Traditional Chinese medicine composition for treating alopecia

Abstract

The invention provides a traditional Chinese medicine composition for relieving alopecia. The traditional Chinese medicine composition is prepared from the following traditional Chinese medicinal materials in parts by weight: 2-10 parts of xanthium sibiricum, 2-10 parts of cacumen biotae, 1-3 parts of pepper and 1-5 parts of ligusticum wallichii. The invention provides a preparation form of the traditional Chinese medicine composition, particularly an ointment, which comprises the following compositions in parts by weight: 4-8 parts of a traditional Chinese medicine extract prepared from xanthium sibiricum, cacumen biotae, pepper and ligusticum wallichii, 2-4 parts of a humectant, 2-11 parts of a conditioner, 0.01-0.1 part of a chelating agent, 0.5-1 part of a thickening agent, 4-8 parts of an emulsifier, 0.05-0.2 part of an antioxidant and 0.5-1.3 parts of a preservative. 0.01-0.5 part of a pH regulator and a proper amount of a solvent. The invention further provides a preparation method of the ointment. The raw materials contained in the ointment supplement each other, and the ointment is externally applied to scalp and can soften and moisten hair, relieve the problem of hair frizziness, remove fat, relieve itching and relieve alopecia. The traditional Chinese medicine composition has an improved treatment effect on the pathogenesis process of frizziness and alopecia.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine compositions, and in particular to a traditional Chinese medicine composition having a scalp care effect. Background Art

[0002] The quality, density, sparseness, dryness, luxuriance, and lustre of hair not only impact a person's image but also serve as a marker of their health. Among those experiencing hair loss, 69.8% are under 30 years old, with the largest proportion, 41.9%, being between 26 and 30 years old. The causes of hair loss are complex. Modern medicine links premature hair loss and graying to genetics, nutritional deficiencies, immune or endocrine disorders, medications, mental health, illness, and improper hair care. However, the specific mechanisms underlying these conditions are not fully understood, limiting treatment options.

[0003] Treatments for hair loss are categorized into medication, non-drug therapy, and surgery. Implant surgery is used when treatment is ineffective, but careful post-implantation care is still required, reintroducing an integrated management model of care, transplantation, and maintenance. Daily care is crucial for preventing hair loss. Using shampoos that contain only chemical antidandruff agents presents challenges such as a single target, a limited antibacterial spectrum, drug resistance, and side effects.

[0004] Traditional Chinese Medicine (TCM) has a long history of preventing and treating itchy, dandruff-causing scalp, premature graying, and hair loss. TCM believes that normal hair growth is closely related to the liver, kidneys, and qi and blood. Liver and kidney deficiency and qi and blood deficiency are the primary pathogenesis of premature hair loss and graying. TCM theories on hair are based on the Yellow Emperor's Classic of Internal Medicine, which dates back over 2,000 years. The "Lingshu: Yin and Yang, Five Words, Five Flavors" chapter states: "Above the Foot Yangming Meridian, when blood and qi are abundant, the beard is long and beautiful; when blood is low and qi is abundant, the beard is short. Therefore, when qi is low and blood is abundant, the beard is short; when both blood and qi are low, there is no beard." Traditional Chinese medicine has a long history of treating hair loss. The use of TCM supplemented with conditioners may improve sebum metabolism, promote scalp microcirculation, inhibit pathogenic bacteria, and repair the skin's microecology. It has unique advantages in drying dampness and clearing heat, removing dandruff and relieving itching, and treating both the symptoms and the root cause.

[0005] In view of the above-mentioned problems in the existing technology and the unique advantages of traditional Chinese medicine, it is necessary to develop a traditional Chinese medicine composition with good technical effects on scalp care to meet market needs. Summary of the Invention

[0006] To address one of the aforementioned technical problems in the prior art, the present invention provides a traditional Chinese medicine composition for alleviating hair loss. Furthermore, a preparation, particularly an ointment, obtained from the composition is provided, which has significant market value. Furthermore, the present invention provides a method for preparing the ointment.

[0007] According to one aspect of the present invention, a traditional Chinese medicine composition for alleviating hair loss is provided, which is prepared from the following traditional Chinese medicines in parts by weight: 2-10 parts of Xanthium sibiricum, 2-10 parts of Platycladus orientalis leaves, 1-3 parts of Zanthoxylum bungeanum, and 1-5 parts of Chuanxiong.

[0008] According to a preferred embodiment of the present invention, the traditional Chinese medicine composition of the present invention comprises 5 parts of Xanthium sibiricum, 5 parts of Platycladus orientalis leaves, 2 parts of Zanthoxylum bungeanum and 2 parts of Ligusticum chuanxiong.

[0009] According to another preferred embodiment of the present invention, the traditional Chinese medicine composition of the present invention comprises 8 parts of Xanthium sibiricum, 8 parts of Platycladus orientalis leaves, 3 parts of Zanthoxylum bungeanum and 3 parts of Ligusticum chuanxiong.

[0010] The composition of the present invention is based on the TCM viscera differentiation system, the understanding of the pathogenesis of hair loss and the treatment principles, and with reference to the achievements of modern pharmacological research. It selects the prescriptions and medicines that Professor Zhao Bingnan, a famous expert in TCM dermatology, often uses to moisturize the skin and nourish the hair, and can indeed expel evil spirits and provide nourishment.

