CN113491738A - 一种中药组合物及其制备方法和应用 - Google Patents

一种中药组合物及其制备方法和应用 Download PDF

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CN113491738A
CN113491738A CN202110932164.8A CN202110932164A CN113491738A CN 113491738 A CN113491738 A CN 113491738A CN 202110932164 A CN202110932164 A CN 202110932164A CN 113491738 A CN113491738 A CN 113491738A
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traditional chinese
chinese medicine
medicine composition
ethanol
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罗震
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Abstract

本发明涉及中药制剂技术领域，具体涉及一种中药组合物及其制备方法和应用，所属中药组合物原料包括：马钱子，制川乌，全虫，狗脊，生杜仲，土鳖虫，淮牛膝，红花，威灵仙，千年健，三七，桃仁，乳香，没药，地枫皮，冰片，樟脑，甘草，筋骨草，苍术，雄黄，黄柏，龙骨，半夏和青黛。本发明中药组合物是一种消炎解毒，消肿止痛，舒筋活络，广谱抗菌的中药组合物，将中草药中的有效成分进行充分提取和利用，提升产品的临床效果。

Description

一种中药组合物及其制备方法和应用
技术领域
本发明涉及中药制剂技术领域，具体涉及一种中药组合物及其制备方法和应用。
背景技术
草药，是利用植物提取物制作而成，主要使用其治疗价值。经分析，有些草药的化学成分，是一般高等植物中共存的，此外还不同程度的含有游离氨基酸、各种维生素、蛋白质、碳水化合物、芳香油、酶、无机盐、微量元素、糖类、油类、脂类、腊、酸、色素、树脂等。每一种草药往往含有多种化学成分，但不是所有化学成分都能产生防治疾病的效用。通常中药里的成分有有效成分和无效成分。有效成分是指具有医疗效用或生物活性的物质，如马钱子碱，番木鳖碱，蝎毒具有神经毒素和细胞毒素，在神经分子，分子免疫，分子进化，蛋白质的结构与功能等方面有广阔的应用前景。目前草药的制备有采摘，提纯，熬制，炮制等方面，针对不同药物，都有不同的制作方法。不同的制作方法在一定程度上也影响了草药的药效和治疗作用；药物喷剂是指将原料药物或与适宜辅料填充于特制的装置中，使用时借助手动泵的压力、高压气体、超声振动或其他方法将内容物呈雾状物释出，从而直接作用于皮肤等表面的一种药物制剂，产品多以跌打损伤药物为主；然而现有技术中多采用将草药药物原料在白酒中浸泡的方法来制备中草药组合喷剂，由于有效成分不能充分的溶出以及浸泡过程中有效成分的流失等问题导致草药的有效成分存在很大的浪费，因此提供一种新的中药喷剂制备方法，以提高外用喷剂的质量，显得尤为必要。
发明内容
本发明的目的在于提供一种中药组合物及其制备方法和应用，具体为一种消炎解毒，消肿止痛，舒筋活络，广谱抗菌的中药组合物，将中草药中的有效成分进行充分提取和利用，提升产品的临床效果。
本发明的技术方案之一，一种中药组合物，质量份数计，原料包括：马钱子20份，制川乌25份，全虫60份，狗脊30份，生杜仲30份，土鳖虫20份，淮牛膝20份，红花15份，威灵仙25份，千年健25份，三七30份，桃仁25份，乳香12份，没药12份，地枫皮20份，冰片5份，樟脑10份，甘草10份，筋骨草20份，苍术20份，雄黄15份，黄柏15份，龙骨15份，半夏15份和青黛5份。
进一步地，所述中药组合物为喷剂。
本发明的技术方案之二，上述中药组合物的制备方法，包括以下步骤：
将除红花、冰片、樟脑以外原料破碎后和红花混匀得混合原料，加乙醇水溶液a浸泡后加热回流提取，过滤，得药液和滤渣；
药液浓缩所得稠膏和冰片、樟脑混合，加乙醇水溶液b稀释后过滤得中药组合物。
进一步地，所述破碎具体为破碎至8-10目；所述乙醇水溶液a中乙醇的体积分数为60％，混合原料和乙醇水溶液a的质量比为1:5，浸泡时间为2h，加热回流提取时间2h。
进一步地，还包括以下步骤：滤渣加入5倍量体积分数为60％的乙醇进行二次加热回流提取1.5h，过滤，所得二次提取药液和前述药液合并。
进一步地，所述稠膏相对密度为1.25g/cm3；所述冰片和樟脑经体积分数为90-98％的乙醇溶解后和稠膏混合；所述乙醇水溶液b中乙醇的体积分数为70-75％，稀释倍数为：3.5--4.5。约1000mL针对263g原料，得到236g浸膏。
本发明的技术方案之三，上述中药组合物在跌打损伤、消炎解毒、消肿止痛、舒筋活络或广谱抗菌药物中的应用。
与现有技术相比，本发明的有益效果：
