CN104258089A - 肾虚血热型月经先期收敛固涩剂及制法 - Google Patents
肾虚血热型月经先期收敛固涩剂及制法 Download PDFInfo
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Abstract
本发明公开了一种肾虚血热型月经先期收敛固涩剂,取下述重量配比的主要原料制备而成:玄参15-25份;千针万线草5-10份;白芍12-22份;草香附6-12份;山萸肉10-18份;草苁蓉5-15份;五味子9-18份;茺蔚子4-8份;地骨皮10-20份;人头七3-9份。本发明为精选药物组方,其药物组分经辩证配伍,在作用上相辅相成,具有滋补肝肾、凉血调经的功效。
Description
技术领域
本发明属于中医中药领域,尤其是涉及一种肾虚血热型月经先期收敛固涩剂及制法。
背景技术
月经先期是以月经周期比正常提前为主要表现的月经病,月经周期提前七天以上,甚至十余天,亦称经期超前,经行先期或经早。如仅提前三五天,且无其他明显症状者属正常范围,或偶然超前一次者,亦不作月经先期病论。本病在历代医籍中与月经后期、月经先后无定期、经期延长、月经过多、月经过少等,同属于月经不调的范畴。如宋代的《圣济总录·妇人月水不调》云:“月水不调者,经血或多或少,或清或浊,或先期而来,或后期而至是也。”本病的病因病理主要是气虚和血热。因为气有摄血功能,气虚则不能摄血,冲任二脉失去调节和固摄功能;血得热则妄行,故血热可使经血运行紊乱而妄行,均可致月经提前。引起气虚和血热的病因有以下几种情况:饮食失节,或劳倦过度,或思虑过极,损伤脾气,因而中气虚弱,统摄无权,冲任不固,经血失,以致月经先期来潮。脾为心之子,脾气既虚,则赖心气以自救。久则心气亦伤,以致心脾气虚。或病延日久,脾损及肾,使月经超前肾气渐衰,又可成为脾肾气虚。血热可分为实热和虚热。实热常见的有阳盛血热和肝郁血热。阳盛血热素体阳盛,或过食辛燥助阳之品,热扰冲任,迫血下行,以致月经提前而至。《万氏女科》说:“如曾误服辛热暖宫之药者,其冲任伏火也。”指明阳盛血热而致月经先期的病理。肝郁血热郁怒伤肝,木火妄动,下扰血海,迫血下行,致使月经先期来潮。《万氏女科·不及期而经先行》说:“如性急躁,多怒多妒者,责其气血俱热,且有郁也。虚热素体阴虚,或因久病明亏,或因失血伤阴,水亏火旺,热扰冲任,血海不宁,经血因而下行,故使月经提前而至。”《傅青主女科》说:“先期而来少者,火热而水不足也。”正是对阴虚血热致月经先期而言。
月经是由于卵巢激素周期性变化引起子宫内膜周期性的脱落而导致的阴道出血。青春期后卵巢在下丘脑—垂体所分泌的促性腺激素的刺激下逐渐发育。在垂体促卵泡激素的作用下卵泡逐渐生长,发育成熟,并分泌大量的雌激素,在雌激素的作用下子宫内膜增生变厚,呈增殖期变化。在黄体生成激素的作用下,成熟的卵泡破裂排出卵子,排卵后卵泡形成黄体,黄体细胞分泌孕激素,在雌、孕激素的共同作用下,子宫内膜进一步增殖,并由于其腺体上皮细胞分泌而呈现分泌期变化。若卵子未受精,黄体即开始萎缩,一般黄体的寿命平均为14天。黄体萎缩后,卵巢雌、孕激素水平迅速下降,使子宫内膜失去支持而萎缩,且由于缺血坏死而脱落,于是出现阴道出血,即通常所说的月经来潮。
目前,治疗月经先期的中药有很多,针对上述问题,公开号CN 102935165 A (申请号201210527417.4)的专利文献公开了一种治疗气虚型月经先期的中药组合物,由以下重量份各原料制成:人参20-40份、黄芪10-30份、当归5-15份、熟地10-30份、甘草8-25份、菟丝子15-25份、山茱萸6-12份、山药15-30份、五味子3-6份、白术10-15份、杜仲6-10份。公开号CN 103705785 A(申请号201410005484.9)的专利文献公开了一种治疗月经先期的中药组合物,由下列重量配比的药材制成的中药制剂:其中药原料及重量份配比为:生地10-40份、当归5-25份、女贞子5-20份、白茅根5-25份、地骨皮5-20份、山茱萸5-25份、泽泻5-25份、云苓5-20份、白芍5-25份、旱莲草5-20份、柴胡5-15份、知母5-20份、栀子5-25份、黄芩5-20份、香附5-20份、木香5-20份、鳖甲5-15份、甘草5-15份。公开号CN 103006900 A(申请号201210527464.9)的专利文献公开了一种治疗血热型月经先期的中药组合物,由以下重量份各原料制成:牡丹皮5-15份、青蒿10-20份、黄柏5-15份、地骨皮10-30份、熟地10-30份、白芍10-20份、阿胶5-15份。
