CN115212252A - 佤药聂良给在治疗脑梗死药物方面的应用 - Google Patents
佤药聂良给在治疗脑梗死药物方面的应用 Download PDFInfo
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Abstract
本发明公开了佤药聂良给在治疗脑梗死药物方面的应用，聂良给学名瓜子金，本发明所说药物可为汤剂、口服液、颗粒；其中颗粒经过冲泡后可供脑梗死恢复期瘀血阻络证患者服用；通过临床病例验证，瓜子金对脑梗死恢复期瘀血阻络证患者的症状恢复改善有显著疗效，且瓜子金用于治疗脑梗死还具有见效快、疗效好、副作用小、服用方便等优点。
Description
技术领域
本发明属于佤族医药领域的应用，具体涉及佤药聂良给在治疗脑梗死药物方面的应用。
背景技术
佤药—聂良给，学名瓜子金，又名瓜子草、来麻回、散血丹、小远志、金锁匙、地藤草，为远志科，远志属植物，主要分布于我国东北、华北、西南及长江流域；瓜子金具有祛痰止咳、活血消肿、解毒止痛的功效，常用于咳嗽痰多、咽喉肿痛、外治跌打损伤、疔疮疖肿、蛇虫咬伤等症；佤族认为聂良给具有强筋健骨之功、壮阳之效；通过现代药理学研究发现，瓜子金具有治疗急性上呼吸道感染、抗抑郁、调节脂代谢的效果，对阿尔兹海默症、帕金森具有改善作用。
脑梗死又称脑梗塞、缺血性脑卒中，是指由各种原因引起的局部脑组织血液供应障碍，导致脑组织缺血缺氧性病变坏死，进而产生临床上相应神经功能缺失的一类病症。该病形成的病理基础主要是动脉粥样硬化；炎症反应贯穿动脉粥样硬化发病的各个阶段，动脉粥样硬化一旦发展到足以阻塞动脉腔，则该动脉所供应的组织或器官将缺血或坏死；脑动脉粥样硬化可引起脑缺血、脑萎缩，或造成脑血管破裂出血等。
中医将脑梗死归属于“中风病”范畴，认为中风病是由于正气亏虚，饮食、情志、劳倦内伤等引起气血逆乱，产生风、火、痰、瘀、毒，导致脑脉痹阻或血溢脑脉之外为基本病机，以突然昏仆、半身不遂、口舌歪斜、言语謇涩或不语、偏身麻木为主要临床表现的病证。佤医则认为肢体瘫痪、不能言语是一种虚弱的表现，治疗当顺势而为，“虚则壮之”。
西医治疗脑梗死的药物有限，以抗血小板聚集、降脂稳斑、改善脑循环等药物为主，一般以化学单体为有效成分，作用靶点单一，且治疗成本及不良反应发生率高。口服中药多为复方制剂，成分过于复杂，而其他中医治疗手段，不同程度的存在见效慢，疗效不够等缺陷。
目前没有临床关于瓜子金在脑梗死治疗方面药物研究和报道。
发明内容
本发明在于研究瓜子金在治疗脑梗死和脑梗死药物方面的疗效和应用；
瓜子金在治疗脑梗死药物中的应用；
优选的，所述药物为汤剂、口服液、颗粒；
优选的，所述汤剂的制备方法为：
S1：称取定量瓜子金药材，按照1:1.3的份量比加入纯净水浸泡1小时至药材变软，膨胀恢复至其天然状态；
S2：浸泡完成的瓜子金按照1:5的份量比加入纯净水进行第一次煎煮30min；过滤药渣，取药液；
S3：按照药渣与水1:3的份量比向药渣中加入纯净水进行第二次煎煮40min；过滤药渣，取药液；
S4：将两次煎煮所得药液合并得汤剂。
本发明的另一目的在于提供一种提取瓜子金制备皂苷元的方法，包括以下步骤：
S1：将干燥瓜子金粉碎至80-100目，加入夹带剂，室温下浸提2-4h，陶瓷膜过滤，得滤渣和滤液；
S2：滤液进入超临界萃取釜内，萃取压力15-20MPa，温度40-60℃下，通入液态CO2和夹带剂临界萃取2-3h，在压力5-10MPa，温度50-60℃解析萃取物；萃取物干燥后的浸膏；
S3：滤渣加入70-90％乙醇溶液微波提取，提取液浓缩后加入大孔树脂中吸附，取3-7倍量40-70％乙醇溶液洗脱，收集洗脱液浓缩得浸膏；
S4：上述浸膏采用高速逆流色谱纯化，蒸发光散射检测器检测，收集目标成分，回收试剂，减压干燥即得目标产物皂苷；
优选的，所述夹带剂包括但不限于甲醇、乙醇、丙酮和乙酸乙酯中的一种。
本发明的另一目的在于提供一种瓜子金颗粒的制备工艺，包括以下步骤：
S1：称取瓜子金与辅料及湿润剂；其中辅料为可溶性淀粉、糊精、微晶纤维素、甘露醇、β-环糊精，瓜子金与上述辅料的比例为：1:2.5、1:3、1:3.5、1:4、1:4.5；湿润剂为65％乙醇、95％乙醇、98％乙醇、无水乙醇；
