Preparation method and application of Korean medicine health-care food for assisting in reducing blood sugar

Abstract

The invention relates to a preparation method and application of Korean medicine health-care food for assisting in reducing blood sugar. Through extraction, purification, freeze-drying, dosage form preparation, preparation function evaluation, toxicological research and cell sugar tolerance research, it is verified that the Korean medicine health-care food has the function of assisting blood sugar reduction, blood sugar reduction is assisted through oral absorption, and main clinical symptoms such as thirst and polydipsia, polyphagia and easy hunger, lassitude and weakness and diuresis are improved.

Description

Technical Field

[0001] The invention relates to a health food composition, in particular to a preparation method and application of a Korean herbal health food with auxiliary blood sugar lowering function, belonging to the field of health food research, production and use. Background Art

[0002] The present invention is based on the theory of Chinese traditional medicine and in accordance with the provisions of the "Health Food Registration Management Measures", develops a health food composition with auxiliary blood sugar lowering function and its preparation method. The formula of the composition is mainly based on the prescription used in traditional Chinese medicine for preventing and treating diabetes in "Taiyin people", and the specific ingredients are derived from commonly used medicinal and edible plants.

[0003] Diabetes mellitus (DM) is a group of endocrine metabolic diseases characterized by persistent hyperglycemia. Type 2 diabetes is the most common, accounting for more than 90% of the total number of diabetics. Type 2 diabetes has become one of the three major non-communicable diseases with the highest morbidity and mortality in the world, and the incidence rate is increasing year by year. Therefore, further strengthening the research on diabetes and actively carrying out the prevention and treatment of diabetes and its complications is an urgent task facing the medical community. Traditional Chinese medicine has a long history of preventing and treating diabetes and has accumulated a lot of valuable experience. In particular, the anti-diabetic active ingredients derived from traditional Chinese medicine have the characteristics of mild and lasting therapeutic effects, small side effects, and long-term use. Their mechanism of action is often a comprehensive effect of multiple targets, multiple effects, and multiple functions, and they have comprehensive advantages that cannot be replaced by Western medicine. The main treatment schemes of traditional Chinese medicine for DM are staged treatment, syndrome differentiation and treatment, and special prescription treatment. They have achieved certain therapeutic effects in clinical individualized treatment, but the development of drugs suitable for group treatment has not made breakthrough progress.

[0004] Chinese Korean medicine was gradually formed and developed on the basis of the inherent cultural foundation of the Korean ethnic group and Eastern medicine, absorbing the theories of traditional Chinese medicine and combining the experience of disease prevention and treatment of the ethnic group. Korean medicine is guided by the holistic view of "heaven, man, world, and earth", with the structure of "four dimensions and four images" as the main form, and is a diagnostic and therapeutic science that combines the identification of images (constitution, disease) with dialectics. One of the important theories of Korean medicine is constitution differentiation, which divides people into four types according to their constitution: Taiyang people, Taiyin people, Shaoyang people, and Shaoyin people. Among them, Taiyin people account for more than 50% and have the largest number of people. Taiyin people are prone to diabetes due to their physical characteristics. Clinical investigations of Korean medicine have found that more than 70% of DM patients are Taiyin people. When treating DM patients, Korean medicine combines the disease with the characteristics of the patient's constitution. The prescriptions used are relatively stable and have significant efficacy, which is particularly suitable for the development of new drugs or health foods for group prevention and treatment. At present, the clinical use of the representative prescriptions of "Taeyin people" of Korean medicine, such as "Tiaowei Shengqing Decoction", has accumulated certain experience in the treatment of DM.

[0005] The formula of this product is based on the clinical prescriptions of Korean medicine, with appropriate additions and subtractions. It is composed of medicinal and edible plants such as coix seed, dried chestnut, radish seed, ephedra, platycodon, ophiopogon, schisandra, calamus, polygala, asparagus, jujube seed, and longan pulp.

[0006] In the formula, coix seed, platycodon grandiflorum, jujube seed, and asparagus cochinchinensis are both food and medicine, while schisandra chinensis and ophiopogon japonicus are items that can be used in health food. The composition of all medicinal ingredients in the formula meets the requirements of health food for the source of raw materials.

[0007] Coix seeds are the dried mature seeds of Coix lacryma-jobi L. var. mayuen (Roman.) Stapf, a plant of the Poaceae family. They are used for edema, beriberi, dysuria, diarrhea due to spleen deficiency, dampness and stiffness, lung abscess, intestinal abscess, warts, and cancer.

