CN102631482A - Chinese medicinal composition for preventing and treating diabetes and complications - Google Patents

Chinese medicinal composition for preventing and treating diabetes and complications Download PDF

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CN102631482A
CN102631482A CN 201210146660 CN201210146660A CN102631482A CN 102631482 A CN102631482 A CN 102631482A CN 201210146660 CN201210146660 CN 201210146660 CN 201210146660 A CN201210146660 A CN 201210146660A CN 102631482 A CN102631482 A CN 102631482A
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diabetes
mulberry
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CN102631482B (en )
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南敏伦
王莲萍
赫玉芳
赵全成
赵昱玮
马吉胜
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赵全成
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The invention discloses a Chinese medicinal composition for preventing and treating related diseases such as diabetes and complications thereof. The Chinese medicinal composition comprises American ginseng or extract thereof, mulberry leaves or extract thereof, centella asiatica or extract thereof, great burdock achene or extract thereof, and grape seeds or extract thereof. Oral preparations such as hard capsules, soft capsules, tablets, granules, powder, pills, tea bags, medicinal liquor and oral liquid are prepared from the five combinations by utilizing the synergistic effects of each component. The composition can be applied to Chinese patent medicaments or health care products, and has the effect of preventing and treating the related diseases such as the diabetes and the complications thereof.

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一种具有防治糖尿病及并发症的中药组合物 Prevention of complications of diabetes and having a composition of traditional Chinese medicine

技术领域 FIELD

[0001] 本发明属医药和食品领域,是一种具有防治糖尿病及其并发症等相关疾病的天然产物制成的组合物。 [0001] The present invention belongs to the field of medicine and food, having a composition prepared prevention of diabetes and its complications related diseases natural products.

背景技术 Background technique

[0002] 糖尿病是由胰岛素绝对或相对不足而引发的慢性内分泌代谢性疾病,其主要特点为高血糖和多种并发症并存。 [0002] Diabetes is absolute or relative insulin deficiency caused by chronic endocrine and metabolic diseases, the main features of high blood sugar, and the coexistence of a variety of complications. 我国糖尿病的发病率呈现出逐年增加趋势,其中90%为非胰岛素依赖型糖尿病。 The incidence of diabetes exhibit an increased year by year, 90% of non-insulin-dependent diabetes mellitus. 患者总数为4000万,根据WHO预测到2025年我国糖尿病患者将突破5000万。 The total number of patients to 40 million, according to the WHO predicted that by 2025 diabetic patients in China will exceed 50 million. 糖尿病特点是慢性高血糖伴随因胰岛素分泌及作用缺陷引起的糖、脂肪和蛋白质代谢紊乱。 Diabetes is characterized by chronic hyperglycemia accompanied sugar, fat and protein metabolism and insulin secretion by acting defect. 其长期的高血糖、高血脂是造成机体脏器损伤的重要原因,因此,纠正糖脂代谢紊乱是治疗糖尿病及其并发症的重要手段。 Its long-term high blood sugar, high cholesterol is a major cause of damage to the body's organs, therefore, correct lipid disorders is an important means to treat diabetes and its complications. 它与人们日常的生活规律、饮食、环境、情绪以及各类化学性物质的损害都有密切的关系。 It is the people's daily patterns of life, diet, environment, emotional damage and various chemical substances have a close relationship. 其基本病理生理为体内胰岛素绝对或相对的分泌不足,从而引起碳水化合物、脂肪、蛋白质、水和电解质代谢紊乱。 The basic pathophysiology of absolute or relative insulin secretion, causing carbohydrate, fat, protein, water and electrolyte metabolism. 糖尿病(高血糖)对各个年龄组均可产生影响,已成为严重威胁人类健康和寿命的公共健康问题。 Diabetes (high blood sugar) can have an impact on all age groups, it has become a serious threat to human health and the life of the public health problem.

[0003] 人们多认为糖尿病是胰岛素功能减退或胰岛素功能受损引起的,糖尿病患者体内胰岛素分泌不足,造成血糖升高。 [0003] most people think that diabetes is insulin or insulin function is impaired dysfunction caused by insufficient insulin secretion in diabetic patients, resulting in elevated blood sugar. 实际上,绝大多数2型糖尿病患者的胰岛功能并没有大的损害,功能在正常范围之内,其中80%的患者还存在有高胰岛素血症。 In fact, islet function majority of patients with type 2 diabetes and no major damage, functions within the normal range, 80% of the patients also present hyperinsulinemia. 因此,不是胰岛素太少,而是由于胰岛素抵抗,正常生物效应不足,造成血糖居高不下,而过高的血糖才是诸多并发症的直接诱因。 So, not too little insulin, but insulin resistance due to the lack of normal biological effect, causing high blood sugar, and high blood sugar is the direct cause of many complications. 产生胰岛素抵抗的原因主要有胰岛B细胞分泌的胰岛素分子结构有缺陷,不具有正常的生理功能,胰岛素受体不足,结合减少,组织细胞对胰岛素不敏感;胰岛素抗体的影响而使胰岛素失去了应有的降血糖功能;拮抗胰岛素的激素水平增高,对抗胰岛素的降血糖作用等,因此减少或消除胰岛素抵抗,使体内正常分泌的胰岛素充分发挥作用,就能达到降低血糖水平并从根本上消除糖尿病及并发症。 The main cause of insulin resistance is the molecular structure of insulin secretion in the islet B cell defects, that does not have normal physiological function, inadequate insulin receptor, decrease binding, tissue cells are not sensitive to insulin; Insulin antibodies lost the insulin should some hypoglycemic function; increased insulin antagonistic hormone levels against the hypoglycemic effect of insulin, etc., thus reducing or eliminating insulin resistance, the body's normal insulin secretion fully play its role, we will be able to reduce blood sugar levels and eliminate diabetes fundamentally and complications.

[0004]目前,国内外市场上用于预防和治疗糖尿病(高血糖)的口服药物很多,有中药,也有西药。 [0004] At present, the domestic market for oral drug for the prevention and treatment of diabetes (high blood sugar) of many, Chinese medicine, Western medicine there. 西药主要有磺酰脲类如优降糖、美吡哒,双胍类如二甲双胍、美迪康,葡萄糖苷酶抑制剂如拜糖平等。 Western mainly sulfonylureas such as glibenclamide, Glipizide, biguanides such as metformin, US dicon, glucosidase inhibitors such as acarbose equality. 中药主要有降糖舒、金芪降糖片、玉泉丸、玉盘消渴片等。 There are traditional Chinese medicine hypoglycemic Shu, Jinqi metformin, Yuquan pills, jade plate diabetes tablets. 这些药物在治疗和预防糖尿病,解除糖尿病人痛苦上起了很大作用。 These drugs in the treatment and prevention of diabetes, relieve the suffering of people with diabetes play a significant role. 但是随着糖尿病人数量的增多和病症的多样化,开发更安全有效地预防和治疗糖尿病(高血糖)的药物或保健品仍然是一件十分有意义的工作。 But with the increase in the number of people with diabetes diversification and conditions, the development of safer and more effective prevention and treatment of diabetes drugs or health products (high blood sugar) is still a very meaningful work.

