Pharmaceutical composition with hypoglycemic effect

By developing a pharmaceutical composition containing chromium picolinate, ginseng saponin Rb1, nitrosaponin B II and thymegua saponin L, the adverse reaction problems of existing diabetes treatment drugs were solved, and synergistically reduced fasting blood sugar and improved glucose tolerance were achieved, with low toxicity and high-efficiency lowering effects.

CN115869327BActive Publication Date: 2025-04-25XIAN GIANT BIOGENE TECH CO LTD
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Patent Information

Application Number
CN202310012141.4
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2023-01-05
Publication Date
2025-04-25
Estimated Expiration
2043-01-05

AI Technical Summary

Technical Problem

There are adverse reactions to existing drugs for the treatment of diabetes, such as hypoglycemia, gastrointestinal discomfort and obesity, and there is basically no study on the synergistic effects between compounds with lowering glycemic effects.

Method used

A pharmaceutical composition containing chromium picolinate, ginseng saponin Rb1, nitrosaponin B II and thymetic saponin L was developed to achieve synergistic effects of reducing fasting blood sugar and improving glucose tolerance through a combination of specific proportions.

Benefits of technology

This composition can significantly reduce fasting blood sugar, improve glucose tolerance, effectively control blood sugar levels in diabetic patients, and has low toxicity characteristics.

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Abstract

The present patent application discloses a pharmaceutical composition with hypoglycemic effect. In the pharmaceutical composition, a certain dose of chromium picolinate and ginsenoside Rb1 combination has a synergistic effect of reducing fasting blood sugar, which can effectively control the fasting blood sugar of the subject; a certain dose of the composition of timosaponin B II and momordica charantia saponin L has a synergistic effect of improving glucose tolerance, which can effectively control the postprandial blood sugar of the subject. The pharmaceutical composition can synergistically reduce fasting blood sugar and synergistically improve glucose tolerance, so it can effectively control the fasting blood sugar and postprandial blood sugar of the subject at the same time, thereby preventing and / or treating diabetes of the subject.
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Description

Technical Field

[0001] The present application belongs to the field of biomedicine, and specifically relates to a pharmaceutical composition with hypoglycemic effect. Background Art

[0002] Diabetes is a chronic metabolic disorder characterized by high blood sugar. Long-term high blood sugar in patients can cause vascular damage, functional and metabolic disorders, and produce a variety of acute and chronic complications. According to statistics, there are more than 110 million diabetes patients in my country, and the number of patients is increasing year by year, and the trend is gradually showing a younger trend. The harm of diabetes is huge, and the complications of diabetes that accompany diabetes also pose a huge threat to the health and life of patients.

[0003] At present, the drugs for treating diabetes mainly include sulfonylureas, glinides, biguanides and insulin, etc. These drugs all have adverse reactions to varying degrees, such as causing hypoglycemia, gastrointestinal discomfort, obesity, etc. Therefore, developing safe and effective natural products with hypoglycemic and lipid-lowering activities from natural plants as auxiliary means of lowering blood sugar and blood lipids is a new development trend in the prevention and treatment of diabetes and hyperlipidemia, and has become a hot topic of research at home and abroad.

[0004] A large number of studies have shown that trace metal elements are closely related to the prevention and treatment of diabetes, and that there is a disorder in the metabolism of trace metal elements in diabetic patients. Among them, trace elements chromium, zinc, and vanadium are essential metal elements for the human body, are the active centers of many proteases, and play an important role in the metabolism of glucose. Studies have shown that compounds of these metal ions have anti-diabetic effects. In 2004, Kim and Shindea et al. conducted a study on diabetic rats using chromium picolinate and showed that chromium picolinate can significantly improve the sugar and lipid metabolism of diabetic rats and reduce glucose tolerance. Anderson et al. supplemented 180 patients with type 2 diabetes with high and low doses of chromium picolinate, and the results showed that the patients' blood sugar, insulin, glycosylated hemoglobin and cholesterol were significantly reduced. Chen et al. conducted a 10-month survey on 833 diabetic patients and showed that blood sugar was significantly reduced after supplementing with chromium picolinate, and clinical symptoms such as frequent urination, thirst and fatigue were improved.

