Oil control and hair growth tincture as well as preparation method and application thereof

Abstract

The invention relates to an oil-controlling and hair-growing tincture as well as a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition comprises the following components in parts by weight: 2-8 parts of cacumen biotae, 1-5 parts of microcos paniculata, 1-6 parts of coix seed, 2-8 parts of tea seed, 1-4 parts of mulberry leaf, 1-5 parts of cowherb seed, 1.5-6 parts of raw hawthorn, 1.5-5 parts of garden balsam stem, 1-3 parts of spina gleditsiae, 0.5-2 parts of alum, 1-5 parts of salvia miltiorrhiza, 1-5 parts of lygodium japonicum and 1-5 parts of ginger. According to the traditional Chinese medicine composition, the cacumen biotae and the microcos paniculata are used as monarch drugs, the coix seeds, the tea seeds, the mulberry leaves, the cowherb seeds and the raw hawthorn fruits are used as ministerial drugs, the garden balsam stems, the spina gleditsiae, the alumen, the radix salviae miltiorrhizae and the lygodium japonicum are used as adjuvant drugs, and the ginger is used as a conductant drug, so that the effects of controlling oil, removing fat, growing hair, clearing heat, removing dampness, dispelling wind and arresting itching are achieved, the clinical curative effect is remarkable, the treatment course is shortened, and the adverse reaction is reduced; grease secretion and alopecia of patients are reduced, and hair growth is promoted.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to an oil-controlling and hair-growing tincture, a preparation method thereof, and an application thereof. Background Art

[0002] With the rapid pace of modern society, androgenic alopecia (AGA) has a high incidence, affecting patients' appearance, severely impacting their physical and mental health, and bringing a high economic burden. Currently, there are various treatment options for this disease, but no specific treatment options exist. Clinically available treatments include medication, hair transplantation, low-intensity laser therapy, mesotherapy, autologous platelet-rich plasma injections, and botulinum toxin type A injections.

[0003] Topical minoxidil tincture is a common medication for oil control and hair growth. The main ingredient of minoxidil tincture is minoxidil 0.5g, and the excipients include 1,2-propylene glycol, ethanol, and potassium dihydrogen phosphate sodium hydroxide buffer. It is used to treat male pattern baldness and alopecia areata. It is an adenosine phosphate-sensitive potassium ion channel activator. It was approved by the US Food and Drug Administration in 1988 for the treatment of androgenic alopecia. It can promote hair growth through various pathways. Studies have shown that the main mechanisms of minoxidil in promoting hair growth are: (1) stimulating the proliferation and differentiation of hair follicle epithelial cells, prolonging the growth phase of hair papilla cells, and prompting resting hair follicles to initiate a new hair growth cycle; (2) promoting angiogenesis in the dermal papilla, increasing skin blood flow and VEGF content; (3) opening potassium channels, inhibiting the influx of calcium ions into cells, and fully exerting the effects of epidermal growth factor and other factors.

[0004] The current disadvantages of minoxidil tincture in the treatment of androgenic alopecia are: (1) Long treatment course and limited effect: It generally takes 12 weeks for topical minoxidil to take effect, and the recommended treatment course is 6 to 12 months. According to foreign research data (RegaineTM instructions), after topical application of 5% minoxidil tincture to the skin, minoxidil is poorly absorbed through the skin, while after oral administration of minoxidil tablets, it can be almost completely absorbed through the gastrointestinal tract. 2% minoxidil tincture can deliver 20 mg of minoxidil to the skin per 1 mL dose, resulting in approximately 0.28 mg of minoxidil being absorbed. 5% minoxidil tincture can deliver 50 mg of minoxidil to the skin per 1 mL dose, resulting in approximately 0.70 mg of minoxidil being absorbed. (2) Increased risk of adverse reactions: Long-term use can lead to an increased risk of adverse reactions such as contact dermatitis, seborrheic dermatitis, scaling, itching, and hirsutism. (3) It has no significant effect on improving hair loss caused by excessive oil secretion.

