CN111759905A - 一种治疗骨关节炎的巴布剂及其制备方法 - Google Patents
一种治疗骨关节炎的巴布剂及其制备方法 Download PDFInfo
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Abstract
本发明提供一种治疗骨关节炎的巴布剂，由背衬层、膏体和防黏膜组成，所述膏体由药物浸膏和基质组成，所述药物浸膏包括以下质量份的原料：川乌8‑12份、花椒8‑12份、青风藤6‑15份、丁香8‑12份、黄柏6‑15份、木鳖子6‑18份。本发明还提供了上述治疗骨关节炎的巴布剂的制备方法。本发明通过对各种药材进行合理配伍，寒温并用、热多寒少，得到的药物浸膏温而不燥，具有温经通络、消肿止痛的功效。
Description
技术领域
本发明涉及巴布剂技术领域，尤其涉及一种治疗骨关节炎的巴布剂及其制备方法。
背景技术
传统的黑膏药、现代的橡胶膏，虽然疗效确切，但是黑膏药使用不便，污染衣物，制作工艺影响环境。橡胶膏的刺激性、过敏性、易老化性等限制了其临床使用。巴布剂作为以水溶性高分子聚合物为基质骨架材料的外用贴剂，恰恰在这些方面显示出明显的优势，巴布剂具有保湿、透气、耐老化、载药量大、刺激性和过敏性小的特点，是中药外用贴剂的适宜剂型。巴布剂非常适合承载中药，因为中药都以复方入药，有效成分提纯比较困难，多半是提取精制成一定浓度的浸膏，再制成相应的制剂，药量较大，而巴布剂的载药量恰恰很大，又可以反复揭贴，再贴上时依然可以保持很好的黏性。在临床治疗各种疼痛性疾病的报告中作为外用中药贴剂的巴布剂较受患者的欢迎。
骨关节炎属于退行性疾病，多发于负重关节，如膝关节，其他如髋、踝、手指间关节、腰椎小关节等也常见，60岁以上的人群基本都受到该疾病的困扰，其主要表现为：疼痛、乏力、打软腿、僵凝等，常因劳累、寒冷刺激、季节变化等因素反复发作，甚至长期疼痛。本疾病属于慢性退行性疾病，对于早中期的骨关节炎的治疗主要以保守治疗为主，主要有口服的非甾体类止痛剂、软骨补充剂(软骨素等)；关节内注射的玻璃酸钠，外用贴剂、涂抹剂等，产品众多，各有优缺点。长期服用非甾体类止痛剂能引起胃肠道不良反应，甚至形成溃疡；关节腔的注射也不宜经常进行，有感染风险。其他外用剂主要是非甾体类止痛药、中成药，主要不良反应是局部的过敏反应。因此有必要提供一种过敏反应少，能长期使用的治疗药剂。
发明内容
有鉴于此，本发明提供了一种治疗骨关节炎的巴布剂及其制备方法。
本发明提供一种治疗骨关节炎的巴布剂，由背衬层、膏体和防黏膜组成，所述膏体由药物浸膏和基质组成，所述药物浸膏包括以下质量份的原料：川乌8-12份、花椒8-12份、青风藤6-15份、丁香8-12份、黄柏6-15份、木鳖子6-18份。
进一步地，川乌、花椒、青风藤、丁香、黄柏、木鳖子的质量比为1:1:1:1:1:1。
进一步地，所述基质包括以下质量份的原料：聚丙烯酸钠0.05-0.1份、甘羟铝2-6份、柠檬酸0.5-1.0份、酒石酸1.2-2.0份、羧甲基纤维素钠0.1-0.6份、交联聚维酮3-5份、聚维酮K90 5-12份、甘油12-25份、蒸馏水50-100份。
进一步地，所述基质和药物浸膏的质量比为8:1-4:1。
进一步地，所述背衬层选用无纺布，所述防黏膜选用PE膜。
本发明还提供了上述治疗骨关节炎的巴布剂的制备方法，包括以下步骤：
S1，制备药物浸膏：称取川乌、花椒、青风藤、丁香、黄柏、木鳖子混合，加水煮提三次，每次1h，合并提取液，减压浓缩，得到浓缩液，向浓缩液中加入乙醇，过滤，收集上清液，回收乙醇并浓缩，即得到药物浸膏；
S2，将柠檬酸和酒石酸加入蒸馏水中，搅拌溶解，然后加入药物浸膏，搅拌混合均匀，得到药物浸膏的混合水溶液；称取聚丙烯酸钠、甘羟铝、羧甲基纤维素钠、交联聚维酮、聚维酮K90和甘油混合，搅拌均匀，然后加入药物浸膏的混合水溶液，搅拌混合均匀，即得到膏体；
S3，将膏体涂布于背衬层上，再将防黏膜覆盖在膏体的上方，切片，即得巴布剂。
川乌具有祛风除湿、温经止痛的功效，用于风寒湿痹、关节疼痛、心腹冷痛、寒疝作痛，用于治疗风寒湿痹、关节疼痛等病症。
