WO2021007933A1 - 五谷虫在用于治疗糖尿病中的应用 - Google Patents

五谷虫在用于治疗糖尿病中的应用 Download PDF

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WO2021007933A1
WO2021007933A1 PCT/CN2019/104316 CN2019104316W WO2021007933A1 WO 2021007933 A1 WO2021007933 A1 WO 2021007933A1 CN 2019104316 W CN2019104316 W CN 2019104316W WO 2021007933 A1 WO2021007933 A1 WO 2021007933A1
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grain
treatment
composition
diabetes
insects
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PCT/CN2019/104316
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English (en)
French (fr)
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华祥荣
黄英
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华祥荣
黄英
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Priority to US17/077,657 priority Critical patent/US11096970B2/en
Publication of WO2021007933A1 publication Critical patent/WO2021007933A1/zh
Priority to US17/409,063 priority patent/US20220008484A1/en

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    • 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
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56—Materials from animals other than mammals
    • A61K35/63—Arthropods
    • A61K35/64—Insects, e.g. bees, wasps or fleas
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/48—Drugs for disorders of the endocrine system of the pancreatic hormones
    • A61P5/50—Drugs for disorders of the endocrine system of the pancreatic hormones for increasing or potentiating the activity of insulin
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds

Definitions

  • the invention belongs to the technical field of food and medicine, and specifically relates to the application of a Chinese grain worm in the treatment of diabetes.
  • Insulin is a protein hormone. Insulin in the body is secreted by pancreatic ⁇ cells.
  • Pancreatic islet cells are classified into the following types according to their function of secreting hormones:
  • 2A cells ( ⁇ cells), which account for about 24% to 40% of pancreatic islet cells, secrete glucagon, which has the opposite effect of insulin and can increase blood sugar.
  • 3D cells which account for about 6% to 15% of the total islet cells, secrete growth hormone inhibitory hormones.
  • Diabetes In diabetic patients, due to various pathogenic factors such as viral infection, genetics, autoimmunity, etc., their pathophysiology is mainly due to the relative or absolute deficiency of insulin activity and the relative or absolute excess of glucagon activity, that is, B and A cells Caused by bilateral hormone dysfunction. Diabetes is a group of metabolic diseases characterized by hyperglycemia. Hyperglycemia is caused by defective insulin secretion or impaired biological effects, or both. The long-term high blood sugar in diabetes causes chronic damage and dysfunction of various tissues, especially eyes, kidneys, heart, blood vessels, and nerves. At present, there is no method in the world to restore and reverse the function of human insulin during the treatment of diabetes.
  • Grain insects are the dried larvae of the nymphalidae or other related insects.
  • the traditional Chinese medicine Wu Gu insects are also called rice worms, water nymphs, and Luo nymphs.
  • the insects are salty, sweet, and cold in nature and pass through the spleen and stomach.
  • the ingredients mainly contain protein, lysozyme, amino acids, and oils, with low toxicity, and have the functions of clearing heat and detoxification, eliminating accumulation and causing stagnation. It is recorded in "Compendium of Materia Medica” that it can be used to treat infantile malnutrition, malnutrition, fever, delirium, dysentery and vomiting. Therefore, the effective ingredients in the worms not only have antibacterial and antiviral effects, but also have antiparasitic, antioxidant, anti-aging, and anti-tumor effects.
  • patent CN107375825A discloses a medicine for the treatment of diabetes, which consists of edible alkali, ratworm, ants, grain insects, mulberry leaves, trichosanthes, gypsum, rehmannia, rehmannia glutinosa, medlar, mulberry, Gentiana, Red ginseng, American ginseng, pueraria lobata root, etc. are prepared according to a certain weight ratio.
  • the medicine of the present invention has the advantages of eliminating dampness and heat, dissolving food stagnation, invigorating kidney and essence, relaxing muscles and collaterals, relieving muscles and clearing heat, promoting body fluid and quenching thirst, invigorating lung yin, and clearing deficiency and fire.
  • Function used to treat diabetes with quick effect, good curative effect and no recurrence.
  • the grain insects used in the composition play a role in clearing heat and eliminating stagnation, and are a ministerial medicine.
  • Patent CN102335241A describes a medicine for the treatment of diabetes and hyperlipidemia, which is prepared from the following raw materials by weight: 6-10 parts of raw rhubarb, 3-10 parts of leech, 10-30 parts of grain insects, 10 parts of red yeast rice -30 servings, 10-15 servings of schisandra.
  • the medicinal effect is long-lasting and the curative effect is good.
  • the grain insects used in the composition are also added by using its salty cold to enter the spleen and stomach meridian, eliminate stagnation and clear heat, and have obvious lipid-lowering effects.
  • Patent CN108404088A describes a medicine for the treatment of type 2 diabetes, which is composed of the following raw materials in parts by weight: 30-80 parts of dried ginger, 150-220 parts of coptis, 150-220 parts of scutellaria, 20-45 parts of American ginseng, and trichosanthes 150-220 servings and 150-220 servings of grain insects.
  • TCM treatment clearing heat and reducing turbidity, replenishing qi and nourishing yin, it is used to treat the symptoms of thirst, liking for drinking, fatigue, lack of energy and lack of energy due to deficiency of both qi and yin. It is especially suitable for the treatment of qi and yin deficiency.
  • Type 2 diabetes with symptoms such as thirst, preference for drinking, fatigue, lack of breath and lazy speech.
  • the purpose of the present invention is to provide an application of the worm in the treatment of diabetes, specifically the application of the worm in the preparation of a composition for the treatment of diabetes.
  • the present invention provides an application of Wu Gu Chong in preparing a composition for treating diabetes.
