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CN106511506A - Traditional Chinese medicine composition for treating diabetes, preparation method and application thereof - Google Patents

Traditional Chinese medicine composition for treating diabetes, preparation method and application thereof Download PDF

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CN106511506A
CN106511506A CN201710037663.4A CN201710037663A CN106511506A CN 106511506 A CN106511506 A CN 106511506A CN 201710037663 A CN201710037663 A CN 201710037663A CN 106511506 A CN106511506 A CN 106511506A
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皮子凤
张亚楠
宋凤瑞
刘志强
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Changchun Institute of Applied Chemistry of CAS
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/40Cornaceae (Dogwood family)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/481Astragalus (milkvetch)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/65Paeoniaceae (Peony family), e.g. Chinese peony
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/71Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/51Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying

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  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
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Abstract

The invention belongs to the technical field of medicines and especially relates to a traditional Chinese medicine composition for treating diabetes, a preparation method and application thereof. The traditional Chinese medicine composition is prepared from the following components in parts by weight: 45-60 parts of dogwood, 20-35 parts of white paeony root and 20-35 parts of astragalus membranaceus. In the traditional Chinese medicine composition, dogwood has the effects of tonifying liver and kidney, astringing and inducing astringency; the white paeony root has the effects of stabilizing liver yang, astringing yin and reducing sweat; the astragalus membranaceus has the effects of tonifying qi, lifting yang and consolidating exterior for arresting sweating; the materials are compounded on the basis of a synergic principle, can mutually effect and have the effects of reducing blood glucose and quenching thirst, promoting blood circulation to remove blood stasis, and replenishing qi to invigorate the spleen; and the traditional Chinese medicine composition can achieve the purposes of reducing blood glucose and treating diabetes in various aspects and has a better effect. A test result proves that the effect of the traditional Chinese medicine composition provided by the invention in reducing blood glucose of a diabetic mouse is better than the effect of the traditional Chinese medicine composition composed of acarbose and similar components.

Description

一种治疗糖尿病的中药组合物及其制备方法和应用A kind of traditional Chinese medicine composition for treating diabetes and its preparation method and application

技术领域technical field

本发明属于药品技术领域,尤其涉及一种治疗糖尿病的中药组合物及其制备方法和应用。The invention belongs to the technical field of medicines, and in particular relates to a traditional Chinese medicine composition for treating diabetes and its preparation method and application.

背景技术Background technique

糖尿病是一种由胰岛素分泌绝对或相对不足而引起的以血糖水平增高为特征的代谢性疾病。通常用血糖水平来诊断糖尿病,当人体空腹血糖水平≥7.0mmol/L或者具有糖尿病特征症状并且任意时间血糖水平≥11.1mmol/L时,则诊断为患有糖尿病。其临床症状为“三多一少”,即多尿、多饮、多食和体重减少。机体长期的高血糖环境会导致眼、肾脏、心脏等众多组织器官的病变,统称糖尿病并发症,糖尿病及其并发症的发病机制和治疗机制复杂而多样。Diabetes mellitus is a metabolic disease characterized by elevated blood glucose levels caused by absolute or relative insufficiency of insulin secretion. Diabetes is usually diagnosed with blood glucose levels. When the fasting blood glucose level is ≥7.0mmol/L or has the characteristic symptoms of diabetes and the blood glucose level is ≥11.1mmol/L at any time, it is diagnosed as having diabetes. Its clinical symptoms are "three excesses and one deficiency", that is, polyuria, polydipsia, polyphagia, and weight loss. The long-term high blood sugar environment of the body will lead to lesions of many tissues and organs such as eyes, kidneys, heart, etc., which are collectively referred to as diabetic complications. The pathogenesis and treatment mechanisms of diabetes and its complications are complex and diverse.

随着经济的飞速发展,人们生活水平的日益提高,糖尿病的发病率逐年增高。目前糖尿病已成为继肿瘤和心血管疾病之后严重危害人类健康的最主要慢性非感染性疾病。全球投入糖尿病治疗费用逐年增长,国内外也有越来越多关于降糖药物研发、降血糖机制研究的报道。With the rapid development of the economy and the improvement of people's living standards, the incidence of diabetes is increasing year by year. At present, diabetes has become the most important chronic non-infectious disease that seriously endangers human health after tumors and cardiovascular diseases. The global investment in diabetes treatment is increasing year by year, and there are more and more reports at home and abroad on the research and development of hypoglycemic drugs and the research on the mechanism of hypoglycemia.

