Equoluxe Multivitamin Tablets: A Natural Hormone Regulator and Its Preparation Process

Abstract

This invention discloses an Equoluxe multivitamin tablet containing a natural hormone regulator and its preparation process, belonging to the field of pharmaceutical technology. The invention comprises the following formula in parts by weight: 80-100 parts soybean extract, 20-55 parts plant-based lactic acid bacteria, 5-10 parts ginseng extract, 80 parts ginger extract, and 10-30 parts excipients. This invention, through a specific combination, works synergistically to promote estrogen secretion in women, enhance ovarian function, and maintain hormonal balance. By microencapsulating the plant-based lactic acid bacteria during pretreatment, this invention significantly improves the activity retention rate during tableting and storage, achieving an activity retention rate of over 87% after 6 months under accelerated conditions, thus solving the technical problem of poor stability in probiotic products. This invention employs a gradient mixing and low-temperature pressing process to avoid local aggregation of highly active ingredients and high-temperature inactivation, ensuring the uniformity of content and bioavailability of key components such as equoluxone and lactic acid bacteria in the tablets.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical technology, specifically to a natural hormone regulator, Equoluxe multivitamin tablets, and its preparation process. Background Technology

[0002] In the field of medical and health technology, hormonal balance plays a crucial role in maintaining women's physiological health. However, currently used hormone-regulating drugs have revealed many serious risks during use. Traditional hormone-regulating drugs are mostly synthetic hormones, and long-term or improper use can easily lead to a series of adverse reactions. For example, they increase the risk of malignant tumors such as breast cancer and endometrial cancer. Numerous clinical research data show that women who rely on synthetic hormone drugs long-term have a significantly higher incidence of breast cancer compared to the general population. Simultaneously, they may also increase the risk of cardiovascular disease and cause thrombosis, posing a serious threat to women's health and lives.

[0003] On the other hand, the incidence of premature ovarian failure (POF) has shown a significant upward trend in recent years, becoming a major health problem troubling many women. POF disrupts the hormonal balance in women, leading not only to premature menopause and symptoms such as hot flashes, night sweats, insomnia, and mood swings, severely impacting quality of life, but also causing infertility and other problems, placing a huge psychological and physiological burden on patients and their families. According to relevant statistics, the incidence of POF among women of childbearing age has reached a certain proportion, and the age of onset is showing a trend towards younger ages.

[0004] There is an urgent need for a safe and effective product that can achieve hormonal balance regulation based on natural ingredients, especially by using the bidirectional regulatory properties of equol to improve hormonal imbalances, while avoiding the harm caused by traditional synthetic hormone drugs. It also has a positive effect on improving problems such as premature ovarian failure or perimenopausal symptoms.

[0005] The information disclosed above in this background section is only for enhancing the understanding of the background section of this invention, and therefore may include prior art that is not known to those skilled in the art. Summary of the Invention

[0006] The purpose of this invention is to provide Equoluxe multivitamin tablets, a natural hormone regulator, and its preparation process, in order to solve the problems in the prior art.

[0007] To achieve the above objectives, the present invention provides the following technical solution: an Equoluxe multivitamin tablet containing a natural hormone regulator, comprising the following ingredients by weight: 80-100 parts soybean extract, 20-55 parts plant-based lactic acid bacteria, 5-10 parts ginseng extract, 80 parts ginger extract, and 10-30 parts excipients.

[0008] Preferably, the soybean extract contains natural equol, and the equol content in the soybean extract is 20%-30% of the total soybean extract mass.

[0009] Preferably, the plant-based lactic acid bacteria are Lactobacillus species, and the content of active bacteria is 1×10⁻⁶. 8 CFU / g up to 1×10¹ 0 CFU / g.

[0010] Preferably, the excipients include one or more of sorbitol, magnesium stearate, and crystalline cellulose, wherein the mass ratio of sorbitol, magnesium stearate, and crystalline cellulose in the excipients is 3:1:2.

