Novel hair blackening dense pill formula

Abstract

The invention discloses a novel hair-blackening dense pill formula, relates to the technical field of traditional Chinese medicine preparations, and particularly solves the core problems of single curative effect, backward process, insufficient quality control and the like of a traditional hair-blackening preparation through a multi-target-point compatibility design, a precise processing process and a modern preparation technology. A scientific, safe and long-acting solution is provided for the liver and kidney essence deficiency type hair diseases.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine preparation technology, specifically a novel formula for black hair pills. Background Technology

[0002] Gray hair and hair loss are hair health problems affecting hundreds of millions of people worldwide. Their causes are complex, mainly including genetics, endocrine disorders, nutritional deficiencies, oxidative stress, and deficiency of liver and kidney essence. Traditional Chinese medicine believes that liver and kidney deficiency and depletion of essence and blood are the core pathogenesis leading to premature graying of hair, and treatment mainly focuses on tonifying the kidneys and replenishing essence, nourishing blood and promoting blood circulation. Currently, common hair-darkening products on the market mainly fall into the following three categories:

[0003] (1) Single-ingredient or simple compound preparations: such as dietary therapy formulas with black sesame and Polygonum multiflorum as the main ingredients, although they can supplement melanin precursor substances, they lack multi-target synergistic effects, have a single therapeutic effect and a long course of treatment. For example, the patented formula uses black sesame as the core, supplemented with red ginseng, Polygonum multiflorum, etc., but it does not solve the problem of imbalance in the ratio of medicinal materials (e.g., the dosage of Rehmannia glutinosa is only 15g, which is far below the effective dose).

[0004] (2) Chemically synthesized drugs: such as copper-containing preparations (e.g., copper sulfate) or minoxidil-like topical medications, although they can promote hair growth in the short term, have drawbacks such as liver and kidney toxicity and high relapse rates after discontinuation. Studies have shown that long-term use of copper-containing drugs can lead to abnormally high levels of ceruloplasmin, causing neurological side effects.

[0005] (3) Traditional Chinese medicine compound

[0006] The processing technology is crude: the medicinal materials are only simply stir-fried or steamed and dried (such as steaming Rehmannia glutinosa 3 times), resulting in a low dissolution rate of active ingredients (such as catalpol);

[0007] Poor disintegration performance: The disintegration time of the water-absorbing capsules exceeds 60 minutes after absorbing water, which affects the absorption efficiency;

[0008] Insufficient stability: Due to the lack of moisture-proof packaging, mold will appear after a short storage period (≤6 months).

[0009] Traditional formulas often focus on a single effect (such as tonifying the kidneys or cooling the blood), lacking a systematic regulation of the "liver-kidney-essence-blood-hair follicle" axis. For example, although the patented formula contains yin-nourishing herbs such as Rehmannia glutinosa and Ligustrum lucidum, it does not contain liver-soothing and mood-regulating ingredients (such as Bupleurum chinense and Curcuma longa), and therefore cannot improve the microcirculation disorders of hair follicles caused by emotional factors. Therefore, there is an urgent need for a new formula for hair-darkening pills. Summary of the Invention

[0010] The purpose of this invention is to provide a novel formula for blackening hair pills that nourishes Yin and tonifies the kidneys, cools and nourishes the blood, and soothes the liver and relieves depression. It is used for symptoms such as premature graying, yellowing, breakage, split ends, and dry, frizzy hair caused by deficiency of liver and kidney essence.

[0011] To achieve the above objectives, the present invention is implemented through the following technical solutions:

[0012] This invention provides a novel formula for hair-darkening pills. The formula is characterized by being made from the following ingredients in parts by weight: 120 parts of Cornus officinalis, 300 parts of Rehmannia glutinosa (processed), 120 parts of Dioscorea opposita, 100 parts of Paeonia suffruticosa, 100 parts of Polygonatum sibiricum (processed with wine), 200 parts of Ligustrum lucidum (processed with wine), 120 parts of Lycium barbarum, 100 parts of Psoralea corylifolia, 100 parts of Cuscuta chinensis, 120 parts of Morus alba, 200 parts of Rehmannia glutinosa (raw), 100 parts of Gardenia jasminoides, 60 parts of Eclipta prostrata, 60 parts of black sesame, 100 parts of Bupleurum chinense, 120 parts of Curcuma longa, 100 parts of Pueraria lobata, 100 parts of Cinnamomum cassia, and 300 parts of honey; wherein the honey is refined at 45°C until it forms beads when dropped into water, and is used as an excipient for the medicinal powder.

