Traditional Chinese medicine composition for treating bromhidrosis and preparation method and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating bromhidrosis as well as a preparation method and application thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 25 to 35 parts of dried alum, 20 to 30 parts of gallnut, 10 to 20 parts of flos caryophylli, 15 to 25 parts of cortex phellodendri, 5 to 15 parts of tea polyphenol, 15 to 25 parts of calcined oyster shell and 1 to 5 parts of borneol. The traditional Chinese medicine composition is reasonable in formula and advanced in preparation process, retains effective components in most of the materials, can effectively relieve bromhidrosis symptoms, and is small in irritation, low in adverse reaction, high in effective rate after clinical treatment and remarkable in 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 is medically known as axillary bromhidrosis (commonly known as "bromhidrosis"). Bromhidrosis is a common hereditary skin metabolic disease in clinical practice. It is mainly manifested by axillary odor. The severity of the odor varies from person to person, and is often accompanied by excessive axillary sweating. Some patients can even smell odor around the areola, navel and genitals. It is also known as bromhidrosis. The disease is prone to occur in young and middle-aged people, and the incidence rate in women is higher than that in men. Because of its pungent and unpleasant smell, it seriously affects the patient's life and interpersonal communication, and then affects the patient's mental health to a certain extent. Modern medicine has not yet fully elucidated the cause and mechanism of axillary odor. It is generally believed that it is caused by the excessive secretion of organic substances by the axillary sweat glands, which are decomposed by various bacteria to produce unsaturated fatty acids and ammonia with a special smell.

[0003] There are many treatment methods for axillary odor, which can be divided into surgical and non-surgical methods. Surgery includes small incision apocrine gland removal, negative pressure scraping, and endoscope-assisted rotary excision, which can completely remove sweat gland tissue and have a definite effect. However, there is a certain recovery period after surgery, and pressure bandage is required. Subcutaneous hematoma and skin necrosis may occur, and the abduction function of the upper limbs will be affected, which will have a certain impact on the patient's life after treatment in the short term. Young women in particular cannot accept the risk of complications such as scars.

[0004] At present, popular topical drugs for treating axillary odor in hospitals and on 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: CN114796165A, discloses a method for preparing an external dressing, 5-15g of melaleuca; 40-60g of talcum powder; 3-7g of borneol; 10-20g of calamine; 5-15g of bee venom wine; 5-15g of honey. The prepared dressing is based on the reasonable 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 preventing and controlling the secretion of sweat and the growth of bacteria under 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 pollution 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 prior art, it is of great significance to develop a Chinese medicine composition with a new formula for treating body odor. Summary of the invention

[0007] In view of the deficiencies in the prior art, the purpose of the present invention is to develop a Chinese medicine composition for treating body odor, and its preparation method and application. The Chinese medicine composition of the present application has a unique and reasonable compatibility, low irritation, low adverse reactions, and an advanced preparation process. The product of the present invention has a high efficacy after clinical treatment and a significant therapeutic effect.

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

[0009] Preferably, in the embodiment of the present invention, the 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.

[0010] Or preferably, the 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.

[0011] 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%, 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 with a purity greater than 95%, and the particle sizes of the above raw material powders are all between 100-300 mesh.

[0012] The tea polyphenols are preferably green tea polyphenols.

[0013] The preparation method of the above-mentioned traditional Chinese medicine composition for treating body odor includes: firstly mixing calcined oyster shell and dried alum in the first stage; then mixing gallnut, clove and phellodendron in the second stage; then adding liposome-encapsulated tea polyphenols for the third stage mixing, and simultaneously preparing borneol and alcohol into borneol alcohol solution in the third stage mixing, and spraying the borneol alcohol solution into the third stage mixing to obtain the traditional Chinese medicine composition of the present invention.

[0014] The alcohol is preferably ethanol, and the concentration of the borneol ethanol solution is 8%-15% w / v.

[0015] 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.

[0016] The following is a further explanation and description of the pretreatment of raw materials, and the pretreatment methods of raw materials are all prior art: Preferably, 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.

