CN108404095A - 一种活血通络用于乳腺增生治疗的中药透皮贴剂 - Google Patents

一种活血通络用于乳腺增生治疗的中药透皮贴剂 Download PDF

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CN108404095A
CN108404095A CN201810508504.2A CN201810508504A CN108404095A CN 108404095 A CN108404095 A CN 108404095A CN 201810508504 A CN201810508504 A CN 201810508504A CN 108404095 A CN108404095 A CN 108404095A
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parts
layer
medicine
film layer
transdermal patch
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许汉珍
许建儿
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Fuzhou Xinmeiyuan Biological Medicine Engineering Co Ltd
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Fuzhou Xinmeiyuan Biological Medicine Engineering Co Ltd
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Priority to CN201810508504.2A priority Critical patent/CN108404095A/zh
Publication of CN108404095A publication Critical patent/CN108404095A/zh
Priority to PCT/CN2018/109988 priority patent/WO2019223218A1/zh
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Abstract

本发明公开了一种活血通络用于乳腺增生治疗的中药透皮贴剂，包括粘胶层、能量层、磁化层、药膜层及背衬层，能量层由位于其上表面的背衬层和位于其下表面的不透气膜包覆，不透气膜的内侧设有永磁体和药膜层，永磁体位于不透气膜和药膜层之间；粘胶层外侧设有背衬层；药膜层由中药组分和高分子材料复合制得，高分子材料为PLA和PHB复合而成。本发明将中药组分包覆于由PLA和PHB复合制得的高分子材料内，能量层中的发热物质与氧气接触而自发产生热量作用于药膜层，能够促进药效迅速释放，对乳腺增生引起的疼痛、肿胀起到很好缓解和消散作用，此外对颈椎病、腰腿痛、慢性劳损、脊椎痛、风湿性关节炎、骨关节炎等慢性病也有很好的疗效。

