Preparation method and application of Korean medicine health food for reducing blood sugar and improving fatty liver

Abstract

The invention relates to a preparation method and application of Korean medicine health food for reducing blood sugar and improving fatty liver. Extraction, purification, freeze-drying, dosage form preparation, preparation function evaluation, toxicological research and cell sugar tolerance research verify that the Korean medicine health food has the functions of reducing blood sugar and improving fatty liver, assists in reducing blood sugar through oral absorption, and improves main clinical symptoms such as thirst and polydipsia, polyphagia and easy hunger, lassitude and weakness, diuresis and the like.

Description

Technical Field

[0001] The invention relates to a health food composition, in particular to a preparation method and application of a Korean medicine health food with the functions of lowering blood sugar and improving fatty liver, 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 and Filing Management Measures", develops a health food composition with the ability to lower blood sugar and improve fatty liver and its preparation method. The formula of the composition is mainly based on the prescription used in traditional Chinese medicine to prevent and treat diabetes in "Taiyin people", and the specific ingredients are derived from commonly used medicinal and edible plants.

[0003] 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, few 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 options for DM in traditional Chinese medicine are staged treatment, syndrome differentiation and treatment, and special prescription treatment. They have achieved certain therapeutic effects in clinical individualized treatment, but there has been no breakthrough in the development of drugs suitable for group treatment.

[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 "Qingfei Xiegan 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 Pueraria lobata, Ligusticum chuanxiong, Cimicifuga heracleifolia, Angelica dahurica, Platycodon grandiflorum, Scutellaria baicalensis, Radish Seed, Rhubarb, Taraxacum mongolicum, and Smilax glabra.

[0006] The kudzu root, platycodon grandiflorum and dandelion in the formula are both food and medicine, and the angelica dahurica is an item that can be used in health food. The composition of all the medicinal flavors in the formula meets the requirements of health food for the source of raw materials.

[0007] Pueraria root is the dried root of Pueraria lobata (willd.)ohwi, a plant of the Leguminosae family. It is dug in spring and autumn, and the impurities are removed and dried. It is sweet, pungent and cool in nature. It enters the spleen and stomach meridians. It is a commonly used wind-dispelling and antipyretic drug in clinical Chinese medicine. It has pharmacological effects such as lowering blood sugar, anti-tumor, antipyretic, dilating cerebral blood vessels, lowering blood pressure, slowing heart rate, reducing myocardial oxygen consumption, and relaxing smooth muscles. Korean doctors believe that Pueraria root is a medicine for Taiyin people. It has the functions of dispersing and relieving muscles, clearing away heat and detoxifying, and promoting body fluid and quenching thirst. It is mainly used for Taiyin people with Yangming, Yang poison and red face, throat disease, aversion to cold and fever, eye pain and dry nose, body heat and abdominal pain, and self-interest. It is also used for Taiyin people with typhoid fever, heat more than cold syndrome, vomiting and diarrhea, cholera, urinary incontinence, five stranguria, headache, and facial heat syndrome. The Ge Gen Jie Ji Tang in Dong Yi Shou Shi Bao Yuan can clear away heat and detoxify, disperse and relax muscles, and treat Yangming disease in Taiyin patients; the Cold More than Heat Tang can disperse wind-heat, clear away heat and detoxify, and treat typhoid fever and heat more than cold syndrome in Taiyin patients.

[0008] Ligusticum sinense Oliv. or Ligusticum jeholense Nakai et Kitag., a plant of the Apiaceae family, is a dried rhizome and root. It is used for wind-cold exterior syndrome, vertex pain, and rheumatic pain.

[0009] Cimicifuga heracleifolia Kom., Cimicifuga dahurica (Turcz.) Maxim. or Cimicifuga foetida L. of the Ranunculaceae family are dried rhizomes. They are harvested in autumn, the sand is removed, and the fibrous roots are dried in the sun. The roots are then burned or removed and dried in the sun. The medicinal properties are pungent, slightly sweet, and slightly cold. It enters the lung, spleen, stomach, and large intestine meridians. It has pharmacological effects such as lowering blood pressure, inhibiting myocardium, slowing heart rate, antibacterial, sedative, anticonvulsant, and antipyretic and temperature-reducing. The Korean doctors believed that Cimicifuga heracleifolia was a medicine for the yin meridian. It has the functions of dispersing wind-heat, detoxifying and clearing rashes, and raising yang energy.

