A traditional Chinese medicine composition for treating body odor, and its preparation method and application

Abstract

The invention discloses a Chinese medicine composition for treating body odor, a preparation method thereof, and an application thereof. The Chinese medicine composition comprises the following raw materials in parts by weight: 25-35 parts of dried alum, 20-30 parts of Chinese gallnut, 10-20 parts of cloves, 15-25 parts of phellodendron, 5-15 parts of tea polyphenols, 15-25 parts of calcined oyster shell, and 1-5 parts of borneol. The present invention adopts a reasonable formula and an advanced preparation process, retains the active ingredients in most of the materials, can effectively alleviate the symptoms of body odor, has low irritation, low adverse reactions, high efficiency after clinical treatment, and significant effect.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition for treating body odor, and a preparation method and application thereof. Background Art

[0002] Bromhidrosis, also known as axillary bromhidrosis (commonly known as "brachial odor"), is a common, inherited metabolic skin disorder characterized by an unpleasant axillary odor. The severity of the odor varies from person to person and is often accompanied by excessive axillary sweating. Some patients may even experience an odor around the areola, umbilicus, and genitals. It is also known as bromhidrosis or "bromhidrosis." The disease is more common in young adults, with a higher incidence in women than in men. Its pungent and unpleasant odor can severely impact patients' daily lives and interpersonal relationships, and in turn, to a certain extent, their mental health. While the causes and mechanisms of bromhidrosis remain largely unexplained, it is generally believed to be caused by the excessive secretion of organic substances by the axillary apocrine sweat glands, which are then broken down by various bacteria into unsaturated fatty acids and ammonia, which have a distinctive odor.

[0003] There are numerous treatments for axillary odor, categorized as surgical and non-surgical. Surgical procedures, including small-incision apocrine gland removal, vacuum curettage, and endoscopically assisted rotary excision, can completely remove sweat gland tissue and are highly effective. However, these procedures require a recovery period, require pressure bandaging, and may result in subcutaneous hematomas and skin necrosis. These procedures can also affect upper limb abduction function, resulting in a short-term impact on the patient's daily life. Young women, in particular, cannot tolerate the risk of complications such as scarring.

[0004] At present, popular topical medications for treating axillary odor in hospitals and the market include odor powder, formaldehyde solution, Xishilan summer dew and various perfumes. There are many types, but they all need to be applied continuously every day. Some are highly irritating or cause local allergies, which brings inconvenience to people who often need to go out.

[0005] After searching, the patent publication number is CN114796165A, which discloses a method for preparing an external dressing, which includes 5-15g of melaleuca; 40-60g of talcum powder; 3-7g of borneol; 10-20g of calamine; 5-15g of bee venom wine; and 5-15g of honey. The prepared dressing is based on the rational combination of the above materials and specific preparation steps. The sweat is collected by applying the sweat-absorbing layer of the gauze, and then the bacteria are killed by the bactericidal layer, thereby effectively preventing and treating the secretion of sweat and the growth of bacteria in the human armpit. However, the above patent formula contains ingredients with high lead content such as melaleuca, which has the problem of easy production line contamination during the preparation and processing, resulting in lead residues, high irritation, and easy to cause symptoms such as skin allergies in patients.

[0006] In view of the shortcomings of the existing technology, it is of great significance to develop a new formula of Chinese medicine composition for treating body odor. Summary of the Invention

[0007] In response to the shortcomings of the prior art, the present invention aims to develop a traditional Chinese medicine composition for treating body odor, its preparation method, and its use. The present traditional Chinese medicine composition has a unique and rational compatibility, low irritation, and few adverse reactions, and is manufactured using an advanced preparation process. The product of the present invention has a high efficacy rate and significant therapeutic effect after clinical treatment.

[0008] In order to achieve the above-mentioned object of the invention, the technical solution of the present invention is:

[0009] A traditional Chinese medicine composition for treating body odor comprises the following raw materials in parts by weight: 25-35 parts of alum, 20-30 parts of gallnut, 10-20 parts of cloves, 15-25 parts of phellodendron, 5-15 parts of tea polyphenols, 15-25 parts of calcined oyster shell, and 1-5 parts of borneol.

[0010] Preferably, in the embodiment of the present invention, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 30 parts of alum, 25 parts of gallnut, 15 parts of cloves, 20 parts of phellodendron, 10 parts of tea polyphenols, 20 parts of calcined oyster shell, and 3 parts of borneol.

[0011] Or preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 28 parts of alum, 22 parts of gallnut, 14 parts of cloves, 16 parts of phellodendron, 9 parts of tea polyphenols, 18 parts of calcined oyster shell, and 2 parts of borneol.