[0005] There are some traditional Chinese medicine preparations on the market that can control oil and promote hair growth. Although they have certain effects, their efficacy is still not satisfactory to patients. Therefore, finding new safe and effective traditional Chinese medicine combinations for controlling oil and promoting hair growth has important social and clinical significance. Summary of the Invention

[0006] The purpose of the present invention is to overcome the deficiencies of the prior art and provide an oil-controlling hair-growing tincture and a preparation method and application thereof.

[0007] To achieve the above object, the technical solution adopted by the present invention is:

[0008] In the first aspect, the present invention provides a traditional Chinese medicine composition comprising the following components in parts by weight: 2 to 8 parts of Platycladus orientalis leaves, 1 to 5 parts of Buza leaves, 1 to 6 parts of Coix seeds, 2 to 8 parts of tea seeds, 1 to 4 parts of mulberry leaves, 1 to 5 parts of Vaccaria segetalis, 1.5 to 6 parts of raw hawthorn, 1.5 to 5 parts of Polygonum aviculare, 1 to 3 parts of Gleditsia chinensis thorns, 0.5 to 2 parts of alum, 1 to 5 parts of Salvia miltiorrhiza, 1 to 5 parts of Lygodium japonicum and 1 to 5 parts of ginger.

[0009] Clinically, in addition to gradually thinning, thinning, and softening hair, patients with androgenic alopecia often experience symptoms such as excessive oiliness on the scalp, erythematous papules on the scalp, excessive dandruff, or itching. According to Traditional Chinese Medicine (TCM), this syndrome is classified as "damp-heat accumulation syndrome." Therefore, external treatment should focus on "controlling oil, removing fat, promoting hair growth, clearing heat and removing dampness, and dispelling wind and relieving itching." The present invention uses Platycladus orientalis leaves and Buza leaves as the main herbs, Coix seeds, tea seeds, mulberry leaves, Vaccaria segetalis, and raw hawthorn as the auxiliary herbs, Herba Polygoni Multiflori, Gleditsiae chinensis, Alum, Salvia miltiorrhiza, and Lygodium japonica as the adjuvant herbs, and ginger as the guiding herb, all of which work together to control oil, remove fat, promote hair growth, clear heat and remove dampness, and dispel wind and relieve itching.

[0010] Platycladus orientalis leaves: The dried branches and leaves of Platycladus orientalis, a plant of the Cupressaceae family. They are bitter and cold in nature, and have the properties of promoting hair growth and blackening, cooling blood and stopping bleeding, and resolving phlegm and relieving cough. They are primarily used to treat hematemesis, hematochezia, blood-heat-induced hair loss, and premature graying of hair. "Compendium of Materia Medica," Volume 34, states: "For hair failure, dry Platycladus orientalis leaves in the shade, grind them into powder, and apply it with sesame oil." "Compendium of Materia Medica" also states: "It can stop vomiting, epistaxis, metrorrhagia, and dysentery, and relieve wind-cold, dampness, and itching, and darken hair." Modern pharmacological research indicates that the four flavonoids in Platycladus orientalis leaves—quercetin, apigenin, kaempferol, and myricetin—as well as the two terpenes, isopimarenol and pinolactone, may be the active ingredients in its treatment of hair loss. Animal experiments have shown that the volatile oil from Platycladus orientalis leaves can enhance the expression of Wnt / β-catenin and Shh pathways in the dorsal skin of mice. These volatile oils, acting together, promote the transition of hair follicles from the telogen phase to the anagen phase, thereby promoting hair growth. Isomarinol and rosmarinol were isolated from the petroleum ether extract of Platycladus orientalis leaves, and a mouse hair loss model was established using the rosin-paraffin wax depilatory method to study the hair growth-promoting activity and mechanism of the above two terpenoid components. The results showed that both isomarinol and rosmarinol could significantly increase the VEGF level in mouse serum, enhance hair follicle activity, and promote hair growth.

[0011] Buzha leaves are the dried leaves of the Tiliaceae plant. They have a slightly sour flavor and cooling properties, promoting digestion, relieving stagnation, and clearing heat and dampness. Modern research has revealed that Buzha leaves have a complex chemical composition, containing alkaloids, flavonoids, volatile oils, and organic acids. They possess antioxidant, lipid-lowering, analgesic, anti-inflammatory, and cardiovascular protective properties.

