Composition with hypoglycemic effect as well as preparation method and application thereof

Abstract

The invention discloses a composition with a hypoglycemic effect and a preparation method thereof. The composition comprises 1-20 parts of pearl shell soft peptide, 1-10 parts of folium mori, 1-10 parts of platycodon grandiflorum, 1-10 parts of liquorice, 1-10 parts of cinnamon, 1-10 parts of dried ginger and 1-10 parts of oyster powder. Under the guidance of traditional Chinese medicine theories, the composition of the traditional Chinese medicine composition is screened and determined, the proportion of the components is scientific and reasonable, and experimental results show that the composition provided by the invention can effectively correct glucose metabolism disorder, reduce blood sugar, improve insulin resistance and increase sugar tolerance, has a relatively good effect of regulating blood fat, and is suitable for clinical application. The traditional Chinese medicine composition can be developed into a novel medicine for preventing and treating diabetes complicated with hyperlipidemia.

Description

Technical Field

[0001] The invention relates to a composition, in particular to a composition with blood sugar lowering effect, a preparation method thereof and an application thereof. Background Art

[0002] Diabetes is prevalent worldwide and poses a serious threat to people's health. Diabetes often occurs in middle-aged and elderly people, especially those over 40 years old. The incidence rate among young people is also increasing. The incidence rate is higher in overweight or obese people, especially those with abdominal obesity. People with a family history of diabetes, unhealthy lifestyles (such as eating more and moving less, drinking, liking sweets, etc.), high blood pressure, dyslipidemia, coronary heart disease, etc. are also more likely to develop diabetes.

[0003] Strengthen the popular science education of diabetes and improve the public's awareness and attention to diabetes. Promote a healthy lifestyle, such as a reasonable diet, moderate exercise, quitting smoking and limiting alcohol consumption, to prevent the occurrence of diabetes. For patients with diabetes who have been diagnosed, active treatment and blood sugar control should be carried out to reduce the occurrence of complications and improve the quality of life. The epidemiological characteristics of diabetes are high incidence, obvious and diverse patient characteristics, and severe epidemic trends.

[0004] Traditional Chinese medicine believes that diabetes belongs to the category of "quenching thirst", with Yin deficiency as the root and dryness and heat as the symptom. Yin deficiency refers to the lack of Yin fluid in the body, and dryness and heat are caused by Yin deficiency. Yin deficiency and dryness and heat lead to dysfunction of internal organs, especially the lungs, stomach, and kidneys, which are the most seriously damaged. Lung dryness will cause the body fluid to not be distributed, stomach heat will digest food and make people hungry, and kidney deficiency will cause water to not transform into gas, thus causing symptoms of thirst. Yin deficiency and internal heat will damage body fluid, blood vessels will be weak and astringent, qi and yin will be deficient, internal organs will not be nourished, and yin and yang will be deficient. Long-term illness will enter the collaterals, blood vessels will be stagnant, resulting in poor circulation of qi and blood, obstruction of internal organ function, and thus aggravating symptoms of thirst.

[0005] Currently, most traditional Chinese medicines for diabetes are single prescriptions and proven prescriptions. The amount of medicinal ingredients in compound prescriptions is large, and the basis for the formulation of traditional Chinese medicines is different, and the treatment principles are not unified. Therefore, based on traditional Chinese medicine and according to the pathogenesis of diabetes, we actively seek and explore efficient and non-toxic treatments for this disease.

[0006] Traditional herbal medicine records that marine shellfish have multiple functions. "Chinese Materia Medica" records that dried scallops are sweet, salty, and slightly warm; "Dietary Materia Medica" records that clam meat is sweet, salty, and cold, and can cure irritability and thirst; razor clam meat is sweet, salty, and cold, and can cure irritability and thirst; "Compendium of Materia Medica" records that oyster meat is sweet, warm, and non-toxic, and can cure irritability and thirst after drinking. Modern research shows that shellfish are mainly composed of protein components, which can release a variety of bioactive peptides after enzymatic hydrolysis, among which hypoglycemic active peptides are particularly concerned. Under the guidance of traditional Chinese medicine theory, the present invention studies pearl oyster soft tissue and develops health products with hypoglycemic activity. Summary of the invention

[0007] Purpose of the invention: The purpose of the present invention is to solve the deficiencies of the prior art and to provide a hypoglycemic composition with scientific and reasonable proportions, definite efficacy, safe clinical use and low adverse reactions. Another purpose of the present invention is to provide a preparation method of the composition and its application in the preparation of drugs for treating diabetes.