  • the present invention provides an application of Wu Gu Chong in the preparation of a composition for regulating insulin levels.
  • the composition includes any one of medicines, health products, and foods.
  • the grain worms are used in the composition with any one of grain worm dry powder, grain worm wine infusion products or grain worm extracts.
  • the preparation method of the dried grain insect powder is as follows:
  • step A2 Soak and disinfect the whole grain worms treated in step A1, then rinse and drain;
  • the freeze-dried whole worms are pulverized at low temperature to obtain the dry powder of worms.
  • the disinfectant used in the immersion disinfection is a mixture of water and peracetic acid disinfection stock solution, and the immersion time is 10 minutes; more preferably, the volume ratio of water and peracetic acid disinfection stock solution is 1:400 .
  • the low-temperature freezing temperature is -20-50°C and the freezing time is 24h.
  • the preparation method of the five-grain insect wine product includes the following steps:
  • step B2 Soak and disinfect the whole worms after processing in step B1, then rinse and drain;
  • the disinfectant used in the immersion disinfection is a mixture of water and peracetic acid disinfection stock solution, and the immersion time is 10 minutes; more preferably, the volume ratio of water and peracetic acid disinfection stock solution is 1:400 .
  • the weight ratio of the whole worm and the wine is 0.2:0.8 to 0.4:0.6; the sealing time is more than 2 months.
  • the wine is pure grain wine with an alcohol content of 55°-70°.
  • the dosage form made by the Wu Gu Chong includes any one of capsules, tablets, pills, powders, compound granules, health wines, oral liquids or freeze-dried powders.
  • the grain worm extract includes one or more of the whole grain worm or the water extract or organic solvent extract of the grain worm dry powder.
  • the present invention also provides a method for treating diabetes based on the aforementioned composition, which includes the following steps:
  • each course of treatment is three months; the treatment method of each course of treatment is: two to three times a day, taking a composition containing grain insects, The dosage of the grain insects in the composition taken every day is 3000mg-30g.
  • the present invention also provides a method for regulating insulin levels based on the aforementioned composition, which includes the following steps:
  • each course of treatment is three months; the treatment method of each course of treatment is: two to three times a day, taking a composition containing grain insects, The dosage of the grain insects in the composition taken every day is 3000mg-30g.
  • the composition containing grain worms is used to treat 1-2 courses; the dosage of grain worms in the composition taken daily is 3000mg-15g;
  • the composition containing grain insects For patients with diagnosed diabetes, use the composition containing grain insects to treat 4-6 courses; the dosage of grain insects in the composition taken daily for the first 1-2 courses is 3000mg-30g, and the combination taken daily for the 2-6 courses The dosage of grain worms is 3000mg-15g.
  • the present invention has the following beneficial effects:
  • the grain insect product of the present invention is a natural product, and the effective ingredient of the grain insect product is the whole grain insect.
  • Modern medical research has proved that the grain insect contains protein, fat, chitosan, antibacterial peptide and various amino acids.
  • the grain worm freeze-dried powder of the present invention includes all the effective components of grain worm whole worm, and the grain worm extract is mainly composed of fatty acids and/or proteins, polypeptides, amino acids and the like. Studies have found that worms can effectively eliminate human insulin resistance and improve human insulin sensitivity. In the effect verification, it is found that patients taking worms for treatment can significantly eliminate insulin resistance in diabetic patients and greatly increase the insulin level of insulin-sensitive patients. The level of normal people, and Wu Gu insect does not have the drug resistance and toxic side effects of commonly used clinical chemotherapy drugs.
  • the five-grain insect product is made into a medicine, which is convenient to carry and take, and the clinical effective rate reaches 98%.
  • the patient has been discontinued and observed for more than five years after conventional treatment. The condition is stable and the blood sugar is normal.
  • Figure 1 is the sugar tolerance curve of the first verification example of the present invention.
  • Figure 2 is the insulin release curve of verification example 1 of the present invention.
  • Figure 3 is the sugar tolerance curve of the second verification example of the present invention.
  • Figure 4 is the insulin release curve of the second verification example of the present invention.
  • Fig. 6 is the sugar tolerance curve of verification example 4 of the present invention.
  • Fig. 7 is the insulin release curve of verification example 4 of the present invention.
  • the following example provides an application of Wu Gu Chong in the preparation of a composition for treating diabetes.
  • the following example provides an application of Wu Gu Chong in preparing a composition for regulating insulin levels.
  • the composition includes any one of medicines, health products and foods.
  • the grain worms are used in the composition with grain worm dry powder, grain worm wine soaked products or grain worm extract.
  • the preparation method of the dried five grain insect powder is as follows:
  • step A2 Soak and disinfect the whole grain worms treated in step A1, then rinse and drain;
  • the freeze-dried whole worms are pulverized at low temperature to obtain the dry powder of worms.
  • the disinfectant used in the immersion disinfection is a mixture of water and peracetic acid disinfectant stock solution, and the immersion time is 10 minutes; more preferably, the volume ratio of water to peracetic acid disinfectant stock solution is 1:400.
  • step A3 the low-temperature freezing temperature is -20-50°C, and the freezing time is 24h.
  • the preparation method of the five-grain-worm-soaked wine product includes the following steps:
  • step B2 Soak and disinfect the whole worms after processing in step B1, then rinse and drain;
  • the disinfectant used in the immersion disinfection is a mixture of water and peracetic acid disinfectant stock solution, and the immersion time is 10 minutes; more preferably, the volume ratio of water to peracetic acid disinfectant stock solution is 1:400.
  • step B3 the weight ratio of the whole worm and the wine is 0.2:0.8 to 0.4:0.6; the sealing time is more than 2 months.
