A black fungus powder composition for regulating glycolipid metabolism and a preparation method and application thereof

Abstract

The present application belongs to the technical field of traditional Chinese medicine preparation, and relates to a black ginseng powder composition for regulating glycolipid metabolism, and a preparation method and application thereof. The black ginseng powder composition for regulating glycolipid metabolism uses black ginseng powder prepared by a one-piece forming process as a medicine, and a new compound formed by the combination of the black ginseng powder, ginger, jujube, japonica rice, ophiopogon japonicus and licorice has certain effects on treating hyperlipidemia and type 2 diabetes. The black ginseng powder composition can ensure stable and reliable traditional Chinese medicine efficacy, and lay a solid foundation for efficient enrichment, extraction, separation and subsequent application of traditional Chinese medicine efficacy components.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine preparation technology, and relates to a black ginseng powder composition for regulating glucose and lipid metabolism, its preparation method and application. Background Technology

[0002] Hyperlipidemia, the most common metabolic complication of diabetes, is a major global public health issue due to the mutually reinforcing and synergistic progression of the two conditions. Clinical data shows that the incidence of hyperlipidemia in type 2 diabetes patients is as high as 60%-80%. Long-term glucose and lipid metabolism disorders not only exacerbate insulin resistance and accelerate pancreatic β-cell dysfunction, but also significantly increase the risk of serious complications such as atherosclerosis, coronary heart disease, cerebral infarction, diabetic nephropathy, and retinopathy, placing a huge burden on clinical diagnosis and treatment as well as on social healthcare.

[0003] Currently, Western medicine mainly treats diabetes and hyperlipidemia by using a combination of hypoglycemic and lipid-lowering drugs. Hypoglycemic drugs focus on controlling blood sugar levels, while lipid-lowering drugs are mainly statins and fibrates. Although they can improve blood sugar and lipid indicators in the short term, they have obvious limitations. They are difficult to regulate the entire process of blood sugar and lipid metabolism simultaneously, and long-term use can easily cause adverse reactions such as liver damage, muscle toxicity, and hypoglycemia. At the same time, they cannot solve the core problems of metabolic disorders, chronic inflammation, and intestinal flora imbalance, so the clinical efficacy is not ideal.

[0004] Traditional Chinese medicine (TCM) considers diabetic hyperlipidemia to fall under the category of "Xiao Ke" (wasting and thirsting syndrome) combined with "phlegm turbidity" and "blood stasis." Its core pathogenesis involves spleen dysfunction, liver dysfunction, internal generation of phlegm and dampness, and blood stasis obstructing the meridians. This aligns with the TCM theory of "spleen qi dispersing essence," where spleen and stomach dysfunction leads to disordered glucose and lipid metabolism. Therefore, this field anticipates the development of a drug composition that simultaneously lowers blood sugar and lipids while regulating the body's overall Qi, blood, and body fluids, which would have significant implications for the clinical treatment of diabetic hyperlipidemia. Summary of the Invention

[0005] The first objective of this invention is to provide a black ginseng powder composition that regulates glucose and lipid metabolism. The composition is obtained by decocting black ginseng powder with Ophiopogon japonicus, ginger, japonica rice, jujube and licorice in a certain proportion. It has good performance in regulating glucose and lipid metabolism and has a significant effect in treating hyperlipidemia. The second objective of this invention is to provide a method for preparing the above-mentioned black ginseng powder composition for regulating glucose and lipid metabolism. This method uses ginseng as the starting material and employs a combination of ultrasonic-normal pressure steaming-microwave time-sequential drying technology, which can increase the content of rare ginsenosides in a shorter processing time. Furthermore, it is co-decocted with Ophiopogon japonicus, ginger, japonica rice, jujube and licorice in a certain proportion. The preparation method is clear and the effect of regulating glucose and lipid metabolism is obvious. A third objective of this invention is to provide the use of the above-mentioned black ginseng powder composition with the function of regulating glucose and lipid metabolism in the preparation of a drug for treating diabetes and hyperlipidemia.

[0006] To solve the above-mentioned technical problems, the present invention provides a black ginseng powder composition for regulating glucose and lipid metabolism, the composition comprising the following components in parts by weight: 6-12 parts black ginseng powder, 30-50 parts Ophiopogon japonicus, 3-9 parts ginger, 3-9 parts licorice, 10-40 parts jujube, and 3-12 parts japonica rice. The preparation method of the black ginseng powder includes the following steps: (1) Ginseng is dried, pulverized and sieved to obtain ginseng powder; the ginseng powder is ultrasonically treated in a vacuum-sealed environment isolated from ultrasonic media to obtain the first processed product; (2) The first processed material is subjected to steaming treatment to obtain the second processed material; (3) The second processed material is subjected to microwave drying to obtain the third processed material; (4) Repeat the above steps (2)-(3) to obtain the fourth processed product; (5) The fourth processed material is dried with hot air to obtain the desired black ginseng powder.

[0007] Specifically, the black ginseng powder composition for regulating glucose and lipid metabolism includes the following components in parts by weight: 9 parts black ginseng powder, 42 parts Ophiopogon japonicus, 6 parts ginger, 6 parts licorice, 40 parts jujube, and 6 parts japonica rice.

[0008] Specifically, in the black ginseng powder composition for regulating glucose and lipid metabolism, and in the method for preparing the black ginseng powder, in step (1): The sieving step uses a sieve mesh size of 50-100 mesh; and / or, The ultrasonic frequency of the ultrasonic treatment step is 30-50 kHz; and / or, The ultrasonic power of the ultrasonic treatment step is 200-300W; and / or, The ultrasonic treatment step takes 10-60 minutes.

[0009] Specifically, in the black ginseng powder composition for regulating glucose and lipid metabolism, and in the preparation method of the black ginseng powder, in step (2): The pressure of the steaming process is atmospheric pressure; and / or, The steaming process takes 1-3 hours.

[0010] Specifically, in the black ginseng powder composition for regulating glucose and lipid metabolism, and in the preparation method of the black ginseng powder, in step (3): The pressure during the microwave drying process is atmospheric pressure; and / or, The temperature of the microwave drying process is 30-60℃; and / or, The power of the microwave drying process is 30-300W; and / or, The frequency of the microwave drying process is 2400-2500 MHz; and / or, The microwave drying process takes 1-10 minutes.

[0011] Specifically, in the method for preparing black ginseng powder, the black ginseng powder composition for regulating glucose and lipid metabolism, the number of cycles in step (4) of the repeated cycle step is 1-10 times.

[0012] Specifically, in the black ginseng powder composition for regulating glucose and lipid metabolism, and in the method for preparing the black ginseng powder, in step (5): The temperature of the hot air drying step is 50-100℃; and / or, The hot air drying step takes 1-20 hours.

[0013] The present invention also discloses the use of the black ginseng powder composition for regulating glucose and lipid metabolism in the preparation of drugs for the prevention or treatment of diabetes and hyperlipidemia.

[0014] The present invention also discloses a pharmaceutical preparation for the prevention or treatment of diabetic hyperlipidemia, wherein the active ingredient of the pharmaceutical preparation includes the black ginseng powder composition for regulating glucose and lipid metabolism.

[0015] Specifically, in the pharmaceutical preparation for the prevention or treatment of diabetic hyperlipidemia, the black ginseng powder composition that regulates glucose and lipid metabolism is used as the sole active ingredient.