[0005] Ginseng is a perennial herb of the Araliaceae family. It is a precious Chinese medicinal material and is known as the "king of herbs". Ginsenoside Rb1 is the main component of ginsenosides responsible for the hypoglycemic effect (YANG CY, WANG J, ZHAO Y, et al. Anti-diabetic effects of Panax notoginseng saponins and its major anti-hyperglycemic components [J]. Ethnopharmacol, 2010, 130 (2): 231-236.).

[0006] Bitter melon (momordica charantia L.) is an annual plant of the Cucurbitaceae family. It has the functions of dispelling summer heat, improving eyesight, and detoxifying. It is mainly used to treat summer heat, thirst, red eye pain, dysentery, and sores and carbuncle. Momordicoside L is a cucurbitane-type triterpenoid compound found in the roots, stems, and fruits of bitter melon. It is one of the main active ingredients that control the bitterness of bitter melon. Studies have shown that momordicoside L can inhibit the activity of α-amylase and β-glucosidase, and has good anti-inflammatory and hypoglycemic effects (PERERA WH, SHIVANAGOUDRA SR, JL, et al. Antiinflammatory, antidiabetic properties and in silico modeling of cucurbitane-type triterpeneglycosides from fruits of an indian cultivar of Momordica charantia L[J]. Molecules, 2021, 26(4): 1038).

[0007] Rhizoma Anemarrhenae is the dry rhizome of Anemarrhenaas-phodeloidesBge, a plant of the Liliaceae family. It is bitter in taste, cold in nature, and enters the lung, stomach, and kidney meridians. It has the effects of clearing away heat and purging fire, nourishing yin and moistening dryness, quenching thirst and relieving restlessness. The chemical components of Rhizoma Anemarrhenae mainly include steroidal saponins, biphenylpyrrolidone, flavonoids, lignans, polysaccharides, organic acids, and trace elements, and saponins are one of its main components, accounting for about 6% of the rhizome of Rhizoma Anemarrhenae. Studies have shown that Rhizoma Anemarrhenae saponin BII can significantly reduce the blood sugar level of diabetic rats induced by alloxan.

[0008] However, there is little research on the synergistic effects among various compounds with hypoglycemic effects. Summary of the invention

[0009] In view of the above technical problems existing in the prior art, the object of the present invention is to provide a hypoglycemic pharmaceutical composition with a synergistic hypoglycemic effect.

[0010] The inventors conducted in-depth research on the synergistic effects between various compounds with hypoglycemic effects, and found that: 1. A certain dose of the combination of chromium picolinate and ginsenoside Rb1 has a synergistic effect of reducing fasting blood sugar; 2. A certain dose of the combination of anemarrhena saponin B II and momordica saponin L has a synergistic effect of improving glucose tolerance, thereby completing the present invention.

[0011] That is, the present invention includes:

[0012] 1. A hypoglycemic composition having the effect of reducing fasting blood sugar (hypoglycemic composition A), comprising chromium picolinate, ginsenoside Rb1 and a pharmaceutically acceptable carrier, wherein the weight ratio of the chromium picolinate to the ginsenoside Rb1 is 1:1-3.

[0013] 2. The hypoglycemic composition according to item 1, wherein the weight ratio of chromium picolinate to ginsenoside Rb1 is 1:1 to 2.5.

[0014] 3. The glucose-lowering composition according to item 1, wherein the chromium picolinate and ginsenoside Rb1 are the only glucose-lowering active ingredients.

[0015] 4. Use of the glucose-lowering composition according to item 1 in the preparation of a medicament for preventing or treating diabetes.

[0016] 5. A hypoglycemic composition having an effect of improving glucose tolerance (hypoglycemic composition B), comprising timosaponin B II, momordica saponin L and a pharmaceutically acceptable carrier, wherein the weight ratio of timosaponin B II to momordica saponin L is 1:1.5-4.

[0017] 6. The hypoglycemic composition according to item 5, wherein the weight ratio of the timosaponin B II to the momordica charantia saponin L is 1:2-3.

