Oral nutritional supplement for preventing hair loss and promoting hair growth as well as preparation process and clinical application of oral nutritional supplement

Abstract

The invention provides an oral nutritional supplement for preventing hair loss and promoting hair growth as well as a preparation process and clinical application thereof, belongs to the field of hair loss beautifying compositions, and solves the problems of low preparation efficiency, poor taste, unsatisfactory effect and the like of the existing oral nutritional supplement for preventing hair loss and promoting hair growth. The preparation process of the hair loss preventing and hair growth promoting oral nutritional supplement comprises the following preparation steps: S1, raw material pretreatment: S1A, embedding microencapsulation treatment; s1B, crushing and drying treatment; s1C, carrying out dilution treatment; s2, grouping and mixing; s3, total mixing; s4, performing granulation; s5, drying and sterilizing; s6, sub-packaging; s7, quality inspection; and S8, packaging and warehousing. According to the invention, active ingredient protection and stability control are ensured, and the mixing uniformity is ensured to the greatest extent through targeted pretreatment; the content of each bag of products is ensured to be consistent, and an all-around protection system of low-temperature sterilization, oxygen isolation, moisture prevention and light shielding is constructed; the whole process is divided into a preprocessing module, a grouping mixing module, a total mixing module and the like, and logic is clear.

Description

Technical Field

[0001] This invention belongs to the technical field of hair loss and beauty composition, and relates to an oral nutritional supplement for preventing hair loss and promoting hair growth, particularly a preparation process of an oral nutritional supplement for preventing hair loss and promoting hair growth and its clinical application. Background Technology

[0002] Hair loss (especially androgenetic alopecia) has become an increasingly prevalent health problem, affecting hundreds of millions of men and women worldwide. With faster-paced lifestyles, increased stress, and changes in dietary habits, hair loss is increasingly affecting younger people. The market demand for safe, effective, and convenient hair loss prevention and regrowth products is growing rapidly. Oral supplements have received widespread attention due to their ease of use, adherence to treatment, and ability to regulate hair loss from within the body.

[0003] Many oral hair loss prevention and hair regrowth products on the market currently suffer from one or more of the following problems: limited formula and limited effectiveness; poor stability of active ingredients; difficulty in ensuring the uniformity of trace ingredient mixing; and bioavailability issues.

[0004] Other dosage forms and taste limitations: Some products are ordinary powders or large capsules, which may have problems such as odor, poor taste, and difficulty in swallowing, affecting user experience and long-term adherence.

[0005] Based on this, we propose an oral nutritional supplement for preventing hair loss and promoting hair growth, its preparation process, and its clinical application. Summary of the Invention

[0006] The purpose of this invention is to address the aforementioned problems in existing technologies by proposing an oral nutritional supplement for preventing hair loss and promoting hair growth, its preparation process, and its clinical application. The technical problem this invention aims to solve is: how to achieve efficient, stable, and consistent production of an oral nutritional supplement with good therapeutic effects on hair loss, while ensuring the taste and easy absorption of the oral nutritional supplement for preventing hair loss and promoting hair growth.

