CN111588771B - 一种中药组合物在制备用于眩晕症药物中的应用 - Google Patents
一种中药组合物在制备用于眩晕症药物中的应用 Download PDFInfo
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Abstract
本发明提供了一种中药组合物在制备治疗眩晕症药物中的应用,所述中药组合物包括:醋延胡索20‑200份、川芎10‑160份、威灵仙10‑160份、防风20‑200份、花椒20‑200份、牛膝10‑160份、伸筋草20‑200份、东北透骨草20‑200份、路路通10‑160份、海桐皮20‑200份、薄荷脑1‑10份、冰片2‑15份。本发明提出的中药组合物对豚鼠实验性眩晕症以及小鼠旋转眩晕症均具有改善作用。
Description
技术领域
本发明属于中药领域,具体涉及一种中药组合物在制备用于眩晕症药物中的应用。
背景技术
眩晕症是因机体对空间定位障碍而产生的一种动性或位置性错觉,是最常见的临床综合征,随着人口老龄化,本症发病率日益增高,受到国内外医务界广泛重视。有报道称眩晕是门诊常见症状的第三位。它涉及多个学科,绝大多数人一生中均经历此症。据统计,眩晕症占内科门诊病人的5%,占耳鼻喉科门诊的15%。生活在家中的老人50-60%有眩晕症,占老年门诊的81-91%;其中65岁以上老人眩晕发病率女性占57%,男性占39%。
眩晕可分为真性眩晕和假性眩晕。真性眩晕是由眼、本体觉或前庭系统疾病引起的,有明显的外物或自身旋转感。假性眩晕多由全身系统性疾病引起,如心血管疾病、脑血管疾病、贫血、尿毒症、药物中毒、内分泌疾病及神经官能症等几乎都有轻重不等的头晕症状,患者感觉“飘飘荡荡”,没有明确转动感。引起眩晕的疾病涉及许多临床科室,包括耳鼻咽喉科、眼科、骨科及内科。眩晕症病因复杂,牵涉学科广泛,往往眩晕的发作并无先兆,有些诱因尚不确切。目前,针对眩晕的治疗效果并不理想。
中医认为,眩晕可由风、痰、虚引起,故有“无风不作眩”、“无痰不作眩”、“无虚不作眩”的说法。中医把眩晕分为虚、实两种。实证的眩晕多见于年轻人,发病快,症状重,其病因以痰饮(体内水液代谢异常)为主;虚证的眩晕多见于老年人,病程持续时间长。中医将眩晕辩证分为:肝阳上亢证、痰浊中阻证、瘀阻脑络证及肾阴不足证。
目前,市场上兼治眩晕的中西药颇多,而专门用于眩晕治疗的药物极为少见,有些药物虽能缓解患者的病情,但多数临床医生及患者,仍感到化学药治疗主要以解除眩晕症状为主,虽然起效快,但毒副作用较大,极易影响患者的内分泌、心脏及肝肾功能,并且对于该病相关的体症不能兼顾治疗,经常复发,例如目前药物对美尼尔氏综合症反复发作很难控制。
发明内容
有鉴于此,本发明提供了一种用于治疗或预防眩晕症的药物及其制备方法,以重量计,所述中药组合物包括:醋延胡索20-200份、川芎10-160份、威灵仙10-160份、防风20-200份、花椒20-200份、牛膝10-160份、伸筋草20-200份、东北透骨草20-200份、路路通10-160份、海桐皮20-200份、薄荷脑1-10份、冰片2-15份。其中,所述原料药可以直接研磨成粉,也可以是经过常规手段制得的提取物或其它形态等。本发明的组合物同样可以直接研磨成粉,也可以是经过本领域常规手段制得的提取物等。
进一步地,所述中药组合物包括:醋延胡索70-107.5份、川芎65-86份、威灵仙80-86份、防风107.5-120份、花椒107.5-130份、牛膝60-86份、伸筋草75-107.5份、东北透骨草107.5-110份、路路通40-86份、海桐皮90-107.5份、薄荷脑3.6-7份、冰片7.2-10份;或者,醋延胡索100-120份、川芎80-90份、威灵仙80-90份、防风100-120份、花椒100-120份、牛膝80-90份、伸筋草100-120份、东北透骨草100-120份、路路通80-90份、海桐皮100-120份、薄荷脑3-4份、冰片7-8份。
