CN114569697A - 一种治疗痹证型颈椎病的中药提取物及其凝胶贴 - Google Patents
一种治疗痹证型颈椎病的中药提取物及其凝胶贴 Download PDFInfo
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Abstract
本发明提供了一种治疗痹证型颈椎病的中药提取物及其凝胶贴,属于治疗骨疾病的药物技术领域。一种治疗痹证型颈椎病的中药提取物,由如下重量份的原料制成:桂枝8‑20份、细辛8‑20份、白芷6‑15份、芥子3‑10份、三七3‑10份、檀香3‑9份、地鳖虫3‑9份、山萸肉3‑9份、白芍2‑7份和生姜3‑9份。本发明提供一种外用治疗痹证型颈椎病的中药提取物,以提高治疗效果。
Description
技术领域
本发明属于治疗骨疾病的药物技术领域,具体涉及一种治疗痹证型颈椎病的中药提取物及其凝胶贴。
背景技术
痹证型颈椎病即神经根型颈椎病,是以颈椎间盘退行性病变及其继发性病理改变,导致神经根受压,引起相应节段神经根刺激或功能障碍为临床表现的疾病,是颈椎病中比较多见的类型,是最常见的引起神经受压症状和体征的颈椎疾患之一。
颈椎病隶属中医学“痹证”、“痿证”、“项强”、“眩晕”等范畴。中医理论认为颈椎病的病因,无外乎外感风寒湿邪、慢性劳损、肝肾亏虚、气血不足、外伤、畸形等几个方面。在内外致病因素的作用下,机体气血瘀滞,经络痹阻不畅,“不通则痛”,随之出现一系列的临床症状。
我国传统医学对颈椎病的治疗方法主要包括内治法和外治法,其中外治法方式多样,包括针灸、推拿、贴敷、药浴等。现代研究表明外治法在治疗颈椎病方面也具有明显的临床效果。
在现有技术中,专利文献CN113813350A涉及一种治疗颈椎病的外用中药组合物、其应用和所制成的药枕,它具体是由下列重量份配比的原料药制成:威灵仙10-20份、羌活、独活、桂枝、徐长卿、当归、川芎、赤芍、丹皮、藿香、佩兰、白芷、藁本、野菊花、升麻、桑叶、石菖蒲、薄荷、木瓜、紫苏、钩藤、枳壳、淫羊藿、丁香、制香附、高良姜、香加皮、降香、苏木、合欢皮、香橼、木香、炒牛蒡子、炒青皮、陈皮、山奈、天葵子、豆蔻、蝉蜕、炒苍术、肉桂、甘松、细辛、制南星、冰片、千年健、乳香、远志各5-15份。该发明还提供了上述中药组合物在制备治疗颈椎病药枕中的应用。其优点表现在:药味符合“君臣佐使”配伍原则,临床试验结果表明在治疗颈椎病时疗效显著,无毒副作用,患者接受度高。
专利文献CN114042033A提供一种用于颈椎腰椎的膏药及其制备方法,涉及药物制作技术领域。用于颈椎腰椎的膏药包括:生马钱子,红花,大黄,川乌,草乌,当归,杜仲,川芎,全蝎,土元,白术,乳香,没药,麻黄和蜈蚣。膏药的制备方法包括:将原料粉碎,过筛70-80目得细粉,向细粉中加入香油,在50-60℃熬制48-72h,过滤得药油,向药油中加入松香、独蒜、大葱、艾叶和生姜,在60-70℃熬制24-48h,得药膏。该发明的膏药能快速消肿止疼,对于脊椎病引起的结缔组织和神经组织损伤有显著的治疗效果,刺激性小,起效快,疗效好。
专利文献CN113368162A涉及一种治疗颈椎病的中药配方,按重量份数计,包括如下组分:当归15-25份、金毛狗脊25-35份、葛根35-45份、丁香10-15份、威灵仙25-35份、乳香15-35份、仙灵脾45-55份、合欢花20-30份、钩藤35-40份。一种治疗颈椎病的药枕,包含上述中药配方制成的药囊,药枕与人体接触的一面设置有凹槽,凹槽内放置药囊,药囊由纯棉面料制成。该药枕可以在颈椎病预防和保健方面起到较好的作用。