[0007] The objective of this invention can be achieved through the following technical solutions: A preparation process for an oral nutritional supplement for preventing hair loss and promoting hair growth includes the following preparation steps: S1, Raw material pretreatment: S1A, encapsulation process: Encapsulation wall material selection: Oil phase mixing, first mix tocotrienol, vitamin D3, Omega-3 fatty acid, Omega-6 fatty acid, and saw palmetto extract, and stir in a 60℃ water bath until melted; Aqueous phase mixing: Maltodextrin and gum arabic are dissolved in purified water and stirred at 60°C until dissolved; Emulsification: Slowly add the oil phase to the aqueous phase, high-speed shearing: 10000 rpm, 5 min, high-pressure homogenization: 20 MPa, 2 times; Then, spray drying is performed to obtain fat-soluble microcapsule powder; S1B, Crushing and Drying Process: The pumpkin seeds are crushed to obtain pumpkin seed powder, and the powder is sieved to remove large particles to ensure uniform particle size. Then it is dried to a moisture content of <5% to avoid introducing moisture. S1C, dilution treatment: Vitamin B2, vitamin B7 and vitamin B12 are mixed and diluted with maltodextrin respectively to obtain vitamin B2 dilution, vitamin B7 dilution and vitamin B12 dilution respectively; S2, Grouped Mixing: Mix the fat-soluble microcapsule powder and vitamin B12 diluent for 5 minutes and record it as Group A mixture; Mix the following components by mass fractions: 4.9±0.1 parts zinc gluconate, 0.36±0.01 parts copper gluconate, 1.1±0.1 parts ferrous gluconate, 30±1 parts L-cysteine, and 200±5 parts L-methionine. Stir for 8 minutes and record as mixture B. Mix 70±1 parts of isoflavones, 200±5 parts of marine collagen peptides, 150±5 parts of curcumin, and 3±0.5 parts of capsaicin by mass for 10 minutes, and record this mixture as Group C. Mix the vitamin B2 diluent and vitamin B7 diluent together for 10 minutes and record this mixture as Group D. Mix the following components by weight: 300±5 parts of fructooligosaccharide, 679±5 parts of pumpkin seed powder, 480±5 parts of maltodextrin, 120±5 parts of erythritol, 15±1 parts of glidin, 0.1±0.01 parts of antioxidant, 5±0.5 parts of flavoring agent, and 35±1 parts of acidulant. Stir for 5 minutes and record as mixture E. S3, Total Mixing: Following the principle of equal incremental addition, first mix the D group mixture with half of the E group mixture, then add the C group mixture and mix thoroughly; then add the B group mixture and mix; then add the A group mixture, and finally add the remaining E group mixture and mix for 20 minutes. The uniformity RSD < 3% is used to obtain the total mixture. S4, Granulation: The total mixture is extruded into granules to obtain uniform granules; S5, Drying and sterilization: Drying temperature 50-60℃, dry to moisture <3%, and then sterilize by cobalt-60 irradiation or microwave sterilization to ensure that the microbial standards are met. The cobalt-60 irradiation sterilization dose is 2-10kGy. S6, Packaging: Granules are bagged, 3.5g per bag, with the weight difference controlled within ±5%, and the packaging material is a composite film with good barrier properties; Nitrogen-filled packaging: Each bag is filled with nitrogen and heat-sealed; Outer packaging: 10 bags / box, with desiccant inside, store in a cool and dry place; S7, Quality Inspection: Conduct quality inspections on the finished product, including but not limited to, quantity variation, content uniformity, moisture content, microorganisms, and disintegration time. S8, Packaging and Warehousing: Store in a cool, dry place away from light.

[0008] The oil phase mixture in S1A comprises 120±5 parts by mass of tocotrienol, 0.005±0.001 parts by mass of vitamin D3, 100±5 parts by mass of Omega-3 fatty acids, 60±1 parts by mass of Omega-6 fatty acids, and 250±5 parts by mass of saw palmetto extract. The spray drying parameters of S1A are: inlet air temperature 180-200℃, outlet air temperature 80-90℃, and injection rate 10-15mL / min.

[0009] The components in the aqueous phase mixture of S1A are 500±5 parts maltodextrin, 165±5 parts gum arabic, and 1335±5 parts purified water, and the solid content of the aqueous phase mixture is 30-40%.

[0010] The vitamin B2 diluent in S1C contains 0.15 ± 0.01 parts vitamin B2 and 1.5 ± 0.1 parts maltodextrin by mass.

[0011] The vitamin B7 diluent contains 0.0006±0.00005 parts vitamin B7 and 0.6±0.01 parts maltodextrin by mass.

[0012] The vitamin B12 diluent in S1C comprises 0.0002±0.00005 parts vitamin B12 and 2±0.1 parts maltodextrin by mass. The vitamin B12 is diluted stepwise with maltodextrin: first, all the vitamin B12 is added and mixed evenly with maltodextrin at a ratio of 1:100 to obtain the first-stage diluent powder. Then, the remaining maltodextrin is added and mixed evenly to obtain the second-stage diluent powder. The ratio of vitamin B12 to maltodextrin is 1:10000.

[0013] The flow aids in S2 include, but are not limited to, silica; antioxidants include, but are not limited to, ascorbic acid; flavoring agents include, but are not limited to, sucralose; and acidulants include, but are not limited to, citric acid.

