CN114681552A - 麝香祛痛巴布膏剂及其制备方法 - Google Patents

麝香祛痛巴布膏剂及其制备方法 Download PDF

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CN114681552A
CN114681552A CN202210396925.7A CN202210396925A CN114681552A CN 114681552 A CN114681552 A CN 114681552A CN 202210396925 A CN202210396925 A CN 202210396925A CN 114681552 A CN114681552 A CN 114681552A
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cataplasm
relieving
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CN114681552B (zh
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王圣军
夏恒建
杜林江
蔡京菁
陈林霖
王伟华
李灿阳
张文才
彭仕梅
孙利伟
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Lishizhen Pharmaceutical Group Co ltd
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Abstract

本发明涉及麝香祛痛巴布膏剂及其制备方法，包括以下步骤：按质量百分数计，取2％～8％的基质加入到0.5％～5％的保湿剂中，分散均匀后加入到86.7％～97.4％的麝香浸膏中，再加入0.1％～0.3％的交联剂，搅拌至溶解完全得到凝胶，再经过涂布、覆膜、静置和切片，得到麝香祛痛巴布膏剂。本发明贴敷膏剂载药量大，持续效果好，耐热、黏附力、赋形性、含量均匀度、透皮吸收性能、稳定性综合得分高，携带和使用方便。