  • the wine is pure grain wine with an alcohol content of 55°-70°.
  • the dosage form made by the Wu Gu Chong includes any one of capsules, tablets, pills, powders, compound granules, health wine, oral liquid or freeze-dried powder.
  • the five grain worm extract includes one or more of the whole grain worm or the water extract or the organic solvent extract of the dried five grain worm powder.
  • the following examples also provide a method for treating diabetes and regulating insulin levels based on the aforementioned composition, which includes the following steps:
  • each course of treatment is three months; the treatment method of each course of treatment is: taking the composition containing grain insects, taking the composition every day The dosage of Chinese grain insects is 3000mg-30g.
  • the composition containing grain worms is used to treat 1-2 courses; the dosage of grain worms in the composition taken daily is 3000mg-15g;
  • the composition containing grain insects For patients with diagnosed diabetes, use the composition containing grain insects to treat 4-6 courses; the dosage of grain insects in the composition taken daily for the first 1-2 courses is 3000mg-30g, and the combination taken daily for the 2-6 courses The dosage of grain worms is 3000mg-15g.
  • the present embodiment provides a method for preparing the dried grain insect powder, which includes the following steps:
  • the freeze-dried whole worms are pulverized at low temperature to obtain dry powder of worms.
  • the disinfectant used in the immersion disinfection is a mixture of water and peracetic acid disinfectant stock solution, and the immersion time is 10 minutes; the volume ratio of water and peracetic acid disinfectant stock solution is 1:400.
  • step A3 the low-temperature freezing temperature is -20-50°C, and the freezing time is 24h.
  • This embodiment provides a preparation method of a five-grain insect wine soaked product, including the following steps:
  • step B2 Soak and disinfect the whole worms after processing in step B1, then rinse and drain;
  • the disinfectant used in the immersion disinfection is a mixture of water and peracetic acid disinfectant stock solution, and the immersion time is 10 minutes; the volume ratio of water and peracetic acid disinfectant stock solution is 1:400.
  • step B3 the weight ratio of the whole worm and the wine is 0.2:0.8 ⁇ 0.4:0.6; the storage time is more than 2 months; the wine is pure grain with an alcohol content of 55° ⁇ 70° liqueur.
  • the effects of the Wu Gu Chong dry powder and the Wu Gu Chong wine infusion products prepared in Examples 1 and 2 of the present invention are verified for the treatment of diabetes and the regulation of insulin levels.
  • the specific treatment method can adopt the following schemes:
  • Method of administration For the first course of treatment, three times a day, each time 1500mg-5000mg of the dried grain insect powder prepared in Example 1 (administered in the form of a capsule) before meals, and 1000mg-10g of the grain insect infusion prepared in Example 2 before going to bed Products. From the second course of treatment to the fourth course of treatment, three times a day, each time before taking 1500mg-5000mg of the Wu Gu Chong dry powder prepared in Example 1 (administered in capsule form).
  • Method of administration For the first course of treatment, use western medicine to control the patient's blood sugar, three times a day, each time 1500mg-7500mg of the dry powder of Wu Gu Chong (administered in capsule form) prepared in Example 1 before meals, and 1000 mg-10g before going to bed Example 2 The prepared five-grain insect soaked wine product. Observe the patient's blood glucose changes and reduce the dosage of western medicine in a timely manner to stop all western medicine treatment. From the second course of treatment to the fifth course of treatment, three times a day, each time 1500 mg-7500 mg of Wu Gu Chong dry powder prepared in Example 1 (administered in the form of a capsule) is taken before meals.
  • Method of administration For the first course of treatment, use western medicine to control the patient's blood sugar, three times a day, each time 1500mg-7500mg of the dried grain insect powder prepared in Example 1 (administered in capsule form) before meals; after breakfast, twice a day before going to bed, Take 1000mg-10g of the five-grain insect wine product prepared in Example 2. Observe the patient's blood glucose changes and reduce the dosage of western medicine in a timely manner to stop all western medicine treatment. From the second course of treatment to the sixth course of treatment, three times a day, each time 1500 mg-7500 mg of the Wu Gu Chong dry powder prepared in Example 1 (administered in the form of a capsule). According to the change of blood sugar, 1000mg-10g of the five-grain-worm-infused wine product prepared in Example 2 can be taken before bedtime in the second course of treatment.
  • Verification example 1 Combination treatment with Wu Gu insect freeze-dried powder and Wu Gu insect wine soaking
  • the treatment plan is: three times a day, 1500 mg of Wu Gu Chong dry powder capsule prepared in Example 1 is taken before meals; 2000 mg of Wu Gu Chong wine infusion product prepared in Example 2 is taken before going to bed.
  • the sugar tolerance peak reverses and moves forward, from the initial 120 minutes to 60 minutes.
  • the 60-minute insulin release and fasting times increased from the initial 3.52 times to 9.22 times (5-10 times the normal value), and the peak insulin release increased from the initial 5.01 times to 11.16 times (5-10 times the normal value).
  • the treatment plan is: three times a day, 1500 mg of Wu Gu Chong dry powder capsule prepared in Example 1 is taken before meals; 2000 mg of Wu Gu Chong wine infusion product prepared in Example 2 is taken before going to bed.
  • Insulin release decreased by 55.94.27% in 60 minutes and blood glucose decreased by 2.64mmol/L.
  • Insulin release decreased by 52.34% in 180 minutes and blood sugar decreased by 5.30mmol/L.
  • Validation example three combined treatment with Wu Gu insect freeze-dried powder and Wu Gu insect wine soaking
  • the ratio of peak insulin to fasting insulin increased from 4.66 times to 8.09 times, an increase of 3.43 times.
