CN113058020A - 一种调经脐贴及其制备方法 - Google Patents

一种调经脐贴及其制备方法 Download PDF

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CN113058020A
CN113058020A CN202110247217.2A CN202110247217A CN113058020A CN 113058020 A CN113058020 A CN 113058020A CN 202110247217 A CN202110247217 A CN 202110247217A CN 113058020 A CN113058020 A CN 113058020A
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张茹
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Abstract

本发明属于医药技术领域,公开了一种调经脐贴及其制备方法,制备方法包括以下步骤:将原药材粉碎后,以95%乙醇超声提取,过滤,留提取液;将步骤一过滤后的滤渣以95%乙醇超声提取,过滤,弃药渣,合并提取液;将提取液减压浓缩,加入6倍水,静置后过滤,保留滤液;将上述滤液减压浓缩,干燥后得浸膏;将浸膏先后加入精油、氮酮和基质,搅拌均匀制成药膏,将药膏置于无纺布贴上,得到调经脐贴。该调经脐贴使用方便,不影响工作学习生活,依从性好,为备受痛经困扰女性提供一款免于服药痛苦,便捷有效的调经产品。

Description

一种调经脐贴及其制备方法
技术领域
本发明属于医药技术领域,具体涉及一种调经脐贴及其制备方法。
背景技术
月经不调、痛经已经成为妇科临床常见病、多发病。月经问题不仅造成很多女性的困扰,尤其可能会引起内分泌失调、无法正常怀孕、引发相关妇科疾病甚至癌症(如卵巢囊肿、盆腔炎、子宫内膜癌)。对于经期的调理及相关症状的缓解越来越受到重视。
但是,在实现本发明过程中,发明人发现现有技术中至少存在如下问题:目前市场上的调经产品大多为止痛药、中药组方制剂、艾灸、暖宝宝等,但大多数产品反映效果不明显,或对症缓解不治根本,或使用不方便。
综上所述,现有技术存在的问题是:
(1)止痛药如布洛芬仅仅在痛经时缓解症状,频繁使用对肝肾造成一定的损害。
(2)中成药或汤药使用不便,使应用的依从性降低,不易坚持。
(3)艾灸使用需要相应场所,需要耗时,限制行动。
(4)暖宝宝等系列产品,仅仅能缓解相应疼痛症状,效果不很明显。
(5)痛经比较常见,且对于多数女性来说发作频次较高,需要简便有效、标本兼治的产品。
发明内容
本发明旨在至少在一定程度上解决上述技术问题。为此,本发明的第一目的在于提供一种调经脐贴的制备方法。
为实现第一目的,本发明所采用的技术方案为:
一种调经脐贴的制备方法,包括以下步骤:
步骤一,将原药材粉碎后,以95%乙醇超声提取,过滤,留提取液;
步骤二,将步骤一过滤后的滤渣以95%乙醇超声提取,过滤,弃药渣,合并提取液;
步骤三,将提取液减压浓缩,加入6倍水,静置后过滤,保留滤液;
步骤四,将上述滤液减压浓缩,干燥后得浸膏;
步骤五,将浸膏先后加入精油、氮酮和基质,搅拌均匀制成药膏,将药膏置于无纺布贴上,得到调经脐贴。
优选地,所述原药材包括以下组分:小茴香、干姜、元胡、没药、当归、川芎、官桂、赤芍、蒲黄和五灵脂。
优选地,所述原药材包括以下重量份的组分:小茴香1份、干姜2份、元胡2份、没药4份、当归6份、川芎4份、官桂2份、赤芍4份、蒲黄6份和五灵脂4份。
优选地,所述药膏置于无纺布贴之前用超声去除药膏气泡。
优选地,所述基质为羊毛脂、甘油、石蜡和凡士林中的一种或几种。
优选地,所述精油为肉桂精油、生姜精油、川芎精油、当归精油、小茴香精油、没药精油中的一种或几种。
优选地,浸膏加入氮酮后使浸膏氮酮含量为5%。
优选地,所述步骤一和步骤二中超声提取的料液比为4:1,在45℃超声提取20分钟。
优选地,所述步骤三和步骤四中减压浓缩的温度为65℃。
本发明的第二目的在于提供一种由上述制备方法制备得到的调经脐贴。
本发明的有益效果为:
本发明所提供的调经脐贴及其制备方法,取自经典调经方剂少腹逐瘀汤,通过改变用药途径,以外用贴剂形式进行制剂,优化制作工艺,提取出有效成分,将其制成具有调理痛经,缓解疼痛、疗效确切的外用脐贴,使用方便,不影响工作学习生活,依从性好,为备受痛经困扰女性提供一款免于服药痛苦,便捷有效的调经产品。
附图说明
图1是本发明调经脐贴的制备方法的流程图。
图2是本发明调经脐贴的结构示意图。
