CN112274619B - 一种缓解痛经的组合物及其在制备药物、保健品或食品中的应用 - Google Patents
一种缓解痛经的组合物及其在制备药物、保健品或食品中的应用 Download PDFInfo
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Abstract
本发明涉及一种缓解痛经的组合物及其在制备药物、保健品或食品中的应用。所述组合物由下列重量份的原料组成:阿胶6‑12份、炮姜6‑20份、生姜6‑15份、生蒲黄10‑30份、小茴香8‑20份、补骨脂10‑30份。动物实验表明,本发明组合物针对原发性痛经大鼠模型,可有效减少大鼠因疼痛扭体次数,减少大鼠子宫促进子宫肌层收缩的PGF2ɑ的含量,增加大鼠子宫抑制子宫平滑肌收缩的PGF2的含量,进而有效减少大鼠子宫平滑肌收缩幅度和收缩频率,在对痛经的缓解作用上效果突出,且安全无毒副作用。
Description
技术领域
本发明涉及中药和食品领域,具体地说,涉及一种缓解痛经的组合物及其在制备药物、保健品或食品中的应用。
背景技术
痛经是女性常见月经病,有资料显示,在年轻女性中,痛经的发生率在60%—80%,痛经发生时不仅患者极为痛苦,甚至影响正常生活和工作。痛经分为原发性痛经和继发性痛经。原发性痛经即功能性痛经,是指月经期疼痛,常呈痉挛性,集中在下腹部。其他症状包括头痛、乏力、头晕、恶心呕吐、腹泻、腰腿痛,常发生于年轻女性,原发性痛经不伴有明显的盆腔器质性疾病。继发性痛经则指生殖器官有明显病变者,如子宫内膜异位症、盆腔炎、肿瘤等。
中医古现代医学著作均表明,中医药治疗痛经有着悠久的历史。关于痛经的病因病机,不同的医家有不同见解。对痛经的记载,最早见于《金贵要略·妇人杂病脉证并治》:“带下,经水不利,少腹满痛,经一月再见者,土瓜根散主之”。指出瘀血内阻而致经行不畅,少腹胀痛,用活血化瘀的土瓜根散治之。《诸病源候论》指出妇人月水来腹痛者,由劳伤血气,以致体虚,受风冷之气客于胞络,损冲任之脉。《景岳全书·妇人规》云:“经行腹痛,证有虚实。实者或因寒滞,或因血滞,或因气滞,或因热滞;虚者有因血虚,有因气虚”,较详细的归纳了痛经的常见病因,并根据疼痛的时间、性质、程度辨虚实。
中医治疗痛经方法较多,包括中药内服、外用、针灸、耳穴敷贴、拔罐等。汤剂内服是中医治疗痛经最为常用且有效的治疗方式。中医妇科名医治疗痛经的经方主要有:四物汤、温经汤、失笑散、少腹逐瘀汤、四逆散、金铃子散、逍遥散等。经验方有加味没竭汤、白莲散结汤、内异止痛汤、活血祛瘀化癥汤等。专利文献也公开了一些治疗痛经的中药复方。如专利文献CN107788530A公开了一种用于女性月经稀少痛经闭经的中药组合物,包括以下重量份的组分:枸杞5-15份、葛根1-10份、蒲公英1-10份、桃仁1-10份、甘草1-10份、益智仁1-10份、肉桂1-15份。专利文献CN105106862A,公开了一种治疗妇女功能性痛经的中药组合物,由以下重量份的原料药制成:蒲黄30-36份、地龙30-36份、赤芍24-30份、三棱18-24份、莪术18-24份、地鳖18-24份、血竭12-18份、乳香(制)18-24份、没药(制)18-24份。专利文献CN107982511A,公开了一种治疗原发性痛经的中药组合物,按重量份数计,包括:当归50-100份、川芎50-100份、黄芪50-100份、熟地黄50-100份、白术50-100份、益母草30-80份、续断30-80份、柴胡20-60份、黄芩20-60份、桂枝10-50份、茯苓10-50份、木香10-50份、香附10-50份、延胡索10-50份、生姜60-100份、羊乳60-100份、红糖60-100份。而目前如本申请的中药组合物尚未见报道。