[0012] Further preferably, the alum is alum powder with a lead content ≤5 mg / kg and an aluminum ion dissolution rate ≤0.1%, the gallnut is gallnut powder with a tannic acid content ≥70%, and the cloves are clove powder with a eugenol purity ≥85%; the Phellodendron amurense is Phellodendron amurense powder, the tea polyphenols are liposome-encapsulated tea polyphenols with an encapsulation rate ≥95%, the calcined oyster is calcined oyster powder, and the borneol is dextrorotatory borneol borneol with a purity greater than 95%, and the particle size of the above raw material powders is between 100-300 mesh.

[0013] The tea polyphenols are preferably green tea polyphenols.

[0014] The preparation method of the above-mentioned traditional Chinese medicine composition for treating body odor includes: firstly mixing calcined oyster shell and alum in the first stage; then mixing gallnut, clove and phellodendron in the second stage; then adding liposome-encapsulated tea polyphenols in the third stage; in the third stage, simultaneously preparing borneol and alcohol into a borneol alcohol solution; spraying the borneol alcohol solution into the third stage for uniform mixing, thereby obtaining the traditional Chinese medicine composition of the present invention.

[0015] The alcohol is preferably ethanol, and the concentration of the borneol ethanol solution is 8%-15% w / v.

[0016] Preferably, the mixing time in the first stage is 15-30 minutes, the mixing time in the second stage is 60-120 minutes, and the mixing time in the third stage is 15-30 minutes.

[0017] The following is a further explanation and description of the pretreatment of raw materials. The pretreatment methods of raw materials are all existing technologies:

[0018] Preferably, the specific processing steps of the alum are: taking alum, crushing it and passing it through an 80-100 mesh sieve, placing it in a calcining pot, controlling the calcining temperature to 300-350°C, and calcining it at a constant temperature for 1-2 hours to completely dehydrate it into a white loose block of alum, and after cooling, crushing the alum and passing it through a 100-300 mesh sieve to obtain alum powder.

[0019] Preferably, the specific processing steps of the gallnut are: taking the gallnut raw medicinal material, removing impurities, mixing and stirring at a mass ratio of gallnut: rice vinegar = (8-12):1, stewing for 3-4 hours, stir-frying over low heat, and then crushing and passing through a 100-300 mesh sieve to obtain gallnut powder.

[0020] Preferably, the specific processing steps of the male cloves are: using supercritical CO2 extraction technology on the male cloves to separate eugenol, spray-drying the separated eugenol into fine powder to obtain clove powder with a eugenol purity of ≥85%, and further preferred parameters: extraction pressure of 30-40MPa, temperature of 40-50°C, CO2 flow rate of 20-30L / h, and extraction time of 3-4 hours.

[0021] Preferably, the specific processing steps of the Phellodendron chinense are: taking the original medicinal material of Phellodendron chinense, putting it into a high-pressure homogenizer for nano-refining to obtain a Phellodendron chinense nanosuspension, the particle size of the Phellodendron chinense nanosuspension is ≤200nm, adding hydroxypropyl cellulose to the Phellodendron chinense nanosuspension, the addition amount of the hydroxypropyl cellulose is 0.4%-0.6%, and after freeze-drying, passing through a 100-300 mesh sieve to obtain Phellodendron chinense powder.

[0022] Preferably, the specific processing steps of the tea polyphenols are: taking phospholipids, cholesterol and tea polyphenols, and mixing them in a mass ratio of phospholipids: cholesterol: tea polyphenols = (6-8): (1-2): 1, and ultrasonically treating them to prepare tea polyphenol liposomes; the power of the ultrasonic treatment is 250W-350W, and the treatment time is 15-30 minutes.

[0023] Preferably, the specific processing steps of the calcined oyster are: take raw oysters, wash them, calcine them at 800-900° C. for 3-4 hours until they turn grayish white, crush them and pass them through a 100-300 mesh sieve to obtain calcined oyster powder.

[0024] Preferably, the borneol processing step is as follows: borneol and alcohol are combined to prepare a borneol alcohol solution with a concentration of 8%-15% w / v. Furthermore, the alcohol is preferably ethanol.

[0025] The present invention also provides application of the traditional Chinese medicine composition in preparing medicine for treating body odor.

[0026] The prescription of the present invention is explained as follows:

[0027] 1. Monarch Medicine

[0028] Alum: It is listed as a medium-grade herb in the Shennong Herbal Classic, which states that it “treats cold and heat diarrhea, leukorrhea, malignant sores, and eye pain.” The later Compendium of Materia Medica details its efficacy in “drying dampness and detoxifying, and relieving itching caused by tapeworms.”

[0029] Alum has a strong astringent effect. The aluminum ions in alum bind to the apocrine sweat gland cell membrane, inhibiting ATPase activity, which can effectively reduce sweat secretion. It has a broad antibacterial spectrum (the inhibition rate of Staphylococcus aureus is >90%), effectively inhibits bacterial growth, and destroys the bacterial living environment. It is the core drug for treating axillary odor.