[0014] The S7 quality control standards are: content variation ±5%; moisture <3%, detected by Karl Fischer method; disintegration time <3 min, disintegration conditions are stirring in 100 mL of water at 25℃; active ingredient content: zinc 0.68-0.71 mg / bag, copper 0.048-0.051 mg / bag, iron 0.09-0.11 mg / bag, Omega-3 fatty acids 180-220 mg / bag, detected by HPLC; total bacterial count <1000 cfu / g, mold <10 cfu / g, and no pathogenic bacteria.

[0015] The oral nutritional supplement for preventing hair loss and promoting hair growth prepared by the above process includes the following ingredients: Fat-soluble components: tocotrienols, vitamin D3, Omega-3 fatty acids, Omega-6 fatty acids, saw palmetto extract; Water-soluble vitamins: Vitamin B2, Vitamin B7, Vitamin B12; Minerals: Zinc gluconate, copper gluconate, ferrous gluconate; Amino acids: L-cysteine, L-methionine; Plant extracts and active peptides: isoflavones, marine collagen peptides, curcumin, capsaicin; Excipients: Pumpkin seed powder, maltodextrin, erythritol, glidin, antioxidant, flavoring agent, acidulant.

[0016] The application of an oral nutritional supplement for preventing and / or treating hair loss in medicines or health foods is as follows: take one packet of granules with warm water twice a day, morning and evening, for no more than 6 months.

[0017] Compared with existing technologies, this oral nutritional supplement for preventing hair loss and promoting hair growth, its preparation process, and its clinical application have the following advantages: This preparation process ensures the protection and stability control of active ingredients. Targeted pretreatment maximizes mixing uniformity, guaranteeing consistent content in each bag of product. It establishes a comprehensive protection system of "low-temperature sterilization + oxygen isolation + moisture protection + light protection." This process is easily replicated, validated, and controlled in industrial production, ensuring quality stability across different production batches. The entire process is divided into clearly defined modules such as pretreatment, group mixing, and final mixing, with a clear logic that facilitates production management and the setting of quality control points.

[0018] This oral nutritional supplement for preventing hair loss and promoting hair growth has a good therapeutic effect on hair loss. Granulation also improves the product's solubility and taste. It can be quickly dispersed in water, making it easy for the human body to absorb. It has no adverse reactions and is safe and reliable. Attached Figure Description

[0019] Figure 1 This is a flowchart of the preparation process of the present invention.

[0020] Figure 2 This is the experimental procedure table for this invention.

[0021] Figure 3 This is a list of materials used in the experiments of this invention.

[0022] Figure 4 Table 1 shows the mechanism of action of the components in this invention.

[0023] Figure 5 Table 2 shows the mechanism of action of the components in this invention.

[0024] Figure 6 Table 3 shows the mechanism of action of the components in this invention.

[0025] Figure 7 This is the test results table of the present invention. Detailed Implementation

[0026] The following are specific embodiments of the present invention, which are described in conjunction with the accompanying drawings. However, the present invention is not limited to these embodiments.

