Composition with functions of reducing blood sugar and increasing insulin sensitivity and preparation method thereof

Abstract

The invention discloses a composition with a blood sugar reducing function and an insulin sensitivity increasing function and a preparation method thereof. The composition is prepared from, by weight, 3-30 parts of astragalus membranaceus, 3-30 parts of rhizoma polygonati, 2-20 parts of fructus lycii, 2-20 parts of rhizoma dioscoreae, 2-20 parts of radix puerariae, 2-20 parts of radix polygonati officinalis and 2-10 parts of radix rehmanniae. The composition takes medicinal and edible traditional Chinese medicinal materials as raw materials, not only is a food, but also exerts the medicinal effect of the traditional Chinese medicinal materials, is reasonable and rigorous in compatibility, adheres to the theory of traditional Chinese medicine, is just independent of monarch, minister, assistant and guide, has the effects of tonifying qi, promoting salivation, tonifying spleen, benefiting lung, nourishing yin, clearing heat and promoting salivation to quench thirst after being used after being combined, and has a wide application prospect. The effects of reducing blood sugar and relieving diabetes diabetes are obvious.

Description

Technical Field

[0001] The present application relates to the technical field of pharmaceutical preparations, and particularly to a composition with hypoglycemic function and increased insulin sensitivity and its preparation method. Background Art

[0002] Astragalus membranaceus, Polygonatum sibiricum, Lycium barbarum, Dioscorea opposita, Pueraria lobata, Polygonatum odoratum, and Rehmannia glutinosa all belong to substances that are both medicine and food. When used as food, they have both medicinal and nutritional functions.

[0003] Diabetes and its complications have become a major global health threat, and the accelerating urbanization process has also led to a high incidence of this disease. According to the report of the International Diabetes Federation, currently, 537 million adults (aged 20 - 79) worldwide are diagnosed with diabetes, and it is expected that the number of patients will increase to 643 million by 2030. Data from the International Diabetes Federation shows that there are more than 140 million diabetes patients in China, showing high lethality and disability rates. Currently, the most common type of diabetes is type II diabetes (T2DM), and the number of its patients accounts for more than 90% of diabetes cases. T2DM is mainly characterized by insulin resistance and impaired insulin secretion. As the disease progresses, it can lead to various complications in the patient's retina, kidneys, cardiovascular system, skeletal system, and nervous system, seriously threatening the health of patients. Developing products that can improve the blood glucose condition of the human body has important practical and economic significance.

[0004] The information disclosed in the background art section is only intended to increase the overall understanding of the present invention and should not be regarded as an admission or any form of implication that this information constitutes the prior art known to those of ordinary skill in the art. Summary of the Invention

[0005] The present application provides a composition with hypoglycemic function and increased insulin sensitivity and its preparation method. The composition is widely and easily available, and the obtained composition has a good effect of assisting in improving blood glucose, preventing and assisting in regulating hyperglycemia, and increasing insulin sensitivity.

[0006] The present application provides a composition with hypoglycemic function and increased insulin sensitivity and its preparation method, which is composed of 3 - 30 parts by weight of Astragalus membranaceus, 3 - 30 parts by weight of Polygonatum sibiricum, 2 - 20 parts by weight of Lycium barbarum, 2 - 20 parts by weight of Dioscorea opposita, 2 - 20 parts by weight of Pueraria lobata, 2 - 20 parts by weight of Polygonatum odoratum, and 2 - 10 parts by weight of Rehmannia glutinosa.

[0007] Preferably, it is composed of 5 - 15 parts by weight of Astragalus membranaceus, 5 - 15 parts by weight of Polygonatum sibiricum, 3 - 10 parts by weight of Lycium barbarum, 3 - 10 parts by weight of Dioscorea opposita, 3 - 10 parts by weight of Pueraria lobata, 3 - 10 parts by weight of Polygonatum odoratum, and 2 - 5 parts by weight of Rehmannia glutinosa.

[0008] Preferably, 10 parts by weight of Astragalus, 10 parts by weight of Polygonatum, 5 parts by weight of Lycium barbarum, 5 parts by weight of Dioscorea opposita, 5 parts by weight of Pueraria root, 5 parts by weight of Polygonatum odoratum, and 3 parts of Rehmannia root.

[0009] Preferably, the dosage form of the composition includes compressed candy, jelly candy, solid beverage, pill, tablet, capsule, liquid preparation or oral liquid.