[0030] 2. Minister medicine

[0031] Gallnut: The Kaibao Materia Medica states that it "treats toothache, irritation, and lung wind poison that overflows into the skin, causing rheumatism." Gallnut cross-links with skin keratin, resulting in a long-lasting astringent effect on pores and inhibiting the hypertrophy and proliferation of apocrine sweat glands, complementing the main herb in enhancing its astringent effect. Gallnut powder with a tannic acid content of 70% or higher is preferred.

[0032] Cloves: The "Compendium of Materia Medica" (Haiyao Bencao) states that they "treat wind-induced sores and ulcers, kill insects and ward off evil." Cloves can also effectively inhibit bacterial growth, particularly against carcinogenic bacteria like aniline and Staphylococcus epidermidis. They can also help reduce odor and break down existing sulfide odors. Clove powder with a eugenol purity of 85% or higher is preferred.

[0033] 3. Adjuvant

[0034] Huangbo: The core ingredient of Huanglian Jiedu Decoction in "Treatise on Febrile Diseases"; Huangbo can selectively release berberine components, regulate the pH value of the armpit to 5.5-6.0, and inhibit fatty acid oxidation. It can selectively inhibit Gram-positive bacteria, promote the colonization of probiotics (such as Propionibacterium), maintain the balance of the bacterial flora, help maintain the health of the skin, and reduce the generation of odor.

[0035] Tea polyphenols: Tea polyphenols can target and inhibit α-reductase activity, blocking the overactivation of apocrine sweat glands induced by androgens, reducing secretory activity from the root, and further assisting the effects of the main and auxiliary drugs. The tea polyphenols are preferably green tea polyphenols.

[0036] Forged oyster powder: It has a natural porous structure, has adsorption and astringent effects, can physically adsorb free fatty acids, block bacterial metabolic substrates, and its calcium ion replacement can also reduce sulfide production, helping to reduce sweat secretion and odor.

[0037] 4. Use medicine

[0038] Borneol: As a promoter, borneol can open the gaps in the stratum corneum, improve the efficiency of drug delivery, accelerate drug penetration, and reduce the concentration of volatile sulfides (VSCs) by more than 90% within 30 minutes. At the same time, it can inhibit the occurrence of TRPV1 receptor glycolytic enzymes, relieve local inflammation, and enhance the overall efficacy of the drug.

[0039] Compared with the prior art, the present invention has the following beneficial effects:

[0040] 1. The present invention has a rational formula. Through the rational combination of monarch, minister, assistant and guiding ingredients, it comprehensively utilizes multiple functions such as astringency, antibacterial, pH regulation and drug absorption promotion to effectively treat the cause of axillary odor. This prescription integrates the three methods of "agglutination, clearing and regulating" to treat the skin and hair externally and regulate the qi internally, ultimately achieving the state of clearing turbidity and unblocking the orifices, and naturally producing body odor.

[0041] 2. The preparation process of the present invention is advanced, retains the effective ingredients in most materials, has good therapeutic effect, can effectively improve drug utilization, and the finished product has little irritation and no toxic side effects.

[0042] 3. The clinical use effect of the product of the present invention proves that patients treated with the Chinese medicine composition of the present invention can effectively alleviate the symptoms of axillary odor without toxic side effects. The clinical treatment efficiency is high and the effect is significant.

[0043] The detailed structure of the present invention is further described below in conjunction with specific embodiments. DETAILED DESCRIPTION

[0044] The parts by weight described in the embodiments of the present invention refer to mass, and the general unit is g or kg. Example 1

[0045] A traditional Chinese medicine composition for treating body odor comprises the following raw materials in parts by weight: 30 parts of alum, 25 parts of gallnut, 15 parts of cloves, 20 parts of phellodendron, 10 parts of tea polyphenols, 20 parts of calcined oyster shell, and 3 parts of borneol.

[0046] The preparation method comprises the following steps: firstly, calcined oyster shell and alum are mixed in the first stage; then, gallnut, clove and phellodendron are mixed in the second stage; then, liposome-encapsulated tea polyphenols are added and mixed in the third stage; during the third stage, borneol and ethanol are simultaneously prepared into a borneol ethanol solution; then, the borneol ethanol solution is added and mixed to obtain the traditional Chinese medicine composition of the present invention.

[0047] The pretreatment process of raw materials is as follows:

[0048] Preparation of alum:

[0049] Grind alum into 80 mesh, place it in a calcining pot, control the calcining temperature at 300-350℃, and calcine at a constant temperature for 2 hours to completely dehydrate it into a white loose lump. After cooling, crush it through a 200-mesh sieve to obtain alum powder.

[0050] In this step, lead content is a key indicator of alum safety. ICP-MS (inductively coupled plasma mass spectrometry) testing is required, and the lead content in the finished alum powder must be ≤5 mg / kg to ensure safe use. Furthermore, the dissolution rate of water-soluble aluminum ions is also a key indicator for assessing its biosafety. In vitro transdermal testing requires a dissolution rate of ≤0.1% for alum powder. Alum preparation can be any method currently available, as long as it meets our requirements for the raw materials.

