Anti-hair-loss traditional Chinese medicine composition for scalp care as well as preparation method and application of anti-hair-loss traditional Chinese medicine composition

Abstract

The invention provides an anti-hair loss traditional Chinese medicine composition for scalp care as well as a preparation method and application thereof, and belongs to the technical field of shampoo. The traditional Chinese medicine composition is prepared from the following raw materials in parts by mass: 8 to 15 parts of ginseng, 20 to 30 parts of cacumen biotae, 12 to 20 parts of radix polygoni multiflori preparata, 15 to 25 parts of radix salviae miltiorrhizae, 18 to 28 parts of herba ecliptae and 10 to 16 parts of rhizoma chuanxiong. The traditional Chinese medicine extract prepared from the raw materials is used as an effective component of the shampoo, and ginseng can tonify qi, strengthen hair and enhance hair follicle activity; the cacumen biotae prevents hair loss and promotes hair growth; prepared fleece-flower root can blacken hair and nourish; salvia miltiorrhiza controls oil, inhibits bacteria and relieves alopecia seborrhoeica; herba ecliptae cools blood and nourishes hair; ligusticum wallichii can promote blood circulation to remove blood stasis and promote scalp microcirculation; various traditional Chinese medicine extracts jointly exert the effects of preventing hair loss, promoting hair growth, controlling oil, removing dandruff, nourishing and repairing.

Description

Technical Field

[0001] The present invention belongs to the technical field of shampoo, and particularly relates to an anti - hair - loss traditional Chinese medicine composition for scalp care, its preparation method and application. Background Art

[0002] With the acceleration of the pace of life, the increase of work pressure and the change of living environment, people's scalp health problems have become increasingly prominent, such as hair loss, dandruff, excessive scalp oil, etc. Hair loss not only affects personal image but also may bring psychological pressure to patients; excessive dandruff and scalp oil will reduce the comfort of the scalp and affect the quality of life.

[0003] At present, there are a wide variety of products for scalp care on the market, but most of them have some limitations. Although some chemically synthesized shampoo products have certain effects in cleaning and anti - dandruff, long - term use may cause damage to the scalp and hair, such as destroying the barrier function of the scalp and making the hair dry and easy to break. And some products claiming to have the effect of preventing hair loss and promoting hair growth often do not achieve satisfactory results in practice, and may contain ingredients such as hormones, posing potential safety hazards.

[0004] In the field of traditional Chinese medicine, many traditional Chinese medicines have the effects of nourishing the scalp, promoting hair growth, antibacterial and anti - inflammatory. However, the existing traditional Chinese medicine scalp care products have deficiencies in formula design and preparation technology, and fail to give full play to the advantages of traditional Chinese medicine. For example, some products simply mix traditional Chinese medicine ingredients without scientific screening and optimization, resulting in insignificant efficacy; in the preparation process, the extraction method is unreasonable, unable to effectively extract the active ingredients in traditional Chinese medicine, or the activity of the active ingredients is damaged in subsequent processing. Therefore, it is of great market demand and practical significance to develop a safe and effective scalp care product that can give full play to the efficacy of traditional Chinese medicine. Summary of the Invention

[0005] In view of this, the purpose of the present invention is to provide an anti - hair - loss traditional Chinese medicine composition for scalp care, its preparation method and application, so as to exert the effects of preventing hair loss and promoting hair growth, controlling oil and removing dandruff, and nourishing and repairing.

[0006] In order to achieve the above - mentioned invention purpose, the present invention provides the following technical solutions:

[0007] An anti - hair - loss traditional Chinese medicine composition for scalp care, comprising the following raw materials by mass parts: 8 - 15 parts of ginseng, 20 - 30 parts of Platycladus orientalis, 12 - 20 parts of processed Polygonum multiflorum Thunb., 15 - 25 parts of Salvia miltiorrhiza, 18 - 28 parts of Eclipta prostrata and 10 - 16 parts of Ligusticum chuanxiong.

[0008] The present invention also provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps: pulverizing the raw materials, and performing three-stage countercurrent extraction; combining the extracts, initially filtering through a 100 kDa ceramic membrane, and then refining through a 5 kDa organic nanofiltration membrane, and collecting the active components with a retention molecular weight of 3000 - 5000 Da; adding ethanol to the membrane separation liquid to a final concentration of 60% - 65%, refrigerating and crystallizing, and then taking the supernatant and concentrating it.

[0009] Preferably, the raw materials are pulverized to 40 - 60 meshes, put into a dynamic countercurrent extraction device, and three-stage countercurrent extraction is carried out at a material-liquid ratio of 1:8 - 10; the three-stage countercurrent extraction process is the first tank at 85°C → the second tank at 75°C → the last tank at 65°C.

[0010] Preferably, the refrigerating and crystallizing is refrigerating at 4°C for 18 - 30 h, centrifuging at 2000 - 4000 rpm for 10 - 20 min to obtain the supernatant, and concentrating by thin-film evaporation at 50 - 55°C to a relative density of 1.25 - 1.30.

[0011] The present invention also provides a traditional Chinese medicine extract for scalp care prepared by the preparation method and its application in the preparation of an anti-hair loss shampoo for scalp care.

[0012] The present invention also provides an anti-hair loss shampoo for scalp care, which comprises 3 - 5 wt% of the traditional Chinese medicine extract.