包括上述专利文献在内的现有技术虽然在治疗月经先期方面已经取得了一定成绩,但也还存在诸多不足,很多药剂的疗效并不理想。
发明内容
针对现有技术的不足,本发明的目的之一是提供一种服用方便、疗效显著的肾虚血热型月经先期收敛固涩剂,该肾虚血热型月经先期收敛固涩剂结合多年临床实践配制而成,对月经先期疗效显著。本发明的另一目的就是提供上述肾虚血热型月经先期收敛固涩剂的制备方法。
本发明的上述目的是通过以下技术方案来实现的:
肾虚血热型月经先期收敛固涩剂,取下述重量配比的主要原料制备而成:玄参15-25份;千针万线草5-10份;白芍12-22份;草香附6-12份;山萸肉10-18份;草苁蓉5-15份;五味子9-18份;茺蔚子4-8份;地骨皮10-20份;人头七3-9份。
肾虚血热型月经先期收敛固涩剂,优选的方案为,取下述重量配比的主要原料制备而成:玄参18-22份;千针万线草6-9份;白芍15-19份;草香附8-10份;山萸肉13-15份;草苁蓉8-12份;五味子12-15份;茺蔚子5-7份;地骨皮13-17份;人头七5-7份。
肾虚血热型月经先期收敛固涩剂,更加优选的方案为,取下述重量配比的主要原料制备而成:玄参20份;千针万线草8份;白芍17份;草香附9份;山萸肉14份;草苁蓉10份;五味子14份;茺蔚子6份;地骨皮15份;人头七6份。
本发明还提供了将上述肾虚血热型月经先期收敛固涩剂制成药学上可接受的颗粒剂、稠膏剂、丸剂和汤剂的制备方法。
所述肾虚血热型月经先期收敛固涩剂颗粒剂的制备方法,步骤如下:
(1)将玄参、千针万线草、白芍、草香附、地骨皮和人头七切成厚2-4mm(优选2.5-3.5mm,更加优选3mm)的片状,置于非铁质容器中浸泡(优选1-3天,更加优选2天),倒入砂锅中,加水煎煮30-50分钟(优选35-45分钟,更加优选40分钟);
(2)将草苁蓉烘干(温度优选80-90℃,更加优选85℃),粉碎,装入灭菌过的600-800目(优选650-750目,更加优选700目)的纱布袋中,置于步骤(1)的砂锅中,煎煮两次,每次煮沸20-40分钟(优选25-35分钟,更加优选30分钟),两次滤液合并,静置3-7小时(优选4-6小时,更加优选5小时),取上清液;
(3)将炼蜜(优选炼蜜的用量为山萸肉质量的10%-20%,更加优选炼蜜的用量为山萸肉质量的15%),置于容器中,温水稀释,加入捣碎的山萸肉,搅拌均匀,闷润20-30分钟(优选23-27分钟,更加优选25分钟),置锅内,文火加热,炒至不粘手,取出放凉;
(4)将五味子和茺蔚子置于锅内,炒至手捏即碎的程度,共研粉末,过100-140目筛(优选110-130目筛,更加优选120目筛);
(5)将乙醇加入步骤(2)所得滤液中,静置4-6小时(优选4.5-5.5小时,更加优选5小时),过滤,滤液回收乙醇并浓缩至相对密度1.20-1.40(优选1.25-1.35,更加优选1.30),加入步骤(3)-(4)所得物,混合均匀,制成手捏成团压之即散的软材,以挤压方式通过14-22目筛网(优选16-20目筛网,更加优选过18目筛网),制成均匀的颗粒,辅以药学上可接受的载体包装即可,每小包6g。
服用方法:每次1包,用35℃左右的温开水冲服,每天2-3次,7天一个疗程。
所述肾虚血热型月经先期收敛固涩剂稠膏剂的制备方法,步骤如下:
(1)将玄参、千针万线草、白芍、草香附、地骨皮和人头七切成厚2-4mm(优选2.5-3.5mm,更加优选3mm)的片状,置于非铁质容器中浸泡(优选1-3天,更加优选2天),倒入砂锅中,加水煎煮30-50分钟(优选35-45分钟,更加优选40分钟);
(2)将草苁蓉、五味子和茺蔚子烘干(温度优选80-90℃,更加优选85℃),粉碎,装入灭菌过的600-800目(优选650-750目,更加优选700目)的纱布袋中,置于步骤(1)的砂锅中,煎煮两次,每次煮沸20-40分钟(优选25-35分钟,更加优选30分钟),两次滤液合并,静置3-7小时(优选4-6小时,更加优选5小时),取上清液;
