CN107468840B - 一种活血止痛的外用贴膏 - Google Patents

一种活血止痛的外用贴膏 Download PDF

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CN107468840B
CN107468840B CN201710708919.XA CN201710708919A CN107468840B CN 107468840 B CN107468840 B CN 107468840B CN 201710708919 A CN201710708919 A CN 201710708919A CN 107468840 B CN107468840 B CN 107468840B
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俞帮和
徐�明
蒋志刚
汪海涛
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Hangzhou Rende Pharmaceutical Co ltd
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Abstract

本发明属于膏药制剂技术领域,一种活血止痛的外用贴膏,由冰片、樟脑、缓释剂、川芎流浸膏、薄荷油、桂皮醛、氧化锌、凡士林、松香、羊毛脂、液状石蜡、透皮促进剂、增粘剂、增乳剂、二甲亚砜、橡胶制成,缓释剂为纳米级椰壳活性炭、硅烷偶联剂改性硅微粉或α‑环糊精中的一种。本发明活性止痛的外用贴膏,具有非常明显的活血止痛的效果,同时具有良好的透皮吸收率,见效快,膏药中有效成分不易挥,膏药粘性好,品质均匀。同时制备中先制成纳米级的乳化浆料再涂胶使外用贴膏的成分更容易被皮肤吸收。

Description

一种活血止痛的外用贴膏
技术领域
本发明属于膏药制剂技术领域,具体涉及一种活血止痛的外用贴膏。
背景技术
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。
但是现有膏药存在以下生产或使用问题:一、部分膏药针对性差,一种膏药治疗多种疾病,药效不理想;二、膏药透皮吸收率低,见效慢,用药周期长;二、膏药中有效成分易挥发造成药效降低;三、膏药厚度薄、粘结性差,膏药覆盖物如剥离纸等的封装效果不好且容易受潮;四、各配料在膏药中分散不均造成膏药品质不一;五、膏药透气性差。
中国专利2017100483299,专利名称一种中草药熬制的膏药及其制备方法,申请日期2017年1月21日,公开了一种由巴戟天,山药,山茱萸,肉苁蓉,肉桂,附子,川断,甘草,牛膝,蜈蚣,全虫,白芍,狗脊,茯苓,白术,伸筋草,透骨草,麻黄,桂枝,三七,生草乌,生川乌,细辛,徐长卿,野木瓜,红花,乳香,土元,栀子,灵仙,生大黄,赤芍,红藤,冰片,麻油,松香,雪松,车前草,和尚头,山珍,石榴根,海苔,生马钱子,生南星,生半夏,五加皮,肉桂,川芎,细辛,干姜,狗尾草,地黄,玄参,桑枝,白芷,赤勺,土木鳖,乳香,没药,柳枝,头发灰,血竭等制备的膏药,该膏药的不足之处在于膏药针对性差,药效不理想。
发明内容
针对部分膏药的针对性差、药效不理想的问题,本发明的目的在于提供一种活血止痛的外用贴膏,具有非常明显的胜湿止痛的效果,同时具有良好的透皮吸收率,见效快,膏药中有效成分不易挥,膏药粘性好,品质均匀。