[0008] Technical solution: In order to achieve the above purpose, the technical solution adopted by the present invention is:

[0009] A composition with hypoglycemic effect comprises 1 to 20 parts of pearl oyster soft body peptide, 1 to 10 parts of mulberry leaves, 1 to 10 parts of platycodon, 1 to 10 parts of liquorice, 1 to 10 parts of cinnamon bark, 1 to 10 parts of dried ginger and 1 to 10 parts of oyster powder.

[0010] As a preferred embodiment, the above-mentioned composition with hypoglycemic effect is made of the following raw materials in parts by weight: 1-10 parts of pearl shell soft body peptide, 1-5 parts of mulberry leaves, 1-5 parts of platycodon, 1-5 parts of licorice, 1-5 parts of cinnamon, 1-5 parts of dried ginger, and 1-5 parts of oyster powder.

[0011] As a preferred embodiment, the above-mentioned composition with hypoglycemic effect is characterized in that it is made of the following raw materials in parts by weight: 20 parts of pearl oyster soft body peptide, 10 parts of mulberry leaves, 10 parts of platycodon, 10 parts of licorice, 10 parts of cinnamon, 10 parts of dried ginger, and 10 parts of oyster powder.

[0012] As a better solution, the above-mentioned composition with the effect of treating diabetes, the pearl oyster soft tissue peptide is prepared by the following method: take the pearl oyster soft tissue water to wash the mud and sand, drain the water, add pure water at a solid-liquid ratio of 1:3, homogenize, and obtain the pearl oyster soft tissue enzymatic peptide after protease treatment.

[0013] As a better solution, the pearl oyster soft tissue peptide described above is prepared by the following method:

[0014] Wash the pearl oyster soft body with water to remove the sediment, drain the water, add pure water at a solid-liquid ratio of 1:3, homogenize, add acid protease, add 1000U / g enzyme, enzymolysis temperature of 40°C, pH 3.0, enzymolysis for 1 hour, after the enzymolysis is completed, inactivate the enzyme in a boiling water bath for 10 minutes, centrifuge at 5000rpm for 20 minutes after cooling, take the supernatant, and obtain the enzymolysis liquid of the pearl oyster soft body;

[0015] or

[0016] Wash the pearl oyster soft body with water to remove the sediment, drain the water, add pure water at a solid-liquid ratio of 1:3, homogenize, add alkaline protease, add 1000U / g enzyme, hydrolyze at 50°C, pH 10.0, and hydrolyze for 1 hour. After the hydrolysis is completed, inactivate the enzyme in a boiling water bath for 10 minutes, cool and centrifuge at 5000rpm for 20 minutes, take the supernatant, and obtain the Margaret oyster soft body hydrolyzate;

[0017] or

[0018] Wash the pearl oyster soft body with water to remove the sediment, drain the water, add pure water at a solid-liquid ratio of 1:3, homogenize, add neutral protease, add 1000U / g enzyme, enzymolysis temperature of 50°C, pH 7.0, enzymolysis for 1 hour, after the enzymolysis is completed, inactivate the enzyme in a boiling water bath for 10 minutes, cool and centrifuge at 5000rpm for 20 minutes, take the supernatant, and obtain the Margaret oyster soft body enzymolysis liquid;

[0019] or

[0020] Wash the pearl oyster soft body with water to remove the sediment, drain the water, add pure water at a solid-liquid ratio of 1:3, homogenize, add composite protease, add enzyme amount of 1000U / g, enzymolysis temperature of 50°C, pH 7.0, enzymolysis for 1 hour, after the enzymolysis is completed, boil water bath to kill the enzyme for 10 minutes, cool and centrifuge at 5000rpm for 20 minutes, take the supernatant, and obtain the Margaret oyster soft body enzymolysis liquid;