[0051] It is worth noting that temperature control is crucial during calcination. When the calcination temperature exceeds 400°C, the aluminum sulfate in alum will decompose and produce harmful gases, affecting product quality and safety. Therefore, the calcination temperature must be strictly controlled to always be maintained between 300-350°C. After calcination, it must be cooled quickly to avoid moisture absorption and agglomeration, which will affect subsequent processing and use.

[0052] 2. Pretreatment of Gallnut;

[0053] Take the original Chinese gallnut medicinal material, remove impurities and insect-damaged materials, mix the Chinese gallnut with rice vinegar in a ratio of 10:1, stew for 4 hours, stir-fry over low heat until the surface is slightly charred, and then crush through a 200-mesh sieve to obtain Chinese gallnut powder; the low heat is generally between 80-120°C.

[0054] In this embodiment, rice vinegar is selected from brewed vinegar with a total acid content of ≥4.5 g / 100 mL to ensure the processing effect and the content of tannic acid in gallnut. The frying time must be strictly controlled within 30 minutes to prevent excessive oxidation of tannic acid, which affects the efficacy.

[0055] In this step, tannic acid, the main active ingredient in gallnuts, is measured using UV-Vis spectrophotometry. The tannic acid content must be ≥70% to ensure efficacy. Gallnuts can be pretreated using any method known in the art, as long as the tannic acid content is ≥70%.

[0056] 3. Pretreatment of cloves:

[0057] Supercritical CO2 extraction technology is used on male cloves to separate eugenol with a purity of ≥85%. The separated eugenol is spray-dried to obtain clove powder.

[0058] The extraction parameters were set as follows: extraction pressure of 35 MPa, temperature of 45°C, CO2 flow rate of 25 L / h, and extraction time of 3 hours to ensure efficient extraction of eugenol.

[0059] The pretreatment of cloves can be any preparation method in the prior art, as long as the purity of eugenol reaches ≥85%.

[0060] 4. Pretreatment of Phellodendron chinense:

[0061] The raw material of Phellodendron chinense was homogenized in a high-pressure homogenizer at a pressure of 1500 bar for 5 cycles to obtain a Phellodendron chinense nanosuspension. 0.5% by weight of hydroxypropyl cellulose was added to the Phellodendron chinense nanosuspension, freeze-dried, and passed through a 300-mesh sieve to obtain Phellodendron chinense powder. The pretreatment of Phellodendron chinense can be performed by any preparation method known in the art.

[0062] 5. Tea polyphenols are encapsulated with liposomes:

[0063] Phospholipids, cholesterol and tea polyphenols were taken so that the ratio of phospholipids: cholesterol: tea polyphenols was 7:2:1 (w / w mass ratio), and tea polyphenol liposomes were prepared by ultrasonic treatment; the ultrasonic treatment power was 300 W and the treatment time was 15 minutes.

[0064] Liposome encapsulation of tea polyphenols can be performed using other methods known in the art. The goal is to achieve an encapsulation efficiency of ≥95% for the liposome-encapsulated tea polyphenols, ensuring that the active ingredients of the tea polyphenols are not lost during storage. This ensures that the storage stability requirement is met: a leakage rate of ≤5% when stored at 4°C in the dark for 6 months.

[0065] 6. Preparation of calcined oysters:

[0066] Wash the raw oysters, calcine them at 800°C for 4 hours until they are off-white, grind them and pass them through a 300-mesh sieve to obtain calcined oyster powder. The present invention has no special requirements for the preparation of calcined oyster powder, and calcined oyster powder prepared by other methods in the prior art can also be used.

[0067] 7. Pretreatment of borneol with ethanol: Prepare borneol ethanol solution by mixing borneol and ethanol, with a concentration of about 10% w / v;

[0068] In the present embodiment, what borneol adopts is natural borneol, and its main component is d-borneol, and purity is 95%-98%, extracted from borneol camphor, and has unique transdermal effect.And its main component of synthetic borneol on the market is racemic borneol, and purity can reach more than 99%, but transdermal effect and safety are slightly inferior to natural borneol.Some studies have found that the skin sensitization rate of synthetic borneol is 0.7%-1.0% higher than that of natural borneol.And the transdermal efficiency of natural borneol is 5%-8% higher than that of synthetic borneol, and skin irritation is lower, and its clinical patch test shows that its sensitization rate is only 0.3%.

[0069] 8. Mixing:

[0070] An external preparation is prepared by mixing alum powder, gallnut powder, clove powder, phellodendron amurense powder, tea polyphenol liposome, calcined oyster powder and borneol.