目前,普遍使用的降糖药物以西药为主,主要有胰岛素及其类似物、磺脲酰类促泌剂、二甲双胍类、α-葡萄糖苷酶抑制剂、噻唑烷二酮类衍生物促敏剂、苯茴酸类衍生物促泌剂、GLP-1受体激动剂和DDP-4酶抑制剂八大类。这些药物虽然能够有效降低血糖,但西药的价格较为昂贵,且长期服用易出现不良反应。因此,开发一种具有良好降糖效果的中成药是十分必要的。At present, the commonly used hypoglycemic drugs are mainly western medicines, mainly insulin and its analogs, sulfonylurea secretagogues, metformin, α-glucosidase inhibitors, thiazolidinedione derivatives sensitizers , phenylanilic acid derivatives secretagogues, GLP-1 receptor agonists and DDP-4 enzyme inhibitors eight categories. Although these medicines can effectively lower blood sugar, the price of western medicine is relatively expensive, and adverse reactions are prone to occur in long-term use. Therefore, it is very necessary to develop a Chinese patent medicine with good hypoglycemic effect.

发明内容Contents of the invention

有鉴于此,本发明的目的在于提供一种治疗糖尿病的中药组合物及其制备方法和应用,本发明提供的中药组合物具有良好的降糖效果。In view of this, the object of the present invention is to provide a traditional Chinese medicine composition for treating diabetes and its preparation method and application. The traditional Chinese medicine composition provided by the present invention has a good hypoglycemic effect.

本发明提供了一种中药组合物,由包括以下重量份组分的原料制成:The invention provides a traditional Chinese medicine composition, which is made of raw materials comprising the following components in parts by weight:

山茱萸 45~60份;Cornus officinalis 45-60 parts;

白芍 20~35份;Radix Paeoniae Alba 20~35 parts;

黄芪 20~35份。Astragalus 20-35 parts.

优选的,所述中药组合物由包括以下重量份的组分组成:山茱萸46~60份、白芍21~34份与黄芪21~34份。Preferably, the traditional Chinese medicine composition is composed of the following components in parts by weight: 46-60 parts of Cornus officinalis, 21-34 parts of Radix Paeoniae Alba and 21-34 parts of Radix Astragali.

优选的,所述中药组合物由包括以下重量份的组分组成:山茱萸47~58份、白芍22~34份与黄芪22~34份。Preferably, the traditional Chinese medicine composition is composed of the following components in parts by weight: 47-58 parts of Cornus officinalis, 22-34 parts of Radix Paeoniae Alba and 22-34 parts of Radix Astragali.

本发明提供了一种上述技术方案所述中药组合物的制备方法,包括以下步骤:The present invention provides a kind of preparation method of Chinese medicine composition described in above-mentioned technical scheme, comprises the following steps:

用醇类溶剂对原料进行提取后,对提取液进行浓缩,得到中药组合物。After the raw material is extracted with alcohol solvent, the extract is concentrated to obtain the traditional Chinese medicine composition.

优选的,所述醇类溶剂包括乙醇。Preferably, the alcoholic solvent includes ethanol.

优选的,所述原料与醇类溶剂的体积比为1:(8~10)。Preferably, the volume ratio of the raw material to the alcohol solvent is 1:(8-10).

优选的,所述提取的方式为回流提取。Preferably, the extraction method is reflux extraction.

优选的,所述中药组合物在25℃下的相对密度为1.15~1.35。Preferably, the relative density of the traditional Chinese medicine composition at 25°C is 1.15-1.35.

本发明提供了一种中药制剂,由上述技术方案所述的中药组合物或上述技术方案所述方法制备的中药组合物,和药学上可接受的辅料制成。The invention provides a traditional Chinese medicine preparation, which is made from the traditional Chinese medicine composition described in the above technical scheme or the traditional Chinese medicine composition prepared by the method described in the above technical scheme, and pharmaceutically acceptable auxiliary materials.

上述技术方案所述的中药组合物或上述技术方案所述方法制备的中药组合物在制备治疗糖尿病药物中的应用。Application of the traditional Chinese medicine composition described in the above technical scheme or the traditional Chinese medicine composition prepared by the method described in the above technical scheme in the preparation of medicines for treating diabetes.

与现有技术相比,本发明提供了一种治疗糖尿病的中药组合物及其制备方法和应用。该中药组合物由包括以下重量份组分的原料制成:山茱萸45~60份;白芍20~35份;黄芪20~35份。在本发明中,山茱萸补益肝肾、收敛固涩;白芍平抑肝阳、敛阴收汗;黄芪补气升阳、固表止汗;将上述几种物质按照君臣佐使进行复配,相互作用,具有降糖止渴、活血化瘀、益气健脾的功效,从多个角度达到降血糖、治疗糖尿病的目的,具有较好的效果。实验结果表明,本发明提供的中药组合物对糖尿病小鼠的降糖效果优于阿卡波糖和类似组成的中药组合物。Compared with the prior art, the invention provides a traditional Chinese medicine composition for treating diabetes and its preparation method and application. The traditional Chinese medicine composition is prepared from raw materials including the following components in parts by weight: 45-60 parts of cornus officinalis; 20-35 parts of white peony; and 20-35 parts of astragalus. In the present invention, Cornus officinalis nourishes liver and kidney, astringes and solidifies astringency; Radix Paeoniae Alba suppresses liver yang, restrains yin and absorbs sweat; Astragalus nourishes qi and promotes yang, strengthens surface and stops sweating; the above-mentioned several substances are compounded and interacted with each other according to the orders of the monarchs and ministers. It has the effects of lowering blood sugar and quenching thirst, promoting blood circulation and removing blood stasis, replenishing qi and invigorating the spleen, and achieves the purpose of lowering blood sugar and treating diabetes from multiple angles, and has good effects. Experimental results show that the hypoglycemic effect of the traditional Chinese medicine composition provided by the invention on diabetic mice is better than that of acarbose and traditional Chinese medicine compositions with similar compositions.

