Production method and formula for balancing female hormone level

Abstract

The invention relates to the technical field of biological medicine and health care, in particular to a production method and formula for balancing female hormone level, and the production method comprises the following steps: mixing plant extract, microbial metabolite and functional lipid to form a basic active mixture, adding a trace element compound, and performing microencapsulation treatment. The composition comprises an evening primrose oil extract, a soy isoflavone extract and the like, and accurate regulation and control are realized by regulating a hormone synthesis route and signal transduction. The invention further provides an application method and an effect evaluation mode, the formula proportion can be adjusted according to individual hormone detection results, and the composition is suggested to be taken after breakfast so as to improve the absorption efficiency. The personalized health management requirement can be efficiently and safely met, and meanwhile the long-term effect stability is improved.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of biological medicine and health care, specifically a production method and formula for balancing female hormone levels. BACKGROUND

[0002] In the field of women's health, balancing hormone levels is an important research direction for improving physiological conditions and enhancing quality of life. In recent years, functional foods, health products, and traditional Chinese medicine compositions have gradually become the main means of regulating female hormone levels. However, there is still room for improvement in the existing technology in terms of precise regulation of hormone levels, individualized adaptability, and long-term stability of effects.

[0003] After searching, a patent with publication number CN108576802A discloses a composition for maintaining women's health, which belongs to the technical field of food and health products. The composition contains cranberry powder, yeast beta-glucan, and various lactobacilli, which quickly improves women's reproductive health problems and improves antioxidant capacity in the body through synergistic effect. Although this technical solution has certain advantages in terms of antioxidant and microecological regulation, the direct regulation mechanism of hormone levels is not explicitly stated, and the ingredient ratio range in the formula is wide, which may lead to insufficient consistency and precision in actual application.

[0004] Another patent with publication number CN109363166A discloses a composition for regulating women's physical health balance, which includes barley sprout powder, round buckwheat shell, fructooligosaccharide, oat fiber, green plum powder, and black sesame in weight parts. The composition aims to supplement qi and blood, regulate endocrine, and improve facial complexion, suitable for family women to take. However, this technical solution mainly focuses on the regulation of overall physical balance, lacks specific intervention measures for hormone secretion disorders, and has many ingredients, which may affect the prominence and specificity of the core efficacy.

[0005] The above two existing technical solutions have certain limitations in precise regulation of female hormone levels, individualized needs, and long-term stability of effects. Therefore, the present application aims to provide a new production method and formula for balancing female hormone levels, which optimizes the combination of ingredients and their action mechanisms to meet the needs of modern women for efficient, safe, and personalized health management. SUMMARY

[0006] The present application provides a production method and formula for balancing female hormone levels, aiming to optimize the combination of natural active ingredients and biological functional substances and their action mechanisms to precisely regulate female hormone secretion and meet the needs of individualized health management.

[0007] To achieve the above-mentioned purpose, the present application provides the following technical solution: a method for preparing a composition for balancing female hormone levels, comprising the following steps:

[0008] S10: mixing plant extracts, microbial metabolites and functional lipids in specific proportions to obtain a basic active mixture; the plant extracts include evening primrose oil extract, soy isoflavone extract and glycyrrhizic acid dipotassium extract; the microbial metabolites are lactic acid bacteria fermentation broth concentrate; the functional lipids include gamma-linolenic acid and phosphatidylserine;

[0009] S20: adding a trace element complex to the basic active mixture, and stirring uniformly to obtain an intermediate mixture; the trace element complex includes selenomethionine, zinc gluconate and vitamin D3;

[0010] S30: subjecting the intermediate mixture to microencapsulation treatment, and drying to obtain a final composition.

[0011] Preferably, in the step S10, the mass ratio of the plant extracts is that the evening primrose oil extract accounts for 40% to 60%, the soy isoflavone extract accounts for 20% to 35%, and the glycyrrhizic acid dipotassium extract accounts for 10% to 20%; the mass fraction of the microbial metabolites is 5% to 15% of the total mixture; and the mass ratio of the functional lipids is that the gamma-linolenic acid accounts for 60% to 70%, and the phosphatidylserine accounts for 30% to 40%.