[0013] This formula is based on the core principles of "nourishing yin and tonifying the kidneys, cooling and nourishing the blood, and soothing the liver and relieving depression." Through the synergistic effect of multiple medicinal herbs, it targets the root cause of gray hair and hair loss caused by deficiency of liver and kidney essence.

[0014] Rehmannia glutinosa (300g): The dosage far exceeds that of traditional prescriptions (15-30g in normal times). Through the nine-steaming and nine-drying process, the content of catalpol is increased to more than 0.3mg / g, which enhances the effect of nourishing yin and replenishing essence.

[0015] Wine-processed Ligustrum lucidum (200g): Combined with wine-processed Polygonatum sibiricum (100g), it forms a "sperm and blood nourishing" structure. The polysaccharides of Ligustrum lucidum and Polygonatum sibiricum synergistically activate the Wnt / β-catenin pathway and promote the proliferation of hair follicle stem cells.

[0016] Bupleurum + Curcuma (total 220g): The ratio of soothing the liver and relieving depression is optimized (1:1.2), which regulates the expression of CRH-R1 receptor and reduces the level of IL-6, an inflammatory factor in hair follicles (experimental results show an inhibition rate of ≥45%).

[0017] advantage:

[0018] Multi-target synergy: Breaking through the limitations of single-herb efficacy, it comprehensively improves the hair follicle microenvironment through the three-in-one effect of nourishing yin, cooling blood, and soothing the liver.

[0019] Scientific Dosage: The dosage of Rehmannia glutinosa is 300g, which meets the clinical recommendation standards for "high-dose yin-nourishing drugs" in the Chinese Pharmacopoeia.

[0020] Furthermore, the prepared Rehmannia glutinosa is processed using a nine-steaming and nine-drying process, with each steaming and drying cycle lasting 24 hours and repeated a total of 9 times.

[0021] Process parameters: Steam for 2 hours (steam temperature 95℃) + sun dry overnight, for a total of 9 cycles, to avoid the decomposition of catalpol caused by "steaming and sun drying" in the traditional process.

[0022] Quality control: HPLC analysis showed that the catalpol content was ≥0.3 mg / g (compared to only 0.1-0.2 mg / g using traditional methods).

[0023] advantage:

[0024] Enriched with active ingredients: The content of catalpol is increased by 3.2 times, enhancing its effects of nourishing yin and tonifying the kidneys.

[0025] Process standardization: Determine the number of steaming and drying cycles and duration to ensure batch consistency.

[0026] Furthermore, the preparation method of the wine-processed Polygonatum is as follows: after soaking in a mixture of Polygonatum and rice wine at a ratio of 10:1 for 24 hours, it is steamed in a water bath for 4 hours and then dried in the sun.

[0027] The ratio of saturation to rice wine is 10:1. Saturation for 24 hours promotes the binding of polysaccharides from Polygonatum sibiricum with small molecules in rice wine.

[0028] Steaming parameters: Steam over water for 4 hours to avoid high temperature damage to the polysaccharide structure (retention rate ≥90%).

[0029] advantage:

[0030] Ingredient stability: The polysaccharide retention rate is increased to over 90%, enhancing the effects of replenishing qi and nourishing yin.

[0031] Reducing bitterness and enhancing efficacy: The use of rice wine to moisten and soften the flavor of Polygonatum reduces its bitterness and improves patient compliance.

[0032] Furthermore, the preparation process of the honey pills includes:

[0033] (1) The medicine powder is ultra-finely pulverized to 100 mesh;

[0034] (2) Mix the medicinal powder with refined honey, with the ratio of medicinal powder to refined honey being 1:0.8;

[0035] (3) The pellets were formed by water-flooding, and the weight of each pellet was 9g ± 0.2g.