[0011] A process for preparing Equoluxe multivitamin tablets as described above includes the following steps:

[0012] S1. Plant-based lactic acid bacteria are mixed with a portion of sorbitol and crystalline cellulose at a mass ratio of 2:1:1, and microencapsulated using fluidized bed spray drying technology to obtain microencapsulated lactic acid bacteria particles.

[0013] S2. Mix soybean extract, ginseng extract, ginger extract and the remaining sorbitol and crystalline cellulose in an equal-incremental manner to obtain a premixed powder;

[0014] S3. Add the microencapsulated lactic acid bacteria particles obtained in step S1 and the premixed powder obtained in step S2 into a three-dimensional mixer and mix for 20-40 minutes. Then add magnesium stearate and continue mixing for 5-10 minutes to obtain the total mixed powder.

[0015] S4. The total mixed powder obtained in step S3 is compressed into tablets using a tableting machine. During the tableting process, the ambient temperature is controlled to be ≤25℃, the tableting machine punch temperature is controlled to be ≤30℃, and the tablet hardness is controlled to be 5-8 kp to obtain the Equoluxe multivitamin tablets.

[0016] Preferably, in step S1, the microencapsulation treatment conditions are: inlet air temperature 50-60℃, outlet air temperature 35-45℃, and spray pressure 0.2-0.3 MPa.

[0017] Preferably, in step S3, the mixing speed of the three-dimensional mixer is 10-20 r / min, and the mixing temperature is 20-25℃.

[0018] Preferably, in step S4, the tablet thickness is 3-6 mm and the disintegration time is 5-8 minutes.

[0019] Preferably, after step S4, step S5 is further included: coating the obtained tablets with a film, with the coating weight gain being 2%-5% of the tablet core weight.

[0020] Preferably, the film coating uses gastrointestinal or enteric coating powder, and the spray gun pressure during the coating process is 0.2-0.3 MPa, the inlet air temperature is 45-55℃, and the tablet bed temperature is 35-40℃.

[0021] Compared with the prior art, the present invention has the following beneficial effects:

[0022] 1. This invention uses a specific ratio of ingredients to work synergistically to promote the secretion of estrogen in women, enhance ovarian function, and maintain hormonal balance. Clinical trial data show that, compared with the placebo group, taking this product can increase the level of estrogen in women's bodies faster and more effectively, and alleviate the symptoms of premature ovarian failure.

[0023] 2. Unlike traditional synthetic estrogen drugs, the formulation of this invention is mainly composed of natural ingredients, such as natural equol contained in soybean extract. This greatly reduces the risk of malignant tumors such as breast cancer and endometrial cancer caused by long-term use of synthetic hormones, and reduces the threat of cardiovascular disease and thrombosis, providing women with a safer way to supplement their hormones.

[0024] 3. This invention significantly improves the activity retention rate of plant-based lactic acid bacteria during tableting and storage by microencapsulating them before pretreatment. Under accelerated conditions, the activity retention rate reaches over 87% after 6 months, solving the technical problem of poor stability in probiotic products. This invention employs gradient mixing and low-temperature pressing processes to avoid local aggregation of highly active ingredients and high-temperature inactivation, ensuring the uniformity of content and bioavailability of key components such as equol and lactic acid bacteria in the tablets.

[0025] 4. This invention utilizes film coating technology to achieve targeted release of active ingredients, thereby improving the intestinal absorption efficiency of the product and enhancing the bidirectional regulatory effect of hormones. Attached Figure Description

[0026] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in this invention. For those skilled in the art, other drawings can be obtained based on these drawings.

[0027] Figure 1 This is a flowchart illustrating the preparation process of the present invention. Detailed Implementation

[0028] To enable those skilled in the art to better understand the technical solutions of the present invention, the present invention will be further described in detail below with reference to the accompanying drawings. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0029] The research and development of this invention took 24 months. Focusing on the core need for natural hormone regulation in women, and adhering to the principles of "safety, high efficiency, synergistic effect, and process feasibility," the core formula and preparation process were screened and optimized in three phases. Key research data and screening results for each phase are as follows:

[0030] I. Screening of core active ingredients

[0031] To target natural estrogen-regulating components, 12 natural raw materials, including soybean extract, kudzu root extract, and flaxseed extract, were screened. Using equol content, bioavailability, and bidirectional hormone regulation activity as core indicators, in vitro cell experiments (human ovarian granulosa cell model) and in vivo animal experiments (premature ovarian failure mouse model) were conducted to verify the results. The results showed that the hormone-regulating activity of natural equol in soybean extract was 3.2 times that of kudzu root extract and 4.5 times that of flaxseed extract, with a bioavailability of 38.6% (far higher than other raw materials), thus identifying soybean extract as the core active ingredient.