[0008] Dried chestnut, this product is Castanea mollissima Blume of Fagaceae, and its fruit, inflorescence, cupule, bark, root bark and leaves are used as medicine. Functions and indications: Fruit: nourishes yin and tonifies kidney. Indications: kidney deficiency and low back pain. Inflorescence: stops diarrhea. Indications: diarrhea, red and white dysentery, chronic diarrhea, indigestion in children. Scrofula and gall. Cupule: treats erysipelas and redness. Bark: treats sores and lacquer sores.

[0009] Radish seeds are the dried mature seeds of the cruciferous plant Raphanus sativus L., which are used to treat food stagnation, abdominal distension and pain, constipation, diarrhea, and cough due to phlegm congestion.

[0010] Ephedra, a traditional Chinese medicine for dispelling wind and cold, is a plant of the genus Ephedra in the Ephedraceae family, 20-40 cm tall; the woody stem is short or creeping, and the herbaceous stem of the plants of the Ephedraceae family, Ephedra sinica, or Ephedra arvense. It is warm in nature, pungent and slightly bitter in taste, and has the effects of sweating and dispelling cold, clearing the lungs and relieving asthma, promoting diuresis and reducing swelling. It can treat colds caused by wind and cold, chest tightness, cough, wind and water edema, bronchial asthma and other symptoms.

[0011] Platycodon grandiflorum (Jacq.) A.DC. is a plant of the Campanulaceae family. It is harvested in spring and autumn, the stems are removed, the skin is scraped off, and the skin is dried in the sun. The medicinal properties are bitter, pungent, and neutral. It enters the lung meridian. It has the effects of clearing the lungs, removing phlegm, relieving sore throat, and draining pus. Platycodon has the pharmacological effects of lowering blood sugar, protecting the liver, relieving cough, relaxing smooth muscles, removing phlegm, and anti-oxidation. The Korean doctors believed that Platycodon grandiflorum was a medicine for people with Taiyin, which had the effect of strengthening the lungs and having the power to repel external pathogens. "Platinum and Scutellaria Decoction" is recorded in "Eastern Medicine Shoushibaoyuan" to dispel external pathogens, relieve throat, and treat throat diseases of people with Taiyin.

[0012] Ophiopogon japonicus is the root of Ophiopogon japonicus (Thumb.) Ker-Gawl., a plant of the Liliaceae family. It is usually dug up in summer, washed to remove the fibrous roots, and dried in the sun. The medicinal properties are sweet, slightly bitter, and slightly cold. It enters the stomach, lung, and heart meridians. It is a commonly used Yin-nourishing medicine in clinical Chinese medicine, and has the pharmacological effects of lowering blood sugar, anti-aging, anti-tumor, anti-radiation, anti-arrhythmia, and enhancing cellular immunity. Chinese medicine believes that Ophiopogon japonicus has the effects of nourishing Yin, promoting body fluid, moistening the lungs and clearing the heart. It can be used to treat dry cough due to lung dryness; lung abscess; yin deficiency and cough due to fatigue; thirst due to loss of body fluid; thirst; restlessness and insomnia; sore throat; dry intestines and constipation; vomiting and bleeding due to blood heat. Korean doctors believe that Ophiopogon japonicus is a medicine for Taiyin people. It has the functions of nourishing the lungs and moistening the lungs, clearing heat and moistening dryness. It is mainly used as a conditioning agent for Taiyin people after illness and for heatstroke, thirst, and summer diseases. It is recorded in "Dongyi Shoushibaoyuan" that "Tiaoli Feiyuan Decoction" can nourish the lungs and lungs, purge fire and moisten dryness, and is used as a conditioning agent after a serious illness.