本发明的另一目的在于提供一种制备活血止痛的外用贴膏的制备方法。
本发明提供如下的技术方案:
一种活血止痛的外用贴膏,所述外用贴膏经由以下重量份的组份制备而成:冰片500~750份、樟脑250~375份、缓释剂150~200份、川芎流浸膏3520~4875份、薄荷油150~225份、桂皮醛100~150份、氧化锌1900~2850份、凡士林150~225份、松香1500~2250份、羊毛脂250~375份、液状石蜡50~75份、透皮促进剂100~160份、增粘剂60~110份、增乳剂60~100份、二甲亚砜50~75份、橡胶1750~2575份。
本发明的活血止痛的外用贴膏中,桂皮醛可以镇痛解热、杀菌,冰片可以透骨散热,樟脑可以镇痛止痒,氧化锌起到填充剂的作用并与松香反应生成松香酸的辛盐,促进橡胶的乳化,羊毛脂起到软化橡胶的作用且增强膏药粘性。薄荷油、松香、樟脑在提供芳香气味的同时起到清凉止痒、消肿止痛、杀菌抑菌的作用。川穹流浸膏起到活血、散寒、止痛的效果。透皮促吸收剂可以提高各药物成分的透皮吸收率与透皮速度,缩短外用贴膏的药效周期并提高药分利用率。增乳剂、增粘剂一方面增强贴膏的粘性,一方面使外用贴膏的药分品质均匀,同时乳化纳米级的外用贴膏更容易被皮肤吸收。因此本发明的外用贴膏的活血止痛效果明显,而且粘性好,透皮吸收效果好,药效块。
作为本发明的一种改进,川穹流浸膏经以下过程制备而成:将重量份的川芎500~750份、大黄500~750份、生附子500~750份、丁香500~750份、石菖蒲500~750份、红花250~375份、徐长卿250~375份、甘松250~375份、麝香3.5~5份、凤仙梗10~15份、醉鱼草10~15份、骨碎补20~35份混合后粉碎得到粗粉料,然后加入95%的酒精加热浸渍,将浸渍液真空浓缩至原体积的30%~40%得川芎流浸膏。川穹可以活血祛瘀,大黄可清热消积,生附子可散寒止痛,丁香可以抑菌,石菖蒲祛湿活血,红花散瘀通经,徐长卿祛风止痛,甘松祛湿消肿,麝香破血化瘀,骨碎补伤止痛,凤仙梗、醉鱼草消积止痛。
作为本发明的一种改进,缓释剂为纳米级椰壳活性炭或α-环糊精。利用纳米级椰壳活性炭的多孔结构或α-环糊精的球笼结构降低樟脑等成分挥发,延长药效时间。
作为本发明的一种改进,透皮促进剂包括主剂与辅剂,主剂为N,N-二甲氨基异丙酸十二烷酯同阿魏酸、α-甜没药萜醇和甘油单辛醚中的任意一种的组合,辅剂为椰油酰胺丙基甜菜碱或溴代1-丁基-3-甲基-咪唑。药物穿过皮肤进入体内,皮肤的角质层是类脂质分子形成的多层脂质分子层、结构致密,是药物透皮吸收的主要屏障。药物的透皮吸收包括从膏药中脱离并扩散到皮肤或粘膜表面,然后通过表皮进入真皮、皮下组织,并通过血管或淋巴管进入靶位。因此通过亲脂性分子进入角质层并破坏角质层的有序紧密排列可以提高药物的透皮率,而N,N-二甲氨基异丙酸十二烷酯具亲脂性好,可明显提高药物的穿过角质层的能力。同时将N,N-二甲氨基异丙酸十二烷酯与亲水的阿魏酸、α-甜没药萜醇或甘油单辛醚复配使用后增强透皮促吸收剂在角质层与亲水性药物之间的连接能力。椰油酰胺丙基甜菜碱或溴代1-丁基-3-甲基-咪唑具有良好的亲水、亲脂能力强,可以强化主剂的促吸收作用。
