Composition for regulating endocrine system function and preparation method thereof

Abstract

The invention belongs to the technical field of health-care products, and particularly relates to a composition for regulating functions of an endocrine system and a preparation method of the composition. The composition comprises 45-55 parts of lily, 5-15 parts of Chinese magnoliavine fruit, 5-15 parts of American ginseng, 1-5 parts of dried ginger, 10-20 parts of cereal powder and 27-35 parts of a kudzuvine root and mulberry leaf extract. Firstly, mulberry leaves are extracted under specific equipment and conditions, and the content of deoxynojirimycin, polysaccharide and polyphenol substances in the mulberry leaf extract is increased by controlling the extraction depth; then, the synergistic effect of deoxynojirimycin in the mulberry leaf extract and flavonoid substances in the radix puerariae is utilized to improve the effect of the composition for reducing the food glycemic index GI; then, lily, schisandra chinensis, American ginseng and dried ginger are added, so that the effects of tonifying qi and moistening dryness are improved; and finally, cereal powder rich in dietary fibers is added, so that the sugar control effect of the composition is further enhanced. Meanwhile, the coating effect of the cereal powder in the composition is utilized, active ingredients in the composition are protected, and the efficacy within the shelf life is improved.

Description

Technical Field

[0001] The invention belongs to the technical field of health care products, and specifically relates to a composition for regulating endocrine system function and a preparation method thereof. Background Art

[0002] The endocrine system is one of the two major control systems responsible for regulating the operation of various physiological functions in animals. It is composed of ductless glands that secrete hormones. Under normal circumstances, various hormones are kept in balance. If this balance is disrupted for some reason, endocrine disorders will occur, causing corresponding clinical symptoms, and the three highs are the most obvious manifestations. The best way to regulate endocrine is to start with a reasonable diet and supplement with appropriate amounts of health products. By reasonably consuming effective ingredients that regulate the functions of the endocrine system, the three highs can be prevented, controlled, and cured.

[0003] In 2011, "CN102274468A" disclosed a Chinese medicine composition for regulating endocrine and its preparation method. Specifically disclosed is that, by weight, it is prepared from 20-40 parts of Astragalus, 10-20 parts of Angelica, 10-20 parts of Codonopsis, 10-20 parts of Chuanxiong, 10-20 parts of Epimedium, 10-20 parts of Patrinia, 3-10 parts of Licorice, 5-10 parts of Curcuma, 5-15 parts of Atractylodes and 3-15 parts of Evodia. Using HGH active factors and antioxidant enzymes extracted from Chinese medicinal materials such as Astragalus, Angelica, Codonopsis, Chuanxiong, etc., it can enhance the vitality of human cells, replenish qi and nourish blood, accelerate the excretion of metabolites in the body, and promote blood circulation, thereby regulating endocrine, comprehensively regulating blood circulation, effectively blocking the invasion of free radicals, and achieving the effect of delaying aging. However, the effect of this Chinese medicine composition for regulating endocrine in controlling the three highs is small.

[0004] In 2024, "CN117941836A" disclosed a rice fiber powder for reducing the glycemic index of rice and a preparation method thereof. The rice fiber powder includes soluble dietary fiber, mulberry leaf extract, multi-grain powder and kudzu root powder, adopts a pure plant formula, and takes into account the thermal stability of steaming and cooking high-temperature raw materials, food diversity, food glycemic index and nutrition. At the same time, a method for preparing low-GI rice is disclosed, and the soluble dietary fiber, mulberry leaf extract, multi-grain powder and kudzu root powder are mixed and stirred evenly according to the proportion to obtain the rice fiber powder. The preparation method has the following problems: 1. The synergistic effect between kudzu root powder and mulberry leaf extract in reducing the glycemic index of food cannot be fully exerted by simple mixing; 2. The composition and proportion of the effective ingredients in the mulberry leaf extract obtained by different extraction methods are very different. The invention does not record the effect of the preparation method of mulberry leaf extract on reducing GI; 3. It is not recorded that the mulberry leaf extract has a weak odor; 4. There is no protection measure for the effective ingredients, and the effective ingredients are easily destroyed by air oxidation.

[0005] In summary, existing compositions for regulating endocrine system functions generally have the following problems: 1. They are not very effective in controlling the three highs, especially in lowering blood sugar; 2. They have a faint characteristic odor of mulberry leaves; 3. The active ingredients are easy to deteriorate, and the efficacy will be reduced during the shelf life. Summary of the invention

[0006] In view of the above technical problems, the present invention aims to provide a composition that has a strong effect of regulating the function of the endocrine system, especially lowering blood sugar, and the active ingredients are not easy to deteriorate. The composition comprises 45-55 parts of lily, 5-15 parts of schisandra chinensis, 5-15 parts of American ginseng, 1-5 parts of dried ginger, 10-20 parts of grain powder, and 27-35 parts of kudzu root and mulberry leaf extract;

[0007] The kudzu root and mulberry leaf extract comprises 25 to 30 parts of kudzu root and 2 to 5 parts of mulberry leaf extract.

[0008] The present invention utilizes the synergistic effect of the effective ingredients in the mulberry leaf extract and the effective ingredients in the kudzu root to improve the ability to regulate the endocrine system and effectively control the glycemic index GI of food. The addition of lily, schisandra chinensis, American ginseng and dried ginger further improves the effect of replenishing qi and moistening dryness and strengthens the effect of regulating endocrine. Cereal flour, as an important dietary fiber, has the effect of reducing the glycemic index GI of food on the one hand, and on the other hand, it has the effect of wrapping other effective ingredients, reducing the deterioration of effective ingredients, and improving the efficacy of the composition within the validity period.