优选地,所述中药组合物包括:醋延胡索107.5份、川芎86份、威灵仙86份、防风107.5份、花椒107.5份、牛膝86份、伸筋草107.5份、东北透骨草107.5份、路路通86份、海桐皮107.5份、薄荷脑3.6份、冰片7.2份。
具体地,所述治疗眩晕症药物选自口服给药剂型、注射给药剂型或外用给药制剂。
具体地,所述治疗眩晕症药物选自汤剂、颗粒剂、胶囊剂、片剂、口服液、丸剂、酊剂、糖浆剂、栓剂、凝胶剂、喷雾剂、注射剂。
进一步地,前述中药组合物制备方法可以为:
将花椒、川芎、防风水蒸气蒸馏提取挥发油、收集挥发油;药渣加入6-20倍量水提取,提取液滤过,滤液备用;醋延胡索、伸筋草、东北透骨草、路路通、海桐皮、牛膝、威灵仙加6-20倍量50%-90%乙醇,加热回流提取,将得到的提取液滤过,回收乙醇,与上述水提取部分滤液合并,浓缩为浸膏;将挥发油、浸膏合并后加入薄荷脑和冰片。
进一步地,当治疗或预防眩晕症药物选自颗粒剂时,所述颗粒剂的制备方法如下:
花椒、川芎、防风水蒸气蒸馏提取挥发油8小时,收集挥发油;药渣加入10倍量水提取1小时,提取液滤过,滤液备用;醋延胡索、伸筋草、东北透骨草、路路通、海桐皮、牛膝、威灵仙加入10倍量70%乙醇,加热回流提取2次,1小时/次,合并提取液,滤过,回收乙醇,与上述水提取部分滤液合并,浓缩为相对密度1.20-1.25的浸膏;减压干燥,粉碎,得干膏粉;
将挥发油用β-环糊精水饱和溶液法包合,形成包合物,干燥,粉碎;
将粉碎后的薄荷脑和冰片细粉、干膏粉、挥发油包合物,适量糊精,混合均匀,干法制成颗粒剂。
本发明以氯仿造豚鼠眩晕症模型以及旋转造小鼠眩晕症模型,研究了中药组合物对豚鼠眩晕症以及小鼠眩晕症的影响。实验结果表明,本发明提出的中药组合物对豚鼠实验性眩晕症以及小鼠旋转眩晕症均具有改善作用。
具体实施方式
如前所述,本发明旨在公开一种中药组合物在制备治疗或预防眩晕症药物中的应用,以下将结合实验例的内容进行具体描述。
特别需要指出的是,针对本发明所有类似的替换和改动对本领域技术人员来说是显而易见的,它们都被视为包括在本发明中。本发明的方法及应用已经通过较佳实施例进行了描述,相关人员明显能在不脱离本发明内容、精神和范围内对本文所述的方法和应用进行改动或适当变更与组合,来实现和应用本发明技术。显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。
本发明如未注明具体条件者,均按照常规条件或制造商建议的条件进行,所用原料药或辅料,以及所用试剂或仪器未注明生产厂商者,均为可以通过市购获得的常规产品。
下面结合实施例,进一步阐述本发明:
实施例1中药组合物颗粒剂的制备
本实施例中药组合物由以下原料药制成:醋延胡索107.5g、川芎86g、威灵仙86g、防风107.5g、花椒107.5g、牛膝86g、伸筋草107.5g、东北透骨草107.5g、路路通86g、海桐皮107.5g、薄荷脑3.6g、冰片7.2g。
花椒、川芎、防风水蒸气蒸馏提取挥发油8小时,收集挥发油;药渣加入10倍量水提取1小时,提取液滤过,滤液备用;醋延胡索、伸筋草、东北透骨草、路路通、海桐皮、牛膝、威灵仙加入10倍量70%乙醇,加热回流提取2次(1小时/次),合并提取液,滤过,回收乙醇,与上述水提取部分滤液合并,浓缩为相对密度1.20-1.25(50℃)的浸膏;减压干燥(60℃),粉碎,得干膏粉。
将挥发油用β-环糊精水饱和溶液法包合,形成包合物,干燥(40℃),粉碎(过80目筛)。
将粉碎后的的薄荷脑和冰片细粉、干膏粉、挥发油包合物,适量糊精,混合均匀,干法制成颗粒剂,分装即得。
实施例2中药组合物片剂的制备
本实施例中药组合物由以下原料药制成:醋延胡索107.5g、川芎86g、威灵仙86g、防风107.5g、花椒107.5g、牛膝86g、伸筋草107.5g、东北透骨草107.5g、路路通86g、海桐皮107.5g、薄荷脑3.6g、冰片7.2g。
