External preparation for removing fat and growing hair and preparation method thereof

Abstract

The invention discloses a fat-removing and hair-growing external preparation and a preparation method thereof, and relates to the technical field of traditional Chinese medicine hair-growing compositions. The external preparation for removing fat and growing hair is prepared by mixing and soaking 8-12 parts of cacumen biotae, 8-12 parts of pine needle, 8-12 parts of garden balsam stem, 5-10 parts of glossy privet fruit, 5-10 parts of radix polygoni multiflori preparata, 4-6 parts of wild chrysanthemum flower, 4-6 parts of mulberry leaf, 5-10 parts of dandelion, 5-10 parts of ligusticum wallichii, 5-10 parts of angelica sinensis, 5-10 parts of spina gleditsiae, 5-10 parts of cortex dictamni and 8-12 parts of Chinese honeylocust fruit, decocting, filtering, concentrating, adding 0.1-0.2 part of menthol, and mixing. The external preparation for removing fat and growing hair, which is high in effective concentration of medicines, is prepared by adopting an ancient ointment decoction technology, and has a remarkable treatment effect on alopecia seborrhoeica, alopecia areata in a resting period, alopecia areata, seborrheic dermatitis and the like; meanwhile, the combination of the cortex dictamni, the Chinese honeylocust fruit, the menthol and the foaming agent is adopted, so that the dosage form stability and the use experience feeling of the preparation can be improved.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicine hair-growth composition, and in particular to an external preparation for removing fat and promoting hair growth and a preparation method thereof. Background Art

[0002] Hair loss is a common and frequently-occurring disease in dermatology, including androgenic alopecia, alopecia areata, autoimmune diseases, chemotherapy, and mental illness. Among them, androgenic alopecia, also known as premature baldness and seborrheic alopecia, is the most common type of hair loss in clinical practice. In recent years, with the development and changes in social living environment and life pressure, the number of patients has increased significantly, the age of onset has tended to be younger, and the incidence of young women has also increased year by year, which has attracted widespread attention in the medical community. Male patients mainly show thinning and reduction of hair on the top of the head or receding hairline on the forehead, and even almost all hair on the top of the head falls off, and the hair on both sides of the head is normal; female patients show thinning and reduction of hair on the top of the head, and the hairline does not move back; male and female patients are usually accompanied by symptoms of excessive scalp oil secretion. In addition to affecting physiological functions, this disease also seriously affects the patient's appearance, brings great mental pressure and psychological burden to patients, and progressively worsens, has a long course of disease, and is difficult to treat. Clinically, there is an urgent need to find effective means to prevent and treat hair loss.

[0003] The cause and pathogenesis of hair loss are not yet fully understood. Western medicine generally believes that it is related to multiple factors such as genetics, abnormal male hormone metabolism, mental and emotional stress, endocrine disorders, local fungal infections of the scalp, and immune inflammation. It may belong to the category of polygenic diseases. Genetic susceptibility and abnormal scalp hair follicle microenvironment are the main causes of this disease. In the hair follicle microenvironment, due to the hypersecretion of the sebaceous glands of the scalp, excessive sebum secretions accumulate around the hair follicles, compressing and blocking the hair follicle pores, thereby seriously interfering with and affecting the normal growth of hair. In addition, when the content of oleic acid and linoleic acid in sebum secretions is too high, it will also have a toxic effect on the hair follicles, gradually causing hair loss. Existing studies have shown that the subcutaneous blood flow of patients with seborrheic alopecia is significantly reduced than that of normal people. People who are engaged in mental work have great mental stress, the central nervous system is in a state of tension for a long time, the autonomic nervous system is disordered, and the skin vascular nerves are dysfunctional, which makes the scalp nutritional disorders prone to hair loss.

[0004] Up to now, Western medicine's treatment of this disease is still relatively limited, and mostly uses drugs such as finasteride and minoxidil. Although there are certain therapeutic effects, due to the long course of the disease and the long course of treatment, it will bring varying degrees of adverse reactions and economic burdens. Once the medication is stopped, it is very easy to relapse. It is only a symptomatic treatment, and the long-term efficacy is poor.

[0005] Traditional Chinese medicine has a long history of preventing and treating hair loss. It has the unique advantages of multi-target, comprehensive and individualized treatment, high patient acceptance, high compliance, few side effects, broad spectrum of activity, and low price. In recent years, it has received more and more attention at home and abroad. Traditional Chinese medicine believes that the etiology and pathogenesis of hair loss are attributed to damp-heat accumulation, liver and kidney deficiency, blood heat and wind excess, blood deficiency and wind dryness, liver depression and blood stasis, etc., which are caused by the inability of blood and qi to moisturize the hair. Traditional Chinese medicine uses dialectics to make Chinese medicine lotions, ointments, tinctures and other dosage forms with medicinal materials that clear heat and dampness, cool blood and nourish blood, and promote hair growth and black hair. It develops hair growth and hair fixation preparations for the prevention and treatment of seborrheic alopecia. For daily use, while treating seborrheic alopecia, it plays a preventive role, which effectively improves the treatment effect of seborrheic alopecia.

[0006] The document "Yang Yufeng's Experience in Treating Seborrheic Alopecia with the Method of Invigorating the Spleen, Eliminating Dampness, Controlling Oil and Removing Fat" (Journal of Guangzhou University of Chinese Medicine, Volume 41, Issue 1, January 2024, Yan Liman) discloses a prescription for external use as follows: 42g of Platycladus orientalis leaves, 42g of processed Polygonum multiflorum, 42g of Impatiens balsamina, 42g of Taraxacum officinale, 42g of Pueraria root, 42g of wild chrysanthemum, 42g of Gleditsia sinensis, 14g of Alum, 14g of Mint, Usage: External use, once a day. Each time, the patient dilutes 1-2 packs of ointment with warm water into 300-400mL to wash the scalp, massage the scalp for 10-15min during the washing process, and finally rinse it with clean water. The prescription of the external medicine contains alum, which is not suitable for decoction concentration and storage stability, because the decoction of natural plant Chinese medicine pieces is acidic. Under acidic conditions, acid radical ions are easy to combine with the aluminum element in alum to form floccules, produce precipitation, and stratify after standing, affecting the efficacy and preparation formability; in addition, alum is processed and refined from alum stone of the sulfate mineral alum family, and mainly contains hydrated potassium aluminum sulfate [KAl(SO4)

[0007] 2·12H2O〕, the neurotoxicity of aluminum has been widely studied in academia. Toxicity experiments have shown that long-term and large-dose administration of alum products can cause learning and memory disorders in experimental animals, affect the liver and kidney functions of animals, and cause oral and laryngeal burns, vomiting, diarrhea, collapse, and even death. At the same time, this ointment has no foaming properties, and the hair is dry after washing. It needs to be used with shampoo and conditioner, which affects the convenience and compliance of use, and is not suitable for daily preventive treatment.

[0008] CN115006336A discloses a kind of anti-hair loss and healthy hair, anti-dandruff and antipruritic plant shampoo and preparation method thereof, and plant combination extract raw material adopts Polygonum multiflorum, Rhizoma Chuanxiong, Sesame nigrum, Radix Angelicae Sinensis, Ginseng, Caulis Spatholobi, Platycladus orientalis, Gleditsia sinensis, Cistanche deserticola, Licorice, Dry ginger, Vitex rotundifolia, Mulberry, Aloe gel, Herba Ecliptae, Herba Portulacae, Magnolia officinalis, Folium Mulberry, Herba Taraxaci, Cordyceps militaris, Leech, Radix Notoginseng, Hippocampus, Cordyceps sinensis. After the extract of plant combination is concentrated, ethanol is added, and impurities in the extract are removed by alcohol precipitation, so as to ensure the stable quality of product. But the process needs to carry out alcohol precipitation, filtration, separation of ethanol and other steps to the extract of plant combination, and the process is complicated, and the alcohol precipitation process also can cause the loss of effective drug components, resulting in reduced efficacy.

