Medicinal and edible composition, solid particle and application thereof

Abstract

The invention belongs to the technical field of diabetes medicines, and particularly relates to a medicinal and edible composition, solid particles and application of the medicinal and edible composition and the solid particles. Solid particles of the medicinal and edible composition based on the medicinal and edible composition can be used for remarkably improving water intake increase, fasting blood glucose increase, glucose tolerance, insulin resistance, insulin sensitivity, blood fat (TC and TG) levels, liver indexes and liver and pancreas histological morphology levels of mice, so that the symptoms of type 2 diabetes mellitus are remarkably improved.

Description

Technical Field

[0001] The invention belongs to the technical field of diabetes medicines, and in particular relates to a medicine-food homologous composition, solid particles and applications thereof. Background Art

[0002] Type 2 diabetes is a metabolic disease, and its incidence has gradually increased in recent years. As the disease progresses, blood sugar tends to rise gradually, and it is often necessary to take hypoglycemic drugs in the early stage and inject insulin for life in the later stage. As the disease develops, a variety of complications will occur. At present, the treatment methods for type 2 diabetes have great limitations and side effects. For example, Baihu Jia Renshen Tang is the main Chinese medicine formula for the treatment of type 2 diabetes. It has been widely recorded in history and is also widely used in modern clinical practice. Its main and auxiliary drugs are gypsum and Anemarrhena asphodeloides, respectively. The medicinal properties are relatively strong and the scope of application is limited.

[0003] The concept of "food and medicine have the same origin" is a dietary health concept that originated from traditional Chinese medicine and has a long history of development. It means that a certain type of food has the characteristics of both food and medicine. By consuming this kind of food for a long time, people can achieve the goal of improving their health level and alleviating diseases.

[0004] Therefore, the present invention can effectively solve the current drawbacks of single treatment methods for type 2 diabetes and large side effects of drugs through the intervention idea of ​​medicine and food being of the same origin. Summary of the invention

[0005] The present invention develops a medicine-food homologous composition and solid particles capable of improving type 2 diabetes based on raw lotus root and yam which are homologous to medicines.

[0006] In order to achieve the above object, the present invention can adopt the following technical solutions:

[0007] One aspect of the present invention provides a medicine-food composition comprising raw lotus root juice and yam juice.

[0008] Preferably, the mass ratio of the raw lotus root juice to the yam juice is (4-16):3.

[0009] More preferably, the mass ratio of the raw lotus root juice to the yam juice is 8:3.

[0010] Another aspect of the present invention provides a preparation, which is prepared from the medicine-food composition of the present invention.

[0011] Preferably, the above-mentioned preparation is solid particles, and its preparation raw materials include a medicine-food composition, a binder and excipients.

[0012] More preferably, the binder is ethanol; and / or the auxiliary material is one or more combinations of maltodextrin, lactose and microcrystalline cellulose.

[0013] More preferably, the ethanol is 45% concentration ethanol.

[0014] In another aspect, the present invention provides a method for preparing the solid particles of the present invention, comprising: (1) preparing the edible and medicinal composition into a dry paste powder; and (2) mixing the dry paste powder, a binder and auxiliary materials to obtain solid particles.

[0015] Preferably, the added amount of the above auxiliary materials is 10%-30% of the mass of the dry paste powder.

[0016] In another aspect, the present invention provides a use of the medicine-food composition of the present invention in the preparation of a medicament for improving type 2 diabetes.

[0017] The beneficial effects of the present invention include at least:

[0018] (1) The edible-medicinal composition or solid particles provided by the present invention can significantly improve the increased water intake, increased fasting blood sugar, glucose tolerance, insulin resistance, insulin sensitivity, blood lipid (TC and TG) levels, liver index, and liver and pancreatic histological morphology of mice, thereby significantly improving type 2 diabetes.