[0032] Meanwhile, to address the limited regulatory effect of soybean extract alone, auxiliary ingredients such as probiotics and extracts from medicinal and edible plants were screened. Ultimately, plant-based lactic acid bacteria (enhancing intestinal absorption of equol), ginseng extract (synergistically improving ovarian function), and ginger extract (promoting the systemic effects of the ingredients) were identified as synergistic ingredients. The in vitro hormone regulation activity of the combination of the four ingredients was 2.8 times higher than that of soybean extract alone.

[0033] II. Orthogonal Optimization of Formula and Proportion

[0034] Using L9(3) 4 An orthogonal experimental design was used, with soybean extract (80, 90, 100 parts), plant-based lactic acid bacteria (20, 35, 55 parts), ginseng extract (5, 8, 10 parts), and ginger extract (75, 80, 85 parts) as the factors to be investigated. The estradiol recovery rate, menopausal symptom relief rate, and lactic acid bacteria activity retention rate in mice with premature ovarian failure were used as evaluation indicators. The results of the orthogonal experiment are shown in Table 1.

[0035]

[0036] Table 1. Results of orthogonal experiments on formulation ratios (n=10, x±s)

[0037] Analysis of orthogonal experimental results: The optimal ratio of soybean extract (90 parts), plant-based lactic acid bacteria (35-40 parts), ginseng extract (8 parts), and ginger extract (80 parts) was found to be the highest overall score. The effective range of each component was determined to be 80-100 parts soybean extract, 20-55 parts plant-based lactic acid bacteria, 5-10 parts ginseng extract, and 80 parts ginger extract.

[0038] III. Raw material screening and key indicator verification experiments

[0039] 3.1 Screening experiment on equol content in soybean extract

[0040] Soybean extracts with different equol contents (10%, 20%, 30%, and 40%) were screened to investigate their bidirectional hormone regulatory activity. The results showed that when the equol content was below 20%, the hormone regulatory activity significantly increased with increasing content; when the content was between 20% and 30%, the activity reached its peak and tended to stabilize; when the content was above 30%, the activity did not significantly increase, and the raw material cost increased by more than 40%. Therefore, the optimal range for equol content in soybean extracts was determined to be 20%-30%, balancing activity and cost-effectiveness.

[0041] 3.2 Screening experiment on plant-based lactic acid bacteria strains and their activities

[0042] Three strains of Lactobacillus—Lactobacillus plantarum, Lactobacillus acidophilus, and Lactobacillus casei—were screened, and different viable bacterial contents (1×10⁻⁶) were measured. 7 1×10 8 1×10 9 1×10¹ 0 The results showed that *Lactobacillus plantarum* (1×10¹¹ CFU / g) promoted equol absorption by 42.3%, significantly higher than *Lactobacillus acidophilus* (28.5%) and *Lactobacillus casei* (21.7%). The viable bacterial content was 1×10¹¹ CFU / g. 8 CFU / g up to 1×10¹ 0 At a concentration of CFU / g, the intestinal colonization ability and activity retention rate are optimal; concentrations below 1×10⁻⁶ are optimal. 8 The effect is limited at CFU / g, and even above 1×10¹ 0 At CFU / g, the bacteria are easily inactivated during preparation; therefore, the plant-based lactic acid bacteria were determined to be *Lactobacillus plantarum*, with an active bacteria content of 1×10⁻⁶. 8 CFU / g up to 1×10¹ 0 CFU / g.