(3)将炼蜜(优选炼蜜的用量为山萸肉质量的10%-20%,更加优选炼蜜的用量为山萸肉质量的15%),置于容器中,温水稀释,加入捣碎的山萸肉,搅拌均匀,闷润20-30分钟(优选23-27分钟,更加优选25分钟),置锅内,文火加热,炒至不粘手,取出放凉;
(4)将乙醇加入步骤(2)所得滤液中,静置4-6小时(优选4.5-5.5小时,更加优选5小时),过滤,滤液回收乙醇并浓缩至相对密度1.20-1.40(优选1.25-1.35,更加优选1.30),加入步骤(3)所得物,混合均匀。
服用方法:每次10-15ml,用35℃左右的温开水送服,每天2-3次,7天一个疗程。
所述肾虚血热型月经先期收敛固涩剂丸剂的制备方法,步骤如下:
(1)将玄参、千针万线草、白芍、草香附、地骨皮和人头七切成厚2-4mm(优选2.5-3.5mm,更加优选3mm)的片状,置于非铁质容器中浸泡(优选1-3天,更加优选2天),倒入砂锅中,加水煎煮30-50分钟(优选35-45分钟,更加优选40分钟);
(2)将草苁蓉烘干(温度优选80-90℃,更加优选85℃),粉碎,装入灭菌过的600-800目(优选650-750目,更加优选700目)的纱布袋中,置于步骤(1)的砂锅中,煎煮两次,每次煮沸20-40分钟(优选25-35分钟,更加优选30分钟),两次滤液合并,静置3-7小时(优选4-6小时,更加优选5小时),取上清液;
(3)将炼蜜(优选炼蜜的用量为山萸肉质量的10%-20%,更加优选炼蜜的用量为山萸肉质量的15%),置于容器中,温水稀释,加入捣碎的山萸肉,搅拌均匀,闷润20-30分钟(优选23-27分钟,更加优选25分钟),置锅内,文火加热,炒至不粘手,取出放凉;
(4)将五味子和茺蔚子置于锅内,炒至手捏即碎的程度,共研粉末,过100-140目筛(优选110-130目筛,更加优选120目筛);
(5)将乙醇加入步骤(2)所得滤液中,静置4-6小时(优选4.5-5.5小时,更加优选5小时),过滤,滤液回收乙醇并浓缩至相对密度1.20-1.40(优选1.25-1.35,更加优选1.30),加入步骤(3)-(4)所得物,混合均匀,调制成轻压则散的软材,过80-120目筛(优选90-110目筛,更加优选100目筛),烘干,粉碎,得药粉;
(6)将蜂蜜置于锅内,用文火熬炼,等蜂蜜熬至粘稠状,再掺入步骤(5)所得的药粉,充分拌匀成药膏,按中医传统制丸方法制成药丸,即得丸剂。
上述肾虚血热型月经先期收敛固涩剂丸剂的制备方法,步骤(6)按每公斤药粉配0.4-0.6公斤蜂蜜(优选每公斤药粉配0.45-0.55公斤蜂蜜,更加优选每公斤药粉配0.5公斤蜂蜜)。
服用方法:每次10-15丸,用35℃左右的温开水送服,每天2-3次,7天一个疗程。
所述肾虚血热型月经先期收敛固涩剂汤剂的制备方法,步骤如下:
(1)将玄参、千针万线草、白芍、草香附、地骨皮和人头七切成厚2-4mm(优选2.5-3.5mm,更加优选3mm)的片状,置于非铁质容器中浸泡(优选1-3天,更加优选2天),倒入砂锅中,加水煎煮30-50分钟(优选35-45分钟,更加优选40分钟);
(2)将草苁蓉、五味子和茺蔚子烘干(温度优选80-90℃,更加优选85℃),粉碎,装入灭菌过的600-800目(优选650-750目,更加优选700目)的纱布袋中,置于步骤(1)的砂锅中,煎煮两次,每次煮沸20-40分钟(优选25-35分钟,更加优选30分钟),两次滤液合并,静置3-7小时(优选4-6小时,更加优选5小时),取上清液;
(3)将炼蜜(优选炼蜜的用量为山萸肉质量的10%-20%,更加优选炼蜜的用量为山萸肉质量的15%),置于容器中,温水稀释,加入捣碎的山萸肉,搅拌均匀,闷润20-30分钟(优选23-27分钟,更加优选25分钟),置锅内,文火加热,炒至不粘手,取出放凉;
(4)将乙醇加入步骤(2)所得滤液中,静置4-6小时(优选4.5-5.5小时,更加优选5小时),过滤,滤液回收乙醇,加入步骤(3)所得物,混合均匀并浓缩至原体积的3/4-1/4(优选5/8-3/8,更加优选1/2),无菌封装,得汤剂。
上述肾虚血热型月经先期收敛固涩剂汤剂的制备方法,步骤(4)乙醇用量为滤液质量的0.5-1.5倍(优选0.75-1.25倍,更加优选1倍)。
服用方法:每次10-15ml,用35℃左右的温开水冲服,每天2次,7天一个疗程。