[0016] This invention also discloses a method for preparing a pharmaceutical formulation for the prevention or treatment of diabetic hyperlipidemia as described above, comprising the following steps: (a) Weigh out the selected amounts of the black ginseng powder, ophiopogon japonicus, ginger, licorice, jujube and japonica rice, mix them together, add water for the first decoction treatment, and collect the first decoction and the first dregs separately after solid-liquid separation; (b) Take the first dregs and add water for a second decoction treatment, and collect the second decoction and the second dregs respectively through solid-liquid separation; (c) Combine the first and second solutions and concentrate them into an extract; (d) Add pharmaceutically acceptable excipients and process to obtain a pharmaceutically acceptable dosage form.

[0017] Specifically, in step (a), the amount of water added is 8-12 times the total amount of raw medicinal materials.

[0018] Specifically, in step (a), the temperature of the first decoction step is 90-95℃, and the decoction time is 1-3h.

[0019] Specifically, in step (b), the amount of water added is 8-12 times the total amount of raw medicinal materials.

[0020] Specifically, in step (b), the temperature of the second decoction step is 90-95℃, and the decoction time is 1-3 hours.

[0021] Specifically, the dosage forms of the pharmaceutical preparations include decoctions, tablets, granules, capsules, ointments, or liquid preparations.

[0022] The black ginseng powder composition for regulating glucose and lipid metabolism described in this invention uses black ginseng powder under specific treatment. This novel compound, formed for the first time, combines black ginseng powder prepared using an integrated molding process with ginger, jujube, japonica rice, ophiopogon japonicus, and licorice root. It has a certain effect on treating hyperlipidemia, specifically demonstrating a significant lipid-lowering effect in a hyperlipidemic hepatocyte model; and it also has a certain effect on treating type 2 diabetes, specifically demonstrating a significant hypoglycemic effect in a diabetic zebrafish model. The black ginseng powder composition of this invention ensures the stable and reliable efficacy of traditional Chinese medicine, while also laying a solid foundation for the efficient enrichment, extraction, separation, and subsequent application of the active ingredients of traditional Chinese medicine.

[0023] The black ginseng powder composition for regulating glucose and lipid metabolism described in this invention follows the principles of traditional Chinese medicine (TCM) and targets the core pathogenesis of diabetes and hyperlipidemia: "yin deficiency and blood stasis, and spleen dysfunction." The formula is simple yet synergistically effective. Black ginseng is the principal ingredient, prepared using a specific process to enrich it with rare saponins, which nourish yin and invigorate blood circulation, alleviating glucose and lipid metabolism disorders at their root. Ginger, jujube, and japonica rice are the assistant ingredients, which strengthen the spleen, resolve dampness, invigorate qi, and nourish the stomach, breaking the vicious cycle of phlegm-dampness generation and glucose-lipid accumulation. Ophiopogon japonicus is the adjuvant ingredient, assisting black ginseng in enhancing its yin-nourishing effects and improving yin deficiency symptoms. Licorice is the guiding ingredient, harmonizing the properties of all the herbs and mitigating the cloying nature of black ginseng and the warming nature of ginger. The entire formula works synergistically to achieve the effects of nourishing yin and invigorating blood circulation, strengthening the spleen and resolving dampness, and regulating both glucose and lipids. It also addresses the overall regulation of blood sugar and lipids as well as the body's qi, blood, and body fluids, making it suitable for long-term treatment.

[0024] The black ginseng powder composition for regulating glucose and lipid metabolism described in this invention contains: black ginseng powder to nourish yin and invigorate blood, and Ophiopogon japonicus to nourish yin and generate fluids, specifically improving the symptoms of "yin deficiency" and "blood stasis" in diabetes mellitus; ginger to warm the middle and resolve dampness, jujube to replenish qi and invigorate the middle, and japonica rice to strengthen the spleen and nourish the stomach, synergistically regulating the spleen and stomach's digestive function and reducing the internal generation of phlegm and dampness from the root; and licorice to invigorate qi and harmonize the other herbs. The synergistic effect of the six herbs not only conforms to the holistic treatment concept of traditional Chinese medicine, but also has been confirmed by modern research to achieve the dual effects of lowering blood sugar and lipids simultaneously through mechanisms such as regulating PI3K / AKT signaling pathways, improving intestinal flora homeostasis, and inhibiting inflammatory responses. At the same time, it reduces the burden on the pancreas and liver, has high safety and few adverse reactions, is suitable for long-term use, and can effectively make up for the shortcomings of single treatment in Western medicine.

[0025] The black ginseng powder composition for regulating glucose and lipid metabolism described in this invention is formulated in accordance with clinical pathogenesis: black ginseng is combined with Ophiopogon japonicus, ginger, jujube, japonica rice and licorice to nourish yin, strengthen the spleen and harmonize the stomach. It can simultaneously regulate blood sugar and blood lipids, improve insulin resistance, and relieve symptoms such as physical weakness and spleen and stomach disharmony in patients with chronic diseases, resulting in a more comprehensive overall conditioning effect.

[0026] The black ginseng powder composition for regulating glucose and lipid metabolism described in this invention aligns with the research hotspots and clinical needs of glucose and lipid metabolism diseases over the past decade. It can efficiently promote glucose consumption and inhibit triglyceride production, with significant effects. It has important clinical value and social significance for optimizing comprehensive prevention and treatment programs for diabetes and hyperlipidemia, reducing the risk of complications, and improving patients' quality of life.

[0027] The black ginseng powder composition for regulating glucose and lipid metabolism described in this invention is not only technologically stable, with clearly defined activity and controllable components, but also provides a new raw material option for developing efficient and safe hypoglycemic and lipid-lowering drugs or health foods. It improves the high-value utilization level of black ginseng and has positive significance for promoting the development of black ginseng and related health industries.

[0028] The black ginseng powder composition of this invention is the first to be processed using a self-developed new technology. This processing method differs from the traditional "nine steaming and nine drying" method for black ginseng, and is simple and efficient, greatly saving processing time. This processing method allows for a shift in the focus of efficacy from ginseng to black ginseng, providing a basis for the new compound formula to regulate glucose and lipid metabolism. It is a key raw material for the new compound formula to exert its glucose and lipid metabolism regulation effect. Furthermore, this processing method is controllable, ensuring the consistency of black ginseng processing quality and providing stable raw material support for the experimental research and subsequent application of the new compound formula.

[0029] The method for preparing black ginseng described in this invention uses dried ginseng as the starting material. After vacuum-sealed ultrasonic pretreatment, it employs a combination of atmospheric pressure steaming and microwave forced-air drying technology. By rationally controlling the process conditions, the resulting black ginseng is rich in ginsenosides S-Rh1, Rk1, Rg5, and F4, with a total content far exceeding that of ordinary ginseng by 10-20 times, greatly increasing the content of rare ginsenosides S-Rh1, Rk1, Rg5, and F4 in ginseng.

[0030] The method for preparing black ginseng described in this invention is adapted to the conversion pattern of ginsenosides during the processing of black ginseng. Because the conversion of ginsenosides during the processing of black ginseng is not a single, constant-rate reaction, but rather exhibits a phased progression under humid heat, based on the cumulative effects of reaction temperature, water activity, and reaction time—that is, the early stage is dominated by hydrolysis of the sugar chain ends, the middle stage by the breaking of the C-20 glycosidic bond, and the later stage is accompanied by dehydration and rearrangement reactions. The method described in this invention combines ultrasound, steaming, and microwave drying in a sequential series to form a "three-stage sequential" processing method. Differentiated physical fields are applied to different stages of the processing to improve the content of rare saponins, effectively overcoming the shortcomings of traditional processes that often use constant steaming temperatures or repeated drying methods, resulting in long processing times and significant loss of effective components.

