Traditional Chinese medicine composition for reinforcing qi, nourishing yin, invigorating spleen, tonifying kidney, promoting salivation, moistening dryness and reducing blood sugar and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for tonifying qi and yin, invigorating spleen and tonifying kidney, promoting salivation and moistening dryness and reducing blood sugar and application, and relates to the field of traditional Chinese medicine, a preparation method of the traditional Chinese medicine composition comprises the following steps that S1, rhizoma polygonati, fructus corni, fructus lycii, rhizoma anemarrhenae, American ginseng and green tea are smashed and sieved, and raw material powder is obtained; s2, adding 5-10 times of an extraction solvent into the raw material powder for soaking at the soaking temperature of 30-50 DEG C, then air-drying the surface, then freezing at the temperature of-20 to-10 DEG C, recovering to 30-50 DEG C, and unfreezing to obtain an unfreezing solution; and S3, carrying out reflux extraction on the unfreezing solution for 2-3 times, combining extracting solutions, and carrying out vacuum concentration and drying. Traditional Chinese medicines and green tea are used as main raw materials, rhizoma polygonati has the effects of tonifying qi, nourishing yin, invigorating spleen, tonifying kidney and moistening lung, American ginseng has the effects of tonifying qi, nourishing yin, clearing heat and promoting salivation, rhizoma anemarrhenae has the effects of nourishing yin and moistening dryness, dogwood has the effects of astringing and inducing astringency and nourishing liver and kidney together with fructus lycii, green tea has the effects of promoting salivation and quenching thirst, and the medicines are compatible and mainly enter lung, spleen and kidney meridians to jointly achieve the effects of tonifying qi, nourishing yin, invigorating spleen, tonifying kidney, promoting salivation and moistening dryness; therefore, the effects of assisting in reducing blood sugar and enhancing immunity are achieved.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition and application thereof which can invigorate qi and nourish yin, strengthen the spleen and benefit the kidney, promote the production of body fluid and relieve dryness, and reduce blood sugar. Background Art

[0002] With the rapid development of the national economy, the dietary and nutritional status of urban and rural residents in my country has been significantly improved, but it is accompanied by the occurrence of comprehensive diseases such as non-communicable and chronic metabolism caused by problems such as imbalanced nutritional structure. Among them, diabetes is a type of disease with greater harm, which has seriously affected people's physical and mental health. As an epidemic and common disease in the world today, the incidence of diabetes has increased rapidly, and it has become the third most serious disease threatening human health after tumors and cardiovascular diseases. In recent years, there are more and more people with high blood sugar in my country, but the current clinical treatment drugs, except for insulin, are mainly oral hypoglycemic drugs. These drugs are taken for a long time, are prone to drug resistance, and are prone to rebound; they cannot effectively inhibit the increase of blood sugar. For this reason, it is necessary to propose a Chinese medicine composition and application that can replenish qi and nourish yin, strengthen the spleen and kidney, promote body fluid and moisten dryness, and reduce blood sugar. Summary of the invention

[0003] The purpose of the present invention is to solve at least one of the technical problems existing in the prior art, and to provide a Chinese medicine composition and application which can invigorate qi and nourish yin, strengthen the spleen and kidney, promote the production of body fluid and moisten dryness, and lower blood sugar.

[0004] The technical solution of the present invention is as follows:

[0005] A Chinese medicine composition for invigorating qi and nourishing yin, strengthening spleen and kidney, promoting body fluid and moistening dryness, and lowering blood sugar, comprising the following raw materials in parts by weight:

[0006] 10-30 parts of polygonatum, 10-20 parts of cornus officinalis, 10-20 parts of wolfberry, 10-20 parts of anemarrhena asphodeloides, 10-20 parts of American ginseng, and 10-30 parts of green tea.

[0007] The present invention also discloses an application of a Chinese medicine composition capable of invigorating qi and nourishing yin, strengthening spleen and kidney, promoting the production of body fluid and moistening dryness, and lowering blood sugar. The preparation method of the Chinese medicine composition comprises the following steps:

[0008] S1: Grind and sieve polygonatum, cornus officinalis, wolfberry, rhizoma anemarrhenae, American ginseng and green tea to obtain raw material powder;

[0009] S2: adding 5-10 times the amount of extraction solvent to the raw material powder for soaking at a soaking temperature of 30-50°C, then air-drying the surface, then freezing at -20 to -10°C for 20-30 minutes, and thawing at 30-50°C to obtain a thawing solution; the extraction solvent contains a plant catalyst;

[0010] S3: reflux the thawed solution for 2-3 times, combine the extracts, concentrate under reduced pressure, and dry to obtain a Chinese medicine composition.

[0011] As a preferred embodiment of the present invention, in step S2, the extraction solvent is a mixture of choline chloride, butanol, ethanol and plant catalyst in a molar ratio of 1-3:1-2:1-2:5-9.