[0011] Xanthium sibiricum fruit has a sweet and bitter taste and warm properties. It dispels wind, relieves pain, removes dampness, and kills insects. The 2020 edition of the Chinese Pharmacopoeia lists it as the dried, mature, involucral fruit of the Asteraceae plant Xanthium sibiricum Patr. It has bitter, sweet, pungent, and warm properties. The 2021 edition of the Cosmetic Ingredients Catalog includes extract of European Xanthium strumarium fruit. Xanthium sibiricum fruit is pungent, warm, and cold-dispelling, while its bitterness can dry out dampness. It can reach the top of the head, travel down to the feet and knees, penetrate the bone marrow, and penetrate the skin and fur, dispelling all rheumatic pathogens. It is a wandering herb. Platycladus orientalis leaves have a bitter, astringent taste and cold properties. They can cool blood, stop bleeding, dispel rheumatism, disperse swelling and toxins, and promote hair growth and darkening. It enters the bloodstream and dispels wind. The Rihuazi Materia Medica claims it can "blacken and moisturize the hair." The Tang Dynasty's "Prescriptions for Emergencies" uses this herb as the main ingredient, decocting it and applying it to the head to keep hair from falling out. It's often used externally to treat hair loss caused by blood heat and premature graying. "Imperial Pharmacy Prescriptions, Volume 8" contains a decoction called "Chrysanthemum Shampoo Powder," which uses a decoction of Platycladus orientalis leaves and chrysanthemum flowers as a wash to treat hair loss. Platycladus orientalis leaves are uniquely effective in preventing hair loss, and the 2020 edition of the Chinese Pharmacopoeia includes them as the dried branches and leaves of Platycladus orientalis (L.) Franco, a plant of the Cupressaceae family.

[0012] Xanthium sibiricum and Pleurotus ostreatus are used together as the main medicine, which can be used to treat both cold and warm diseases, and to disperse and astringe diseases. It can eliminate rheumatism in the head, relieve pain and itching, and promote hair growth and nourishment.

[0013] The auxiliary ingredient, Sichuan peppercorn, is pungent and warm in nature. It can open the pores and unclog the meridians, thus supporting the main ingredient. The 2020 edition of the Chinese Pharmacopoeia lists it as the dried mature peel of the Rutaceae plant Zanthoxylum schinifolium Sieb. et Zucc. or Zanthoxylum bungeanum Maxim. The 2021 edition of the Cosmetic Ingredients Catalogue includes Zanthoxylum bungeanum fruit extract. In cosmetics, Sichuan peppercorns offer excellent stability, antiseptic properties, and anti-aging properties.

[0014] The adjuvant is Chuanxiong, which is pungent and warm. It enters the liver and gallbladder meridians. It promotes qi circulation, relieves depression, dispels wind and dampness, and promotes blood circulation to relieve pain. It treats wind-cold headaches, dizziness, flank pain and abdominal pain, cold arthritis and muscle spasms, amenorrhea, dystocia, postpartum blood stasis and pain, carbuncles and sores. It is used for irregular menstruation, amenorrhea, dysmenorrhea, abdominal pain due to lumps, stabbing pain in the chest and flanks, swelling and pain from falls, headaches, and rheumatic pain. "Bencao Gangmu" (Compendium of Materia Medica): It treats all wind, all qi, all strains, all blood, replenishes the five labors, strengthens the muscles and bones, regulates the meridians, breaks up old blood, nourishes new blood, promotes flesh growth, nosebleeds, hematemesis, hematuria, hematuria, hematuria, hematuria, hematuria, fistulas, brain abscesses, scrofula, goiters, sores, and scabies, and promotes the discharge of pus and the elimination of blood stasis. In vitro tests for antibacterial effects show that Chuanxiong has inhibitory effects on large intestine, dysentery (Sonne's disease), deformity, pus aeruginosa, typhoid fever, Salmonella paratyphi, and Vibrio cholerae. A 1:3 water extract of Chuanxiong rhizome also inhibits certain pathogenic skin fungi in vitro. According to the 2021 edition of the "Catalogue of Used Cosmetic Ingredients," Chuanxiong rhizome root powder is widely used in cosmetics and other personal care products as a skin protectant.

[0015] According to another aspect of the present invention, the Chinese herbal formula for improving hair loss can be prepared into various Chinese herbal composition preparations, such as decoctions, pills, soups, granules, ointments, pills, tablets, wet compresses, wine preparations, etc., using methods and excipients known in the art.

[0016] According to one aspect of the present invention, the Chinese medicine composition preparation can be a paste, comprising the following composition in weight percentage: 4-8 parts of Chinese medicine extracts prepared from Xanthium sibiricum, Platycladus orientalis leaves, Zanthoxylum bungeanum, and Ligusticum chuanxiong, 2-4 parts of moisturizer, 2-11 parts of conditioner, 0.01-0.1 parts of chelating agent, 0.5-1 parts of thickener, 4-8 parts of emulsifier, 0.05-0.2 parts of antioxidant, 0.5-1.3 parts of preservative, 0.01-0.5 parts of pH regulator, and appropriate solvent.

[0017] The Chinese medicine composition ointment provided by the present invention, wherein the Chinese medicine extract can be prepared by methods commonly used in the art, such as decoction, water decoction and alcohol precipitation, immersion, percolation, reflux extraction, continuous reflux extraction, ultrasonic extraction, microwave extraction, etc.

