CN114886946A - 一种药物组合物及自发热中药暖腰带 - Google Patents

一种药物组合物及自发热中药暖腰带 Download PDF

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CN114886946A
CN114886946A CN202210547759.6A CN202210547759A CN114886946A CN 114886946 A CN114886946 A CN 114886946A CN 202210547759 A CN202210547759 A CN 202210547759A CN 114886946 A CN114886946 A CN 114886946A
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伍勇
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Abstract

本发明涉及中药技术领域，具体涉及一种药物组合物及自发热中药暖腰带。所述药物组合物，按照重量份数计，包括如下组分：红藤13‑20份、独活6‑9份、艾纳香10‑14份、虎杖5‑10份、防风5‑8份和五加皮6‑10份。本发明具有可以同时治疗腰颈部位疾病以及缓解女性宫寒、痛经，并且配方简单、无副作用的优点。

Description

一种药物组合物及自发热中药暖腰带
技术领域
本发明涉及中药技术领域，具体涉及一种药物组合物及自发热中药暖腰带。
背景技术
在长期久坐、做家务带娃等情况下，身体会出现腰颈部位僵硬、紧张、酸痛、肿胀，腰酸背痛等症状，而且大部分经期女性伴有宫寒、痛经等表现。
痛经是月经期和月经期前后出现的周期性下腹痛，常发生在月经前和月经期，偶尔发生在月经期后数日内。痛经有寒热虚实之分，临床可分气滞血瘀、寒湿凝滞、气血虚弱、湿热下注四个证型。中医学认为该病总体来说是经脉因风寒致使气机受阻，血气通行不调畅而引发的。痛经一症，从内因来说，主要在于气血的凝滞；从外因来说，主要由于瘀滞或寒凝。目前，治疗痛经的方法主要有西药治疗及中药治疗，而以中药治疗居多。而目前市场上有许多中药效果并不太理想，有的愈后还易复发，有的治疗时间很长，但效果不太好。
“宫寒”是中医学的一个概念。狭义的“宫寒”即子宫受寒，感受寒邪；广义的“宫寒”可理解为女性生殖系统等阴寒内盛、阳气不足、肾阳虚衰的寒。中医认为，宫寒一般与女性肾阳不足，胞宫失于温煦，或感受寒邪，胞脉阻滞有关，其主要临床特点如下：下腹冷痛，得热痛减，四肢不温，腰膝酸软，或腰痛如折，口淡无味，喜食辛燥，气短乏力，失眠多梦，夜尿增多，小便频或失禁，大便稀糖，性欲淡漠，面浮肢肿，或体型肥胖，行经腹痛，经暗有块；舌质暗淡或暗，苔白，脉沉细尺弱或沉涩。
宫寒而致的妇科疾病较多，如月经病的月经过少、月经后期、痛经、闭经、经行浮肿、经行泄泻；带下病的带下量多清稀，甚者带下清冷；妊娠病的胎漏﹑胎动不安、滑胎、小产、胎萎不长、胎死不下、妊娠腹痛﹑异位妊娠；产后病的产后腹痛、产后身痛、产后恶露不绝、产后小便不通；杂病的不孕、盆腔炎、瘾瘕等等。
目前治疗宫寒主要为中药治疗，如中国专利申请CN101879294A公开了由阿胶、当归、川芎、红花等22味中药组成的中药组合物，用于治疗宫寒；中国专利申请CN104984316A公开了由吴茱萸、当归、川芎、芍药等11味中药组成的中药组合物，用于治疗女性宫寒；中国专利申请CN104998061A公开了由猪殃殃、蛇床子、巴戟天、艾叶等22味中药组成的中药组合物，用于治疗宫寒不孕。但是上述治疗宫寒的中药组合物药味都较多，组成较复杂，这一方面增加了药物的成本，另一方面增加了安全性方面的风险。
中国专利申请CN101455770A公开了一种以牛滕、土鳖虫、麻黄、苍术、当归、白芍、首乌、枸杞、方粉、五加皮、艾叶、对山药、党参、黄芪、土茯苓、补骨脂、菟丝子、红花、陈皮、细辛、石莒蒲、附子、肉桂、甘草、蛤蚡、马钱子、乳香、没药、全虫和蜂蜜等三十味中药为原料制得的治疗腰椎间盘突出症的中药丸，但是所用原料种类多、价格贵。
中国专利申请CN101185699A公开了一种以防风10克、龟板15克、骨碎补10克、当归10克、杜仲15克、鹿角霜15克、熟地10克、川芎15克、威灵仙15克、土鳖虫15克、鸡血藤15克、细辛3克为原料制得的治疗颈椎病的中药汤剂，但是该中药汤剂只适用于颈椎病的治疗。
目前急需一种可以同时治疗腰颈部位疾病以及缓解女性宫寒、痛经，并且配方简单、无副作用的中药组合物。
因此，开发一种能解决上述技术问题的药物组合物是非常必要的。
发明内容