[0031] The method for preparing black ginseng described in this invention, compared with the traditional "nine steaming and nine sun-drying" method for processing black ginseng, shortens the overall processing time by 5-10 times. It features a simple, linear process, eliminates the need for high-pressure equipment, significantly reduces processing time, and prevents the loss of effective components. It greatly increases the content of rare saponins and avoids the drawbacks of repeated processing of the same steps in the traditional "nine steaming and nine sun-drying" process. This lays the foundation for subsequent research on black ginseng and provides new ideas for the extraction and application of active ingredients from other traditional Chinese medicines.

[0032] The method for preparing black ginseng with increased content of rare ginsenosides described in this invention is the first to adopt a combination of ultrasonic pretreatment followed by atmospheric pressure steaming and microwave forced-air drying. This novel and efficient preparation method is expected to promote the development of the ginseng industry, enhance the competitiveness of ginseng products in the market, bring more business opportunities to the ginseng industry in Northeast China, thereby promoting the development of local specialty industries and boosting economic growth.

[0033] The method for preparing black ginseng with increased content of rare ginsenosides described in this invention can provide new ideas and reference examples for the research and production of other traditional Chinese medicines, as well as for quality standard research. The research method is simple and quick, the operation process is easy to understand, requires no complex equipment or cumbersome steps, and has low cost. It is suitable for large-scale market applications as well as for general individual operation. Attached Figure Description

[0034] To make the content of this invention easier to understand, the invention will be further described in detail below with reference to specific embodiments and accompanying drawings, wherein... Figure 1 The image shows the HPLC analysis chromatogram of the black ginseng powder obtained by the method in Example 1; where 1-4 represent ginsenosides S-Rh1, F4, Rk1, and Rg5, respectively. Figure 2 The results show the effect of different concentrations of the compositions from Experimental Example 1 and Comparative Example 1 on the GLU values ​​of diabetic zebrafish. Figure 3 The effect of different concentrations of the composition of Experimental Example 1 and Comparative Example 1 on the survival rate of HepG2 cells; Figure 4 The study investigated the effect of different concentrations of the composition used in Experimental Example 1 and Comparative Example 1 on the inhibition of intracellular TG secretion in HepG2 hepatocyte lipid accumulation models. Detailed Implementation

[0035] To better understand the purpose, features, structure, and materials of this invention, the present invention will be described in further detail below with reference to the accompanying drawings. All other embodiments obtained by those skilled in the art based on the embodiments in this application without inventive effort are within the scope of protection of this application.

[0036] In the following embodiments of the present invention, a black ginseng powder composition for regulating glucose and lipid metabolism is provided. The composition comprises the following components in parts by weight: 6-12 parts black ginseng powder, 30-50 parts Ophiopogon japonicus, 3-9 parts ginger, 3-9 parts licorice, 10-40 parts jujube, and 3-12 parts japonica rice. The preparation method of the black ginseng powder includes the following steps: (1) Ginseng is dried, pulverized and sieved to obtain ginseng powder; the ginseng powder is ultrasonically treated in a vacuum-sealed environment isolated from ultrasonic media to obtain the first processed product; (2) The first processed material is subjected to steaming treatment to obtain the second processed material; (3) The second processed material is subjected to microwave drying to obtain the third processed material; (4) Repeat the above steps (2)-(3) to obtain the fourth processed product; (5) The fourth processed material is dried with hot air to obtain the desired black ginseng powder.

[0037] As a preferred embodiment, the composition comprises the following components in parts by weight: 9 parts black ginseng powder, 42 parts Ophiopogon japonicus, 6 parts ginger, 6 parts licorice, 40 parts jujube, and 6 parts japonica rice.

[0038] As an exemplary embodiment, the present invention provides a method for preparing black ginseng powder with high efficiency in increasing the content of rare ginsenosides S-Rh1, Rk1, Rg5, and F4 in the following embodiments, comprising the following steps: (1) After drying the ginseng, it is pulverized and passed through a 50-100 mesh sieve to obtain ginseng powder; the ginseng powder is placed in a vacuum bag, vacuumed and sealed, and then ultrasonically treated to obtain the first processed product; (2) The first treated material after ultrasound was placed in a steam oven and steamed under normal pressure to obtain the second treated material; (3) The steamed second processed material is placed in a microwave drying oven for microwave drying to obtain the third processed material; (4) Repeat steps (2) and (3) above 1-10 times to obtain the fourth processed product; (5) The fourth processed material is dried with hot air to obtain the final product.

[0039] In the following embodiments of the present invention, a pharmaceutical preparation for the prevention or treatment of diabetic hyperlipidemia is also provided, wherein the active ingredient of the pharmaceutical preparation includes the black ginseng powder composition for regulating glucose and lipid metabolism.

[0040] In some specific embodiments, the pharmaceutical preparation for preventing or treating diabetic hyperlipidemia uses the black ginseng powder composition that regulates glucose and lipid metabolism as the sole active ingredient.

[0041] The present invention also provides a method for preparing a pharmaceutical preparation for preventing or treating diabetic hyperlipidemia as described in the following embodiments, comprising the following steps: (a) Weigh out the selected amounts of the black ginseng powder, ophiopogon japonicus, ginger, licorice, jujube and japonica rice, mix them together, add water for the first decoction treatment, and collect the first decoction and the first dregs separately after solid-liquid separation; (b) Take the first dregs and add water for a second decoction treatment, and collect the second decoction and the second dregs respectively through solid-liquid separation; (c) Combine the first and second solutions and concentrate them into an extract; (d) Add pharmaceutically acceptable excipients and process to obtain a pharmaceutically acceptable dosage form.

[0042] As an exemplary embodiment, the present invention provides a method for preparing the pharmaceutical preparation for preventing or treating diabetic hyperlipidemia in the following embodiments, comprising the following steps: (a) Weigh out the selected amount of black ginseng powder, ophiopogon japonicus, ginger, licorice, jujube and japonica rice, mix them together, put them in a decoction pot, add 8-12 times the amount of water, and decoct at 90-95℃ for 1-3 hours. After filtration, collect the first decoction and the first dregs respectively. (b) Place the first dregs in a decoction pot, add 8-12 times the amount of water, and decoct at 90-95℃ for 1-3 hours. After filtration, collect the second decoction and the second dregs respectively. (c) Combine the first and second solutions and concentrate them into an extract; (d) Add pharmaceutically acceptable excipients and process according to conventional processes to obtain a pharmaceutically acceptable dosage form, such as decoction, tablet, granule, capsule, ointment or liquid preparation.

[0043] In the following preparation examples and embodiments of the present invention, 5-year-old ginseng is selected, with a cylindrical taproot, 6-10 cm long, grayish-yellow in color, with longitudinal wrinkles and annular markings, 2-3 lateral roots, few and slender fibrous roots, prominent tubercles, and a slender rhizome with stem scars and adventitious roots. The selected ginseng is carefully washed and dried for later use.

