CN109276689A - 一种治疗痛经的外用贴剂及其制备方法 - Google Patents
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Abstract
一种治疗痛经的外用贴剂由蒲黄、丁香、肉桂、当归、香附、莪术、五灵脂、延胡索、月季花、远红外线陶瓷粉等原料配制而成，制备方法采用渗漉法提取药材，亲水性基质原料做贴剂基质，涂于无纺布上制成贴剂。本发明贴剂使用时不过敏、粘性适中，贴于小腹疼痛部位，局部可持续产生温热感，可标本兼治、迅速暖宫止痛，止痛快、复发率低、无过敏。
Description
技术领域
本发明涉及药学技术领域，尤其涉及一种治疗痛经的外用贴剂。
背景技术
痛经，主要是指女性每次来月经前后或月经期间出现的下腹部疼痛，疼痛延至骶腰背部，甚至涉及大腿及足部。常伴有腰酸、乳房胀痛、肛门坠胀、头痛头晕、胃痛、腹泻、倦怠乏力、四肢冰凉、冷汗淋漓、恶心不适等症状，疼痛严重者可能会影响工作与学习。目前对于痛经问题，西医一般采用化学药物调节激素水平或使用止痛剂，但大多仅可控制症状，不能根治，而且副作用大；中医通过行气活血、祛湿散寒、泄实补虚等法，调理身体阴阳平衡，达到治疗的目的；另外也采用外用贴剂的方式治疗或缓解痛经。
目前使用的一些痛经类贴膏治疗痛经，多采用中药粗加工的方式制成贴膏。由于这类贴膏有效成分不提取或提取不完全等原因，会导致皮肤对药物的吸收浓度降低而影响疗效，同时可能造成污染皮肤、皮肤过敏等问题，影响患者的正常使用。
发明内容
本发明针对现有技术的不足，根据中医理论，选用具有温经散寒、活血化瘀、理气止痛的中药材为主要原料，加入远红外陶瓷粉合理组方；同时，采用现代中药加工工艺提取有效成分；选用水溶性基质材料制成的外用贴剂与皮肤的亲和性好，携药量大，释药性好，透皮吸收良好。亲水性基质对皮肤无刺激，可反复揭帖。主要用于女性生理期下腹部疼痛、乳房胀痛、肛门坠胀、四肢冰凉等。
为了实现上述发明目的，本发明提供以下技术方案：
一种治疗痛经的外用贴剂，按照重量份数计，由以下原料配制：蒲黄5-10份、丁香1-5份、肉桂1-3份、当归3-8份、香附1-3份、莪术3-8份、五灵脂1-3份、延胡索3-8份、月季花1-3份、远红外线陶瓷粉0.1-10份。
本发明一种治疗痛经的外用贴剂的制备方法如下：
步骤1：上述原料按重量份数称取净制后备用，远红外瓷粉研细过120-300目筛，收集细粉备用；
步骤2：采用亲水性原料为制贴基质，具体为聚乙烯吡咯烷酮3-6份、依地酸二钠0.01-2份、聚丙烯酸钠3--9份、甘油15--45份、明胶2-8份、丙二醇（v/v）0.01-7份、羧甲基纤维素钠6-30份、去离子水20～80份；
步骤3：将肉桂、丁香、当归、香附、月季花、莪术低温干燥，粉碎，过24目筛使成粗粉，用50-95%乙醇浸渍24h，以0.5-8ml/min速度渗漉，渗漉液低温（20-60℃）减压回收乙醇至尽，浓缩至相对密度0.8～1.30（60℃）的浸膏；
步骤4： 蒲黄、延胡索、五灵脂加8倍量水煎煮2小时，随后加6倍量水煎煮1小时，合并煎液，滤过，滤液减压浓缩至相对密度0.8～1.30（60℃）的浸膏；
步骤5： 将步骤3、步骤4得到的浸膏和步骤2的基质按一定顺序混合，搅拌，混匀后，加入远红外线陶瓷粉，继续搅拌，混匀，涂膏，盖衬，切块，制贴，分装，包装。
以下列举几个典型的使用本发明外用贴剂治愈病例：
王小姐，19岁，每次痛经必吃止痛药，连用本发明贴剂三个月，现在经期一点感觉都没有了。
韩小姐，每次来月经前两天就开始肚子痛了，还伴有拉肚子，严重时直接滚到地，使用本发明贴剂两个月，彻底摆脱痛经困扰。
刘小姐 ，是属于痛经比较严重的，严重的时候都抱着肚子在床上打滚，之前什么办法都试过了，一点用也没有，使用本发明贴剂一个月后，来例假时就没有以前那么疼了，感觉真的缓解了好多，一贴能贴两晚上，肚子热热的，很舒服，并且没有别的贴剂那么大的药味，也没有过敏，连续用了三个月痛经彻底好了。
本发明以温经散寒、活血化瘀、理气止痛的中药材为主要原料，配合远红外线材料，主要用于生理期下腹部疼痛、乳房胀痛、四肢冰凉等的女性痛经人群；本发明贴剂使用时不过敏、粘性适中，贴于小腹疼痛部位，局部可持续产生温热感，可标本兼治、迅速暖宫止痛。本发明贴剂试用期间，有效率在96%以上，治愈率76%以上，均反映止痛快、复发率低、无过敏。