[0009] Preferably, the cereal flour includes one or more of corn flour, barley flour, oat flour, quinoa flour, buckwheat flour, rye flour, white kidney bean flour, black kidney bean flour, chickpea flour, soybean flour, mung bean flour, and pea flour. The cereal flours can provide sufficient dietary fiber, which is very beneficial for reducing the glycemic index GI of food. Especially chickpea flour, the active ingredients therein have a positive effect on controlling cholesterol and preventing type II diabetes. The particle size of the cereal flour can be artificially controlled at 5-30 μm, which is convenient for wrapping other components in the composition, reducing the chance of active ingredients in other components contacting with air, reducing the probability of active ingredients being oxidized and destroyed by air, and improving the efficacy of the composition within the validity period.

[0010] Preferably, the Pueraria lobata mulberry leaf extract is prepared by the following steps:

[0011] S1. Wash and dry the kudzu root;

[0012] S2, grinding the dried kudzu root in a grinding device to obtain kudzu root powder;

[0013] S3, washing, draining, freezing and shearing the fresh mulberry leaves to obtain mulberry leaves;

[0014] S4, grinding the mulberry leaves and water in a ball mill to obtain an extract;

[0015] S5, filtering and steam distilling the extract to obtain an extract;

[0016] S6, adding kudzu root powder in parts by weight to the extract, and obtaining a suspension by high-speed shearing;

[0017] S7. The suspension is spray-dried to obtain a kudzu root and mulberry leaf extract.

[0018] Different from the prior art, the present invention gives full play to the synergistic effect of kudzu root and mulberry leaf extract in lowering blood sugar. First, the kudzu root is washed and dried, and the dried kudzu root is crushed in a crushing device to obtain kudzu root powder for standby use; then, the fresh mulberry leaves are washed with water to remove dust and other impurities adhering to the surface of the mulberry leaves. The washed mulberry leaves are drained to reduce the surface water content while keeping the mulberry leaf cells fully moistened, which is convenient for subsequent low-temperature freezing and shearing operations. The drained mulberry leaves are frozen by low-temperature freezing, and the water in the mulberry leaf cells is frozen and expanded in volume, causing damage to the cell wall, which is beneficial to improve the subsequent extraction effect. The mulberry leaves after low-temperature freezing are mechanically sheared to obtain mulberry leaves of 0.5 to 1 cm in size; then, the mulberry leaves and water are ball-milled and extracted in a ball mill. The ball milling extraction has the following advantages: 1. It can be carried out at low temperature to avoid oxidation and deterioration of the polyphenol active ingredients in the mulberry leaves, which reduces the efficacy; 2. By controlling the ball milling bead diameter and ball milling time, the apparent particle size of the mulberry leaves is controlled in a very narrow range close to the normal distribution, thereby improving the effect of selective extraction; 3. The controllable parameters of ball milling extraction include: temperature, time, ball milling bead diameter, ball milling bead loading, water-to-material ratio, etc. Compared with the ordinary extraction process, there are more controllable parameters, which makes it easier to improve the selectivity of the extraction. The extract is filtered to remove the mulberry leaf powder leaking from the ball mill filter. The unfavorable odor substances are eliminated by steam distillation using the large partial pressure of odor substances to obtain an extract with extremely low odor; finally, kudzu root powder is added to the extract by weight, and a suspension is obtained by high-speed shearing. The suspension is spray-dried to obtain a kudzu root mulberry leaf extract. High-speed shearing is conducive to the dissolution of active ingredients in kudzu root powder, and it is fused with the active ingredients in mulberry leaf extract, which is conducive to synergistic effect in reducing blood sugar, overcoming the problem of slow dissolution rate of kudzu root active ingredients entering the human body and weak synergistic effect. Spray drying has a fast drying speed and a short time, which can remove moisture under the premise of ensuring that the active ingredients of kudzu root and mulberry leaf extract remain stable as much as possible. The adoption of the above technical scheme enables the entire extraction process to be carried out at a relatively low temperature, avoiding the adverse effects of high temperature and air on the active ingredients in kudzu root and mulberry leaf. Controlling the depth of leaching well increases the content of deoxynojirimycin, polysaccharides, and polyphenols in mulberry leaf extract for effectively reducing the glycemic index GI of food, and improves the effect of controlling sugar and lowering blood sugar. Mulberry leaf powder is obtained by filtration, and other active ingredients therein are extracted by organic solvent extraction or other extraction methods to achieve the purpose of comprehensive utilization.

[0019] Further preferably, the temperature of the cryogenic freezing in step S3 is -24 to -16°C. The cryogenic freezing of the mulberry leaves at -24 to -16°C can freeze the free water in the mulberry leaf cells into ice, and the volume expansion of the frozen water causes tiny defects in the mulberry leaf cell walls, which is beneficial to the subsequent extraction process. After cryogenic freezing, the mulberry leaves will become very brittle flakes, which is also beneficial to the shearing and crushing process.

[0020] Further preferably, the mass ratio of the mulberry leaf to the water in step S4 is 1:8-15; the temperature of the ball milling extraction process is 20-40°C. The smaller the ratio of mulberry leaf to water, the lower the selectivity of the extraction, and the greater the energy consumption of the later spray drying. The larger the ratio of mulberry leaf to water, the problem of incomplete extraction of deoxynojirimycin, polysaccharides, and polyphenols in mulberry leaves exists. The best comprehensive effect can be achieved by using a ratio of mulberry leaf to water of 1:8-15. Different from the prior art, the present invention performs a ball milling extraction process of mulberry leaf at 20-40°C. At this temperature, combined with the mulberry leaf size of 0.1-0.8mm during the ball milling process, the deoxynojirimycin, polysaccharides, and polyphenols in the mulberry leaf can be extracted into the aqueous phase to the maximum extent, thereby increasing the content of the above three types of components in the final mulberry leaf extract and improving the ability to reduce the glycemic index GI of food. When the ball milling extraction temperature is lower than 20°C, the above three types of components in the mulberry leaf cannot be completely extracted under the condition of 8-15 times the weight of the mulberry leaf. When the ball mill extraction temperature is higher than 40°C, under the condition of 8 to 15 times the weight of the mulberry leaves in water, excessive flavonoids, glycosides, sterols, amino acids and other substances in the mulberry leaves will be extracted into the aqueous phase, reducing the content of deoxynojirimycin, polysaccharides and polyphenols in the mulberry leaf extract.