[0044] Preparation Example 1 The preparation method of black ginseng powder described in this example includes the following steps: (1) Take ginseng and clean, dry and crush it. Pass it through a 50-mesh sieve to obtain ginseng powder. Place the ginseng powder in a vacuum bag, vacuum and seal it, and then perform ultrasonic treatment for 55 minutes. Adjust the ultrasonic frequency to 40KHz and the ultrasonic power to 240W to obtain the first processed product. (2) The first processed material is placed in a steamer and steamed at normal pressure for 2 hours to obtain the second processed material; (3) Place the second processed material in a microwave drying oven and microwave dry it for 7 minutes. Adjust the microwave temperature to 40°C, microwave power to 140W, and microwave frequency to 2450MHz to obtain the third processed material. (4) Repeat the above steps (2)-(3) 7 times, that is, perform a total of 8 steaming-microwave drying processes to obtain the fourth processed product; (5) The fourth processed material is dried with hot air at 95°C for 8 hours to obtain the desired black ginseng powder.

[0045] Preparation Example 2 The preparation method of black ginseng powder described in this example includes the following steps: (1) Take ginseng and clean, dry and crush it. Pass it through a 50-mesh sieve to obtain ginseng powder. Place the ginseng powder in a vacuum bag, vacuum and seal it, and then perform ultrasonic treatment for 55 minutes. Adjust the ultrasonic frequency to 40KHz and the ultrasonic power to 240W to obtain the first processed product. (2) The first processed material is placed in a steamer and steamed at normal pressure for 2 hours to obtain the second processed material; (3) Place the second processed material in a microwave drying oven and microwave dry it for 7 minutes. Adjust the microwave temperature to 40°C, microwave power to 140W, and microwave frequency to 2450MHz to obtain the third processed material. (4) Repeat the above steps (2)-(3) 5 times, that is, perform a total of 6 steaming-microwave drying processes to obtain the fourth processed product; (5) The fourth processed material is dried with hot air at 95°C for 8 hours to obtain the desired black ginseng powder.

[0046] Preparation Example 3 The preparation method of black ginseng powder described in this example includes the following steps: (1) Take ginseng and clean, dry and crush it. Pass it through a 50-mesh sieve to obtain ginseng powder. Place the ginseng powder in a vacuum bag, vacuum and seal it, and then perform ultrasonic treatment for 55 minutes. Adjust the ultrasonic frequency to 40KHz and the ultrasonic power to 240W to obtain the first processed product. (2) The first processed material is placed in a steamer and steamed at normal pressure for 2 hours to obtain the second processed material; (3) Place the second processed material in a microwave drying oven and microwave dry it for 7 minutes. Adjust the microwave temperature to 40°C, microwave power to 140W, and microwave frequency to 2450MHz to obtain the third processed material. (4) Repeat the above steps (2)-(3) 3 times, that is, perform a total of 4 steaming-microwave drying processes to obtain the fourth processed product; (5) The fourth processed material is dried with hot air at 95°C for 8 hours to obtain the desired black ginseng powder.

[0047] Preparation Example 4 The preparation method of black ginseng powder described in this example includes the following steps: (1) Take ginseng and clean, dry and crush it. Pass it through a 100-mesh sieve to obtain ginseng powder. Place the ginseng powder in a vacuum bag, vacuum and seal it, and then perform ultrasonic treatment for 55 minutes. Adjust the ultrasonic frequency to 40KHz and the ultrasonic power to 240W to obtain the first processed product. (2) The first processed material is placed in a steamer and steamed at normal pressure for 2 hours to obtain the second processed material; (3) Place the second processed material in a microwave drying oven and microwave dry it for 7 minutes. Adjust the microwave temperature to 40°C, microwave power to 140W, and microwave frequency to 2450MHz to obtain the third processed material. (4) Repeat the above steps (2)-(3) 5 times, that is, perform a total of 6 steaming-microwave drying processes to obtain the fourth processed product; (5) The fourth processed material is dried with hot air at 95°C for 8 hours to obtain the desired black ginseng powder.

[0048] Preparation Example 5 The preparation method of black ginseng powder described in this example includes the following steps: (1) Take ginseng and clean, dry and crush it. Pass it through an 80-mesh sieve to obtain ginseng powder. Place the ginseng powder in a vacuum bag, seal it after vacuuming, and perform ultrasonic treatment for 35 minutes. Adjust the ultrasonic frequency to 45KHz and the ultrasonic power to 270W to obtain the first processed product. (2) The first processed material is placed in a steamer and steamed at atmospheric pressure for 1.5 hours to obtain the second processed material; (3) Place the second processed material in a microwave drying oven and microwave dry it for 5 minutes. Adjust the microwave temperature to 30°C, microwave power to 145W, and microwave frequency to 2450MHz to obtain the third processed material. (4) Repeat the above steps (2)-(3) 6 times, that is, perform a total of 7 steaming-microwave drying processes to obtain the fourth processed product; (5) The fourth processed material is dried with hot air at 75°C for 10 hours to obtain the desired black ginseng powder.

[0049] Preparation Example 6 The preparation method of black ginseng powder described in this example includes the following steps: (1) Take ginseng and clean, dry and crush it. Use a 50-mesh sieve to obtain ginseng powder. Place the ginseng powder in a vacuum bag, vacuum and seal it, and then perform ultrasonic treatment for 25 minutes. Adjust the ultrasonic frequency to 35KHz and the ultrasonic power to 220W to obtain the first processed product. (2) The first processed material is placed in a steamer and steamed at normal pressure for 2.5 hours to obtain the second processed material; (3) Place the second processed material in a microwave drying oven and microwave dry it for 3 minutes. Adjust the microwave temperature to 60°C, microwave power to 120W, and microwave frequency to 2450MHz to obtain the third processed material. (4) Repeat the above steps (2)-(3) 9 times, that is, perform a total of 10 steaming-microwave drying processes to obtain the fourth processed product; (5) The fourth processed material is dried with hot air at 100°C for 3 hours to obtain the desired black ginseng powder.

[0050] Preparation Example 7 The preparation method of black ginseng powder described in this example includes the following steps: (1) Take ginseng and clean, dry and crush it. Pass it through a 50-mesh sieve to obtain ginseng powder. Place the ginseng powder in a vacuum bag, seal it after vacuuming, and perform ultrasonic treatment for 10 minutes. Adjust the ultrasonic frequency to 30KHz and the ultrasonic power to 200W to obtain the first processed product. (2) The first processed material is placed in a steamer and steamed at normal pressure for 3 hours to obtain the second processed material; (3) Place the second processed material in a microwave drying oven and microwave dry it for 1 minute. Adjust the microwave temperature to 40°C, microwave power to 100W, and microwave frequency to 2450MHz to obtain the third processed material. (4) Repeat the above steps (2)-(3) 5 times, that is, perform a total of 6 steaming-microwave drying processes to obtain the fourth processed product; (5) The fourth processed material is dried with hot air at 50°C for 9 hours to obtain the desired black ginseng powder.

[0051] Preparation Example 8 The preparation method of black ginseng powder described in this example includes the following steps: (1) Take ginseng and clean, dry and crush it. Pass it through a 100-mesh sieve to obtain ginseng powder. Place the ginseng powder in a vacuum bag, seal it after vacuuming, and perform ultrasonic treatment for 60 minutes. Adjust the ultrasonic frequency to 50KHz and the ultrasonic power to 300W to obtain the first processed product. (2) The first processed material is placed in a steamer and steamed at normal pressure for 1 hour to obtain the second processed material; (3) Place the second processed material in a microwave drying oven and microwave dry it for 10 minutes. Adjust the microwave temperature to 50°C, microwave power to 200W, and microwave frequency to 2450MHz to obtain the third processed material. (4) Repeat the above steps (2)-(3) once, that is, perform the steaming-microwave drying process twice to obtain the fourth processed product; (5) The fourth processed material is dried with hot air at 100°C for 1 hour to obtain the desired black ginseng powder.