[0013] Schisandra chinensis is the mature fruit of Schisandra chinesis (Turcz.) Bail or Schisandra sphenanthera Rehd.et Wils. of the Magnoliaceae family. The fruit is harvested in autumn when it is ripe and dried in the sun. The medicinal properties are sour, sweet and warm. It enters the lung, heart and kidney meridians. It has the effects of astringing and consolidating, replenishing qi and promoting body fluid, and nourishing the kidney and calming the mind. It is used to treat replenishing qi and promoting body fluid, astringing the lungs and nourishing the kidneys, stopping diarrhea, astringing essence, and calming the mind. It can treat chronic cough and asthma, lack of body fluid and dry mouth, spermatorrhea and chronic diarrhea, forgetfulness and insomnia. Traditional Chinese medicine believes that Schisandra chinensis has the pharmacological effects of protecting the liver, lowering blood sugar, lowering blood pressure, stimulating the central nervous system and respiratory system, relieving cough and expectoration, enhancing cellular immunity, anti-oxidation, anti-aging, anti-stress, and vasodilation. Korean doctors believe that Schisandra chinensis is a medicine for people with Taiyin, and has the effects of strengthening and nourishing the lungs. It is mainly used for cough, thirst, sweating, palpitations, insomnia, and dreaminess in people with Taiyin. This product has the function of strengthening the lungs, and is often used with Radix Ophiopogonis and Platycodon grandiflorum. The "Ephedra Golden Water Soup" in "New Edition of Eastern Medicine Four Symbols" has the function of promoting fluid and restraining sweat, and is often used with Radix Ophiopogonis to promote fluid and restrain sweat, clear away heat and relieve summer heat, and treat palpitations, insomnia, and nightmares. Modern research believes that Schisandra chinensis contains rich organic acids, vitamins, flavonoids, plant sterols, and lignans (such as schisandrin A, schisandrin B, or schisandrin) with strong restorative effects. It is also one of the few medicinal materials that can replenish the three major benefits of essence, qi, and spirit. It can replenish qi and strengthen the liver, improve the efficiency of cell waste elimination, supply more oxygen, create and use energy, and improve memory and sexual endurance.

[0014] Acorus tatarinowii Schott is the dried rhizome of Acorus tatarinowii Schott, a plant of the Araceae family. It has the functions of removing dampness and stimulating appetite, opening the orifices and removing phlegm, refreshing the mind and improving intelligence. It is used for abdominal distension without hunger, dysentery with muteness, coma, epilepsy, forgetfulness and deafness.

[0015] Polygala tenuifolia Willd., also known as Polygala tenuifolia, Polygala tenuifolia, etc., is produced in Northeast China, North China, Northwest China, Central China and Sichuan. It is a perennial herb with a thick taproot and fleshy phloem. It has the functions of calming the mind, improving intelligence, removing phlegm and reducing swelling. It is used for insomnia, dreaminess, forgetfulness, palpitations, confusion, coughing and expectoration, sores, swelling and pain in the breast caused by disharmony between the heart and kidney.

[0016] Asparagus cochinchinensis (Lour.) Merr. is a tuberous root of Asparagus cochinchinensis (Lour.) Merr., a plant of the genus Asparagus in the family Liliaceae. It has the effects of nourishing yin and moistening dryness, clearing the lungs and reducing fire. It is mainly used to treat dry-heat cough, yin deficiency and fatigue cough, yin damage caused by febrile disease, internal heat and thirst, dry intestines and constipation, and sore throat.

[0017] Suanzaoren, a Chinese medicinal material. This product is the seed of Semen Ziziphi Spinosae, a plant of the Rhamnaceae family. Its functions and indications are: nourishing the liver, calming the mind, tranquilizing the nerves, and restraining sweat. It can treat insomnia, palpitations, thirst, and sweating.

[0018] Longan pulp is the aril of Dimocarpus longan Lour., a plant of the Sapindaceae family. It has the effects of nourishing the heart and spleen, nourishing blood and calming the mind. It is often used for insufficient qi and blood, palpitations, forgetfulness and insomnia, and blood deficiency and chlorosis.

[0019] At present, no health food based on Chinese traditional medicine theory has been marketed. No patent or research report on health food with similar formula to the composition of the present invention has been found in the Chinese patent and literature database. The design theory and idea of ​​the composition of the present invention are innovative. The development of health food with auxiliary blood sugar lowering function based on the present invention has broad market demand prospects. Summary of the invention

[0020] The technical scheme of the present invention provides a health food composition with auxiliary blood sugar lowering function based on the Chinese traditional medicine health theory, which is prepared by combining natural raw materials and auxiliary materials in accordance with the "Health Food Registration Management Measures". The present invention also provides a preparation method and use of the compound health food composition.