[0012] Preferably, in the step S20, the mass ratio of the trace element complex is that the selenomethionine accounts for 30% to 40%, the zinc gluconate accounts for 40% to 50%, and the vitamin D3 accounts for 10% to 20%; and the total mass of the trace element complex accounts for 0.5% to 2% of the intermediate mixture.

[0013] Preferably, in the step S30, the microencapsulation treatment adopts a spray drying method, the inlet air temperature is 180 to 220℃, the outlet air temperature is 80 to 100℃, and the spray pressure is 0.2 to 0.5 MPa; and the microencapsulation wall material is a mixture of gum arabic and malt dextrin, with the mass ratio of gum arabic accounting for 40% to 50% and malt dextrin accounting for 50% to 60%.

[0014] Preferably, the composition comprises the following ingredients and their mass ratios: evening primrose oil extract accounts for 10% to 20%, soy isoflavone extract accounts for 5% to 15%, glycyrrhizic acid dipotassium extract accounts for 2% to 8%, lactic acid bacteria fermentation broth concentrate accounts for 3% to 10%, gamma-linolenic acid accounts for 2% to 6%, phosphatidylserine accounts for 1% to 4%, selenomethionine accounts for 0.1% to 0.5%, zinc gluconate accounts for 0.2% to 0.8%, and vitamin D3 accounts for 0.05% to 0.2%.

[0015] Preferably, the composition further comprises auxiliary ingredients, including an antioxidant and a filler; the antioxidant is ascorbyl palmitate or tocopherol, with a mass fraction of 0.1% to 0.5% of the total composition; the filler is microcrystalline cellulose or starch, with a mass fraction of 50% to 70% of the total composition.

[0016] Preferably, the stability of the composition is determined by a stability test; the final composition is stored in an environment with a temperature of 40 to 50℃ and a relative humidity of 75% to 85% for 30 days, and the change rate of the active ingredient content is determined; a composition with a change rate less than 10% is considered to have good stability.

[0017] Preferably, the application method of the composition includes the following steps:

[0018] T10: determining the recommended daily intake according to the age, physiological cycle stage, and hormone test results of the individual;

[0019] T20: preparing the composition into tablet, capsule, or powder form for easy consumption;

[0020] T30: recommending consumption within 30 minutes after breakfast to improve absorption efficiency.

[0021] Preferably, in step T10, the hormone test results of the individual include the concentration ranges of estradiol, progesterone, testosterone, and follicle-stimulating hormone; based on the test results, the proportion of evening primrose oil extract and soy isoflavone extract in the composition is adjusted; when the estradiol concentration is lower than the normal range, the proportion of evening primrose oil extract is increased to 50% to 60%; when the testosterone concentration is higher than the normal range, the proportion of potassium glycyrrhizinate extract is increased to 15% to 20%.

[0022] Preferably, the method includes the following steps:

[0023] U10: collecting blood samples before and after the individual takes the composition, and determining the concentration changes of estradiol, progesterone, testosterone, and follicle-stimulating hormone;

[0024] U20: recording the improvement of symptoms during the period when the individual takes the composition, including mood swings, sleep quality, skin condition, and menstrual regularity;

[0025] U30: comprehensively analyzing the hormone concentration changes and symptom improvement, and evaluating the overall effect of the composition.

[0026] Compared with the prior art, the beneficial effects of the present application are: the present application provides a production method and formula for balancing female hormone levels by optimizing the combination of natural active ingredients and biological functional substances and their action mechanisms. The method not only solves the deficiencies of the prior art in precise regulation of hormone levels, individualized adaptability and long-term effect stability, but also achieves the goals of efficient, safe and personalized hormone regulation through specific technical means. DETAILED DESCRIPTION

[0027] The technical solutions in the embodiments of the present application are described clearly and completely, obviously, the described embodiments are only part of the embodiments of the present application, not all. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor are within the scope of protection of the present application.

