WO2008122174A1 - Préparation médicamenteuse chinoise destinée à traiter et à prevenir le diabète et ses complications, à améliorer l'immunité vis-à-vis du diabète et de ses complications ainsi que leur traitement - Google Patents

Préparation médicamenteuse chinoise destinée à traiter et à prevenir le diabète et ses complications, à améliorer l'immunité vis-à-vis du diabète et de ses complications ainsi que leur traitement Download PDF

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Publication number
WO2008122174A1
WO2008122174A1 PCT/CN2007/003893 CN2007003893W WO2008122174A1 WO 2008122174 A1 WO2008122174 A1 WO 2008122174A1 CN 2007003893 W CN2007003893 W CN 2007003893W WO 2008122174 A1 WO2008122174 A1 WO 2008122174A1
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parts
chinese medicine
add
preparation
medicine preparation
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PCT/CN2007/003893
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English (en)
Chinese (zh)
Inventor
Guanxiang Li
Ruixiang Zhang
Jianxun Liu
Yan Tong
Xianchang Li
Chuanji Zhang
Jiming Yao
Original Assignee
Tangbeining Medicine Science And Technology (Beijing) Co Ltd.
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Application filed by Tangbeining Medicine Science And Technology (Beijing) Co Ltd. filed Critical Tangbeining Medicine Science And Technology (Beijing) Co Ltd.
Publication of WO2008122174A1 publication Critical patent/WO2008122174A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/232—Angelica
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/35—Caprifoliaceae (Honeysuckle family)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/70—Polygonaceae (Buckwheat family), e.g. spineflower or dock
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • A61K36/718—Coptis (goldthread)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/80—Scrophulariaceae (Figwort family)
    • A61K36/804—Rehmannia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/80—Scrophulariaceae (Figwort family)
    • A61K36/808—Scrophularia (figwort)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8964—Anemarrhena
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants

Definitions

  • the invention relates to a pure traditional Chinese medicine preparation, in particular to a novel pure Chinese medicine preparation for treating and preventing diabetes and its complications and improving immunity.
  • Diabetes complications have a high mortality rate. At present, there are more than 200 million people with diabetes in the world, and the number of people dying from complications every year has exceeded 3.2 million (2003 WHO data statistics).
  • Traditional Chinese medicine has mainly treated syndrome differentiation and treatment of diabetic complications. There have been many reports of Chinese medicine treatment of diabetes in recent years, but there are relatively few reports on treatment complications. At present, domestic folks also use pure Chinese medicine prescriptions to treat diabetes and complications, but it is still in the initial understanding that only patients with disease treatment are treated with soil single prescription. Modern medicine mostly uses oral hypoglycemic agents and antibacterial liquids for the treatment of diabetic complications. The purpose is to control blood sugar and control the deterioration of complications. There are not many effective methods. Once the blood sugar control fails, amputation is mostly used.
  • Amputation is not only expensive, but most patients cannot heal after a long time or they can't heal at all, which brings more pain to the patient, and even sees the patient's lifelong disability or death.
  • the research and application of biological agents for diabetes and its complications has aroused widespread concern among scholar, researchers and people in the industry. With the deepening of research on pure Chinese medicine and biological drugs, people treat diabetes and concomitant with modern western medicine. The understanding of the symptoms caused by the disease and the side effects caused by it are becoming more and more clear. If you simply take metformin, the hypoglycemic effect will be obvious for a while, but long-term use will not only reduce blood sugar, but also complications or illness.
  • the object of the present invention is to provide a formulation of a novel pure Chinese medicine preparation and a preparation method thereof, which can effectively improve the shortcomings of the current medicine for treating and preventing diabetes.
  • the invention has the advantages of low cost, effective treatment and prevention of various complications of diabetics, and can improve the immunity of diabetics and prolong the life of diabetics.
  • the specific embodiment is 666 ⁇ 668 parts of Angelica, 666 68 parts, 332-334 pieces of Lonicera japonica, 332-334 parts of Rehmannia glutinosa, 332-334 parts of honeysuckle, 166-168 parts of safflower, licorice 166-168 166-168 parts of Scrophulariae, 499-501 parts of Rhizoma Coptidis, 499-501 parts of Rhizoma Coptidis, the specific production method is as follows: Take 1/3 of the fine powder of 666-668 parts of Angelica, and take 2/3 of the amount of 666-668 parts of Angelica 666-668 parts of mother, 332-334 pieces of Lonicera japonica, 332-334 parts of Rehmannia glutinosa, 332-334 parts of honeysuckle, 166-168 parts of Scrophularia sinensis, 166-168 parts of Shuihuazi, 166-168 parts of licorice, 499-
  • the temperature of the vacuum drying paste should be controlled below 70 degrees Celsius.
  • the dry paste is pulverized into fine powder and added to the amount of 1/3 of 666-668 parts of the angelica, and the dextrin is added to 1000g, and the hard fat is added.
  • Magnesium magnesium 3g mixed dry pressed to make 18-60 mesh particles.
  • the invention has low cost, can effectively treat diabetes and various complications, and has good curative effect especially for various complications of diabetes.
  • the pure Chinese medicine preparation of the present invention can be prepared into various clinical pharmaceutical dosage forms, including oral preparations or parenteral dosage forms, and the oral preparations can be tablets, capsules, pills, granules. Any one of a suspension, a dropping, an oral liquid, and the like; the parenteral dosage form may be one of an injection, an aerosol, a suppository, or a subcutaneous dosage form, and the like. .
  • a rat model of experimental diabetes was induced by intraperitoneal injection of streptozotocin (STZ) 55 mg/kg. After 7 days, skin damage was further induced on this model to form a model of experimental diabetic rat skin ulcer. Continuous intragastric administration for 4 weeks.
  • the results showed that the wound healing rates of the three dose groups (0.81g/kg), medium (1.62g kg) and large (3.24g/kg) reached 89.68%, 89.98% and 89.69%, respectively, compared with the model group. The difference was significant (both P ⁇ 0.001). It is suggested that the drug granule has a strong skin healing effect on the ulcer model of experimental diabetic rats.
  • the experimental diabetic rat model was induced by intraperitoneal injection of streptozotocin (STZ) 50 mg/kg. Continuous intragastric administration for 6 weeks.
  • STZ streptozotocin
  • the results showed that the drug doses of small (0.81g / kg), medium (1.62g / kg), large (3.24g / kg) three dose groups compared with the model group have different degrees of blood glucose lowering, especially in large doses (3.24g/kg) group is more obvious (P ⁇ 0. 05-0. 01 ).
  • the experiment was performed in a mouse model of experimental diabetes with a total intravenous injection of 70 mg/kg of alloxan. Continuous intragastric administration for 8 weeks.
  • the results showed that the trend of lowering blood glucose in the drug granules (4.68g kg) group was significantly different from that in the model group (P ⁇ 0.01), while the small (0.81g/kg) and medium (1.62g kg) dose groups were lower.
  • the trend of blood sugar is not obvious.
  • the liquid sample dilution method was used to determine the inhibitory effect of the dry powder of the drug particles on six common pathogenic bacteria of 46 strains.
  • the results showed that the drug inhibited Staphylococcus aureus, Staphylococcus epidermidis and Proteus, and the inhibition rates were 90, 70 and 60% respectively.
  • Pseudomonas aeruginosa, Escherichia coli and Streptococcus sanguis did not inhibit, and the total inhibition rate was The ratio was 41.3% and the MICso was 28.42 mg/ml.
  • the experiment was carried out by injecting 15% high molecular weight dextrose into the auricle microcirculation obstruction model in mice, and the effect of the drug particles on the blood flow of the auricle microcirculation was observed.
  • the results showed that the drug group with small (U7g kg) and large (4.68g/kg) doses significantly improved the flow pattern of the auricle microcirculation in mice during the 20min and 30m infusion periods, which was significantly different from the control group. P ⁇ 0. 05- 0. 01). It is suggested that the drug particles have obvious improvement on the auricle microcirculation disorder.
  • the experiment used xylene to cause an acute inflammation model of mouse ear swelling.
  • the results showed that the ear swelling rate of the three dose groups of small (1.17g kg), medium (2.34g kg) and large (4.68g/kg) was significantly reduced. The difference was significant compared with the model group (both P ⁇ 0.05). It is suggested that the drug granule has anti-acute inflammatory effects.
  • the experiment used an acute inflammation model of rat foot spasm caused by carrageenan, and was administered by intragastric administration for 3 days.
  • the results showed that the small (0.81g kg), medium (1.62g/kg), and large (3.24g kg) dose groups had less swelling of the foot at different time points than the control group, with a large dose (3.24g).
  • the inhibition effect of the /kg) group was the most obvious at the 2h, 3h, and 4h time points, and the difference was significant compared with the control group ( ⁇ 0.05, ⁇ 0. 01, ⁇ 0.05). It is suggested that the drug granule has a strong anti-inflammatory effect. 3. Effect on rat granuloma
  • the animal model of rat cotton granuloma was used for continuous administration for 10 days.
  • the results showed that the drug group with small (0.81g/kg), medium (1.62g/kg) and large (3.24g/kg) doses significantly reduced the wet weight and dry weight of granuloma, which was significantly different from the control group. P ⁇ 0.01.). It is suggested that the drug granules have a significant inhibitory effect on the chronic inflammatory model of rat granuloma.
  • xylene was used as an inflammatory agent, which caused an increase in capillary permeability in mice, resulting in an early model of exudative inflammation, which was administered by intragastric administration for three days.
  • the results showed that the three doses of the drug granules could reduce the capillary permeability of the mice, especially in the large dose (4.68g kg) group, and the difference was significant compared with the control group (both P ⁇ 0.05). It is suggested that the drug granule has a strong inhibitory effect on early exudation of inflammation.
  • the foot of the mouse was exposed to the hot plate, and the pain response ( ⁇ hind foot) was used as an index after the heat stimulation.
  • the pain threshold of the mice at different time points after administration was observed and administered by gavage for three days. the result shows, The three dose groups of small (1.17g/kg), medium (2.34g/kg) and large (4.68g/kg) could significantly prolong the pain threshold of mice at 90 minutes after administration, which was significantly different from the control group.
  • Test example The effect of pure Chinese medicine preparation on promoting wound healing of diabetic complications
  • mice were fasted for 18 hours, according to streptozotocin 55 mg/kg, with 0. lmol/L citrate buffer (pH 4.2) formulated into a 1% solution, caused by intraperitoneal injection.
  • 6m mo l / L (300mg / dl) as a standard for diabetes modeling animals were randomly divided into 5 groups, each group of 10-11, (1) blank control group, (2) Model group, (3) small dose (0.81g/kg) group, (4) medium dose (1.62g/kg) group, (5) large dose (3.24g kg) group, (6) positive control drug Rehabilitation new fluid (3ml/kg) group.
  • the wound skin was taken for pathological examination, histopathological examination was performed, and fibroblasts and inflammatory cells were used as observation indexes.
  • the experimental data were statistically processed according to the reference difference method.
  • the experimental results showed that the three-dose group of small, medium and large doses of 4 weeks of administration had a strong effect on promoting the wound healing of experimental diabetic rats.
  • the wound healing rate was 89.68%, 89.98%, respectively. 89. 69%; Histopathological examination showed that the rat ulcer model was relieved compared with the model group.
  • the reference drug rehabilitation new fluid also promotes the healing of skin wounds in experimental diabetic rats.