作为本发明的一种改进,增粘剂为纳米二氧化硅气凝胶。纳米二氧化硅气凝胶具有较高的粘性,而且乳化作用好,可以提高外用贴膏的粘结能力,强化增乳剂的作用。同时纳米二氧化硅气凝胶具有丰富的孔隙率,经高速均质分布后在外用贴膏内形成交联网络,增强外用贴膏的透气性能。
作为本发明的一种改进,增乳剂为甘油磷酸酯或大豆磷脂。提高胶浆的乳化性能,同时大豆磷脂、甘油磷酸酯同时具有良好的亲水与亲脂能力,强化透皮促进剂的作用。
一种活血止痛的外用贴膏的制备方法,包括以下步骤:
(1)制胶:将橡胶切成13~17cm的橡胶条,投于炼胶机辊压得到0.1~1.8mm厚的橡胶薄片,然后置于搅拌机内加入汽油溶剂浸泡溶胀;
(2)配料:将川芎流浸膏溶于18~28倍体积的乙醇中搅拌均匀,然后将樟脑、冰片、二甲亚砜、松香、薄荷油、桂皮醛、缓释剂投入乙醇中并在20~27℃内静置24~48小时,再依次加入透皮促进剂、氧化锌、凡士林、液状石蜡搅拌均匀得到混合料液,将羊毛脂溶于3~7倍体积的乙醚中搅拌溶解得到乙醚料液;
(3)打浆:将溶胀后的橡胶薄片剪成长度小于1cm的橡胶段,再投入打胶机内并加入混和料液、乙醚料液搅拌打胶,经筛网过筛得到胶浆,同时将筛网截留的料液再次返回打胶;
(4)匀浆:向胶浆中加入增粘剂、增乳剂后搅拌均匀,送入高速均质机中保持转速8000~10000r/min均质处理得到乳化浆料;
(5)涂胶:将背衬送入涂胶机的两辊压筒中,向涂胶机投加乳化浆料涂覆在背衬上制成膏剂;
(6)卷轴:加热卷轴机并控制卷轴机中各烘箱处的温度分别为:第一道烘箱温度55~65℃,第二道烘箱温度85~95℃,第三道烘箱温度65~75℃,将膏剂卷轴处理;
(7)贴纸:在膏剂的膏药面贴合剥离纸,在剥离纸外侧涂覆挥发阻止层;
(8)封装:按规定尺寸切片后套袋封装得到用于治疗关节痛的外用贴膏。
本发明的方法中将各药物成分混合加入溶胀后的橡胶薄片中打胶制成胶浆,然后经高速均质制成乳化浆料,再涂胶成型,并在剥离纸外侧涂覆挥发阻止层制成用于祛风湿的外用贴膏,对缓解风湿疼痛并治愈具有非常明显的效果。经添加增乳剂后高速均质的乳化浆料的粒径细小甚至达到纳米级,一方面增强贴膏的粘性、一方面使外用贴膏的药分品质均匀,同时乳化纳米级的外用贴膏更容易被皮肤吸收,强化了透皮促进剂的增强透皮率的作用。
作为本发明方法的一种改进,步骤(1)中橡胶薄片与汽油溶剂的质量比为1:5.3~10.7,汽油溶剂由120号汽油与乙醇混合而成,120号汽油的体积百分比为75%~95%。120号汽油的橡胶溶胀效果好,而与乙醇混合后可以加快汽油溶剂与乙醇混合液、乙醚混合液的充分混合,强化各配料与溶胀橡胶的均匀混合。
作为本发明方法的一种改进,背衬由竹纤维、聚丙烯纤维与聚丙烯腈基炭纤维混纺制成,三者的重量比为1.2~1.5:0.6~0.9:0.1~0.4。竹纤维具有良好的透气性能,可以增强外用贴膏的透气性,而且具有杀菌、抑菌的效果。聚丙烯腈基炭纤维具有较高的生物相容性,而且比重小、强度高、不易变形且不易受潮。
作为本发明方法的一种改进,步骤(7)中挥发阻止层由以下重量份的组份混合喷涂而成:羟丙基甲基纤维素5~10份、槐豆胶5~11份、乙醇40~50份、水80~100份,层厚为1~5μm。通过在剥离纸表面涂覆挥发阻止层,一方面阻止挥发性成分挥发逸出,一方面防潮防湿。羟丙基甲基纤维素具有骨架阻止作用,可有效阻止成分挥发,延长药效。
本发明的有益效果如下:
本发明活性止痛的外用贴膏,具有非常明显的活血止痛的效果,同时具有良好的透皮吸收率,见效快,膏药中有效成分不易挥,膏药粘性好,品质均匀。同时制备中先制成乳化浆料再涂胶使外用贴膏的成分更容易被皮肤吸收。
具体实施方式
下面就本发明的具体实施方式作进一步说明。
如无特别说明,本发明中所采用的原料均可从市场上购得或是本领域常用的,如无特别说明,下述实施例中的方法均为本领域的常规方法。
实施例1
一种活血止痛的外用贴膏,经以下组份制备而成:冰片500g、樟脑250g、缓释剂150g、川芎流浸膏3520g、薄荷油150g、桂皮醛100g、氧化锌1900g、凡士林150g、松香1500g、羊毛脂250g、液状石蜡50g、透皮促进剂100g、增粘剂60g、增乳剂60g、二甲亚砜50g、橡胶1750g。
其中川穹流浸膏经以下过程制备而成:将川芎500g、大黄500g、生附子500g、丁香500g、石菖蒲500g、红花250g、徐长卿250g、甘松250g、麝香3.5g、凤仙梗10g、醉鱼草10g、骨碎补20g混合后粉碎得到粗粉料,然后加入95%的酒精加热浸渍,将浸渍液真空浓缩至原体积的30%得川芎流浸膏。
缓释剂优选为纳米级椰壳活性炭,透皮促进剂包括主剂与辅剂,主剂的质量百分比为55%,主剂为N,N-二甲氨基异丙酸十二烷酯与阿魏酸的组合,N,N-二甲氨基异丙酸十二烷酯与阿魏酸的质量比为1:0.3,辅剂为椰油酰胺丙基甜菜碱,增粘剂优选为纳米二氧化硅气凝胶,增乳剂优选为甘油磷酸酯。
一种活血止痛的外用贴膏的制备方法,包括以下步骤:
(1)制胶:将橡胶除膜后切成13cm长的橡胶条,投于炼胶机辊压得到0.1mm厚的橡胶薄片,再置于搅拌机内加入橡胶薄片质量5.3倍的汽油溶剂在10℃浸泡使橡胶薄片充分溶胀软化,浸泡时间不少于24小时,优选为24小时,汽油溶剂优选由120号汽油与乙醇混合而成,120号汽油的体积百分比为75%%;
(2)配料:将川芎流浸膏溶于18倍体积的乙醇中搅拌均匀,然后将樟脑、冰片、二甲亚砜、松香、薄荷油、桂皮醛、缓释剂投入乙醇中并在20℃内静置24小时,再依次加入透皮促进剂、氧化锌、凡士林、液状石蜡搅拌均匀得到混合料液,将羊毛脂溶于3倍体积的乙醚中搅拌溶解得到乙醚料液;
(3)打浆:将溶胀后的橡胶薄片剪成长度小于1cm的橡胶段,再投入打胶机内并加入混和料液、乙醚料液搅拌打胶,经筛网过筛得到胶浆,同时将筛网截留的料液再次返回打胶;
(4)匀浆:向胶浆中加入增粘剂、增乳剂后搅拌均匀,送入高速均质机中保持转速8000r/min均质处理得到乳化浆料;
(5)涂胶:将背衬送入涂胶机的两辊压筒中,向涂胶机投加乳化浆料涂覆在背衬上制成膏剂,背衬由竹纤维、聚丙烯纤维与聚丙烯腈基炭纤维混纺制成,三者的重量比为1.2:0.6:0.1;
(6)卷轴:加热卷轴机并控制卷轴机中各烘箱处的温度分别为:第一道烘箱温度55℃,第二道烘箱温度85℃,第三道烘箱温度65℃,将膏剂卷轴处理,每卷100m长切断一次,并且在卷轴开始5min后剪取小样测试含膏量;
(7)贴纸:在膏剂的膏药面贴合剥离纸,在剥离纸外侧涂覆厚度为1μm的挥发阻止层,挥发阻止层由以下组份混合喷涂而成:羟丙基甲基纤维素5g、槐豆胶5g、乙醇40g、水80g;
(8)封装:按规定尺寸切片后套袋封装得到用于治疗关节痛的外用贴膏。
实施例2
一种活血止痛的外用贴膏,经由以下组份制备而成:冰片625g、樟脑310g、缓释剂175g、川芎流浸膏4200g、薄荷油185g、桂皮醛125g、氧化锌2375g、凡士林185g、松香1850g、羊毛脂310g、液状石蜡62.5g、透皮促进剂130g、增粘剂85g、增乳剂80g、二甲亚砜62.5g、橡胶2150g。