[0010] Angelica dahurica is the dried root of Angelica dahurica (Fisch.ex Hoffm.) Benth.et Hook.f. or Angelica dahurica (Fisch.ex Hoffm.) Benth.et Hook.f. Var.formosana (Boiss.) Shan et Yuan. of the Umbelliferae family. It is harvested in summer and autumn when the leaves turn yellow, the fibrous roots are removed, and the rootlets are dried in the sun. It is pungent and warm in nature. It enters the stomach, large intestine, and lung meridians. The main active ingredient of Angelica dahurica is furanocoumarin. It has pharmacological effects such as analgesia, antipyretic, anti-inflammatory, anti-pathogenic microorganisms, antispasmodic, and central nervous system excitement. Korean doctors believe that Angelica dahurica is a medicine for Taiyin people. It has the functions of dispelling exterior pathogens, dispelling wind and relieving pain. It is mainly used for headaches of Taiyin people, red face due to yang poison, sore throat, and sinusitis.

[0011] Scutellaria baicalensis, a Chinese medicine. Also known as Camellia root and Tujin tea root, it is a perennial herbaceous plant of the genus Scutellaria baicalensisGeorgi of the Lamiaceae family. Its root is used as medicine, bitter in taste and cold in nature, with the effects of clearing away heat and dampness, purging fire and detoxifying, stopping bleeding, and calming the fetus. It is mainly used to treat febrile diseases, upper respiratory tract infections, lung heat cough, damp-heat jaundice, pneumonia, dysentery, hemoptysis, red eyes, fetal movement disorders, hypertension, carbuncles, boils, etc.

[0012] 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.

[0013] 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.

[0014] Rhubarb is the root and rhizome of Rheum palmatum L., Rheum tanguticum Maxim. ex Balf. or Rheum officinale Baill. of the Polygonaceae family. It has the effects of purging and attacking accumulation, clearing away heat and purging fire, cooling blood and detoxifying, and removing blood stasis and dredges the menstrual cycle. It is mainly used to treat constipation due to stagnation of blood, vomiting and bleeding due to blood heat, red eyes and swollen throat, ulcers caused by heat toxins, burns and scalds, blood stasis, damp-heat dysentery, jaundice, and stranguria.

[0015] Dandelion is the dried whole herb of Taraxacum mongolicum Hand.-Mazz., Taraxacum sinicum Kitag. or several plants of the same genus in the Asteraceae family. It is dug when the flowers first bloom from spring to autumn, and then the impurities are removed, washed and dried. It is bitter, sweet and cold in nature. It enters the liver and stomach meridians. It is a commonly used heat-clearing and detoxifying medicine in clinical Chinese medicine. It has pharmacological effects such as anti-pathogenic microorganisms, liver protection, gallbladder, anti-gastric ulcer, immune function enhancement, and diuresis. Korean doctors believe that dandelion is a Taiyin human medicine. It has the functions of clearing heat and detoxifying, promoting dampness and relieving stranguria, eliminating carbuncle and dispersing knots. It is mainly used for carbuncle, throat disease and liver and kidney damp-heat syndrome. "Eastern Medicine Shoushibaoyuan" adds dandelion to the hot and cold soup to treat liver and kidney damp-heat disease.

[0016] Smilax glabra Roxb is a dried rhizome of the Liliaceae plant Smilax glabra Roxb. It is a perennial evergreen climbing shrub that grows mostly on hillsides or under forests. It tastes sweet and light, and is neutral in nature. It has the effects of detoxification, dehumidification, and joint unblocking. It is mainly used for limb cramps and muscle and bone pain caused by syphilis and mercury poisoning; damp-heat stranguria, leucorrhea, carbuncle, scrofula, and scabies.

[0017] 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

[0018] The technical solution 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 and Filing Management Measures". The present invention also provides a preparation method and use of the compound health food composition.

[0019] 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:

[0020] 1-15 parts of Pueraria root, 1-15 parts of Ligusticum chuanxiong, 1-8 parts of Cimicifuga heracleifolia, 1-5 parts of Angelica dahurica, 1-5 parts of Platycodon grandiflorum, 1-5 parts of Scutellaria baicalensis, 1-5 parts of Radish Seed, 1-5 parts of Rhubarb, 1-5 parts of Taraxacum herb, and 1-5 parts of Smilax glabra.

[0021] More preferably, it is a preparation made from the following raw materials in weight ratio:

[0022] 15 parts of Puerariae Radix, 15 parts of Ligusticum chuanxiong, 8 parts of Cimicifuga heracleifolia, 5 parts of Angelica dahurica, 5 parts of Platycodon grandiflorum, 5 parts of Scutellaria baicalensis, 5 parts of Radish Seed, 5 parts of Rhubarb, 5 parts of Taraxacum herb, and 5 parts of Smilax glabra.