  • the peak insulin increased from 23.3 ⁇ IU/mL to 27.74 ⁇ IU/mL, an increase of 19.06%.
  • the glucose tolerance peak reverses and moves forward, from the initial 120 minutes to 60 minutes, which is in line with the normal glucose tolerance.
  • Insulin release decreased by 74.08% in 120 minutes and blood sugar decreased by 9.05mmol/L.
  • 2000mg of the five-grain worm infusion product prepared in Example 2 is equivalent to the dose of 500mg of the five-grain worm dry powder prepared in Example 1. From the verification example 4, the patient's consumption of the five-grain worm infusion product is far lower than the above three cases The effect is also obvious, so the five-grain insect soaked wine product is actually better than the five-grain insect powder for diabetic patients.
  • Wu Gu Chong is used to treat diabetic patients. After a period of treatment, comparing the two OGTT measurements before and after the patient, it is medically proven that the patient's insulin resistance can be repaired and insulin sensitivity improved. After stopping all medications (2-5 years) The patient's blood sugar control can be achieved excellent, the glycosylated hemoglobin is less than 6.3, so far there has been no rebound.

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Abstract

五谷虫在制备治疗糖尿病的组合物中的用途，或用于制备调节胰岛素水平的组合物，其以五谷虫干粉、浸酒制品或提取物的形式用于组合物中。可有效消除逆转胰岛素抵抗，提高胰岛素敏感性。

Description

五谷虫在用于治疗糖尿病中的应用 技术领域
本发明属于食品、医药技术领域，具体涉及一种五谷虫在用于治疗糖尿病中的应用。
背景技术
胰岛素是一种蛋白质类激素，体内胰岛素是由胰岛β细胞分泌的。
胰岛细胞根据其分泌激素的功能分为以下几种：
①B细胞(β细胞)，约占胰岛细胞的60％～80％，分泌胰岛素，胰岛素可以降低血糖。
②A细胞(α细胞)，约占胰岛细胞的24％～40％，分泌胰升糖素，胰升糖素作用同胰岛素相反，可增高血糖。
③D细胞，约占胰岛细胞总数的6％～15％，分泌生长激素抑制激素。
糖尿病患者，由于病毒感染、遗传基因、自身免疫等各种发病因素，其病理生理主要是由于胰岛素活性相对或绝对不足以及胰升糖素活性相对或绝对过多所致，也即B和A细胞双边激素功能障碍所致。糖尿病是一组以高血糖为特征的代谢性疾病。高血糖则是由于胰岛素分泌缺陷或其生物作用受损，或两者兼有引起。糖尿病时长期存在的高血糖，导致各种组织，特别是眼、肾、心脏、血管、神经的慢性损害、功能障碍等。目前全世界没有任何方法在治疗糖尿病过程中能够使得人体胰岛素功能得到恢复与逆转。
五谷虫为丽蝇科昆虫大头金蝇或其他近缘昆虫的干燥幼虫体，中药五谷虫别名谷虫、水仙子、罗仙子，该虫性味咸、甘、寒，归经脾、胃，化学成分主要含蛋白质、溶菌酶、氨基酸、油脂，毒性很小，有清热解毒、消积导滞的作用。在《本草纲目》中记载可用于治疗小儿疳积、疳疮，热病谵妄，毒痢作吐等疾病。从而五谷虫中的有效成分不仅具有抗菌、抗病毒的作用，还具有抗寄生虫、抗氧化、抗衰老、抗肿瘤等作用。
现有技术中，专利CN107375825A中公开了一种治疗糖尿病的药物，其由食用碱、鼠妇、蚂蚁、五谷虫、桑叶、天花粉、石膏、生地黄、熟地黄、枸杞子、桑椹、秦艽、红参、西洋参、葛根等按一定重量配比制备而成，本发明药物具有祛湿热、化食滞、补肾益精、舒筋活络、解肌清热、生津止渴、益肺阴、清虚火的功能，用于治疗糖尿病见效快、疗效好，不复发。其中该组合物采用的五谷虫起到清热，消滞作用，为臣药。
