CN114949065A - 一种治疗早期跌打损伤的中药贴敷及其制备方法 - Google Patents
一种治疗早期跌打损伤的中药贴敷及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗早期跌打损伤的中药贴，由部分中和聚丙烯酸钠、甘羟铝、依地酸钠、酒石酸、甘油、水、聚维酮、薄荷脑樟脑组合物、苯甲酸及中药组分组成；其中中药组分由大黄、侧柏叶、赤芍、当归尾、泽兰、红花、薄荷、黄柏组成。该中药亲水性贴膏既继承了中医药的传统理论，又结合现代制剂新工艺、新技术，过敏性低，兼具药物治疗和冷敷理疗的效果，适合治疗早期跌打损伤，具有广阔的应用前景和临床价值。
Description
技术领域
本发明涉及中药领域，特别涉及一种治疗早期跌打损伤的中药贴敷及其制备方法。
背景技术
如今，体育运动受到越来越多人的喜爱，其中年轻人更是将健身运动当成一种时尚，但因为运动而受伤的人也越来越多了，医院接诊的局部跌打损伤患者也逐渐出现年轻化的趋势。在中国，高达96.4％的跑步爱好者在跑步中受过伤，《2009-2014健身行业产值规模》同时表明，经常运动的人运动损伤率达到85％以上。在治疗方法上，慢性、陈旧性损伤以温热舒筋活络为主，而早期的急性跌打损伤则以“冷”疗舒筋为主，早期的跌打损伤要及时治疗，否则容易演变成慢性损伤，影响后续的健康生活。而目前医院或市场上外用治疗损伤的贴敷类产品多是针对慢性损伤类型的，不太适合早期跌打损伤出现的红肿包块的治疗。我院结合省名中医李万逸主任中医师多年临床经验，专门研制了一种治疗早期跌打损伤的中药贴敷，主治跌打损伤早期，局部红肿热痛；或疮疡初起、局部包块形成而无溃疡者。
医院内传统贴敷的使用方法是由医务人员取适量混合药粉，加水加热调成糊状帮助贴敷，病人需每天到医院换药，极为不便，且用药剂量难以控制，另外热敷也不适用部分早期损伤患者。
中药亲水性贴膏既继承了中医药的传统理论，又结合现代制剂新工艺、新技术，经查阅有关文献资料，未见有与本组合物相同的制备工艺与质量标准的研究的公开报道，具有广阔的应用前景和临床价值。
发明内容
为了解决上述技术问题，本发明的目的是公开一种治疗早期跌打损伤的中药贴敷及其制备方法。
为了实现上述目的，本发明的技术方案是：一种治疗早期跌打损伤的组合物，由大黄、侧柏叶、赤芍、当归尾、泽兰、红花、薄荷、黄柏组成。
优选的，按质量份计，中药组合物由4～8份大黄，1～3份侧柏叶，2～6份赤芍，2～4份当归尾，2～6份泽兰，1～2份红花，1～4份薄荷，2～6份黄柏组成。
一种治疗早期跌打损伤的中药贴，由部分中和聚丙烯酸钠、甘羟铝、依地酸钠、酒石酸、甘油、水、聚维酮、薄荷脑樟脑组合物、苯甲酸及中药组分组成；其中中药组分由大黄、侧柏叶、赤芍、当归尾、泽兰、红花、薄荷、黄柏组成。
优选的，中药贴由5～8％部分中和聚丙烯酸钠、0.1～0.5％甘羟铝、0.05～0.3％依地酸钠、0.1～0.6％酒石酸、20～35％甘油、35～50％水、0.5～2％聚维酮、1～5％薄荷脑樟脑组合物、0.1～0.3％苯甲酸及中药组分组成。
优选的，中药组分按质量份计，所由4～8份大黄，1～3份侧柏叶，2～6份赤芍，2～4份当归尾，2～6份泽兰，1～2份红花，1～4份薄荷，2～6份黄柏组成。
优选的，薄荷脑樟脑组合物按质量比计，薄荷：樟脑＝1：0.2～1。