Description

麝香祛痛巴布膏剂及其制备方法
技术领域
本发明涉及医药领域，具体涉及麝香祛痛巴布膏剂及其制备方法。
背景技术
麝香浸膏由人工麝香、红花、樟脑、独活、冰片、龙血竭、薄荷脑、地黄、三七、乙醇配制而成。功能活血祛瘀，疏经活络，消肿止痛。用于各种跌打损伤，瘀血肿痛，风湿瘀阻，关节疼痛。使用时，取本品涂搽患处，按摩5-10分钟至患处发热，一日2-3次；软组织扭伤严重或有出血者，将药液浸湿的棉垫敷于患处。本品含乙醇、薄荷脑、冰片等易挥发物质，涂于患处，数分钟后即挥发。对于扭伤严重者，需要将药液浸湿的棉垫敷于患处，以延长药物作用时间、增强使用效果，但是棉垫容易移位或脱落，给部分患者带来不便。
巴布膏，又称凝胶贴膏，是指原料药物与适宜的亲水性基质混匀后涂布于背衬材料上制成的贴膏剂。巴布膏具有载药量大、作用时间长、对皮肤刺激小等优点。常用基质有聚丙烯酸钠、羧甲纤维素钠、明胶、甘油和微粉硅胶等。经过查阅科技文献和试验，以麝香浸膏的有效成分为主成分，分别以聚丙烯酸钠、羧甲纤维素钠、明胶、甘油和微粉硅胶等作为基质，结果黏附力、赋形性、耐热性、透皮吸收效果等理化指标均不甚理想，有必要提供一种指标结果更好的巴布膏。
发明内容
本发明的目的在于克服现有技术不足，提供一种麝香祛痛巴布膏剂及其制备方法，在不影响膏剂药用性能的同时，提升其黏附力和透皮吸收效果。
为达到上述技术目的，本发明巴布膏剂的技术方案是：
按质量百分数计，包括基质2％～8％、交联剂0.1％～0.3％、保湿剂0.5％～5％以及86.7％～97.4％的麝香浸膏。
进一步地，基质包括质量比为(2～5)：(0～1.0)：(0～2)的聚丙烯酸钠、羧甲基壳聚糖和明胶。
进一步地，交联剂为京尼平。
进一步地，保湿剂为聚乙二醇200。
进一步地，麝香浸膏由如下质量份的原料加乙醇浸提得到：人工麝香0.33份、红花1份、樟脑30份、独活1份、冰片20份、龙血竭0.33份、薄荷脑10份、地黄20份和三七0.33份。
本发明制备方法的技术方案是：包括以下步骤：
按质量百分数计，取2％～8％的基质加入到0.5％～5％的保湿剂中，分散均匀后加入到86.7％～97.4％的麝香浸膏中，再加入0.1％～0.3％的交联剂，搅拌至溶解完全得到凝胶，再经过涂布、覆膜、静置和切片，得到麝香祛痛巴布膏剂。
进一步地，麝香浸膏的制备步骤包括：取人工麝香0.33g、三七0.33g和红花1g，分别用50％乙醇10mL分三次浸渍，每次7天，合并浸渍液，滤过，滤液备用；地黄20g用50％乙醇100mL分三次浸渍，每次7天，合并浸渍液，滤过，滤液备用；龙血竭0.33g和独活1g分别用乙醇10mL分三次浸渍，每次7天，合并浸渍液，滤过，滤液备用；冰片20g和樟脑30g加入乙醇100mL搅拌使溶解，混匀，加入50％乙醇700mL，加入上述各浸渍液，混匀；将薄荷脑10g用适量50％乙醇溶解，加入上述药液中，加50％乙醇至总量为1000mL，混匀，静置，滤过，即得。
进一步地，涂布是将凝胶涂布在防渗布上。
进一步地，覆膜后静置24h再切片。
进一步地，切片的尺寸为40mm×40mm，每片含药量为1.5～2.5g。
与现有技术相比，本发明的有益效果包括：
1.本发明贴敷膏剂载药量大，一片凝胶药量相对擦剂一次喷药量能够提升十倍以上，持续效果好，可以持续8h缓慢释放药量(擦剂喷药后约1min药物就被吸收)，耐热、黏附力、赋形性、含量均匀度、透皮吸收性能、稳定性综合得分高。
2.携带和使用方便，即撕即贴，常温放置无流膏或渗油现象，不会沾到衣物上；黏着力合适，在1208～1830mN，在保证贴敷性好的同时，又不会紧贴皮肤，保证使用后轻松取下，避免拉伤皮肤。
3.使用后，无膏剂残留在皮肤上，有效避免传统膏药残留现象，方便清理。
进一步地，本发明采用的基质利于巴布膏涂布成型，且其中的羧甲基壳聚糖具有止血、愈合、抗菌抗感染、镇痛作用，利于提高巴布膏剂的药效。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白，以下结合实施例，对本发明进行进一步详细说明。应当理解，此处所描述的具体实施例仅仅用以解释本发明，并不用于限定本发明。
实施例一
本实施例产品处方及制法：
(1)人工麝香0.33g红花1g樟脑30g独活1g冰片20g龙血竭0.33g薄荷脑10g地黄20g三七0.33g
(2)以上9味药材，取人工麝香、三七、红花，分别用50％乙醇10mL分三次浸渍，每次7天，合并浸渍液，滤过，滤液备用；地黄用50％乙醇100mL分三次浸渍，每次7天，合并浸渍液，滤过，滤液备用；龙血竭、独活分别用乙醇10mL分三次浸渍，每次7天，合并浸渍液，滤过，滤液备用；冰片、樟脑加入乙醇100mL搅拌使溶解，混匀，加入50％乙醇700mL，加入上述各浸渍液，混匀；前述8味药材50％(wt)乙醇用量合计920mL，即每组原料对应的乙醇用量为该组原料的总乙醇量；将薄荷脑用适量(如20～30mL)50％乙醇溶解，加入上述药液中，加50％乙醇至总量为1000mL，混匀，静置，滤过，即得麝香浸膏药液。
(3)凝胶制备：取聚丙烯酸钠(2.2％)、羧甲基壳聚糖(0.8％)、明胶(2％)(由聚丙烯酸钠、羧甲基壳聚糖和明胶组成5％的基质)、京尼平(0.1％)、聚乙二醇200(0.5％)、麝香浸膏药液(94.4％)。先用聚乙二醇200将基质分散均匀后，再加入到麝香浸膏中，最后加入交联剂，这样基质容易在所得凝胶中分散开，不易结团。
(4)涂布：将凝胶均匀涂布在防渗布上，贴上膜放置24h再切片即得麝香祛痛巴布膏剂。本实施例所得膏剂易涂布，易成形，涂布后表面光滑。涂布后先放置再切片，能够保证膏剂更好地固化。
对本实施例制得的样品以及申请人所产的本草纲目麝香祛痛擦剂进行测试，结果如下表1所示。
表1实施例一制得的麝香祛痛巴布膏剂和麝香祛痛擦剂测试对比
Figure BDA0003599388990000041
由表1可知，本发明贴敷膏剂载药量大，一片凝胶约2g药量(相对擦剂一次喷药量提升十倍以上)，持续效果好，可以持续8h缓慢释放药量(擦剂喷药后约1min药物就被吸收)。
实施例二
步骤(3)采用2.5％的聚丙烯酸钠，0.6％的羧甲基壳聚糖、1％的明胶、0.05％的京尼平，5％的聚乙二醇200，90.85％的麝香浸膏药液，其它步骤及条件同实施例一，制得麝香祛痛巴布膏剂。
实施例三
步骤(3)采用2％的聚丙烯酸钠，1％的羧甲基壳聚糖、1.8％的明胶、0.15％的京尼平，0.6％的聚乙二醇200，94.45％的麝香浸膏药液，其它步骤及条件同实施例一，制得麝香祛痛巴布膏剂。
对比例一
采用聚乙二醇600替换聚乙二醇200，其它步骤及条件同实施例一。
对比例二
取等量的聚丙烯酸钠、羧甲纤维素钠、明胶、甘油和微粉硅胶混合，以该混合物替换实施例一的基质(聚丙烯酸钠、羧甲基壳聚糖和明胶，总量为5％)，用量及其它步骤条件同实施例一。
对比例三
基质仅采用5％的羧甲基壳聚糖，用量及其它步骤条件同实施例一。
对实施例一～实施例三以及对比例一～对比例三所得的麝香祛痛巴布膏剂样品进行测试，测试方法参考《中国药典》凝胶贴的相关测试，结果如下表2所示。
表2实施例一至三以及对比例一至七所制得的样品测试结果
Figure BDA0003599388990000051
由表2可知，本发明膏剂耐热、黏附力、赋形性、含量均匀度、透皮吸收性能、稳定性综合得分高；其中黏着力在1208～1830mN，在保证贴敷性好的同时，又不会紧贴皮肤，保证使用后能够较轻松地取下，避免拉伤皮肤。
实施例四
步骤(3)采用5％的聚丙烯酸钠，0.1％的京尼平，0.5％的聚乙二醇200，94.4％的麝香浸膏药液，其它步骤及条件同实施例一，制得麝香祛痛巴布膏剂。
本发明以聚丙烯酸钠、羧甲基壳聚糖和明胶为骨架、京尼平为交联剂，聚乙二醇200作为溶剂和保湿剂，结果耐热、黏附力、赋形性、含量均匀度、透皮吸收性能、稳定性综合得分最高，各项指标均符合《中国药典》的要求。
以上所述本发明的具体实施方式，并不构成对本发明保护范围的限定。任何根据本发明的技术构思所做出的各种其他相应的改变与变形，均应包含在本发明权利要求的保护范围内。