[0071] The mixing is a gradient mixing, comprising the following steps:

[0072] S1. Place calcined oyster powder and alum into a mixer for the first stage of mixing to initially disperse the light powder and avoid agglomeration;

[0073] S2. After the first stage of mixing is completed, the gallnut powder, clove powder, and phellodendron chinense powder are added to the mixer for the second stage of mixing to evenly disperse the active ingredients and prevent the nanopowder from agglomerating;

[0074] S3. After the second stage of mixing is completed, the tea polyphenol liposomes are added to the mixer for the third stage of mixing to protect the liposome structure and avoid mechanical shearing to destroy the encapsulation rate. At the same time, the borneol ethanol solution is added to the mixer in the form of a spray for mixing. The volatile borneol is adsorbed by the porous structure of the calcined oyster to reduce the loss. The nozzle pressure is 0.3MPa and the atomized particle size is ≤50 microns.

[0075] It is worth noting that the interval time between step S1 and step S2 is ≤10 minutes to ensure that the calcined oyster shell and alum are initially mixed evenly, which is confirmed by detecting their relative standard deviation RSD ≤8%. The interval time between step S2 and step S3 is ≤5 minutes to avoid the precipitation of the active ingredients. Liposomes should be added immediately to encapsulate the active particles, and the borneol ethanol solution should be sprayed and adsorbed in real time and continuously in parallel with the mixing.

[0076] The mixing equipment is a three-dimensional motion mixer (volume ≥ 200L) with a rotation speed of 10-12rpm.

[0077] The mixing mode is batch mixing, and each batch is ≤80% of the equipment volume to prevent overfilling that affects convection mixing.

[0078] Mixing frequency: In the first stage, mix for 15 minutes → sample and test (RSD ≤ 8%) → enter the second stage, with a total mixing time of 60 minutes, and sample every 15 minutes to ensure RSD ≤ 5%. RSD is the relative standard deviation.

[0079] After mixing, the finished drug powder is obtained, which can be sterilized by irradiation (cobalt-60 gamma ray, dose 25kGy, microbial limit ≤ 100CFU / g) to ensure the sterility of the product.

[0080] After sterilization, use brown glass bottles lined with aluminum foil (oxygen permeability ≤ 0.1cc / pkg·day) to prevent oxidation and deterioration. Nitrogen filling (residual oxygen content ≤ 1%) further prolongs liposome stability and ensures product quality. Strict hygiene conditions must be maintained during the repackaging process to prevent contamination and ensure product quality.

[0081] The product prepared in Example 1 was subjected to quality inspection:

[0082] The particle size distribution is measured by the existing laser particle size analyzer method, D90≤10 μm, nano phase D50≤200 nm, and the product particle size meets the requirements.

[0083] Heavy metals: using the existing ICP-MS detection method, lead ≤ 1 mg / kg, total heavy metals ≤ 10 mg / kg, product safety.

[0084] Microbial limits, using the existing plate test method, aerobic bacteria ≤ 1000 CFU / g, mold ≤ 100 CFU / g, the product is sterile.

[0085] Accelerated test, 40℃ / 75% RH, 6 months, index change ≤5%. The accelerated test shows that the product quality is stable.

[0086] Long-term testing, 25°C / 60% RH, 36 months, with regular spot checks, shows that product quality remains stable during storage.

[0087] All of the above detection methods are conventional detection methods in the prior art.

[0088] Comparative Example 1

[0089] A traditional Chinese medicine composition for treating body odor comprises the following raw materials in parts by weight: 30 parts of alum, 25 parts of gallnut, 20 parts of phellodendron, 15 parts of cloves and 3 parts of borneol.

[0090] The preparation method is the same as that in Example 1.

[0091] Comparative Example 2

[0092] A traditional Chinese medicine composition for treating body odor comprises the following raw materials in parts by weight: 30 parts of alum, 25 parts of gallnut, 15 parts of cloves, 20 parts of phellodendron, 10 parts of tea polyphenols, 20 parts of calcined oyster shell, and 3 parts of borneol.

[0093] Preparation method: After drying, the above seven herbs are directly crushed into fine powder, and passed through a 200-300 mesh sieve to obtain finished medicinal powder, thereby obtaining the Chinese medicine composition of Comparative Example 2.

[0094] Observation of clinical effects

[0095] 225 patients who met the diagnostic criteria for axillary odor were selected and divided into two groups according to the random number table method, with 75 cases in each group: the control group 1 had 32 males and 43 females, aged (18-45) years, with an average age of (28.43±3.61) years; among them, 9 cases were mild, 15 cases were moderate, and 51 cases were severe; the example group 1 had 30 males and 45 females, aged (19-46) years, with an average age of (29.15±3.52) years, among them, 8 cases were mild, 17 cases were moderate, and 50 cases were severe; the control group 2 had 33 males and 42 females, aged (19-45) years, with an average age of (28.84±3.71) years, among them, 9 cases were mild, 17 cases were moderate, and 49 cases were severe. There was no statistical difference in gender, age, and disease course among the three groups (P>0.05).