图3是本发明调经脐贴的验证实验结果图。
图中:1-无纺布贴;2-载药圈;3-药膏。
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更为清楚。但实施例仅用于说明本发明,并不对本发明的保护范围构成任何限制。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。
下述实施例中所使用的实验方法如无特殊说明,均为常规方法。下述实施例中所用的材料、试剂等,如无特殊说明,均可从商业途径获得。
如图1所示,本实施例的一种调经脐贴的制备方法,包括以下步骤:
步骤一,称取小茴香1.5g、干姜3g、元胡3g、没药6g、当归9g、川芎6g、官桂3g、赤芍6g、蒲黄9g和五灵脂6g,混合后粉碎,以95%乙醇,料液比为4:1,在45℃超声提取20分钟,过滤得滤渣和提取液a;
步骤二,将滤渣以95%乙醇,料液比为4:1,在45℃超声提取20分钟,过滤得药渣和提取液b,弃药渣,合并提取液ab;
步骤三,将合并后的提取液65℃减压浓缩至20ml,加入6倍水,静置后24h,过滤,保留滤液;
步骤四,将上述滤液65℃,0.08Pa减压浓缩,干燥2h后得浸膏;
步骤五,将浸膏加入肉桂精油、生姜精油、川芎精油、当归精油、小茴香精油、没药精油后,加入氮酮,使氮酮含量为5%,最后加入羊毛脂、甘油、石蜡和凡士林,搅拌至整体质量均匀制成药膏,超声去除药膏气泡,将制得的药膏置于无纺布贴上,得到调经脐贴,并包装密封。
一种上述制备方法制备得到的调经脐贴,如图2所示,包括无纺布贴1、载药圈2和药膏3,载药圈2与无纺布贴1相连,药膏3置于载药圈2上。
以下通过动物实验对调经脐贴的效果进行验证,实验药品包括:苯甲酸雌二醇,缩宫素,益母草颗粒剂,少腹逐瘀汤水煎剂,调经脐贴。
实验动物为清洁级雌性小鼠20±2g,50只,将小鼠随机分为5组,即空白对照组、模型组、益母草颗粒组、少腹逐瘀汤灌胃组、调经脐贴组,每组10只。
各组动物分别按照相应给药途径给予对应药物,共10天。在给药第5天,以苯甲酸雌二醇溶液腹腔注射进行痛经模型复制,共5天,并于末次给药1h后,注射缩宫素0.2u/10g激发痛经反应,立即用秒表记录小鼠30min内扭体次数。具体操作方法如下:
(1)空白对照组:小鼠背部以6%的Na2S溶液脱毛,1%的月桂氮卓酮和3.5%的羊毛脂等比例混合和生理盐水浸湿的纱布代替药物,于鼠腹部神阙穴上,覆盖纱布和硫酸纸,用白胶布固定。
(2)模型组:小鼠背部以6%的Na2S溶液脱毛,1%的月桂氮卓酮和3.5%的羊毛脂等比例混合和生理盐水浸湿的纱布代替药物,于鼠腹部神阙穴上,覆盖纱布和硫酸纸,用白胶布固定。在其他各给药组给药第5天时,模型组以0.02mg/10g苯甲酸雌二醇溶液腹腔注射复制痛经模型,共5天,并于末次给药1h后,注射缩宫素2u/10g,立即用秒表记录小鼠30min内扭体次数。
(3)益母草颗粒组:每天以0.2ml/10g益母草颗粒水溶液灌胃,给药第5天时复制痛经模型(同模型组),同时继续给药5天,第10天注射缩宫素0.2u/10g,立即用秒表记录小鼠30min内扭体次数。
(4)少腹逐瘀汤灌胃组:每天以0.2ml/10g少腹逐瘀汤水溶液灌胃,给药第5天时复制痛经模型(同模型组),同时继续给药5天,第10天注射缩宫素0.2u/10g,立即用秒表记录小鼠30min内扭体次数。
(5)调经脐贴组:小鼠背部以6%的Na2S溶液脱毛,调经脐贴于鼠覆盖固定于腹部神阙穴上,每天更换,第5天时复制痛经模型(同模型组),同时继续给药5天,第10天注射缩宫素0.2u/10g,立即用秒表记录小鼠30min内扭体次数。
小鼠痛经等级评价见表1。
表1小鼠痛经等级
Figure BDA0002964526310000051
Figure BDA0002964526310000061
以各组小鼠发生Ⅱ级及以上扭体发应作为痛经发生指标,实验结果见表2和图3所示。
表2各组动物发生扭体次数
Figure BDA0002964526310000062
动物分组 扭体次数
空白对照组 0
模型组 11.43±0.98
益母草颗粒组 3.63±0.74
少腹逐瘀汤灌胃组 0.75±0.71
调经脐贴组 1.38±0.92
通过上述实验结果,调经脐贴透皮吸收良好,可以有效的调理痛经,缓解疼痛,其效果仅次于少腹逐瘀汤,优于益母草颗粒,但调经脐贴的使用形式相对于少腹逐瘀汤更加的方便。
本发明不局限于上述可选实施方式,任何人在本发明的启示下都可得出其他各种形式的产品,但不论在其形状或结构上作任何变化,凡是落入本发明权利要求界定范围内的技术方案,均落在本发明的保护范围之内。