[0013] Preferably, it further comprises the following auxiliary components: tea bran powder 0.5 - 1.2 wt%, tea tree oil 0.3 - 0.8 wt%, ganoderma spore powder 0.2 - 0.5 wt%, menthol 0.1 - 0.3 wt%, rosemary essential oil 0.2 - 0.5 wt%, artemisia argyi essential oil 0.3 - 0.6 wt%, and asiatic pennywort extract 0.4 - 0.7 wt%.

[0014] Preferably, it further comprises a surfactant 35 - 50 wt%, a scalp conditioner 0.8 - 1.5 wt%, and the balance is a natural solvent and a pH regulator.

[0015] The present invention also provides a preparation method of the anti-hair loss shampoo for scalp care, which comprises the following steps: premixing the traditional Chinese medicine extract, the auxiliary components and the natural solvent at 40 - 45°C, and sequentially adding the surfactant, the scalp conditioner and the pH regulator until the pH is 5.5 - 6.5; nitrogen protection is adopted throughout the process and the water activity is controlled to be < 0.6.

[0016] Compared with the prior art, the present invention has the following beneficial effects:

[0017] In the traditional Chinese medicine composition of the present invention, ginseng replenishes qi and consolidates hair growth, enhancing the activity of hair follicles; Platycladus orientalis prevents hair loss and promotes hair growth; rosemary essential oil stimulates the proliferation of dermal papilla cells; Ligusticum wallichii promotes blood circulation to remove blood stasis and improves scalp microcirculation. The combined action of various ingredients effectively activates hair follicles and promotes hair growth. Through anti-hair loss and hair growth tests, it can be seen that for patients using the scalp care shampoo of the present invention, the hair density increases, which is significantly better than commercially available products, and the diameter of the newly grown hair is close to the level of healthy hair, effectively alleviating the problem of seborrheic alopecia.

[0018] The various ingredients of the present invention act synergistically to effectively inhibit the secretion of sebum by sebaceous glands, inhibit the growth of bacteria such as Malassezia, reduce the problems of oily hair and dandruff; also significantly improve the hair quality, such as enhancing the glossiness of hair strands, reducing the dry and split ends of hair tails, and alleviating the redness, swelling, itching symptoms of the scalp, achieving the soothing and repair of the scalp.

[0019] The present invention uses natural traditional Chinese medicine raw materials and mild auxiliary ingredients, and strictly controls the conditions during the preparation process to ensure product quality. Through clinical trials, it can be seen that the shampoo of the present invention has zero irritating reactions, higher product safety, and a wider range of applicable populations. Detailed implementation mode

[0020] The present invention provides an anti-hair loss traditional Chinese medicine composition for scalp care, which includes the following raw materials by mass: 8-15 parts of ginseng, 20-30 parts of Platycladus orientalis, 12-20 parts of processed Polygonum multiflorum, 15-25 parts of Salvia miltiorrhiza, 18-28 parts of Eclipta prostrata, and 10-16 parts of Ligusticum wallichii; preferably, it includes 10 parts of ginseng, 25 parts of Platycladus orientalis, 15 parts of processed Polygonum multiflorum, 20 parts of Salvia miltiorrhiza, 25 parts of Eclipta prostrata, and 15 parts of Ligusticum wallichii.

[0021] The present invention also provides a preparation method of the traditional Chinese medicine composition, which includes the following steps: crushing the raw materials and performing three-stage countercurrent extraction; combining the extraction solutions, initially filtering through a 100 kDa ceramic membrane, and then refining through a 5 kDa organic nanofiltration membrane, and collecting the effective components with a molecular weight cut-off of 3000-5000 Da; adding ethanol to the membrane separation solution to a final concentration of 60%-65%, refrigerating and crystallizing, and then taking the supernatant and concentrating.

[0022] In the present invention, preferably, the raw materials are crushed to 40-60 meshes, and more preferably to 50 meshes. Preferably, the crushed raw materials are mixed and then put into a dynamic countercurrent extraction device for three-stage countercurrent extraction with a material-liquid ratio of 1:8-10, and more preferably a material-liquid ratio of 1:9. The preferred solvent is acidified water containing 0.1-0.3 wt% citric acid (pH 4.5-5.0), more preferably containing 0.2 wt% citric acid; more preferably, the fresh solvent flows reversely from the last tank to the first tank, with a flow rate of 2.5-3.0 m 3 / h → the second tank 1.8-2.2 m 3 / h → the last tank 1.0-1.5 m 3 / h. Preferably, the first tank is at 85 ± 1 °C (dissolving fat-soluble components) → the second tank is at 75 ± 1 °C (extracting glycosides) → the last tank is at 65 ± 1 °C (protecting heat-sensitive components).

[0023] In the present invention, when the extraction solution is preferably pre-filtered through a 100 kDa ceramic membrane, the transmembrane pressure is 0.3 - 0.5 MPa, and the cross-flow velocity is 4 - 6 m / s; more preferably, the transmembrane pressure is 0.4 MPa and the cross-flow velocity is 5 m / s. When refined through a 5 kDa organic nanofiltration membrane, the operating pressure is 1.2 - 1.5 MPa, and the temperature is maintained at 40 ± 2 °C; more preferably, the operating pressure is 1.4 MPa and the temperature is maintained at 40 °C; more preferably, the organic nanofiltration membrane is made of polyethersulfone.