本发明所用主要中药原料的药理如下:
玄参:味甘、苦、咸,性微寒。归肺、胃、肾经。为玄参科植物玄参的干燥根。具有凉血滋阴,泻火解毒的功效。用于热病伤阴,舌绛烦渴,温毒发斑,津伤便秘,骨蒸劳嗽,目赤,咽痛,瘰病,白喉,痈肿疮毒。
千针万线草:味甘,性平。为石竹科植物云南繁缕的根。具有健牌,养肝,益肾的功效。用于体虚贫血,精神短少,头晕心慌,耳鸣眼花,潮热,遗精,腰痛脚弱,月经不调,带下淋沥,小儿疳积。
白芍:为苦、酸,行微寒。归肝、脾经。为毛茛科植物芍药的干燥根。具有平肝止痛,养血调经,敛阴止汗的功效。用于头痛眩晕,胁痛,腹痛,四肢挛痛,血虚萎黄,月经不调,自汗,盗汗。
草香附:味辛、微苦,性平。为灯芯草科植物走茎灯心草的根茎。具有理气止痛,调经和血的功效。用于肝郁气滞,胸胁疼痛,月经失调,崩中带下。
山萸肉:味酸、涩,性微温。归肝、肾经。为山茱萸科植物山茱萸的干燥成熟果肉。据化学分析,山茱萸含有生理活性较强的山茱萸甙、酒石酸、没食子酸、苹果酸、树酯、鞣质和多种维生素等有效成分,具有增强免疫、抗炎、抗菌等药理作用。具有补益肝肾,收敛固涩,固精缩尿,止带止崩,止汗,生津止渴的功效。用于腰膝酸痛,头晕耳鸣,健忘,遗精滑精,遗尿尿频,崩漏带下,月经不调,大汗虚脱。
草苁蓉:为味甘、咸、性温。列当科草苁蓉属植物草苁蓉的全草。全草含糖苷类:草苁蓉苯丙烯醇苷A、B、C、D,草苁蓉苷,草苁蓉醛苷。环烯醚萜苷类,酸类:8-表去氧马钱子甘酸,没食子酸,桂皮酸,咖啡酸,对香豆酸,等。地上部分含有苁蓉醛碱,和草苁蓉内酯。具有补肾壮阳,润肠通便,止血的功效。用于肾虚阳痿,遗精,腰膝冷痛,小便遗沥,尿血,宫冷不孕,崩漏,带下,肠燥便秘。
五味子:味酸、甘,性温。归肺、心、肾经。为木兰科植物五味子的干燥成熟果实、习称“北五味子”。 具有收敛固涩,益气生津,补肾宁心的功效。用于久嗽虚喘,梦遗滑精,遗尿尿频,久泻不止,自汗,盗汗,津伤口渴,短气脉虚,内热消渴,心悸失眠。
茺蔚子:味辛、苦,性微寒。归心包、肝经。为唇形科植物益母草的干燥成熟果实。具有活血调经,清肝明目的功效。用于月经不调,经闭,痛经,目赤翳障,头晕胀痛。
地骨皮:味甘,性寒。归肺、肝、肾经。为茄科植物枸杞或宁夏枸杞的干燥根皮。具有凉血除蒸,清肺降火的功效。用于阴虚潮热,骨蒸盗汗,肺热咳嗽,咯血,衄血,内热消渴。
人头七:味甘,性温。为兰科角盘兰属植物角盘兰的带块根茎。具有补肾健脾,活血调经,解毒的功效。用于头昏失眠,须发早白,不欲食,月经不调,毒蛇咬伤。
本发明治疗肾虚血热型月经先期收敛固涩剂具有养阴清热、凉血调经的功效,治疗月经先期的疗效显著,作用可靠。
本发明的技术优势还主要体现在:
1.本发明药剂基于中医治疗月经先期的原理,是在研究了大量文献、药理工作和临床试验的基础上制成的,效果显著。
2.本药剂所选材料大多数为传统中药材,药材药源易得,成本低廉,不会给患者带来大的经济负担,而且具有无毒无痛苦的优点。
3.本发明的各药物组分经辩证配伍,在作用上相辅相成,对月经先期的治疗达到标本兼治。
附图说明
图1为服用实施例4所得妇女月经先期益阴补肾药剂汤剂后月经先期得到缓解的情况;
图2为服用实施例4所得妇女月经先期益阴补肾药剂汤剂后精神状态得到缓解的情况。
具体实施方式
下面结合实施例和实验例详细说明本发明的技术方案,但保护范围不限于此。
实施例1肾虚血热型月经先期收敛固涩剂,取下述重量配比的主要原料制备而成(每份取20g):玄参15份;千针万线草5份;白芍12份;草香附6份;山萸肉10份;草苁蓉5份;五味子9份;茺蔚子4份;地骨皮10份;人头七3份。
上述肾虚血热型月经先期收敛固涩剂颗粒剂的制备方法,步骤如下:
(1)将玄参、千针万线草、白芍、草香附、地骨皮和人头七切成厚3mm的片状,置于非铁质容器中浸泡2天,倒入砂锅中,加水煎煮40分钟;
(2)将草苁蓉烘干,粉碎,装入灭菌过的700目的纱布袋中,置于步骤(1)的砂锅中,煎煮两次,每次煮沸30分钟,两次滤液合并,静置5小时,取上清液;
(3)将相当于山萸肉质量的15%的炼蜜置于容器中,温水稀释,加入捣碎的山萸肉,搅拌均匀,闷润25分钟,置锅内,文火加热,炒至不粘手,取出放凉;
(4)将五味子和茺蔚子置于锅内,炒至手捏即碎的程度,共研粉末,过120目筛;