跌打损伤为骨科常见外伤，患者软组织肿胀，皮下出血，本发明根据药理作用，运用马钱子，散结消肿。红花，活血通经。全虫，通络止痛。狗脊，祛风湿，强腰脊。生杜仲祛风湿，降压。土鳖虫，消肿块，散结节。怀牛膝，利水气，清热解毒。威灵仙，祛风除湿。千年健，舒筋活络。三七，化瘀止血，活血定痛，解毒消肿。桃仁，抗炎镇痛。乳香，外用消肿生肌。没药，理气止痛。地枫皮祛风除湿，行气止痛。筋骨草，凉血平肝，消肿散结。冰片，通诸窍，散郁火。甘草，缓拘急，调和诸药。临床验证具有消肿止痛，行气散结，消肿生肌，祛风湿，凉血散热等疗效。
进一步地，在上述具有消肿止痛功能，中药组方的基础上，利用中药药理作用，发现组合运用黄柏，雄黄，樟脑，青黛，配以原消肿止痛的中药组方，具有良好的抗菌，解毒，祛瘟，避秽等广谱抗菌作用的功效。黄柏泻火除蒸年，解毒疗疮，治疗皮肤湿疹，瘙痒，消除樟脑引起的皮肤不适，保留凉血消肿作用。青黛消瘟毒发斑，血热。雄黄具有抗肿瘤作用，体外用水浸液对金黄色葡萄球菌，人体结核杆菌，变形杆菌，绿脓球菌及多种皮肤真菌，均有不同程度的抑制作用，本方法对多种中草药的浸泡，提纯工艺，不仅保留了乙醇的消毒作用，更强化了中草药对人体外用，达到抗过敏，清热毒，祛瘟避秽，抗菌解毒的功效。
本发明药物组分配方中：
君药，全虫，含有神经毒性，并对细胞组织有影响。药性辛，平。通络止痛，攻毒散结，抗肿瘤。
臣药，马钱子，药性温，苦。含马钱子碱，中和全虫神经毒性，强化消肿止痛功效，可凉血，除风湿顽痹。
辅药，雄黄含四硫化四砷，解毒杀虫，强化抑菌作用。
佐药，甘草，药性平，味甘，归心，肺，脾，胃经。缓急止痛，清热解毒，调和诸药。
附图说明
图1为本发明实施例1中药组合物制备的工艺流程图。
具体实施方式
现详细说明本发明的多种示例性实施方式，该详细说明不应认为是对本发明的限制，而应理解为是对本发明的某些方面、特性和实施方案的更详细的描述。
应理解本发明中所述的术语仅仅是为描述特别的实施方式，并非用于限制本发明。另外，对于本发明中的数值范围，应理解为还具体公开了该范围的上限和下限之间的每个中间值。在任何陈述值或陈述范围内的中间值以及任何其他陈述值或在所述范围内的中间值之间的每个较小的范围也包括在本发明内。这些较小范围的上限和下限可独立地包括或排除在范围内。
除非另有说明，否则本文使用的所有技术和科学术语具有本发明所述领域的常规技术人员通常理解的相同含义。虽然本发明仅描述了优选的方法和材料，但是在本发明的实施或测试中也可以使用与本文所述相似或等同的任何方法和材料。本说明书中提到的所有文献通过引用并入，用以公开和描述与所述文献相关的方法和/或材料。在与任何并入的文献冲突时，以本说明书的内容为准。
在不背离本发明的范围或精神的情况下，可对本发明说明书的具体实施方式做多种改进和变化，这对本领域技术人员而言是显而易见的。由本发明的说明书得到的其他实施方式对技术人员而言是显而易见得的。本申请说明书和实施例仅是示例性的。
关于本文中所使用的“包含”、“包括”、“具有”、“含有”等等，均为开放性的用语，即意指包含但不限于。
实施例1
(1)称取原料：马钱子20克，制川乌25克，全虫60克，狗脊30克，生杜仲30克，土鳖虫20克，淮牛膝20克，红花15克，威灵仙25克，千年健25克，三七30克，桃仁25克，乳香12克，没药12克，地枫皮20克，冰片5克，樟脑10克，甘草10克，筋骨草20克，苍术20克，雄黄15克，黄柏15克，龙骨15克，半夏15克，青黛5克。
(2)将除红花、冰片、樟脑以外的原料破碎机破碎至8-10目后和红花混合均匀，放入提取罐中，加5倍量60％乙醇浸泡2小时，加热回流第一次提取2小时，过滤，得药液和滤渣，滤渣第二次加5倍量60％乙醇，加热回流提取1.5小时，过滤(350目)，合并两次所得药液，回收乙醇，浓缩至相对密度1.25g/cm3的稠膏，加入冰片、樟脑(用95％左右乙醇浓度酒精溶解)，用酒精、纯化水将药液配制成1000ml(乙醇体积浓度70-75％)，静置时间48小时，过滤(350目)、灌装、即得中药组合物喷剂；图1为本实施例中药组合物制备的工艺流程图。
(3)将制备的产品进行临床验证结果见表1；
表1
Figure BDA0003211506050000041
上述实验过程中，偶见小水泡状皮疹，停药可自愈。
实施例2
(1)称取原料：马钱子20克，制川乌25克，全虫60克，狗脊30克，生杜仲30克，土鳖虫20克，淮牛膝20克，红花15克，威灵仙25克，千年健25克，三七30克，桃仁25克，乳香12克，没药12克，地枫皮20克，冰片5克，樟脑10克，甘草10克，筋骨草20克，苍术20克，雄黄15克，黄柏15克，龙骨15克，半夏15克，青黛5克。
(2)将上述原料加白酒10斤浸泡30天后过滤(350目)、灌装、即得中药组合物喷剂。
(3)将所得产品进行临床验证结果见表2；
表2
Figure BDA0003211506050000051
实施例3
同实施例1，区别在于，省略组分：马钱子，全虫，
将所得产品进行临床验证结果见表3；
表3
Figure BDA0003211506050000052
以上所述仅为本发明的较佳实施例，并不用以限制本发明，凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等，均应包含在本发明的保护范围之内。

