CN105214028A - Application of a pharmaceutical composition in the preparation of medicines for treating amenorrhea - Google Patents
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Abstract
Description
技术领域 technical field
本发明属于中药领域,尤其涉及一种药物组合物用于制备治疗闭经药物中的用途。 The invention belongs to the field of traditional Chinese medicines, and in particular relates to the application of a pharmaceutical composition in the preparation of medicines for treating amenorrhea.
背景技术 Background technique
闭经是妇科疾病中常见的症状,可以由各种不同的原因引起。通常将闭经分为原发性和继发性两种。凡年过18岁仍未行经者称为原发性闭经;在月经初潮以后,正常绝经以前的任何时间内(妊娠或哺乳期除外),月经闭止超过6个月者称为继发性闭经。月经是由下丘脑-垂体-卵巢轴的周期性调节造成子宫内膜周期脱落形成的,因此在下丘脑、垂体、卵巢和生殖道特别是子宫的各个环节上出现的任何器质性或功能性的变化,均可能引起闭经。其他内分泌腺的器质性和功能性异常,也可能影响月经以致发生闭经。 Amenorrhea is a common symptom in gynecological diseases and can be caused by various reasons. Amenorrhea is usually divided into primary and secondary two. Those who have not menstruated after the age of 18 are called primary amenorrhea; those who have stopped menstruation for more than 6 months after menarche and at any time before normal menopause (except pregnancy or lactation) are called secondary amenorrhea . Menstruation is formed by the periodic regulation of the hypothalamus-pituitary-ovarian axis, resulting in the shedding of the endometrium cycle, so any organic or functional abnormalities in the hypothalamus, pituitary, ovary and reproductive tract, especially the uterus Changes may cause amenorrhea. Organic and functional abnormalities of other endocrine glands may also affect menstruation so that amenorrhea occurs.
近年来,随着生活压力的增大,很多女性在绝经前就过早出现了闭经的现象。闭经对女性身心健康影响很大。闭经是一种妇科常见疾病,临床表现:从月经停止,协腹胀痛症状最为突出,中医认为:闭经的产生,有虚有实,以虚者多,实者少,虚者由于先天不足或后天多产房劳、久病大病、饮食劳倦、忧思多虑等因素致肾气虚弱,或气血虚弱,或阴虚血燥,无血可下,而导致血枯经闭,实者由于七情内伤或感受寒热湿邪或素体肥胖,多痰多湿,致气滞血瘀,或痰湿阻滞,脉道不通,经血不得下行而导致血隔经闭。根据中医理论,针对闭经的发病机理,以疏肝理气、补益气血、温经散寒、活血化瘀为治则,进行辩证组方配伍,以达到标本兼治的目的。目前,治疗闭经的药物也很多,但存在疗效不稳定、治疗时间长、副作用大等不足。 In recent years, with the increase of life pressure, many women have premature amenorrhea before menopause. Amenorrhea has a great impact on women's physical and mental health. Amenorrhea is a common gynecological disease. The clinical manifestations are: from the cessation of menstruation, the symptoms of abdominal distension and pain are the most prominent. Traditional Chinese medicine believes that: the occurrence of amenorrhea is caused by deficiency and excess. Labor in the delivery room, chronic illness, fatigue from eating, worrying and worrying and other factors lead to weakness of kidney qi, or weakness of qi and blood, or deficiency of yin and dryness of blood, resulting in amenorrhea due to blood dryness. Or feel cold, heat and dampness evil or body obesity, phlegm and dampness, resulting in stagnation of qi and blood stasis, or blockage of phlegm and dampness, blocked arteries, and menstrual blood cannot descend, resulting in amenorrhea. According to the theory of traditional Chinese medicine, according to the pathogenesis of amenorrhea, the treatment principles are to soothe the liver and regulate qi, tonify qi and blood, warm the meridians and dispel cold, and activate blood to remove blood stasis. At present, there are many drugs for the treatment of amenorrhea, but there are shortcomings such as unstable curative effect, long treatment time, and large side effects.