(5)将乙醇加入步骤(2)所得滤液中,静置5小时,过滤,滤液回收乙醇并浓缩至相对密度1.30,加入步骤(3)-(4)所得物,混合均匀,制成手捏成团压之即散的软材,以挤压方式通过18目筛网,制成均匀的颗粒,辅以药学上可接受的载体包装即可,每小包6g。
服用方法:每次1包,用35℃左右的温开水冲服,每天2次,7天一个疗程。
典型病例一何XX,女,27岁,未婚,山东省临沂市罗庄区人。14岁月经初潮,次年起经行量多,2年后又恢复正常。不到一年又经转提前,每3周1行,经量偏多,为先期9天而转,量少色暗,乳房微胀,大便溏薄。舌质红,苔薄腻,脉细软。证属月经先期脾肾不足,冲任统摄乏力。
服用实施例1所得肾虚血热型月经先期收敛固涩剂颗粒剂2个疗程后,经量初少后为中量,伴腹痛隐隐,大便溏薄,日1-2次。脉细软,舌暗偏红,苔薄腻。坚持服用实施例1所得肾虚血热型月经先期收敛固涩剂颗粒剂2个疗程,复诊时:经后便溏转实,但时而反复,神疲乏力,舌边尖红,苔薄,脉细软。1个月后复诊,经期已准,经量中等,而予实施例1所得肾虚血热型月经先期收敛固涩剂颗粒剂1个疗程,以资巩固。
实施例2肾虚血热型月经先期收敛固涩剂,取下述重量配比的主要原料制备而成(每份30g):玄参18份;千针万线草6份;白芍15份;草香附8份;山萸肉13份;草苁蓉8份;五味子12份;茺蔚子5份;地骨皮13份;人头七5份。
上述肾虚血热型月经先期收敛固涩剂稠膏剂的制备方法,步骤如下:
(1)将玄参、千针万线草、白芍、草香附、地骨皮和人头七切成厚3mm的片状,置于非铁质容器中浸泡2天,倒入砂锅中,加水煎煮40分钟;
(2)将草苁蓉、五味子和茺蔚子烘干,粉碎,装入灭菌过的700目的纱布袋中,置于步骤(1)的砂锅中,煎煮两次,每次煮沸30分钟,两次滤液合并,静置5小时,取上清液;
(3)将相当于山萸肉质量的15%的炼蜜置于容器中,温水稀释,加入捣碎的山萸肉,搅拌均匀,闷润25分钟,置锅内,文火加热,炒至不粘手,取出放凉;
(4)将乙醇加入步骤(2)所得滤液中,静置5小时,过滤,滤液回收乙醇并浓缩至相对密度1.30,加入步骤(3)所得物,混合均匀。
服用方法:每次10ml,用35℃左右的温开水送服,每天2-3次,7天一个疗程。
典型病例二杨XX,女,36岁,山东省烟台市蓬莱市人。患者已经连续几个月半月一行。总是疲劳感重,失眠易怒,月经量少色暗。量多,色紫红,质稠有块,胸、胁、乳房、少腹胀痛,心烦易怒,口苦咽干,舌红苔薄黄,脉弦数。舌面开始有细纹出现,舌偏上部位色红,整个舌面有白粘苔。脉象无力,特别是肾脉。诊断为肾虚性月经先期。
服用实施例2所得肾虚血热型月经先期收敛固涩剂稠膏剂2个疗程后,患者自诉调理效果明显,疲劳感基本消失,爱着急的现象也有很大好转。但仍感口干,腰背痛,膝关节也不好,头皮触痛,便干无力。继续服用实施例2所得肾虚血热型月经先期收敛固涩剂稠膏剂2个疗程后,患者月经周期已经出现明显的改变,当时已经22天一个周期,经量增多,疲劳感基本消失,目前遗留一些口干、便干的症状。后期的随访中得知,当时近三个月行经时间分别为9月30日,10月22日,11月18日,周期渐长,而且经期基本恢复正常。
实施例3肾虚血热型月经先期收敛固涩剂,取下述重量配比的主要原料制备而成(每份取20g):玄参22份;千针万线草9份;白芍19份;草香附10份;山萸肉15份;草苁蓉12份;五味子15份;茺蔚子7份;地骨皮17份;人头七7份。
上述肾虚血热型月经先期收敛固涩剂丸剂的制备方法,步骤如下:
(1)将玄参、千针万线草、白芍、草香附、地骨皮和人头七切成厚3mm的片状,置于非铁质容器中浸泡2天,倒入砂锅中,加水煎煮40分钟;
(2)将草苁蓉烘干,粉碎,装入灭菌过的700目的纱布袋中,置于步骤(1)的砂锅中,煎煮两次,每次煮沸30分钟,两次滤液合并,静置5小时,取上清液;
(3)将相当于山萸肉质量的15%的炼蜜置于容器中,温水稀释,加入捣碎的山萸肉,搅拌均匀,闷润25分钟,置锅内,文火加热,炒至不粘手,取出放凉;
(4)将五味子和茺蔚子置于锅内,炒至手捏即碎的程度,共研粉末,过120目筛;
(5)将乙醇加入步骤(2)所得滤液中,静置5小时,过滤,滤液回收乙醇并浓缩至相对密度1.30,加入步骤(3)-(4)所得物,混合均匀,调制成轻压则散的软材,过100目筛,烘干,粉碎,得药粉;