Claims (7)

1.一种中药组合物，其特征在于，质量份数计，原料包括：马钱子20份，制川乌25份，全虫60份，狗脊30份，生杜仲30份，土鳖虫20份，淮牛膝20份，红花15份，威灵仙25份，千年健25份，三七30份，桃仁25份，乳香12份，没药12份，地枫皮20份，冰片5份，樟脑10份，甘草10份，筋骨草20份，苍术20份，雄黄15份，黄柏15份，龙骨15份，半夏15份和青黛5份。
2.根据权利要求1所述的中药组合物，其特征在于，所述中药组合物为喷剂。
3.一种根据权利要求2所述的中药组合物的制备方法，其特征在于，包括以下步骤：
将除红花、冰片、樟脑以外原料破碎后和红花混匀得混合原料，加乙醇水溶液a浸泡后加热回流提取，过滤，得药液和滤渣；
药液浓缩所得稠膏和冰片、樟脑混合，加乙醇水溶液b稀释后过滤得中药组合物。
4.根据权利要求3所述的中药组合物的制备方法，其特征在于，所述破碎具体为破碎至8-10目；所述乙醇水溶液a中乙醇的体积分数为60％，混合原料和乙醇水溶液a的质量比为1:5，浸泡时间为2h，加热回流提取时间2h。
5.根据权利要求3所述的中药组合物的制备方法，其特征在于，还包括以下步骤：滤渣加入5倍量体积分数为60％的乙醇进行二次加热回流提取1.5h，过滤，所得二次提取药液和前述药液合并。
6.根据权利要求3所述的中药组合物的制备方法，其特征在于，所述稠膏相对密度为1.25g/cm3；所述冰片和樟脑经体积分数为90-98％的乙醇溶解后和稠膏混合；所述乙醇水溶液b中乙醇的体积分数为70-75％，稀释倍数为3.5--4.5。
7.一种根据权利要求1-2任一项所述的中药组合物在跌打损伤、消炎解毒、消肿止痛、舒筋活络或广谱抗菌药物中的应用。
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