S2：将瓜子金浸膏与β-环糊精按1:3.5的比例混合均匀，选用无水乙醇作为润湿剂，制备软材，过20目筛制粒，60℃干燥至恒重，过一号筛与五号筛整粒。
瓜子金根含三菇皂甙，树脂，脂肪油，远志醇及四乙酸酯；地上部分含瓜子金皂甙甲、乙、丙、丁与瓜子金皂甙I-XIX；叶含山柰酚-3-O-6/-O-(3-羟基-3-甲基-戊二酰基)葡萄糖甙，紫云英甙，山柰酚3-(6"-乙酰基)葡萄糖甙，山柰酚3,7-二葡萄糖甙；
佤医认为瓜子金具有益气壮阳、强筋健骨的功效，有望改善中风后肢体瘫痪、失语等虚损表现。从中医角度看，瓜子金具有活血、化痰、解毒的功效，可针对缺血性中风病的瘀、痰、毒等致病因素发挥作用。药理学研究发现，瓜子金具有显著的抗炎作用；脑缺血发生后可产生强烈的炎症反应，造成脑组织继发性损伤，因此早期抗炎治疗能减轻脑损伤程度。赵清超等研究发现瓜子金有效部位群能显著抑制炎症因子NO、TNF-α及IL-6的生成与释放，显著降低TNF-α和IL-6mRNA的表达。石瑞丽等在以0.1μg/mL LPS刺激BV-2细胞构建神经炎症模型研究时发现，瓜子金的有效成分瓜子金皂苷己(polygalasaponinF,PGSF)(10,1μmol/L)可减少炎性介质IL-1β、TNF-α和NO的合成释放，抑制炎性蛋白酶一氧化氮合成酶(iNOS)和环氧化酶-2(COX-2)的基因和蛋白表达，并降低小胶质细胞TLR4mRNA的表达，抑制小胶质细胞激活，起到抗神经炎症的作用而发挥脑保护效应。PGSF还能明显增加氧糖剥夺/复氧模型(OGD/R)、氧化应激和去血清处理细胞的存活率；在OGD/R模型中，PGSF可改善神经元形态，减少Caspase-3活性片段的表达，并与MAPK通路抑制剂协同降低神经元死亡率。
本发明的有益效果是：
见效快：所有病例在服用瓜子金颗粒4周后症状即开始出现改善；
疗效好：通过临床病例观察，瓜子金对98％的患者均有疗效；
副作用小：利用本发明的瓜子金应用于脑梗死的治疗，几乎没有副作用，克服了西药或组方药物副作用大的缺陷；
服用方便：通过将瓜子金煎煮成汤剂或制备成口服液，颗粒，可直接进行服用。
具体实施方式
下面将结合具体实施例对本发明的技术方案进行清楚、完整地描述，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。基于本发明中的实施例，本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其它实施例，都属于本发明保护的范围。
实施例1
瓜子金在治疗脑梗死药物中的应用；
优选的，所述药物为汤剂、口服液、颗粒；
优选的，所述汤剂的制备方法为：
S1：称取定量瓜子金药材，按照1:1.3的份量比加入纯净水浸泡1小时至药材变软，膨胀恢复至其天然状态；
S2：浸泡完成的瓜子金按照1:5的份量比加入纯净水进行第一次煎煮30min；过滤药渣，取药液；
S3：按照药渣与水1:3的份量比向药渣中加入纯净水进行第二次煎煮40min；过滤药渣，取药液；
S4：将两次煎煮所得药液合并得汤剂。
一种提取瓜子金制备皂苷元的方法，包括以下步骤：
S1：将干燥瓜子金粉碎至80-100目，加入夹带剂，室温下浸提2-4h，陶瓷膜过滤，得滤渣和滤液；
S2：滤液进入超临界萃取釜内，萃取压力15-20MPa，温度40-60℃下，通入液态CO2和夹带剂临界萃取2-3h，在压力5-10MPa，温度50-60℃解析萃取物；萃取物干燥后的浸膏；
S3：滤渣加入70-90％乙醇溶液微波提取，提取液浓缩后加入大孔树脂中吸附，取3-7倍量40-70％乙醇溶液洗脱，收集洗脱液浓缩得浸膏；
S4：上述浸膏采用高速逆流色谱纯化，蒸发光散射检测器检测，收集目标成分，回收试剂，减压干燥即得目标产物皂苷；
优选的，所述夹带剂包括但不限于甲醇、乙醇、丙酮和乙酸乙酯中的一种。
一种瓜子金颗粒的制备工艺，包括以下步骤：
S1：称取瓜子金与辅料及湿润剂；其中辅料为可溶性淀粉、糊精、微晶纤维素、甘露醇、β-环糊精，瓜子金与上述辅料的比例为：1:2.5、1:3、1:3.5、1:4、1:4.5；湿润剂为65％乙醇、95％乙醇、98％乙醇、无水乙醇；