[0021] The present invention provides a Korean medicine health food composition with the function of assisting in lowering blood sugar, which is a preparation made of the following raw materials in weight ratio:

[0022] 1-15 parts of coix seed, 1-15 parts of dried chestnut, 1-8 parts of radish seed, 1-5 parts of ephedra, 1-5 parts of schisandra, 1-5 parts of ophiopogon, 1-5 parts of platycodon, 1-5 parts of calamus, 1-5 parts of polygala, 1-5 parts of asparagus, 1-5 parts of jujube seed, and 1-5 parts of longan pulp.

[0023] More preferably, it is a preparation made from the following raw materials in weight ratio:

[0024] 15 parts of coix seeds, 15 parts of dried chestnuts, 8 parts of radish seeds, 5 parts of schisandra chinensis, 5 parts of ophiopogon japonicus, 5 parts of platycodon grandiflorum, 5 parts of calamus, 5 parts of polygala tenuifolia, 5 parts of asparagus cochinchinensis, 5 parts of spiny jujube seeds, and 5 parts of longan pulp.

[0025] The health food composition of the present invention is a preparation prepared by taking coix seed, dried chestnut, radish seed, ephedra, schisandra chinensis, ophiopogon japonicus, platycodon grandiflorum, calamus calamus, polygala tenuifolia, asparagus cochinchinensis, spiny jujube seed and longan pulp medicinal materials or medicinal material extracts as active ingredients and adding auxiliary materials or auxiliary ingredients acceptable to health food.

[0026] The dosage forms of the preparations include: pills, powders, granules, tablets, chewable tablets, capsules, soft capsules, oral liquids, pastes, concentrates, ointments, soups, cakes, and beverages.

[0027] The present invention also provides a method for preparing the health food composition, which comprises the following steps:

[0028] (1) Weigh the following raw materials in weight ratio: 1-15 parts of coix seed, 1-15 parts of dried chestnut, 1-8 parts of radish seed, 1-5 parts of ephedra, 1-5 parts of schisandra, 1-5 parts of ophiopogon, 1-5 parts of platycodon, 1-5 parts of calamus, 1-5 parts of polygala, 1-5 parts of asparagus, 1-5 parts of spiny jujube seed, and 1-5 parts of longan pulp;

[0029] (2) extracting coix seed, dried chestnut, radish seed, schisandra chinensis, ophiopogon japonicus, platycodon grandiflorum, ephedra, calamus calamus, polygala tenuifolia, asparagus cochinchinensis, jujube seed, and longan pulp with water or an organic solvent to obtain an extract;

[0030] (3) The extract is added to acceptable excipients or auxiliary ingredients in health food and prepared into preparations according to corresponding molding processes.

[0031] The health food composition of the present invention is based on the theory of Chinese traditional medicine and the clinical prescription of traditional Chinese medicine for the prevention and treatment of diabetes, and the formula that meets the requirements of health food raw materials is screened out, and the specific ingredients are derived from commonly used medicinal and edible plants. Aiming at the causes of "Taiyin people" constitution, such as careless joy and anger, excessive mental exhaustion, blood deficiency after illness, unregulated diet, and yin deficiency of the body, which cause the inflammatory fire to smoke the internal organs, generate heat and dryness, hot qi and dry body fluids, and cannot drink and restrain themselves, resulting in symptoms such as thirst, the purpose of assisting blood sugar reduction is achieved through the functions of tonifying the lungs, moistening dryness and resolving phlegm, promoting body fluids and relieving exterior symptoms, and clearing away heat, so as to provide a new choice for the development of health food. DETAILED DESCRIPTION

[0032] The present invention is described in more detail below with reference to experimental examples and embodiments.

[0033] Example 1

[0034] The health food of the present invention is prepared from the following raw materials by weight: 150g of coix seed, 150g of dried chestnut, 80g of radish seed, 50g of ephedra, 50g of schisandra, 50g of ophiopogon, 50g of platycodon, 50g of calamus, 50g of polygala, 50g of asparagus, 50g of spiny jujube seed and 50g of longan pulp.

[0035] Furthermore, the health food of the present invention is prepared through the following stages:

[0036] (1) taking the above-mentioned weight of coix seed, dried chestnut, radish seed, ephedra, schisandra chinensis, ophiopogon japonicus, platycodon grandiflorum, calamus calamus, polygala tenuifolia, asparagus cochinchinensis, spiny jujube seed, and longan pulp, decocting and extracting twice, filtering, combining the filtrate to obtain an extract, refining the extract by adsorption clarification method or ultracentrifugation method to obtain a refined solution, and concentrating the refined solution under reduced pressure to obtain an extract for later use;

[0037] (2) Take appropriate auxiliary materials and mix them with the above extract, dry, crush, pass through a 100-mesh sieve, use 50% ethanol as a wetting agent to prepare a soft material, pass through a 14-mesh sieve by extrusion to granulate, dry, pass through a 16-mesh sieve to obtain granules.