中国专利201310308011.1公开了一种治疗闭经的中药组合物,该中药组合物由以下重量份的原料制备而成:党参20-30份、熟地黄20-30份、淫羊藿20-30份、石楠叶20-30份、当归20-30份、白芍20-30份、益母草10-20份、黄芪10-15份、鹿角霜10-15份、白术5-15份、茯苓5-15份、漏芦5-15份、路路通5-15份、茺蔚子5-15份、香附5-15份、桂枝5-15份、枸杞子5-15份、女贞子5-15份、菟丝子5-15份、覆盆子5-15份、麻黄5-15份、桑白皮5-15份、牛膝5-15份、红花5-15份、柴胡5-15份、泽兰5-15份、郁金5-15份、甘草5-15份、土鳖虫3-9份、水蛭3-9份、桔梗3-9份、川芎3-9份。该中药组合物具有疗效稳定、治疗时间短、副作用小的功效,但是在散寒止痛方面效果不是十分显著。 Chinese patent 201310308011.1 discloses a traditional Chinese medicine composition for treating amenorrhea. 20-30 parts of leaves, 20-30 parts of angelica, 20-30 parts of white peony, 10-20 parts of motherwort, 10-15 parts of astragalus, 10-15 parts of antler cream, 5-15 parts of Atractylodes macrocephala, 5-15 parts of Poria cocos, 5-15 parts of Leulu, 5-15 parts of Passepartout, 5-15 parts of Fructus Chinensis, 5-15 parts of Rhizoma Cyperus, 5-15 parts of Guizhi, 5-15 parts of Lycium barbarum, 5-15 parts of Ligustrum lucidum 5-15 parts of dodder, 5-15 parts of raspberry, 5-15 parts of ephedra, 5-15 parts of Morus alba, 5-15 parts of Achyranthes bidentata, 5-15 parts of safflower, 5-15 parts of Bupleurum, 5-15 parts of Eupatorium, 5-15 parts of Curcuma, 5-15 parts of Licorice, 3-9 parts of Wood Beetle, 3-9 parts of Leech, 3-9 parts of Campanulaceae, and 3-9 parts of Chuanxiong. The traditional Chinese medicine composition has the effects of stable curative effect, short treatment time and small side effects, but the effect in expelling cold and relieving pain is not very significant.
发明内容 Contents of the invention
本发明要解决的技术问题是提供一种药物组合物用于制备治疗闭经药物中的用途,该药物组合物具有活血祛瘀、调经止痛、养阴润肺、清心安神和凉血解毒的功效,还具有配伍科学,疗效迅速,治愈率高,成本低等优点。此外,本发明还提供相应的制造工艺将该药物组合物在保证疗效的前提下制成方便易用的制剂。 The technical problem to be solved by the present invention is to provide a pharmaceutical composition used in the preparation of medicines for treating amenorrhea. The pharmaceutical composition has the effects of promoting blood circulation and removing blood stasis, regulating menstruation and relieving pain, nourishing yin and moistening lung, clearing heart and tranquilizing mind, cooling blood and detoxifying, It also has the advantages of scientific compatibility, rapid curative effect, high cure rate and low cost. In addition, the present invention also provides a corresponding manufacturing process to make the pharmaceutical composition into a convenient and easy-to-use preparation under the premise of ensuring the curative effect.
本发明药物组合物由以下重量份数的原料制备而成: The pharmaceutical composition of the present invention is prepared from the following raw materials in parts by weight:
何首乌6-12份、山药5-13份、麦冬6-16份、艾叶6-28份、延胡索5-8份、当归6-11份、川楝子5-8份、乌药4-10份、丹皮5-12份、麦芽10-14份、桑葚6-12份、肉桂4-8份、青皮4-8份、大黄10-18份、白芍6-16份、莪术7-14份、牡蛎10-16份、干姜2-6份、茯苓10-15份和甘草4-12份。 Polygonum multiflorum 6-12 parts, Chinese yam 5-13 parts, Ophiopogon japonicus 6-16 parts, Artemisia argyi 6-28 parts, Corydalis 5-8 parts, Angelica 6-11 parts, Toosendan 5-8 parts, Wuyao 4-10 parts 5-12 parts of paeonol, 10-14 parts of malt, 6-12 parts of mulberry, 4-8 parts of cinnamon, 4-8 parts of green skin, 10-18 parts of rhubarb, 6-16 parts of white peony, 7-14 parts of curcuma 10-16 parts of oysters, 2-6 parts of dried ginger, 10-15 parts of Poria cocos and 4-12 parts of licorice.
进一步地,所述药物组合物由以下重量份数的原料制备而成: Further, the pharmaceutical composition is prepared from the following raw materials in parts by weight:
何首乌6份、山药5份、麦冬6份、艾叶6份、延胡索5份、当归6份、川楝子5份、乌药4、丹皮5份、麦芽10份、桑葚6份、肉桂4份、青皮4份、大黄10份、白芍6份、莪术7份、牡蛎10份、干姜2份、茯苓10份和甘草4份。 6 parts of Polygonum multiflorum, 5 parts of Chinese yam, 6 parts of Ophiopogon japonicus, 6 parts of mugwort leaves, 5 parts of Yanhusuo, 6 parts of angelica, 5 parts of Toosendan, 4 parts of black medicine, 5 parts of paeonol, 10 parts of malt, 6 parts of mulberry, 4 parts of cinnamon 4 parts of green skin, 10 parts of rhubarb, 6 parts of white peony root, 7 parts of curcuma, 10 parts of oyster, 2 parts of dried ginger, 10 parts of Poria cocos and 4 parts of licorice.
进一步地,所述药物组合物由以下重量份数的原料制备而成: Further, the pharmaceutical composition is prepared from the following raw materials in parts by weight:
何首乌12份、山药3份、麦冬16份、艾叶28份、延胡索8份、当归11份、川楝子8份、乌药10份、丹皮12份、麦芽14份、桑葚12份、肉桂8份、青皮8份、大黄18份、白芍16份、莪术14份、牡蛎16份、干姜6份、茯苓15份和甘草12份。 12 parts of Polygonum multiflorum, 3 parts of Chinese yam, 16 parts of Ophiopogon japonicus, 28 parts of Artemisia argyi, 8 parts of Yanhusuo, 11 parts of Angelica sinensis, 8 parts of Toosendan, 10 parts of black medicine, 12 parts of paeonol, 14 parts of malt, 12 parts of mulberry, cinnamon 8 parts, 8 parts of green bark, 18 parts of rhubarb, 16 parts of white peony root, 14 parts of curcuma, 16 parts of oyster, 6 parts of dried ginger, 15 parts of Poria cocos and 12 parts of licorice.