[0018] According to the Chinese medicine composition preparation provided by the present invention, the conditioning agent can be a combination of one or more of several common types of conditioning agents. For example, it can be a cationic conditioning agent, including cetearyl trimethyl ammonium chloride, cocamidopropyl PG-dimethyl ammonium chloride phosphate sodium, stearamidopropyl dimethylamine; another example is plant oils and fats, including jojoba oil and camellia oil; another example is silicone oil, including amino-terminated polydimethylsiloxane and polydimethylsiloxane alcohol; another example is protein derivatives, including silk protein and hydrolyzed protein; and it can also be phospholipids. The above conditioning agents are only examples, and those skilled in the art will understand that other conditioning agents not listed may also be suitable for use in the ointment of the present invention.

[0019] According to the present invention, the humectant is of a type commonly found in the art, for example, glycerin.

[0020] According to the present invention, the chelating agent is a common type in the art, for example, it can be disodium EDTA.

[0021] According to the present invention, the thickener is a common type in the art, for example, it can be selected from a combination of one or more of sodium chloride, hydroxyethyl cellulose, disodium hydrogen phosphate, sodium dihydrogen phosphate, and polysorbate 60.

[0022] According to the present invention, the emulsifier is a common type in the art, for example, cetearyl alcohol. In addition to its emulsifying effect, cetearyl alcohol also acts as a thickener, making the product stable and having a certain viscosity.

[0023] According to the present invention, the antioxidant is a common type in the art, for example, it can be selected from a combination of one or more of tocopheryl acetate, vitamin C, tea polyphenols, and pentaerythritol tetraester.

[0024] According to the present invention, the preservative is a common type in the art, for example, it can be selected from a combination of one or more of 1,2-hexanediol, p-hydroxyacetophenone, phenoxyethanol, ethylhexylglycerin, and sodium benzoate.

[0025] According to the present invention, the pH adjuster is a common type in the art, for example, it can be a combination of one or more of lactic acid and citric acid.

[0026] According to the present invention, the solvent is selected from water, ethanol or a combination of one or more thereof.

[0027] According to one preferred embodiment of the present invention, the Chinese medicine composition preparation may further contain essential oil.

[0028] The ointment provided by the present invention has the effects of improving hair softness, relieving scalp itching, solidifying hair growth and darkening hair, and has no side effects.

[0029] According to another aspect of the present invention, there is provided a method for preparing the above-mentioned ointment, comprising the following steps:

[0030] (1) Preparing a Chinese herbal medicine extract: taking corresponding weight portions of Xanthium sibiricum, Platycladus orientalis leaves, Zanthoxylum bungeanum, and Ligusticum chuanxiong, adding double the amount of water, heating and boiling, extracting once or multiple times, combining the extracts, concentrating, and adding a preservative to obtain a Chinese herbal medicine extract;

[0031] (2) preparing a first mixture: taking a chelating agent, a thickening agent, and a moisturizing agent, adding a solvent, heating to 75-90° C., stirring until completely dissolved, adding a first portion of a conditioning agent, and continuing to stir until completely dissolved, evaporating in an open container and keeping warm for 20-35 minutes, and then adding a pH adjuster to obtain a first mixture;

[0032] (3) preparing a second mixture: heating the emulsifier, the second portion of the conditioning agent, and the antioxidant to 75-85° C., melting them into a liquid state, and then keeping the temperature warm for later use to obtain a second mixture;

[0033] (4) Preparation of ointment: Add the second mixture to the first mixture, stir, homogenize for 2-10 minutes until completely emulsified, keep warm for more than 10 minutes to eliminate foam, then cool to 55-70°C, add the third part of the conditioning agent, stir and mix, continue to cool to 35-50°C, add the Chinese medicine extract, preservatives and the fourth part of the conditioning agent, add or not add essential oil as needed, stir evenly, and cool to room temperature to obtain the ointment of the Chinese medicine composition.

[0034] As described above, the preparation of the Chinese herbal medicine extract can be carried out using a common preparation process in the art. As one preferred method, the Chinese herbal medicine extract is obtained by decoction: taking the corresponding weight portion of the Chinese herbal medicine, adding 2-20 times the amount of water, heating and decoction, extracting once or multiple times, for example, 2-10 times, combining the extracts, concentrating, and adding a preservative to obtain the Chinese herbal medicine extract.

[0035] According to the present invention, the stirring speed is preferably controlled at a medium speed, for example, 55-65 rpm.

[0036] According to the present invention, the homogenization speed is preferably controlled at 2500-3500 rpm to fully emulsify the ointment.

[0037] According to a preferred embodiment of the present invention, a combination of multiple conditioning agents may be used. When a combination of multiple conditioning agents is used, they are preferably added to the ointment in batches and categories during the preparation process, with the first portion of conditioning agents, including cationic conditioning agents and / or phospholipids, being added first, followed by the second portion of conditioning agents, which may be vegetable oils and fats, the third portion of conditioning agents, which may be silicone oils, and finally the fourth portion of conditioning agents, which may be protein derivatives. The benefits of adding different types of conditioners in batches are: 1. Ensuring that the ingredients are fully dissolved and dispersed. Different conditioners have different solubilities. Adding them in batches can avoid insufficient dissolution and agglomeration caused by adding them at the same time; 2. Reducing adverse reactions between ingredients. Adding them in batches can avoid compatibility problems caused by direct contact by controlling the order and environment of addition (such as adjusting the pH before adding ingredients sensitive to a specific pH); 3. Accurately controlling process conditions. Adding conditioners with higher thermal stability in the high temperature stage to thicken and stabilize the system, and adding heat-sensitive ingredients in the low temperature stage to avoid degradation; 4. Adding in batches is also beneficial to improving production efficiency and controllability, facilitating orderly operation according to process steps, reducing human errors or equipment load, and timely testing of intermediates (such as pH, viscosity, stability). If problems are found, they can be adjusted in subsequent steps to avoid scrapping the entire pot of product. It is especially suitable for industrial large-scale production.