[0043] 3.3 Screening experiment for excipient ratio

[0044] Sorbitol, magnesium stearate, and crystalline cellulose were used as excipients and mixed in different mass ratios (2:1:3, 3:1:2, 4:1:1). The tablet formation, flowability, and disintegration time were examined, and the results are shown in Table 2.

[0045] Table 2. Results of the screening experiment for excipient ratio

[0046]

[0047] The results showed that the excipient combination with a mass ratio of 3:1:2 was the optimal ratio, taking into account the tablet's flowability, formability, and disintegration time.

[0048] IV. Optimization Experiment of Preparation Process Parameters

[0049] To determine the optimal preparation process for the Equoluxe multivitamin tablets of this invention, the microencapsulation process conditions, gradient mixing process parameters, tableting temperature, and hardness were optimized using single-factor and orthogonal experiments, with lactic acid bacteria activity retention rate, tablet content uniformity, disintegration time, and hardness as the main evaluation indicators.

[0050] 4.1 Optimization of Microencapsulation Process Conditions

[0051] Using plant-based lactic acid bacteria as the core material and sorbitol and crystalline cellulose as the wall material, microencapsulation was performed using fluidized bed spray drying technology. The inlet air temperature (A), outlet air temperature (B), and spray pressure (C) were considered, and the retention rate of lactic acid bacteria activity was used as the evaluation index. L9(3) 4 Orthogonal experiment. Factor levels are shown in Table 3, and experimental results are shown in Table 4.

[0052] Table 3. Microencapsulation process factor level table

[0053]

[0054] Table 4. Results of orthogonal experiments on microencapsulation process

[0055]

[0056] Range analysis showed that the order of influence of each factor on the retention rate of lactic acid bacteria activity was: inlet air temperature (A) > outlet air temperature (B) > spray pressure (C). The optimal combination was A2B2C3, i.e., inlet air temperature 55℃, outlet air temperature 40℃, and spray pressure 0.3MPa. Under these conditions, the retention rate of lactic acid bacteria activity reached 93.4%±1.1%, which was significantly better than the 78.6%±2.3% of the non-microencapsulated control group (P<0.01).

[0057] 4.2 Optimization of Gradient Mixing Process Parameters

[0058] To ensure the uniformity of the content of each component in the total powder mixture, the mixing time, mixing speed, and mixing temperature during the gradient mixing process were examined. Single-factor experiments were conducted using content uniformity (expressed as the relative standard deviation (RSD) of equol content) as the evaluation index.

[0059] Table 5. Effects of gradient mixing process parameters on content uniformity

[0060]

[0061] The results showed that when the mixing time was above 20 minutes, the content uniformity tended to stabilize, with an RSD value ≤ 2.5%; the uniformity was optimal when the mixing speed was in the range of 10-15 r / min; and the activity of lactic acid bacteria decreased slightly when the mixing temperature exceeded 25℃. Taking all factors into consideration, the gradient mixing process parameters were determined to be: mixing time 20-40 minutes, mixing speed 10-20 r / min, and mixing temperature 20-25℃.

[0062] 4.3 Optimization of tableting process parameters

[0063] To balance tablet formability and lactic acid bacteria activity retention, the ambient temperature, punch temperature, and tablet hardness during the tableting process were investigated. Single-factor experiments were conducted using tablet disintegration time, hardness, and lactic acid bacteria activity retention rate as evaluation indicators.

[0064] Table 6. Effects of tableting process parameters on tablet quality

[0065]

[0066] The results showed that when the tablet hardness was controlled within 5-8 kp, the disintegration time was within 5-8 minutes, and the lactic acid bacteria activity retention rate was >90%. When the hardness exceeded 10 kp, the disintegration time was prolonged, and the lactic acid bacteria activity decreased significantly. When the ambient temperature was ≤25℃ and the punch temperature was ≤30℃, the lactic acid bacteria activity retention rate could be maintained above 90%. Therefore, the tableting process parameters were determined to be: ambient temperature ≤25℃, punch temperature ≤30℃, and tablet hardness controlled within 5-8 kp.