具体实施方式detailed description

下面对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。The following clearly and completely describes the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only some of the embodiments of the present invention, but not all of them. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts belong to the protection scope of the present invention.

本发明提供了一种中药组合物,由包括以下重量份组分的原料制成:The invention provides a traditional Chinese medicine composition, which is made of raw materials comprising the following components in parts by weight:

山茱萸 45~60份;Cornus officinalis 45-60 parts;

白芍 20~35份;Radix Paeoniae Alba 20~35 parts;

黄芪 20~35份。Astragalus 20-35 parts.

其中,本发明对所有原料的来源并没有特殊的限制,为市售即可。Among them, the present invention has no special limitation on the sources of all raw materials, which can be commercially available.

本发明提供的中药组合物的原料包括山茱萸、白芍和黄芪。其中,山茱萸科植物山茱萸的干燥成熟果肉。酸、涩、微温、归肝、肾经;可补益肝肾,涩精固脱。其药理作用主要表现在降血糖、抑菌、抑制血小板凝集等方面。在本发明中,所述山茱萸在原料中的含量为45~60重量份,优选为46~60重量份,更优选为47~58重量份,具体可为47.5重量份、48重量份、50重量份、51重量份或55.5重量份。The raw materials of the traditional Chinese medicine composition provided by the invention include Cornus officinalis, Radix Paeoniae Alba and Radix Astragali. Among them, the dried and mature pulp of Cornus officinalis. Sour, astringent, lukewarm, returns to the liver and kidney meridians; it can nourish the liver and kidney, astringent essence and detoxification. Its pharmacological effects are mainly manifested in the aspects of lowering blood sugar, inhibiting bacteria, and inhibiting platelet aggregation. In the present invention, the content of the Cornus officinalis in raw materials is 45-60 parts by weight, preferably 46-60 parts by weight, more preferably 47-58 parts by weight, specifically 47.5 parts by weight, 48 parts by weight, 50 parts by weight parts, 51 parts by weight or 55.5 parts by weight.

在本发明中,白芍为毛莨科植物芍药的干燥根。味苦、酸,性微寒;归肝、脾经;具有养血调经,平抑肝阳等作用。在本发明中,所述白芍在原料中的含量为20~35重量份,优选为21~34重量份,更优选为22~34重量份,具体可为22重量份、23重量份、23.5重量份、25重量份或24.5重量份。In the present invention, Radix Paeoniae Alba is the dry root of Radix Paeoniae Alba. Bitter, sour, slightly cold in nature; returns to the liver and spleen meridian; has the effects of nourishing blood, regulating menstruation, and calming liver yang. In the present invention, the content of the Radix Paeoniae Alba in raw materials is 20 to 35 parts by weight, preferably 21 to 34 parts by weight, more preferably 22 to 34 parts by weight, specifically 22 parts by weight, 23 parts by weight, 23.5 parts by weight parts by weight, 25 parts by weight or 24.5 parts by weight.

在本发明中,黄芪为豆科植物蒙古黄芪或膜荚黄芪的干燥根。味甘,微温;归肺、脾经。具有补气升阳,固表止汗,利水消肿,生津养血等功效。在本发明中,所述黄芪在原料中的含量为20~35重量份,优选为21~34重量份,更优选为22~34重量份,具体可为22重量份、23重量份、23.5重量份、25重量份或24.5重量份。In the present invention, Astragalus is the dried root of the leguminous plant Astragalus mongolica or Astragalus membranaceus. Sweet in taste, slightly warm; returns lung, spleen meridian. It has the effects of invigorating qi and promoting yang, solidifying the surface and antiperspirant, diuretic and swelling, promoting body fluid and nourishing blood. In the present invention, the content of the astragalus in the raw material is 20-35 parts by weight, preferably 21-34 parts by weight, more preferably 22-34 parts by weight, specifically 22 parts by weight, 23 parts by weight, 23.5 parts by weight parts, 25 parts by weight or 24.5 parts by weight.

在本发明提供的一些实施例中,所述中药组合物由如下重量份的组分制成:山茱萸47.5重量份、白芍23.5重量份、黄芪23.5重量份。In some embodiments provided by the present invention, the traditional Chinese medicine composition is made of the following components by weight: 47.5 parts by weight of Cornus officinalis, 23.5 parts by weight of Radix Paeoniae Alba, and 23.5 parts by weight of Radix Astragali.