(6)将蜂蜜置于锅内,用文火熬炼,等蜂蜜熬至粘稠状,再掺入步骤(5)所得的药粉,充分拌匀成药膏,按中医传统制丸方法制成药丸,即得丸剂。
服用方法:每次10丸,用35℃左右的温开水送服,每天2-3次,7天一个疗程。
典型病例三 叶XX,女,29岁,已婚,山东省德州市宁津县人。结婚4年有余,一直未孕,月经周期提前,每月提前8天至10天,量少,色淡,较正常时经量的1/2,质稠有块,胸、胁、乳房、少腹胀痛,心烦易怒,口苦咽干,自觉疲惫无力,反应迟钝,记忆力差,夜晚失眠,多梦易醒,醒后头痛,白天嗜睡困倦。面色萎黄,舌红苔薄黄,脉弦数。
服用实施例3所得肾虚血热型月经先期收敛固涩剂丸剂1个疗程后,诸症均减,饮食睡眠记忆及反应力好转,脸色好转,既往经前腹痛。坚持服用实施例1所得肾虚血热型月经先期收敛固涩剂丸剂2个疗程左右时,月经来潮,量稍多,色淡,经前乳房,少腹不胀痛,心烦易怒,口苦咽干已随之消失,好转明显。后坚持服用实施例1所得肾虚血热型月经先期收敛固涩剂丸剂2个疗程后,完全恢复正常,在至今一年多的时间里一直保持正常。
实施例4肾虚血热型月经先期收敛固涩剂,取下述重量配比的主要原料制备而成(每份取10g):玄参20份;千针万线草8份;白芍17份;草香附9份;山萸肉14份;草苁蓉10份;五味子14份;茺蔚子6份;地骨皮15份;人头七6份。
所述肾虚血热型月经先期收敛固涩剂汤剂的制备方法,步骤如下:
(1)将玄参、千针万线草、白芍、草香附、地骨皮和人头七切成厚3mm的片状,置于非铁质容器中浸泡2天,倒入砂锅中,加水煎煮40分钟;
(2)将草苁蓉、五味子和茺蔚子烘干,粉碎,装入灭菌过的700目的纱布袋中,置于步骤(1)的砂锅中,煎煮两次,每次煮沸30分钟,两次滤液合并,静置5小时,取上清液;
(3)将相当于山萸肉质量的15%的炼蜜置于容器中,温水稀释,加入捣碎的山萸肉,搅拌均匀,闷润25分钟,置锅内,文火加热,炒至不粘手,取出放凉;
(4)将乙醇加入步骤(2)所得滤液中,静置5小时,过滤,滤液回收乙醇,加入步骤(3)所得物,混合均匀并浓缩至原体积的1/2,无菌封装,得汤剂。
服用方法:每次15ml,用35℃左右的温开水冲服,每天2次,7天一个疗程。
试验例实施例4所得肾虚血热型月经先期收敛固涩剂汤剂的临床应用:2008年8月-2011年2月,筛选30例月经先期患者,试验之前2周,对该人群进行连续观察,记录症状及变化,随机分为实验组和对照组两个组(其中实验组200人,对照组100人)。使用方法为:实验组服用实施例4所得肾虚血热型月经先期收敛固涩剂汤剂,每次15ml,用35℃左右的温开水冲服,每天2次,7天一个疗程;对照组服用其它药品(如当归丸、加味逍遥丸等),每天3次,用35℃左右的温开水冲服。疗效判定标准:治愈:服用药物3个疗程后月经完全正常,不适症状消失;显效:服用药物3个疗程后月经基本正常,不适症状减轻或部分消失,至少有三个月经周期以上正常;无效:服用药物3个疗程后月经先期无任何改善,不适症状无变化或后期复发。其中,有效包括治愈和显效。
服用完3个疗程的药物后开始观察病症的缓解情况,观察期限为4个周期,观察内容如下:
1、5天为一个观察周期,记录下月经先期得到缓解的情况,统计每个周期月经先期得到缓解的比例,结果如附图1:
分析:从附图1中可以看出,实施例4所得肾虚血热型月经先期收敛固涩剂汤剂的效果更好,对月经先期有更好的治疗作用,远比使用其他药物的对照组的疗效好。
2、5天为一个观察周期,记录下患者的精神状况,统计每个周期精神状况恢复的比例,结果如附图2:
分析:从附图2中可以看出使用实施例4所得肾虚血热型月经先期收敛固涩剂汤剂的实验组的疗效远比使用其他药物的对照组的疗效好。
3、使用其他药物的对照组和使用实施例4所得肾虚血热型月经先期收敛固涩剂汤剂的实验组的疗效相比,结果如表1所示:
表1
治疗效果:从表1可以看出,服用实施例4所得肾虚血热型月经先期收敛固涩剂汤剂的治愈率高达81%,有效率98.5%,无效率仅为1.5%;而服用其他药物(如当归丸、加味逍遥丸等)的治愈率仅39%,有效率为85%,而无效率却高达15%。可以看出:服用实施例4所得肾虚血热型月经先期收敛固涩剂汤剂的效果明显优于服用其他药物的效果。
