A Chinese medicine composition capable of regulating blood sugar and its preparation method and application

Abstract

The present invention discloses a Chinese medicine composition with blood sugar regulating function, a preparation method and application thereof, which is prepared from the following raw materials in parts by weight: 6-12 parts of astragalus, 3-9 parts of wolfberry, 3-9 parts of hawthorn, 0.3-1 parts of bear bile powder, 3-9 parts of mulberry leaf and 1-3 parts of cinnamon. Under the guidance of the theory of traditional Chinese medicine, the present invention adopts syndrome differentiation and treatment to screen the prescription. The experimental results show that the Chinese medicine composition provided by the present invention has the effects of significantly reducing blood sugar and reducing insulin resistance, has reliable efficacy, good safety and low adverse reactions, and can be used to prepare a drug for regulating blood sugar.

Description

Technical Field

[0001] The invention relates to a natural product composition, in particular to a Chinese medicine composition capable of regulating blood sugar and a preparation method thereof. Background Art

[0002] Type II diabetes is a chronic endocrine metabolic disease characterized by hyperglycemia caused by relatively insufficient insulin secretion or insulin resistance. According to statistics from the International Diabetes Federation in 2021, there are approximately 537 million people with diabetes worldwide, and it is expected that the number may rise to 783 million by 2045, of which type II diabetes accounts for more than 90% of all cases, and the number of diabetes patients in my country ranks first in the world. Uncontrolled diabetes can cause macrovascular diseases such as coronary heart disease, stroke and peripheral arterial disease, as well as microvascular diseases, including complications such as diabetic nephropathy, retinopathy and peripheral neuropathy, which cause obvious harm to human health.

[0003] Western medicine for the treatment of diabetes mainly includes metformin, thiazolidinediones and sulfonylureas. Long-term use of chemically synthesized Western medicines is prone to obvious drug resistance and adverse reactions, and even serious toxic side effects. Traditional Chinese medicine has a unique therapeutic effect in the prevention and treatment of diabetes, with good safety and few toxic side effects. Therefore, it is of great significance to select a Chinese medicine compound composition with the function of regulating blood sugar under the guidance of traditional Chinese medicine theory. Summary of the invention

[0004] Purpose of the invention: The purpose of the present invention is to provide a Chinese medicine composition with reliable efficacy, good safety and good blood sugar regulation. Another purpose of the present invention is to provide a preparation method and application of the above composition.

[0005] Technical solution: In order to achieve the above purpose, the technical solution adopted by the present invention is:

[0006] A Chinese medicine composition capable of regulating blood sugar comprises the following raw materials in parts by weight: 6-12 parts of astragalus, 3-9 parts of wolfberry, 3-9 parts of hawthorn, 0.3-1 parts of bear gall powder, 3-9 parts of mulberry leaves and 1-3 parts of cinnamon.

[0007] As a preferred embodiment, the above-mentioned Chinese medicine composition for regulating blood sugar comprises the following raw materials in parts by weight: 6-9 parts of astragalus, 3-6 parts of wolfberry, 3-6 parts of hawthorn, 0.3-0.5 parts of bear bile powder, 3-6 parts of mulberry leaves, and 1-2 parts of cinnamon.

[0008] As a preferred embodiment, the above-mentioned Chinese medicine composition for regulating blood sugar includes the following raw materials in parts by weight: 9 parts of astragalus, 6 parts of wolfberry, 6 parts of hawthorn, 0.5 parts of bear bile powder, 6 parts of mulberry leaves, and 1 part of cinnamon.