[0005] 本发明就是将从天然植物中发现和提取的一种具有防治糖尿病及其并发症等相关疾病的中药组合物。 [0005] The present invention has been found from natural plant extract and a method for controlling diabetes and complications associated with diseases of the traditional Chinese medicine composition. 该组合物是由有效成分创新组合成天然产物组合物,从几种不同作用机制上入手治疗糖尿病,达到长短结合,标本兼治的效果,以期从疗效和安全性上有显著的突破和提高。 The composition is a combination of the active ingredient into the innovative natural product composition, several different mechanisms of action from the start treating diabetes, reach length in combination, solve the problem of the effect, in order to significantly improve the break and the efficacy and safety.

[0006] 西洋参为五加科植物西洋参Panax quinquefolium L.的根。 [0006] American ginseng American ginseng Araliaceae Panax quinquefolium L. roots. 亦名洋参《药性考》、花旗参《中国药植志》等。 Yiming Yang Shen "Medicinal test" ginseng "Chinese medicine plant Chi" and so on. 味甘、微苦,性凉。 Sweet, bitter, cool. 归心、肺、肾经。 Heart, lung and kidney. 具有益肺阴、清虚火、生津止渴的功能。 Has Yifei Yin, Qing Xu fire, thirst features. 主治肺虚久嗽、失血、咽干口渴、虚热烦倦。 Jiusou attending lung deficiency, blood loss, throat thirsty, tired and Hot trouble. 西洋参含有降血糖活性的人参多糖,命名为karusanA、B、C、D、E以及水溶性粗果胶、盐酸可溶性果胶、氨基酸、微量元素及皂苷。 Ginseng American ginseng polysaccharides containing hypoglycemic activity, named karusanA, B, C, D, E and crude soluble pectin, pectin soluble acid, amino acids, trace elements and saponins. John Zeqi Luo等研究结果表明,西洋参具有调节人体葡萄糖达到动态平衡的作用,大多数糖尿病的病因是由于胰腺β细胞分泌胰岛素的功能被破坏所致。 John Zeqi Luo and other findings suggest that ginseng can regulate body glucose homeostasis achieve the role of the cause of the majority of diabetes is due to insulin secretion of pancreatic β cell function is damaged due. 初步研究发现,西洋参提取物能够抑制胰腺β细胞线粒体中的UCP-2的活性,提高胰岛素合成能力和抗细胞凋亡。 Initial studies found that ginseng extract can inhibit the activity of pancreatic β cells in the mitochondria of UCP-2, the ability to increase insulin synthesis and anti-apoptotic. 所以,西洋参提取物能够通过抑制线粒体UCP-2的活性来刺激胰岛素的产生、预防β细胞的流失,结果导致ATP水平的提高,抗细胞凋亡因子Bcl-2的增加,同时下调促细胞凋亡因子caspase-9,从而降低细胞凋亡的发生。 Therefore, the American ginseng extract can be stimulated by inhibiting the activity of mitochondrial UCP-2 insulin-producing, preventing the loss of β cells, resulting in improved ATP levels, increased anti-apoptotic factor Bcl-2, and also cut pro-apoptotic factor caspase-9, thereby reducing the incidence of apoptosis. HasegawaH等对西洋参的有效成分Rbl、Rg的研究中发现,人参皂苷在通常情况下具有促进葡萄糖转移的功能,人参皂苷Rbl在最低lmmol/L的浓度条件下就可以增加(24±5%)的葡萄糖转移生理活性,人参皂苷Rg3也表现出对诱导抑制绵羊红细胞运转葡萄糖的重要作用。 Active components of ginseng is HasegawaH like Rbl, research Rg found that ginsenoside has a function of promoting glucose transport in general, ginsenoside Rbl at the lowest lmmol / L conditions of concentration can be increased (24 ± 5%) of physiological glucose transport activity, ginsenosides Rg3 also showed an important role in glucose-induced inhibition of SRBC operation. Yokozawa T等人研究发现,人参皂苷Rb2可以激活模型大鼠的脂质代谢和糖代谢。 Yokozawa T et al found that ginsenoside Rb2 can activate lipid metabolism and glucose metabolism in rats. 所以说明,西洋参可以降低血糖、调节胰岛素分泌、促进糖代谢和脂肪代谢,对治疗糖尿病有一定辅助作用。 So described, ginseng may lower blood sugar, regulating insulin secretion, promotion of glucose metabolism and fat metabolism, have a secondary effect on the treatment of diabetes.

[0007] 桑叶为桑科植物桑Morus alba L.的干燥叶。 [0007] mulberry Moraceae mulberry Morus alba L. dried leaves. 具有疏散风热,清肺润燥,清肝明目的功效,主要含有黄酮、多糖及生物碱。 Have evacuation wind-heat, clearing the lungs and moistening, Liver eyesight, mainly contains flavonoids, polysaccharides and alkaloids. 《本草纲目》记载桑叶乃手、足阳明之药,治劳热咳嗽,明目长发,止消渴。 "Compendium of Materia Medica" records mulberry leaf is the hand, foot Yangming medicine, cure labor hot cough, eyesight hair, only diabetes. 日本古书《吃茶养生记》也记载桑叶有改善“饮水病”的作用。 Japanese ancient books "tea health in mind," also recorded the role of mulberry leaves to improve the "water" disease. 《本草备要》记载桑叶代茶止消渴。 "Materia Medica prepared to" record only diabetes mulberry leaf tea. 国内外研究资料证实,生物碱和多糖是桑叶中主要的降血糖成分。 Domestic and foreign research data confirm, alkaloids and polysaccharides are the major hypoglycemic ingredients from mulberry leaves. 桑叶的降血糖作用是通过两个途径实现的:一是通过生物碱I-脱氧野尻霉素对二糖类分解酶活性产生抑制作用,从而抑制小肠对双糖的吸收,降低食后血糖的高峰值(Kimura, Mulberry hypoglycemic effect is achieved by two ways: First, the inhibition of the enzyme activity produced by alkaloids disaccharides I- deoxynojirimycin, thus inhibiting intestinal absorption of disaccharides, reducing postprandial glucose peak value (Kimura,

1995) ;二是通过桑叶生物碱fagomine及桑叶多糖促进β细胞分必胰岛素,而胰岛素可以促进细胞对糖的利用、肝糖原合成以及改善糖代谢,最终达到降血糖的效果(陈福君等, 1995); the second is facilitated through fagomine fagomine and mulberry leaves β cell sorting will insulin, which can promote the cells to use sugar, glycogen synthesis and improve glucose metabolism, and ultimately achieve hypoglycemic effect (Chen Fujun et ,

1996)。 1996). 从桑叶中分离出的多羟基去甲莨菪碱具有很强的糖苷酶抑制作用(Asano等,1994);N-Me-DNJ、GAL-DNJ和fagomine都可显著地降低血糖水平,其中GAL-DNJ和fagomine降血糖作用最强(Kimura等,1995)。 Separated from mulberry leaves polyhydroxy norepinephrine scopolamine highly glycosidase inhibition (Asano et, 1994); N-Me-DNJ, GAL-DNJ, and fagomine can significantly lower blood glucose levels, wherein GAL- DNJ and fagomine strongest hypoglycemic (Kimura et al., 1995). 桑叶在脱皮甾酮对四氧嘧啶引起的大鼠糖尿病;或肾上腺素、胰高血糖素、抗胰岛素血清引起的小鼠高血糖症均有降血糖作用。 Mulberry leaf ecdysterone alloxan diabetic rats induced; or epinephrine, glucagon, insulin serum induced hyperglycemia mice have a hypoglycemic effect. 脱皮留酮促进葡萄糖转变为糖原,但不改变正常动物的血糖水平。 Peeling stay ketone promote glucose into glycogen, but does not change the animal's normal blood sugar levels. 有人认为桑叶中所含某些氨基酸能刺激胰岛素的分泌以降低血糖。 It was contained in mulberry leaves that certain amino acids can stimulate the secretion of insulin to lower blood glucose. 同时,桑叶为可食用的资源,没有毒副作用,10%桑叶注射液小鼠I次腹腔注射的安全用量相当于人用量的250倍。 Meanwhile, mulberry edible resources, no toxic side effects, the I 10% mulberry secondary injection mice were injected intraperitoneally secure an amount equivalent to 250 times the human dosage. 以相当于人用量的60倍连续给小鼠腹腔注射21天,对肝、肾、肺等无损害。 Equivalent to 60 times the amount of people is continuously injected to mice intraperitoneally 21 days, liver, kidney, lung without damage.

