CN107982507A - 一种具有止呕功效的植物提取物混合物及其制备方法 - Google Patents
一种具有止呕功效的植物提取物混合物及其制备方法 Download PDFInfo
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Abstract
本发明提出了一种具有止呕功效的植物提取物混合物,按重量份计算包括:沉香15‑30份、橘皮10‑20份、紫苏8‑15份、生姜8‑15份、枇杷叶8‑15份、前胡5‑12份、人参5‑10份、白术5‑10份、枳壳2‑4份和甘草3‑10份。本发明采用中药组方制剂,体现了中药多靶点、综合协同治疗的特点,治疗效果好;本发明还可以制成喷雾剂,使用方便、见效快,对恶心呕吐不能服药的病人有非常好的治疗效果。另外,本发明所用药物混合组分均为纯天然植物提取物,无副作用,且使用范围广,适用于怀孕产生的孕吐、放化疗及外科手术等所引起的呕吐。
Description
技术领域
本发明涉及中药领域,特别涉及一种具有止呕功效的植物提取物混合物及其制备方法。
背景技术
呕吐是临床常见且难以治疗的一种症状,如中医临床胃肠道病证,胃中气滞则胃脘胀痛,气滞上逆则恶心、呕吐;西医中迷走神经刺激性疾病、胃肠道疾病、外科手术及肿瘤放、化疗等均可诱发恶心、呕吐;其中,肿瘤放、化疗副作用呕吐最常见且发生率高,如顺铂(DDP)所致呕吐率高达90%-100%,严重影响患者的生活质量和治疗效果。因此,防治呕吐及寻找可治疗呕吐相关胃肠道疾病的新型药物是目前药物研究人员面临的紧急问题。
化疗呕吐是指化疗药物导致胃肠黏膜损伤、胃肠动力障碍或刺激胃肠道的嗜铬细胞释放5-HT等神经递质和其受体结合产生神经冲动传入呕吐中枢诱发呕吐。据已有研究报道,化疗呕吐的作用机制主要包括:中枢和外周两条途径。中枢方面,化疗导致呕吐主要与呕吐中枢的神经递质和受体有关,其中主要包括多巴胺(DA)、5-HT、P物质、组胺、乙酰胆碱及其受体等。外周方面,化疗导致呕吐主要与胃肠道黏膜、胃肠道激素及胃肠动力有关。因此,有效阻止它们乃是止呕的主要作用机理。但是,目前西药止呕机制主要以拮抗中枢各神经递质及其受体为主。由于引发呕吐病因的多样性,临床多考虑联合用药以提高疗效,同时带来诸多不良反应,如最新研发的5-羟色胺3(5-HT3)受体拮抗剂,治疗急性呕吐有较好疗效,但对迟发型呕吐疗效较差,且价格昂贵并伴有肝脏转移酶升高、心脏电功能异常、头痛、便秘等副作用。
中医理论亦认为,化疗药物为一种化学毒,可直中脾胃,导致脾胃虚弱、升降失常而出现恶心呕吐,脏腑胀满等症状。祖国医学以“温胃散寒,健脾和胃,降逆止呕”为治则,目前已有生姜、半夏、旋覆花、代赭石、连翘等中药单用或君臣组方治疗化疗呕吐,目前市售的治疗哮喘的复方制剂有,并从对中枢神经递质及其受体作用、对胃肠道黏膜的保护、对胃肠动力的调节等多方面综合评价了止呕的作用机制,验证了中药作用的多靶点和综合协同治疗。
发明内容
鉴以此,本发明的目的在于提出一种具有止呕功效的植物提取物混合物及其制备方法。