[0038] The present invention aims to provide a Chinese medicine composition capable of alleviating hair loss, as well as its formulation and preparation method. The present invention provides a scientifically formulated formula that not only conforms to the basic theory of traditional Chinese medicine (TCM) based on syndrome differentiation and treatment, but also has a modern pharmacological basis for treating hair loss.

[0039] The ingredients in the ointment complement each other and, when applied externally to the scalp, can soften and condition the hair, relieve frizz, remove fat and relieve itching, and alleviate hair loss. It has a therapeutic effect on improving the pathogenesis of frizzy hair loss.

[0040] The ointment provided by the present invention can actually be used as a traditional Chinese medicine hair conditioner. It can be used after shampooing. An appropriate amount of the conditioner is squeezed onto the hair and hair roots, and gently massaged until absorbed. The hair needs to be rinsed clean after use.

[0041] The topical ointment provided by the present invention contains, in addition to the Chinese medicine extract, cetearyl alcohol, glycerin, cetearyl trimethyl ammonium chloride, amodimethicone, dimethicone, cocamidopropyl PG-dimethyl ammonium chloride sodium phosphate, and other active ingredients, all of which are small molecules and can be directly absorbed through the skin. The matrix may also contain ethanol, which can promote skin absorption, help the active ingredients penetrate the skin, and provide oil control and astringent effects. DETAILED DESCRIPTION

[0042] To make the objectives, technical solutions, and advantages of the present invention more clearly understood, the present invention will be further described in detail below with reference to the following examples. The specific embodiments described herein are intended only to illustrate the present invention and are not intended to limit the present invention in any way. In addition, in the following description, descriptions of known structures and technologies are omitted to avoid unnecessary confusion about the concepts of the present disclosure. Such structures and technologies are also described in many publications.

[0043] definition

[0044] Unless otherwise defined, all technical and scientific terms used in the present invention have the same meaning as commonly used in the field to which the present invention belongs. For the purpose of interpreting this specification, the following definitions will apply, and where appropriate, terms used in the singular will also include the plural form, and vice versa.

[0045] Unless the context clearly dictates otherwise, as used herein, the expressions "a" and "an" include plural references. For example, reference to "a cell" includes a plurality of such cells and equivalents thereof known to those skilled in the art, and so forth.

[0046] As used herein, the term "about" refers to a range of ±20% of the value that follows. In some embodiments, the term "about" refers to a range of ±10% of the value that follows. In some embodiments, the term "about" refers to a range of ±5% of the value that follows.

[0047] The following examples are provided to assist in understanding the present invention. However, it should be understood that these examples are intended to illustrate the present invention only and are not intended to limit the present invention in any way. The actual scope of the present invention is set forth in the claims. It should be understood that any modifications and variations may be made without departing from the spirit of the present invention. The reagents and / or kits used in the following examples are commercially available or can be synthesized by known methods.

[0048] It should be noted that, where specific conditions are not specified in the examples, the experiments were conducted according to conventional conditions, manufacturer recommendations, or publicly reported experimental conditions. Reagents or instruments used without manufacturer information are commercially available. For reagents with manufacturer information, similar products from other manufacturers are considered substitutes.

[0049] Preparation Example 1 Preparation of ointment

[0050] The ratio table of cream conditioner is as follows

[0051] Table 1 Ingredients

[0052]

[0053] Prepare the paste by following the steps below:

[0054] Step S1: Chinese medicine extraction process:

[0055] Weigh 5 parts of Xanthium sibiricum, 5 parts of Platycladus orientalis leaves, 2 parts of Zanthoxylum bungeanum, and 2 parts of Chuanxiong, add 10 times the amount of water, and boil and extract 3 times. Combine the extracts, concentrate to 100 parts, add 1 part of preservative (1,2-hexanediol or p-hydroxyacetophenone) and 85 parts of deionized water to obtain a prepared traditional Chinese medicine solution.

[0056] Step S2: ointment preparation:

[0057] 1. Add the raw materials of phase A, including 75.95 parts of deionized water, 0.05 parts of chelating agent disodium EDTA, 3 parts of glycerol, and 0.8 parts of hydroxyethyl cellulose, into a pot, heat to 80-85°C, and stir at medium speed (60 rpm) until completely dissolved;

[0058] 2. Add Phase B ingredients, including 3 parts of cetearyl trimethyl ammonium chloride and 1 part of biomimetic lecithin, into a pot and stir at medium speed (60 rpm) until completely dissolved. Evaporate in an open container and keep warm for 25-30 minutes. Then add Phase C ingredients, i.e. 0.3 parts of lactic acid.

[0059] 3. Prepare the ingredients of phase D, including 6 parts of emulsifier cetearyl alcohol, 0.1 parts of camellia oil, 0.1 parts of jojoba oil, and 0.1 parts of tocopheryl acetate. Heat to 80-82°C, melt into liquid, keep warm, and set aside.