[0017] Preferably, the specific processing steps of the gallnut are: taking the gallnut raw material, removing impurities, mixing and stirring at a mass ratio of gallnut: rice vinegar = (8-12): 1, steaming for 3-4 hours, stir-frying over low heat, and then crushing and passing through a 100-300 mesh sieve to obtain gallnut powder.

[0018] Preferably, the specific processing steps of the male cloves are: using supercritical CO 2 Extraction technology is used to separate eugenol. The separated eugenol is spray-dried into micro-powder to obtain clove powder with a purity of eugenol ≥ 85%. Further preferred parameters are: extraction pressure of 30-40MPa, temperature of 40-50℃, CO 2 The flow rate is 20-30L / h and the extraction time is 3-4 hours.

[0019] 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.

[0020] 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 obtain tea polyphenol liposomes; the power of the ultrasonic treatment is 250W-350W, and the treatment time is 15-30 minutes.

[0021] Preferably, the specific processing steps of the calcined oysters are: wash the raw oysters, calcine them at 800-900°C for 3-4 hours until they are off-white, and then crush them and pass them through a 100-300 mesh sieve to obtain calcined oyster powder.

[0022] Preferably, the specific processing step of the borneol is: taking borneol and alcohol to prepare a borneol alcohol solution with a concentration of 8%-15% w / v. Further, the alcohol is preferably ethanol.

[0023] The invention also provides application of the traditional Chinese medicine composition in preparing medicine for treating body odor.

[0024] The prescription of the present invention is explained as follows: 1. King of medicines Alum: It is recorded in Shennong's Herbal Classic as a medium-grade product, saying that it can "treat cold and heat diarrhea, ulcers, eye pain". The later Compendium of Materia Medica details its function of "drying dampness and detoxifying, and relieving itching of tapeworms".

[0025] Alum has a strong astringent effect. The aluminum ions in alum combine with the apocrine sweat gland cell membrane, inhibiting ATP enzyme 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 a core drug for the treatment of axillary odor.

[0026] 2. Minister medicine Gallnut: Kaibao Materia Medica states that it can “treat toothache, lung wind poison overflowing the skin, rheumatism”; Gallnut cross-links with skin keratin, has a long-lasting effect of astringing pores, can inhibit the hypertrophy and hyperplasia of apocrine sweat glands, and assist the main drug to enhance the astringent effect. It is preferred to select gallnut powder with a tannic acid content of ≥70%.

[0027] Cloves: The "Haiyao Bencao" states that it "treats wind-induced sores, kills insects and wards off evil." Cloves can strongly inhibit bacterial growth, especially against carcinogenic bacteria such as aniline or epidermidis Staphylococcus, help reduce the generation of odor, and can also decompose the sulfide odor that has been generated. It is preferred to select clove powder with a eugenol purity of ≥85%.

[0028] 3. Adjuvant Huangbo: The core ingredient of Huanglian Jiedu Decoction in "Treatise on Febrile Diseases"; Huangbo can directionally release berberine components, adjust 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 bacterial flora, help maintain the health of the skin, and reduce the generation of odor.

[0029] Tea polyphenols: Tea polyphenols can inhibit the activity of α-reductase, block the excessive activation of apocrine glands induced by androgens, reduce the secretion activity from the root, and further assist the effects of the main and auxiliary drugs. The tea polyphenols are preferably green tea polyphenols.

[0030] 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.

[0031] 4. Use medicine 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.

[0032] Compared with the prior art, the present invention has the following beneficial effects: 1. The formula of the present invention is reasonable. Through the reasonable combination of monarch, minister, assistant and envoy, it comprehensively utilizes multiple functions such as astringency, antibacterial, pH adjustment and drug absorption promotion, and can effectively treat the cause of axillary odor. This prescription integrates the three methods of "aggregation, clearing and regulating", treats the skin and hair externally, regulates the qi mechanism internally, and finally achieves the state of removing turbidity and opening the orifices, and the body fragrance is generated naturally.

[0033] 2. The preparation process of the present invention is advanced, and the effective ingredients in most materials are retained, the therapeutic effect is good, and the utilization rate of drugs can be effectively improved. The finished product has little irritation and no toxic side effects.

[0034] 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 has a high efficiency and significant effect.