[0036] (4) Dry at 40℃ for 6 hours.

[0037] Ultrafine grinding (100 mesh): The particle size of medicinal materials D90≤150μm, the specific surface area increases by 4 times, and the dissolution rate increases by 60% (e.g., the dissolution rate of Polygonatum polysaccharide increases from 1.2mg / min to 3.8mg / min).

[0038] Low-temperature drying (40℃): retains paeonol (retention rate ≥90%) and reduces the loss of volatile components.

[0039] advantage:

[0040] Improved bioavailability: Ultrafine grinding makes the active ingredients easier to absorb.

[0041] Moisture-proof process: The moisture content of the refined honey is ≤10%, and the moisture absorption rate of the pills is ≤3% (traditional honey pills >10%).

[0042] Furthermore, the gardenia is processed using a ginger juice charcoal-frying technique, with the amount of ginger juice being 10% of the gardenia's weight.

[0043] Ginger juice dosage: 10% (w / w), carbonization degree control D90≤200μm, tannin loss rate≤15%.

[0044] Enhanced efficacy: The hemostatic component (tannin) and the anti-inflammatory component (genipin) work synergistically to inhibit hair follicle bleeding.

[0045] advantage:

[0046] Enhanced hemostatic effect: Tannin retention rate increased to 85%, which is superior to the traditional charcoal roasting process (60%-70%).

[0047] Controllable process: Quantify the amount of ginger juice used to avoid insufficient or excessive carbonization.

[0048] Furthermore, after the Bupleurum is processed with vinegar, the amount of vinegar used is 20% of its weight.

[0049] Vinegar dosage: 20% (w / w). After vinegar processing, the content of saikosaponin a increased to 1.2 mg / g (the raw product is only 0.5 mg / g).

[0050] Liver-soothing effect: It regulates liver FXR receptors and reduces serum ALT levels (animal experiments show an enzyme reduction rate of ≥30%).

[0051] advantage:

[0052] Targeted liver-soothing: Enhances the anti-inflammatory effect of Bupleurum and improves microcirculation in hair follicles.

[0053] Quality controllable: The vinegar-processing ratio is clearly defined to ensure the content of effective ingredients.

[0054] Furthermore, the formulation may contain 0.5% Angelica sinensis powder as an auxiliary ingredient.

[0055] Angelica sinensis (0.5%): assists tyrosinase activity and promotes melanin synthesis (in vitro experiments showed an increase in activity of 50%).

[0056] advantage:

[0057] Improved disintegration performance: Disintegration time is reduced by 50%, accelerating drug absorption.

[0058] Promotes hair growth: Angelica powder, combined with black sesame and mulberry, enhances melanin production.

[0059] Furthermore, the disintegration time of the honey pill is ≤30 minutes, and the weight difference of the formulation is ≤±5% over 6 months under accelerated testing (temperature 40℃±2℃, humidity 75%±5%).

[0060] Accelerated test: 6 months at 40℃ / 75%RH, weight difference ≤±5%, polysaccharide content change ≤5%.

[0061] Microbial control: Total aerobic bacteria count ≤100 CFU / g, mold and yeast count ≤10 CFU / g.

[0062] advantage:

[0063] Long-term stability: Superior to traditional honey pills (traditional products have a weight difference of ±15% over 6 months).

[0064] High safety: Strict microbiological standards, meeting the requirements of the Chinese Pharmacopoeia.

[0065] The advantages of this invention are: 1. Multi-target synergistic design

[0066] Formula composition:

[0067] The core medicinal materials—Rehmannia glutinosa (300g), Ligustrum lucidum (200g), and Polygonatum sibiricum (100g)—form a "nourishing essence and blood" structure, activating the Wnt / β-catenin pathway and promoting the proliferation of hair follicle stem cells.

[0068] Soothe the liver and relieve depression: Bupleurum (100g) and Curcuma longa (120g) are combined in a ratio of 1:1.2 to regulate the expression of CRH-R1 receptor and reduce the level of IL-6, an inflammatory factor in hair follicles (inhibition rate ≥45%).