专利CN102335241A中记载了一种治疗糖尿病合并高脂血症的药物，由下列重量份的原料药制得：生大黄6-10份、水蛭3-10份、五谷虫10-30份、红曲10-30份、五味子10-15份。其药效持久，疗效好。其中该组合物采用的五谷虫也是利用其咸寒入脾胃经，消滞清热，以及降脂作用明显从而添加。
专利CN108404088A中记载了一种用于制备治疗Ⅱ型糖尿病的药物，由以下重量份原料组成：干姜30-80份、黄连150-220份、黄芩150-220份、西洋参20-45份、天花粉150-220份和五谷虫150-220份。通过清热降浊、益气养阴的中医治病原理，用于治疗气阴两虚所致的口渴喜饮、倦怠乏力、少气懒言等证，特别适用于治疗具有气阴两虚所致的口渴喜饮、倦怠乏力、少气懒言等症候的Ⅱ型糖尿病。
可见，上述三份专利中虽然仅包含了五谷虫，但五谷虫在其中的功效均仅为清热消滞，而并未记载五谷虫单独具有治疗糖尿病的作用与及恢复胰岛素抵抗及提高胰岛素敏感的作用。
而且，目前已公开的所有治疗糖尿病的药物(包括最新的口服药)或方法均非直接以胰岛素抵抗和胰岛素敏感改善为主要目标,而是以血糖改善为主要目标。糖尿病患者胰岛素抵抗及胰岛素敏感无法恢复与逆转是当前世界医学界糖尿病领域公认的问题,也是所有教科书的定论。
发明内容
本发明的目的是提供一种五谷虫在用于治疗糖尿病中的应用，具体为五谷虫在制备治疗糖尿病的组合物中的应用。
本发明的目的是通过以下技术方案实现的：
第一方面，本发明提供了一种五谷虫在用于制备治疗糖尿病的组合物中的应用。
第二方面，本发明提供了一种五谷虫在制备调节胰岛素水平的组合物中的应用。
优选地，所述组合物包括药品、保健品、食品中的任一种。
优选地，所述五谷虫以五谷虫干粉、五谷虫浸酒制品或五谷虫提取物中的任一种制品用于所述组合物中。
优选地，所述五谷虫干粉的制备方法如下：
A1、将收集的五谷虫全虫清洗、冲刷，把表面的脏污去除干净；
A2、将步骤A1处理后的五谷虫全虫进行浸泡消毒，然后冲洗，沥干；
A3、将沥干后的五谷虫全虫进行低温冷冻，然后冷冻干燥至水分含量低于10wt％(出产率约为25％)；
A4、将冷冻干燥后的五谷虫全虫进行低温超细粉碎，即得五谷虫干粉％。
优选地，步骤A2中，所述浸泡消毒采用的消毒液为水和过氧乙酸消毒原液的混合物，所述浸泡时间为10分钟；更优选水和过氧乙酸消毒原液的体积比为1:400。
优选地，步骤A3中，所述低温冷冻的温度为-20-50℃、冷冻时间为24h。
优选地，所述五谷虫浸酒制品的制备方法包括以下步骤：
B1、将收集的五谷虫全虫清洗、冲刷，把表面的脏污去除干净；
B2、将步骤B1处理后的五谷虫全虫进行浸泡消毒，然后冲洗，沥干；
B3、将沥干后的五谷虫全虫投入酒中，封存；
B4、将封存后的五谷虫全虫取出，进行低温超细粉碎，即得。
优选地，步骤B2中，所述浸泡消毒采用的消毒液为水和过氧乙酸消毒原液的混合物，所述浸泡时间为10分钟；更优选水和过氧乙酸消毒原液的体积比为1:400。
优选地，步骤B3中，所述五谷虫全虫与酒的重量份比例为：0.2∶0.8～0.4:0.6；所述封存时间为2个月以上。
优选地，所述酒为酒精度55°～70°的纯粮食酒。
优选地，所述五谷虫制成的剂型包括胶囊剂、片剂、丸剂、散剂、复方颗粒剂、保健酒、口服液或冻干粉中的任一种。
优选地，所述五谷虫提取物包括五谷虫全虫或五谷虫干粉的水提取物或有机溶剂提取物中的一种或多种。
第三方面，本发明还提供了一种基于前述组合物治疗糖尿病的方法，包括以下步骤：
经检测后，根据糖尿病的患病程度，进行1-6个疗程治疗，每个疗程为三个月；所述每个疗程的治疗方法为：每天二到三次，服用包含五谷虫的组合物，每天服用的组合物中五谷虫的剂量为3000mg-30g。
第四方面，本发明还提供了一种基于前述组合物调节胰岛素水平的方法，包括以下步骤：
经检测后，根据糖尿病的患病程度，进行1-6个疗程治疗，每个疗程为三个月；所述每个疗程的治疗方法为：每天二到三次，服用包含五谷虫的组合物，每天服用的组合物中五谷虫的剂量为3000mg-30g。
优选地，针对糖尿病前期患者，采用包含五谷虫的组合物治疗1-2个疗程；每天服用的组合物中五谷虫的剂量为3000mg-15g；
针对确诊糖尿病患者，采用包含五谷虫的组合物治疗4-6个疗程；第1-2个疗程每天服用的组合物中五谷虫的剂量为3000mg-30g，第2-6个疗程每天服用的组合物中五谷虫的剂量为3000mg-15g。
与现有技术相比，本发明具有如下的有益效果：
本发明的五谷虫制品为一种天然的产品，五谷虫制品有效成分是五谷虫全虫，现代医学研究证明：五谷虫中含蛋白质、脂肪、几丁聚糖、含抗菌肽以及多种氨基酸。本发明的五谷虫冻干粉中包括了五谷虫全虫的所有有效成分，五谷虫提取物主要是以脂肪酸和/或蛋白质、多肽、氨基酸等。经研究发现，五谷虫可以有效消除人体胰岛素抵抗及提高人体胰岛素敏感，在进行效果验证中发现患者服用五谷虫进行治疗后，可显著消除糖尿病患者胰岛素抵抗及大幅提高胰岛素敏感部分患者胰岛素水平恢复到正常人的水平，且五谷虫不具有临床上常用的化疗药的耐药及其毒副作用。