[0021] or

[0022] Wash the pearl oyster soft body with water to remove the sediment, drain the water, add pure water at a solid-liquid ratio of 1:3, homogenize, add trypsin, the enzyme amount is 1000U / g, the enzymatic hydrolysis temperature is 37°C, pH 8.0, enzymatic hydrolysis is performed for 1 hour, after the enzymatic hydrolysis is completed, the enzyme is inactivated in a boiling water bath for 10 minutes, and after cooling, centrifuge at 5000rpm for 20 minutes, and take the supernatant to obtain the enzymatic hydrolyzate of the pearl oyster soft body;

[0023] or

[0024] Wash the pearl oyster soft body with water to remove the sediment, drain the water, add pure water at a solid-liquid ratio of 1:3, homogenize, add flavor protease, the enzyme amount is 1000U / g, the enzymatic hydrolysis temperature is 53°C, pH 6.5, enzymatic hydrolysis is performed for 1 hour, after the enzymatic hydrolysis is completed, the enzyme is inactivated in a boiling water bath for 10 minutes, and after cooling, centrifuge at 5000rpm for 20 minutes, and take the supernatant to obtain the Martensii pearl oyster soft body enzymatic hydrolysate;

[0025] or

[0026] Wash the pearl oyster soft body with water to remove the mud and sand, drain the water, add pure water at a solid-liquid ratio of 1:3, homogenize, add papain, the enzyme amount is 1000U / g, the enzymatic hydrolysis temperature is 60℃, pH 6.5, enzymatic hydrolysis is carried out for 1 hour, after the enzymatic hydrolysis is completed, the enzyme is inactivated in a boiling water bath for 10 minutes, and after cooling, centrifuge at 5000rpm for 20 minutes, take the supernatant, and obtain the enzymatic hydrolysate of the pearl oyster soft body.

[0027] The mulberry leaf, platycodon, licorice, cinnamon and dried ginger extracts of the present invention are prepared by the following method: taking mulberry leaf, platycodon, licorice, cinnamon and dried ginger, adding 8 to 12 times of water to extract 1 to 3 times, each time for 1 to 3 hours, combining the filtrate, concentrating, and drying under reduced pressure or spray drying to obtain an extract dry product. Oysters are crushed and mixed with the extract dry product to obtain a composition with hypoglycemic effect.

[0028] The Chinese medicine formula provided by the present invention adopts syndrome differentiation and treatment according to the theory of traditional Chinese medicine, determines the compatibility formula through a large number of experiments, and prepares the extract through an optimal method. The compatibility is scientific and reasonable, and has good effects of lowering blood sugar and regulating blood lipids.

[0029] The composition with hypoglycemic effect provided by the present invention can be prepared into medicines in the form of oral liquid, granules, capsules, tablets and pills by extracts of various raw materials and pharmaceutically acceptable carriers.

[0030] When the extract of the composition provided by the invention is made into capsules, the enzymatic peptides, extracts and oyster powder of the raw materials are evenly mixed, granulated, and then filled into capsules to make capsules.

[0031] When the extracts of the raw materials of the composition provided by the present invention are made into tablets, the enzymatic peptides, extracts and oyster powder of the raw materials are evenly mixed, granulated, and lubricant magnesium stearate is added when necessary, and then tablets are pressed.

[0032] When the extracts of the raw materials of the composition provided by the invention are made into granules, the enzymatic peptides, extracts and oyster powder of the raw materials are evenly mixed, granulated and dried to make the granules.

[0033] The method for preparing the composition with hypoglycemic effect provided by the present invention comprises the following steps:

[0034] (1) Wash the pearl oyster soft body with water to remove the sediment, drain the water, add pure water at a solid-liquid ratio of 1:3, homogenize, add composite protease, add 1000U / g enzyme, hydrolyze at 50°C, pH 7.0, and hydrolyze for 1 hour. After the hydrolysis is completed, inactivate the enzyme in a boiling water bath for 10 minutes, cool and centrifuge at 5000rpm for 20 minutes, and take the supernatant to obtain the Margaret oyster soft body hydrolysate.

