CN111437300A - 一种清热燥湿、散风止痒的中药组合物及其制备方法 - Google Patents
一种清热燥湿、散风止痒的中药组合物及其制备方法 Download PDFInfo
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Abstract
本发明提供了一种清热燥湿、散风止痒的中药组合物，所述的中药组合物包括如下中药材原料：茵陈、蒲公英和苦参。本发明还提供了所述的中药组合物的制备方法。本发明所述的中药组合物适于治疗小儿湿疹、痱子、尿布疹等由湿热内蕴肌肤引起的皮疹。
Description
技术领域
本发明涉及中医药技术领域，具体来说涉及一种清热燥湿、散风止痒的中药组合物及其制备方法。
背景技术
小儿湿疹、痱子、尿布疹等由湿热内蕴肌肤引起的皮疹主要表现为皮肤表面凸起密集型红色丘疹、伴痒感，抓破后易渗出液体。中医认为该病症由湿热侵表、发而不畅导致的。具体的病因为：饮食不当损伤脾胃，脾运化水湿功能失常郁积皮肤，外邪袭表，玄府开合功能失常，使体内热邪无所出，湿与热结于皮肤而成湿疹。病机为湿热互结、蕴于肌表。中医的治疗原则为清热燥湿、散风止痒。
茵陈为菊科植物茵陈蒿的干燥地上部分。味苦，微寒。归脾、胃、肝、胆经。具有清湿热、退黄疸、利胆、解热、保肝、抑菌、抗病毒、利尿、抗癌、镇痛、和消炎等功效。用于治疗黄疸尿少、湿温暑湿和湿疮瘙痒。
蒲公英为菊科植物蒲公英的干燥全草。味甘，微苦，寒。归肝、胃经。具有利尿、缓泻、退黄疸、利胆等功效。用于治疗热毒、痈肿、疮疡、内痈、目赤肿痛、湿热、黄疸、小便淋沥涩痛和尿路感染。
苦参为豆科植物苦参的干燥根。味苦，性寒。归心、肝、胃、大肠、膀胱经。具有清热燥湿、杀虫和利尿的功效。用于治疗热痢、便血、黄疸尿闭、赤白带下、阴肿阴痒、湿疹、湿疮、皮肤瘙痒、疥癣麻风和外治滴虫性阴道炎。
茵陈为君药，清热利湿、脱敏止痒。苦参、蒲公英为臣药，苦参苦寒燥湿，同时又有杀虫止痒之功，蒲公英清热解毒、消肿散结助君药除皮疹。此方治疗湿热内蕴而成的湿疹，对于干性湿疹慎用。找出茵陈、蒲公英和苦参的适宜配比，将其用于清热燥湿、散风止痒的药物应用，可以满足中药领域对该类新产品的需求。
文献“茵陈蒿汤治疗阴道炎310例的临床分析”以及“茵陈蒿汤治疗阴道炎160例”中公开了一种由茵陈、蒲公英、苦参配伍其他的中药制备而成，在临床上用于治疗阴道炎，疗效显著。但是该方法需要口服和外用，如果患者为小儿，口服起来会十分麻烦，还可能呛着患者。
专利文献CN106420490A公开了一种具有祛痘功效的中药组合物，由茵陈、蒲公英、苦参配伍其他的中药制备而成，适用于治疗青春痘、粉刺和暗疮等症状。
专利文献CN106266977A公开了一种治疗急、慢性乙肝的中药组合物，由茵陈、蒲公英、苦参配伍其他的中药制备而成，治疗乙肝疗效显著。
专利文献CN106728751A公开了一种治疗牛皮癣的中药组合物，由茵陈、蒲公英、苦参配伍其他的中药制备而成，有疗效但是治疗时间长。
可见，现有技术中缺少治疗小儿湿疹、痱子、尿布疹等由湿热内蕴肌肤引起的皮疹的中药组合物。
发明内容
本发明目的在于提供一种清热燥湿、散风止痒的中药组合物，该中药组合物疗效好，制备简单，无毒副作用。
为了实现本发明的目的，本发明提供一种清热燥湿、散风止痒的中药组合物，该中药组合物原料包括如下中药材：茵陈、蒲公英和苦参。
