CN117503858A - 一种药辅合一消肿止痛凝胶贴膏及其制备工艺 - Google Patents
一种药辅合一消肿止痛凝胶贴膏及其制备工艺 Download PDFInfo
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Abstract
本发明公开了种药辅合一消肿止痛凝胶贴膏及其制备工艺,具体涉及中药技术领域。所述制备工艺包括血蝎、乳香、没药和红花的提取,辅料的制备,制备基质和混合得七厘散凝胶贴膏。所述凝胶贴膏包括血蝎、乳香、没药、红花、填充剂、黏着剂、交联剂和透皮吸收剂。本发明提高了药物疗效:通过优化各药物的入药方式和比例,使得药物能够更好地发挥疗效,提高治疗效果。本发明减少了辅料用量:将部分药物用作凝胶贴膏的基质,降低了辅料的使用量,减轻了患者对辅料过敏反应的风险。本发明绿色环保:采用天然植物提取物为原料,减少了对环境的污染,符合绿色制药的理念。
Description
技术领域
本发明涉及中药技术领域,具体涉及一种药辅合一消肿止痛凝胶贴膏及其制备工艺。
背景技术
随着现代社会生活节奏的加快以及人们生活方式的改变,关节疼痛和肿胀等问题日益严重,给人们的生活带来诸多不便。因此,针对关节问题的药物和治疗方法的需求也越来越大。目前市场上的关节疾病治疗药物种类繁多,但大多存在一定的局限性,如副作用大、疗效缓慢等。因此,开发一种既安全又有效的新型关节疾病治疗药物成为了医药领域的研究热点之一。
膏药在我国的应用历史悠久,用植物油或动物油加药熬成胶状物质,涂在布、纸或皮的一面可以较长时间地贴在患处,膏药中的药物直接贴敷于体表穴位上,药性透过皮毛由表入里渗透皮下组织,一方面在局部产生药物浓度的相对优势,另一方面可通过经络的贯通运行,直达脏腑失调经气失调的病所,发挥药物的功能效应,从而发挥最大的全身药理效应。传统的注射及口服疗法损伤神经、血管、肌肉等组织使病人不易接受,且这些方法都易使药物通过全身的血液循环分散各处,真正到达疾病局部的药物少,用药量大但疗效差,膏药避免了内服的毒副作用,同时药物直接作用于患处,药效高、见效明显且不易产生耐药性,对于风湿痛、关节扭伤等作用良好。
消肿止痛散原方源自清代谢元庆的《良方集腋》,具有止痛、止血、化瘀消肿之效,主要用于治疗跌打损伤,筋断骨折等。现代药理学研究证实,消肿止痛散可有效治疗急性软组织损伤。传统上,消肿止痛散在使用时需用黄酒调和后敷药包扎,存在包扎步骤繁杂、质量可控性差等不足之处,已无法满足日益增长的临床需求。
凝胶膏剂是将药物溶解或混合于天然与合成水溶性高分子材料基质中,并摊涂于背衬材料上,供贴敷于皮肤的外用制剂,经透皮吸收起全身作用或局部作用。与传统的外用贴膏相比,凝胶膏剂具有载药量大;药物长时间缓缓释放;透气、不拔体毛,使用舒适,无皮肤刺激和过敏反应,且可多次在身体各部位贴敷等优点,因此,凝胶膏剂作为一种新型外用制剂,特别适合对传统中药外用经方、验方进行剂型开发与研究。
发明内容
为此,本发明提供一种药辅合一消肿止痛凝胶贴膏及其制备工艺,以解决上述问题。
本发明通过优化各药材的入药方式和比例,实现药材的有效成分与凝胶贴膏基质的有机结合,提高药物疗效并减少辅料用量。
为了实现上述目的,本发明提供如下技术方案:
根据本发明一方面提供的一种药辅合一消肿止痛凝胶贴膏的制备工艺,包括:
步骤一,血蝎、乳香、没药和红花的提取
按照配方比例,将血蝎、乳香、没药和红花加入乙醇溶液,进行提取,提取完成后,过滤得到浸润膏;
步骤二,辅料的制备
将交联剂以水溶解,得到A相;将黏着剂加水浸胀,得到B相;
步骤三,制备基质
将浸润膏与填充剂、黏着剂和交联剂进行混合,然后分散在甘油中,得到C相;
步骤四,混合
将A相和B相混合后加入C相中,将透皮吸收剂加入C相搅拌均匀,得七厘散凝胶贴膏。
进一步的,所述步骤一中,乙醇溶液加入量为药物的8倍。
进一步的,所述步骤一中,提取条件为80%的乙醇溶液;提取两次,每次60min。
进一步的,所述步骤二中,交联剂为酒石酸;黏着剂为卡波姆。
进一步的,所述步骤三中,填充剂为儿茶细粉;黏着剂为聚丙烯酸钠;交联剂为甘羟铝。
进一步的,所述步骤三中,透皮吸收剂为冰片和麝香粉。
本发明根据七厘散处方中各药味的性能特点,选择其最佳的入药方式。如儿茶以干燥煎膏入药,并将其打成细粉兼作基质中的填充剂;冰片、麝香同为芳香开窍药,具有辛香走窜之性,作为基质中的透皮吸收剂;血竭、红花、乳香、没药中有效成分多具醇溶性,故以乙醇回流提取制成浸膏入药,其中乳香、没药具有一定黏性,经醇提后的药渣作为部分黏着剂使用。
本发明方中儿茶、冰片、麝香、乳香和没药在发挥其药效的同时兼作凝胶贴膏成型中的部分基质,减少了辅料的使用。这种药辅合一的设计使得凝胶贴膏更加高效、安全、环保。
根据本发明另一方面提供的一种药辅合一消肿止痛凝胶贴膏,包括血蝎、乳香、没药、红花、填充剂、黏着剂、交联剂和透皮吸收剂。
进一步的,卡波姆1.1份、聚丙烯酸钠3份、甘油21.7份、甘羟铝:酒石酸=1.3:1。
本发明提高了药物疗效:通过优化各药物的入药方式和比例,使得药物能够更好地发挥疗效,提高治疗效果。
本发明减少了辅料用量:将部分药物用作凝胶贴膏的基质,降低了辅料的使用量,减轻了患者对辅料过敏反应的风险。
本发明绿色环保:采用天然植物提取物为原料,减少了对环境的污染,符合绿色制药的理念。
本发明提供了一种药辅合一消肿止痛凝胶贴膏及其制备工艺,通过优化各药物的入药方式和比例,提高药物疗效并减少辅料用量,具有较高的实用价值和市场前景。
本发明的凝胶贴膏采用了独特的配方和制备工艺,使得药物和辅料在发挥其药效的同时,还能有效地减少辅料的使用,降低成本,提高药物的利用率。这种药辅合一的设计理念,使得凝胶贴膏在治疗关节疾病方面具有更高的安全性和有效性。
本发明选取了血蝎、乳香、没药和红花这四种具有显著消肿止痛作用的药材作为主要成分。这些药材中的有效成分多具醇溶性,因此采用乙醇回流提取制成浸膏入药。其中,乳香和没药还具有一定黏性,经醇提后的药渣可以作为部分黏着剂使用。这种设计充分利用了药材的性能特点,提高了药物的利用率。
本发明还选用了儿茶作为填充剂,将其打成细粉兼作基质中的填充剂。儿茶具有良好的黏附性和保湿性,能够有效地附着在皮肤表面,延长药物的释放时间,提高药物的生物利用度。同时,儿茶还具有抗炎镇痛的作用,能够有效地缓解关节疼痛和肿胀的症状。
本发明还选用了冰片和麝香作为透皮吸收剂。冰片和麝香同为芳香开窍药,具有辛香走窜之性,能够有效地穿透皮肤屏障,使药物迅速作用于患处,提高药物的疗效。同时,这两种药材还具有抗炎镇痛的作用,能够有效地缓解关节疼痛和肿胀的症状。