[0012] Vaccaria segetalis: The dried mature seeds of the Caryophyllaceae plant, Caryophyllaceae. It tastes bitter and is neutral in nature. It has the effects of promoting blood circulation and menstruation, promoting lactation and reducing swelling, and promoting diuresis and relieving stranguria. Modern research has revealed that Vaccaria segetalis contains a diverse range of chemical components, including volatile oils, flavonoid glycosides, cyclic peptides, and saponins. The cyclic peptide compounds in Vaccaria segetalis have estrogenic effects, while the flavonoids and saponins can promote lactation by promoting the expression of mitogen-activated protein kinases, milk protein synthesis signaling factors, prolactin receptors, and estrogen receptors. Vaccaria segetalis also has pharmacological effects such as anti-tumor activity, angiogenesis inhibition, anti-inflammatory, antioxidant, vascular smooth muscle regulation, and anticoagulant.

[0013] Raw hawthorn: The dried, mature fruit of the plant Shanlihong (Crataegus pinnatifida) or Crataegus pinnatifida, also known as hawthorn, belongs to the Rosaceae family. It has a sour, sweet, and slightly warm nature, and is known to aid digestion, invigorate the stomach, promote qi circulation, dissipate blood stasis, and reduce turbidity and lipids. Modern research has revealed that hawthorn contains numerous chemical components, including flavonoids, organic acids, oligomeric proanthocyanidins, triterpenoid acids, 14 sterols, and trace amounts of cardiac-active amines. Total flavonoids and organic acids are the most abundant chemical components in hawthorn, and total flavonoids and oligomeric proanthocyanidins are the two major classes of bioactive components. Research has shown that hawthorn has a wide range of pharmacological activities, particularly in the cardiovascular system, including cardiotonic, antiarrhythmic, antihypertensive, hypolipidemic, and antioxidant activities. Hawthorn also has a potent regulatory effect on digestive tract dysfunction, enhancing spleen function and promoting food excretion. Hawthorn is rich in vitamin C, vitamin B2, carotene, and various organic acids, which can enhance the secretion of digestive enzymes and the activity of gastric enzymes. Hawthorn also exhibits hypoglycemic, antibacterial, anti-inflammatory, and immunomodulatory properties.

[0014] Lygodium japonicum: The dried mature spores of Lygodium japonicum, a plant of the Lygodium family. It has a sweet and salty taste and a cold nature, and is effective in clearing heat and dampness. Modern pharmacological research has shown that Lygodium japonicum inhibits the activity of 5α-reductase, the enzyme that activates testosterone to convert to dihydrotestosterone. A 50% ethanol extract of Lygodium japonicum significantly inhibits testosterone 5α-reductase activity in vitro, suggesting that Lygodium japonicum may promote hair growth in patients with androgenic alopecia.

[0015] Coix seed: The dried, mature kernel of the grass plant Coix lachryma-jobi, with a sweet and mild flavor and cooling properties, has the benefits of promoting diuresis and dispelling dampness, strengthening the spleen and arresting diarrhea, eliminating numbness, draining pus, and detoxifying and dispersing stagnation. Clinically, coix seed has been shown to have a lipid-removing effect. Modern pharmacological research has revealed that coix seed polysaccharides have anti-inflammatory and analgesic properties; coix seed sterols and squalene exhibit anti-tumor, anti-inflammatory, lipid-lowering, and antioxidant activities; coix seed polyphenol extracts can scavenge DPPH free radicals and have strong antioxidant capacity; and coixol can exert certain anti-inflammatory effects by inhibiting the expression of pro-inflammatory mediators such as TNF-α, NO, iNOS, and COX-2 in vitro.

[0016] Tea seeds are the mature seeds of the Camellia sinensis plant, a member of the Theaceae family. They are sweet in flavor and cooling in nature, known for their heat-clearing and wind-relief properties, detoxifying and insecticidal, improving eyesight, and brightening hair. Modern pharmacological research has revealed that tea seed oil, rich in antioxidant compounds such as vitamin E and polyphenols, possesses multiple physiological functions, including antioxidant, anti-inflammatory, stomach-protecting, antibacterial, antiviral, and laxative properties. Tea seed oil exhibits significant inhibitory effects against Staphylococcus aureus, Escherichia coli, Aspergillus flavus, and brewer's yeast, increasing antioxidant enzyme activity, heat shock protein production, and progesterone (PGE2) production. It also inhibits lipid peroxidation, apoptosis-related proteins, and the production of proinflammatory cytokines and nitric oxide (NO), thereby suppressing inflammation.