[0009] CN117137849A discloses a Chinese medicine lotion for removing dandruff, relieving itching and promoting hair growth, which comprises, by weight, 300-500 parts of mint, 180-250 parts of wormwood leaves, 180-250 parts of chrysanthemums, 180-250 parts of siler, 180-250 parts of siler, 180-250 parts of ligusticum ligusticum, 180-250 parts of nard, 180-250 parts of vitex rotundifolia, 180-250 parts of patches, 180-250 parts of sophora flavescens, 180-250 parts of atractylodes, 180-250 parts of angelica dahurica, 180-250 parts of kochia scoparia, 180-250 parts of Dictamni Cortex, 180-250 parts of Stemona, 180-250 parts of Phellodendron, 180-250 parts of Gleditsia Spina, 180-250 parts of Tribulus Terrestris, 180-250 parts of Platycladus Orientalis Leaves, 180-250 parts of Radix Polygoni Multiflori Processed, 180-250 parts of Notopterygium, 180-250 parts of Angelica Sinensis, 180-250 parts of White Peony Roots, 180-250 parts of Chaenomeles Chaenomeles, 180-250 parts of Fructus Ligustri Lucidi, 180-250 parts of Ligustrum lucidum, 180-250 parts of Platycodon grandiflorum, and 180-250 parts of Radix Astragali. The method of use is: put a packet of powder into a kettle, add 1000ml of water, boil it and let it cool, repeat three times, then pour it into a basin and add 3-5 drops of white vinegar; use a comb or fingertips to tap the scalp 80-150 times to make the scalp congested, then soak the hair in water and rub it several times, and massage the scalp. The Chinese medicine lotion in this recipe is ready-to-use, but it is troublesome to decoct, and the effective concentration of the decoction is low, which is not suitable for daily convenient use and long-term storage.

[0010] Therefore, although some existing Chinese medicine external preparations have certain anti-hair loss and hair growth effects, they mostly use Chinese medicine extracts or Chinese medicine decoctions (density is only 1.0-1.05), with low effective drug concentration or poor user experience, and their efficacy and safety cannot satisfy patients. Finding a new drug for the prevention and treatment of seborrheic alopecia that has high effective drug concentration, stable quality, convenient use, safe, effective and non-irritating has important social value and clinical significance. Summary of the invention

[0011] One of the purposes of the present invention is to provide a fat-removing and hair-growing topical preparation and a preparation method thereof, which are used to treat seborrheic alopecia, telogen effluvium and alopecia areata. The fat-removing and hair-growing topical preparation is more effective than general traditional Chinese medicine preparations, has a high effective drug concentration, a mild system, can be used daily, and has a significant effect on preventing and improving related accompanying symptoms such as itchy, scaly, and greasy hair. At the same time, the side effects are far less than those of Western medicine, the treatment cost is low, and the quality of life of patients can be further improved. Another purpose of the invention is to solve the problems of dosage form stability and poor user experience of hair-growing topical preparations with high effective drug concentrations.

[0012] In order to solve the above technical problems, the purpose of the present invention is achieved through the following technical solutions.

[0013] Provided is a method for preparing a fat-removing and hair-growing external preparation, comprising the following steps:

[0014] 1) In parts by weight, 8-12 parts of raw medicinal materials including Platycladus orientalis leaves, 8-12 parts of pine needles, 8-12 parts of Impatiens balsamina, 5-10 parts of Ligustrum lucidum fruits, 5-10 parts of processed Polygonum multiflorum, 4-6 parts of wild chrysanthemum, 4-6 parts of mulberry leaves, 5-10 parts of dandelions, 5-10 parts of Chuanxiong, 5-10 parts of Angelica sinensis, 5-10 parts of Gleditsia sinensis thorns, 5-10 parts of Dictamni cortex, and 8-12 parts of Gleditsia sinensis are mixed, and the mixture is soaked and boiled in water 8-20 times the weight of the raw medicinal materials, and then squeezed and filtered to obtain a filtrate;

[0015] 2) Concentrate the filtrate to a thick paste with a relative density of 1.31 to 1.40 at 25°C, add 0.1 to 0.2 parts of menthol at a temperature below 60°C and mix evenly to obtain a fat-removing and hair-growing external preparation;

[0016] or,

[0017] Add 15-50% of the mass of the filtrate into the filtrate with a foaming agent, continue to concentrate to a thick paste with a relative density of 1.26-1.30, add 0.1-0.2 parts of menthol at below 60°C and mix evenly to obtain a fat-removing and hair-growing external preparation.

[0018] Preferably, in the step 1), the raw medicinal materials of 9-11 parts of Platycladus orientalis leaves, 9-11 parts of pine needles, 9-11 parts of Impatiens balsamina, 7-8 parts of Ligustrum lucidum fruits, 7-8 parts of processed Polygonum multiflorum, 4-6 parts of wild chrysanthemum, 4-6 parts of mulberry leaves, 7-8 parts of dandelions, 7-8 parts of Chuanxiong, 7-8 parts of Angelica sinensis, 7-8 parts of Gleditsia sinensis thorns, 7-8 parts of Dictamni cortex, and 9-11 parts of Gleditsia sinensis are mixed.

[0019] Preferably, in the step 1), the raw medicinal materials 10 parts of Platycladus orientalis leaves, 10 parts of pine needles, 10 parts of Impatiens balsamina, 7.5 parts of Ligustrum lucidum fruits, 7.5 parts of processed Polygonum multiflorum, 5 parts of wild chrysanthemum, 5 parts of mulberry leaves, 7.5 parts of dandelions, 7.5 parts of Chuanxiong, 7.5 parts of Angelica sinensis, 7.5 parts of Gleditsia sinensis spines, 7.5 parts of Dictamni cortex, and 10 parts of Gleditsia sinensis are mixed.

[0020] Traditional Chinese medicine believes that hair is the residue of blood, and the kidney is responsible for bone and marrow production, and its beauty is in the hair. It is nourished by qi, blood, and yin essence. The kidney stores essence and consolidates yin, so kidney yin deficiency causes hair to turn yellow and loosen and fall out; it is also called "hair rot and hair loss" and "hair rot ringworm". The clinical manifestations are mainly greasy, dandruffy, and itchy scalp. Therefore, the present invention believes that hair loss is related to blood circulation, oil metabolism, and liver and kidney deficiency. Blood heat, blood deficiency, damp heat, and insufficient kidney essence can all lead to hair loss. Damp heat accumulation and blood heat and wind are the primary pathogenesis. The present invention is aimed at the pathogenesis, and takes elimination, clearing, and replenishing as the main treatment principles. The main treatment principles are Platycladus orientalis leaves, pine needles, and Impatiens balsamina. Platycladus orientalis leaves, "Ben Cao Meng Quan" records: "Platycladus orientalis leaves, ... regenerate hair temples and eyebrows." Platycladus orientalis leaves are cool in nature and can clear away heat. They are especially good at entering the blood. In addition to cooling blood and stopping bleeding, they also have the effect of growing hair and blackening hair. They are the key medicine for those who lose their hair due to blood heat and hair loss. Although pine needles were not specifically discussed in ancient times for treating hair loss, the nature of pine is tenacious and evergreen all year round. Chinese medicine uses its image to treat diseases. It is believed that pine needles can dredge meridians, activate qi and blood, and eliminate rheumatism. They complement each other with Platycladus orientalis leaves, and play the role of clearing heat and dampness, activating blood circulation and dredge meridians, and promote hair regeneration. Impatiens balsamina, with its pungent, dispersing, warming and unblocking nature, can dispel wind and dampness, penetrate bones and search for wind, and can help the medicinal power penetrate into the hair roots, promote local blood circulation, improve the nutritional status of hair follicles, and thus help hair regeneration. Platycladus orientalis leaves, pine needles, and Impatiens balsamina can cool blood and stop bleeding, promote hair growth and black hair; one can dredge meridians and activate meridians, remove dampness and strengthen the body; one can penetrate bones and search for wind, activate blood circulation and stop pain. The three complement each other and play the role of clearing heat and dampness, cooling blood and activating blood circulation, and promoting hair growth and black hair. It is indeed a model of the main medicine for treating hair loss. The minister uses Ligustrum lucidum fruit, processed Polygonum multiflorum, wild chrysanthemum, mulberry leaf, and dandelion. Ligustrum lucidum fruit and processed Polygonum multiflorum are both excellent products for nourishing the liver and kidney. There is an ancient saying that "Ligustrum lucidum blackens hair and brightens eyes, and Polygonum multiflorum replenishes kidney and essence". The two are combined to nourish the liver and kidney, nourish essence and blood, and provide sufficient nutrition for hair growth. Angelica sinensis is a holy medicine for blood. It can both replenish blood and activate blood circulation. It is used together with Ligustrum lucidum fruit and processed Polygonum multiflorum to replenish essence and blood, so that hair growth is active. Wild chrysanthemum, mulberry leaf and dandelion not only clear away heat and detoxify, but also have the function of cooling blood and relieving itching. They have a significant effect on relieving the symptoms of oily, dandruffy and itchy scalp. In particular, dandelion has the effect of "blackening hair" recorded in "Compendium of Materia Medica", and it works together with the whole recipe to achieve the miraculous effect of blackening hair. It is supplemented with Chuanxiong, Angelica sinensis, Gleditsia sinensis, and Dictamni. Chuanxiong and Angelicae Sinensis can promote the flow of Qi and blood, and guide the medicine to the head, which can treat hair loss caused by liver depression and Qi stagnation, and poor Qi and blood circulation that cannot nourish the hair normally. Gleditsia sinensis can clear away heat, detoxify, kill insects and relieve itching, while Dictamni can clear away heat and dry dampness, dispel wind and detoxify, which can enhance the efficacy of the main and auxiliary medicines. Gleditsia sinensis and menthol are the adjuvant medicines, which have the effects of clearing heat and dampness, eliminating fat and relieving itching, and can effectively eliminate the damp heat state inside the body and improve seborrheic alopecia caused by damp heat in the body.