一种治疗早期跌打损伤的中药贴的制备方法，由以下步骤制备而成：1)将大黄、当归尾、赤芍粉碎成细粉；2)将侧柏叶、泽兰、红花、薄荷、黄柏先用80～90％乙醇渗漉，收集渗漉液浓缩成密度1.05-1.10的浸膏，得提取物1；3)将药渣用水煎煮提取，收集水提取液浓缩成密度1.05-1.10的浸膏，得提取物2；
4)将细粉与提取物1、提取物2组合；5)将步骤4)所得产物与酒石酸、依地酸二钠、苯甲酸溶解于水中作为A相；6)将薄荷脑、樟脑溶解后加入甘油中，再加入部分中和聚丙烯酸钠、甘羟铝、聚维酮，共同分散在甘油中，充分混合均匀作为B相；7)将B相加入到A相中，混合均匀后，即得亲水性膏体，涂布于无纺布上，并同时覆盖聚乙烯薄膜，室温放置1-2周即可使用。
优选的，提取物1的制备方法是：取侧柏叶、泽兰、红花、薄荷、黄柏，粉碎成粗粉，用3倍量80～90％的乙醇浸泡12-24h，使溶剂充分渗透扩散；打开渗漉液出口接收漉液，漉液流出速度以每分钟1～3ml，渗漉过程中应不断补充溶剂，使溶剂始终浸没药粉，渗漉时间48h；收集渗漉液，40～50℃减压浓缩至浸膏密度1.05-1.10，即得。
优选的，提取物2的制备方法是：取渗漉后的药渣，挥干乙醇，加入水提取两次，每次8倍量的水，提取2h，收集两次煎液，混合均匀后，60～70℃减压浓缩至浸膏密度1.05-1.10，即得。
一种治疗早期跌打损伤的中药贴膏体基质，由部分中和聚丙烯酸钠、甘羟铝、依地酸钠、酒石酸、甘油、水、聚维酮、薄荷脑樟脑组合物、苯甲酸组成。
本发明的有益效果是，该中药亲水性贴膏既继承了中医药的传统理论，又结合现代制剂新工艺、新技术，过敏性低，兼具药物治疗和冷敷理疗的效果，适合治疗早期跌打损伤，具有广阔的应用前景和临床价值。
具体实施方式
以下将结合实施例对本发明的构思及产生的技术效果进行清楚、完整地描述，以充分地理解本发明的目的、特征和效果。显然，所描述的实施例只是本发明的一部分实施例，而不是全部实施例，基于本发明的实施例，本领域的技术人员在不付出创造性劳动的前提下所获得的其他实施例，均属于本发明保护的范围。
实施例1
按照如下方法制备中药贴：
1)中药组合物制备
处方由大黄、侧柏叶、赤芍、当归尾、泽兰、红花、薄荷、黄柏，八味中药组成。将处方中的药物一部分直接粉碎入药，一部分经醇、水提取后入药。其中大黄、当归尾、赤芍粉碎成细粉，侧柏叶、泽兰、红花、薄荷、黄柏先用80～90％乙醇渗漉，收集渗漉液浓缩成密度1.05-1.10的浸膏，得提取物1；再将药渣用水煎煮提取，收集水提取液浓缩成密度1.05-1.10的浸膏，得提取物2。将细粉与提取物1、提取物2组合，即得。
2)膏体制备
将处方量的中药组合物、酒石酸、依地酸二钠、苯甲酸溶解于水中作为A相；将薄荷脑、樟脑溶解后加入甘油中，再加入部分中和聚丙烯酸钠、甘羟铝、聚维酮，共同分散在甘油中，充分混合均匀作为B相；将B相加入到A相中，混合均匀后，即得亲水性膏体，涂布于无纺布上，并同时覆盖聚乙烯薄膜，室温放置1-2周即可使用。
实施例2
采用正交试验进行工艺优化。具体步骤：
药粉：按质量份计，取8大黄、2当归尾、3赤芍粉碎成100目以上的粉末。
提取物1：按质量份计，取3侧柏叶、4泽兰、1红花、4薄荷、4黄柏，粉碎成粗粉，用3倍量80～90％的乙醇浸泡12-24h，使溶剂充分渗透扩散。打开渗漉液出口接收漉液，漉液流出速度以每分钟1～3ml，渗漉过程中应不断补充溶剂，使溶剂始终浸没药粉，渗漉时间48h。收集渗漉液，40～50℃减压浓缩至浸膏密度1.05-1.10，即得。