进一步地,所述药物组合物由以下重量份数的原料制备而成: Further, the pharmaceutical composition is prepared from the following raw materials in parts by weight:
何首乌10份、山药8份、麦冬12份、艾叶18份、延胡索6份、当归8份、川楝子6份、乌药6份、丹皮10份、麦芽12份、桑葚8份、肉桂6份、青皮6份、大黄16份、白芍12份、莪术8份、牡蛎10份、干姜4份、茯苓12份和甘草8份。 10 parts of Polygonum multiflorum, 8 parts of Chinese yam, 12 parts of Ophiopogon japonicus, 18 parts of mugwort leaves, 6 parts of Yanhusuo, 8 parts of angelica, 6 parts of Toosendan, 6 parts of black medicine, 10 parts of paeonol, 12 parts of malt, 8 parts of mulberry, cinnamon 6 parts, 6 parts of green bark, 16 parts of rhubarb, 12 parts of white peony root, 8 parts of curcuma, 10 parts of oyster, 4 parts of dried ginger, 12 parts of Poria cocos and 8 parts of licorice.
进一步地,所述药物组合物被制成胶囊剂、片剂、散剂、颗粒剂或丸剂。 Further, the pharmaceutical composition is made into capsules, tablets, powders, granules or pills.
相应的,所述药物组合物的制备方法包含下述步骤: Correspondingly, the preparation method of described pharmaceutical composition comprises the following steps:
S1取麦冬粉碎,置于超临界二氧化碳萃取装置中,加入麦冬粗粉总量2-3倍浓度为75-85%的乙醇,调控二氧化碳流量为16-22L/h,萃取压力为18-25MPa,萃取温度为55-65℃,萃取时间为2-3h,减压分离得到麦冬提取物; S1 Take Ophiopogon japonicus and pulverize it, place it in a supercritical carbon dioxide extraction device, add ethanol with a concentration of 75-85% 2-3 times the total amount of Ophiopogon japonicus powder, adjust the carbon dioxide flow rate to 16-22L/h, and extract the pressure to 18- 25MPa, the extraction temperature is 55-65°C, the extraction time is 2-3h, and separated under reduced pressure to obtain the Ophiopogon japonicus extract;
S2取何首乌、山药、艾叶、延胡索、当归、川楝子、乌药、丹皮、麦芽、桑葚、肉桂、青皮、大黄、白芍、莪术、牡蛎、干姜、茯苓和甘草粉碎,加入上述粗粉总量10-15倍量的水加热回流提取2-3次,每次2-3小时,过滤,合并滤液,得水提取液; S2 Take Polygonum multiflorum, Yam, Artemisia argyi, Corydalis, Angelica, Toosendan, Cinnamon, Paeonol, Malt, Mulberry, Cinnamon, Qingpi, Rhubarb, Radix Paeoniae Alba, Curcuma, Oyster, Dried Ginger, Poria cocos and Licorice, add the above crude 10-15 times the total amount of the powder, heated and refluxed for extraction 2-3 times, each time for 2-3 hours, filtered, and combined filtrates to obtain a water extract;
S3将步骤S2得到的水提取液减压浓缩至60℃下测相对密度为1.15-1.25的浸膏,在55-65℃下加入上述浸膏总量7-10%的质量分数为0.8-1.2%的壳聚糖胶体溶液,搅拌5-10分钟,在常温下静置12-24小时,1000-1200r/min离心10-15分钟,取上清液,与步骤S1得到的麦冬提取物混合,并减压浓缩至60℃下测相对密度为1.20-1.35的浸膏,即得。 S3 Concentrate the water extract obtained in step S2 under reduced pressure to an extract with a relative density of 1.15-1.25 at 60°C, add 7-10% of the total amount of the above extract at 55-65°C to a mass fraction of 0.8-1.2 % chitosan colloidal solution, stirred for 5-10 minutes, stood at room temperature for 12-24 hours, centrifuged at 1000-1200r/min for 10-15 minutes, took the supernatant, and mixed with the Ophiopogon japonicus extract obtained in step S1 , and concentrated under reduced pressure to an extract with a relative density of 1.20-1.35 measured at 60 ° C, that is, too.
本发明所用组分的来源、性味、归经及功效: The source, nature and flavor, meridian distribution and efficacy of the components used in the present invention:
何首乌:本品为蓼科植物何首乌的干燥块根;味苦、甘、涩,性温;归肝、心、肾经;解毒,消痈,润肠通便。 Polygonum Polygoni Multiflori: This product is the dry root tuber of Polygonum Polygoni Multiflori Polygonum Polygonum; taste bitter, sweet, astringent, warm in nature; returns to liver, heart, and kidney channels; detoxifies, eliminates carbuncles, moistens the intestines and laxes the bowels.