[0021] Looking at the whole prescription, it clears away heat and dampness without hurting the body, and promotes blood circulation and removes blood stasis without hurting the blood, playing the effects of clearing heat and dampness, cooling blood and nourishing blood, and promoting hair growth and darkening hair. This prescription uses appropriate drugs, has strict compatibility, is easy to use in dosage form, and has a significant effect in treating hair loss.

[0022] The main ingredient of the prescription is pine needles, which have the functions of dispelling wind and dampness, promoting blood circulation and calming the mind, killing insects, and relieving itching. They are used for rheumatism, paralysis, insomnia, edema, wet sores, scabies, and urticaria. The "Famous Doctors' Records" of the Wei and Jin Dynasties recorded: "Pine leaves are bitter and warm in taste, and are used to treat rheumatism, promote hair growth, and calm the five internal organs." Modern research has shown that pine needles are rich in flavonoids, volatile oils, polysaccharides, lignans, pigments, vitamins, amino acids, and a variety of trace elements, and have pharmacological effects such as lowering blood sugar, regulating blood lipids, anti-tumor, anti-virus, antibacterial, analgesic and anti-inflammatory. Professor Xuan Guowei, a dermatologist and master of traditional Chinese medicine, uses pine needles in prescriptions for the treatment of hair loss. In "Master Xuan Guowei of Traditional Chinese Medicine", every prescription for the treatment of hair loss must use pine needles. Professor Xuan believes that pine needles can clear away heat and dampness, nourish hair, and point out that pine needles contain a large amount of proanthocyanidins, which have the functions of scavenging free radical activity, anti-oxidation, promoting hair growth, and regulating immune activity. Some domestic scholars, such as Zhu Peicheng, have also used pine needles in clinical treatment of hair loss, with significant results. Foreign studies have found that proanthocyanidin B2 can promote the proliferation of hair epithelial cells, shorten the resting period, and induce hair to enter a new round of growth cycle. In the culture solution containing oligomeric proanthocyanidins, hair follicle epithelial cells show undifferentiated stem cell characteristics. Proanthocyanidins inhibit T-bet mRNA expression, reverse Th1 type reactions, activate hair stem cells and promote hair regeneration.

[0023] In the prescription, mint can dispel wind-heat, clear the head and eyes, and penetrate rash. It is used for wind-heat cold, headache, red eyes, throat paralysis, mouth sore, rubella, measles, etc. Its main effective ingredient is volatile substance mint ice (menthol), which is easy to lose in decoction and concentration process, resulting in low extraction rate and fluctuation of content between batches. The present invention directly uses mint ice (menthol) obtained by distillation, freezing and recrystallization, with high purity, more definite curative effect and more stable content. Menthol is a kind of Chinese medicine volatile oil penetration enhancer at the same time, compared with the chemical penetration enhancers such as azone, ethanol, oleic acid that are used earlier, it has the advantages of good penetration effect, short time lag and low toxicity, and many existing studies have shown that menthol has good penetration effect on hydrophilic and lipophilic drugs, such as the permeability of various components such as quercetin, osthole, ligustrazine, antibiotics, salicylates, etc. can be promoted. Menthol has a good penetration-enhancing effect, which promotes the effective absorption of the active ingredients in the prescription. Combined with its own effects of dispelling wind and relieving itching, it can play the role of "drug-excipient combination" in transdermal drug delivery preparations.

[0024] The Chinese soapberry in the prescription: also known as Chinese soapberry, Chinese soapberry, Chinese soapberry, hanging knife, and chicken quilt. It can remove phlegm and open the orifices, kill insects, disperse knots and reduce swelling, and treat carbuncle, scabies and tinea externally. "Prescriptions for Emergencies" Volume 13 "Heart Collection" contains "Mutou Soup", which uses hemp seeds, pepper, and Chinese soapberry (shavings) soaked in rice water for one night, used to wash the hair, and then washed with Chinese soapberry soup, and applied cream after combing the hair to treat itchy head and excessive dandruff. According to ancient medical records, Tao Hongjing's "Famous Doctors' Records" in the Jin Dynasty first recorded that it "can be used as a bath medicine, not in soup." "Compendium of Materia Medica" records that it can remove rheumatism and dirt, so it can be used for bathing and washing the face, and it has miraculous effects in treating unknown swelling and poison. Modern research shows that Chinese soapberry contains rich triterpenoid saponins, which have an amphiphilic structure and are a surfactant that is friendly to the human body and the environment. Chinese soapberry can be added to the prescription to prepare a shampoo containing natural saponin extracts.

[0025] The soapberry thorn in the prescription can reduce swelling, expel toxins, drain pus, and kill insects. It is used for the initial stage of carbuncle or pus that has not broken; it is used for external treatment of scabies, leprosy and leprosy. "Compendium of Materia Medica" says: "Soapberry is an insecticide; applying it can disperse swelling and disinfect, remove wind and treat sores, and treat wind-induced leprosy and scabies. Soapberry thorn can treat wind and kill insects, and has the same function as soapberry, but it is sharp and reaches the diseased area directly." Soapberry and soapberry thorn come from different medicinal parts of the same plant. The two are used together and complement each other to eliminate rheumatism, remove dirt and grease, and reach the lesion directly.

[0026] The Dictamni peel in the prescription is used for its effects of clearing away heat and drying dampness, dispelling wind and detoxifying. The Dictamni peel in the present invention can not only detoxify and dry dampness, but also dispel wind and clear heat, and is used for damp-heat sores, yellow water dripping, eczema, urticaria, scabies, sores, rheumatism and heat arthralgia, and is compatible with other medicines to avoid precipitation in the preparation system.

[0027] The sources of the raw materials of the present invention are as follows:

[0028] Platycladus orientalis leaves: dried branches and leaves of Platycladus orientalis (L.) Franco, a plant of the Cupressaceae family.

[0029] Pine needles: fresh or dried needles of Pinus massoniana Lamb., Pinus tabuliformis Carr. or Pinus yunnanensis Franch. of the Pinaceae family.

[0030] Impatiens balsamina: the dried stems of Impatiens balsamina L., a plant of the Impatiens family.

[0031] Ligustrum lucidum fruit: the dried mature fruit of Ligustrum lucidumAit., a plant of the Oleaceae family.

[0032] Processed Polygonum multiflorum: The dried tuberous roots of Polygonummultiflorum Thunb., a plant of the Polygonaceae family, are processed.

[0033] Wild chrysanthemum: the dried inflorescence of Chrysanthemumindicum L., a plant of the Asteraceae family.

[0034] Mulberry leaves: dried leaves of Morus alba L., a plant of the Moraceae family.

[0035] Dandelion: The dried whole herb of Taraxacum mongolicum Hand.-Mazz., Taraxacum borealisinense Kitam., or several plants of the same genus, from the Asteraceae family.

[0036] Chuanxiong: The dried rhizome of Ligusticum chuanxiongHort., a plant of the Umbelliferae family.

[0037] Angelica: The dried root of Angelica sinensis (Oliv.) Diels of the Apiaceae family.