[0021] Further preferably, the diameter of the ball milling beads loaded in the ball mill in step S4 is 3 to 5 mm, and the aperture of the ball mill filter is 2.0 to 2.8 mm. Controlling the diameter of the ball milling beads controls the particle size of the mulberry leaf blade during ball milling and extraction. The diameter of the ball milling beads controlled by the present invention is 3 to 5 mm, and the size of the mulberry leaf blade can be controlled within a very narrow range of about 0.1 to 0.8 mm. The smaller the size of the mulberry leaf blade during ball milling, the deeper the depth of extraction, the more completely deoxynojirimycin, polysaccharides, and polyphenols can be extracted as much as possible, and other types of substances will also be extracted, reducing the content of deoxynojirimycin, polysaccharides, and polyphenols in the mulberry leaf extract. The larger the size of the mulberry leaf blade during ball milling, the shallower the extraction depth, the incomplete extraction of deoxynojirimycin, polysaccharides, and polyphenols, and other phenolic substances are extracted less, resulting in a reduced utilization rate of mulberry leaves. The inventor has determined through a large number of experiments that the comprehensive effect of ball milling extraction is best when the diameter of the ball milling beads is controlled at 3 to 5 mm and the diameter of the mulberry leaves is 0.1 to 0.8 mm during extraction. The pore size of the ball mill filter is selected to be 2.0 to 2.8 mm, which can not only ensure that the mulberry leaves after ball milling extraction can leave the ball mill smoothly, but also limit the ball milling beads from leaving the internal cavity of the ball mill. Compared with other extraction methods, ball milling extraction exerts the greatest mechanical force on the mulberry leaves. Under the continuous extrusion, grinding and shearing of the mulberry leaves, the deoxynojirimycin, polysaccharides and polyphenols therein are squeezed into the aqueous phase. Combined with the destructive effect of low-temperature freezing on the cell wall, deoxynojirimycin, polysaccharides and polyphenols can be leached into the aqueous phase with less water and lower temperature, reducing the entry of other substances into the aqueous phase and increasing the content of deoxynojirimycin, polysaccharides and polyphenols in the extract.

[0022] Further preferably, the mesh number of the filter in the filtering process of step S5 is 100-200 meshes. Step S5 uses a 100-200 mesh filter to filter the extract, which can reduce the amount of solid matter in the extract and avoid clogging the atomizer nozzle during subsequent spray drying.

[0023] Further preferably, the pressure of the steam distillation process in step S5 is -0.02 to -0.04 MPa; the mass of the extract in step S5 is controlled to be not less than the mass of the leaching solution after filtration in step S5. The purpose of the steam distillation of the present invention is to distill out trace amounts of odorous substances in the mulberry leaf extract to reduce the adverse effects of the substances entering the mulberry leaf extract on the odor of the final composition. Steam distillation also has the effect of inactivating enzymes, inactivating various enzymes in the mulberry leaf extract to avoid adverse effects on the active ingredients. If the pressure of the steam distillation is too low, more water needs to be distilled to obtain the same removal effect; if the pressure of the steam distillation is too high, less water needs to be distilled to obtain the same removal effect, but the distillation temperature will be higher, causing the effective ingredients in the extract to deteriorate. Taking all factors into consideration, the use of a steam distillation pressure of -0.02 to -0.04 MPa can avoid losing one thing for the other. The inventors found that if the relationship between the mass of the extract and the leaching solution after filtration is not controlled, the mass of the extract is less than the mass of the leaching solution after filtration, and the extract will have a faint burnt odor. By controlling the amount of water vapor added during steam distillation to be greater than the amount of light components distilled out, the problem of burnt odor in the extract during steam distillation can be effectively avoided.

[0024] The present invention also discloses a method for preparing the composition for regulating the function of the endocrine system as described above. The Pueraria lobata and mulberry leaf extract is prepared according to the method as described above. The preparation method is carried out according to the following steps:

[0025] (1) Wash and dry lily, schisandra chinensis, American ginseng, and dried ginger separately;

[0026] (2) grinding the dried lily, schisandra chinensis, American ginseng, and dried ginger in a grinding device to obtain dry powder;

[0027] (3) Weighing weight portions of lily powder, schisandra powder, American ginseng powder, dried ginger powder, and kudzu root and mulberry leaf extract and adding them into a single cone double helix mixer and mixing them evenly;

[0028] (4) Weighing the weight portions of the cereal flour, adding them into a single-cone double-screw mixer and mixing them evenly to obtain mixed flour;

[0029] (5) sterilizing the mixed powder by ultraviolet light to obtain the endocrine regulating composition;

[0030] Wherein, in step (2), the passing rate of the dry powder after the components are crushed on a 100-mesh sieve is 100%.