[0038] Example 2

[0039] The health food of the present invention is prepared from the following raw materials by weight: 150g of coix seed, 150g of dried chestnut, 80g of radish seed, 50g of ephedra, 50g of schisandra, 50g of ophiopogon, 50g of platycodon, 50g of calamus, 50g of polygala, 50g of asparagus, 50g of spiny jujube seed and 50g of longan pulp.

[0040] Furthermore, the health food of the present invention is prepared through the following stages:

[0041] (1) taking the above-mentioned weight of coix seed, dried chestnut, radish seed, ephedra, schisandra chinensis, ophiopogon japonicus, platycodon grandiflorum, calamus calamus, polygala tenuifolia, asparagus cochinchinensis, spiny jujube seed, and longan pulp, decocting and extracting twice, filtering, combining the filtrate to obtain an extract, refining the extract by adsorption clarification method or ultracentrifugation method to obtain a refined solution, and concentrating the refined solution under reduced pressure to obtain an extract for later use;

[0042] (2) Drying, crushing, passing through a 100-mesh sieve, using 50% ethanol as a wetting agent to prepare a soft material, passing through a 14-mesh sieve to prepare granules by extrusion, drying, passing through a 16-mesh sieve to prepare whole granules, and compressing the dry granules with a tablet press to obtain chewable tablets.

[0043] Implementation Example 3

[0044] The health food of the present invention is prepared from the following raw materials by weight: 150g of coix seed, 150g of dried chestnut, 80g of radish seed, 50g of ephedra, 50g of schisandra, 50g of ophiopogon, 50g of platycodon, 50g of calamus, 50g of polygala, 50g of asparagus, 50g of spiny jujube seed and 50g of longan pulp.

[0045] Furthermore, the health food of the present invention is prepared through the following stages:

[0046] (1) taking the above-mentioned weight of coix seed, dried chestnut, radish seed, ephedra, schisandra chinensis, ophiopogon japonicus, platycodon grandiflorum, calamus calamus, polygala tenuifolia, asparagus cochinchinensis, spiny jujube seed, and longan pulp, decocting and extracting twice, filtering, combining the filtrates to obtain an extract, refining the extract by adsorption clarification method or ultracentrifugation method to obtain a refined solution, and concentrating the refined solution under reduced pressure to obtain a concentrated solution for standby use;

[0047] (2) Take 100 g of agar and put it into 20 times the amount of concentrated liquid. Soak it for 10 hours and then heat it until dissolved. Add cyclamate and natural preservatives, stir well, heat it to 80°C, stir well, sterilize it by hot pressing, cool it to 80°C and cast it into a mold to obtain a soup.

[0048] Implementation Example 4

[0049] The health food of the present invention is prepared from the following raw materials by weight: 150g of coix seed, 150g of dried chestnut, 80g of radish seed, 50g of ephedra, 50g of schisandra, 50g of ophiopogon, 50g of platycodon, 50g of calamus, 50g of polygala, 50g of asparagus, 50g of spiny jujube seed and 50g of longan pulp.

[0050] Furthermore, the health food of the present invention is prepared through the following stages:

[0051] (1) taking the above-mentioned weight of coix seed, dried chestnut, radish seed, ephedra, schisandra chinensis, ophiopogon japonicus, platycodon grandiflorum, calamus calamus, polygala tenuifolia, asparagus cochinchinensis, spiny jujube seed, and longan pulp, decocting and extracting twice, filtering, combining the filtrate to obtain an extract, and refining the extract by adsorption clarification method or ultracentrifugation method to obtain a refined solution, which is set aside;

[0052] (2) Take the above refined liquid, add appropriate amount of flavoring agent and stabilizer, mix well, filter, add appropriate amount of pure water to dilute to the specified amount, mix well, fill, sterilize, and obtain a beverage.

[0053] Experimental Example 1 Determination of the content of total flavonoids in the granules of the present invention

[0054] The total flavonoids content in the preparation was determined by ultraviolet spectrophotometry.