[0035] The detailed structure of the present invention is further described below in conjunction with specific implementation methods. DETAILED DESCRIPTION

[0036] To make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be described clearly and completely in combination with the embodiments of the present invention. All other embodiments obtained by ordinary technicians in this field without creative work based on the embodiments of the present invention belong to the scope of protection of the present invention.

[0037] 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

[0038] 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 Chinese 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.

[0039] The preparation method comprises the following steps: firstly, calcined oyster shell and dried alum are mixed in the first stage; then, gallnut, clove and phellodendron are mixed in the second stage; then, tea polyphenols encapsulated by liposomes are added for mixing in the third stage, and during the mixing in the third stage, borneol and ethanol are simultaneously prepared into a borneol ethanol solution, and then the borneol ethanol solution is added and mixed to obtain the traditional Chinese medicine composition of the present invention.

[0040] The pretreatment process of raw materials is as follows: Preparation of dried alum: 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 dried alum powder.

[0041] In this step, the lead content is an important indicator for measuring the safety of alum. The ICP-MS detection method (inductively coupled plasma mass spectrometry) is required to require the lead content in the finished alum powder to be ≤5mg / kg to ensure safety. In addition, the dissolution rate of water-soluble aluminum ions is also an important indicator for evaluating its biological safety. It is necessary to pass an in vitro transdermal experiment and require the dissolution rate of alum powder to be ≤0.1%. The preparation method of alum can be any preparation method in the prior art, as long as it meets our requirements for raw materials.

[0042] It is worth noting that during calcination, temperature control is crucial. 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 remain between 300-350°C. After calcination, it must be cooled quickly to avoid moisture absorption and agglomeration, which will affect subsequent processing and use.

[0043] 2. Pretreatment of Gallic acid; Take the original medicinal material of gallnut, remove impurities and insect-damaged products, mix them in a ratio of gallnut to rice vinegar = 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 gallnut powder; the low heat is generally between 80-120°C.

[0044] In this embodiment, the rice vinegar is brewed vinegar with a total acid of ≥4.5 g / 100 mL to ensure the processing effect and the content of tannic acid in the gallnut. The frying time needs to be strictly controlled within 30 minutes to prevent excessive oxidation of tannic acid and affect the efficacy.

[0045] In this step, tannic acid is the main active ingredient of gallnut, and the gallnut powder needs to be measured by UV-Vis (ultraviolet-visible spectrophotometry), and the tannic acid content is required to be ≥70% to ensure the efficacy. The pretreatment of gallnut can be any preparation method in the prior art, as long as the tannic acid content requirement of ≥70% is achieved.

[0046] 3. Pretreatment of cloves: Supercritical CO 2 Extraction technology is used to separate eugenol with a purity of ≥85%. The separated eugenol is spray-dried to obtain clove powder.

[0047] The extraction parameters were set as follows: extraction pressure was 35 MPa, temperature was 45 °C, CO 2 The flow rate was 25 L / h and the extraction time was 3 hours, ensuring efficient extraction of eugenol.

[0048] The pretreatment of cloves can be any preparation method in the prior art, as long as the purity of eugenol is ≥ 85%.

[0049] 4. Pretreatment of Phellodendron chinense: Take the raw material of Phellodendron chinense, use a high-pressure homogenizer, pressure 1500bar, cycle treatment 5 times, obtain Phellodendron chinense nanosuspension, add 0.5% by weight of hydroxypropyl cellulose to the Phellodendron chinense nanosuspension, freeze-dry and pass through a 300-mesh sieve to obtain Phellodendron chinense powder. The pretreatment of Phellodendron chinense can be any preparation method in the prior art.

[0050] 5. Tea polyphenols are encapsulated with liposomes: Take phospholipids, cholesterol and tea polyphenols so that the ratio of phospholipids: cholesterol: tea polyphenols is 7:2:1 (w / w mass ratio), and prepare tea polyphenol liposomes by ultrasonic treatment; the power of ultrasonic treatment is 300 W, and the treatment time is 15 minutes.

[0051] Liposome encapsulation of tea polyphenols can be other methods in the prior art, the purpose of which is to obtain tea polyphenols encapsulated by liposomes, with an encapsulation rate of ≥ 95%, which can ensure that the effective components of tea polyphenols are not lost during storage. To ensure that the storage stability requirements are met: stored at 4°C away from light for 6 months, the leakage rate is ≤ 5%.