[0060] 4. Slowly add the D phase ingredients to the pot and stir at medium speed (60 rpm). After adding, increase the speed to medium-high homogenization (3000 rpm). Homogenize for 3-5 minutes until completely emulsified. Keep warm for 15 minutes, defoam and cool down.

[0061] 5. Cool to 60-65°C, add Phase E ingredients, i.e. 2 parts of conditioning agent polydimethylsiloxane; cool to 40-45°C, add Phase F ingredients, including 6 parts of traditional Chinese medicine liquid, 0.8 parts of preservative ethylhexylglycerin, 0.5 parts of silk protein, and 0.3 parts of lily of the valley essence, stir at medium speed (60 rpm) until uniform; cool to room temperature.

[0062] 6. Take samples, test, and discharge after passing the test.

[0063] Step S3: Quality Control

[0064] The test items are:

[0065] pH (25°C, 10%): 3.5-5.0

[0066] Viscosity (25°C, mPa.s): 15000-50000 (4# rotor, 12rpm) Stability: No abnormality Centrifugation (45°C×1h, 2000r / min×30min)

[0067] Appearance: Slightly yellow to brownish yellow opaque paste

[0068] Microbial detection: total colony count ≤ 1000 CFU / g

[0069] Total number of molds and yeasts ≤ 100 CFU / g

[0070] Preparation Example 2 Preparation of ointment

[0071] Referring to the method of Preparation Example 1, the ointment was prepared according to the proportions in the following formula table.

[0072] Table 2 Ingredients

[0073]

[0074] Preparation Example 3 Preparation of ointment

[0075] Referring to the method of Preparation Example 1, the ointment was prepared according to the proportions in the following formula table.

[0076] Table 3 Ingredients

[0077]

[0078] Preparation Example 4: Oral Chinese Medicine Liquid

[0079] ① Weigh 8 parts of medicinal materials: Xanthium sibiricum, 8 parts of Platycladus orientalis leaves, 3 parts of Zanthoxylum bungeanum, and 3 parts of Chuanxiong.

[0080] ② Preparation method of Chinese medicine liquid:

[0081] Weigh the above Chinese medicinal materials according to the proportion, wash them, place them in a decoction pot, add 8 times the amount of water, and soak for 30 minutes. Boil over high heat, then reduce the heat and simmer for 30 minutes. Filter the liquid and retain the filtrate. Add 6 times the amount of water to the residue again, simmer for 20 minutes, filter, and combine the two liquids. Concentrate the combined liquid to 1 / 3 of the original volume, cool, bottle, sterilize, and seal for storage.

[0082] Preparation Example 5: Chinese medicine capsules

[0083] ① Weigh 10 parts of medicinal materials: Xanthium sibiricum, 10 parts of Platycladus orientalis leaves, 1 part of Zanthoxylum bungeanum, and 3 parts of Chuanxiong.

[0084] Preparation: Weigh the Chinese medicinal materials according to the appropriate weight, clean, and crush into a fine powder. Pass through a 100-mesh sieve. Place the powder into empty capsules, with each capsule containing 0.5 g of powder. Bottle and seal for storage.

[0085] Preparation Example 6: External wet compress Chinese medicine solution

[0086] ① Weigh 2 parts of Xanthium sibiricum, 5 parts of Platycladus orientalis leaves, 3 parts of Zanthoxylum bungeanum, and 1 part of Ligusticum chuanxiong.

[0087] ② Weigh the above herbs according to the appropriate weight, wash them, and place them in a decoction pot. Add 12 times the amount of water and soak for 30 minutes. Bring to a boil over high heat, then reduce heat and simmer for 20 minutes. Add 8 times the amount of water to the residue and simmer for 15 minutes. Filter and combine the two solutions. Cool the solution to room temperature, sterilize, and seal in a bottle for storage. Use without dilution.

[0088] ③How to use: Take an appropriate amount of the liquid medicine and soak it in sterile gauze or cotton pads, then apply it to the affected area of ​​the cleaned skin for 15-20 minutes each time, twice a day.

[0089] Preparation Example 7: External ointment

[0090] 1. Weigh the following raw materials: Xanthium sibiricum 30g, Platycladus orientalis leaves 30g, Chuanxiong 12g, Zanthoxylum bungeanum 12g;

[0091] 2. Add the above raw Chinese medicinal materials to 140g soybean oil, soak them at 20°C for 2 days and nights, heat the soaking liquid at 160°C in an induction cooker until it boils (about 180°C), then adjust to a low heat (about 100°C) and heat until the surface of Chuanxiong and the surface of Zanthoxylum bungeanum are burnt black and the heating is stopped (it takes about 8 minutes), continue soaking until it returns to room temperature, pass through a 120-mesh sieve to remove the residue and set aside to obtain 144g of Chinese medicinal preparation;

[0092] 3. Take 100g of the medicament obtained in step 2 (about 80g of the original medicinal material is used for every 100g of Chinese medicine), put it into a measuring cup, and take another 300g of the matrix, including 297g of white vaseline and 3g of beeswax, melt them in a 65-80℃ water bath and mix them to obtain the Chinese medicine ointment. Use a 200ml syringe to extract it while it is hot, inject it into the medicine box, cool it, cover it, and label it to make an ointment (17.5g of the original medicinal material is used for every 100g of the finished product).

[0093] 4. When using, apply an appropriate amount of ointment to the affected area, massage until absorbed, and then wash or wipe off the excess ointment.