Claims (10)

1.麝香祛痛巴布膏剂，其特征在于，按质量百分数计，包括基质2％～8％、交联剂0.1％～0.3％、保湿剂0.5％～5％以及86.7％～97.4％的麝香浸膏。
2.根据权利要求1所述的麝香祛痛巴布膏剂，其特征在于，基质包括质量比为(2～5)：(0～1.0)：(0～2)的聚丙烯酸钠、羧甲基壳聚糖和明胶。
3.根据权利要求1所述的麝香祛痛巴布膏剂，其特征在于，交联剂为京尼平。
4.根据权利要求1所述的麝香祛痛巴布膏剂，其特征在于，保湿剂为聚乙二醇200。
5.根据权利要求1所述的麝香祛痛巴布膏剂，其特征在于，麝香浸膏由如下质量份的原料加乙醇浸提得到：人工麝香0.33份、红花1份、樟脑30份、独活1份、冰片20份、龙血竭0.33份、薄荷脑10份、地黄20份和三七0.33份。
6.如权利要求1-5任一项所述麝香祛痛巴布膏剂的制备方法，其特征在于，包括以下步骤：
按质量百分数计，取2％～8％的基质加入到0.5％～5％的保湿剂中，分散均匀后加入到86.7％～97.4％的麝香浸膏中，再加入0.1％～0.3％的交联剂，搅拌至溶解完全得到凝胶，再经过涂布、覆膜、静置和切片，得到麝香祛痛巴布膏剂。
7.根据权利要求6所述的麝香祛痛巴布膏剂的制备方法，其特征在于，麝香浸膏的制备步骤包括：取人工麝香0.33g、三七0.33g和红花1g，分别用50％乙醇10mL分三次浸渍，每次7天，合并浸渍液，滤过，滤液备用；地黄20g用50％乙醇100mL分三次浸渍，每次7天，合并浸渍液，滤过，滤液备用；龙血竭0.33g和独活1g分别用乙醇10mL分三次浸渍，每次7天，合并浸渍液，滤过，滤液备用；冰片20g和樟脑30g加入乙醇100mL搅拌使溶解，混匀，加入50％乙醇700mL，加入上述各浸渍液，混匀；将薄荷脑10g用适量50％乙醇溶解，加入上述药液中，加50％乙醇至总量为1000mL，混匀，静置，滤过，即得。
8.根据权利要求6所述的麝香祛痛巴布膏剂的制备方法，其特征在于，涂布是将凝胶涂布在防渗布上。
9.根据权利要求6所述的麝香祛痛巴布膏剂的制备方法，其特征在于，覆膜后静置24h再切片。
10.根据权利要求6所述的麝香祛痛巴布膏剂的制备方法，其特征在于，切片的尺寸为40mm×40mm，每片含药量为1.5～2.5g。
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CN1729997A (zh) * 2005-08-03 2006-02-08 包头中药有限责任公司 一种麝香祛痛喷雾剂的制法
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CN1729997A (zh) * 2005-08-03 2006-02-08 包头中药有限责任公司 一种麝香祛痛喷雾剂的制法
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