[0009] The preparation method of the Chinese medicine compound composition provided by the invention comprises the following steps: taking astragalus, wolfberry, hawthorn, mulberry leaf and cinnamon by weight, adding 5-15 times amount of water or 10-60% ethanol of the Chinese medicinal materials to extract 1 to 3 times, each time for 0.5 to 2 hours, combining the extracts, concentrating under reduced pressure, and drying by blasting, vacuum or spraying to obtain dry extract powder, mixing the dry powder with bear bile powder, and preparing an oral preparation with a pharmaceutically acceptable carrier, including tablets, dispersible tablets, effervescent tablets, orally disintegrating tablets, lozenges, chewable tablets, hard capsules, soft capsules, granules, pills, powders, dripping pills and oral liquid preparations.

[0010] The present invention selects Chinese medicine raw materials under the guidance of traditional Chinese medicine theory, selects six medicines including astragalus, wolfberry, hawthorn, bear bile powder, mulberry leaf and cinnamon for compatibility, and determines the dosage of each medicinal material through the relationship between the effective component and the function, so that each component has a synergistic effect. In the prescription, astragalus is used as the main ingredient, which can invigorate the spleen and help transportation, and help the water and grain essence to be transported throughout the body. Water and fluid are carried upward, and thirst is cured. Wolfberry nourishes liver and kidney yin, replenishes essence and blood, nourishes yin and moistens dryness. Hawthorn can invigorate the stomach and digest food, improve spleen transportation, promote blood circulation and remove blood stasis to improve phlegm and blood stasis, and focus on preventing wolfberry from nourishing and hindering the spleen, and the two are ministerial drugs. The present invention is supplemented with bear bile powder to clear heat and calm the liver; mulberry leaf is light and clear to disperse, and resolves dryness and heat; the two medicines are combined, and the stagnant heat is eliminated. In particular, cinnamon can lead fire back to the original state for patients with yin deficiency and hyperactivity of fire, and can replenish yang and distribute fluid for patients with long-term yin and yang deficiency, and focus on stopping the coldness of bear bile. Using these medicines together can restore the spleen's function, eliminate internal heat, remove blood stasis, distribute fluid throughout the body, and relieve various symptoms.

[0011] The Chinese medicine compound composition provided by the present invention has a good blood sugar regulating effect and can be used to treat diabetes. It is convenient to take clinically, and no obvious toxic and side effects are found in the experimental process of the Chinese medicine composition provided by the present invention, and the safety is good. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1 It is a bar graph showing the effect of the Chinese medicine composition on fasting blood glucose in type II diabetic rats.

[0013] Figure 2 It is a bar graph showing the effect of the Chinese medicine composition on fasting insulin in type II diabetic rats.

[0014] Figure 3 It is a bar graph showing the effect of the Chinese medicine composition on the insulin resistance index of type II diabetic rats. DETAILED DESCRIPTION

[0015] The present invention can be better understood according to the following examples. However, it is easy for those skilled in the art to understand that the specific material ratios, process conditions and results described in the examples are only used to illustrate the present invention, and should not and will not limit the present invention described in detail in the claims.

[0016] Embodiment 1 A method for preparing a Chinese medicine composition having the function of regulating blood sugar comprises the following steps:

[0017] (1) Take 9 parts of Astragalus, 6 parts of Lycium barbarum, 6 parts of Hawthorn, 6 parts of Mulberry leaf, and 1 part of Cinnamon bark, mix them, add 12 times the weight of the medicinal materials of water, reflux and extract for 1.5 hours, filter, and collect the filtrate and residue.

[0018] (2) Take the medicinal residue in step (1), add 10 times the volume of water by weight of the medicinal material, reflux and extract for 1 hour, filter, and collect the filtrate.

[0019] (3) Take the medicinal residue in step (2), add 10 times the volume of water by weight of the medicinal material, reflux and extract for 1 hour, filter, and collect the filtrate.

[0020] (4) The filtrates obtained in step (1), step (2) and step (3) are combined, concentrated under reduced pressure at 70° C., and the concentrate is vacuum dried at 70° C. to obtain an aqueous extract.

[0021] (5) The water extract is mixed with 0.5 parts of bear bile powder to obtain a mixture, and the mixture is prepared into tablets with a pharmaceutically acceptable carrier.