[0019] (2) The medicinal and edible composition or solid particles provided by the present invention are mainly prepared from raw lotus root juice and yam juice. Both raw lotus root and yam are medicinal and edible and have no side effects. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 is the fasting blood sugar of mice in each group of medicine-food combination;

[0021] Figure 2A The changes of oral glucose amount of mice over time after intervention with the medicine-food combination;

[0022] Figure 2B To investigate the effect of the food-drug combination intervention on oral glucose tolerance in mice;

[0023] Figure 3A The changes of oral insulin in mice over time after intervention with the medicine-food combination;

[0024] Figure 3B The effect of the medicine-food combination intervention on oral insulin tolerance in mice;

[0025] Figure 4 The insulin resistance index of mice in each group of medicine-food combination;

[0026] Figure 5 The insulin sensitivity index of mice in each group of medicine-food combination;

[0027] Fig. 6A is the serum TC level of mice in each group of medicine and food combination;

[0028] Figure 6B The serum TG levels of mice in each group of medicine-food combination;

[0029] Figure 7 is the organ index of the liver of mice in each group of the medicine-food combination;

[0030] Figure 8 Pathological histological analysis of liver and pancreas of each group of medicine-food combination;

[0031] Fig. 9 Solid particles for fasting blood glucose in mice;

[0032] Fig. 10A This is the change of oral glucose amount over time in mice after solid particle intervention;

[0033] Fig. 10B To investigate the effect of solid particle intervention on oral glucose tolerance in mice;

[0034] Fig.11A This is the change of oral insulin in mice over time after solid particle intervention;

[0035] Fig. 11B To investigate the effect of solid particle intervention on oral insulin tolerance in mice;

[0036] Fig.12 The insulin resistance index of mice in each group of medicine-food combination;

[0037] Fig.13 The insulin sensitivity index of mice in each group of medicine-food combination;

[0038] Fig.14A is the serum TC level of mice in each solid particle group;

[0039] Fig. 14B Serum TG levels of mice in each solid particle group;

[0040] Fig.15 is the organ index of the liver of mice in each solid particle group;

[0041] Fig.16 Pathological histological analysis of liver and pancreas in each solid particle group. DETAILED DESCRIPTION

[0042] The examples are provided to better illustrate the present invention, but the present invention is not limited to the examples. Therefore, those skilled in the art may make non-essential improvements and adjustments to the implementation scheme according to the above invention content, which still fall within the protection scope of the present invention.

[0043] The terms used herein are only used to describe specific embodiments and are not intended to limit the present disclosure. Unless the context has a significantly different meaning, expressions in the singular include expressions in the plural. As used herein, it should be understood that terms such as "include", "have", "comprise" and the like are intended to indicate the presence of features, numbers, operations, components, parts, elements, materials or combinations. The terms of the present invention are disclosed in the specification, and are not intended to exclude the possibility that one or more other features, numbers, operations, components, parts, elements, materials or combinations thereof may exist or may be added. As used herein, " / " may be interpreted as "and" or "or", depending on the circumstances.

[0044] The embodiment of the present invention provides a medicine and food composition, which comprises raw lotus root juice and yam juice.

[0045] In some specific examples, the mass ratio of the raw lotus root juice and the yam juice can be (4-16):3, such as 5:3, 8:3, 10:3, 12:3 or 15:3, etc.; among which 8:3 is more preferred, and the medicine-food composition with this ratio has a better effect on improving diabetes.

[0046] An embodiment of the present invention provides a preparation, which is prepared from the medicine-food composition of the present invention.

[0047] It should be noted that the medicine-food composition of the present invention can be prepared into different preparations, such as oral liquid, capsule, tablet or granule.

[0048] In some specific examples, the above-mentioned preparation is solid particles, and the raw materials for its preparation include a medicine-food combination.

[0049] It should be noted that the preparation of the present invention may preferably be solid particles, which are convenient to carry and can be taken with water, thus increasing patient compliance.

[0050] In some specific examples, the above-mentioned preparation raw materials also include adhesives and auxiliary materials.

[0051] It should be noted that the solid particles in the present invention can be prepared by a method known in the present invention, preferably using a binder and auxiliary materials.

[0052] In some specific examples, the binder is ethanol; and / or the auxiliary material is one or more combinations of maltodextrin, lactose and microcrystalline cellulose.

[0053] It should be noted that the adhesive of the present invention can be ethanol, and the auxiliary material can be one or more combinations of maltodextrin, lactose and microcrystalline cellulose; maltodextrin is more preferred, which has a higher molding rate, a lower solid content, and a lower angle of repose.

[0054] In some specific examples, the ethanol may be 45% (V / V) ethanol.

[0055] It should be noted that the above-mentioned ethanol can be ethanol of any concentration, preferably 45% concentration ethanol, which has better moldability than ethanol of other concentrations and has moderate viscosity.

[0056] In some specific examples, the particle size of the solid particles is 240 μm-2070 μm.