发明内容
本发明的目的是针对现有技术中的不足,提供一种治疗痛经的组合物。
本发明的再一的目的是,提供所述组合物的制备方法。
本发明的另一的目的是,提供所述组合物的用途。
为实现上述第一个目的,本发明采取的技术方案是:
一种治疗痛经的组合物,由下列重量份的原料组成:阿胶6-12份、炮姜6-20份、生姜6-15份、生蒲黄10-30份、小茴香8-20份、补骨脂10-30份。
作为本发明的一个优选例,所述组合物由下列重量份的原料组成:阿胶8-12份、炮姜8-15份、生姜8-15份、生蒲黄12-20份、小茴香10-15份、补骨脂10-20份。
更优选地,所述组合物由下列重量份的原料组成:阿胶10份、炮姜10份、生姜12份、生蒲黄12份、小茴香12份、补骨脂15份。
作为本发明的另一优选例,所述组合物还包含制备药物、保健品或食品的常规辅料。
作为本发明的另一优选例,所述组合物被进一步制成片剂、颗粒剂、胶囊剂或合剂。
作为本发明的另一优选例,所述组合物的制备方法包括以下步骤:
(a)称取炮姜、生姜、生蒲黄、小茴香、补骨脂;
(b)加6-10倍量的水煎煮两次,每次煎煮0.5-2小时,合并两次水煎液,静置,过滤,浓缩,
(c)向浓缩液加入2-3倍90%-95%酒精,搅拌沉淀过夜,取上清液浓缩至稠浸膏;
(d)称取阿胶,倒入适量黄酒,以没过阿胶为度,浸泡至溶解,和入(c)所得稠浸膏。
为实现上述第二个目的,本发明采取的技术方案是:
如上所述的组合物的制备方法,包括以下步骤:
(a)称取炮姜、生姜、生蒲黄、小茴香、补骨脂;
(b)加6-10倍量的水煎煮两次,每次煎煮0.5-2小时,合并两次水煎液,静置,过滤,浓缩,
(c)向浓缩液加入2-3倍90%-95%酒精,搅拌沉淀过夜,取上清液浓缩至稠浸膏;
(d)称取阿胶,倒入适量黄酒,以没过阿胶为度,浸泡至溶解,和入(c)所得稠浸膏。
为实现上述第三个目的,本发明采取的技术方案是:
如上任一所述的组合物在制备缓解痛经的药物、保健品或食品中的应用。
作为本发明的一个优选例,所述痛经为原发性痛经。
本文中,所述“阿胶”为马科动物驴Equus asinus L.的皮,经煎煮、浓缩制成的固体胶。所述“炮姜”为干姜的炮制加工品,方法为取净干姜,照烫法用沙烫至鼓起,表面棕褐色。所述“生姜”为姜科植物姜Zingiber offcinale Rosc.的新鲜根茎。所述“生蒲黄”为香蒲科植物水烛香蒲Typha angustifoliaL.的花粉。所述“小茴香”为伞形科植物茴香Forniculum vulgare Mill.的果实。所述“补骨脂”为豆科植物补骨脂PsoraleacorylifoliaL.的成熟果实。
本发明优点在于:
1、本发明的组合物,阿胶的应用历史悠久,早在《神农本草经》既有明确的记载:“味甘,平。主心腹内崩,劳极,洒洒如疟状,腰腹痛,四肢酸疼,女子下血,安胎。久服,轻身、益气。”,本发明选用阿胶养血止痛,为君药;《本草征要》认为姜:“生能发表,熟可温中……气胀腹疼俱妙,痰凝血滞皆良。”,故生姜、炮姜同用,温经止痛,为臣药;生蒲黄,《神农本草经疏》言:“治一切跌扑伤损,瘀血停滞腹中。”,《本草征要》也说:“蒲黄……血分瘀滞之痛,皆可用之”,为佐药;小茴香,辛、温,散寒止痛,《中医辞典》云其用于胃寒胀痛,少腹冷痛,痛经,疝痛,睾丸肿痛等各种疼痛;补骨脂,《本草求真》言:“补骨脂(即破故纸,专入肾)辛苦大温,色黑,书皆载能敛神明,使心胞之火与命门之火相通,因而元阳坚固,骨髓充实”,本发明以小茴香入肝经达冲脉、补骨脂入肾经达胞宫共为使药,全方温经养血,活血止痛,对原发性痛经有很好的缓解作用。而且全组合物皆选用药食同源之品,无毒副作用,可作为保健食品服用。经检索已经申报的治疗本病的中药组合物专利均为中药组合,本组合物补充了针对现有技术中的不足。动物实验表明,本发明组合物针对原发性痛经大鼠模型,可有效减少大鼠因疼痛扭体次数,减少大鼠子宫促进子宫肌层收缩的PGF2ɑ的含量,增加大鼠子宫抑制子宫平滑肌收缩的PGF2的含量,进而有效减少大鼠子宫平滑肌收缩幅度和收缩频率,在对痛经的缓解作用上效果突出。
2、本发明的组合物经动物实验,未发现明显毒副作用。
3、本发明组合物各原料均是天然食品,属药食同源名单,因此制备成药品、保健品或食品均可。
具体实施方式
下面对本发明提供的具体实施方式作详细说明。
实施例1本发明组合物(一)
(a)按重量份称取炮姜6份、生姜15份、生蒲黄10份、小茴香20份、补骨脂10份;
(b)加10倍量的水煎煮两次,每次煎煮1小时,合并两次水煎液,静置,过滤,浓缩;
(c)向浓缩液加入2倍90%酒精,搅拌沉淀过夜,取上清液浓缩至稠浸膏;
(d)称取阿胶10份,倒入适量黄酒,以没过阿胶为度,浸泡24小时溶解,和入(c)所得稠浸膏。
实施例2本发明组合物(二)
(a)按重量份称取炮姜20份、生姜6份、生蒲黄30份、小茴香8份、补骨脂30份;
(b)加6倍量的水煎煮两次,每次煎煮2小时,合并两次水煎液,静置,过滤,浓缩;
(c)向浓缩液加入3倍95%酒精,搅拌沉淀过夜,取上清液浓缩至稠浸膏;
(d)称取阿胶6份,倒入适量黄酒,以没过阿胶为度,浸泡24小时溶解,和入(c)所得稠浸膏。
实施例3本发明组合物(三)
(a)按重量份称取炮姜20份、生姜15份、生蒲黄30份、小茴香8份、补骨脂30份;
(b)加6倍量的水煎煮两次,每次煎煮2小时,合并两次水煎液,静置,过滤,浓缩;
(c)向浓缩液加入3倍95%酒精,搅拌沉淀过夜,取上清液浓缩至稠浸膏;
(d)称取阿胶12份,倒入适量黄酒,以没过阿胶为度,浸泡24小时溶解,和入(c)所得稠浸膏。
实施例4本发明组合物(四)
(a)按重量份称取炮姜10份、生姜15份、生蒲黄30份、小茴香8份、补骨脂30份;
(b)加8倍量的水煎煮两次,每次煎煮0.5小时,合并两次水煎液,静置,过滤,浓缩;
(c)向浓缩液加入2倍95%酒精,搅拌沉淀过夜,取上清液浓缩至稠浸膏;
(d)称取阿胶6份,倒入适量黄酒,以没过阿胶为度,浸泡24小时溶解,和入(c)所得稠浸膏。
实施例5本发明组合物(五)
(a)按重量份称取炮姜8份、生姜15份、生蒲黄12份、小茴香15份、补骨脂10份;
(b)加8倍量的水煎煮两次,每次煎煮1.5小时,合并两次水煎液,静置,过滤,浓缩;
(c)向浓缩液加入2倍90%酒精,搅拌沉淀过夜,取上清液浓缩至稠浸膏;
(d)称取阿胶8份,倒入适量黄酒,以没过阿胶为度,浸泡24小时溶解,和入(c)所得稠浸膏。
实施例6本发明组合物(六)
(a)按重量份称取炮姜15份、生姜8份、生蒲黄20份、小茴香10份、补骨脂20份;