[0012] As a preferred embodiment of the present invention, in step S2, the preparation method of the plant catalyst is as follows: take banana peels and celery leaves, add them into water with a mass 3-5 times that of the leaves, heat them at 40-60°C for 20-40 minutes, then perform ultrasonic treatment at a power of 1500-2000w for 20-40 minutes, filter and obtain.

[0013] As a preferred embodiment of the present invention, the mass ratio of banana peel to celery leaf is 1-3:1.

[0014] As a preferred embodiment of the present invention, in step S2, a surfactant is also added during soaking, and specifically, the surfactant is Tween 80.

[0015] As a preferred embodiment of the present invention, in step S2, a mixed gas containing carbon dioxide gas is introduced while soaking.

[0016] As a preferred embodiment of the present invention, the volume concentration of the carbon dioxide is 10-50%, and the remainder is nitrogen.

[0017] As a preferred embodiment of the present invention, the concentration of the carbon dioxide gas is gradually increased. In the first stage, a mixed gas with a volume concentration of 10-20% carbon dioxide is introduced, in the second stage, a mixed gas with a volume concentration of 20-30% carbon dioxide is introduced, and in the third stage, a mixed gas with a volume concentration of 30-50% carbon dioxide is introduced.

[0018] As a preferred embodiment of the present invention, the dosage form of the finished Chinese medicine composition is not limited to tea bags, but can also be pills, tablets, capsules, granules, oral liquids, and decoctions.

[0019] The beneficial effects of the present invention are:

[0020] (1) The present invention uses Chinese medicine and green tea as main raw materials, and Chinese medicine is added with polygonatum, American ginseng, rhizoma anemarrhenae, cornus officinalis, wolfberry and green tea;

[0021] Among them, Polygonatum sibiricum replenishes Qi and nourishes Yin, strengthens the spleen and kidneys, and moistens the lungs; American ginseng replenishes Qi and nourishes Yin, clears away heat and produces fluid; Anemarrhena asphodeloides nourishes yin and moistens dryness; Cornus officinalis is astringent and firm; together with Lycium barbarum, it nourishes the liver and kidneys. It is nourishing, clearing, and astringent. It is nourishing without being greasy, clearing without being cold, astringent without being stagnant, it replenishes Qi and produces fluid, transforms Yin with sour and sweet, and replenishes both Qi and yin. Green tea produces fluid and quenches thirst. The combination of these medicines mainly enters the lung, spleen, and kidney meridians, and together they play the effects of replenishing Qi and nourishing Yin, strengthening the spleen and kidneys, producing fluid and moistening dryness, thereby achieving the purpose of assisting in lowering blood sugar.

[0022] (2) The present invention soaks the raw material powder in an extraction solvent first, then air-dries the surface, so that the water content inside the powder is higher than that on the surface, and then freezes and thaws the powder, thereby improving the freeze swelling effect in the cells and greatly increasing the dissolution rate of the active substance.

[0023] (3) The present invention adopts a composite extraction solvent method, wherein the added plant catalyst contains plant enzymes, which greatly improves the enzymatic reaction on the cell wall of the raw material powder. In addition, the use of choline chloride, butanol and ethanol greatly improves the dissolution of active substances. In addition, the plant catalyst itself contains rich vitamins and various minerals, which further provide active substances.

[0024] (4) The present invention also adds a surfactant during soaking, which can further improve the contact between the various substances and fully improve the soaking effect. Furthermore, the mixed gas containing carbon dioxide is introduced during soaking. On the one hand, it cooperates with the plant catalyst to adjust the pH environment of its enzymatic reaction. On the other hand, the carbon dioxide acts as a medium to improve the dissolution of active substances in the raw material powder during soaking. In addition, by gradually adjusting the concentration of carbon dioxide, the plant catalyst can be gradually regulated and stabilized in the catalytic environment. DETAILED DESCRIPTION

[0025] The embodiments of the present invention are described in detail below. The embodiments described below are exemplary and are only used to explain the present invention, and should not be construed as limiting the present invention. If no specific techniques or conditions are specified in the embodiments, the techniques or conditions described in the literature in this area or the product specifications are used. The reagents or instruments used that do not specify the manufacturer are all conventional products that can be obtained commercially.

[0026] Example 1

[0027] A Chinese medicine composition for invigorating qi and nourishing yin, strengthening spleen and kidney, promoting body fluid and moistening dryness, and lowering blood sugar, comprising the following raw materials in parts by weight:

[0028] 25 parts of Polygonatum sibiricum, 15 parts of Cornus officinalis, 12 parts of Lycium barbarum, 13 parts of Anemarrhena asphodeloides, 18 parts of American ginseng, and 20 parts of green tea.