[0055] 1. Solution preparation

[0056] 1.1 Sample solution

[0057] Take the granules, crush them and pass them through a 60-mesh sieve, accurately weigh 2 g of powder, add ethanol and ultrasonicate for 30 min, make the volume to 25 mL, shake well, and filter through a microporous filter membrane to obtain the sample solution.

[0058] 1.2 Test solution

[0059] Accurately measure 4 mL of the sample solution and place it in an evaporating dish, add 1 g of polyamide powder for adsorption, evaporate the ethanol in a water bath or thermostat, and then transfer it to a chromatography column. First wash it with 30 mL of petroleum ether, discard the petroleum ether liquid, elute the flavonoids with methanol, collect the methanol liquid, evaporate it to dryness under reduced pressure, and then dissolve it with methanol to make up to 25 mL.

[0060] 1.3 Reference solution

[0061] Accurately weigh 5 mg of rutin reference substance, dissolve it in methanol, cool it by ultrasonication, and make up the volume to 100 mL with methanol to obtain 50 μg﹒ mL -1 Reference solution.

[0062] 2 Linear relationship investigation

[0063] Take 0, 1, 2, 3, 4, 5 mL of the reference solution in a 10 mL volumetric flask, add methanol to the mark, shake well, and measure the absorbance at 360 nm. Perform a linear regression between the concentration of the reference solution (X) and the absorbance value (Y), and the regression equation is Y = 0.0263X-0.0485, r = 0.9992 (n = 6). The results show that in the range of 0-25 μg mL -1 There is a good linear relationship between the concentration of the reference substance and the absorbance value within the range.

[0064] 3. Precision inspection

[0065] The reference solution was accurately measured and the measurement was repeated 5 times. The results are shown in Table 1, indicating that the instrument has good precision.

[0066] Table 1 Precision investigation results

[0067]

[0068] 4. Stability investigation

[0069] The test solution was accurately aspirated and the absorbance was measured at 0, 2, 4, 8, 12, and 24 hours. The results are shown in Table 2. The results showed that the test solution was stable within 24 hours.

[0070] Table 2 Stability test results

[0071]

[0072] 5 Repeatability study

[0073] Weigh the same batch of samples accurately, prepare 5 samples under the test solution, and measure the absorbance. The results are shown in Table 3. The results show that this method has good repeatability.

[0074] Table 3 Repeatability test results

[0075]

[0076] 6. Sample recovery rate investigation

[0077] Accurately measure 6 portions of sample solutions with known contents, accurately add appropriate amounts of reference substances, prepare according to the test solution, calculate the recovery rate, and the results are shown in Table 4. Results The average recovery rate of this method is 95.14%, RSD = 1.42%, indicating that this method has good accuracy and is feasible.

[0078] Table 4 Results of sample recovery investigation

[0079]

[0080] 7. Sample content determination

[0081] Three batches of samples were measured according to the above method and the contents were calculated. The results are shown in Table 5.

[0082] Table 5 Sample content determination results

[0083]

[0084] Experimental Example 2 Functional evaluation and toxicological study of the preparation

[0085] 1. Evaluation experiment of auxiliary hypoglycemic function

[0086] 1.1 Samples The samples were granules of this product. In this experiment, 5, 10, and 20 times the dosage were used as the test substances.

[0087] 1.2 Experimental Animal Selection Adult animals, mice (26±2g) of a single sex were selected, with 10-15 mice per group.

[0088] 1.3 Dosage grouping and test sample administration time The experiment set up three dose groups and a model control group. One dose group was 10 times the recommended dose for humans, and the other two dose groups were set up. At the same time, a normal animal group was set up to be given a high dose of the test sample. The test sample was administered for 30 days.

[0089] 1.4 After fasting for 24 hours, the hyperglycemia model animals were given streptozotocin to establish the model. After 5-7 days, they were fasted for 3-5 hours and their blood sugar was measured. Animals with blood sugar values ​​of 10-25 mmol / L were considered to have successfully established the hyperglycemia model.

[0090] 1.4.1 Experiment on reducing fasting blood sugar Select hyperglycemia model animals and group them according to the blood sugar level after fasting for 3-5 hours, and randomly select 1 model control group and 3 dose groups (the difference between groups is not more than 1.1mmol / L). The dose group is given different concentrations of the test sample, and the model control group is given the solvent for 30 consecutive days. The fasting blood sugar value (fasting is the same as before the experiment) is measured, and the blood sugar value and blood sugar reduction percentage of each group of animals are compared. Blood sugar reduction percentage = (blood sugar value before the experiment - blood sugar value after the experiment) / blood sugar value before the experiment × 100%. Select healthy adult animals and group them according to the blood sugar level after fasting for 3-5 hours, and randomly select 1 control group and 1 test sample group (high dose), and the rest of the operation is the same as above.