进一步地，所述的中药组合物原料包括下列重量配比的中药材：茵陈30-60份、蒲公英30-60份和苦参30-60份。
进一步地，所述的中药组合物原料包括下列重量配比的中药材：茵陈30份、蒲公英40份和苦参60份。
进一步地，所述的中药组合物原料包括下列重量配比的中药材：茵陈60份、蒲公英30份和苦参40份。
进一步地，所述的中药组合物原料包括下列重量配比的中药材：茵陈50份、蒲公英50份和苦参50份。
进一步地，所述的中药组合物原料由下列重量配比的中药材组成：茵陈30-60份、蒲公英30-60份和苦参30-60份。
本发明所述的中药组合物可以选用各种符合药典以及监管部门规定的种类，不局限特别的种类或产地。
上述中药组合物优选为外用剂型，包括但不限于贴剂、粉剂、片剂(包括崩解片、泡腾片等)、丸剂、颗粒剂、胶囊剂、锭剂、溶液剂、乳剂、混悬剂、气雾剂、膜剂、透皮吸收制剂(包括巴布剂)、凝胶剂、膏剂、软膏剂、洗剂、粘附制剂等。优选地，所述的中药组合物为散剂。优选地，所述的中药组合物为洗剂。
在制备上述剂型时，本领域技术人员可以根据药剂学常识为本申请的中药组合物选用适合的辅料，可包括芳香剂(如香料、香精等)、胶浆剂(具体如，海藻酸钠、阿拉伯胶、明胶、甲基纤维素、羧甲基纤维素钠等)、澄清剂(具体如，壳聚糖、明胶等)、防腐剂(具体如，苯甲酸及其盐、山梨酸及其盐、尼泊金类系列等)、崩解剂(具体如，低取代羟丙基纤维素、交聚维酮、羧基乙酸淀粉钠、交联羧甲基纤维素钠、淀粉等)、粘结剂(具体如，羟丙基纤维素、羟丙甲纤维素、聚维酮、共聚维酮、预胶凝淀粉等)、润滑剂(具体如，硬脂酸、硬脂酸镁、富马酰硬脂酸钠等)、润湿剂(具体如，聚氧乙烯山梨糖醇酐脂肪酸酯、泊洛沙姆、聚氧乙烯蓖麻油衍生物等)、悬浮剂(具体如，羟丙甲纤维素、羟丙基纤维素、聚维酮、共聚维酮、羧甲基纤维素钠、甲基纤维素等)、稳定剂(具体如，柠檬酸、富马酸、琥珀酸等)、填充剂(具体如，淀粉、蔗糖、乳糖、微晶纤维素等)、粘合剂(具体如，纤维素衍生物、藻酸盐、明胶和聚乙烯吡咯烷酮等)等中的一种或多种。
本领域技术人员可以理解，本发明所述的中药组合物可以是中药材原料物理混合制备得到，也可以是全部或部分中药材原料经过提取制备得到，所述的提取可以以本领域的常规溶剂提取得到，例如水、乙醇、乙醇水溶液、乙酸乙酯、二氯甲烷、正己烷、石油醚或丙酮等。
优选地，本发明所述的中药组合物由上述中药材原料水煎煮制备得到。
进一步地，所述的中药材原料和水按照重量体积比g/mL为1:10-40加入，更优选地，所述的中药材原料和水按照重量体积比g/mL为1:20-30加入，特别优选地，所述的中药材原料和水按照重量体积比g/mL为1:25-30加入。
进一步地，所述的水煎煮时间为60-180min，优选为90-120min。
本发明还提供一种清热燥湿、散风止痒的中药组合物的制备方法，该制备方法包括：
(1)称取中药材原料；
(2)加水煎煮；
(3)静置，过滤得上清液。
进一步地，所述的步骤(2)中，中药材原料和水按照重量体积比g/mL为1:10-40加入，更优选地，所述的中药材原料和水按照重量体积比g/mL为1:20-30加入，特别优选地，所述的中药材原料和水按照重量体积比g/mL为1:25-30加入。
进一步地，所述的步骤(2)中，水煎煮时间为60-180min，优选为90-120min。
进一步地，所述的步骤(3)中，静置时间为1-5h，优选为2-3h。
进一步地，所述的中药组合物的制备方法包括：