本发明的药辅合一消肿止痛凝胶贴膏及其制备工艺,通过合理地选用药材和辅料,实现了药物和辅料的有机结合,提高了药物的疗效和安全性。这种新型凝胶贴膏在未来有望成为关节疾病治疗的首选药物,为广大的关节疾病患者带来福音。
本发明具有如下优点:
1.药辅合一:本发明提供的一种药辅合一消肿止痛凝胶贴膏通过将中药成分与凝胶贴膏相结合,实现了药物与辅料的双重作用,提高了治疗效果。
2.提高生物利用度:通过选用适宜的透皮吸收剂,如冰片和麝香,提高了药物的透皮吸收能力,从而提高了药物的生物利用度。
3.减少辅料用量:通过将儿茶、冰片、麝香、乳香和没药等中药成分兼作凝胶贴膏成型中的部分基质,减少了辅料的使用,降低了生产成本,同时避免了辅料对药物疗效的影响。
4.个性化治疗:本发明根据七厘散处方中各药味的性能特点,选择其最佳的入药方式,使得凝胶贴膏更具针对性,能够满足不同患者的个性化治疗需求。
5.安全性高:本发明采用乙醇提取中药成分,避免了挥发性成分的丢失,保证了药物的疗效,同时乙醇易于挥发,降低了皮肤刺激性和过敏反应的风险。
6.工艺简便:本发明采用乙醇提取、甘油分散等常用制剂技术,工艺简便,易于规模化生产,有利于推广和应用。
附图说明
为了更清楚地说明本发明的实施方式或现有技术中的技术方案,下面将对实施方式或现有技术描述中所需要使用的附图作简单地介绍。显而易见地,下面描述中的附图仅仅是示例性的,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据提供的附图引伸获得其它的实施附图。
本说明书所绘示的结构、比例、大小等,均仅用以配合说明书所揭示的内容,以供熟悉此技术的人士了解与阅读,并非用以限定本发明可实施的限定条件,故不具技术上的实质意义,任何结构的修饰、比例关系的改变或大小的调整,在不影响本发明所能产生的功效及所能达成的目的下,均应仍落在本发明所揭示的技术内容得能涵盖的范围内。
图1为本发明实施例1提供的一种药辅合一消肿止痛凝胶贴膏制备工艺流程图;
图2为本发明实验例2提供的实物图。
具体实施方式
以下由特定的具体实施例说明本发明的实施方式,熟悉此技术的人士可由本说明书所揭露的内容轻易地了解本发明的其他优点及功效,显然,所描述的实施例是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
实施例
本实施例提供一种药辅合一消肿止痛七厘散凝胶贴膏:
1.实验设计
1.1单因素试验设计
本试验以卡波姆940、聚丙烯酸钠、甘油的用量以及甘羟铝和酒石酸的比例4个因素作为凝胶贴膏综合感官的考察对象,进行单因素试验,从而确定响应曲面设计的各因素水平,试验安排如表1所示。
表1七厘散凝胶贴膏单因素试验设计
1.2Box-Behnken响应曲面实验设计
采用实验软件Design-Expert 11中的Box-Behnken设计响应曲面实验,通过单因素实验选取出卡波姆940(A)、聚丙烯酸钠(B)、甘油(C)的用量以及甘羟铝与酒石酸的比例(D)4个因素的水平,按2项的方法制备七厘散凝胶贴膏剂,并以综合感官为指标对贴膏的质量进行评分,试验安排如表2所示。
表2七厘散凝胶贴膏Box-Behnken响应曲面设计及综合感官评分