山药:为薯蓣科植物山药干燥根茎;甘、平;归脾、肺、肾经;补脾、养肺、固肾、益精。 Yam: It is the dried rhizome of yam, a plant of Dioscoreaceae; sweet and flat; it returns to the spleen, lung, and kidney meridian; it nourishes the spleen, nourishes the lung, strengthens the kidney, and benefits the essence.
麦冬:为百合科沿阶草属多年生常绿草本植物的根;甘,微苦,微寒;归心、肺、胃经;养阴生津,润肺清心。 Ophiopogon japonicus: the root of perennial evergreen herbaceous plant belonging to the genus Liliaceae; sweet, slightly bitter, slightly cold; Guixin, lung, and stomach meridian; nourishing yin and promoting body fluid, moistening lung and clearing heart.
艾叶:为菊科植物艾的干燥叶;其性味辛、苦、温,归肝、脾、肾经;艾叶具有温经止血、散寒止痛、调经安胎、除湿止痒、通经活络等功效。 Artemisia argyi: the dry leaf of Artemisia argyi; its nature and flavor are pungent, bitter, and warm, and it returns to the liver, spleen, and kidney meridians; Artemisia argyi has the functions of warming the meridians to stop bleeding, dispelling cold and relieving pain, regulating menstruation and preventing fetus, dehumidifying and relieving itching, dredging meridian and activating collaterals, etc. effect.
延胡索:本品为罂粟科植物延胡索的干燥块茎;味辛、苦,性温;归肝、脾经;活血,利气,止痛。 Corydalis Corydalis: This product is the dried tuber of Corydalis Corydalis of Poppyaceae; pungent, bitter, warm in nature; returns to liver and spleen meridians; promotes blood circulation, sharpens qi, and relieves pain.
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;补气活血,调经止痛,润肠通便。 Angelica: This product is the dried root of Angelica sinensis of Umbelliferae; sweet, pungent, warm in nature; returns to the liver, heart, and spleen meridians; invigorates qi and blood circulation, regulates menstruation and relieves pain, moistens the intestines and relieves constipation.
川楝子:本品为楝科植物川楝的干燥成熟果实;味苦,性寒;归肝、小肠、膀胱经;舒肝行气止痛。 Toosendan: This product is the dry ripe fruit of Toosendan of Meliaceae; bitter in taste, cold in nature; returns to liver, small intestine, and bladder meridians; relieves liver, promotes qi and relieves pain.
乌药:本品为樟科植物乌药的干燥块根;味辛,性温;归肺、脾、肾、膀胱经;顺气止痛,温肾散寒。 Wuyao: This product is the dry root tuber of Lauraceae plant Wuyao; pungent in taste, warm in nature; returns to lung, spleen, kidney, and bladder meridian; smoothes qi to relieve pain, warms kidney and dispels cold.
丹皮:本品为毛茛科植物牡丹的干燥根皮;味苦、辛,性微寒;归心、肝、肾经;清热凉血,活血化瘀。 Cortex paeonol: This product is the dry root bark of the Ranunculaceae plant peony; bitter, pungent, slightly cold in nature; Guixin, liver, and kidney channels; clearing away heat and cooling blood, promoting blood circulation and removing blood stasis.
麦芽:本品为禾本科植物大麦的成熟果实经发芽干燥而得;味甘,性平;归脾、胃经;行气消食,健脾开胃。 Malt: This product is obtained by germinating and drying the mature fruit of barley, a grass family plant; it is sweet in taste and flat in nature; it returns to the spleen and stomach meridians;
桑葚:本品为桑树的成熟果实;味甘酸,性寒;入肺、肝、肾、大肠经;补肝益肾、生津润肠、乌发明目、止渴解毒、美容养颜。 Mulberry: This product is the mature fruit of the mulberry tree; it tastes sweet and sour, and is cold in nature; it enters the lung, liver, kidney, and large intestine meridians; it nourishes the liver and kidney, promotes body fluid and moistens the intestines, blackens the eyes, quenches thirst and detoxifies, and beautifies the skin.
肉桂:本品为樟科植物肉桂的干燥树皮;味辛、甘,性大热;归肾、脾、心、肝经;补火助阳,引火归源,散寒止痛,活血通经。 Cinnamon: This product is the dry bark of Cinnamon lauraceae plant; spicy, sweet, and hot in nature; it returns to the kidney, spleen, heart, and liver meridian; it nourishes fire and supports yang, ignites fire to the source, dispels cold and relieves pain, promotes blood circulation and stimulates menstrual flow.
青皮:本品为芸香科植物橘及其栽培变种的干燥幼果或未成熟果实的果皮;味苦、辛,性温;归肝、胆、胃经;疏肝破气,消积化滞。 Qingpi: This product is the dried young fruit of Rutaceae plant orange and its cultivars or the pericarp of immature fruit; bitter, pungent, warm in nature; returns to the liver, gallbladder, and stomach meridians; soothes the liver and breaks qi, eliminates accumulation and resolves stagnation.