[0024] In the present invention, it is preferred to add 95% food-grade ethanol to the membrane separation liquid at a rate of 0.5 L / min until the final ethanol concentration is 60% - 65%.

[0025] In the present invention, it is preferred that cold storage crystallization is carried out at 4 °C for 18 - 30 h, more preferably for 24 h, and more preferably 0.01% chitosan quaternary ammonium salt is added to accelerate flocculation; it is preferred to centrifuge at 2000 - 4000 rpm for 10 - 20 min to obtain the supernatant, more preferably centrifuge at 3000 rpm for 15 min; it is preferred to concentrate by thin-film evaporation at 50 - 55 °C to a relative density of 1.25 - 1.30.

[0026] The present invention also provides a traditional Chinese medicine extract for scalp care prepared by using the above raw materials and preparation method and its application in the preparation of an anti-hair loss shampoo for scalp care.

[0027] The present invention also provides an anti-hair loss shampoo for scalp care, which includes 3 - 5 wt% of the above traditional Chinese medicine extract, preferably 4 wt%. As an active ingredient of the anti-hair loss shampoo for scalp care, this traditional Chinese medicine extract has the following effects: ginseng - replenishing qi and strengthening hair growth, enhancing hair follicle activity; Platycladus orientalis - preventing hair loss and promoting hair growth; Polygonum multiflorum Thunb. - nourishing black hair; Salvia miltiorrhiza - controlling oil and inhibiting bacteria, relieving seborrheic alopecia; Eclipta prostrata - cooling blood and nourishing hair; Ligusticum chuanxiong - promoting blood circulation and removing stasis, promoting scalp microcirculation. Multiple traditional Chinese medicine extracts jointly exert the effects of preventing hair loss and promoting hair growth, controlling oil and removing dandruff, and nourishing and repairing.

[0028] In the present invention, preferably, the above scalp care anti - hair - loss shampoo further comprises the following auxiliary components: tea bran powder 0.5 - 1.2 wt%, tea tree oil 0.3 - 0.8 wt%, ganoderma spore powder 0.2 - 0.5 wt%, menthol 0.1 - 0.3 wt%, rosemary essential oil 0.2 - 0.5 wt%, mugwort essential oil 0.3 - 0.6 wt%, and centella asiatica extract 0.4 - 0.7 wt%. Further preferably, the tea bran powder is 1.0 wt%, the tea tree oil is 0.5 wt%, the ganoderma spore powder is 0.4 wt%, the menthol is 0.2 wt%, the rosemary essential oil is 0.4 wt%, the mugwort essential oil is 0.5 wt%, and the centella asiatica extract is 0.5 wt%. Among the above - mentioned auxiliary components of the present invention, the tea bran powder - naturally decontaminates while retaining hair keratin; the tea tree oil - has antifungal and antipruritic effects and enhances the dandruff - removing ability; the ganoderma spore powder - the antioxidant component is more easily absorbed; the menthol - has a cooling and antipruritic effect; the rosemary essential oil - is a hair - growth - promoting component; the mugwort essential oil - has antibacterial and cold - expelling effects and improves the scalp environment; the centella asiatica extract - repairs the scalp barrier and reduces hair breakage. All the above - mentioned auxiliary components of the present invention can be purchased through market channels.

[0029] The present invention prepares the above - mentioned traditional Chinese medicine extracts and auxiliary components into a scalp care anti - hair - loss shampoo, which has the following effects: The ginseng extract enhances the ATP energy metabolism of hair follicle cells; the biota orientalis extract inhibits DHT (the main culprit of hair loss) and prolongs the growth phase of hair follicles; the rosemary essential oil stimulates the proliferation of dermal papilla cells; the ligusticum wallichii improves scalp microcirculation. The four components work together to activate hair follicles, prevent hair loss and promote hair growth. The polygonum multiflorum thunb extract is used as a melanin - generating promoter; the eclipta prostrata extract contains tannins and melanin precursors and synergistically combines with polygonum multiflorum thunb; the ganoderma spore powder repairs damaged hair cuticles and reduces hair breakage. The three components work together to achieve the effects of blackening hair and strengthening hair. The tea tree oil has antifungal activity, which is stronger than ordinary antibacterial agents; the mugwort essential oil has broad - spectrum antibacterial properties; the salvia miltiorrhiza extract inhibits 5α - reductase and reduces sebum secretion. The three components work together to inhibit malassezia and other fungi and play the role of antibacterial and dandruff - removing. The tea bran powder adsorbs excess sebum while retaining necessary protective oils and also has the function of cleaning and foaming; the menthol inhibits the over - activity of sebaceous glands through cold - sensation reflex. The two components regulate the scalp environment and achieve oil - control conditioning. The centella asiatica extract promotes collagen production and repairs the tissues around hair follicles; the ganoderma spore powder contains triterpenoids with anti - inflammatory and antioxidant effects, and the eclipta prostrata extract relieves the redness, swelling and itching caused by damp - heat in the scalp. The three components work together to form a scalp barrier maintenance and soothe and repair the scalp. In addition, the plant essential oils used also have an aromatic effect.