[0035] (2) taking mulberry leaves, platycodon, licorice, cinnamon, and dried ginger, crushing them, adding 8-12 times the amount of water to extract 1-3 times, each time for 2-3 hours, combining the filtrates to obtain a water extract, concentrating to a relative density of 1.03-1.10, and obtaining an extract for later use;

[0036] (3) Ultrafinely crush the oysters for later use;

[0037] (4) The enzymatic hydrolysate obtained in step (1), the extract obtained in step (2) and the oyster powder obtained in step (3) are mixed by weight, and prepared into conventional dosage forms such as granules, capsules, tablets and pills with a pharmaceutically acceptable carrier.

[0038] Preferably, in the method for preparing the above-mentioned composition having hypoglycemic effect, the extraction method in step (1) is decoction, reflux extraction or percolation.

[0039] Beneficial effects: Compared with the prior art, the composition provided by the present invention has the following advantages:

[0040] The present invention adopts the theory of syndrome differentiation and treatment to screen Chinese medicine prescriptions according to the theory of traditional Chinese medicine, and the composition ratio is scientific and reasonable. The experimental results show that the composition provided by the present invention has good blood sugar lowering and blood lipid regulating effects. In addition, the extract of the composition provided by the present invention can be conveniently prepared into a variety of dosage forms with pharmaceutical carriers, which is convenient to take clinically, and the experimental results show that the composition provided by the present invention is safe to use and has no toxic side effects in long-term use. At the same time, the preparation method of the compound Chinese medicine preparation provided by the present invention has reasonable process design, high content of extracted effective ingredients, strong operability, and is suitable for large-scale industrial production. DETAILED DESCRIPTION

[0041] The present invention is further explained below in conjunction with specific examples. It should be understood that these examples are only used to illustrate the present invention and are not used to limit the scope of the present invention. After reading the present invention, various equivalent modifications of the present invention by those skilled in the art all fall within the scope defined by the claims attached to this application.

[0042] Example 1

[0043] 1. Prescription: 20g pearl oyster soft body, 10g mulberry leaf, 10g platycodon, 10g licorice, 10g cinnamon, 10g dried ginger, 10g oyster.

[0044] 2. Preparation method: Wash 20g of pearl oyster soft body, drain the water, add pure water at a material-liquid ratio of 1:3, homogenize, add composite protease (100000U / g, Beijing Solebaugh Technology Co., Ltd., C8800-10), add 1000U / g enzyme, enzymolysis temperature 50℃, pH 7.0, enzymolysis for 1 hour, after the enzymolysis is completed, boil water bath to kill enzyme for 10min, centrifuge at 5000rpm for 20min after cooling, take the supernatant, get the pearl oyster soft body enzymolysis liquid, spray dry, and set aside. Take 10g of mulberry leaves, 10g of platycodon, 10g of licorice, 10g of cinnamon, and 10g of dried ginger, crush them, add 8 times the amount of water to decoct and extract twice, each time for 2 hours, combine the filtrates, get the water extract, concentrate to a relative density of 1.05, spray dry, and get each Chinese medicine extract for use. Ultrafine grind 10g of oyster. The enzymatic hydrolysate, various Chinese medicinal extracts and oyster powder are packed into capsules to prepare capsules.

[0045] Example 2

[0046] 1. Prescription: 20g pearl oyster, 5g mulberry leaf, 5g platycodon, 5g licorice, 5g cinnamon, 5g dried ginger, 10g oyster.