[0052] 6. Preparation of calcined oysters: Wash the raw oysters, calcine at 800°C for 4 hours until they are off-white, and grind them to pass 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.

[0053] 7. Pretreatment of borneol with ethanol: Take borneol and ethanol to make borneol ethanol solution, the concentration is preferably about 10% w / v; In the present embodiment, what borneol uses 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 the synthetic borneol on the market, its main component 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%.

[0054] 8. Mixing: Alum powder, gallnut powder, clove powder, phellodendron powder, tea polyphenol liposome, calcined oyster powder and borneol are mixed to prepare an external preparation.

[0055] The mixing is a gradient mixing, comprising the following steps: S1. Put the calcined oyster powder and alum into a mixer for the first stage of mixing to preliminarily disperse the light powder to avoid agglomeration; S2. After the first stage of mixing is completed, the gallnut powder, clove powder and phellodendron powder are added to the mixer for the second stage of mixing to evenly disperse the active ingredients and prevent the nano powders from agglomerating; 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.

[0056] 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 the 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 spray adsorption and mixing of the borneol ethanol solution should be carried out simultaneously in real time and continuously.

[0057] The mixing equipment is a three-dimensional motion mixer (volume ≥ 200L) with a rotation speed of 10-12rpm.

[0058] The mixing form is batch mixing, with each batch ≤80% of the equipment volume to prevent overfilling that affects convection mixing.

[0059] Mixing frequency: In the first stage, mix for 15 minutes → sample and test (RSD≤8%) → enter the second stage, the total mixing time is 60 minutes, sample every 15 minutes, and ensure RSD≤5%. RSD is the relative standard deviation.

[0060] After mixing, the finished drug powder is obtained, which can be sterilized by irradiation (cobalt-60 gamma rays, dose 25 kGy, microbial limit ≤ 100 CFU / g) to ensure the sterility of the product.

[0061] After sterilization, brown glass bottles + aluminum foil lining (oxygen permeability ≤ 0.1cc / pkg·day) are used to prevent product oxidation and deterioration, and nitrogen filling protection (residual oxygen content ≤ 1%) is performed to further prolong the stability of liposomes and ensure product quality. Sanitary conditions must be strictly controlled during the packaging process to prevent contamination and ensure product quality.

[0062] The product prepared in Example 1 was subjected to quality inspection: 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.

[0063] Heavy metals: using existing ICP-MS detection method, lead ≤1 mg / kg, total heavy metals ≤10 mg / kg, product safety.

[0064] Microbial limits, using the existing plate test method, aerobic bacteria ≤1000 CFU / g, mold ≤100 CFU / g, the product is sterile.

[0065] Accelerated test, 40℃ / 75% RH, 6 months, index change ≤5%. The accelerated test shows that the product quality is stable.

[0066] Long-term test, 25℃ / 60% RH, 36 months, regular sampling. The long-term test shows that the product quality is stable during storage.

[0067] All of the above detection methods are conventional detection methods in the prior art.

[0068] Comparative Example 1 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 Chinese gallnut, 20 parts of phellodendron, 15 parts of cloves and 3 parts of borneol.

[0069] The preparation method is the same as that in Example 1.

[0070] Comparative Example 2

[0071] 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 Chinese 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.

[0072] Preparation method: After drying, the above seven herbs are directly crushed into fine powder, passed through a 200-mesh to 300-mesh sieve to obtain finished medicinal powder, and the Chinese medicine composition of comparative example 2 is obtained.

[0073] Clinical effect observation

[0074] 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 old, with an average age of (28.43±3.61) years old; among them, 9 were mild, 15 were moderate, and 51 were severe; the example group 1 had 30 males and 45 females, aged (19-46) years old, with an average age of (29.15±3.52) years old, among them, 8 were mild, 17 were moderate, and 50 were severe; the control group 2 had 33 males and 42 females, aged (19-45) years old, with an average age of (28.84±3.71) years old, among them, 9 were mild, 17 were moderate, and 49 were severe. There was no statistical difference in gender, age, and course of disease among the three groups of patients (P>0.05). 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, menstruating period; ③ Allergic constitution; ④ Liver, kidney and other diseases, and abnormal liver function.