[0010] Another aspect of the present application also provides a method for preparing a composition having the function of lowering blood sugar and increasing insulin sensitivity as claimed in any one of claims 1 to 4, comprising the following steps:

[0011] After weighing each raw material medicine according to the formula, crushing it to obtain coarse powder, and then preparing the oral composition according to the required dosage form.

[0012] Preferably, when the desired dosage form is a tablet, the preparation method is as follows: crush the raw medicinal material into coarse powder, extract twice with 6 times the amount of 75% ethanol, concentrate under reduced pressure to an extract, dry at 75°C, crush the dry extract into fine powder, pass through an 80-mesh sieve, and then use 80% ethanol aqueous solution to make a soft material, pass through a 30-mesh sieve and granulate, dry at 40°C, and then pass through a 30-mesh sieve to make whole granules, add magnesium stearate to mix, and press into tablets to obtain the product.

[0013] Preferably, when the desired dosage form is a compressed sugar preparation, the preparation method is: crush the raw medicinal material into coarse powder, extract twice with 6 times the amount of water, concentrate the obtained extract under reduced pressure to an extract, dry at 75°C, crush the dry extract into fine powder, and then add 2 to 3 times the amount of matrix, grind, filter and tablet, to obtain compressed sugar; the matrix is ​​a sweetener, a binder and a disintegrant, the sweetener is xylitol, the binder is starch slurry, the disintegrant is sodium carboxymethyl starch, and the seasoning is flavor and fruit acid.

[0014] Preferably, when the required dosage form is an oral preparation, the preparation method is: crush the raw medicinal materials into coarse powder, extract twice with 6 times the amount of water, concentrate under reduced pressure to an extract, concentrate 5g of the raw drug into 1g of extract, then add an appropriate amount of starch, stir well, sieve with 8-10 mesh to make granules, dry at 80°C, cool, spray with edible flavors. Pack in 5g plastic bags and seal them to obtain the finished product.

[0015] Preferably, when the required dosage form is an oral liquid, the preparation method is: crush the raw medicinal materials into coarse powder, extract twice with 6 times the amount of water, concentrate under reduced pressure to a relative density of about 1.2, add ethanol to make the alcohol content reach 70%, and store at 5-10°C for 8 hours, filter and remove the residue to recover the ethanol, concentrate to the original volume, then add refined honey and stir well, let it stand and filter, and obtain.

[0016] The beneficial effects of this application include:

[0017] 1) The composition provided by this application, which has a hypoglycemic function and increases insulin sensitivity, is formulated with Chinese medicinal materials that can be used both as food and medicine. It is both a food and exerts the medicinal properties of Chinese medicinal materials. The composition is rationally and rigorously formulated, adhering to traditional Chinese medicine theory, with the monarch, minister, assistant, and courier herbs being appropriately combined. After combination, the composition has the effects of replenishing qi and generating fluid, invigorating the spleen and benefiting the lung, nourishing yin and clearing heat, and promoting the production of body fluid to quench thirst. It has a significant hypoglycemic effect and can alleviate diabetes mellitus. Animal experiments show that this preparation has an auxiliary improvement effect on type II diabetes, can significantly reduce blood sugar, reduce insulin resistance, and achieve a health care function for people with high blood sugar. Since the preparation of this invention is made from Chinese medicinal materials that can be used both as food and medicine, it can be made into different dosage forms according to needs for convenient consumption.

[0018] 2) In the animal experiments of the composition provided by this application, among the five formula treatments of the composition, after intragastric administration of the extract suspension of the five formulas to the successfully modeled mice, the fasting blood glucose of the mice was lower than that of the model group, the fasting insulin was higher than that of the model group, and the insulin resistance index was lower than that of the model group; this indicates that the composition can significantly reduce the blood glucose value and insulin resistance of diabetic mice, showing a significant difference compared with the model group (P<0.01); this shows that QWT can significantly reduce the hyperglycemia of type 2 diabetes. In addition, QWT can significantly reduce the insulin resistance of type 2 diabetes and increase insulin sensitivity, and the effect is significantly better than that of the positive control group (P<0.01). Detailed implementation methods

[0019] The following examples further illustrate the present invention in detail, but do not limit the present invention in any way. Any transformation or improvement based on the teachings of the present invention falls within the protection scope of the present invention.

[0020] Examples

[0021] In the following examples, the materials and instruments used are obtained from commercial channels without special instructions; the detection methods used are existing methods without special instructions.