在本发明提供的一些实施例中,所述中药组合物由如下重量份的组分制成:山茱萸48重量份、白芍25重量份、黄芪25重量份。In some embodiments provided by the present invention, the traditional Chinese medicine composition is made of the following components by weight: 48 parts by weight of Cornus officinalis, 25 parts by weight of Radix Paeoniae Alba, and 25 parts by weight of Radix Astragali.

在本发明提供的一些实施例中,所述中药组合物由如下重量份的组分制成:山茱萸50重量份、白芍24.5重量份、黄芪24.5重量份。In some embodiments provided by the present invention, the traditional Chinese medicine composition is made of the following components by weight: 50 parts by weight of Cornus officinalis, 24.5 parts by weight of Radix Paeoniae Alba, and 24.5 parts by weight of Radix Astragali.

在本发明提供的一些实施例中,所述中药组合物由如下重量份的组分制成:山茱萸51重量份、白芍23重量份、黄芪23重量份。In some embodiments provided by the present invention, the traditional Chinese medicine composition is made of the following components by weight: 51 parts by weight of Cornus officinalis, 23 parts by weight of Radix Paeoniae Alba, and 23 parts by weight of Radix Astragali.

在本发明提供的另外一些实施例中,所述中药组合物由如下重量份的组分制成:山茱萸55.5重量份、白芍22重量份、黄芪22重量份。In some other embodiments provided by the present invention, the traditional Chinese medicine composition is made of the following components by weight: 55.5 parts by weight of Cornus officinalis, 22 parts by weight of Radix Paeoniae Alba, and 22 parts by weight of Radix Astragali.

本发明将山茱萸、白芍、黄芪的有效成分按照君臣佐使进行组方,山茱萸为君药,白芍、黄芪为臣药,其中,山茱萸补益肝肾、收敛固涩;白芍平抑肝阳、敛阴收汗;黄芪补气升阳、固表止汗。将上述几种物质按照君臣佐使进行复配,相互作用,具有降糖止渴、活血化瘀、益气健脾的功效,从多个角度达到降血糖、治疗糖尿病的目的,具有较好的效果。实验结果表明,本发明提供的中药组合物对糖尿病小鼠的降糖效果优于阿卡波糖和类似组成的中药组合物。In the present invention, the active ingredients of Cornus officinalis, Radix Paeoniae Alba, and Radix Astragalus are formulated according to the order of the emperor and ministers. Cornus officinalis is the monarch drug, and Radix Paeoniae Alba and Astragalus are the ministerial drugs. Among them, Cornus officinalis nourishes the liver and kidney, astringes and solidifies astringency; Radix Paeoniae Alba suppresses liver-yang and restrains yin. Sweating; Radix Astragali invigorates qi and raises yang, strengthens the surface and stops sweating. The above-mentioned several substances are compounded and interacted with each other according to the order of the emperor and ministers, and have the effects of lowering blood sugar and quenching thirst, promoting blood circulation and removing blood stasis, replenishing qi and invigorating the spleen, and achieving the goals of lowering blood sugar and treating diabetes from multiple angles, and have good effects. Experimental results show that the hypoglycemic effect of the traditional Chinese medicine composition provided by the invention on diabetic mice is better than that of acarbose and traditional Chinese medicine compositions with similar compositions.

本发明提供了一种上述技术方案所述中药组合物的制备方法,包括以下步骤:The present invention provides a kind of preparation method of Chinese medicine composition described in above-mentioned technical scheme, comprises the following steps:

用醇类溶剂对原料进行提取后,对提取液进行浓缩,得到中药组合物。After the raw material is extracted with alcohol solvent, the extract is concentrated to obtain the traditional Chinese medicine composition.

在本发明提供的制备方法中,首先用醇类溶剂对原料进行提取。其中,所述原料包括山茱萸、白芍和黄芪;所述醇类溶剂包括但不限于乙醇。在本发明提供的一个实施例中,所述醇类溶剂为体积浓度为65~75%的乙醇水溶液。在本发明中,所述原料与醇类溶剂的体积比优选为1:(8~10);所述提取的方式优选为回流提取;所述提取的时间优选为1.5~2h。在本发明中,优选用醇类溶剂对原料进行多次提取,提取的次数优选为2~3次。提取完毕后,得到提取液。In the preparation method provided by the invention, the raw materials are firstly extracted with an alcoholic solvent. Wherein, the raw materials include Cornus officinalis, Radix Paeoniae Alba and Radix Astragali; the alcohol solvent includes but not limited to ethanol. In one embodiment provided by the present invention, the alcohol solvent is an aqueous ethanol solution with a volume concentration of 65-75%. In the present invention, the volume ratio of the raw material to the alcohol solvent is preferably 1: (8-10); the extraction method is preferably reflux extraction; the extraction time is preferably 1.5-2 hours. In the present invention, the raw material is preferably extracted multiple times with an alcoholic solvent, and the number of extractions is preferably 2 to 3 times. After the extraction is completed, an extract is obtained.