[0052] Comparative Preparation Example 1 This comparative preparation example uses dried ginseng that has not undergone any treatment, as described in Preparation Example 1.

[0053] Comparative Preparation Example 2 The preparation method of black ginseng powder described in this comparative preparation example includes the following steps: (1) Take ginseng and clean, dry and crush it. Pass it through a 50-mesh sieve to obtain ginseng powder. Place the ginseng powder in a vacuum bag, vacuum and seal it, and then perform ultrasonic treatment for 55 minutes. Adjust the ultrasonic frequency to 40KHz and the ultrasonic power to 240W to obtain the first processed product. (2) The first processed material is placed in a steamer and steamed at normal pressure for 16 hours to obtain the second processed material; (3) Place the second processed material in a microwave drying oven and microwave dry it for 7 minutes. Adjust the microwave temperature to 40°C, microwave power to 140W, and microwave frequency to 2450MHz to obtain the third processed material. (4) The third processed material is dried with hot air at 95°C for 8 hours to obtain the desired black ginseng powder.

[0054] Comparative preparation example 3 The preparation method of black ginseng powder described in this comparative preparation example includes the following steps: (1) Take ginseng and clean, dry and crush it. Pass it through a 50-mesh sieve to obtain ginseng powder. Place the ginseng powder in an ultrasonic machine and ultrasonically treat it for 20 minutes. Adjust the ultrasonic frequency to 40KHz and the ultrasonic power to 240W to obtain the first processed product. (2) The first processed material is placed in a steamer and steamed at normal pressure for 12 hours to obtain the second processed material; (3) The second processed material is dried with hot air at 80°C for 8 hours to obtain the desired black ginseng powder.

[0055] Comparative preparation example 4 The preparation method of black ginseng powder described in this comparative preparation example includes the following steps: (1) Take ginseng and clean, dry and crush it. Pass it through a 50-mesh sieve to obtain ginseng powder. Place the ginseng powder in a steamer and steam it under normal pressure for 12 hours to obtain the first processed product. (2) The first processed material is dried with hot air at 80°C for 8 hours to obtain the desired black ginseng powder.

[0056] Comparative preparation example 5 The preparation method of the black ginseng powder in this comparative preparation example is the same as that in preparation example 1, except that the order of the ultrasonic treatment and steaming treatment is reversed. Specifically, it includes the following steps: (1) Take ginseng and clean, dry and crush it. Pass it through a 50-mesh sieve to obtain ginseng powder. Place the ginseng powder in a steamer and steam it under normal pressure for 2 hours to obtain the first processed product. (2) Place the first processed material in a vacuum bag, evacuate and seal it, and perform ultrasonic treatment for 55 minutes. Adjust the ultrasonic frequency to 40KHz and the ultrasonic power to 240W to obtain the second processed material. (3) Place the second processed material in a microwave drying oven and microwave dry it for 7 minutes. Adjust the microwave temperature to 40°C, microwave power to 140W, and microwave frequency to 2450MHz to obtain the third processed material. (4) Repeat steps (1) and (3) above 7 times, that is, perform the steaming-microwave drying process a total of 8 times; (5) The third processed material is dried with hot air at 95°C for 8 hours to obtain the desired black ginseng powder.

[0057] Comparative preparation example 6 The preparation method of the black ginseng powder in this comparative preparation example is the same as that in preparation example 1, except that the microwave drying step is omitted. Specifically, it includes the following steps: (1) Take ginseng and clean, dry and crush it. Pass it through a 50-mesh sieve to obtain ginseng powder. Place the ginseng powder in a vacuum bag, vacuum and seal it, and then perform ultrasonic treatment for 55 minutes. Adjust the ultrasonic frequency to 40KHz and the ultrasonic power to 240W to obtain the first processed product. (2) The first processed material is placed in a steamer and steamed at normal pressure for 2 hours to obtain the second processed material; (3) Allow the second processed material to cool naturally to obtain the third processed material; (4) Repeat the above steps (2)-(3) 7 times, that is, perform a total of 8 steaming-cooling processes to obtain the fourth processed product; (5) The fourth processed material is dried with hot air at 95°C for 8 hours to obtain the desired black ginseng powder.

[0058] Comparative preparation example 7 The preparation method of the black ginseng powder in this comparative preparation example is the same as that in preparation example 1. The only difference is that the microwave drying step in step (3) is omitted, and microwave drying is used to fully dry the powder in step (5). Specifically, the following steps are included: (1) Take ginseng and clean, dry and crush it. Pass it through a 50-mesh sieve to obtain ginseng powder. Place the ginseng powder in a vacuum bag, vacuum and seal it, and then perform ultrasonic treatment for 55 minutes. Adjust the ultrasonic frequency to 40KHz and the ultrasonic power to 240W to obtain the first processed product. (2) The first processed material is placed in a steamer and steamed at normal pressure for 2 hours to obtain the second processed material; (3) Allow the second processed material to cool naturally to obtain the third processed material; (4) Repeat the above steps (2)-(3) 7 times, that is, perform a total of 8 steaming-cooling processes to obtain the fourth processed product; (5) The fourth processed material is microwave dried until the moisture content of black ginseng reaches the required level, thus obtaining the desired black ginseng powder.

[0059] Comparative Preparation Example 8 The preparation method of the black ginseng powder in this comparative preparation example is the same as that in preparation example 1, except that the ginseng is directly subjected to long-term steaming and microwave drying, while omitting the domestication step. The specific steps include the following: (1) Take ginseng and clean, dry and crush it. Pass it through a 50-mesh sieve to obtain ginseng powder. Place the ginseng powder in a vacuum bag, vacuum and seal it, and then perform ultrasonic treatment for 55 minutes. Adjust the ultrasonic frequency to 40KHz and the ultrasonic power to 240W to obtain the first processed product. (2) The first processed material is placed in a steamer and steamed at normal pressure for 18 hours to obtain the second processed material; (3) Place the second processed material in a microwave drying oven and microwave dry it for 8 minutes. Adjust the microwave temperature to 40°C, microwave power to 140W, and microwave frequency to 2450MHz to obtain the third processed material. (5) The third processed material is dried with hot air at 95°C for 8 hours to obtain the desired black ginseng powder.

[0060] Example 1 The black ginseng powder composition for regulating glucose and lipid metabolism described in this embodiment includes the following components: 9g of black ginseng powder (Preparation Example 1), 42g of Ophiopogon japonicus, 6g of ginger, 6g of japonica rice, 40g of jujube, and 6g of licorice.

[0061] Weigh out the above-mentioned black ginseng powder, Ophiopogon japonicus, ginger, japonica rice, jujube, and licorice root, and place them in a decoction pot. Add water equal to 10 times the total mass of the raw herbs, and then decoct at 92°C for 1.5 hours. Filter and collect the first decoction and the first dregs separately. Place the first dregs in a decoction pot, add water equal to 10 times the total mass of the raw herbs, and decoct at 92°C for 1 hour. Filter and collect the second decoction and the second dregs separately. Combine the first and second decoctions, and concentrate them into an extract to obtain the final product.

