CN112022988B - 一种具有预防和/或治疗痛经作用的中药组合物及其制备方法和应用 - Google Patents
一种具有预防和/或治疗痛经作用的中药组合物及其制备方法和应用 Download PDFInfo
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- CN112022988B CN112022988B CN202010923146.9A CN202010923146A CN112022988B CN 112022988 B CN112022988 B CN 112022988B CN 202010923146 A CN202010923146 A CN 202010923146A CN 112022988 B CN112022988 B CN 112022988B
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Abstract
本发明涉及中药技术领域,具体公开了一种中药组合物及其制备方法和应用。所述的中药组合物由以下重量份的中药原料药制备而成:高良姜3‑9份,佛手4‑12份,玫瑰花4‑12份,三七1‑5份。该中药组合物是发明人根据中医理论经过多年的临床经验摸索、总结所得,并经过分析、研究、验证。其组方合理,药味少而精,制备方法简单,服用方便,经药效学实验证明,对痛经具有良好的治疗效果。
Description
技术领域
本发明涉及中药技术领域,具体涉及一种中药组合物及其制备方法和应用。
背景技术
痛经指行经前后或月经期出现下腹部疼痛、坠胀,伴有腰酸或其他不适,疼痛可延至骶腰背部甚至涉及大腿及足部。每随***而发,严重者可伴恶心呕吐、冷汗淋漓,严重影响生活质量。痛经分为原发性痛经和继发性痛经两类,原发性痛经指生殖器官无器质性病变的痛经,一般在初潮开始或初潮后6~24个月就会发生,疼痛持续8~72h;继发性痛经指由盆腔器质性疾病,如子宫内膜异位症、子宫腺肌病、***炎性疾病等引起的痛经,痛经出现的时间是在正常行经2年后才开始发生。流行病学研究表明原发性痛经是目前妇科最常见疾病,影响世界上50%的女性,其中10%患者症状严重。在中国,33.2%女性患有痛经,其中原发性痛经在中国女大学生中的发病率为60%~80%。原发性痛经一般有以下几种原因:内分泌因素、内膜管型脱落、子宫发育不良、颈管狭窄、精神因素、不良体资及体质因素等。
临床上,西医对于痛经的治疗主要是口服化学制剂,目前应用最广泛的是抑制***药物和非甾体抗炎止痛药。但是,口服避孕药容易导致大出血和高血压,长期服用激素类药物易导致癌症、骨质疏松、肥胖等后遗症;非甾体抗炎药易造成胃粘膜损伤。中医药治疗痛经有独特的优势和丰富的经验,临床疗效显著。市售的治疗痛经的中成药有很多,如乌鸡白凤丸、痛经宝颗粒、花红片、元胡止痛片等。绝大多数中成药如花红片是治疗继发性痛经的;部分中成药药味繁多、服用量大;中成药常用的配方中经常加入一些具有止痛效果但毒性较大的中药如细辛、法夏等,不宜长期服用。因此,市场上急需一种疗效确切、毒副作用小、普遍适应性较强的治疗原发性痛经的药物。
现代中医认为痛经病因有气滞血瘀、寒凝胞中、湿热蕴结、气血虚弱、肝肾虚损。因此,痛经可以分为气滞血瘀型痛经、寒凝血瘀型痛经和湿(痰)热瘀阻型痛经等。中国专利CN102488763A公开了由当归、三七、红花、玫瑰花等四味药组成的治疗痛经作用的中药组合物;其中,当归具有补血活血,调经止痛的功效;三七具有散瘀止血,消肿定痛功效;红花具有活血通经,散瘀止痛的功效;玫瑰花具有行气解郁,和血,止痛功效。根据当归、三七、红花、玫瑰花的功效以及与其在专利CN102488763A中的用法用量可知,专利CN102488763A公开的由当归、三七、红花、玫瑰花等四味药组成的中药组合物只能用于气滞血瘀型痛经,不能用于其它类型的痛经。此外,该中药组合物中使用了红花,而红花存在一定的毒副作用,导致该中药组合物也存在不宜长期服用的缺陷。