[0028] The present application provides a method for preparing a composition for balancing female hormone levels, comprising the following steps:

[0029] S10: mixing plant extracts, microbial metabolites and functional lipids in a specific ratio to obtain a basic active mixture; the plant extracts include evening primrose oil extract, soy isoflavone extract and glycyrrhizic acid dipotassium extract; the microbial metabolites are lactic acid bacteria fermentation broth concentrate; the functional lipids include gamma-linolenic acid and phosphatidylserine;

[0030] S20: adding a trace element complex to the basic active mixture, and stirring uniformly to obtain an intermediate mixture; the trace element complex includes selenomethionine, zinc gluconate and vitamin D3;

[0031] S30: subjecting the intermediate mixture to microencapsulation treatment, and drying to obtain a final composition.

[0032] In step S10, the mass ratio of the plant extracts ranges from 40% to 60% for evening primrose oil extract, 20% to 35% for soy isoflavone extract, and 10% to 20% for glycyrrhizic acid dipotassium extract. The mass fraction of microbial metabolites is 5% to 15% of the total mixture. The mass ratio of functional lipids ranges from 60% to 70% for gamma-linolenic acid and 30% to 40% for phosphatidylserine. The mixing order of the above components is to mix the evening primrose oil extract and the soy isoflavone extract first, then add the glycyrrhizic acid dipotassium extract, and finally add the lactic acid bacteria fermentation broth concentrate, gamma-linolenic acid and phosphatidylserine in sequence. The temperature is controlled at 20 to 30℃ during mixing, the stirring speed is 80 to 120 revolutions per minute, and the stirring time is 30 to 60 minutes.

[0033] In step S20, the mass ratio of the trace element compound ranges from 30% to 40% of selenomethionine, 40% to 50% of zinc gluconate, and 10% to 20% of vitamin D3. The total mass of the trace element compound accounts for 0.5% to 2% of the intermediate mixture. When adding the trace element compound, the selenomethionine is first dissolved in deionized water, and then the mixed powder of zinc gluconate and vitamin D3 is added. After stirring uniformly, the mixture is gradually added to the base active mixture. The stirring speed is 100 to 150 revolutions per minute, and the stirring time is 20 to 40 minutes.

[0034] In step S30, the microencapsulation process uses a spray drying method, with an inlet temperature of 180 to 220°C, an outlet temperature of 80 to 100°C, and a spray pressure of 0.2 to 0.5 MPa. The microencapsulation wall material is a mixture of gum arabic and malt dextrin, with a mass ratio of 40% to 50% of gum arabic and 50% to 60% of malt dextrin. During the microencapsulation process, the intermediate mixture is first mixed with the microencapsulation wall material at a mass ratio of 1:1 to 1:2, and then processed through the spray drying equipment. The particle size of the dried particles ranges from 50 to 200 microns, and the moisture content is less than 5%.

[0035] In a second aspect, the present application provides a composition for balancing female hormone levels, which is prepared by the method according to any one of the embodiments of the first aspect. The composition contains the following ingredients and their mass ratios: 10% to 20% of evening primrose oil extract, 5% to 15% of soy isoflavone extract, 2% to 8% of glycyrrhizic acid dipotassium extract, 3% to 10% of lactic acid bacteria fermentation broth concentrate, 2% to 6% of γ-linolenic acid, 1% to 4% of phosphatidylserine, 0.1% to 0.5% of selenomethionine, 0.2% to 0.8% of zinc gluconate, and 0.05% to 0.2% of vitamin D3.

[0036] In some embodiments, the composition further contains auxiliary ingredients, including antioxidants and fillers. The antioxidant is ascorbic acid palmitate or tocopherol, with a mass fraction of 0.1% to 0.5% of the total composition. The filler is microcrystalline cellulose or starch, with a mass fraction of 50% to 70% of the total composition. The order of adding auxiliary ingredients is to first mix the antioxidant with the filler, and then gradually add them to the final composition. The mixing time is 10 to 20 minutes, and the mixing temperature is 20 to 25°C.