[0031] Different from the prior art, in the process of preparing the composition for regulating the function of the endocrine system, the present invention firstly mixes the kudzu root powder and the mulberry leaf extract microscopically through a high-speed shearing device, which is conducive to the combination of deoxynojirimycin in the mulberry leaf extract and the flavonoids in the kudzu root powder to form pancreatic sedative, strengthens the hypoglycemic effect of deoxynojirimycin, and also has the effects of lowering blood lipids, anti-inflammatory and detumescence, etc. The high-speed shearing device can be a stator-rotor shearing device or a dispersion disk, and the linear speed of the high-speed shearing device can be controlled at 15-25 m / s; then, lily powder, schisandra powder, American ginseng powder, dried ginger powder and kudzu root and mulberry leaf extract are mixed. The addition of lily, schisandra chinensis, American ginseng and dried ginger further strengthens the effect of lowering blood sugar and blood lipids, and at the same time has the effect of replenishing qi and nourishing yin, overcoming the peculiar smell of the composition and improving the taste; then, the cereal powder is added to the mixture for final mixing. The cereal powder is rich in dietary fiber and starch, has the characteristics of small particles, and can be used as a coating to wrap the aforementioned mixture, play the effect of isolating air and moisture, and reduce the deterioration of active ingredients; finally, after the mixed powder is sterilized, the composition for regulating the function of the endocrine system is obtained. The particle size of each component of the composition for regulating the function of the endocrine system has a great influence on the synergistic effect of the active ingredients in the composition. The present invention requires that the dry powder particle size of each component in the composition be controlled to have a pass rate of 100% on a 100-mesh sieve. In this way, when used, the effective ingredients of each component in the composition can be fully utilized, and the synergistic effect between each component can be promoted, thereby improving the effect of regulating the function of the endocrine system and achieving the purpose of reducing the three highs, especially blood sugar. The present invention performs the ultraviolet sterilization process described in step (5) by ultraviolet irradiation, and the ultraviolet light source is selected from a common low-pressure mercury lamp. The wavelength generated by the low-pressure mercury lamp is mainly 253.7nm, which can effectively kill microorganisms such as bacteria, fungi, viruses, etc., and will not cause photolysis and deterioration of the active ingredients in the composition. The composition is sterilized by ultraviolet rays, which is fast and efficient, and can minimize the destructive effect of the sterilization process on the active ingredients in the composition. In order to improve the mixing effect and promote the synergistic effect of the active ingredients in each component of the composition, the present invention performs the mixing process described in steps (3) and (4) in a single-cone double-helix mixer. The single-cone double-helix mixer has the characteristics of good mixing effect, and the prepared composition has better uniformity. The single-cone double-helix mixer is also easy to clean and is not prone to bacterial contamination of the composition.

[0032] The present invention also discloses the use of the composition for regulating the function of the endocrine system as described above. The composition for regulating the function of the endocrine system is prepared according to the preparation method as described above. The composition for regulating the function of the endocrine system is compressed into a tablet dosage form or packaged into a granule dosage form. The prepared tablets can be taken with meals to reduce the glycemic index GI of food, and play a role in controlling and lowering blood sugar; the prepared granules can be added to boiling water as a plant beverage to be taken with meals, and reduce the glycemic index GI of food, and play a role in controlling and lowering blood sugar.

[0033] The efficacy and indications of each component in the composition:

[0034] 1. Lily

[0035] It nourishes yin and moistens the lungs, clears the heart and soothes the mind. It is used for dry cough due to yin deficiency, coughing up blood due to exhaustion, restlessness, palpitations, insomnia, and mental confusion.

[0036] 2. Pueraria root:

[0037] It can relieve muscle pain, reduce fever, clear rash, promote the production of body fluids and quench thirst, raise yang and stop diarrhea, promote blood circulation and activate collaterals, and relieve alcohol poisoning. It can be used for exogenous fever and headache, stiff neck and back pain, thirst, thirst, measles that do not clear up, dysentery, diarrhea, dizziness and headache, hemiplegia caused by stroke, headache caused by chest pain, and alcohol poisoning.

[0038] 3. Schisandra chinensis:

[0039] It can astringe and strengthen the body, replenish qi and produce body fluid, nourish the kidney and calm the mind. It is used for long-term cough and asthma, nocturnal emission and spermatorrhea, enuresis and frequent urination, chronic diarrhea, spontaneous sweating and night sweats, thirst due to loss of body fluid, internal heat and thirst, palpitations and insomnia.

[0040] 4. American ginseng:

[0041] It can replenish qi and yin, clear away heat and promote the production of body fluids. It can improve the body's ability to resist fatigue and regulate immune function.

[0042] 5. Dried ginger:

[0043] Warms the middle and dispels cold, restores yang and dredges the meridians, warms the lungs and transforms fluid. Used for cold pain in the abdomen, vomiting and diarrhea, cold limbs and weak pulse, asthma and cough due to cold fluid.

[0044] 6. Mulberry leaf extract:

[0045] It can dispel wind-heat, clear the lungs and moisten dryness, soothe the liver and improve eyesight, cool blood and stop bleeding. It is used for wind-heat cold, early stage of febrile disease, cough due to lung heat, hyperactivity of liver yang, dizziness, red and blurred eyes, and coughing and vomiting blood due to blood heat.

[0046] 7. Cereal flour:

[0047] Used to supplement dietary fiber, plant protein and carbohydrates.

[0048] In summary, the present invention discloses a composition for regulating the function of the endocrine system and a preparation method thereof. Through the synergistic effect of various components, the functions of the endocrine system are regulated to the maximum extent, especially the effects of lowering blood sugar and blood lipids. Through the innovative preparation method from mulberry leaf extraction, to the preparation of kudzu root and mulberry leaf extract, to the preparation of the composition, the destruction of effective ingredients is effectively reduced, the characteristic smell of mulberry leaves is weakened, the effect of the composition on reducing the glycemic index of food is improved, and the efficacy of the composition within the shelf life is improved. DETAILED DESCRIPTION

[0049] The present invention is described in detail below by way of examples, but the present invention is not limited to these examples.