发明内容
本发明目的在于至少在一定程度上解决相关技术中存在的其中之一的技术问题。
本发明第一方面提出了一种中药组合物,其特征在于,由以下中药原料药制备而成:高良姜、佛手、玫瑰花和三七。
上述药材选择是发明人根据中医理论经过多年的临床经验摸索、总结所得,并经过分析、研究、验证。以高良姜、佛手、玫瑰花和三七等四味药组成的中药组合物可以用于预防和治疗痛经;该组合物克服了大部分中成药药味复杂繁多的缺点,处方精简合理,疗效确切,且原料便宜易得。
发明人进一步研究表明,以高良姜、佛手、玫瑰花和三七等四味药组成的中药组合物,其可以发挥抑制子宫平滑肌收缩、镇痛以及活血作用,从而可以有效地预防和治疗痛经。
根据中医理论:本发明处方中,三七性温,味甘、微苦,归肝、胃经,具有散瘀止血,消肿定痛功效。玫瑰花性温,味甘、微苦,归肝、脾经,具有行气解郁,和血,止痛功效。佐以高良姜散寒止痛,佛手疏肝理气,化痰宽胸。诸位药配合行气活血,调经止痛,使冲任、胞宫的气血通畅,通则不痛,可用于气滞血瘀型痛经,兼顾寒凝血瘀型痛经和湿(痰)热瘀阻型痛经。
优选地,所述的中药组合物,由以下重量份的中药原料药制备而成:高良姜 3-9份,佛手4-12份,玫瑰花4-12份,三七1-5份。
进一步优选地,所述的中药组合物,由以下重量份的中药原料药制备而成:高良姜4-6份,佛手6-8份,玫瑰花6-8份,三七2-3份。
最优选地,所述的中药组合物,由以下重量份的中药原料药制备而成:高良姜6份,佛手8份,玫瑰花8份,三七3份。
上述药材选择和用量是发明人根据中医理论经过多年的临床经验摸索、总结所得,并经过分析、研究、验证。以上述重量份的高良姜、佛手、玫瑰花和三七等四味药组成的中药组合物可以用于预防和治疗痛经,且效果显著;该组合物克服了大部分中成药药味复杂繁多的缺点,处方精简合理,疗效确切,且原料便宜易得,用药方便,成本较低。
发明人进一步研究表明,以上述重量份的高良姜、佛手、玫瑰花和三七等四味药组成的中药组合物,其可以更加有效的发挥抑制子宫平滑肌收缩、镇痛以及活血作用,从而可以更加有效地预防和治疗痛经。
本发明各种原料药的药理作用:
高良姜:为姜科植物高良姜Alpinia officinarum Hance的干燥根茎。性热味辛,归脾、胃经。具有温胃止呕,散寒止痛的功效,用于脘腹冷痛、胃寒呕吐、嗳气吞酸。
佛手:为芸香科植物佛手Citrus medica L.var.sarcodactylis Swingle的干燥果实。性温味辛、苦、酸,归肝、脾、胃、肺经。具疏肝理气,和胃止痛之功效,用于肝胃气滞、胃脘痞满、食少呕吐、咳嗽痰多。
玫瑰花:为蔷薇科植物玫瑰Rose rugosa Thunb.的干燥花蕾。性温味甘、微苦,归肝、脾经。具有行气解郁、和血止痛的功效,用于肝胃气痛、食少呕恶、***、跌扑伤痛。
三七:为五加科植物三七Panax notoginseng(Burk.)F.H.Chen的干燥根和根茎。性温味甘、微苦,归肝、胃经。具有散瘀止血、消肿定痛的功效,用于咯血、吐血、衄血、便血、崩漏、外伤出血、胸腹刺痛、跌扑肿痛。
本发明的第二方面提出了一种制备上述中药组合物的方法,其包含如下步骤:
(1)将高良姜、佛手、玫瑰花和三七加水煎煮得煎煮液;