其中川穹流浸膏经以下过程制备而成:将川芎625g、大黄625g、生附子625g、丁香625g、石菖蒲625g、红花310g、徐长卿310g、甘松310g、麝香4.25g、凤仙梗12.5g、醉鱼草12.5g、骨碎补27.5g混合后粉碎得到粗粉料,然后加入95%的酒精加热浸渍,将浸渍液真空浓缩至原体积的35%得川芎流浸膏。
其中缓释剂优选为纳米级椰壳活性炭,透皮促进剂包括主剂与辅剂,主剂的质量百分比为70%,主剂为N,N-二甲氨基异丙酸十二烷酯与甘油单辛醚的组合,N,N-二甲氨基异丙酸十二烷酯与甘油单辛醚的质量比为1:1.7,辅剂为溴代1-丁基-3-甲基-咪唑,增粘剂优选为纳米二氧化硅气凝胶,增乳剂优选为大豆磷脂。
一种活血止痛的外用贴膏的制备方法,包括以下步骤:
(1)制胶:将橡胶除膜后切成15cm长的橡胶条,投于炼胶机辊压得到1.1mm厚的橡胶薄片,再置于搅拌机内加入橡胶薄片质量8倍的汽油溶剂在15℃浸泡使橡胶薄片充分溶胀软化,浸泡时间不少于24小时,优选为36小时,汽油溶剂优选由120号汽油与乙醇混合而成,120号汽油的体积百分比为85%;
(2)配料:将川芎流浸膏溶于23倍体积的乙醇中搅拌均匀,然后将樟脑、冰片、二甲亚砜、松香、薄荷油、桂皮醛、缓释剂投入乙醇中并在25℃内静置36小时,再依次加入透皮促进剂、氧化锌、凡士林、液状石蜡搅拌均匀得到混合料液,将羊毛脂溶于5倍体积的乙醚中搅拌溶解得到乙醚料液;
(3)打浆:将溶胀后的橡胶薄片剪成长度小于1cm的橡胶段,再投入打胶机内并加入混和料液、乙醚料液搅拌打胶,经筛网过筛得到胶浆,同时将筛网截留的料液再次返回打胶;
(4)匀浆:向胶浆中加入增粘剂、增乳剂后搅拌均匀,送入高速均质机中保持转速9000r/min均质处理得到乳化浆料;
(5)涂胶:将背衬送入涂胶机的两辊压筒中,向涂胶机投加乳化浆料涂覆在背衬上制成膏剂,背衬由竹纤维、聚丙烯纤维与聚丙烯腈基炭纤维混纺制成,三者的重量比为1.3:0.7:0.2;
(6)卷轴:加热卷轴机并控制卷轴机中各烘箱处的温度分别为:第一道烘箱温度60℃,第二道烘箱温度80℃,第三道烘箱温度70℃,将膏剂卷轴处理,每卷100m长切断一次,并且在卷轴开始5min后剪取小样测试含膏量;
(7)贴纸:在膏剂的膏药面贴合剥离纸,在剥离纸外侧涂覆厚度为3μm的挥发阻止层,挥发阻止层由以下组份混合喷涂而成:羟丙基甲基纤维素7.5g、槐豆胶8g、乙醇45g、水90g;
(8)封装:按规定尺寸切片后套袋封装得到用于治疗关节痛的外用贴膏。
实施例3
一种活血止痛的外用贴膏,经由以下组份制备而成:冰片750g、樟脑375g、缓释剂200g、川芎流浸膏4875g、薄荷油225g、桂皮醛150g、氧化锌2850g、凡士林225g、松香2250g、羊毛脂375g、液状石蜡75g、透皮促进剂160g、增粘剂110g、增乳剂100g、二甲亚砜75g、橡胶2575g。
其中川穹流浸膏经以下过程制备而成:将川芎750g、大黄750g、生附子750g、丁香750g、石菖蒲750g、红花375g、徐长卿375g、甘松375g、麝香5g、凤仙梗15g、醉鱼草15g、骨碎补35g混合后粉碎得到粗粉料,然后加入95%的酒精加热浸渍,将浸渍液真空浓缩至原体积的40%得川芎流浸膏。