[0027] like Figure 1 As shown, the preparation process of this oral nutritional supplement for preventing hair loss and promoting hair growth includes the following steps: S1, Raw material pretreatment: S1A, encapsulation process: Encapsulation wall material selection: Oil phase mixing, first mix tocotrienol, vitamin D3, Omega-3 fatty acid, Omega-6 fatty acid, and saw palmetto extract, and stir in a 60℃ water bath until melted; Aqueous phase mixing: Maltodextrin and gum arabic are dissolved in purified water and stirred at 60°C until dissolved; Emulsification: Slowly add the oil phase to the aqueous phase, high-speed shearing: 10000 rpm, 5 min, high-pressure homogenization: 20 MPa, 2 times; Then, spray drying is performed to obtain fat-soluble microcapsule powder; S1B, Crushing and Drying Process: The pumpkin seeds are crushed to obtain pumpkin seed powder, and the powder is sieved to remove large particles to ensure uniform particle size. Then it is dried to a moisture content of <5% to avoid introducing moisture. S1C, dilution treatment: Vitamin B2, vitamin B7 and vitamin B12 are mixed and diluted with maltodextrin respectively to obtain vitamin B2 dilution, vitamin B7 dilution and vitamin B12 dilution respectively; S2, Grouped Mixing: Mix the fat-soluble microcapsule powder and vitamin B12 diluent for 5 minutes and record it as Group A mixture; Mix the following components by mass fractions: 4.9±0.1 parts zinc gluconate, 0.36±0.01 parts copper gluconate, 1.1±0.1 parts ferrous gluconate, 30±1 parts L-cysteine, and 200±5 parts L-methionine. Stir for 8 minutes and record as mixture B. Mix 70±1 parts of isoflavones, 200±5 parts of marine collagen peptides, 150±5 parts of curcumin, and 3±0.5 parts of capsaicin by mass for 10 minutes, and record this mixture as Group C. Mix the vitamin B2 diluent and vitamin B7 diluent together for 10 minutes and record this mixture as Group D. Mix the following components by weight: 300±5 parts of fructooligosaccharide, 679±5 parts of pumpkin seed powder, 480±5 parts of maltodextrin, 120±5 parts of erythritol, 15±1 parts of glidin, 0.1±0.01 parts of antioxidant, 5±0.5 parts of flavoring agent, and 35±1 parts of acidulant. Stir for 5 minutes and record as mixture E. S3, Total Mixing: Following the principle of equal incremental addition, first mix the D group mixture with half of the E group mixture, then add the C group mixture and mix thoroughly; then add the B group mixture and mix; then add the A group mixture, and finally add the remaining E group mixture and mix for 20 minutes. The uniformity RSD < 3% is used to obtain the total mixture. S4, Granulation: The total mixture is extruded into granules to obtain uniform granules; S5, Drying and sterilization: Drying temperature 50-60℃, dry to moisture <3%, and then sterilize by cobalt-60 irradiation or microwave sterilization to ensure that the microbial standards are met. The cobalt-60 irradiation sterilization dose is 2-10kGy. S6, Packaging: Granules are bagged, 3.5g per bag, with the weight variation controlled within ±5%. The packaging material is a composite film with good barrier properties, such as PET / AL / PE or aluminum-plastic composite film, which is light-proof, moisture-proof, and oxygen-proof, extending the shelf life; Nitrogen-filled packaging: Each bag is filled with nitrogen, with an oxygen content of <3%, and heat-sealed at 180℃ for 1 second; Outer packaging: 10 bags / box, with an internal desiccant such as silica gel, stored in a cool, dry place, <25℃, RH <60%; S7, Quality Inspection: Conduct quality inspections on the finished product, including but not limited to, quantity variation, content uniformity, moisture content, microorganisms, and disintegration time. S8, Packaging and Warehousing: Store in a cool, dry place away from light.

[0028] The oil phase mixture in S1A consists of 120±5 parts by mass of tocotrienol, 0.005±0.001 parts of vitamin D3, 100±5 parts of Omega-3 fatty acids, 60±1 parts of Omega-6 fatty acids, and 250±5 parts of saw palmetto extract. The spray drying parameters for S1A are: inlet air temperature 180-200℃, outlet air temperature 80-90℃, and injection rate 10-15 mL / min.

[0029] The components in the aqueous phase mixture of S1A are 500±5 parts maltodextrin, 165±5 parts gum arabic, and 1335±5 parts purified water, and the solid content after the aqueous phase mixture is 30-40%.

[0030] The vitamin B2 diluent in S1C contains 0.15±0.01 parts vitamin B2 and 1.5±0.1 parts maltodextrin by mass.

[0031] The components of the vitamin B7 diluent are 0.0006±0.00005 parts vitamin B7 and 0.6±0.01 parts maltodextrin.

[0032] The vitamin B12 diluent in S1C contains 0.0002±0.00005 parts vitamin B12 and 2±0.1 parts maltodextrin by mass. The vitamin B12 is diluted stepwise with maltodextrin: first, all the vitamin B12 is added and mixed evenly with maltodextrin at a ratio of 1:100 to form the first-stage diluent powder. Then, the remaining maltodextrin is added and mixed evenly to form the second-stage diluent powder. The ratio of vitamin B12 to maltodextrin is 1:10000.

[0033] The gliding agents in S2 include, but are not limited to, silica; the antioxidants include, but are not limited to, ascorbic acid; the flavoring agents include, but are not limited to, sucralose; and the acidulants include, but are not limited to, citric acid.