花椒、川芎、防风水蒸气蒸馏提取挥发油6小时,收集挥发油;药渣加入12倍量水提取2小时,提取液滤过,滤液备用;醋延胡索、伸筋草、东北透骨草、路路通、海桐皮、牛膝、威灵仙加入12倍量60%乙醇,加热回流提取2次(1.5小时/次),合并提取液,滤过,回收乙醇,与上述水提取部分滤液合并,浓缩为相对密度1.20-1.25(50℃)的浸膏;减压干燥(60℃),粉碎,得干膏粉。
将挥发油用β-环糊精水饱和溶液法包合,形成包合物,干燥(40℃),粉碎(过80目筛)。
将再依次加入粉碎后的薄荷脑和冰片细粉、干膏粉、挥发油包合物,适量淀粉、硬脂酸镁,按照常规方法制成片剂,即得。
实施例3中药组合物凝胶剂的制备
本实施例中药组合物由以下原料药制成:醋延胡索107.5g、川芎86g、威灵仙86g、防风107.5g、花椒107.5g、牛膝86g、伸筋草107.5g、东北透骨草107.5g、路路通86g、海桐皮107.5g、薄荷脑3.6g、冰片7.2g、卡波姆20g、三乙醇胺16g、甘油100g。
花椒、川芎、防风水蒸气蒸馏提取挥发油8小时,收集挥发油;药渣加入15倍量水提取1.5小时,提取液滤过,滤液备用;醋延胡索、伸筋草、东北透骨草、路路通、海桐皮、牛膝、威灵仙加入12倍量70%乙醇,加热回流提取2次(2小时/次),合并提取液,滤过,回收乙醇,与上述水提取部分滤液合并,浓缩为相对密度1.20-1.30(50℃)的浸膏;
取卡波姆溶解于适量蒸馏水中,让其充分溶胀均匀,依次加入三乙醇胺、甘油搅拌均匀,再依次加入研磨至共熔后的薄荷脑和冰片、挥发油、浸膏及适量蒸馏水至1000g,研磨均匀,分装即得。
实验例4本发明中药组合物对豚鼠眩晕症的影响
1试验材料
1.1药物及试剂
受试药物:
按照实施例1的方法制备,规格1g生药/g颗粒剂;
对照药物:盐酸地芬尼多片,湖南千金湘江药业股份有限公司,批号130318;
试剂:氯仿,南京化学试剂股份有限公司,批号170517105E。
1.2仪器:
实验用三通迷宫(上海豪敦工贸有限公司);
离心机(FRESCO21,美国Thermo公司)。
1.3动物
豚鼠50只,雌雄兼用,体重230~260g,购于南京市浦口区莱芙养殖场,许可证号SCXK(苏)2019-0005。动物饲养环境按自然昼夜节律采光,自由摄食和饮水。
2试验方法与结果
2.1.1造模、分组、给药取健康合格的豚鼠,雌雄各半,体质量250~300g,随机分为5组,即模型组,盐酸地芬尼多片组(阳性对照组,6mg/kg),本发明组合物高、中、低剂量(4.2、2.1、1.05g/kg)组,每组10只动物,静养隔日后各组动物灌胃给予相应的药物,每日给药1次,持续14天。末次给药30min后,自豚鼠右耳滴入20μl氯仿,在其后30、60min仔细观察,记录1min内豚鼠头部摇摆次数;并观察豚鼠出现眼球震颤的潜伏期和持续时间,持续时间以60min为界。
2.1.2实验结果见表1、2。
表1本发明组合物对氯仿致豚鼠眩晕反应的影响
注:与模型组比较,**P<0.01
表2本发明组合物对豚鼠眼球震颤潜伏期及持续时间的影响
注:与模型组比较,*P<0.05,**P<0.01
由表1、2可知,与模型组比较,本发明组合物3个剂量组及阳性药组均能有效减少氯仿致豚鼠眩晕30min时动物的头部摆动次数,有效延长豚鼠眼球震颤的潜伏期并缩短其持续时间。
实验例5中药组合物对小鼠旋转性眩晕症的影响
1试验材料
1.1药物及试剂
受试药物:
按照实施例2的方法制备,规格1g生药/g片剂;
对照药物:盐酸地芬尼多片,湖南千金湘江药业股份有限公司,批号130318。
1.2仪器:
实验用三通迷宫(上海豪敦工贸有限公司);
离心机(FRESCO21,美国Thermo公司)。
1.3动物
清洁级ICR小鼠,雌雄各半,体质量20~22g(购于南通大学,许可证号SCXK(苏)2019-0001),动物饲养环境按自然昼夜节律采光,自由摄食和饮水。
2试验方法与结果