[0047] 2. Preparation method: Take 20g of pearl oyster soft body, wash the mud and sand with water, drain the water, add pure water at a material-liquid ratio of 1:3, homogenize, add papain, add enzyme amount 1000U / g, enzymolysis temperature 60℃, pH 6.5, enzymolysis for 1 hour, after the enzymolysis is completed, boil water bath to kill enzyme for 10min, centrifuge at 5000rpm for 20min after cooling, take the supernatant, get the pearl oyster soft body enzymolysis liquid, spray dry, and set aside. Take 5g of mulberry leaves, 5g of platycodon, 5g of licorice, 5g of cinnamon, and 5g of dried ginger, crush them, add 10 times the amount of water to decoct and extract twice, each time for 1 hour, combine the filtrates, get the water extract, concentrate to a relative density of 1.08, spray dry, and get the Chinese medicine extracts for use. Ultrafinely grind 10g of oysters. Add lubricant magnesium stearate to the enzymolysis product, Chinese medicine extract and oyster powder, mix them evenly, make granules, and press them into tablets.

[0048] Example 3

[0049] 1. Prescription: pearl oyster soft body 10g, mulberry leaf 10g, platycodon 10g, licorice 10g, cinnamon 10g, dried ginger 10g, oyster 2g.

[0050] 2. Preparation method: Take 10g of pearl oyster soft body, wash the mud and sand with water, drain the water, add pure water at a material-liquid ratio of 1:3, homogenize, add flavor protease, add enzyme amount 1000U / g, enzymolysis temperature 53℃, pH 6.5, enzymolysis for 1 hour, after the enzymolysis is completed, boil water bath to kill enzyme for 10min, cool and centrifuge at 5000rpm for 20min, take the supernatant, get the pearl oyster soft body enzymolysis liquid, spray dry and set aside. Take 10g of mulberry leaves, 10g of platycodon, 10g of licorice, 10g of cinnamon, and 10g of dried ginger, crush them, add 12 times the amount of water to decoct and extract 3 times, each time for 2 hours, combine the filtrates, get the water extract, concentrate to a relative density of 1.10, spray dry, get the Chinese medicine extracts, and set aside. Ultrafinely grind the oyster. Evenly mix the enzymolysis product, the Chinese medicine extracts and the oyster powder, make granules, whole granules, dry, and make granules.

[0051] Example 4: Effect of the composition of the present invention on blood glucose in db / db mice

[0052] 1. Materials and Methods

[0053] Animals: 6 db / m mice, male, 7 weeks old; 32 db / db mice, male, 7 weeks old, provided by Jiangsu Jicui Pharmaceutical Biotechnology Co., Ltd., license number: SCXK(Su)2018-0008, certificate number: NO.202108881.

[0054] Instruments: Omron blood glucose meter HGM-112 (Suzhou Erda Medical Equipment Co., Ltd.); Omron blood glucose test strips (Suzhou Erda Medical Equipment Co., Ltd., batch number: 1620A2112C).

[0055] Animal grouping: db / m mice were the blank group, and db / db mice were randomly divided into the model group, the positive drug sitagliptin hydrochloride metformin group, the low-dose group of the composition of Example 1 (300 mg / kg), and the high-dose group of the composition (900 mg / kg) according to blood sugar, with 8 mice in each group. The blank group mice were given ordinary maintenance feed, and the remaining mice were given high-fat feed. Each group was given once a day for 28 consecutive days, and the blank group and the model group were given an equal volume of normal saline.

[0056] Determination of fasting blood glucose (FBG): After the start of drug administration, fasting blood glucose was measured every 7 days. Before measurement, the mice were fasted (but not water-deprived) for 12 hours, and blood was collected by cutting their tails. The second drop of blood was dripped onto a blood glucose test strip, and the fasting blood glucose of the mice was measured using a blood glucose meter.

[0057] Oral glucose tolerance (OGTT): On the 24th day of administration, the oral glucose tolerance of mice was measured. Before the experiment, mice were fasted overnight (water was not allowed) for 12 hours, and their fasting body weight was measured and their fasting blood glucose was measured. After the mice recovered for 30 minutes, they were given 20% glucose solution by gavage at 0.1ml / 10g. Blood samples were collected from the tail vein of mice at 30, 60, 90 and 120 minutes after gavage, and blood glucose values ​​were measured using a blood glucose meter and blood glucose test strips.