[0094] Preparation Example 8: External ointment

[0095] 1. Recipe: 30g Xanthium sibiricum, 30g Platycladus orientalis leaves, 30g Chuanxiong, 12g Zanthoxylum bungeanum. Preparation method: Weigh 30g Platycladus orientalis leaves by weight, grind into powder, and pass through a 120-200 mesh sieve to obtain Platycladus orientalis leaf powder, set aside.

[0096] 2. Add 30g of Xanthium sibiricum, 30g of Chuanxiong, and 12g of Zanthoxylum bungeanum to 200g of soybean oil, soak at 20°C for 2 days and nights, transfer to an induction cooker and heat to boiling (about 180°C) at 160°C, then adjust to a slow fire (about 100°C) and heat until the surface of Chuanxiong is burnt brown and the cross section is burnt yellow, stop heating, pass through a 120-mesh sieve to obtain the medicinal oil, wait until the temperature drops to 60-80°C, add Platycladus orientalis leaf powder and stir thoroughly, return to room temperature to obtain the newly prepared Platycladus orientalis oil. Measure 100g of the newly prepared Platycladus orientalis oil and put it into a measuring cup, take another 400g of the matrix, 396g of white vaseline and 4g of beeswax, add them, melt in a 65-80°C water bath and mix well, extract with a 200ml syringe while hot, inject into a medicine box, let it cool, cover and label, and you are done.

[0097] 3. When using, apply an appropriate amount of ointment to the affected area, massage until absorbed, and then wash or wipe off the excess ointment.

[0098] Experimental Example 1: Study on the clinical efficacy of Chinese medicine ointment:

[0099] 1.1 Clinical Research Plan

[0100] 1.1.1 Clinical Research Methods

[0101] Prospective, pre- and post-treatment controlled study.

[0102] 1.1.2 Sample Size

[0103] 23 subjects who meet the criteria will be included. The inclusion criteria are as follows:

[0104] Men or women with hair length between 5 and 40 cm who experience itchy scalp, frizzy or oily hair, excessive hair loss, or thinning hair.

[0105] No special hair treatments such as hair dyeing, perming, styling, etc. were performed within 1 month before the test.

[0106] No products related to hair growth, hair strengthening, or hair loss prevention were used in the two weeks prior to the trial. Hair loss medications such as finasteride, minoxidil tincture, or traditional Chinese medicine were used in the past month.

[0107] The volunteers were informed and voluntarily participated in this study.

[0108] No hair transplantation.

[0109] 1.1.3 Intervention measures

[0110] Patients were instructed to apply the conditioner after shampooing. Apply 4 ml of the ointment from Preparation Example 1 to the hair and scalp, centering on the Baihui acupoint. Apply evenly and gently massage with the fingertips for 2-3 minutes to promote drug absorption. Each patient was instructed to apply the ointment once every three days and rinse thoroughly after conditioning. A 6 mm x 6 mm area of ​​the scalp located at the Baihui acupoint on the same volunteer was designated as the treatment group. The course of treatment was set at 2 weeks, with a total dosage of approximately 20 ml.

[0111] 1.1.4. Efficacy evaluation

[0112] The efficacy evaluation of this trial adopted a method that combined objective trichoscope data evaluation with the volunteers' subjective feelings and independent scoring.

[0113] (1) Trichoscopic image acquisition and analysis: The analysis area is the scalp and hair of the volunteers before and after use of the Baihui acupoint.

[0114] ① Self-rating: This involves self-assessment of hair frizziness, oiliness, itching, and shine. Significantly effective: A difference of 4 or more before and after treatment indicates that dry, dull, split ends, and frizzy hair have essentially disappeared as observed by trichoscope. Effective: A difference of 2 or more but less than 4 before and after treatment indicates that dry, dull, split ends, and frizzy hair have improved as observed by trichoscope. Ineffective: A difference of 1 or less before and after treatment indicates that there has been no significant change in clinical symptoms or signs. Effective rate = (significantly effective + effective) / number of cases × 100%. Significant and effective are collectively referred to as significant effect, while ineffective is collectively referred to as insignificant effect.

[0115] ② Hair density: total number of hairs (FU) ÷ area (c㎡).

[0116] Hair density growth = hair density at the last check-hair density at the first check

[0117] ③The ratio (%) of hair follicles containing 1, 2, or 3 hairs to the total number of hair follicles.

[0118] ④The ratio of vellus hair, intermediate hair and terminal hair (%).

[0119] 1.2 Results

[0120] 1.2.1 Comparison of Self-Evaluation

[0121] Comparison of the effects of patients' self-evaluation before and after use.

[0122] After 2 weeks of use, the before and after comparison results of the volunteers' hair mirror data are as follows:

[0123] Table 4 Comparison of scores before and after treatment

[0124]

[0125] Comparing the conditioner before use, the treatment group showed a more obvious trend of increasing hair density and effectively alleviating hair problems after use.

[0126] The difference between the proportion of vellus hair, intermediate hair, and terminal hair before and after treatment was analyzed, and the difference in the rate of change between the two groups was analyzed to obtain the following table:

[0127] Table 5 Comparison of hair type proportion and growth rate before and after treatment in the two groups

[0128]

[0129]

[0130] The hair density on the side using scalp care liquid and the types and proportions of hair on the side not using it were compared. The proportion of terminal hair in the treatment group increased after use (P<0.05), and the difference was statistically significant.