[0022] Example 1 Preparation of the tablet candy preparation of the composition provided by this application

[0023] According to each formula shown in Table 1, after respectively weighing the raw materials corresponding to each formula, the raw medicinal materials are crushed into coarse powder, extracted twice with 6 times the amount of water, the obtained extract is concentrated under reduced pressure to an extract, dried at 75°C, the dried extract is crushed into fine powder, and then 2 - 3 times the amount of matrix is added. After grinding, filtering, and tableting, the tablet candy is obtained; the matrix is a sweetening agent, binder, and disintegrant. The sweetening agent is xylitol, the binder is starch paste, the disintegrant is sodium carboxymethyl starch, and the flavoring agent is essence and fruit acid.

[0024] Table 1 The Chinese medicinal materials and their dosages (g) in the 5 formulas of the composition of the present invention

[0025] The drug of the present invention Astragalus membranaceus Polygonatum sibiricum Lycium barbarum Dioscorea opposita Pueraria lobata Polygonatum odoratum Rehmannia glutinosa Formulation 1 of the composition of the present invention 30 30 20 20 20 20 10 Formulation 2 of the composition of the present invention 30 30 15 15 15 15 10 Formulation 3 of the composition of the present invention 20 20 15 15 15 15 10 Formulation 4 of the composition of the present invention 10 10 5 5 5 5 3 Formulation 5 of the composition of the present invention 5 5 3 3 3 3 2

[0026] Example 2 Preparation of tablets of the composition provided by the present application

[0027] The difference from Example 1 is as follows: The raw medicinal materials are crushed into coarse powder, extracted twice with 6 times the amount of 75% ethanol, concentrated under reduced pressure to an extract, dried at 75 °C, the dry extract is crushed into fine powder, passed through an 80-mesh sieve, then made into soft material with 80% ethanol aqueous solution, granulated through a 30-mesh sieve, dried at 40 °C, granulated again through a 30-mesh sieve, mixed with magnesium stearate, and pressed into tablets to obtain the product.

[0028] Example 3 Preparation of the instant preparation of the composition provided by the present application

[0029] The difference from Example 1 is as follows: The raw medicinal materials are crushed into coarse powder, extracted twice with 6 times the amount of water, concentrated under reduced pressure to an extract, concentrated to 1 g of extract from 5 g of crude drug, then an appropriate amount of starch is added, stirred well, granulated through an 8-10-mesh sieve, dried at 80 °C, cooled, sprayed with edible essence, and sealed in a 5 g plastic bag to obtain the finished product.

[0030] Example 4 Preparation of the oral liquid of the composition provided by the present application

[0031] The difference from Example 1 is as follows: The raw medicinal materials are crushed into coarse powder, extracted twice with 6 times the amount of water, concentrated under reduced pressure to a relative density of about 1.2, ethanol is added to make the alcohol content reach 70%, and stored at 5-10 °C for 8 hours, filtered to remove residues and the ethanol is recovered, concentrated to the original volume, then mixed with refined honey, allowed to stand and filtered to obtain the product.

[0032] Example 5 Animal experiment on the hypoglycemic effect of the composition obtained in Example 1

[0033] 1. Materials

[0034] 1.1 Experimental animals

[0035] C57BL / 6 mice, male, weighing 20-22 g, purchased from Beijing Huafukang Biotechnology Co., Ltd., animal certificate number SYXK(Dian)K2022-0004. The mice were purchased one week before the experiment and placed in a sound-insulated animal room at a temperature of 25-27 °C. The animals were allowed to freely feed and drink water.

[0036] 1.2 The composition and reagents of the present invention

[0037] The composition of the present invention is named Qiwei Tangmai, abbreviated as QWT.

[0038] QWT extract: Extracted by the R & D center of Kunming Longjin Pharmaceutical Co., Ltd., obtained by extracting and drying 7 kinds of medicinal materials including Astragalus membranaceus, Polygonatum sibiricum, Lycium barbarum, Dioscorea opposita, Pueraria lobata, Polygonatum odoratum, and Rehmannia glutinosa.

[0039] Streptozotocin (STZ, Sigma-Aldrich); high-fat KK feed (Speyford Biotechnology Co., Ltd., general standard formula); metformin hydrochloride tablets (Merck Pharmaceuticals (Jiangsu) Co., Ltd., batch number H20023370, specification 0.5 g / tablet); insulin injection (Jiangsu Wanbang Biochemical Medicine Co., Ltd., batch number 22212209, specification 400 U / 10 mL); mouse insulin ELISA kit, Shanghai Enzyme-linked Biotechnology Co., Ltd. 20210601.