[0057] It should be noted that the solid particles in the present invention can be sieved through No. 1 Pharmacopoeia sieve and No. 4 Pharmacopoeia sieve to obtain particles with a moderate particle size, that is, the particle size can be 240 μm-2070 μm.

[0058] The present invention also provides a method for preparing the solid particles of the present invention, comprising: (1) preparing the edible and medicinal composition into a dry paste powder; and (2) mixing the dry paste powder, a binder and auxiliary materials to obtain solid particles.

[0059] It should be noted that the edible and medicinal composition can be prepared into a dry paste powder by a method known in the art; similarly, the dry paste powder, a binder and auxiliary materials are mixed and granulated to obtain solid particles, which can also be prepared by a method known in the art.

[0060] In some specific examples, the above step (2) includes: putting the dry paste powder and auxiliary materials into a wet granulator, then spraying the binder, and granulating at a temperature of 20° C.-65° C. to obtain solid particles.

[0061] In some specific examples, the added amount of the above auxiliary materials is 10%-30% of the mass of the dry paste powder, such as 15%, 20% or 25%.

[0062] The embodiment of the present invention also provides a use of the medicine-food composition of the present invention in the preparation of a drug for improving type 2 diabetes.

[0063] It should be noted that the medicine-food composition or solid particles provided by the present invention can significantly improve the increased water intake, increased fasting blood sugar, glucose tolerance, insulin resistance, insulin sensitivity, blood lipid (TC and TG) levels, liver index, and liver and pancreatic histological morphology of mice, thereby significantly improving type 2 diabetes.

[0064] In order to better understand the present invention, the content of the present invention is further explained below in conjunction with specific examples, but the content of the present invention is not limited to the following examples.

[0065] 1. Preparation of food-drug combination

[0066] Example 1

[0067] Take 400g lotus root and 150g yam, add 750ml water respectively, put into juicer for stirring, filter through 100-mesh filter cloth to obtain raw lotus root juice and yam juice; mix the raw lotus root juice and yam juice to obtain a medicine and food composition.

[0068] Example 2

[0069] Take 800g lotus root and 150g yam, add 1500ml water respectively, put into juicer and stir, filter through 100-mesh filter cloth to obtain raw lotus root juice and yam juice; mix the raw lotus root juice and yam juice to obtain a medicine and food composite.

[0070] Example 3

[0071] Take 200g lotus root and 150g yam, add 750ml water respectively, put into juicer for stirring, filter through 100-mesh filter cloth to obtain raw lotus root juice and yam juice; mix the raw lotus root juice and yam juice to obtain a medicine and food composition.

[0072] 2. Solid Particle Preparation

[0073] Example 4

[0074] (1) Concentrating to prepare a paste: The edible and medicinal composition prepared in Example 1 is concentrated to a volume that is 1 / 4 of the original volume, and the concentrated liquid is dried to prepare a dry paste;

[0075] (2) Crushing: crush the dry paste into pieces and put them into a grinder for 5 seconds, repeat 2 to 3 times;

[0076] (3) Wet granulation: put the dry paste powder into a 100-mesh wet granulator, pour in 10% maltodextrin (10% refers to the mass proportion of the dry paste powder); set the cutting knife speed to 2000r; the propeller speed to 300r; after the knife rotates, spray in the adhesive (45% (V / V) food grade ethanol) (Henan Hanyong Alcohol Co., Ltd. - edible dealdehyde deodorized tasteless corn alcohol 95%, add pure water, make up to 45%) 2ml each time, stop after spraying and check the state of the powder particles, repeat until the powder particles show a physical state of kneading into a ball, patting the ball and breaking up, and showing obvious granularity, that is, the granulation is completed; keep the instrument temperature between 20 degrees Celsius and 65 degrees Celsius;

[0077] (4) Drying: Spread the wet granules in a 60°C oven until they are dried;

[0078] (5) Drying: The granules are passed through the No. 1 pharmacopoeia sieve. The large granules that do not pass the sieve are placed in the drying machine. The cutting knife speed is set to 2000r. The instrument temperature is ensured to be between 20 and 80 degrees Celsius.

[0079] (6) Sieving: All the granules are passed through No. 1 and No. 4 pharmacopoeia sieves in turn. Repeat step (6) for the granules that do not pass through the No. 1 pharmacopoeia sieve, and collect the granules that pass through the No. 1 sieve but do not pass through the No. 4 sieve to obtain the finished product;

[0080] (7) Packaging: Pack the product into bags under sterile conditions.