得到提取液后,对所述提取液进行浓缩。其中,所述浓缩的方式优选为减压浓缩。本发明对所述浓度的时间没有特别限定,可将提取液浓缩到要求浓度即可。浓缩完毕后,得到中药组合物。在本发明提供的一个实施例中,所述中药组合物的相对密度为1.15~1.35。在本发明中,所述相对密度为在25℃时,相同压力条件下,中药组合物的密度与水的密度之比。After obtaining the extract, the extract is concentrated. Wherein, the method of concentration is preferably concentration under reduced pressure. The present invention has no special limitation on the concentration time, and the extract can be concentrated to the required concentration. After the concentration is completed, the traditional Chinese medicine composition is obtained. In an embodiment provided by the present invention, the relative density of the traditional Chinese medicine composition is 1.15-1.35. In the present invention, the relative density is the ratio of the density of the traditional Chinese medicine composition to the density of water at 25°C under the same pressure conditions.

采用本发明提供的方法能够制备得到具有良好的降糖效果的中药组合物。实验结果表明,采用本发明提供的方法制得的中药组合物对糖尿病小鼠的降糖效果优于阿卡波糖和类似组成的中药组合物。The traditional Chinese medicine composition with good hypoglycemic effect can be prepared by adopting the method provided by the invention. Experimental results show that the hypoglycemic effect of the traditional Chinese medicine composition prepared by the method provided by the invention on diabetic mice is better than that of acarbose and traditional Chinese medicine compositions with similar compositions.

本发明提供了一种中药制剂,由上述中药组合物及药学上可接受的辅料制成,所述辅料优选为可溶性淀粉、糊精、微晶纤维素、甘露醇、甜菊糖苷、硬脂酸镁中的一种或多种;所述中药制剂可为颗粒剂、胶囊剂或片剂。The invention provides a traditional Chinese medicine preparation, which is made of the above-mentioned traditional Chinese medicine composition and pharmaceutically acceptable auxiliary materials, and the auxiliary materials are preferably soluble starch, dextrin, microcrystalline cellulose, mannitol, steviol glycoside, and magnesium stearate One or more of them; the traditional Chinese medicine preparation can be granules, capsules or tablets.

本发明还提供了一种上述中药组合物在制备治疗糖尿病药物中的应用。The present invention also provides an application of the above-mentioned traditional Chinese medicine composition in the preparation of medicaments for treating diabetes.

为了进一步说明本发明,以下结合实施例对本发明提供的一种中药组合物、其制备方法及中药制剂进行详细描述。In order to further illustrate the present invention, a Chinese medicine composition provided by the present invention, its preparation method and Chinese medicine preparation are described in detail below in conjunction with the examples.

以下实施例中所用的试剂均为市售。The reagents used in the following examples are all commercially available.

实施例1Example 1

将山茱萸47.5重量份、白芍23.5重量份与黄芪23.5重量份混合,加入8~10倍体积的70%的乙醇,回流提取2~3次,每次1.5~2h,将提取的滤液混合,减压浓缩制成浓度为0.165g生药/mL的药液,药液相对密度为1.15~1.35(25℃)。Mix 47.5 parts by weight of Cornus officinalis, 23.5 parts by weight of Radix Paeoniae Alba and 23.5 parts by weight of Radix Astragali, add 8 to 10 times the volume of 70% ethanol, reflux extraction for 2 to 3 times, each time for 1.5 to 2 hours, mix the extracted filtrate, reduce Concentrate under pressure to make a medicinal solution with a concentration of 0.165g crude drug/mL, and the relative density of the medicinal solution is 1.15-1.35 (25°C).

比较例1Comparative example 1

将山茱萸70重量份、白芍15重量份与黄芪15重量份混合,加入8~10倍体积的70%的乙醇,回流提取2~3次,每次1.5~2h,将提取的滤液混合,减压浓缩制成浓度为0.165g生药/mL的药液,药液相对密度为1.15~1.35(25℃)。Mix 70 parts by weight of Cornus officinalis, 15 parts by weight of Radix Paeoniae Alba and 15 parts by weight of Astragalus membranaceus, add 8 to 10 times the volume of 70% ethanol, reflux and extract for 2 to 3 times, each time for 1.5 to 2 hours, mix the extracted filtrate, reduce Concentrate under pressure to make a medicinal solution with a concentration of 0.165g crude drug/mL, and the relative density of the medicinal solution is 1.15-1.35 (25°C).

将比较例1中得到的中药组合物与实施例1中得到的中药组合物进行治疗糖尿病药效比较,具体实验过程如下:The Chinese medicine composition obtained in Comparative Example 1 is compared with the Chinese medicine composition obtained in Example 1 for treating diabetes, and the specific experimental process is as follows:

药效学考察实验:Pharmacodynamic investigation experiment:

实验动物:雄性昆明小鼠,体重20±2g,由吉林大学实验动物中心提供。Experimental animals: male Kunming mice, weighing 20±2g, provided by the Experimental Animal Center of Jilin University.

