CN103272154A - Drug combination for caring and treating mammary hyperplasia - Google Patents
Drug combination for caring and treating mammary hyperplasia Download PDFInfo
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Abstract
Description
技术领域 technical field
本发明属于中医药技术领域，具体而言，涉及一种治疗乳腺增生的药物组合物。 The invention belongs to the technical field of traditional Chinese medicine, and in particular relates to a pharmaceutical composition for treating mammary gland hyperplasia.
背景技术 Background technique
乳腺增生病是育龄妇女最常见的一种乳房疾病，尤以2O～45岁的女性居多，其发病率占全部乳房疾病的74.1％，占育龄妇女的40％，且有逐年上升的趋势。乳腺增生病是以乳腺腺泡、导管上皮细胞及结缔组织增生为基本的病理变化，是一种既非肿瘤又非炎症的乳腺病变。患者以乳房肿块、乳房疼痛为主症，常伴有经前乳痛加重，乳头溢液。目前认为该病与内分泌紊乱有关，雌激素比例失衡，黄体期雌激素相对或绝对升高，且孕激素分泌不足，或黄体期催乳素异常升高，直接刺激乳腺组织和进一步抑制孕激素的分泌，导致雌激素对乳腺长期刺激而发。中医认为该病属“乳癖” 的范畴，为冲任失调、肝气郁滞血瘀所致。中药治疗乳腺增生性疾病具有调节内分泌失调，不良反应低等优点。 Mammary gland hyperplasia is the most common breast disease in women of childbearing age, especially in women aged 20 to 45. Its incidence rate accounts for 74.1% of all breast diseases and 40% of women of childbearing age, and it has an increasing trend year by year. Mammary gland hyperplasia is a pathological change based on the hyperplasia of mammary acini, ductal epithelial cells, and connective tissue. It is a non-tumor and non-inflammatory breast lesion. The main symptoms of patients are breast lumps and breast pain, often accompanied by exacerbation of premenstrual mastalgia and nipple discharge. At present, it is believed that the disease is related to endocrine disorders, estrogen ratio imbalance, relative or absolute increase of estrogen in luteal phase, and insufficient secretion of progesterone, or abnormal increase of prolactin in luteal phase, which directly stimulates breast tissue and further inhibits the secretion of progesterone. , leading to long-term estrogen stimulation of the mammary glands. Traditional Chinese medicine believes that this disease belongs to the category of "breast addiction", which is caused by imbalance of Chong and Ren, stagnation of liver qi and blood stasis. Traditional Chinese medicine has the advantages of regulating endocrine disorders and low adverse reactions in the treatment of hyperplasia of mammary glands.
目前，乳腺增生病在治疗方面多采用降低雌二醇、纠正激素分泌紊乱的方法，而中医药治疗此病有其独特的优势，且不良反应少，易被患者接受。 At present, in the treatment of mammary gland hyperplasia, the methods of lowering estradiol and correcting hormone secretion disorders are mostly used. Traditional Chinese medicine has its unique advantages in treating this disease, and has few adverse reactions, which is easy to be accepted by patients.
发明内容 Contents of the invention
本发明根据传统中医理论，经过对药物组分的大量筛选、重组、尝试、又通过大量动物实验研究作出的。因此，本发明的目的在于通过对传统药物药理进行研究后重新组方，提供一种疗效显著的治疗乳腺增生的药物组合物。 According to the theory of traditional Chinese medicine, the present invention is made through a large number of screening, reorganization, trials of drug components, and a large number of animal experiments. Therefore, the object of the present invention is to provide a pharmaceutical composition with significant curative effect for treating hyperplasia of mammary glands by recombining prescriptions after conducting research on the pharmacology of traditional medicines.