[0037] In some embodiments, the preparation process of the composition further comprises a stability test step. The final composition is stored in an environment with a temperature of 40 to 50°C and a relative humidity of 75% to 85% for 30 days, and the change rate of the active ingredient content is determined. The composition with a change rate less than 10% is considered to have good stability. During the stability test, the determination method of the active ingredient content is high performance liquid chromatography, the detection wavelength is 254 nanometers, the mobile phase is a mixed solution of methanol and water with a volume ratio of 70:30, and the flow rate is 1 milliliter per minute.

[0038] In a third aspect, the present application provides a use method based on the above-mentioned composition, comprising the following steps:

[0039] T10: determining the recommended daily intake according to the age, physiological cycle stage and hormone test results of the individual;

[0040] T20: preparing the composition into tablet, capsule or powder form for easy consumption;

[0041] T30: recommending to take within 30 minutes after breakfast to improve absorption efficiency.

[0042] In step T10, the hormone test results of the individual include the concentration ranges of estradiol, progesterone, testosterone and follicle-stimulating hormone. According to the test results, the proportion of evening primrose oil extract and soy isoflavone extract in the composition is adjusted. For example, when the estradiol concentration is lower than the normal range, the proportion of evening primrose oil extract is increased to 50% to 60%; when the testosterone concentration is higher than the normal range, the proportion of potassium glycyrrhizinate extract is increased to 15% to 20%. The recommended daily intake is calculated by linear fitting according to the individual's body weight and hormone concentration deviation value, and the recommended daily intake range is 1 to 3 grams.

[0043] In step T20, when the composition is prepared into tablets, the weight of each tablet is 0.5 to 1 gram; when prepared into capsules, the loading capacity of each capsule is 0.3 to 0.6 grams; when prepared into powder, the loading capacity of each bag is 1 to 2 grams. The preparation method of the tablet is to mix the composition with the filler and then press the tablet, the pressing pressure is 10 to 15 kilonewtons, and the tablet hardness is 5 to 8 kilograms of force. The preparation method of the capsule is to fill the composition into the gelatin capsule shell, and the filling speed is 50 to 100 capsules per minute. The preparation method of the powder is to mix the composition with the filler and then pack it into aluminum foil bags with a packing accuracy of ±0.05 grams.

[0044] In step T30, it is recommended to take within 30 minutes after breakfast, because at this time the gastric acid secretion is moderate, which is conducive to the absorption of active ingredients in the composition. At the same time, it is recommended not to take other calcium or iron supplements at the same time to avoid the formation of insoluble precipitates affecting the absorption efficiency. When taking, the water amount is 150 to 200 milliliters, and the water temperature is 20 to 30°C.

[0045] In a fourth aspect, the present application provides a method for evaluating the effect of the above composition, comprising the following steps:

[0046] U10: Collect blood samples of the individual before and after taking the composition, and determine the concentration changes of estradiol, progesterone, testosterone and follicle stimulating hormone;

[0047] U20: Record the improvement of symptoms during the period of taking the composition, including mood swings, sleep quality, skin condition and menstrual regularity;

[0048] U30: Comprehensive analysis of hormone concentration changes and symptom improvement, to evaluate the overall effect of the composition.

[0049] In step U10, the blood sample collection time is in the morning on an empty stomach to avoid the influence of diet on hormone concentration. The serum is separated immediately after collection and stored at -20 to -80°C for testing. The hormone concentration determination method is enzyme-linked immunosorbent assay, with a detection sensitivity of 0.1 ng / mL, an intra-batch coefficient of variation of less than 5%, and an inter-batch coefficient of variation of less than 10%.