[0081] Example 5 to Example 11

[0082] The difference between Examples 5 to 11 and Example 4 is that the volume fraction of food-grade ethanol used is different; the volume fraction of food-grade ethanol used in Examples 5 and 11 is shown in Table 1 below, and the rest is the same as Example 4; and the soft material properties and particle formability of the particles prepared in Examples 4 to 11 were tested, and the results are shown in Table 1 below.

[0083] Table 1 Different volume fractions of food grade ethanol

[0084] Example Adhesives Soft material properties Particle Formability Example 4 45% ethanol Moderate viscosity Good formability Example 5 40% ethanol Viscosity is too high Too strong formability Example 6 50% ethanol Low viscosity Poor formability Example 7 60% ethanol Low viscosity Poor formability Example 8 70% ethanol Low viscosity Poor formability Example 9 80% ethanol Viscosity is too low Too much fine powder, poor formability Example 10 90% ethanol Viscosity is too low Too much fine powder, poor formability Embodiment 11 95% ethanol Viscosity is too low Too much fine powder, poor formability

[0085] It can be seen from Table 1 above that 45% ethanol has the most moderate viscosity and good formability for soft materials, so 45% concentration of food-grade ethanol is preferably used as the binder for solid particles.

[0086] Example 12 to Example 13

[0087] The difference between Example 12 to Example 13 and Example 4 is that different excipients are used; the excipients used in Example 10 and Example 11 are shown in Table 2 below, and the others are the same as Example 4; and the forming rate, dissolution rate, angle of repose and solid content of the particles prepared in Example 4 and Example 12 to Example 13 were tested, and the results are shown in Table 2 below.

[0088] Table 2 Different types of auxiliary materials

[0089] Example Excipients Forming rate Dissolution rate Angle of repose Solid content Example 4 Maltodextrin 73.6％ <25s 33.19° 2.6％ Example 12 lactose 70.1％ <25s 35.92° 4.8％ Example 13 Microcrystalline Cellulose 74.3％ <25s 32.77° 3.5％

[0090] It can be seen from Table 2 above that maltodextrin has a higher molding rate, the lowest solid content, and a lower angle of repose, so maltodextrin can be preferred as an auxiliary material.

[0091] Example 14 to Example 15

[0092] The difference between Examples 14 to 15 and Example 4 is that the mass fraction of maltodextrin used is different; the mass fraction of maltodextrin used in Examples 14 and 15 is shown in Table 3 below, and the others are the same as Example 4; and the forming rate, dissolution rate, angle of repose and solid content of the particles prepared in Examples 4 and 14 to 15 were tested, and the results are shown in Table 3 below.

[0093] Table 3 Mass fraction of different maltodextrins

[0094]

[0095] It can be seen from Table 3 above that 30% maltodextrin has the highest molding rate and the smallest solid content, and 30% mass fraction of maltodextrin is preferred in the present invention.

[0096] 3. Experiment on the intervention effect of the medicinal and edible combination on STZ-induced type 2 diabetic mice

[0097] 1. Experimental animals

[0098] 80 clean-grade 4-week-old C57BL / 6J mice, weighing 12-16 g, were purchased from Jiangsu Jicui Pharmaceutical Biotechnology Co., Ltd.; daily basic maintenance feed, Jiangsu Jicui Pharmaceutical Biotechnology Co., Ltd.; 60% high-fat feed D12492, American Research Diets.

[0099] (II) Establishment of STZ-induced type 2 diabetes model

[0100] 70 C57 mice, weighing 12g-16g, were kept in the following environment during the experiment: temperature 25℃, humidity 50±5%, 12h light / 12h dark alternation, adaptive feeding for one week, free diet and water; after one week of adaptive feeding, 10 mice were divided into the normal group (N) and fed with standard feed, and the remaining 60 mice were fed with high-fat feed in the experimental group. The mice in each group were free diet and water, and the diet, water intake and body weight of the mice in each group were recorded regularly. After 5 weeks of high-fat intervention, the mice in the experimental group were fasted for 12h, and 85g / kg of streptozotocin (STZ) was injected intraperitoneally. 200g / L glucose aqueous solution was given 4h after injection to prevent the model animals from dying due to hypoglycemia, and the normal group was injected with normal saline; after that, they continued to be fed with high-fat feed and ordinary feed respectively, fasted for 12h after one week, blood was collected from the tail vein, and blood sugar was tested. Mice with a blood sugar greater than 11.1mmolL were considered diabetic mice. Mice whose blood sugar levels did not meet the standard were given an additional injection of 80 mg / kg streptozotocin (STZ).