发明内容
有鉴于此,本发明所要解决的技术问题是,提供一种外用治疗痹证型颈椎病的中药提取物,以提高治疗效果。
本发明所要解决的另一个技术问题是,提供一种含有上述中药提取物的凝胶贴,以改善贴剂性能,并提高治疗效果。
为解决上述技术问题,本发明所采用的技术方案是:
一种治疗痹证型颈椎病的中药提取物,由如下重量份的原料制成:桂枝8-20份、细辛8-20份、白芷6-15份、芥子3-10份、三七3-10份、檀香3-9份、地鳖虫3-9份、山萸肉3-9份、白芍2-7份和生姜3-9份。
在本发明的一些具体实施方案中,桂枝可以为:8、9、10、12、15、16、18或20重量份;细辛可以为:8、9、10、12、15、16、18或20重量份;白芷可以为:6、7、8、9、10、12、13或15份;芥子可以为:3、4、5、6、8、9或10份;三七可以为:3、4、5、6、8、9或10份;檀香可以为:3、4、5、6、7、8或9份;地鳖虫可以为:3、4、5、6、7、8或9份;山萸肉可以为:3、4、5、6、8或9份;白芍可以为:2、3、4、5、6或7份;生姜可以为:3、4、5、6、8或9份。
优选地,所述治疗痹证型颈椎病的中药提取物,由如下重量份的原料制成:桂枝10-15份、细辛10-15份、白芷9-12份、芥子5-8份、三七5-8份、檀香5-7份、地鳖虫5-7份、山萸肉5-7份、白芍3-6份和生姜5-8份。
优选地,所述治疗痹证型颈椎病的中药提取物,由如下重量份的原料制成:桂枝13份、细辛13份、白芷10份、芥子7份、三七7份、檀香6份、地鳖虫6份、山萸肉6份、白芍5份和生姜7份。
优选地,所述治疗痹证型颈椎病的中药提取物的制备方法,包括以下步骤:
S1:称取上述重量份的桂枝、细辛、白芷、芥子、三七、檀香、地鳖虫、山萸肉和白芍,置于提取罐中,8-10倍量70-75%乙醇在80-85℃下加热,回流提取2-3次,每次0.5-1h,过滤,取滤液,并将滤液在60℃下浓缩回收乙醇,得湿浸膏;
S2:将生姜榨汁,取姜汁与所述湿浸膏均匀混合,真空干燥,得中药提取物。
本发明还提供了一种含有上述中药提取物的凝胶贴,还包括:基质,所述基质的组成成分为聚丙烯酸钠、柠檬酸铝、酒石酸、羧甲基纤维素、二甲基亚砜、甘油和水。
优选地,所述基质的组成成分以重量份计为:聚丙烯酸钠10-15份、柠檬酸铝0.4-0.9份、酒石酸0.5-1份、羧甲基纤维素12-25份、二甲基亚砜2-5份、甘油3-7份和水40-60份。
优选地,所述中药提取物与所述基质的重量比为(0.1-10%):(90-99.9%),例如选择0.1%:99.9%、0.5%:99.5%、1%:99%、3%:97%、5%:95%、7%:93%、9%:91%或10%:90%。
优选地,所述凝胶贴,还包括底层和离型层,所述底层为粘性无纺布,所述基质位于所述底层和所述离型层之间。
优选地,所述凝胶贴的制备方法为:首先将聚丙烯酸钠、柠檬酸铝和甘油混合,加入中药提取物,搅拌均匀,得到第一混合物;然后将酒石酸、羧甲基纤维素、二甲基亚砜和水混合,与所述第一混合物搅拌均匀,干燥,得到凝胶;最后在凝胶的上表面和下表面分别覆盖离型层和底层,得到凝胶贴。
在本发明的上述方案中,各原料的药性如下:
