CN110859914B - 一种治疗口腔溃疡的中药贴膜 - Google Patents

一种治疗口腔溃疡的中药贴膜 Download PDF

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CN110859914B
CN110859914B CN201911220944.9A CN201911220944A CN110859914B CN 110859914 B CN110859914 B CN 110859914B CN 201911220944 A CN201911220944 A CN 201911220944A CN 110859914 B CN110859914 B CN 110859914B
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oral ulcer
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朱立彬
黄志军
李丽娟
向阳
陈骞
曾庆恢
翟莉
李霞
蔡威
邱冬梅
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Jianmin Pharmaceutical Groups Corp ltd
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Abstract

本发明公开了一种治疗口腔溃疡的中药贴膜，它由以下重量份数的中药材制成：大黄50‑120份、黄连20‑60份、甘草20‑60份、天花粉50‑120份、川贝母20‑60份、赤芍50‑120份、乳香20‑60份、没药20‑60份、珍珠3‑12份、牛黄3‑12份、雄黄1‑5份、冰片1‑5份。本发明提供的中药贴膜具有清热解毒，活血消肿之功，对口腔溃疡具有很好的疗效。

Description

一种治疗口腔溃疡的中药贴膜
技术领域
本发明涉及中药，具体涉及一种治疗口腔溃疡的中药贴膜。
背景技术
口腔溃疡俗称“口疮”，是一种常见的发生于口腔黏膜的溃疡性损伤病症，发作时疼痛剧烈，局部灼痛明显，严重者还会影响饮食、说话，对日常生活造成极大不便，主要表现为口腔黏膜出现圆形或椭圆形的溃疡，溃疡表浅，呈淡黄色或白色，中央凹陷，边缘整齐，周围绕以红晕，可单发或多发，可发生于口腔黏膜的任何部位。
目前对口腔溃疡大多采用化疗、中药、补充维生素等方法进行治疗，其中中医主要是采用一些清热解毒的中药进行全身治疗，由于口腔溃疡的病因非常复杂，现有的中药起效较慢，疗效欠佳，而且副作用较大。相比之下，局部给药直接作用于患病部位，可避免药物引发的全身不良反应，而且还能避免肝脏的首过效应和药物在胃肠道内的降解，具有生物利用度高，起效速度快，个体差异小等优点。
发明内容
本发明的目的是提供一种疗效确切、副作用小、起效快的治疗口腔溃疡中药贴膜。
一种治疗口腔溃疡的中药贴膜，它由以下重量份数的中药材制成：大黄50-120份、黄连20-60份、甘草20-60份、天花粉50-120份、川贝母20-60份、赤芍50-120份、乳香20-60份、没药20-60份、珍珠3-12份、牛黄3-12份、雄黄1-5份、冰片1-5份。
优选地，所述中药材的重量份数是：大黄80份、黄连40份、甘草30份、天花粉80份、川贝母40份、赤芍80份、乳香40份、没药40份、珍珠6份、牛黄5份、雄黄3份、冰片3份。
优选地，所述牛黄为体外培育牛黄。
优选地，所述制备方法包括以下步骤：
1)将牛黄、珍珠、雄黄、冰片粉碎成100目以上细粉并混匀；
2)取黄连、甘草、天花粉、川贝母、赤芍，加水煎煮1-5次，合并煎煮液并浓缩成相对密度为1.2-1.3的清膏，然后向清膏中加入乙醇至含醇量达40-70％，静置过夜后分离上清液；
3)取大黄、乳香、没药，用50～90％乙醇回流提取1-3次，将提取液与步骤2)的上清液合并浓缩成相对密度为1.3-1.4的稠膏；
4)将稠膏与步骤1)的细粉搅拌混合均匀，然后向中药混合物中加入辅料制成中药贴膜。
进一步优选地，所述辅料包括成膜材料、增塑剂、促渗剂、甜味剂和芳香剂，各成分的重量配比如下：
Figure BDA0002300825540000021
所述成膜材料为聚乙烯醇、聚乙烯吡洛烷酮、卡波姆、羧甲基纤维素钠、羟丙基甲基纤维素、乙基纤维素中的一种或多种。
所述增塑剂为甘油。
所述促渗剂为丙二醇和氮酮。
所述芳香剂为薄荷精油。
所述甜味剂包括但不限于蔗糖、甘露醇、乳糖、山梨醇、阿斯巴甜、甜菊糖甙、麦芽糖等。
本发明中所涉及的乙醇含量，均指重量含量，如70％乙醇指的是每100g乙醇水溶液中含有乙醇70g。
本发明的有益效果是：
1)本发明提供的中药具有清热解毒，活血消肿之功，对口腔溃疡具有很好的疗效。
2)本发明采用局部给药，药物成分直接作用于患病部位，不仅减少了雄黄等毒性药材引发的全身不良反应，而且药物起效速度更快。
3)本发明制备的中药贴膜还具有活性成分含量高，透皮吸收速度快等优点。
具体实施方式
以下通过实施例对本发明进行详细说明。
实施例1
处方：