[0096] 1.2 Inclusion and exclusion criteria 1.2.1 Inclusion criteria: 1. Patients diagnosed with axillary odor and have not received surgical treatment; 2. Aged 18 to 50 years; 1.2.2 Exclusion criteria: ① Infection, eczema, and fungal infection of the axillary skin; ② Pregnant and lactating women, and those during menstruation; ③ Allergic constitution; ④ Liver, kidney, and other diseases, and abnormal liver function.

[0097] Treatment Method: 1. Cleanse both sides thoroughly before testing. Do not use similar products within 2 weeks before testing. 2. Cleanse the underarms with saline. After 1 hour, assess the baseline value of both underarms. Apply Comparative Example 1, Comparative Example 2, and Example 1 until absorbed. After 5 minutes, assess both underarms and photograph using a dermatoscope. After the test, provide the subject with usage instructions and provide the product and a usage diary. 3. After using the product for 7 consecutive days, on the 8th day, cleanse the underarms with saline. After 1 hour, apply the product to both underarms until absorbed. After 5 minutes, assess one underarm and photograph using a dermatoscope. 4. Adjust the dosage and usage according to the patient's physical condition and the severity of the disease. 2 times a day; 14 days constitutes one course of treatment, and 2 courses of treatment are required.

[0098] Statistical analysis was performed using SPSS 21.0 software. ). Intergroup comparisons were performed using the t-test. Enumeration data are presented as number of cases and percentages (%), and the chi-square test was used for comparisons between groups. P < 0.05 was considered statistically significant, and P < 0.01 was considered highly significant.

[0099] Efficacy evaluation criteria

[0100] The treatment effect was determined as follows: markedly effective: after treatment, no odor was detected within 20 cm of the armpits while sweating, and the amount of sweat under the armpits was significantly reduced; effective: after treatment, no odor was detected within 20 cm of the armpits while sweating, and the amount of sweat under the armpits was reduced to a certain extent; ineffective: after treatment, odor was detected within 20 cm of the armpits while sweating, and the amount of sweat under the armpits did not change significantly. Total effective rate = (number of markedly effective cases + number of effective cases) ÷ total number of cases × 100%

[0101] The severity of axillary odor was assessed using a scoring system (Table 1). Patients self-assessed their symptoms as follows: 0: no odor; 1: occasional odor after strenuous activity, even when the nose is placed close to the armpit, which does not affect social activities; 2: odor even when the nose is not placed close to the armpit, which the patient believes affects social activities; and 3: constant odor, which the patient believes severely affects social activities.

[0102] Physician evaluation: evaluated by two fixed doctors: 0 point, no odor; 1 point, only occasional odor on the gauze after wiping the armpit with gauze; 2 point, odor can be smelled when the armpit is exposed during examination; 3 point, odor can be smelled next to the patient or at a distance without exposing the armpit.

[0103] Table 1 Odor degree rating

[0104] score 0 1 2 3 Patient self-assessment A doctor's evaluation Doctor A Doctor B Total score

[0105] Normal: score 0; mild: 1-3; moderate: 4-6; severe: 7-9

[0106] Table 2 Changes in the average odor level after 7 days of medication

[0107] Group Number of cases Before treatment First use 7 consecutive days of use Example 1 75 7.02±1.42 2.01±0.37##△& 1.41±0.31##*△& Comparative Example 1 75 6.83±1.34 2.53±0.42## 1.92±0.36##* Comparative Example 2 75 6.91±1.39 2.67±0.32## 1.89±0.35##*

[0108] Comparison before and after treatment in the same group: "##" indicates P < 0.01; compared with the first use, "*" indicates P < 0.05;

[0109] Compared with control group 1, “△” indicates P < 0.05; compared with control group 2, “&” indicates P < 0.05.

[0110] Table 3 Observation of total effective rate (treatment 14 days)

[0111] Group patient Significant effect efficient invalid Total efficiency Example 1 75 30 37 8 89.33%△& Comparative Example 1 75 21 35 19 74.67% Comparative Example 2 75 25 32 18 76%

[0112] Compared with control group 1, “△” indicates P < 0.05; compared with control group 2, “&” indicates P < 0.05.

[0113] Table 4 Observation of total effective rate (treatment 28 days)

[0114] Group patient Significant effect efficient invalid Total efficiency Example 1 75 48 26 1 98.67% Comparative Example 1 75 31 37 7 90.67% Comparative Example 2 75 35 35 5 93.33%

[0115] Adverse reactions occur

[0116] Comparative groups 1 and 2 were compared with Example 1 to observe the occurrence of skin necrosis, ulcers, nodules, bruises, infection, discomfort, allergies, etc. after treatment, and none of the cases showed any symptoms.

