CN105663758A - 一种含有艾叶的治疗月经不调的中药组合物及其制备方法 - Google Patents
一种含有艾叶的治疗月经不调的中药组合物及其制备方法 Download PDFInfo
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Abstract
本发明属于中药领域,具体涉及一种含有艾叶的治疗月经不调的中药组合物及其制备方法。所述的中药组合物主要由以下重量份数的原料制备而成:艾叶28~36份、茺蔚子23~28份、麦斛20~25份、伸筋草13~18份、丹参13~17份、益母草12~17份、当归15~20份、熟地黄15~19份、附子8~12份、白芍6~14份、金盏菊7~11和甘草5~13份。本发明中药组合物具有活血通络,散瘀止痛,益气养血,温经散寒、燥湿化瘀和滋阴清热等功效,用于预防和治疗月经不调效果显著。
Description
技术领域
本发明属于中药领域,具体涉及一种含有艾叶的治疗月经不调的中药组合物及其制备方法。
背景技术
月经不调是妇女最常见的病症之一,凡月经周期、经期、月经量与正常月经不同者均属此范畴。人体内外许多因素,诸如精神过度紧张、恐惧,环境和气候的骤然变化,以及其他全身性疾病,都可通过大脑皮层和中枢神经系统影响下丘脑—垂体—卵巢轴的内分泌调节而导致月经不调。常见的类型有月经过多、月经过少、月经频发、月经稀发、月经先后不定期及月经中期出血等。
中医辨证治疗称经间期为氤氲期。该病虽以肾阴虚证候为主,但需要根据具体病情辨证分析、用药。肾阴虚,见经间期出血量少或稍多,色红,无血块,腹不痛,夜寐不熟,便艰,尿黄,舌红,脉细弦。可用滋阴止血法,方用两地汤合二至丸。气滞血瘀,见经间期出血量少或多,色紫黑或有血块,少腹两侧胀痛或刺痛,胸闷烦躁,舌有紫点,脉弦涩。可用行气化瘀止血,方用逐瘀止血汤。脾气亏虚,见经间期出血量少,色淡,质稀,神疲乏力,气短懒言,食少腹胀,舌淡,苔薄,脉缓弱。可用健脾益气止血法,方用归脾汤加减。
中国专利申请201310528890.9公开了一种治疗月经不调的中药,其主要由以下重量份的原料制成:蛇根草8份、桃金娘3份、杜仲3份、当归6份、甜远志3份、头巾草3份、土砂仁3份、芒果3份、蜜蜂子3份、甘菊3份、胖儿草3份、片姜黄6份、泡泡草4份、海松子4份、橘皮3份、秃疮花3份、酸枣仁4份、红花2份和甘草6份。该中药明能够安全有效治疗月经不调,但针对性差,具体功效不确切,未做到辨证治疗,对症下药,给医者和患者带来诸多不便。
发明内容
本发明的目的在于克服现有技术对月经不调治疗的不足,提供一种治疗月经不调的中药组合物及其制备方法,本发明中药组合物具有活血通络,散瘀止痛,益气养血,温经散寒、燥湿化瘀和滋阴清热等功效,用于预防和治疗月经不调效果显著,并且本发明中药组合物生产工艺简单,药效稳定、标本兼治、适用范围广和易于推广应用。此外,本发明还提供相应的制造工艺将该中药在保证疗效的前提下制成方便易用的成品制剂。
本发明中药组合物主要由以下重量份数的原料制备而成:
艾叶28~36份、茺蔚子23~28份、麦斛20~25份、伸筋草13~18份、丹参13~17份、益母草12~17份、当归15~20份、熟地黄15~19份、附子8~12份、白芍6~14份、金盏菊7~11和甘草5~13份。
优选地,所述的中药组合物主要由以下重量份数的原料制备而成:
艾叶28份、茺蔚子23份、麦斛20份、伸筋草13份、丹参13份、益母草12份、当归15份、熟地黄15份、附子8份、白芍6份、金盏菊7和甘草5份。
优选地,所述的中药组合物主要由以下重量份数的原料制备而成:
艾叶36份、茺蔚子28份、麦斛25份、伸筋草18份、丹参17份、益母草17份、当归20份、熟地黄19份、附子12份、白芍14份、金盏菊11和甘草13份。