[0030] In the present invention, preferably, the above-mentioned anti-hair-loss shampoo for scalp care further comprises 35-50 wt% of surfactant, 0.8-1.5 wt% of scalp conditioner. More preferably, the surfactant is 42 wt% and the scalp conditioner is 1 wt%; the balance is natural solvent and pH regulator. Further preferably, the content of the pH regulator can adjust the shampoo to pH 5.5-6.5, and more preferably to pH 6.0. The preferred surfactant is a compound of sodium lauroyl sarcosinate, decyl glucoside, cocamidopropyl betaine and sodium methyl cocoyl taurate. Further preferably, the mass ratio of sodium lauroyl sarcosinate, decyl glucoside, cocamidopropyl betaine and sodium methyl cocoyl taurate is 5:1:2:0.4; the preferred scalp conditioner is a compound of zinc pyrrolidone carboxylate and panthenol. Further preferably, the mass ratio of zinc pyrrolidone carboxylate and panthenol is 1:1; the preferred natural solvent is a compound solvent of propylene glycol / 1,3-propanediol, and the pH regulator is a citric acid / sodium citrate buffer system with pH 5.5-6.0.

[0031] The present invention also provides a preparation method of the anti-hair-loss shampoo for scalp care containing traditional Chinese medicine extract and auxiliary components, comprising the following steps: premixing the traditional Chinese medicine extract, auxiliary components and natural solvent at 40-45 °C, and sequentially adding surfactant, scalp conditioner and pH regulator until the pH is 5.5-6.5; nitrogen protection is adopted throughout the process and the water activity is controlled to be <0.6.

[0032] In the present invention, preferably, the surfactant system preheated to 80±2 °C is added in three stages, and high-shear mixing is carried out at 200-800 rpm for 5-8 min at each stage. Further preferably, high-shear mixing is carried out at 500 rpm for 6 min; preferably, the temperature is lowered to 45±1 °C and then the scalp conditioner and pH regulator are added in sequence, and the temperature is further lowered to 39±1 °C for discharging; preferably, it also includes filtration through a 80-120 mesh sieve after discharging.

[0033] The technical solutions provided by the present invention are described in detail below with reference to the embodiments, but they should not be construed as limiting the protection scope of the present invention.

[0034] Example 1

[0035] A combined anti-hair-loss traditional Chinese medicine extract for scalp care is prepared as follows:

[0036] (1) Raw material preparation: Weigh 10 parts of ginseng, 25 parts of Platycladus orientalis, 15 parts of processed Polygonum multiflorum, 20 parts of Salvia miltiorrhiza, 25 parts of Eclipta prostrata and 15 parts of Ligusticum chuanxiong, and crush the raw materials to 50 meshes.

[0037] (2) Three-stage countercurrent extraction: Put the crushed raw materials into a dynamic countercurrent extraction device, and use acidified water containing 0.2 wt% citric acid as the solvent for extraction with a material-liquid ratio of 1:9. Fresh solvent flows reversely from the last tank to the first tank, and the flow rate is controlled to be 3.0 m in the first tank3 / h, the secondary tank is 2.2 m 3 / h, the final tank is 1.5 m 3 / h. The extraction temperature is 85 ± 1 °C for the first tank, 75 ± 1 °C for the secondary tank, and 65 ± 1 °C for the final tank.

[0038] (3) Primary filtration and refinement: Combine the extracts and conduct primary filtration through a 100 kDa ceramic membrane with a transmembrane pressure of 0.4 MPa and a cross-flow velocity of 5 m / s; then refine through an organic nanofiltration membrane made of 5 kDa polyethersulfone with an operating pressure of 1.4 MPa and a temperature maintained at 40 °C, and collect the active components with a molecular weight cut-off of 3000 - 5000 Da.

[0039] (4) Cold storage crystallization and concentration: Add 95% food-grade ethanol to the membrane separation liquid at a rate of 0.5 L / min until the final ethanol concentration reaches 65%, refrigerate at 4 °C for 24 h, add 0.01% chitosan quaternary ammonium salt to accelerate flocculation, centrifuge at 3000 rpm for 15 min to obtain the supernatant, and concentrate by thin-film evaporation at 55 °C to a relative density of 1.30 to obtain the combined traditional Chinese medicine extract.

[0040] Example 2

[0041] A combined traditional Chinese medicine extract for preventing hair loss in scalp care, the preparation method is as follows:

[0042] (1) Raw material preparation: Weigh 8 parts of ginseng, 20 parts of Platycladus orientalis leaf, 12 parts of processed Polygonum multiflorum Thunb., 15 parts of Salvia miltiorrhiza Bunge, 18 parts of Eclipta prostrata L., and 10 parts of Ligusticum wallichii Franch., and crush them to 40 mesh.

[0043] (2) Three-stage countercurrent extraction: Put the crushed raw materials into a dynamic countercurrent extraction device, with a material-liquid ratio of 1:8, and use acidified water containing 0.1 wt% citric acid as the solvent for extraction. The solvent flows reversely, with a flow rate of 2.5 m 3 / h for the first tank, 1.8 m 3 / h for the secondary tank, 1.0 m 3 / h for the final tank, and the temperature is 85 ± 1 °C for the first tank, 75 ± 1 °C for the secondary tank, and 65 ± 1 °C for the final tank.

[0044] (3) Primary filtration and refinement: Combine the extracts and conduct primary filtration through a 100 kDa ceramic membrane with a transmembrane pressure of 0.3 MPa and a cross-flow velocity of 4 m / s, and then refine through an organic nanofiltration membrane made of 5 kDa polyethersulfone with an operating pressure of 1.2 MPa and a temperature of 38 °C, and collect the 3000 - 5000 Da active components.