本发明的目的是克服现有技术的不足而提供一种可以同时治疗腰颈部位疾病以及缓解女性宫寒、痛经，并且配方简单、无副作用的药物组合物及自发热中药暖腰带。
本发明是通过以下技术方案予以实现的：
一种药物组合物，按照重量份数计，包括如下组分：红藤13-20份、独活6-9份、艾纳香10-14份、虎杖5-10份、防风5-8份和五加皮6-10份。
优选地，所述的药物组合物，按照重量份数计，包括如下组分：红藤15-18份、独活7-8份、艾纳香11-13份、虎杖6-9份、防风6-7份和五加皮7-9份。
本发明还涉及上述的药物组合物的制备工艺，包括如下步骤：
(1)将虎杖、红藤和艾纳香混合后粉碎，分别用水和有机溶剂A提取，过滤，分别得到滤液A和滤液B；
(2)将独活粉碎后加水煎煮，过滤，得到滤液C；
(3)将防风和五加皮混合后粉碎，用有机溶剂B提取，过滤，得到滤液D；
(4)将滤液A、B、C和D分别浓缩后干燥，混合均匀，即得。
优选地，步骤(1)中所述有机溶剂A为70-85％乙醇。
优选地，步骤(1)中将虎杖、红藤和艾纳香混合后粉碎，先加入5-10倍量的水在30-40℃提取0.5-1h，过滤，得到滤渣A和滤液A；将滤渣A再加入5-10倍量的70-85％乙醇回流提取0.5-1h，过滤，得到滤液B。
优选地，步骤(2)中将独活粉碎后加5-10倍量的水煎煮1-2h，过滤，得到滤液C。
优选地，步骤(3)中所述有机溶剂B为乙醇和氯仿的混合溶剂，两者体积比为1-2:1。
优选地，步骤(3)中将防风和五加皮混合后粉碎，用5-10倍量的溶剂B在30-40℃提取0.5-1h，过滤，得到滤液D。
更优选地，所述制备工艺包括如下步骤：
(1)将虎杖、红藤和艾纳香混合后粉碎，先加入5-10倍量的水在30-40℃提取0.5-1h，过滤，得到滤渣A和滤液A；将滤渣A再加入5-10倍量的70-85％乙醇回流提取0.5-1h，过滤，得到滤液B；
(2)将独活粉碎后加5-10倍量的水煎煮1-2h，过滤，得到滤液C；
(3)将防风和五加皮混合后粉碎，用5-10倍量的溶剂B在30-40℃提取0.5-1h，过滤，得到滤液D；
(4)将滤液A、B、C和D分别浓缩后干燥，混合均匀，即得。
本发明还涉及一种制剂，包括上述的药物组合物或上述的制备工艺制备得到的药物组合物和药学上可接受的辅料。
本发明还涉及上述的药物组合物或上述的制备工艺制备得到的药物组合物或上述的制剂在制备治疗痛经、和/或宫寒、和/或腰颈椎疾病的药物中的应用。
本发明的药物组合物口服或者外用均可。
优选地，所述腰颈椎疾病的症状包括腰颈部位僵硬、紧张、酸痛和肿胀中的至少一种。
本发明还涉及一种自发热中药暖腰带，所述腰带内装有上述的药物组合物或上述的制备工艺制备得到的药物组合物或上述的制剂。
优选地，所述腰带包括腰带主体和分别位于腰带主体两端的连接带。
更优选地，所述腰带主体包括4层结构，依次为面层、发热层、中药层和亲肤层，所述药物组合物或所述制剂装于所述中药层内。
所述亲肤层直接与人体接触。
更优选地，所述发热层内装有发热材料。
更优选地，所述连接带为弹性带，两侧连接带由魔术贴连接。
本发明的有益效果是：
本发明的药物组合物可以缓解经期女性腰颈部位僵硬、紧张、酸痛、肿胀；改善宫寒、月经量少、痛经症状；活血化瘀、疏通经络。
本发明的自发热中药暖腰带将热敷与中草药结合，通过发热材料热敷在驱寒保暖、防止腰腹部位着凉的同时，可以引药物的有效成分局部渗透，通过开泄的腠理直达病所，进一步加强温经散寒、通络止痛等功效。
本发明的虎杖、红藤和艾纳香之间协同作用明显，可以显著提高组合物在治疗痛经、宫寒和腰颈椎疾病方面的效果。
本发明优化了组合物的制备工艺，进一步提高了组合物的治疗效果。
本发明的药物组合物，经测试没有任何副作用。
具体实施方式
下面结合具体实施例来进一步描述本发明，本发明的优点和特点将会随着描述而更为清楚。但这些实施例仅是范例性的，并不对本发明的范围构成任何限制。本领域技术人员应该理解的是，在不偏离本发明的精神和范围下可以对本发明技术方案的细节和形式进行修改或替换，但这些修改和替换均落入本发明的保护范围内。
实施例1
一种药物组合物，按照重量份数计，包括如下组分：红藤13份、独活6份、艾纳香10份、虎杖5份、防风5份和五加皮6份。
所述药物组合物的制备工艺包括如下步骤：
(1)将虎杖、红藤和艾纳香混合后粉碎，先加入5倍量的水在30℃提取0.5h，过滤，得到滤渣A和滤液A；将滤渣A再加入5倍量的70％乙醇回流提取0.5h，过滤，得到滤液B；
(2)将独活粉碎后加5倍量的水煎煮1h，过滤，得到滤液C；
(3)将防风和五加皮混合后粉碎，用5倍量的溶剂B(溶剂B为乙醇和氯仿的混合溶剂，两者体积比为1:1)在30℃提取0.5h，过滤，得到滤液D；