[0067] 4.4 Optimization Process Validation Experiment

[0068] Three batches of Equoluxe multivitamin tablets were prepared according to the optimized process parameters described above, and their key quality indicators were tested. The results are shown in Table 7.

[0069] Table 7. Results of the process optimization verification experiment (n=3, x±s)

[0070]

[0071] The verification results show that, using the optimized preparation process, all indicators of the three batches of samples met the expected requirements, with good process repeatability and high stability, and can be used for large-scale production.

[0072] Through the above process parameter optimization experiments, the optimal preparation process of the Equoluxe multivitamin tablets of the present invention was determined to be as follows: for the microencapsulation process, the inlet air temperature is 55℃, the outlet air temperature is 40℃, and the spray pressure is 0.3 MPa; for the gradient mixing process, the mixing time is 20-40 minutes, the mixing speed is 10-20 r / min, and the mixing temperature is 20-25℃; for the tableting process, the ambient temperature is ≤25℃, the punch temperature is ≤30℃, and the tablet hardness is 5-8 kp.

[0073] The above process can effectively protect the activity of plant-based lactic acid bacteria, ensure the uniformity of tablet content and good disintegration properties, and provide process assurance for the quality stability and effectiveness of the product.

[0074] V. Stability Test

[0075] To verify the storage stability of the Equoluxe multivitamin tablets of the present invention, three batches of samples were prepared according to the determined preparation process and stored in a cool and dry place (25℃±2℃, relative humidity 60%±5%) and under accelerated conditions (40℃±2℃, relative humidity 75%±5%) for 6 months. Samples were taken at 0, 1, 3 and 6 months respectively to examine the appearance, hardness, disintegration time, equorol content, lactic acid bacteria activity and other indicators. The results are shown in Table 8.

[0076] Table 8. Stability test results (n=3, x±s)

[0077]

[0078] Stability test results show that the Equoluxe multivitamin tablets of the present invention, when stored under cool and dry conditions for 6 months, showed no significant changes in any of the indicators, and the equorol content and lactic acid bacteria activity retention rates were both above 85%; even when stored under accelerated conditions for 6 months, the tablets still maintained good shape retention and activity, proving that the product of the present invention has excellent storage stability and a shelf life of up to 36 months.

[0079] Example 1: Preparation of Equoluxe Multivitamin Tablets

[0080] This embodiment provides an Equoluxe multivitamin tablet containing a natural hormone regulator, which is composed of the following ingredients by weight:

[0081] 90 parts of soybean extract, with 25% equol content;

[0082] 35 samples of plant-based lactic acid bacteria, including *Lactobacillus plantarum*, with a live bacteria content of 5 × 10⁻⁶. 8 CFU / g;

[0083] 8 portions of ginseng extract;

[0084] 80 parts of ginger extract;

[0085] 20 parts of excipients, sorbitol, magnesium stearate and crystalline cellulose are mixed in a mass ratio of 3:1:2.

[0086] The preparation process is as follows:

[0087] S1. Plant-based lactic acid bacteria are mixed with a portion of sorbitol and crystalline cellulose at a mass ratio of 2:1:1, and microencapsulated using fluidized bed spray drying technology. The inlet air temperature is 55℃, the outlet air temperature is 40℃, and the spray pressure is 0.3 MPa to obtain microencapsulated lactic acid bacteria particles.

[0088] S2. Mix soybean extract, ginseng extract, ginger extract and the remaining sorbitol and crystalline cellulose in an equal-incremental manner to obtain a premixed powder;

[0089] S3. Add the microencapsulated lactic acid bacteria particles obtained in step S1 and the premixed powder obtained in step S2 into a three-dimensional mixer. Mix at 15 r / min and 22℃ for 30 minutes. Then add magnesium stearate and continue mixing for 8 minutes to obtain the total mixed powder.

[0090] S4. The total mixed powder obtained in step S3 is compressed into tablets using a tablet press. The ambient temperature is ≤25℃, the punch temperature is ≤30℃, and the tablet hardness is controlled at 6.5 kp to obtain tablet cores.