优选地,所述的中药组合物主要由以下重量份数的原料制备而成:
艾叶32份、茺蔚子25份、麦斛23份、伸筋草15份、丹参16份、益母草15份、当归18份、熟地黄17份、附子11份、白芍8份、金盏菊8和甘草12份。
优选地,所述的中药组合物由以下步骤制得:
S1:制备艾叶提取物:取干燥的艾叶,粉碎后过200~270目筛,按照艾叶细粉总重量的8~10倍加入体积百分浓度为60%~80%的乙醇溶液,回流提取2~3次,每次回流时间为3~6h,合并提取液,回收乙醇,减压浓缩至60~65℃环境下相对密度为1.20~1.25的浸膏,喷雾干燥粉碎,过80~100目筛,得到艾叶提取物;
S2:取当归、熟地黄、附子、白芍、金盏菊和甘草,粉碎,加入药材总重量6~8倍量的水煎煮3~4h,过滤;滤渣加入药材总重量4~6倍量的水煎煮2.5~3h,过滤;合并两次滤液,减压浓缩至60~65℃环境下相对密度为1.20~1.25的浸膏,减压干燥,粉碎后过80~100目筛,得到浸膏细粉;
S3:取茺蔚子、麦斛、伸筋草、丹参和益母草,研成粉末,过80~100目筛,与上述艾叶提取物、浸膏细粉充分混匀,得到本中药组合物。
本发明还提供了所述中药组合物的制备方法,主要包括以下步骤:
S1:取干燥的艾叶,粉碎后过200~270目筛,按照艾叶细粉总重量的8~10倍加入体积百分浓度为60%~80%的乙醇溶液,回流提取2~3次,每次回流时间为3~6h,合并提取液,回收乙醇,减压浓缩至60~65℃环境下相对密度为1.20~1.25的浸膏,喷雾干燥粉碎,过80~100目筛,得到艾叶提取物;
S2:取当归、熟地黄、附子、白芍、金盏菊和甘草,粉碎,加入药材总重量6~8倍量的水煎煮3~4h,过滤;滤渣加入药材总重量4~6倍量的水煎煮2.5~3h,过滤;合并两次滤液,减压浓缩至60~65℃环境下相对密度为1.20~1.25的浸膏,减压干燥,粉碎后过80~100目筛,得到浸膏细粉;
S3:取茺蔚子、麦斛、伸筋草、丹参和益母草,研成粉末,过80~100目筛,与上述艾叶提取物、浸膏细粉充分混匀,得到本中药组合物。
利用现代通用的中药组合物技术,本发明中药组合物被制成临床需要的成品制剂,如颗粒剂、丸剂、散剂、片剂或胶囊剂等剂型。
本发明中药组合物所用中药材的来源、性味、归经及功效:
艾叶:本品为菊科植物艾的干燥叶;味辛、苦,性温;归肝、脾、肾经;散寒止痛,温经止血。
茺蔚子:本品为唇形科植物益母草的干燥成熟果实;味辛、苦,性微寒;归心包、肝经;活血调经,清肝明目。
麦斛:本品为兰科石豆兰属植物麦斛,以全草入药;味甘、淡,性凉;归肺、胃经;滋阴清热,化痰止咳。
伸筋草:本品为石松科植物石松的干燥全草;味微苦、辛,性温;归肝、脾、肾经;祛风除湿,舒筋活络。
丹参:本品为唇形科植物丹参的干燥根及根茎;味苦,性微寒;归心、肝经;祛瘀止痛,活血通经,清心除烦。
益母草:本品为唇形科植物益母草的新鲜或干燥地上部分;味苦、辛,性微寒;归肝、心包经;活血调经,利尿消肿。
当归:本品为伞形科植物当归的干燥根;味甘、辛,性温;归肝、心、脾经;补血活血,调经止痛,润肠通便。
熟地黄:本品为生地黄的炮制加工品;味甘,性微温;归肝、肾经;滋阴补血,益精填髓。
附子:本品为毛茛科植物乌头的子根的加工品;味辛、甘,性大热;归心、肾、脾经;回阳救逆,补火助阳,逐风寒湿邪。
白芍:本品为毛茛科植物芍药的干燥根;味苦、酸,性微寒;归肝、脾经;平肝止痛,养血调经,敛阴止汗。
金盏菊:本品为菊科金盏菊,以根、花入药;味苦、性寒;清热解毒;活血调经。
甘草:本品为豆科植物甘草、胀果甘草或光果甘草的干燥根;味甘,性平;归心、肺、脾、胃经;补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药。