Description

一种活血通络用于乳腺增生治疗的中药透皮贴剂
技术领域
本发明属于中药贴剂技术领域，具体涉及一种活血通络、临床上用于治疗乳腺增生的中药透皮给药贴剂。
背景技术
乳腺增生病是以腺泡上皮、导管上皮及纤维结缔组织一种或多种组织增生为主要病理改变的乳房疾病，是非肿瘤、非炎症性的乳腺上皮增生性疾患，属于中医“乳癖”范畴。发病年龄集中于20～50岁，50岁以后发病率急骤下降。其发病率占育龄妇女的40％左右，占全部乳房病的75％，是最常见的乳房疾病。一般认为黄体素不足，使月经周期中乳腺增生和复旧不全，日久形成本病。
现代中医认为乳腺增生病的发生由肝郁气滞，或肝肾虚损，冲任失调，或痰凝血淤而成。中医治疗乳腺增生病，历史悠久，疗效确切且无明显毒副反应，复发率低。中医以整体观念对本病辨证论治，辨证与辨病相结合，整体与局部相结合，内治与外治相结合，长期治疗与短期治疗相结合，通过疏肝理气、活血化瘀、散结，从多方面、多角度起到调整内分泌，标本兼治的作用。尤其是中医外治法针对乳腺增生病患者以局部症状和体征为主的特点，采用集成外治治疗能直达病所，是治疗乳腺增生病的重要途径之一。
本发明的中药透皮给药制剂是集药疗、温炙、磁疗、热疗于一体的新型多功能治疗贴，以其药疗、温炙、磁疗、热疗等直接作用于乳腺病变部位，可通过对丰富的乳腺血管和经络或穴位的刺激，改善乳腺病变部位局部的微循环，起到疏通经络，活血化瘀、软坚散结作用，达到减轻症状，缓解乳腺小叶增生引起的疼痛，对乳腺增生病有辅助治疗作用。
目前市面上用于乳腺增生的药剂贴中的药物成分，往往是将中药材直接粉碎后装包使用，这样有效成份不易释放，皮肤吸收甚微，药物的生物效价下降，而且药效损耗大，影响临床效果。因此，发明一种新型的活血通络的多功能中药制剂是非常必要的。
发明内容
本发明的目的在于提供一种活血通络的中药透皮贴剂，其能够有效改善女性乳腺增生引起的乳房疼痛、乳房肿块、乳头溢液等症状。由于该药物具有活血通络功能，对颈椎病、腰腿痛、慢性劳损、脊椎痛、风湿性关节炎、骨关节炎等慢性病也有很好的疗效。
为实现上述目的，本发明采用如下技术方案：
一种活血通络的中药透皮贴剂，包括粘胶层、能量层、永磁体（磁化层）、药膜层及背衬层，所述能量层由位于其上表面的胶粘层和位于其下表面的不透气膜包覆，所述不透气膜的内侧设有永磁体和药膜层，永磁体位于不透气膜和药膜层之间；所述粘胶层的外侧设有背衬层；所述药膜层的下表面还设有一层离型纸覆盖在药膜层和粘胶层上。使用时，撕去药膜层下方的离型纸，将中药透皮制剂贴于患处，使药膜层直接与患处皮肤接触。上述的不透气膜的内侧是指靠近人体皮肤的一侧，粘胶层的外侧是指远离人体皮肤的一侧。
进一步的，所述背衬层采用透气的无纺布制成。
进一步的，所述能量层内含发热物质。
进一步的，所述不透气膜由不透气材料制成，所述不透气材料包括不透气塑胶、不透气布料。
进一步的，所述药膜层由中药组分和高分子材料复合制得。本发明将中药组分包覆于由聚乳酸和聚3-羟基丁酸酯复合制得的高分子材料内，配制成药膜层。药膜层中的中药组分由以下重量份的药材原料制成：鹿衔草5~7份、 蚤休6~10份、桃仁3~5份、红花2~4份、乳香3~5份、没药3~5份、茜草3~5份、葵蓬菜8-10份、柴胡3~5份、枳壳2~4份、蒲公英4~8份、三棱3~5份、莪术3~5份、漏芦2~4份、山慈菇2~4份、大黄3~5份、干姜2~4份、蜈蜙3~5份、青皮1~3份、全蝎4~6份、水蛭4~6份、雪上一枝蒿1~3份、秦艽1~3份、阿魏2~4份和血竭4~8份；所述高分子材料为聚乳酸（PLA）和聚3-羟基丁酸酯（PHB）。
所述药膜层的制备方法具体包括以下步骤：
1）按重量份数计，将鹿衔草5~7份、蚤休6~10份、桃仁3~5份、红花2~4份、乳香3~5份、没药3~5份、茜草3~5份、葵蓬菜8-10份、柴胡3~5份、枳壳2~4份、蒲公英4~8份、三棱3~5份、莪术3~5份、漏芦2~4份、山慈菇2~4份、大黄3~5份、干姜2~4份、蜈蜙3~5份、青皮1~3份、全蝎4~6份、水蛭4~6份、雪上一枝蒿1~3份、秦艽1~3份、阿魏2~4份和血竭4~8份粉碎后，加入其重量3-5倍85wt%的乙醇回流提取2次，每次1小时，合并两次提取液，过滤并回收乙醇；将所得提取液减压浓缩并干燥后，过80-100目筛，得到中药组分；
2）用乙酸乙酯分别溶解PLA和PHB，分别配制成8~10wt%的溶液，室温下将两种溶液混合，制得PLA/ PHB共混物，备用；
3）取步骤1）制得的中药组分溶于乙醇中，得到中药液，将所得中药液加入到步骤2）制得的PLA/PHB共混物中，磁力搅拌6h，浇铸成膜，室温下真空干燥48h以除去溶剂，制得所述药膜层。
进一步的，步骤2）中，PLA和PHB的质量比为(1~5):5。
进一步的，所述中药组分的质量与PLA和PHB总质量的比值为1:9。
本发明的显著优点在于：
（1）本发明将中药组分包覆于由聚乳酸和聚3-羟基丁酸酯复合制得的高分子材料内，能量层中含有的发热物质与氧气接触而自发产生热量作用于药膜层，能够使得药物快速释放，并且由于高分子材料的包覆，使得药效作用持续时间延长，维持稳定、持久的血药浓度，同时降低药物的毒性和副作用；对人体的乳房、子宫或关节部位的痛症能够起到很好的治疗效果；且随着能量层的温度提高，可促进药膜层中各药效成分的挥发、渗透，从而进一步达到良好的活血通络，行气止痛的效果；