[0045] (4) Refrigeration crystallization and concentration: Add 95% food-grade ethanol to the membrane separation liquid at a rate of 0.5 L / min until the final ethanol concentration reaches 60%. Refrigerate at 4°C for 18 h, add 0.01% quaternary ammonium chitosan to accelerate flocculation, centrifuge at 2000 rpm for 10 min to obtain the supernatant, and concentrate by thin-film evaporation at 50°C to a relative density of 1.25 to prepare the combined traditional Chinese medicine extract.

[0046] Example 3

[0047] A combined traditional Chinese medicine extract for preventing hair loss in scalp care, the preparation method is as follows:

[0048] (1) Raw material preparation: Weigh 15 parts of ginseng, 30 parts of Platycladus orientalis leaf, 20 parts of processed Polygonum multiflorum Thunb., 25 parts of Salvia miltiorrhiza Bunge, 28 parts of Eclipta prostrata L., and 16 parts of Ligusticum chuanxiong Hort., and crush them to 60 meshes.

[0049] (2) Three-stage countercurrent extraction: Put the crushed raw materials into a dynamic countercurrent extraction device, and use acidified water containing 0.3 wt% citric acid as the solvent for extraction at a solid-liquid ratio of 1:10. The solvent flow rate is 2.8 m 3 / h for the first tank, 2 m 3 / h for the second tank, and 1.2 m 3 / h for the last tank, and the temperature is 85 ± 1°C for the first tank, 75 ± 1°C for the second tank, and 65 ± 1°C for the last tank.

[0050] (3) Primary filtration and refining: Combine the extraction liquids, conduct primary filtration through a 100 kDa ceramic membrane with a transmembrane pressure of 0.5 MPa and a cross-flow velocity of 6 m / s, and then refine through a 5 kDa organic nanofiltration membrane made of polyethersulfone with an operating pressure of 1.5 MPa and a temperature of 42°C, and collect the target active components.

[0051] (4) Refrigeration crystallization and concentration: Add 95% food-grade ethanol to the membrane separation liquid at a rate of 0.5 L / min until the final ethanol concentration reaches 65%. Refrigerate at 4°C for 30 h, add 0.01% quaternary ammonium chitosan to accelerate flocculation, centrifuge at 4000 rpm for 20 min to obtain the supernatant, and concentrate by thin-film evaporation at 55°C to a relative density of 1.28 to obtain the combined traditional Chinese medicine extract.

[0052] Example 4

[0053] An anti-hair loss shampoo for scalp care, the components and preparation method are as follows:

[0054] Take 4 wt% of the traditional Chinese medicine extract prepared in Example 1, 1.0 wt% of tea bran powder, 0.5 wt% of tea tree oil, 0.4 wt% of ganoderma spore powder, 0.2 wt% of menthol, 0.4 wt% of rosemary essential oil, 0.5 wt% of mugwort essential oil, 0.5 wt% of centella asiatica extract, and a surfactant (sodium lauroyl sarcosinate, decyl glucoside, cocamidopropyl betaine and sodium methyl cocoyl taurate, mass ratio 5:1:2:0.4) of 42 wt%, a scalp conditioner (zinc pyrrolidone carboxylate and panthenol, mass ratio 1:1) of 1 wt%, and an appropriate amount of propylene glycol / 1,3-propanediol compound solvent and citric acid / sodium citrate buffer system.

[0055] Premix the traditional Chinese medicine extract, auxiliary components and natural solvent at 45 °C; add the surfactant system preheated to 80 ± 2 °C in three stages, with a high shear of 500 rpm for 6 min at each stage interval; cool down to 45 ± 1 °C, add the scalp conditioner and pH regulator in sequence, and adjust the pH to 6.0; continue to cool down to 39 ± 1 °C for discharging, and filter through a 100-mesh sieve to obtain the scalp care shampoo.

[0056] Example 5

[0057] An anti-hair loss shampoo for scalp care, the components and preparation method are as follows:

[0058] Use 3 wt% of the traditional Chinese medicine extract in Example 2, 0.5 wt% of tea bran powder, 0.3 wt% of tea tree oil, 0.2 wt% of ganoderma spore powder, 0.1 wt% of menthol, 0.2 wt% of rosemary essential oil, 0.3 wt% of mugwort essential oil, 0.4 wt% of centella asiatica extract, 35 wt% of surfactant (sodium lauroyl sarcosinate, decyl glucoside, cocamidopropyl betaine and sodium methyl cocoyl taurate, mass ratio 5:1:2:0.4), 0.8 wt% of scalp conditioner (zinc pyrrolidone carboxylate and panthenol, mass ratio 1:1), and an appropriate amount of propylene glycol / 1,3-propanediol compound solvent and citric acid / sodium citrate buffer system.

[0059] Premix the traditional Chinese medicine extract, auxiliary components and natural solvent at 40 °C, add the surfactant preheated to 80 ± 2 °C in three stages, with a high shear of 800 rpm for 5 min at each stage interval; cool down to 45 ± 1 °C, add the scalp conditioner and pH regulator in sequence, and adjust the pH to 5.5; continue to cool down to 39 ± 1 °C for discharging, and filter through a 120-mesh sieve to obtain the scalp care shampoo.