本发明药物组方以艾叶和茺蔚子为君药,散寒止痛,温经止血,活血调经和滋阴清热;以麦斛、伸筋草、丹参、益母草和当归为臣药,活血通经,补血止痛;以熟地黄、附子、白芍和金盏菊为佐药,滋阴补血,逐风寒湿邪,养血调经;以甘草为使药,益气生津、补肾宁心,调和诸药,使诸药搭配,协同作用,共同达到活血通络,散瘀止痛,益气养血的功效,同时还能够温经散寒、燥湿化瘀和滋阴清热,彻底消除病灶,缓解患者临床症状及提高生活质量。
与现有技术相比,本发明中药组合物具有如下技术优势:
(1)与当前治疗月经不调的化学治疗药物相比,本发明中药组合物为天然纯中药组合物,不良反应和副作用显著降低,且本发明中药组合物作用全面,药物治疗效果更佳。
(2)本发明中药组合物具有活血通络,散瘀止痛,益气养血,温经散寒、燥湿化瘀和滋阴清热等功效,用于预防和治疗月经不调效果显著。
(3)本发明中药组合物对缩宫素所致小鼠痛经样反应有明显的缓解作用,延长其反应潜伏期,并抑制子宫平滑肌收缩,同时还具有明显的提高大鼠子宫外膜微循环的作用。
具体实施方式
以下将通过具体实施例进一步描述本发明,本发明不仅仅限于以下实施例。在本发明的范围内或者在不脱离本发明的内容、精神和范围内,对本发明进行的变更、组合或替换,对于本领域的技术人员来说是显而易见的,包含在本发明的范围之内。
实施例1
本发明实施例1中药组合物由以下重量份数的原料制备而成:
艾叶28份、茺蔚子23份、麦斛20份、伸筋草13份、丹参13份、益母草12份、当归15份、熟地黄15份、附子8份、白芍6份、金盏菊7和甘草5份。
制备方法如下:
S1:制备艾叶提取物:取干燥的艾叶,粉碎后过200目筛,按照艾叶细粉总重量的8倍加入体积百分浓度为70%的乙醇溶液,回流提取3次,每次回流时间为4h,合并提取液,回收乙醇,减压浓缩至65℃环境下相对密度为1.25的浸膏,喷雾干燥粉碎,过90目筛,得到艾叶提取物;
S2:取当归、熟地黄、附子、白芍、金盏菊和甘草,粉碎,加入药材总重量7倍量的水煎煮4h,过滤;滤渣加入药材总重量5倍量的水煎煮2.5h,过滤;合并两次滤液,减压浓缩至60℃环境下相对密度为1.20的浸膏,减压干燥,粉碎后过90目筛,得到浸膏细粉;
S3:取茺蔚子、麦斛、伸筋草、丹参和益母草,研成粉末,过90目筛,与上述艾叶提取物、浸膏细粉充分混匀,得到本中药组合物。
S4:添加适当的辅料,利用现代通用的中药组合物技术,将所得中药组合物制成胶囊剂,折合生药含量为1.08g生药/粒胶囊。
实施例2
本发明实施例2中药组合物由以下重量份数的原料制备而成:
艾叶36份、茺蔚子28份、麦斛25份、伸筋草18份、丹参17份、益母草17份、当归20份、熟地黄19份、附子12份、白芍14份、金盏菊11和甘草13份。
制备方法同实施例1。
实施例3
本发明实施例3中药组合物由以下重量份数的原料制备而成:
艾叶32份、茺蔚子25份、麦斛23份、伸筋草15份、丹参16份、益母草15份、当归18份、熟地黄17份、附子11份、白芍8份、金盏菊8和甘草12份。
制备方法同实施例1。
本发明中药组合物的药效学考察
试验例1本发明中药组合物对缩宫素所致小鼠痛经反应的影响
1、试验动物:昆明种雌性小鼠50只,体重25~30g,购买自北京实验动物研究中心,随机分成5组,每组10只。
2、试验药物及给药方案:
生理盐水组:灌胃给予同体积的生理盐水;
阳性对照组:阳性对照药为田七痛经胶囊(国药准字Z14020029,山西华康药业股份有限公司),用水调配成0.6g/ml的混悬液,取1组小鼠,按2.4g/kg的剂量灌胃给药。