实验药物:实施例1中得到的药液;比较例1中得到的药液;Experimental drug: the medicinal solution obtained in Example 1; the medicinal solution obtained in Comparative Example 1;

阳性对照:阿卡波糖;Positive control: acarbose;

实验分组和造模:糖尿病模型,将50只小鼠随机分为正常组10只,造模组40只,禁食12小时,腹腔注射STZ 50mg/kg(每日一次,连续5天),于造模7天后剪尾取血测血糖值(测前禁食过夜),大于16mmol/L则造模成功,造成糖尿病模型;Experimental grouping and modeling: Diabetic model, 50 mice were randomly divided into normal group 10, model group 40, fasted for 12 hours, intraperitoneal injection of STZ 50mg/kg (once a day, 5 consecutive days), in After 7 days of modeling, cut the tail and take blood to measure the blood sugar value (fasting overnight before the test), if it is greater than 16mmol/L, the modeling is successful and a diabetic model is formed;

实验给药:将造模组随机分为模型组、中药组合物给药组与阳性对照组。分别灌胃给药实施例1中得到的中药液、比较例1中得到的中药液和阳性药阿卡波糖,每天一次,连续7天,于第7天给药前禁食12h,给药后1h后测定小鼠血糖值。Experimental administration: the modeling group was randomly divided into a model group, a Chinese medicine composition administration group and a positive control group. The Chinese medicinal liquid obtained in Example 1, the Chinese medicinal liquid obtained in Comparative Example 1, and the positive drug acarbose were administered by intragastric administration, once a day, for 7 consecutive days, and fasted for 12 hours before administration on the 7th day. The blood glucose level of the mice was measured 1 h after administration.

按表1所示,各组小鼠每天给药1次,7天后,于第7天给药前禁食12h,给药后1h后测定小鼠血糖,结果如表2所示:As shown in Table 1, the mice in each group were administered once a day. After 7 days, they were fasted for 12 hours before the administration on the 7th day, and the blood glucose of the mice was measured 1 hour after the administration. The results are shown in Table 2:

表1 实验给药情况Table 1 Experimental drug administration

表2 给药后血糖及血糖降低百分率Table 2 Blood sugar and blood sugar reduction percentage after administration

实验结果表明,实施例1中制备的中药提取液作用较好,对糖尿病小鼠具有一定的降低血糖的作用。比较例1中制备的中药提取液对糖尿病小鼠治疗作用较弱,降糖程度较小。The experimental results show that the traditional Chinese medicine extract prepared in Example 1 has a better effect, and has a certain effect on lowering blood sugar in diabetic mice. The traditional Chinese medicine extract prepared in Comparative Example 1 has a weak therapeutic effect on diabetic mice, and the degree of hypoglycemia is small.

实施例2Example 2

将山茱萸48重量份、白芍25重量份与黄芪25重量份混合,加入8~10倍体积的70%的乙醇,回流提取2~3次,每次1.5~2h,将提取的滤液混合,减压浓缩至相对密度为1.15~1.35(25℃),得到中药组合物。Mix 48 parts by weight of Cornus officinalis, 25 parts by weight of Radix Paeoniae Alba and 25 parts by weight of Astragalus membranaceus, add 8 to 10 times the volume of 70% ethanol, reflux and extract for 2 to 3 times, each time for 1.5 to 2 hours, mix the extracted filtrate, reduce Concentrate under pressure until the relative density is 1.15-1.35 (25°C) to obtain the traditional Chinese medicine composition.

按照上文实验方法进行药效学考察实验,除不设置比较例1之外,实验给药情况于表1一致,于第7天给药前禁食12h,给药后1h后测定小鼠血糖,结果如表3所示:According to the above experimental method, the pharmacodynamic investigation experiment was carried out. Except that Comparative Example 1 was not set, the experimental administration was consistent with Table 1. On the 7th day, before the administration, fasting was performed for 12 hours, and the blood glucose of the mice was measured 1 hour after the administration. , the results are shown in Table 3:

表3 给药后血糖及血糖降低百分率Table 3 Blood sugar and blood sugar reduction percentage after administration

通过表中数据可以看出,实施例2制备的中药组合物对糖尿病小鼠具有较好的降低血糖的作用。It can be seen from the data in the table that the traditional Chinese medicine composition prepared in Example 2 has a better effect of lowering blood sugar on diabetic mice.