本发明的目的是这样实现的： The purpose of the present invention is achieved like this:
本发明一种护理治疗乳腺增生的药物组合物，由如下重量份的中药材原料组成：三棱18-25份、牛蒡子18-25份、白苞蒿12-18份、夏枯草12-18份、赤芍12-18份、乌药8-13份、水红花子8-13份、刘寄奴8-13份。 A pharmaceutical composition for nursing and treating mammary gland hyperplasia of the present invention is composed of the following Chinese medicinal materials in parts by weight: 18-25 parts of trigonium, 18-25 parts of Arctium chinensis, 12-18 parts of Artemisia alba, 12-18 parts of Prunella vulgaris, 12-18 parts of Radix Paeoniae Rubra, 8-13 parts of Wuyao, 8-13 parts of Shuihonghuazi, and 8-13 parts of Liu Jinu.
在本发明一个优选的实施例中，所述护理治疗乳腺增生的药物组合物由如下重量份的中药材原料组成：三棱22份、牛蒡子22份、白苞蒿15份、夏枯草15份、赤芍15份、乌药10份、水红花子10份、刘寄奴10份。 In a preferred embodiment of the present invention, the pharmaceutical composition for nursing and treating hyperplasia of mammary glands consists of the following Chinese medicinal materials in parts by weight: 22 parts of Sanlong, 22 parts of Arctium, 15 parts of Artemisia alba, 15 parts of Prunella vulgaris, 15 parts of peony, 10 parts of black medicine, 10 parts of Shuihonghuazi, 10 parts of Liu Jinu.
上述任意一种护理治疗乳腺增生的药物组合物，它可以被制成口服液、颗粒剂、片剂、胶囊剂；优选地，上述任意一种治疗乳腺增生的药物组合物，它被制成口服液。 Any of the above-mentioned pharmaceutical compositions for nursing and treating mammary gland hyperplasia, which can be made into oral liquids, granules, tablets, and capsules; preferably, any of the above-mentioned pharmaceutical compositions for treating mammary gland hyperplasia, which can be made into oral liquid.
根据中医药史料记载，上述中药材原料具有如下药理活性： According to historical records of traditional Chinese medicine, the raw materials of the above-mentioned Chinese medicinal materials have the following pharmacological activities:
三棱：破血行气，消积止痛。用于症瘕痞块，瘀血经闭，食积胀痛。选用黑三棱科植物黑三棱SparganiumstoloniferumBuch.-Ham.的干燥块茎。 Sanleng: breaking blood and promoting qi, eliminating stagnation and relieving pain. For lump in the abdomen in the abdomen, amenorrhea due to blood stasis, distending pain due to indigestion. The dry tubers of Sparganium stoloniferum Buch.-Ham. are selected for use.
牛蒡子：具有疏散风热、宣肺透疹、利咽散结、解毒消肿的功效，主治风热咳嗽、咽喉肿痛、斑疹不透、风疹瘙痒、疮疡肿毒。选自菊科植物牛蒡Arctium lappa L.的干燥成熟果实。 Burdock Fructus: It has the effects of evacuating wind-heat, clearing lung and clearing rash, relieving throat and dispelling stagnation, detoxifying and reducing swelling. It is selected from the dried ripe fruit of Arctium lappa L., a plant of Compositae.
白苞蒿：全草入药，有清热、解毒、止咳、消炎、活血、散瘀、通经等作用，常用于治肝、肾疾病。 Artemisia albicans: The whole herb is used as medicine. It has the effects of clearing heat, detoxifying, relieving cough, reducing inflammation, promoting blood circulation, dispelling blood stasis, and dredging menstrual flow. It is often used to treat liver and kidney diseases.
夏枯草：清火，明目，散结，消肿。用于目赤肿痛，目珠夜痛，头痛眩晕，瘰疬，瘿瘤，肿痛；甲状腺肿大，淋巴结结核，乳腺增生，高血压、高血糖、高血脂和高血粘。选用唇形科植物夏枯草 Prunella vulgaris L. 的干燥果穗。 Prunella vulgaris: clearing fire, improving eyesight, dispelling stagnation, detumescence. It is used for conjunctival congestion and swelling pain, eye pain at night, headache and dizziness, scrofula, goiter, swelling and pain; goiter, lymph node tuberculosis, breast hyperplasia, high blood pressure, high blood sugar, high blood fat and high blood viscosity. The dried fruit ears of Prunella vulgaris L., a plant of Lamiaceae, were selected.