[0034] The S7 quality control standards are: content variation ±5%; moisture <3%, tested using the Karl Fischer method; disintegration time <3 min, disintegration conditions are stirring in 100 mL of water at 25℃; active ingredient content: zinc 0.68-0.71 mg / bag, copper 0.048-0.051 mg / bag, iron 0.09-0.11 mg / bag, Omega-3 fatty acids 180-220 mg / bag, tested using HPLC; total bacterial count <1000 cfu / g, mold <10 cfu / g, and no pathogenic bacteria.

[0035] Summary of the advantages of the preparation process for this oral nutritional supplement for preventing hair loss and promoting hair growth: Active ingredient protection and stability control: Microencapsulation of fat-soluble components: By encapsulating easily oxidized and unstable fat-soluble components such as tocotrienols and Omega-3 / 6 fatty acids, oxygen, light and moisture are effectively isolated, greatly preventing oxidative rancidity and extending the product's shelf life.

[0036] Targeted pretreatment: Pumpkin seed powder is dried to a moisture content of <5%, which controls the moisture content of the raw materials from the source and avoids clumping of the finished product and microbial growth caused by moisture migration.

[0037] The trace amounts of vitamins B7 and B12 are diluted stepwise to ensure the uniform distribution of these low-content components in the total mixture, thereby guaranteeing the consistent content of each bag of product.

[0038] Irradiation or microwave sterilization (rather than high temperature) is used to avoid the degradation of heat-sensitive active ingredients. Combined with nitrogen-filled packaging and a high-barrier composite film, a comprehensive protection system of "low-temperature sterilization + oxygen isolation + moisture protection + light protection" is constructed.

[0039] By adopting the principle of group mixing and equal incremental addition, the raw materials are scientifically grouped, and the powder mixing principle of "equal incremental addition" is adopted to maximize the mixing uniformity and effectively solve the common problem of uneven content in solid dosage forms.

[0040] This process is easy to replicate, verify, and control in industrial production, ensuring quality stability across different production batches. The entire process is divided into clearly defined modules such as pretreatment, group mixing, and final mixing, with a clear logic that facilitates production management and the setting of quality control points.

[0041] Balancing product performance and user experience, the powder's flowability has been improved, facilitating accurate subsequent dispensing and granulation. Granulation also improves the product's solubility and taste. The optimized oral experience enhances patient adherence. These solid granules disperse rapidly upon contact with water, facilitating absorption and improving ease of administration.

[0042] The oral nutritional supplement for preventing hair loss and promoting hair growth prepared by the above process includes the following ingredients: Fat-soluble components: tocotrienols, vitamin D3, Omega-3 fatty acids, Omega-6 fatty acids, saw palmetto extract; Water-soluble vitamins: Vitamin B2, Vitamin B7, Vitamin B12; Minerals: Zinc gluconate, copper gluconate, ferrous gluconate; Amino acids: L-cysteine, L-methionine; Plant extracts and active peptides: isoflavones, marine collagen peptides, curcumin, capsaicin; Excipients: Pumpkin seed powder, maltodextrin, erythritol, glidin, antioxidant, flavoring agent, acidulant.

[0043] This oral nutritional supplement for preventing and / or treating hair loss is used in medicines or health foods. Take one packet of granules with warm water twice a day, morning and evening, for no more than 6 months.

[0044] Clinical trial protocol for verifying the efficacy and safety of oral nutritional supplements for preventing hair loss and promoting hair growth 1. Experiment Title A randomized, double-blind, placebo-controlled clinical study to evaluate the effects of oral nutritional supplements for preventing hair loss and promoting hair growth on hair density, growth, and safety in patients with hair loss.

[0045] 2. Research Objectives 2.1. Main objective: To evaluate whether the effect of this product on improving hair density in the target area of ​​the subjects after continuous use for 6 months is superior to that of placebo.

[0046] 2.2. Secondary objective: To assess the effects of this product on hair thickness, growth rate, amount of hair loss, and quality of life.

[0047] Assess the safety and incidence of adverse reactions of this product.

[0048] 3. Experimental Design Design type: multicenter, randomized, double-blind, placebo-controlled trial.