[0069] Melanin synthesis: Black sesame (60g) + mulberry (120g) activate tyrosinase activity and enhance melanin production efficiency.

[0070] Innovation:

[0071] Breaking through the limitations of traditional single-herb efficacy, it comprehensively improves the microenvironment of hair follicles through a three-pronged approach of nourishing yin, cooling blood, and soothing the liver.

[0072] The dosage of prepared Rehmannia root reached 300g, far exceeding the conventional prescription (15-30g), significantly increasing the content of catalpol (0.3mg / g vs 0.1-0.2mg / g).

[0073] 2. Optimization of precision processing techniques

[0074] Key processes:

[0075] Nine-times steaming and nine-times drying of Rehmannia glutinosa: each cycle involves steaming for 2 hours (95℃ steam) and drying overnight, for a total of 9 cycles, resulting in a 3.2-fold increase in catalpol content (HPLC verification).

[0076] Processing of Polygonatum sibiricum: After soaking in rice wine (material-to-liquid ratio 1:10), steam for 4 hours, polysaccharide retention rate ≥90%.

[0077] Gardenia and ginger juice charcoal: ginger juice dosage is 10% (w / w), tannin retention rate is 85% (60%-70% in traditional process).

[0078] Innovation:

[0079] Quantify the evaporation parameters (time, temperature) to ensure the enrichment of effective ingredients.

[0080] Reduce the bitterness of medicinal materials (such as Polygonatum) to improve patient compliance.

[0081] 3. Innovation in modern formulation technology

[0082] Preparation process:

[0083] Ultrafine grinding (100 mesh): The particle size of medicinal materials D90≤150μm, and the dissolution rate is increased by 60% (e.g., the dissolution rate of Polygonatum polysaccharide increases from 1.2mg / min to 3.8mg / min).

[0084] Low-temperature honey refining (45℃): Honey moisture content ≤10%, improved moisture resistance (moisture absorption rate ≤3% vs. traditional >10%).

[0085] Innovation:

[0086] Modern pulverization and low-temperature technology retains volatile components (such as paeonol retention rate ≥90%).

[0087] Optimize disintegration properties and accelerate drug absorption.

[0088] 4. Improved quality standards and stability

[0089] Quality control:

[0090] Disintegration time: ≤30 minutes, which meets the requirements for rapid release in the Chinese Pharmacopoeia.

[0091] Accelerated test: 6 months at 40℃ / 75%RH, weight difference ≤±5%, polysaccharide content change ≤5%.

[0092] Microbial control: Total aerobic bacteria count ≤100 CFU / g, mold and yeast count ≤10 CFU / g.

[0093] Innovation:

[0094] Strict quality standards ensure product safety and consistency.

[0095] The shelf life can be extended through a moisture-proof process (honey refining).

[0096] 5. Clinical efficacy verification

[0097] Experimental data:

[0098] Hair growth phase: The treatment group (n=120) had a 40% shorter growth phase than the control group (P<0.01).

[0099] Melanin synthesis: Hair follicle tyrosinase activity increased by 50%, and hair diameter increased by 12.3%.

[0100] Safety: Acute toxicity test LD50 50 >15g / kg, long-term toxicity tests showed no abnormalities in liver and kidney function.

[0101] Innovation:

[0102] Multicenter clinical trial data support efficacy, which is superior to traditional empirical products.

[0103] Summarize the advantages

[0104] Scientific formulation: multi-target synergistic intervention of the hair follicle microenvironment, breaking through the limitations of single-herb efficacy.

[0105] Technological innovation: technologies such as nine-steaming and nine-sun-drying and low-temperature drying improve the content of active ingredients and bioavailability.

[0106] Controllable quality: Strict quality standards and stability testing ensure product safety and effectiveness.

[0107] Clinically proven: Significantly shortens the hair growth phase, increases hair diameter, and has a high safety profile.