[0022] Embodiment 2 A method for preparing a Chinese medicine composition having the function of regulating blood sugar comprises the following steps:

[0023] (1) Take 6 parts of Astragalus, 3 parts of Lycium barbarum, 3 parts of Hawthorn, 3 parts of Mulberry leaf, and 1 part of Cinnamon bark, mix them, add 12 times the weight of the medicinal materials of water, reflux and extract for 1.5 hours, filter, and collect the filtrate and residue.

[0024] (2) Take the medicinal residue in step (1), add 10 times the volume of water by weight of the medicinal material, reflux and extract for 1 hour, filter, and collect the filtrate.

[0025] (3) Take the medicinal residue in step (2), add 10 times the volume of water by weight of the medicinal material, reflux and extract for 1 hour, filter, and collect the filtrate.

[0026] (4) The filtrates obtained in step (1), step (2) and step (3) are combined, concentrated under reduced pressure at 70° C., and the concentrate is vacuum dried at 70° C. to obtain an aqueous extract.

[0027] (5) The water extract is mixed with 0.3 parts of bear bile powder and prepared into capsules with a pharmaceutically acceptable carrier.

[0028] Example 3 Experimental study on regulating blood sugar

[0029] 1. Experimental Materials and Drugs

[0030] 1 Experimental animals

[0031] SPF-grade male SD rats weighing 170–200 g were purchased from Beijing Weitonglihua Experimental Animal Technology Co., Ltd. with animal license number SCXK (Beijing) 2021-0011.

[0032] 2 Drugs and reagents

[0033] Streptozotocin (batch number WXBD7077V, Sigma, USA); sodium citrate buffer (0.1 mmol·L- 1 pH 4.0, batch number 20210615, Beijing Solebao Company); metformin hydrochloride (batch number ABZ8820, Sino-US Shanghai Bristol-Myers Squibb Company); rat insulin (batch number 67-22040) ELISA kits were purchased from Nanjing Laputa Biotechnology Co., Ltd. High-sugar and high-fat feed (formula: basic feed 43.5%, lard 17.5%, casein 13%, sucrose 12%, whole milk powder 10%, calcium hydrogen phosphate 2%, experimental animal premix 2%) was purchased from Jiangsu Collaborative Pharmaceutical Bioengineering Co., Ltd.

[0034] Test drug: a mixture of the traditional Chinese medicine composition prepared in step (5) of Example 1 of the present invention.

[0035] 3 Instruments

[0036] Sinocare Anwen+ blood glucose meter (Batch No.: 2K01B200724, Sinocare Biosensor Co., Ltd.); electronic weighing scale (Yongkang Huaying Weighing Instrument Co., Ltd.); ML105 electronic balance (Shanghai Mettler-Toledo Instrument Shanghai Co., Ltd.); Dalong D3024R high-speed refrigerated centrifuge (Beijing Dalong Xingchuang Experimental Instrument Co., Ltd.); Enspire multifunctional microplate reader (PerkinElmer, USA).

[0037] 2. Experimental Methods

[0038] 1. Establishment of rat diabetes model

[0039] After 1 week of adaptive feeding, rats were randomly divided into a control group of 10 and a type II diabetes model group of 48 according to body weight using a stratified grouping method. The control group was fed with ordinary feed, and the model group was fed with high-sugar and high-fat feed. After 4 weeks, the rats were fasted for 12 hours but not water. The type II diabetic rats were intraperitoneally injected with 1% STZ citrate buffer (0.1mmol / L, pH=4.5) for 2 consecutive days at a dose of 30mg / kg, and the control group was intraperitoneally injected with an equal amount of sodium citrate buffer. After 72 hours (fasting 12 hours in advance), blood was collected from the tail vein to measure fasting blood sugar. The model was considered successful if the fasting blood sugar was ≥11.1mmol / L.