[0038] Gleditsia thorn: the dried thorn of the leguminous plant Gleditsia sinensis Lam.

[0039] Dictamnus dasycarpus Turcz.: The dried root bark of Dictamnus dasycarpus Turcz., a plant of the Rutaceae family.

[0040] Gleditsia sinensis Lam.: The dried mature fruit of the leguminous plant Gleditsia sinensis Lam.

[0041] Mint ice: also known as menthol, it is a saturated cyclic alcohol obtained by steam distillation, freezing and recrystallization of the fresh stems and leaves of Menthahaplocalyx Briq., a plant of the Lamiaceae family. It is l-1-methyl-4-isopropylcyclohexanol-3.

[0042] Preferably, in the step 1), the soaking time is 2-3 hours and the boiling time is 1-2 hours.

[0043] In some other embodiments, the raw medicinal material is first soaked in water 8 times the weight of the medicinal material for 2 hours, decocted in a sealed container for 1 hour, the juice is squeezed and filtered, and then decocted in water 6 times the weight for 30 minutes to 1 hour, the juice is squeezed and filtered, and the two filtered juices are combined to obtain a filtrate;

[0044] Preferably, in step 2), the specific operation of concentration is to first use high heat to accelerate the evaporation of water, and the filtrate gradually becomes thick, and then use low heat to further concentrate to the target relative density. In large-scale production, vacuum concentration can be used.

[0045] Preferably, the step 2) is to concentrate the filtrate to a thick paste with a relative density of 1.35 to 1.38 at 25° C., add 0.1 to 0.2 parts of menthol at below 60° C. and mix evenly to obtain a fat-removing and hair-growing external preparation.

[0046] Preferably, the step 2) is to concentrate the filtrate to a thick paste with a relative density of 1.36 at 25° C., add 0.15 parts of menthol at a temperature below 60° C. and mix evenly to obtain a fat-removing and hair-growing external preparation.

[0047] Preferably, the step 2) is to add polysorbates, higher fatty alcohol sulfates, and amino acid foaming agents to the filtrate, continue to concentrate to a thick paste with a relative density of 1.26 to 1.28, add 0.1 to 0.2 parts of menthol at below 60°C and mix evenly to obtain a fat-removing and hair-growing external preparation.

[0048] Preferably, the step 2) is to add polysorbates, higher fatty alcohol sulfates, and amino acid foaming agents to the filtrate, continue to concentrate to a thick paste with a relative density of 1.27, add 0.15 parts of menthol at below 60° C. and mix evenly to obtain a fat-removing and hair-growing external preparation.

[0049] Preferably, a foaming agent in an amount of 20 to 30% by mass of the filtrate is added to the filtrate; the foaming agent is selected from at least one of polysorbate 80, sodium lauryl sulfate, methyl glucoside polyoxyethylene (120) ether trioleate, cocamide apple amino acid, and cocamidopropyl betaine.

[0050] In some embodiments, the foaming agent is composed of cocamide apple amino acids, sodium lauryl sulfate and propyl betaine, wherein the amount of cocamide apple amino acids added is 10-30% of the mass of the filtrate, the amount of sodium lauryl sulfate added is 0-4% of the mass of the filtrate, and the amount of propyl betaine added is 5-10% of the mass of the filtrate.

[0051] The present invention also provides an external preparation for removing fat and promoting hair growth, which is prepared by the above-mentioned preparation method.

[0052] The fat-removing and hair-growing external preparation of the present invention is an ointment. In terms of preparation method, the ointment is one of the eight dosage forms of pills, powders, pastes, pills, wine, dew, soup, and tablets in traditional Chinese medicine. It has the characteristics of high drug concentration and strong nourishing effect. It is often used for internal tonic and can also be used for external application. The external application ointment is semi-solid or semi-fluid at room temperature. It is used for shampooing. It can better adhere to the scalp than liquid Chinese medicine lotion, and can better promote drug absorption, improve drug efficacy, and be more conducive to maintaining the advantages of Chinese medicine characteristics. However, there are many types of active ingredients in Chinese medicine ointments, and the drug concentration is high. To produce a good foaming effect and dosage form stability, higher requirements are placed on the prescription composition and process. In the preparation method of the fat-removing and hair-growing external preparation of the present invention, a combination of Dictamni, Gleditsia sinensis, menthol and a foaming agent is used to improve the dosage form stability and user experience of the preparation with a high effective drug concentration.

[0053] The technical effects of the present invention are as follows:

[0054] The invention uses Platycladus orientalis leaves, pine needles, Impatiens balsamina, Ligustrum lucidum fruit, processed Polygonum multiflorum, wild chrysanthemum, mulberry leaves, dandelion, Ligusticum chuanxiong, angelica, Gleditsia sinensis, Dictamni cortex, Gleditsia sinensis and menthol together to achieve the effects of clearing away heat and dampness, cooling blood and nourishing blood, and promoting hair growth and darkening hair. Meanwhile, the invention adopts the ancient paste prescription boiling technology to prepare the fat-removing and hair-growing external preparation (such as shampoo) with high effective drug concentration and foaming function, which is used for daily smearing and washing, and has significant therapeutic effects on seborrheic alopecia, telogen effluvium, alopecia areata, seborrheic dermatitis and the like. Meanwhile, the combination of Dictamni cortex, menthol and Gleditsia sinensis can improve the dosage form stability of the preparation. BRIEF DESCRIPTION OF THE DRAWINGS

[0055] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings required for use in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other accompanying drawings can be obtained based on these accompanying drawings without paying any creative work.

[0056] Figure 1 This is a comparison chart of the preparations of Test 1, Example 1, Example 3, Test 7, and Example 8 after standing for 48 hours.

[0057] Figure 2 This is a comparison of the appearance of the preparations of Comparative Example 25 and Example 8 after standing for 24 hours.

[0058] Figure 3 The figure shows the hair growth on the back of mice in each group.

[0059] Figure 4 The hair growth of mice in each group was scored.

[0060] Figure 5These are the results of each group's effects on hormone levels in mice with hair loss.

[0061] Figure 6 The blank group is the skin pathological results of alopecia mice.

[0062] Figure 7 These are the skin pathological results of the hair loss mice in the model group.

[0063] Figure 8 This is the skin pathological result of anti-fat hair growth cream on mice with hair loss.

[0064] Fig. 9 The following are the skin pathological results of the hair loss mice in the negative group.

[0065] Fig.10 The skin pathological results of the positive group of alopecia mice.

[0066] Fig.11 Statistical chart of the number of hair follicles in each group. DETAILED DESCRIPTION

[0067] The technical solution of the present invention will be clearly and completely described below in conjunction with the embodiments. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0068] It should be understood that when used in this specification and the appended claims, the terms "include" and "comprises" indicate the presence of described features, integers, steps, operations, elements and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components and / or combinations thereof.

[0069] It should be further understood that the term "and / or" used in the present description and the appended claims refers to any and all possible combinations of one or more of the associated listed items, and includes these combinations.

[0070] In the following embodiments or tests, the specific operations of soaking, decocting and squeezing and filtering are as follows: the raw medicinal materials are first soaked in water 8 times the weight of the medicinal materials for 2 hours, decocted in a closed manner for 1 hour, the juice is squeezed and filtered, and then 6 times the amount of water is added and decocted for 45 minutes, the juice is squeezed and filtered, and the two filtered juices are combined to obtain a filtrate.

[0071] The specific operation of concentration is: first use high heat to accelerate the evaporation of water, the filtrate slowly becomes thick, and then use low heat to further concentrate to the target relative density.

[0072] Example 1

[0073] The fat-removing and hair-growing external preparation of this embodiment has a preparation method comprising the following steps:

[0074] 1) By weight, the raw medicinal materials of Platycladus orientalis leaf 8g, pine needle 8g, Impatiens balsamina 8g, Ligustrum lucidum fruit 5g, Polygonum multiflorum processed 5g, Chrysanthemum indici 4g, Mulberry leaf 4g, Taraxacum herba 5g, Ligusticum chuanxiong 5g, Angelica sinensis 5g, Gleditsia sinensis 5g, Dictamni cortex 5g, and Gleditsia sinensis 8g were mixed, soaked in water, decocted, squeezed and filtered to obtain a filtrate;

[0075] 2) The filtrate is concentrated to a thick paste with a relative density of 1.31 at 25°C, 0.1 g of menthol is added at below 60°C and mixed evenly to obtain a fat-removing and hair-growing external preparation.