[0008] 积雪草是伞形科植物积雪草Centella asiatica Linn.的全草,始载于《神农本草经》,列为中品,苦、辛、寒,归肝、脾、肾经,具有清热利湿,解毒消肿的功效。 [0008] gotu kola is Umbelliferae Centella asiatica Centella asiatica Linn. The whole plant, only contained in the "Shen Nong's Herbal Classic", as in the goods, bitter, acrid, cold, liver, spleen, kidney, It has heat and dampness, detoxification swelling effect. 用于湿热黄疸,中暑腹泻,砂淋血淋,痈肿疮毒,跌打损伤。 For heat jaundice, diarrhea, heat stroke, sand pouring discredited by a few, carbuncle swollen sore, bruises. 近年研究报道积雪草有促进伤口愈合,软化疤痕,抗牛皮癣,抗抑郁,抗乳腺增生,抗肝纤维化,抗癌,治疗水肿,保肝,降血糖及并发症的治疗等作用。 Recent studies have reported that gotu kola promote wound healing, soften scars, anti-psoriasis, anti-depressants, anti-proliferative breast, liver fibrosis, cancer, the treatment of edema, liver, treatment and complications of hypoglycemic effects. 积雪草的有效成分为积雪草总皂苷、积雪草酸、羟基积雪草酸等,宋纯清研究报道了积雪草中的有效成分积雪草酸、羟基积雪草酸具有降低餐后血糖及防治糖尿病的功效,其原理是通过抑制α -葡萄糖苷酶的活性而产生功效;郑承红研究发现,积雪草水提取液具有明显降低血糖水平,减轻体重,降低血脂及胰岛素抵抗指数水平、改善2型糖尿病大鼠胰岛素抵抗的作用,其降低血糖、血脂水平的作用与二甲双胍疗效相当,其降低IRI水平的作用优于二甲双胍。 The active ingredient is Centella asiatica total asiaticoside, asiatic acid, oxalic acid and other hydroxy snow, Song Chunqing studies have reported the active ingredient Centella Asiatic acid, oxalic acid hydroxy snow has reduced postprandial hyperglycemia and diabetes control effect, which works by inhibiting α - generating efficacy of the active glucosidase; Cheng Cheng red found Centella aqueous extract having a significantly lower blood glucose levels, weight loss, lower blood lipids and insulin resistance index level, to improve the type 2 diabetes the role of insulin resistance, which lowers blood glucose, blood lipid levels and metformin considerable effect, which reduces the IRI levels superior to metformin. 王雪松研究发现,积雪草多糖具有蛋白磷酸酯酶PTPlB抑制剂的作用、及调节免疫的作用。 Xuesong found Centella polysaccharide interacting protein phosphatase PTPlB inhibitors, and immune regulation. [0009] 牛蒡子为菊科二年生草本植物牛蒡Arctium lappa L.的干燥成熟果实。 [0009] Arctiin Asteraceae biennial herb Burdock Arctium lappa L. dry ripe fruit. 性寒,味辛、苦。 Cold, spicy and bitter. 疏散风热,宣肺透疹,解毒利咽。 Evacuation of wind-heat, Xuanfei Touzhen, detoxification pharynx. 用于风热感冒、咳嗽痰多、麻疹、风疹、咽喉肿痛、痄腮丹毒、痈肿疮毒。 For the common cold, cough, phlegm, measles, rubella, sore throat, mumps erysipelas, carbuncle swollen sore. 牛蒡子含牛蒡苷(arctiin)、牛蒡酚A、B、脂肪油等成分。 Burdock Arctium containing glycoside (arctiin), burdock phenol A, B, fatty oil content. 牛蒡子对金黄色葡萄球菌、肺炎双球菌有抑制作用。 Arctiin Staphylococcus aureus, Streptococcus pneumoniae inhibited. 提取物能显著持久地降低大鼠血糖。 Extract significantly reduced blood glucose permanently. 上海中医药大学中药学院研究证实,牛蒡子治疗糖尿病肾病(DN)机制与降低尿蛋白、尿微量白蛋白及影响肾组织转化生长因子Pl (TGF-pl)和单核趋化蛋白l(MCP-l)mRNA的表达有关。 College of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine confirmed that Arctiin treatment of diabetic nephropathy (DN) mechanism and reducing urinary protein, urinary albumin and renal effects of transforming growth factor Pl (TGF-pl) and monocyte chemotactic protein-l (MCP- expression l) mRNA concerned. 研究人员以链脲佐菌素(STZ)诱导的糖尿病大鼠为动物模型,结果表明,牛蒡子提取物能明显改善STZ大鼠多饮、多食和消瘦,降低尿蛋白、尿微量白蛋白,减少TGF-plmRNA、MCP-ImRNA的表达。 Researchers in streptozotocin (STZ) induced diabetic rats as an animal model, the results showed that, burdock fruit extract can significantly improve the STZ rats polydipsia, polyphagia and weight loss, reduce proteinuria, microalbuminuria, reduce the expression of TGF-plmRNA, MCP-ImRNA of. 牛蒡子提取物可能通过减轻MCP-ImRNA表达而改善糖尿病大鼠的肾损害。 Arctium extract may improve kidney damage in diabetic rats by reducing MCP-ImRNA expression. 牛蒡子及其提取物可有效降低糖尿病大鼠尿微量白蛋白,及24小时尿蛋白、内生肌酐清除率。 Arctium its extract can effectively reduce urinary albumin in diabetic rats, and 24-hour urinary protein, endogenous creatinine clearance. 牛蒡子及其提取物能降低DN大鼠的血糖水平,减少尿蛋白的排泄率,能通过减轻DN大鼠肾脏的高滤过、高灌注,从而保护肾功能。 Arctium its extract can reduce blood sugar levels in rats DN, reduce urinary protein excretion rate, can reduce the DN rat kidney hyperfiltration, hyperperfusion, to protect renal function. 文献报道牛蒡子提取物具有较强的醛糖还原酶抑制作用,可以用于制备防治糖尿病并发症一如糖尿病性白内障、视网膜病变、角膜病变和糖尿病周围神经病变的药物。 It reported that extracts of Arctium strong aldose reductase inhibiting activity, can be used for preventing and treating diabetic complications as diabetic cataracts, retinopathy, keratopathy and pharmaceutical diabetic peripheral neuropathy. [0010] 葡萄籽是葡萄酒厂的下脚料,经晒干后分离葡萄皮、葡萄梗后所得产物。 [0010] Grape seed is winery waste, the resulting product was separated from grape skins, grape stems after dried. 葡萄籽含有丰富的氨基酸、维生素、矿物质及大量的原花青素。 Grape seed is rich in amino acids, vitamins, minerals and a large amount of proanthocyanidins. 葡萄籽提取物原花青素(OPC)是一种高效的自由基清除剂。 Grape seed extract proanthocyanidin (OPC) is a potent free radical scavengers. 其抗自由基的氧化功能是维生素E的50倍、维生素C的20倍。 Anti-free radical oxidation function of vitamin E is 50 times, 20 times the vitamin C. 能清除人体内有毒的自由基,保护人体细胞组织免被自由基的氧化损伤,防止过敏、癌症、衰老等八十多种与自由基有关的疾病。 Can remove the body of toxic free radicals, oxidative damage human cells and tissues from being radical, prevent allergies, cancer, aging and other eighty kinds of free radical-related diseases. 正是基于葡萄籽的这种作用,欧洲人称葡萄籽为天然体内化妆品,它能恢复胶原蛋白活力,使皮肤平滑而有弹性。 This action is based on grape seed, grape seed known as the European body for the natural cosmetics, which can restore the vitality of collagen, making skin smooth and elastic. 葡萄籽还是天然的阳光遮盖物,能够阻止紫外线侵害皮肤。 Grape seed or natural sun shelter, can prevent the skin from ultraviolet rays. 葡萄籽能降低血液中低密度胆固醇,同时能提高高密度胆固醇的水平,两者兼顾,从而预防心血管疾病。 Grape seed can lower blood LDL cholesterol, while improving HDL cholesterol levels, both, in order to prevent cardiovascular disease. 除此之外,葡萄籽提取物含有丰富的维生素E,维生素E是有名的抗氧化剂,所以葡萄籽的作用还包括预防各种疾病,同时使皮肤和肌肉保持健康状态。 In addition, grape seed extract is rich in vitamin E, vitamin E are known antioxidants, so the effects of grape seed also includes prevention of various diseases, while the skin and muscles to maintain a healthy state. 葡萄籽还有抗前列腺肿瘤和抗肝脏肿瘤作用。 Grape seeds have anti-tumor and anti-liver prostate tumor effect. 从而保护人体器官和组织,防治心脏病、癌症、早衰、糖尿病、动脉硬化等100多种由自由基所引起的疾病。 Thereby protecting human organs and tissues, prevent heart disease, cancer, premature aging, diabetes, arteriosclerosis and other 100 kinds of diseases caused by free radicals.