[0018] 7. The hypoglycemic composition according to item 5, wherein the timosaponin B II and momordica charantia saponin L are the only hypoglycemic active ingredients.

[0019] 8. Use of the glucose-lowering composition according to item 5 in the preparation of a medicament for preventing or treating diabetes.

[0020] 9. A pharmaceutical composition having a glucose-lowering effect (a glucose-lowering pharmaceutical composition), comprising the glucose-lowering composition described in any one of items 1 to 3 and the glucose-lowering composition described in any one of items 5 to 7.

[0021] In the pharmaceutical composition with hypoglycemic effect, chromium picolinate, ginsenoside, anemarrhena saponin B II and momordica saponin L can be the only hypoglycemic active ingredients.

[0022] 10. Use of the pharmaceutical composition with hypoglycemic effect according to item 9 in the preparation of a medicament for preventing or treating diabetes.

[0023] 11. A method for preventing or treating diabetes, comprising the step of administering to a subject a preventive or therapeutically effective amount of the glucose-lowering composition described in any one of Items 1 to 3, the lipid-lowering composition described in any one of Items 5 to 7, and / or the pharmaceutical composition having a glucose-lowering effect described in Item 9. Here, the subject may be a human.

[0024] In this specification, the diabetes refers to type 2 diabetes.

[0025] In the present invention, there is no particular limitation on the dosage form of the composition or drug, for example, it can be an oral dosage form or an injection dosage form. The oral dosage form can be a liquid dosage form or a solid dosage form. The oral dosage form can be, for example, a hard capsule, a soft capsule, a sustained-release capsule, a compressed tablet, a sugar-coated tablet, a powder, a granule, a dripping pill, a honeyed pill, a syrup or an oral liquid; the injection dosage form can be, for example, a solution type, a suspension type, an emulsion type or a lyophilized powder. The composition or drug may contain excipients or other pharmaceutically acceptable carriers. The excipients can be, for example, one or more of sodium hyaluronate, sodium alginate, chitosan or collagen.

[0026] Effects of the Invention

[0027] In the above-mentioned hypoglycemic composition A, a certain dose of the combination of chromium picolinate and ginsenoside Rb1 has a synergistic effect of reducing fasting blood sugar, and can effectively control the fasting blood sugar of the subject; in the above-mentioned hypoglycemic composition B, a certain dose of the combination of timosaponin B II and momordica charantia saponin L has a synergistic effect of improving glucose tolerance, and can effectively control the postprandial blood sugar of the subject; the hypoglycemic pharmaceutical composition can both synergistically reduce fasting blood sugar and synergistically improve glucose tolerance, so it can effectively control the fasting blood sugar and postprandial blood sugar of the subject at the same time, thereby preventing and / or treating diabetes of the subject. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 This is a morphological picture of the liver tissue of diabetic mice after treatment with the combination of chromium picolinate & ginsenoside Rb1 & momordica charantia saponin L & anemarrhena saponin B II after H&E staining (magnification: 200×).

[0029] Figure 2This is a morphological picture of the pancreatic tissue of diabetic mice after treatment with the combination of chromium picolinate & ginsenoside Rb1 & momordica charantia saponin L & anemarrhena saponin B II after H&E staining (magnification: 200×).

[0030] Specific embodiments of the invention

[0031] The present invention is described in detail below in conjunction with specific embodiments. In the absence of conflict, the scientific terms in this specification have the meanings commonly understood by those skilled in the art. If there is a conflict, the definitions in this specification shall prevail.

[0032] In the present specification, chromium picolinate refers to a compound represented by the following Chemical Formula 1.

[0033]

Chemical formula 1

[0034]

[0035] In the present specification, ginsenoside Rb1 refers to the compound described in the following Chemical Formula 2.

[0036]

Chemical formula 2

[0037]

[0038] In the present specification, momordica charantia saponin L refers to the compound described in the following Chemical Formula 3.

[0039]

Chemical formula 3

[0040]

[0041] In the present specification, timosaponin B II refers to the compound described by the following chemical formula 4.