[0108] Patient compliance: The pills disintegrate quickly (≤30 minutes) and have an improved taste (with honey excipients). Detailed Implementation

[0109] Example 1: Standard Formulation and Process Validation

[0110] Formula composition: 120g of Cornus officinalis, 300g of Rehmannia glutinosa (steamed and dried nine times), 120g of Dioscorea opposita, 100g of Paeonia suffruticosa, 100g of Polygonatum sibiricum (soaked in rice wine and steamed for 4 hours), 200g of Ligustrum lucidum (processed with wine), 120g of Lycium barbarum, 100g of Psoralea corylifolia, 100g of Cuscuta chinensis, 120g of Morus alba, 200g of Rehmannia glutinosa (raw), 100g of Gardenia jasminoides (stir-fried with ginger juice), 60g of Eclipta prostrata, 60g of black sesame seeds, 100g of Bupleurum chinense (processed with vinegar), 120g of Curcuma longa, 100g of Pueraria lobata, 100g of Cinnamomum cassia, and 300g of honey (refined at 45℃).

[0111] Preparation process:

[0112] The medicine powder is ultra-finely pulverized to 100 mesh;

[0113] Mix medicinal powder and refined honey in a ratio of 1:0.8.

[0114] Formed using the water-flooding method (pill weight 9g±0.2g);

[0115] Dry at 40℃ for 6 hours.

[0116] Key parameters:

[0117] Nine steaming and nine sun-drying: each time steaming for 2 hours (95℃) + sun-drying overnight, for a total of 9 times;

[0118] Stir-frying ginger juice over charcoal: Gardenia: Ginger juice = 100:10 (w / w);

[0119] Vinegar-processed Bupleurum: Bupleurum: Vinegar = 100:20 (w / w).

[0120] Effect verification:

[0121] Catastrophin content: 0.32±0.05 mg / g (HPLC);

[0122] Disintegration time limit: 28±2 minutes;

[0123] Hair growth cycle: The treatment group had a 40% shorter growth cycle than the control group (n=120, P<0.01); Stability: Weight difference ≤±3% after 6 months at 40℃ / 75%RH.

[0124] Example 2: Comparison of Optimized Dosage of Rehmannia glutinosa

[0125] Formula adjustments:

[0126] Comparison of Rehmannia glutinosa dosage: conventional group (30g) vs. the group of the present invention (300g).

[0127] Preparation process:

[0128] The nine-steaming and nine-drying process is the same as in Example 1;

[0129] Other medicinal materials and procedures remain unchanged.

[0130] Effect comparison:

[0131]

[0132] Conclusion: Increasing the dosage of Rehmannia glutinosa to 300g significantly enhances its yin-nourishing effect and improves its taste.

[0133] Example 3: Comparison of Gardenia Processing Techniques

[0134] Process adjustments:

[0135] Traditional charcoal frying vs. the ginger juice charcoal frying of this invention (10% ginger juice).

[0136] Preparation process:

[0137] Gardenia preparation: Traditional group (directly charred) vs. this invention group (simmered in ginger juice and then charred).

[0138] Comparison of effects:

[0139] index Traditional Group This invention group Tannin retention rate 62％ 85％ Anti-inflammatory activity (IL-6 inhibition rate) 38％ 65％ Hemostasis time (mouse tail docking experiment) 18±2min 12±1min

[0140] Conclusion: The ginger juice charcoal-frying process significantly enhances the hemostatic and anti-inflammatory effects of gardenia.

[0141] Example 4: Optimization of Bupleurum processing technology

[0142] Process adjustments:

[0143] Raw Bupleurum vs. Vinegar-processed Bupleurum (20% vinegar dosage).

[0144] Preparation process:

[0145] Bupleurum processing: raw product vs. vinegar-processed product (vinegar:bupleurum = 20:100, w / w).

[0146] Comparison of effects:

[0147]

[0148]

[0149] Conclusion: The vinegar-processing technique significantly enhances the liver-soothing and enzyme-lowering effects of Bupleurum chinense.

[0150] Example 5: Disintegration performance and stability verification

[0151] Process parameters:

[0152] Ultrafine grinding particle size: 100 mesh vs 200 mesh;

[0153] Honey refining at 45℃ (moisture ≤ 10%) vs. traditional high-temperature honey refining (moisture 15%). Results comparison:

[0154]

[0155] Conclusion: Ultrafine grinding and low-temperature honey refining significantly improve disintegration rate and moisture resistance.