[0091] S5. The obtained tablets are coated with a gastrosoluble coating powder. The coating weight gain is 3% of the tablet core weight. The spray gun pressure is 0.25 MPa, the air inlet temperature is 50℃, and the tablet bed temperature is 38℃.

[0092] The resulting tablets had a smooth appearance, a disintegration time of 6.5 minutes, a lactic acid bacteria activity retention rate of 93.2%, and an equol content uniformity RSD of 2.3%.

[0093] Example 2: Preparation of Equoluxe Multivitamin Tablets

[0094] The difference between this embodiment and Embodiment 1 lies in the different formulation:

[0095] 80 parts of soybean extract, with 20% equol content;

[0096] 20 samples of plant-based lactic acid bacteria, with an active bacteria content of 1×10⁻⁶. 8 CFU / g;

[0097] 5 portions of ginseng extract;

[0098] 80 parts of ginger extract;

[0099] The excipients are 10 parts, with a mass ratio of sorbitol, magnesium stearate, and crystalline cellulose of 3:1:2.

[0100] The preparation process was basically the same as in Example 1. The resulting tablets had a disintegration time of 5.8 minutes, a lactic acid bacteria activity retention rate of 90.5%, and an equol content uniformity RSD of 2.8%.

[0101] Example 3: Preparation of Equoluxe Multivitamin Tablets

[0102] The difference between this embodiment and Embodiment 1 lies in the different formulation:

[0103] 100 parts of soybean extract contain 30% equol;

[0104] 55 samples of plant-based lactic acid bacteria, with a live bacteria content of 1×10¹ 0 CFU / g;

[0105] 10 portions of ginseng extract;

[0106] 80 parts of ginger extract;

[0107] 30 parts of excipients, sorbitol, magnesium stearate and crystalline cellulose in a mass ratio of 3:1:2.

[0108] The preparation process was basically the same as in Example 1. The resulting tablets had a disintegration time of 7.0 minutes, a lactic acid bacteria activity retention rate of 91.2%, and an equol content uniformity RSD of 2.5%.

[0109] Experimental Case 1: In vivo pharmacodynamic experiment of a mouse model of premature ovarian failure

[0110] To verify the effect of the Equoluxe multivitamin tablets of the present invention on premature ovarian failure, a premature ovarian failure model was established using female Kunming mice (intraperitoneal injection of cyclophosphamide). The mice were randomly divided into a model control group, a positive control group (estradiol), Example 1 group, Example 2 group, and Example 3 group. The mice were administered the medication continuously for 30 days, and the serum estradiol (E2), follicle-stimulating hormone (FSH) levels and ovarian index were measured.

[0111] The results are shown in Table 9 below:

[0112]

[0113] The results showed that all groups of the present invention could significantly increase the E2 level, decrease the FSH level, and improve the ovarian index in mice with premature ovarian failure. Among them, the effect of the first group was the best, close to the level of the normal control group and better than the positive control group.

[0114] Experimental Case 2: Acute Toxicity Experiment

[0115] To evaluate the safety of this invention, acute toxicity experiments were conducted using Kunming mice. The mice were administered the tablet suspension from Example 1 at a maximum dose of 20 g / kg, equivalent to 200 times the human clinical dose, and observed for 14 consecutive days. Results showed that all mice exhibited normal activity, with no deaths or significant toxic reactions, and no abnormalities were observed in major organs, indicating that this invention has high safety.

[0116] Experimental Case 3: Genotoxicity Experiment (Ames Experiment)

[0117] The Ames test was conducted using Salmonella Typhimurium strains TA97, TA98, TA100, and TA102 to evaluate the genotoxicity of the tablets in Example 1. The results showed that, under both conditions with and without the S9 metabolic activation system, the number of revertant colonies in each dosage group did not exceed twice that of the control group, indicating no dose-response relationship and demonstrating that the present invention has no genotoxicity.

[0118] Experiment Case 4: Comparison Experiment with Commercially Available Products

[0119] A commercially available brand of soy isoflavone tablets was selected as a control and compared with the tablets in Example 1 to examine the estradiol recovery rate, lactic acid bacteria activity retention rate, and disintegration time of the two tablets in mice with premature ovarian failure at the same dosage.