[0091] 1.4.2 Glucose tolerance test The hyperglycemia model animals were fasted for 3-5 hours. The dose groups were given different concentrations of test samples, and the model control group was given the same volume of solvent. 2.0 g / kg of glucose was orally administered 15-20 minutes later. The blood glucose levels at 0, 0.5, and 2 hours after the administration of glucose or at 0, 1, and 2 hours after the administration of medical starch were measured. The changes in the area under the blood glucose curve at each time point after the administration of glucose were observed in the model control group and the test sample group.

[0092] Area under the blood glucose curve: = 1 / 2 × (0 hour blood glucose value + 0.5 hour blood glucose value) × 0.5 + 1 / 2 × (2 hour blood glucose value + 0.5 hour blood glucose value) × 1.5 = 0.25 × (0 hour blood glucose value + 4 × 0.5 hour blood glucose value + 3 × 2 hour blood glucose value)

[0093] 1.5 Data processing and result determination

[0094] The data can be analyzed by variance analysis, but the variance homogeneity test must be performed according to the variance analysis procedure. If the variance is homogeneous, the F value is calculated. <F 0.05 Conclusion: There is no significant difference in the mean values ​​of each group; F value>F 0.05 , P < 0.05, and the statistical data were analyzed by pairwise comparison method between multiple experimental groups and one control group.

[0095] Fasting blood glucose lowering experiment: Under the premise of the establishment of the model, if the fasting blood glucose measured value of the test sample dosage group is compared with the control group or the blood glucose reduction percentage is statistically significant, it can be determined that the fasting blood glucose lowering experiment result of the test sample is positive.

[0096] Glucose tolerance test: Under the premise of the establishment of the model, the area under the blood glucose curve of the test sample dosage group was reduced significantly at 0, 0.5, and 2 hours after the administration of glucose or medical starch compared with the control group, and the test sample glucose tolerance test result was determined to be positive.

[0097] 1.6 Results

[0098] Different doses of the granules of the present invention were orally administered to mice for 30 days. The percentage of blood glucose reduction in the medium and high dose experimental groups was significantly different from that in the model control group (P<0.05), and a dose-effect relationship was presented; the area under the blood glucose curve of the mice in each experimental group was not significantly different from that in the model control group (P>0.05); and there was no effect on the fasting blood glucose of the normal animal group given a high dose of the test sample. The experimental results show that the animal experimental results of the granules of the present invention are positive for the auxiliary hypoglycemic function.

[0099] 2 Toxicology studies

[0100] The results showed that the acute toxicity test LD 50 Greater than 15.0g / kg.bw, it is non-toxic according to toxicity classification. Mouse micronucleus test, mouse sperm deformity test and Ames test were all negative. The 30-day feeding experiment had no adverse effects on blood routine, blood biochemical indexes, organ coefficients, body weight, weight gain, food intake, food utilization rate and other indicators. Pathological histological observation showed no significant pathological changes in the liver, spleen, kidney, stomach, duodenum, testicles and ovaries.

[0101] Experimental Example 3 Study on Cellular Glucose Consumption

[0102] Glucose consumption is an important indicator of the cell's ability to absorb and utilize glucose and insulin sensitivity, so it can be measured by measuring the sample's ability to promote HepG2 cells. The results showed that compared with the blank group, the glucose uptake of IR-HepG2 cells treated with different concentrations of preparations increased significantly, and the increase was 0.70, 0.58, and 0.35 mmol / L, respectively. The above results show that Tiaowei Shengqing Decoction has a strong ability to promote HepG2 cell glucose absorption and has a significant effect on lowering blood sugar.