[0076] Example 2

[0077] The fat-removing and hair-growing external preparation of this embodiment has a preparation method comprising the following steps:

[0078] 1) by weight, the raw medicinal materials of Platycladus orientalis leaf 9g, pine needle 9g, Impatiens balsamina 9g, Ligustrum lucidum fruit 7g, Polygonum multiflorum processed 7g, Chrysanthemum indici 4g, Mulberry leaf 4g, Taraxacum herba 7g, Ligusticum chuanxiong 7g, Angelica sinensis 7g, Gleditsia sinensis 7g, Dictamni cortex 7g, Gleditsia sinensis 9g were mixed, soaked in water, decocted, squeezed and filtered to obtain a filtrate;

[0079] 2) The filtrate is concentrated to a thick paste with a relative density of 1.35 at 25°C, 0.12 g of menthol is added at below 60°C and mixed evenly to obtain a fat-removing and hair-growing external preparation.

[0080] Example 3

[0081] The fat-removing and hair-growing external preparation of this embodiment has a preparation method comprising the following steps:

[0082] 1) In parts by weight, the raw medicinal materials of Platycladus orientalis leaf 10g, pine needle 10g, Impatiens balsamina 10g, Ligustrum lucidum fruit 7.5g, Polygonum multiflorum processed 7.5g, wild chrysanthemum 5g, mulberry leaf 5g, dandelion 7.5g, Chuanxiong 7.5g, Angelica sinensis 7.5g, Gleditsia sinensis 7.5g, Dictamni cortex 7.5g, and Gleditsia sinensis 10g were mixed, soaked in water, decocted, squeezed and filtered to obtain a filtrate;

[0083] 2) The filtrate is concentrated to a thick paste with a relative density of 1.36 at 25°C, 0.15 g of menthol is added at below 60°C and mixed evenly to obtain a fat-removing and hair-growing external preparation.

[0084] Example 4

[0085] The fat-removing and hair-growing external preparation of this embodiment has a preparation method comprising the following steps:

[0086] 1) In parts by weight, the raw medicinal materials of Platycladus orientalis leaf 11g, pine needle 11g, Impatiens balsamina 11g, Ligustrum lucidum fruit 8g, Polygonum multiflorum processed 8g, Chrysanthemum indici 6g, Mulberry leaf 6g, Taraxacum herba 8g, Ligusticum chuanxiong 8g, Angelica sinensis 8g, Gleditsia sinensis 8g, Dictamni cortex 8g, and Gleditsia sinensis 11g were mixed, soaked in water, decocted, squeezed and filtered to obtain a filtrate;

[0087] 2) The filtrate is concentrated to a thick paste with a relative density of 1.38 at 25°C, 0.2 g of menthol is added at below 60°C and mixed evenly to obtain a fat-removing and hair-growing external preparation.

[0088] Example 5

[0089] The fat-removing and hair-growing external preparation of this embodiment has a preparation method comprising the following steps:

[0090] 1) In parts by weight, the raw medicinal materials of Platycladus orientalis leaf 12g, pine needle 12g, Impatiens balsamina 12g, Ligustrum lucidum fruit 10g, Polygonum multiflorum processed 10g, wild chrysanthemum 6g, mulberry leaf 6g, dandelion 10g, Chuanxiong 10g, Angelica 10g, Gleditsia sinensis 10g, Dictamni cortex 10g, and Gleditsia sinensis 12g were mixed, soaked in water, decocted, squeezed and filtered to obtain a filtrate;

[0091] 2) The filtrate is concentrated to a thick paste with a relative density of 1.40 at 25°C, and 0.2 parts of menthol is added at below 60°C and mixed evenly to obtain a fat-removing and hair-growing external preparation.

[0092] Example 6

[0093] The fat-removing and hair-growing external preparation of this embodiment has a preparation method comprising the following steps:

[0094] 1) By weight, the raw medicinal materials of Platycladus orientalis leaf 8g, pine needle 8g, Impatiens balsamina 8g, Ligustrum lucidum fruit 5g, Polygonum multiflorum processed 5g, Chrysanthemum indici 4g, Mulberry leaf 4g, Taraxacum herba 5g, Ligusticum chuanxiong 5g, Angelica sinensis 5g, Gleditsia sinensis 5g, Dictamni cortex 5g, and Gleditsia sinensis 8g were mixed, soaked in water, decocted, squeezed and filtered to obtain a filtrate;

[0095] 2) Add 15% of the mass of polysorbate 80 to the filtrate, continue to concentrate to a thick paste with a relative density of 1.26, add 0.1 g of menthol at below 60° C. and mix well to obtain a fat-removing and hair-growing external preparation.

[0096] Example 7

[0097] The fat-removing and hair-growing external preparation of this embodiment has a preparation method comprising the following steps:

[0098] 1) by weight, the raw medicinal materials of Platycladus orientalis leaf 9g, pine needle 9g, Impatiens balsamina 9g, Ligustrum lucidum fruit 7g, Polygonum multiflorum processed 7g, Chrysanthemum indici 4g, Mulberry leaf 4g, Taraxacum herba 7g, Ligusticum chuanxiong 7g, Angelica sinensis 7g, Gleditsia sinensis 7g, Dictamni cortex 7g, Gleditsia sinensis 9g were mixed, soaked in water, decocted, squeezed and filtered to obtain a filtrate;

[0099] 2) Add 20% of the mass of sodium dodecyl sulfate to the filtrate, continue to concentrate to a thick paste with a relative density of 1.26, add 0.12 g of menthol at below 60° C. and mix well to obtain a fat-removing and hair-growing external preparation.

[0100] Example 8

[0101] The fat-removing and hair-growing external preparation of this embodiment has a preparation method comprising the following steps:

[0102] 1) In parts by weight, the raw medicinal materials of Platycladus orientalis leaf 10g, pine needle 10g, Impatiens balsamina 10g, Ligustrum lucidum fruit 7.5g, Polygonum multiflorum processed 7.5g, wild chrysanthemum 5g, mulberry leaf 5g, dandelion 7.5g, Chuanxiong 7.5g, Angelica sinensis 7.5g, Gleditsia sinensis 7.5g, Dictamni cortex 7.5g, and Gleditsia sinensis 10g were mixed, soaked in water, decocted, squeezed and filtered to obtain a filtrate;

[0103] 2) Add 25% of the mass of the filtrate to the filtrate of a foaming agent (composed of cocamide apple amino acid, sodium lauryl sulfate and propyl betaine, wherein the amount of cocamide apple amino acid added is 15% of the mass of the filtrate, the amount of sodium lauryl sulfate added is 2% of the mass of the filtrate, and the amount of cocamide propyl betaine is 8% of the mass of the filtrate), continue to concentrate to a thick paste with a relative density of 1.27, add 0.15 g of menthol at below 60° C. and mix evenly to obtain a fat-removing and hair-growing external preparation.

[0104] Example 9

[0105] The fat-removing and hair-growing external preparation of this embodiment has a preparation method comprising the following steps:

[0106] 1) In parts by weight, the raw medicinal materials of Platycladus orientalis leaf 11g, pine needle 11g, Impatiens balsamina 11g, Ligustrum lucidum fruit 8g, Polygonum multiflorum processed 8g, Chrysanthemum indici 6g, Mulberry leaf 6g, Taraxacum herba 8g, Ligusticum chuanxiong 8g, Angelica sinensis 8g, Gleditsia sinensis 8g, Dictamni cortex 8g, and Gleditsia sinensis 11g were mixed, soaked in water, decocted, squeezed and filtered to obtain a filtrate;

[0107] 2) Add a foaming agent (composed of cocamide apple amino acid and cocamidopropyl betaine) in an amount of 30% by mass of the filtrate, wherein the amount of cocamide apple amino acid added is 20% by mass of the filtrate, and the amount of cocamidopropyl betaine added is 10% by mass of the filtrate) to the filtrate, continue to concentrate to a thick paste with a relative density of 1.28, add 0.2 g of menthol at a temperature below 60° C. and mix evenly to obtain a fat-removing and hair-growing external preparation.