[0058] Determination of insulin tolerance (ITT): On the 26th day of administration, the insulin tolerance of mice was determined. Before the experiment, mice were fasted (water was not allowed) for 4 hours, and their fasting body weight was measured and their fasting blood sugar was measured. After the mice recovered for 30 minutes, 0.75U / kg insulin injection was intraperitoneally injected at 0.1ml / 10g. Blood samples were collected from the tail vein of mice at 30, 60, 90 and 120 minutes after gavage, and blood sugar levels were measured using a blood glucose meter and blood glucose test strips.

[0059] 2. Results

[0060] Effect of the composition on fasting blood glucose (FBG) of db / db mice: As shown in Table 1, the blood glucose of db / db mice was significantly higher than that of mice in the blank group (p<0.01). The blood glucose levels of mice in the drug-treated groups were similar, both significantly higher than those in the blank group. The blood glucose of the sitagliptin hydrochloride and metformin group began to decrease after one week of administration, and the blood glucose of the high- and low-dose groups of the composition decreased significantly after three weeks of administration (p<0.01).

[0061] As shown in Table 2, the blood glucose values ​​at each measuring point in the model group were significantly higher than those in the blank group, and the AUC was significantly increased (p<0.01). Compared with the model group, the positive drug group, the low-dose group of the combination (300 mg / kg), and the high-dose group of the combination (900 mg / kg) were able to reduce the blood glucose values ​​at each measuring point, and the AUC was significantly reduced (p<0.01).

[0062] Effect of the composition on insulin tolerance (ITT) of db / db mice: As shown in Table 3, the blood glucose values ​​at each measuring point in the model group were significantly higher than those in the blank group, and the AUC was significantly increased (p<0.01); compared with the model group, the positive drug group and the composition group (300, 900 mg / kg) were able to reduce the blood glucose values ​​at each measuring point, and the AUC was significantly reduced (p<0.05).

[0063] Table 1 Effect of the composition on fasting blood glucose in db / db mice ( n=6)

[0064]

[0065] Note: Compared with the blank control group, #p<0.05, ##p<0.01; compared with the model group, *p<0.05, **p<0.01

[0066] Table 2 Effect of oral glucose tolerance in db / db mice in each group ( n=6)

[0067]

[0068] Note: Compared with the blank control group, #p<0.05, ##p<0.01; compared with the model group, *p<0.05, **p<0.01

[0069] Table 3 Effects of each group on insulin tolerance in db / db mice ( n=6)

[0070]

[0071] Note: Compared with the blank control group, #p<0.05, ##p<0.01; compared with the model group, *p<0.05, **p<0.01

[0072] Example 5: Effects of the composition of the present invention on biochemical parameters of db / db mice

[0073] 1. Materials and Methods

[0074] Animals: 6 db / m mice, male, 7 weeks old; 32 db / db mice, male, 7 weeks old, provided by Jiangsu Jicui Pharmaceutical Biotechnology Co., Ltd., license number: SCXK(Su)2018-0008, certificate number: NO.202108881.

[0075] Kits: Total cholesterol detection kit (batch number: 20201229); triglyceride determination kit (batch number: 20201228); high-density lipoprotein cholesterol test kit (batch number: 20201228); low-density lipoprotein cholesterol test kit (batch number: 20201228); aspartate aminotransferase kit (batch number: 20201228) and alanine aminotransferase kit (batch number: 20201228) are all provided by Nanjing Jiancheng Bioengineering Institute.

[0076] Animal grouping: db / m mice were the blank group, and db / db mice were randomly divided into the model group, the positive drug sitagliptin hydrochloride metformin group, the low-dose group of the composition of Example 1 (300 mg / kg), and the high-dose group of the composition (900 mg / kg) according to blood sugar, with 8 mice in each group. The blank group mice were given ordinary maintenance feed, and the remaining mice were given high-fat feed. Each group was given once a day for 28 consecutive days, and the blank group and the model group were given an equal volume of normal saline.

[0077] Serum collection: On the 28th day after administration, blood was collected from the eye sockets, placed at room temperature for 1 hour, and then centrifuged at 3500 rpm for 10 minutes to separate the upper serum, packaged, and stored at -80°C for later use.