[0042]

Chemical formula 4

[0043]

[0044] The inventors found that by combining chromium picolinate, ginsenoside Rb1, timosaponin B II, and momordicin L according to the ratio range defined by the present invention, the hypoglycemic effect of each component can be fully exerted, and the drugability is very strong. In addition, the composite use of chromium picolinate, ginsenoside Rb1 of the present invention and the composite use of momordicin L and timosaponin B II show significant synergistic effect (CI value is less than 1, preferably CI value is less than 0.7) in hypoglycemic aspect, and also show low toxicity characteristics. The inventors also found that if the content of chromium picolinate, ginsenoside Rb1, timosaponin B II, and momordicin L in the composition is not within the ratio range defined by the present invention, there is no synergistic effect. From the perspective of significant synergistic effect (CI value less than 0.7), in the composition, the weight ratio of chromium picolinate, ginsenoside Rb1, anemarrhena saponin B II, and momordica saponin L is preferably 1:(1-3):1:(2-3):, more preferably 1:2.5:1:3.

[0045] The purity of the chromium picolinate, ginsenoside Rb1, anemarrhena saponin B II, and momordica saponin L can be 95% to 100%, for example, 98% or 99%.

[0046] The contents of chromium picolinate, ginsenoside Rb1, timosaponin BII, and momordicin L can be determined by HPLC. The hypoglycemic composition may contain other hypoglycemic active ingredients, or may not contain other hypoglycemic ingredients (i.e., chromium picolinate, ginsenoside Rb1, timosaponin BII, and momordicin L are the only hypoglycemic active ingredients).

[0047] The hypoglycemic composition may include a pharmaceutically acceptable carrier, such as an adjuvant. There are no particular restrictions on the adjuvant in the composition of the present invention, and for example, adjuvants commonly used in medicines or health products in the art can be used. Specifically, the adjuvant is oligofructose, xylitol, mannitol, xanthan gum, etc.

[0048] There is no particular limitation on the dosage form of the hypoglycemic composition, for example, it can be an oral dosage form or an injection dosage form. The oral dosage form can be a liquid dosage form or a solid dosage form. The oral dosage form can be, for example, a hard capsule, a soft capsule, a sustained-release capsule, a compressed tablet, a sugar-coated tablet, a powder, a granule, a dripping pill, a honeyed pill, a syrup or an oral liquid; the injection dosage form can be, for example, a solution type, a suspension type, an emulsion type or a lyophilized powder.

[0049] When preparing liquid preparations for oral use, appropriate sweeteners, colorants, and flavoring agents may be added to the main drug, and beverages or oral liquid dosage forms of different specifications may be prepared in a conventional manner. When preparing solid preparations for oral use, excipients and, as required, binders, disintegrants, lubricants, colorants, flavoring agents, etc. may be added to the main drug, and tablets, coated tablets, granules, fine granules, powders, capsules, etc. may be prepared in a conventional manner.

[0050] In addition, examples of stabilizers include sodium sulfite and sodium metasulfite, and examples of preservatives include methyl parahydroxybenzoate, ethyl parahydroxybenzoate, sorbic acid, phenol, cresol, and chlorocresol. Example

[0051] The following examples are provided to facilitate understanding of the present invention and are not intended to limit the scope of the claims of the present invention in any way.

[0052] Example 1 Therapeutic effects of chromium picolinate, ginsenoside Rb1, and a combination of chromium picolinate and ginsenoside Rb1 on fasting blood glucose in type II diabetic mice

[0053] 1.1 Establishment of diabetic mouse model

[0054] 250 healthy female, SPF-grade C57BL / 6 mice (weight 18±2g) aged 5-6 weeks were purchased from the Experimental Animal Center of the School of Medicine, Xi'an Jiaotong University, Xi'an. The mice were adaptively fed for about 7 days and randomly divided into two groups, one group of 10 mice was given a basic diet as a blank control group; the other group of 240 mice was given a high-fat and high-sugar diet. After 6 weeks, the high-fat and high-sugar diet group fasted for 12 hours but could not be watered, and then injected intraperitoneally with STZ (prepared in citric acid buffer) 30mg / kg once a day for 5 consecutive days to establish a diabetic model. The mice were fasted for 12 hours (without watering), and blood was collected from the tail tip of each mouse to measure the fasting blood glucose value. Mice with blood glucose values ​​between 11.1 and 25.0mmol / L were screened as diabetic model mice for subsequent experiments.