[0103] Experimental Example 4: Human Food Tasting Experiment

[0104] Adult type 2 diabetic patients whose condition is relatively stable after diet control or oral hypoglycemic drug treatment, who do not need to change the drug type and dosage, and who only take the maintenance dose, with fasting blood sugar ≥ 7.8mmol / L (140mg / dl) or 2h blood sugar after meal ≥ 11.1mmol / L (200mg / dl); people with high blood sugar of 7.8mmol / L ≥ fasting blood sugar ≥ 6.7mmol / L (120mg / dl) or 11.1mmol / L ≥ 2h blood sugar after meal ≥ 7.8mmol / L can also be selected. During the observation period, the subjects stopped using diabetes treatment drugs and other related health foods for 2 months. The results of the trial showed that after taking the health food of the present invention, the main clinical symptoms of type 2 diabetic patients, such as thirst, polydipsia, polyphagia, fatigue, and polyuria, were improved.

[0105] The above functional evaluation experiments and human food trial experiments show that the health food of the present invention has the function of assisting in lowering blood sugar and has no toxic side effects.

[0106] The protection scope of the present invention cannot be considered to be limited to the above-mentioned specific implementation methods and specific examples. For ordinary technicians in the relevant technical field, several simple deductions or equivalent substitutions can be made without departing from the basic premise of the concept of the present invention, and these equivalent substitution schemes will still be considered to be within the protection scope of the present invention.

Claims

1. A method for preparing and applying a Korean herbal medicine health food for assisting in lowering blood sugar, comprising the following steps: (1) extracting the raw material of the Korean herb extract with an ethanol aqueous solution having a mass fraction of 20 to 40% as a solvent, collecting the liquid portion, and obtaining an extract; The raw materials of the Chinese medicine extract are composed of the following components by weight, including 2-4 parts of coix seeds, 2-4 parts of dried chestnuts, 2-4 parts of radish seeds, 2-4 parts of ephedra, 1-2 parts of schisandra, 1-2 parts of platycodon, 1-2 parts of ophiopogon, 1-2 parts of calamus, 1-2 parts of polygala, 1-2 parts of asparagus, 1-2 parts of jujube seeds and 1-2 parts of longan pulp; (2) adsorbing the extract by an adsorption clarification method, collecting the liquid portion, and obtaining a refined liquid; (3) purifying the refined solution with a D101 macroporous resin column, collecting the eluate, and drying it to obtain the Korean herb extract; The purification conditions include: the eluent is an ethanol aqueous solution with a mass fraction of 25-35%, the loading concentration is 0.05g / ml, the loading amount is 6-7BV, the loading flow rate is 1BV / h, the eluent volume is 6-7BV, and the elution flow rate is 1BV / h.

2. The preparation method according to claim 1, characterized in that: The eluent is an ethanol aqueous solution with a mass fraction of 30%.

3. A Chinese medicinal extract for assisting in lowering blood sugar obtained by the preparation method according to any one of claims 1 to 2, characterized in that: The mass ratio of total flavonoids, total polysaccharides and total saponins in the Korean herb extract is 5-15:1-3:1-4.

4. The Chinese medicinal extract for assisting in lowering blood sugar according to claim 3, characterized in that: The extract of the Chinese medicinal plant has a total flavonoid content of 6-8 mg / g, a total polysaccharide content of 0.5-1.5 mg / g, and a total saponin content of 1-2 mg / g.

5. A drug for assisting in lowering blood sugar, comprising the extract of Rhizoma Dictamni as claimed in claim 3 or 4 and pharmaceutical excipients.

6. The drug for assisting in lowering blood sugar according to claim 5, characterized in that: By weight percentage, it comprises 50-80% of the Korean yam extract according to claim 4 or 5 and 20-50% of pharmaceutical excipients.

7. The drug for assisting in lowering blood sugar according to claim 5 or 6, characterized in that: The pharmaceutical excipients include lactose, MCC, CMC-Na, magnesium stearate and 60-80% by mass ethanol aqueous solution.

8. The drug for assisting in lowering blood sugar according to claim 5, characterized in that: The dosage form of the drug is selected from granules, tablets, powders, capsules, oral liquids, injections, sprays, aerosols, powder sprays, nasal drops, suppositories, pills, microsphere preparations or tinctures.

9. The drug for assisting in lowering blood sugar according to claim 8, characterized in that: When the pharmaceutical dosage form is a tablet, it comprises the following components in parts by weight: 320 to 400 parts of the Korean herb extract according to claim 3 or 4, 60 to 80 parts of lactose, 40 to 60 parts of MCC, 20 to 30 parts of CMS-Na, 1 to 8 parts of magnesium stearate and 0.1 to 1 part of an ethanol aqueous solution with a mass fraction of 60 to 80%.

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