S2：将瓜子金浸膏与β-环糊精按1:3.5的比例混合均匀，选用无水乙醇作为润湿剂，制备软材，过20目筛制粒，60℃干燥至恒重，过一号筛与五号筛整粒。
实施例2
本实施例为按照实施例1中制备所得颗粒进行服用，进行临床病例的疗效观察及统计；
1)病例对象：临床观察脑梗死恢复瘀血阻络患者，NIHSS积分5-20分，现有47例，男25例，女15例，年龄18-80岁，发病时间14-180天，脱落2例，观察结束45例；
2)症状及疗效评判标准：采用中风病病类诊断评分、NIHSS量表、Barthel指数评价病人临床疗效；
3)服药方式：瓜子金颗粒，温水冲服，早中晚饭后半小时各一次，根据个体及病情差异，服药量为4-8克/天，8周为一个疗程；
4)疗效结果：疗程结束后的45例病例，有效率98％，临床缓解率7％，显效率58％；
疗效指数统计：中医症状疗效评定标准(参照《中药新药临床研究指导原则》的疗效评定标准)：疗效指数＝(疗前积分-疗后积分)÷疗前积分×100％；
①临床缓解：用药前、服药后，症状和体征明显改善(疗效指数≥95％)；
②显效：服药后，症状和体征明显改善(70％≤疗效指数<95％)；
③有效：服药后，症状和体征有改善(30％≤疗效指数<70％)；
④无效：服药后，症状和体征无明显减轻或加重者(疗效指数<30％)；
5)神经功能缺陷评分：
评分标准：
基本痊愈：神经功能缺陷评分下降91％-100％，并且失能水平为0；
显著改善：神经功能缺陷评分下降46％-90％，并且失能水平为1-3；
改善：神经功能缺陷评分下降18％-45％；
无变化：神经功能缺陷评分下降或上升<17％；
恶化：神经功能缺陷评分上升>18％；
统计结果：45例中基本痊愈7例，显著改善的31例，改善的6例，无变化1例。
结论：瓜子金能够有效改善脑梗死恢复期瘀血阻络证患者的肢体偏瘫、语言障碍等神经功能缺损症状。
实施例3
急毒实验
1)实验方法：采用最大给药量法，取健康SD大鼠40只，雌雄各半；按性别、体重随机分为2组，每组20只，雌雄各半；第一组，正常对照组；第二组，瓜子金组，给药浓度为0.167g·ml-1，按最大可行性给药容积20ml·kg-1进行给药，给药总剂量为6.68g·kg-1·d-1。给药当日上午、下午各给药一次，两次给药间隔6h，末次给药后连续观察14d。
2)结果
a、一般症状观察：试验期间未见动物死亡，给药后动物仅出现自主活动减少症状，给药后30min症状恢复；
b、体质量：给药前，瓜子金组动物体质量与溶媒对照组比较未见统计学差异(P>0.05)。给药后，瓜子金组(♂)第1、3d动物体质量与溶媒对照组比较有显著性降低(P>0.05)，给药后第5d开始，体质量恢复正常；瓜子金组(♀)动物体质量与溶媒对照组比较未见统计学差异(P>0.05)；
c、大体剖检：对试验结束时存活大鼠大体剖检肉眼未见明显异常，未发现明显毒性靶器官。
3)结论
本试验条件下，采用最大给药量法，灌胃给药后，可轻微影响实验动物自主活动和♂大鼠体质量，各症状均可逐渐恢复正常，未见其他明显毒性；瓜子金对SD大鼠的最大给药量(MFD)为6.68g·kg-1。
实施例4
药效学
1)实验方法
取健康雄性SD大鼠75只，随机分为5组，每组15只；第一组，假手术(Sham)组；第二组，局灶性脑缺血模型(MCAO)组；第三组瓜子金低剂量组；第四组瓜子金中剂量组；第五组瓜子金高剂量组。Sham组与MCAO组按照1mL/100g灌胃生理盐水，瓜子金组分别按照400mg生药/kg、800mg生药/kg、1600mg生药/kg灌胃给药。每天给药一次，连续给药7d，采用ZeaLonga改良后的大脑中动脉线栓法造模，缺血2h、再灌注24h进行检测。
2)结果
脑缺血再灌注24h后，进行神经功能缺损评分，Sham组大鼠无神经功能障碍；与Sham组相比，MCAO组神经功能缺损评分显著升高；与MCAO组相比，瓜子金高剂量组神经功能评分显著下降；
脑组织含水量结果表明，与Sham组相比，MCAO组大鼠脑组织含水量显著增加；与MCAO组相比，瓜子金高剂量组脑组织含水量明显下降；