[0108] Example 10

[0109] The fat-removing and hair-growing external preparation of this embodiment has a preparation method comprising the following steps:

[0110] 1) In parts by weight, the raw medicinal materials of Platycladus orientalis leaf 12g, pine needle 12g, Impatiens balsamina 12g, Ligustrum lucidum fruit 10g, Polygonum multiflorum processed 10g, wild chrysanthemum 6g, mulberry leaf 6g, dandelion 10g, Chuanxiong 10g, Angelica 10g, Gleditsia sinensis 10g, Dictamni cortex 10g, and Gleditsia sinensis 12g were mixed, soaked in water, decocted, squeezed and filtered to obtain a filtrate;

[0111] 2) Add a foaming agent (composed of cocamide apple amino acid and methyl glucoside polyoxyethylene (120) ether trioleate) in an amount of 50% of the mass of the filtrate to the filtrate, wherein the amount of cocamide apple amino acid added is 30% of the mass of the filtrate, and the amount of methyl glucoside polyoxyethylene (120) ether trioleate added is 20% of the mass of the filtrate), continue to concentrate to a thick paste with a relative density of 1.30, add 0.2 g of menthol at below 60° C. and mix evenly to obtain a fat-removing and hair-growing external preparation.

[0112] The fat-removing and hair-growing external preparations of Examples 1-10 were tested for usage experience and dosage form stability.

[0113] Dosage form stability test: observe the stability of the fat-removing and hair-growing topical preparation after standing for 1h, 24h, and 48h.

[0114] Usage experience test: Use a fat-removing and hair-growing topical preparation to clean the wig and evaluate its foaming, comfort and odor.

[0115] The test results of the fat-removing and hair-growing external preparations of Examples 1-10 are shown in Table 1.

[0116] Table 1 Test results of fat-removing and hair-growing external preparations of Examples 1-10

[0117]

[0118]

[0119] In the process of formulating and compatibility, the present invention also explored experiments on different formulas and preparation processes, and conducted user experience and dosage form stability tests on the preparations obtained from the relevant experiments, as follows.

[0120] Test 1

[0121] The preparation of this test is different from that of Example 3 in that the Dictamni cortex is replaced by Alum.

[0122] Test 2

[0123] The preparation of this test is different from that of Example 3 in that no Dictamni cortex is added.

[0124] Test 3

[0125] The preparation of this test is different from that of Example 3 in that no saponins and menthol are added.

[0126] Test 4

[0127] The preparation of this test is different from that of Example 3 in that the amount of menthol added is 0.5 g.

[0128] Test 5

[0129] The preparation of this test is different from that of Example 3 in that the amount of Dictamni cortex is 15 g and the amount of Gleditsia sinensis is 20 g.

[0130] Test 6

[0131] The preparation of this test is different from that of Example 3 in that the Gleditsia sinensis is replaced by the peel of Soapberry.

[0132] Test 7

[0133] The preparation of this test is different from that of Example 3 in that the saponins are replaced by tea kudzu powder.

[0134] Test 8

[0135] The preparation of this test is different from that of Example 3 in that in step 2), the filtrate is concentrated to a thick paste having a relative density of 1.50 at 25°C.

[0136] Test 9

[0137] The preparation of this test is different from that of Example 3 in that in step 2), the filtrate is concentrated to a thick paste having a relative density of 1.15 at 25°C.

[0138] Test 10

[0139] The preparation method of this test is as follows:

[0140] 1) In parts by weight, the raw medicinal materials of Platycladus orientalis leaf 10g, pine needle 10g, Impatiens balsamina 10g, Ligustrum lucidum fruit 7.5g, Polygonum multiflorum processed 7.5g, wild chrysanthemum 5g, mulberry leaf 5g, dandelion 7.5g, Chuanxiong 7.5g, Angelica sinensis 7.5g, Gleditsia sinensis 7.5g, Dictamni cortex 7.5g, Gleditsia sinensis 10g, and mint leaf 0.15g were mixed, soaked and decocted in water, squeezed and filtered to obtain a filtrate;

[0141] 2) The filtrate is concentrated to a thick paste having a relative density of 1.36 at 25°C to obtain the preparation.

[0142] Test 11

[0143] The preparation method of this test is as follows:

[0144] 1) In parts by weight, the raw medicinal materials of Platycladus orientalis leaf 10g, pine needle 10g, Impatiens balsamina 10g, Ligustrum lucidum fruit 7.5g, Polygonum multiflorum processed 7.5g, wild chrysanthemum 5g, mulberry leaf 5g, dandelion 7.5g, Chuanxiong 7.5g, Angelica sinensis 7.5g, Gleditsia sinensis 7.5g, Dictamni cortex 7.5g, Gleditsia sinensis 10g, and mint leaf 15g were mixed, soaked and decocted in water, squeezed and filtered to obtain a filtrate;

[0145] 2) The filtrate is concentrated to a thick paste having a relative density of 1.36 at 25°C to obtain the preparation.

[0146] Test 12

[0147] The preparation method of this test is as follows:

[0148] 1) In parts by weight, the raw medicinal materials of Platycladus orientalis leaf 10g, pine needle 10g, Impatiens balsamina 10g, Ligustrum lucidum fruit 7.5g, Polygonum multiflorum processed 7.5g, wild chrysanthemum 5g, mulberry leaf 5g, dandelion 7.5g, Chuanxiong 7.5g, Angelica sinensis 7.5g, Gleditsia sinensis 7.5g, Dictamni cortex 7.5g, Gleditsia sinensis 10g, and mint leaf 50g were mixed, soaked in water, decocted, squeezed and filtered to obtain a filtrate;

[0149] 2) The filtrate is concentrated to a thick paste having a relative density of 1.36 at 25°C to obtain the preparation.

[0150] Test 13

[0151] The preparation of this test is different from that of Example 8 in that the Dictamni cortex is replaced by Alum.

[0152] Test 14

[0153] The preparation of this test is different from that of Example 8 in that no Dictamni cortex is added.

[0154] Test 15

[0155] The preparation of this test is different from that of Example 8 in that no saponins and menthol are added.

[0156] Test 16

[0157] The preparation of this test is different from that of Example 8 in that the amount of menthol added is 0.5 g.

[0158] Test 17

[0159] The preparation of this test is different from that of Example 8 in that the amount of Dictamni cortex is 15 g and the amount of Gleditsia sinensis is 20 g.

[0160] Test 18

[0161] The preparation of this test is different from that of Example 8 in that the Gleditsia sinensis is replaced by the peel of Soapberry.

[0162] Test 19

[0163] The preparation of this test is different from that of Example 8 in that the saponins are replaced by tea kudzu powder.

[0164] Test 20

[0165] The preparation of this test is different from that of Example 8 in that in step 2), the filtrate is concentrated to a thick paste having a relative density of 1.40 at 25°C.

[0166] Test 21

[0167] The preparation of this test is different from that of Example 8 in that in step 2), the filtrate is concentrated to a thick paste having a relative density of 1.15 at 25°C.

[0168] Test 22

[0169] The preparation method of this test is as follows:

[0170] 1) In parts by weight, the raw medicinal materials of Platycladus orientalis leaf 10g, pine needle 10g, Impatiens balsamina 10g, Ligustrum lucidum fruit 7.5g, Polygonum multiflorum processed 7.5g, wild chrysanthemum 5g, mulberry leaf 5g, dandelion 7.5g, Chuanxiong 7.5g, Angelica sinensis 7.5g, Gleditsia sinensis 7.5g, Dictamni cortex 7.5g, Gleditsia sinensis 10g, and mint leaf 0.15g were mixed, soaked and decocted in water, squeezed and filtered to obtain a filtrate;

[0171] 2) Add 25% of the mass of the filtrate to the filtrate of a foaming agent (composed of cocamide apple amino acid, sodium lauryl sulfate and propyl betaine, wherein the amount of cocamide apple amino acid added is 15% of the mass of the filtrate, the amount of sodium lauryl sulfate added is 2% of the mass of the filtrate, and the amount of cocamide propyl betaine is 8% of the mass of the filtrate), continue to concentrate to a thick paste with a relative density of 1.27, add 0.15 g of menthol at below 60° C. and mix evenly to obtain a preparation.