赤芍：清热凉血；活血祛瘀。主温毒发斑；吐血衄血；肠风下血；目赤肿痛；痈肿疮疡；闭经；痛经；崩带淋浊；瘀滞胁痛；疝瘕积聚；跌扑损伤。用于温毒发斑，吐血衄血，目赤肿痛，肝郁胁痛，经闭痛经，症瘕腹痛，跌扑损伤，痈肿疮疡。选用毛茛科植物芍药 Paeonia lactiflora Pall. 或川赤芍 Paeonia veitchii Lynch 的干燥根。 Radix Paeoniae Rubra: clearing heat and cooling blood; promoting blood circulation and removing blood stasis. Mainly warm and poisonous spots; vomiting blood and epistaxis; intestinal wind and blood; conjunctival congestion and pain; carbuncle sores; amenorrhea; It is used for warming and poisoning spots, vomiting blood and epistaxis, conjunctival congestion and swelling pain, liver depression and hypochondriac pain, amenorrhea dysmenorrhea, abdominal pain in the abdomen, injury from falls, carbuncle sores. Use the dried roots of Paeonia lactiflora Pall. or Paeonia veitchii Lynch in the family Ranunculaceae.
乌药：顺气，开郁，散寒，止痛。治气逆胸腹胀痛，宿食不消，反胃吐食，寒疝，脚气，小便频数。选自樟科植物乌药Lindera aggregata (Sims) Kosterm．的块根。 Wuyao: Shun Qi, relieve stagnation, dispel cold, relieve pain. Control qi inverse chest and abdomen distension and pain, persistent food loss, nausea and vomiting, cold colic, athlete's foot, frequent urination. Selected from Lauraceae plant Lindera aggregata (Sims) Kosterm. of tubers.
水红花子：有化痞散结，清热止痛功能。用于痞块腹胀，肝脾肿大，颈淋巴结核，消渴，胃痛。外用适量熬膏或捣积，健脾利湿。治胁腹症积，水臌，胃疼，食少腹胀，火眼，疮肿，瘰疬。选用蓼科植物红蓼PolygonumorientaleLinn.的干燥成熟果实。 Shuihonghuazi: It has the functions of dispelling swelling and dispelling stagnation, clearing away heat and relieving pain. For lump abdominal distension, hepatosplenomegaly, cervical lymphatic tuberculosis, quench one's thirst, stomachache. Appropriate amount of boiled ointment or smashed for external use can invigorate the spleen and dampness. Treatment of hypochondriac syndrome, water retention, stomach pain, abdominal distension due to lack of food, burning eyes, sores, and scrofula. Use the dry ripe fruit of Polygonum morientale Linn. of Polygonaceae plant.
刘寄奴：破血通经，敛疮消肿。治经闭症瘕，胸腹胀痛，产后血瘀，跌打损伤，金疮出血，痈毒焮肿。选用菊科植物奇蒿的全草。 Liu Jinu: dispelling blood to stimulate the menstrual flow, suppressing sores and detumescence. Control amenorrhea lump in the abdomen, distending pain in chest and abdomen, postpartum blood stasis, traumatic injury, incision hemorrhage, carbuncle poisonous ulcer swelling. The whole herb of Artemisia annua of Compositae is selected.
将上述各中药组分制备成本发明的口服液的制备方法为：称取清洗干净且干燥的上述中药材原料合并，加水煎煮两次，合并煎液，减压浓缩至70℃时相对密度为1.15-1.20，加乙醇使含醇量的体积百分比达75-85%，搅拌，静置，过滤，滤液减压浓缩至65℃时相对密度为1.25-1.30并回收乙醇得浓缩液，将浓缩液加水及辅料配制成口服液。 The preparation method of the above-mentioned Chinese medicine components into the oral liquid of the present invention is as follows: Weigh the cleaned and dried above-mentioned Chinese medicinal materials and combine them, add water to decoct them twice, combine the decoctions, and concentrate under reduced pressure to 70°C when the relative density is 1.15-1.20, add ethanol so that the volume percentage of the alcohol content reaches 75-85%, stir, stand still, filter, and the filtrate is concentrated under reduced pressure to 65 ° C. When the relative density is 1.25-1.30 and the ethanol is recovered to obtain a concentrated solution, the concentrated solution Add water and auxiliary materials to prepare oral liquid.