(b)加10倍量的水煎煮两次,每次煎煮2小时,合并两次水煎液,静置,过滤,浓缩;
(c)向浓缩液加入3倍90%酒精,搅拌沉淀过夜,取上清液浓缩至稠浸膏;
(d)称取阿胶12份,倒入适量黄酒,以没过阿胶为度,浸泡24小时溶解,和入(c)所得稠浸膏。
实施例7本发明组合物(七)
(a)按重量份称取炮姜10份、生姜12份、生蒲黄12份、小茴香12份、补骨脂15份;
(b)加10倍量的水煎煮两次,每次煎煮2小时,合并两次水煎液,静置,过滤,浓缩;
(c)向浓缩液加入2倍90%酒精,搅拌沉淀过夜,取上清液浓缩至稠浸膏;
(d)称取阿胶10份,倒入适量黄酒,以没过阿胶为度,浸泡24小时溶解,和入(c)所得稠浸膏。
实施例8本发明组合物片剂/胶囊剂的制备
按实施例1-7任一所述的方法制备得到阿胶和稠浸膏的混合物,干燥粉碎制成颗粒,加入制药辅料(蔗糖、甘露醇、硬脂酸镁等),压制成片剂或填充装胶囊。
实施例9本发明组合物合剂的制备
按实施例1-7任一所述的方法制备得到阿胶和稠浸膏的混合物,加适当制药辅料(白糖、蜂蜜、苯甲丙酸或羟苯乙酯等),制成合剂。
实施例10本发明组合物颗粒剂的制备
按实施例1-7任一所述的方法制备得到阿胶和稠浸膏的混合物,将浸膏干燥粉碎制成颗粒,分装,即得。
实施例11本发明组合物治疗痛经的动物试验
1动物
清洁级雌性SD大鼠,体质量200±15g,由上海中医药大学实验动物中心提供。实验前将动物于室内适应环境1周,室温20-25℃。
2试剂
己烯雌酚注射液,天津金耀药业有限公司;缩宫素注射液,上海禾丰制药有限公司;生理盐水,上海长征富民金山制药有限公司;大鼠前列腺素PGF2ɑ酶联免疫检测试剂盒:上海蓝基生物科技有限公司;大鼠前列腺素PGF2ɑ酶联免疫检测试剂盒:上海蓝基生物科技有限公司。
3药物
本发明组合物:按照实施例7的方法制备。
对照组合物一:制备方法为:
(a)按重量份称取炮姜22份、生蒲黄12份、小茴香12份、补骨脂15份;
(b)加10倍量的水煎煮两次,每次煎煮2小时,合并两次水煎液,静置,过滤,浓缩;
(c)向浓缩液加入2倍90%酒精,搅拌沉淀过夜,取上清液浓缩至稠浸膏;
(d)称取阿胶10份,倒入适量黄酒,以没过阿胶为度,浸泡24小时溶解,和入(c)所得稠浸膏。
对照组合物二:制备方法为:
(a)按重量份称取生姜22份、生蒲黄12份、小茴香12份、补骨脂15份;
(b)加10倍量的水煎煮两次,每次煎煮2小时,合并两次水煎液,静置,过滤,浓缩;
(c)向浓缩液加入2倍90%酒精,搅拌沉淀过夜,取上清液浓缩至稠浸膏;
(d)称取阿胶10份,倒入适量黄酒,以没过阿胶为度,浸泡24小时溶解,和入(c)所得稠浸膏。
对照组合物三,制备方法为:
(a)按重量份称取生姜22份、生蒲黄12份、小茴香12份、附子15份;
(b)加10倍量的水煎煮两次,每次煎煮2小时,合并两次水煎液,静置,过滤,浓缩;
(c)向浓缩液加入2倍90%酒精,搅拌沉淀过夜,取上清液浓缩至稠浸膏;
(d)称取阿胶10份,倒入适量黄酒,以没过阿胶为度,浸泡24小时溶解,和入(c)所得稠浸膏。
田七痛经胶囊:四川升和药业股份有限公司。
4分组
将70只SD大鼠随机分为空白对照组、模型组、阳性药物组、本发明组合物治疗组、对照组合物一治疗组、对照组合物二治疗组和对照组合物三治疗组,每组10只。
5给药方法