[0117] As shown in Tables 2 to 4, Example 1 has a more significant therapeutic effect than Comparative Examples 1 and 2, and the treatment time of 28 days is better than that of 14 days, the number of patients with significant effects is significantly increased, and the total effective rate is significantly increased, indicating that Example 1 has the best effect and the longer the duration of treatment, the better the efficacy. No adverse reactions occurred in the Example 1, Comparative Examples 1, and Comparative Examples 2 groups, indicating high safety. Example 2

[0118] A traditional Chinese medicine composition for treating body odor, comprising the following raw materials (active ingredients) in parts by weight: 28 parts of alum, 22 parts of gallnut, 14 parts of cloves, 16 parts of phellodendron, 9 parts of tea polyphenols, 18 parts of calcined oyster shell, and 2 parts of borneol.

[0119] The alum is alum powder with a lead content of ≤5 mg / kg and an aluminum ion dissolution rate of ≤0.1%, the gallnut is gallnut powder with a tannic acid content of ≥70%, and the cloves are clove powder with a eugenol purity of ≥85%; the phellodendron is phellodendron powder, the tea polyphenols are liposome-encapsulated tea polyphenols, the calcined oyster is calcined oyster powder, and the borneol is dextrorotatory borneol borneol with a purity greater than 95%. The particle sizes of the above raw material powders are all between 100-300 meshes.

[0120] The preparation method comprises: firstly, mixing calcined oyster shell and alum in the first stage; then mixing gallnut, clove and phellodendron in the second stage; then adding tea polyphenols encapsulated by liposomes and mixing in the third stage; during the third stage, simultaneously preparing borneol and ethanol into a borneol ethanol solution; spraying the borneol ethanol solution into the third stage for uniform mixing, thereby obtaining the traditional Chinese medicine composition of the present invention.

[0121] Preferably, the specific processing steps of the alum are: taking alum, crushing it and passing it through a 100-mesh sieve, placing it in a calcining pot, controlling the calcination temperature to 320° C., and calcining it at a constant temperature for 1.5 hours to completely dehydrate it into a white loose block of alum, and after cooling, crushing the alum and passing it through a 200-mesh sieve to obtain alum powder.

[0122] The specific processing steps of the gallnut are: taking the original gallnut medicinal material, removing impurities, mixing and stirring the gallnut and rice vinegar according to the mass ratio of gallnut and rice vinegar = 9:1, stewing for 3.5 hours, stir-frying over low heat, and then crushing and passing through a 200-mesh sieve to obtain gallnut powder.

[0123] The specific processing steps of the male cloves are: using supercritical CO2 extraction technology on the male cloves to separate eugenol, and spray-drying the separated eugenol into micropowder to obtain clove powder. Further preferred parameters are: extraction pressure of 35MPa, temperature of 40°C, CO2 flow rate of 25L / h, and extraction time of 3.5 hours.

[0124] The specific processing steps of the Phellodendron chinense are as follows: taking the original medicinal material of Phellodendron chinense, putting it into a high-pressure homogenizer for nano-refining to obtain a Phellodendron chinense nanosuspension, wherein the particle size of the Phellodendron chinense nanosuspension is ≤200nm, adding hydroxypropyl cellulose to the Phellodendron chinense nanosuspension, wherein the addition amount of the hydroxypropyl cellulose is 0.6%, and after freeze-drying, passing it through a 200-mesh sieve to obtain Phellodendron chinense powder.

[0125] The specific processing steps of the tea polyphenols are: taking phospholipids, cholesterol and tea polyphenols, and mixing them in a mass ratio of phospholipids: cholesterol: tea polyphenols = 8:2:1, and ultrasonically treating them to prepare tea polyphenol liposomes; the ultrasonic treatment power is 350W, and the treatment time is 25 minutes.

[0126] The specific processing steps of the calcined oyster are: taking raw oysters, washing them, calcining them at 800° C. for 4 hours until they turn grayish white, crushing them and passing them through a 300-mesh sieve to obtain calcined oyster powder.

[0127] The specific processing steps of the borneol are: taking borneol and ethanol to prepare a borneol ethanol solution with a concentration of 12% w / v.

[0128] According to the testing method of Example 1, the product of Example 2 is qualified.

[0129] Clinical verification shows that the product of Example 2 has similar effects to that of Example 1, has good efficacy, and has no adverse reactions.

[0130] The above is a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any technician familiar with the technical field, within the technical scope disclosed by the present invention, who makes equivalent replacements or changes based on the technical solutions and concepts of the present invention, should be covered by the scope of protection of the claims of the present invention.