[0062] Example 2 The black ginseng powder composition for regulating glucose and lipid metabolism described in this embodiment includes the following components: 6g of black ginseng powder (Preparation Example 2), 50g of Ophiopogon japonicus, 3g of ginger, 12g of japonica rice, 10g of jujube, and 9g of licorice.

[0063] Weigh out the above-mentioned black ginseng powder, Ophiopogon japonicus, ginger, japonica rice, jujube, and licorice root, and place them in a decoction pot. Add water equal to eight times the total mass of the raw herbs, and then decoct at 90°C for 1 hour. After filtration, collect the first decoction and the first dregs separately. Place the first dregs in a decoction pot, add water equal to eight times the total mass of the raw herbs, and decoct at 90°C for 3 hours. After filtration, collect the second decoction and the second dregs separately. Combine the first and second decoctions, and concentrate them into an extract to obtain the final product.

[0064] Example 3 The black ginseng powder composition for regulating glucose and lipid metabolism described in this embodiment includes the following components: 12g black ginseng powder (Preparation Example 2), 30g Ophiopogon japonicus, 9g ginger, 3g japonica rice, 40g jujube, and 3g licorice.

[0065] Weigh out the above-mentioned black ginseng powder, Ophiopogon japonicus, ginger, japonica rice, jujube, and licorice root, and place them in a decoction pot. Add water equal to 12 times the total mass of the raw herbs, and then decoct at 95°C for 3 hours. After filtration, collect the first decoction and the first dregs separately. Place the first dregs in a decoction pot, add water equal to 12 times the total mass of the raw herbs, and decoct at 95°C for 1 hour. After filtration, collect the second decoction and the second dregs separately. Combine the first and second decoctions, and concentrate them into an extract to obtain the final product.

[0066] Comparative Example 1 The composition described in this comparative example comprises the following components: 9g of ginseng powder (the same untreated raw ginseng powder as in Preparation Example 1), 42g of Ophiopogon japonicus, 6g of ginger, 6g of japonica rice, 40g of jujube, and 6g of licorice.

[0067] Weigh out the ginseng powder, ophiopogon japonicus, ginger, japonica rice, jujube, and licorice root, and place them in a decoction pot. Add water equal to 10 times the total mass of the raw herbs, and then decoct at 92°C for 1.5 hours. Filter and collect the first decoction and the first dregs separately. Place the first dregs in a decoction pot, add water equal to 10 times the total mass of the raw herbs, and decoct at 92°C for 1 hour. Filter and collect the second decoction and the second dregs separately. Combine the first and second decoctions, and concentrate them into an extract to obtain the final product.

[0068] Experimental Example 1. Detection of ginsenoside content In this experimental example, the ginsenoside content of the black ginseng powder prepared under the above preparation examples 1-4 and comparative preparation examples 1-8 was detected.

[0069] In this experimental example, high performance liquid chromatography was used to detect the content of rare ginsenosides such as S-Rh1, Rk1, Rg5, and F4 in the black ginseng.

[0070] As a feasibility testing method, in this experimental example, the ginsenoside reference standards S-Rh1, Rk1, Rg5, and F4 in the high-performance liquid chromatography detection method were developed by Efavi Biotechnology, and their batch numbers and specifications are shown in Table 1 below.

[0071] Table 1. Batch Numbers and Specifications of Ginsenoside Reference Standards

[0072] Preparation of test solution After accurately weighing the processed samples and pulverizing them into fine powder, accurately weigh 1g of each sample and add 20mL of 70% methanol solution for ultrasonic extraction for 60 minutes. After ultrasonic extraction, centrifuge at 1200r / min for 3min, collect the supernatant, evaporate to dryness in an 80℃ water bath, weigh the alcohol extract, add methanol solution, shake well to prepare a 20mg / ml solution, and filter through a 0.22μm microporous membrane to obtain the final product.

[0073] Preparation of reference solution Ginsenoside S-Rh1, ginsenoside Rg5, ginsenoside Rk1, and ginsenoside F4 reference standards were accurately weighed and added to chromatographic methanol to prepare a mixed reference solution of ginsenoside detection components. After gradual dilution with methanol, the mass concentrations obtained were 1, 0.5, 0.25, 0.125, 0.0625, 0.03125, 0.015625, 0.078125, 0.0390625, and 0.01953125 mg / mL, respectively, which were used to plot standard curves with different mass concentration gradients.

[0074] Chromatographic conditions The instrument used an Agilent SB-C18 column (100 mm × 4.6 mm, 1.8 μm); the mobile phase was 0.1% formic acid water (A) - acetonitrile (B), the elution gradient program is shown in Table 2 below, the flow rate was 0.3 mL / min; the column temperature was 30 ℃, and the injection volume was 10 μL.

[0075] Table 2 Elution gradient for high performance liquid chromatography

[0076] High performance liquid chromatography detection Under the above chromatographic conditions, the reference standard and black ginseng sample were injected and analyzed.

[0077] In this experimental example, the HPLC analysis chromatogram of the black ginseng powder obtained by the method in Preparation Example 1 above is attached. Figure 1 The above; wherein, 1-4 represent ginsenosides S-Rh1, F4, Rk1, and Rg5, respectively.

[0078] The results of ginsenoside content in black ginseng prepared by each scheme in this experiment are shown in Table 3 below.

[0079] Table 3. Content of ginsenosides S-Rh1, Rk1, Rg5, and F4 in black ginseng powder

[0080] Calculations show that the black ginseng prepared by the method of this invention contains 0.06%, 0.16%, 0.11%, and 0.04% rare ginsenosides S-Rh1, Rk1, Rg5, and F4, respectively, and the total content of rare ginsenosides reaches 0.37%, which is 5-20 times that of the initial ginseng powder.

[0081] 2. Determination of the color value of black ginseng In this experimental example, the light source selected was CIE (International Commission on Illumination) approved D65 light (natural light, color temperature 6504K), the measurement mode was reflected light, the measurement field of view was 10°, and the measurement aperture was 4mm. The measurement space was L. a b and E ab, where E ab = (L) 2 +a 2 +b 2 ) 1 / 2 After calibration with a black and white blank plate, 1.00 g of black ginseng powder obtained from Preparation Examples 1-3 and Comparative Preparation Examples 1-2 were weighed out sequentially, evenly spread in a colorimetric plate, leveled, and the plate was properly installed to prevent the powder from moving around. The L value was then measured sequentially. a b Value and record, and calculate the total chromaticity value E. ab. Each sample was measured three times, and the average value was recorded. The results are shown in Table 4 below.

[0082] Table 4. Determination of colorimetric values ​​of black ginseng powder

[0083] As can be seen from the data in Table 4, compared with unprocessed ginseng, the chromaticity value of the black ginseng described in this invention is significantly reduced by 2-4 times, and the chromaticity value is in the range of 20-30, with the color becoming significantly darker.

[0084] 3. Hypoglycemic activity test Experimental animals: Zebrafish (3 months old, type AB, Nanjing EzeRinka Biotechnology Co., Ltd.). Zebrafish were housed separately by sex in aquariums equipped with lighting and heating devices, with the water temperature controlled at 28.5℃ and a 14-hour light / 10-hour dark cycle. Zebrafish embryo reproduction was carried out through natural mating. Male and female zebrafish were placed in each spawning box at a 2:1 ratio. Eggs were collected within 2 hours of spawning and incubated at a constant temperature of 28.5℃. The water was changed every 24 hours, and egg membranes and dead eggs were removed. Zebrafish fry hatched after 3 days.