(4)将滤液A、B、C和D分别浓缩后干燥，混合均匀，即得。
实施例2
一种药物组合物，按照重量份数计，包括如下组分：红藤20份、独活9份、艾纳香14份、虎杖10份、防风8份和五加皮10份。
所述药物组合物的制备工艺包括如下步骤：
(1)将虎杖、红藤和艾纳香混合后粉碎，先加入10倍量的水在40℃提取1h，过滤，得到滤渣A和滤液A；将滤渣A再加入10倍量的85％乙醇回流提取1h，过滤，得到滤液B；
(2)将独活粉碎后加10倍量的水煎煮2h，过滤，得到滤液C；
(3)将防风和五加皮混合后粉碎，用10倍量的溶剂B(溶剂B为乙醇和氯仿的混合溶剂，两者体积比为2:1)在40℃提取1h，过滤，得到滤液D；
(4)将滤液A、B、C和D分别浓缩后干燥，混合均匀，即得。
实施例3
一种药物组合物，按照重量份数计，包括如下组分：红藤18份、独活8份、艾纳香12份、虎杖8份、防风6份和五加皮8份。
所述药物组合物的制备工艺包括如下步骤：
(1)将虎杖、红藤和艾纳香混合后粉碎，先加入8倍量的水在35℃提取0.75h，过滤，得到滤渣A和滤液A；将滤渣A再加入8倍量的80％乙醇回流提取0.75h，过滤，得到滤液B；
(2)将独活粉碎后加8倍量的水煎煮1.5h，过滤，得到滤液C；
(3)将防风和五加皮混合后粉碎，用8倍量的溶剂B(溶剂B为乙醇和氯仿的混合溶剂，两者体积比为1.5:1)在35℃提取0.75h，过滤，得到滤液D；
(4)将滤液A、B、C和D分别浓缩后干燥，混合均匀，即得。
对比例1-对比例3与实施例3的区别仅在于药物组合物的组成不同，具体如表1所示。
表1
实施例3(重量份) 对比例1(重量份) 对比例2(重量份) 对比例3(重量份)
红藤 18 / 22.8 26.3
虎杖 8 15.2 / 11.7
艾纳香 12 22.8 15.2 /
独活 8 8 8 8
防风 6 6 6 6
五加皮 8 8 8 8
对比例4
与实施例3的区别仅在于步骤(1)中虎杖、红藤和艾纳香均单独提取，提取方法与步骤(1)相同。
对比例5
与实施例3的区别仅在于步骤(3)中溶剂B的组成不同，具体为乙醇和氯仿的混合溶剂，两者体积比为1:3。
实施例4
一种自发热中药暖腰带，所述腰带包括腰带主体和分别位于腰带主体两端的弹性带，两侧弹性带依靠魔术贴连接。所述腰带主体包括4层结构，依次为面层、发热层、中药层和亲肤层，实施例1-3任一所述药物组合物装于所述中药层内。
所述亲肤层直接与人体接触，面层和亲肤层均为无纺布。
所述发热层内装有发热材料。发热材料组成为：按照重量份数计，铁粉50份，水25份，食用盐2份，活性炭10份，蛭石12份和聚丙烯酰胺1份。
测试例1
治疗颈椎病效果测试
动物：新西兰大白兔，雌雄各半，体重2.2±0.3kg。
动物造模：参照文献“周红海,沈培芝,徐宇.颈椎病动物血清超氧化歧化酶的变化[J].广西中医药,2002,25(1):2”中记载的方法进行造模，造模时间24周。
造模成功后，随机选取动物8组，每组5只，分别灌胃实施例1-3和对比例1-5制备得到的药物组合物，每日剂量为0.3g/kg，2个月后观察大白兔的治疗效果，椎间盘恢复如初，标记为痊愈；椎间盘明显改善，标记为有效；椎间盘改善不明显，标记为无效。结果如表2所示。
表2
痊愈(只) 有效(只) 无效(只)
实施例1 4 1 0
实施例2 4 1 0
实施例3 5 0 0
对比例1 2 1 2
对比例2 2 2 1
对比例3 3 1 1
对比例4 3 2 0
对比例5 3 1 1
测试例2
治疗宫寒、痛经和腰颈部位疾病效果测试
将含有(1)小腹或四肢寒冷；(2)痛经或小腹胀痛；(3)腰颈部位僵硬、紧张、酸痛和肿胀；以上三个症状中任意一种症状的经期女性志愿者采用本申请实施例4记载的自发热中药暖腰带进行治疗。腹部不适者将腰带主体位于腹部进行治疗；腰颈部位不适者，将腰带主体位于腰后部进行治疗；腹部和腰颈部位均有不适者，两个腰带主体分别位于腹部和腰后部进行治疗。中药组合物剂量为每日0.12g/kg，发热时间8h，发热结束后取下腰带即可。将志愿者随机分为8组，每组18人，每组保证各个症状的志愿者至少6人。治疗1个月后，效果如表3所示。其中，上述症状消失标记为痊愈，症状明显改善标记为有效，症状改善不明显标记为无效。
表3
痊愈(人) 有效(人) 无效(人)
实施例1 15 3 0
实施例2 16 1 1
实施例3 17 1 0
对比例1 8 5 5
对比例2 8 7 3
对比例3 10 6 2
对比例4 12 4 2
对比例5 10 7 1
上述详细说明是针对本发明其中之一可行实施例的具体说明，该实施例并非用以限制本发明的专利范围，凡未脱离本发明所为的等效实施或变更，均应包含于本发明技术方案的范围内。