[0049] Subject grouping: Subjects meeting the inclusion criteria were randomly assigned to: Experimental group: Oral [product name] supplement, once daily, 1 sachet (3.5g) each time.

[0050] Control group: Oral administration of a placebo with the same appearance and taste as the experimental group, with the same dosage and administration method.

[0051] Study period: The total period is 24 weeks (approximately 6 months), including the baseline visit (day 0), the 4th week visit, the 12th week visit, and the 24th week visit.

[0052] 4. Subject selection criteria 4.1. Selection Criteria: 4.1.1. Age 18-50 years old, both men and women are welcome.

[0053] 4.1.2. Clinical diagnosis of mild to moderate alopecia (according to Hamilton-Norwood classification, men are grade III-V, and women are grade I-II according to Ludwig classification).

[0054] 4.1.3. Voluntarily sign the informed consent form and abide by the research protocol.

[0055] 4.2. Exclusion criteria: 4.2.1. Women who are pregnant, breastfeeding, or planning to become pregnant.

[0056] 4.2.2. Have received or are currently receiving other hair regrowth treatments (such as minoxidil, finasteride, hair transplant surgery, etc.) within the past 6 months.

[0057] 4.2.3. Hair loss caused by other causes (such as alopecia areata, scarring alopecia, thyroid dysfunction, severe nutritional deficiency, etc.).

[0058] 4.2.4. Hypersensitivity to any component of this product.

[0059] 4.2.5. Suffering from severe heart, liver, kidney dysfunction or immune system disease.

[0060] 4.2.6. Have participated in other clinical trials within the past 3 months.

[0061] 5. Evaluation Methods and Indicators 5.1. Main therapeutic indicators: Trichoscopy: Using professional trichoscopy equipment, high-resolution images are taken at baseline and at week 24 on a fixed target area of ​​the scalp (usually the area with the most obvious hair loss on the top of the head). The hair density (roots / cm²) per square centimeter is calculated using image analysis software.

[0062] 5.2. Secondary efficacy endpoints: 5.2.1. Hair thickness: The average diameter (μm) of the hair in the target area was measured using a trichoscope.

[0063] 5.2.2. Hair growth rate: Mark specific hairs and measure their growth length (mm / month) over a certain period of time.

[0064] 5.2.3. Hair tension test: Under standardized conditions (e.g., 5 days after shampooing), a quantitative hair tension test was conducted, and the number of hairs that fell out was recorded.

[0065] 5.3. Patient self-assessment questionnaire: 5.3.1. Hair loss score: self-assessment of the amount of hair loss per day (1-7 points, 1 being very little).

[0066] 5.3.2. Hair growth score: perception of new hair growth (1-7 points, 7 being highly significant).

[0067] 5.3.3. Quality of life questionnaire: The impact of hair loss on life was assessed using scales such as DLQI.

[0068] 5.4. Safety Indicators: 5.4.1. Vital signs: blood pressure, heart rate, etc.

[0069] 5.4.2. Laboratory tests: Complete blood count, urinalysis, liver and kidney function (ALT, AST), blood glucose, and blood lipids were tested at baseline and at the end of the study.

[0070] 5.4.3. Adverse Event Records: Record in detail the time of occurrence, severity, treatment measures, and relevance to the test product for all adverse events (such as gastrointestinal discomfort, allergies, etc.).

[0071] 6. Test procedure, test procedure table, see Figure 2 .

[0072] 7. Experimental materials, see the experimental materials list. Figure 3 、( Figure 4 Table 1 shows the mechanism of action of the components. Figure 5 Table 2 shows the mechanism of action of the components. Figure 6 (See Table 3 for the mechanism of action of the components) 7.1. Experimental Group: Finished products from test examples 1, 2, and 3. Specifications: 3.5g / bag (consistent with the final product), take one bag twice a day, morning and evening, dissolved in warm water; Storage: Store in a cool, dry place below 25℃, away from light and moisture.

[0073] 7.2. Control group: Placebo Formula: Contains only maltodextrin, erythritol, sucralose, and citric acid (the same excipients as the test product, but without active ingredients); Appearance / Taste / Packaging: Completely identical to the test product (e.g., same composite film bag, same printing) to avoid blinding. Take one sachet twice a day, morning and evening, dissolved in warm water.