[0101] (III) Grouping of mice

[0102] All mice were grouped as shown in Table 4 below, with 8 mice in each group. The drug was administered at 10 mL / kg per day for 4 weeks, and the mice were free to eat during the period.

[0103] Table 4 Different groups of mice

[0104] Grouping Grouping Normal group (N) Intragastric administration of saline Model group (M) Intragastric administration of saline Metformin positive drug group (A) Oral administration of metformin 120 mg / kg·d Original group (C) Intragastric administration of Baihu Jia Renshen Decoction 34.125g / kg Example 1 (D) Group Oral administration D 33.75 g / kg·d Example 2 (E) Group Oral administration of E 26.54 g / kg Example 3 (F) Group Oral administration of F 36.02 g / kg·d

[0105] (IV) Verification of the effect of medicine-food combination

[0106] In the following verification, GraphPad Prism 8.0 was used to perform One-way ANOVA to analyze the differences between groups. The experimental data results of each group were expressed as mean ± standard deviation (mean ± SD), and P < 0.05 was considered to be significantly different between groups. In all data in this chapter, * indicates P < 0.05, ** indicates P < 0.01, and both indicate significant differences compared with group M. # indicates P < 0.05, ## indicates P < 0.01, and both indicate significant differences between group M and group N.

[0107] (1) Changes in animal water intake and fasting blood glucose (FBG) measurement

[0108] Body weight, diet and drinking water were measured every three days. After 12 hours overnight, blood was collected from the tail and FBG of mice was measured using a Roche blood glucose meter (ACCU-CHEK) and matching test strips.

[0109] Type 2 diabetes can lead to an increase in the amount of water consumed by animals. The changes in water consumption of mice in each group during the 5 weeks of experimental intervention are shown in Table 5. The results show that all intervention groups have the ability to significantly alleviate the increase in water consumption, with Group C being the strongest, followed by Groups F and D.

[0110] Table 5 Changes in water intake of mice in each group

[0111]

[0112]

[0113] Fasting blood sugar Figure 1 As shown, the results showed that after five weeks of intervention, the original prescription group C (Baihu Jia Renshen Tang) and groups D, E and F were all able to significantly intervene in the increase of fasting blood glucose in mice; among them, group C had the best effect, group D was equivalent to group A, and group D was stronger than groups E and F.

[0114] (2) Oral glucose tolerance test (OGTT) and insulin tolerance test (ITT)

[0115] Twelve weeks after the start of the experiment, the mice were subjected to an oral glucose tolerance test (OGTT test is generally used to evaluate the biological body's ability to regulate blood sugar). The mice in each group were fasted for 12 hours, and a 50% glucose solution was prepared at a concentration of 2g / kg (BW) to allow the mice to ingest glucose by gavage. At the five time points of the experiment, 0, 15min, 30min, 60min, 90min, 120min, and 180min, the blood glucose of the mice was measured using a blood glucose meter and matching test strips; the area under the blood glucose concentration curve (AUC) of the mice was calculated according to the following formula:

[0116]

[0117] AUC: area under the curve; BGX: blood glucose concentration of mice at the Xth min.

[0118] Oral glucose tolerance test was performed after 5 weeks of continuous intervention. Figure 2A and Figure 2B As shown in the figure, the blood glucose of mice reached a peak 15 minutes after the intake of glucose, and 30 minutes later, the blood glucose of mice gradually returned to stability. Compared with the NC group, the fasting blood glucose, peak blood glucose level and blood glucose concentration AUC of mice in the M group caused by high-fat diet were significantly increased. Compared with the M group, the other intervention groups were significantly downregulated; among them, the original group C and the modified group D were more significant. This means that the modified recipe can significantly improve the oral glucose tolerance of type 2 diabetic mice.