从附图1-2明显地看出,使用本发明实施例4所得肾虚血热型月经先期收敛固涩剂汤剂比服用其他药物的效果显著。服用完本发明实施例4所得肾虚血热型月经先期收敛固涩剂汤剂3个疗程后的4个周期里,95%患者的月经先期症状得到缓解,自感有所好转,而对照组只有79%的患者有所缓解;而且在4个观察期内有高达94%患者的精神状态得到改善,体力增强,而对照组只有81%的患者精神状态有所缓解。可以推断出本发明肾虚血热型月经先期收敛固涩剂疗效更好。
应当指出的是,具体实施方式只是本发明比较有代表性的例子,显然本发明的技术方案不限于上述实施例,还可以有很多变形。本领域的普通技术人员,以本发明所明确公开的或根据文件的书面描述毫无异议得到的,均应认为是本专利所要保护的范围。
Claims (10)
1.肾虚血热型月经先期收敛固涩剂,其特征是,取下述重量配比的主要原料制备而成:玄参15-25份;千针万线草5-10份;白芍12-22份;草香附6-12份;山萸肉10-18份;草苁蓉5-15份;五味子9-18份;茺蔚子4-8份;地骨皮10-20份;人头七3-9份。
2.根据权利要求1所述的肾虚血热型月经先期收敛固涩剂,其特征是,取下述重量配比的主要原料制备而成:玄参18-22份;千针万线草6-9份;白芍15-19份;草香附8-10份;山萸肉13-15份;草苁蓉8-12份;五味子12-15份;茺蔚子5-7份;地骨皮13-17份;人头七5-7份。
3.根据权利要求1所述的肾虚血热型月经先期收敛固涩剂,其特征是,取下述重量配比的主要原料制备而成:玄参20份;千针万线草8份;白芍17份;草香附9份;山萸肉14份;草苁蓉10份;五味子14份;茺蔚子6份;地骨皮15份;人头七6份。
4.根据权利要求1-3任一所述的肾虚血热型月经先期收敛固涩剂,其特征是,将该肾虚血热型月经先期收敛固涩剂制成药学上可接受的颗粒剂、稠膏剂、丸剂和汤剂。
5.根据权利要求4所述的肾虚血热型月经先期收敛固涩剂,其特征是,所述颗粒剂的制备方法,步骤如下:
(1)将玄参、千针万线草、白芍、草香附、地骨皮和人头七切成厚2-4mm(优选2.5-3.5mm,更加优选3mm)的片状,置于非铁质容器中浸泡(优选1-3天,更加优选2天),倒入砂锅中,加水煎煮30-50分钟(优选35-45分钟,更加优选40分钟);
(2)将草苁蓉烘干(温度优选80-90℃,更加优选85℃),粉碎,装入灭菌过的600-800目(优选650-750目,更加优选700目)的纱布袋中,置于步骤(1)的砂锅中,煎煮两次,每次煮沸20-40分钟(优选25-35分钟,更加优选30分钟),两次滤液合并,静置3-7小时(优选4-6小时,更加优选5小时),取上清液;
(3)将炼蜜(优选炼蜜的用量为山萸肉质量的10%-20%,更加优选炼蜜的用量为山萸肉质量的15%),置于容器中,温水稀释,加入捣碎的山萸肉,搅拌均匀,闷润20-30分钟(优选23-27分钟,更加优选25分钟),置锅内,文火加热,炒至不粘手,取出放凉;
(4)将五味子和茺蔚子置于锅内,炒至手捏即碎的程度,共研粉末,过100-140目筛(优选110-130目筛,更加优选120目筛);
(5)将乙醇加入步骤(2)所得滤液中,静置4-6小时(优选4.5-5.5小时,更加优选5小时),过滤,滤液回收乙醇并浓缩至相对密度1.20-1.40(优选1.25-1.35,更加优选1.30),加入步骤(3)-(4)所得物,混合均匀,制成手捏成团压之即散的软材,以挤压方式通过14-22目筛网(优选16-20目筛网,更加优选过18目筛网),制成均匀的颗粒,辅以药学上可接受的载体包装即可,每小包10g。
6.根据权利要求4所述的肾虚血热型月经先期收敛固涩剂,其特征是,所述稠膏剂的制备方法,步骤如下:
(1)将玄参、千针万线草、白芍、草香附、地骨皮和人头七切成厚2-4mm(优选2.5-3.5mm,更加优选3mm)的片状,置于非铁质容器中浸泡(优选1-3天,更加优选2天),倒入砂锅中,加水煎煮30-50分钟(优选35-45分钟,更加优选40分钟);
(2)将草苁蓉、五味子和茺蔚子烘干(温度优选80-90℃,更加优选85℃),粉碎,装入灭菌过的600-800目(优选650-750目,更加优选700目)的纱布袋中,置于步骤(1)的砂锅中,煎煮两次,每次煮沸20-40分钟(优选25-35分钟,更加优选30分钟),两次滤液合并,静置3-7小时(优选4-6小时,更加优选5小时),取上清液;