(2)将煎煮液浓缩干燥得浸膏,即得所述的中药组合物。
优选地,步骤(1)中水的重量用量为中药原料药重量的5-20倍;煎煮次数为1-3次,每次0.5-1.5h。
发明人研究表明,采用上述方法可以有效地制备前述中药组合物。
进一步地,在步骤(2)后进一步包括:
将步骤(2)制备得到的浸膏进行粉碎得到药粉,即得所述的中药组合物。
发明人研究表明,将浸膏进行粉碎成药粉,可以便于后续剂型的制备。
本发明的第三方面提出的一种治疗痛经的药物,其以上述中药组合物作为有效成分。
所述的进一步加入药学上可接受的辅料制成片剂、浓缩丸剂、颗粒剂、胶囊剂或口服液体制剂。
所述辅料为常规药用辅料。上述剂型的制备方法采用药剂学中常规的制药方法。
所述的治疗痛经的药物以上述中药组合物作为有效成分,具有显著的治疗痛经效果。
本发明的第四方面提出了上述中药组合物在制备药物或健康产品中的应用。
具体地,所述的药物为预防和/或治疗痛经的药物。
具体地,所述的药物为抑制子宫平滑肌收缩的药物、具有镇痛作用的药物和 /或具有活血作用的药物。
上述的健康产品具体可以为保健食品或功能性饮品。
与现有技术相比,本发明具有以下优点及有益效果:
(1)本发明的药材选择和用量是发明人根据中医理论经过多年的临床经验摸索、总结所得,并经过分析、研究、验证。本发明克服了大部分中成药药味复杂繁多的缺点,处方精简合理,疗效确切。根据中医理论:本发明以高良姜、佛手、玫瑰花和三七四味药组成的中药组合物不仅可以预防和治疗气滞血瘀型痛经,还可以兼顾寒凝血瘀型痛经和湿(痰)热瘀阻型痛经;几乎涵盖所有的痛经类型。此外,本发明中药组合物不含毒副作用的药材,可以长期服用。
(2)本发明所述的中药组合物能够抑制小鼠离体子宫平滑肌自发性收缩,同时对催产素致离体子宫平滑肌收缩也有抑制作用。
(2)本发明所述的中药组合物可以延长催产素所致小鼠扭体反应的潜伏期,减少扭体次数,对催产素所致小鼠痛经模型有较好的镇痛治疗作用,高剂量组的活性强于阳性药桂枝茯苓胶囊。
(3)本发明所述的中药组合物可以增加大鼠子宫韧带毛细血管交叉网点开放个数,活血作用强于阳性药桂枝茯苓胶囊。
(4)本发明所述的中药组合物在体内毒性低。
(5)本发明所述中药组合物治疗痛经普遍适用性强、制备方法简单,用药方便,成本较低,适合工业化生产。
具体实施方式
以下结合具体实施例对本发明做进一步详细的说明,但实施例对本发明不做任何形式的限定。凡根据本公开内容所做出的的等同替换均属于本发明的保护范围。
实施例1中药组合物的制备
取高良姜0.6kg,佛手0.8kg,玫瑰花0.8kg,三七0.3kg,粉碎成最粗粉,混合均匀。第一次加入12.5L的水煎煮1.5h,第二次加入10L水煎煮1h,第三次加入10L水煎煮0.5h,共煎煮3次,合并煎煮液,静置至50℃,将药液减压浓缩干燥得到浸膏309g(收率12.36%),粉碎后过100目筛得到药粉,即所述的中药组合物。
实施例2中药组合物的制备
取高良姜1.8kg,佛手2.5kg,玫瑰花2.5kg,三七1.2kg,粉碎成最粗粉,混合均匀。第一次加入50L的水煎煮1.5h,第二次加入40L水煎煮1.5h,第三次加入35L水煎煮1h,共煎煮3次,合并煎煮液,静置至60℃,将药液减压浓缩干燥得到浸膏1.072kg(收率13.4%),粉碎后过100目筛得到药粉,即所述的中药组合物。
实施例3小鼠急性毒性试验
动物:昆明种小鼠40只,体重18~22g,雌雄各半,购自广东省医学实验动物中心。
药品:中药组合物为实施例1制备得到的中药组合物。
实验方法:昆明种小鼠随机分为实验组(剂量为千克体重20g)和阴性对照组 (1g/dL羧甲基纤维素),每组20只,雌雄各半。小鼠2次灌胃,间隔2h,观察 7d,记录动物中毒症状及死亡情况。