桂枝,为樟科植物肉桂Cinnamomum cassia Presl的干燥嫩枝。归心、肺、膀胱经。性味辛、甘,温。
细辛,为马兜铃科植物北细辛Asarum heterotropoides Fr.Schmidtvar.mandshuricum(Maxim.)Kitag.、汉城细辛Asarum sieboldii Miq.var.seoulenseNakai或华细辛Asarum sieboldii Miq.的干燥全草。归心、肺、肾经。性味辛,温。
白芷,为伞型科植物白芷Angelica dahurica(Fisch.ex Hoffm.)Benth.etHook.f.或杭白芷Angelica dahurica(Fisch.ex Hoffm.)Benth.etHook.f.var.formosana(Boiss.)Shan et Yuan的干燥根。归胃、大肠、肺经。性味辛,温。
芥子,为十字花科植物白芥Sinapis alba L.或芥Brassica juncea(L.)Czern.etCoss.的干燥成熟种子。归肺经。性味辛,温。
三七,为五加科植物三七Panax notoginseng(Burk.)F.H.Chen的干燥根。归肝、胃经。性味甘、微苦,温。
檀香,为檀香科檀香属植物檀香Santalum album L.树干的心材。归脾、胃、心、肺经。性味辛,温。功能主治行气温中,开胃止痛。
地鳖虫,为鳖蠊科昆虫地鳖Eupolyphaga sinensis Walker或冀地鳖Steleophagaplancyi(Boleny)的雌虫干燥体。归经归肝经。性味咸,寒。
山萸肉,为山茱萸科植物山茱萸Cornus officinalis Sieb.et Zucc.的干燥成熟果肉,除去杂质和残留果核。归肝、肾经。性味酸、涩,微温。
白芍,为毛茛科植物芍药Paeonia lactiflora Pall.的干燥根。归肝、脾经。性味苦、酸,微寒。
生姜,为姜科植物姜Zingiber officinale Rosc.的新鲜根茎。归肺、脾、胃经。性味辛,微温。
痹症型颈椎病为颈椎病的一种类型,病因包括生活中姿势不良,风寒湿邪,疲劳和外伤等,随着年龄的增长,人体脏器衰退,筋骨虚寒,腠理空虚,气血衰少,筋骨失于濡养,风寒湿邪易于骤袭,痹阻经络,气滞血瘀,引起酸痛不仁等症。同时,“肝藏血,主筋。肾藏精,主骨。”肝肾不足则筋骨失去濡养而瘘软,不营则痛,因此肝肾亏虚也为发病之因。
本发明以桂枝、细辛、白芷、芥子、三七、檀香、地鳖虫、山萸肉、白芍和生姜进行组配,其中桂枝温通经脉、助阳化气,细辛温散寒邪、通阳止痛,白芷散风除湿,合为君药,重在温阳化湿;芥子豁痰利气、散结通络,三七活血化瘀,檀香行气温中,地鳖虫活血散瘀、疏通经络,合为臣药,主在行气活血,辅助君药加强治疗主症;山萸肉补益肝肾,白芍柔肝养血,二者合用为佐药,补肝益肾;生姜辛香,可促进血液循环,引导药力直达病所。
与现有技术相比,本发明的有益效果如下:
本发明基于对痹证型颈椎病的病因病机的认识,通过自拟方外用以增强本病的治疗效果。研究结果显示,本发明凝胶贴外用与常规牵引治疗相结合,治疗后总有效率明显高于对照组,表明本发明凝胶贴联合常规牵引治疗可以明显提高治疗效果。