[0017] Mulberry leaves: The dried leaves of the Morus alba plant (Moraceae). They are sweet and bitter in taste and cold in nature. They dispel wind-heat, clear the lungs and moisten dryness, and clear the liver and improve eyesight. Ben Jing Feng Yuan states: "Mulberry leaves clear the lungs and stomach, dispel wind and improve eyesight. Take those that have been frosted and boil them in a decoction to wash away wind and tears. Combined with black sesame honey pills, long-term use prevents graying of hair and promotes longevity." Modern pharmacological research has found that mulberry leaf flavonoids can reduce the production of TNF-α, IL-6, and other proteins, demonstrating excellent anti-inflammatory activity. Mulberry leaf polysaccharides and polyphenols also have antipyretic and analgesic properties, regulate immunity, and have antibacterial and anti-disease properties.

[0018] Impatiens balsamina (Balsamic Balsamina) is a plant of the Impatiens family. It has a pungent, spicy flavor and warm properties. Its benefits include dispelling wind and dampness, relaxing muscles and promoting blood circulation, providing anti-inflammatory and analgesic effects, and removing fat and relieving itching. Modern pharmacological research has revealed the presence of progesterone in pelvic flooring. Excessive levels of androgens like testosterone and dihydrotestosterone (DHT) are a key factor in androgenic alopecia. Progesterone can prevent the conversion of testosterone into DHT, which damages hair follicles. Furthermore, many components of pelvic flooring, such as organic acids and volatile oils, have astringent properties on wounds and possess anti-inflammatory and effective anti-allergic properties.

[0019] Soapberry thorns are the thorns of the leguminous plant Gleditsia sinensis. They are pungent and warm in nature, and have the effects of reducing swelling, expelling toxins, draining pus, and killing insects. Modern pharmacological research has found that soapberry thorns have varying degrees of inhibitory effects on different bacteria, with significant antibacterial activity against Listeria, Escherichia coli, Salmonella enterica, Staphylococcus aureus, and Pseudomonas aeruginosa. Soapberry thorns are rich in polyphenols and flavonoids, both of which have strong antioxidant and free radical scavenging abilities. They reduce the expression of cyclooxygenase-2 and inflammatory cytokine mRNA in macrophages, reduce the expression of lipopolysaccharide-activated cyclooxygenase-2, and significantly reduce the production of progesterone-2, tumor necrosis factor-α, interleukin-1β, and IL-6 in lipopolysaccharide-activated macrophages.

[0020] Alum: A crystal derived from the naturally occurring sulfate mineral alunite, primarily containing potassium aluminum sulfate. It has a sour, astringent flavor and a cold nature. Externally applied, it has detoxifying, insecticidal, and antipruritic properties. Modern pharmacological research has shown that alum absorbs water from cells, causing them to dehydrate and shrink, reducing glandular secretions and inflammatory exudates. It also binds to serum proteins to form insoluble protein compounds that precipitate, drying out tissues or wounds. This astringent and anti-inflammatory effect is also beneficial. 1% alum and dried alum solutions have demonstrated significant antibacterial activity against Escherichia coli, Shigella dysenteriae, Staphylococcus albus, Staphylococcus aureus, Proteus, Bacillus anthracis, Salmonella paratyphi A, and Salmonella typhi.

[0021] Danshen (Salvia miltiorrhiza) is the dried root and rhizome of the Lamiaceae plant Salvia miltiorrhiza. It is bitter and slightly cold in nature, and has the effects of promoting blood circulation, removing blood stasis, relieving menstrual pain, clearing the heart and relieving restlessness, and cooling blood and eliminating carbuncle. Modern experimental research shows that Danshen can dilate subcutaneous capillaries, improve microcirculation, enhance hair follicle nutrition, and promote hair regeneration. Its active ingredient, tanshinone, has moderate estrogen-like activity, exhibiting anti-androgenic, immune-modulating, and antibacterial and lipid-removing properties.