Claims (10)

1.一种药物组合物，其特征在于，按照重量份数计，包括如下组分：红藤13-20份、独活6-9份、艾纳香10-14份、虎杖5-10份、防风5-8份和五加皮6-10份。
2.根据权利要求1所述的药物组合物，其特征在于，按照重量份数计，包括如下组分：红藤15-18份、独活7-8份、艾纳香11-13份、虎杖6-9份、防风6-7份和五加皮7-9份。
3.一种权利要求1-2任一所述的药物组合物的制备工艺，其特征在于，包括如下步骤：
(1)将虎杖、红藤和艾纳香混合后粉碎，分别用水和有机溶剂A提取，过滤，分别得到滤液A和滤液B；
(2)将独活粉碎后加水煎煮，过滤，得到滤液C；
(3)将防风和五加皮混合后粉碎，用有机溶剂B提取，过滤，得到滤液D；
(4)将滤液A、B、C和D分别浓缩后干燥，混合均匀，即得。
4.根据权利要求3所述的制备工艺，其特征在于，步骤(1)中所述有机溶剂A为70-85％乙醇；步骤(3)中所述有机溶剂B为乙醇和氯仿的混合溶剂，两者体积比为1-2:1。
5.根据权利要求3所述的制备工艺，其特征在于，步骤(1)中将虎杖、红藤和艾纳香混合后粉碎，先加入5-10倍量的水在30-40℃提取0.5-1h，过滤，得到滤渣A和滤液A；将滤渣A再加入5-10倍量的70-85％乙醇回流提取0.5-1h，过滤，得到滤液B。
6.根据权利要求3所述的制备工艺，其特征在于，步骤(2)中将独活粉碎后加5-10倍量的水煎煮1-2h，过滤，得到滤液C。
7.根据权利要求3所述的制备工艺，其特征在于，步骤(3)中将防风和五加皮混合后粉碎，用5-10倍量的溶剂B在30-40℃提取0.5-1h，过滤，得到滤液D。
8.一种制剂，其特征在于，包括权利要求1-2任一所述的药物组合物或权利要求3-7任一所述的制备工艺制备得到的药物组合物和药学上可接受的辅料。
9.权利要求1-2任一所述的药物组合物或权利要求3-7任一所述的制备工艺制备得到的药物组合物或权利要求8所述的制剂在制备治疗痛经、和/或宫寒、和/或腰颈椎疾病的药物中的应用。
10.一种自发热中药暖腰带，其特征在于，所述腰带内装有权利要求1-2任一所述的药物组合物或权利要求3-7任一所述的制备工艺制备得到的药物组合物或权利要求8所述的制剂。
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