具体实施方式
以下结合实施例对本发明做进一步的说明，但本发明并不局限于实施例。
实施例1
一种治疗痛经的外用贴剂，按照重量份数计，由以下原料配制：蒲黄10份、丁香5份、肉桂3份、当归7份、香附2份、莪术8份、五灵脂3份、延胡索7份、月季花2份、远红外线陶瓷粉5份。
制备方法如下：
步骤1：上述原料按重量份数称取净制后备用，远红外瓷粉研细过200目筛，收集细粉备用；
步骤2：采用亲水性原料为制贴基质，具体为聚乙烯吡咯烷酮6份、依地酸二钠1份、聚丙烯酸钠9份、甘油45份、明胶8份、丙二醇（v/v）4份、羧甲基纤维素钠30份、去离子水80份；
步骤3：将肉桂、丁香、当归、香附、月季花、莪术低温干燥，粉碎，过24目筛使成粗粉，用80%乙醇浸渍24h，以0.5-8ml/min速度渗漉，渗漉液低温（45℃）减压回收乙醇至尽，浓缩至相对密度0.8～1.30（60℃）的浸膏；
步骤4： 蒲黄、延胡索、五灵脂加8倍量水煎煮2小时，随后加6倍量水煎煮1小时，合并煎液，滤过，滤液减压浓缩至相对密度0.8～1.30（60℃）的浸膏；
步骤5： 将步骤3、步骤4得到的浸膏和步骤2的基质按一定顺序混合，搅拌，混匀后，加入远红外线陶瓷粉，继续搅拌，混匀，涂膏，盖衬，切块，制贴，分装，包装。
实施例2
一种治疗痛经的外用贴剂，按照重量份数计，由以下原料配制：蒲黄5份、丁香2份、肉桂2份、当归4份、香附1份、莪术3份、五灵脂1份、延胡索5份、月季花1份、远红外线陶瓷粉3份。
制备方法如下：
步骤1：上述原料按重量份数称取净制后备用，远红外瓷粉研细过300目筛，收集细粉备用；
步骤2：采用亲水性原料为制贴基质，具体为聚乙烯吡咯烷酮3份、依地酸二钠0.05份、聚丙烯酸钠3份、甘油20份、明胶3份、丙二醇（v/v）1份、羧甲基纤维素钠15份、去离子水30份；
步骤3：将肉桂、丁香、当归、香附、月季花、莪术低温干燥，粉碎，过24目筛使成粗粉，用70%乙醇浸渍24h，以0.5-8ml/min速度渗漉，渗漉液低温（60℃）减压回收乙醇至尽，浓缩至相对密度0.8～1.30（60℃）的浸膏；
步骤4： 蒲黄、延胡索、五灵脂加8倍量水煎煮2小时，随后加6倍量水煎煮1小时，合并煎液，滤过，滤液减压浓缩至相对密度0.8～1.30（60℃）的浸膏；
步骤5： 将步骤3、步骤4得到的浸膏和步骤2的基质按一定顺序混合，搅拌，混匀后，加入远红外线陶瓷粉，继续搅拌，混匀，涂膏，盖衬，切块，制贴，分装，包装。
上述实施例，只是本发明的较佳实施例，并非用来限制本发明实施范围，故凡以本发明权利要求所述内容所做的等效变化，均应包括在本发明权利要求范围之内。
Claims (2)
1.一种治疗痛经的外用贴剂，其特征在于：按照重量份数计，由以下原料配制：蒲黄5-10份、丁香1-5份、肉桂1-3份、当归3-8份、香附1-3份、莪术3-8份、五灵脂1-3份、延胡索3-8份、月季花1-3份、远红外线陶瓷粉0.1-10份。
2.如权利要求1所述的一种治疗痛经的外用贴剂的制备方法其特征在于：包括如下步骤：
步骤1：上述原料按重量份数称取净制后备用，远红外瓷粉研细过120-300目筛，收集细粉备用；
步骤2：采用亲水性原料为制贴基质，具体为聚乙烯吡咯烷酮3-6份、依地酸二钠0.01-2份、聚丙烯酸钠3--9份、甘油15--45份、明胶2-8份、丙二醇（v/v）0.01-7份、羧甲基纤维素钠6-30份、去离子水20～80份；
步骤3：将肉桂、丁香、当归、香附、月季花、莪术低温干燥，粉碎，过24目筛使成粗粉，用50-95%乙醇浸渍24h，以0.5-8ml/min速度渗漉，渗漉液低温（20-60℃）减压回收乙醇至尽，浓缩至相对密度0.8～1.30（60℃）的浸膏；
步骤4： 蒲黄、延胡索、五灵脂加8倍量水煎煮2小时，随后加6倍量水煎煮1小时，合并煎液，滤过，滤液减压浓缩至相对密度0.8～1.30（60℃）的浸膏；
步骤5： 将步骤3、步骤4得到的浸膏和步骤2的基质按一定顺序混合，搅拌，混匀后，加入远红外线陶瓷粉，继续搅拌，混匀，涂膏，盖衬，切块，制贴，分装，包装。
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