实施例3Example 3

将山茱萸50重量份、白芍24.5重量份与黄芪24.5重量份混合,加入8~10倍体积的70%的乙醇,回流提取2~3次,每次1.5~2h,将提取的滤液混合,减压浓缩至相对密度为1.15~1.35(25℃),得到中药组合物。再加入糊精(与中药组合物重量比为160%,即100g中药组合物加入160g糊精),甜菊糖苷(与糊精重量比为1%)等辅料混合均匀,制软材,过14目筛制粒,60~65℃干燥2h,过14目筛整粒,得到中药制剂颗粒剂。Mix 50 parts by weight of Cornus officinalis, 24.5 parts by weight of Radix Paeoniae Alba and 24.5 parts by weight of Astragalus membranaceus, add 8 to 10 times the volume of 70% ethanol, reflux extraction for 2 to 3 times, each time for 1.5 to 2 hours, mix the extracted filtrate, reduce Concentrate under pressure until the relative density is 1.15-1.35 (25°C) to obtain the traditional Chinese medicine composition. Then add dextrin (with the weight ratio of the traditional Chinese medicine composition being 160%, that is, 100g of the traditional Chinese medicine composition adds 160g of dextrin), steviol glycoside (with the weight ratio of the dextrin is 1%) and other auxiliary materials are mixed evenly, and the soft material is passed through 14 mesh Sieve and granulate, dry at 60-65°C for 2 hours, pass through a 14-mesh sieve for granulation, and obtain traditional Chinese medicine preparation granules.

按照上文实验方法进行药效学考察实验,除不设置比较例1之外,实验给药情况于表1一致,于第7天给药前禁食12h,给药后1h后测定小鼠血糖,结果如表4所示:According to the above experimental method, the pharmacodynamic investigation experiment was carried out. Except that Comparative Example 1 was not set, the experimental administration was consistent with Table 1. On the 7th day, before the administration, fasting was performed for 12 hours, and the blood glucose of the mice was measured 1 hour after the administration. , the results are shown in Table 4:

表4 给药后血糖及血糖降低百分率Table 4 Blood sugar and blood sugar reduction percentage after administration

通过表中数据可以看出,实施例3制备的中药颗粒剂对糖尿病小鼠具有较好的降低血糖的作用。It can be seen from the data in the table that the traditional Chinese medicine granules prepared in Example 3 have a better effect of lowering blood sugar on diabetic mice.

实施例4Example 4

将山茱萸51重量份、白芍23重量份与黄芪23重量份混合,加入8~10倍体积的70%的乙醇,回流提取2~3次,每次1.5~2h,将提取的滤液混合,减压浓缩至相对密度为1.15~1.35(25℃),得到中药组合物。再加入糊精(与中药组合物重量比为85%),可溶性淀粉(与中药组合物重量比为75%)混合均匀,制颗粒,干燥整粒,填装胶囊,得到中药制剂胶囊剂。Mix 51 parts by weight of Cornus officinalis, 23 parts by weight of Radix Paeoniae Alba and 23 parts by weight of Astragalus membranaceus, add 8 to 10 times the volume of 70% ethanol, reflux and extract for 2 to 3 times, each time for 1.5 to 2 hours, mix the extracted filtrate, reduce Concentrate under pressure until the relative density is 1.15-1.35 (25°C) to obtain the traditional Chinese medicine composition. Then add dextrin (85% by weight with the traditional Chinese medicine composition), mix evenly with soluble starch (75% by weight with the traditional Chinese medicine composition), make granules, dry and granulate, fill capsules, and obtain Chinese medicine preparation capsules.

按照上文实验方法进行药效学考察实验,除不设置比较例1之外,实验给药情况于表1一致,于第7天给药前禁食12h,给药后1h后测定小鼠血糖,结果如表5所示:According to the above experimental method, the pharmacodynamic investigation experiment was carried out. Except that Comparative Example 1 was not set, the experimental administration was consistent with Table 1. On the 7th day, before the administration, fasting was performed for 12 hours, and the blood glucose of the mice was measured 1 hour after the administration. , the results are shown in Table 5:

表5 给药后血糖及血糖降低百分率Table 5 Blood sugar and blood sugar reduction percentage after administration

通过表中数据可以看出,实施例4制备的中药胶囊剂对糖尿病小鼠具有较好的降低血糖的作用。It can be seen from the data in the table that the traditional Chinese medicine capsule prepared in Example 4 has a better effect of lowering blood sugar on diabetic mice.

实施例5Example 5

将山茱萸55.5重量份、白芍22重量份与黄芪22重量份混合,加入8~10倍体积的70%的乙醇,回流提取2~3次,每次1.5~2h,将提取的滤液混合,减压浓缩至相对密度为1.15~1.35(25℃),得到中药组合物。再加入糊精(与中药组合物重量比为137%)、微晶纤维素(与中药组合物重量比为14%)、甘露醇(与中药组合物重量比为8%)、甜菊糖苷(与中药组合物重量比为1%)等辅料混合均匀,制颗粒,干燥整粒,加入硬脂酸镁(与中药组合物总重量比为1%)压片,得到中药制剂片剂。Mix 55.5 parts by weight of Cornus officinalis, 22 parts by weight of Radix Paeoniae Alba and 22 parts by weight of Astragalus membranaceus, add 8 to 10 times the volume of 70% ethanol, reflux and extract for 2 to 3 times, each time for 1.5 to 2 hours, mix the extracted filtrate, reduce Concentrate under pressure until the relative density is 1.15-1.35 (25°C) to obtain the traditional Chinese medicine composition. Then add dextrin (with the weight ratio of Chinese medicine composition is 137%), microcrystalline cellulose (with the weight ratio of Chinese medicine composition is 14%), mannitol (with the weight ratio of Chinese medicine composition is 8%), steviol glycoside (with the weight ratio of Chinese medicine composition is 8%), The traditional Chinese medicine composition is 1% by weight) and other auxiliary materials are mixed evenly, granulated, dried and granulated, magnesium stearate (1% by weight of the traditional Chinese medicine composition) is added and compressed into tablets to obtain Chinese medicine preparation tablets.