[0050] Example 1

[0051] (1) Preparation of Pueraria lobata mulberry leaf extract:

[0052] Wash, slice and dry the kudzu root;

[0053] The dried kudzu root is crushed in a crushing device to obtain kudzu root dry powder for later use;

[0054] Take 5.0 kg of fresh mulberry leaves, wash them with drinking water, and drain them. Put the drained mulberry leaves into a -20℃ freezer for quick freezing for 24 hours. Use a grinder to grind the frozen mulberry leaves into 0.5-1 cm mulberry leaves. Transfer the mulberry leaves to a ball mill pre-loaded with 8.0 kg of ball milling beads (ball milling bead diameter: 4 mm), and then add 60.0 kg of drinking water to the ball mill. Turn on the ball mill and control the ball mill speed to 120 r / min. Control the temperature inside the ball mill to 30℃ and ball mill for 2.0 hours. After the ball milling extraction is completed, discharge the material. Wash the ball mill with 12.0 kg of drinking water, and combine the washing liquid with the ball milling extract as the extract.

[0055] The extract is filtered through 150 mesh silk cloth to obtain a filtrate, and the filter residue is concentrated to recover other effective components remaining in the mulberry leaves.

[0056] The filtrate was transferred to a 200L stainless steel still with a stator-rotor shearing device, and the vacuum was controlled at -0.03MPa. At the same time, 0.2MPa steam was introduced into the stainless steel still for steam distillation. When the amount of water evaporated was about 2-5Kg, nitrogen was filled to break the vacuum, and the steam distillation was stopped to obtain about 75.2kg of extract. 200ml of the sample was vacuum dehydrated in a rotary evaporator to detect the DNJ content: 6.9%, the mulberry leaf polysaccharide content: 52.6%, the mulberry leaf polyphenol content: 11.4%, and the amount of mulberry leaf extract was converted to 0.374kg (the Folin-ciocalteu colorimetric method was used to determine the mulberry leaf polyphenol content; the RP-HPLC method was used to determine the DNJ content; the phenol-sulfuric acid method was used to determine the mulberry leaf polysaccharide content).

[0057] Add 3.6 kg of kudzu root powder to the extract, fill the distillation kettle with nitrogen, start the stator shearing device, control the speed to 2900 r / min (linear speed of about 15.2 m / s), control the internal temperature not to exceed 50°C, and perform high-speed shearing for 30 minutes.

[0058] After high-speed shearing is completed, the kettle liquid is spray-dried to obtain the kudzu root and mulberry leaf extract for later use;

[0059] (2) Preparation of a composition for regulating endocrine system function:

[0060] Wash and dry lily, schisandra chinensis, American ginseng and dried ginger separately;

[0061] The dried lily, schisandra chinensis, American ginseng and dried ginger are crushed in a crushing device to obtain dry powder;

[0062] Weigh 3.60 kg of Pueraria lobata mulberry leaf extract, 6.40 kg of lily powder, 1.05 kg of Schisandra chinensis powder, 0.92 kg of American ginseng powder, and 0.45 kg of dried ginger powder, add them into a single cone double helix mixer and mix for 30 minutes under nitrogen protection conditions;

[0063] Weigh 0.8 kg of chickpea flour and 1.05 kg of corn flour, add them into a single-cone double-screw mixer and mix for 30 minutes under nitrogen protection conditions to obtain a mixed powder;

[0064] A single-cone double-screw mixer was opened with a built-in 20W low-pressure mercury lamp, and the mixture was stirred and sterilized for 30 minutes to obtain a functional composition for regulating the endocrine system.

[0065] (3) Preparation of tablets for regulating endocrine system function:

[0066] Turn off the low-pressure mercury lamp, add 1.05 kg of starch and 0.055 kg of magnesium stearate into the single cone double screw mixer, mix well, and press the mixture into tablets on a tablet press to obtain tablets for regulating endocrine system functions.

[0067] 50 volunteers were selected to participate in the clinical trial of the tablet for regulating the function of the endocrine system prepared in this example.

[0068] Among them: the male-female ratio is: 1:1, and the average pre-meal blood sugar level is: 7.7mmol / L. Each person takes 2 tablets with meals three times a day for a total of 30 days. After the experiment, the average pre-meal blood sugar level was detected: 48 people had an average pre-meal blood sugar level below 7.0mmol / L, the effective rate was: 96.0%, and no one reported that the tablets had an abnormal odor.

[0069] The tablets packaged in aluminum foil were placed in a cool and dry place for one year, and 50 volunteers were selected to participate in the clinical trial for evaluating the hypoglycemic effect. The ratio of men to women was 1:1, and the average pre-meal blood sugar level was 7.6mmol / L. Each person took 2 tablets with meals three times a day for a total of 30 days. After the experiment, the average pre-meal blood sugar level was tested: 47 people had an average pre-meal blood sugar level below 7.0mmol / L, the effective rate was 94.0%, and 0 people reported that the tablets had an abnormal odor.

[0070] Example 2

[0071] The preparation process of Example 2 is basically the same as that of Example 1, except that the diameter of the ball milling beads is 3 mm during ball milling and extraction. After the steam distillation is completed, 200 ml of the sample is vacuum dehydrated in a rotary evaporator and the DNJ content is 6.5%, the mulberry leaf polysaccharide content is 48.2%, and the mulberry leaf polyphenol content is 8.9%. The amount of mulberry leaf extract is converted to 0.422 kg.

[0072] 50 volunteers were selected to participate in the clinical trial of the tablet for regulating the function of the endocrine system prepared in this example.