[0050] In step U20, the improvement of symptoms is recorded by questionnaire survey, with a score range of 0 to 10. Among them, the mood swing score of 0 indicates no fluctuation, and the score of 10 indicates severe fluctuation; the sleep quality score of 0 indicates extremely poor, and the score of 10 indicates extremely good; the skin condition score of 0 indicates extremely poor, and the score of 10 indicates extremely good; the menstrual regularity score of 0 indicates completely irregular, and the score of 10 indicates completely regular. The time interval of the questionnaire survey is once a week, and the duration is 4 weeks.

[0051] In step U30, the overall effect of the composition is evaluated by comprehensive analysis of hormone concentration changes and symptom improvement. The data processing method is statistical analysis using SPSS software, with a significance level of P<0.05.

[0052] The technical solutions of the present application are described in detail in combination with the following examples.

[0053] Example 1

[0054] S10: Mix the evening primrose oil extract (50% by mass), soy isoflavone extract (30% by mass) and glycyrrhizic acid dipotassium extract (20% by mass), then add lactic acid bacteria fermentation liquid concentrate (10% by mass), γ-linolenic acid (65% by mass) and phosphatidylserine (35% by mass), stir for 30 minutes, control the temperature at 25°C, and the stirring speed at 100 rpm.

[0055] S20: After dissolving selenomethionine (35% by mass), zinc gluconate (45% by mass) and vitamin D3 (20% by mass), stirring for 20 minutes at a stirring speed of 120 revolutions per minute.

[0056] S30: The mixture was mixed with microcapsule wall material (arabic gum and malt dextrin at a mass ratio of 45:55) at a ratio of 1:1.5, and was treated by spray drying at an inlet temperature of 200°C, an outlet temperature of 90°C and a spray pressure of 0.3 MPa.

[0057] Example 2

[0058] The difference from Example 1 is that the mass ratio of evening primrose oil extract is 60%, the mass ratio of soy isoflavone extract is 25%, and the mass ratio of glycyrrhizic acid dipotassium extract is 15%.

[0059] Example 3

[0060] The difference from Example 1 is that the mass ratio of selenomethionine in the trace element compound is 40%, the mass ratio of zinc gluconate is 50%, and the mass ratio of vitamin D3 is 10%.

[0061] Comparative Example 1

[0062] The difference from Example 1 is that the lactic acid bacteria fermentation liquid concentrate is not added.

[0063] Comparative Example 2

[0064] The difference from Example 1 is that the microcapsulation treatment is not performed.

[0065] The following are comparative data of the examples and comparative examples:

[0066] Item Rate of change in hormone concentration (%) Emotional fluctuation score Sleep quality score Skin condition score Menstrual regularity score Example 1 15 2 8 7 9 Example 2 18 3 7 8 8 Example 3 16 2 8 7 9 Comparative Example 1 8 5 5 5 6 Comparative Example 2 10 4 6 6 7

[0067] According to the above data, the effects of Examples 1 to 3 are better than those of Comparative Examples 1 and 2, indicating that the lactic acid bacteria fermentation liquid concentrate and the microcapsulation treatment have a significant improvement effect on the composition.

[0068] Although the present application has been described in detail with reference to the foregoing embodiments, those skilled in the art can modify the technical solutions described in the foregoing embodiments, or make equivalent replacements to part of the technical features, and any modification, equivalent replacement, improvement, etc. made within the spirit and principles of the present application shall be included in the protection scope of the present application.

Claims

1. A method for preparing a composition for balancing female hormone levels, characterized in that, The method comprises the following steps: S10: mixing plant extracts, microbial metabolites and functional lipids according to specific proportions to obtain a basic active mixture; the plant extracts comprise evening primrose oil extract, soybean isoflavone extract and glycyrrhizic acid dipotassium extract; the microbial metabolites are lactic acid bacteria fermentation broth concentrate; and the functional lipids comprise gamma-linolenic acid and phosphatidylserine; S20: adding a trace element compound to the basic active mixture, and stirring uniformly to obtain an intermediate mixture; the trace element compound comprises selenomethionine, zinc gluconate and vitamin D3; S30: performing microencapsulation treatment on the intermediate mixture, and drying to obtain a final composition.