[0156] Summary of Implementation Examples

[0157] Standard formulation validation: Through multi-target synergistic action, it significantly improves the hair follicle microenvironment and shortens the hair growth phase.

[0158] Optimized dosage of Rehmannia glutinosa: 300g of Rehmannia glutinosa increases the content of catalpol by 3.2 times, enhancing the yin-nourishing effect.

[0159] Gardenia processing innovation: The ginger juice charcoal-frying process increases the tannin retention rate to 85%, resulting in significant hemostatic and anti-inflammatory effects.

[0160] Enhanced efficacy of Bupleurum chinense processed with vinegar: The addition of 20% vinegar doubles the content of saikosaponin A, resulting in outstanding liver-soothing and enzyme-lowering effects.

[0161] Process parameter control: Ultrafine grinding and low-temperature honey refining ensure rapid disintegration, excellent moisture resistance, and a 70% improvement in stability.

[0162] Data support:

[0163] A multicenter clinical trial (n=120) validated the efficacy;

[0164] HPLC, animal model, and accelerated testing data support quality standards.

Claims

1. A novel formula for hair-darkening pills, characterized in that, Made from the following ingredients in parts by weight: 120 parts of Cornus officinalis, 300 parts of Rehmannia glutinosa (processed), 120 parts of Dioscorea opposita, 100 parts of Paeonia suffruticosa, 100 parts of Polygonatum sibiricum (processed with wine), 200 parts of Ligustrum lucidum (processed with wine), 120 parts of Lycium barbarum, 100 parts of Psoralea corylifolia, 100 parts of Cuscuta chinensis, 120 parts of Morus alba, 200 parts of Rehmannia glutinosa (raw), 100 parts of Gardenia jasminoides, 60 parts of Eclipta prostrata, 60 parts of black sesame, 100 parts of Bupleurum chinense, 120 parts of Curcuma longa, 100 parts of Pueraria lobata, 100 parts of Cinnamomum cassia, and 300 parts of honey; the honey is refined at 45℃ until it forms beads when dropped into water, and is used as an excipient for the medicinal powder.

2. The novel hair-darkening pill formula according to claim 1, characterized in that, The prepared Rehmannia glutinosa is processed using a nine-steaming and nine-drying process, with each steaming and drying cycle lasting 24 hours and repeated a total of 9 times.

3. The novel hair-darkening pill formula according to claim 1, characterized in that, The preparation method of the wine-processed Polygonatum is as follows: after soaking in a mixture of Polygonatum and rice wine at a ratio of 10:1 for 24 hours, steam it in water for 4 hours and then sun-dry it.

4. The novel hair-darkening pill formula according to claim 1, characterized in that, The preparation process of the honey pills includes: (1) The medicine powder is ultra-finely pulverized to 100 mesh; (2) Mix the medicinal powder with refined honey, with the ratio of medicinal powder to refined honey being 1:0.8; (3) The pellets were formed by water-flooding, and the weight of each pellet was 9g ± 0.2g. (4) Dry at 40℃ for 6 hours.

5. The novel hair-darkening pill formula according to claim 1, characterized in that... The gardenia is prepared using a ginger juice charcoal-frying process, with the amount of ginger juice being 10% of the gardenia's weight.

6. The novel hair-darkening pill formula according to claim 1, characterized in that... The Bupleurum chinense, after being processed with vinegar, uses vinegar at a rate of 20% of its weight.

7. The novel hair-darkening pill formula according to claim 1, characterized in that... The disintegration time of the honey pill is ≤30 minutes.

8. The novel hair-darkening pill formula according to claim 1, characterized in that... The weight difference of the formulation is ≤ ±5% after 6 months in accelerated testing (temperature 40℃±2℃, humidity 75%±5%).

9. The novel hair-darkening pill formula according to claim 1, characterized in that... The preparation may contain 0.5% Angelica sinensis powder as an auxiliary ingredient.

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