[0011] 综上所述,五味药合用以不同的药效物质从不同的作用靶点和途径都有非常明确的降血糖药理作用,可将糖尿病人的血糖调节到正常水平。 [0011] In summary, drugs with different flavors of effective substance from different targets and have a very clear way hypoglycaemic pharmacological effects, can be adjusted for people with diabetes to normal glucose levels. 因此该组合物可用于制备具有防治糖尿病及其并发症等相关疾病的药品和保健品。 The composition may thus for the preparation of treating diabetes and its related complications of the disease drugs and health products.

发明内容 SUMMARY

[0012] 本发明人依据科学理论、经过反复试验,选用了卫生部规定的既是食品又是药品和可用于保健食品的药物进行组方,所以该处方组成非常安全、无任何副作用。 [0012] The present invention is based on scientific theory, through trial and error, the choice of both food and provisions of the Ministry of Health and medicine can be used in health food and medicines were prescription, the prescription form so very safe, without any side effects. 选取了可以直接服用的西洋参、桑叶、牛蒡子、积雪草、葡萄籽五种原料用以制备本发明具有治疗糖尿病及其并发症的保健食品。 Choose the direct taking of American ginseng, mulberry leaves, Arctium, gotu kola, grape seed five kinds of raw materials for the preparation of the present invention is the treatment of diabetes and its complications have a health food. 在选取本发明保健食品的各原料进行组合搭配时,必须考虑到它们各自所能发挥的功效及将它们进行搭配所能产生的协调效果。 When selecting the raw materials in the health food of the present invention in combination with, we must take into account their respective effect can play with them and can be produced by harmonizing effect. 首先,选择西洋参,是因为西洋参通过改变细胞的新陈代谢,增加胰岛素的分泌,减少细胞的凋亡来对胰岛β细胞起作用,促进糖代谢和脂肪代谢,同时降血脂和血小板聚集率,可明显改善糖尿病症状,如乏力、口干等。 First, select American ginseng, American ginseng is because by changing the cell metabolism, increase insulin secretion, reduce apoptotic cells to act on pancreatic β cells and promote glucose metabolism and fat metabolism, and lipid-lowering and platelet aggregation rate, may be significantly improved diabetic symptoms, such as fatigue, dry mouth. 中医理论还认为西洋参味甘、微苦,性寒,适用人群广泛。 TCM theory also believe that American ginseng sweet, bitter, cold, widely applicable crowd. 具有益气养阴,生津止渴,消除疲劳,安神益智,凉心脾以降虚火以及消暑的作用。 Qi and Yin, thirst, fatigue, tranquilizer puzzle, to reduce false fire Heart cool and refreshing effect. 选择桑叶,是因为桑叶具有降低血脂,抑制有害的过氧化物的生成的作用,桑叶中含有I-脱氧野尻霉素(DNJ),DNJ作为α -葡萄糖苷酶的抑制剂,从而抑制小肠对双糖的吸收,降低食后血糖的高峰值;桑叶多糖促进β细胞分泌胰岛素,而胰岛素可以促进细胞对糖的利用、肝糖原合成以及改善糖代谢,最终达到降血糖的效果。 Mulberry choice, because mulberry reduce blood lipids, inhibiting generation of harmful peroxide, mulberry leaves containing I- deoxynojirimycin (DNJ), DNJ as α - glucosidase inhibitor, thereby inhibiting intestinal absorption of disaccharides, reduced peak postprandial blood glucose; mulberry leaves promote β cells secrete insulin, which can promote the cells to use sugar, glycogen synthesis and improve glucose metabolism, and ultimately achieve the effect of lowering blood sugar. 中医理论认为桑叶味苦甘、寒,入肺肝经,轻清疏散,甘凉滋润,可清肺热,润肺燥,以缓解气阴不足,燥热内生,口渴引饮之主证;《本草纲目》记载桑叶具有明目长发,止消渴,《本草备要》记载桑叶代茶止消渴。 TCM theory holds that mulberry leaves bitter sweet, cold, lung liver, light clear evacuation, Ganliang moisture, can Qingfei heat, lungs and dry, to alleviate the shortage of Qi and Yin, born in the heat, thirst cited drink master card; "Compendium of Materia Medica" mulberry described with eyesight hair, only diabetes, "herbal preparation to" record only diabetes mulberry leaf tea. 将桑叶选用本方为主要组成是基于现代研究和中医古籍医学记载科学的结合。 Mulberry leaves the choice of the party as the main composition is based on a combination of modern and ancient Chinese medicine research medical records science. 选择牛蒡子加入本配方,是因为牛蒡子具有降低血糖、减少尿蛋白的排泄率,能通过减轻肾脏的高滤过、高灌注,从而保护肾功能。 Select Arctiin joined the recipe, because Arctiin lower blood sugar, reduce urinary protein excretion rate, can reduce the high kidney filtration, high perfusion, thereby protecting renal function. 同时,牛蒡子具有较强的醛糖还原酶抑制作用,可以用于治疗糖尿病并发症——如糖尿病性白内障、视网膜病变、角膜病变和糖尿病周围神经病变等。 Meanwhile, Arctium a strong aldose reductase inhibiting activity and to be useful in the treatment of diabetic complications - such as diabetic cataracts, retinopathy, keratopathy and diabetic peripheral neuropathy. 中医认为牛蒡子辛苦而寒,至秋乃成,得天地清凉之气,具有清肺泻胃作用。 Chinese medicine believes Arctiin hard and cold, to autumn is into, get cool air of heaven and earth, with Qingfei diarrhea stomach effect. 选择积雪草加入本方,是因为积雪草具有抑制α-葡萄糖苷酶的活性,具有明显降低血糖水平,减轻体重,降低血脂及胰岛素抵抗指数水平、改善2型糖尿病大鼠胰岛素抵抗的作用,同时积雪草多糖具有蛋白磷酸酯酶PTPlB抑制剂的作用、及调节免疫的作用。 Select Centella joining side, because Centella having α- glucosidase inhibiting activity of type 2 diabetes have insulin resistance in rats with blood glucose levels significantly lower effect, weight loss, lower blood lipid levels and insulin resistance index, improved while Centella polysaccharide interacting protein phosphatase PTPlB inhibitors, and regulation of the immune effects. 中医认为,积雪草,苦、辛、寒,归肝、脾、肾经,具有清热利湿,解毒消肿的功效。 Chinese medicine, gotu kola, bitter, acrid, cold, liver, spleen, kidney, with heat and dampness, detoxification swelling effect. 选择葡萄籽加入本配方,是因为申请人经过多次试验,证实了葡萄籽中的原花青素对血脂升高有一定的阻抑作用,可调节血脂,降低血脂水平,降低肝脏胆固醇、甘油三酯的含量,而且原花青素还具有辅助清除机体内自由基的作用。 Select grape seed joined the recipe, because the applicant After several tests, confirmed that grape seed proanthocyanidins on elevated blood lipids have a certain inhibitory effect, can regulate blood lipids, lowering blood lipid levels, reduce liver cholesterol, triglycerides content, but also has an auxiliary proanthocyanidins body free radical scavenging effect. 由于原花青素可清除机体内自由基作用,再配以具有可抑制体内有害过氧化物生成作用的桑叶联合使用,可发挥协调作用,进一步增强直接或间接清除体内自由基的能力,达到全面系统除去机体内对人体有害物质的功效;而且牛蒡子、积雪草、桑叶、原花青素均可改善血糖代谢、降低血脂。 Since scavenging free radical Procyanidins body, together with a peroxide generating mulberry leaves have a detrimental role in vivo is suppressed used in combination, they work synergistically, directly or indirectly, to further enhance the scavenging of the free radicals, to achieve a comprehensive removal system vivo efficacy of harmful substances; and Arctium, gotu kola, mulberry leaves, proanthocyanidins can improve glucose metabolism, lower blood lipids. 西洋参与桑叶还可促进胰岛素分泌,所以它们综合使用,可对人体起到很好的辅助降血糖的作用。 American ginseng and mulberry also promote insulin secretion, so they integrated use, can play a good role hypoglycemic of the human body. 故诸品合用,可相互促进、相互协同作用,达到真正的降血糖的目的。 Therefore, all products in combination, promote mutual synergy, the true purpose of hypoglycemic.