[0040] 1.3 Dose design

[0041] The recommended dosage of Qiweitangmai (QWT) compressed tablets is as follows: the daily dosage of crude drugs for humans is 24 g. Calculated based on a human body weight of 60 kg, the human dosage is 0.4 g / kg. Given that the extraction rate of QWT extract is 20%, the human dosage of QWT extract is 0.08 g / kg. The equivalent dosage for mice is calculated by multiplying by 10 (converted according to body surface area), that is, 0.8 g / kg.

[0042] According to the drug instruction manual, the adult dosage of metformin is 0.5 g once and 2 times a day. So the maximum daily dosage for humans is 1 g. Calculated based on a human body weight of 60 kg, the human dosage is 0.0167 g / kg; for mice, it is calculated by multiplying the human dosage by 10, that is, 0.167 g / kg, and in the experiment, the dosage is 0.2 g / kg.

[0043] (1) QWT1: Formulation 1 of the composition of the present invention.

[0044] (2) QWT2: Formulation 2 of the composition of the present invention.

[0045] (3) QWT3: Formulation 3 of the composition of the present invention.

[0046] (4) QWT4: Formulation 4 of the composition of the present invention.

[0047] (5) QWT5: Formulation 5 of the composition of the present invention.

[0048] 1.4 Instruments

[0049] Electronic balance (Sartorius Scientific Instruments Co.); Accu-Chek glucose meter and matching test strips (Roche); CNC ultrasonic cleaner (Kunshan Ultrasonic Instruments Co., Ltd.); Bio-Rad 550 microplate reader, product of Bio-Rad, USA; Vortex mixer: Zhejiang Lecheng Electric Appliance Factory.

[0050] 2. Methods

[0051] 2.1 Establishment of diabetes model

[0052] Establish a type 2 diabetes model by referring to the literature method and pre-experiment: Male C57 mice were fed a high-fat diet (formula: 83% normal feed, 10% lard, 5% sucrose, 1.5% cholesterol, 0.5% bile salt) for six weeks. After 6 weeks, they were fasted for 12 hours, and streptozotocin at a dose of 55 mg / kg was intraperitoneally injected into the diabetes model mice for five consecutive days. After 72 hours, the blood glucose of the mice in the diabetes model group was measured. A blood glucose level > 11.1 mM indicated successful modeling.

[0053] 2.2 Grouping and drug administration

[0054] Eighty mice were used to establish a diabetes model according to the above method. Another 10 male mice were used as the normal control group and fed a normal diet. The mice in the normal control group were intraperitoneally injected with an equal volume of normal saline, 0.1 mL / 10 g. Seventy successfully modeled diabetes model mice were randomly divided into 7 groups, with 10 mice in each group (excluding failed and redundant animals), namely: the model group, the positive control group, and the extracts (QWT) of the active ingredients obtained from the five formula groups in Example 1.

[0055] The mice in each group were administered drugs as follows, once a day for 2 consecutive weeks: The positive control group was given metformin tablets by gavage at a dose of 0.2 g / kg; The five dose groups of QWT were respectively given the suspension prepared from the extract of QWT of the corresponding formula by gavage at a dose of 0.8 g / kg (the QWT extract was prepared into a suspension of the corresponding concentration with purified water); The normal control group and the model group were given an equal volume of normal saline by gavage, 0.1 mL / 10 g. After 2 consecutive weeks of drug administration, they were fasted for 12 hours, blood was collected from the orbital cavity, serum was separated, and stored at -80 °C for later use to detect various indicators.

[0056] 2.3 Blood glucose and insulin resistance detection

[0057] After thawing the frozen serum, fasting blood glucose (FBG) was detected using a blood glucose meter and test strips, and fasting insulin (FINS) was measured using a mouse insulin ELISA kit. The insulin resistance index (HOMA-IR) was calculated as HOMA-IR = FBG × FINS / 22.5.

[0058] 3. Results

[0059] 3.1 Treatment of type 2 diabetes model by QWT

[0060] The blood glucose levels, insulin levels, and insulin resistance indices of the mice in the model group were significantly increased, showing significant differences compared with the normal control group (P<0.01), indicating that type 2 diabetes can cause obvious insulin resistance. The positive control group and the five dose groups of QWT could significantly reduce the blood glucose levels and insulin resistance of diabetic mice, showing significant differences compared with the model group (P<0.01), indicating that QWT can significantly reduce the hyperglycemia in type 2 diabetes. In addition, QWT could significantly reduce the insulin resistance in type 2 diabetes and increase insulin sensitivity, with the effect being significantly better than that of the positive control group (P<0.01). The results are shown in Table 1.