除空白对照组外,其余各组均皮下连续注射乙烯雌酚10天,每天1次,人工使动物处于发情前期或动情期,以提高药物敏感性。首日及第10天为0.5mg/只,第2到第9天为0.25mg/只,第10天开始灌胃给药相应药物,连续两天,本发明治疗组、对照组合物一治疗组、对照组合物二治疗组和对照组合物三治疗组给药量均合3g生药/(kg·d),阳性药组灌胃田七痛经胶囊混悬液1.6g/(kg·d),空白组和模型组每天灌胃生理盐水10mL/kg。末次给药40min后,除空白对照组外,其余各组大鼠腹腔注射缩宫素2U。
6检测方法
6.1大鼠疼痛扭体反应观察
记录大鼠腹腔注射缩宫素后30min内扭体动物数、扭体次数和各组平均扭体次数。扭体反应以大鼠腹部内凹,躯干与后肢伸展,臀部歪扭为标准。
6.2大鼠子宫组织PGF2ɑ、PGE2含量的检测
在扭体反应观察结束后30min,处死大鼠,剥离大鼠子宫,精密称取0.5g,加1mL生理盐水,匀浆,离心,取上清液,采用前列腺素PGF2ɑ酶联免疫检测试剂盒、前列腺素PGE2酶联免疫检测试剂盒检测大鼠子宫PGF2ɑ、PGE2含量。
6.3子宫平滑肌收缩幅度、频率测定
剥离大鼠子宫后迅速剖取大鼠一侧子宫,剪取子宫2cm,置于盛有30ml洛氏液的小槽,连于传感器上,水浴保持(36±0.5)℃,并持续通入氧气,采用MS-302多媒体化生物信号记录分析系统记录子宫平滑肌收缩曲线,采集收缩幅度、频率数据。
7数据处理
8结果
8.1大鼠疼痛扭体反应观察结果
结果表明,与空白对照组比较,模型组发生扭体动物数和扭体次数均显著增加,平均扭体次数相比于空白对照组差异有统计学意义。与模型对照组比较,各用药组发生扭体动物数虽然没有减少,但是平均扭体次数却显著下降,差异有统计学意义。其中本发明组合物治疗组对缩宫素所致大鼠的30min内扭体次数具有明显的抑制作用,与其余各给药组比较差异有统计学意义。见表1。
表1各组大鼠扭体次数比较
注:与空白对照组比较,*P<0.05;与模型组比较,#P<0.05;与本发明组合物治疗组比较,▲P<0.05。
8.2大鼠子宫组织PGF2ɑ、PGE2含量的检测结果
结果表明,与空白对照组比较,模型组大鼠子宫组织PGF2ɑ含量增加,PGE2含量降低,差异均具有统计学意义。与模型组比较,除对照组合物一治疗组外,各给药组均具有降低大鼠子宫组织PGF2ɑ含量的作用,其中本发明组合物治疗组降低大鼠子宫组织PGF2ɑ的作用最为显著,与其他各给药组相比差异具有统计学意义。与模型组比较,各给药组均具有增加大鼠子宫组织PGE2含量的作用,差异有统计学意义,其中本发明组合物治疗组增加大鼠子宫组织PGE2含量的作用最为显著,与其他各给药组相比差异均具有统计学意义。见表2。
表2各组大鼠子宫组织PGF2ɑ、PGE2含量的比较
注:与空白对照组比较,*P<0.05;与模型组比较,#P<0.05;与本发明组合物治疗组比较,▲P<0.05。
8.3大鼠子宫平滑肌收缩幅度、频率测定结果
结果表明,与模型组比较,各给药组能显著降低大鼠子宫平滑肌收缩幅度和收缩频率,差异有统计学意义。其中本发明组合物治疗组的作用最为明显,显著优于其余各给药组。见表3。
表3各组大鼠子宫平滑肌收缩幅度、频率的比较
注:与空白对照组比较,*P<0.05;与模型组比较,#P<0.05;与本发明组合物治疗组比较,▲P<0.05。
以上结果表明,本发明组合物可以显著减少缩宫素诱导的大鼠痛经模型的扭体发生次数,有助于减少大鼠子宫促进子宫肌层收缩的PGF2ɑ的含量,增加大鼠子宫抑制子宫平滑肌收缩的PGF2的含量,进而有效减少大鼠子宫平滑肌收缩幅度和收缩频率,在对痛经的缓解作用上显著优于阳性药物及其他药物组合物。