[0085] Establishing a diabetic zebrafish model: Fifteen wild-type AB strain zebrafish juveniles with normal development (5 dpf) were taken and given 5 mL of zebrafish culture water containing 0.08 mM ALX (tetraoxine).

[0086] This experiment investigated the effect of different concentrations of the compositions in Example 1 and Comparative Example 1 on the GLU value of diabetic zebrafish.

[0087] A diabetic model was induced in wild-type AB strain zebrafish (5 dpf growth rate) by administering 5 mL of zebrafish culture water containing 0.08 mM ALX. The established diabetic zebrafish were then randomly divided into 7 groups: a model group, a treatment group, and a positive control group, with 3 replicates per group and 15 fish per replicate. The fish were incubated for 24 h with the compositions of Example 1 and Comparative Example 1 at concentrations of 0 μg / mL, 400 μg / mL, 200 μg / mL, and 100 μg / mL, respectively, or with 400 μg / mL ACA (acarbose). A blank control group was simultaneously incubated with 0 mM ALX for 24 h. At the end of the experiment, 10 fish from each replicate were homogenized in 120 μL of phosphate buffered saline solution for GLU content determination.

[0088] Detection method: Take an appropriate amount of phosphate buffer solution into a 1.5 mL centrifuge tube containing fish, homogenize for 1 min using a high-speed handheld homogenizer until the fish tissue is fully lysed, and then centrifuge at 9000 rpm for 20 min at 4℃. After the centrifugation, take 20 μL of the supernatant sample and determine the GLU concentration using a GLU detection kit (GLU oxidase method). The determination procedure and method shall be performed in accordance with the steps specified in the kit instructions.

[0089] (5) Statistical analysis: All experimental data were initially processed using Excel 2016 and then plotted using Graphpad Prism 9.5. One-way ANOVA was performed using SPSS Statistics 17.0. All data are presented as mean ± standard deviation. The significance of differences was determined using Duncan analysis and multiple comparisons were performed. p < 0.05 indicated a significant difference between groups.

[0090] In this experimental example, the effects of different concentrations of the compositions of Example 1 and Comparative Example 1 on the GLU values ​​of diabetic zebrafish are shown in the appendix. Figure 2 As shown.

[0091] As can be seen, in the zebrafish hyperglycemia model, the glucose level in the model group was significantly elevated, while the composition in Example 1 of this invention exhibited a clear dose-dependent hypoglycemic effect. Compared with the model group, at a high dose (400 μg / mL), the glucose level of zebrafish treated with the composition in Example 1 decreased by 54%, while the decrease was only 13% after treatment with the composition in Comparative Example 1; at a medium dose (200 μg / mL), the glucose level decreased by 36% after treatment with the composition in Example 1, while the decrease was only 19% after treatment with the composition in Comparative Example 1; at a low dose (100 μg / mL), the glucose level decreased by 17% after treatment with the composition in Example 1, while the decrease was only 5% after treatment with the composition in Comparative Example 1.

[0092] Statistical differences showed that the composition in Example 1 of the present invention exhibited a significant hypoglycemic effect in all dosage groups (high dose group p<0.0001, medium dose group p<0.001, low dose group p<0.01), and its effect on improving glucose metabolism was significantly better than that of the composition in Comparative Example 1. Moreover, the hypoglycemic effect of the high dose group was even better than that of the positive control ACA group.

[0093] The above results indicate that the composition of the present invention can effectively reduce glucose levels in zebrafish models, and its hypoglycemic activity is more prominent than that of the untreated ginseng group, suggesting that it has significant advantages in improving glucose metabolism disorders.

[0094] 4. Cell proliferation-toxicity detection This experimental example is based on the cell proliferation-toxicity test of the compositions in Example 1 and Comparative Example 1.

[0095] Hepg2 cells were placed in a culture medium containing 90% DMEM, 10% fetal bovine serum, and 0.1% penicillin and streptomycin, and cultured in an incubator at 37°C, 5% CO2, and saturated humidity. Cell morphology and density were observed every 24 hours using an inverted microscope. When the cell morphology was normal and the density reached more than 80%, the culture medium was aspirated, the cells were gently washed once with pH 7.4 phosphate buffer, the medium was discarded, and the cells were digested with trypsin. After the digestion was stopped with serum, the cells were gently pipetted and passaged.

[0096] Cells in the logarithmic growth phase were respectively injected with 1×10 4Cells were seeded at a concentration of [number] cells / well in 96-well plates and divided into groups. Blank group: normal culture medium; Drug-treated groups: fresh culture medium supplemented with different concentrations of black ginseng powder composition, at concentrations of 900 μg / mL, 600 μg / mL, 300 μg / mL, 100 μg / mL, and 50 μg / mL, respectively. Control group: cell-free normal culture medium. After 24 h of culture, the supernatant was discarded, and 10% CCK8 was added. After 20 min, the absorbance (A) was measured at 450 nm using an ELISA reader. Cell viability was calculated using the following formula: Cell survival rate % = .

[0097] This experiment used the CCK-8 assay to evaluate the survival status of HepG2 cells under different concentrations of intervention. The results are shown in the attached figure. Figure 3 It is evident that treatment at concentrations of 100, 300, and 600 μg / mL for 24 h did not adversely affect cell proliferation and survival, demonstrating good in vitro biosafety.

[0098] 5. Lipid-lowering activity test In this experiment, the TG content of cells in the experimental groups treated with the compositions of Example 1 and Comparative Example 1 were detected.

[0099] In this experimental example, cell passage culture was performed according to the experimental method for cell proliferation-toxicity detection in Experiment Example 4 above.

[0100] Two types of cells in the logarithmic growth phase were respectively injected with 1×10 4 Cells were seeded at a concentration of [number] cells / well in 6-well culture plates and divided into groups. The control group received normal culture medium; the treatment groups received black ginseng powder mixtures in fresh culture medium containing 2% serum at concentrations of 600 μg / mL, 300 μg / mL, and 100 μg / mL, respectively. After 2 hours of protection, both the treatment and model groups were treated with a 0.4 mM oleic acid (OA) modeling agent containing 50% OA. After 24 hours of culture, the supernatant was discarded, and the cells were collected as cell pellets. The triglyceride content of the cells in each well was measured according to the instructions of the TG assay kit.

[0101] In this experimental example, the intracellular triglyceride detection results of the HepG2 hepatocyte lipid accumulation model established by oleic acid induction are attached. Figure 4 .

[0102] It is evident that the model group showed significant abnormal lipid accumulation compared to the normal control group, indicating stable and reliable model establishment. The black ginseng powder composition of this invention can significantly downregulate triglyceride levels in model cells in a concentration-dependent manner, effectively improving hepatocyte steatosis and metabolic disorders.

[0103] Application examples This application example uses black ginseng powder obtained after ginseng activation for compound optimization. The black ginseng powder composition has the effect of regulating glucose and lipid metabolism and can be used to prepare drugs for the prevention or treatment of diabetic hyperlipidemia.

[0104] The drug for preventing or treating diabetic hyperlipidemia according to the present invention uses the black ginseng powder composition and its extract as an active ingredient or as the sole active ingredient. The drug formulation has the effect of regulating glucose and lipid metabolism and treating diabetic hyperlipidemia. It is understood that the black ginseng powder composition and its extract, as the active ingredients of the drug, can exert a better therapeutic effect.