与现有技术相比，本发明涉及的药物组合物护理治疗乳腺增生疾病的疗效显著，能降低乳腺增生患者血清雌二醇及泌乳素含量，升高孕酮含量，调节血液中雌孕激素的相对平衡，从而改善乳腺复旧不全所致慢性乳腺增生的病变过程。 Compared with the prior art, the pharmaceutical composition involved in the present invention has significant curative effect in nursing and treating mammary gland hyperplasia, can reduce serum estradiol and prolactin levels in patients with mammary gland hyperplasia, increase progesterone content, and regulate estrogen and progesterone levels in blood. Relatively balanced, thereby improving the pathological process of chronic mammary gland hyperplasia caused by incomplete breast involution.
具体实施方式 Detailed ways
以下是本发明的具体实施例，对本发明的技术方案做进一步作描述，但是本发明的保护范围并不限于这些实施例。凡是不背离本发明构思的改变或等同替代均包括在本发明的保护范围之内。 The following are specific examples of the present invention, and further describe the technical solution of the present invention, but the protection scope of the present invention is not limited to these examples. All changes or equivalent substitutions that do not depart from the concept of the present invention are included in the protection scope of the present invention.
实施例1 Example 1
生药处方：三棱22份、牛蒡子22份、白苞蒿15份、夏枯草15份、赤芍15份、乌药10份、水红花子10份、刘寄奴10份。 Herbal medicine prescription: 22 parts of Sanleng, 22 parts of Burdock, 15 parts of Artemisia albicans, 15 parts of Prunella vulgaris, 15 parts of Radix Paeoniae Rubra, 10 parts of Wuyao, 10 parts of Shuihonghuazi, 10 parts of Liu Jinu.
制备工艺：称取上述处方量的药材合并，加水煎煮两次，第一次加水为药材重量的10倍量，煎煮2h，第二次加水为药材重量的8倍量，煎煮1.5h，合并煎液，0.08MPa、70℃下减压浓缩至70℃时相对密度为1.15，加95%(v/v)乙醇使含醇量达85%(v/v)， 搅拌， 静置过夜，过滤，滤液在0.08MPa、65℃条件下减压浓缩成至65℃时相对密度为1.30，加水及蔗糖配制成口服液。 Preparation process: Weigh and combine the above-mentioned medicinal materials, add water to decoct twice, add water for the first time to 10 times the weight of the medicinal materials, decoct for 2 hours, add water for the second time to 8 times the weight of the medicinal materials, and decoct for 1.5 hours , combined decoction, concentrated under reduced pressure at 0.08MPa and 70°C to a relative density of 1.15 at 70°C, added 95% (v/v) ethanol to make the alcohol content reach 85% (v/v), stirred, and stood overnight , filtered, and the filtrate was concentrated under reduced pressure at 0.08MPa and 65°C to a relative density of 1.30 at 65°C, and was prepared into an oral liquid by adding water and sucrose.
实施例2 Example 2
生药处方：三棱19份、牛蒡子25份、白苞蒿18份、夏枯草12份、赤芍18份、乌药13份、水红花子10份、刘寄奴8份。 Herbal medicine prescription: 19 parts of Sanleng, 25 parts of Burdock, 18 parts of Artemisia alba, 12 parts of Prunella vulgaris, 18 parts of Radix Paeoniae Rubra, 13 parts of Wuyao, 10 parts of Shuihonghuazi, 8 parts of Liu Jinu.