[0055] 1.2 Grouping and Dosing

[0056] The successfully modeled diabetic mice were randomly divided into a control group, a model group, a chromium picolinate group, a ginsenoside Rb1 group (including ginsenoside Rb1 20 mg / kg, 50 mg / kg, 100 mg / kg, 10 mg / kg, respectively), and a chromium picolinate & ginsenoside Rb1 combination group, with 10 mice in each group. The gavage volume of each group was 10 mL / kg·BW. The preparation method of the chromium picolinate & ginsenoside Rb1 combination group is as follows: chromium picolinate and ginsenoside Rb1 were uniformly mixed at a weight ratio of 1:1, 1:2.5, 1:0.5, and 1:10, which was called composition 1 (20 mg / kg chromium picolinate + 20 mg / kg ginsenoside Rb1, respectively prepared 2 mg / mL of chromium picolinate and ginsenoside Rb1 were obtained, and the following compositions were prepared in the same way), composition 2 (20 mg / kg chromium picolinate + 50 mg / kg ginsenoside Rb1), composition 3 (20 mg / kg chromium picolinate + 100 mg / kg ginsenoside Rb1), and composition 4 (20 mg / kg chromium picolinate + 10 mg / kg ginsenoside Rb1). The model group and the control group were given equal doses of normal saline by gavage for 30 consecutive days.

[0057] 1.3 Index detection

[0058] The fasting blood glucose of mice was measured before and 4 weeks after administration. The specific operation was as follows: the animals were fasted (but not water-deprived) for 12 hours, and the glucose level was measured by blood sampling from the tail vein, which was the fasting blood glucose.

[0059] At the same time, the interaction index CI = AB / (A×B) was calculated, where T was the blood glucose value of the experimental group (need to deduct the blood glucose value of the blank control group), C was the blood glucose value of the model control group (need to deduct the blood glucose value of the blank control group), AB was the T / C value of the combination group, and A and B were the T / C values ​​of the ginsenosides alone group (if two ginsenosides were used in combination, the formula became CI = AB / (A×B)). When CI < 1, it indicates that the combination has a synergistic effect, and when CI ≤ 0.7, the synergistic effect is obvious.

[0060] 1.4 Results

[0061] There was no significant difference in the initial body weight of mice in each group before administration. After 4 weeks of intragastric administration, the body weight of mice in the normal group increased steadily, while the body weight of mice in the model group decreased significantly compared with the normal group. The body weight of mice in each administration group was basically the same as that of the model group, and the drug itself did not cause a significant decrease in the body weight of mice, indicating that the safety of each composition itself was good.

[0062] The therapeutic effects of the above-mentioned chromium picolinate, ginsenoside Rb1 and compositions 1-4 on fasting blood glucose in diabetic mice are shown in Table 1.

[0063] Table 1 The therapeutic effects of chromium picolinate, ginsenoside Rb1 and their combination on fasting blood glucose in mice

[0064]

[0065] Table 2 T / C and CI values ​​of chromium picolinate, ginsenoside Rb1 and combination on fasting blood glucose value in diabetes

[0066] Group T / C CI Composition 1 0.248 0.845 Composition 2 0.196 0.696 Composition 3 0.297 1.065 Composition 4 0.329 1.076

[0067] From the results of Example 1 above, it can be seen that compared with the use of chromium picolinate and ginsenoside Rb1 alone, the composition 1 and composition 2 of the present invention can significantly reduce the fasting blood glucose value of diabetic mice, and the combined index of the two compositions for the treatment of fasting blood glucose in diabetic mice is less than 1. Among them, the combined index of the therapeutic effect of composition 2 on the fasting blood glucose of diabetic mice is less than 0.7, indicating that the combined use of chromium picolinate and ginsenoside Rb1 at a weight ratio of 1:2.5 has a very significant synergistic effect on the treatment of fasting blood glucose. The combined index of composition 1 for fasting blood glucose is less than 1, indicating that chromium picolinate and ginsenoside Rb1=1:1 have a synergistic effect on the treatment of fasting blood glucose.