大黄:本品为蓼科植物大黄的干燥根及根茎;味苦,性寒;归脾、胃、大肠、肝、心包经;泻热通肠,凉血解毒,逐瘀通经。 Rhubarb: This product is the dried root and rhizome of rhubarb of Polygonaceae; bitter in taste, cold in nature; it returns to the spleen, stomach, large intestine, liver, and pericardium meridians; relieves heat and unblocks the intestines, cools blood and detoxifies, expels blood stasis and stimulates menstrual flow.
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。 Radix Paeoniae Alba: This product is the dry root of Paeoniae Alba, a plant of the family Ranunculaceae; bitter, sour, slightly cold in nature; returns to the liver and spleen meridians; calms the liver and relieves pain, nourishes blood and regulates menstruation, astringes yin and stops sweating.
莪术:本品为姜科植物莪术的干燥根茎;味辛、苦,性温;归肝、脾经;行气破血,消积止痛。 Curcuma: This product is the dried rhizome of Zedoary Zingiberaceae; it is pungent, bitter, and warm in nature;
牡蛎:本品为牡蛎科动物牡蛎的贝壳;味咸,性微寒;归肝、胆、肾经;重镇安神,潜阳补阴,软坚散结。 Oyster: This product is the shell of oyster, an animal of the Oyster family; it tastes salty and slightly cold in nature; it belongs to the liver, gallbladder, and kidney channels;
干姜:本品为姜科植物姜的干燥根茎;味辛、性热;归脾、胃、肾、心、肺经;温中散寒,回阳通脉,燥湿消痰。 Dried Ginger: This product is the dried rhizome of Zingiber officinale; spicy in taste and hot in nature; it belongs to spleen, stomach, kidney, heart and lung meridian;
茯苓:本品为多孔菌科真菌茯苓的干燥菌核;味甘、淡,性平;归心、肺、脾、肾经;利水渗湿,健脾宁心。 Poria cocos: This product is the dried sclerotia of Poria cocos fungus of the family Polyporaceae; sweet, light in taste, flat in nature; directs heart, lung, spleen and kidney meridian; diures water and eliminates dampness, invigorates the spleen and calms the heart.
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。 Licorice: This product is the dried root of leguminous licorice, licorice inflating or licorice glabra. Sweet in taste, calm in nature; Guixin, lung, spleen, stomach meridians; invigorating spleen and replenishing qi, clearing heat and detoxification, eliminating phlegm and relieving cough, relieving spasm and relieving pain, harmonizing various medicines.
与现有技术相比,本发明具有如下技术优势: Compared with the prior art, the present invention has the following technical advantages:
1、本发明药物组合物与其他治疗闭经的药物相比,在活血祛瘀、调经止痛、养阴润肺、清心安神和凉血解毒方面,具有显著的的功效。 1. Compared with other medicines for treating amenorrhea, the pharmaceutical composition of the present invention has remarkable effects in promoting blood circulation and removing blood stasis, regulating menstruation and relieving pain, nourishing yin and moistening lung, clearing heart and calming nerves, cooling blood and detoxifying.
2、与当前治疗闭经的化学治疗药物相比,本发明药物组合物为天然纯中药制剂,不良反应和副作用显著降低,且本发明药物组合物作用全面,药物治疗效果更佳,有效地解决了闭经的发病根源,并提高了患者的生活质量。 2. Compared with the current chemotherapeutic drugs for the treatment of amenorrhea, the pharmaceutical composition of the present invention is a natural pure Chinese medicine preparation, and the adverse reactions and side effects are significantly reduced, and the pharmaceutical composition of the present invention has comprehensive effects, better drug treatment effect, and effectively solves the problem of The root cause of amenorrhea, and improve the quality of life of patients.
3、本发明药物组合物还具有配伍科学,疗效迅速,治愈率高,成本低等优点。 3. The pharmaceutical composition of the present invention also has the advantages of scientific compatibility, rapid curative effect, high cure rate and low cost.
具体实施方式 detailed description
本领域技术人员应理解,以下实施例中所公开的技术代表本发明人发现的在本发明的实践中发挥良好作用的技术。然而,在所公开的具体实施方案中可以做出许多改变,并仍然获得相同或相似的结果,而不脱离本发明的精神和范围。 It should be appreciated by those of skill in the art that the techniques disclosed in the examples which follow represent techniques discovered by the inventors to function well in the practice of the invention. However, many changes can be made in the specific embodiments which are disclosed and still obtain a like or similar result without departing from the spirit and scope of the invention.