沉香为瑞香科(Thymelaeaceae)植物白木香Aquilaria sinensis(Lour.)Gilg.含有树脂的木材。我国沉香主产于海南、广东、广西、云南、台湾等地,为名贵南药,其味辛苦,性微温;归脾、胃、肾经;具有行气止痛、温中止呕、纳气平喘的功效。中医临床主要用于胸腹胀闷疼痛,胃寒呃逆呕吐,肾虚气逆喘急等病证。沉香药用非常广泛,2015版《中国药典》中有38个复方制剂含有沉香,在中国以沉香组方配伍的中成药有160多种,《中医方剂大辞典》中有414个含有沉香的方剂。一直以来,沉香药用资源匮乏,我们课题组发明的“通体结香技术”高效、稳定结香,解决了药用原料问题,并实现了规模化生产。
橘皮又称为陈皮,为芸香科植物橘及其栽培变种的成熟果皮,橘常绿小乔木或灌木,栽培于丘陵、低山地带、江河湖泊沿岸或平原。橘皮性温,味辛、苦,入脾、胃、肺经,具有理气健脾、调中、燥湿的功效,主治脾胃气滞之脘腹胀满或疼痛、消化不良等。在中药归类中,橘皮属于理气药物,同时具有健胃、驱风、止呕、降逆的作用,常与消化药或脾胃药并用。
紫苏是唇形科一年生草本植物,具有特异的芳香,气清香,味微辛。紫苏叶能行气宽中,常用于脾胃气滞、胸闷、呕恶等症,不论有无表症,均可应用,常配生姜、陈皮、香附等同用。
生姜是姜科多年生草本植物姜的新鲜根茎,辛、微温,归肺、脾、胃经;具有温中止呕、温肺止咳、发汗解表的功效,适用于脾胃虚寒,食欲减退,恶心、痰饮、咳嗽,或胃气不和、胃寒导致的呕吐。
枇杷叶为蔷薇科植物枇杷的叶子,苦、微寒、味甘,归肺、胃经,主治肺热咳嗽,气逆喘急,胃热呕吐,哕逆。枇杷叶善清胃热、降胃气而奏止呕哕、治呃逆之效,胃热呕逆可以单用,暴吐服药不止可配以生姜、半夏,以加强止呕;妊娠呕吐,可以用枇杷叶配生姜煎服。
前胡是伞形科,前胡属多年生草本植物,根含多种香豆精类,味苦、辛、性微寒,归经肺、脾、肝经;能疏散风热;降气化痰。主治外感风热,咳喘痰多,胸膈满闷,支气管炎等。
人参性平、味甘、微苦、微温,归脾、肺、心经,大补元气,复脉固脱,补脾益肺,生津止渴,安神益智,可以治疗劳伤虚损、食少、倦怠、反胃吐食、大便滑泄等一切虚证。
白术是菊科苍术属的一种植物,以根茎入药,苦、甘、温,归脾、胃经,健脾益气、燥湿利水,常与枇杷叶、半夏、橘皮等配伍应用,治疗脾胃虚弱,吐逆等病症。
枳壳为芸香科植物酸橙及其栽培变种的干燥未成熟果实,性苦、辛、酸、温,具有理气宽中、行滞消胀的功效,主治胸胁气滞,胀满疼痛,食积不化,痰饮内停等病症。
甘草味甘甜,性平和,入心、脾、肺、胃四经,甘草善于调和药性,解百草诸毒。
本发明以沉香为君药,橘皮、紫苏、生姜和枇杷叶为臣药,前胡、人参、白术和枳壳为佐药,甘草为使药,合理配伍,得到了一种具有止呕功效的中草药植物提取物混合物。
本发明的技术方案是这样实现的:
一种具有止呕功效的植物提取物混合物,按重量份计算,包括:沉香15-30份、橘皮10-20份、紫苏8-15份、生姜8-15份、枇杷叶8-15份、前胡5-12份、人参5-10份、白术5-10份、枳壳2-4份和甘草3-10份。
一种具有止呕功效的植物提取物混合物的制备方法,包括以下步骤:
步骤1:分别制备沉香或白术的乙醇提取物;
步骤2:分别将橘皮和枳壳破碎,采用水蒸气蒸馏法,获得橘皮提取物和枳壳提取物;
步骤3:分别制备紫苏、生姜、枇杷叶、前胡、人参或甘草的去离子水提取物;
步骤4:将步骤1、步骤2和步骤3所得提取物,按照比例混合,即得到所述的具有止呕功效的植物提取物混合物。
进一步的,所述的沉香或白术的乙醇提取物,包括以下制备步骤:
步骤1:分别将沉香或白术的原料粉碎,加入5-20倍量95%乙醇,浸泡1-4h后,缓缓加热至溶液沸腾,并保持微沸1h,停止加热,放置冷却后,过滤,得到滤液;
步骤2:将步骤1中过滤后的药渣按照以上步骤1操作重复2-3次,最后合并滤液,加热,蒸干2-6h,浓缩至无醇味,得到黑褐色固体浸膏,即为所述沉香或白术的醇提取物。
进一步的,所述的紫苏、生姜、枇杷叶、前胡、人参或甘草的去离子水提取物,包括以下制备步骤:
步骤1:分别将紫苏、生姜、枇杷叶、前胡、人参或甘草的原料粉碎,加入5-20倍量的去离子水,浸泡2-4h后,缓缓加热至溶液沸腾,并保持微沸1h,停止加热,放置冷却后,过滤,得到滤液;
步骤:2:将步骤1中过滤后的药渣按照以上步骤1操作重复2-3次,最后合并滤液,加热,蒸干2-5h,浓缩,得到上述中药组分的去离子水提取物。
进一步的,所述的植物提取物混合物还可以按常规方法制成喷剂、散剂、丸剂、片剂、丹剂和口服液。
与现有技术相比,本发明的有益效果为:
1)本发明采用中药制剂,多靶点综合协同治疗,治疗效果好,见效快;
2)本发明可以制成喷雾,使用方便,见效快,对恶心呕吐不能服药的病人有非常好的治疗效果;
3)本发明所用药物为纯天然制剂,使用范围广,适用于怀孕产生的孕吐和化疗引起的呕吐。
具体实施方式
为对本发明中的技术方案进行清楚、完整地描述,显然,发明人结合实施例进行说明,但以下实施例所描述的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。
植物提取物混合物的制备:
制备沉香、白术的醇提取物,包括以下步骤:
步骤1:分别将沉香或白术的原料粉碎,加入5-20倍量95%乙醇,浸泡1-4h后,缓缓加热至溶液沸腾,并保持微沸1h,停止加热,放置冷却后,过滤,得到滤液;
步骤2:将步骤1中过滤后的药渣按照以上步骤1操作重复2-3次,最后合并滤液,加热,蒸干2-6h,浓缩至无醇味,得到黑褐色固体浸膏,即为所述沉香或白术的醇提取物。
制备紫苏、生姜、枇杷叶、前胡、人参或甘草的去离子水提取物,包括以下步骤:
步骤1:分别将紫苏、生姜、枇杷叶、前胡、人参或甘草的原料粉碎,加入5-20倍量的去离子水,浸泡2-4h后,缓缓加热至溶液沸腾,并保持微沸1h,停止加热,放置冷却后,过滤,得到滤液;
步骤:2:将步骤1中过滤后的药渣按照以上步骤1操作重复2-3次,最后合并滤液,加热,蒸干2-5h,浓缩,得到上述中药组分的去离子水提取物。
制备一种具有止呕功效的植物提取物混合物的制备方法,将上述方法制备得到的沉香、橘皮、紫苏、生姜、枇杷叶、前胡、人参、白术、枳壳和甘草提取物,按照表1所示比例,实施例1-4,对比例1-4混合,即得到所述的具有止呕功能的植物提取物混合物。
实施例1-4、对比例1-4:
表1:
准备实验动物:
试验动物:雄性家鸽(350~400g)
试验方法:雄性家鸽随机分为正常组、呕吐模型组、甲氧氯普胺组(0.05g/kg)、实施例4组(生药量2.84g/kg)和对比例4组(生药量2.84g/kg),每组20只。正常组和模型组分别灌胃给予相应体积的蒸馏水,甲氧氯普胺组灌胃给药50mg/kg,受试药物组分别灌胃给予相应的植物提取物混合物,1次/d,20mL/kg,连续给药7d。除正常组外,其它各组家鸽分别腹腔注射顺铂(6mg/kg),制备家鸽呕吐模型,观察家鸽的呕吐现象,并记录。