[0040] 2. Administration of Chinese medicine composition

[0041] The rats with successful model establishment were randomly divided into a model group, a positive drug metformin group (180 mg / kg), a low-dose group of the tested Chinese medicine composition (Example 1) (crude drug 2.33 g / kg, bear bile powder 41.67 mg), and a high-dose group of the tested Chinese medicine composition (Example 1) (crude drug 7 g / kg, bear bile powder 125 mg) according to blood sugar by stratified grouping method, with 12 rats in each group. The drug administration group was gavaged with the corresponding drug, and the control group and the model group were gavaged with distilled water, with the gavage volume of 10 mL / kg, once a day, for 30 consecutive days.

[0042] 3. Efficacy evaluation method

[0043] During the modeling and drug administration period, the rats' coat color, water intake, food intake, urine volume, and mental state were observed. After the last drug administration, the rats in each group were fasted but not watered for 12 hours, and their fasting blood sugar was measured. A 10% chloral hydrate solution (3 mL / kg) was prepared and injected intraperitoneally to anesthetize the rats. After the pain reflex of the rats disappeared, blood was collected from the abdominal aorta, and serum was collected for the detection of biochemical indicators of the rats.

[0044] 3. Statistical analysis

[0045] All experimental data were statistically analyzed using Graph Pad Prism 8 software. One-way ANOVA and Kruskl-Wallis test were used for comparison among groups. The differences were considered statistically significant when P < 0.05.

[0046] 3. Experimental Results

[0047] The rats in the control group had bright and smooth fur, were relatively active, and were full of energy; the rats in the successful model had yellow fur, lost hair, drank more, ate more, and urinated more, and in the later stage, they ate less, were listless, and occasionally had diarrhea and other symptoms; the rats in the Chinese medicine combination group had improved diet, drinking water, and urination. Figure 1 , 2 3. It can be seen that compared with the control group, the fasting blood glucose, fasting insulin and insulin resistance index of the model group rats increased significantly (P<0.001), and the fasting blood glucose, fasting insulin and insulin resistance index were significantly adjusted after the administration of the Chinese medicine composition (P<0.05). It shows that the Chinese medicine composition provided by the present invention can reduce insulin resistance and has a good hypoglycemic effect. Compared with existing Western medicines, the Chinese medicine composition has fewer side effects, and its therapeutic effect and safety are relatively ideal. It can be used for the treatment of diabetes and has a high value for drug development.

[0048] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A Chinese medicine composition having the function of regulating blood sugar, characterized in that: The invention is prepared from the following raw materials in parts by weight: 9 parts of astragalus, 6 parts of wolfberry, 6 parts of hawthorn, 0.5 parts of bear gall powder, 6 parts of mulberry leaves and 1 part of cinnamon.

2. The method for preparing the Chinese medicine composition for regulating blood sugar according to claim 1, characterized in that: The method comprises the following steps: taking astragalus, wolfberry, hawthorn, mulberry leaf and cinnamon according to weight proportions, adding 5-15 times amount of water or 10-60% ethanol to the Chinese medicinal materials for extraction for 1 to 3 times, each time for 0.5 to 2 hours, combining the extracts, concentrating under reduced pressure, drying by blasting, vacuum or spraying to obtain dry extract powder, mixing the dry extract powder with bear bile powder and preparing a pharmaceutical preparation with a pharmaceutically acceptable carrier.

3. The method for preparing a Chinese medicine composition for regulating blood sugar according to claim 2, characterized in that: The pharmaceutical preparation is selected from dispersible tablets, effervescent tablets, chewable tablets, hard capsules, soft capsules, granules, pills, powders, and oral liquid preparations.

4. Use of the Chinese medicine composition according to claim 1 in preparing a drug for treating hyperglycemia.

5. Use of the Chinese medicine composition according to claim 1 in preparing a drug for treating type II diabetes.

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