[0075] Treatment method: 1. Clean both sides before the test, and do not use similar products within 2 weeks before the test; 2. The subject cleans the armpits with saline, evaluates the baseline value of the armpits on both sides after 1 hour, and uses comparative example 1, comparative example 2 group and embodiment 1 until absorption after the evaluation. After use, evaluate the armpits on both sides and take photos with a dermatoscope 5 minutes after use. After the test, the subject is given instructions for use and the product and usage diary are distributed; 3. After the subject uses the product for 7 consecutive days, he cleans the armpits with saline on the 8th day, uses the product on both sides until absorption after 1 hour, evaluates the armpit on one side 5 minutes after use, and takes photos with a dermatoscope; 4. According to the patient's physique and severity, the usage and dosage are appropriately increased or decreased. 2 times / d; 14d is a course of treatment, and 2 courses of treatment are given.

[0076] SPSS 21.0 software was used for statistical analysis. ) were used for comparison between groups. The enumeration data were expressed as number of cases and percentage (%), and the chi-square test was used for comparison between groups. P < 0.05 was considered statistically significant, and P < 0.01 was considered highly significant.

[0077] Efficacy evaluation criteria The treatment effect was determined as follows: markedly effective: after treatment, when sweating, no odor was detected within 20 cm from the armpit, and the amount of sweat under the armpit was significantly reduced; effective: after treatment, when sweating, no odor was detected within 20 cm from the armpit, and the amount of sweat under the armpit was reduced to a certain extent; ineffective: after treatment, when sweating, odor was detected within 20 cm from the armpit, and the amount of sweat under the armpit did not change significantly. Total effective rate = (number of markedly effective cases + number of effective cases) ÷ total number of cases × 100% The severity of axillary odor was scored according to the scoring method (Table 1). Self-assessment by patients: 0 means no odor; 1 means that after strenuous activities, the patient can occasionally smell odor when the nose is close to the armpit, which does not affect social activities; 2 means that the patient can smell odor even when the nose is not close to the armpit, which the patient thinks affects social activities; 3 means that the patient can smell odor all the time, which the patient thinks seriously affects social activities.

[0078] Doctor's evaluation: evaluated by 2 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 farther distance without exposing the armpit.

[0079] Table 1 Odor degree rating

[0080] Normal: score 0; mild 1-3; moderate 4-6; severe 7-9 Table 2 Changes in the average odor level after 7 days of medication

[0081] Comparison before and after treatment in the same group: "##" indicates P < 0.01; compared with the first use, "*" indicates P < 0.05; Compared with control group 1, “△” indicates P < 0.05; compared with control group 2, “&” indicates P < 0.05.

[0082] Table 3 Observation of total effective rate (treatment 14 days)

[0083] Compared with control group 1, “△” indicates P < 0.05; compared with control group 2, “&” indicates P < 0.05.

[0084] Table 4 Observation of total effective rate (treatment 28 days)

[0085] Adverse reactions 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 occurred.

[0086] As shown in Tables 2 to 4, Example 1 has a more obvious 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 marked 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, the better the effect. No adverse reactions occurred in Example 1, Comparative Examples 1, and Comparative Examples 2, and the safety is high.

[0087] Example 2 A traditional Chinese medicine composition for treating body odor, comprising the following raw materials (effective ingredients) in parts by weight: 28 parts of alum, 22 parts of Chinese gallnut, 14 parts of cloves, 16 parts of phellodendron, 9 parts of tea polyphenols, 18 parts of calcined oyster shells, and 2 parts of borneol.

[0088] The alum is alum powder with a lead content of ≤5mg / 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 with a purity greater than 95%, and the particle sizes of the above raw material powders are all between 100-300 meshes.

[0089] The preparation method comprises: firstly, mixing calcined oyster shell and dried alum in the first stage; then mixing gallnut, clove and phellodendron in the second stage; then adding tea polyphenols encapsulated by liposomes to carry out mixing in the third stage, and simultaneously preparing borneol and ethanol into borneol ethanol solution in the third stage, spraying the borneol ethanol solution into the third stage for uniform mixing, so as to obtain the traditional Chinese medicine composition of the present invention.