花椒具有温中行气、逐寒、止痛、杀虫等功效。
青风藤具有明显抗炎、免疫调节、保肝、抗病毒、降血压、抗心率失常、镇咳镇静等多种功效。
丁香辛温，归脾胃肾经，有温中降逆、散寒止痛、温肾助阳的作用。
木鳖子具有散结消肿、攻毒疗疮的功效，常用于疮疡肿毒、乳痈、瘰疬、痔瘘、干癣、秃疮。
黄柏，苦寒，具有燥湿止痛的功效。
本发明提供的技术方案带来的有益效果是：本发明通过对各种药材进行合理配伍，寒温并用、热多寒少，得到的药物浸膏温而不燥，具有温经通络、消肿止痛的功效；本发明提供的巴布剂无毒、无刺激、不易过敏、载药量大，渗透性强，对皮肤具有较好的亲和力。
附图说明
图1是本发明一种治疗骨关节炎的巴布剂的制备方法的流程示意图。
具体实施方式
为使本发明的目的、技术方案和优点更加清楚，下面将结合附图对本发明实施方式作进一步地描述。
本发明的实施例提供了一种治疗骨关节炎的巴布剂，由背衬层、膏体和防黏膜组成，膏体由药物浸膏和基质组成，药物浸膏包括以下质量份的原料：川乌8-12份、花椒8-12份、青风藤6-15份、丁香8-12份、黄柏6-15份、木鳖子6-18份；基质包括以下质量份的原料：聚丙烯酸钠0.05-0.1份、甘羟铝2-6份、柠檬酸0.5-1.0份、酒石酸1.2-2.0份、羧甲基纤维素钠0.1-0.6份、交联聚维酮3-5份、聚维酮K90 5-12份、甘油12-25份、蒸馏水50-100份。
参考图1，本发明还提供了一种治疗骨关节炎的巴布剂的制备方法，包括以下步骤：
步骤S1，制备药物浸膏：按质量份计，称取川乌8-12份、花椒8-12份、青风藤6-15份、丁香8-12份、黄柏6-15份、木鳖子6-18份混合，加水煮提三次，每次1h，合并提取液，减压浓缩，得到浓缩液，向浓缩液中加入乙醇，过滤，收集上清液，回收乙醇并浓缩，即得到药物浸膏；
步骤S2，按质量份计，将0.5-1.0份柠檬酸和1.2-2.0份酒石酸加入50-100份蒸馏水中，搅拌溶解，然后加入药物浸膏，搅拌混合均匀，得到药物浸膏的混合水溶液；称取聚丙烯酸钠0.05-0.1份、甘羟铝2-6份、羧甲基纤维素钠0.1-0.6份、交联聚维酮3-5份、聚维酮K90 5-12份和甘油12-25份混合，搅拌均匀，然后加入药物浸膏的混合水溶液，搅拌混合均匀，即得到膏体；
步骤S3，将膏体涂布于无纺布上，再将PE膜覆盖在膏体的上方，切片成合适的尺寸，即得巴布剂。
其中，基质和药物浸膏的质量比为8:1-4:1。
下面结合实施例1-实施例3对本发明提供的治疗骨关节炎的巴布剂及其制备方法进行详细说明。
实施例1：
称取川乌10g、花椒10g、青风藤10g、丁香10g、黄柏10g、木鳖子10g混合，加水煮提三次，每次1h，合并提取液，减压浓缩，得到浓缩液，向浓缩液中加入乙醇，过滤，收集上清液，回收乙醇并浓缩，即得到药物浸膏；
将0.6g柠檬酸和1.5g酒石酸加入55mL蒸馏水中，搅拌溶解，然后加入20g药物浸膏，搅拌混合均匀，得到药物浸膏的混合水溶液；称取聚丙烯酸钠0.08g、甘羟铝3g、羧甲基纤维素钠0.2g、交联聚维酮3g、聚维酮K90 6g和甘油15g混合，搅拌均匀，然后加入药物浸膏的混合水溶液，搅拌混合均匀，即得到膏体；
将膏体涂布于无纺布上，再将PE膜覆盖在膏体的上方，切片成合适的尺寸，即得巴布剂。
实施例1中，每1g为一份。
实施例2：
称取川乌110g、花椒110g、青风藤110g、丁香110g、黄柏110g、木鳖子110g混合，加水煮提三次，每次1h，合并提取液，减压浓缩，得到浓缩液，向浓缩液中加入乙醇，过滤，收集上清液，回收乙醇并浓缩，即得到药物浸膏；
将8g柠檬酸和15g酒石酸加入600mL蒸馏水中，搅拌溶解，然后加入150g药物浸膏，搅拌混合均匀，得到药物浸膏的混合水溶液；称取聚丙烯酸钠0.9g、甘羟铝35g、羧甲基纤维素钠3g、交联聚维酮35g、聚维酮K90 65g和甘油160g混合，搅拌均匀，然后加入药物浸膏的混合水溶液，搅拌混合均匀，即得到膏体；
将膏体涂布于无纺布上，再将PE膜覆盖在膏体的上方，切片成合适的尺寸，即得巴布剂。