[0119] Insulin tolerance test:

[0120] Twelve weeks after the start of the experiment, the mice were subjected to an insulin tolerance test (ITT test is generally used to evaluate the ability of biological organisms to regulate exogenous insulin, and can also be used to evaluate the sensitivity of biological organisms to insulin). Each group of mice was fasted for 6 hours; insulin solution was injected intraperitoneally at 1u / kg (BW), and the blood glucose levels of the mice were measured at 0, 30min, 60min, 90min, 120min, and 180min using a blood glucose meter and matching test strips. The area under the blood glucose concentration curve (AUC) of the mice was calculated according to the following formula.

[0121]

[0122] AUC: area under the curve; BGX: blood glucose concentration of mice at the Xth min.

[0123] After 5 weeks, an insulin tolerance test was conducted. The results were as follows: Figure 3A and 3B As shown in the figure, the blood glucose of mice significantly decreased after intraperitoneal injection of insulin solution, and it dropped to the lowest value in about 30 minutes and then continued to rise. Compared with the M group, the blood glucose concentration curve area of ​​mice in the experimental groups C and F after 5 weeks of intervention was significantly reduced. The above results show that the original recipe and the modified recipe F have the effect of improving insulin tolerance in type 2 diabetic mice.

[0124] (3) Evaluation of insulin resistance and sensitivity

[0125] After the mice were killed, the insulin resistance index (HOMA-IR) (the serum insulin content insulin resistance index can accurately reflect the state of glucose metabolism disorder in the body) and the insulin sensitivity test index (QUICKI) (an indicator used to evaluate insulin sensitivity, calculated based on fasting blood glucose and insulin levels) were calculated according to the following formula to evaluate the insulin resistance of the mice;

[0126] HOMA-IR = [serum insulin concentration (μIU / mL) × fasting serum glucose concentration (mmol / L)] / 22.5;

[0127] QUICKI=1 / [log(serum insulin concentration (μIU / mL))+log(fasting serum glucose concentration (mmol / L)].

[0128] Serum insulin content insulin resistance index (HOMA-IR) Figure 4 As shown, the results showed that group D, group F and group C all had the effect of significantly improving insulin resistance.

[0129] Insulin sensitivity test index Figure 5 As shown in the results, both group D and group F had a significant effect on improving insulin sensitivity.

[0130] (4) Determination of blood lipid indexes

[0131] Total test kits (mouse tissue total cholesterol (TC), triglycerides (TG) Nanjing Jiancheng Bioengineering Institute) were used and the levels of total cholesterol (TC) and triglycerides (TG) in serum were detected strictly according to the instructions of the test kits (TG abnormalities will significantly increase the incidence of MS and serve as one of the diagnostic indicators of metabolic syndrome, while TC abnormalities in the body play a key role in the occurrence of coronary heart disease).

[0132] TC results are as follows Fig. 6A As shown in the figure, compared with the NC group, the TC level in the serum of mice in the M group increased significantly; after 5 weeks of intervention, the TC level in the serum of mice in each intervention group was significantly lower than that in the M group, among which the C group, D group, and E group had higher significance. Figure 6B As shown, compared with the NC group, the serum TG level of mice in group M was significantly increased. After 5 weeks of intervention in groups D, E and F, the serum TG levels of mice in each intervention group were significantly lower than those in group M.

[0133] (5) Determination of organ index

[0134] Insulin resistance and liver steatosis are both metabolic diseases, and insulin resistance is related to liver steatosis. Liver weight can reflect the obesity level of mice. At the same age, the larger the liver mass, the more liver damage the mouse has, and there may be adverse symptoms such as non-alcoholic fatty liver. After the experiment, spleen tissues of mice in each group were collected, washed with saline, and weighed to calculate their liver index. The calculation method is as follows:

[0135]

[0136] The results are as follows Figure 7 As shown, the liver weights of mice in group N and each intervention group were significantly smaller than those in group M; groups C, D, E and F had a more obvious effect in alleviating the increase in liver weight caused by a high-fat diet.

[0137] (6) Histopathological observation

[0138] The pancreas and spleen tissues of mice were taken, washed with saline, and then quickly placed in paraformaldehyde solution for staining with hematoxylin and eosin (H&E) and oil red O. The tissue sections were photographed and observed using a microscope slide scanner.