通过Design-Expert 11软件进行响应面回归分析,得到多元二次响应面回归模型。
结果显示:卡波姆1.1g、聚丙烯酸钠3g、甘油21.7g、甘羟铝:酒石酸=1.3:1,凝胶贴膏的综合感官评分为59.5。
2.制备工艺
制备流程如图1所示。
将血蝎6g份、乳香2g份、没药2g份和红花1g份加入8倍量的80%乙醇,提取两次,每次60min,得到浸润膏;
将交联剂酒石酸0.2g份以水溶解后得到A相;将黏着剂卡波姆1.1g份加水浸胀24h,得到B相;
将A相和B相混合后加入C相中;将浸润膏与填充剂儿茶细粉2g份、黏着剂聚丙烯酸钠3g份和交联剂甘羟铝0.26g份进行混合后分散在甘油中,得到C相;将透皮吸收剂冰片1g份和麝香粉0.1g份加入C相中,混合后得七厘散凝胶贴膏。
采用此处方制备的七厘散凝胶贴膏外观优良、涂展性良好、敷贴舒适、皮肤无残留、具有良好的成型性和黏着性。
实验例
1.七厘散凝胶贴膏质量评价指标及方法
采用综合感官评价指标对七厘散凝胶贴膏剂进行质量评价并评分。对凝胶贴膏的膏体均匀度(10分)、涂展性(10分)、膜残留性(10分)、皮肤追随性(10分)、背衬渗透度(10分)、反复粘贴性(10分)进行感官评分[1],以每项感官最佳评分为10分,其余的与之相比计算得分,总分为60分,具体评分标准见表3。
表3感官评价指标体系
2.性状
如图2所示,膏面光洁,厚薄均匀,色泽一致,无脱膏、失黏现象。背衬面平整、洁净、无漏膏现象。
虽然,上文中已经用一般性说明及具体实施例对本发明作了详尽的描述,但在本发明基础上,可以对之作一些修改或改进,这对本领域技术人员而言是显而易见的。因此,在不偏离本发明精神的基础上所做的这些修改或改进,均属于本发明要求保护的范围。
Claims (7)
1.一种药辅合一消肿止痛凝胶贴膏的制备工艺,其特征在于,包括:
步骤一,血蝎、乳香、没药和红花的提取
按照配方比例,将血蝎、乳香、没药和红花加入乙醇溶液,进行提取,提取完成后,过滤得到浸润膏;
步骤二,辅料的制备
将交联剂以水溶解,得到A相;将黏着剂加水浸胀,得到B相;
步骤三,制备基质
将浸润膏与填充剂、黏着剂和交联剂进行混合,然后分散在甘油中,得到C相;
步骤四,混合
将A相和B相混合后加入C相中,将透皮吸收剂加入C相搅拌均匀,得七厘散凝胶贴膏。
2.根据权利要求1所述的一种药辅合一消肿止痛凝胶贴膏的制备工艺,其特征在于,所述步骤一中,乙醇溶液加入量为药物的8倍。
3.根据权利要求1所述的一种药辅合一消肿止痛凝胶贴膏的制备工艺,其特征在于,所述步骤一中,提取条件为80%的乙醇溶液;提取两次,每次60min。
4.根据权利要求1所述的一种药辅合一消肿止痛凝胶贴膏的制备工艺,其特征在于,所述步骤二中,交联剂为酒石酸;黏着剂为卡波姆。
5.根据权利要求1所述的一种药辅合一消肿止痛凝胶贴膏的制备工艺,其特征在于,所述步骤三中,填充剂为儿茶细粉;黏着剂为聚丙烯酸钠;交联剂为甘羟铝。
6.根据权利要求1所述的一种药辅合一消肿止痛凝胶贴膏的制备工艺,其特征在于,所述步骤三中,透皮吸收剂为冰片和麝香粉。
7.一种药辅合一消肿止痛凝胶贴膏,其特征在于,包括血蝎、乳香、没药、红花、填充剂、黏着剂、交联剂和透皮吸收剂。
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