[0078] 2. Results

[0079] Effect of the composition on the content of TC, TG, HDL-C and LDL-C in the serum of db / db mice: As shown in Table 4, compared with the blank group, the blood lipid metabolism of the model group mice was significantly abnormal, and the content of TC, TG and LDL-C was significantly higher than that of the blank group (p<0.01). Compared with the model group, the positive drug sitagliptin hydrochloride metformin group and the composition group (900mg / kg) can significantly reduce the content of TC, TG and LDL-C in db / db mice (p<0.01 or p<0.05), and have a certain dose dependence; the positive drug sitagliptin hydrochloride metformin group can significantly increase the content of HDL-C in the serum of diabetic mice (p<0.05), and the low-dose group and high-dose group of the composition can increase the content of HDL-C in the serum of mice but there is no significant difference. This shows that the composition can improve the blood lipid index of mice and has the function of regulating blood lipids.

[0080] Table 4 Effect of the composition on the levels of TC, TG, HDL-C and LDL-C in the serum of db / db mice (±SD, n=6)

[0081]

[0082] Note: Compared with the blank control group, #p<0.05, ##p<0.01; compared with the model group, *p<0.05, **p<0.01.

Claims

1. A composition having a hypoglycemic effect, characterized in that: It contains 1 to 20 parts of pearl oyster soft body peptide, 1 to 10 parts of mulberry leaves, 1 to 10 parts of platycodon, 1 to 10 parts of licorice, 1 to 10 parts of cinnamon, 1 to 10 parts of dried ginger, and 1 to 10 parts of oyster powder.

2. The composition with hypoglycemic effect according to claim 1, characterized in that The invention is prepared from the following raw materials in parts by weight: 1-10 parts of pearl shell soft body peptide, 1-5 parts of mulberry leaves, 1-5 parts of platycodon, 1-5 parts of liquorice, 1-5 parts of cinnamon bark, 1-5 parts of dried ginger and 1-5 parts of oyster powder.

3. The composition with hypoglycemic effect according to claim 1, characterized in that The invention is prepared from the following raw materials in parts by weight: 20 parts of pearl shell soft body peptide, 10 parts of mulberry leaves, 10 parts of platycodon, 10 parts of liquorice, 10 parts of cinnamon bark, 10 parts of dried ginger and 10 parts of oyster powder.

4. The method for preparing the composition having hypoglycemic effect according to any one of claims 1 to 3, characterized in that: The following steps are involved: Weigh the raw materials according to the raw material ratio, wherein the pearl oyster soft tissue peptide is prepared by enzymatic hydrolysis; extract mulberry leaves, platycodon, licorice, cinnamon and dried ginger with water, combine the enzymatic peptide with the extract, concentrate to obtain a concentrated solution, dry under reduced pressure or spray dry to obtain an extract dry product; grind oysters, mix with the extract dry product, and obtain a composition with hypoglycemic effect.

5. The method for preparing the composition having hypoglycemic effect according to claim 4, characterized in that: The pearl oyster soft body was washed with water to remove the sediment, the water was drained, and pure water was added at a solid-liquid ratio of 1:3, the mixture was homogenized, and the pearl oyster soft body enzymatic peptide was obtained after protease treatment.