[0105] Furthermore, it should be noted that the extract of the black ginseng hair-based composition can be prepared using conventional extraction methods in the art, such as water extraction, alcohol extraction, water extraction with alcohol precipitation, alcohol extraction with water precipitation, and other conventional extraction methods.

[0106] In this application example, the pharmaceutical preparation may select the black ginseng powder composition and its extract as the sole active ingredient of the drug; it may also include other active ingredients known in the art that regulate glucose and lipid metabolism or treat diabetes and hyperlipidemia.

[0107] In this application example, the pharmaceutical preparation comprises a therapeutically effective amount of the black ginseng powder composition and its extract. It should be noted that the term "therapeutically effective amount" refers to the dosage of the drug required to produce an effective effect. This "therapeutically effective amount" can be adjusted and varied according to actual circumstances and is ultimately determined by medical personnel, taking into account factors such as the route of administration and the nature of the preparation, the recipient's weight, age, and other general characteristics, as well as the nature and severity of the disease being treated.

[0108] In this application example, the pharmaceutical formulation also includes other pharmaceutically acceptable carriers and / or excipients that are compatible with the black ginseng powder composition and its extracts. It should be noted that "other pharmaceuticals" here refers to drugs that are compatible with the black ginseng powder composition and its extracts, and that will not cause inactivation, reduced activity, or hydrolysis of the black ginseng powder composition and its extracts, and that, after synergistic action with the black ginseng powder composition and its extracts, can improve their therapeutic effect. The aforementioned carriers can be commonly used drug carriers in the art, such as chitosan, liposomes, alginate, agar, fibrin, collagen, and synthetic polymer carriers. The excipients mentioned above are physiologically inactive and do not affect the efficacy, content determination, or stability of the active pharmaceutical ingredient. Their main purpose is to facilitate the preparation and clinical application of the formulation. For example, they can be commonly used materials in this field such as starch, pregelatinized starch, dextrin, sucrose, lactose, mannitol, microcrystalline cellulose, calcium sulfate, calcium hydrogen phosphate, light magnesium oxide, calcium carbonate, dry starch, sodium hydroxymethyl starch, low-substituted hydroxypropyl cellulose, effervescent disintegrants, and crospovidone.

[0109] In this application example, the pharmaceutical preparation is a pharmaceutically acceptable oral dosage form, injectable dosage form, mucosal delivery dosage form, transdermal delivery dosage form, etc. Examples include tablets, capsules, granules, powders, pills, implants, gels, solutions, syrups, suspensions, aerosols, liposomes, microspheres, nanoparticles, etc. Accordingly, depending on the actual pharmaceutical dosage form, the route of administration can be selected from inhalation, oral inhalation, nasal administration, sublingual administration, parenteral administration, etc.

[0110] In summary, this invention utilizes independently developed ginseng processing technology to obtain black ginseng powder that can increase the content of rare ginsenosides S-Rh1, Rk1, Rg5, and F4, and uses this black ginseng powder to form a new compound formula. Through this ginseng processing technology, the focus of efficacy can be shifted from ginseng to black ginseng, providing the new compound formula with an active basis for regulating glucose and lipid metabolism.

[0111] The embodiments of the present invention have been described in detail above. Specific examples have been used to illustrate the principles and implementation methods of the present invention. The description of the above embodiments is only for the purpose of helping to understand the method and core ideas of the present invention. At the same time, for those skilled in the art, there will be changes in the specific implementation methods and application scope based on the ideas of the present invention. Therefore, the content of this specification should not be construed as a limitation of the present invention.

Claims

1. A black ginseng powder composition for regulating glucose and lipid metabolism, characterized in that, The composition comprises the following components in parts by weight: 6-12 parts black ginseng powder, 30-50 parts Ophiopogon japonicus, 3-9 parts ginger, 3-9 parts licorice, 10-40 parts jujube, and 3-12 parts japonica rice. The preparation method of the black ginseng powder includes the following steps: (1) Ginseng is dried, pulverized and sieved to obtain ginseng powder; the ginseng powder is ultrasonically treated in a vacuum-sealed environment isolated from ultrasonic media to obtain the first processed product; (2) The first processed material is subjected to steaming treatment to obtain the second processed material; (3) The second processed material is subjected to microwave drying to obtain the third processed material; (4) Repeat the above steps (2)-(3) to obtain the fourth processed product; (5) The fourth processed material is dried with hot air to obtain the desired black ginseng powder.

2. The black ginseng powder composition for regulating glucose and lipid metabolism according to claim 1, characterized in that, The composition comprises the following components in parts by weight: 9 parts black ginseng powder, 42 parts Ophiopogon japonicus, 6 parts ginger, 6 parts licorice, 40 parts jujube, and 6 parts japonica rice.

3. The black ginseng powder composition for regulating glucose and lipid metabolism according to claim 1 or 2, characterized in that, In the preparation method of the black ginseng powder, in step (1): The sieving step uses a sieve mesh size of 50-100 mesh; and / or, The ultrasonic frequency of the ultrasonic treatment step is 30-50 kHz; and / or, The ultrasonic power of the ultrasonic treatment step is 200-300W; and / or, The ultrasonic treatment step takes 10-60 minutes.

4. The black ginseng powder composition for regulating glucose and lipid metabolism according to claim 1 or 2, characterized in that, In the preparation method of the black ginseng powder, in step (2): The pressure of the steaming process is atmospheric pressure; and / or, The steaming process takes 1-3 hours.

5. The black ginseng powder composition for regulating glucose and lipid metabolism according to claim 1 or 2, characterized in that, In the preparation method of the black ginseng powder, in step (3): The pressure during the microwave drying process is atmospheric pressure; and / or, The temperature of the microwave drying process is 30-60℃; and / or, The power of the microwave drying process is 30-300W; and / or, The frequency of the microwave drying process is 2400-2500 MHz; and / or, The microwave drying process takes 1-10 minutes.

6. The black ginseng powder composition for regulating glucose and lipid metabolism according to claim 1 or 2, characterized in that, In the preparation method of the black ginseng powder, in step (4), the number of cycles of the repeated cycle step is 1-10 times.

7. The black ginseng powder composition for regulating glucose and lipid metabolism according to claim 1 or 2, characterized in that, In the preparation method of the black ginseng powder, in step (5): The temperature of the hot air drying step is 50-100℃; and / or, The hot air drying step takes 1-20 hours.

8. The use of the black ginseng powder composition for regulating glucose and lipid metabolism according to any one of claims 1-7 in the preparation of a drug for the prevention or treatment of diabetes and hyperlipidemia.

9. A pharmaceutical preparation for the prevention or treatment of diabetic hyperlipidemia, characterized in that, The active ingredient of the pharmaceutical preparation includes the black ginseng powder composition for regulating glycolipid metabolism as described in any one of claims 1-7.

10. A method for preparing a pharmaceutical formulation for the prevention or treatment of diabetic hyperlipidemia as described in claim 9, characterized in that, Includes the following steps: (a) Weigh out the selected amounts of the black ginseng powder, ophiopogon japonicus, ginger, licorice, jujube and japonica rice, mix them together, add water for the first decoction treatment, and collect the first decoction and the first dregs separately after solid-liquid separation; (b) Take the first dregs and add water for a second decoction treatment, and collect the second decoction and the second dregs respectively through solid-liquid separation; (c) Combine the first and second solutions and concentrate them into an extract; (d) Add pharmaceutically acceptable excipients and process to obtain a pharmaceutically acceptable dosage form.

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