实施例1:Example 1:
本发明实施例1药物组合物由以下重量份数的原料制备而成:何首乌6份、山药5份、麦冬6份、艾叶6份、延胡索5份、当归6份、川楝子5份、乌药4、丹皮5份、麦芽10份、桑葚6份、肉桂4份、青皮4份、大黄10份、白芍6份、莪术7份、牡蛎10份、干姜2份、茯苓10份和甘草4份。 The pharmaceutical composition of Example 1 of the present invention is prepared from the following raw materials in parts by weight: Polygonum multiflorum 6 parts, Chinese yam 5 parts, Ophiopogon japonicus 6 parts, Artemisia argyi 6 parts, Corydalis 5 parts, Angelica sinensis 6 parts, Toosendan 5 parts, 4 parts of black medicine, 5 parts of paeonol, 10 parts of malt, 6 parts of mulberry, 4 parts of cinnamon, 4 parts of green skin, 10 parts of rhubarb, 6 parts of white peony root, 7 parts of curcuma, 10 parts of oyster, 2 parts of dried ginger, and 10 parts of Poria cocos And licorice 4 parts.
制备方法如下: The preparation method is as follows:
S1取麦冬粉碎,置于超临界二氧化碳萃取装置中,加入麦冬粗粉总量2倍浓度为75%的乙醇,调控二氧化碳流量为16L/h,萃取压力为18MPa,萃取温度为55℃,萃取时间为2h,减压分离得到麦冬提取物; S1 Take Ophiopogon japonicus and pulverize it, put it in a supercritical carbon dioxide extraction device, add ethanol with a concentration of 75% twice the total amount of Ophiopogon japonicus, adjust the flow rate of carbon dioxide to 16L/h, extract pressure to 18MPa, and extract temperature to 55°C. The extraction time is 2 hours, and the Ophiopogon japonicus extract is obtained by separating under reduced pressure;
S2取何首乌、山药、艾叶、延胡索、当归、川楝子、乌药、丹皮、麦芽、桑葚、肉桂、青皮、大黄、白芍、莪术、牡蛎、干姜、茯苓和甘草粉碎,加入上述粗粉总量10倍量的水加热回流提取2次,每次2小时,过滤,合并滤液,得水提取液; S2 Take Polygonum multiflorum, Yam, Artemisia argyi, Corydalis, Angelica, Toosendan, Cinnamon, Paeonol, Malt, Mulberry, Cinnamon, Qingpi, Rhubarb, Radix Paeoniae Alba, Curcuma, Oyster, Dried Ginger, Poria cocos and Licorice, add the above crude Heat reflux to extract 10 times the amount of the total amount of powder for 2 times, each time for 2 hours, filter, and combine the filtrates to obtain a water extract;
S3将步骤S2得到的水提取液减压浓缩至60℃下测相对密度为1.15的浸膏,在55℃下加入上述浸膏总量7%的质量分数为0.8%的壳聚糖胶体溶液,搅拌5分钟,在常温下静置12小时,1000r/min离心10分钟,取上清液,与步骤S1得到的麦冬提取物混合,并减压浓缩至60℃下测相对密度为1.20的浸膏,加入相应的辅料,制成胶囊剂。 S3 concentrating the water extract obtained in step S2 under reduced pressure to an extract whose relative density is 1.15 at 60° C., adding a chitosan colloid solution with a mass fraction of 7% of the total amount of the extract at 55° C., which is 0.8%, Stir for 5 minutes, let stand at room temperature for 12 hours, centrifuge at 1000r/min for 10 minutes, take the supernatant, mix it with the Ophiopogon japonicus extract obtained in step S1, and concentrate under reduced pressure to 60°C to measure the extract with a relative density of 1.20. ointment, adding corresponding auxiliary materials to make capsules.
实施例2:Example 2:
本发明实施例2药物组合物由以下重量份数的原料制备而成:何首乌12份、山药3份、麦冬16份、艾叶28份、延胡索8份、当归11份、川楝子8份、乌药10份、丹皮12份、麦芽14份、桑葚12份、肉桂8份、青皮8份、大黄18份、白芍16份、莪术14份、牡蛎16份、干姜6份、茯苓15份和甘草12份。 The pharmaceutical composition of Example 2 of the present invention is prepared from the following raw materials in parts by weight: Polygonum multiflorum 12 parts, Chinese yam 3 parts, Ophiopogon japonicus 16 parts, Artemisia argyi 28 parts, Corydalis 8 parts, Angelica sinensis 11 parts, Toosendan 8 parts, 10 parts of black medicine, 12 parts of paeonol, 14 parts of malt, 12 parts of mulberry, 8 parts of cinnamon, 8 parts of green skin, 18 parts of rhubarb, 16 parts of white peony root, 14 parts of curcuma, 16 parts of oyster, 6 parts of dried ginger, and 15 parts of Poria 12 parts and 12 parts of licorice.