大黄800g、黄连400g、甘草300g、天花粉800g、川贝母400g、赤芍800g、乳香400g、没药400g、珍珠60g、体外培育牛黄50g、雄黄30g、冰片30g。
制法：
1)将体外培育牛黄、珍珠、雄黄、冰片粉碎成150目细粉并混匀；
2)取黄连、甘草、天花粉、川贝母、赤芍，加10倍水煎煮2次，每次1.5小时，合并两次煎煮液并浓缩成相对密度为1.22的清膏，然后向清膏中加入乙醇至含醇量达70％，静置过夜后分离上清液；
3)取大黄、乳香、没药，用70％乙醇回流提取2次，每次2小时，将提取液与步骤2)的上清液合并浓缩成相对密度为1.35的稠膏；
4)将稠膏与步骤1)的细粉搅拌混合均匀，然后按以下配比称重：
Figure BDA0002300825540000031
Figure BDA0002300825540000041
取聚乙烯醇和聚乙烯吡洛烷酮，加入10倍重量水搅拌直到完全溶解，接着依次加入中药混合物、甘油、丙二醇、氮酮、甘露醇、薄荷精油，边加边搅拌，直至形成均匀的粘稠液体，然后将液体倒入预先擦有少量液体石蜡的平板玻璃上，50℃干燥后揭膜，切割成1.5×1.5cm/片后包装，即得。
实施例2
处方：
大黄500g、黄连200g、甘草200g、天花粉500g、川贝母200g、赤芍500g、乳香200g、没药200g、珍珠30g、人工牛黄30g、雄黄10g、冰片10g。
制法：
1)将人工牛黄、珍珠、雄黄、冰片粉碎成120目细粉并混匀；
2)取黄连、甘草、天花粉、川贝母、赤芍，加6倍水煎煮3次，第一次2小时，第二次1小时，第三次0.5小时，合并三次煎煮液并浓缩成相对密度为1.28的清膏，然后向清膏中加入乙醇至含醇量达50％，静置过夜后分离上清液；
3)取大黄、乳香、没药，用50％乙醇回流提取3次，每次1小时，将提取液与步骤2)的上清液合并浓缩成相对密度为1.38的稠膏；
4)将稠膏与步骤1)的细粉搅拌混合均匀，然后按以下配比称重：
Figure BDA0002300825540000042
Figure BDA0002300825540000051
取聚乙烯吡洛烷酮和卡波姆，加入10倍重量水搅拌直到完全溶解，接着依次加入中药混合物、甘油、氮酮、乳糖、甜橙香精，边加边搅拌，直至形成均匀地粘稠液体，然后将液体倒入预先擦有少量液体石蜡的平板玻璃上，50℃干燥后揭膜，切割成1.5×1.5cm/片后包装，即得。
实施例3
处方：
大黄1200g、黄连500g、甘草500g、天花粉500g、川贝母500g、赤芍500g、乳香600g、没药200g、珍珠30g、天然牛黄30g、雄黄10g、冰片10g
制法：
1)将天然牛黄、珍珠、雄黄、冰片粉碎成180目细粉并混匀；
2)取黄连、甘草、天花粉、川贝母、赤芍，加20倍水煎煮3小时，过滤，将煎煮液浓缩成相对密度为1.20的清膏，然后向清膏中加入乙醇至含醇量达60％，静置过夜后分离上清液；
3)取大黄、乳香、没药，用90％乙醇回流提取2次，每次1.5小时，将提取液与步骤2)的上清液合并浓缩成相对密度为1.32的稠膏；
4)将稠膏与步骤1)的细粉搅拌混合均匀，然后按以下配比称重：
Figure BDA0002300825540000052
取羧甲基纤维素钠和羟丙基甲基纤维素，加入10倍重量水搅拌直到完全溶解，接着依次加入中药混合物、甘油、丙二醇、氮酮、山梨醇、柠檬香精，边加边搅拌，直至形成均匀地粘稠液体，然后将液体倒入预先擦有少量液体石蜡的平板玻璃上，50℃干燥后揭膜，切割成1.5×1.5cm/片后包装，即得。
实施例4
取2.0-2.5Kg雄性家兔25只，随机分为五组，即模型组、实施例1-3药物组、对照组，每组5只。
按照《口腔溃疡动物模型制备规范》(中华中医药学会中药实验药理专业委员会制定)的规定制备家兔口腔溃疡动物模型，具体采用规范中的2.3法—冰醋酸烧灼法：各组家兔先用10％水合氯醛麻醉，将内径0.6cm的玻璃管垂直固定在家兔口腔黏膜表面，并向管内注入30％的冰醋酸，维持30s后，用干净棉签蘸除多余的冰醋酸，48h后灼烧面形成直径约5.5mm的溃疡病灶。
溃疡形成后，药物组分别在溃疡部位给予实施例1、2、3制备的贴膜一片；对照组给于全生药材粉末制成的贴膜；模型组给予空白贴膜。给药后轻按10秒以固定，每日1次，连续6天，测量各组动物溃疡面积，并计算治愈率，结果见表1。
治愈率＝(0天溃疡面积-6天溃疡面积)/0天溃疡面积×100％。
表1中药贴膜对家兔口腔溃疡面积的影响(n＝5)
Figure BDA0002300825540000061
注：对照组药物是将实施例1中的处方药材经全部粉碎后制成的贴膜，具体如下：大黄8g、黄连4g、甘草3g、天花粉8g、川贝母4g、赤芍8g、乳香4g、没药4g、珍珠0.6g、体外培育牛黄0.5g、雄黄0.3g、冰片0.3g。
以上药材全部粉碎成粒径100目细粉，取聚乙烯吡洛烷酮15g、聚乙烯醇5g，加入500g水搅拌直到完全溶解，然后加入上述细粉和5g甘油、1g氮酮搅拌均匀，倒入预先擦有少量液体石蜡的平板玻璃上，50℃干燥后揭膜，切割成1.5×1.5cm/片。
从以上结果可以看出，本发明制备的中药贴膜能明显促进口腔溃疡动物模型的愈合。