[0172] Test 23

[0173] The preparation method of this test is as follows:

[0174] 1) In parts by weight, the raw medicinal materials of Platycladus orientalis leaf 10g, pine needle 10g, Impatiens balsamina 10g, Ligustrum lucidum fruit 7.5g, Polygonum multiflorum processed 7.5g, wild chrysanthemum 5g, mulberry leaf 5g, dandelion 7.5g, Chuanxiong 7.5g, Angelica sinensis 7.5g, Gleditsia sinensis 7.5g, Dictamni cortex 7.5g, Gleditsia sinensis 10g, and mint leaf 15g were mixed, soaked and decocted in water, squeezed and filtered to obtain a filtrate;

[0175] 2) Add 25% of the mass of the filtrate to the filtrate of a foaming agent (composed of cocamide apple amino acid, sodium lauryl sulfate and propyl betaine, wherein the amount of cocamide apple amino acid added is 15% of the mass of the filtrate, the amount of sodium lauryl sulfate added is 2% of the mass of the filtrate, and the amount of cocamide propyl betaine is 8% of the mass of the filtrate), continue to concentrate to a thick paste with a relative density of 1.27, add 0.15 g of menthol at below 60° C. and mix evenly to obtain a preparation.

[0176] Test 24

[0177] The preparation method of this test is as follows:

[0178] 1) In parts by weight, the raw medicinal materials of Platycladus orientalis leaf 10g, pine needle 10g, Impatiens balsamina 10g, Ligustrum lucidum fruit 7.5g, Polygonum multiflorum processed 7.5g, wild chrysanthemum 5g, mulberry leaf 5g, dandelion 7.5g, Chuanxiong 7.5g, Angelica sinensis 7.5g, Gleditsia sinensis 7.5g, Dictamni cortex 7.5g, Gleditsia sinensis 10g, and mint leaf 50g were mixed, soaked in water, decocted, squeezed and filtered to obtain a filtrate;

[0179] 2) adding 25% of the mass of the filtrate to the filtrate of a foaming agent (composed of cocamide apple amino acid, sodium lauryl sulfate and propyl betaine, wherein the amount of cocamide apple amino acid added is 15% of the mass of the filtrate, the amount of sodium lauryl sulfate added is 2% of the mass of the filtrate, and the amount of cocamide propyl betaine is 8% of the mass of the filtrate), and continuing to concentrate to a thick paste with a relative density of 1.27 to obtain a preparation.

[0180] Test 25

[0181] The preparation of this experiment is different from that of Example 8 in that: in step 2), the foaming agent consists of sodium lauroyl sarcosinate and polyoxyethylene (120) methyl glucoside trioleate, wherein the addition amount of sodium lauroyl sarcosinate is 15% of the mass of the filtrate, and the addition amount of polyoxyethylene (120) methyl glucoside trioleate is 10% of the mass of the filtrate).

[0182] The test results of the preparations of Experiments 1-25 are shown in Table 2.

[0183] Table 2 Test results of the preparations of Experiments 1-25

[0184]

[0185]

[0186] The stability of the preparation of Experiment 1 after standing for 48 hours is as shown in Figure 1 a. The stability of the anti-seborrheic alopecia and hair growth external preparation of Example 1 after standing for 48 hours is as shown in Figure 1 b. The stability of the anti-seborrheic alopecia and hair growth external preparation of Example 3 after standing for 48 hours is as shown in Figure 1 c. The stability of the preparation of Experiment 7 after standing for 48 hours is as shown in Figure 1 d. The stability of the anti-seborrheic alopecia and hair growth external preparation of Example 8 after standing for 48 hours is as shown in Figure 1 e.

[0187] The comparison of the preparation of Comparative Example 25 and the preparation of Example 8 after standing for 24 hours is as shown in Figure 2 wherein the preparation of Comparative Example 25 is as shown in Figure 2 a, and the preparation of Example 8 is as shown in Figure 2 b. It can be seen from Figure 2 that after using the foaming agent of Comparative Example 25, particles precipitate after the preparation stands for 24 hours, and the stability requirements cannot be met.

[0188] Furthermore, a mouse androgenetic alopecia model induced by testosterone propionate was used to evaluate the therapeutic effect of the anti-seborrheic alopecia and hair growth external preparation (hereinafter referred to as anti-seborrheic alopecia and hair growth paste) of Example 3 of the present invention on androgenetic alopecia.

[0189] Experimental animals

[0190] SPF-grade 7-week-old male experimental C57BL / 6 mice from the Guangdong Provincial Center for Medical Experimental Animals (animal license number: SYXK (Guangdong) 2023-0324) with a body weight of 18-20 g were selected as experimental animals.

[0191] Experimental materials

[0192] Platycladus orientalis leaves, pine needles, Impatiens balsamina, Ligustrum lucidum fruit, processed Polygonum multiflorum, wild chrysanthemum, mulberry leaves, dandelion, Ligusticum chuanxiong, Angelica sinensis, Gleditsia sinensis spines, Dictamni cortex, Gleditsia sinensis, and menthol were purchased from Shenzhen Jianhua Pharmaceutical Co., Ltd., normal saline and minoxidil tincture were purchased from the Pharmacy Department of Shenzhen Chronic Disease Prevention and Control Center, ethanol was purchased from Xilong Science Co., Ltd., testosterone was purchased from Guangzhou Baidu Biotechnology Co., Ltd., and ELISA kits and HE staining kits were purchased from Guangzhou Wenrui Scientific Instrument Co., Ltd.

[0193] Establishment of a testosterone-induced hair loss model in C57BL / 6 mice and drug administration

[0194] Thirty-five male C57BL / 6 mice were randomly divided into blank group, model group, negative group, positive group and anti-fat hair growth cream group after one week of adaptive feeding, with 7 mice in each group. The back skin of all animals was shaved by electric hair removal one day before modeling, with a range of about 2cm x 3cm. The skin was pink and undamaged, confirming that the mouse hair follicles were in the resting phase. 0.1% testosterone (50% ethanol dilution) 0.1ml was applied to the back skin of mice in the model group (depilatory treatment), and the model was established for 30 consecutive days to establish the mouse androgenic alopecia (AGA) model. At the same time, 30 minutes after modeling every day, the anti-fat hair growth cream group was treated with anti-fat hair growth cream, the positive control group was treated with commercially available 5% minoxidil tincture, and the negative control group was treated with normal saline. The dose of both the positive control group and the negative control group was 0.2ml / d. The blank group was fed conventionally without any treatment; the model group was not treated after modeling and fed conventionally. All experimental operations were completed in a clean environment.

[0195] Inspection items and evaluation indicators

[0196] Hair growth status and scoring

[0197] The time from the start of drug administration to the darkening of the skin in the hair-loss area on the back of the mice and from the start of darkening to the growth of hair on the epidermis were observed every day. Two mice were randomly selected from each group and photographed on the 1st, 5th, 7th, 11th and 16th days to observe the hair-loss area on the back of the mice.

[0198] Hair growth length and weight measurement

[0199] On the 19th day of administration, 10 hairs were randomly plucked from the hair removal area of ​​each mouse, and their lengths were measured and recorded with a vernier caliper under a magnifying glass. The furthest distance between the two ends of the hair was recorded as the hair length, and the average value was calculated. At the end of the experiment, the remaining mice were killed by cervical vertebrae removal, and the hair of 2cmx3cm area of ​​the hair removal area on the back of each mouse was shaved with an electric shaver, and weighed with an analytical balance to calculate the average value.

[0200] The experimental data were expressed as mean ± standard deviation (X ± s) and statistically processed. One-way analysis of variance was used for comparison among multiple groups. If there was statistical significance, P < 0.05 or P < 0.01 indicated statistical significance.

[0201] Blood was collected after killing mice, and serum was separated after centrifugation at 3000rpm for 10 minutes. The levels of testosterone (T), dihydrotestosterone (DHT) and estrogen (E2) in the blood of each group of mice were determined using ELISA kits, and their average values ​​were recorded and calculated. One-way analysis of variance was used to compare experimental data among multiple groups, and P < 0.05 or P < 0.01 indicated statistical significance.

[0202] After killing the mice, the hair removal area on the back was taken and placed in a 4% paraformaldehyde solution, fixed at 4°C for 24 hours, dehydrated in a dehydrator, and embedded in paraffin to prepare paraffin sections with a thickness of 5 μm for HE staining.