本发明将上述原料制作成凝胶贴,以穴位贴敷方式使用,每次贴敷时间可选择在8-12个小时,通过药物的渗透,实现内病外治,一方面有刺激穴位、发挥经络穴位本身的理气血、调阴阳、补虚损作用;另一方面,药物透皮吸收,也发挥了其药理作用;总的来说,是结合了局部刺激、经络调衡及药物自身作用三方面的功能。而且,中药穴位贴敷不经过消化道,可避免肝脏的首过效应和胃肠道的干扰影响,药物经皮肤进入机体直接发挥作用。除此之外,凝胶贴还可以解决某些给药过程中的实际问题,提高患者的顺应性。
具体实施方式
为了更好地理解本发明,下面结合实施例进一步清楚阐述本发明的内容,但本发明的保护内容不仅仅局限于下面的实施例。在下文的描述中,给出了大量具体的细节以便提供对本发明更为彻底的理解。然而,对于本领域技术人员来说显而易见的是,本发明可以无需一个或多个这些细节而得以实施。
在这里示出和讨论的所有示例中,任何具体值应被解释为仅仅是示例性的,而不是作为限制。因此,示例性实施例的其它示例可以具有不同的值。
本发明所述的“重量份”可以为克,千克等常规重量单位。
实施例1:中药提取物的制备
提供桂枝、细辛、白芷、芥子、三七、檀香、地鳖虫、山萸肉、白芍和生姜;称取桂枝13份、细辛13份、白芷10份、芥子7份、三七7份、檀香6份、地鳖虫6份、山萸肉6份、白芍5份和生姜7份,置于提取罐中,9倍量72%乙醇在82℃下加热,回流提取3次,每次0.5h,过滤,取滤液,并将滤液在60℃下浓缩回收乙醇,得湿浸膏;
将生姜榨汁,取姜汁与所述湿浸膏均匀混合,真空干燥,得中药提取物。
实施例2:中药提取物的制备
提供桂枝、细辛、白芷、芥子、三七、檀香、地鳖虫、山萸肉、白芍和生姜;称取桂枝8重量份、细辛8重量份、白芷6重量份、芥子3重量份、三七3重量份、檀香3重量份、地鳖虫3重量份、山萸肉3重量份、白芍2重量份和生姜3重量份,置于提取罐中,8倍量70%乙醇在80℃下加热,回流提取2次,每次0.8h,过滤,取滤液,并将滤液在60℃下浓缩回收乙醇,得湿浸膏;
将生姜榨汁,取姜汁与所述湿浸膏均匀混合,真空干燥,得中药提取物。
实施例3:中药提取物的制备
提供桂枝、细辛、白芷、芥子、三七、檀香、地鳖虫、山萸肉、白芍和生姜;称取桂枝20重量份、细辛20重量份、白芷15重量份、芥子10重量份、三七10重量份、檀香9重量份、地鳖虫9重量份、山萸肉9重量份、白芍7重量份和生姜9重量份,置于提取罐中,10倍量75%乙醇在85℃下加热,回流提取2次,每次1h,过滤,取滤液,并将滤液在60℃下浓缩回收乙醇,得湿浸膏;
将生姜榨汁,取姜汁与所述湿浸膏均匀混合,真空干燥,得中药提取物。
实施例4:凝胶贴的制备
提供如下表1所示的原料,按中药提取物与基质的重量比为2.5%:97.5%,称取实施例1制取的中药提取物;将聚丙烯酸钠、柠檬酸铝和甘油混合,加入中药提取物,搅拌均匀,得到第一混合物;将酒石酸、羧甲基纤维素、二甲基亚砜和水混合,与第一混合物搅拌均匀,干燥,得到凝胶;最后在凝胶的上表面和下表面分别覆盖离型层和底层,得到凝胶贴。
实施例5:凝胶贴的制备
提供如下表1所示的原料,按中药提取物与基质的重量比为4%:96%,称取实施例2制取的中药提取物;将聚丙烯酸钠、柠檬酸铝和甘油混合,加入中药提取物,搅拌均匀,得到第一混合物;将酒石酸、羧甲基纤维素、二甲基亚砜和水混合,与第一混合物搅拌均匀,干燥,得到凝胶;最后在凝胶的上表面和下表面分别覆盖离型层和底层,得到凝胶贴。
实施例6:凝胶贴的制备
提供如下表1所示的原料,按中药提取物与基质的重量比为6%:94%,称取实施例3制取的中药提取物;将聚丙烯酸钠、柠檬酸铝和甘油混合,加入中药提取物,搅拌均匀,得到第一混合物;将酒石酸、羧甲基纤维素、二甲基亚砜和水混合,与第一混合物搅拌均匀,干燥,得到凝胶;最后在凝胶的上表面和下表面分别覆盖离型层和底层,得到凝胶贴。