实验结果:试验期间,两组小鼠均未出现明显症状,也无死亡。本发明所述的中药组合物对雌雄小鼠经口LD50每千克体重均大于20g,按急性毒性分级,该受试物属无毒类物质。
实施例4中药组合物对小鼠离体子宫平滑肌自发性收缩的影响
动物:昆明种小鼠40只,体重18~22g,雌性,购自广东省医学实验动物中心。
药品:桂枝茯苓胶囊(江苏康缘药业股份有限公司);己烯雌酚(上海信谊康捷药业有限公司);中药组合物为实施例1制备得到的中药组合物。
主要仪器:智能型超级恒温水槽;张力换能器。
实验方法:
(1)实验分组:40只小鼠随机分成四组,桂枝茯苓胶囊组、中药组合物高剂量组、中药组合物中剂量组、中药组合物低剂量组。
(2)小鼠离体子宫标本的制备:取未孕雌性小鼠,实验前连续3天皮下注射己烯雌酚0.05mg/0.025ml/只,使各小鼠的子宫同步化并增强子宫肌层对药物的敏感性。第4天颈椎脱臼处死小鼠,剖腹取出子宫,立即置于盛有台氏液的玻璃平皿中。轻轻剥离子宫壁上的脂肪组织和***,找出一侧子宫角,两端分别用线结扎,一端与张力换能器连接,另一端与浴槽中的支架相连,置于含20ml 营养液的恒温浴槽中,设定温度为37℃,通入氧气,保持每分钟50-70个气泡。给予子宫负荷1g,平衡30min,换液2-3次。待子宫收缩稳定后,记录正常状态子宫平滑肌10min内的收缩曲线,计算子宫收缩频率(收缩次数/10min)和子宫收缩强度(g)。
(3)加药:分别加入用营养液配制的各组药物,加药体积为200μl,记录加药后10min的子宫收缩曲线,计算收缩频率和收缩强度。
实验结果:桂枝茯苓胶囊组合加药后10min与自身加药前相比,子宫收缩频率和收缩强度均显著减少(P<0.05);中药组合物低剂量组加药后10min与加药前相比,子宫收缩频率显著减少(P<0.05),收缩强度显著减低(P<0.01);中药组合物高、中剂量组加药后与自身加药前相比,子宫收缩频率和收缩强度均显著性减少(P<0.01)。具体结果见表1和表2。
注:各组给药前后自身对比,*P<0.05,**P<0.01
注:各组给药前后自身对比,*P<0.05,**P<0.01
实验结论:桂枝茯苓胶囊和中药组合物高中低剂量组均能显著抑制离体子宫自发性收缩,其收缩频率和收缩强度均显著减少,且表明本发明所述的中药组合物抑制作用强于阳性药桂枝茯苓胶囊,说明中药组合物对痛经有较好的治疗作用。
实施例5中药组合物对催产素致离体子宫平滑肌收缩的影响
动物:昆明种小鼠40只,体重18~22g,雌性,购自广东省医学实验动物中心。
药品:桂枝茯苓胶囊(江苏康缘药业股份有限公司);己烯雌酚(上海信谊康捷药业有限公司);缩宫素注射液(上海禾丰制药有限公司);中药组合物为实施例1 制备得到的中药组合物。
主要仪器:智能型超级恒温水槽;张力换能器
实验方法:
(1)实验分组:40只小鼠随机分成四组,桂枝茯苓胶囊组、中药组合物高剂量组、中药组合物中剂量组、中药组合物低剂量组。
(2)小鼠离体子宫标本的制备:取未孕雌性小鼠,实验前连续3天皮下注射己烯雌酚0.05mg/0.025ml/只,使各小鼠的子宫同步化并增强子宫肌层对药物的敏感性。第4天颈椎脱臼处死小鼠,剖腹取出子宫,立即置于盛有台氏液的玻璃平皿中。轻轻剥离子宫壁上的脂肪组织和***,找出一侧子宫角,两端分别用线结扎,一端与张力换能器连接,另一端与浴槽中的支架相连,置于含20ml 营养液的恒温浴槽中,设定温度为37℃,通入氧气,保持每分钟50-70个气泡。给予子宫负荷1g,平衡30min,换液2-3次。待子宫收缩稳定后,记录正常状态子宫平滑肌10min内的收缩曲线,计算子宫收缩频率(收缩次数/10min)和子宫收缩强度(g)。