[0029] The preparation method thereof comprises the following steps:

[0030] S1: Grind polygonatum, cornus officinalis, wolfberry, rhizoma anemarrhenae, American ginseng and green tea, and pass through an 80-mesh sieve to obtain raw material powder;

[0031] S2: Add 8 times the amount of extraction solvent to the raw material powder and soak for 30 minutes at a soaking temperature of 40°C, then air-dry the surface until its moisture content is 10% and the internal moisture content is 60%, then freeze at -15°C for 25 minutes, and thaw at 45°C to obtain a thawed solution;

[0032] S3: reflux the thawed solution for extraction three times, combine the extracts, concentrate under reduced pressure, and dry to obtain a Chinese medicine composition.

[0033] In step S2, the extraction solvent is a plant catalyst.

[0034] In step S2, the preparation method of the plant catalyst is as follows: take banana peels and celery leaves in a mass ratio of 3:1, add them into water with a mass ratio of 4 times, heat them at 50°C for 30 minutes, then perform ultrasonic treatment at a power of 1800W for 30 minutes, filter and obtain.

[0035] In step S2, Tween 80 accounting for 1 wt% of the raw material powder is also added during soaking.

[0036] While soaking, a mixed gas containing carbon dioxide gas is also introduced at a flow rate of 3L / min.

[0037] The volume concentration of the carbon dioxide is 30%, and the rest is nitrogen.

[0038] Example 2

[0039] Different from Example 1, in step S2, the extraction solvent is a mixture of choline chloride, butanol, ethanol and plant catalyst in a molar ratio of 2:1:1:9.

[0040] Example 3

[0041] Different from Example 1, the concentration of the carbon dioxide gas is gradually increased. In the first stage, a mixed gas with a volume concentration of 10% carbon dioxide is passed for 10 minutes. In the second stage, a mixed gas with a volume concentration of 25% carbon dioxide is passed for 20 minutes. In the third stage, a mixed gas with a volume concentration of 35% carbon dioxide is passed for 20 minutes.

[0042] Comparative Example 1

[0043] The difference from Example 1 is that S2: 8 times the amount of extraction solvent is added to the raw material powder and soaked for 30 minutes at a soaking temperature of 40°C, followed by freezing at -15°C for 25 minutes and thawing at 45°C to obtain a thawed solution.

[0044] Comparative Example 2

[0045] The difference from Example 1 is that the extraction solvent is ethanol.

[0046] Comparative Example 3

[0047] The difference from Example 1 is that the extraction solvent is choline chloride, butanol and ethanol in a molar ratio of 3:1:1.

[0048] Comparative Example 4

[0049] The difference from Example 1 is that no mixed gas containing carbon dioxide gas is introduced during the soaking.

[0050] Comparative Example 5

[0051] Different from Example 1, Tween 80 was not added.

[0052] Control

[0053] A Chinese medicine composition for invigorating qi and nourishing yin, strengthening spleen and kidney, promoting body fluid and moistening dryness, and lowering blood sugar, comprising the following raw materials in parts by weight:

[0054] 25 parts of Polygonatum sibiricum, 15 parts of Cornus officinalis, 12 parts of Lycium barbarum, 13 parts of Anemarrhena asphodeloides, 18 parts of American ginseng, and 20 parts of green tea.

[0055] The preparation method thereof comprises the following steps:

[0056] Grind polygonatum, cornus officinalis, wolfberry, anemarrhena asphodeloides, American ginseng and green tea, and pass through an 80-mesh sieve to obtain raw material powder; add water and boil for 3 times, each time for 2 hours, combine the decoctions, concentrate, and dry to obtain the product.

[0057] Test 1:

[0058] The total saponin content of the samples of the above embodiments and comparative examples and the control samples was tested, and the change rate of the total saponin content of the samples of the embodiments and comparative examples and the control samples was calculated. The test results are shown in Table 1.

[0059] Table 1 Total saponin change rate of the samples

[0060]

[0061]

[0062] It can be seen from Table 1 that the growth rate of the total saponin content of the samples tested in the embodiment is better than that in the comparative example. The main reasons are as follows: From the analysis of comparative examples 1-5, it can be seen that in the embodiment, the raw material powder is first soaked in the extraction solvent, and then the surface is air-dried, the water content inside the powder is higher than the surface, and then it is frozen and then thawed, so that the frost heave effect in the cells is improved, and the dissolution rate of the active substance is greatly increased; furthermore, the plant catalyst added in the embodiment contains plant enzymes, which greatly improves the enzymatic reaction of the cell wall of the raw material powder, and further combined with the use of choline chloride, butanol and ethanol, the dissolution of the active substance is greatly improved, and the plant catalyst itself contains rich vitamins and various minerals, which further provide active substances. In addition, a surfactant is added during soaking, which can further improve the contact of various substances and fully improve the soaking effect. Furthermore, when a mixed gas containing carbon dioxide is introduced during soaking, on the one hand, it cooperates with the plant catalyst to adjust the pH environment of its enzymatic reaction, and on the other hand, the carbon dioxide acts as a medium to increase the dissolution of active substances in the raw material powder during soaking; in addition, by gradually adjusting the concentration of carbon dioxide, the plant catalyst can be gradually regulated and stabilized in the catalytic environment, indicating that gradually increasing the carbon dioxide content is more conducive to the dissolution of active substances, and the mixing of nitrogen must also play a role in buffering and dilution.