[0131] At the same time, the proportion of vellus hair in the control group decreased and the proportion of terminal hair increased before and after observation, P<0.05, showing a similar trend.

[0132] 1.2.2 Safety comparison. The comparison results are shown in Table 6:

[0133] Table 6 Comparison of the incidence of adverse scalp reactions in the control group and treatment group before and after use

[0134]

[0135] During the use period, the vital signs of all subjects were stable and no serious adverse reactions occurred. A few volunteers experienced local irritation symptoms after taking the medicine, but the degree was mild and could be relieved on its own, indicating that the external use of Kuanjie Wujun Platycladus Orientalis Softening Conditioner has good safety.

[0136] Experimental Example 2: Clinical efficacy trial of case A

[0137] Patient's basic information: Female, 34 years old, came to the clinic due to sparse hair on the top of her head, and the whorl area was selected for observation.

[0138] Treatment method: Referring to the method described in Experimental Example 1, the subject was treated with the scalp care cream prepared in Example 1, applied once every 3 days for 15 minutes each time, and washed off after use.

[0139] Evaluation of therapeutic effect: The method described in Example 1 was used. The results of trichoscope before and after treatment are shown in Tables 7 and 8:

[0140] Table 7 Comparison of hair follicles before and after treatment

[0141]

[0142] Table 8 Comparison of hair shaft conditions before and after treatment

[0143]

[0144] Tables 7 and 8 show the trichoscope results before and after treatment in this case. The number and percentage of single hairs decreased, while the number and percentage of double and triple hairs increased. The number of vellus and intermediate hairs also increased. The hair growth and strengthening effects were significant.

[0145] Self-evaluation showed that hair quality was improved, with the difference in score before and after two uses being ≥2.

[0146] Experimental Example 3: Clinical efficacy trial of case B

[0147] Patient's basic information: Male, 36 years old, came to the hospital for treatment due to sparse hair on the top of his head, and the whorl area was selected for observation.

[0148] Treatment method: The subject was treated with the scalp care cream prepared in Example 1, applied once every 3 days for 15 minutes each time, and washed off after use.

[0149] The trichoscope results before and after treatment are shown in Tables 9 and 10:

[0150] Table 9 Comparison of hair follicles before and after treatment

[0151]

[0152] Table 10 Comparison of hair shaft conditions before and after treatment

[0153]

[0154] Tables 9 and 10 show the comparison of the hair mirror before and after treatment in Experiment B. The number and percentage of one, two, and three hairs were all increased. The number of vellus hairs and terminal hairs also increased. The hair growth and strengthening effect was significant.

[0155] Self-evaluation showed that hair quality was improved, with the difference in score before and after two uses being ≥2.

[0156] Experimental Example 4C Clinical Efficacy Trial

[0157] Patient's basic information: Female, 31 years old, came to the clinic due to sparse hair on the top of her head, and the whorl area was selected for observation.

[0158] Treatment method: The subject was treated with the scalp care cream prepared in Example 2, applied once every 3 days for 15 minutes each time, and washed off after use.

[0159] The trichoscope results before and after treatment are shown in Tables 11 and 12:

[0160] Table 11 Comparison of hair follicles before and after treatment

[0161]

[0162] Table 12 Comparison of hair shaft conditions before and after treatment

[0163]

[0164] Tables 11 and 12 show the comparison of the hair mirror before and after the treatment in Experiment C. One hair was reduced, while two hairs and the percentage increased. The number of middle hairs increased, demonstrating a hair growth and strengthening effect.

[0165] Self-evaluation showed that hair quality was improved, with the difference in score before and after two uses being ≥2.

[0166] Experimental Example 5D: Clinical efficacy trial

[0167] Patient's basic information: Female, 38 years old, came to the clinic due to sparse hair on the top of her head, and the whorl area was selected for observation.

[0168] Treatment method: The subject was treated with the scalp care cream prepared in Example 2, applied once every 3 days for 15 minutes each time, and washed off after use.

[0169] The trichoscope results before and after treatment are shown in Tables 13 and 14:

[0170] Table 13 Comparison of hair follicles before and after treatment

[0171]

[0172] Table 14 Comparison of hair shaft conditions before and after treatment

[0173]

[0174] Tables 13 and 14 show a comparison of the hair count in Experiment D before and after the treatment. The number and percentage of hair counts for 1 hair decreased, while those for 2 and 3 hairs increased. The number of terminal hairs also increased, demonstrating a hair growth and strengthening effect.

[0175] Self-evaluation showed that hair quality was improved, with the difference in score before and after two uses being ≥2.

[0176] Experimental Example 6: Clinical efficacy trial of case E

[0177] Patient's basic information: Female, 37 years old, came to the clinic due to sparse hair on the top of her head, and the whorl area was selected for observation.

[0178] Treatment method: The subject was treated with the scalp care cream prepared in Example 3, applied once every 3 days for 15 minutes each time, and washed off after use.

[0179] The trichoscope results before and after treatment are shown in Tables 15 and 16:

[0180] Table 15 Comparison of hair follicles before and after treatment

[0181]

[0182] Table 16 Comparison of hair shaft conditions before and after treatment

[0183]

[0184] Tables 15 and 16 show the number and percentage of 1, 2, and 3 hairs reduced before and after use in Experiment E. Self-assessed hair quality improved, with a difference of ≥2 before and after use.