[0073] Among them: the male-female ratio is: 1:1, and the average pre-meal blood sugar level is: 7.8mmol / L. Each person takes 2 tablets with meals three times a day for a total of 30 days. After the experiment, the average pre-meal blood sugar level was detected: 47 people had an average pre-meal blood sugar level below 7.0mmol / L, the effective rate was: 94.0%, and 0 people reported that the tablets had an abnormal odor.

[0074] The tablets packaged in aluminum foil were placed in a cool and dry place for one year, and 50 volunteers were selected to participate in the clinical trial for evaluating the hypoglycemic effect. The ratio of men to women was 1:1, and the average pre-meal blood sugar level was 7.6mmol / L. Each person took 2 tablets with meals three times a day for a total of 30 days. After the experiment, the average pre-meal blood sugar level was tested: 47 people had an average pre-meal blood sugar level below 7.0mmol / L, the effective rate was 94.0%, and 0 people reported that the tablets had an abnormal odor.

[0075] Example 3

[0076] The preparation process of Example 3 is basically the same as that of Example 1, except that the diameter of the ball milling beads is 5 mm during ball milling and extraction. After the steam distillation is completed, 200 ml of the sample is vacuum dehydrated in a rotary evaporator and the DNJ content is 7.0%, the mulberry leaf polysaccharide content is 58.6%, and the mulberry leaf polyphenol content is 14.3%. The amount of mulberry leaf extract is converted to 0.357 kg. 3.5 kg of kudzu root powder is added to the extract.

[0077] 50 volunteers were selected to participate in the clinical trial of the tablet for regulating the function of the endocrine system prepared in this example.

[0078] Among them: the male-female ratio is: 1:1, and the average pre-meal blood sugar level is: 7.9mmol / L. Each person takes 2 tablets with meals three times a day for a total of 30 days. After the experiment, the average pre-meal blood sugar level was tested: 46 people had an average pre-meal blood sugar level below 7.0mmol / L, the effective rate was: 92.0%, and 0 people reported that the tablets had an abnormal odor.

[0079] The tablets packaged in aluminum foil were placed in a cool and dry place for one year, and 50 volunteers were selected to participate in the clinical trial for evaluating the hypoglycemic effect. The ratio of men to women was 1:1, and the average pre-meal blood sugar level was 7.7mmol / L. Each person took 2 tablets with meals three times a day for a total of 30 days. After the experiment, the average pre-meal blood sugar level was tested: 45 people had an average pre-meal blood sugar level below 7.0mmol / L, the effective rate was 90.0%, and 0 people reported that the tablets had an abnormal odor.

[0080] Example 4

[0081] The preparation process of Example 4 is basically the same as that of Example 1, except that the amount of water added for extraction during ball milling is 40 kg. After steam distillation, 200 ml of the sample is vacuum dehydrated in a rotary evaporator to detect the DNJ content: 7.3%, the mulberry leaf polysaccharide content: 59.4%, the mulberry leaf polyphenol content: 11.5%, and the amount of mulberry leaf extract: 0.341 kg. 3.4 kg of kudzu root powder is added to the extract.

[0082] 50 volunteers were selected to participate in the clinical trial of the tablet for regulating the function of the endocrine system prepared in this example.

[0083] Among them: the male-female ratio is: 1:1, and the average pre-meal blood sugar level is: 7.6mmol / L. Each person takes 2 tablets with meals three times a day for a total of 30 days. After the experiment, the average pre-meal blood sugar level was tested: 49 people had an average pre-meal blood sugar level below 7.0mmol / L, the effective rate was: 98.0%, and 0 people reported that the tablets had an abnormal odor.

[0084] The tablets packaged in aluminum foil were placed in a cool and dry place for one year, and 50 volunteers were selected to participate in the clinical trial for evaluating the hypoglycemic effect. The ratio of men to women was 1:1, and the average pre-meal blood sugar level was 7.6mmol / L. Each person took 2 tablets with meals three times a day for a total of 30 days. After the experiment, the average pre-meal blood sugar level was tested: 48 people had an average pre-meal blood sugar level below 7.0mmol / L, the effective rate was 96.0%, and 0 people reported that the tablets had an abnormal odor.

[0085] Example 5

[0086] The preparation process of Example 5 is basically the same as that of Example 1, except that the amount of water added for extraction during ball milling is 75 kg. After steam distillation, 200 ml of the sample is vacuum dehydrated in a rotary evaporator to detect the DNJ content: 5.9%, the mulberry leaf polysaccharide content: 46.6%, the mulberry leaf polyphenol content: 7.9%, and the amount of mulberry leaf extract: 0.443 kg. 3.7 kg of kudzu root powder is added to the extract.

[0087] 50 volunteers were selected to participate in the clinical trial of the tablet for regulating the function of the endocrine system prepared in this example.

[0088] Among them: the male-female ratio is: 1:1, and the average pre-meal blood sugar level is: 7.6mmol / L. Each person takes 2 tablets with meals three times a day for a total of 30 days. After the experiment, the average pre-meal blood sugar level was tested: 46 people had an average pre-meal blood sugar level below 7.0mmol / L, the effective rate was: 92.0%, and 0 people reported that the tablets had an abnormal odor.

[0089] The tablets packaged in aluminum foil were placed in a cool and dry place for one year, and 50 volunteers were selected to participate in the clinical trial for evaluating the hypoglycemic effect. The ratio of men to women was 1:1, and the average pre-meal blood sugar level was 7.6mmol / L. Each person took 2 tablets with meals three times a day for a total of 30 days. After the experiment, the average pre-meal blood sugar level was tested: 46 people had an average pre-meal blood sugar level below 7.0mmol / L, the effective rate was 92.0%, and 0 people reported that the tablets had an abnormal odor.