其中缓释剂优选为α-环糊精,透皮促进剂包括主剂与辅剂,主剂的质量百分比为85%,主剂为N,N-二甲氨基异丙酸十二烷酯与α-甜没药萜醇,N,N-二甲氨基异丙酸十二烷酯与α-甜没药萜醇的质量比为1:0.8,辅剂为椰油酰胺丙基甜菜碱,增粘剂优选为纳米二氧化硅气凝胶,增优选为甘油磷酸酯。
一种活血止痛的外用贴膏的制备方法,包括以下步骤:
(1)制胶:将橡胶除膜后切成17cm长的橡胶条,投于炼胶机辊压得到1.8mm厚的橡胶薄片,再置于搅拌机内加入橡胶薄片质量10.7倍的汽油溶剂在20℃浸泡使橡胶薄片充分溶胀软化,浸泡时间不少于24小时,优选为48小时,汽油溶剂优选由120号汽油与乙醇混合而成,120号汽油的体积百分比为95%;
(2)配料:将川芎流浸膏溶于28倍体积的乙醇中搅拌均匀,然后将樟脑、冰片、二甲亚砜、松香、薄荷油、桂皮醛、缓释剂投入乙醇中并在27℃内静置48小时,再依次加入透皮促进剂、氧化锌、凡士林、液状石蜡搅拌均匀得到混合料液,将羊毛脂溶于7倍体积的乙醚中搅拌溶解得到乙醚料液;
(3)打浆:将溶胀后的橡胶薄片剪成长度小于1cm的橡胶段,再投入打胶机内并加入混和料液、乙醚料液搅拌打胶,经筛网过筛得到胶浆,同时将筛网截留的料液再次返回打胶;
(4)匀浆:向胶浆中加入增粘剂、增乳剂后搅拌均匀,送入高速均质机中保持转速10000r/min均质处理得到乳化浆料;
(5)涂胶:将背衬送入涂胶机的两辊压筒中,向涂胶机投加乳化浆料涂覆在背衬上制成膏剂,背衬由竹纤维、聚丙烯纤维与聚丙烯腈基炭纤维混纺制成,三者的重量比为1.5:0.9:0.4;
(6)卷轴:加热卷轴机并控制卷轴机中各烘箱处的温度分别为:第一道烘箱温度65℃,第二道烘箱温度95℃,第三道烘箱温度75℃,将膏剂卷轴处理,每卷100m长切断一次,并且在卷轴开始5min后剪取小样测试含膏量;
(7)贴纸:在膏剂的膏药面贴合剥离纸,在剥离纸外侧涂覆厚度为5μm的挥发阻止层,挥发阻止层由以下重量份的组份混合喷涂而成:羟丙基甲基纤维素10g、槐豆胶11g、乙醇50g、水100g;
(8)封装:按规定尺寸切片后套袋封装得到用于治疗关节痛的外用贴膏。
体外透皮测试
以麝香中含有的成分麝香酮为测试成分,测试外用贴膏的透皮能力,麝香酮具有消肿止痛的作用,具体测试条件如下:
在容积为60mL、有效面积为4.2cm2的自制Franz扩散池中添加30%乙醇生理盐水作为接受介质,并保持温度为37.0±0.1℃,将离体皮肤固定于扩散池上,离体皮肤的真皮层一侧与接受介质接触,离体皮肤的角质层侧贴附本发明的外用贴膏,外用贴膏的膏药侧的面积为3.0cm2,设置搅拌速度为600r/min,分别于1h、2h、4h、6h、8h、12h、24h后取出2mL的接受介质,并立即补充等体积的新的30%乙醇生理盐水,测试麝香酮含量,计算累积透过率L。
Figure BDA0001382199260000081
其中,Ln为累积透过率%,Cn为第n个取样时间点的样品浓度μg/mL,V为接收池的体积,Ci为第i个取样时间点的样品浓度μg/mL,V0表示取样体积,W表示外用贴膏中麝香酮的含量mg。实施例1~3中外用贴膏的测试结果如表1所示。
Figure BDA0001382199260000082

Claims (4)