(3)将炼蜜(优选炼蜜的用量为山萸肉质量的10%-20%,更加优选炼蜜的用量为山萸肉质量的15%),置于容器中,温水稀释,加入捣碎的山萸肉,搅拌均匀,闷润20-30分钟(优选23-27分钟,更加优选25分钟),置锅内,文火加热,炒至不粘手,取出放凉;
(4)将乙醇加入步骤(2)所得滤液中,静置4-6小时(优选4.5-5.5小时,更加优选5小时),过滤,滤液回收乙醇并浓缩至相对密度1.20-1.40(优选1.25-1.35,更加优选1.30),加入步骤(3)所得物,混合均匀。
7.根据权利要求4所述的肾虚血热型月经先期收敛固涩剂,其特征是,所述丸剂的制备方法,步骤如下:
(1)将玄参、千针万线草、白芍、草香附、地骨皮和人头七切成厚2-4mm(优选2.5-3.5mm,更加优选3mm)的片状,置于非铁质容器中浸泡(优选1-3天,更加优选2天),倒入砂锅中,加水煎煮30-50分钟(优选35-45分钟,更加优选40分钟);
(2)将草苁蓉烘干(温度优选80-90℃,更加优选85℃),粉碎,装入灭菌过的600-800目(优选650-750目,更加优选700目)的纱布袋中,置于步骤(1)的砂锅中,煎煮两次,每次煮沸20-40分钟(优选25-35分钟,更加优选30分钟),两次滤液合并,静置3-7小时(优选4-6小时,更加优选5小时),取上清液;
(3)将炼蜜(优选炼蜜的用量为山萸肉质量的10%-20%,更加优选炼蜜的用量为山萸肉质量的15%),置于容器中,温水稀释,加入捣碎的山萸肉,搅拌均匀,闷润20-30分钟(优选23-27分钟,更加优选25分钟),置锅内,文火加热,炒至不粘手,取出放凉;
(4)将五味子和茺蔚子置于锅内,炒至手捏即碎的程度,共研粉末,过100-140目筛(优选110-130目筛,更加优选120目筛);
(5)将乙醇加入步骤(2)所得滤液中,静置4-6小时(优选4.5-5.5小时,更加优选5小时),过滤,滤液回收乙醇并浓缩至相对密度1.20-1.40(优选1.25-1.35,更加优选1.30),加入步骤(3)-(4)所得物,混合均匀,调制成轻压则散的软材,过80-120目筛(优选90-110目筛,更加优选100目筛),烘干,粉碎,得药粉;
(6)将蜂蜜置于锅内,用文火熬炼,等蜂蜜熬至粘稠状,再掺入步骤(5)所得的药粉,充分拌匀成药膏,按中医传统制丸方法制成药丸,即得丸剂。
8.根据权利要求7所述的肾虚血热型月经先期收敛固涩剂丸剂的制备方法,其特征是:步骤(6)按每公斤药粉配0.4-0.6公斤蜂蜜(优选每公斤药粉配0.45-0.55公斤蜂蜜,更加优选每公斤药粉配0.5公斤蜂蜜)。
9.根据权利要求4所述的肾虚血热型月经先期收敛固涩剂,其特征是,所述汤剂的制备方法,步骤如下:
(1)将玄参、千针万线草、白芍、草香附、地骨皮和人头七切成厚2-4mm(优选2.5-3.5mm,更加优选3mm)的片状,置于非铁质容器中浸泡(优选1-3天,更加优选2天),倒入砂锅中,加水煎煮30-50分钟(优选35-45分钟,更加优选40分钟);
(2)将草苁蓉、五味子和茺蔚子烘干(温度优选80-90℃,更加优选85℃),粉碎,装入灭菌过的600-800目(优选650-750目,更加优选700目)的纱布袋中,置于步骤(1)的砂锅中,煎煮两次,每次煮沸20-40分钟(优选25-35分钟,更加优选30分钟),两次滤液合并,静置3-7小时(优选4-6小时,更加优选5小时),取上清液;
(3)将炼蜜(优选炼蜜的用量为山萸肉质量的10%-20%,更加优选炼蜜的用量为山萸肉质量的15%),置于容器中,温水稀释,加入捣碎的山萸肉,搅拌均匀,闷润20-30分钟(优选23-27分钟,更加优选25分钟),置锅内,文火加热,炒至不粘手,取出放凉;
(4)将乙醇加入步骤(2)所得滤液中,静置4-6小时(优选4.5-5.5小时,更加优选5小时),过滤,滤液回收乙醇,加入步骤(3)所得物,混合均匀并浓缩至原体积的3/4-1/4(优选5/8-3/8,更加优选1/2),无菌封装,得汤剂。
10.根据权利要求9所述的肾虚血热型月经先期收敛固涩剂汤剂的制备方法,其特征是:步骤(4)乙醇用量为滤液质量的0.5-1.5倍(优选0.75-1.25倍,更加优选1倍)。
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