[0074] 8. The average value at week 24 was measured and compared with the initial state. See the test results table. Figure 7 .

[0075] 9. Conclusion: After 24 weeks, the experimental groups of Examples 1, 2 and 3 showed a significantly greater increase in hair density in the target area than the control group. Among them, Example 1 had the best overall effect. Furthermore, patients in Examples 1, 2 and 3 reported improved self-reported quality of life, and the incidence of adverse reactions was not significantly different from that in the control group.

[0076] The specific embodiments described herein are merely illustrative of the spirit of the invention. Those skilled in the art to which this invention pertains may make various modifications or additions to the described specific embodiments or use similar methods to substitute them, without departing from the spirit of the invention or exceeding the scope defined by the appended claims.

Claims

1. A preparation process for an oral nutritional supplement for preventing hair loss and promoting hair growth, comprising the following preparation steps, S1, Raw material pretreatment: S1A, encapsulation process: Encapsulation wall material selection: Oil phase mixing, first mix tocotrienol, vitamin D3, Omega-3 fatty acid, Omega-6 fatty acid, and saw palmetto extract, and stir in a 60℃ water bath until melted; Aqueous phase mixing: Maltodextrin and gum arabic are dissolved in purified water and stirred at 60°C until dissolved; Emulsification: Slowly add the oil phase to the aqueous phase, high-speed shearing: 10000 rpm, 5 min, high-pressure homogenization: 20 MPa, 2 times; Then, spray drying is performed to obtain fat-soluble microcapsule powder; S1B, Crushing and Drying Process: The pumpkin seeds are crushed to obtain pumpkin seed powder, and the powder is sieved to remove large particles to ensure uniform particle size. Then it is dried to a moisture content of <5% to avoid introducing moisture. S1C, dilution treatment: Vitamin B2, vitamin B7 and vitamin B12 are mixed and diluted with maltodextrin respectively to obtain vitamin B2 dilution, vitamin B7 dilution and vitamin B12 dilution respectively; S2, Grouped Mixing: Mix the fat-soluble microcapsule powder and vitamin B12 diluent for 5 minutes and record it as Group A mixture; Mix the following components by mass fractions: 4.9±0.1 parts zinc gluconate, 0.36±0.01 parts copper gluconate, 1.1±0.1 parts ferrous gluconate, 30±1 parts L-cysteine, and 200±5 parts L-methionine. Stir for 8 minutes and record as mixture B. Mix 70±1 parts of isoflavones, 200±5 parts of marine collagen peptides, 150±5 parts of curcumin, and 3±0.5 parts of capsaicin by mass for 10 minutes, and record this mixture as Group C. Mix the vitamin B2 diluent and vitamin B7 diluent together for 10 minutes and record this mixture as Group D. Mix the following components by weight: 300±5 parts of fructooligosaccharide, 679±5 parts of pumpkin seed powder, 480±5 parts of maltodextrin, 120±5 parts of erythritol, 15±1 parts of glidin, 0.1±0.01 parts of antioxidant, 5±0.5 parts of flavoring agent, and 35±1 parts of acidulant. Stir for 5 minutes and record as mixture E. S3, Total Mixing: Following the principle of equal incremental addition, first mix the D group mixture with half of the E group mixture, then add the C group mixture and mix thoroughly; then add the B group mixture and mix; then add the A group mixture, and finally add the remaining E group mixture and mix for 20 minutes. The uniformity RSD < 3% is used to obtain the total mixture. S4, Granulation: The total mixture is extruded into granules to obtain uniform granules; S5, Drying and sterilization: Drying temperature 50-60℃, dry to moisture <3%, and then sterilize by cobalt-60 irradiation or microwave sterilization to ensure that the microbial standards are met. The cobalt-60 irradiation sterilization dose is 2-10kGy. S6, Packaging: Granules are bagged, 3.5g per bag, with the weight difference controlled within ±5%, and the packaging material is a composite film with good barrier properties; Nitrogen-filled packaging: Each bag is filled with nitrogen, with an oxygen content of <3%, and heat-sealed; Outer packaging: 10 bags / box, with desiccant inside, store in a cool and dry place; S7, Quality Inspection: Conduct quality inspections on the finished product, including but not limited to, quantity variation, content uniformity, moisture content, microorganisms, and disintegration time. S8, Packaging and Warehousing: Store in a cool, dry place away from light.