[0022] Ginger: The fresh rhizome of the ginger plant, Zingiber officinale, is pungent and slightly warm in nature. It has the effects of dispelling cold, warming the middle and stopping vomiting, resolving phlegm and relieving coughs, and detoxifying fish and crab poisons. Its pungent, dispersing, warming, and unblocking properties are known to open the pores and promote local blood circulation. Modern pharmacological research has shown that ginger can replenish serum zinc levels; its volatile oils and gingerols have anti-inflammatory and analgesic properties; and gingerols can modulate immunity, act as anticoagulants, and act as antioxidants.

[0023] Preferably, the following components are included in parts by weight: 5 parts of Platycladus orientalis leaves, 2 parts of Buza leaves, 3 parts of Coix seeds, 5 parts of tea seeds, 2 parts of mulberry leaves, 2 parts of Vaccaria segetalis, 3 parts of raw hawthorn, 3 parts of Radix schizonepetae, 2 parts of Gleditsia chinensis, 1 part of alum, 3 parts of Salvia miltiorrhiza, 3 parts of Lygodium japonicum and 3 parts of ginger.

[0024] In a second aspect, the present invention provides the use of the traditional Chinese medicine composition in the preparation of oil-controlling and hair-growing medicines.

[0025] Furthermore, the dosage form of the oil-controlling and hair-growing drug is an oral preparation, a gel, an ointment or a tincture.

[0026] In a third aspect, the present invention provides an oil-controlling and hair-growing medicine, which is prepared from the traditional Chinese medicine composition.

[0027] Furthermore, the traditional Chinese medicine composition is extracted with ethanol to obtain an oil-controlling and hair-growing medicine.

[0028] Furthermore, the ratio of the traditional Chinese medicine composition to ethanol is 155-670 g:775-2235 mL.

[0029] Preferably, the ratio of the traditional Chinese medicine composition to ethanol is 370g:1235mL.

[0030] Furthermore, the Chinese medicine composition is soaked in ethanol for 7 to 21 days. Preferably, the Chinese medicine composition is soaked in ethanol for 14 days.

[0031] Furthermore, the volume concentration of ethanol is 50% to 95%. Preferably, the volume concentration of ethanol is 75%.

[0032] Compared with the prior art, the present invention has the following beneficial effects:

[0033] The traditional Chinese medicine combination of the present invention uses Platycladus orientalis leaves and Buza leaves as main medicines, Coix seeds, tea seeds, mulberry leaves, Vaccaria segetalis, and raw hawthorn as auxiliary medicines, Herba schizonepetae, Gleditsiae thorns, Alum, Salvia miltiorrhiza, and Lygodium japonica as adjuvant medicines, and ginger as a guiding medicine. Together, they have the effects of controlling oil, removing fat, promoting hair growth, clearing away heat and dampness, dispelling wind and relieving itching, have significant clinical efficacy, shorten the course of treatment, reduce adverse reactions, reduce oil secretion and hair loss in patients, and promote hair growth. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 These are pictures of the skin and hair of Case 1 before and after treatment.

[0035] Figure 2 These are pictures of the skin and hair of Case 2 before and after treatment.

[0036] Figure 3 These are pictures of the skin and hair of Case 3 before and after treatment. DETAILED DESCRIPTION

[0037] To better illustrate the purpose, technical solutions and advantages of the present invention, the present invention will be further described below with reference to specific examples. Other materials, reagents, etc. used in the examples, unless otherwise specified, can be obtained from commercial sources.

[0038] Example 1

[0039] The formula of the Chinese medicine composition (by weight): 5 parts of Platycladus orientalis leaves, 2 parts of Buza leaves, 3 parts of Coix seeds, 5 parts of tea seeds, 2 parts of mulberry leaves, 2 parts of Vaccaria segetalis, 3 parts of raw hawthorn, 3 parts of Radix schizonepetae, 2 parts of Gleditsia spinulosae, 1 part of alum, 3 parts of Salvia miltiorrhiza, 3 parts of Lygodium japonicum, and 3 parts of ginger.