1.一种活血止痛的外用贴膏,其特征在于,所述外用贴膏经由以下重量份的组份制备而成:冰片500~750份、樟脑250~375份、缓释剂150~200份、川芎流浸膏3520~4875份、薄荷油150~225份、桂皮醛100~150份、氧化锌1900~2850份、凡士林150~225份、松香1500~2250份、羊毛脂250~375份、液状石蜡50~75份、透皮促进剂100~160份、增粘剂60~110份、增乳剂60~100份、二甲亚砜50~75份、橡胶 1750~2575份;
所述透皮促进剂包括主剂和辅剂,主剂的质量百分比为85%,主剂由N,N-二甲氨基异丙酸十二烷酯与α-甜没药萜醇按质量比为1:0.8组成,辅剂为椰油酰胺丙基甜菜碱;
缓释剂为α-环糊精;
增乳剂为甘油磷酸酯;
增粘剂为纳米二氧化硅气凝胶;
所述川穹流浸膏经以下过程制备而成:将重量份的川芎500~750份、大黄500~750份、生附子500~750份、丁香500~750份、石菖蒲500~750份、红花250~375份、徐长卿250~375份、甘松250~375份、麝香3.5~5份、凤仙梗10~15份、醉鱼草10~15份、骨碎补20~35份混合后粉碎得到粗粉料,然后加入95%的酒精加热浸渍,将浸渍液真空浓缩至原体积的30%~40%得川芎流浸膏;
上述活血止痛的外用贴膏的制备方法,包括以下步骤:
(1)制胶:将橡胶切成13~17cm的橡胶条,投于炼胶机辊压得到0.1~1.8mm厚的橡胶薄片,然后置于搅拌机内加入汽油溶剂浸泡溶胀;
(2)配料:将川芎流浸膏溶于18~28倍体积的乙醇中搅拌均匀,然后将樟脑、冰片、二甲亚砜、松香、薄荷油、桂皮醛、缓释剂投入乙醇中并在20~27℃内静置24~48小时,再依次加入透皮促进剂、氧化锌、凡士林、液状石蜡搅拌均匀得到混合料液,将羊毛脂溶于3~7倍体积的乙醚中搅拌溶解得到乙醚料液;
(3)打浆:将溶胀后的橡胶薄片剪成长度小于1cm的橡胶段,再投入打胶机内并加入混和料液、乙醚料液搅拌打胶,经筛网过筛得到胶浆,同时将筛网截留的料液再次返回打胶;
(4)匀浆:向胶浆中加入增粘剂、增乳剂后搅拌均匀,送入高速均质机中保持转速8000~10000r/min均质处理得到乳化浆料;
(5)涂胶:将背衬送入涂胶机的两辊压筒中,向涂胶机投加乳化浆料涂覆在背衬上制成膏剂;
(6)卷轴:加热卷轴机并控制卷轴机中各烘箱处的温度分别为:第一道烘箱温度55~65℃,第二道烘箱温度85~95℃,第三道烘箱温度65~75℃,将膏剂卷轴处理;
(7)贴纸:在膏剂的膏药面贴合剥离纸,在剥离纸外侧涂覆挥发阻止层;
(8)封装:按规定尺寸切片后套袋封装得到用于治疗关节痛的外用贴膏。
2.根据权利要求1所述的活血止痛的外用贴膏,其特征在于,步骤(1)中橡胶薄片与汽油溶剂的质量比为1:5.3~10.7,汽油溶剂由120号汽油与乙醇混合而成,120号汽油的体积百分比为75%~95%。
3.根据权利要求1所述的活血止痛的外用贴膏,其特征在于,背衬由竹纤维、聚丙烯纤维与聚丙烯腈基炭纤维混纺制成,三者的重量比为1.2~1.5:0.6~0.9:0.1~0.4。
4.根据权利要求1所述的活血止痛的外用贴膏,其特征在于,步骤(7)中挥发阻止层由以下重量份的组份混合喷涂而成:羟丙基甲基纤维素5~10份、槐豆胶5~11份、乙醇40~50份、水80~100份,层厚为1~5 µm。
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