[0063] Test 2: Blood sugar lowering test:

[0064] Sample: Take 100g of the sample of Example 1 and add 1000ml of distilled water to soak at 80-90℃ and normal pressure for 30min, extract twice, combine the extracts and concentrate to 533ml using a rotary evaporator at 60-70℃ as the test substance stock solution, 1ml is equivalent to 0.1875g of the original sample.

[0065] Experimental animals: Kunming male mice, 24g-28g, provided by Beijing Weitonglihua Experimental Animal Technology Co., Ltd., certificate number: 0256547, SPF grade.

[0066] Dose selection: three dose groups and one model control group. The doses of the three dose groups were 0.63g / kg (low dose), 1.25g / kg (medium dose), and 3.75g / kg (high dose), respectively. Take 15ml and 30ml of the sample stock solution and add distilled water to 90ml to mix well as the gavage solution for the low and medium dose groups. The high dose group was directly given the sample concentrate, and the model control group was given distilled water. At the same time, two normal animal groups were set up, and high doses of the test substance and distilled water were given respectively. The test substance was given orally once a day, and the gavage volume was 20ml / kg.

[0067] Instruments and reagents ACCU-CHEK blood glucose meter (Roche, Germany), blood glucose test strips (Roche, Germany), and tetraoxidine (Sigma, USA).

[0068] Experimental Methods: Hyperglycemia Model Animals

[0069] Healthy male mice weighing 24g-28g were selected and fasted for 24 hours. 45mg / kg of tetraoxine (administered in an amount of 10ml / kg) was administered through the tail vein. After 7 days of fasting for 5 hours, tail blood was taken to measure blood sugar levels. Blood sugar levels of 10mmol / L-25mmol / L were considered successful hyperglycemia model animals. The hyperglycemia model animals were randomly divided into 4 groups according to blood sugar levels, namely, model control group, low-dose group, medium-dose group and high-dose group. The dose group was given the test substance at the corresponding concentration, and the model control group was given distilled water. The gavage volume was 20ml / kg. After 30 consecutive days of fasting for 5 hours, tail blood was taken to measure fasting blood sugar levels, and the blood sugar levels of animals in each group were compared.

[0070] Normal animals: 24 healthy male mice were selected, fasted for 5 hours, and tail blood was taken to measure blood sugar levels. According to blood sugar levels, they were randomly divided into 2 groups with 12 mice in each group, namely high-dose group and normal control group. The high-dose group was given the test substance, and the normal control group was given distilled water, with an intragastric dose of 20ml / kg. After 30 consecutive days of fasting for 5 hours, tail blood was taken to measure fasting blood sugar levels, and the blood sugar levels of the two groups of animals were compared.

[0071] Test 3: Glucose tolerance test

[0072] The dose group was given the test substance of the corresponding concentration, and the model control group was given distilled water. The intragastric volume was 20 ml / kg. After 30 consecutive days of administration, the subjects were fasted for 5 hours. The dose group was given the test substance of the corresponding concentration again, and the model control group was given the same volume of distilled water. After 20 minutes, 2.0 g / kg of glucose was orally administered. The tail blood was taken to measure the blood sugar level at 0, 0.5, and 2 hours after the administration of glucose. The changes in the area under the blood sugar curve at each time point after the administration of glucose in the model control group and the test substance group were calculated as the observation index of glucose tolerance.

[0073] Area under the blood glucose curve = 0.25 × (0 hour blood glucose value + 4 × 0.5 hour blood glucose value + 3 × 2 hour blood glucose value)

[0074] The experimental data were analyzed by variance analysis using SPSS13.0 for Windows software.

[0075] Results: Effects on the body weight of mice

[0076] Table 2 Effects on the body weight of mice

[0077] Dosage (g / kg) Number of animals Initial body weight (g) Middle period weight (g) Final weight (g) Normal control 12 24.2±1.4 32.6±1.2 37.9±1.6 3.75 12 25.0±0.9 33.2±1.0 38.7±1.1

[0078] Note: P>0.05 compared with the control group

[0079] As shown in Table 2, there was no significant difference in body weight between the 3.75 g / kg dose group and the normal control group at each stage (p>0.05), indicating that the sample had no significant effect on the body weight of normal mice under the experimental conditions.

[0080] Table 3 Effects on body weight of hyperglycemia model mice

[0081] Dosage (g / kg) Number of animals Initial body weight (g) Middle period weight (g) Final weight (g) 0.63 12 27.9±1.5 31.1±1.6 34.4±2.4 1.25 12 27.2±1.0 31.2±1.3 34.2±1.8 3.75 12 28.4±1.5 31.2±1.0 33.8±1.5 Model comparison 12 28.1±1.5 31.7±1.9 34.2±1.9

[0082] Note: P>0.05 compared with the control group

[0083] As shown in Table 3, there was no significant difference in body weight between each dose group and the model control group at each stage (P>0.05), indicating that the samples had no significant effect on the body weight of hyperglycemia model mice under the experimental conditions.