2.1.1造模、分组、给药取健康小鼠50只,随机分成5组:正常对照组,盐酸地芬尼多片组(阳性对照组,6mg/kg),本发明组合物高、中、低(4.2、2.1、1.05g/kg)剂量组。静养隔日后称量体重并开始灌胃给予对应药物,正常对照组灌胃生理盐水。各组小鼠均进行三通迷宫训练,每日训练2次,以建立起小鼠逃避电击的条件反射。7d后在试验前1h给药,迷宫训练1次后,除正常组外,将小鼠在旋转仪上300r/min匀速旋转1min并骤停,立即将小鼠置于迷宫中,打开电源,记录小鼠成功逃避电击所用的时间。
2.1.2实验结果,见表3。
表3本发明组合物对小鼠眩晕迷宫实验逃避时间的影响
注:与正常组比较,*P<0.05,**P<0.01
由表3可知,本发明组合物各剂量组和阳性药组均可显著缩短眩晕小鼠在迷宫中的逃避时间,缓解其眩晕症状。
从以上实验可知,本发明组合物可以减少眩晕豚鼠的头摆动次数,延长眩晕豚鼠的眼球震颤潜伏期,并能有效缩短震颤持续时间。另外,在迷宫实验中也证明,本发明组合物能显著缩短眩晕小鼠逃避电击所用时间。综上所述,本发明组合物在豚鼠和小鼠眩晕模型具有肯定的药效作用。
以上所述仅是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明原理的前提下,还可以做出若干改进和润饰,这些改进和润饰也应视为本发明的保护范围。
Claims (7)
1.一种中药组合物在制备用于眩晕症药物中的应用,以重量计,所述中药组合物由以下组分组成:醋延胡索20-200份、川芎10-160份、威灵仙10-160份、防风20-200份、花椒20-200份、牛膝10-160份、伸筋草20-200份、东北透骨草20-200份、路路通10-160份、海桐皮20-200份、薄荷脑1-10份、冰片2-15份。
2.根据权利要求1所述的应用,其特征在于,所述中药组合物由以下组分组成:醋延胡索70-107.5份、川芎65-86份、威灵仙80-86份、防风107.5-120份、花椒107.5-130份、牛膝60-86份、伸筋草75-107.5份、东北透骨草107.5-110份、路路通40-86份、海桐皮90-107.5份、薄荷脑3.6-7份、冰片7.2-10份。
3.根据权利要求1所述的应用,其特征在于,所述中药组合物由以下组分组成:醋延胡索107.5份、川芎86份、威灵仙86份、防风107.5份、花椒107.5份、牛膝86份、伸筋草107.5份、东北透骨草107.5份、路路通86份、海桐皮107.5份、薄荷脑3.6份、冰片7.2份。
4.根据权利要求1-3任一所述的应用,其特征在于,所述治疗眩晕症药物选自口服给药剂型或外用给药剂型。
5.根据权利要求4所述的应用,其特征在于,所述治疗眩晕症药物包括汤剂、颗粒剂、胶囊剂、片剂、口服液、丸剂、酊剂、糖浆剂、栓剂、凝胶剂、喷雾剂、注射剂。
6.根据权利要求1-3任一所述的应用,其特征在于,所述中药组合物的制备方法如下:
将花椒、川芎、防风水蒸气蒸馏提取挥发油、收集挥发油;药渣加入6-20倍量水提取,提取液滤过,滤液备用;醋延胡索、伸筋草、东北透骨草、路路通、海桐皮、牛膝、威灵仙加6-20倍量50%-90%乙醇,加热回流提取,将得到的提取液滤过,回收乙醇,与上述水提取部分滤液合并,浓缩为浸膏;将挥发油、浸膏合并后加入薄荷脑和冰片。
7.根据权利要求1-3任一所述的应用,其特征在于,当所述用于眩晕症药物选自颗粒剂时,所述颗粒剂的制备方法如下:
花椒、川芎、防风水蒸气蒸馏提取挥发油8小时,收集挥发油;药渣加入10倍量水提取1小时,提取液滤过,滤液备用;醋延胡索、伸筋草、东北透骨草、路路通、海桐皮、牛膝、威灵仙加入10倍量70%乙醇,加热回流提取2次,1小时/次,合并提取液,滤过,回收乙醇,与上述水提取部分滤液合并,浓缩为相对密度1.20-1.25的浸膏;减压干燥,粉碎,得干膏粉;
将挥发油用β-环糊精水饱和溶液法包合,形成包合物,干燥,粉碎;
将粉碎后的薄荷脑和冰片细粉、干膏粉、挥发油包合物,适量糊精,混合均匀,干法制成颗粒剂。
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