[0139] The results are as follows Figure 8 As shown in the figure, from left to right are group N, group M, group A, group C, group D, group E and group F; from top to bottom are H&E staining of liver tissue, Oil Red O special staining of liver and H&E staining of pancreas;

[0140] Among them, H&E staining of liver tissue showed that the liver lobule structure of mice in group N was normal, and the hepatocytes were arranged radially around the central vein and were of uniform size; the hepatocytes in group M showed vacuolar degeneration, and lipid deposition was visible in the hepatocytes; compared with group M, intervention in groups A, C, D and F significantly improved fatty degeneration and vacuolation of hepatocytes, and the liver tissue morphology of mice in groups C and D was closer to that of the normal group.

[0141] Oil red O special staining of the liver (which can be used to diagnose fatty degeneration of the liver) showed that the oil red O staining of the liver of mice in group N was mainly blue, while the oil red O staining of the liver of mice in group M was obviously orange-red, indicating that the liver of mice in group M had obvious fatty lesions; compared with group M, the liver lesions of mice treated with the modified prescription were more significantly alleviated, and this result was consistent with the results of H&E staining of liver tissue. In summary, the original prescription group C and the modified prescription group D were more effective in improving liver tissue damage.

[0142] Pancreatic H&E staining analysis showed that groups A, C, D, E, and F all had a certain protective effect compared with group M. The figure shows that the islet cells of normal mice were clearly visible, with regular morphology, neat arrangement, uniform distribution, and uniform size. The islet cells in group M were necrotic, autolyzed, and the cell groups were destroyed, with intracellular degranulation and vascular congestion. The figure shows that the autolysis symptoms of the islets of diabetic rats in groups C, D, and F were significantly improved after intervention, and the cell groups were clear and complete.

[0143] IV. Interventional effect of solid particles on STZ-induced type 2 diabetic mice

[0144] In the following experiments, the experimental animals, changes in animal weight, diet, changes in water intake, fasting blood sugar, oral glucose tolerance test and insulin tolerance test, evaluation of insulin resistance and sensitivity, determination of blood lipid indexes, determination of lipoprotein cholesterol levels, organ index and pathological histological observation and analysis, and statistical analysis methods are the same as the method for the intervention effect test of the above-mentioned medicine-food composition on STZ-induced type 2 diabetic mice.

[0145] (I) Model establishment and grouping

[0146] 27 C57 mice were used, and the rest of the time arrangement and modeling method were the same as the above-mentioned method for testing the intervention effect of the medicine-food composition on STZ-induced type 2 diabetic mice; all mice were divided into the following groups: normal group (N), gavage with normal saline; model group, gavage with normal saline; product group (G) gavage with 2.045 g / kg·d of the solid particles prepared in Example 15.

[0147] (II) Verification of the effect of solid particles

[0148] (1) Changes in animal weight, diet, water intake, and fasting blood sugar

[0149] Type 2 diabetes can lead to an increase in the amount of water consumed by animals. The changes in water consumption of mice in each group during the 5 weeks of experimental intervention are shown in Table 6; among them, the product group (Group G) has the ability to significantly alleviate the increase in water consumption.

[0150] Table 6 Changes in water intake of mice in each group

[0151] Group 1week 2week 3week 4week 5week N 4.00±0.45** 2.72±0.44** 3.28±0.33** 3.54±0.32** 3.54±0.10** M 6.22±0.40 5.75±0.19 6.97±0.31 6.87±0.25 6.71±0.09 G 5.31±0.96* 3.36±1.03** 4.73±1.43** 4.04±0.19** 4.47±0.14**

[0152] In addition, by Fig. 9 It can be seen that after five weeks of intervention, group G was able to significantly reduce the fasting blood glucose of type 2 diabetic mice.

[0153] (2) Oral glucose tolerance test and insulin tolerance test

[0154] After 5 weeks of continuous intervention, oral glucose tolerance test was performed. The experimental results were as follows Fig. 10A and 10B As shown, the blood glucose level of mice reached a peak 15 minutes after ingestion of glucose, and 30 minutes later, the blood glucose level of mice gradually returned to stability; compared with the M group, the blood glucose level of the G group was significantly lower; this means that the product can significantly improve the oral glucose tolerance of type 2 diabetic mice.

[0155] After five weeks, an insulin tolerance test was conducted. The results were as follows: Fig.11A and 11B As shown in the figure, the blood sugar of mice significantly decreased after intraperitoneal injection of insulin solution, and it dropped to the lowest value in about 30 minutes and then continued to rise. Compared with the M group, the blood sugar concentration AUC of mice in the G group after 5 weeks of intervention was significantly reduced. The above results show that the product group has the effect of improving insulin tolerance in type 2 diabetic mice.