6. The method for preparing the composition having hypoglycemic effect according to claim 5, characterized in that: The enzymatic peptide is prepared by the following method: washing the pearl oyster soft body with water to remove the sediment, draining the water, adding pure water at a solid-liquid ratio of 1:3, homogenizing, adding acidic protease, adding enzyme amount of 1000U / g, enzymatic hydrolysis temperature of 40°C, pH 3.0, enzymatic hydrolysis for 1 hour, after the enzymatic hydrolysis is completed, boiling water bath to kill the enzyme for 10 minutes, cooling and centrifuging at 5000rpm for 20 minutes, taking the supernatant to obtain the Martensii pearl oyster soft body enzymatic hydrolyzate; or Wash the pearl oyster soft body with water to remove the sediment, drain the water, add pure water at a solid-liquid ratio of 1:3, homogenize, add alkaline protease, add 1000U / g enzyme, hydrolyze at 50°C, pH 10.0, and hydrolyze for 1 hour. After the hydrolysis is completed, inactivate the enzyme in a boiling water bath for 10 minutes, cool and centrifuge at 5000rpm for 20 minutes, take the supernatant, and obtain the Margaret oyster soft body hydrolyzate; or Wash the pearl oyster soft body with water to remove the sediment, drain the water, add pure water at a solid-liquid ratio of 1:3, homogenize, add neutral protease, add 1000U / g enzyme, enzymolysis temperature of 50°C, pH 7.0, enzymolysis for 1 hour, after the enzymolysis is completed, inactivate the enzyme in a boiling water bath for 10 minutes, cool and centrifuge at 5000rpm for 20 minutes, take the supernatant, and obtain the Margaret oyster soft body enzymolysis liquid; or Wash the pearl oyster soft body with water to remove the sediment, drain the water, add pure water at a solid-liquid ratio of 1:3, homogenize, add composite protease, add enzyme amount of 1000U / g, enzymolysis temperature of 50°C, pH 7.0, enzymolysis for 1 hour, after the enzymolysis is completed, boil water bath to kill the enzyme for 10 minutes, cool and centrifuge at 5000rpm for 20 minutes, take the supernatant, and obtain the Margaret oyster soft body enzymolysis liquid; or Wash the pearl oyster soft body with water to remove the sediment, drain the water, add pure water at a solid-liquid ratio of 1:3, homogenize, add trypsin, the enzyme amount is 1000U / g, the enzymatic hydrolysis temperature is 37°C, pH 8.0, enzymatic hydrolysis is performed for 1 hour, after the enzymatic hydrolysis is completed, the enzyme is inactivated in a boiling water bath for 10 minutes, and after cooling, centrifuge at 5000rpm for 20 minutes, and take the supernatant to obtain the enzymatic hydrolyzate of the pearl oyster soft body; or Wash the pearl oyster soft body with water to remove the sediment, drain the water, add pure water at a solid-liquid ratio of 1:3, homogenize, add flavor protease, the enzyme amount is 1000U / g, the enzymatic hydrolysis temperature is 53°C, pH 6.5, enzymatic hydrolysis is performed for 1 hour, after the enzymatic hydrolysis is completed, the enzyme is inactivated in a boiling water bath for 10 minutes, and after cooling, centrifuge at 5000rpm for 20 minutes, and take the supernatant to obtain the Martensii pearl oyster soft body enzymatic hydrolysate; or Wash the pearl oyster soft body with water to remove the mud and sand, drain the water, add pure water at a solid-liquid ratio of 1:3, homogenize, add papain, the enzyme amount is 1000U / g, the enzymatic hydrolysis temperature is 60℃, pH 6.5, enzymatic hydrolysis is carried out for 1 hour, after the enzymatic hydrolysis is completed, the enzyme is inactivated in a boiling water bath for 10 minutes, and after cooling, centrifuge at 5000rpm for 20 minutes, take the supernatant, and obtain the enzymatic hydrolysate of the pearl oyster soft body.

7. The method for preparing the composition having hypoglycemic effect according to claim 4, characterized in that: Weigh mulberry leaves, platycodon, licorice, cinnamon and dried ginger according to the raw material ratio, add 8-12 times the amount of water, decoct and extract 1-3 times, each extraction time is 1-3 hours, combine the enzymatic peptides with the extract, concentrate to a relative density of 1.03-1.10 to obtain a concentrated solution, dry under reduced pressure or spray dry to obtain an extract dry product; crush oysters and mix with the extract dry product to obtain a composition with hypoglycemic effect.

8. The preparation method according to claim 4, characterized in that: Water extraction methods include decoction, reflux extraction or percolation.

9. Use of the composition according to any one of claims 1 to 3 in the preparation of a medicament for preventing and treating diabetes combined with hyperlipidemia.

10. The use according to claim 9, characterized in that: The composition and a pharmaceutically acceptable carrier are prepared into medicines in the form of oral liquid, suspension, granule, capsule, tablet and pill.

Images