[0023] The health food composition of the present invention is a preparation prepared by taking Pueraria root, Ligusticum chuanxiong, Cimicifuga heracleifolia, Angelica dahurica, Platycodon grandiflorum, Scutellaria baicalensis, Radish seed, Rhubarb, Taraxacum mongolicum, Smilax glabra and other medicinal materials or medicinal material extracts as active ingredients, and adding auxiliary materials or auxiliary ingredients acceptable to health food.

[0024] 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.

[0025] The present invention also provides a method for preparing the health food composition, which comprises the following steps:

[0026] (1) Weigh the following raw materials in a weight ratio: 1-15 parts of Pueraria root, 1-15 parts of Ligusticum chuanxiong, 1-8 parts of Cimicifuga heracleifolia, 1-5 parts of Angelica dahurica, 1-5 parts of Platycodon grandiflorum, 1-5 parts of Scutellaria baicalensis, 1-5 parts of Radish seeds, 1-5 parts of Rhubarb, 1-5 parts of Taraxacum herba, and 1-5 parts of Smilax glabra;

[0027] (2) extracting Pueraria root, Ligusticum chuanxiong, Cimicifuga heracleifolia, Angelica dahurica, Platycodon grandiflorum, Scutellaria baicalensis, Radish seed, Rhubarb, Taraxacum mongolicum, and Smilax glabra with water or an organic solvent to obtain an extract;

[0028] (3) The extract is added to acceptable excipients or auxiliary ingredients in health food and prepared into preparations according to corresponding molding processes.

[0029] The health food composition of the present invention is based on the Chinese traditional medicine theory 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 lowering blood sugar and improving fatty liver is achieved through the functions of nourishing the lungs, moistening dryness and resolving phlegm, promoting body fluid and relieving exterior symptoms, and clearing away heat, providing a new choice for the development of health food. DETAILED DESCRIPTION

[0030] The present invention is described in more detail below with reference to experimental examples and embodiments.

[0031] Example 1

[0032] The health food of the present invention is prepared from the following raw materials by weight: 150g of kudzu root, 150g of ligusticum rhizome, 80g of cimicifuga heracleifolia, 50g of angelica dahurica, 50g of scutellaria baicalensis, 50g of platycodon grandiflorum, 50g of radish seed, 50g of rhubarb, 50g of dandelion and 50g of smilax glabra.

[0033] Furthermore, the health food of the present invention is prepared through the following stages:

[0034] (1) taking the above-mentioned weight of Pueraria root, Ligusticum chuanxiong, Cimicifuga heracleifolia, Angelica dahurica, Platycodon grandiflorum, Scutellaria baicalensis, Radish seed, Rhubarb, Taraxacum mongolicum, and Smilax glabra, 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;

[0035] (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.

[0036] Example 2

[0037] The health food of the present invention is prepared from the following raw materials by weight: 150g of kudzu root, 150g of ligusticum chuanxiong, 80g of cimicifuga, 50g of angelica dahurica, 50g of platycodon, 50g of scutellaria baicalensis, 50g of radish seed, 50g of rhubarb, 50g of dandelion and 50g of smilax glabra.

[0038] Furthermore, the health food of the present invention is prepared through the following stages:

[0039] (1) taking the above-mentioned weight of Pueraria root, Ligusticum chuanxiong, Cimicifuga heracleifolia, Angelica dahurica, Platycodon grandiflorum, Scutellaria baicalensis, Radish seed, Rhubarb, Taraxacum mongolicum, and Smilax glabra, 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;

[0040] (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.

[0041] Example 3

[0042] The health food of the present invention is prepared from the following raw materials by weight: 150g of kudzu root, 150g of ligusticum chuanxiong, 80g of cimicifuga, 50g of angelica dahurica, 50g of platycodon, 50g of scutellaria baicalensis, 50g of radish seed, 50g of rhubarb, 50g of dandelion and 50g of smilax glabra.

[0043] Furthermore, the health food of the present invention is prepared through the following stages:

[0044] (1) taking the above-mentioned weight of Pueraria root, Ligusticum chuanxiong, Cimicifuga heracleifolia, Angelica dahurica, Platycodon grandiflorum, Scutellaria baicalensis, Radish seed, Rhubarb, Taraxacum mongolicum, and Smilax glabra, 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, concentrating the refined solution under reduced pressure to obtain a concentrated solution for standby use;

[0045] (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.