[0060] Example 6

[0061] An anti-hair loss shampoo for scalp care, the components and preparation method are as follows:

[0062] Take 5 wt% of the traditional Chinese medicine extract from Example 3, 1.2 wt% of tea bran powder, 0.8 wt% of tea tree oil, 0.5 wt% of ganoderma spore powder, 0.3 wt% of menthol, 0.5 wt% of rosemary essential oil, 0.6 wt% of mugwort essential oil, 0.7 wt% of centella asiatica extract, 50 wt% of surfactant (the mass ratio of sodium lauroyl sarcosinate, decyl glucoside, cocamidopropyl betaine to sodium methyl cocoyl taurate is 5:1:2:0.4), 1.5 wt% of scalp conditioner (the mass ratio of zinc pyrrolidone carboxylate to panthenol is 1:1), and an appropriate amount of propylene glycol / 1,3-propanediol compound solvent and citric acid / sodium citrate buffer system.

[0063] Premix the traditional Chinese medicine extract, auxiliary components and natural solvent at 43 °C, and add the surfactant preheated to 80 ± 2 °C in three stages, with a high-shear of 200 rpm for 8 min at each stage; cool down to 45 ± 1 °C, add the scalp conditioner and pH regulator in sequence, and adjust the pH to 6.5; continue to cool down to 39 ± 1 °C for discharging, and filter with an 80-mesh sieve to obtain the scalp care shampoo.

[0064] Test Example 1

[0065] Hair follicle activity test

[0066] 1. Construction of cell culture system

[0067] Cell source: The third-generation normal human dermal papilla cells are used, and the medium is DMEM / F12 (containing 10% FBS, 1% penicillin-streptomycin), and subculture is carried out in an incubator at 37 °C and 5% CO2.

[0068] 2. Experimental grouping

[0069] It is divided into 3 groups. Group A is the traditional Chinese medicine combined extract prepared in Example 1; Group B is the auxiliary component formula of 1.0 wt% of tea bran powder, 0.5 wt% of tea tree oil, 0.4 wt% of ganoderma spore powder, 0.2 wt% of menthol, 0.4 wt% of rosemary essential oil, 0.5 wt% of mugwort essential oil, 0.5 wt% of centella asiatica extract; Group A + B is the traditional Chinese medicine combined extract + auxiliary components prepared in Example 1. The solvent is DMSO + Tween 80.

[0070] 3. Cell treatment and detection

[0071] Cell seeding: Take HHDPCs in the logarithmic growth phase and seed them in a 96-well plate at a density of 5×10 3 cells / well. After adherent for 24 h, replace the medium with the drug-containing medium (200 μL / well), and set 6 replicates for each group.

[0072] Time gradient: Detection is carried out at 72 h after adding the drug, and a solvent control group (containing an equal amount of DMSO + Tween 80) is set synchronously.

[0073] 4. Index determination

[0074] The cell proliferation rate, the multiple of VEGF expression, and the TGF-β1 inhibition rate were measured respectively.

[0075] 5. Test results

[0076] As shown in Table 1, the effects of different pharmacodynamic components on the activity of human dermal papilla cells were significantly different. The combined extract of traditional Chinese medicine in Group A could effectively promote cell proliferation, increase the VEGF expression level, and inhibit TGF-β1, showing a significant enhancing effect on the activity of human dermal papilla cells. Although the auxiliary components in Group B had a certain effect on cell activity, the effect was not as good as that of Group A. The effect of Group A+B was much higher than that of Group A and Group B alone, indicating that there was a synergistic effect between the combined extract of traditional Chinese medicine and the auxiliary components, which could more effectively enhance the activity of human dermal papilla cells and provide strong support for promoting hair growth.

[0077] Table 1 Effects of different pharmacodynamic components on the activity of human dermal papilla cells

[0078]

[0079]

[0080] Test Example 2

[0081] Oil control and antibacterial test

[0082] 1. Construction of experimental system

[0083] Sources of cells and strains:

[0084] Sebaceous gland cells: Human sebaceous gland cell line SZ95 (purchased from DSMZ, Germany, No. ACC 757), and the culture medium was DMEM / F12 (containing 10% FBS, 1% ITS+Premix), and the culture conditions were 37°C and 5% CO2.

[0085] Malassezia: Standard strain of Malassezia, inoculated on modified Dixon agar medium (containing 1% Tween 80, 1% olive oil), and anaerobically cultured at 37°C for 72 h.

[0086] 2. Experimental grouping

[0087] Divided into 4 groups, group A is the traditional Chinese medicine combined extract prepared in Example 1; group B is the auxiliary components including 1.0 wt% tea seed powder, 0.5 wt% tea tree oil, 0.4 wt% ganoderma spore powder, 0.2 wt% menthol, 0.4 wt% rosemary essential oil, 0.5 wt% mugwort essential oil, and 0.5 wt% centella asiatica extract; group A+B is the traditional Chinese medicine combined extract prepared in Example 1 + auxiliary components; the solvent is DMSO + Tween 80. Another group D is set as the positive control group (1% salicylic acid for oil control + 2% ketoconazole), and the solvent is ethanol.

[0088] 3. Test operation and detection

[0089] (1) Oil control effect:

[0090] Cell treatment: Inoculate SZ95 cells at 1×10 5 cells / well into a 6-well plate. After adhering for 24 h, replace the medium with the drug-containing medium (2 mL / well), and set 3 replicates for each group.