[0013] 所以,本发明目的之一是,基于现代病理分子机制和传统中医理论结合的原则,经过大量的研究发现,西洋参或提取物、桑叶或提取物、积雪草或提取物、牛蒡子或提取物、葡萄籽或提取物的混合物对于糖尿病的治疗具有显著的疗效,可以用来制备成治疗糖尿病的药物。 [0013] Therefore, one object of the present invention is based on the principle of pathology and molecular mechanisms of modern traditional Chinese medicine theory bound, after a large number of studies have found, or American ginseng extract, mulberry leaves or extract, Centella asiatica or an extract, burdock promoter or a mixture of an extract, or grape seed extract has a significant effect for the treatment of diabetes, drugs used for treating diabetes may be prepared. 这种现代天然产物组合物,其中蕴涵了大量蛋白酪氨酸磷酸酶(PTPlB)抑制剂成分、醛糖还原酶抑制成分、α -葡萄糖苷酶抑制剂成分、促进胰岛素分泌成分、降血脂成分、消除氧自由基成分,相互协同作用、多靶点、多途径作用,五药组合从根本上全面调节糖尿病人的机体,改善糖尿病人的身体健康状况,并且,五味中药所含的不同药效物质从不同的作用靶点和途径都有非常明确的降血糖药理作用,可将糖尿病人的血糖调节到正常水平。 Such modern natural product composition, which contains a large number of protein tyrosine phosphatases (PTPlB) inhibitor component, aldose reductase inhibitory component, α - glucosidase enzyme inhibitor component, component promoting insulin secretion, lipid-lowering ingredients, eliminate oxygen free radicals ingredients interact synergistically, multi-target, multi-channel effect, a combination of five drugs for people with diabetes comprehensive regulation of the body fundamentally improve the physical health of people with diabetes, and different flavors of traditional Chinese medicine effective substances contained in from different targets and ways to have a very clear pharmacological effect of lowering blood sugar, blood sugar in people with diabetes can be adjusted to normal levels. 可用于制备具有防治糖尿病及其并发症等相关疾病的药品和保健品。 It is useful for making prevention and treatment of diabetes and its complications and other diseases related to drugs and health care products. 具有明显的创新性和技术进步。 It has obvious innovation and technological progress.

[0014] 本发明目的之二是,本处方中的各中药协同作用,减少了胰岛素抵抗,提高了胰岛素的敏感性,使其发挥出原有的生物效应,从而达到降低血糖及糖尿病并发症的治疗作用,这种天然的组合物达到的效果是目前已有的化学药品和中药制剂治疗糖尿病所不具备的,这是本发明最突出的贡献。 [0014] Second object of the present invention, each of the medicine of the present formulation is a synergistic effect, reducing insulin resistance, increased insulin sensitivity, to play the original biological effects, which can reduce blood sugar and diabetes complications therapeutic effect, this natural composition to achieve the effect of chemicals present, and traditional Chinese medicines for treating diabetes are not available, which is the most prominent contribution to the present invention.

[0015] 本发明所要解决的技术问题在于从天然植物西洋参、桑叶、积雪草、牛蒡子、葡萄籽中提取具有降糖作用的活性组分、制备天然产物组合物。 [0015] The present invention solves the technical problem from natural ginseng plant, mulberry, Centella asiatica, Arctium, grape seed extract has hypoglycemic effect of the active ingredient, a natural product composition was prepared.

[0016] 本发明提供了一种具有防治糖尿病及其并发症等相关疾病的中药制成的组合物,该组合物包括西洋参50-100份,桑叶200-500份,积雪草100-300份,牛蒡子100-300份,葡萄籽50-200份。 [0016] The present invention provides a composition made of the traditional Chinese medicine with diabetes mellitus and its complications related disease, the composition comprising 50-100 parts of ginseng, mulberry leaf parts 200-500, 100-300 Centella parts Arctiin 100-300 copies, grape seed 50 to 200 parts. 也可以是西洋参提取物10-30份,桑叶提取物40-100份,积雪草提取物20-50份,牛蒡子提取物20-50份,葡萄籽提取物10-30份。 American ginseng extract may be 10-30 parts, 40 to 100 parts mulberry leaf extract, Centella asiatica extract 20 to 50 parts burdock extracts 20-50, 10-30 parts of grape seed extract. 按照上述比例混合组成活性成份与药用辅料制成的。 According to the above mixture composition ratio of the active ingredient with the pharmaceutical excipients prepared.