实施例12本发明组合物的急性毒性实验
1动物
SPF级ICR小鼠,雌性,体重20.0-23.0g,共12只,购于上海斯莱克实验动物有限责任公司。
2药物
本发明组合物:按照实施例7的方法制备。
3分组
动物在SPF级饲养室适应性饲养1天后,随机分为2组,每组6只,分别为试验组和对照组。
4给药方法
试验组给予本发明组合物灌胃,合3g生药/(kg·d);对照组给予生理盐水灌胃。连续给药15天。
5观察方法
从试验开始的第1天起,每天上、下午各观察记录1次动物的外观体征、行为活动、腺体分泌、呼吸、排泄物、动物异常反应的症状、起始时间、严重程度、持续时间以及死亡情况。试验结束后处死小鼠,解剖观察心脏、肺脏、肾脏、肝脏、脾脏、胃肠道等内脏。
6结果
观察期结束,试验组和对照组小鼠未出现死亡,未见异常反应,活动状况、精神状况良好,大、小便正常。试验结束后,解剖观察小鼠内脏,心脏、肺脏、肾脏、肝脏、脾脏、胃肠道外观均正常,未见水肿或出血。表明本发明组合物无明显毒副作用。
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,在不脱离本发明方法的前提下,还可以做出若干改进和补充,这些改进和补充也应视为本发明的保护范围。
Claims (9)
1.一种治疗痛经的组合物,其特征在于,由下列重量份的原料制成:阿胶6-12份、炮姜6-20份、生姜6-15份、生蒲黄10-30份、小茴香8-20份、补骨脂10-30份。
2.根据权利要求1所述的组合物,其特征在于,由下列重量份的原料制成:阿胶8-12份、炮姜8-15份、生姜8-15份、生蒲黄12-20份、小茴香10-15份、补骨脂10-20份。
3.根据权利要求2所述的组合物,其特征在于,由下列重量份的原料制成:阿胶10份、炮姜10份、生姜12份、生蒲黄12份、小茴香12份、补骨脂15份。
4.根据权利要求1所述的组合物,其特征在于,所述组合物还包含制备药物或食品的常规辅料。
5.根据权利要求1所述的组合物,其特征在于,所述组合物被进一步制成片剂、颗粒剂、胶囊剂或合剂。
6.根据权利要求1所述的组合物,其特征在于,所述组合物的制备方法包括以下步骤:
(a)称取炮姜、生姜、生蒲黄、小茴香、补骨脂;
(b)加6-10倍量的水煎煮两次,每次煎煮0.5-2小时,合并两次水煎液,静置,过滤,浓缩,
(c)向浓缩液加入2-3倍90%-95%酒精,搅拌沉淀过夜,取上清液浓缩至稠浸膏;
(d)称取阿胶,倒入适量黄酒,以没过阿胶为度,浸泡至溶解,和入(c)所得稠浸膏。
7.权利要求1所述的组合物的制备方法,其特征在于,包括以下步骤:
(a)称取炮姜、生姜、生蒲黄、小茴香、补骨脂;
(b)加6-10倍量的水煎煮两次,每次煎煮0.5-2小时,合并两次水煎液,静置,过滤,浓缩,
(c)向浓缩液加入2-3倍90%-95%酒精,搅拌沉淀过夜,取上清液浓缩至稠浸膏;
(d)称取阿胶,倒入适量黄酒,以没过阿胶为度,浸泡至溶解,和入(c)所得稠浸膏。
8.权利要求1-6任一所述的组合物在制备缓解痛经的药物或食品中的应用。
9.根据权利要求8所述的应用,其特征在于,所述痛经为原发性痛经。
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