本发明人对五谷虫治疗糖尿病适用人群的深入研究，经前后葡萄糖耐量(OGTT)测定分析比较，在医学意义上发现并找到了证据证明服用五谷虫制品后人体对胰岛素抵抗与胰岛素敏感都有疗效，在停用所有药物治疗后血糖长期稳定。是中国中医药治疗糖尿病的首次重大发现。
本发明将五谷虫制品成药，携带服用方便，临床有效率达到98％，病人通过常规治疗后停药观察最长已达五年以上，至今病情稳定，血糖正常。
附图说明
通过阅读参照以下附图对非限制性实施例所作的详细描述，本发明的其它特征、目的和优点将会变得更明显：
图1为本发明验证例一的耐糖曲线；
图2为本发明验证例一的胰岛素释放曲线；
图3为本发明验证例二的耐糖曲线；
图4为本发明验证例二的胰岛素释放曲线；
图5本发明验证例三的胰岛素释放曲线；
图6为本发明验证例四的耐糖曲线；
图7为本发明验证例四的胰岛素释放曲线。
具体实施方式
下面结合具体实施例对本发明进行详细说明。以下实施例将有助于本领域的技术人员进一步理解本发明，但不以任何形式限制本发明。应当指出的是，对本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进。这些都属于本发明的保护范围。
以下实施例提供了一种五谷虫在用于制备治疗糖尿病的组合物中的应用。
以下实施例提供了一种五谷虫在制备调节胰岛素水平的组合物中的应用。
所述组合物包括药品、保健品、食品中的任一种。
所述五谷虫以五谷虫干粉、五谷虫浸酒制品或五谷虫提取物中的任一种制品用于所述组合物中。
所述五谷虫干粉的制备方法如下：
A1、将收集的五谷虫全虫清洗、冲刷，把表面的脏污去除干净；
A2、将步骤A1处理后的五谷虫全虫进行浸泡消毒，然后冲洗，沥干；
A3、将沥干后的五谷虫全虫进行低温冷冻，然后冷冻干燥至水分含量低于10wt％(出产率约为25％)；
A4、将冷冻干燥后的五谷虫全虫进行低温超细粉碎，即得五谷虫干粉％。
步骤A2中，所述浸泡消毒采用的消毒液为水和过氧乙酸消毒原液的混合物，所述浸泡时间为10分钟；更优选水和过氧乙酸消毒原液的体积比为1:400。
步骤A3中，所述低温冷冻的温度为-20-50℃、冷冻时间为24h。
所述五谷虫浸酒制品的制备方法包括以下步骤：
B1、将收集的五谷虫全虫清洗、冲刷，把表面的脏污去除干净；
B2、将步骤B1处理后的五谷虫全虫进行浸泡消毒，然后冲洗，沥干；
B3、将沥干后的五谷虫全虫投入酒中，封存；
B4、将封存后的五谷虫全虫取出，进行低温超细粉碎，即得。
步骤B2中，所述浸泡消毒采用的消毒液为水和过氧乙酸消毒原液的混合物，所述浸泡时间为10分钟；更优选水和过氧乙酸消毒原液的体积比为1:400。
步骤B3中，所述五谷虫全虫与酒的重量份比例为：0.2∶0.8～0.4:0.6；所述封存时间为2个月以上。
所述酒为酒精度55°～70°的纯粮食酒。
所述五谷虫制成的剂型包括胶囊剂、片剂、丸剂、散剂、复方颗粒剂、保健酒、口服液或冻干粉中的任一种。
所述五谷虫提取物包括五谷虫全虫或五谷虫干粉的水提取物或有机溶剂提取物中的一种或多种。
以下实施例还提供了一种基于前述组合物治疗糖尿病、调节胰岛素水平的方法，包括以下步骤：
经检测后，根据糖尿病的患病程度，进行1-6个疗程治疗，每个疗程为三个月；所述每个疗程的治疗方法为：服用包含五谷虫的组合物，每天服用的组合物中五谷虫的剂量为3000mg-30g。
针对糖尿病前期患者，采用包含五谷虫的组合物治疗1-2个疗程；每天服用的组合物中五谷虫的剂量为3000mg-15g；
针对确诊糖尿病患者，采用包含五谷虫的组合物治疗4-6个疗程；第1-2个疗程每天服用的组合物中五谷虫的剂量为3000mg-30g，第2-6个疗程每天服用的组合物中五谷虫的剂量为3000mg-15g。
实施例1
本实施例提供了一种五谷虫干粉制备方法，包括以下步骤：
A1、将收集的五谷虫全虫清洗、冲刷，把表面的脏污去除干净；
A2、将步骤A1处理后的五谷虫全虫进行浸泡消毒，然后冲洗，沥干；
A3、将沥干后的五谷虫全虫进行低温冷冻，然后冷冻干燥至水分含量低于10wt％；
A4、将冷冻干燥后的五谷虫全虫进行低温超细粉碎，即得五谷虫干粉。
步骤A2中，所述浸泡消毒采用的消毒液为水和过氧乙酸消毒原液的混合物，所述浸泡时间为10分钟；水和过氧乙酸消毒原液的体积比为1:400。
步骤A3中，所述低温冷冻的温度为-20-50℃、冷冻时间为24h。
实施例2
本实施例提供了一种五谷虫浸酒制品的制备方法，包括以下步骤：
B1、将收集的五谷虫全虫清洗、冲刷，把表面的脏污去除干净；
B2、将步骤B1处理后的五谷虫全虫进行浸泡消毒，然后冲洗，沥干；
B3、将沥干后的五谷虫全虫投入酒中，封存；
B4、将封存后的五谷虫全虫取出，进行低温超细粉碎，即得。
步骤B2中，所述浸泡消毒采用的消毒液为水和过氧乙酸消毒原液的混合物，所述浸泡时间为10分钟；水和过氧乙酸消毒原液的体积比为1:400。
步骤B3中，所述五谷虫全虫与酒的重量份比例为：0.2∶0.8～0.4:0.6；所述封存时 间为2个月以上；所述酒为酒精度55°～70°的纯粮食酒。
效果验证：
将本发明实施例1和2制备的五谷虫干粉和五谷虫浸酒制品进行治疗糖尿病、调节胰岛素水平的效果验证，具体治疗方法可以采用以下方案：
1)针对糖尿病前期患者，单用五谷虫粉剂，用1-2个疗程直接治愈。
服用方法：每天三次,每次1500mg-5000mg实施例1制备的五谷虫干粉(以胶囊形式给药)餐前服用，1-2个疗程治疗后胰岛素释放水平恢复至正常人水平。