[0040] Example 2

[0041] The formula of the Chinese medicine composition (by weight): 2 parts of Platycladus orientalis leaves, 1 part of Buza leaves, 1 part of Coix seeds, 2 parts of tea seeds, 1 part of mulberry leaves, 1 part of Vaccaria segetalis, 1.5 parts of raw hawthorn, 1.5 parts of Radix schizonepetae, 1 part of Gleditsia sinensis thorn, 0.5 part of alum, 1 part of Salvia miltiorrhiza, 1 part of Lygodium japonicum, and 1 part of ginger.

[0042] Example 3

[0043] The formula of the Chinese medicine composition (by weight): 8 parts of Platycladus orientalis leaves, 5 parts of Buza leaves, 6 parts of Coix seeds, 8 parts of tea seeds, 4 parts of mulberry leaves, 5 parts of Vaccaria segetalis, 6 parts of raw hawthorn, 5 parts of Radix Polygoni Multiflori, 3 parts of Gleditsia spinosa, 2 parts of alum, 5 parts of Salvia miltiorrhiza, 5 parts of Lygodium japonicum, and 5 parts of ginger.

[0044] Comparative Example 1

[0045] The formula of the Chinese medicine composition (by weight): 5 parts of Platycladus orientalis leaves, 3 parts of Coix seeds, 5 parts of tea seeds, 2 parts of mulberry leaves, 3 parts of Herba Polygoni Multiflori, 2 parts of Gleditsiae Spina, 1 part of Alum, 3 parts of Salvia miltiorrhiza, 3 parts of Lygodium japonicum, and 3 parts of ginger.

[0046] Comparative Example 2

[0047] The Buza leaves in Example 1 were replaced with the same weight portions of Cnidium officinale.

[0048] Comparative Example 3

[0049] The Vaccaria segetalis in Example 1 was replaced by safflower of the same weight.

[0050] Comparative Example 4

[0051] The raw hawthorn of Example 1 was replaced with the Shenqu of the same weight.

[0052] Example 4

[0053] The Chinese medicine compositions of Examples 1 to 3 or Comparative Examples 1 to 4 were respectively mixed with 75% (v / v) alcohol in a ratio of 370 g of the Chinese medicine composition to 75% (v / v) alcohol: 1235 mL. The mixture was soaked for 14 days, filtered, and the residue was removed to obtain the juice to obtain the oil-controlling and hair-growing tincture, which was packaged into 100 mL bottles for later use.

[0054] Example 5 Animal Experiment

[0055] 1. Using a skin hair observation instrument (Nanjing Bening Medical Instrument Co., Ltd., model BN-PFMF-8001, Su Xie No. 20172221767), 200 C3H male mice aged 2 months with no statistically significant difference in hair density per square meter on the back (same part) were selected. A depilatory cream (with no damaging effect on hair follicles) was used to remove hair from the back in an area of 4 cm. 2 Use a dermatoscope to ensure that there is no visible hair in the hair removal area within 48 hours.

[0056] 2. The mice were divided into 8 groups, each containing 25 mice.

[0057] 3. The mice in the corresponding groups of Example and Comparative Example were respectively smeared with 3 mL of oil-controlling hair-growing tincture on the hair removal area every day, while the control group was washed with 3 mL of clean water on the hair removal area every day;

[0058] 4. On the 7th and 15th day after the experiment, the hair regrowth area at the shaved site was measured. The results were expressed as the average of the hair regrowth area of each group of mice. The results are shown in Table 1 below:

[0059] Table 1 Hair regeneration area (%)

[0060] Day 7 Day 15 Example 1 41.2 93.4 Example 2 28.3 70.7 Example 3 26.9 72.1 Comparative Example 1 21.3 65.1 Comparative Example 2 23.7 67.4 Comparative Example 3 19.9 63.6 Comparative Example 4 20.3 63.9 control group 16.4 60.2

[0061] Conclusion: From the above experimental comparison data, it can be seen that the oil-control and hair-growing tincture prepared in the embodiment of the present invention can effectively promote hair growth in the hair-depilatory area of mice; at the same time, from the effects of the embodiment, the control group and the comparative example, it can be seen that the raw material composition has a great influence on the hair growth effect, and the raw material ratio according to the method of the present invention is significantly higher than that of other raw material groups.