A组:取1组小鼠,标记为A组中剂量组(2.4g/kg),将本发明实施例1制得的胶囊剂,用水调配成中剂量浓度为0.6g/ml的混悬液,按2.4g/kg的剂量灌胃给药。
B组:试验药物为本发明实施例2制得的胶囊剂,给药方案同A组。
C组:试验药物为本发明实施例3制得的胶囊剂,给药方案同A组。
3、试验方法
每隔3h于各组小鼠连续给药4次,分别于给药的第2、3天,每组小鼠皮下注射己烯雌酚0.5mg/kg,给药后禁食10h。末次给药90min,给予缩宫素1u/kg腹腔注射,记录由于子宫过度收缩,小鼠扭体反应出现的潜伏期t/min,检验进行组间统计比较,结果见表1。
表1本发明中药组合物对缩宫素致小鼠扭体反应的影响
组别 | N | 潜伏期t/min |
生理盐水组 | 10 | 4.05±2.32 |
阳性对照组 | 10 | 8.52±2.32**4 --> |
A组 | 10 | 9.58±1.46**# |
B组 | 10 | 10.86±2.24**## |
C组 | 10 | 13.34±2.48**## |
注:与生理盐水组比较,*P<0.05,**P<0.01;与阳性对照组比较,#P<0.05,##P<0.01。
由表1知,本发明中药组合物对缩宫素所致小鼠扭体反应有明显的缓解作用,延长其反应潜伏期,A、B、C组的疗效均优于阳性对照药田七痛经胶囊,其中C组即实施例3所制备的胶囊剂效果最优。
试验例2、本发明中药组合物对大鼠在体子宫平滑肌收缩的影响
1、试验动物:Wistar雌性大鼠50只,体重25~30g,购买自北京实验动物研究中心,随机分成5组,每组10只。
2、试验药物及给药方案:
将本发明实施例3制得的胶囊剂,用水调配成浓度为0.8g/ml、0.6g/ml和0.4g/ml的混悬液,备用。取3组大鼠,标记为高剂量组(3.2g/kg)、中剂量组(2.4g/kg)和低剂量组(1.6g/kg),高剂量组用浓度为0.8g/ml的药物混悬液,中剂量组用浓度为0.6g/ml的药物混悬液,低剂量组用浓度为0.4g/ml的药物混悬液,按剂量每天灌胃1次,连续给药7天。
阳性对照组:阳性对照药为田七痛经胶囊(国药准字Z14020029,山西华康药业股份有限公司),用水调配成0.8g/ml的混悬液,取1组大鼠,按3.2g/kg的剂量每天灌胃给药1次,连续给药7天。
生理盐水组:灌胃给予同体积的生理盐水;
3、试验仪器:RM6240多道生理信号处理系统,成都仪器厂生产;JZJ01A肌肉张力换能器,量程50g,成都仪器厂生产。
4、试验方法
实验前24h,各组大鼠按4mg/kg皮下注射己烯雌酚,禁食8h,末次给药90min,各组大鼠用40mg/kg巴比妥钠腹腔注射麻醉,麻醉大鼠后,仰位固定在鼠板上,备皮后在下腹部沿腹正中线做5cm矢状切口,打开腹腔,找出左侧子宫,分离周围组织,将左侧子宫用中段细线吊起2cm,连接在10g肌肉张力换能器上,打开RM6240多道生理信号处理系统,调零、定标,在二、四通道的入接口上安装张力换能器,通道模式选择张力,扫面速度25.00ms/div,灵敏度1.87g,时间常数选择直流,滤波调节频率为30Hz。子宫收缩稳定30min后,记录10min正常活动曲线。分别记录给药前10min及给药后0-10min、10-20min、20-30min、30-40min、40-50min子宫平滑肌收缩的频率和振幅。分别计算给药振幅变化值,变化值=给药后值-给药前值。结果见表2。
表2本发明中药组合物对大鼠在体子宫平滑肌收缩幅度的影响
由表2知,本发明中药组合物对子宫平滑肌收缩有一定抑制作用,对缩宫素所致大鼠在体子宫的过度收缩有明显的抑制作用,能缓解子宫平滑肌的过度收缩。
由于已经通过以上较佳实施例描述了本发明,在本发明的精神和/或范围内,任何针对本发明的替换/或组合来实施本发明,对于本领域的技术人员来说都是显而易见的,且包含在本发明之中。