[0091] Induced secretion: Add 50 μM testosterone to stimulate sebum secretion, and collect the cell supernatant after 72 h.

[0092] Triglyceride detection: Measure the absorbance (570 nm) and calculate the sebum inhibition rate.

[0093] (2) Bacteriostatic effect:

[0094] Bacterial suspension preparation: Pick a single colony of Malassezia and inoculate it into Dixon liquid medium. Culture it in a shaker at 37 °C for 48 h (200 rpm), and adjust the bacterial liquid concentration to 1×10 6 CFU / mL.

[0095] Oxford cup method: Uniformly coat 100 μL of the bacterial suspension on a Dixon agar plate; place a sterile Oxford cup (inner diameter 6 mm), and add 200 μL of the test drug solution to each cup; after culturing at 37 °C for 72 h, measure the diameter of the inhibition zone with a vernier caliper (accurate to 0.1 mm).

[0096] Calculation of the synergy index: Use the Chou-Talalay method to calculate the CI value of different concentration combinations (CI < 1 indicates synergy).

[0097] 4. Test results

[0098] As shown in Table 2, in terms of oil control and bacteriostatic effects, different active pharmaceutical ingredients showed different performances. In terms of the sebum inhibition rate index, the A+B group had the highest sebum inhibition rate, indicating that the combined traditional Chinese medicine extract and auxiliary ingredients synergistically inhibited the sebum secretion of sebaceous glands more effectively, controlled the problem of oily scalp, and the effect was better than that of the positive control group. In terms of the diameter of the inhibition zone index, the A+B group had the largest diameter of the inhibition zone, indicating that its inhibitory effect on Malassezia was the strongest, and the components synergistically enhanced the antibacterial ability, and the effect was better than that of the positive control group.

[0099] The combination index (CI) calculated by the Chou-Talalay method for the A+B group was 0.62 (CI<1 indicates synergy), further proving that the combined traditional Chinese medicine extract and auxiliary ingredients had a synergistic effect in oil control and bacteriostasis, and could better exert the efficacy of scalp care.

[0100] Table 2 Oil control and bacteriostatic effects of different active pharmaceutical ingredients

[0101] Detection indicators Group A Group B Group A + B Positive control Sebum inhibition rate (72h) 58.3±4.2％ 22.1±3.1％ 84.7±5.6％ 73.5±4.8％ Inhibition zone diameter (mm) 10.2±0.9 14.5±1.2 19.3±1.5 18.7±1.3 Synergy index (CI) - - 0.62 -

[0102] Test Example 3

[0103] Anti-hair loss and hair growth promotion test

[0104] 1. Test design

[0105] Ninety patients with mild to moderate seborrheic alopecia (60 males and 30 females) aged 18 - 50 years who met the diagnostic criteria of "Chinese Guidelines for the Diagnosis and Treatment of Androgenetic Alopecia" were recruited and randomly divided into 3 groups:

[0106] The shampoo group of the present invention (30 cases): used the scalp care shampoo of Example 4 of the present invention;

[0107] Control group 1 (30 cases): used a commercially available anti-hair loss and hair growth promotion shampoo of Brand A;

[0108] Control group 2 (30 cases): used a commercially available 5% minoxidil tincture for treatment.

[0109] Note: All groups used the corresponding products once every 2 days for 6 consecutive months, and other anti-hair loss products were prohibited during the test period.

[0110] 2. Evaluation indicators

[0111] (1) Change in hair density (number of hairs / cm 2 ) in the target area (1 cm on the top of the head 2 );

[0112] (2) Change in hair diameter (μm);

[0113] (3) Amount of hair loss (count the hair loss on the pillow every morning and take the average value for 7 consecutive days);

[0114] (4) Patient self - rated satisfaction (5 - level scale: 1 = ineffective, 5 = significant improvement);

[0115] (5) The effective rate of blinded evaluation by dermatologists (judged effective based on an improvement in SALT score of ≥ 30%).

[0116] Statistical method: ANOVA variance analysis and chi - square test were performed using SPSS 26.0, and p < 0.05 was considered significant.

[0117] 3. Test results

[0118] As shown in Table 3, the hair - growth effect of the shampoo of the present invention is significant. The hair density of the patients in the shampoo group of the present invention increased by 84.0%, which is significantly better than 24.5% in Comparative Example 1 group and 65.7% in Comparative Example 2 group (p < 0.05), and the diameter of the newly - grown hair is close to the level of healthy hair. In addition, the shampoo of the present invention has zero irritation reaction, while in Comparative Example 2 group, due to the propylene glycol solvent, some patients had scalp itching or folliculitis, and the use effect was not good.

[0119] Table 3 The remission effect of different shampoo products on mild - to - moderate seborrheic alopecia

[0120]

[0121] Note: In the table, ▲: p < 0.01 compared with Comparative Example 1 group; ●: p < 0.05 compared with Comparative Example 2 group; *: p < 0.05 compared with the baseline.

[0122] Test Example 4

[0123] Recruit 200 patients with seborrheic alopecia accompanied by dandruff and oily scalp (150 cases in the experimental group: 50 males and 100 females, aged 18 - 75 years old; 50 cases in the control group: 18 males and 32 females, aged 17 - 65 years old), and randomly divide them into two groups.