[0120] The results are shown in Table 10 below:

[0121]

[0122] The results show that the present invention is significantly superior to commercially available products in terms of hormone regulation effect, disintegration performance and retention of active ingredients.

[0123] The above embodiments and experimental cases demonstrate that the Equoluxe multivitamin tablets provided by this invention have significant advantages in terms of formulation, preparation process, pharmacodynamic effects, and safety, and possess good industrial application prospects and market promotion value.

[0124] The foregoing has only described certain exemplary embodiments of the present invention by way of illustration. Undoubtedly, those skilled in the art can modify the described embodiments in various ways without departing from the spirit and scope of the present invention. Therefore, the foregoing drawings and descriptions are illustrative in nature and should not be construed as limiting the scope of protection of the claims of the present invention.

Claims

1. An Equoluxe multivitamin tablet containing a natural hormone regulator, characterized in that: The formula consists of the following parts by weight: 80-100 parts soybean extract, 20-55 parts plant-based lactic acid bacteria, 5-10 parts ginseng extract, 80 parts ginger extract, and 10-30 parts excipients.

2. The Equoluxe multivitamin tablet, a natural hormone regulator according to claim 1, is characterized in that: The soybean extract contains natural equol, and the equol content in the soybean extract is 20%-30% of the total soybean extract mass.

3. The Equoluxe multivitamin tablet, a natural hormone regulator according to claim 1, is characterized in that: The plant-based lactic acid bacteria are Lactobacillus species, and their active bacteria content is 1×10⁻⁶. 8 CFU / g up to 1×10¹ 0 CFU / g.

4. The Equoluxe multivitamin tablet, a natural hormone regulator according to claim 1, is characterized in that: The excipients include one or more of sorbitol, magnesium stearate, and crystalline cellulose, wherein the mass ratio of sorbitol, magnesium stearate, and crystalline cellulose in the excipients is 3:1:

2.

5. A process for preparing Equoluxe multivitamin tablets as described in any one of claims 1-4, characterized in that: Includes the following steps: S1. Plant-based lactic acid bacteria are mixed with a portion of sorbitol and crystalline cellulose at a mass ratio of 2:1:1, and microencapsulated using fluidized bed spray drying technology to obtain microencapsulated lactic acid bacteria particles. S2. Mix soybean extract, ginseng extract, ginger extract and the remaining sorbitol and crystalline cellulose in an equal-incremental manner to obtain a premixed powder; S3. Add the microencapsulated lactic acid bacteria particles obtained in step S1 and the premixed powder obtained in step S2 into a three-dimensional mixer and mix for 20-40 minutes. Then add magnesium stearate and continue mixing for 5-10 minutes to obtain the total mixed powder. S4. The total mixed powder obtained in step S3 is compressed into tablets using a tableting machine. During the tableting process, the ambient temperature is controlled to be ≤25℃, the tableting machine punch temperature is controlled to be ≤30℃, and the tablet hardness is controlled to be 5-8 kp to obtain the Equoluxe multivitamin tablets.

6. The preparation process according to claim 5, characterized in that: In step S1, the microencapsulation conditions are: inlet air temperature 50-60℃, outlet air temperature 35-45℃, and spray pressure 0.2-0.3 MPa.

7. The preparation process according to claim 5, characterized in that: In step S3, the mixing speed of the three-dimensional mixer is 10-20 r / min, and the mixing temperature is 20-25℃.

8. The preparation process according to claim 5, characterized in that: In step S4, the tablet thickness is 3-6 mm and the disintegration time is 5-8 minutes.

9. The preparation process according to claim 5, characterized in that: After step S4, step S5 is also included: coating the obtained tablets with a film, with the coating weight gain being 2%-5% of the tablet core weight.

10. The preparation process according to claim 9, characterized in that: The film coating uses gastrointestinal or enteric coating powder. During the coating process, the spray gun pressure is 0.2-0.3 MPa, the inlet air temperature is 45-55℃, and the tablet bed temperature is 35-40℃.

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