实施例2中，每10g为一份。
实施例3：
称取川乌140g、花椒140g、青风藤140g、丁香140g、黄柏140g、木鳖子140g混合，加水煮提三次，每次1h，合并提取液，减压浓缩，得到浓缩液，向浓缩液中加入乙醇，过滤，收集上清液，回收乙醇并浓缩，即得到药物浸膏；
将6.5g柠檬酸和18g酒石酸加入750mL蒸馏水中，搅拌溶解，然后加入300g药物浸膏，搅拌混合均匀，得到药物浸膏的混合水溶液；称取聚丙烯酸钠1g、甘羟铝55g、羧甲基纤维素钠5g、交联聚维酮45g、聚维酮K90 70g和甘油200g混合，搅拌均匀，然后加入药物浸膏的混合水溶液，搅拌混合均匀，即得到膏体；
将膏体涂布于无纺布上，再将PE膜覆盖在膏体的上方，切片成合适的尺寸，即得巴布剂。
实施例3中，每10g为一份。
1、取实施例1-3制得的巴布剂各5片，180度剥离后，在聚乙烯薄膜上无残留；取实施例1-实施例3制得的巴布剂各5片，分别贴于不同试验者的手腕背部处，用力甩10下后均不脱落；取实施例1-3制得的巴布剂各5片，分别不停的贴上、揭下10次，结果表明巴布剂的粘贴性良好，可以反复粘贴。
2、对实施例1-实施例3制得的巴布剂进行刺激性试验、过敏性实验：
小白鼠背部剪去毛，分别粘贴按实施例1-3制备的巴布剂于剪去毛的部位，和没贴的部位进行比较，结果没有刺激性和过敏反应。
3、巴布剂效果试验：
选取120名有骨关节炎的患者作为试用对象，任意平均分成三组，分别用实施例1、2、3制备的巴布剂贴于疼痛部位，每天1贴，使用时间为7天。所产生的效果标准：显效，疼痛消失；有效，疼痛缓解；无效，症状依旧。结果见表1：
表1:消肿止痛试验结果
| 显效(人) | 有效(人) | 无效(人) | 总有效率(％) | |
| 实施例1 | 35 | 3 | 2 | 95 |
| 实施例2 | 36 | 3 | 1 | 97.5 |
| 实施例3 | 36 | 2 | 2 | 95 |
在不冲突的情况下，本文中上述实施例及实施例中的特征可以相互结合。
以上所述仅为本发明的较佳实施例，并不用以限制本发明，凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。
Claims (6)
1.一种治疗骨关节炎的巴布剂，由背衬层、膏体和防黏膜组成，所述膏体由药物浸膏和基质组成，其特征在于，所述药物浸膏包括以下质量份的原料：川乌8-12份、花椒8-12份、青风藤6-15份、丁香8-12份、黄柏6-15份、木鳖子6-18份。
2.根据权利要求1所述的治疗骨关节炎的巴布剂，其特征在于，川乌、花椒、青风藤、丁香、黄柏、木鳖子的质量比为1:1:1:1:1:1。
3.根据权利要求2所述的治疗骨关节炎的巴布剂，其特征在于，所述基质包括以下质量份的原料：聚丙烯酸钠0.05-0.1份、甘羟铝2-6份、柠檬酸0.5-1.0份、酒石酸1.2-2.0份、羧甲基纤维素钠0.1-0.6份、交联聚维酮3-5份、聚维酮K90 5-12份、甘油12-25份、蒸馏水50-100份。
4.根据权利要求3述的治疗骨关节炎的巴布剂，其特征在于，所述基质和药物浸膏的质量比为8:1-4:1。
5.根据权利要求4所述的治疗骨关节炎的巴布剂，其特征在于，所述背衬层选用无纺布，所述防黏膜选用PE膜。
6.权利要求5所述治疗骨关节炎的巴布剂的制备方法，其特征在于，包括以下步骤：
S1，称取川乌、花椒、青风藤、丁香、黄柏、木鳖子混合，加水煮提三次，每次1h，合并提取液，减压浓缩，得到浓缩液，向浓缩液中加入乙醇，过滤，收集上清液，回收乙醇并浓缩，即得到药物浸膏；
S2，将柠檬酸和酒石酸加入蒸馏水中，搅拌溶解，然后加入药物浸膏，搅拌混合均匀，得到药物浸膏的混合水溶液；称取聚丙烯酸钠、甘羟铝、羧甲基纤维素钠、交联聚维酮、聚维酮K90和甘油混合，搅拌均匀，然后加入药物浸膏的混合水溶液，搅拌混合均匀，即得到膏体；
S3，将膏体涂布于背衬层上，再将防黏膜覆盖在膏体的上方，切片，即得巴布剂。
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