表1实施例4-实施例6基质原料及其重量份
效果评价:
1、凝胶贴性能测试:
将实施例4-6制备的凝胶贴进行如下测试,将测试结果记录在表2中。
1.1初黏力测定方法:参照《中国药典》2015版Ⅳ部通则贴膏剂黏附力测定法第一法测定(国家药典委员会.中国药典2015年版(一部).中国医药科技出版社[M])。
1.2持黏力测定方法:参照《中国药典》2015版Ⅳ部通则贴膏剂持黏力测定法第二法。
表2初黏力和持黏力测试结果
原料/重量份 | 初黏力/分 | 持黏力/分 |
实施例4 | 25 | 20 |
实施例5 | 20 | 15 |
实施例6 | 20 | 20 |
由测试结果可知,本发明凝胶贴的初黏力在20分以上,持黏力在15分以上,表现出较好的粘贴效果。
2、临床疗效观察
2.1一般资料
研究对象为河南省洛阳正骨医院脊柱外科2019年7月~2021年7月期间120例神经根型颈椎病患者,采用随机数字表法分为对照组和实验组。对照组60例,男32例,女28例;年龄37~60岁,平均(45.3±3.5)岁;病程30d~4年,平均(1.5±0.2)年。实验组60例,男31例,女29例;年龄38~60岁,平均(45.6±3.4)岁;病程30d~4年,平均(1.6±0.1)年。两组患者在性别、年龄和病程等方面比较差异无统计学意义(P>0.05),具有可比性。
2.2病例选择
纳入标准:符合《颈椎病》(张红星,张武昌.颈椎病[M].北京:中国医药科技出版社,2010:27.)中神经根型颈椎病的诊断标准:有颈椎外伤史、颈椎退行性变及颈椎先天性畸形;颈肩背部疼痛,上肢肌力下降,病变侧颈椎可摸到条索状硬结,臂丛牵拉实验及压头实验阳性。X线显示钩椎关节增生,颈椎曲度变直,椎间隙变窄,椎间孔变小;CT显示神经根管变窄,椎体后可见赘生物。排除标准:颈椎病其他类型、合并糖尿病及严重心、肺疾病患者,颈椎骨骼其他实质性病变、肩周炎、网球肘等其他上肢疼痛性疾病。
2.3治疗方法
对照组给予牵引治疗,患者平卧于电脑间歇自动牵引床上,用枕领牵引带固定于颈部,在颈后部放一只枕头,使头部前倾约20°~30°,牵引重量4kg~6kg,以患者感觉合适为度,一般不超过15kg。每次30min,1次/天,15天为1疗程。在此基础上,实验组给予实施例4制备的凝胶贴贴敷治疗,贴敷于颈夹脊、天柱、大椎、肩井、天宗等穴位上,贴敷固定后给予以上穴位拇指轻手法按揉,每穴按揉2~3min,使穴位贴和皮肤更好的接触,贴敷时间12小时,每日一次,15天一个疗程。
2.4疗效判定标准
参照《中医病证诊断疗效标准》(国家中医药管理局.中医病证诊断疗效标准[S].南京:南京大学出版社,1994:189.)判定,治愈:临床症状、体征基本消失,颈、肢体功能恢复正常,能参加正常工作;显效:临床症状、体征明显改善,颈、肩、背疼痛减轻,功能改善,稍有轻度不适,但不影响日常生活及工作;有效:临床症状、体征有所减轻或改善;无效:症状及体征基本无改善。注:总有效率=(治愈例数+显效例数+有效例数)/总例数×100%。
2.5统计学方法
应用SPSS20.0统计软件分析相关数据;计数资料采用%表示,组间比较采用x2校验,P<0.05提示差异具有统计学意义。
2.6结果
两组患者治疗后综合疗效比较,结果见表3。