[0156] (3) Evaluation of insulin resistance and sensitivity

[0157] Insulin resistance effects such as Fig.12 As shown in Figure 2, group G had a significant effect on improving insulin resistance; the insulin sensitivity was as shown in Figure 2 Fig.13 As shown, group G could significantly improve the insulin sensitivity of the intervention.

[0158] (4) Determination of blood lipid indexes

[0159] TC results are as follows Fig.14A As shown in the figure, compared with the NC group, the TC level in the serum of mice in the M group increased significantly; after 5 weeks of intervention in the product group (G group), the TC level in the serum of mice in each intervention group was significantly lower than that in the M group. Fig. 14B As shown, compared with the NC group, the TG level in the serum of mice in the M group was significantly increased; after 5 weeks of intervention, the serum TG level of mice in the product group (G group) was significantly lower than that in the M group.

[0160] (5) Organ index analysis

[0161] Liver weight Fig.15 As shown, the liver weights of mice in group N and product group (group G) were significantly smaller than those in group M.

[0162] (6) Histopathological observation and analysis

[0163] Histopathological observation and analysis Fig.16 As shown in the figure, from left to right are group N, group M and group G; from top to bottom are H&E staining of liver tissue, Oil Red O special staining of liver and H&E staining of pancreas;

[0164] Among them, H&E staining of liver tissue showed that the liver lobule structure of mice in group N was normal, and the hepatocytes were arranged radially around the central vein and were of uniform size; the hepatocytes in group M showed vacuolar degeneration, and lipid deposition was visible in the hepatocytes; compared with group M, the intervention of the product group could significantly improve the fatty degeneration and vacuolation of hepatocytes.

[0165] Oil red O special staining of the liver showed that the oil red O staining of the liver of the N group mice was mainly blue, while the oil red O staining of the liver of the M group mice was obviously orange-red, indicating that the liver of the M group mice had obvious fatty lesions; compared with the M group, the liver lesions of the mice in the product group were more significantly alleviated after intervention, and this result was consistent with the results of H&E staining of liver tissue. In short, the product group has a certain effect in improving liver tissue damage.

[0166] Pancreatic H&E staining showed that the product group had a certain protective effect compared with the M group; the figure showed that the pancreatic islet cells of normal mice were clearly visible, with regular morphology, neat arrangement, uniform distribution and uniform size; the pancreatic islet cells in the M group were necrotic, autolyzed, and the cell groups were destroyed, with intracellular degranulation and vascular congestion. The figure showed that the autolysis symptoms of the pancreatic islets of diabetic rats were significantly improved after the intervention of the product group, and the cell groups were clear and complete.

[0167] Finally, it should be noted that the above embodiments are only used to illustrate the technical solution of the present invention rather than to limit it. Although the present invention has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solution of the present invention can be modified or replaced by equivalents without departing from the purpose and scope of the technical solution of the present invention, which should be covered by the scope of the claims of the present invention.

Claims

1. A medicine-food composition, characterized in that: Including raw lotus root juice and yam juice.

2. The medicine-food composition according to claim 1, characterized in that: The mass ratio of raw lotus root juice to yam juice is (4-16):

3.

3. The medicine-food composition according to claim 2, characterized in that: The mass ratio of raw lotus root juice to yam juice is 8:

3.

4. A preparation, characterized in that The medicine-food composition is prepared from the medicine-food composition according to any one of claims 1 to 3.

5. The preparation according to claim 4, characterized in that The preparation is solid particles, and its preparation raw materials include a medicine-food homologous composition, a binder and auxiliary materials.

6. The solid particles according to claim 5, characterized in that The binder is ethanol; and / or the auxiliary material is one or more combinations of maltodextrin, lactose and microcrystalline cellulose.

7. The solid particles according to claim 6, characterized in that The ethanol is 45% ethanol.

8. The method for preparing solid particles according to any one of claims 6 to 7, characterized in that: include: (1) preparing the edible and medicinal composition into a dry paste powder; (2) mixing the dry paste powder, a binder and auxiliary materials to obtain solid particles.

9. The preparation method according to claim 8, characterized in that: The amount of auxiliary materials added is 10%-30% of the mass of the dry paste powder.

10. Use of the medicine-food composition according to any one of claims 1 to 3 in the preparation of a product for improving type 2 diabetes.

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