(3)加入催产素(终浓度5IU/L),待节律稳定后,记录10min曲线。
(4)加药:分别加入用营养液配制的各组药物,加药体积为200μl,记录加药后10min的子宫收缩曲线,计算收缩频率和收缩强度。
实验结果:桂枝茯苓胶囊组合加药后10min与加催产素后相比,子宫收缩频率和收缩强度均显著减少(P<0.05);中药组合物低剂量组加药后10min与加催产素后相比,子宫收缩频率显著减少(P<0.05),收缩强度显著降低(P<0.01);中药组合物中剂量组加药后与加催产素后相比,子宫收缩频率和收缩强度均显著性减少 (P<0.01);中药组合物高剂量组加药后与加催产素后相比,收缩频率显著减少 (P<0.01),收缩强度显著性降低(P<0.005)。具体结果见表3和表4。
注:各组给药前后自身对比,*P<0.05,**P<0.01
注:各组给药后与加催产素后对比,*P<0.05,**P<0.01,***P<0.005。
实验结论:桂枝茯苓胶囊和中药组合物高、中、低剂量组均能显著抑制催产素致离体子宫平滑肌收缩,其收缩频率和收缩强度均显著减少,且表明本发明所述的中药组合物抑制作用强于阳性药桂枝茯苓胶囊,说明中药组合物对痛经有较好的治疗作用。
实施例6中药组合物对催产素所致小鼠痛经模型的影响
动物:昆明种小鼠60只,体重18~22g,雌性,购自广东省医学实验动物中心。
药品:阿司匹林(广东九明制药有限公司),苯甲酸***(广州白云山明兴制药有限公司),催产素(上海禾丰制药有限公司),中药组合物为实施例1制备得到的中药组合物。
实验方法:
(1)实验分组:60只昆明小鼠随机分成六组,正常对照组、模型组、阿司匹林阳性对照组、中药组合物高剂量组、中药组合物中剂量组、中药组合物低剂量组,每组10只,给药剂量见表5。
(2)给药:阳性药组和中药组合物高中低剂量组按照剂量连续灌胃10天,正常对照组和模型组则每天灌胃0.2mL的生理盐水。除正常对照组外,其余各组小组每天同时皮下注射苯甲酸***2mg/kg。
(3)第10天给药后1h,各组小鼠均腹腔注射催产素25U/kg,记录注射后30 min内小鼠的扭体潜伏期和扭体次数,并计算镇痛率,实验结果见表5。镇痛百分率(%)=(模型组扭体均数-给药组扭体均数)/模型组扭体均数×100%。
注:与模型对照组对比,*P<0.05,**P<0.01,***P<0.005;与正常对照组对比,#P<0.05,##P<0.01,###P<0.01。
实验结果:连续10天皮下注射苯甲酸***后,再腹腔注射催产素,可引起大鼠痛经,模型组与正常对照组相比,扭体潜伏期显著性延长(P<0.005),扭体次数显著减少(P<0.005),说明造模成功。中药组合物高、中、低剂量组与模型对照组比较,均可明显延长小鼠扭体反应的潜伏期,并减少扭体次数,均具有显著性差异(P<0.05);中药组合物高剂量组镇痛率较阳性药组高,表明中药组合物高剂量组具有较好的镇痛作用。
实施例7对大鼠子宫韧带毛细血管交叉网点开放个数的影响。
动物:昆明大鼠50只,雌性,体重180~220g,雌性,购自广东省医学实验动物中心。
药品:桂枝茯苓胶囊(江苏康缘药业股份有限公司);中药组合物为实施例1 制备得到的中药组合物。
实验方法:
(1)分组:50只昆明大鼠随机分成五组,每组10只,分别为对照组、阳性药组和中药组合物高、中、低剂量组。
(2)给药:灌胃给予受试药物,对照组给予等体积的生理盐水,连续给药三天。