[0062] Example 6 Human Experiment

[0063] 1. Experimental Methods

[0064] Test subjects: 200 volunteers diagnosed with androgenic alopecia, aged between 18 and 50 years old, were selected and divided into 8 groups, 25 people in each group, and the oil-control and hair-growing tinctures prepared in the examples and comparative examples, as well as a control group (pure water) were used.

[0065] Instructions for use: Each person should apply the corresponding experimental formulation, 3 times a day, 3-5 mL each time, for 90 consecutive days.

[0066] Detection method:

[0067] 1. Use a non-invasive skin detector (specification model: Danish DERMALAB series C044002-392) to detect changes in sebum content in the hair loss areas of all volunteers in each group.

[0068] 2. Use a skin hair observation device (Nanjing Bening Medical Instrument Co., Ltd., model BN-PFMF-8001, Su Xie registration number 20172221767) to detect the number of hairs per square meter in the hair loss area.

[0069] 3. Hair Pulling Test: This test assesses the activity and severity of alopecia. After 90 days of treatment, each group performed the hair pulling test. The subjects, without shampooing for 5 days prior to the test, pinched a bunch of 50 to 100 hairs at the root with their thumb and index finger using moderate force. The hairs were then gently pulled outward along the longitudinal axis of the hair. This test was repeated 6 to 8 times at different locations, and the number of hairs pulled out was counted. Normally, 2 to 5 loose, resting hairs can be pulled out. If the amount of hair pulled out exceeds 10% of the pulled hairs, meaning more than 6 hairs, the test is positive, indicating the presence of alopecia.

[0070] 2. Experimental Results

[0071] Table 2 Changes in sebum content in the hair loss area of each group ( ±s,au)

[0072] Before treatment 90 days after treatment Example 1 98.33±10.32 23.11±9.78 Example 2 97.46±9.12 50.46±10.45 Example 3 93.89±10.98 49.67±9.98 Comparative Example 1 92.46±9.13 55.14±10.78 Comparative Example 2 95.19±9.98 59.41±9.85 Comparative Example 3 96.24±10.02 63.27±9.88 Comparative Example 4 93.57±10.51 67.45±10.35 control group 94.87±10.21 79.65±9.72

[0073] Table 3 The number of hairs per square meter in the hair loss area of each group ( ±s, root)

[0074] Before treatment 90 days after treatment Example 1 20.01±3.21 67.11±4.32 Example 2 24.96±3.72 40.23±3.87 Example 3 27.76±4.01 38.12±3.67 Comparative Example 1 23.11±4.01 33.11±4.02 Comparative Example 2 24.06±3.85 32.23±3.11 Comparative Example 3 26.96±3.91 33.12±3.57 Comparative Example 4 26.61±4.27 34.32±3.88 control group 24.34±4.65 32.98±4.01

[0075] Table 4 Hair pulling test results of each group ( ±s, root)

[0076] Before treatment 90 days after treatment Example 1 20.65±2.43 3.78±1.23 Example 2 23.12±3.22 10.45±2.01 Example 3 20.45±3.54 13.76±1.98 Comparative Example 1 22.05±2.13 11.78±1.72 Comparative Example 2 21.12±3.08 12.15±2.21 Comparative Example 3 20.76±3.14 13.06±1.79 Comparative Example 4 20.95±3.00 14.12±1.99 control group 22.77±4.21 15.33±1.32

[0077] Conclusion: As can be seen from the data in Tables 2 to 4 above, the oil-controlling hair-growing tinctures of the present invention can effectively reduce scalp oiliness. At the same time, the results of the present invention and the comparative example show that the raw material composition has a significant impact on the effect of promoting hair growth and reducing the amount of hair loss, and the raw material ratio according to the method of the present invention is significantly more effective. At the same time, after the three-month trial period, the volunteers in each group were followed up, and all volunteers reported that the scalp oiliness had not recurred, and there were no adverse reactions on the scalp during and after the experiment.

[0078] Example 7 Clinical Efficacy Evaluation of Oil-Controlling Hair-Growing Tincture

[0079] Case 1: Liu, female, 23 years old, was first diagnosed on February 26, 2024 because of "hair thinning and thinning for more than a year". The skin hair observation instrument picture at the first visit is as follows Figure 1As shown in A, the hair diameter is diverse and the hair follicles are smaller, there is a perifollicular sign (brown halo around the hair), dystrophic hair, exclamation mark hair, and follicle openings without hair shafts. The patient applied the oil-control hair growth tincture of Example 1 externally, 3 times a day, 3 to 5 ml each time, and persisted in the treatment. He was re-examined on May 31, 2024. The skin hair observation instrument picture is as follows Figure 1 As shown in B, the hair has become denser and thicker than when the patient was first diagnosed.

