石粉、山梨酸、苯甲酸、对羟基苯甲酸脂类等。
步骤8：合剂的制备
取步骤2制备的中药提取物，加入适量药用辅料，配液，滤过，灭菌，分装，制成合剂。可选用辅料包括但不限于蜂蜜、单糖浆、甘草甜素、甜菊苷、山梨酸、苯甲酸、对羟基苯甲酸脂类等。
以上所述仅是本发明的优选实施方式，应当指出，对于本技术领域的普通技术人员，在不脱离本发明方法的前提下，还可以做出若干改进和补充，这些改进和补充也应视为本发明的保护范围。
实验、小儿止哮平喘颗粒的临床应用
本实验采用小儿止哮平喘颗粒，在治疗小儿支气管哮喘方面，观察其哮喘治疗情况。
1、材料
本发明一种治疗小儿热性哮喘的中药组合物，于2002年成为中国中医科学院西苑医院院内制剂。
2、制备方法
所述治疗小儿哮喘的中药组合物是由如下所述重量份的中药制成：麻黄5份、苦杏仁10份、黄芩10份、地骨皮10份、地龙10份、葶苈子6份、紫苏子6份、丹参10份、赤芍10份、仙鹤草10份。
(1)中药组合物
称取原料药：蜜麻黄5份、苦杏仁10份、黄芩10份、地骨皮10份、地龙10份、葶苈子6份、紫苏子6份、丹参10份、赤芍10份、仙鹤草10份。
(2)中药提取物一的制备
中药提取物一：取步骤(1)所述的中药，加入7-10倍量水，煎煮提取2次，每次1.5-2.5小时，提取液滤过，精制，浓缩至一定密度的流浸膏。
(3)中药提取物二的制备
中药提取物二：取步骤(1)所述的中药，加入7-10倍量水，加热煎煮提取2次，每次1.5-2.5小时，提取液滤过，精制，浓缩至一定密度的流浸膏，干燥成干浸膏，粉碎，混合。
(4)颗粒剂的制备
取步骤2或3制备的中药提取物，加入适量药用辅料，混合均匀，采用制粒设备，制成颗粒。
实际临床应用：
在儿科临床用于治疗儿童支气管哮喘近二十年，年均使用该中药制剂的病人约1000余人次，疗效显著，且未发现不良反应。通过多年临床观察总结及实验研究，从提升止咳化痰平喘等方面证实了本发明所涉及中药组合物对治疗儿童哮喘的优势——安全有效，且是双效或多效，作用持久，针对西药无效的患儿或对拒绝应用西药的患儿，能明显减轻咳嗽喘憋症状；对西药依赖的患儿，能帮助西药逐渐减量到停止，避免了长期使用西药引起的毒副作用所导致更加严重的危害。本发明所涉及中药组合物对治疗儿童哮喘有着整体调节、多靶点、副作用小等优势，可以达到双效或多靶点的疗效。
Claims (6)
1.一种治疗小儿热性哮喘的中药组合物，其特征在于，所述中药组合物是由如下所述重量份的中药制成：麻黄3-7份、苦杏仁8-12份、黄芩8-12份、地骨皮8-12份、地龙8-12份、葶苈子4-8份、紫苏子4-8份、丹参8-12份、赤芍8-12份、仙鹤草8-12份。
2.根据权利要求1所述的治疗小儿热性哮喘的中药组合物，其特征在于，所述中药组合物是由如下所述重量份的中药制成：麻黄4-6份、苦杏仁9-11份、黄芩9-11份、地骨皮9-11份、地龙9-11份、葶苈子5-7份、紫苏子5-7份、丹参9-11份、赤芍9-11份、仙鹤草9-11份。
3.根据权利要求1所述的治疗小儿热性哮喘的中药组合物，其特征在于，所述中药组合物是由如下所述重量份的中药制成：麻黄5份、苦杏仁10份、黄芩10份、地骨皮10份、地龙10份、葶苈子6份、紫苏子6份、丹参10份、赤芍10份、仙鹤草10份。
4.根据权利要求1-3任一所述的治疗小儿热性哮喘的中药组合物，其特征在于，所述中药组合物还包括药用载体或辅料，制备成中药口服制剂。
5.根据权利要求4所述的治疗小儿热性哮喘的中药组合物，其特征在于，所述口服制剂为颗粒剂、胶囊剂、片剂、糖浆剂、合剂等。
6.一种权利要求1-5所述的治疗小儿热性哮喘的中药组合物的制备方法，其特征在于，包括如下步骤：制备过程如下：
步骤1：中药组合物；
称取原料药：蜜麻黄5份、苦杏仁10份、黄芩10份、地骨皮10份、地龙10份、葶苈子6份、紫苏子6份、丹参10份、赤芍10份、仙鹤草10份；
步骤2：中药提取物一的制备；
中药提取物一：取步骤1所述的中药，加入7-10倍量水，煎煮提取2次，每次1.5-2.5小时，提取液滤过，精制，浓缩至一定密度的流浸膏；
步骤3：中药提取物二的制备；
中药提取物二：取步骤1所述的中药，加入7-10倍量水，加热煎煮提取2次，每次1.5-2.5小时，提取液滤过，精制，浓缩至一定密度的流浸膏，干燥成干浸膏，粉碎，混合；
步骤4：颗粒剂的制备；
取步骤2或3制备的中药提取物，加入适量药用辅料，混合均匀，采用制粒设备，制成颗粒，可选用辅料包括但不限于淀粉、纤维素、糖粉、乳糖、糊精、甘露醇、滑石粉、硬脂酸镁等；
步骤5：胶囊剂的制备；
取步骤2或3制备的中药提取物，加入适量药用辅料，混合均匀，制粒，并采用胶囊填充设备灌装胶囊，制成胶囊剂，可选用辅料包括但不限于蔗糖、乳糖、微晶纤维素、改良性淀粉、二氧化硅、滑石粉、硬脂酸镁等；
步骤6：片剂的制备；
取步骤2或3制备的中药提取物，加入适量药用辅料，混合均匀，制粒，加入润滑剂，采用压片机压制成片剂，可选用辅料包括但不限于淀粉、预胶化淀粉、蔗糖、糊精、乳糖、微晶纤维素、糖醇类、无机盐类、羧甲淀粉钠、低取代羟丙纤维素、交联羧甲基纤维素钠、交联聚维酮、聚维酮、羟丙基纤维素、硬脂酸镁、硬脂酸、滑石粉、微粉硅胶、氢化植物油、聚乙二醇类、蔗糖素、阿司帕坦、安赛蜜、甜叶菊苷、木糖醇等；
步骤7：糖浆剂的制备；
取步骤2或3制备的中药提取物，加入适量单糖浆及其它药用辅料，混合，滤过，分装，制成糖浆剂；可选用辅料包括但不限于甘油、滑石粉、山梨酸、苯甲酸、对羟基苯甲酸脂类等；
步骤8：合剂的制备；
取步骤2制备的中药提取物，加入适量药用辅料，配液，滤过，灭菌，分装，制成合剂；可选用辅料包括但不限于蜂蜜、单糖浆、甘草甜素、甜菊苷、山梨酸、苯甲酸、对羟基苯甲酸脂类等。
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