[0046] Example 4

[0047] The health food of the present invention is prepared from the following raw materials by weight: 150g of kudzu root, 150g of ligusticum chuanxiong, 80g of cimicifuga, 50g of angelica dahurica, 50g of platycodon, 50g of scutellaria baicalensis, 50g of radish seed, 50g of rhubarb, 50g of dandelion and 50g of smilax glabra.

[0048] Furthermore, the health food of the present invention is prepared through the following stages:

[0049] (1) taking the above-mentioned weight of Pueraria root, Ligusticum chuanxiong, Cimicifuga heracleifolia, Angelica dahurica, Platycodon grandiflorum, Scutellaria baicalensis, Radish seed, Rhubarb, Taraxacum mongolicum, and Smilax glabra, 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;

[0050] (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.

[0051] Experimental Example 1 Determination of the content of total flavonoids in the granules of the present invention

[0052] The total flavonoids content in the preparation was determined by ultraviolet spectrophotometry.

[0053] 1. Solution preparation

[0054] 1.1 Sample solution

[0055] 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.

[0056] 1.2 Test solution

[0057] 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.

[0058] 1.3 Reference solution

[0059] 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.

[0060] 2 Linear relationship investigation

[0061] 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.

[0062] 3. Precision inspection

[0063] 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.

[0064] Table 1 Precision investigation results

[0065]

[0066] 4. Stability investigation

[0067] 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.

[0068] Table 2 Stability test results

[0069]

[0070] 5 Repeatability study

[0071] 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.

[0072] Table 3 Repeatability test results

[0073]

[0074] 6. Sample recovery rate investigation

[0075] 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.

[0076] Table 4 Results of sample recovery investigation

[0077]

[0078] 7. Sample content determination

[0079] Three batches of samples were measured according to the above method and the contents were calculated. The results are shown in Table 5.

[0080] Table 5 Sample content determination results

[0081]

[0082]

[0083] Experimental Example 2 Functional evaluation and toxicological study of the preparation

[0084] 1. Evaluation experiment of auxiliary hypoglycemic function

[0085] 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.

[0086] 1.2 Experimental Animal Selection Adult animals, mice (26±2g) of a single sex, were selected, with 10-15 mice per group.

[0087] 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.

[0088] 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.

[0089] 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.

[0090] 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.

[0091] 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)

[0092] 1.5 Data processing and result determination

[0093] 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 0.05Conclusion: 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.

[0094] 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.

[0095] 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.

[0096] 1.6 Results

[0097] 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.

[0098] 2 Toxicology studies

[0099] 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.

[0100] Experimental Example 3 Study on Cellular Glucose Consumption

[0101] 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.

[0102] Experimental Example 4: Human Food Tasting Experiment

[0103] 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.

[0104] 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.

[0105] 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 preparation method and application of a Korean medicinal health food for lowering blood sugar and improving fatty liver, comprising the following steps: (1) extracting the raw material of the Korean herb extract with an ethanol aqueous solution having a mass fraction of 40 to 60% as a solvent, collecting the liquid portion, and obtaining an extract; The raw materials of the Chinese medicinal herbs extract are composed of the following components by weight, including 2-4 parts of Pueraria root, 2-4 parts of Ligusticum chuanxiong, 2-4 parts of Cimicifuga heracleifolia, 2-4 parts of Angelica dahurica, 1-2 parts of Scutellaria baicalensis, 1-2 parts of Platycodon grandiflorum, 1-2 parts of Radish seeds, 1-2 parts of Rhubarb, 1-2 parts of Taraxacum herba and 1-2 parts of Smilax glabra. (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 20-45%, 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 yam extract for lowering blood sugar and improving fatty liver 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 yam extract is 5-15:1-3:1-4.

4. The extract of Korean Medicinal Herb for lowering blood sugar and improving fatty liver 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 lowering blood sugar and improving fatty liver, comprising the Korean Medicinal Herb extract according to claim 3 or 4 and pharmaceutical excipients.

6. The drug for lowering blood sugar and improving fatty liver according to claim 5, characterized in that: By weight percentage, it comprises 50-70% of the Korean yam extract according to claim 4 or 5 and 20-60% of pharmaceutical excipients.

7. The drug for lowering blood sugar and improving fatty liver 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 lowering blood sugar and improving fatty liver 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 lowering blood sugar and improving fatty liver 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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