（2）本发明在中药透皮贴剂中加入永磁体，一方面是利用其磁力线的穿透作用，达到舒经活络、调理气血的效果，另一方面，磁石吸收能量层所释放的热量后，通过热磁场效应增强，能够激发药膜层中所含的挥发油等药效成分，使其分解成更小的分子，从而有助于促进药效成分的透皮吸收；
（3）本发明中药透皮贴剂集药疗、温灸、热疗、磁疗于一体，能够有效改善女性乳腺增生引起的乳房疼痛、乳房肿块、乳头溢液等症状；对颈椎病、腰腿痛、慢性劳损、脊椎痛、风湿性关节炎、骨关节炎等慢性病也有很好的疗效。
附图说明
图1为本发明中药透皮贴剂的结构示意图；其中，1-粘胶层，2-能量层（内含发热物质），3-永磁体（磁化层），4-药膜层，5-背衬层，6-不透气膜，7-离型纸；
图2为本发明图1的仰视图。
具体实施方式
实施例
如图1、2所示，本发明的中药透皮贴剂，包括粘胶层1、能量层2（内含发热物质）、永磁体（磁化层）3、药膜层4和背衬层5；能量层2由位于其上表面的的粘胶层1和位于其下表面的不透气膜6包覆，不透气膜6的内侧设有永磁体3和药膜层4，所述永磁体3位于不透气膜6和药膜层2之间；所述粘胶层1的外侧设有背衬层5。
进一步的，所述背衬层5采用无纺布制成。
进一步的，所述不透气膜6由不透气材料制成，所述不透气材料包括不透气塑胶、不透气布料。
进一步的，所述药膜层4的下表面还设有一层离型纸7覆盖在药膜层4和粘胶层1上。
使用时，将该中药透皮贴剂从密封袋中取出，掀去覆盖在粘胶层及药物层上的离型纸，然后贴于乳房的疼痛部位或是关节患处。此时，空气通过背衬层进入能量层，引起发热物质发热，达到热疗的效果，并使药膜层和永磁体的温度提高，促进药物释放，以进一步达到药疗和磁疗的效果。
为了使本发明所述的内容更加便于理解，下面结合具体实施方式对本发明所述的技术方案做进一步的说明，但是本发明不仅限于此。
实施例1
中药透皮贴剂中的药物层由中药组分和高分子材料复合制得；所述药物层的制备方法具体包括以下步骤：
1）按重量份数计，将鹿衔草5份、蚤休6份、桃仁3份、红花2份、乳香3份、没药3份、茜草3份、葵蓬菜8份、柴胡3份、枳壳2份、蒲公英4份、三棱3份、莪术3份、漏芦2份、山慈菇2份、大黄3份、干姜2份、蜈蜙3份、青皮1份、全蝎4份、水蛭4份、雪上一枝蒿1份、秦艽1份、阿魏2份和血竭4份粉碎后，加入其重量3倍85wt%的乙醇回流提取2次，每次1小时，合并两次提取液，过滤并回收乙醇；将所得提取液减压浓缩并干燥后，过80目筛，得到中药组分；
2）用乙酸乙酯分别溶解PLA和PHB（其中PLA和PHB的质量比为1:5），分别配制成8wt%的溶液，室温下将两种溶液混合，制得PLA/ PHB共混物，备用；
3）取步骤1）制得的中药组分溶于乙醇中，得到中药液，将所得中药液加入到步骤2）制得的PLA/PHB共混物中，磁力搅拌6h，浇铸成膜，室温下真空干燥48h以除去溶剂，制得所述药物层；所述中药组分的质量与PLA和PHB总质量的比值为1:9。
实施例2
中药透皮贴剂中的药物层由中药组分和高分子材料复合制得；所述药物层的制备方法具体包括以下步骤：
1）按重量份数计，将鹿衔草7份、蚤休10份、桃仁5份、红花4份、乳香5份、没药5份、茜草5份、葵蓬菜9份、柴胡5份、枳壳4份、蒲公英8份、三棱5份、莪术5份、漏芦4份、山慈菇4份、大黄5份、干姜4份、蜈蜙5份、青皮3份、全蝎6份、水蛭6份、雪上一枝蒿3份、秦艽3份、阿魏4份和血竭8份粉碎后，加入其重量5倍85wt%的乙醇回流提取2次，每次1小时，合并两次提取液，过滤并回收乙醇；将所得提取液减压浓缩并干燥后，过80目筛，得到中药组分；
2）用乙酸乙酯分别溶解PLA和PHB（其中PLA和PHB的质量比为1:1），分别配制成10wt%的溶液，室温下将两种溶液混合，制得PLA/ PHB共混物，备用；
3）取步骤1）制得的中药组分溶于乙醇中，得到中药液，将所得中药液加入到步骤2）制得的PLA/PHB共混物中，磁力搅拌6h，浇铸成膜，室温下真空干燥48h以除去溶剂，制得所述药物层；所述中药组分的质量与PLA和PHB总质量的比值为1:9。
实施例3
中药透皮贴剂中的药物层由中药组分和高分子材料复合制得；所述药物层的制备方法具体包括以下步骤：
1）按重量份数计，将鹿衔草6份、蚤休8份、桃仁4份、红花3份、乳香4份、没药4份、茜草4份、葵蓬菜10份、柴胡4份、枳壳3份、蒲公英6份、三棱4份、莪术4份、漏芦3份、山慈菇3份、大黄4份、干姜3份、蜈蜙4份、青皮2份、全蝎5份、水蛭5份、雪上一枝蒿2份、秦艽2份、阿魏3份和血竭6份粉碎后，加入其重量4倍85wt%的乙醇回流提取2次，每次1小时，合并两次提取液，过滤并回收乙醇；将所得提取液减压浓缩并干燥后，过100目筛，得到中药组分；
2）用乙酸乙酯分别溶解PLA和PHB（其中PLA和PHB的质量比为3:5），分别配制成9wt%的溶液，室温下将两种溶液混合，制得PLA/ PHB共混物，备用；
3）取步骤1）制得的中药组分溶于乙醇中，得到中药液，将所得中药液加入到步骤2）制得的PLA/PHB共混物中，磁力搅拌6h，浇铸成膜，室温下真空干燥48h以除去溶剂，制得所述药物层；所述中药组分的质量与PLA和PHB总质量的比值为1:9。
以上所述仅为本发明的较佳实施例，凡依本发明申请专利范围所做的均等变化与修饰，皆应属本发明的涵盖范围。