[0084] Effects on fasting blood glucose in normal mice

[0085] Table 4 Effect on fasting blood glucose in normal mice (mmol / L)

[0086] Dosage (g / kg) Number of animals Fasting blood glucose before the test Fasting blood glucose after test Normal control 12 6.2±0.7 6.6±1.0 3.75 12 6.9±0.7 6.9±0.8

[0087] Note: P>0.05 compared with the control group

[0088] As shown in Table 4, there was no significant difference in fasting blood glucose between the 3.75 g / kg dosage group and the normal control group before and after the test (P>0.05), indicating that the sample of Example 1 had no significant effect on the fasting blood glucose of normal mice under the experimental conditions.

[0089] Test 4: Effects on fasting blood glucose and glucose tolerance in hyperglycemia model mice.

[0090] Table 5 Effects on fasting blood glucose and glucose tolerance of hyperglycemia model mice (mmol / L)

[0091]

[0092] Note: **P<0.01 compared with the control group

[0093] As can be seen from Table 5, after the test, the fasting blood glucose levels of the hyperglycemic model mice in the three dose groups were lower than that in the model control group, and the difference was extremely significant (P<0.01), indicating that the fasting blood glucose test results of the hyperglycemic model mice of the example sample under the experimental conditions were positive; the 3.75 g / kg dose group was able to reduce the area under the blood glucose curve of the hyperglycemic model mice, and the difference was extremely significant compared with the model control group (P<0.01), indicating that the tolerance test results were positive under the experimental conditions.

[0094] After oral administration of different doses of the sample of Example 1 to mice for 30 days, the 0.63g / kg, 1.25g / kg, and 3.75g / kg dose groups were able to reduce the fasting blood glucose of the hyperglycemic model mice, and the 3.75g / kg dose group was able to reduce the blood glucose area under the curve of the hyperglycemic model mice, and the difference compared with the model control group was extremely significant (P < 0.01). The 3.75g / kg dose group had no significant effect on the fasting blood glucose of normal mice. This indicates that the sample of Example 1 has an auxiliary blood glucose lowering function under the conditions of this experiment.

[0095] Test 5: Human Trials

[0096] 110 patients with type 2 diabetes were selected and randomly divided into a control group and a trial group according to their blood sugar levels, and the age, course of disease, type of medication, blood lipid level, etc. of the subjects were taken into consideration. There were 55 cases in each of the control group and the trial group, and 54 cases in each of the effective control group and the trial group. The trial group was given the sample of Example 1, 3 times a day, 1 bag each time, 2.5g per bag; the control group was a placebo control. The subjects were observed for 30 days, and diet control was maintained during the observation period. The types and dosages of the original diabetes treatment drugs remained unchanged.

[0097] Materials and Methods

[0098] Sample: 2.5g / bag, intake is 3 times a day, 1 bag each time.

[0099] Subject selection:

[0100] Inclusion criteria: Adult patients with type 2 diabetes who are in a relatively stable condition after diet control or oral hypoglycemic drugs, who do not need to change the drug type and dosage, and who only take maintenance doses, with fasting blood sugar > 7.8mmol / L or 2h postprandial blood sugar > 11.1mmol / L. Patients with high blood sugar levels (7.8mmol / L > fasting blood sugar > 6.7mmol / L or 11.1mmol / L > 2h postprandial blood sugar > 7.8mmol / L) can also be selected. Patients who meet the above conditions, are willing to participate and guarantee cooperation can be included in the trial.

[0101] Exclusion criteria: patients with type 2 diabetes (insulin-dependent).

[0102] Those under 18 or over 65, pregnant or lactating women, those who are allergic to the test samples, those with complications of major organs such as heart, liver, kidney, or other serious diseases, mental patients taking glucocorticoids or other drugs that affect blood sugar.

[0103] Patients with diabetic ketoacidosis or infection in the past 3 months.

[0104] Those who cannot cooperate with dietary control and thus affect the observation results.

[0105] Taking items related to the function being tested in the short term will affect the judgement of the results.

[0106] Anyone who does not meet the inclusion criteria, does not take the test sample as required, or has incomplete information that affects the observation results.

[0107] Subject groups:

[0108] Two control designs, self-control and inter-control, were used. Grouping was performed according to the requirements of random blind method. 110 patients with type 2 diabetes who met the above criteria were selected and randomly divided into a trial group and a control group according to the blood sugar levels of the subjects. The main factors affecting the results, such as the course of disease and the type of medication (sulfonates, biguanides), were considered as much as possible for balance test to ensure the comparability between the groups. There were 55 cases in each control group and trial group, and the final effective cases were 54 cases in the control group and 54 cases in the trial group.