表3两组患者治疗后综合疗效比较(n,%)
组别 | 例数 | 治愈 | 显效 | 有效 | 无效 | 总有效率 |
对照组 | 60 | 15(25.00) | 16(26.67) | 20(33.33) | 9(15.00) | 85.00 |
实验组 | 60 | 19(31.67) | 21(35.00) | 18(30.00) | 2(3.33) | 96.67<sup>*</sup> |
注:*表示与对照组相比具有显著性差异,P<0.05。
结果显示,实验组治疗后总有效率96.67%明显高于对照组85.00%,差异具有统计学意义(P<0.05)。
最后说明的是,以上实施例仅用以说明本发明的技术方案而非限制,本领域普通技术人员对本发明的技术方案所做的其他修改或者等同替换,只要不脱离本发明技术方案的精神和范围,均应涵盖在本发明的权利要求范围当中。
Claims (10)
1.一种治疗痹证型颈椎病的中药提取物,其特征在于:由如下重量份的原料制成:桂枝8-20份、细辛8-20份、白芷6-15份、芥子3-10份、三七3-10份、檀香3-9份、地鳖虫3-9份、山萸肉3-9份、白芍2-7份和生姜3-9份。
2.如权利要求1所述的一种治疗痹证型颈椎病的中药提取物,其特征在于:桂枝10-15份、细辛10-15份、白芷9-12份、芥子5-8份、三七5-8份、檀香5-7份、地鳖虫5-7份、山萸肉5-7份、白芍3-6份和生姜5-8份。
3.如权利要求2所述的一种治疗痹证型颈椎病的中药提取物,其特征在于:桂枝13份、细辛13份、白芷10份、芥子7份、三七7份、檀香6份、地鳖虫6份、山萸肉6份、白芍5份和生姜7份。
4.如权利要求3所述的一种治疗痹证型颈椎病的中药提取物的制备方法,其特征在于:包括以下步骤:
S1:称取上述重量份的桂枝、细辛、白芷、芥子、三七、檀香、地鳖虫、山萸肉和白芍,置于提取罐中,8-10倍量70-75%乙醇在80-85℃下加热,回流提取2-3次,每次0.5-1h,过滤,取滤液,并将滤液在60℃下浓缩回收乙醇,得湿浸膏;
S2:将生姜榨汁,取姜汁与所述湿浸膏均匀混合,真空干燥,得中药提取物。
5.一种凝胶贴,其特征在于:包括如权利要求1-4任一项所述的中药提取物。
6.如权利要求5所述的一种凝胶贴,其特征在于:还包括基质,所述基质的组成成分为聚丙烯酸钠、柠檬酸铝、酒石酸、羧甲基纤维素、二甲基亚砜、甘油和水。
7.如权利要求6所述的一种凝胶贴,其特征在于:所述基质的组成成分以重量份计为:聚丙烯酸钠10-15份、柠檬酸铝0.4-0.9份、酒石酸0.5-1份、羧甲基纤维素12-25份、二甲基亚砜2-5份、甘油3-7份和水40-60份。
8.如权利要求7所述的一种凝胶贴,其特征在于:所述中药提取物与所述基质的重量比为(0.1-10%):(90-99.9%)。
9.如权利要求8所述的一种凝胶贴,其特征在于:还包括底层和离型层,所述底层为粘性无纺布,所述基质位于所述底层和所述离型层之间。
10.如权利要求9所述的一种凝胶贴的制备方法,其特征在于:首先将聚丙烯酸钠、柠檬酸铝和甘油混合,加入中药提取物,搅拌均匀,得到第一混合物;然后将酒石酸、羧甲基纤维素、二甲基亚砜和水混合,与所述第一混合物搅拌均匀,干燥,得到凝胶;最后在凝胶的上表面和下表面分别覆盖离型层和底层,得到凝胶贴。
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