[0068] Example 2 Effects of Momordica Saponin L, Anemarrhena Saponin B II and Combination on Glucose Tolerance of Type II Diabetic Mice

[0069] The establishment of the diabetic mouse model is shown in Example 1.

[0070] 2.1 Grouping and Dosing

[0071] The diabetic mice with successful modeling were randomly divided into a control group, a model group, anemarrhena saponin BII (40 mg / kg), bitter melon saponin L (40 mg / kg, 80 mg / kg, 120 mg / kg, 200 mg / kg), and a combination of bitter melon saponin L and anemarrhena saponin B II, with 10 mice in each group. The intragastric volume of each group was 10 mL / kg·BW. The timosaponin B II and momordicans L were uniformly mixed at a ratio of 1:1, 1:2, 1:3, and 1:5, and were called composition 5 (40 mg / kg timosaponin B II + 40 mg / kg momordicans L) (prepared with timosaponin B II 4 mg / mL and momordicans L 4 mg / mL, and the preparation methods of the following compositions are similar), composition 6 (40 mg / kg timosaponin B II + 80 mg / kg momordicans L), composition 7 (40 mg / kg timosaponin B II + 120 mg / kg momordicans L), composition 8 (40 mg / kg timosaponin B II + 200 mg / kg momordicans L), and the model group and the blank control group were intragastrically administered with equal doses of normal saline for 30 consecutive days.

[0072] 2.3 Index detection

[0073] After 4 weeks of administration, the mice were fasted but not watered for 12 hours, and then each group of mice was gavaged with 50% glucose solution at a dose of 2g / kg, and blood was collected from the tail vein for glucose tolerance test (OGTT). The blood glucose levels of each group of mice were measured at 0, 30, and 120 minutes after gavage with glucose solution, and the area under the curve (AUC) was calculated. The area under the blood glucose curve S (mmol / L) = (a+4b+3c) / 4, where a, b, and c are the blood glucose values ​​0, 30, and 120 minutes after gavage with glucose solution, respectively.

[0074] 2.4 Results

[0075] The effects of the above-mentioned Anemarrhena saponin B II, Momordica saponin L and the combination on glucose tolerance of diabetic mice are shown in Table 3. The combined medication index results of Compositions 5-8 on blood glucose in diabetic mice are shown in Table 4.

[0076] Table 4 Effects of Anemarrhena Saponin B II, Momordica Saponin L and the combination on glucose tolerance in mice (x±s, n=10)

[0077]

[0078] Table 4 Area under the glucose tolerance curve (AUC) T / C and CI values ​​of compositions 5-8 for diabetes

[0079] Group T / C CI Composition 5 0.743 1.006 Composition 6 0.612 0.873 Composition 7 0.524 0.692 Composition 8 0.757 1.113

[0080] From the results of Example 2 above, it can be seen that compared with the use of timosaponin B II and momordicin L alone, the composition 6 and composition 7 of the present invention can effectively improve the glucose tolerance of diabetic mice, and the combined index of the fasting blood glucose treatment effect of the two compositions on diabetic mice is less than 1. And by adjusting the weight ratio of timosaponin B and momordicin L in the composition, a better improvement effect can be achieved. Among them, the combined index of composition 7 on the improvement of glucose tolerance in diabetic mice is less than 0.7, indicating that momordicin L and timosaponin B in a weight ratio of 1:3 have a very significant synergistic effect on improving glucose tolerance. The combined index of composition 6 on glucose tolerance is less than 1, indicating that timosaponin B II: momordicin L=1:2 has a synergistic effect on improving glucose tolerance. The combined index of composition 5 and composition 8 on the improvement of glucose tolerance in diabetic mice is greater than 1, indicating that these two compositions cannot play a synergistic role.