[0109] Test method:

[0110] Before the test, each subject was prescribed a corresponding diet according to gender, age, different labor intensity, and ideal body weight with reference to the original living habits. During the test, the diet control, the type and dosage of the drug for treating diabetes remained unchanged. The test group took the sample of Example 1, 3 times a day, 1 bag each time, orally, and observed for 30 consecutive days. The control group was a placebo control.

[0111] Observation indicators: Each indicator was tested once at the beginning and end of the feeding trial.

[0112] Safety indicators: General condition signs include mental state, sleep, diet, urination, defecation, blood pressure, etc.

[0113] Routine blood, urine and stool examinations.

[0114] Liver and kidney function tests: abdominal B-ultrasound, electrocardiogram, chest X-ray (only once before the test).

[0115] Symptom observation:

[0116] Inquire about the patient's medical history in detail, understand the patient's diet, medication, and activity level, observe the main clinical symptoms such as thirst and polydipsia, polyphagia, fatigue, and polyuria, score the symptoms according to their severity, and calculate the score values ​​before and after the trial meal. Observe the improvement of the main symptoms (improvement of 1 point is effective) and observe the improvement rate of clinical symptoms.

[0117] Table 6 Clinical symptom score table

[0118]

[0119] Fasting blood sugar: Observe the fasting blood sugar value and the percentage of blood sugar decrease before and after the test meal.

[0120] The blood sugar level 2 hours after meal was observed before and after the test meal, and the percentage of blood sugar decrease 2 hours after eating 100g of refined flour steamed bread.

[0121] Urine sugar: Use fasting morning urine for qualitative analysis, and score -, ±, ++, +++, and ++++ as 0, 0.5, 1, 2, 3, and 4 points respectively. The integral values ​​are calculated before and after the tasting.

[0122] Blood lipids: Observe the levels of serum total cholesterol, triglycerides, and high-density lipoprotein cholesterol before and after the tasting.

[0123] Statistical treatment:

[0124] The results were expressed as mean ± standard deviation, and paired t-test was used for self-comparison before and after the trial, and group t-test was used for comparison between groups.

[0125] The general data results are shown in Table 7. Before the trial, there were no significant differences in age, gender, disease course, blood sugar, and types of medication (sulfonylureas, metformin) between the two groups of subjects (P>0.05), and the two groups were comparable.

[0126] Table 7 Comparison of general information before tasting

[0127] project Control group Food taster Number of cases (n) 54 54 men and women 32 / 22 38 / 16 Age (years) 52.54±7.83 50.39±7.25 Disease duration (years) 4.31±1.48 4.13±1.71 Fasting blood glucose (mmol / L) 7.91±0.75 7.91±0.67 Blood glucose 2h after meal (mmol / L) 13.06±1.02 12.91±0.80 No medication 33 33 Sulfonylureas 14 12 Metformin 5 6 Sulfonylureas + metformin 2 3

[0128] Efficacy observation:

[0129] As for the effect on clinical symptoms, it can be seen from Tables 8-13 that the main clinical symptoms such as thirst and frequent drinking, frequent hunger, fatigue, and polyuria were significantly improved after the trial meal.

[0130] Table 8 Comparison of clinical observation efficacy before and after the test

[0131]

[0132]

[0133] Table 9 Statistics of total clinical symptom scores

[0134] Group Number of cases Before eating After eating P value (self) Control group 54 4.63±2.16 4.13±2.02 0 Food tasting group 54 4.85±2.47 3.28±2.24 0 P-value 0.623 0.024

[0135] Table 10: Thirst and frequent drinking

[0136] Group Number of cases Before eating After eating Control group 54 1.31±0.99 1.17±0.95 Food tasting group 54 1.33±1.00 0.91±0.91

[0137] Table 11 Eating too much can cause hunger

[0138] Group Number of cases Before eating After eating Control group 54 1.07±0.99 1.07±1.01 Food tasting group 54 1.05±0.89 0.67±0.75

[0139] Table 12 Fatigue and fatigue

[0140] Group Number of cases Before eating After eating Control group 54 1.17±1.06 1.07±1.01 Food tasting group 54 1.16±0.98 0.80±0.85

[0141] Table 13 Polyuria

[0142]

[0143]

[0144] As for the effect on fasting blood glucose, as shown in Table 14, there was no statistically significant difference in fasting blood glucose between the two groups before the trial (P>0.05); after the trial, there was a statistically significant difference in fasting blood glucose between the trial group and the control group (P<0.01); the fasting blood glucose of the trial group after the trial was lower than that before the trial, and the difference was statistically significant (P<0.01); the fasting blood glucose of the trial group after the trial was lowered by 10.36% compared with that before the trial, while the fasting blood glucose of the control group after the trial was lowered by 0.20%.