Claims

1. A Chinese medicine composition for treating body odor, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 25-35 parts of alum, 20-30 parts of gallnut, 10-20 parts of cloves, 15-25 parts of phellodendron, 5-15 parts of tea polyphenols, 15-25 parts of calcined oyster shell, and 1-5 parts of borneol; The preparation method comprises: firstly mixing calcined oyster shell and alum in the first stage; then mixing gallnut, clove and phellodendron in the second stage; then adding tea polyphenols encapsulated by liposomes and mixing in the third stage, synchronously preparing borneol and alcohol into borneol alcohol solution in the third stage, spraying the borneol alcohol solution into the third stage for uniform mixing, and obtaining a traditional Chinese medicine composition.

2. A Chinese medicine composition for treating body odor according to claim 1, characterized in that, The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 30 parts of alum, 25 parts of gallnut, 15 parts of cloves, 20 parts of phellodendron, 10 parts of tea polyphenols, 20 parts of calcined oyster shell, and 3 parts of borneol; or, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 28 parts of alum, 22 parts of gallnut, 14 parts of cloves, 16 parts of phellodendron, 9 parts of tea polyphenols, 18 parts of calcined oyster shell, and 2 parts of borneol.

3. A Chinese medicine composition for treating body odor according to claim 1 or 2, characterized in that: The alum is alum powder with a lead content of ≤5 mg / kg and an aluminum ion dissolution rate of ≤0.1%, the gallnut is gallnut powder with a tannic acid content of ≥70%, and the cloves are clove powder with a eugenol purity of ≥85%; the phellodendron is phellodendron powder, the tea polyphenols are liposome-encapsulated tea polyphenols with an encapsulation rate of ≥95%, the calcined oyster is calcined oyster powder, and the borneol is dextrorotatory borneol borneol with a purity greater than 95%, and the particle sizes of the raw material powders are all between 100-300 meshes.

4. A Chinese medicine composition for treating body odor according to claim 1 or 2, characterized in that, The specific processing steps of the dried alum are: taking alum, crushing it and passing it through an 80-100 mesh sieve, placing it in a calcining pot, controlling the calcining temperature to 300-350° C., and calcining it at a constant temperature for 1-2 hours to completely dehydrate it into a white loose block of dried alum, and after cooling, crushing the dried alum and passing it through a 100-300 mesh sieve to obtain dried alum powder.

5. A Chinese medicine composition for treating body odor according to claim 1 or 2, characterized in that, The specific processing steps of the gallnut are: taking the original gallnut medicinal material, removing impurities, mixing and stirring at a mass ratio of gallnut to rice vinegar = (8-12):1, stewing for 3-4 hours, stir-frying over low heat, and then crushing and passing through a 100-300 mesh sieve to obtain gallnut powder.

6. A Chinese medicine composition for treating body odor according to claim 1 or 2, characterized in that, The specific processing steps of the male cloves are: using supercritical CO2 extraction technology to separate the male cloves to obtain eugenol, and spray-drying the separated eugenol into fine powder to obtain clove powder with a eugenol purity of ≥85%.

7. A Chinese medicine composition for treating body odor according to claim 6, characterized in that, The parameters of supercritical CO2 extraction technology are: extraction pressure of 30-40MPa, temperature of 40-50℃, CO2 flow rate of 20-30L / h, and extraction time of 3-4 hours.

8. A Chinese medicine composition for treating body odor according to claim 1 or 2, characterized in that, The specific processing steps of the Phellodendron chinense are as follows: taking the original medicinal material of Phellodendron chinense, putting it into a high-pressure homogenizer for nano-refining to obtain a Phellodendron chinense nanosuspension, wherein the particle size of the Phellodendron chinense nanosuspension is ≤200nm, adding hydroxypropyl cellulose to the Phellodendron chinense nanosuspension, wherein the addition amount of the hydroxypropyl cellulose is 0.4%-0.6%, and after freeze-drying, passing through a 100-300 mesh sieve to obtain Phellodendron chinense powder.

9. A Chinese medicine composition for treating body odor according to claim 1 or 2, characterized in that: The specific processing steps of the tea polyphenols are: taking phospholipids, cholesterol and tea polyphenols, and mixing them in a mass ratio of phospholipids: cholesterol: tea polyphenols = (6-8): (1-2): 1, and ultrasonically treating them to prepare tea polyphenol liposomes; the power of the ultrasonic treatment is 250W-350W, and the treatment time is 15-30 minutes.

10. A Chinese medicine composition for treating body odor according to claim 1 or 2, characterized in that: The specific processing steps of the calcined oyster are: taking raw oysters, washing them, calcining them at 800-900° C. for 3-4 hours until they turn grayish white, crushing them and passing them through a 100-300 mesh sieve to obtain calcined oyster powder.

11. A Chinese medicine composition for treating body odor according to claim 1 or 2, characterized in that: The specific processing steps of the borneol are: taking borneol and alcohol to prepare a borneol alcohol solution with a concentration of 8%-15% w / v.

12. Use of the traditional Chinese medicine composition according to claim 1 or 2 in preparing a medicament for treating body odor.