(1)称取中药材原料；
(2)加水煎煮90-120min；
(3)静置2-3h，过滤得上清液。
本发明还提供了一种上述清热燥湿、散风止痒的中药组合物在制备药物中的应用，所述的药物用于预防和/或治疗小儿病症，优选地，所述的病症选自小儿湿疹、痱子、尿布疹等由湿热内蕴肌肤引起的皮疹。
具体实施方式
以下通过具体实施方式的描述对本发明作进一步说明，但这并非是对本发明的限制，本领域技术人员根据本发明的基本思想，可以做出各种修改或改进，但是只要不脱离本发明的基本思想，均在本发明的范围之内。
实施例1：本发明中药组合物的制备
取茵陈30g、蒲公英40g和苦参60g；加入3500mL水煎煮90min；静置2h，过滤得上清液，得到中药组合物。
实施例2：本发明中药组合物的制备
取茵陈50g、蒲公英50g和苦参50g；加入4000mL水煎煮90min；静置2h，过滤得上清液，得到中药组合物。
实施例3：本发明中药组合物的制备
取茵陈60g、蒲公英30g和苦参40g；加入3500mL水煎煮90min；静置2h，过滤得上清液，得到中药组合物。
实施例4：本发明中药组合物的制备
取茵陈30g、蒲公英40g和苦参60g；加入3500mL水煎煮120min；静置2h，过滤得上清液，得到中药组合物。
实施例5：本发明中药组合物的制备
取茵陈50g、蒲公英50g和苦参50g；加入4000mL水煎煮120min；静置2h，过滤得上清液，得到中药组合物。
实施例6：本发明中药组合物的制备
取茵陈60g、蒲公英30g和苦参40g；加入3500mL水煎煮120min；静置2h，过滤得上清液，得到中药组合物。
实施例7：本发明中药组合物的制备
取茵陈30g、蒲公英40g和苦参60g；加入3500mL水煎煮120min；静置3h，过滤得上清液，得到中药组合物。
实施例8：本发明中药组合物的制备
取茵陈50g、蒲公英50g和苦参50g；加入4000mL水煎煮120min；静置3h，过滤得上清液，得到中药组合物。
实施例9：本发明中药组合物的制备
取茵陈60g、蒲公英30g和苦参40g；加入3500mL水煎煮120min；静置3h，过滤得上清液，得到中药组合物。
实施例10：本发明中药组合物的治疗效果
所有患者均按统一科研设计进行观察和统计，参照《中药新药临床研究指导原则》诊断标准临床症状为小儿湿疹、痱子、尿布疹等由湿热内蕴肌肤引起的皮疹。
随机选取100个使用本发明实施例2方法制备得到中药组合物的患儿，平均年龄为7岁2个月，男、女各占一半，采取自身前后对照的方式进行研究。每天外洗患处2次，每次擦洗10-20分钟，观察三周。
症状划分标准见表1：
表1、症状划分标准
| 皮疹 | 瘙痒 | |
| 轻症 | 少数聚集 | 轻微持续瘙痒 |
| 较重 | 连聚成片，发疱 | 瘙痒明显，抓挠不能缓解 |
| 严重 | 成片发疱或有溃烂 | 严重瘙痒，越挠越痒，影响生活 |
治愈标准：采取分制统计法，设定每个症状改善情况由弱到强10分制。
皮疹改善情况：症状同前(0分)，皮疹范围和红肿程度明显改善(1-5分)，皮疹疾病消失(6-10分)。
痒感改善情况：无明显变化(0分)，肤痒略有减轻抓挠频率减少(1-5分)，抓挠频率明显减少，基本无痒感(6-10分)。
治愈标准分为三个等级，总积分0分为无效，1—12分为有效，13—20分为痊愈。
实验结果见表2：
表2、用药效果评价