2. The preparation process of the oral nutritional supplement for preventing hair loss and promoting hair growth according to claim 1, characterized in that, The oil phase mixture in S1A comprises 120±5 parts by mass of tocotrienol, 0.005±0.001 parts by mass of vitamin D3, 100±5 parts by mass of Omega-3 fatty acids, 60±1 parts by mass of Omega-6 fatty acids, and 250±5 parts by mass of saw palmetto extract. The spray drying parameters of S1A are: inlet air temperature 180-200℃, outlet air temperature 80-90℃, and injection rate 10-15mL / min.

3. The preparation process of the oral nutritional supplement for preventing hair loss and promoting hair growth according to claim 2, characterized in that, The components in the aqueous phase mixture of S1A are 500±5 parts maltodextrin, 165±5 parts gum arabic, and 1335±5 parts purified water, and the solid content of the aqueous phase mixture is 30-40%.

4. The preparation process of the oral nutritional supplement for preventing hair loss and promoting hair growth according to claim 3, characterized in that, The vitamin B2 diluent in S1C contains 0.15 ± 0.01 parts vitamin B2 and 1.5 ± 0.1 parts maltodextrin by mass.

5. The preparation process of the oral nutritional supplement for preventing hair loss and promoting hair growth according to claim 4, characterized in that, The vitamin B7 diluent contains 0.0006±0.00005 parts vitamin B7 and 0.6±0.01 parts maltodextrin by mass.

6. The preparation process of an oral nutritional supplement for preventing hair loss and promoting hair growth according to claim 5, characterized in that, The vitamin B12 diluent in S1C comprises 0.0002±0.00005 parts vitamin B12 and 2±0.1 parts maltodextrin by mass. The vitamin B12 is diluted stepwise with maltodextrin: first, all the vitamin B12 is added and mixed evenly with maltodextrin at a ratio of 1:100 to obtain the first-stage diluent powder. Then, the remaining maltodextrin is added and mixed evenly to obtain the second-stage diluent powder. The ratio of vitamin B12 to maltodextrin is 1:10000.

7. The preparation process of an oral nutritional supplement for preventing hair loss and promoting hair growth according to claim 6, characterized in that, The flow aids in S2 include, but are not limited to, silica; antioxidants include, but are not limited to, ascorbic acid; flavoring agents include, but are not limited to, sucralose; and acidulants include, but are not limited to, citric acid.

8. The preparation process of an oral nutritional supplement for preventing hair loss and promoting hair growth according to claim 7, characterized in that, The S7 quality control standards are: content variation ±5%; moisture <3%, detected by Karl Fischer method; disintegration time <3 min, disintegration conditions are stirring in 100 mL of water at 25℃; active ingredient content: zinc 0.68-0.71 mg / bag, copper 0.048-0.051 mg / bag, iron 0.09-0.11 mg / bag, Omega-3 fatty acids 180-220 mg / bag, detected by HPLC; total bacterial count <1000 cfu / g, mold <10 cfu / g, and no pathogenic bacteria.

9. An oral nutritional supplement for preventing hair loss and promoting hair growth prepared by the preparation process described in claim 8, characterized in that, Includes the following ingredients: Fat-soluble components: tocotrienols, vitamin D3, Omega-3 fatty acids, Omega-6 fatty acids, saw palmetto extract; Water-soluble vitamins: Vitamin B2, Vitamin B7, Vitamin B12; Minerals: Zinc gluconate, copper gluconate, ferrous gluconate; Amino acids: L-cysteine, L-methionine; Plant extracts and active peptides: isoflavones, marine collagen peptides, curcumin, capsaicin; Excipients: Pumpkin seed powder, maltodextrin, erythritol, glidin, antioxidant, flavoring agent, acidulant.

10. The use of an oral nutritional supplement for preventing and / or treating hair loss as described in any one of claims 1-8 in a medicament or health food for preventing and / or treating hair loss, characterized in that, Take one packet of granules with warm water twice a day, morning and evening, for no more than 6 months.

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