[0145] Table 14 Fasting blood glucose (mmol / L) changes before and after

[0146] Group Number of cases Before eating After eating Decrease percentage % P value (self) Control group 54 7.91±0.75 7.89±0.83 0.20±4.23 0.115 Food tasting group 54 7.91±0.67 7.06±0.45 10.36±7.41 0.000 P value (between groups) 0.875 0.000 0.000

[0147] Table 15 shows that before the trial, there was no significant difference in blood sugar 2 hours after meal between the two groups (P>0.05); after the trial, the blood sugar 2 hours after meal in the trial group was significantly lower than that in the control group (P<0.01), and there was a significant difference in blood sugar 2 hours after meal before and after the trial in the trial group (P<0.01); the blood sugar 2 hours after meal in the trial group decreased by 10.65% compared with that before the trial. The blood sugar 2 hours after meal in the control group decreased by 0.70% compared with that before the trial.

[0148] Table 15 Changes in blood glucose (mmol / L) 2 hours after meal before and after the test

[0149] Group Number of cases Before eating After eating Decrease percentage % P value (self) Control group 54 13.06±1.02 12.97±1.05 0.70±3.30 0.325 Food tasting group 54 7.91±0.67 11.51±0.84 10.65±6.79 0.000 P value (between groups) 0.386 0.000 0.000

[0150] As shown in Table 16, the fasting blood glucose before and after the appropriate diet, the effective rate of blood glucose 2 hours after the meal and the total effective rate in the appropriate diet group were significantly higher than those in the control group.

[0151] Table 16 Comparison of blood sugar effectiveness before and after the trial meal

[0152]

[0153]

[0154] Effect on urine sugar: Table 17 shows that after taking the medicine for 30 days, the urine sugar score of the trial group was significantly reduced, and there was a significant difference compared with before and after the trial and the control group (P < 0.01).

[0155] Table 17 Changes in urine sugar scores before and after the trial

[0156] Group Number of cases Before eating After eating P value (self) Control group 54 0.72±0.46 0.76±0.55 0.356 Food tasting group 54 0.78±0.46 0.41±0.26 0.000 P value (between groups) 0.604 0.000

[0157] Table 18 Changes in cholesterol before and after the test meal (mmol / L)

[0158] Group Number of cases Before eating After eating P value (self) Control group 54 4.57±0.72 4.53±0.76 0.737 Food tasting group 54 4.60±0.68 4.52±0.53 0.511 P value (between groups) 0.858 0.969

[0159] Table 19 Changes in triglycerides before and after the test meal (mmol / L)

[0160] Group Number of cases Before eating After eating P value (self) Control group 54 1.36±0.28 1.36±0.25 0.989 Food tasting group 54 1.40±0.26 1.30±0.29 0.067 P value (between groups) 0.444 0.267

[0161] Table 20 Changes in high-density lipoprotein cholesterol before and after the trial meal (mmol / L)

[0162]

[0163]

[0164] As shown in Tables 18, 19 and 20, there was no significant difference in blood lipids between the trial group and the control group before and after the trial (P>0.05); there was no significant difference in blood lipids between the trial group and before the trial (P>0.05).

[0165] Example 1 Observation of safety indicators before and after the sample tasting:

[0166] Example 1 Before the sample tasting, no abnormalities were found in the subjects' abdominal B-ultrasound, electrocardiogram, and chest X-ray.

[0167] Example 1 Changes in urine and feces routine indicators before and after the sample tasting There were 108 subjects in the two groups, and no obvious abnormalities were found in urine and feces routine examination indicators before and after the tasting.

[0168] Example 1 Safety inspection of sample tea before and after tasting

[0169] As can be seen from Table 21, the safety indicators of the sample of Example 1 before and after tasting were all within the normal range.

[0170] Table 21 Safety inspection before and after tasting

[0171]

[0172]

[0173] Table 22 Adverse reactions and allergic reactions after food tasting

[0174] Number of cases Adverse Reactions Allergic reactions Control group 54 0 0 Food tasting group 54 0 0

[0175] As can be seen from Table 22, after the trial, no adverse reactions or allergic reactions were observed in the subjects.

[0176] The results showed that after taking the sample of the embodiment, the fasting blood sugar and 2h blood sugar after meal in the trial group were significantly lower than those in the control group, and the difference was significant; the fasting blood sugar and 2h blood sugar after meal in the trial group were significantly different before and after the trial; the fasting blood sugar and 2h blood sugar after meal in the trial group decreased by 10.36% and 10.65% respectively after the trial. The main clinical symptoms such as thirst and polydipsia, polyphagia and hunger, fatigue and polyuria in the trial group were significantly improved after the trial, and the improvement rate was higher than that in the control group, and the difference was statistically significant; there was no significant change in the safety indicators such as blood picture, liver and kidney function, urine and stool routine in the two groups before and after the trial, and no adverse reactions and allergic reaction symptoms were seen after the trial. There was no abnormality in chest X-ray, electrocardiogram, and abdominal B-ultrasound examination before the experiment. It has an auxiliary hypoglycemic effect and no obvious damage.