[0185] The technical solution of the present invention is not limited to the above-mentioned specific embodiments. Any technical variations made according to the technical solution of the present invention fall within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for alleviating hair loss, which is prepared from the following traditional Chinese medicines in parts by weight: 2-10 parts of Xanthium sibiricum, 2-10 parts of Platycladus orientalis leaves, 1-3 parts of Zanthoxylum bungeanum, and 1-5 parts of Ligusticum chuanxiong.

2. The Chinese medicine composition according to claim 1, wherein 5 parts of Xanthium sibiricum, 5 parts of Platycladus orientalis leaves, 2 parts of Zanthoxylum bungeanum, and 2 parts of Ligusticum chuanxiong.

3. The Chinese medicine composition according to claim 1, wherein 8 parts of Xanthium sibiricum, 8 parts of Platycladus orientalis leaves, 3 parts of Zanthoxylum bungeanum, and 3 parts of Ligusticum chuanxiong.

4. A traditional Chinese medicine composition preparation for alleviating hair loss, comprising the traditional Chinese medicine composition according to any one of claims 1 to 3 and pharmaceutically acceptable excipients.

5. The Chinese medicine composition preparation according to claim 4, which is a paste, comprising the following composition in parts by weight: 4-8 parts of traditional Chinese medicine extracts prepared from Xanthium sibiricum, Platycladus orientalis leaves, Zanthoxylum bungeanum and Ligusticum chuanxiong, 2-4 parts of moisturizing agent, 2-11 parts of conditioning agent, 0.01-0.1 parts of chelating agent, 0.5-1 parts of thickening agent, 4-8 parts of emulsifier, 0.05-0.2 parts of antioxidant, 0.5-1.3 parts of preservative, 0.01-0.5 parts of pH regulator and appropriate solvent.

6. Chinese medicine composition preparation according to claim 5, wherein the conditioning agent is selected from cetearyl trimethyl ammonium chloride amino dimethicone, polydimethylsiloxane alcohol, cocamidopropyl PG-dimethyl ammonium chloride sodium phosphate, stearamidopropyl dimethylamine, silk protein, hydrolyzed silk, phospholipids, camellia oil, jojoba oil.

7. The Chinese medicine composition preparation according to claim 5, wherein the humectant is glycerol.

8. The Chinese medicine composition preparation according to claim 5, wherein the chelating agent is disodium EDTA.

9. The Chinese medicine composition preparation according to claim 5, wherein the thickener is selected from one or more combinations of sodium chloride, hydroxyethyl cellulose, disodium hydrogen phosphate, sodium dihydrogen phosphate, and polysorbate 60.

10. The Chinese medicine composition preparation according to claim 5, wherein the emulsifier is cetearyl alcohol.

11. The Chinese medicine composition preparation according to claim 5, wherein the antioxidant is selected from a combination of one or more of tocopherol acetate, vitamin C, tea polyphenols, and pentaerythritol tetraester.

12. The Chinese medicine composition preparation according to claim 5, wherein the preservative is selected from one or more combinations of 1,2-hexanediol, p-hydroxyacetophenone, phenoxyethanol, ethylhexylglycerin, and sodium benzoate.

13. The Chinese medicine composition preparation according to claim 5, wherein the pH regulator is a combination of one or more of lactic acid and citric acid.

14. The Chinese medicine composition preparation according to claim 5, wherein the solvent is selected from a combination of one or more of water and ethanol.

15. The Chinese medicine composition preparation according to claim 5, further comprising essential oil.

16. A method for preparing an ointment of the Chinese medicine composition according to claims 5 to 15, comprising the following steps: (1) Preparing a Chinese herbal medicine extract: taking corresponding weight portions of Xanthium sibiricum, Platycladus orientalis leaves, Zanthoxylum bungeanum, and Ligusticum chuanxiong, adding double the amount of water, heating and boiling, extracting once or multiple times, combining the extracts, concentrating, and adding a preservative to obtain a Chinese herbal medicine extract; (2) preparing a first mixture: taking a chelating agent, a thickening agent, and a moisturizing agent, adding a solvent, heating to 75-90° C., stirring until completely dissolved, adding a first portion of a conditioning agent, and continuing to stir until completely dissolved, evaporating in an open container and keeping warm for 20-35 minutes, and then adding a pH adjuster to obtain a first mixture; (3) preparing a second mixture: heating the emulsifier, the second portion of the conditioning agent, and the antioxidant to 75-85° C., melting them into a liquid state, and then keeping the temperature warm for later use to obtain a second mixture; (4) Preparation of ointment: Add the second mixture to the first mixture, stir, homogenize for 2-10 minutes until completely emulsified, keep warm for more than 10 minutes to eliminate foam, then cool to 55-70°C, add the third part of the conditioning agent, stir and mix, continue to cool to 35-50°C, add the Chinese medicine extract, preservatives, and the fourth part of the conditioning agent, add or not add essential oil as needed, stir evenly, and cool to room temperature to obtain the ointment of the Chinese medicine composition.

17. The preparation method according to claim 16, wherein the stirring speed is 55-65 rpm; and the homogenizing speed is 2500-3500 rpm.

18. The preparation method according to claim 16, wherein the first part of the conditioning agent is a cationic conditioning agent and / or a phospholipid, the second part of the conditioning agent is a vegetable oil, the third part of the conditioning agent is a silicone oil, and the fourth part of the conditioning agent is a protein derivative.

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