[0017] 本发明的另一目的是提供了分别从西洋参、桑叶、积雪草、牛蒡子、葡萄籽中提取活性组分的方法,该方法包括: [0017] Another object of the present invention is to provide a process for extracting the active ingredient are from ginseng, leaves, Centella asiatica, Arctium, grape seed, the method comprising:

[0018] (I)桑叶提取物制备:桑叶用8-20倍去离子水,提取1-3次,每次1-3小时,过滤,滤液浓缩,干燥,粉碎,即得桑叶提取物; [0018] (I) Preparation Mulberry extract: mulberry 8-20 fold with deionized water and extracted 1-3 times, 1-3 hours each time, filtered, the filtrate was concentrated, dried and pulverized to obtain mulberry extract thing;

[0019] (2)积雪草提取物制备:积雪草用8-20倍去离子水,提取2-4次,每次1_3小时,过滤,滤液浓缩,干燥,粉碎,即得积雪草提取物; [0019] Preparation (2) Centella asiatica extract: Centella asiatica with a 8-20-fold with deionized water and extracted 2-4 times 1_3 hours, filtered and the filtrate was concentrated, dried and pulverized to obtain Centella Extract;

[0020] (3)牛蒡子提取物制备:牛蒡子用8-14倍40% -90%的乙醇溶液,提取2_3次,每次1-3小时,过滤,滤液回收乙醇,浓缩,干燥,粉碎,即得牛蒡子提取物; [0020] (3) Preparation burdock fruit extract: Arctium 8-14 times with 40% -90% ethanol, extraction 2_3 times 1-3 hours, filtered, filtrate recovery of ethanol, concentrated and dried, pulverized , Arctium to obtain an extract;

[0021] (4)葡萄籽提取物制备:葡萄籽用8-14倍30% -80%的乙醇溶液,提取2_3次,每次1-3小时,过滤,滤液回收乙醇,浓缩,干燥即得葡萄籽提取物; Preparation of [0021] (4) Grape seed extract: grape seeds with 8-14 times 30% -80% ethanol, extraction 2_3 times 1-3 hours, filtered, filtrate recovery of ethanol, concentrated, and dried to obtain grape seed extract;

[0022] (5)西洋参粉碎成细粉。 [0022] (5) crushed into powder American ginseng.

[0023] 本发明又一个目的是提供了上述从西洋参、桑叶、积雪草、牛蒡子、葡萄籽中分离的活性组分在制备防治糖尿病的药物和保健食品中的应用。 [0023] Yet another object of the present invention provides the use of the above-described isolated from American ginseng, mulberry, Centella asiatica, Arctium, grape seed active ingredient in the manufacture of a pharmaceutical diabetes prevention and health food.

[0024] 本发明相对于现有技术具有疗效确切、无毒副作用、服用方便、价格低廉的优点。 [0024] The prior art relative to the present invention having a curative effect, toxic side effects, for convenient, low-cost advantages.

[0025] 由于本发明首次公开了由西洋参或提取物、桑叶或提取物、积雪草或提取物、牛蒡子或提取物、葡萄籽或提取物组成的组合物具有防治糖尿病及其并发症等相关疾病的作用,因此,将本组合物单独或与其它活性组份或辅料配合制成药剂,只要是该药剂用于预防和治疗高血糖及其并发症,均属于本发明的保护范围。 [0025] Since the present invention discloses a composition of the first or American ginseng extract, mulberry leaves or extract, Centella asiatica or an extract, burdock fruit or extract, or grape seed extract having a composition prevention of diabetes and its complications and other diseases related action, therefore, the present compositions alone or in combination with other active ingredients, or pharmaceutical excipients fitting made, as long as the agent for the prevention and treatment of hyperglycemia and its complications, belong to the scope of the present invention. 本发明的组合物在制成任何一种剂型时,均具有预防和治疗高血糖的作用。 The composition of the present invention when made into any dosage form, each has the effect of prevention and treatment of hyperglycemia.

[0026] 由西洋参或提取物,桑叶或提取物、积雪草或提取物、牛蒡子或提取物、葡萄籽或提取物组成的组合物(简称组合物)具有降血糖作用,通过以下药效学实验得到证实。 [0026] or by the American ginseng extract, mulberry leaves or extract, Centella asiatica or an extract, burdock fruit or extract, or grape seed extract composition consisting of (referred to as composition) having a hypoglycemic action, the following drugs effect experiments to be confirmed.

[0027] I、本品组合物对葡萄糖弓I起小鼠高血糖的影响 [0027] I, hyperglycemia mice influence the product composition from the bow I glucose

[0028] 取雌雄各半小鼠60只,按体重随机分为6组,分别为空白对照组(10ml/kg水),模型对照组(10ml/kg水),玉盘消渴片组、组合物组按照下表给药,于7日内每天灌胃给药一次,灌胃体积均为10ml/kg,末次给药前禁食5小时,末次给药2小时后,除空白对照组外,其余各组均腹腔注射葡萄糖2g/kg,分别于注射葡萄糖后O. 5、1和2小时,将动物处死,取血,以葡萄糖氧化酶法测血糖。 [0028] Take 60 male and female mice were randomly divided into 6 groups, blank control group (10ml / kg water), model control group (10ml / kg water), jade plate sheet Diabetes group, a combination of was set according to the table administration, oral administration, within 7 days once a day, are fed volume 10ml / kg, fasted for 5 hours prior to the last administration, two hours after the last administration, addition to the control group, the remaining in each group were injected glucose 2g / kg, respectively, in O. 5,1 and 2 hours after glucose injection, the animals were sacrificed, blood, blood sugar glucose oxidase. 试验结果见表I。 The test results are shown in Table I.

[0029] 表I本品组合物对葡萄糖引起小鼠高血糖的影响 Effect of hyperglycemia in mice [0029] The composition of Table I The product due to glucose

[0030]、 [0030],

Figure CN102631482AD00081

[0031]与模型对照组比较:* Ρ〈0· 05;** Ρ〈0· 01;*** Ρ〈0· 001 [0031] Compared with the model group: * Ρ <0 · 05; ** Ρ <0 · 01; *** Ρ <0 · 001

[0032] 结果表明:本品在注射葡萄糖后O. 5和I小时可明显降低葡萄糖引起的高血糖,且有明显的量效关系,在2小时时,没有明显降低葡萄糖引起的小鼠高血糖。 [0032] The results showed that: The product in O. 5 hours after the injection of glucose and I significantly decreased glucose-induced high blood sugar, and a clear dose-effect relationship, at 2 hours, no significant decrease of glucose induced hyperglycemia mice .