提取物2：取渗漉后的药渣，挥干乙醇，加入水提取两次，每次8倍量的水，提取2h，收集两次煎液，混合均匀后，60～70℃减压浓缩至浸膏密度1.05-1.10，即得。
选择主要基质，部分中和聚丙烯酸钠、甘羟铝、依地酸二钠、酒石酸、聚维酮进行优化，试验方法按正交设计表L16(34)安排实验，见表“因素水平表”，其余组分按35％甘油、35％水、2％薄荷脑樟脑组合物(1:0.2～1)、0.2％苯甲酸，18.8％中药组合物添加。
配制方法：将处方量的中药组合物、酒石酸、依地酸二钠、苯甲酸溶解于水中作为A相；将薄荷脑、樟脑溶解后加入甘油中，再加入部分中和聚丙烯酸钠、甘羟铝、聚维酮，共同分散在甘油中，充分混合均匀作为B相；将B相加入到A相中，混合均匀后，即得亲水性膏体，涂布于无纺布上，并同时覆盖聚乙烯薄膜，观察。以感官评价综合得分为考察指标来优选制备方法参数。结果见表“正交试验结果”。
表综合感官评分具体要求
备注：感官相应的评分，“很好”10分、“正常”8分、“一般”6分、“较差”5分、“很差”3分、“无此性质”0分。
表因素水平表
表正交试验结果
由表中的结果可知，A2B4C2D3E3是评分较高的组合，极差差异最大的是聚丙烯酸钠和甘羟铝，即对工艺影响最大的是部分中和聚丙烯酸钠和甘羟铝。
经过验证，优化后工艺所制备的贴膏具有黏度好、不残留、贴合皮肤、可反复揭帖的使用特点，显著提高了患者使用贴膏时的体验感。
经研究最佳的配比为：7.2％部分中和聚丙烯酸钠、0.3％甘羟铝、0.1％依地酸二钠、0.4％酒石酸、35％甘油、35％水、2％聚维酮、2％薄荷脑樟脑组合物(1:0.2～1)、0.2％苯甲酸，18.8％中药组合物。
实施例3
将实施例2的亲水性中药贴膏治疗早期跌打损伤，兼具药物治疗和冷敷理疗的作用。设计实验对比本研究自制的亲水性中药贴膏与市售膏药(以橡胶膏为例)的降温情况。
在温度为39℃±2℃的恒温箱中，放置1支温度计。当温度计到达目标温度Ta＝39℃时，用亲水性中药贴膏包裹住温度计的水银头，1h、2h、3h、4h、5h、6h、7h、8h时读取温度计所显示的温度分别为Tbi，计算降温性能Ti＝︱Ta-Tbi︱，并计算其平均值ΔT＝(T1+T2+···+T8)/8(其中，Tbi、Ti、ΔT的单位均为℃，i＝1～8)。
结果表明，自制亲水性中药贴膏至少能持续8h降温2.5℃。市售膏药(以橡胶膏为例)无降温效果。
表降温实验温度记录
实施例4
将实施例2的亲水性中药贴膏主要用于跌打损伤早期，出现红肿热痛的情况。所选患者为扭挫伤、筋肉肿痛局部有红、肿、热、痛等临床表现，同时疼痛部位皮肤无破损，无药物过敏史，常规检查正常。以上患者20例用于消肿止痛作用疗效观察。
4.1试验方式
取自制亲水性中药贴膏贴于患处，每次4h，连续3天。
4.2疗效评价
疗效评价观察表
疗效评价结果
以上临床观察结果显示，本文所述的自制亲水性中药贴膏能够有效缓解疼痛和消肿。
实施例5
对中药具体配比进行进一步研究(按质量份计)，按照以下表格配比不同药方：并按照实施例1的方法制备中药贴。
表配方
筛选合格小鼠，随机分组(每组10只)给药前24h腹部脱毛，给药前24h腹部脱毛。分别给配方1～5的中药贴，外敷；试验前12小时禁食，自由饮水，末次给药60min后，将二甲苯涂于小鼠右耳前后两面，50uL/只，30min后将小鼠颈椎脱臼处死，沿耳廓基线剪下两耳，用9mm打孔器分别在同一部位打下圆耳片，用电子天平分别精密称重，计算肿胀抑制率，肿胀度＝右耳片重量-左耳片重量。实验结果如下表所示：