| 用药前例数 | 治愈例数 | 有效例数 | 无效例数 | |
| 轻症 | 54 | 48 | 6 | 0 |
| 较重 | 29 | 26 | 3 | 0 |
| 严重 | 17 | 12 | 5 | 0 |
经过三周的治疗，所有患儿均符合有效的疗效标准，并且治疗过程中未发现明显的不良反应。
实施例11：本发明中药组合物的治疗效果
患儿5岁，性别男，症状双手掌心及指缝丘疹，皮肤瘙痒，微发红，不痛。使用本发明实施例2方法制备得到的中药组合物外洗治疗两周以后症状有所好转，皮肤发红消失，微有瘙痒，掌心皮疹消退，指缝偶有皮疹。继续使用跟踪观察三周以后，瘙痒、皮疹症状全部消失。
患儿2岁，性别女，症状肛周皮肤瘙痒、红肿、疼痛、有散在丘疹。使用本发明实施例2方法制备得到的中药组合物外洗治疗两周后症状有所好转，瘙痒、红肿减轻，疼痛消失，丘疹减少。继续使用，三周以后跟踪观察瘙痒红肿及皮疹症状全部消失。
最后应说明的是：以上所述仅为本发明的优选实施例而已，并不用于限制本发明，尽管参照前述实施例对本发明进行了详细的说明，对于本领域的技术人员来说，其依然可以对前述各实施例所记载的技术方案进行修改，或者对其中部分技术特征进行等同替换。凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。
Claims (10)
1.一种清热燥湿、散风止痒的中药组合物，其特征在于，所述的中药组合物原料包括如下中药材：茵陈、蒲公英和苦参。
2.根据权利要求1所述的清热燥湿、散风止痒的中药组合物，其特征在于，所述的中药组合物原料包括下列重量配比的中药材：茵陈30-60份、蒲公英30-60份和苦参30-60份。
3.根据权利要求1所述的清热燥湿、散风止痒的中药组合物，其特征在于，所述的中药组合物原料包括下列重量配比的中药材：茵陈50份、蒲公英50份和苦参50份。
4.根据权利要求1所述的清热燥湿、散风止痒的中药组合物，其特征在于，所述的中药组合物原料由下列重量配比的中药材组成：茵陈30-60份、蒲公英30-60份和苦参30-60份。
5.根据权利要求1至4中任一项所述的清热燥湿、散风止痒的中药组合物，其特征在于，所述的中药组合物为外用制剂，优选地，所述的中药组合物为洗剂。
6.根据权利要求1至5中任一项所述的清热燥湿、散风止痒的中药组合物，其特征在于，所述的中药组合物由所述的中药材水煎煮制备得到。
7.根据权利要求6所述的清热燥湿、散风止痒的中药组合物，其特征在于，所述的中药材和水按照重量体积比g/mL为1:10-40加入，优选地，所述的中药材原料和水按照重量体积比g/mL为1:20-30加入，更优选地，所述的中药材原料和水按照重量体积比g/mL为1:25-30加入。
8.根据权利要求6所述的清热燥湿、散风止痒的中药组合物，其特征在于，所述的水煎煮时间为60-180min，优选为90-120min。
9.根据权利要求1-8中任一项所述的清热燥湿、散风止痒的中药组合物的制备方法，其特征在于，包括：
(1)称取中药材原料；
(2)加水煎煮；
(3)静置，过滤得上清液。
10.根据权利要求1至8中任一项所述的清热燥湿、散风止痒的中药组合物在制备药物中的应用，所述的药物用于预防和/或治疗小儿病症，所述的病症选自小儿湿疹、痱子、尿布疹由湿热内蕴肌肤引起的皮疹。
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