[0033] 2、本品对肾上腺素引起小鼠高血糖的影响 [0033] 2, the product of epinephrine on mouse hyperglycemia induced

[0034] 取雌雄各半小鼠60只,按体重随机分为6组,分别为空白对照组(10ml/kg水),模型对照组(10ml/kg水),玉盘消渴片组、组合物组按照下表给药,于7日内每天灌胃给药一次,灌胃体积均为10ml/kg,末次给药前禁食5小时,末次给药2小时后,除空白对照组外,其余各组均腹腔注射肾上腺素240ug/kg,分别于注射肾上腺素后O. 5、1和2小时,将动物处死,取血,以葡萄糖氧化酶法测血糖。 [0034] Take 60 male and female mice were randomly divided into 6 groups, blank control group (10ml / kg water), model control group (10ml / kg water), jade plate sheet Diabetes group, a combination of was set according to the table administration, oral administration, within 7 days once a day, are fed volume 10ml / kg, fasted for 5 hours prior to the last administration, two hours after the last administration, addition to the control group, the remaining in each group were injected epinephrine 240ug / kg, respectively, in O. 5,1 and 2 hours after injection of epinephrine, the animals were sacrificed, blood, blood sugar glucose oxidase. 试验结果见表2。 The test results are shown in Table 2.

[0035] 表2本品组合物对肾上腺素引起小鼠高血糖的影响 [0035] Effect of hyperglycemic mice Table 2. The product composition caused Epinephrine

[0036] [0036]

Figure CN102631482AD00082

[0037]与模型对照组比较:* Ρ〈0· 05 ;林Ρ〈0· 01 ;*** Ρ〈0· 01 [0037] Compared with the model group: * Ρ <0 · 05; Lin Ρ <0 · 01; *** Ρ <0 · 01

[0038] 结果表明:本品组合物在所观察时间范围内均可明显降低肾上腺素引起的高血糖,尤以0. 5、I小时作用最为显著。 [0038] The results showed that: The product composition can be significantly decreased epinephrine-induced hyperglycemia in the time range observed, especially 0. 5, I h most significant effect. 2小时效果相对较差,但是也有一定效果。 2 hours less effective, but also have some effect.

[0039] 3、本品组合物对链脲佐菌素引起小鼠高血糖的影响 [0039] 3 Effects of hyperglycemia in mice caused the product composition of streptozotocin

[0040] 雄性小鼠80只,随机取10只作为空白对照组,其余小鼠尾静脉注射链脲佐菌素(在4°C冰浴中用0. 05M柠檬酸pH4. 5溶液配制,立即使用)200mg/kg,造成糖尿病模型。 [0040] 80 male mice, 10 were randomly selected as a control group, intravenous injection of streptozotocin (0. 05M citrate pH4. 5 was formulated to rest at 4 ° C mouse tail with an ice bath was immediately use) 200mg / kg, resulting in diabetes model. 注射后72小时小鼠眶静脉取血测血糖,删除未造成糖尿病模型者(测前禁食12小时,血糖值低于11. I lmmol/L),留用小鼠随机分为5组,每组10只,于7日内按表3所示剂量每天给药一次,末次给药后2小时,,眶静脉取血,以邻甲苯胺法(超微量法)测血糖。 72 hours after injection, the mice orbital vein blood glucose test, were deleted without causing diabetes model (fasted 12 hours before the test, the blood glucose value below 11. I lmmol / L), retention mice were divided into 5 groups, each group 10, 7 days at a dose shown in table 3 given once a day, two hours ,, orbital venous blood, o-toluidine method (method ultra) blood glucose after the last administration. 试验结果见表30 The results in Table 30

[0041] 表3本品组合物对链服佐菌素引起小鼠闻血糖的影响 [0041] Effect of glucose smell mice Table 3 cosmetic composition due to streptozotocin

[0042] [0042]

Figure CN102631482AD00091

[0043]与模型对照组比较:* Ρ〈0· 05 ;林Ρ〈0· 01 ;*** Ρ〈0· 01 [0043] Compared with the model group: * Ρ <0 · 05; Lin Ρ <0 · 01; *** Ρ <0 · 01

[0044] 结果表明:本品组合物高、中、低剂量组对链脲佐菌素引起小鼠高血糖均有明显的降低作用。 [0044] The results show: the product composition of high, middle and low dose of streptozotocin induced hyperglycemia mice have significant lowering effects.

[0045] 4、本品组合物对四氧嘧啶性糖尿病小鼠血糖及血清胰岛素水平的影响 [0045] 4, it affects the serum insulin compositions alloxan diabetic mice and the blood glucose

[0046] 雄性小鼠80只,随机取10只作为空白对照组,其余小鼠尾静脉注射四氧嘧啶70mg/kg,造成糖尿病模型,注射后96小时小鼠眶静脉取血以邻甲苯胺法(超微量法)测血糖,删除未造成糖尿病模型者或血糖超高者(血糖值低于20mmol/L和高于40mmol/L弃去),留用小鼠立即随机分为5组,每组10只,每天称体重、饮水量、食量和尿便量,于12日内按表4所示剂量每天给药一次,末次给药后2小时,眶静脉取血,分离血清,以葡萄糖氧化酶法测血糖,以放射免疫分析法测定胰岛素含量。 [0046] 80 male mice, 10 were randomly selected as a control group, the remaining tail vein injection of alloxan 70mg / kg, resulting in diabetes model mice 96 hours after injection orbital phlebotomy o-toluidine method (ultra method) blood glucose, causing diabetes model not remove or by ultra high glucose (blood glucose level below 20mmol / L and higher than 40mmol / L discarded), immediately retained mice were randomly divided into 5 groups of 10 rats weighed daily water intake, food intake and urinary volume in 12 days, given once a day at a dose shown in table 4, two hours after the last administration, the orbital venous blood, serum was separated, the enzymatic oxidation of glucose measured blood glucose to insulin was measured by radioimmunoassay content. 试验结果见表4。 The test results are shown in Table 4.

[0047] 表4本品对四氧卩密唳性糖尿病小鼠血糖及血清膜岛素水平的影响 [0047] Table 4 Effect of product oxygen for four Jie tight blood glucose and serum hormone levels Li film islands in diabetic

[0048] [0048]

Figure CN102631482AD00092

[0049] 与模型对照组比较:* Ρ〈0· 05 ;林Ρ〈0· 01 [0049] Compared with the model group: * Ρ <0 · 05; Lin Ρ <0 · 01

[0050] 结果表明:在所用剂量下,本品对四氧嘧啶引起小鼠高血糖具有明显的降低作用,且有明显量效关系,并可明显改善四氧嘧啶性高血糖小鼠多饮、多食、多尿等三多症状,但对小鼠体重增长却无明显影响;其各剂量组对四氧嘧啶性高血糖小鼠血清中胰岛素的释放也具有促进作用。 [0050] The results showed that: at the doses used, the product of alloxan induced hyperglycemia mice have significant lowering effect, and a clear dose-effect relationship, and can significantly improve the alloxan-induced hyperglycemia mice drink, polyphagia, polyuria and other symptoms of more than three, but the weight gain in mice but no significant effect; which releases each dose group on serum pyrimidin hyperglycemia mouse in insulin also promoted. [0051] 本发明是通过下面的实施例进行详细的说明,但不意味着本发明仅限于此,具体实施方案如下: [0051] The present invention is carried out by the following detailed description of embodiments, but the present invention is not meant to be limited thereto, the following specific embodiments:

[0052] 实施例I提取物的制备 [0052] Example I Preparation of extracts

[0053] (I)桑叶提取物制备:桑叶用14倍蒸馏水,提取2次,每次2小时,过滤,滤液浓缩,干燥即得桑叶提取物; [0053] (I) Preparation Mulberry extract: mulberry 14 times with distilled water, extracted 2 times 2 hours, filtered, the filtrate was concentrated and dried to obtain the mulberry leaves extract;

[0054] (2)积雪草提取物制备:积雪草用14倍蒸馏水,提取3次,每次I小时,过滤,滤液浓缩,干燥即得积雪草提取物; [0054] Preparation (2) Centella asiatica extract: Centella asiatica with distilled water 14 times, extracted three times, each time I h, filtered and the filtrate concentrated and dried to obtain Centella asiatica extract;

[0055] (3)牛蒡子提取物制备:牛蒡子用8倍70%的乙醇溶液,提取3次,每次2小时,过滤,滤液回收乙醇,浓缩,干燥即得牛蒡子提取物; [0056] (4)葡萄籽提取物制备:葡萄籽用8倍50%的乙醇溶液,提取3次,每次I小时,过滤,滤液回收乙醇,浓缩,干燥即得葡萄籽提取物; [0055] (3) Preparation burdock fruit extract: Arctium eight times with 70% ethanol solution, extracted three times, each time 2 hours, filtered, filtrate recovery of ethanol, concentrated, and dried to obtain extract of Arctium; [0056 ] (4) grape seed extract were prepared: 8-fold grape seeds with 50% ethanol solution, extracted three times, each time I h, filtered, the filtrate recovery of ethanol, concentrated, and dried to obtain the grape seed extract;

[0057] 实施例2 (胶囊剂) [0057] Example 2 (capsule) Example

[0058] 西洋参细粉50g,桑叶提取物180g,积雪草提取物70g,牛蒡子提取物70g,葡萄籽提取物50g,辅料适量,混合均匀,制粒,干燥,整粒,装入胶囊,制成1000粒,即得。 [0058] American ginseng powder 50g, 180g mulberry leaf extract, Centella asiatica extract 70g, burdock fruit extract 70g, grape seed extract 50g, an appropriate amount of excipients, mixing, granulating, dried, sieved and filled into capsules made 1000, that is, too. 每次2粒、每日2次。 2 capsules twice daily.

[0059] 实施例3、(片剂) [0059] Example 3 (tablets)

[0060] 西洋参细粉50g,桑叶提取物180g,积雪草提取物70g,牛蒡子提取物70g,葡萄籽提取物50g,辅料适量,混合均匀,制粒,干燥,整粒,压片,制成1000片,即得。 [0060] American ginseng powder 50g, 180g mulberry leaf extract, Centella asiatica extract 70g, burdock fruit extract 70g, grape seed extract 50g, an appropriate amount of excipients, mixing, granulating, dried, sieved, tableting, 1000 is made, that is, too. 每次2片、每日2次。 2 tablets, 2 times a day.

Claims (5)

  1. 1. 一种具有防治糖尿病及其并发症等相关疾病的中药组合物,其特征在于:由西洋参或提取物、桑叶或提取物、积雪草或提取物、牛蒡子或提取物、葡萄籽或提取物组成。 A treating diabetes and its complications with other related diseases Chinese medicine composition, comprising: a ginseng or an extract, mulberry leaves or extract, Centella asiatica or an extract, burdock fruit or extract, grape seed or extract composition.
  2. 2.根据权利要求I所述的具有防治糖尿病及其并发症等相关疾病的中药组合物,其特征在于,它是由下述重量份的原料制成: 西洋参50-100份,桑叶200-500份,积雪草100-300份,牛蒡子100-300份,葡萄籽50-200 份。 The traditional Chinese medicine composition with prevention of diabetes and its related complications of the disease as claimed in claim I, characterized in that it is made from the following raw materials by weight: 50-100 parts of ginseng, mulberry 200- 500, 100-300 parts of Centella asiatica, Arctiin 100-300 copies, grape seed 50 to 200 parts.
  3. 3.根据权利要求I所述的具有防治糖尿病及其并发症等相关疾病的中药组合物,其特征在于,它是由下述重量份的原料制成: 西洋参提取物10-30份,桑叶提取物40-100份,积雪草提取物20-50份,牛蒡子提取物20-50份,葡萄籽提取物10-30份。 The traditional Chinese medicine composition with prevention of diabetes and its related complications of the disease as claimed in claim I, characterized in that it is made from the following raw materials by weight: 10-30 parts of ginseng extract, mulberry 40 to 100 parts extract, Centella asiatica extract 20-50, 20-50 Arctiin extract, grape seed extract 10-30 parts.
  4. 4.根据权利要求I所述的中药组合物,其特征在于:所述中药组合物的制备方法包括以下步骤: (I)桑叶用8-20倍去离子水,提取1-3次,每次1-3小时,过滤,滤液浓缩,干燥,粉碎,即得桑叶提取物;(2)积雪草用8-20倍去离子水,提取2-4次,每次1-3小时,过滤,滤液浓缩,干燥,粉碎,即得积雪草提取物; (3)牛蒡子用8-14倍40% -90%的乙醇溶液,提取2-3次,每次1_3小时,过滤,滤液回收乙醇,浓缩,干燥,粉碎,即得牛蒡子提取物;(4)葡萄籽用8-14倍30% -80%的乙醇溶液,提取2-3次,每次1-3小时,过滤,滤液回收乙醇,浓缩,干燥,粉碎,即得葡萄籽提取物; (5)西洋参粉碎成细粉; (6)将制得的桑叶提取物40-100份、积雪草提取物20-50份、牛蒡子提取物20-50份、葡萄籽提取物10-30份及西洋参粉20份按配方比例混合后,再与药用辅料一起混合,按常规方法制成口服制 The traditional Chinese medicine composition as claimed in claim I, wherein: the preparation of Chinese medicinal composition comprising the steps of: (I) a 8-20 fold mulberry deionized water and extracted 1-3 times per time 1-3 hours, filtered, the filtrate was concentrated, dried and pulverized to obtain the mulberry leaf extract; (2) 8-20 times Centella asiatica with deionized water and extracted 2-4 times, 1-3 hours each time, the filtrate was concentrated, dried and pulverized to obtain Centella asiatica extract; (3) Arctium 8-14 times with 40-90% ethanol solution and extracted 2-3 times 1_3 hours, filtered and the filtrate recovering ethanol, concentrated, dried and pulverized to obtain the extract of Arctium; (4) grape seeds with 8-14 times 30% -80% ethanol, extraction 2-3 times, 1-3 hours each time and filtered, recovering ethanol filtrate was concentrated, dried and pulverized to obtain grape seed extract; (5) crushed into powder American ginseng; (6) the resulting 40 to 100 parts mulberry leaf extract, Centella asiatica extract 20-50 parts, 20-50 parts of burdock fruit extract, grape seed extract and mixing 10-30 parts of ginseng powder, 20 parts by formula ratio, and then mixed with a pharmaceutically acceptable adjuvant, prepared by a conventional method in an oral .
  5. 5.如权利要求I所述的具有降糖作用的中药组合物,其特征在于:它是硬胶囊、软胶囊、片剂、颗粒剂、散剂、丸剂、袋泡茶、药酒中的一种或多种。 5. The herbal composition having a hypoglycemic action according to claim I, characterized in that: it is a hard capsule, soft capsules, tablets, granules, powders, pills, teabag, wine or variety.
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