Claims (10)

1.一种活血通络的中药透皮贴剂，包括粘胶层、能量层、永磁体、药膜层及背衬层，其特征在于：所述能量层由位于其上表面的胶粘层和位于其下表面的不透气膜包覆，所述不透气膜的内侧设有永磁体和药膜层，所述永磁体位于不透气膜和药膜层之间；所述粘胶层的外侧设有背衬层；所述药膜层由中药组分和高分子材料复合制得。
2. 根据权利要求1所述的中药透皮贴剂，其特征在于：药膜层中的中药组分由以下重量份的药材原料制成：鹿衔草5~7份、 蚤休6~10份、桃仁3~5份、红花2~4份、乳香3~5份、没药3~5份、茜草3~5份、葵蓬菜8-10份、柴胡3~5份、枳壳2~4份、蒲公英4~8份、三棱3~5份、莪术3~5份、漏芦2~4份、山慈菇2~4份、大黄3~5份、干姜2~4份、蜈蜙3~5份、青皮1~3份、全蝎4~6份、水蛭4~6份、雪上一枝蒿1~3份、秦艽1~3份、阿魏2~4份和血竭4~8份。
3.根据权利要求2所述的中药透皮贴剂，其特征在于：所述药膜层中的中药组分的制备方法为：按重量份数计，将鹿衔草5~7份、蚤休6~10份、桃仁3~5份、红花2~4份、乳香3~5份、没药3~5份、茜草3~5份、葵蓬菜8-10份、柴胡3~5份、枳壳2~4份、蒲公英4~8份、三棱3~5份、莪术3~5份、漏芦2~4份、山慈菇2~4份、大黄3~5份、干姜2~4份、蜈蜙3~5份、青皮1~3份、全蝎4~6份、水蛭4~6份、雪上一枝蒿1~3份、秦艽1~3份、阿魏2~4份和血竭4~8份粉碎后，加入其重量3-5倍85wt%的乙醇回流提取2次，每次1小时，合并两次提取液，过滤并回收乙醇；将所得提取液减压浓缩并干燥后，过80-100目筛，得到中药组分。
4.根据权利要求1所述的中药透皮贴剂，其特征在于：所述高分子材料为聚乳酸和聚3-羟基丁酸酯。
5.根据权利要求1所述的中药透皮贴剂，其特征在于：所述药膜层的制备方法具体包括以下步骤：
1）用乙酸乙酯分别溶解聚乳酸和聚3-羟基丁酸酯，分别配制成8~10wt%的溶液，室温下将两种溶液混合，制得聚乳酸/聚3-羟基丁酸酯共混物，备用；
2）取中药组分溶于乙醇中，得到中药液，将所得中药液加入到步骤1）制得的聚乳酸/聚3-羟基丁酸酯共混物中，磁力搅拌6h，浇铸成膜，室温下真空干燥48h以除去溶剂，制得所述药膜层。
6.根据权利要求5所述的中药透皮贴剂，其特征在于：步骤1）中，聚乳酸和聚3-羟基丁酸酯的质量比为(1~5):5。
7.根据权利要求5所述的中药透皮贴剂，其特征在于：所述中药组分的质量与聚乳酸和聚3-羟基丁酸酯总质量的比值为1:9。
8.根据权利要求1所述的中药透皮贴剂，其特征在于：所述背衬层采用透气的无纺布制成。
9.根据权利要求1所述的中药透皮贴剂，其特征在于：所述能量层内含发热物质。
10.根据权利要求1所述的中药透皮贴剂，其特征在于：所述药膜层的下表面还设有一层离型纸覆盖在药膜层和粘胶层上。
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