S1取麦冬粉碎,置于超临界二氧化碳萃取装置中,加入麦冬粗粉总量2倍浓度为80%的乙醇,调控二氧化碳流量为20L/h,萃取压力为22MPa,萃取温度为60℃,萃取时间为2h,减压分离得到麦冬提取物; S1 Take Ophiopogon japonicus and pulverize it, put it in a supercritical carbon dioxide extraction device, add ethanol with a concentration of 80% twice the total amount of Ophiopogon japonicus, adjust the carbon dioxide flow rate to 20L/h, the extraction pressure to 22MPa, and the extraction temperature to 60°C. The extraction time is 2 hours, and the Ophiopogon japonicus extract is obtained by separating under reduced pressure;
S2取何首乌、山药、艾叶、延胡索、当归、川楝子、乌药、丹皮、麦芽、桑葚、肉桂、青皮、大黄、白芍、莪术、牡蛎、干姜、茯苓和甘草粉碎,加入上述粗粉总量12倍量的水加热回流提取2次,每次2小时,过滤,合并滤液,得水提取液; S2 Take Polygonum multiflorum, Yam, Artemisia argyi, Corydalis, Angelica, Toosendan, Cinnamon, Paeonol, Malt, Mulberry, Cinnamon, Qingpi, Rhubarb, Radix Paeoniae Alba, Curcuma, Oyster, Dried Ginger, Poria cocos and Licorice, add the above crude 12 times the amount of the total amount of the powder, heated and refluxed for extraction twice, each time for 2 hours, filtered, and the filtrates were combined to obtain a water extract;
S3将步骤S2得到的水提取液减压浓缩至60℃下测相对密度为1.20的浸膏,在60℃下加入上述浸膏总量8%的质量分数为1.0%的壳聚糖胶体溶液,搅拌8分钟,在常温下静置18小时,1100r/min离心12分钟,取上清液,与步骤S1得到的麦冬提取物混合,并减压浓缩至60℃下测相对密度为1.30的浸膏,加入相应的辅料,制成片剂。 S3 concentrates the water extract obtained in step S2 under reduced pressure to an extract whose relative density is 1.20 at 60° C., and adds a chitosan colloid solution with a mass fraction of 8% of the total amount of the extract above at 60° C., Stir for 8 minutes, let stand at room temperature for 18 hours, centrifuge at 1100r/min for 12 minutes, take the supernatant, mix it with the Ophiopogon japonicus extract obtained in step S1, and concentrate under reduced pressure to 60°C to measure the leached extract with a relative density of 1.30. Ointment, adding corresponding auxiliary materials, made into tablets.
实施例3:Example 3:
本发明实施例3药物组合物由以下重量份数的原料制备而成:何首乌10份、山药8份、麦冬12份、艾叶18份、延胡索6份、当归8份、川楝子6份、乌药6份、丹皮10份、麦芽12份、桑葚8份、肉桂6份、青皮6份、大黄16份、白芍12份、莪术8份、牡蛎10份、干姜4份、茯苓12份和甘草8份。 The pharmaceutical composition of Example 3 of the present invention is prepared from the following raw materials in parts by weight: Polygonum multiflorum 10 parts, Chinese yam 8 parts, Ophiopogon japonicus 12 parts, Artemisia argyi 18 parts, Corydalis 6 parts, Angelica sinensis 8 parts, Toosendan 6 parts, 6 parts of black medicine, 10 parts of paeonol, 12 parts of malt, 8 parts of mulberries, 6 parts of cinnamon, 6 parts of green skin, 16 parts of rhubarb, 12 parts of white peony, 8 parts of curcuma, 10 parts of oysters, 4 parts of dried ginger, 12 parts of Poria cocos 8 parts and 8 parts of licorice.
S1取麦冬粉碎,置于超临界二氧化碳萃取装置中,加入麦冬粗粉总量3倍浓度为85%的乙醇,调控二氧化碳流量为22L/h,萃取压力为25MPa,萃取温度为65℃,萃取时间为3h,减压分离得到麦冬提取物; S1 Take Ophiopogon japonicus and pulverize it, place it in a supercritical carbon dioxide extraction device, add 85% ethanol with a concentration three times the total amount of Ophiopogon japonicus, control the carbon dioxide flow rate to 22L/h, the extraction pressure to 25MPa, and the extraction temperature to 65°C. The extraction time is 3 hours, and the Ophiopogon japonicus extract is obtained by separating under reduced pressure;
S2取何首乌、山药、艾叶、延胡索、当归、川楝子、乌药、丹皮、麦芽、桑葚、肉桂、青皮、大黄、白芍、莪术、牡蛎、干姜、茯苓和甘草粉碎,加入上述粗粉总量15倍量的水加热回流提取3次,每次3小时,过滤,合并滤液,得水提取液; S2 Take Polygonum multiflorum, Yam, Artemisia argyi, Corydalis, Angelica, Toosendan, Cinnamon, Paeonol, Malt, Mulberry, Cinnamon, Qingpi, Rhubarb, Radix Paeoniae Alba, Curcuma, Oyster, Dried Ginger, Poria cocos and Licorice, add the above crude 15 times of the total amount of the powder was heated and refluxed for extraction 3 times, each time for 3 hours, filtered, and the filtrates were combined to obtain a water extract;
S3将步骤S2得到的水提取液减压浓缩至60℃下测相对密度为1.25的浸膏,在65℃下加入上述浸膏总量10%的质量分数为1.2%的壳聚糖胶体溶液,搅拌10分钟,在常温下静置24小时,1200r/min离心15分钟,取上清液,与步骤S1得到的麦冬提取物混合,并减压浓缩至60℃下测相对密度为1.35的浸膏,加入相应的辅料,制成丸剂。 S3 concentrates the water extract obtained in step S2 under reduced pressure to an extract whose relative density is 1.25 at 60° C., and adds a chitosan colloid solution with a mass fraction of 1.2% of the total amount of the extract at 65° C., Stir for 10 minutes, let stand at room temperature for 24 hours, centrifuge at 1200r/min for 15 minutes, take the supernatant, mix it with the Ophiopogon japonicus extract obtained in step S1, and concentrate under reduced pressure to 60°C to measure the leaching extract with a relative density of 1.35. Paste, add corresponding auxiliary materials, and make pills.