[0080] Case 2: Luo Moumou, female, 34 years old, was first diagnosed on March 22, 2024 because of "hair thinning and thinning for more than 2 years". The skin hair observation instrument picture at the first visit is as follows Figure 2 As shown in A, there is a diversity of hair diameters and smaller follicles, perifollicular signs (brown halo around the hair), yellow dot signs, dystrophic hair, exclamation mark hair, and follicular openings without hair shafts. The patient applied the oil-control hair growth tincture of Example 1 externally, 3 times a day, 3 to 5 ml each time, and persisted in the treatment. The follow-up visit was on June 22, 2024. The skin and hair observation instrument picture is as follows Figure 2 As shown in B, the hair has become denser and thicker than when the patient was first diagnosed.

[0081] Case 3: Zang, male, 25 years old, was first diagnosed on September 30, 2023 because of "thinning hair for more than 2 years". The skin hair observation instrument picture at the first visit is as follows Figure 3 As shown in A, there is a diversity of hair diameters and smaller follicles, perifollicular signs (brown halo around the hair), dystrophic hair, exclamation mark hair, and follicular openings without hair shafts. The patient applied the oil-control hair growth tincture of Example 1 externally, 3 times a day, 3 to 5 ml each time, and persisted in the treatment. The follow-up visit was on December 31, 2023. The skin and hair observation instrument picture is as follows Figure 3 As shown in B, the hair has become denser and thicker than when the patient was first diagnosed.

[0082] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit the scope of protection of the present invention. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that the technical solutions of the present invention may be modified or replaced by equivalents without departing from the essence and scope of the technical solutions of the present invention.

Claims

1. A Chinese medicine composition, characterized in that The invention comprises the following components in parts by weight: 2-8 parts of Platycladus orientalis leaves, 1-5 parts of Buza leaves, 1-6 parts of Coix seeds, 2-8 parts of tea seeds, 1-4 parts of mulberry leaves, 1-5 parts of Vaccaria segetalis, 1.5-6 parts of raw hawthorn, 1.5-5 parts of Radix schizonepetae, 1-3 parts of Gleditsia sinensis thorns, 0.5-2 parts of alum, 1-5 parts of Salvia miltiorrhiza, 1-5 parts of Lygodium japonicum and 1-5 parts of ginger.

2. The Chinese medicine composition according to claim 1, wherein The invention comprises the following components in parts by weight: 5 parts of orientalis leaves, 2 parts of sedge leaves, 3 parts of coix seeds, 5 parts of tea seeds, 2 parts of mulberry leaves, 2 parts of fenugreek, 3 parts of raw hawthorn, 3 parts of radix polygoni lobata, 2 parts of gleditsia thorn, 1 part of alum, 3 parts of salvia miltiorrhiza, 3 parts of sea sand and 3 parts of ginger.

3. Use of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of oil-controlling and hair-growing medicines.

4. The use according to claim 3, characterized in that The dosage form of the oil-controlling and hair-growing medicine is an oral preparation, a gel, an ointment or a tincture.

5. A drug for oil control and hair growth, characterized in that: The oil-controlling and hair-growing medicine is prepared from the traditional Chinese medicine composition according to claim 1 or 2.

6. The method for preparing the oil-controlling hair growth drug according to claim 5, wherein: The traditional Chinese medicine composition according to claim 1 or 2 is extracted with ethanol to obtain an oil-controlling and hair-growing medicine.

7. The method for preparing the oil-controlling hair growth drug according to claim 6, wherein: The ratio of the traditional Chinese medicine composition to ethanol is 155-670 g:775-2235 mL.

8. The preparation method according to claim 5, wherein The traditional Chinese medicine composition is soaked in ethanol for 7 to 21 days.

9. The preparation method according to claim 5, wherein The volume concentration of ethanol is 50% to 95%.

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