[0177] In actual application, the dosage form of the finished Chinese medicine composition of the present invention is not limited to tea bags, but can also be pills, tablets, capsules, granules, oral liquids, and decoctions, all of which have the effects of invigorating qi and nourishing yin, strengthening the spleen and kidneys, promoting body fluid and moistening dryness, and assisting in lowering blood sugar.

[0178] The above-mentioned embodiments only express the preferred implementation modes of the present invention, and the description thereof is relatively specific and detailed, but it cannot be understood as limiting the scope of the present invention. It should be pointed out that, for ordinary technicians in this field, various other corresponding changes and deformations can be made according to the technical solutions and concepts described above, and all these changes and deformations should fall within the scope of protection of the claims of the present invention.

Claims

1. A Chinese medicine composition for invigorating qi and nourishing yin, strengthening spleen and kidney, promoting body fluid and moistening dryness, and lowering blood sugar, characterized in that: It includes the following raw materials in parts by weight: 10-30 parts of polygonatum, 10-20 parts of cornus officinalis, 10-20 parts of wolfberry, 10-20 parts of anemarrhena asphodeloides, 10-20 parts of American ginseng, and 10-30 parts of green tea.

2. An application of a Chinese medicine composition for invigorating qi and nourishing yin, strengthening the spleen and kidney, promoting body fluid and moistening dryness, and lowering blood sugar, characterized in that: The preparation method of the Chinese medicine composition comprises the following steps: S1: Grind and sieve polygonatum, cornus officinalis, wolfberry, rhizoma anemarrhenae, American ginseng and green tea to obtain raw material powder; S2: adding 5-10 times the amount of extraction solvent to the raw material powder for soaking at a soaking temperature of 30-50°C, then air-drying the surface, then freezing at -20 to -10°C for 20-30 minutes, and thawing at 30-50°C to obtain a thawing solution; the extraction solvent contains a plant catalyst; S3: reflux the thawed solution for 2-3 times, combine the extracts, concentrate under reduced pressure, and dry to obtain a Chinese medicine composition.

3. The use of a Chinese medicine composition for invigorating qi and nourishing yin, strengthening spleen and kidney, promoting body fluid and moistening dryness, and lowering blood sugar according to claim 2, characterized in that: In step S2, the extraction solvent is a mixture of choline chloride, butanol, ethanol and plant catalyst in a molar ratio of 1-3:1-2:1-2:5-9.

4. The use of a Chinese medicine composition for invigorating qi and nourishing yin, strengthening spleen and kidney, promoting body fluid and moistening dryness, and lowering blood sugar according to claim 2, characterized in that: In step S2, the preparation method of the plant catalyst is as follows: take banana peels and celery leaves, add them into water with a mass 3-5 times that of the leaves, heat them at 40-60°C for 20-40 minutes, then perform ultrasonic treatment at a power of 1500-2000w for 20-40 minutes, filter and obtain.

5. The use of a Chinese medicine composition for invigorating qi and nourishing yin, strengthening spleen and kidney, promoting body fluid and moistening dryness, and lowering blood sugar according to claim 4, characterized in that: The mass ratio of banana peel and celery leaf is 1-3:

1.

6. The use of a Chinese medicine composition for invigorating qi and nourishing yin, strengthening spleen and kidney, promoting body fluid and moistening dryness, and lowering blood sugar according to claim 2, characterized in that: In step S2, a surfactant is also added during the soaking.

7. The use of a Chinese medicine composition for invigorating qi and nourishing yin, strengthening spleen and kidney, promoting body fluid and moistening dryness, and lowering blood sugar according to claim 2, characterized in that: In step S2, a mixed gas containing carbon dioxide gas is introduced during soaking.

8. The use of a Chinese medicine composition for invigorating qi and nourishing yin, strengthening spleen and kidney, promoting body fluid and moistening dryness, and lowering blood sugar according to claim 7, characterized in that: The volume concentration of the carbon dioxide is 10-50%, and the remainder is nitrogen.

9. The use of a Chinese medicine composition for invigorating qi and nourishing yin, strengthening spleen and kidney, promoting body fluid and moistening dryness, and lowering blood sugar according to claim 7, characterized in that: The concentration of the carbon dioxide gas is gradually increased. In the first stage, a mixed gas with a volume concentration of 10-20% carbon dioxide is introduced, in the second stage, a mixed gas with a volume concentration of 20-30% carbon dioxide is introduced, and in the third stage, a mixed gas with a volume concentration of 30-50% carbon dioxide is introduced.

10. The use of a Chinese medicine composition for invigorating qi and nourishing yin, strengthening spleen and kidney, promoting body fluid and moistening dryness, and lowering blood sugar according to claim 2, characterized in that: The dosage form of the finished Chinese medicine composition includes at least one of tea bag, pill, tablet, capsule, granule, oral liquid and decoction.

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