[0124] The experimental group used the scalp - care shampoo of Example 4 of the present invention; the control group used a commercially available anti - hair - loss shampoo (containing 1% ketoconazole + ginger extract). Both groups washed their hair once every 3 days, and the test period was 90 days.

[0125] After 7 days of use: In the experimental group, 126 people (40 males and 86 females) had a hair loss reduction of ≥ 50%, and the root strength of the hair increased; in the control group, only 9 people (3 males and 6 females) had a slight reduction in hair loss, and there was no improvement in hair quality.

[0126] After 15 days of use: In the experimental group, for 146 people (46 males and 100 females), the scalp oil secretion decreased by more than 80%, the dandruff completely disappeared, and the glossiness of the hair strands increased significantly; in the control group, for 22 people (7 males and 15 females), the scalp oiliness decreased by about 30%, and there were still sporadic dandruff.

[0127] After 30 days of use: Among the 150 people (48 males and 102 females) in the experimental group, the density of new-born villi increased by 2 times, and there was no scalp itching or hair loss during the shampoo interval; among the 31 people (10 males and 21 females) in the control group, there were new-born soft and fine hairs, and scalp oiliness and itching reappeared 48 hours after shampooing.

[0128] After 60 days of use: Among the 148 people (47 males and 101 females) in the experimental group, the hair volume increased by 40%-60%, the diameter of the hair shaft thickened by 25%, and the hair quality recovered to be healthy and strong; among the 35 people (11 males and 24 females) in the control group, the hair volume only increased by 10%-15%, and the hair tips were still dry and split.

[0129] After 90 days of use: Among the 150 people (48 males and 102 females) in the experimental group, four-dimensional repair was achieved: the hair loss control rate was 98%+no recurrence of scalp oil / dandruff+the hair follicle survival rate increased by 90%+the elasticity of the hair strands reached the undamaged state; among the 40 people (13 males and 27 females) in the control group, they needed to rely on hair conditioner to maintain smoothness, and the symptoms rebounded 3 days after stopping use.

[0130] The above are only the preferred embodiments of the present invention. It should be noted that for those of ordinary skill in the art of this technology, without departing from the principle of the present invention, several improvements and refinements can still be made, and these improvements and refinements should also be regarded as the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for preventing hair loss in scalp care, characterized in that, It comprises the following raw materials by mass parts: 8 - 15 parts of ginseng, 20 - 30 parts of Platycladus orientalis leaves, 12 - 20 parts of processed Polygonum multiflorum Thunb., 15 - 25 parts of Salvia miltiorrhiza Bunge, 18 - 28 parts of Eclipta prostrata L. and 10 - 16 parts of Ligusticum chuanxiong Hort.

2. A preparation method of the traditional Chinese medicine composition according to claim 1, characterized in that, It comprises the following steps: Crush the said raw materials and conduct three - stage counter - current extraction; combine the extracts, preliminarily filter through a 100 kDa ceramic membrane, then refine through a 5 kDa organic nanofiltration membrane, and collect the effective components with a molecular weight cut - off of 3000 - 5000 Da; add ethanol to the membrane separation liquid to a final concentration of 60% - 65%, take the supernatant after refrigerated crystallization and concentrate it.

3. The preparation method according to claim 2, characterized in that, Crush the said raw materials to 40 - 60 meshes, put them into a dynamic counter - current extraction device, and conduct three - stage counter - current extraction with a material - to - liquid ratio of 1:8 - 10; the process of the three - stage counter - current extraction is the first tank at 85 ± 1 °C → the second tank at 75 ± 1 °C → the last tank at 65 ± 1 °C.

4. The preparation method according to claim 2, characterized in that, The refrigerated crystallization is to refrigerate at 4 °C for 18 - 30 h, centrifuge at 2000 - 4000 rpm for 10 - 20 min to obtain the supernatant, and concentrate it by thin - film evaporation at 50 - 55 °C to a relative density of 1.25 - 1.

30.

5. A traditional Chinese medicine extract for scalp care prepared by the preparation method according to any one of claims 2 - 4.

6. The application of the traditional Chinese medicine extract according to claim 5 in the preparation of a scalp care shampoo.

7. A scalp care anti - hair - loss shampoo, characterized in that, It comprises 3 - 5 wt% of the traditional Chinese medicine extract according to claim 5.

8. The scalp care anti-hair loss shampoo according to claim 7, wherein It also comprises the following auxiliary components: 0.5 - 1.2 wt% of tea bran powder, 0.3 - 0.8 wt% of tea tree oil, 0.2 - 0.5 wt% of ganoderma spore powder, 0.1 - 0.3 wt% of menthol, 0.2 - 0.5 wt% of rosemary essential oil, 0.3 - 0.6 wt% of artemisia argyi essential oil and 0.4 - 0.7 wt% of asiatic pennywort extract.

9. The scalp care anti-hair loss shampoo according to claim 7 or 8, characterized in that, It also comprises 35 - 50 wt% of a surfactant, 0.8 - 1.5 wt% of a scalp conditioner, and the balance is a natural solvent and a pH regulator.

10. The preparation method of the anti - hair - loss shampoo for scalp care according to any one of claims 7 - 9, characterized in that, It comprises the following steps: Premix the traditional Chinese medicine extract, auxiliary components and natural solvent at 40 - 45 °C, sequentially add the surfactant, scalp conditioner and pH regulator until the pH is 5.5 - 6.5; protect the whole process with nitrogen and control the water activity < 0.6.

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