[0061] Table 1. Effects of QWT on blood glucose, insulin, and insulin resistance index in diabetic mice

[0062]

[0063]

[0064] #P<0.05, ##P<0.01, compared with the normal control group; *P<0.05, **P<0.01, compared with the model group

[0065] a P<0.05, aa P<0.01, compared with the positive control group.

[0066] Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or perform equivalent replacements for some of the technical features. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of the present invention shall be included within the protection scope of the present invention.

Claims

1. A composition having the function of lowering blood sugar and increasing insulin sensitivity, characterized in that: The invention is composed of 5-30 parts by weight of astragalus, 5-30 parts by weight of polygonatum, 3-20 parts by weight of wolfberry, 3-20 parts by weight of yam, 3-20 parts by weight of kudzu root, 3-20 parts by weight of polygonatum and 2-10 parts of rehmannia.

2. The composition having the function of lowering blood sugar and increasing insulin sensitivity according to claim 1, characterized in that: 5-15 parts by weight of Astragalus, 5-15 parts by weight of Polygonatum, 3-10 parts by weight of Lycium barbarum, 3-10 parts by weight of Dioscorea opposita, 3-10 parts by weight of Pueraria root, 3-10 parts by weight of Polygonatum odoratum, and 2-5 parts of Rehmannia root.

3. The composition having the function of lowering blood sugar and increasing insulin sensitivity according to claim 1, characterized in that: 10 parts by weight of Astragalus, 10 parts by weight of Polygonatum, 5 parts by weight of Lycium barbarum, 5 parts by weight of Dioscorea opposita, 5 parts by weight of Pueraria root, 5 parts by weight of Polygonatum odoratum, and 3 parts of Rehmannia root.

4. The composition having the function of lowering blood sugar and increasing insulin sensitivity according to claim 1, characterized in that: The dosage form of the composition includes compressed candy, jelly candy, solid beverage, pill, tablet, capsule, liquid preparation or oral liquid.

5. A method for preparing a composition having the function of lowering blood sugar and increasing insulin sensitivity as claimed in any one of claims 1 to 4, characterized in that: The following steps are involved: After weighing each raw material medicine according to the formula, crushing it to obtain coarse powder, and then preparing the oral composition according to the required dosage form.

6. The preparation method according to claim 5, characterized in that: When the required dosage form is tablets, the preparation method is as follows: crush the raw medicinal materials into coarse powder, extract twice with 6 times the amount of 75% ethanol, concentrate under reduced pressure to obtain an extract, dry at 75°C, crush the dry extract into fine powder, pass through an 80-mesh sieve, and then use 80% ethanol aqueous solution to make a soft material, pass through a 30-mesh sieve and then granulate, dry at 40°C, and then pass through a 30-mesh sieve to make whole granules, add magnesium stearate to mix evenly, and press into tablets to obtain the product.

7. The preparation method according to claim 5, characterized in that: When the required dosage form is a compressed sugar preparation, the preparation method is as follows: crush the raw medicinal materials into coarse powder, extract twice with 6 times the amount of water, concentrate the obtained extract under reduced pressure to an extract, dry at 75°C, crush the dry extract into fine powder, add 2 to 3 times the amount of matrix, grind, filter and tablet, and obtain compressed sugar; the matrix is ​​a sweetener, a binder and a disintegrant, the sweetener is xylitol, the binder is starch slurry, the disintegrant is sodium carboxymethyl starch, and the seasoning is flavor and fruit acid.

8. The preparation method according to claim 5, characterized in that: When the required dosage form is an oral preparation, the preparation method is as follows: crush the raw medicinal materials into coarse powder, extract twice with 6 times the amount of water, and concentrate under reduced pressure to an extract, 5g of the raw drug is concentrated into 1g of extract, and then add an appropriate amount of starch, stir well, sieve with 8-10 mesh to make granules, dry at 80°C, cool, and spray with edible flavors. Pack into 5g plastic bags and seal them to obtain the finished product.

9. The preparation method according to claim 5, characterized in that: When the required dosage form is an oral liquid, the preparation method is as follows: crush the raw medicinal materials into coarse powder, extract twice with 6 times the amount of water, concentrate under reduced pressure to a relative density of about 1.2, add ethanol to make the alcohol content reach 70%, and store at 5-10°C for 8 hours, filter and remove the residue to recover the ethanol, concentrate to the original volume, then add refined honey and stir well, let it stand and filter, and the product is obtained.

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