制备工艺：称取上述处方量的药材合并，加水煎煮两次，第一次加水为药材重量的10倍量，煎煮2h，第二次加水为药材重量的8倍量，煎煮1.5h，合并煎液，0.08MPa、70℃下减压浓缩至70℃时相对密度为1.20，加95%(v/v)乙醇使含醇量达80%(v/v)， 搅拌， 静置过夜，过滤，滤液在0.08MPa、65℃条件下减压浓缩成至65℃时相对密度为1.30，加水及蔗糖配制成口服液。 Preparation process: Weigh and combine the above-mentioned medicinal materials, add water to decoct twice, add water for the first time to 10 times the weight of the medicinal materials, decoct for 2 hours, add water for the second time to 8 times the weight of the medicinal materials, and decoct for 1.5 hours , combined decoction, concentrated under reduced pressure at 0.08MPa and 70°C until the relative density was 1.20 at 70°C, added 95% (v/v) ethanol to make the alcohol content reach 80% (v/v), stirred, and stood overnight , filtered, and the filtrate was concentrated under reduced pressure at 0.08MPa and 65°C to a relative density of 1.30 at 65°C, and was prepared into an oral liquid by adding water and sucrose.
实施例3 Example 3
生药处方：三棱25份、牛蒡子20份、白苞蒿12份、夏枯草18份、赤芍12份、乌药8份、水红花子13份、刘寄奴13份。 Herbal medicine prescription: 25 parts of Sanleng, 20 parts of Burdock, 12 parts of Artemisia alba, 18 parts of Prunella vulgaris, 12 parts of Radix Paeoniae Rubra, 8 parts of Wuyao, 13 parts of Shuihonghuazi, and 13 parts of Liu Jinu.
制备工艺：称取上述处方量的药材合并，加水煎煮两次，第一次加水为药材重量的10倍量，煎煮2h，第二次加水为药材重量的8倍量，煎煮1.5h，合并煎液，0.08MPa、70℃下减压浓缩至70℃时相对密度为1.15，加95%(v/v)乙醇使含醇量达75%(v/v)， 搅拌， 静置过夜，过滤，滤液在0.08MPa、65℃条件下减压浓缩成至65℃时相对密度为1.30，加水及蔗糖配制成口服液。 Preparation process: Weigh and combine the above-mentioned medicinal materials, add water to decoct twice, add water for the first time to 10 times the weight of the medicinal materials, decoct for 2 hours, add water for the second time to 8 times the weight of the medicinal materials, and decoct for 1.5 hours , combined decoction, concentrated under reduced pressure at 0.08MPa and 70°C to a relative density of 1.15 at 70°C, added 95% (v/v) ethanol to make the alcohol content reach 75% (v/v), stirred, and stood overnight , filtered, and the filtrate was concentrated under reduced pressure at 0.08MPa and 65°C to a relative density of 1.30 at 65°C, and was prepared into an oral liquid by adding water and sucrose.
实施例4 本发明药物组合物对乳腺增生模型大鼠的治疗研究 Embodiment 4 Therapeutic research of the pharmaceutical composition of the present invention on mammary gland hyperplasia model rats
Wistar大鼠48只，雌性未孕，体质量(250±10)g，随机分为4组，每组12只。除正常对照组外，其余各组大鼠按如下方法进行处理：每只肌注苯甲酸雌二醇0.2ml/kg/d，连续25d后肌注黄体酮注射液0.4ml/kg/d，共5d，从而得到乳腺增生大鼠模型。各组大鼠按如下方式和剂量给予受试物： Forty-eight Wistar rats, non-pregnant females, weighing (250±10) g, were randomly divided into 4 groups, 12 rats in each group. Except for the normal control group, the rats in other groups were processed as follows: each rat was intramuscularly injected with 0.2ml/kg/d of estradiol benzoate, and intramuscularly injected with 0.4ml/kg/d of progesterone injection after 25 consecutive days. 5d, so as to obtain the mammary gland hyperplasia rat model. Each group of rats was given the test substance in the following manner and dosage:
正常对照组：肌注0.9％氯化钠溶液1ml/kg/d，第31天灌服0.9％氯化钠溶液，1次/d，共30d。 Normal control group: Intramuscular injection of 0.9% sodium chloride solution 1ml/kg/d, 0.9% sodium chloride solution was given by gavage on the 31st day, once a day, for a total of 30 days.