TTC染色结果显示，Sham组大鼠无梗死区；与Sham组相比，MCAO组大鼠脑梗死面积明显增加；与MCAO组相比，瓜子金低、中、高剂量组脑梗死面积均明显减小。
在本说明书的描述中，参考术语“一个实施例”、“示例”、“具体示例”等的描述意指结合该实施例或示例描述的具体特征、结构、材料或者特点包含于本发明的至少一个实施例或示例中。在本说明书中，对上述术语的示意性表述不一定指的是相同的实施例或示例。而且，描述的具体特征、结构、材料或者特点可以在任何的一个或多个实施例或示例中以合适的方式结合。
以上公开的本发明优选实施例只是用于帮助阐述本发明。优选实施例并没有详尽叙述所有的细节，也不限制该发明仅为所述的具体实施方式。显然，根据本说明书的内容，可作很多的修改和变化。本说明书选取并具体描述这些实施例，是为了更好地解释本发明的原理和实际应用，从而使所属技术领域技术人员能很好地理解和利用本发明。本发明仅受权利要求书及其全部范围和等效物的限制。
Claims (6)
1.瓜子金在治疗脑梗死药物中的应用。
2.根据权利要求1所述瓜子金在治疗脑梗死药物中的应用，其特征在于，所述药物为汤剂、口服液、颗粒。
3.根据权利要求2所述瓜子金在治疗脑梗死药物中的应用，其特征在于，所述汤剂的制备方法为：
S1：称取定量瓜子金药材，按照1:1.3的份量比加入纯净水浸泡1小时至药材变软，膨胀恢复至其天然状态；
S2：浸泡完成的瓜子金按照1:5的份量比加入纯净水进行第一次煎煮30min；过滤药渣，取药液；
S3：按照药渣与水1:3的份量比向药渣中加入纯净水进行第二次煎煮40min；过滤药渣，取药液；
S4：将两次煎煮所得药液合并得汤剂。
4.一种提取瓜子金制备皂苷元的方法，其特征在于，包括以下步骤：
S1：将干燥瓜子金粉碎至80-100目，加入夹带剂，室温下浸提2-4h，陶瓷膜过滤，得滤渣和滤液；
S2：滤液进入超临界萃取釜内，萃取压力15-20MPa，温度40-60℃下，通入液态CO2和夹带剂临界萃取2-3h，在压力5-10MPa，温度50-60℃解析萃取物；萃取物干燥后的浸膏；
S3：滤渣加入70-90％乙醇溶液微波提取，提取液浓缩后加入大孔树脂中吸附，取3-7倍量40-70％乙醇溶液洗脱，收集洗脱液浓缩得浸膏；
S4：上述浸膏采用高速逆流色谱纯化，蒸发光散射检测器检测，收集目标成分，回收试剂，减压干燥即得目标产物皂苷。
5.根据权利要求4所述一种利用瓜子金制备皂苷元的方法，其特征在于，所述夹带剂包括但不限于甲醇、乙醇、丙酮和乙酸乙酯中的一种。
6.一种瓜子金颗粒的制备工艺，包括以下步骤：
S1：称取瓜子金与辅料及湿润剂；其中辅料为可溶性淀粉、糊精、微晶纤维素、甘露醇、β-环糊精，瓜子金与上述辅料的比例为：1:2.5、1:3、1:3.5、1:4、1:4.5；湿润剂为65％乙醇、95％乙醇、98％乙醇、无水乙醇；
S2：将瓜子金浸膏与β-环糊精按1:3.5的比例混合均匀，选用无水乙醇作为润湿剂，制备软材，过20目筛制粒，60℃干燥至恒重，过一号筛与五号筛整粒。
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| CN106511492A (zh) * | 2016-12-27 | 2017-03-22 | 南昌大学 | 一种瓜子金提取物的制备及其促海马神经发生的应用 |
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| JP2009046465A (ja) * | 2007-07-23 | 2009-03-05 | Maruzen Pharmaceut Co Ltd | 皮膚化粧料及び飲食品 |
| CN102391350A (zh) * | 2011-10-10 | 2012-03-28 | 南京泽朗医药科技有限公司 | 一种瓜子金皂苷己的提纯方法 |
| CN106511492A (zh) * | 2016-12-27 | 2017-03-22 | 南昌大学 | 一种瓜子金提取物的制备及其促海马神经发生的应用 |
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