按照上文实验方法进行药效学考察实验,除不设置比较例1之外,实验给药情况于表1一致,于第7天给药前禁食12h,给药后1h后测定小鼠血糖,结果如表6所示:According to the above experimental method, the pharmacodynamic investigation experiment was carried out. Except that Comparative Example 1 was not set, the experimental administration was consistent with Table 1. On the 7th day, before the administration, fasting was performed for 12 hours, and the blood glucose of the mice was measured 1 hour after the administration. , the results are shown in Table 6:

表6 给药后血糖及血糖降低百分率Table 6 Blood sugar and blood sugar reduction percentage after administration

通过表中数据可以看出,实施例5制备的中药片剂对糖尿病小鼠具有较好的降低血糖的作用。It can be seen from the data in the table that the traditional Chinese medicine tablet prepared in Example 5 has a better effect of lowering blood sugar on diabetic mice.

以上所述仅是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明原理的前提下,还可以做出若干改进和润饰,这些改进和润饰也应视为本发明的保护范围。The above is only a preferred embodiment of the present invention, it should be pointed out that, for those of ordinary skill in the art, without departing from the principle of the present invention, some improvements and modifications can also be made, and these improvements and modifications can also be made. It should be regarded as the protection scope of the present invention.

Claims (10)

1. a kind of Chinese medicine composition, is made up of the raw material including following parts by weight of component:
45~60 parts of Fructus Corni;
20~35 parts of the Radix Paeoniae Alba;
20~35 parts of the Radix Astragali.
2. Chinese medicine composition according to claim 1, it is characterised in that be made up of the component including following weight portion:Mountain 21~34 parts of 46~60 parts of the Fructus Evodiae, 21~34 parts of the Radix Paeoniae Alba and the Radix Astragali.
3. Chinese medicine composition according to claim 2, it is characterised in that be made up of the component including following weight portion:Mountain 22~34 parts of 47~58 parts of the Fructus Evodiae, 22~34 parts of the Radix Paeoniae Alba and the Radix Astragali.
4. a kind of preparation method of Chinese medicine composition described in claim 1, comprises the following steps:
After being extracted to raw material with alcohols solvent, extracting solution is concentrated, obtain Chinese medicine composition.
5. preparation method according to claim 4, it is characterised in that the alcohols solvent includes ethanol.
6. preparation method according to claim 4, it is characterised in that the raw material is 1 with the volume ratio of alcohols solvent:(8 ~10).
7. preparation method according to claim 4, it is characterised in that the mode of the extraction is reflux, extract,.
8. the preparation method according to any one of claim 4~7, it is characterised in that the Chinese medicine composition is at 25 DEG C Relative density be 1.15~1.35.
9. a kind of Chinese medicine preparation, the Chinese medicine composition or claim 4~8 by described in claims 1 to 3 any one are any one Chinese medicine composition prepared by methods described, and pharmaceutically acceptable adjuvant makes.
10. it is prepared by Chinese medicine composition or claim 4~8 any one methods described described in claims 1 to 3 any one Chinese medicine composition prepare treatment diabetes medicament in application.
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Publication number Priority date Publication date Assignee Title
CN102274482A (en) * 2011-08-19 2011-12-14 张丙焕 Chinese medicinal preparation for treating diabetes
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CN104013803A (en) * 2014-05-20 2014-09-03 柳晖 Traditional Chinese medicine composition for treating diabetes
CN104027450A (en) * 2014-06-26 2014-09-10 粟春生 Traditional Chinese medicine composition for treating diabetes
CN102631526B (en) * 2011-02-14 2015-07-15 王宇红 Chinese medicinal composition for treating diabetes mellitus
CN104800758A (en) * 2015-04-30 2015-07-29 淄博齐鼎立专利信息咨询有限公司 Traditional Chinese medicine for reducing blood glucose
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CN102631526B (en) * 2011-02-14 2015-07-15 王宇红 Chinese medicinal composition for treating diabetes mellitus
CN102274482A (en) * 2011-08-19 2011-12-14 张丙焕 Chinese medicinal preparation for treating diabetes
CN102302673A (en) * 2011-09-02 2012-01-04 西南大学 Traditional Chinese medicine compound preparation for preventing and treating diabetic nephropathy (DN)
CN104013803A (en) * 2014-05-20 2014-09-03 柳晖 Traditional Chinese medicine composition for treating diabetes
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Application publication date: 20170322