Claims (8)

1.一种治疗口腔溃疡的中药贴膜，其特征在于由以下重量份数的中药材制成：
大黄50-120份、黄连20-60份、甘草20-60份、天花粉50-120份、川贝母20-60份、赤芍50-120份、乳香20-60份、没药20-60份、珍珠3-12份、牛黄3-12份、雄黄1-5份、冰片1-5份，
制备方法包括以下步骤：
1)将牛黄、珍珠、雄黄、冰片粉碎成100目以上细粉并混匀；
2)取黄连、甘草、天花粉、川贝母、赤芍，加水煎煮1-5次，合并煎煮液并浓缩成相对密度为1.2-1.3的清膏，然后向清膏中加入乙醇至含醇量达40-70％，静置过夜后分离上清液；
3)取大黄、乳香、没药，用50～90％乙醇回流提取1-3次，将提取液与步骤2)的上清液合并浓缩成相对密度为1.3-1.4的稠膏；
4)将稠膏与步骤1)的细粉搅拌混合均匀，然后向中药混合物中加入辅料制成中药贴膜。
2.如权利要求1所述治疗口腔溃疡的中药贴膜，其特征在于由以下重量份数的中药材制成：
大黄80份、黄连40份、甘草30份、天花粉80份、川贝母40份、赤芍80份、乳香40份、没药40份、珍珠6份、牛黄5份、雄黄3份、冰片3份。
3.如权利要求1所述治疗口腔溃疡的中药贴膜，其特征在于：所述牛黄为体外培育牛黄。
4.如权利要求1所述治疗口腔溃疡的中药贴膜，其特征在于，所述辅料包括成膜材料、增塑剂、促渗剂、甜味剂和芳香剂，各成分的重量配比如下：
Figure FDA0003073274920000011
Figure FDA0003073274920000021
5.如权利要求4所述治疗口腔溃疡的中药贴膜，其特征在于：所述成膜材料为聚乙烯醇、聚乙烯吡洛烷酮、卡波姆、羧甲基纤维素钠、羟丙基甲基纤维素、乙基纤维素中的一种或多种。
6.如权利要求4所述治疗口腔溃疡的中药贴膜，其特征在于：所述增塑剂为甘油。
7.如权利要求4所述治疗口腔溃疡的中药贴膜，其特征在于：所述促渗剂为丙二醇和氮酮。
8.如权利要求4所述治疗口腔溃疡的中药贴膜，其特征在于：所述芳香剂为薄荷精油。
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