模型对照组：造模后灌服0.9％氯化钠溶液，1次／d，共30d。 Model control group: After modeling, they were fed with 0.9% sodium chloride solution, once a day, for a total of 30 days.
阳性对照组：造模后灌服三苯氧胺20mg/kg/d，1次／d，共30d。 Positive control group: After modeling, the rats were given tamoxifen 20 mg/kg/d, once/d, for a total of 30 days.
中药组：造模后灌服如下中药样品15ml·kg-1·d-1，1次／d，共30d。 Traditional Chinese medicine group: after modeling, the following traditional Chinese medicine samples 15ml·kg -1 ·d -1 were gavaged, once per day, for a total of 30 days.
中药样品的制备：称取三棱22份、牛蒡子22份、白苞蒿15份、夏枯草15份、赤芍15份、乌药10份、水红花子10份和刘寄奴10份合并，加水煎煮两次，第一次加水为药材重量的10倍量，煎煮2h，第二次加水为药材重量的8倍量，煎煮1.5h，合并煎液，0.08MPa、70℃下减压浓缩至70℃时相对密度为1.15，加95%(v/v)乙醇使含醇量达85%(v/v)， 搅拌， 静置过夜，过滤，滤液在0.08MPa、65℃条件下减压浓缩成至65℃时相对密度为1.30，即可。 Preparation of traditional Chinese medicine samples: Weigh 22 parts of Sanleng, 22 parts of Burdock, 15 parts of Artemisia albicans, 15 parts of Prunella vulgaris, 15 parts of Radix Paeoniae Rubra, 10 parts of Wuyao, 10 parts of Shuihonghuazi and 10 parts of Liu Jinu. Add water to decoct twice, add water for the first time to 10 times the weight of the medicinal material, decoct for 2 hours, add water for the second time to 8 times the weight of the medicinal material, decoct for 1.5 hours, combine the decoction, reduce When concentrated under pressure to 70°C, the relative density is 1.15, add 95% (v/v) ethanol to make the alcohol content reach 85% (v/v), stir, let stand overnight, filter, and the filtrate is at 0.08MPa, 65°C Concentrate under reduced pressure until the relative density is 1.30 at 65°C.
末次给药后8 h用精密游标卡尺测量第3对乳头直径；于第2天取眼球血后分离血清，采用放射免疫法测定血清雌二醇、孕酮、泌乳素之值。 Eight hours after the last administration, the diameter of the third pair of nipples was measured with a precision vernier caliper; the eyeball blood was collected on the second day, and the serum was separated, and the values of serum estradiol, progesterone, and prolactin were measured by radioimmunoassay.
模型组与正常对照组比较乳头直径明显增大 (P<0.01)，说明造模成功。而与模型组相比，阳性对照组、中药组的乳头直径减小(P<0.01)，血清中雌二醇和泌乳素含量均降低(P<0.01，或P<0.05)，血清中孕酮含量升高，说明三苯氧胺及本发明的中药治疗均可以有效对抗雌激素引起的乳腺增生，中药组与阳性对照组间无显著性差异(P>0.05，见表1)。 Compared with the normal control group, the nipple diameter in the model group was significantly larger ( P <0.01), indicating that the modeling was successful. Compared with the model group, the nipple diameters of the positive control group and the traditional Chinese medicine group were reduced ( P <0.01), the contents of estradiol and prolactin in serum were all reduced ( P <0.01, or P <0.05), and the contents of progesterone in serum were reduced. increased, indicating that both tamoxifen and the traditional Chinese medicine treatment of the present invention can effectively resist mammary gland hyperplasia caused by estrogen, and there is no significant difference between the Chinese medicine group and the positive control group ( P >0.05, see Table 1).
表l 各组大鼠乳头直径和雌激素水平比较 Table 1 Comparison of nipple diameter and estrogen level of rats in each group
与模型对照组比较，￥ P＜0.05，￥￥ P＜0.01。 Compared with the model control group, ￥ P <0.05, ￥￥ P <0.01.
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