本发明药物组合物对闭经临床志愿者患者的疗效观察Observation of curative effect of pharmaceutical composition of the present invention on clinical volunteer patients with amenorrhea
一、诊断标准 1. Diagnostic criteria
(1)年逾18周岁女子,月经尚未初潮者,属原发性闭经; (1) Women who are over 18 years old and who have not menstruated yet belong to primary amenorrhea;
(2)女子已行经而又中断3个月以上者,属继发性闭经; (2) A woman who has already had menstruation but has interrupted it for more than 3 months belongs to secondary amenorrhea;
(3)须与妊娠期、哺乳期、绝经期等生理性停经相鉴别。 (3) It must be differentiated from physiological menopause such as pregnancy, lactation, and menopause.
二、疗效标准 2. Curative effect standard
(1)治愈:月经来潮,连续3次以上正常行经; (1) Cure: menstrual cramps, normal menstruation for more than 3 consecutive times;
(2)有效:月经恢复来潮,但月经周期未正常; (2) Effective: menstrual cramps resume, but the menstrual cycle is not normal;
(3)无效;月经仍未来潮。 (3) invalid; menstruation is still imminent.
三、临床试验 3. Clinical trials
1、一般资料 1. General Information
将140名入选的闭经临床志愿者患者随机均分成2组,每组70人,分别为治疗组和对照组,年龄为18-48岁,各组年龄、症状等影响因素,经统计学处理,无显著性差异,符合分组条件。 140 selected amenorrhea clinical volunteer patients were randomly divided into two groups, 70 people in each group, respectively, the treatment group and the control group, aged 18-48 years old, age, symptoms and other influencing factors in each group, after statistical processing, No significant difference, in line with the grouping conditions.
2、治疗方法 2. Treatment method
治疗组:服用实施例3制备得到的丸剂,每次6g,每日2次,连服2个月; Treatment group: take the pill prepared in Example 3, each 6g, 2 times a day, for 2 months;
对照组:服用活血调经丸(广西梧州三鹤药业有限公司,国药准字Z45020639,9g*10丸/盒),一次1丸,一日2次,连服2个月。 Control group: taking Huoxue Tiaojing Pills (Guangxi Wuzhou Sanhe Pharmaceutical Co., Ltd., Z45020639, 9g*10 pills/box), 1 pill at a time, twice a day, for 2 months.
3、治疗结果,如表1所示: 3. Treatment results, as shown in Table 1:
本发明的药物组合物的治愈率均大于80%,总有效率均大于90%,远大于对照组的治愈率和总有效率,可见,本发明药物组合物疗效好,治愈率高,可以作为治疗闭经的药物使用。 The cure rate of the pharmaceutical composition of the present invention is all greater than 80%, and the total effective rate is all greater than 90%, far greater than the cure rate and total effective rate of the matched group. It can be seen that the pharmaceutical composition of the present invention has good curative effect, high cure rate, and can be used as Drug use to treat amenorrhea.
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。 Since the present invention has been described by the above preferred embodiments, within the spirit and/or scope of the present invention, any replacement/or combination of the present invention to implement the present invention will be obvious to those skilled in the art , and is included in the present invention.
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CN1203805A (en) * | 1998-06-04 | 1999-01-06 | 李胤良 | Health-care drink capable of preventing and curing menopathy |
CN101829308A (en) * | 2010-07-01 | 2010-09-15 | 泰一和浦(北京)中医药研究院有限公司 | Traditional Chinese medicine combination for treating amenorrhea and preparation method thereof |
CN104984297A (en) * | 2015-07-24 | 2015-10-21 | 青岛蓝盛洋医药生物科技有限责任公司 | Application of pharmaceutical composition in preparation of drugs for treating amenorrhea |
CN105288538A (en) * | 2015-09-30 | 2016-02-03 | 叶宗耀 | Application of medicine composition for preparing medicine for treating amenorrhea |
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CN1203805A (en) * | 1998-06-04 | 1999-01-06 | 李胤良 | Health-care drink capable of preventing and curing menopathy |
CN101829308A (en) * | 2010-07-01 | 2010-09-15 | 泰一和浦(北京)中医药研究院有限公司 | Traditional Chinese medicine combination for treating amenorrhea and preparation method thereof |
CN104984297A (en) * | 2015-07-24 | 2015-10-21 | 青岛蓝盛洋医药生物科技有限责任公司 | Application of pharmaceutical composition in preparation of drugs for treating amenorrhea |
CN105288538A (en) * | 2015-09-30 | 2016-02-03 | 叶宗耀 | Application of medicine composition for preparing medicine for treating amenorrhea |
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