[0090] Example 6

[0091] The preparation process of Example 6 is basically the same as that of Example 1, except that the extraction temperature is controlled to be 20°C during ball milling extraction. After steam distillation, 200 ml of the sample is vacuum dehydrated in a rotary evaporator and the DNJ content is 7.7%, the mulberry leaf polysaccharide content is 66.5%, and the mulberry leaf polyphenol content is 4.7%. The amount of mulberry leaf extract is converted to 0.337 kg. 3.3 kg of kudzu root powder is added to the extract.

[0092] 50 volunteers were selected to participate in the clinical trial of the tablet for regulating the function of the endocrine system prepared in this example.

[0093] Among them: the male-female ratio is: 1:1, and the average pre-meal blood sugar level is: 7.4mmol / L. Each person takes 2 tablets with meals three times a day for a total of 30 days. After the experiment, the average pre-meal blood sugar level was tested: 50 people had an average pre-meal blood sugar level below 7.0mmol / L, the effective rate was: 100.0%, and 0 people reported that the tablets had an abnormal odor.

[0094] The tablets packaged in aluminum foil were placed in a cool and dry place for one year, and 50 volunteers were selected to participate in the clinical trial for evaluating the hypoglycemic effect. The ratio of men to women was 1:1, and the average pre-meal blood sugar level was 7.5mmol / L. Each person took 2 tablets with meals three times a day for a total of 30 days. After the experiment, the average pre-meal blood sugar level was tested: 49 people had an average pre-meal blood sugar level below 7.0mmol / L, the effective rate was 98.0%, and 0 people reported that the tablets had an abnormal odor.

[0095] Example 7

[0096] The preparation process of Example 7 is basically the same as that of Example 1, except that the extraction temperature is controlled to be 40°C during ball milling extraction. After steam distillation, 200 ml of the sample is vacuum dehydrated in a rotary evaporator to detect the DNJ content: 6.0%, the mulberry leaf polysaccharide content: 53.2%, the mulberry leaf polyphenol content: 11.1%, and the amount of mulberry leaf extract: 0.437 kg. 3.7 kg of kudzu root powder is added to the extract.

[0097] 50 volunteers were selected to participate in the clinical trial of the tablet for regulating the function of the endocrine system prepared in this example.

[0098] Among them: the male-female ratio is: 1:1, and the average pre-meal blood sugar level is: 7.5mmol / L. Each person takes 2 tablets with meals three times a day for a total of 30 days. After the experiment, the average pre-meal blood sugar level was tested: 46 people had an average pre-meal blood sugar level below 7.0mmol / L, the effective rate was: 92.0%, and 0 people reported that the tablets had an abnormal odor.

[0099] The tablets packaged in aluminum foil were placed in a cool and dry place for one year, and 50 volunteers were selected to participate in the clinical trial for evaluating the hypoglycemic effect. The ratio of men to women was 1:1, and the average pre-meal blood sugar level was 7.7mmol / L. Each person took 2 tablets with meals three times a day for a total of 30 days. After the experiment, the average pre-meal blood sugar level was tested: 46 people had an average pre-meal blood sugar level below 7.0mmol / L, the effective rate was 92.0%, and 0 people reported that the tablets had an abnormal odor.

[0100] Comparative Example 1

[0101] The preparation process of Comparative Example 1 is basically the same as that of Example 1, except that the drained mulberry leaves are not frozen. After the steam distillation is completed, 200 ml of the sample is vacuum dehydrated in a rotary evaporator to detect the DNJ content: 5.8%, the mulberry leaf polysaccharide content: 60.8%, the mulberry leaf polyphenol content: 9.7%, and the amount of mulberry leaf extract: 0.358 kg. 3.5 kg of kudzu root powder is added to the extract.

[0102] 50 volunteers were screened to participate in the clinical trial of the tablet for regulating the function of the endocrine system prepared in this comparative example.

[0103] Among them: the male-female ratio is: 1:1, and the average pre-meal blood sugar level is: 7.6mmol / L. Each person takes 2 tablets with meals three times a day for a total of 30 days. After the experiment, the average pre-meal blood sugar level was detected: 43 people had an average pre-meal blood sugar level below 7.0mmol / L, the effective rate was: 86.0%, and no one reported that the tablets had an abnormal odor.

[0104] The tablets packaged in aluminum foil were placed in a cool and dry place for one year, and 50 volunteers were selected to participate in the clinical trial for evaluating the hypoglycemic effect. The ratio of men to women was 1:1, and the average pre-meal blood sugar level was 7.5mmol / L. Each person took 2 tablets with meals three times a day for a total of 30 days. After the experiment, the average pre-meal blood sugar level was tested: 42 people had an average pre-meal blood sugar level below 7.0mmol / L, the effective rate was 84.0%, and 0 people reported that the tablets had an abnormal odor.

[0105] Comparative Example 2

[0106] The preparation process of Comparative Example 2 is basically the same as that of Example 1, except that the filtrate is not subjected to steam distillation. 200 ml of the sample is vacuum dehydrated in a rotary evaporator to detect the DNJ content: 6.6%, the mulberry leaf polysaccharide content: 53.2%, the mulberry leaf polyphenol content: 12.2%, and the converted mulberry leaf extract amount: 0.381 kg.

[0107] 50 volunteers were screened to participate in the clinical trial of the tablet for regulating the function of the endocrine system prepared in this comparative example.

[0108] Among them: the male-female ratio is: 1:1, and the average pre-meal blood sugar level is: 7.4mmol / L. Each person takes 2 tablets with meals three times a day for a total of 30 days. After the experiment, the average pre-meal blood sugar level was tested: 44 people had an average pre-meal blood sugar level below 7.0mmol / L, the effective rate was: 88.0%, and 11 people reported that the tablets had an abnormal odor.