[0203] Results Analysis

[0204] (1) The growth of hair on the back of mice in each group was as follows Figure 3 As shown in the figure, after applying testosterone to mice, it was found that the skin of mice changed from red to black on the 7th to 8th day after hair removal, the hair follicles entered the growth phase, and hair began to grow on the 11th to 12th day. The skin of mice in the anti-fat hair growth cream group changed from pink to black on the 8th day after hair removal, and hair began to grow on the 9th day. The skin gradually changed from black to gray on the 20th day. The hair growth scores of each group are shown in the figure. Figure 4 Compared with the blank group, there was no significant difference in the scores of each group on days 0, 3, 6, and 9 after hair removal. The hair growth score of the model group on days 15-30 was significantly reduced; compared with the model group, the hair growth score of the anti-fat hair growth cream group was significantly increased. In terms of the color change time of the hair removal area and the hair growth time, as shown in Table 3, the test results of the effects of each group on the growth cycle of hair loss mice showed that compared with the blank group, the skin color change time (P < 0.05) and hair growth time of the hair removal area of ​​the model group mice were significantly prolonged (P < 0.01), indicating that the model was successfully established; compared with the model group, the positive drug group and the hair growth cream group significantly shortened the skin color change and hair growth time of the hair removal area of ​​the mice (P < 0.05).

[0205] Table 3 Test results of the effects of each group on the growth cycle of hair loss mice

[0206] Group Skin color change time / d Hair growth time / d Blank Group 7.83±0.41 10.33±0.52 Model Group 9.71±0.69△ 12.86±0.69△△ Positive drug group 8.83±0.52☆ 10.67±0.82☆ Negative drug group 9.67±1.03△ 13±0.63△△ Anti-fat hair growth cream group 8.86±0.38☆ 10.86±0.79☆

[0207] Note: Compared with the blank group, △P<0.05, △△P<0.01; compared with the model group, ☆P<0.05.

[0208] (2) The results of the effects of each group on the hair length and weight of mice with hair loss are shown in Table 4. Compared with the blank group, the hair length and weight of the mice in the model group were significantly reduced, and there was statistical significance (P < 0.01); compared with the model group, the hair length and weight of the positive drug group and the anti-fat hair growth cream group were significantly increased (P < 0.01).

[0209] Table 4 Measurement results of the effects of each group on hair length and hair weight of alopecia mice

[0210] Group Hair length(mm) Gross weight (mg) Blank Group 9.25±0.2141 25.13±5.81 Model Group 6.4±0.6325△△ 10.3±2.26△△ Positive drug group 9.2333±0.725☆☆ 25.03±7.05☆☆ Negative drug group 6.2±0.7211△△ 13.72±4.69△△ Anti-fat hair growth cream group 8.3714±0.8031☆☆ 24.61±7.37☆☆

[0211] Note: Compared with the blank group, △△P<0.01; compared with the model group, ☆☆P<0.01.

[0212] (3) The results of the determination of the effects of each group on the hormone content of alopecia mice are shown in Figure 5 Compared with the blank group, the T and DHT levels in the blood of the mice in the model group were significantly increased (P < 0.01 and P < 0.05), and the E2 content was decreased, and there was statistical significance (P < 0.01). Compared with the model group, the positive group and the anti-fat hair growth cream group could significantly reduce the T and DHT levels (P < 0.05), and increase the E2 content, and there was statistical significance (P < 0.05).

[0213] (4) The skin pathological results of the alopecia mice in each group are shown in Figure 7-10 Compared with the blank group, the number of hair follicles in the model group decreased, and there was significant difference (P < 0.01). Fig.11 As shown in the figure, compared with the model group, the number of hair follicles in the anti-fat hair growth cream group increased significantly, and the follicle morphology was more complete. After applying the anti-fat hair growth cream, the mice did not experience redness, swelling, itching, allergies, etc. during the entire experiment. Animal experiments indicate that the anti-fat hair growth cream should be non-irritating to the skin and has good safety.

[0214] The above is only a specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any technician familiar with the technical field can easily think of various equivalent modifications or replacements within the technical scope disclosed by the present invention, and these modifications or replacements should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention shall be based on the protection scope of the claims.

Claims

1. A method for preparing a fat-removing and hair-growing external preparation, characterized in that: The following steps are involved: 1) In parts by weight, 8-12 parts of raw medicinal materials including Platycladus orientalis leaves, 8-12 parts of pine needles, 8-12 parts of Impatiens balsamina, 5-10 parts of Ligustrum lucidum fruits, 5-10 parts of processed Polygonum multiflorum, 4-6 parts of wild chrysanthemum, 4-6 parts of mulberry leaves, 5-10 parts of dandelions, 5-10 parts of Chuanxiong, 5-10 parts of Angelica sinensis, 5-10 parts of Gleditsia sinensis thorns, 5-10 parts of Dictamni cortex, and 8-12 parts of Gleditsia sinensis are mixed, and the mixture is soaked and boiled in water 8-20 times the weight of the raw medicinal materials, and then squeezed and filtered to obtain a filtrate; 2) Concentrate the filtrate to a thick paste with a relative density of 1.31 to 1.40 at 25°C, add 0.1 to 0.2 parts of menthol at a temperature below 60°C and mix evenly to obtain a fat-removing and hair-growing external preparation; or, Add 15-50% of the mass of the filtrate into the filtrate with a foaming agent, continue to concentrate to a thick paste with a relative density of 1.26-1.30, add 0.1-0.2 parts of menthol at below 60°C and mix evenly to obtain a fat-removing and hair-growing external preparation.

2. The method for preparing the fat-removing and hair-growing external preparation according to claim 1, characterized in that: In the step 1), the raw medicinal materials of 9-11 parts of Platycladus orientalis leaves, 9-11 parts of pine needles, 9-11 parts of Impatiens balsamina, 7-8 parts of Ligustrum lucidum fruits, 7-8 parts of processed Polygonum multiflorum, 4-6 parts of wild chrysanthemum, 4-6 parts of mulberry leaves, 7-8 parts of dandelions, 7-8 parts of Chuanxiong, 7-8 parts of Angelica sinensis, 7-8 parts of Gleditsia sinensis thorns, 7-8 parts of Dictamni cortex, and 9-11 parts of Gleditsia sinensis are mixed.

3. The method for preparing the fat-removing and hair-growing external preparation according to claim 1 or 2, characterized in that: In the step 1), the soaking time is 2-3 hours and the boiling time is 1-2 hours.

4. The method for preparing the fat-removing and hair-growing external preparation according to claim 3, characterized in that: The step 2) is to concentrate the filtrate to a thick paste with a relative density of 1.35-1.38 at 25°C, add 0.1-0.2 parts of menthol at below 60°C and mix evenly to obtain a fat-removing and hair-growing external preparation.

5. The method for preparing the fat-removing and hair-growing external preparation according to claim 3, characterized in that: The step 2) is to concentrate the filtrate to a thick paste with a relative density of 1.36 at 25° C., add 0.15 parts of menthol at a temperature below 60° C. and mix evenly to obtain a fat-removing and hair-growing external preparation.

6. The method for preparing the fat-removing and hair-growing external preparation according to claim 3, characterized in that: The step 2) is to add polysorbates, higher fatty alcohol sulfates, and amino acid foaming agents to the filtrate, continue to concentrate to a thick paste with a relative density of 1.26 to 1.28, add 0.1 to 0.2 parts of menthol at below 60°C and mix evenly to obtain a fat-removing and hair-growing external preparation.

7. The method for preparing the fat-removing and hair-growing external preparation according to claim 3, characterized in that: The step 2) is to add polysorbates, higher fatty alcohol sulfates, and amino acid foaming agents to the filtrate, continue to concentrate to a thick paste with a relative density of 1.27, add 0.15 parts of menthol at below 60°C and mix evenly to obtain a fat-removing and hair-growing external preparation.

8. The method for preparing the fat-removing and hair-growing external preparation according to claim 1, characterized in that: The foaming agent is selected from at least one of polysorbate 80, sodium lauryl sulfate, methyl glucoside polyoxyethylene (120) ether trioleate, cocamide apple amino acid, and cocamidopropyl betaine.

9. The method for preparing the fat-removing and hair-growing external preparation according to claim 1, characterized in that: In the step 2), the specific operation of concentration is to first use high heat to accelerate the evaporation of water, so that the filtrate gradually becomes thick, and then use low heat to further concentrate to the target relative density.

10. A fat-removing and hair-growing external preparation, characterized in that: The method is prepared according to any one of claims 1 to 9.

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