2. The method of claim 1, wherein, In the step S10, the mass ratio of the plant extracts is that the evening primrose oil extract accounts for 40% to 60%, the soybean isoflavone extract accounts for 20% to 35%, and the glycyrrhizic acid dipotassium extract accounts for 10% to 20%; the mass fraction of the microbial metabolites is 5% to 15% of the total mixture; and the mass ratio of the functional lipids is that the gamma-linolenic acid accounts for 60% to 70%, and the phosphatidylserine accounts for 30% to 40%.

3. The method of claim 1, wherein, In the step S20, the mass ratio of the trace element compound is that the selenomethionine accounts for 30% to 40%, the zinc gluconate accounts for 40% to 50%, and the vitamin D3 accounts for 10% to 20%; and the total mass of the trace element compound accounts for 0.5% to 2% of the intermediate mixture.

4. The method of claim 1, wherein, In the step S30, the microencapsulation treatment adopts a spray drying method, the inlet air temperature is 180 to 220 ℃, the outlet air temperature is 80 to 100 ℃, and the spray pressure is 0.2 to 0.5 MPa; and the microencapsulation wall material is a mixture of gum arabic and malt dextrin, and the mass ratio is that the gum arabic accounts for 40% to 50% and the malt dextrin accounts for 50% to 60%.

5. A composition for balancing female hormone levels, characterized in that, The method is prepared according to any one of claims 1 to 4; and the composition comprises the following ingredients and mass ratios: the evening primrose oil extract accounts for 10% to 20%, the soybean isoflavone extract accounts for 5% to 15%, the glycyrrhizic acid dipotassium extract accounts for 2% to 8%, the lactic acid bacteria fermentation broth concentrate accounts for 3% to 10%, the gamma-linolenic acid accounts for 2% to 6%, the phosphatidylserine accounts for 1% to 4%, the selenomethionine accounts for 0.1% to 0.5%, the zinc gluconate accounts for 0.2% to 0.8%, and the vitamin D3 accounts for 0.05% to 0.2%.

6. The composition of claim 5, wherein, The composition further comprises auxiliary ingredients, including an antioxidant and a filler; the antioxidant is ascorbic acid palmitate or tocopherol, and the mass fraction is 0.1% to 0.5% of the total composition; and the filler is microcrystalline cellulose or starch, and the mass fraction is 50% to 70% of the total composition.

7. The composition of claim 5, wherein, The stability of the composition is determined by a stability test; the final composition is stored in an environment with a temperature of 40 to 50 ℃ and a relative humidity of 75% to 85% for 30 days, and the change rate of the content of effective components is determined; the composition with a change rate less than 10% is considered to have good stability.

8. A method of use based on the composition according to any one of claims 5 to 7, characterized in that, The method comprises the following steps: T10: determining the daily recommended intake according to the age, physiological cycle stage and hormone test result of an individual; T20: The composition is made into tablet, capsule or powder form for easy consumption; T30: It is recommended to take within 30 minutes after breakfast to improve absorption efficiency.

9. The method of claim 8, wherein, In step T10, the hormone test results of the individual include the concentration ranges of estradiol, progesterone, testosterone and follicle-stimulating hormone; according to the test results, the proportion of evening primrose oil extract and soy isoflavone extract in the composition is adjusted; when the estradiol concentration is lower than the normal range, the proportion of evening primrose oil extract is increased to 50% to 60%; when the testosterone concentration is higher than the normal range, the proportion of glycyrrhizic acid dipotassium extract is increased to 15% to 20%.

10. A method of evaluating the effect of the composition according to any one of claims 5 to 7, characterized in that, Including the following steps: U10: Collect blood samples before and after the individual takes the composition, and measure the concentration changes of estradiol, progesterone, testosterone and follicle-stimulating hormone; U20: Record the improvement of symptoms during the individual taking the composition, including mood swings, sleep quality, skin condition and menstrual regularity; U30: Comprehensive analysis of hormone concentration changes and symptom improvement, evaluate the overall effect of the composition.