(3)各组大鼠按50mg/kg剂量腹腔注射戊巴比妥钠麻醉,切开腹腔拉出一侧子宫及韧带,固定于10mL洛氏生理平衡液中,控制温度在37℃,稳定30min 后,用4×10倍倒置显微镜观察计数给药前的毛细血管在1mm2范围内的交叉点数,结扎幽门,各组于十二指肠内给药,给药体积4mL,正常对照组给予等体积的生理盐水,给药30min后,同法观察毛细血管网点交叉数。增加百分率 (%)=(给药后毛细血管交叉网点开放式-对照组毛细血管交叉网点开放个数)/对照组毛细血管交叉网点开放个数×100%。
注:与对照组对比,*P<0.05,**P<0.01,***P<0.005。
实验结果:由表6可知,与对照组相比,中药组合物高、中、低剂量组和桂枝茯苓组所测得的毛细管交叉网点开放个数均显著性增加(P<0.05);中药组合物中剂量组和高剂量组的活性强于桂枝茯苓阳性药组,说明本发明所述的中药组合物活血作用强于阳性药桂枝茯苓胶囊。
实施例8治疗痛经的中药组合物胶囊的制备
取实施例1制备得到的中药组合物60g、淀粉150g、羧甲基淀粉20g混匀,加入70%乙醇制成软材,过筛干燥,整粒,加入0.62g硬脂酸镁,混匀,装入1 号胶囊,制成1000粒胶囊,抛光,即得所述中药组合物胶囊。每粒含中药组合物60mg。口服,每次2粒,每日3次。
实施例9治疗痛经的中药组合物颗粒剂的制备
取实施例2制备得到的中药组合物120g,加入适量辅料如二氧化硅、淀粉甘露醇、木糖醇、山梨醇、甘氨酸等稀释辅料中的一种或者多种,干燥,混合均匀,加入合适的粘合剂如PEG200、微晶纤维素、明胶浆、淀粉浆、糖浆等的一种或多种,制粒,整粒制成颗粒剂1000剂,每剂含中药组合物120mg,口服,每次1袋,每日3次。
Claims (11)
1.一种具有预防和/或治疗痛经作用的中药组合物,其特征在于,由以下重量份的中药原料药制备而成:高良姜3-9份,佛手4-12份,玫瑰花4-12份,三七1-5份。
2.根据权利要求1所述的具有预防和/或治疗痛经作用的中药组合物,其特征在于,由以下重量份的中药原料药制备而成:高良姜4-6份,佛手6-8份,玫瑰花6-8份,三七2-3份。
3.根据权利要求1所述的具有预防和/或治疗痛经作用的中药组合物,其特征在于,由以下重量份的中药原料药制备而成:高良姜6份,佛手8份,玫瑰花8份,三七3份。
4.一种制备权利要求1-3任一项所述的具有预防和/或治疗痛经作用的中药组合物的方法,其特征在于,包含如下步骤:
(1)将高良姜、佛手、玫瑰花和三七加水煎煮得煎煮液;
(2)将煎煮液浓缩干燥得浸膏,即得所述的中药组合物。
5.根据权利要求4所述的方法,其特征在于,步骤(1)中水的重量用量为中药原料药重量的5-20倍;煎煮次数为1-3次,每次0.5-1.5h。
6.根据权利要求4所述的方法,其特征在于,在步骤(2)后进一步包括:
将步骤(2)制备得到的浸膏进行粉碎得到药粉,即得所述的中药组合物。
7.一种治疗痛经的药物,其特征在于,以权利要求1-3任一项所述的具有预防和/或治疗痛经作用的中药组合物作为有效成分。
8.根据权利要求7所述的治疗痛经的药物,其特征在于,进一步加入药学上可接受的辅料制成片剂、浓缩丸剂、颗粒剂、胶囊剂或口服液体制剂。
9.权利要求1-3任一项所述的具有预防和/或治疗痛经作用的中药组合物在制备药物中的应用。
10.根据权利要求9所述的应用,其特征在于,所述的药物为预防和/或治疗痛经的药物。
11.根据权利要求9所述的应用,其特征在于,所述的药物为抑制子宫平滑肌收缩的药物、具有镇痛作用的药物和/或具有活血作用的药物。
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