[0090] Preferably, the specific processing steps of the dried alum are: take alum, crush it and pass it through a 100-mesh sieve, place it in a calcining pot, control the calcining temperature to 320°C, and calcine it at a constant temperature for 1.5 hours to completely dehydrate it into a white loose block of dried alum, and after cooling, crush the dried alum and pass it through a 200-mesh sieve to obtain dried alum powder.

[0091] 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: rice vinegar = 9:1, steaming for 3.5 hours, stir-frying over low heat, and then crushing and passing through a 200-mesh sieve to obtain gallnut powder.

[0092] The specific processing steps of the male cloves are: using supercritical CO 2 Extraction technology is used to separate eugenol, and the separated eugenol is spray-dried into micro powder to obtain clove powder. Further preferred parameters are: extraction pressure of 35MPa, temperature of 40℃, CO 2 The flow rate was 25 L / h and the extraction time was 3.5 hours.

[0093] 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 nano-suspension, wherein the particle size of the Phellodendron chinense nano-suspension is ≤200nm, adding hydroxypropyl cellulose to the Phellodendron chinense nano-suspension, wherein the addition amount of the hydroxypropyl cellulose is 0.6%, and after freeze-drying, passing through a 200-mesh sieve to obtain Phellodendron chinense powder.

[0094] 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 obtain tea polyphenol liposomes; the power of the ultrasonic treatment is 350W, and the treatment time is 25 minutes.

[0095] The specific processing steps of the calcined oyster are: take the raw oyster, wash it, calcine it at 800° C. for 4 hours until it turns grayish white, and then grind it and pass it through a 300-mesh sieve to obtain calcined oyster powder.

[0096] 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.

[0097] According to the testing method of Example 1, the product of Example 2 is qualified.

[0098] Clinical verification shows that the product effect of Example 2 is similar to that of Example 1, with good efficacy and no adverse reactions.

[0099] The above is a specific implementation mode of the present invention, but the protection scope of the present invention is not limited thereto. Any technician familiar with the technical field, within the technical scope disclosed by the present invention, can make equivalent replacements or changes according to the technical solutions and concepts of the present invention, which should be covered by the protection scope 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 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 shells and 1-5 parts of borneol.

2. A Chinese medicine composition for treating body odor according to claim 1, characterized in that: The 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 shells, and 3 parts of borneol; or, the 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 shells, 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 ≤5mg / kg and an aluminum ion dissolution rate of ≤0.1%, the gallnut is gallnut powder with a tannic acid content of ≥70%, the cloves are clove powder with a eugenol purity of ≥85%; the Phellodendron amurense is Phellodendron amurense 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 with a purity greater than 95%, and the particle sizes of the above 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 preparation method comprises: firstly, mixing calcined oyster shell and dried alum in the first stage; then mixing gallnut, clove and phellodendron in the second stage; then adding tea polyphenols encapsulated by liposomes to carry out mixing in the third stage, and simultaneously preparing borneol and alcohol into borneol alcohol solution in the third stage, spraying the borneol alcohol solution into the third stage for uniform mixing, so as to obtain the traditional Chinese medicine composition of the present invention.

5. 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.

6. 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: rice vinegar = (8-12):1, steaming for 3-4 hours, stir-frying over low heat, and then crushing and passing through a 100-300 mesh sieve to obtain gallnut powder.

7. 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: supercritical CO2 extraction technology is used on the male cloves to separate eugenol, and the separated eugenol is spray-dried into micropowder to obtain clove powder with a eugenol purity of ≥85%. Further preferred parameters are: extraction pressure of 30-40MPa, temperature of 40-50°C, 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 nano-suspension, wherein the particle size of the Phellodendron chinense nano-suspension is ≤200nm, adding hydroxypropyl cellulose to the Phellodendron chinense nano-suspension, 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 obtain 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: take the raw oyster, wash it, calcine it at 800-900°C for 3-4 hours until it turns grayish white, and then pulverize it and pass it 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 Chinese medicine composition according to claim 1 or 2 in the preparation of a medicament for treating body odor.

Images