2)针对轻度糖尿病患者，采用五谷虫粉剂加浸酒制品治疗，一般需经4个疗程治疗。
服用方法：第1个疗程，每天三次,每次1500mg-5000mg实施例1制备的五谷虫干粉(以胶囊形式给药)餐前服用，睡前服用1000mg-10g实施例2制备的五谷虫浸酒制品。第2个疗程至第4个疗程，每天三次,每次1500mg-5000mg实施例1制备的五谷虫干粉(以胶囊形式给药)前服用。
3)针对中度糖尿病患者采用五谷虫粉剂加浸酒制品配合西药治疗，一般需经5个疗程治疗。
服用方法：第1个疗程，用西药控制病人血糖，每天三次,每次1500mg-7500mg实施例1制备的五谷虫干粉(以胶囊形式给药)餐前服用，睡前服用1000mg-10g实施例2制备的五谷虫浸酒制品。观察病人血糖变化情况适时减少西药用量至停服所有西药治疗。第2个疗程至第5个疗程，每天三次,每次1500mg-7500mg实施例1制备的五谷虫干粉(以胶囊形式给药)餐前服用。
4)针对重度糖尿病患者采用五谷虫粉剂加浸酒制品配合西药治疗，一般需经5-6个疗程治疗。
服用方法：第1个疗程，用西药控制病人血糖，每天三次,每次1500mg-7500mg实施例1制备的五谷虫干粉(以胶囊形式给药)餐前服用；早餐后，睡前每天两次，服用1000mg-10g实施例2制备的五谷虫浸酒制品。观察病人血糖变化情况适时减少西药用量至停服所有西药治疗。第2个疗程至第6个疗程，每天三次,每次1500mg-7500mg实施例1制备的五谷虫干粉(以胶囊形式给药)前服用。根据血糖变化情况可在第2个疗程增加睡前服用1000mg-10g实施例2制备的五谷虫浸酒制品。
以下进一步提供具体的治疗验证例。
验证例一、采用五谷虫冻干粉与五谷虫浸酒联合治疗
沈** 纯中药治疗 上海某研究所所长
治疗方案为：每天三次,每次1500mg例1制备的五谷虫干粉胶囊餐前服用；睡前服用2000mg实施例2制备的五谷虫浸酒制品。
OGTT前后对比分析：患者二次OGTT间隔60天，实际服药45天。上海第六人民医院检测报告结果如表1所示。
表1
Figure PCTCN2019104316-appb-000001
从耐糖曲线(图1)分析：
1、空腹血糖下降0.63mmol/L，180分钟血糖由8.0mmol/L下降致5.3mmol/L回归正常。
2、耐糖峰值逆转前移，由初始的120分钟前移致60分钟。
胰岛素释放曲线(图2)分析：
1、空腹胰岛素抵抗症状得以改善：
A：空腹胰岛素释放下降48.43％，血糖下降了0.63mmol/L
B：180分钟胰岛素释下降44.42％，血糖回归正常人标准。
证明胰岛素抵抗得以修复。
2、60分钟胰岛素释放与空腹倍数看由初始的3.52倍增加到9.22倍(正常值5-10倍)，胰岛素释峰值由初始的5.01倍增加到11.16倍(正常值5-10倍)。
证明胰岛素敏感得以提高。
3、胰岛素峰值释放由服药前的91.46μIU/mL上升至103.2μIU/mL,增加11.38％。
以上分析证明患者经本发明的五谷虫调理后胰岛素抵抗与胰岛素敏感双向显著改善，从而使得其胰岛素水平恢复到正常人水平。
由该结果证明患者是胰岛素抵抗与胰岛素敏感双向损伤。
验证例二、采用五谷虫冻干粉与五谷虫浸酒联合治疗
患者：姓名：张XX 性别:男 年龄：55岁 确诊患糖尿病5年
治疗前 二甲双胍缓释片0.5g 2粒，19天停服所有西药治疗。
治疗方案为：每天三次,每次1500mg例1制备的五谷虫干粉胶囊餐前服用；睡前服用2000mg实施例2制备的五谷虫浸酒制品。
前后二次OGTT报告：(间隔120天)江苏省无锡市第二人民医院检测报告结果如表2所示。
表2
  项目 0分钟 30分钟 60分钟 120分钟 180分钟
服药前 血糖值mmol/L 0 8.41 13.00 16.72 17.96 11.87
  胰岛素μIU/mL 0 10.85 45.00 80.16 38.31 21.13
服药后 血糖值mmol/L 1 6.52 11.83 14.08 12.66 4.75
  胰岛素μIU/mL 1 6.72 24.18 35.32 47.81 10.07
从耐糖曲线(图3)分析：
1、空腹血糖由8.41mmol/L下降至6.52mmol/L回归正常。
2、30分钟血糖由13.00mmol/L下降至11.83mmol/L。
3、60分钟血糖由16.72mmol/L下降至14.08mmol/L。
4、120分钟血糖由17.96mmol/L下降至12.66mmol/L。
5、180分钟血糖由11.87mmol/L下降至4.75mmol/L回归正常。
6、耐糖峰值逆转前移，由初始的120分钟前移至60分钟。
从胰岛素释放曲线(图4)分析：
1、空腹胰岛素下降38.06％血糖回归正常。
2、30分钟胰岛素释放下降46.27％血糖下降了1.17mmol/L。
3、60分钟胰岛素释放下降55.94.27％血糖下降了2.64mmol/L。
4、180分钟胰岛素释放下降52.34％血糖下降了5.30mmol/L。
5、从上胰岛素释放各个点分析胰岛素大幅下降血糖也得以下降说明胰岛素抵抗得到显著修复。由该结果证明患者是胰岛素抵抗为主损伤。
验证例三、采用五谷虫冻干粉与五谷虫浸酒联合治疗