根据WHO分级标准,将恶心呕吐分为Ⅳ级:
0级:无恶心呕吐;
I级:轻微恶心无呕吐,不影响进食;
Ⅱ级:每日呕吐1~2次,不影响正常进食和生活;
III级:每日呕吐3~5次,影响正常进食和生活,需要治疗;
IV级:难以控制的呕吐,每日超过5次。
按照QOL各项指标的记分将食欲记为1~5分:
1分:几乎不进食;
2分:食量小于正常的1/2;
3分:食量为正常的1/2;
4分:食量略少;
5分:食量正常。
根据以上标准,恶心呕吐疗效判断标准为:0级、I级为显效;Ⅱ级为有效;Ⅲ级、IV级为无效。
食欲改善疗效评价标准为:4分、5分为显效;3分为有效;1分、2分为无效,以显效和有效的病例数除以总例数计算有效率。实验结果如表2、3所示:
表2呕吐实验:
表3食欲实验:
可以发现,通过本发明制备合成的植物提取物混合物对治疗呕吐有着很好的效果,优于对比例,优于治疗呕吐的常用药甲氧氯普胺。其中,以实施例3,沉香25份、橘皮15份、紫苏10份、生姜15份、枇杷叶10份、前胡10份、人参7份、白术5份、枳壳4份和甘草3份为最优。
以上所述仅为本发明的较佳实施例而已,并不用以限制本发明,凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (5)
1.一种具有止呕功效的植物提取物混合物,其特征在于,按重量份计算,包括:沉香15-30份、橘皮10-20份、紫苏8-15份、生姜8-15份、枇杷叶8-15份、前胡5-12份、人参5-10份、白术5-10份、枳壳2-4份和甘草3-10份。
2.一种具有止呕功效的植物提取物混合物的制备方法,其特征在于,包括以下步骤:
步骤1:分别制备沉香或白术的乙醇提取物;
步骤2:分别将橘皮和枳壳破碎,采用水蒸气蒸馏法,获得橘皮提取物和枳壳提取物;
步骤3:分别制备紫苏、生姜、枇杷叶、前胡、人参和甘草的去离子水提取物;
步骤4:将步骤1、步骤2和步骤3所得提取物,按照权利要求1所述的重量份数比例混合,即得到所述的具有止呕功效的植物提取物混合物。
3.根据权利要求2所述的沉香或白术的乙醇提取物,其特征在于,包括以下制备步骤:
步骤1:分别将沉香或白术的原料粉碎,加入5-20倍量95%乙醇,浸泡1-4h后,缓缓加热至溶液沸腾,并保持微沸1h,停止加热,放置冷却后,过滤,得到滤液;
步骤2:将步骤1中过滤后的药渣按照上述步骤1操作重复2-3次,最后合并滤液,加热,蒸干2-6h,浓缩至无醇味,得到黑褐色固体浸膏,即为所述沉香或白术的醇提取物。
4.根据权利要求2所述的紫苏、生姜、枇杷叶、前胡、人参和甘草的去离子水提取物,其特征在于,包括以下制备步骤:
步骤1:分别将紫苏、生姜、枇杷叶、前胡、人参和甘草的原料粉碎,加入5-20倍量的去离子水,浸泡2-4h后,缓缓加热至溶液沸腾,并保持微沸1h,停止加热,放置冷却后,过滤,得到滤液;
步骤:2:将步骤1中过滤后的药渣按照以上步骤1操作重复2-3次,最后合并滤液,加热,蒸干2-5h,浓缩,得到上述中药组分的去离子水提取物。
5.根据权利要求2所述的具有止呕功效的植物提取物混合物的制备方法,其特征在于,上述步骤4中,所述的植物提取物混合物还可以按常规方法制成喷剂、散剂、丸剂、片剂、丹剂和口服液。
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