[0109] The tablets packaged in aluminum foil were placed in a cool and dry place for one year, and 50 volunteers were selected to participate in the clinical trial for evaluating the hypoglycemic effect. The ratio of men to women was 1:1, and the average pre-meal blood sugar level was 7.6mmol / L. Each person took 2 tablets with meals three times a day for a total of 30 days. After the experiment, the average pre-meal blood sugar level was tested: 44 people had an average pre-meal blood sugar level below 7.0mmol / L, the effective rate was 88.0%, and 13 people reported that the tablets had an abnormal odor.

[0110] Comparative Example 3

[0111] The preparation process of Comparative Example 3 is basically the same as that of Example 1, except that after steam distillation, the mixture is directly spray-dried to obtain 0.379 kg of mulberry leaf extract, wherein the DNJ content is 6.7%, the mulberry leaf polysaccharide content is 54.3%, and the mulberry leaf polyphenol content is 12.6%. When preparing the endocrine regulating composition, the mulberry leaf extract, kudzu root powder and other components are mixed together.

[0112] 50 volunteers were screened to participate in the clinical trial of the tablet for regulating the function of the endocrine system prepared in this comparative example.

[0113] Among them: the male-female ratio is: 1:1, and the average pre-meal blood sugar level is: 7.4mmol / L. Each person takes 2 tablets with meals three times a day for a total of 30 days. After the experiment, the average pre-meal blood sugar level was tested: 47 people had an average pre-meal blood sugar level below 7.0mmol / L, the effective rate was: 94.0%, and 9 people reported that the tablets had an abnormal odor.

[0114] The tablets packaged in aluminum foil were placed in a cool and dry place for one year, and 50 volunteers were selected to participate in the clinical trial for evaluating the hypoglycemic effect. The ratio of men to women was 1:1, and the average pre-meal blood sugar level was 7.5mmol / L. Each person took 2 tablets with meals three times a day for a total of 30 days. After the experiment, the average pre-meal blood sugar level was tested: 43 people had an average pre-meal blood sugar level below 7.0mmol / L, the effective rate was 86.0%, and 14 people reported that the tablets had an abnormal odor.

Claims

1. A composition for regulating endocrine system function, characterized in that: The composition comprises 45-55 parts of lily, 5-15 parts of schisandra chinensis, 5-15 parts of American ginseng, 1-5 parts of dried ginger, 10-20 parts of cereal powder, and 27-35 parts of kudzu root and mulberry leaf extract; The kudzu root and mulberry leaf extract comprises 25 to 30 parts of kudzu root and 2 to 5 parts of mulberry leaf extract.

2. The composition for regulating endocrine system function according to claim 1, characterized in that: The cereal flour includes one or more of corn flour, barley flour, oat flour, quinoa flour, buckwheat flour, rye flour, white kidney bean flour, black kidney bean flour, chickpea flour, soybean flour, mung bean flour, and pea flour.

3. The composition for regulating endocrine system function according to claim 1, characterized in that: The Pueraria lobata mulberry leaf extract is prepared by the following steps: S1. Wash and dry the kudzu root; S2, grinding the dried kudzu root in a grinding device to obtain kudzu root powder; S3, washing, draining, freezing and shearing the fresh mulberry leaves to obtain mulberry leaves; S4, grinding the mulberry leaves and water in a ball mill to obtain an extract; S5, filtering and steam distilling the extract to obtain an extract; S6, adding kudzu root powder in parts by weight to the extract, and obtaining a suspension by high-speed shearing; S7. The suspension is spray-dried to obtain a kudzu root and mulberry leaf extract.

4. The composition for regulating endocrine system function according to claim 3, characterized in that: The temperature of the low-temperature freezing in step S3 is -24 to -16°C.

5. The composition for regulating endocrine system function according to claim 3, characterized in that: In step S4, the mass ratio of the mulberry leaves to the water is 1:8-15; and the temperature of the ball milling extraction process is 20-40°C.

6. The composition for regulating endocrine system function according to claim 3, characterized in that: In step S4, the diameter of the ball milling beads filled in the ball mill is 3-5 mm, and the pore size of the ball mill filter is 2.0-2.8 mm.

7. The composition for regulating endocrine system function according to claim 3, characterized in that: The mesh size of the filter in the filtering process in step S5 is 100 to 200 meshes.

8. The composition for regulating endocrine system function according to claim 3, characterized in that: The pressure of the steam distillation process in step S5 is -0.02 to -0.04 MPa; the mass of the extract in step S5 is controlled to be not less than the mass of the extract after filtration in step S5.

9. A method for preparing a composition for regulating endocrine system function according to any one of claims 1 or 2, wherein the Pueraria lobata mulberry leaf extract is prepared according to the method according to any one of claims 3 to 8, characterized in that: The preparation method of the composition for regulating endocrine system function is carried out according to the following steps: (1) Wash and dry lily, schisandra chinensis, American ginseng, and dried ginger separately; (2) grinding the dried lily, schisandra chinensis, American ginseng, and dried ginger in a grinding device to obtain dry powder; (3) Weighing weight portions of lily powder, schisandra powder, American ginseng powder, dried ginger powder, and kudzu root and mulberry leaf extract and adding them into a single cone double helix mixer and mixing them evenly; (4) Weighing the weight portions of the cereal flour, adding them into a single-cone double-screw mixer and mixing them evenly to obtain mixed flour; (5) sterilizing the mixed powder by ultraviolet light to obtain the composition for regulating endocrine system function; Wherein, in step (2), the passing rate of the dry powder after the components are crushed on a 100-mesh sieve is 100%.