Claims (10)

1.一种调经脐贴的制备方法,其特征在于,包括以下步骤:
步骤一,将原药材粉碎后,以95%乙醇超声提取,过滤,留提取液;
步骤二,将步骤一过滤后的滤渣以95%乙醇超声提取,过滤,弃药渣,合并提取液;
步骤三,将提取液减压浓缩,加入6倍水,静置后过滤,保留滤液;
步骤四,将上述滤液减压浓缩,干燥后得浸膏;
步骤五,将浸膏先后加入精油、氮酮和基质,搅拌均匀制成药膏,将药膏置于无纺布贴上,得到调经脐贴。
2.根据权利要求1所述的调经脐贴的制备方法,其特征在于:所述原药材包括以下组分:小茴香、干姜、元胡、没药、当归、川芎、官桂、赤芍、蒲黄和五灵脂。
3.根据权利要求1所述的调经脐贴的制备方法,其特征在于:所述原药材包括以下重量份的组分:小茴香1份、干姜2份、元胡2份、没药4份、当归6份、川芎4份、官桂2份、赤芍4份、蒲黄6份和五灵脂4份。
4.根据权利要求1-3任一所述的调经脐贴的制备方法,其特征在于:所述药膏置于无纺布贴之前用超声去除药膏气泡。
5.根据权利要求1-3任一所述的调经脐贴的制备方法,其特征在于:所述基质为羊毛脂、甘油、石蜡和凡士林中的一种或几种。
6.根据权利要求1-3任一所述的调经脐贴的制备方法,其特征在于:所述精油为肉桂精油、生姜精油、川芎精油、当归精油、小茴香精油、没药精油中的一种或几种。
7.根据权利要求1-3任一所述的调经脐贴的制备方法,其特征在于:浸膏加入氮酮后使浸膏氮酮含量为5%。
8.根据权利要求1-3任一所述的调经脐贴的制备方法,其特征在于:所述步骤一和步骤二中超声提取的料液比为4:1,在45℃超声提取20分钟。
9.根据权利要求1-3任一所述的调经脐贴的制备方法,其特征在于:所述步骤三和步骤四中减压浓缩的温度为65℃。
10.一种由权利要求1-9任一所述的制备方法制备得到的调经脐贴。
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