以上是对本发明的较佳实施进行了具体说明，但本发明创造并不限于所述实施例，熟悉本领域的技术人员在不违背本发明精神的前提下还可做作出种种的等同变形或替换，这些等同的变形或替换均包含在本申请权利要求所限定的范围内。
Claims (10)
1.一种治疗早期跌打损伤的组合物，其特征在于，所述中药组合物由大黄、侧柏叶、赤芍、当归尾、泽兰、红花、薄荷、黄柏组成。
2.根据权利要求1所述的中药贴，其特征在于，按质量份计，所述中药组合物由4～8份大黄，1～3份侧柏叶，2～6份赤芍，2～4份当归尾，2～6份泽兰，1～2份红花，1～4份薄荷，2～6份黄柏组成。
3.一种治疗早期跌打损伤的中药贴，其特征在于，所述中药贴由部分中和聚丙烯酸钠、甘羟铝、依地酸钠、酒石酸、甘油、水、聚维酮、薄荷脑樟脑组合物、苯甲酸及中药组分组成；其中中药组分由大黄、侧柏叶、赤芍、当归尾、泽兰、红花、薄荷、黄柏组成。
4.根据权利要求3所述的中药贴，其特征在于，所述中药贴由5～8％部分中和聚丙烯酸钠、0.1～0.5％甘羟铝、0.05～0.3％依地酸钠、0.1～0.6％酒石酸、20～35％甘油、35～50％水、0.5～2％聚维酮、1～5％薄荷脑樟脑组合物、0.1～0.3％苯甲酸及中药组分组成。
5.根据权利要求3所述的中药贴，其特征在于，所述中药组分按质量份计，所由4～8份大黄，1～3份侧柏叶，2～6份赤芍，2～4份当归尾，2～6份泽兰，1～2份红花，1～4份薄荷，2～6份黄柏组成。
6.根据权利要求3所述的中药贴，其特征在于，所述薄荷脑樟脑组合物按质量比计，薄荷：樟脑＝1：0.2～1。
7.一种治疗早期跌打损伤的中药贴的制备方法，由以下步骤制备而成：1)将大黄、当归尾、赤芍粉碎成细粉；2)将侧柏叶、泽兰、红花、薄荷、黄柏先用80～90％乙醇渗漉，收集渗漉液浓缩成密度1.05-1.10的浸膏，得提取物1；3)将药渣用水煎煮提取，收集水提取液浓缩成密度1.05-1.10的浸膏，得提取物2；4)将细粉与提取物1、提取物2组合；5)将步骤4)所得产物与酒石酸、依地酸二钠、苯甲酸溶解于水中作为A相；6)将薄荷脑、樟脑溶解后加入甘油中，再加入部分中和聚丙烯酸钠、甘羟铝、聚维酮，共同分散在甘油中，充分混合均匀作为B相；7)将B相加入到A相中，混合均匀后，即得亲水性膏体，涂布于无纺布上，并同时覆盖聚乙烯薄膜，室温放置1-2周即可使用。
8.根据权利要求6所述的制备方法，其特征在于，所述提取物1的制备方法是：取侧柏叶、泽兰、红花、薄荷、黄柏，粉碎成粗粉，用3倍量80～90％的乙醇浸泡12-24h，使溶剂充分渗透扩散；打开渗漉液出口接收漉液，漉液流出速度以每分钟1～3ml，渗漉过程中应不断补充溶剂，使溶剂始终浸没药粉，渗漉时间48h；收集渗漉液，40～50℃减压浓缩至浸膏密度1.05-1.10，即得。
9.根据权利要求6所述的制备方法，其特征在于，所述提取物2的制备方法是：取渗漉后的药渣，挥干乙醇，加入水提取两次，每次8倍量的水，提取2h，收集两次煎液，混合均匀后，60～70℃减压浓缩至浸膏密度1.05-1.10，即得。
10.一种治疗早期跌打损伤的中药贴膏体基质，其特征在于，所述膏体基质由部分中和聚丙烯酸钠、甘羟铝、依地酸钠、酒石酸、甘油、水、聚维酮、薄荷脑樟脑组合物、苯甲酸组成。
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