Claims (7)
1.一种含有艾叶的治疗月经不调的中药组合物,其特征在于,所述的中药组合物主要由以下重量份数的原料制备而成:
艾叶28~36份、茺蔚子23~28份、麦斛20~25份、伸筋草13~份、丹参13~17份、益母草12~17份、当归15~20份、熟地黄15~19份、附子8~12份、白芍6~14份、金盏菊7~11和甘草5~13份。
2.如权利要求1所述的含有艾叶的治疗月经不调的中药组合物,其特征在于,所述的中药组合物主要由以下重量份数的原料制备而成:
艾叶28份、茺蔚子23份、麦斛20份、伸筋草13份、丹参13份、益母草12份、当归15份、熟地黄15份、附子8份、白芍6份、金盏菊7和甘草5份。
3.如权利要求1所述的含有艾叶的治疗月经不调的中药组合物,其特征在于,所述的中药组合物主要由以下重量份数的原料制备而成:
艾叶36份、茺蔚子28份、麦斛25份、伸筋草18份、丹参17份、益母草17份、当归20份、熟地黄19份、附子12份、白芍14份、金盏菊11和甘草13份。
4.如权利要求1所述的含有艾叶的治疗月经不调的中药组合物,其特征在于,所述的中药组合物主要由以下重量份数的原料制备而成:
艾叶32份、茺蔚子25份、麦斛23份、伸筋草15份、丹参16份、益母草15份、当归18份、熟地黄17份、附子11份、白芍8份、金盏菊8和甘草12份。
5.如权利要求1-4任一所述的含有艾叶的治疗月经不调的中药组合物,其特征在于,所述的中药组合物被制成颗粒剂、丸剂、散剂、片剂或胶囊剂。
6.如权利要求1-4任一所述的含有艾叶的治疗月经不调的中药组合物,其特征在于,所述的中药组合物由以下步骤制得:
S1:取干燥的艾叶,粉碎后过200~270目筛,按照艾叶细粉总重量的8~10倍加入体积百分浓度为60%~80%的乙醇溶液,回流提取2~3次,每次回流时间为3~6h,合并提取液,回收乙醇,减压浓缩至60~65℃环境下相对密度为1.20~1.25的浸膏,喷雾干燥粉碎,过80~100目筛,得到艾叶提取物;
S2:取当归、熟地黄、附子、白芍、金盏菊和甘草,粉碎,加入药材总重量6~8倍量的水煎煮3~4h,过滤;滤渣加入药材总重量4~6倍量的水煎煮2.5~3h,过滤;合并两次滤液,减压浓缩至60~65℃环境下相对密度为1.20~1.25的浸膏,减压干燥,粉碎后过80~100目筛,得到浸膏细粉;
S3:取茺蔚子、麦斛、伸筋草、丹参和益母草,研成粉末,过80~100目筛,与上述艾叶提取物、浸膏细粉充分混匀,得到本中药组合物。
7.如权利要求1-6任一所述的含有艾叶的治疗月经不调中药组合物的制备方法,其特征在于,所述的中药组合物的制备方法包括以下步骤:
S1:制备艾叶提取物:取干燥的艾叶,粉碎后过100~200目筛,按照艾叶细粉总重量的8~10倍加入体积百分浓度为60%~80%的乙醇溶液,回流提取2~3次,每次回流时间为3~6h,合并提取液,回收乙醇,减压浓缩至60~65℃环境下相对密度为1.20~1.25的浸膏,喷雾干燥粉碎,过80~100目筛,得到艾叶提取物;
S2:取当归、熟地黄、附子、白芍、金盏菊和甘草,粉碎,加入药材总重量6~8倍量的水煎煮3~4h,过滤;滤渣加入药材总重量4~6倍量的水煎煮2.5~3h,过滤;合并两次滤液,减压浓缩至60~65℃环境下相对密度为1.20~1.25的浸膏,减压干燥,粉碎后过80~100目筛,得到浸膏细粉;
S3:取茺蔚子、麦斛、伸筋草、丹参和益母草,研成粉末,过80~100目筛,与上述艾叶提取物、浸膏细粉充分混匀,得到本中药组合物。
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