[0081] Example 3 Protective effect of the combination of chromium picolinate, ginsenoside Rb1, momordica charantia saponin L, and anemarrhena saponin B II on the liver and pancreatic tissues of diabetic mice

[0082] Chromium picolinate, ginsenoside Rb1, timosaponin B II, and momordicin L were mixed uniformly at a ratio of 1:2.5:1:3 to form composition 9, and the dose was set to 230 mg / kg·BW (chromium picolinate 2 mg / mL, ginsenoside Rb1 5 mg / mL, timosaponin B II 4 mg / mL, momordicin L 12 mg / mL were prepared and mixed) and mice were gavaged for treatment. The gavage volume was 10 mL / kg·BW, and the model group was gavaged with an equal dose of normal saline. After continuous gavage for 30 days, the mice were killed, and the liver and pancreas of the mice were taken for HE staining and pathological sections were prepared.

[0083] In order to evaluate the effect of the combination of chromium picolinate, ginsenoside Rb1, momordica charantia saponin L, and anemarrhena saponin B II on the liver morphology of mice, the morphological changes of the liver tissues of each group of mice were detected by H&E staining. Figure 1 As shown, the hepatocytes of normal mice are arranged in lines, radiating to the surrounding central veins, and the hepatocytes are branched and anastomosed into a network. In contrast, the hepatocytes of the mice in the model group showed degenerative changes, the hepatocyte outlines were unclear, and the hepatic lobules lost their cord-like arrangement. In addition, the experimental results showed that the hepatocytes of diabetic mice had significant inflammation, irregular arrangement of hepatocytes, vacuolar fatty degeneration and fibrotic changes. After treatment with composition 9, the degenerative changes in the hepatocytes of diabetic mice were significantly alleviated, the hepatic lobules returned to a near-normal state, and inflammation and vacuolar fatty degeneration were partially restored. This shows that composition 9 can improve liver fat accumulation in diabetic mice, thereby protecting the liver.

[0084] In addition, histopathological analysis of pancreatic tissue showed that ( Figure 2 ), the islets of normal control mice were round or oval, with clear boundaries, and the islet cells were neatly arranged. The islet structure of diabetic mice was irregular, the edges were unclear, the pancreatic cells were irregularly arranged, and there was obvious vacuolar degeneration. This shows that diabetic mice did have damaged islet cells, but after treatment with composition 9, the islet cells were neatly arranged, the islet structure had clear edges, there was no adverse reaction of vacuolar degeneration, and the islet cells returned to a near normal state. This shows that composition 9 can repair the damage to islet cells, enabling them to better secrete insulin and exert a hypoglycemic effect. These results show that composition 9 can protect pancreatic damage in diabetic mice.

[0085] It should be noted that, under the premise that it is feasible and does not obviously violate the main purpose of the present invention, any technical feature or combination of technical features described as a component of a technical solution in this specification can also be applied to other technical solutions; and, under the premise that it is feasible and does not obviously violate the main purpose of the present invention, the technical features described as components of different technical solutions can also be combined in any way to form other technical solutions. The present invention also includes technical solutions obtained by combination under the above circumstances, and these technical solutions are equivalent to those recorded in this specification.

[0086] The present invention is described above through specific implementation modes and examples, but those skilled in the art should understand that these are not intended to limit the scope of the present invention, and the scope of the present invention should be determined by the claims.

[0087] Industrial Applicability

[0088] The invention provides a synergistic composition comprising chromium picolinate, ginsenoside Rb1, anemarrhena saponin B II and momordica saponin L and having a hypoglycemic effect.

Claims

1. A pharmaceutical composition with hypoglycemic effect, comprising chromium picolinate, ginsenoside Rb1, anemarrhena saponin BII and momordica saponin L and a pharmaceutically acceptable carrier; wherein: The weight ratio of chromium picolinate, ginsenoside Rb1, anemarrhena saponin B II and momordica saponin L is 1:2.5:1:3; In the pharmaceutical composition, chromium picolinate, ginsenoside Rb1, anemarrhena saponin BII and momordica saponin L are the only active ingredients for reducing blood sugar.

2. Use of the pharmaceutical composition with hypoglycemic effect according to claim 1 in the preparation of a medicament for preventing or treating diabetes.

Citation Information

Patent Citations

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