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  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Mycology (AREA)
  • Biotechnology (AREA)
  • Epidemiology (AREA)
  • Microbiology (AREA)
  • Medical Informatics (AREA)
  • Botany (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Immunology (AREA)
  • Diabetes (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Medicines Containing Plant Substances (AREA)

Abstract

L'invention concerne une préparation médicamenteuse chinoise destinée à traiter et à prévenir le diabète et ses complications, à améliorer l'immunité vis-à-vis du diabète et de ses complications ainsi que leur traitement. Ladite préparation est obtenue à l'aide de 666 à 668 parties de rhizoma anemarrhena asphodeloides Bge., 166 à 168 parties de radix scrophularia ningpoensis Hemsl, 332 à 334 parties de radix rehmannia glutinosa (Gaerth) Libosch, 499 à 501 parties de rhizoma coptis chinensis Franch., 166 à 168 parties de fructus polygonum orientalis L., 166 à 168 parties de radix glycyrrhiza uralensis Fisch., 332 à 334 parties de caulis lonicera japonica Thunb., 332 à 334 parties de flos lonicera japonica Thunb., 666 à 668 parties de radix angelica sinensis (Oliv.) Diels, en tant que matières premières.
PCT/CN2007/003893 2007-04-09 2007-12-29 Préparation médicamenteuse chinoise destinée à traiter et à prevenir le diabète et ses complications, à améliorer l'immunité vis-à-vis du diabète et de ses complications ainsi que leur traitement WO2008122174A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN200710065258.X 2007-04-09
CNA200710065258XA CN101032592A (zh) 2007-04-09 2007-04-09 一种新型纯中药制剂的配方及其制备方法

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WO2008122174A1 true WO2008122174A1 (fr) 2008-10-16

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PCT/CN2007/003893 WO2008122174A1 (fr) 2007-04-09 2007-12-29 Préparation médicamenteuse chinoise destinée à traiter et à prevenir le diabète et ses complications, à améliorer l'immunité vis-à-vis du diabète et de ses complications ainsi que leur traitement

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CN (1) CN101032592A (fr)
WO (1) WO2008122174A1 (fr)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103656111A (zh) * 2012-09-06 2014-03-26 唐贝宁医药科技（北京）有限公司 治疗并预防糖尿病足的内服中药制剂及制备方法
CN105194245A (zh) * 2014-06-16 2015-12-30 唐贝宁医药科技（北京）有限公司 治疗并预防糖尿病并发症心脑血管病变的内服中药制剂
CN105267588A (zh) * 2014-06-16 2016-01-27 唐贝宁医药科技（北京）有限公司 治疗并预防糖尿病并发症眼部病变的内服中药制剂
CN105311341A (zh) * 2014-07-30 2016-02-10 唐贝宁医药科技（北京）有限公司 一种同步治疗和预防“4高”的内服中药制剂
CN117482168A (zh) * 2023-11-29 2024-02-02 唐宁医药科技(济南)有限公司 一种归知糖疽制剂的制备方法
CN117298132B (zh) * 2023-11-30 2024-02-23 唐宁医药科技(济南)有限公司 一种归知糖疽有效成分配方在制备治疗糖尿病肾病药物中的应用
CN117777074A (zh) * 2023-12-13 2024-03-29 唐宁医药科技(济南)有限公司 一种归知糖疽有效成分配方的纯化方法

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1243006A (zh) * 1999-07-07 2000-02-02 陈大明 一种治疗糖尿病中药制剂

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1243006A (zh) * 1999-07-07 2000-02-02 陈大明 一种治疗糖尿病中药制剂

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