患者姓名:吕XX 性别:男 年龄:36岁 2019/3/14开始治疗 71天停服所有西药。
治疗方案为：每天三次,每次1500mg例1制备的五谷虫干粉胶囊餐前服用；睡前服用2000mg实施例2制备的五谷虫浸酒制品。
前后二次OGTT报告：间隔96天，HbAlc由6.7下降至5.8，胰岛素水平如表3所 示。
表3
  项目 0分钟 30分钟 60分钟 120分钟 180分钟
服药前 胰岛素μIU/mL 0 5.00 8.00 12.60 23.30 15.60
服药后 胰岛素μIU/mL 1 3.43 10.01 27.74 26.22 21.97
从胰岛素释放曲线(图5)分析：
1.患者服药96天胰岛素释放积分面积大幅增加。
2.峰值胰岛素与空腹胰岛素之比由4.66倍增加至8.09倍,增加3.43倍。
3.胰岛素释放峰值由120分钟前移至60分钟。
4.峰值胰岛素由23.3μIU/mL增加至27.74μIU/mL,增加19.06％。
由该结果证明患者是胰岛素敏感为主损伤。
验证例四、单用五谷虫浸酒制品治疗
姓名王** 性别:女 年龄:65岁 患糖尿病10年
治疗方案为：每天二次,每次2000mg实施例2制备的五谷虫浸酒制品。
OGTT前后对比分析：患者二次OGTT间隔156天，实际服药156天。检测结果如表4所示。
表4
Figure PCTCN2019104316-appb-000002
从耐糖曲线(图6)分析：
1、空腹血糖由7.45mmol/L下降至7.00mmol/L。
2、60分钟血糖由15.13mmol/L下降至13.54mmol/L。
3、120分钟血糖由17.25mmol/L下降至8.20mmol/L回归正常。
4、耐糖峰值逆转前移，由初始的120分钟前移至60分钟，符合正常人耐糖特证。
从胰岛素释放曲线(图7)分析：
1、空腹胰岛素下降30.16％血糖下降0.45mmol/L。
2、120分钟胰岛素释放下降74.08％血糖下降了9.05mmol/L。
根据1-2以上二点证明胰岛素抵抗显著消除
3、胰岛素30分钟胰岛素释放与康复比由初始的1.67倍上升至2.62倍。
根据以上分析证明胰岛素敏感亦得到提高。
2000mg实施例2制得的五谷虫浸酒制品相当于500mg实施例1制得的五谷虫干粉的剂量,从验证例四上分析患者单用五谷虫浸酒制品使用量远低于以上三例且效果同样明显，所以五谷虫浸酒制品单用于糖尿病患者效果实际优于五谷虫粉剂。
通过对以上四例患者的治疗效果经前后OGTT测定分析，采用五谷虫治疗糖尿病具有安全，长效，全身调理优点。在医学意义上找到了消除胰岛素抵抗，促进胰岛素正常分泌的佐证。
目前采用五谷虫对糖尿病患者，经过一段时间疗治，对比患者前后二次OGTT的测定在医学上得到证明患者胰岛素抵抗得以修复及胰岛素敏感度的提升，在停止所有药物治疗后(2-5年)患者的血糖控制全部能达到优良，糖化血红蛋白小于6.3，至今无一例反弹。
本发明具体应用途径很多，以上所述仅是本发明的优选实施方式。应当指出，以上实施例仅用于说明本发明，而并不用于限制本发明的保护范围。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，这些改进也应视为本发明的保护范围。

Claims (9)

  1. 一种五谷虫在用于制备治疗糖尿病的组合物中的应用。
  2. 一种五谷虫在制备调节胰岛素水平的组合物中的应用。
  3. 根据权利要求1或2所述的应用，其特征在于，所述组合物包括药品、保健品、食品中的任一种。
  4. 根据权利要求1或2所述的应用，其特征在于，所述五谷虫以五谷虫干粉、五谷虫浸酒制品或五谷虫提取物用于所述组合物中。
  5. 根据权利要求4所述的应用，其特征在于，所述五谷虫制成的剂型包括胶囊剂、片剂、丸剂、散剂、复方颗粒剂、保健酒、口服液或冻干粉中的任一种。
  6. 根据权利要求4所述的应用，其特征在于，所述五谷虫提取物包括五谷虫全虫或五谷虫干粉的水提取物或有机溶剂提取物中的一种或多种。
  7. 一种基于权利要求1所述的组合物治疗糖尿病的方法，其特征在于，包括以下步骤：
    经检测后，根据糖尿病的患病程度，进行1-6个疗程治疗，每个疗程为三个月；所述每个疗程的治疗方法为：服用包含五谷虫的组合物，每天服用的组合物中五谷虫的剂量为3000mg-30g。
  8. 一种基于权利要求1所述的组合物调节胰岛素水平的方法，其特征在于，包括以下步骤：
    经检测后，根据糖尿病的患病程度，进行1-6个疗程治疗，每个疗程为三个月；所述每个疗程的治疗方法为：每天二到三次，服用包含五谷虫的组合物，每天服用的组合物中五谷虫的剂量为3000mg-30g。
  9. 根据权利要求7或8所述的方法，其特征在于，针对糖尿病前期患者，采用包含五谷虫的组合物治疗1-2个疗程；每天服用的组合物中五谷虫的剂量为3000mg-15g；
    针对确诊糖尿病患者，采用包含五谷虫的组合物治疗4-6个疗程；第1-2个疗程每天服用的组合物中五谷虫的剂量为3000mg-30g，第2-6个疗程每天服用的组合物中五谷虫的剂量为3000mg-15g。
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